chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: having numbness in his right toe; 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 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jun2021 14:30 (Lot number: EW0178) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "slightly high blood pressure" (unspecified if ongoing), notes: no major condition may be just slightly high blood pressure. Concomitant medication(s) included: PROPECIA. The following information was reported: HYPOAESTHESIA (non-serious) with onset Jun2021, outcome "unknown", described as "having numbness in his right toe".  Additional information: Patient does not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Patient mentioned that he has numbness in his right toe and he got his first shot 3 weeks ago on 01Jun2021 and the second shot is scheduled in a couple of days.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Hypoaesthesia, Neuralgia, Paraesthesia, Thyroxine
Clinical narrative: numbing on right side of the body; Pins and needles sensation; Nerve pain all over body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): ACL21-10245.  A 53 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Lyme disease" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Thyroid, reaction(s): "heart rate irregular", notes: 120mg tablets(lot : UNK ; exp : 09/2021); Thyroid, reaction(s): "constipation"; Benadryl, reaction(s): "allergies"; Thyroid, reaction(s): "difficulty sleeping"; Trovan, reaction(s): "allergies". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbing on right side of the body"; PARAESTHESIA (non-serious), outcome "unknown", described as "Pins and needles sensation"; NEURALGIA (non-serious), outcome "unknown", described as "Nerve pain all over body". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient takes the following concomitants medications (therapy dates : UNK). the consumer advised that Cytomel cause " horrible side effect" so she was switched to nature Throid (Strength, dose, frequency :UNK). On an unknown date, Nature Throid "quit working" and she was switched to armour Thyroid (Strength, dose, frequency :UNK). Approximately six years ago, she was switched to NP thyroid 120mg tablets, one half tablet by mouth in the morning and one quarter tablet by mouth in the morning. At the time, her labs were normal, and she didn't want to "over do it". In 2021, after picking up new fill of the suspect medication she began to experience an irregular heart rate, difficulty sleeping(insomnia), and constipation. In Feb2021, she complete lab work with her physician (results : TSH: 2.5, T3 low normal, and T4 low normal). In Apr2021, she received another fill of the suspect medication and her heart rate irregular, and constipation resolved. No treatment was reported. at the time of this report, she continuous to take the suspect. The outcome of her insomnia is ongoing and the outcome of her heart rate irregular, and constipation remain resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine
Clinical narrative: numbing on right side of the body; Pins and needles sensation; Nerve pain all over body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): ACL21-10245.  A 53 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Lyme disease" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Thyroid, reaction(s): "heart rate irregular", notes: 120mg tablets(lot : UNK ; exp : 09/2021); Thyroid, reaction(s): "constipation"; Benadryl, reaction(s): "allergies"; Thyroid, reaction(s): "difficulty sleeping"; Trovan, reaction(s): "allergies". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbing on right side of the body"; PARAESTHESIA (non-serious), outcome "unknown", described as "Pins and needles sensation"; NEURALGIA (non-serious), outcome "unknown", described as "Nerve pain all over body". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient takes the following concomitants medications (therapy dates : UNK). the consumer advised that Cytomel cause " horrible side effect" so she was switched to nature Throid (Strength, dose, frequency :UNK). On an unknown date, Nature Throid "quit working" and she was switched to armour Thyroid (Strength, dose, frequency :UNK). Approximately six years ago, she was switched to NP thyroid 120mg tablets, one half tablet by mouth in the morning and one quarter tablet by mouth in the morning. At the time, her labs were normal, and she didn't want to "over do it". In 2021, after picking up new fill of the suspect medication she began to experience an irregular heart rate, difficulty sleeping(insomnia), and constipation. In Feb2021, she complete lab work with her physician (results : TSH: 2.5, T3 low normal, and T4 low normal). In Apr2021, she received another fill of the suspect medication and her heart rate irregular, and constipation resolved. No treatment was reported. at the time of this report, she continuous to take the suspect. The outcome of her insomnia is ongoing and the outcome of her heart rate irregular, and constipation remain resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Pain, stiffness when you get up in the morning from the lower back all way down to the knee; Pain, stiffness when you get up in the morning from the lower back all way down to the knee; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 29Mar2021 (Lot number: EN6205) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 06Mar2021, for COVID-19 immunization. The following information was re  ported: MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Pain, stiffness when you get up in the morning from the lower back all way down to the knee". Therapeutic measures were taken as a result of musculoskeletal stiffness, pain.  