chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 19Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 47 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Narcolepsy" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: SUNOSI, start date: 25Apr2022; TRAZODONE, start date: 05Apr2021; VITAMIN D [COLECALCIFEROL], start date: 05Mar2018; QVAR REDIHALER, start date: 11May2022, stop date: 17May2022; SHAKLEE'S VITALIZER MULTIVITAMIN, start date: 30Oct2019; also reported as other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Negative; (25May2022) Positive, notes: I tested positive on a rapid at home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started from 11May2022 to 16May2022. Clinical course was reported as, the patient tested negative on 16May2022 and felt fine. She started noticing mild symptoms again around 22May2022 which she first assumed were allergies. But then she tested positive on a rapid at home test on 25May2022. No therapeutic measures were taken as result of symptoms. The patient was not recovered from the symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 11:30 as dose 3 (booster), single (Lot number: feb527) at the age of 51 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications and reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: symptoms returned after completing Paxlovid course and testing negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (start date: 02May2022, stop date: 06May2022). Clinical course was reported as, on 14May2022 the patient had symptoms returned after completing Paxlovid course and testing negative. No therapeutic measures were taken as result of symptoms and on 20May2022 patient was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: en6206), in right arm, on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: ff2590) at the age of 42 years, in right arm for covid-19 immunization. The patient had no relevant medical history and no known allergies. There were no concomitant medications; also reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) positive, notes: Rebound Covid positive test on day 8 after stopping Paxlovid 5 day treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 11May2022 and stopped on 15May2022. Clinical course was reported as, Symptoms reoccurred on 23May2022 and tested positive again on 22May2022. Rebound Covid positive test on day 8 after stopping Paxlovid 5 day treatment. No treatment received for symptoms and patient was recovering from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EN6208), on 12Apr2021 as dose 2, single (Lot number: EW0153) and on 31Dec2021 as dose 3 (booster), single (Lot number: 4302580) at the age of 51 years for covid-19 immunization. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa; "sore throat" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE; BUSPIRONE; SAM-E; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; SELENIUM; FISH OIL; MAGNESIUM; LUDEN'S taken for oropharyngeal pain; METHYL ASSIST; KSM-66; VCLEAR EPS 7630; also reported as other medication in 2weeks. Past drug history included: Codeine, reaction(s): "known allergies: Codeine"; Macrobid, reaction(s): "known allergies: macrobid"; Frovatriptin, reaction(s): "known allergies: frovatriptin". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid (Lot number: FY9901) started from 18May2022 to 23May2022. Clinical course was reported as, Metallic taste while taking medication. Burning tongue sensation after stopping or thrush; feels like recurrence of symptoms with cough, exhaustion started on 24May2022. The patient did not receive treatment for the symptoms and was not recovered from the symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: I lost my little brother to a Pfizer heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "I lost my little brother to a Pfizer heart attack". The patient date of death was unknown. Reported cause of death: "I lost my little brother to a Pfizer heart attack". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: I lost my little brother to a Pfizer heart attack
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Biopsy skin, Blood pressure diastolic, Blood pressure measurement, Blood pressure systolic
Clinical narrative: Postural orthostatic tachycardia syndrome; report describes neuropathic symptoms/Neurological symptoms/Severe orthostatic tachycardia, paler, diarrhea, fluctuation in blood pressure; This is a literature report.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid -19" (unspecified if ongoing). The patient's family history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE Unknown manufacture), for Covid -19 Immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown"; NEUROLOGICAL SYMPTOM (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "report describes neuropathic symptoms/Neurological symptoms/Severe orthostatic tachycardia, paler, diarrhea, fluctuation in blood pressure". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Biopsy skin: normal; 17.2; Normal; 11.1, notes: wnl; 15, notes: wnl; Blood pressure diastolic: Unknown result; Blood pressure measurement: fluctuation; Blood pressure systolic: Unknown result; Heart rate: Unknown result; Immunohistochemistry: Unknown result; Autonomic testing: POTS; Unknown result; Normal; CSF pattern II OCB;negative autoimmune, notes: dysautonomia panel; negative; Unknown result; Magnetic resonance imaging: Not Done; Neurological examination: Normal; Respiratory rate: Unknown result; Valsalva maneuver: Unknown result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200764439 Same article/ drug and different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Immunohistochemistry, Investigation, Magnetic resonance imaging, Neurological examination
