chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Headache, Injection site rash, Oropharyngeal pain, Rash erythematous
Clinical narrative: Headache; difficulty swallowing; rash at injection site; sore throat; Red body rash; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on an unknown date, for tolerance refer case US2021AMR194171). Concurrent medical conditions included multiple allergies (taking medication for allergy).   On 7th September 2021, the patient received the 2nd dose of Shingrix. On 8th September 2021, 1 days after receiving Shingrix, the patient experienced headache. In September 2021, the patient experienced swallowing difficult, injection site rash, sore throat and red rash. On an unknown date, the outcome of the headache, swallowing difficult, injection site rash, sore throat and red rash were unknown.   It was unknown if the reporter considered the headache, swallowing difficult, injection site rash, sore throat and red rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not provided but it could be 59 or 60 years. The patient had allergies and was taking medication for them (allergy pills). The patient received 2nd dose of Shingrix in her left arm and had headache the day after the injection. After 2 days of vaccination, the patient went to hospital emergency room because she had pain, sore throat, had difficulty swallowing and had a rash at injection site but also a red rash on her entire body. No other information was provided. The patient refused to provide name, date of birth or demographics. The patient did not consent to follow-up.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, HEP, HIBV, TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursion, some were administered; This case was reported by a other health professional and described the occurrence of incorrect product storage in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Boostrix, Engerix B and Hiberix. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Boostrix, Engerix B and Hiberix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported by Medical assistant. The age at vaccination was not reported. Medical assistant reported that, several doses of Kinrix, Pediarix, Boostrix, Engerix-B, Hiberix and Rotarix suffered a temperature excursion below freezing temperatures (on Aug 6th 2021, doses were exposed from 28.88 degree F up to 47.15 degree F) and that some of these vaccines were administered to several patients, which led to incorrect product storage. Health care professional mentioned that needs time to revised files in order to had patient's details involved in this situation. The reporter consented to follow-up.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Accidental exposure to product, Exposure via eye contact
Clinical narrative: accidental exposure (eye); accidental exposure (eye); This case was reported by a nurse via call center representative and described the occurrence of accidental occupational exposure to product in a 26-year-old female patient who received HBV (Engerix B) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 13th September 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced accidental occupational exposure to product and exposure via eye contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via eye contact were recovered/resolved.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported by Nurse Practitioner. Age at vaccination was not reported. The reporter reported that, a colleague who was also an health care professional got some Kinrix vaccine into her eye, which led to accidental occupational exposure to product and exposure via eye contact. No symptoms were reported. The call was transferred to Medical information quickly for instructions to eye wash to be provided. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes Zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 11th March 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up via email.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the adjuvant component of Shingrix only.; administered the adjuvant component of Shingrix only.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MM59F, expiry date 14th October 2022) for prophylaxis.   On 27th August 2021, the patient received the 1st dose of Shingrix. On 27th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional detaails were provided as follows: The medical assistant reported that, the patient was administered the adjuvant component of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise
Clinical narrative: Malaise; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2021, several hours after receiving Shingrix, the patient experienced malaise and fatigue. In August 2021, the outcome of the malaise and fatigue were recovered/resolved.   It was unknown if the reporter considered the malaise and fatigue to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient's wife. The patient received 0.5 ml of 2nd dose of Shingrix in the second week of August 2021 and after hours of vaccination, the patient had malaise and fatigue. The malaise and fatigue were resolved after a day and a half. The reporter did not consented to follow-up. The case was linked with case US2021194319 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021194319:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st in 2019, hasn't received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, did they need to restart the series. No further details on patient or vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional would like to know how to proceed on this case. The health care professional did not have any vaccine information. The reporter stated that, the patient had not received the vaccine at the time of the call. The reporter consented to follow up by phone. The VAERS details were reported for 1st dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: shot 1 in November 2020, has not received shot 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had mild case of shingles during pregnancy). Previously administered products included Shingrix (1st dose received intramuscularly in an unspecified deltoid during the first week of November 2020 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix and was past the 6 month window, which led to incomplete course of vaccination. The reporter did not consent to follow with physician. The VAERS detail provided for 1st dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: first dose January 2020, late for second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. No patient's identifiers provided. No lot number and expiration date provided. No specific vaccination date provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received at least 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not have patient details at time of call, only gender. The VAERS details reported for 1st dose of Shingrix.
