chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: have muscle pain /spasms; neurological effects; have muscle pain /spasms; pins and needles; jittery; shaky; can't sleep; have hot and cold flashes; have hot and cold flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 19Jan2021 13:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious) with onset 2021, outcome "not recovered", described as "neurological effects"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "not recovered", PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered" and all described as "pins and needles"; FEELING JITTERY (non-serious) with onset 2021, outcome "not recovered", described as "jittery"; NERVOUSNESS (non-serious) with onset 2021, outcome "not recovered", described as "shaky"; INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "can't sleep"; HOT FLUSH (non-serious), CHILLS (non-serious) all with onset 2021, outcome "not recovered" and all described as "have hot and cold flashes"; MYALGIA (non-serious), outcome "not recovered", described as "have muscle pain /spasms". The events "neurological effects", "have muscle pain /spasms", "pins and needles", "jittery", "shaky", "can't sleep", "have hot and cold flashes" and "have hot and cold flashes" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient was still not right, she was through hell for the last couple of months, and the issues all started within the last couple months after taking the vaccine. It was stated that the patient has been to two primary care physicians, 2 neurologists, to the ER twice, an immunologist and has a second opinion with a different neurologist. She has seen 2 PCPs, went to ER 2 times, Have seen other HCPs about the side effects but no one knows what is going on. Caller stated his wife is not herself, she has neurological effects, have muscle pain/spasms, pins and needles, shaky, jittery, can't sleep, have hot and cold flashes, have blood work done, CT scan and all seems fine. Caller wanted to know what can they do about it, any treatment guidance on it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Within five minutes of the injection, I experienced tinnitus in both ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021494860 (Pfizer).  A 56 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 11:00 (Lot number: EN6206) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1:, Date/Time: 11Feb2021 13:00, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 11Feb2021, when the patient was 56 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 09Mar2021 11:02, outcome "not recovered", described as "Within five minutes of the injection, I experienced tinnitus in both ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Within five minutes of the injection, I experienced tinnitus in both ears. The patient received other vaccines within 4 weeks prior to the COVID vaccine. Was treatment received for the adverse event: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No.I developed tinnitus in both ears within five minutes of receiving the vaccine. Today is the 11th day after the second dose and the ringing continues in both ears.The tinnitus continues to ring incessantly. Never had tinnitus before.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: After her second shot, she was only sick for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), reaction(s): "after receiving her first shot, she was sick for 18 days". The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "After her second shot, she was only sick for 2 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: After her second shot, she was only sick for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), reaction(s): "after receiving her first shot, she was sick for 18 days". The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "After her second shot, she was only sick for 2 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: light headed / dizzy; her arm became numb 7 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021305545 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "light headed / dizzy"; HYPOAESTHESIA (non-serious) with onset 05Mar2021, outcome "unknown", described as "her arm became numb 7 minutes".  Additional information: She felt dizzy and light headache and her arm became numb 7 minutes after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling so well; This is a spontaneous report received from a contactable reporter(s) (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling so well".  Additional information: The patient reported that she was on blood thinner and not feeling so well. She was scheduled for her second dose the day after report and wanted to know if she can take it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Retinal injury
