chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Condition aggravated, Nephropathy, Presyncope
Clinical narrative: Vaso vagal; Uveitis aggravated; Condition aggravated; Renal disease aggravated; Renal disease aggravated; sarcoidosis aggravated; sarcoidosis aggravated; This is a spontaneous report from a contactable consumer. This consumer reported in response to consumer letter sent via follow-up letter.  A 46-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202, Expiration date: unknown), via intramuscular route of administration, administered in right arm on 27Feb2021 at 04:00 pm (at the age of 46-year-old) as dose 2, single for COVID-19 immunization. Patient historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9809) via intramuscular route of administration administered in right arm as dose 1, single on 06Feb2021 1:00 pm for COVID-19 immunisation and patient experienced Extreme Fatigue, sarcoidosis, Uveitis, Renal disease aggravations. The patient medical history includes Covid -19 from 09July2020 till 26Jul2020 with no hospitalization and breast cancer from 12Oct2006 to 15Mar2007 (Stage 2. Treated with Lumpectomy, chemo, radiation). concomitant medications included escitalopram oxalate (LEXAPRO), orally at 30 mg for Anxiety, buspirone hydrochloride (BUSPAR) orally at 5 mg (twice a day) orally for Anxiety, prednilison and cyclopentolate Hcl ophthalmic for uveitis, levocetirizine dihydrochloride (XYZAL), oral 5mg for allergy, Potassium chloride 20 meq (twice a day) orally for kidney potassium, iron- orally 30 mg for anaemia all from an unspecified date and ongoing. The patient did not take any prior vaccinations within 4 weeks. On 04Mar2021, 4 days after the vaccination, the patient experienced Vaso vagal which resulted in hospitalisation, also patient experienced worsening of uveitis, sarcoidosis and renal disease after second dose of vaccine. Patient had sarcoidosis caused by Covid-19 (Jul2020) and then worsened/ flared by vaccine. Patient has uveitis, fatigue and renal disease. Under care of GP, Nephrologist, retina specialist and rheumatologist. Treatment was given to the patient with prednisone 60 mg. Patient lab data includes blood test with unknown result in Mar2021 and chest X-ray with normal findings in Mar2021. The outcome of the event vasovagal (presyncope) was recovered on 07Mar2021, and the outcome of uveitis and renal disease aggravated was not recovered and the outcome of sarcoidosis aggravated was unknown.  No follow-up attempts possible. No further information expected.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Sarcoidosis, Uveitis
Clinical narrative: Vaso vagal; Uveitis aggravated; Condition aggravated; Renal disease aggravated; Renal disease aggravated; sarcoidosis aggravated; sarcoidosis aggravated; This is a spontaneous report from a contactable consumer. This consumer reported in response to consumer letter sent via follow-up letter.  A 46-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202, Expiration date: unknown), via intramuscular route of administration, administered in right arm on 27Feb2021 at 04:00 pm (at the age of 46-year-old) as dose 2, single for COVID-19 immunization. Patient historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9809) via intramuscular route of administration administered in right arm as dose 1, single on 06Feb2021 1:00 pm for COVID-19 immunisation and patient experienced Extreme Fatigue, sarcoidosis, Uveitis, Renal disease aggravations. The patient medical history includes Covid -19 from 09July2020 till 26Jul2020 with no hospitalization and breast cancer from 12Oct2006 to 15Mar2007 (Stage 2. Treated with Lumpectomy, chemo, radiation). concomitant medications included escitalopram oxalate (LEXAPRO), orally at 30 mg for Anxiety, buspirone hydrochloride (BUSPAR) orally at 5 mg (twice a day) orally for Anxiety, prednilison and cyclopentolate Hcl ophthalmic for uveitis, levocetirizine dihydrochloride (XYZAL), oral 5mg for allergy, Potassium chloride 20 meq (twice a day) orally for kidney potassium, iron- orally 30 mg for anaemia all from an unspecified date and ongoing. The patient did not take any prior vaccinations within 4 weeks. On 04Mar2021, 4 days after the vaccination, the patient experienced Vaso vagal which resulted in hospitalisation, also patient experienced worsening of uveitis, sarcoidosis and renal disease after second dose of vaccine. Patient had sarcoidosis caused by Covid-19 (Jul2020) and then worsened/ flared by vaccine. Patient has uveitis, fatigue and renal disease. Under care of GP, Nephrologist, retina specialist and rheumatologist. Treatment was given to the patient with prednisone 60 mg. Patient lab data includes blood test with unknown result in Mar2021 and chest X-ray with normal findings in Mar2021. The outcome of the event vasovagal (presyncope) was recovered on 07Mar2021, and the outcome of uveitis and renal disease aggravated was not recovered and the outcome of sarcoidosis aggravated was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Retinal vasculitis