Age: 0.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old was given Kinrix; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by patient's mother. The patient's mother stated that 4 month old son was given a shot of Kinrix which was indicated for 4 to 6 year old children, which led to inappropriate age at vaccine administration. No health care professional information was provided. The reporter did not consent to follow up.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On 14th September 2021, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The nurse reported that a patient received a dose of Kinrix vaccine which was already expired on 31st August 2021. The reporter consented to follow-up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old male patient was given a dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported by nurse on behalf of the patient's mother. The nurse reported that a 4 months old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. No symptoms were reported. The reporter stated that the patient's mother was not affiliated with the health care professional clinic that administered the vaccine. The reporter agreed to provide the patient's mother contact information in order to get the health care professional's contact information. The reporter did not have the patient's initials, date of birth, or lot/expiry date. The reporter consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose April but did not get (second dose); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose April but did not get (second dose)) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose April but did not get (second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose April but did not get (second dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia
Clinical narrative: not feeling good; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good), HEADACHE (headache) and MYALGIA (body aches) in a  patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling good), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, MALAISE (not feeling good), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong patient
Clinical narrative: Error: Wrong Patient (documentation
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Injection site erythema, Visual impairment
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Late-
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Cough, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: Within 5 min of admin, patient spiked a fever, w/ HR > 90, coughing, trouble breathing, stomach pains (had prev hx of hernia surgery/condition). Had patient lie down, elevated feet, take 3 deep breaths. Brought epipen next to me in case, however, within 2-3 minutes, patients HR was lowering to baseline and fever was going down with a cold compress. Offered water and she was able to drink/swallow water. Told patient to stay as long as she needed - she later was sitting up and drinking water.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: Within 5 min of admin, patient spiked a fever, w/ HR > 90, coughing, trouble breathing, stomach pains (had prev hx of hernia surgery/condition). Had patient lie down, elevated feet, take 3 deep breaths. Brought epipen next to me in case, however, within 2-3 minutes, patients HR was lowering to baseline and fever was going down with a cold compress. Offered water and she was able to drink/swallow water. Told patient to stay as long as she needed - she later was sitting up and drinking water.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Mild, Additional Details: I did not witness the event but girlfriend started yelling for help saying that patient was seizing and when I got to him he was alert and sweating.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Additional Details: pt came to pharmacy on 09/12/2021 after receiving pfizer vaccine on 09/10/2021 -- very large bruise on arm starting upper arm extending to elbow. pt stated that bruise was spreading. very dark and edges defined with dark areas. advised to seek immediate treatment but was reluctant because no pain. stated on eliquis. said would contact her doctor monday. said normal  her pharmacy told her not to worry about it
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Mild, Additional Details: pt came to pharmacy on 09/12/2021 after receiving pfizer vaccine on 09/10/2021 -- very large bruise on arm starting upper arm extending to elbow. pt stated that bruise was spreading. very dark and edges defined with dark areas. advised to seek immediate treatment but was reluctant because no pain. stated on eliquis. said would contact her doctor monday. said normal  her pharmacy told her not to worry about it
