chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: [Pfizer Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): booster given on 12/14/2021. On pt noticed headache on Sunday (1/16) described as generalized, aching and constant with associated photophobia and phonophobia. The headache continued, with associated daily vomiting. on 1/25 Brain MRI showed CVST. Potential etiologies include occult malignancy and exposure to the Covid 19 vaccine. This has been very rarely associated with thrombocytopenia and extensive VST, although there are very few cases in which this occurred without thrombocytopenia. Extensive venous sinus thrombosis involving the middle third and posterior third of the superior sagittal sinus, the paramedian aspects of multiple draining cortical veins at the vertex, the medial left transverses sinus the entire right transverse sinus, right sigmoid sinus, right jugular bulb and proximal right jugular vein.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Dizziness; Arm pain; Diarrhea; Insomnia; Decreased appetite; Short of breath/Easily winded; Chills; Feeling unwell; Muscle soreness; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 16:00 (Lot number: 331308A) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Huntington's Disease & thyroid" (unspecified if ongoing), notes: Huntington's Disease & thyroid; "Huntington's Disease & thyroid" (unspecified if ongoing), notes: Huntington's Disease & thyroid; "known allergies: Latex and penicillin" (unspecified if ongoing), notes: known allergies: Latex and penicillin; "known allergies: Latex and penicillin" (unspecified if ongoing), notes: known allergies: Latex and penicillin. Concomitant medication(s) included: LEVOTHYROXINE; B12 [CYANOCOBALAMIN]; CINNAMON. The following information was reported: DIZZINESS (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Dizziness"; PAIN IN EXTREMITY (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Arm pain"; DIARRHOEA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Diarrhea"; INSOMNIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Insomnia"; DECREASED APPETITE (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Decreased appetite"; DYSPNOEA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Short of breath/Easily winded"; CHILLS (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Chills"; MALAISE (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Feeling unwell"; MYALGIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Muscle soreness"; ASTHENIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Weakness". Therapeutic measures were not taken as a result of dizziness, pain in extremity, diarrhoea, insomnia, decreased appetite, dyspnoea, chills, malaise, myalgia, asthenia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 Since the vaccination, the patient has been tested for COVID-19. Device Date was 23Feb2022.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: Dizziness; Arm pain; Diarrhea; Insomnia; Decreased appetite; Short of breath/Easily winded; Chills; Feeling unwell; Muscle soreness; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 16:00 (Lot number: 331308A) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Huntington's Disease & thyroid" (unspecified if ongoing), notes: Huntington's Disease & thyroid; "Huntington's Disease & thyroid" (unspecified if ongoing), notes: Huntington's Disease & thyroid; "known allergies: Latex and penicillin" (unspecified if ongoing), notes: known allergies: Latex and penicillin; "known allergies: Latex and penicillin" (unspecified if ongoing), notes: known allergies: Latex and penicillin. Concomitant medication(s) included: LEVOTHYROXINE; B12 [CYANOCOBALAMIN]; CINNAMON. The following information was reported: DIZZINESS (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Dizziness"; PAIN IN EXTREMITY (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Arm pain"; DIARRHOEA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Diarrhea"; INSOMNIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Insomnia"; DECREASED APPETITE (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Decreased appetite"; DYSPNOEA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Short of breath/Easily winded"; CHILLS (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Chills"; MALAISE (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Feeling unwell"; MYALGIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Muscle soreness"; ASTHENIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Weakness". Therapeutic measures were not taken as a result of dizziness, pain in extremity, diarrhoea, insomnia, decreased appetite, dyspnoea, chills, malaise, myalgia, asthenia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 Since the vaccination, the patient has been tested for COVID-19. Device Date was 23Feb2022.