Clinical narrative: I had two of my patients have retinal vasculitis after getting the Pfizer-BioNTech COVID-19 vaccine; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number and Expiration date was not reported),via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter, who worked in the clinic but was also involved in research, reported that the Pfizer-BioNTech COVID-19 vaccine has a design flaw because "they left the transmembrane domain in the mRNA and that can lead to cell damage. He had seen people lose their eyes, have immune activation, and have had patients die on me. He was going to the Post and the media and everybody to try and block full approval. He had already reached out to the FDA and asked to block approval but have not heard anything back yet. There was not enough thought, and testing done, and it was a mistake to use the whole spike mRNA. If you are immune and get the spike mRNA, it can cause a lot of damage. It gets stuck in the membrane and does not get secreted. It can cause T-call attack and antibody and compliment attack, and they can wind up with a lot of problems. There is a good chance this is the reason for the myocarditis seen in some young men, the pericarditis we have seen in quite number of patients, and vasculopathy with related clotting. He had two of his patients lose their eyes due to central retinal vein thrombosis after the second dose of the Pfizer-BioNTech COVID-19 vaccine. He had two of his patients have retinal vasculitis after getting the Pfizer-BioNTech COVID-19 vaccine. He was concerned if they go 6 to 9 months from now and tell people to get a booster of the Pfizer-BioNTech COVID-19 vaccine, we might see horrors. He had stopped recommending the Pfizer-BioNTech COVID-19 vaccine to all my patients and my family. I am very pro vaccine but think we need to be more vigilant with the Pfizer-BioNTech COVID-19 vaccine. The reporter refused transfer to Safety saying he was at the clinic right now and did not have time. He agreed to be contacted by Safety for follow-up if needed. The outcome of event was unknown.  Information about batch/Lot number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Retinal vasculitis and the suspect drug  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient vaccinated by both IPOL and KINRIX / No AE; Initial information received on 26-Jun-2021 regarding an unsolicited valid non-serious case received from other healthcare professional via call center via Agency (reference number- 00657668).  The case was linked to 2021SA215597 (same reporter).  This case involves a 4-years-old male patient who vaccinated with double dose of polio vaccine from suspect IPV (VERO) [IPOL] (strength: standard, frequency: once, batch number: 26-Jun-2021 and expiry date: 25-Jul-2022 via intramuscular route in right arm) and fourth dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [KINRIX] (batch number and expiry date not reported) (extra dose administered) on 26-Jun-2021 for prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to extra dose administered (latency: same day).  Reporter calling to find out if there are any known side effects for someone who got 2 doses of polio. Caller wants to know what to look for since it was given today at the clinic to twins. It was reported as dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5ml.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Chest discomfort, Heart rate increased
Clinical narrative: Heart beat increase. Chest tight. Short of breath. Blood pressure fluctuate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Headache, Inflammation, Neck pain
Clinical narrative: I had typical common side effects for the two days following the second vaccine (fever, chills, body ache and head ache).  Beginning on third day following the second vaccine started severe pain in back of neck, left should blade and arm.  Started on Celebrex and steroid to help with inflammation.  Nothing is cutting the pain.  Muscle relaxers along with prescription pain medication helps slightly.  Pain is severe still almost one month later with only being able to sleep a couple of hours at night because of pain.  Pain seems to be worse at night than during the day.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: I had typical common side effects for the two days following the second vaccine (fever, chills, body ache and head ache).  Beginning on third day following the second vaccine started severe pain in back of neck, left should blade and arm.  Started on Celebrex and steroid to help with inflammation.  Nothing is cutting the pain.  Muscle relaxers along with prescription pain medication helps slightly.  Pain is severe still almost one month later with only being able to sleep a couple of hours at night because of pain.  Pain seems to be worse at night than during the day.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AEs reported; administration of improperly stored VARIVAX; This spontaneous report as received from a physician refers to a 17-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 11-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, one time (route of administration and anatomical location were not reported) lot # T025944, expiration date: 30-JUL-2022 for prophylaxis. No adverse event was reported.  Administered dose of vaccine underwent the temperature excursion of 19.7 degrees Fahrenheit (F) max, 14F to 46 F for 2 hours, 6F to 14F for 40 minutes. Digital data logger was involved. There were no previous excursions reported.