Clinical narrative: retina damage to right eye; major blood pressure spikes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "blood pressure increased" (ongoing). The patient took concomitant medications. The following information was reported: RETINAL INJURY (medically significant), outcome "unknown", described as "retina damage to right eye"; HYPERTENSION (non-serious), outcome "unknown", described as "major blood pressure spikes". The patient underwent the following laboratory tests and procedures: blood pressure measurement: blood pressure spikes. Clinical course: The reporter asked why Pfizer has not warned people on ACE inhibitor blood pressure medicines that their vaccine which binds with the ACE 2 receptor could cause blood pressure spikes. Prior to receiving the Pfizer mRNA vaccinations, the patient was on a minimal ACE inhibitor drug (drug name unspecified). It was the patient's only medicine. The patient now has had a major blood pressure spikes and retina damage to right eye as a result of the vaccine. The patient mentioned that someone needs to be held responsible for these kind of side effects from a vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Speech disorder
Clinical narrative: Elevated blood pressure - 193/130, dizziness, unable to speak clearly. EMP had to be called 5 mins after receiving vaccination. Monitored blood pressure and heart rate for 20 mins. Blood pressure decreased within that time period.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Dizziness, Dyspnoea, Ear discomfort
Clinical narrative: NOSE HURTS; FEEL ANXIOUS; HYPOCHONDRIA; TASTE BLOOD IN MOUTH; BLURRED VISION; VERY SWOLLEN LYMPH NODES; TINGLING SENSATION/LEGS/BACK; EAR SENSATIONS; NUMBNESS IN HEAD/LEG/BODY; HEADACHES; BURNING SENSATION; DIZZY; SPECKS OF BLOOD IN SPIT; SHORTNESS OF BREATH; VOMITING; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. patient exercise, eat fruits, and stay fit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included levonorgestrel for birth control. On 12-APR-2021, the patient experienced vomiting. On 18-APR-2021, the patient experienced dizzy, specks of blood in spit, shortness of breath, burning sensation, and headaches. On 21-APR-2021, the patient experienced numbness in head/leg/body. On 25-APR-2021, the patient experienced ear sensations, and tingling sensation/legs/back. On 11-JUN-2021, the patient experienced very swollen lymph nodes. On 25-AUG-2021, the patient experienced blurred vision. On an unspecified date, the patient experienced nose hurts, feel anxious, hypochondria, and taste blood in mouth. Laboratory data (dates unspecified) included: Endoscopy (NR: not provided) no abnormal findings, Fibrin D dimer (NR: not provided) no abnormal findings, IUCD (NR: not provided) Not reported, and MRI (NR: not provided) no abnormal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, numbness in head/leg/body, specks of blood in spit, shortness of breath, blurred vision, tingling sensation/legs/back, headaches, burning sensation, and very swollen lymph nodes, and the outcome of nose hurts, hypochondria, taste blood in mouth, ear sensations, vomiting and feel anxious was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Fibrin D dimer, Haemoptysis, Headache, Hypoaesthesia
Clinical narrative: NOSE HURTS; FEEL ANXIOUS; HYPOCHONDRIA; TASTE BLOOD IN MOUTH; BLURRED VISION; VERY SWOLLEN LYMPH NODES; TINGLING SENSATION/LEGS/BACK; EAR SENSATIONS; NUMBNESS IN HEAD/LEG/BODY; HEADACHES; BURNING SENSATION; DIZZY; SPECKS OF BLOOD IN SPIT; SHORTNESS OF BREATH; VOMITING; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. patient exercise, eat fruits, and stay fit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included levonorgestrel for birth control. On 12-APR-2021, the patient experienced vomiting. On 18-APR-2021, the patient experienced dizzy, specks of blood in spit, shortness of breath, burning sensation, and headaches. On 21-APR-2021, the patient experienced numbness in head/leg/body. On 25-APR-2021, the patient experienced ear sensations, and tingling sensation/legs/back. On 11-JUN-2021, the patient experienced very swollen lymph nodes. On 25-AUG-2021, the patient experienced blurred vision. On an unspecified date, the patient experienced nose hurts, feel anxious, hypochondria, and taste blood in mouth. Laboratory data (dates unspecified) included: Endoscopy (NR: not provided) no abnormal findings, Fibrin D dimer (NR: not provided) no abnormal findings, IUCD (NR: not provided) Not reported, and MRI (NR: not provided) no abnormal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, numbness in head/leg/body, specks of blood in spit, shortness of breath, blurred vision, tingling sensation/legs/back, headaches, burning sensation, and very swollen lymph nodes, and the outcome of nose hurts, hypochondria, taste blood in mouth, ear sensations, vomiting and feel anxious was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Illness anxiety disorder, Intrauterine contraception, Lymphadenopathy, Magnetic resonance imaging, Paraesthesia