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Mild, Additional Details: Pt reported red/black marks extending past her elbow starting saturday and that the continued to extent into sunday. Pt advised to go to the ER, but she opt'ed to call her MD monday morning. Pt states having an appt ths coming wednesday with her MD after a phone call monday afternoon. Pt states MD stated this is likely a struck vein or blood vessel from the administration.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Mild, Additional Details: Pt reported red/black marks extending past her elbow starting saturday and that the continued to extent into sunday. Pt advised to go to the ER, but she opt'ed to call her MD monday morning. Pt states having an appt ths coming wednesday with her MD after a phone call monday afternoon. Pt states MD stated this is likely a struck vein or blood vessel from the administration.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Injection site pain, Paraesthesia, Tremor
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Bell's Palsy-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Error: Booster Given Too Early-
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Myalgia, Pyrexia
Clinical narrative: low grade fever, malaise, myalgias, arthralgias for 3-4 days after vaccination and mild malaise myalgias arthralgias continue now one month later
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain, Pain in extremity, Swelling
Clinical narrative: Systemic: Body Aches Generalized-Severe, Additional Details: UPPER LEFT ARM PAIN STARTED 9/6. NOT IT HURS LIKE A POOLED MUSCLE SPREADING ACROSS THE RIGHT BACK AND SWALLEN. PAIN SEVERITY IS SEVERE. ADVISED TO CONTACT HER PRIMARY CARE PHYSICIAN TOMORROW.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysmenorrhoea, Dyspnoea, Headache, Heavy menstrual bleeding
Clinical narrative: Joint pain, headache, rash, trouble breathing, and unexpected period with heavy flow and pain. (Menopausal woman without period for almost a year now.)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Rash
Clinical narrative: Joint pain, headache, rash, trouble breathing, and unexpected period with heavy flow and pain. (Menopausal woman without period for almost a year now.)
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Flushing, Hypotension, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: Patient became extremely lethargic while sitting on the chair 2  to 3 mins after receive first dose of pfizer covid-19 vaccination. Alert and oriented x3, c/o intermitent blurry vision, Bp 73/28  HR 108. Asked for water, given above 5oz. No s/s allergic reaction.  Taken to ER by ambulance 4 to 5mins later while still extremely lethargic.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: Patient became extremely lethargic while sitting on the chair 2  to 3 mins after receive first dose of pfizer covid-19 vaccination. Alert and oriented x3, c/o intermitent blurry vision, Bp 73/28  HR 108. Asked for water, given above 5oz. No s/s allergic reaction.  Taken to ER by ambulance 4 to 5mins later while still extremely lethargic.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Additional Details: patient felt chills, pharmacist follow up on sunday patient feeling better a little sore on the arm but nothing else
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: SEVERE NOSE BLEED THAT LASTED ABOUT 5-10 MINUTES
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Severe
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Adnexa uteri pain, Arthralgia, Back pain, Chest discomfort
Clinical narrative: Vaccine at 4pm. At 5pm started having a sharp, shooting, electrical shock sensation under Left side of tongue. Around 7:30 I had localized redness and swelling under the left side of my tongue and a weird tingling sensation throughout my body. The next day the swelling increased with difficulty eating and drinking that lasted through 9/14/21. The following day 9/9/21 I had swelling of my left tonsil and left side of throat, bilateral nasal turbinate swelling, bilateral ear pressure and 99.5.F temp. The following day, 9/10/21, I had red blotches in my throat and on my tonsils, my swallowing felt different/weird/a little more difficult, my throat and tonsil swelling worsened, the nasal turbinate swelling worsened where I could barely breath through nose, I had nerve pain and sensitivity behind My left ear that radiates down my neck and to My left shoulder, I had midline upper back pain/pressure, and at 3pm had sharp stabbing pain to my right lower quadrant of abdomen/uterus/ovary (this resolved after an hour). All symptoms have continued through 9/14/21. 9/13/21 I felt very fatigued, unable to do much of anything, barely ate much due to fatigue.  