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Dizziness; Arm pain; Diarrhea; Insomnia; Decreased appetite; Short of breath/Easily winded; Chills; Feeling unwell; Muscle soreness; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 16:00 (Lot number: 331308A) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Huntington's Disease & thyroid" (unspecified if ongoing), notes: Huntington's Disease & thyroid; "Huntington's Disease & thyroid" (unspecified if ongoing), notes: Huntington's Disease & thyroid; "known allergies: Latex and penicillin" (unspecified if ongoing), notes: known allergies: Latex and penicillin; "known allergies: Latex and penicillin" (unspecified if ongoing), notes: known allergies: Latex and penicillin. Concomitant medication(s) included: LEVOTHYROXINE; B12 [CYANOCOBALAMIN]; CINNAMON. The following information was reported: DIZZINESS (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Dizziness"; PAIN IN EXTREMITY (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Arm pain"; DIARRHOEA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Diarrhea"; INSOMNIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Insomnia"; DECREASED APPETITE (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Decreased appetite"; DYSPNOEA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Short of breath/Easily winded"; CHILLS (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Chills"; MALAISE (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Feeling unwell"; MYALGIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Muscle soreness"; ASTHENIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Weakness". Therapeutic measures were not taken as a result of dizziness, pain in extremity, diarrhoea, insomnia, decreased appetite, dyspnoea, chills, malaise, myalgia, asthenia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 Since the vaccination, the patient has been tested for COVID-19. Device Date was 23Feb2022.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Insomnia, Malaise, Myalgia, Pain in extremity
Clinical narrative: Dizziness; Arm pain; Diarrhea; Insomnia; Decreased appetite; Short of breath/Easily winded; Chills; Feeling unwell; Muscle soreness; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 16:00 (Lot number: 331308A) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Huntington's Disease & thyroid" (unspecified if ongoing), notes: Huntington's Disease & thyroid; "Huntington's Disease & thyroid" (unspecified if ongoing), notes: Huntington's Disease & thyroid; "known allergies: Latex and penicillin" (unspecified if ongoing), notes: known allergies: Latex and penicillin; "known allergies: Latex and penicillin" (unspecified if ongoing), notes: known allergies: Latex and penicillin. Concomitant medication(s) included: LEVOTHYROXINE; B12 [CYANOCOBALAMIN]; CINNAMON. The following information was reported: DIZZINESS (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Dizziness"; PAIN IN EXTREMITY (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Arm pain"; DIARRHOEA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Diarrhea"; INSOMNIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Insomnia"; DECREASED APPETITE (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Decreased appetite"; DYSPNOEA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Short of breath/Easily winded"; CHILLS (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Chills"; MALAISE (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Feeling unwell"; MYALGIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Muscle soreness"; ASTHENIA (non-serious) with onset 21Jan2022 17:00, outcome "not recovered", described as "Weakness". Therapeutic measures were not taken as a result of dizziness, pain in extremity, diarrhoea, insomnia, decreased appetite, dyspnoea, chills, malaise, myalgia, asthenia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 Since the vaccination, the patient has been tested for COVID-19. Device Date was 23Feb2022.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vein disorder
Clinical narrative: Report an adverse reaction; what I am feeling/having certain feelings inside my body; 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 male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: 30145BA) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE taken for blood pressure measurement; OLMESARTAN MEDOXOMIL taken for blood pressure measurement. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Report an adverse reaction; what I am feeling/having certain feelings inside my body". Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: It was reported that with the first 2 shots, patient had no problem but a little body ache which the patient expected. But the patient was concerned about having certain feelings inside his body after taking the booster shot.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal
Clinical narrative: Report an adverse reaction; what I am feeling/having certain feelings inside my body; 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 male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: 30145BA) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE taken for blood pressure measurement; OLMESARTAN MEDOXOMIL taken for blood pressure measurement. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Report an adverse reaction; what I am feeling/having certain feelings inside my body". Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: It was reported that with the first 2 shots, patient had no problem but a little body ache which the patient expected. But the patient was concerned about having certain feelings inside his body after taking the booster shot.