Additional information:Consumer stated, Am I going to report side effects to you or you are going to transfer me to someone for this Pfizer vaccine the COVID-19 vaccine.Consumer stated, I got both shot in March, one on March 6th and one on March 29th and I am still having the pain, stiffness when you get up in the morning from the lower back all way down to the knee and that was the result of vaccine when I got it. I did not see it so much at the first shot but at the second shot. I am hoping it with, I know that the other people experience the same thing some says its gone away and some says they are still having that problem. Have that been reported to you at all. Do you know?Age: Consumer stated, It is from lower back and all the way down to the back of the leg all way down to the knee and when you get up in the morning you can hardly, you know, I have to take some pain medicine. I am very (Incomprehensible voice) should be able to move about like I need to.Consumer stated, That would be fine you know do I need to go to the doctor to therapy or anything if it still going on. I take pain medicine.Treatment: Consumer stated, Over the counter pain medicine. I just take it whenever I need it.No, I am hoping this would eventually go away so I will not have to take the pain medicine everyday but my sister in research told me to report it.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021751197 Same reporter/ drug/ AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited a little bit; This is a spontaneous report received from a non-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 1, single for covid-19 immunisation. Relevant medical history included: "Gallbladder surgery" (unspecified if ongoing); "certain food bothers her" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomited a little bit".  Additional information: Caller stated she was calling about an appointment she has this morning at 08:30 for her second Pfizer vaccine. She stated that 2 years ago she had gallbladder surgery and since then, certain foods bother her. Last night, caller clarified that it was around 1500  this morning, she vomited a little bit, but she is better now. She stated she ate graham crackers with margarine and thinks it was a little too greasy. Caller stated that she vomits about once a month since her gallbladder surgery. She is ok now and she was wondering if she can keep her appointment for today. Caller states she took the first vaccine and was fine. She reports she was fine now, she reports her appointment is at 0830 and the doctor won't be in yet that early.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Dates for just felt blah, tired, draggy: First dose; Dates for just felt blah, tired, draggy: First dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23May2021 (Lot number: EW0187) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Leukemia" (unspecified if ongoing), notes: Verbatim: Leukemia. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: FEELING ABNORMAL (non-serious), FATIGUE (non-serious), outcome "recovering" and all described as "Dates for just felt blah, tired, draggy: First dose".  Additional information: No previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No vaccines administered on same date with the Pfizer vaccine considered as suspect. Events not resulted in emergency room or physician office. No prior vaccinations (within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine. The patient sometimes takes on the weekend if he was feeling sore and he takes two 500 mg which is the max amount for every 6-8 hours. Takes 2 before he goes to work every day. The patient has history of Leukaemia.  Follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: experienced leg & ankle swelling; experienced leg & ankle swelling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male 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: PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "experienced leg & ankle swelling".  Additional Information: The caller experienced a leg and ankle swelling 3-4 weeks after receiving the first dose, would that be a reason to not get the second shot. The caller's doctor said no. The caller is unsure if other people are reporting this. The caller is supposed to get the second shot soon.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vitamin D