I woke up at 1pm on 9/14/21 with A heart rate of 148 just standing and 125 resting which continued for the past 8-9 hrs. Chest discomfort toward the 7 hour mark, slightly winded with some dizziness and HA. My nerve pain behind my left ear had moved up into my l face, forehead, and behind my left eye. Had ekg that showed just tachycardia. All other Vital signs were normal. My nasal turbinate, throat and tonsil swelling was beginning to improve but not resolved and the tongue swelling and pain had resolved. I had fluids to help with the heart rate. And Sudafed and Afrin to try  to help with the nasal turbinate swelling. Continue to nave some nasal turbinate swelling and congestion, left tonsil swelling with blotches in the throat and ear pressure as well as fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Dysphagia, Dyspnoea, Ear discomfort
Clinical narrative: Vaccine at 4pm. At 5pm started having a sharp, shooting, electrical shock sensation under Left side of tongue. Around 7:30 I had localized redness and swelling under the left side of my tongue and a weird tingling sensation throughout my body. The next day the swelling increased with difficulty eating and drinking that lasted through 9/14/21. The following day 9/9/21 I had swelling of my left tonsil and left side of throat, bilateral nasal turbinate swelling, bilateral ear pressure and 99.5.F temp. The following day, 9/10/21, I had red blotches in my throat and on my tonsils, my swallowing felt different/weird/a little more difficult, my throat and tonsil swelling worsened, the nasal turbinate swelling worsened where I could barely breath through nose, I had nerve pain and sensitivity behind My left ear that radiates down my neck and to My left shoulder, I had midline upper back pain/pressure, and at 3pm had sharp stabbing pain to my right lower quadrant of abdomen/uterus/ovary (this resolved after an hour). All symptoms have continued through 9/14/21. 9/13/21 I felt very fatigued, unable to do much of anything, barely ate much due to fatigue.  I woke up at 1pm on 9/14/21 with A heart rate of 148 just standing and 125 resting which continued for the past 8-9 hrs. Chest discomfort toward the 7 hour mark, slightly winded with some dizziness and HA. My nerve pain behind my left ear had moved up into my l face, forehead, and behind my left eye. Had ekg that showed just tachycardia. All other Vital signs were normal. My nasal turbinate, throat and tonsil swelling was beginning to improve but not resolved and the tongue swelling and pain had resolved. I had fluids to help with the heart rate. And Sudafed and Afrin to try  to help with the nasal turbinate swelling. Continue to nave some nasal turbinate swelling and congestion, left tonsil swelling with blotches in the throat and ear pressure as well as fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Electrocardiogram abnormal, Erythema, Eye pain, Facial pain
Clinical narrative: Vaccine at 4pm. At 5pm started having a sharp, shooting, electrical shock sensation under Left side of tongue. Around 7:30 I had localized redness and swelling under the left side of my tongue and a weird tingling sensation throughout my body. The next day the swelling increased with difficulty eating and drinking that lasted through 9/14/21. The following day 9/9/21 I had swelling of my left tonsil and left side of throat, bilateral nasal turbinate swelling, bilateral ear pressure and 99.5.F temp. The following day, 9/10/21, I had red blotches in my throat and on my tonsils, my swallowing felt different/weird/a little more difficult, my throat and tonsil swelling worsened, the nasal turbinate swelling worsened where I could barely breath through nose, I had nerve pain and sensitivity behind My left ear that radiates down my neck and to My left shoulder, I had midline upper back pain/pressure, and at 3pm had sharp stabbing pain to my right lower quadrant of abdomen/uterus/ovary (this resolved after an hour). All symptoms have continued through 9/14/21. 9/13/21 I felt very fatigued, unable to do much of anything, barely ate much due to fatigue.  I woke up at 1pm on 9/14/21 with A heart rate of 148 just standing and 125 resting which continued for the past 8-9 hrs. Chest discomfort toward the 7 hour mark, slightly winded with some dizziness and HA. My nerve pain behind my left ear had moved up into my l face, forehead, and behind my left eye. Had ekg that showed just tachycardia. All other Vital signs were normal. My nasal turbinate, throat and tonsil swelling was beginning to improve but not resolved and the tongue swelling and pain had resolved. I had fluids to help with the heart rate. And Sudafed and Afrin to try  to help with the nasal turbinate swelling. Continue to nave some nasal turbinate swelling and congestion, left tonsil swelling with blotches in the throat and ear pressure as well as fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Neck pain, Neuralgia