Clinical narrative: Postural orthostatic tachycardia syndrome; report describes neuropathic symptoms/Neurological symptoms/Severe orthostatic tachycardia, paler, diarrhea, fluctuation in blood pressure; This is a literature report.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid -19" (unspecified if ongoing). The patient's family history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE Unknown manufacture), for Covid -19 Immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown"; NEUROLOGICAL SYMPTOM (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "report describes neuropathic symptoms/Neurological symptoms/Severe orthostatic tachycardia, paler, diarrhea, fluctuation in blood pressure". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Biopsy skin: normal; 17.2; Normal; 11.1, notes: wnl; 15, notes: wnl; Blood pressure diastolic: Unknown result; Blood pressure measurement: fluctuation; Blood pressure systolic: Unknown result; Heart rate: Unknown result; Immunohistochemistry: Unknown result; Autonomic testing: POTS; Unknown result; Normal; CSF pattern II OCB;negative autoimmune, notes: dysautonomia panel; negative; Unknown result; Magnetic resonance imaging: Not Done; Neurological examination: Normal; Respiratory rate: Unknown result; Valsalva maneuver: Unknown result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200764439 Same article/ drug and different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Postural orthostatic tachycardia syndrome, Respiratory rate, Valsalva maneuver
Clinical narrative: Postural orthostatic tachycardia syndrome; report describes neuropathic symptoms/Neurological symptoms/Severe orthostatic tachycardia, paler, diarrhea, fluctuation in blood pressure; This is a literature report.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid -19" (unspecified if ongoing). The patient's family history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE Unknown manufacture), for Covid -19 Immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown"; NEUROLOGICAL SYMPTOM (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "report describes neuropathic symptoms/Neurological symptoms/Severe orthostatic tachycardia, paler, diarrhea, fluctuation in blood pressure". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Biopsy skin: normal; 17.2; Normal; 11.1, notes: wnl; 15, notes: wnl; Blood pressure diastolic: Unknown result; Blood pressure measurement: fluctuation; Blood pressure systolic: Unknown result; Heart rate: Unknown result; Immunohistochemistry: Unknown result; Autonomic testing: POTS; Unknown result; Normal; CSF pattern II OCB;negative autoimmune, notes: dysautonomia panel; negative; Unknown result; Magnetic resonance imaging: Not Done; Neurological examination: Normal; Respiratory rate: Unknown result; Valsalva maneuver: Unknown result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200764439 Same article/ drug and different patient/event
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angioedema, Burning sensation, Lymphadenopathy, Pruritus, Urticaria
Clinical narrative: SWELLING OF THE LYMPH NODE UNDER ARM OF INJECTION SITE. SEVERE BURNING AND ITCHING URTICARIA  ON THE INSIDE OF THE THIGH, INSIDE CROOKS OF THE ELBOW HANDS, AND LOWER LIMBS ( KNEE'S ) COUPLED WITH ANGIOEDEMA OF THE LIPS.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Exposure during pregnancy, Foetal disorder
Clinical narrative: Normal pregnancy, due 2/4/22,  7 lbs 8 ounces  Baby was born with a large  brain tumor, a high grade glioma  Baby has hypospadius and an abdominal wall hernia
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Immunisation reaction, Tinnitus
Clinical narrative: following my booster Moderna shot, I had bilateral ears full for about 2 weeks, followed by Tinnitis which persists currently.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Dysstasia, Gait inability, Joint range of motion decreased, Pain
Clinical narrative: Dose 1-Injection site pain - very, very, sore, swollen which lasted about 1 week, back pain near scapula, which lasted for three weeks, fever for two days. Dose 2- Injection site pain, fever, under arm  lymph node pain for a week, weird back pain on entire back which lasted about a week. Dose 3- No side effects. Dose 4- Extreme lower back pain, across entire lower back and down both legs.  I could not stand, could not walk, could not bend for three days.  I had to lie flat for three days.  The fourth day was a little better. By the fifth day I was almost back to normal.  I will not get a 3rd booster.  The 4th shot was too frightening and painful. I feared my ability to walk was gone. I am done with the vaccines!