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: deceased 45 minutes after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 72 year-old female patient received bnt162b2 (COMIRNATY), administered in deltoid right, administration date 15Mar2022 (Lot number: FK9729, Expiration Date: 18Mar2022, NDC number of Comirnaty: 59267102504) at the age of 72 years as dose 3 (booster) 0.3ml, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Date: 10Aug2021, Lot: EW0187, Expiry:  31Aug2021 , NDC: Unknown), administration date: 10Aug2021, when the patient was 72 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Date: 01Sep2021 , Lot: EW0186, Expiry: 30Nov2021 , NDC: Unknown), administration date: 01Sep2021, when the patient was 72 years old, for COVID-19 Immunization. The following information was reported: DEATH (death) with onset 15Mar2022, outcome "fatal", described as "deceased 45 minutes after receiving the vaccine". The patient date of death was 15Mar2022. The reported cause of death was "Cause of death was unknown". It was not reported if an autopsy was performed.  Additional information: Caller states the patient had heart disease, she was off and on and not doing well, she was slowly declining. Thinks that this could have been a coincidence. Causality: Honestly, the caller feels as the patient was not doing well and this nudged the patient in the wrong direction if anything. Adds in (place withheld) any patient 90+ years old they are not giving the vaccine to those patients for the same reason, it is hard on their immune systems. Caller states it is challenging, she doesn't think this is necessary the cause, she thinks it is a terrible coincidence again. Concomitant Products: Caller knows the patient was being treated by a cardiologist, but does not know the medications she was on exactly, she has no idea. Relevant Tests was unknown.; Sender's Comments: Based on the information available, the causal relationship between the reported event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: Cause of death was unknown
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: but every bone and everything hurt for two days; but every bone and everything hurt for two days; she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days; she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 20Jan2021 (Lot number: EL0142) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "tetanus" (unspecified if ongoing), notes: she went to another country, got a tetanus and everything and never had any issues until the Pfizer Vaccine. The patient's concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), DISCOMFORT (non-serious) all with onset 20Jan2021, outcome "unknown" and all described as "she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days"; BONE PAIN (non-serious), PAIN (non-serious), outcome "unknown" and all described as "but every bone and everything hurt for two days".  Additional information: Patient did not administered additional vaccines on same date of the pfizer suspect. Patient did not received prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient's did not medical history (including any illness at time of vaccination).  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Discomfort, Gait disturbance, Pain
Clinical narrative: but every bone and everything hurt for two days; but every bone and everything hurt for two days; she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days; she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 20Jan2021 (Lot number: EL0142) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "tetanus" (unspecified if ongoing), notes: she went to another country, got a tetanus and everything and never had any issues until the Pfizer Vaccine. The patient's concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), DISCOMFORT (non-serious) all with onset 20Jan2021, outcome "unknown" and all described as "she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days"; BONE PAIN (non-serious), PAIN (non-serious), outcome "unknown" and all described as "but every bone and everything hurt for two days".  Additional information: Patient did not administered additional vaccines on same date of the pfizer suspect. Patient did not received prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient's did not medical history (including any illness at time of vaccination).  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache
Clinical narrative: Diagnosed with episodic cluster headaches by general practitioner. Provided with care instructions and advised to report to VAERS by general practitioner.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Musculoskeletal discomfort, Tinnitus
Clinical narrative: Ringing in both ears, starting at 3am on March 22. 2022. Left ear was extreme. Abated around 8 am. in both ears. Muscular discomfort at neck still applicable and up left side of head. Taking no medication for it. Will see if any more side effects tonight during or after sleep. If so I will make an appointment to see my Doctor.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Chest X-ray normal, Computerised tomogram normal, Dyspnoea
Clinical narrative: A few days after the booster I started feeling anxious, tired, and with flu-like symptoms including deep cold body aches, headaches, burning sensation, numbness and tingling in different parts of the body, and pins and needles . Also, ringing in the ears (tinnitus) and difficulty sleeping. One night (1/29/22) woke up feeling like I couldn?t breathe and ended up in the ER.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Feeling cold, Headache, Hypoaesthesia