Clinical narrative: first dose- sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8734) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (ongoing); "Anxiety" (ongoing); "Blood Pressure" (ongoing), notes: she used to take blood pressure medication; "Vitamin D Low" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased (ongoing); ESCITALOPRAM taken for anxiety (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Apr2021, outcome "recovered" (2021), described as "first dose- sore left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Concomitant Products Atorvastatin: (Start: Unknown Stop: Ongoing, expiration date of May2022, lot 100017564, Dosage text : 80mg tablet with water once a day after supper). Escitalopram: (Start: Unknown Stop: Ongoing) her doctor increased it, patient was on 40mg. Later stated that she does not know if he increased it or not, Dosage text:  one 20mg by mouth once daily around noon. Patient used to take blood pressure medication but was doing okay and does not have medication name. Caller stated that she wanted to report that when she got her first shot of Pfizer that on the third day her arm was sore and she took Aleve. Stated that it was okay. Stated that her arm was still hurting but not as much as it was.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: it was just a needle in arm and hurt a little bit but that is fine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 10:00 (Lot number: EN6206) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "it was just a needle in arm and hurt a little bit but that is fine".  Additional information: No previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. No Medical History (including any illness at time of vaccination). No Relevant Tests. Caller reporting on the Pfizer COVID vaccine and who wants to report he has an adverse reaction after the vaccine. It was reported that after the first and second dose he was fine, it was just a needle in arm and hurt a little bit but that is fine.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: trouble with our voice/couldn't hit high notes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient in his 40's 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: DYSPHONIA (non-serious), outcome "unknown", described as "trouble with our voice/couldn't hit high notes". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: IBS flare up; 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. Other Case identifier(s): US-PFIZER INC-2021766601 (Pfizer).  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 24May2021 (Lot number: EW0191) at the age of 63 years as dose 2, single for covid-19 immunization. Relevant medical history included: "IBS" (unspecified if ongoing), notes: Verbatim: IBS; "Acid reflux" (unspecified if ongoing), notes: Verbatim: Acid reflux (esophageal); "headaches" (unspecified if ongoing); "diarrhea" (unspecified if ongoing). Concomitant medication(s) included: LINZESS; FOLIC ACID; B COMPLEX (B50); VITAMIN D [ERGOCALCIFEROL]. Past drug history included: Aleve, reaction(s): "acid reflux worse". Vaccination history included: Bnt162b2 (First dose, Batch/lot number: EW0168, Dosage text: Unknown dosage; first dose; upper left arm), administration date: 03May2021, for COVID-19 immunization, reaction(s): "IBS flare up". The following information was reported: IRRITABLE BOWEL SYNDROME (non-serious) with onset May2021, outcome "not recovered", described as "IBS flare up".  Additional information: The stated that IBS and has been pretty good about controlling his flare ups. The patient stated he had IBS flare ups 3-4 days after the first dose of the vaccine. The second vaccine was 3 weeks ago and the caller is getting another IBS flare up. The caller has not had any changes to his diet or stress levels.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, SARS-CoV-2 test
Clinical narrative: Now my period has completely stopped. I have not had a period since the second week of April; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 08:15 (Lot number: ENG206) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MULTIVITAMIN [VITAMINS NOS]. Past drug history included: Zithromax, reaction(s): "zithromax allergy". Vaccination history included: Bnt162b2 (Dose 1, Anatomical Location: Arm Left, Batch/lot number: ENG202, Administration time: 18:15 AM), administration date: 25Feb2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Heavy periods". The following information was reported: AMENORRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "Now my period has completely stopped. I have not had a period since the second week of April". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhoea.  Additional information: Reporter stated that, it was confirmed by the doctor that the patient was not going through menopause. It was reported that the patient's first 2 periods after starting the injections where extremely heavy. Now her period has completely stopped. She have not had a period since the second week of April. She did not take other vaccine in four weeks and patient took multivitamin one a day in two weeks. She did not have COVID prior vaccination and she was tested with COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Pain