Clinical narrative: NOSE HURTS; FEEL ANXIOUS; HYPOCHONDRIA; TASTE BLOOD IN MOUTH; BLURRED VISION; VERY SWOLLEN LYMPH NODES; TINGLING SENSATION/LEGS/BACK; EAR SENSATIONS; NUMBNESS IN HEAD/LEG/BODY; HEADACHES; BURNING SENSATION; DIZZY; SPECKS OF BLOOD IN SPIT; SHORTNESS OF BREATH; VOMITING; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. patient exercise, eat fruits, and stay fit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included levonorgestrel for birth control. On 12-APR-2021, the patient experienced vomiting. On 18-APR-2021, the patient experienced dizzy, specks of blood in spit, shortness of breath, burning sensation, and headaches. On 21-APR-2021, the patient experienced numbness in head/leg/body. On 25-APR-2021, the patient experienced ear sensations, and tingling sensation/legs/back. On 11-JUN-2021, the patient experienced very swollen lymph nodes. On 25-AUG-2021, the patient experienced blurred vision. On an unspecified date, the patient experienced nose hurts, feel anxious, hypochondria, and taste blood in mouth. Laboratory data (dates unspecified) included: Endoscopy (NR: not provided) no abnormal findings, Fibrin D dimer (NR: not provided) no abnormal findings, IUCD (NR: not provided) Not reported, and MRI (NR: not provided) no abnormal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, numbness in head/leg/body, specks of blood in spit, shortness of breath, blurred vision, tingling sensation/legs/back, headaches, burning sensation, and very swollen lymph nodes, and the outcome of nose hurts, hypochondria, taste blood in mouth, ear sensations, vomiting and feel anxious was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinalgia, Taste disorder, Vision blurred, Vomiting
Clinical narrative: NOSE HURTS; FEEL ANXIOUS; HYPOCHONDRIA; TASTE BLOOD IN MOUTH; BLURRED VISION; VERY SWOLLEN LYMPH NODES; TINGLING SENSATION/LEGS/BACK; EAR SENSATIONS; NUMBNESS IN HEAD/LEG/BODY; HEADACHES; BURNING SENSATION; DIZZY; SPECKS OF BLOOD IN SPIT; SHORTNESS OF BREATH; VOMITING; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. patient exercise, eat fruits, and stay fit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included levonorgestrel for birth control. On 12-APR-2021, the patient experienced vomiting. On 18-APR-2021, the patient experienced dizzy, specks of blood in spit, shortness of breath, burning sensation, and headaches. On 21-APR-2021, the patient experienced numbness in head/leg/body. On 25-APR-2021, the patient experienced ear sensations, and tingling sensation/legs/back. On 11-JUN-2021, the patient experienced very swollen lymph nodes. On 25-AUG-2021, the patient experienced blurred vision. On an unspecified date, the patient experienced nose hurts, feel anxious, hypochondria, and taste blood in mouth. Laboratory data (dates unspecified) included: Endoscopy (NR: not provided) no abnormal findings, Fibrin D dimer (NR: not provided) no abnormal findings, IUCD (NR: not provided) Not reported, and MRI (NR: not provided) no abnormal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, numbness in head/leg/body, specks of blood in spit, shortness of breath, blurred vision, tingling sensation/legs/back, headaches, burning sensation, and very swollen lymph nodes, and the outcome of nose hurts, hypochondria, taste blood in mouth, ear sensations, vomiting and feel anxious was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Pulmonary embolism, Thrombosis, Ultrasound scan abnormal
Clinical narrative: pulmonary embolism; blood clot in right calf.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report from a contactable consumer received from Pfizer-sponsored program Pfizer First Connect, the patient. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Lot number: EM9810), intramuscular, administered in arm left on 07Feb2021 as dose 1, single dose and dose 2 (Lot number: EN6198), intramuscular, administered in arm left on 25Feb2021 as dose 2, single (at the age of 70-years-old) for covid-19 immunization. The patient medical history included ongoing multiple myeloma from Jan2019. Concomitant medications were not reported. On an unspecified date, the patient experienced sore arm. It was reported that the patient took azithromycin before and after the first dose. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.  Follow-up (15Mar2021 and 10May2021): This is a follow-up spontaneous report from a contactable consumer: Updated information included: Added patient age, age at vaccination, relevant medical history, dosage details for dose 1 and dose 2 of vaccine, new event (sore arm) and deleted the event (circumstance or information capable of leading to medication error).   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: pain in her arm; the soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm"; PAIN (non-serious), outcome "unknown", described as "the soreness". Therapeutic measures were taken as a result of pain in extremity, pain.  Additional information: The patient took Tylenol that same day due to pain in her arm, the soreness.