Clinical narrative: A few days after the booster I started feeling anxious, tired, and with flu-like symptoms including deep cold body aches, headaches, burning sensation, numbness and tingling in different parts of the body, and pins and needles . Also, ringing in the ears (tinnitus) and difficulty sleeping. One night (1/29/22) woke up feeling like I couldn?t breathe and ended up in the ER.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Insomnia, Laboratory test normal, Pain, Paraesthesia
Clinical narrative: A few days after the booster I started feeling anxious, tired, and with flu-like symptoms including deep cold body aches, headaches, burning sensation, numbness and tingling in different parts of the body, and pins and needles . Also, ringing in the ears (tinnitus) and difficulty sleeping. One night (1/29/22) woke up feeling like I couldn?t breathe and ended up in the ER.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus, Urine analysis normal
Clinical narrative: A few days after the booster I started feeling anxious, tired, and with flu-like symptoms including deep cold body aches, headaches, burning sensation, numbness and tingling in different parts of the body, and pins and needles . Also, ringing in the ears (tinnitus) and difficulty sleeping. One night (1/29/22) woke up feeling like I couldn?t breathe and ended up in the ER.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: On date of vaccination, pain developed at site of injection and pain continued up the arm from vaccine site and down the arm from vaccine site.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Hypoaesthesia, Muscle spasms, Neck pain
Clinical narrative: Within 24 hours of receiving the booster I began having a pain in my right armpit and neck. Two days later the pain in my right armpit went away but the intensity between my shoulders increased. The pain is sharp, like a knife being stabbed in my back. I started taking 3 Advil  at a time, 3x a day to lower the pain level. After one week the intense pain pushed into my left arm. The thumb on my left hand, index finger, and middle finger became numb. After 5 days I went to the chiropractor. The adjustment, followed by ice, helped slightly. After 9 days from receiving the booster (3/16/2022) I saw my general medicine doctor.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, X-ray abnormal
Clinical narrative: Within 24 hours of receiving the booster I began having a pain in my right armpit and neck. Two days later the pain in my right armpit went away but the intensity between my shoulders increased. The pain is sharp, like a knife being stabbed in my back. I started taking 3 Advil  at a time, 3x a day to lower the pain level. After one week the intense pain pushed into my left arm. The thumb on my left hand, index finger, and middle finger became numb. After 5 days I went to the chiropractor. The adjustment, followed by ice, helped slightly. After 9 days from receiving the booster (3/16/2022) I saw my general medicine doctor.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: On 2/17/2022 I was administered the second dose of the Pfizer shot  in my right arm. At the time of the shot it was very painful compared to the first shot, and My arm has been in excruciating pain since the day after the injection. I can barely move or rotate my arm, yawning I cannot lift my arm fully at all, lift items, and I?ve been in pain daily. Nothing seems to subside the pain from trying to stretch my arm to taking OTC medication.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Dizziness, Dyspnoea, Fatigue, Feeding disorder
Clinical narrative: She came down with a virus on August 30, 2021 (27 days after Pfizer dose #1) which presented with fever, congestion, fatigue, sore throat and swollen glands through September 3rd. September 4-5 she seemed to be better, but then developed severe Urticaria on her feet, legs, torso and hands on September 6, 2021. Her feet, fingers and hands swelled and her fever returned. She developed dizziness and  shortness of breath so I took her to the ED on September 7, 2021. They sent us home with instructions for Benadryl, Ibuprofen and Oatmeal Baths which we'd already been doing, but this did nothing and she got progressively worse. She was unable to walk, eat or sleep. I took her back to the ED on September 8, 2021. This time they gave her prednisone and a stronger antihistamine and she was finally able to sleep. She was on a 6 day course of prednisone and her immune system finally calmed down and cleared the Urticaria, swelling and fever. We were told that it was a response to the virus she had, but she has never had anything like this happen before. The only variable was the Pfizer vaccine less than a month prior. Her immune system acted very differently and couldn't clear the histamines. She has never been that sick.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Immune-mediated adverse reaction, Insomnia, Lymphadenopathy, Lymphocyte count decreased