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Anaphylactic reaction, Hypersensitivity, Rash, Swelling, Vaccination complication
Clinical narrative: anaphylaxis and allergic reactions; This spontaneous report was received from a consumer concerning herself. No concurrent condition, medical history, or concomitant therapy was reported.   On unknown dates, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were unknown) and zoster vaccine live (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were unknown) (reported as unspecified Hepatitis A vaccine and unspecified "shingles shot'') for prophylaxis.    She had anaphylaxis and allergic reactions to the vaccines. Unspecified Hepatitis A vaccine affected her for 6 months. Unspecified "shingles shot'' caused swelling and rash on unknown dates. The outcome of anaphylaxis and allergic reactions was unknown. The reporter considered the event to be related to the both vaccines.     Upon internal review, anaphylaxis and allergic reactions was determined to be medically significant.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2101USA013273: US-009507513-2101USA013252:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a 4 years old patient. No medical history, concurrent condition, or concomitant therapy was reported.       On 14-JUN-2021, there was a temperature excursion on measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). This vaccine was improperly stored at the temperature of 6 F to 14 F (10 F) for 7 hours (product storage error). On the same day, the patient was vaccinated with this improper vaccine (lot # T027112, expiration date: 07-FEB-2022; dose, frequency and route were not reported) as prophylaxis. Previously, there was also temperature excursion at 6 F to 14 F (6.10 F) for 1 hour 30 minutes. The call was not because of a data logger. No adverse event was reported.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No AE; Drug administered to patient of inappropriate age; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a 16 years old patient. No medical history, concurrent condition, or concomitant therapy was reported.       On 01-JUN-2021, there was a temperature excursion on measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). This vaccine was improperly stored at the temperature of 6 F to 14 F (10 F) for 7 hours (product storage error). On the same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027112, expiration date: 07-FEB-2022; dose, frequency and route were not reported) as prophylaxis (product administered to patient of inappropriate age). Previously, there was also temperature excursion at 6 F to 14 F (6.10 F) 1 hour 30 minutes. The call was not because of a data logger. No adverse event was reported.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Injection site mass
Clinical narrative: BLOOD SQUIRTED; LUMP AT INJECTION SITE; This spontaneous report received from a pharmacist concerned a unknown age, race, and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood squirted, and lump at injection site. The HCP was informed these events had to be reported, but did not want to report them. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood squirted and lump at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210709552-covid-19 vaccine ad26.cov2.s-blood squirted. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination site pain, Vomiting
Clinical narrative: sick in the stomach and throwing up; sick in the stomach and throwing up; Soreness in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick in the stomach and throwing up), VOMITING (sick in the stomach and throwing up) and VACCINATION SITE PAIN (Soreness in the arm of injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included CALCIUM and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced ILLNESS (sick in the stomach and throwing up) (seriousness criterion medically significant), VOMITING (sick in the stomach and throwing up) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Soreness in the arm of injection) (seriousness criterion medically significant). On 05-Feb-2021, ILLNESS (sick in the stomach and throwing up), VOMITING (sick in the stomach and throwing up) and VACCINATION SITE PAIN (Soreness in the arm of injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications also included were hypertensive medications 1 pill a day and statin at night from an unknown date. Treatment information was not provided by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria none of the events was serious (not IME listed and resolved).   This case was linked to MOD-2021-237390 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria none of the events was serious (not IME listed and resolved).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: severe pain ,difficult to brush teeth due to pain & difficult to eat due to pain & difficult to talk due to pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (severe pain ,difficult to brush teeth due to pain & difficult to eat due to pain & difficult to talk due to pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 000) for COVID-19 vaccination.     