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: I also have great fatigue with this; Two days after the second vaccine my lymph nodes became sore in my chest to under arm area and neck and jaw; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Feb2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ibs" (unspecified if ongoing). Concomitant medication(s) included: PAXIL [PAROXETINE HYDROCHLORIDE]; OMEPRAZOLE; LIPITOR [ATORVASTATIN]. Vaccination history included: Bnt162b2 (Dose number=1, Brand=Pfizer covid 19, Lot number=EL 9261, Administration time=12:00 AM, Vaccine location=Right arm), administration date: 26Jan2021, when the patient was 67 years old, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 19Feb2021, outcome "recovering", described as "I also have great fatigue with this"; LYMPHADENOPATHY (non-serious) with onset 19Feb2021, outcome "recovering", described as "Two days after the second vaccine my lymph nodes became sore in my chest to under arm area and neck and jaw". Therapeutic measures were taken as a result of fatigue. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: Concomitant medication also includes unspecified vitamins. It was also further reported that events started on 19Feb2021 at 12:00AM. Fatigue has lasted 3 weeks now and although better it was still a problem. Patient have been taking ibuprofen. Activity seems to make it worse so patient have been resting most of the time. The patient was very concerned. The patient has not been tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Oropharyngeal pain
Clinical narrative: patient received the first moderna vaccination on 08/07/2021 which resulted in swelling of left eye for several hours. During the second vaccination on 9/4/2021, the pharmacist instructed the patient to remain in the pharmacy area for 30 minutes for observation. Patient did not show signs of allergic reaction during the second vaccination. After the 30 minute observation period, patient walked around the store and experience sore throat and difficulty breathing. At the time the pharmacy was closed for lunch. Patient was able to pick up diphenhydramine over the counter and took the medication for 3 days and resolved. Did not require additional medical care.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 79 year old female. The patient's weight was 145 pounds, and height was 62 inches. The patient's concurrent conditions included: sleep/anxiety (for years), environmental allergy, and seasonal allergy otherwise very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination on right arm (dose number in series 1). Concomitant medications included alprazolam for sleep/anxiety.  On 28-SEP-2021, patient began not feeling well and went to the emergency department. There patient underwent Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive and diagnosed with covid-19 (confirmed covid-19 infection and confirmed clinical vaccination failure) (dose number in series 1). Patient was subsequently hospitalized for 3 days (date unspecified). Patient added that she was told by healthcare professional that if not vaccinated, patient may have needed intubation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000210038. This case, involving the same patient is linked to 20220105844 (Dose number in series 2).; Sender's Comments: V0 - 20220104484- covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20220104484- covid-19 vaccine ad26.cov2.s- Confirmed COVID 19 Infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Anaemia, COVID-19, Hypotension, Mental status changes
Clinical narrative: Patient is fully vaccinated including a booster on 11/18/2021.  COVID + on 11/25/2021.  Hospitalized 11/25-12/09/2021.  Admitting dx:  altered mental status, hypotension, sepsis, COVID-19 , acute kidney injury. Treatment:   broad-spectrum IV antibiotics with IV vancomycin pharmacy dose and IV cefepime.  Respiratory failure is related to COVID-19.  supplemental oxygen.  Patient will continue on Breo inhaler daily.  Patient will continue on albuterol nebulizer p.r.n..  HYdration and monitoring for AKI. 2 units blood for anemia.  Discussed the case with the family who made the patient DNR comfort but they declined hospice care at this point.  Plan for the patient be discharged to go to subacute rehab and to consider hospice care and comfort care at the rehab.  Discharged to skilled nursing home.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, SARS-CoV-2 test positive, Sepsis, Transfusion
Clinical narrative: Patient is fully vaccinated including a booster on 11/18/2021.  COVID + on 11/25/2021.  Hospitalized 11/25-12/09/2021.  Admitting dx:  altered mental status, hypotension, sepsis, COVID-19 , acute kidney injury. Treatment:   broad-spectrum IV antibiotics with IV vancomycin pharmacy dose and IV cefepime.  Respiratory failure is related to COVID-19.  supplemental oxygen.  Patient will continue on Breo inhaler daily.  Patient will continue on albuterol nebulizer p.r.n..  HYdration and monitoring for AKI. 2 units blood for anemia.  Discussed the case with the family who made the patient DNR comfort but they declined hospice care at this point.  Plan for the patient be discharged to go to subacute rehab and to consider hospice care and comfort care at the rehab.  Discharged to skilled nursing home.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Breast pain, Dysgeusia, Gastric disorder, Headache