Clinical narrative: She came down with a virus on August 30, 2021 (27 days after Pfizer dose #1) which presented with fever, congestion, fatigue, sore throat and swollen glands through September 3rd. September 4-5 she seemed to be better, but then developed severe Urticaria on her feet, legs, torso and hands on September 6, 2021. Her feet, fingers and hands swelled and her fever returned. She developed dizziness and  shortness of breath so I took her to the ED on September 7, 2021. They sent us home with instructions for Benadryl, Ibuprofen and Oatmeal Baths which we'd already been doing, but this did nothing and she got progressively worse. She was unable to walk, eat or sleep. I took her back to the ED on September 8, 2021. This time they gave her prednisone and a stronger antihistamine and she was finally able to sleep. She was on a 6 day course of prednisone and her immune system finally calmed down and cleared the Urticaria, swelling and fever. We were told that it was a response to the virus she had, but she has never had anything like this happen before. The only variable was the Pfizer vaccine less than a month prior. Her immune system acted very differently and couldn't clear the histamines. She has never been that sick.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Mononucleosis heterophile test negative, Neutrophil count increased, Oropharyngeal pain, Peripheral swelling, Pyrexia
Clinical narrative: She came down with a virus on August 30, 2021 (27 days after Pfizer dose #1) which presented with fever, congestion, fatigue, sore throat and swollen glands through September 3rd. September 4-5 she seemed to be better, but then developed severe Urticaria on her feet, legs, torso and hands on September 6, 2021. Her feet, fingers and hands swelled and her fever returned. She developed dizziness and  shortness of breath so I took her to the ED on September 7, 2021. They sent us home with instructions for Benadryl, Ibuprofen and Oatmeal Baths which we'd already been doing, but this did nothing and she got progressively worse. She was unable to walk, eat or sleep. I took her back to the ED on September 8, 2021. This time they gave her prednisone and a stronger antihistamine and she was finally able to sleep. She was on a 6 day course of prednisone and her immune system finally calmed down and cleared the Urticaria, swelling and fever. We were told that it was a response to the virus she had, but she has never had anything like this happen before. The only variable was the Pfizer vaccine less than a month prior. Her immune system acted very differently and couldn't clear the histamines. She has never been that sick.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative, Urticaria, Viral infection
Clinical narrative: She came down with a virus on August 30, 2021 (27 days after Pfizer dose #1) which presented with fever, congestion, fatigue, sore throat and swollen glands through September 3rd. September 4-5 she seemed to be better, but then developed severe Urticaria on her feet, legs, torso and hands on September 6, 2021. Her feet, fingers and hands swelled and her fever returned. She developed dizziness and  shortness of breath so I took her to the ED on September 7, 2021. They sent us home with instructions for Benadryl, Ibuprofen and Oatmeal Baths which we'd already been doing, but this did nothing and she got progressively worse. She was unable to walk, eat or sleep. I took her back to the ED on September 8, 2021. This time they gave her prednisone and a stronger antihistamine and she was finally able to sleep. She was on a 6 day course of prednisone and her immune system finally calmed down and cleared the Urticaria, swelling and fever. We were told that it was a response to the virus she had, but she has never had anything like this happen before. The only variable was the Pfizer vaccine less than a month prior. Her immune system acted very differently and couldn't clear the histamines. She has never been that sick.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: No additional AE information provided; they are 31 weeks pregnant and were administered GARDASIL; visit to receive their Tdap vaccine and they were accidentally given GARDASIL; This spontaneous report was received from a consumer referring to herself, a 31-weeks pregnant female patient of unspecified age. Her pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 25-FEB-2022, the patient went to facility for a schedule visit to receive a Tdap vaccine (manufacturer unknown) but stated that they accidentally gave her either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) as she was unsure which one was administered, with a route of administration reported as injection (unidentified Merck hpv vaccine administered (lot number not provided); dose, vaccination scheme frequency, exact route of administration and anatomical site of application were also not reported) (exposure during pregnancy and wrong product administered) for prophylaxis.  No additional adverse event (AE) information was provided (no adverse event).
Age: 81.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; Accidentaly an expired dose of PNEUMOVAX 23 (SYRINGE) was administered on 03-MAR-2022; This spontaneous report has been received from a medical assistant, concerning an 81-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, current conditions, concomitant medications, previous drug reactions, or allergies.  On 03-MAR-2022, the patient was accidentaly vaccinated with an expired Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) syringe administered once as prophylaxis (lot number T016160 has been verified to be a valid lot number, expiration date reported and established as 13-FEB-2022) (dose, route and anatomical location of administration were not reported) (expired product administered). No other adverse events (AE) reported (no adverse event), no temperature excursion.