Clinical narrative: his left side of his body,his chest ,hurt; had a ball under his armpit; his left side of his body,his chest ,hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jun2021 (Batch/Lot number: unknown) at the age of 18 years 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 (non-serious), CHEST PAIN (non-serious) all with onset Jun2021, outcome "unknown" and all described as "his left side of his body,his chest ,hurt"; AXILLARY PAIN (non-serious) with onset Jun2021, outcome "unknown", described as "had a ball under his armpit".  Additional Information: Two days ago, on Tuesday (22Jun2021) reporter took her son to receive the Pfizer Covid-19 vaccine, the first dose. He was given the vaccine in his left arm. Yesterday his left side of his body, his  chest, hurt and when he raised his arm he realized that he had a ball under his armpit.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site is continuing to red and swell; continued to get redder larger and itching; Injection site is continuing to red and swell; continued to get redder larger and itching; Injection site is continuing to red and swell; continued to get redder larger and itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 24Jun2021 (Lot number: EW0183) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Tachycardia" (unspecified if ongoing); "Hypersensitivity" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; METOPROLOL; MONTELUKAST taken for hypersensitivity. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 2021, for COVID-19 Immunization. The following information was reported: INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE SWELLING (non-serious), INJECTION SITE PRURITUS (non-serious) all with onset 25Jun2021, outcome "not recovered" and all described as "Injection site is continuing to red and swell; continued to get redder larger and itching". Therapeutic measures were not taken as a result of injection site erythema, injection site swelling, injection site pruritus.  Additional Information:It was reported that, Reaction/event as reported by primary source: Injection site is continuing to red and swell; continued to get redder larger and itching. Date of start of reaction/event: 25Jun2021. Outcome of reaction/event at the time of last observation: NOT RECOVERED/NOT RESOLVED. When probed for the consumer stated, "I am concerned because I had the Covid Vaccine (second dose) last Thursday (24Jun2021) and the injection site is continuing to red and swell." When paraphrased the concern, consumer stated, "Yes, I want to know is that normal." Consumer was informed about the Role of Pfizer Drug Safety. When probed for vaccine (second dose) NDC#, consumer stated, "No." When probed for vaccine (second dose) expiration date, consumer stated, "They don't have that on there either, anything expect from the LOT. When probed for any laboratory test and its date, consumer stated, "My internal medication Doctor did my lab work probably in April." When probed for ay treatment for event, consumer stated, "No, It's worsening that's why I am calling you."  Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Pain in extremity
Clinical narrative: Severe arm soreness, severe fatigue, weakness, lightheadedness, violent shivering during the night, feverish feeling without elevated temp, slightly irritated sinuses.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Paranasal sinus discomfort, Pyrexia
Clinical narrative: Severe arm soreness, severe fatigue, weakness, lightheadedness, violent shivering during the night, feverish feeling without elevated temp, slightly irritated sinuses.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Periorbital swelling, Rash, Rash vesicular
Clinical narrative: But she developed a painful rash on her forehead on Friday night.  She did get the Shingrix immunization about 1.5 weeks ago.  Her one eye feels a little puffy too.  Does appear she has vesicular rash across her forehead, like a shingles rash.  Started her on Valtrex and told her to make appt to see eye doctor today or tomorrow.   This should be reported to VAERS, that she developed a painful rash on forehead after her Shingrix injection
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, COVID-19, Cardiac arrest, Chronic obstructive pulmonary disease
Clinical narrative: pt had recent hosp admission with positive COVID test, was improved and dc'd to home; back to hosp again with severe hypoxemia; COVID test negative this time; O2 sats 71% on RA; placed on 15L High-flow O2; AHRF, post acute sequelae of COVID infection; pulmonary fibrosis; emphysema COPD, paroxysmal A Fib; required intubation due to failing condition; suffered cardiac arrest and despite resuscitation efforts the pt died in the hospital