Clinical narrative: Vaccine at 4pm. At 5pm started having a sharp, shooting, electrical shock sensation under Left side of tongue. Around 7:30 I had localized redness and swelling under the left side of my tongue and a weird tingling sensation throughout my body. The next day the swelling increased with difficulty eating and drinking that lasted through 9/14/21. The following day 9/9/21 I had swelling of my left tonsil and left side of throat, bilateral nasal turbinate swelling, bilateral ear pressure and 99.5.F temp. The following day, 9/10/21, I had red blotches in my throat and on my tonsils, my swallowing felt different/weird/a little more difficult, my throat and tonsil swelling worsened, the nasal turbinate swelling worsened where I could barely breath through nose, I had nerve pain and sensitivity behind My left ear that radiates down my neck and to My left shoulder, I had midline upper back pain/pressure, and at 3pm had sharp stabbing pain to my right lower quadrant of abdomen/uterus/ovary (this resolved after an hour). All symptoms have continued through 9/14/21. 9/13/21 I felt very fatigued, unable to do much of anything, barely ate much due to fatigue.  I woke up at 1pm on 9/14/21 with A heart rate of 148 just standing and 125 resting which continued for the past 8-9 hrs. Chest discomfort toward the 7 hour mark, slightly winded with some dizziness and HA. My nerve pain behind my left ear had moved up into my l face, forehead, and behind my left eye. Had ekg that showed just tachycardia. All other Vital signs were normal. My nasal turbinate, throat and tonsil swelling was beginning to improve but not resolved and the tongue swelling and pain had resolved. I had fluids to help with the heart rate. And Sudafed and Afrin to try  to help with the nasal turbinate swelling. Continue to nave some nasal turbinate swelling and congestion, left tonsil swelling with blotches in the throat and ear pressure as well as fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pharyngeal swelling, Rash macular, Respiratory tract congestion
Clinical narrative: Vaccine at 4pm. At 5pm started having a sharp, shooting, electrical shock sensation under Left side of tongue. Around 7:30 I had localized redness and swelling under the left side of my tongue and a weird tingling sensation throughout my body. The next day the swelling increased with difficulty eating and drinking that lasted through 9/14/21. The following day 9/9/21 I had swelling of my left tonsil and left side of throat, bilateral nasal turbinate swelling, bilateral ear pressure and 99.5.F temp. The following day, 9/10/21, I had red blotches in my throat and on my tonsils, my swallowing felt different/weird/a little more difficult, my throat and tonsil swelling worsened, the nasal turbinate swelling worsened where I could barely breath through nose, I had nerve pain and sensitivity behind My left ear that radiates down my neck and to My left shoulder, I had midline upper back pain/pressure, and at 3pm had sharp stabbing pain to my right lower quadrant of abdomen/uterus/ovary (this resolved after an hour). All symptoms have continued through 9/14/21. 9/13/21 I felt very fatigued, unable to do much of anything, barely ate much due to fatigue.  I woke up at 1pm on 9/14/21 with A heart rate of 148 just standing and 125 resting which continued for the past 8-9 hrs. Chest discomfort toward the 7 hour mark, slightly winded with some dizziness and HA. My nerve pain behind my left ear had moved up into my l face, forehead, and behind my left eye. Had ekg that showed just tachycardia. All other Vital signs were normal. My nasal turbinate, throat and tonsil swelling was beginning to improve but not resolved and the tongue swelling and pain had resolved. I had fluids to help with the heart rate. And Sudafed and Afrin to try  to help with the nasal turbinate swelling. Continue to nave some nasal turbinate swelling and congestion, left tonsil swelling with blotches in the throat and ear pressure as well as fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia, Swelling, Uterine pain