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Dose 1-Injection site pain - very, very, sore, swollen which lasted about 1 week, back pain near scapula, which lasted for three weeks, fever for two days. Dose 2- Injection site pain, fever, under arm  lymph node pain for a week, weird back pain on entire back which lasted about a week. Dose 3- No side effects. Dose 4- Extreme lower back pain, across entire lower back and down both legs.  I could not stand, could not walk, could not bend for three days.  I had to lie flat for three days.  The fourth day was a little better. By the fifth day I was almost back to normal.  I will not get a 3rd booster.  The 4th shot was too frightening and painful. I feared my ability to walk was gone. I am done with the vaccines!
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Interchange of vaccine products, Pain
Clinical narrative: "Screaming" headache (started @ 8pm, increased til midnight, continued til 10am next day), extreme fatigue, body aches, diarrhea (2 days). Took Tylenol which lessened headache and body aches somewhat.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: "Screaming" headache (started @ 8pm, increased til midnight, continued til 10am next day), extreme fatigue, body aches, diarrhea (2 days). Took Tylenol which lessened headache and body aches somewhat.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/07/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/07/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/07/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/07/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Joint swelling, Weight increased
Clinical narrative: Pt developed joint pain and swelling w/ dizziness (every 2 to 3 days) and 8 lb weight gain (? fluid)  since the booster was given.  In the process of seeing Rheum for further w/u but the swelling has not improved yet and it is still unclear if the vaccine may have triggered these symptoms.   Course of steroids helped but symptoms recurred after stopping.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Borrelia test negative
Clinical narrative: Bell's palsy which started on 4/19, patient was seen in the emergency department and given steroids and symptoms resolved
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness, Skin discolouration
Clinical narrative: Purple Toes and extreme foot pain particularly standing. Feet feel very cold, like your toes might break off.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Diarrhoea, Erythema, Localised oedema, Tenderness
Clinical narrative: in the evening after vaccination, pt experienced chills and loose stools. Resolved by next day 3 days later (on 5/23/22), pt started with tenderness and local edema of erythema of left deltoid (site of meningitis injection). Worsening on 5/24, then started to improve on 5/25 when pt was seen in clinic
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abortion spontaneous
Clinical narrative: After two full term pregnancies in 2018 and 2019, I had three miscarriages in six months. The only change in my life was getting the COVID-19 vaccine (Pfizer 1 and 2 and Moderna booster). Miscarriages all occurred at 5 weeks. Here are the dates: November 8, 2021 January 30, 2022 May 22, 2022
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/08/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and a repeat dose is recommended.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/08/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Strong headache for ~24 hours
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension
Clinical narrative: Several hours after vaccine, I become dizzy/light headed. I took blood pressure and it was 92/56.    I took 50 mg of Benadryl and the blood pressure came back up. Over the next several hours blood pressure remained low and a subsequent 50 mg of Benadryl was taken and finally blood pressure was up to 112/72.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: Pfizer Covid-19 vaccine administered on  04/08/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/08/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and a repeat dose is recommended.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis
Clinical narrative: Joint inflamation after shots.  Low back after first shot, left shoulder after second shot.  Neither was brought on by acute injury.  Overall inflamation was much higher following vaccination
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/08/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/09/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral herpes