Age: 68.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Pharmacist who had a patient to report that they had redness and swelling at injection site.; Pharmacist who had a patient to report that they had redness and swelling at injection site.; This spontaneous report has been received from a pharmacist via company representative, concerning 68-year-old female patient. No information was provided regarding the patient's pertinent medical history, current conditions, concomitant medications, previous drug reactions, or allergies.  On 01-MAR-2022, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (formulation, strength, dose, vaccination scheme, route of administration and anatomical location, indication, lot number and expiration date were not provided)  On 02-MAR-2022, the patient experienced redness and swelling at the injection site (vaccination site erythema, vaccination site swelling). The reporter stated that the patient also received on 17-FEB-2021 the first dose of COVID 19 vaccine (also reported as Pfizer vaccine), on 10-MAR-2021 with the second dose and finally on 19-DEC-2021 with a booster dose (formulation, strength, dose, vaccination scheme, route of administration and anatomical location, indication, lot number and expiration date were not provided), and did not know if there was a correlation on timing of getting vaccines.   The outcome of the event, and the causality assessment between the suspect therapies and the events were not provided.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE / the patient had no reaction; Patient was administered expired MMRII; This spontaneous report was received from a nurse practitioner referring to a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 08-MAR-2022, the patient was vaccinated with an expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, administered in the right arm subcutaneously as prophylaxis (lot number T000892 which has been verified to be valid, expiration date reported and validated as 08-JAN-2022) (dose was not reported) (expired product administered). In addition, the patient had no reaction and left the clinic in a stable condition.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: administration of an improperly stored vaccine; No additional AE reported; This spontaneous report was received from a healthcare business professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number T028929, expiration date 08-MAR-2023, dose 1 (units not provided) (exact dose and route of administration not provided) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 27.8 degrees Fahrenheit for 3 hours.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Patient had no reported side effects; expired dose administered to a patient; This spontaneous report was received from a nurse, and refers to a 6-months-old patient of unknown gender. Concomitant medications, concurrent conditions and medical history were not reported.  On 11-MAR-2022, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, in dose 2 ml, by mouth, lot # P028132, expiration date 22-FEB-2022. Lot number P028132 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Lot number P028132 does not match any Company product as confirmed by Lot Verification team.. It was reported, that vaccine had no known temperature excursions. Patient had no reported side effects.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired PROQUAD with an expiration date of 1/23/2022 was administered to a patient on 3/11/2022; This spontaneous report was received from a consumer, referring to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-MAR-2022, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T025508, expiration date was reported and validated as 23-JAN-2022) as prophylaxis (expired product administered). No additional adverse event reported.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: shows no antibody reaction to PNEUMOVAX 23; This spontaneous report was received from a physician referring to a male patient of unknown age. The patient's concurrent conditions included immunodeficiency. The patient's medical history, historical drugs and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route of administration, lot number and expiration date not reported) for prophylaxis.         On an unknown date, the patient showed no antibody reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (antibody test negative).      The outcome of antibody test negative and its causal relationship with the vaccine were not reported.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; a patient received a dose of VARIVAX intramuscularly; This spontaneous report was received from a registered nurse referring to a 14-month-old patient of unknown gender. Information about the patient's concomitant medication, pertinent medical history and drug reactions/allergies was not reported.   On 04-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly (strength, dose, lot# and expiration date were not provided) for prophylaxis (incorrect route of product administration). The reporter had no additional information regarding the adverse event (AE). No additional AE reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administration of improperly stored vaccine; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, or medical history were not provided.  On 18-MAR-2022, the patient was vaccinated with an improperly storage dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1742465, expiration date 21-SEP-2022, 2 milliliter once orally for prophylaxis. No additional events were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Received the Shingrix vaccination before she broke out with 1st round of Shingles; Always on eye; 1st round of shingles. Always on face; cheek, lower face,  jaw line. Above right eye and on chin; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and dermatologicals nos (Ointment). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix.     Additional information were received as follows: The age at vaccination was not reported. It was reported that the patient did received shingrix vaccination right before breakout with first round of shingles in late October 2021 or early November 2021.  The patient reported 2 more outbreaks since initially diagnosed by primary health care. The patient was prescribed antivirals by primary health care provider and ointment for around her eye by ophthalmologist since shingles were almost in her eyes. The patient reported 3 occurrences of shingles always on face, eyes, cheek and lower face and jaw line, above right eye and on chin under mouth. The reporter did not consented to follow up. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule and laboratory confirmation was not provided.
Age: 12.0
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old received Twinrix; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter had a 12 year old with no prior immunization history that needed catch up vaccines.  The reporter was unaware Twinrix was for above 18 years and the patient received Twinrix, which led to inappropriate age at vaccine administration. The patient was doing fine/denied side effects.  The reporter asked if this immunization was still able to be counted toward her vaccine history or not.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood test, Pruritus, Rash, Skin discolouration
Clinical narrative: Rash on thigh; Lighter in morning. Gets darker after hours; Doesn't itch anymore; This case was reported by a consumer via call center representative and described the occurrence of rash in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced rash, darkened skin and pruritus. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the darkened skin was recovering/resolving and the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the rash, darkened skin and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was self-reported by the patient. After 2 days of first dose of Shingrix vaccine patient developed rash on thighs was in January, rash still not gone away. The patient was asking for help. The patient had seen dermatologist and had blood work done.  The patient reported rash wash lighter when he get up in morning, got darker after couple of hours.  The patient had reported rash seemed to be fading a little and does not itch anymore.