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Emphysema, Endotracheal intubation, General physical health deterioration
Clinical narrative: pt had recent hosp admission with positive COVID test, was improved and dc'd to home; back to hosp again with severe hypoxemia; COVID test negative this time; O2 sats 71% on RA; placed on 15L High-flow O2; AHRF, post acute sequelae of COVID infection; pulmonary fibrosis; emphysema COPD, paroxysmal A Fib; required intubation due to failing condition; suffered cardiac arrest and despite resuscitation efforts the pt died in the hospital
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Post-acute COVID-19 syndrome, Pulmonary fibrosis, Resuscitation, SARS-CoV-2 test positive
Clinical narrative: pt had recent hosp admission with positive COVID test, was improved and dc'd to home; back to hosp again with severe hypoxemia; COVID test negative this time; O2 sats 71% on RA; placed on 15L High-flow O2; AHRF, post acute sequelae of COVID infection; pulmonary fibrosis; emphysema COPD, paroxysmal A Fib; required intubation due to failing condition; suffered cardiac arrest and despite resuscitation efforts the pt died in the hospital
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Vaccinated pt admitted to inpatient facility with covid infection
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Covid vaccine administered to patient      Event details:  o         Vial opened on Wed 2/16 at 3pm; Vial was dated/labelled. Evening nurse was to take the booster, then discard. At the end of shift she refused booster, but vial wasn?t discarded/waisted.  o         Opened vial was refrigerated, dated/initialed.  o         CN/CM were at another clinic due to bad weather. A nurse from another clinic offered to help with vaccinations and gave a booster dose was given to 3 employees from opened vial.  o         Vaccines given Friday 2/18 at 3pm to patient   o         CM/CN noted there was still one unopened vial left in refrigerator on Monday 2/21/2022
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Vaccinated pt admitted with covid infection
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Blood test normal, C-reactive protein normal, Chronic spontaneous urticaria, Differential white blood cell count normal
Clinical narrative: Spontaneous urticaria developed exactly 1 week after booster moderna vaccine.  Symptoms occur all times of day, worse at night, and all over body with raised hives/wheels.  Extensive blood lab work completed about 1 month after onset of symptoms and unremarkbale; follow up with dermatologist and subsequently diagnosed as chronic spontaneous urticaria as symptoms have lasted > 6week (now 3+ months).  Steroid taper x 2 made symptoms worse.  High dose Loratadine 2x/day with Benadryl at night have made symptoms tolerable, but have been unable to wean off of Loratadine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Laboratory test normal, Metabolic function test normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Spontaneous urticaria developed exactly 1 week after booster moderna vaccine.  Symptoms occur all times of day, worse at night, and all over body with raised hives/wheels.  Extensive blood lab work completed about 1 month after onset of symptoms and unremarkbale; follow up with dermatologist and subsequently diagnosed as chronic spontaneous urticaria as symptoms have lasted > 6week (now 3+ months).  Steroid taper x 2 made symptoms worse.  High dose Loratadine 2x/day with Benadryl at night have made symptoms tolerable, but have been unable to wean off of Loratadine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Urticaria
Clinical narrative: Spontaneous urticaria developed exactly 1 week after booster moderna vaccine.  Symptoms occur all times of day, worse at night, and all over body with raised hives/wheels.  Extensive blood lab work completed about 1 month after onset of symptoms and unremarkbale; follow up with dermatologist and subsequently diagnosed as chronic spontaneous urticaria as symptoms have lasted > 6week (now 3+ months).  Steroid taper x 2 made symptoms worse.  High dose Loratadine 2x/day with Benadryl at night have made symptoms tolerable, but have been unable to wean off of Loratadine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Migraine, Nausea, Rash, Vomiting
Clinical narrative: 2/18/22 debilitating migraine, progressed to nausea and vomiting. Rash on torso began over the weekend and then running up neck/throat area. Took Benadryl Sunday and was feeling some better Monday 2/21/22. Completely gone 2/22/22.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Tachycardia
Clinical narrative: A 40 y/o female patient presents with diaphoresis and dizziness immediately after being immunized with the Pfizer Covid Vaccine (Booster Dose).   The patient was taken to the paramedic area and vital signs were taken. The pressure was slightly elevated 130/100, which is normal in a hypertensive patient which had not taken her medication, Labetalol. Other than that, the patient was slightly tachycardic. She refers similar episodes with other stressors, such as other types of vaccination, although she did not give specific examples. She was discharged with stable vital signs and referred to feeling better.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Dizziness, Immediate post-injection reaction