Clinical narrative: Oral herpes after covid booster. I have never had a cold sore before. I woke up on the morning of May 27th with a swollen lip that apparently is a cold sore. This morning I have two little sores (not canker sores) in the inside of my lip. They look water filled. I'm single and I do not know how I would be getting this nor do I share anything (straws etc) with anyone. I researched side effects of the Pfizer vaccine and found that other people have reported getting oral herpes and shingles after getting the vaccine. I had the J&J vaccine 06/17/2021 and just got a sore arm.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Rash, Rash erythematous, Rash papular, Somnolence
Clinical narrative: Very sleepy. Lack of appetite. Red & raised bumps all over body.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site pain
Clinical narrative: Very sore in the left arm pit. Can?t use his left arm much. Started the day after the booster shot with arm sore at the injection site. The following two days has been very sore in the left arm pit.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: none
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: PATIENT RECEIVED BOOSTRIX ON 5/25/22.  ABOUT 36 HOURS LATER HE DEVELOPED HIVES AND ITCHING OVER HIS WHOLE BODY.  HE CONTACTED PHARMACY ON 5/28/22 TO SEE WHAT HE COULD TAKE.  SYMTOMS ARE NOT GETTING WORSE,  BUT SLIGHTLY BETTER TODAY. HE DID START A NEW SPECIALTY ANTIBIOTIC THAT IS MAILED TO HIM AND IS ON HIS 2ND 2 WEEK BOUT. HE DOESNT KNOW WHICH HE IS REACTING TO. BUT HE HAS NOT HAD ALLERGY TO TETANUS IN THE PAST.  I RECOMMENDED BENADRYL TO SEE IF THAT WOULD HELP, WHICH HE WILL TRY.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test, Computerised tomogram head, Computerised tomogram thorax, Intensive care
Clinical narrative: Shortly after my booster I began having severe pain in my left leg.  I went to the Urgent Care.  They gave me a cortisone injection and refused imaging.  The next day I went to my Primary Care Physician and requested imaging as the pain was at a level 8/9 which started in my calf, and was now in my biceps femoris.  He refused imaging.  He didn't ask if I had been vaccinated, and refused imaging.  A week later the pain returned, again he refused imaging.  On May 12th I was taken by ambulance to ER where they identified a Pulmonary Embolism from the first bout of pain, and another blood clot in my leg that should have been evident by the second bout of pain.  After three days in the ICU I was given a clot breaker, heparin, heparin shots, and after three days, released myself under the condition that I pick up a prescription of Pradaxa on the way home.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pulmonary embolism, Thrombosis, Ultrasound scan
Clinical narrative: Shortly after my booster I began having severe pain in my left leg.  I went to the Urgent Care.  They gave me a cortisone injection and refused imaging.  The next day I went to my Primary Care Physician and requested imaging as the pain was at a level 8/9 which started in my calf, and was now in my biceps femoris.  He refused imaging.  He didn't ask if I had been vaccinated, and refused imaging.  A week later the pain returned, again he refused imaging.  On May 12th I was taken by ambulance to ER where they identified a Pulmonary Embolism from the first bout of pain, and another blood clot in my leg that should have been evident by the second bout of pain.  After three days in the ICU I was given a clot breaker, heparin, heparin shots, and after three days, released myself under the condition that I pick up a prescription of Pradaxa on the way home.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: Redness, itching, and pain at injection site.  Patient also reports having had a fever which has resolved.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Tinnitus
Clinical narrative: Migraine headaches  Thumping in  both ears Chronic ringing in both ears
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pollakiuria
Clinical narrative: Beginning at about 12:30am May 25, I had to urinate and about every 60-90 minutes after that until about 7:30am that same day. After urination I never felt like I had completely emptied and felt a light pressure in the groin area. I have returned to a normal pattern since that episode.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: After receiving the 2nd Booster on 5/25... left arm very painful, then at about 48 hours after vaccine the left upper arm very swollen and painful, became erythematous with extending rash along lateral ram extending to antecubital area. Arm swelled to 3x normal size. Next morning swelling and red induration extended down to forearm. Tight swelling and painful.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin tightness
Clinical narrative: After receiving the 2nd Booster on 5/25... left arm very painful, then at about 48 hours after vaccine the left upper arm very swollen and painful, became erythematous with extending rash along lateral ram extending to antecubital area. Arm swelled to 3x normal size. Next morning swelling and red induration extended down to forearm. Tight swelling and painful.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Lethargy, Pain