Concurrent medical conditions included Trigeminal neuralgia and Epilepsy. Concomitant products included PHENYTOIN (DILANTIN [PHENYTOIN]) and PREGABALIN (LYRICA) for Neuropathic pain, LEVETIRACETAM for Seizures.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (severe pain ,difficult to brush teeth due to pain & difficult to eat due to pain & difficult to talk due to pain) (seriousness criterion intervention required). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; PHENYTOIN (DILANTIN [PHENYTOIN]) at a dose of 300 mg and Surgery for Myalgia. At the time of the report, MYALGIA (severe pain ,difficult to brush teeth due to pain & difficult to eat due to pain & difficult to talk due to pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported severe pain and was difficult to brush her teeth, eat and talk without experiencing pain at a higher level then had been experienced prior to receiving the Moderna vaccine. Treatment also includes surgery and a sponge was placed between the nerve and vein to reduce pain which patient reported was working. Prior to surgery, he was taking high doses of pain medication as well as anti seizure medication to control epilepsy. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-237448 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Peripheral swelling
Clinical narrative: Temporary loss of vision; unilateral leg swelling; This spontaneous case was reported by a physician and describes the occurrence of BLINDNESS TRANSIENT (Temporary loss of vision) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement. Concurrent medical conditions included Blood pressure high since 2014 and Benign prostatic hypertrophy since 2000.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLINDNESS TRANSIENT (Temporary loss of vision) (seriousness criterion medically significant) and PERIPHERAL SWELLING (unilateral leg swelling). At the time of the report, BLINDNESS TRANSIENT (Temporary loss of vision) and PERIPHERAL SWELLING (unilateral leg swelling) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-235138, MOD-2021-040178 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow normal, Blood test, Contusion, Full blood count, Immunoglobulin therapy
Clinical narrative: Noticed Petechiae, bruising and blood blisters in mouth 6/15/21.  Went to urgent care and had CBC done and platelets were at 2,000 and was instructed to go to ER.  Got second opinion from primary care physician an instructed to go to ER.  Went to ER on 6/15/21 and was immediately admitted to hospital.  Began steroid IV treatment and had completed blood profile done.  Underwent bone marrow biopsy and abdominal ultrasound 6/18/21 - all normal.  Was given platelet infusion and human immune globulin infusions.  Release from hospital on 6/21/21 with platelet count at 32,000.  Continued steroid treatment and regular CBC tests.  Platelet count dropped to 6,000 on 7/2/21 and was readmitted to hospital.  Given steroid infusions and began 1 of 4 Bitruxan treatments. Released from hospital on 7/5/21.  Continuing steroid treatment and Bitruxan  treatments with regular CBC tests.  Outcome to be determined
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Oral blood blister, Petechiae, Platelet count decreased, Platelet transfusion, Ultrasound abdomen normal
Clinical narrative: Noticed Petechiae, bruising and blood blisters in mouth 6/15/21.  Went to urgent care and had CBC done and platelets were at 2,000 and was instructed to go to ER.  Got second opinion from primary care physician an instructed to go to ER.  Went to ER on 6/15/21 and was immediately admitted to hospital.  Began steroid IV treatment and had completed blood profile done.  Underwent bone marrow biopsy and abdominal ultrasound 6/18/21 - all normal.  Was given platelet infusion and human immune globulin infusions.  Release from hospital on 6/21/21 with platelet count at 32,000.  Continued steroid treatment and regular CBC tests.  Platelet count dropped to 6,000 on 7/2/21 and was readmitted to hospital.  Given steroid infusions and began 1 of 4 Bitruxan treatments. Released from hospital on 7/5/21.  Continuing steroid treatment and Bitruxan  treatments with regular CBC tests.  Outcome to be determined
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms or reactions were developed by client
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms or adverse reactions were reported by client
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms or adverse reactions were reported by client
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: No symptoms or adverse reactions reported by client