Clinical narrative: A 40 y/o female patient presents with diaphoresis and dizziness immediately after being immunized with the Pfizer Covid Vaccine (Booster Dose).   The patient was taken to the paramedic area and vital signs were taken. The pressure was slightly elevated 130/100, which is normal in a hypertensive patient which had not taken her medication, Labetalol. Other than that, the patient was slightly tachycardic. She refers similar episodes with other stressors, such as other types of vaccination, although she did not give specific examples. She was discharged with stable vital signs and referred to feeling better.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Exercise tolerance decreased, Insomnia, Palpitations, Paraesthesia
Clinical narrative: Insomnia, shortness of breath, sleep apnea, rash, palpitations, exercise intolerance, weight loss, off/on tingling in hands and feet.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Post-acute COVID-19 syndrome, Rash, Sleep apnoea syndrome, Weight decreased
Clinical narrative: Insomnia, shortness of breath, sleep apnea, rash, palpitations, exercise intolerance, weight loss, off/on tingling in hands and feet.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Dyspnoea exertional, Exercise tolerance decreased, Fatigue
Clinical narrative: I felt sick after receiving the second shot, I was told that was normal but there are long term effects that are have not gone away after 10 months.  Initially I just felt sick (headache, mild fever, fatigue, chest pain) and that all subsided after a day or two.  More concerning is that I was fairly athletic prior to the shot and have not been able to recover to my pre-shot abilities.  For example, prior to the shot I would run a 5K in about 23 minutes and have not been able to go any faster than 28 minutes since then, which is a struggle and is limited by my ability to breathe.  I realize that this is still decent for a 46 year old male but it represents a significant decrease in lung function.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lung disorder, Malaise, Pyrexia
Clinical narrative: I felt sick after receiving the second shot, I was told that was normal but there are long term effects that are have not gone away after 10 months.  Initially I just felt sick (headache, mild fever, fatigue, chest pain) and that all subsided after a day or two.  More concerning is that I was fairly athletic prior to the shot and have not been able to recover to my pre-shot abilities.  For example, prior to the shot I would run a 5K in about 23 minutes and have not been able to go any faster than 28 minutes since then, which is a struggle and is limited by my ability to breathe.  I realize that this is still decent for a 46 year old male but it represents a significant decrease in lung function.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: ARM SORE AT INJECTIO  SITE;  ARM SORE FROM ELBOW TO SHOULDER WITH INTERMITTEN SHOOTING PAINS FROM INJECTION SITE TO SHOULDER.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Vaccinated pt admitted with covid infection
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: expired Covid vaccine administered to patient      Event details:  o         Vial opened on Wed 2/16 at 3pm; Vial was dated/labelled. Evening nurse was to take the booster, then discard. At the end of shift she refused booster, but vial wasn?t discarded/waisted.  o         Opened vial was refrigerated, dated/initialed.  o         CN/CM were at another clinic due to bad weather. A nurse from another clinic offered to help with vaccinations and gave a booster dose was given to employee from opened vial.  o         Vaccines given Friday 2/18 at 3pm to 3 employees.  o         CM/CN noted there was still one unopened vial left in refrigerator on Monday.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy endometrium abnormal, Blood pressure increased, Endometrial disorder, Postmenopausal haemorrhage, Vaginal haemorrhage
Clinical narrative: The patient measured her BP the day after vaccination and found it was elevated , SBP 150's. On 12/09/2021 she  started having postmenopausal heavy vaginal bleeding with clots for approximately 2 weeks then decreased to occasional spotting  until 1/20/2022. Her blood pressure  remained elevated for several weeks. On 1/7/2022 the  BP was 156/80.On 1/24/2022 the BP was 124/80