Clinical narrative: 12 hours after booster was given, I developed a bad headache, all over body ache. I was also freezing for about an hour. The symptoms subsided by morning but I was lethargic most of that day.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, warmth, tender to the touch below injection site on arm.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt erroneously administered 30 mcg dose from gray cap vial
Age: 59.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives covering arms and legs, some on torso. Extremely itchy.  Still present one week later. No change in severity for the first five days with daily use of antihistamine.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: 102.8 fever under arm approximately 6 hours after injection.  5ml infant tylenol broke fever to 101.  Following day, fever 100 unmedicated.  Confirm with doctor what hep-b vaccine as chart is listed as "unspecified formulation"
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Headache
Clinical narrative: Patient received vaccine and began filling dizzy. She then said her head was hurting behind her eyes. Blood pressure was 161/99. Patient left with ems
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient was given 2ml of Pfizer orange cap vaccine that was diluted with 1.0 ml of diluent instead of 1.3 ml of diluent
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient was given a dose of Pfizer 5-11 yr orange cap that had been diluted with 1.0 ml diluent instead of 1.3 ml diluent.  There were no immediate reactions noted; parents were instructed to watch and notify us of any adverse reaction.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Stiffness of shoulder/neck area-Medium, Additional Details: Patient stated shortly after the vaccine her arm became red and swollen from elbow up and she had stiffness in the neck and shoulder area. The redness and swelling resolved, however she still has mobility issues in the arm and shoulder consistently.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was suppose to Receive a Menactra shot. However, a Havrix shot was given. No adverse events reported.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was given 2ml of Pfizer 5-11yr orange cap that had been prepared with 1.0ml of diluent instead of 1.3ml of diluent.  There was no adverse reaction noted at observation and none reported by parents 5 hours after vaccination.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient was given 2ml of Pfizer 5-11yr orange cap that had been prepared with 1.0ml of diluent instead of 1.3ml of diluent.  There was no adverse reaction noted at observation and none reported by parents 5 hours after vaccination.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: Patient complained of  difficulty breathing and swallowing  post vaccine.  Patient broke out into sweat became pale, lightheaded, and lost consciousness.   Patient  woke up and reported difficulty breathing  & ,rapid heart beat.   Patinet was given 50 mg of Benadryl and monitored by parents.  Patinet complains of constant fatigue  and low energy which has not resolved.  Patient also reports abnormal menstrual cycles.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Loss of consciousness, Menstrual disorder, Pallor
Clinical narrative: Patient complained of  difficulty breathing and swallowing  post vaccine.  Patient broke out into sweat became pale, lightheaded, and lost consciousness.   Patient  woke up and reported difficulty breathing  & ,rapid heart beat.   Patinet was given 50 mg of Benadryl and monitored by parents.  Patinet complains of constant fatigue  and low energy which has not resolved.  Patient also reports abnormal menstrual cycles.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient was given 2ml of Pfizer 5-11yr orange cap that had been prepared with 1.0ml of diluent instead of 1.3ml of diluent.  There was no adverse reaction noted at observation and none reported by parents 5 hours after vaccination.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Hypersomnia, Influenza, Pain in extremity
Clinical narrative: Flu symptoms, weakness, fatigue, sleeping all day. Sore arm
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE REACTION  REPORTED
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Laboratory test, Muscle spasms