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient had slight rash posterior base of neck to mid back.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was given the PFIZER COVID SHOT (1st Shot)... The patient was informed to seat for 15 minutes after the shot. Unfortunately, he arised from his seat accidently prior to the 15 mins and fell down.. He had a dizzy spell.. He is currently being monitored by EMT and the emergency room. Prior to leaving the pharmacy he was doing much better and responsive.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: Severe body aches, joint pain, headaches, chills, diarrhea, sweating for 1.5 days. Severe headaches have continued but not as frequently. Swollen lymph nodes near right breast and under right arm (pain went away after 3 days).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Severe body aches, joint pain, headaches, chills, diarrhea, sweating for 1.5 days. Severe headaches have continued but not as frequently. Swollen lymph nodes near right breast and under right arm (pain went away after 3 days).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Flushing, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Severe, Additional Details: Patient fainted 5 minutes after vaccine administered. Patient came to within a minute. Refused to be sent to the hospital. Patieent was given water and a ice pack. Girlfriend picked up patient.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Myocarditis, Pericarditis, Vaccination complication
Clinical narrative: 19 y.o. patient who was hospitalized with the diagnosis of vaccine related pericarditis/myocarditis after developing SOB and chest pain.  She is going to try to get more information on this patient, but she needs his consent. I will speak with patients father. In the interim, she is going to check with the hospital. In regards to the discharge summary, we will have to wait until the patient is discharged today, and it is translated. The reaction occurred about 3 days after receiving second dose.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Hypotension, Listless, Pallor
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: I gave the patient the vaccine and within 5 minutes she reported to her mother her vision was blurry and she did not feel right. Shortly after reporting this she fainted and her eyes went back into her head. I ran to her and helped her mother lower her to the ground. I noticed her eyes were now open but she was pale and listless. I called to a tech to call 911. I asked her if she could speak and she nodded. I asked if she had eaten and she shook her head no and her mother said she had not.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli, Vision blurred, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: I gave the patient the vaccine and within 5 minutes she reported to her mother her vision was blurry and she did not feel right. Shortly after reporting this she fainted and her eyes went back into her head. I ran to her and helped her mother lower her to the ground. I noticed her eyes were now open but she was pale and listless. I called to a tech to call 911. I asked her if she could speak and she nodded. I asked if she had eaten and she shook her head no and her mother said she had not.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Facial pain, Pallor, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pale and slight pain on left cheek/gave water.   Patient stated she didn't eat anything all day except Chexmix.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: pt fell from chair and felt dizzy and fainted .Rph got water and gatorade . she felt  better and went home . Rph checkecd  on pt .Mom have taled tp pedtricaid . she was much better . no too much concerned
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Hyperhidrosis, Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient had adverse side effect 30 mins after the vaccine administration. Patient had difficulty breathing, rash on the arm where injection was given and it radiating out to the forearm. Patient managed the adverse effects by taking benadryl. Upon doctor's visit medrol dose pak was prescribed. Advese effects are under control.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient had adverse side effect 30 mins after the vaccine administration. Patient had difficulty breathing, rash on the arm where injection was given and it radiating out to the forearm. Patient managed the adverse effects by taking benadryl. Upon doctor's visit medrol dose pak was prescribed. Advese effects are under control.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: After vaccination patient was instructed to wait 15 minutes in the store, within a few minutes pharmacist was alerted patient had fainted. 911 was contacted immediately, patients vitals were checked, patient was breathing/normal pulse. Patient became responsive and allerted severe anxiety to needles and noted fainting had occured in the past.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Left atrial enlargement