Clinical narrative: Pain to her left breast; Gastric problems; Metallic taste and I smelled smoke; Metallic taste and I smelled smoke; Headache; Feeling anxious; Trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EN9581), administration date: 05Feb2021, for COVID-19 Immunization, reaction(s): "Ive had so many gastric problems after having the vaccine", "Metallic taste and I smelled smoke for 7 days", "Metallic taste and I smelled smoke for 7 days", "Headache", "Feeling anxious", "Trouble sleeping", "Severe pain that was bad after the first vaccine dose", "Pain to her left breast". The following information was reported: BREAST PAIN (non-serious), outcome "not recovered", described as "Pain to her left breast"; GASTRIC DISORDER (non-serious), outcome "not recovered", described as "Gastric problems"; DYSGEUSIA (non-serious), PAROSMIA (non-serious), outcome "not recovered" and all described as "Metallic taste and I smelled smoke"; HEADACHE (non-serious), outcome "not recovered", described as "Headache"; ANXIETY (non-serious), outcome "not recovered", described as "Feeling anxious"; SLEEP DISORDER (non-serious), outcome "not recovered", described as "Trouble sleeping".  Additional Information: consumer asking how long the vaccine remains in the system and how long her side effects will last. Reported that she has had both vaccine doses with side effects after each dose. She reported that her side effects were worse after the second vaccine dose. Stated that she really concerned about the fact that she weighed 90 pounds and she get the same dose as people weigh much more than she do and she think that contributed to her side effects. Also reported that her and her husbands second vaccine dose was administered 18 days after the first instead of the recommended 3 weeks. consumer asked about the ingredients in the vaccine, are there steroids in the vaccine and how much Miralax, or PEG was in it and how long will it stay in her body.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Sleep disorder
Clinical narrative: Pain to her left breast; Gastric problems; Metallic taste and I smelled smoke; Metallic taste and I smelled smoke; Headache; Feeling anxious; Trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EN9581), administration date: 05Feb2021, for COVID-19 Immunization, reaction(s): "Ive had so many gastric problems after having the vaccine", "Metallic taste and I smelled smoke for 7 days", "Metallic taste and I smelled smoke for 7 days", "Headache", "Feeling anxious", "Trouble sleeping", "Severe pain that was bad after the first vaccine dose", "Pain to her left breast". The following information was reported: BREAST PAIN (non-serious), outcome "not recovered", described as "Pain to her left breast"; GASTRIC DISORDER (non-serious), outcome "not recovered", described as "Gastric problems"; DYSGEUSIA (non-serious), PAROSMIA (non-serious), outcome "not recovered" and all described as "Metallic taste and I smelled smoke"; HEADACHE (non-serious), outcome "not recovered", described as "Headache"; ANXIETY (non-serious), outcome "not recovered", described as "Feeling anxious"; SLEEP DISORDER (non-serious), outcome "not recovered", described as "Trouble sleeping".  Additional Information: consumer asking how long the vaccine remains in the system and how long her side effects will last. Reported that she has had both vaccine doses with side effects after each dose. She reported that her side effects were worse after the second vaccine dose. Stated that she really concerned about the fact that she weighed 90 pounds and she get the same dose as people weigh much more than she do and she think that contributed to her side effects. Also reported that her and her husbands second vaccine dose was administered 18 days after the first instead of the recommended 3 weeks. consumer asked about the ingredients in the vaccine, are there steroids in the vaccine and how much Miralax, or PEG was in it and how long will it stay in her body.  No follow-up attempts are needed. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: inadvertently got the adult dose of Pfizer Covid19 vaccine; inadvertently got the adult dose of Pfizer Covid19 vaccine; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Nov2021 14:45 (Lot number: FK5127) at the age of 7 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 08Nov2021, outcome "unknown" and all described as " inadvertently got the adult dose of Pfizer Covid19 vaccine"; PAIN IN EXTREMITY (non-serious) with onset 08Nov2021, outcome "unknown", described as "sore arm".  Additional information: patient inadvertently got the adult dose of Pfizer Covid19 vaccine. The pediatric sticker was put on the vaccine card, but that is not what patient received. The one she got was clear and the pediatric one is supposed to be orange.  Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Albumin CSF increased, Asthenia, CSF protein increased, Chest discomfort