Clinical narrative: Injection given at 3:30pm. At approximately 8pm, I began having an intense headache with dizziness, muscle aches, and low grade fever. At approximately 1:30am, fever spiked to 103 despite taking Tylenol and ibuprofen alternating, still having headache and dizziness and then I began full body shaking. Not chills but uncontrolled shaking and muscle spasms throughout body.  This continued for 5 hours with Intense body shaking, muscle spasms, fever, headache, dizziness, exhaustion and sore arm. The shaking and muscle spasms stopped but the other symptoms continued. Fever fluctuated between 101-103. I went to the doctor Friday morning at 11am to report this. As the time of filling this out, it is Saturday at 4pm and I still have headache, dizziness, fever between 99-101 while taking OTC meds, sore arm,  and fatigue.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Injection given at 3:30pm. At approximately 8pm, I began having an intense headache with dizziness, muscle aches, and low grade fever. At approximately 1:30am, fever spiked to 103 despite taking Tylenol and ibuprofen alternating, still having headache and dizziness and then I began full body shaking. Not chills but uncontrolled shaking and muscle spasms throughout body.  This continued for 5 hours with Intense body shaking, muscle spasms, fever, headache, dizziness, exhaustion and sore arm. The shaking and muscle spasms stopped but the other symptoms continued. Fever fluctuated between 101-103. I went to the doctor Friday morning at 11am to report this. As the time of filling this out, it is Saturday at 4pm and I still have headache, dizziness, fever between 99-101 while taking OTC meds, sore arm,  and fatigue.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 antibody test
Clinical narrative: This medication had expired without the knowledge of the medical assistants administering the medication.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: Lymphadenitis - 10 day course of antibiotics.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Suicidal ideation
Clinical narrative: Patient came back to my pharmacy 5/28 and said his shot on 5/25 gave him suicidal ideations.  He previous had these when taking Cipro.  He wants to make sure its being studied as he wants to help others.  He has a history of depression, currently on Trintellix but this medication caused him some great deal of suicidal ideation.  He had a headache start 4 hours after the shot.  The ideation happened the next 2 days on the 26th and 27th.  On the 28th he came in said he's feeling much better but he is reaching out to his psychiatrist.  He had pfizer on his other 3 doses and said he will probably not get moderna again unless he has a "babysitter".
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site pain
Clinical narrative: patient didn't report adverse reaction until today 5/28/22. But, patient had dark purple and yellow bruising from her shoulder down to her elbow. it started a few days after vaccination. this purple and yellow bruising has lasted almost a month now.  patient is still having some pain at the injection site.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
Clinical narrative: There was no adverse event reported. The parent of the patient purposefully lied about the patient's date of birth, resulting in the adult dose of the COVID-19 vaccine to be given to a patient who was eligible for the pediatric vaccine instead. This is not the first time the patient had done so, leading the writer to determine this was intentional.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Induration, Pain in extremity, Peripheral swelling, Pulmonary thrombosis
Clinical narrative: 2nd booster of Moderna COVID-19 Vaccine, administered 05/18/2022  5/18 Wednesday, within 2 hours I had swelling and pain in the arm, left leg started swelling  5/22 Sunday, the leg was very large and hard as a rock  5/23 Monday, ultrasound showed extensive blood clots in left leg from crotch to knee  5/23 Monday, Ct Scan showed many blood clots in lungs  5/23 Monday, admitted to ER   5/24 Tuesday, admitted to hospital   5/25 Thursday afternoon, left hospital with oxygen tank  5/25 in home oxygen system delivered and installed
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: 2nd booster of Moderna COVID-19 Vaccine, administered 05/18/2022  5/18 Wednesday, within 2 hours I had swelling and pain in the arm, left leg started swelling  5/22 Sunday, the leg was very large and hard as a rock  5/23 Monday, ultrasound showed extensive blood clots in left leg from crotch to knee  5/23 Monday, Ct Scan showed many blood clots in lungs  5/23 Monday, admitted to ER   5/24 Tuesday, admitted to hospital   5/25 Thursday afternoon, left hospital with oxygen tank  5/25 in home oxygen system delivered and installed
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph node under left arm  Fever, greater than 100.2
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: The patient received her vaccine Wednesday, 5/25/22 for their Adacel TDAP vaccine. Her doctor advised her to get one since it was 11 years since she last had one. She seemed fine after receiving her vaccine. On Saturday, 5/28/22, she approached the pharmacy and showed me her arm where she received her shot. It was red, hot, swollen, and painful. She had no signs of a systemic allergic reaction as well as no breathing issues. I informed her it was probably an injection site reaction, but since it was rather large (about 3 inches in diameter) I would report it and she were to call her doctor Tuesday if still an issue (closed Monday). I will also contact the patient and follow up with her.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Disturbance in attention, Fatigue, Feeling abnormal, Impaired work ability