Clinical narrative: After my second dose of Moderna (which was on 1/26/21), I started having palpitations on Feb. 19th.  I also experienced occasional shoulder blade pain while running while exercising.  I was attributing the palpitations to possibly being anxiety and working the night shift, but they persisted, so I eventually went to see my Doctor on April 30th.  To this day, I continue to have palpitations (despite stopping caffeine for a period of time back in Feb/March).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mitral valve incompetence, Mitral valve prolapse, Palpitations, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: After my second dose of Moderna (which was on 1/26/21), I started having palpitations on Feb. 19th.  I also experienced occasional shoulder blade pain while running while exercising.  I was attributing the palpitations to possibly being anxiety and working the night shift, but they persisted, so I eventually went to see my Doctor on April 30th.  To this day, I continue to have palpitations (despite stopping caffeine for a period of time back in Feb/March).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram ST segment abnormal, Electrocardiogram ST segment elevation, Electrocardiogram T wave inversion, Myocarditis
Clinical narrative: Patient developed chest pain and was found to have elevated troponin and ECG changes consistent with myocarditis. Was admitted and observed on telemetry and given scheduled NSAIDs and troponin trended. Symptoms resolved and troponin improved however remained elevated and patient was discharged with 1 week follow up and cardiac MRI ordered.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin I increased, Troponin increased
Clinical narrative: Patient developed chest pain and was found to have elevated troponin and ECG changes consistent with myocarditis. Was admitted and observed on telemetry and given scheduled NSAIDs and troponin trended. Symptoms resolved and troponin improved however remained elevated and patient was discharged with 1 week follow up and cardiac MRI ordered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Rash, Urticaria
Clinical narrative: First vaccine 04/23/21. Starting exactly one week after first dose, I broke out in a hive rash on both thighs which lasted a couple hours.  Subsequent rash outbreaks occurred on 05/07, 05/21, 05/28, 06/03, 06/04, 06/05, 06/06, 06/17, 06/29, 06/30, 07/02.  Second vaccine was received 06/04/2021.    I am currently pregnant and due 10/29/2021.  OBGYN unsure if it?s a pregnancy related symptom, or what the cause is.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Blood test, Computerised tomogram, Fall, Gait disturbance
Clinical narrative: Approximately 9 days after receiveing Covid19 shot I start having issues with my legs where they felt very heavy. Over the course of the next approx 17 days my legs got weaker, walking became more difficult, my balance started to be affected.  My legs would randomly collapse and I would fall.  By the 17th day I was barely able to walk and what little I could was only for very short distances, less than 50'!  On June 15th I went to the Emergency room located at where multiple tests were run on me.  I was admitted into the hospital with Guillan-Barre Syndrome and I was given four doses of Immune Globulin (IVIG) and sent over to rehabilitation.  After four days I went back to ER with recurring symptoms was returned to Rehab facility and five days later I  returned to hospital a 3rd time and was five more rounds of Immune Globulin, I have again been returned to rehabilitation facility.  As of this writing of this I have been hospitalized 23 days and I have at least 14 days more of rehabi before I can go home in a wheel chair.  My full revcovery outlook is 6-12 months.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Limb discomfort, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Approximately 9 days after receiveing Covid19 shot I start having issues with my legs where they felt very heavy. Over the course of the next approx 17 days my legs got weaker, walking became more difficult, my balance started to be affected.  My legs would randomly collapse and I would fall.  By the 17th day I was barely able to walk and what little I could was only for very short distances, less than 50'!  On June 15th I went to the Emergency room located at where multiple tests were run on me.  I was admitted into the hospital with Guillan-Barre Syndrome and I was given four doses of Immune Globulin (IVIG) and sent over to rehabilitation.  After four days I went back to ER with recurring symptoms was returned to Rehab facility and five days later I  returned to hospital a 3rd time and was five more rounds of Immune Globulin, I have again been returned to rehabilitation facility.  As of this writing of this I have been hospitalized 23 days and I have at least 14 days more of rehabi before I can go home in a wheel chair.  My full revcovery outlook is 6-12 months.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Approximately 9 days after receiveing Covid19 shot I start having issues with my legs where they felt very heavy. Over the course of the next approx 17 days my legs got weaker, walking became more difficult, my balance started to be affected.  My legs would randomly collapse and I would fall.  By the 17th day I was barely able to walk and what little I could was only for very short distances, less than 50'!  On June 15th I went to the Emergency room located at where multiple tests were run on me.  I was admitted into the hospital with Guillan-Barre Syndrome and I was given four doses of Immune Globulin (IVIG) and sent over to rehabilitation.  