Clinical narrative: Patient presented with sudden onset generalized lower extremity weakness and gait instability. The patient had received the Pfizer COVID-19 vaccination series roughly one month prior to presentation (dose #1 on 1/22/21, dose #2 on 2/15/21) after discussion of risk vs. benefit with physician. Work-up during inpatient admission resulted in a diagnosis of probable acute inflammatory demyelinating polyneuropathy (AIDP) in the setting of CIDP.  The patient was treated with 5 sessions of plasmapheresis and then resumed his previous outpatient plasmapheresis schedule. On discharge the patient was stable and continued to improve in terms of his strength. Of note, during the patient's initial hospital course he experienced episodes of dull chest pain/pressure and was diagnosed with NSTEMI, EKG not concerning for acute ischemic process.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated, Electrocardiogram normal, Electromyogram
Clinical narrative: Patient presented with sudden onset generalized lower extremity weakness and gait instability. The patient had received the Pfizer COVID-19 vaccination series roughly one month prior to presentation (dose #1 on 1/22/21, dose #2 on 2/15/21) after discussion of risk vs. benefit with physician. Work-up during inpatient admission resulted in a diagnosis of probable acute inflammatory demyelinating polyneuropathy (AIDP) in the setting of CIDP.  The patient was treated with 5 sessions of plasmapheresis and then resumed his previous outpatient plasmapheresis schedule. On discharge the patient was stable and continued to improve in terms of his strength. Of note, during the patient's initial hospital course he experienced episodes of dull chest pain/pressure and was diagnosed with NSTEMI, EKG not concerning for acute ischemic process.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Guillain-Barre syndrome, Inappropriate schedule of product administration, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Patient presented with sudden onset generalized lower extremity weakness and gait instability. The patient had received the Pfizer COVID-19 vaccination series roughly one month prior to presentation (dose #1 on 1/22/21, dose #2 on 2/15/21) after discussion of risk vs. benefit with physician. Work-up during inpatient admission resulted in a diagnosis of probable acute inflammatory demyelinating polyneuropathy (AIDP) in the setting of CIDP.  The patient was treated with 5 sessions of plasmapheresis and then resumed his previous outpatient plasmapheresis schedule. On discharge the patient was stable and continued to improve in terms of his strength. Of note, during the patient's initial hospital course he experienced episodes of dull chest pain/pressure and was diagnosed with NSTEMI, EKG not concerning for acute ischemic process.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Plasmapheresis
Clinical narrative: Patient presented with sudden onset generalized lower extremity weakness and gait instability. The patient had received the Pfizer COVID-19 vaccination series roughly one month prior to presentation (dose #1 on 1/22/21, dose #2 on 2/15/21) after discussion of risk vs. benefit with physician. Work-up during inpatient admission resulted in a diagnosis of probable acute inflammatory demyelinating polyneuropathy (AIDP) in the setting of CIDP.  The patient was treated with 5 sessions of plasmapheresis and then resumed his previous outpatient plasmapheresis schedule. On discharge the patient was stable and continued to improve in terms of his strength. Of note, during the patient's initial hospital course he experienced episodes of dull chest pain/pressure and was diagnosed with NSTEMI, EKG not concerning for acute ischemic process.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of ineffective vaccine due to bacteriostatic solution.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Product preparation issue
Clinical narrative: Administration of ineffective vaccine due to bacteriostatic solution.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Back pain, Hypoaesthesia
Clinical narrative: This is a duplicate report as my original did not have the lot number for the flu vaccine. It was Fluzone HD UJ768AA. As stated before. I began to have progressively severe right leg pain 30 hours after the vaccines. Pain variably from rt SI joint down thru L3-L4 distribution, subsequently associated with numbness and weakness. Xray showed only mild right hip arthritis, at which point PCP lost interest. Subsequent LS MRI as ordered by ortho showed chronic lumbar changes (worse on the unaffected left side). Pain progressed to bed ridden status for two weeks, gradually resolving by 6-7 weeks.  My assessment was likely inflammatory neuropathy, possibly  vaccine-related.  Please note I am a board-certified Internist.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Magnetic resonance imaging, Mobility decreased, Neuropathy peripheral, Pain in extremity