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: About 2 hours after the shot.  I noticed that my face was starting to get swollen and red.  This lasted for a few hours.  I went to urgent care about it.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I developed a ringing in my ears (mostly right ear) a short while father getting the first vaccine. Tinnitus.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: expired Covid vaccine administered to 3 employees.     Event details:  o         Vial opened on Wed 2/16 at 3pm; Vial was dated/labelled. Evening nurse was to take the booster, then discard. At the end of shift she refused booster, but vial wasn?t discarded/waisted.  o         Opened vial was refrigerated, dated/initialed.  o         CN/CM were at another clinic due to bad weather. A nurse from another clinic offered to help with vaccinations and gave a booster dose was given to 3 employees from opened vial.  o         Vaccines given Friday 2/18 at 3pm to 3 employees.  o         CM/CN noted there was still one unopened vial left in refrigerator on Monday.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac arrest, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: 10/1/21 pt brought to ED via EMS; EMS called by wife, states pt got SOB and stopped breathing; she started CPR; EMS intubated pt; pt in full arrest; pt brought to ED; unable to revive pt; pt had a positive COVID test on 9/9/21
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory arrest, Resuscitation, SARS-CoV-2 test positive
Clinical narrative: 10/1/21 pt brought to ED via EMS; EMS called by wife, states pt got SOB and stopped breathing; she started CPR; EMS intubated pt; pt in full arrest; pt brought to ED; unable to revive pt; pt had a positive COVID test on 9/9/21
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: On 03/31/2021 about 2PM I started feeling tired and had chills, nausea. I had a fever of 103, and a headache that lasted for five days. I called the doctor and he said to take Motrin and Tylenol. I felt awful for about 24 hours.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: On 03/31/2021 about 2PM I started feeling tired and had chills, nausea. I had a fever of 103, and a headache that lasted for five days. I called the doctor and he said to take Motrin and Tylenol. I felt awful for about 24 hours.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: patient had none after waiting for 15 minutes
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Genital herpes, Lymphadenopathy, Pain
Clinical narrative: I've had genital herpes for 10 years. This is my 1st outbreak post-vaccine. This outbreak caused severe fever, aches, chills, & swollen lymph nodes in groin & armpits. Worse than even my original outbreak. Could this be from the vaccines?
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I've had genital herpes for 10 years. This is my 1st outbreak post-vaccine. This outbreak caused severe fever, aches, chills, & swollen lymph nodes in groin & armpits. Worse than even my original outbreak. Could this be from the vaccines?
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Fatigue, Hyperventilation, Hypoxia
Clinical narrative: BODY ACHES, CHILLS, CONGESTION, RIGHT SIDED RIB PAIN, FATIGUE, PRODUCTIVE COUGH W/ VOMITING, PAIN W/ DEEP BREATHS, HYPOXIA,  FEBRILE
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Pain, Productive cough, Pyrexia, Respiratory tract congestion
Clinical narrative: BODY ACHES, CHILLS, CONGESTION, RIGHT SIDED RIB PAIN, FATIGUE, PRODUCTIVE COUGH W/ VOMITING, PAIN W/ DEEP BREATHS, HYPOXIA,  FEBRILE
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: BODY ACHES, CHILLS, CONGESTION, RIGHT SIDED RIB PAIN, FATIGUE, PRODUCTIVE COUGH W/ VOMITING, PAIN W/ DEEP BREATHS, HYPOXIA,  FEBRILE
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Headache, Tinnitus
Clinical narrative: Loss of balance, Headaches, Ringing of the ears, Experienced loss of balance and fell during a walk.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Pt reports she received the Moderna vaccine booster, #3 on 2/24/22 at the  Pharmacy. Pt initially experienced a fever of about  99.4 F . The fever resolved within 48 hours. Pt also experienced localized pain, erythema measures 7x6" and swelling 3x2.5" noted 4 days after vaccination during clinic visit. The examination showed a swollen tender lymph node under the patient's L arm. The erythematous area was warm to touch. The patient has been treating with Benadryl which she states helps her sleep at night.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling
Clinical narrative: Pt reports she received the Moderna vaccine booster, #3 on 2/24/22 at the  Pharmacy. Pt initially experienced a fever of about  99.4 F . The fever resolved within 48 hours. Pt also experienced localized pain, erythema measures 7x6" and swelling 3x2.5" noted 4 days after vaccination during clinic visit. The examination showed a swollen tender lymph node under the patient's L arm. The erythematous area was warm to touch. The patient has been treating with Benadryl which she states helps her sleep at night.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated she has pain down her arm and has trouble lifting it by afternoon/evening.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: patient was given pediactric dose  no adverse reactions noted or reported