Clinical narrative: Brain fog, unclear, mild confusion, brain and physical fatigue. Patient is a life sciences professional engineer with complaints of symptoms that will begin after receiving the vaccine. Patient has reported symptoms to his PCP and the  feedback. Patient says symptoms have been severe enough for him to opt out, miss out on important work activities as he's unable to focus, and respond to activities requiring short-term memory. Symptoms will improve within a week or two after the vaccine has been introduced.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Memory impairment, Mental fatigue, Mental impairment
Clinical narrative: Brain fog, unclear, mild confusion, brain and physical fatigue. Patient is a life sciences professional engineer with complaints of symptoms that will begin after receiving the vaccine. Patient has reported symptoms to his PCP and the  feedback. Patient says symptoms have been severe enough for him to opt out, miss out on important work activities as he's unable to focus, and respond to activities requiring short-term memory. Symptoms will improve within a week or two after the vaccine has been introduced.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site rash
Clinical narrative: Rash developed surrounding injection site approximately 42 hours after vaccination.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Patient had the area with pain, red and hot. You are advised to see your doctor.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN TO PATIENT, EXPIRED 5/2/22
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient - expired on 5/2/22
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE, VACCINE EXPIRED 5/2/22
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS EXPIRED AT TIME OF ADMINISTRATION - EXPIRED ON 5/2/22
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT, VACCINE EXPIRED 5/2/22
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Red, swollen arm, hot to touch, baseball sized. Looks bigger today than yesterday
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT, VACCINE EXPIRED 5/2/22
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE WAS ADMINISTERED TO PATIENT - EXPIRED ON 5/2/22
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT, VACCINE EXPIRED 5/2/22
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE WAS ADMINISTERED  TO PATIENT - EXPIRED ON 5/2/22
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: On 05/28/22 a patient with parent arrived with a document for a COVID (Pfizer) vaccine appointment from the previous day. The document was taken and processed and the vaccine was given. After vaccination, the incident was discovered. The standard Pfizer 0.3 mL dose was administered in place of the pediatric vaccination dose. No known adverse effects from the incident, patient's parent was informed and understanding.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE WAS ADMINISTERED TO PATIENT - EXPIRED ON 5/2/22
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT, VACCINE EXPIRED 5/2/22
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT - EXPIRED ON 5/2/22
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT, VACCINE EXPIRED 5/2/22
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE WAS ADMINISTERED TO PATIENT - EXPIRED ON 5/2/22
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT, VACCINE EXPIRED 5/2/22
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE WAS ADMINISTERED TO PATIENT - EXPIRED ON 5/2/22
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Nausea, Rash macular
Clinical narrative: Nausea, lethargy, blotchy redness on the arm with the injection
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE ADMINSTERED TO PATIENT WAS EXPIRED - EXPIRED ON 5/2/22
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT, VACCINE EXPIRED 5/2/22
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT, VACCINE EXPIRED 5/2/22
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS EXPIRED WHEN ADMINISTERED TO PATIENT - EXPIRED ON 5/2/22
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient had an injection site reaction starting the morning after receiving immunization. The injection site area was red, hot to the touch, hard/swollen, and painful. These symptoms have persisted til today. She is using ice, ibuprofen, and acetaminophen to  help with pain and swelling.
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth
Clinical narrative: Patient had an injection site reaction starting the morning after receiving immunization. The injection site area was red, hot to the touch, hard/swollen, and painful. These symptoms have persisted til today. She is using ice, ibuprofen, and acetaminophen to  help with pain and swelling.