Clinical narrative: This is a duplicate report as my original did not have the lot number for the flu vaccine. It was Fluzone HD UJ768AA. As stated before. I began to have progressively severe right leg pain 30 hours after the vaccines. Pain variably from rt SI joint down thru L3-L4 distribution, subsequently associated with numbness and weakness. Xray showed only mild right hip arthritis, at which point PCP lost interest. Subsequent LS MRI as ordered by ortho showed chronic lumbar changes (worse on the unaffected left side). Pain progressed to bed ridden status for two weeks, gradually resolving by 6-7 weeks.  My assessment was likely inflammatory neuropathy, possibly  vaccine-related.  Please note I am a board-certified Internist.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: This is a duplicate report as my original did not have the lot number for the flu vaccine. It was Fluzone HD UJ768AA. As stated before. I began to have progressively severe right leg pain 30 hours after the vaccines. Pain variably from rt SI joint down thru L3-L4 distribution, subsequently associated with numbness and weakness. Xray showed only mild right hip arthritis, at which point PCP lost interest. Subsequent LS MRI as ordered by ortho showed chronic lumbar changes (worse on the unaffected left side). Pain progressed to bed ridden status for two weeks, gradually resolving by 6-7 weeks.  My assessment was likely inflammatory neuropathy, possibly  vaccine-related.  Please note I am a board-certified Internist.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Cerebrovascular accident, Death, Life support
Clinical narrative: per pt friend report patient had a stroke 11/19 not found until 11/22. He was put on life support then passed away 12/7/21
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Chest pain, Palpitations, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). A 6-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm right, administration date 04Dec2021 12:00 (Lot number: FK5618) at the age of 6 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: COVID prior to vaccination. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: CHEST PAIN (non-serious) with onset 05Dec2021 19:00, outcome "recovered" (2021), described as "chest pain"; PALPITATIONS (non-serious) with onset 05Dec2021 19:00, outcome "recovered" (2021), described as "heart palpitations"; CARDIAC MURMUR (non-serious) with onset 05Dec2021 19:00, outcome "recovered" (2021), described as "heart murmur". The events "chest pain", "heart palpitations" and "heart murmur" were evaluated at the physician office visit and emergency room visit. The patient had a negative iHealth Nasal Swab COVID test on 02Jan2022, post vaccination. Therapeutic measures were not taken as a result of chest pain, palpitations, cardiac murmur. Follow-up attempts are completed; information about lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Pruritus, Rash
Clinical narrative: Itchiness that starts and resolves in the day; Rashes that appear and disappear; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In June 2021, the patient received the 2nd dose of Shingrix. In June 2021, 2 weeks after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pruritus, rash and dizziness. On an unknown date, the outcome of the pruritus, rash and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, rash and dizziness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The age at vaccination was not reported. The patient received his first dose of Shingrix in April 2021 and second dose of Shingrix in June 2021.  The patient stated that 2 weeks after his second dose he started experiencing itchiness, rash, and dizziness.  The patient stated that the itchiness usually started in the afternoon and resolved during the day. He also stated that he experienced rashes that appear and disappear. He occasionally experienced dizziness. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pulmonary thrombosis, Thrombosis
Clinical narrative: booster dose; I developed blood clots. In my leg and lungs.; I developed blood clots. In my leg and lungs.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date at an unspecified age as dose 3 (booster) single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization, reaction(s): "condition worsened", "itching", "rash". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster dose"; THROMBOSIS (medically significant), PULMONARY THROMBOSIS (medically significant), outcome "unknown" and all described as "I developed blood clots. In my leg and lungs.". Additional information: About 3 weeks after receiving the Pfizer COVID-19 booster shot, the patient developed blood clots in leg and lungs. The patient has no history of clots, no travel, and no injuries.   The lot number for bnt162b2 was not provided and will be requested during follow up.