After four days I went back to ER with recurring symptoms was returned to Rehab facility and five days later I  returned to hospital a 3rd time and was five more rounds of Immune Globulin, I have again been returned to rehabilitation facility.  As of this writing of this I have been hospitalized 23 days and I have at least 14 days more of rehabi before I can go home in a wheel chair.  My full revcovery outlook is 6-12 months.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Approximately 9 days after receiveing Covid19 shot I start having issues with my legs where they felt very heavy. Over the course of the next approx 17 days my legs got weaker, walking became more difficult, my balance started to be affected.  My legs would randomly collapse and I would fall.  By the 17th day I was barely able to walk and what little I could was only for very short distances, less than 50'!  On June 15th I went to the Emergency room located at where multiple tests were run on me.  I was admitted into the hospital with Guillan-Barre Syndrome and I was given four doses of Immune Globulin (IVIG) and sent over to rehabilitation.  After four days I went back to ER with recurring symptoms was returned to Rehab facility and five days later I  returned to hospital a 3rd time and was five more rounds of Immune Globulin, I have again been returned to rehabilitation facility.  As of this writing of this I have been hospitalized 23 days and I have at least 14 days more of rehabi before I can go home in a wheel chair.  My full revcovery outlook is 6-12 months.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome
Clinical narrative: Approximately 9 days after receiveing Covid19 shot I start having issues with my legs where they felt very heavy. Over the course of the next approx 17 days my legs got weaker, walking became more difficult, my balance started to be affected.  My legs would randomly collapse and I would fall.  By the 17th day I was barely able to walk and what little I could was only for very short distances, less than 50'!  On June 15th I went to the Emergency room located at where multiple tests were run on me.  I was admitted into the hospital with Guillan-Barre Syndrome and I was given four doses of Immune Globulin (IVIG) and sent over to rehabilitation.  After four days I went back to ER with recurring symptoms was returned to Rehab facility and five days later I  returned to hospital a 3rd time and was five more rounds of Immune Globulin, I have again been returned to rehabilitation facility.  As of this writing of this I have been hospitalized 23 days and I have at least 14 days more of rehabi before I can go home in a wheel chair.  My full revcovery outlook is 6-12 months.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Fatigue the next day, then extreme joint pain, extreme headache, difficulty in breathing, foggy feeling in brain, allergy symptoms, weakness
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Fatigue the next day, then extreme joint pain, extreme headache, difficulty in breathing, foggy feeling in brain, allergy symptoms, weakness
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock 15 minutes after being vaccinated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Injury, Product administration error
Clinical narrative: During injection, felt burning in arm, across the top of shoulder, and up my neck into my head.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Myocarditis, Palpitations, Pericarditis
Clinical narrative: myocarditis/pericarditis - shortness of breath, heart palipations, chest pains ongoing for multiple weeks
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: administration error
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: I can't say that I had an adverse reaction to the Covid10 shot. Only that I was sick from the end of May 2021 thru June 2021 with some sort of respiratory illness that took about a month to get better.  I took antibiotics and ended up in the ER as my doctor advised me to get check out to make sure I didn't have a blood clot in my lungs.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: I can't say that I had an adverse reaction to the Covid10 shot. Only that I was sick from the end of May 2021 thru June 2021 with some sort of respiratory illness that took about a month to get better.  I took antibiotics and ended up in the ER as my doctor advised me to get check out to make sure I didn't have a blood clot in my lungs.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: The person received Pfizer Covid Vaccine on 4/22/21.  We administered based on the information received from patient. The person denied received any previous Covid vaccines prior to 4/22/21 appointment. Upon investigation of the this person had received two doses on 3/15/21 and 4/5/21. We attempted to contact the patient to determine whether or not this patient had indeed received a third dose and to check if they had any adverse events. After multiple attempts person was not able to be reached.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head, Laboratory test
Clinical narrative: Bells Palsy