Clinical narrative: Vaccine at 4pm. At 5pm started having a sharp, shooting, electrical shock sensation under Left side of tongue. Around 7:30 I had localized redness and swelling under the left side of my tongue and a weird tingling sensation throughout my body. The next day the swelling increased with difficulty eating and drinking that lasted through 9/14/21. The following day 9/9/21 I had swelling of my left tonsil and left side of throat, bilateral nasal turbinate swelling, bilateral ear pressure and 99.5.F temp. The following day, 9/10/21, I had red blotches in my throat and on my tonsils, my swallowing felt different/weird/a little more difficult, my throat and tonsil swelling worsened, the nasal turbinate swelling worsened where I could barely breath through nose, I had nerve pain and sensitivity behind My left ear that radiates down my neck and to My left shoulder, I had midline upper back pain/pressure, and at 3pm had sharp stabbing pain to my right lower quadrant of abdomen/uterus/ovary (this resolved after an hour). All symptoms have continued through 9/14/21. 9/13/21 I felt very fatigued, unable to do much of anything, barely ate much due to fatigue.  I woke up at 1pm on 9/14/21 with A heart rate of 148 just standing and 125 resting which continued for the past 8-9 hrs. Chest discomfort toward the 7 hour mark, slightly winded with some dizziness and HA. My nerve pain behind my left ear had moved up into my l face, forehead, and behind my left eye. Had ekg that showed just tachycardia. All other Vital signs were normal. My nasal turbinate, throat and tonsil swelling was beginning to improve but not resolved and the tongue swelling and pain had resolved. I had fluids to help with the heart rate. And Sudafed and Afrin to try  to help with the nasal turbinate swelling. Continue to nave some nasal turbinate swelling and congestion, left tonsil swelling with blotches in the throat and ear pressure as well as fatigue.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Confusional state, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: Over the course of about 1 minute, the patient felt sweaty and clammy. He then fainted/passed out in his chair. A customer noticed and said, "I think he's passed out." A technician responded and asked the patient if he was alright. After awakening, patient was given water and juice. The patient was given time to recuperate for about 10 minutes. Patient then reported feeling better and was able to leave on his own. Patient was encouraged to follow up with pharmacy should anything change.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: Over the course of about 1 minute, the patient felt sweaty and clammy. He then fainted/passed out in his chair. A customer noticed and said, "I think he's passed out." A technician responded and asked the patient if he was alright. After awakening, patient was given water and juice. The patient was given time to recuperate for about 10 minutes. Patient then reported feeling better and was able to leave on his own. Patient was encouraged to follow up with pharmacy should anything change.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test normal, Borrelia test negative, Carotid artery stenosis
Clinical narrative: Nine days after vaccination, she started having periodic dizziness, tightness/soreness around front and sides of neck, chest and shoulders, and feeling of racing/pounding heart.  Symptoms grew worse and came to include difficulty with concentration and focus, muscles spasms in arms, lethargy, and weight loss, peaking around 6-8 weeks after onset of symptoms.  During the peak of symptoms, she found it nearly impossible to read and struggled to comprehend simple written instructions.  She started missing work and had to stop work entirely about two months after symptoms started.  Since the peak of symptoms around 8 weeks, racing/pounding heart has resolved and energy level has partially rebounded, weight loss has ceased.  Periodic dizziness still occurs multiple times per day, generally it is less common and occurs for shorter durations than at the peak of her symptoms.  Three months after symptoms started, she has been able to resume reading and working, though with some difficulty, only working a few hours per week.  Looking at computer screens, and other things that move quickly in her near field of vision is disorienting and seems to bring on symptoms as does being in low-light conditions such as dusk/dawn, or performing rapid movements.   Treatment: About 1 week after symptoms, treated as ear-infection by primary care provider (pcp) based on initial report of dizziness.  Symptoms did not improve with antibiotics and subsequent trip to ENT showed now signs of ear-infection.     ENT has proposed a problem with the Vestibular system, suggesting "mal-disembarkment syndrome" and prescribed Vestibular PT which she is attending weekly while performing daily exercises at-home as directed by the therapist.  She has spoken with mental health professionals who do not believe this to be the result of a mental health issue.    Doctors say they cannot confirm one way or another if this is related to the vaccine, but the consensus is that she should avoid a second dose until a cause is identified or symptoms fully resolve.