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Death
Clinical narrative: pt had previous positive COVID test on 8/18/21; to hosp ED on 8/22/21 due to SOB; O2 sats 80% on RA; placed on 100% NRB; chest x-ray  showed bilateral pneumonia; transferred to ICU; acute hypoxemia due to COVID pneumonia; Decadron, Remdesivir, baricitinib, Lovenox; eventually required intubation with mechanical ventilation; MRSA bacterium found in sputum; antibiotic changed; pt's condition worsened; hypotensive; family decided to make pt DNR/DNI, comfort care; pt passed away in the hospital
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, General physical health deterioration, Hypotension, Hypoxia
Clinical narrative: pt had previous positive COVID test on 8/18/21; to hosp ED on 8/22/21 due to SOB; O2 sats 80% on RA; placed on 100% NRB; chest x-ray  showed bilateral pneumonia; transferred to ICU; acute hypoxemia due to COVID pneumonia; Decadron, Remdesivir, baricitinib, Lovenox; eventually required intubation with mechanical ventilation; MRSA bacterium found in sputum; antibiotic changed; pt's condition worsened; hypotensive; family decided to make pt DNR/DNI, comfort care; pt passed away in the hospital
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Mechanical ventilation, Pneumonia, SARS-CoV-2 test positive, Sputum culture positive
Clinical narrative: pt had previous positive COVID test on 8/18/21; to hosp ED on 8/22/21 due to SOB; O2 sats 80% on RA; placed on 100% NRB; chest x-ray  showed bilateral pneumonia; transferred to ICU; acute hypoxemia due to COVID pneumonia; Decadron, Remdesivir, baricitinib, Lovenox; eventually required intubation with mechanical ventilation; MRSA bacterium found in sputum; antibiotic changed; pt's condition worsened; hypotensive; family decided to make pt DNR/DNI, comfort care; pt passed away in the hospital
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Staphylococcus test positive
Clinical narrative: pt had previous positive COVID test on 8/18/21; to hosp ED on 8/22/21 due to SOB; O2 sats 80% on RA; placed on 100% NRB; chest x-ray  showed bilateral pneumonia; transferred to ICU; acute hypoxemia due to COVID pneumonia; Decadron, Remdesivir, baricitinib, Lovenox; eventually required intubation with mechanical ventilation; MRSA bacterium found in sputum; antibiotic changed; pt's condition worsened; hypotensive; family decided to make pt DNR/DNI, comfort care; pt passed away in the hospital
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Injection site pain, Interchange of vaccine products
Clinical narrative: Sever body aches, fever, lethargy, fatigue, sever headache, pain at the injection sight, elevated heart rate.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Sever body aches, fever, lethargy, fatigue, sever headache, pain at the injection sight, elevated heart rate.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever w/ simple febrile seizure
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: noticed ringing in my ears beginning in November-December 2021.  It has been a steady hum since then.  I never had hearing problems or tinnitus before the Covid booster shot.   I thought it had lessened last night and this morning (March 1, 2022), but it's back.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Induration, Rash, Rash pruritic
Clinical narrative: After receiving the Pfizer Vaccine, first dose on the 12/3/2022, Patient had an allergic reaction neck down. After 3 hours of the vaccine she  had a rash all over her body except her private parts or her face. I can compare it with goosebumps but 3x the size, round and very hard at touching.  Itchy on times. This rash lasted for around 8 days. I provided Zyrtec and Benadryl.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient reported having 2nd dose of J&J COVID vaccine yesterday at 1300 and reports 1 hour later having bodyaches, fevers/chills and rash along b/l arms and back that looked like welts. States she became itchy and took benadryl which improved her rash. Upon exam today at 11:00 patient had erythematous fine macular rash on forehead, no hives. No s/s of angioedema or anaphylaxis.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, SARS-CoV-2 test negative, Urticaria
Clinical narrative: Patient reported having 2nd dose of J&J COVID vaccine yesterday at 1300 and reports 1 hour later having bodyaches, fevers/chills and rash along b/l arms and back that looked like welts. States she became itchy and took benadryl which improved her rash. Upon exam today at 11:00 patient had erythematous fine macular rash on forehead, no hives. No s/s of angioedema or anaphylaxis.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Upon administration of pfizer adult dose, the self retracting syringe retracted prior to complete administration of immunization. Some of the dose leaked out onto the arm. Per standing order, if equal to or greater than half the dose was administered, do NOT administer a second dose. I am confident patient received over half the dose.