chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Did not mix the two vials; Only gave one vial; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 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 Information: GSK receipt date: 09-FEB-2023 Reporter's comment: The reporter reported that the office manager contacted and said that the nurse in her office had given a Shingrix shot, but only gave one vial and did not mix the two vials before giving to patient. The office manager was contacting medical information regarding next steps for patient and office. The reporter did not agree to follow up from GlaxoSmithKline. Additional Supportive Information: The patient received Shingrix vaccines but only gave one vial and did not mix the two vials before giving to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 09-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The reporters husband got second dose of vaccine and had sick for only one day but told to be prepared. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Oedema peripheral
Clinical narrative: Swelling bellowarmpit, 3 inches diameter, fluid-filled; This case was reported by a consumer via call center representative and described the occurrence of blister in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2023, less than a day after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.     Additional Information: GSK Receipt date: 07-Feb-2023. Reporter's Comment: The patient self-reported this case. The patient received Shingrix on right deltoid. The patient stated that in the evening when preparing to go to bed, she noticed swelling below her right armpit.  It was about 3 inches in diameter and felts like it was fluid filled. The patient was asking if it was something to be concerned about.   The reporter did not consent to follow-up. Note: Time to onset was conservatively capture as less than a day instead of 8 (unspecified unit) reported in structural field.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 6 YO received adult dose; 6 YO received adult dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 6-year-old male patient who received HBV (Engerix B adult) (batch number N73FA, expiry date 31st May 2024) for prophylaxis.   On 5th December 2022, the patient received Engerix B adult. On 5th December 2022, unknown after receiving Engerix B adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt date: 07-Feb-2023. Reporter's Comment: An adult dose of Engerix-B was administered to a pediatric patient by accident. The reporter consented to follow-up. Additional Supportive Information: An adult dose of Engerix-B was administered to a pediatric patient by accident which led to accidental overdose and adult product administered to child.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: 2 drops came out from needle and hub; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 6th February 2023, the patient received Menveo. On 6th February 2023, unknown after receiving Menveo, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the nurse administered Menveo vaccine to a 12 years old patient in which the 2 drops are came out from the needle and hub. The healthcare professional does not know if the part of the liquid was touched to the arm of the patient. No other information was available of the vaccine. The reporter did consent to follow up. Additional supportive information: The patient did not receive the full dose of vaccine as there was a 2 drops are came out from the needle and hub, which led to Incomplete dose administered.
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to pediatric patient; Adult dose given to pediatric patient; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 7-month-old male patient who received HBV (Engerix B adult) (batch number AX2D5, expiry date 7th December 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2023, the patient received the 3rd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 7th February 2023, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-Feb-2023. Reporter's Comment: The reporter consented to follow-up via email. Additional Supportive Information: An adult dose of Engerix-B was administered to a pediatric, which led to overdose and adult product administered to child.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Therapeutic response decreased
Clinical narrative: Hep B titer was 3; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a adult female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.   Additional Information: GSK receipt date: 07-Feb-2023 Reporter's comment: The nurse administered 4th dose of Engerix B pediatric formulation to a patient. The Hepatitis-B titer was 3.  The reporter consent to follow up. Additional supportive information: The patients received doses of Hepatitis-B vaccine series and had insufficient titers of Hepatitis-B, which led to therapeutic response decreased. Note: 4th dose of Engerix B pediatric was not captured as suspect as it seems it was received as corrective action for low titer and as per start date it could not possible antibody developed in 1 day.
Age: 74.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Hepatitis A vaccine not received; 1st dose on 15Jun2022, 2nd on 18Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and HEPATITIS B VACCINE (HEPLISAV-B).   On 18th August 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 18th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received first dose of Twinrix vaccine on 15th June 2022 and the second dose on 18th August 2022. The patient received a dose of Heplisav b on 28th December 2022. The reporter wanted to know how would the patient continue with the Twinrix series when the patient did not receive the hepatitis A portion from the Heplisav b. The reporter did not provided the additional details. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Twinrix late than recommended time frame, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive the 3rd dose of hepatitis A antigen, which led to incomplete course of vaccination. Note: As the patient did not received hepatitis A component of the Twinrix vaccine the event incomplete course of vaccination was coded conservatively. As the Heplisav b is a non GSK product and we cannot took medication error for Heplisav-b it was captured as concomitant product.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Third dose adminstered; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 Information: GSK receipt date: 9-Feb-2023 Reporter's comment: The reporter wanted to remain anonymous, did not have Rotarix lot or expiry date. Additional supportive information: The patient received third dose of Rotarix inadvertently, which led to extra dose administered. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus
Clinical narrative: Itching around eye; This case was reported by a consumer via call center representative and described the occurrence of eye pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced eye pruritus. On an unknown date, the outcome of the eye pruritus was unknown.   It was unknown if the reporter considered the eye pruritus to be related to Shingrix.     Additional Information: GSK Receipt date: 09-FEB-2023 Reporter comment: The consumer reporting that, the itching around the eye which developed few months ago and wanted to know if its shingles. The patient said she got Shingrix few years ago and not sure if she got both the doses but sure she got at least one of the dose. The reporter did not consent to follow up. No other information available.
Age: 70.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Expired Havrix administered; Dose given over 12 months after dose 1; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (first dose was received on an unknown date).   On 9th February 2023, the patient received the 2nd dose of Havrix (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On 9th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's comments: The nurse reported that a patient had received dose of the Havrix vaccine in left deltoid on the day of reporting The vaccine expiration date was 6 February 2023. This dose was also late- given over 12 months after fist dose. Nurse had been transferred to Medical inquirer (MI) for more information. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received an expired dose of Havrix vaccine, which had led to expired vaccine used.  At the time of reporting, the patient had received the second dose of the Havrix vaccine later than the recommended interval, which had led to lengthening of vaccination schedule. This case was linked with US2023021173, reported by the same reporter.; Sender's Comments:  US-GSK-US2023021173:Same reporter - female patient
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered; Only adjuvant administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 5M39B, expiry date 28th May 2024) for prophylaxis.   On 8th February 2023, the patient received the 1st dose of Shingrix. On 8th February 2023, 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 Information: GSK receipt date: 9-Feb-2023 Reporter's comment: The  vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was supposed to received the first dose of Shingrix  but was administered only the adjuvant component of such vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Use diluent from another vaccine to reconstitute Menveo; Use diluent from another vaccine to reconstitute Menveo; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comments: The clinic supervisor reported that the patient was administered a dose of Menveo. The dose was reconstituted with the diluent from MMR vaccine and not with the supplied Menveo CYW-135 diluent. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. Reporter consented to follow up. Additional supportive information: As dose was reconstituted with the diluent from MMR vaccine and not with the supplied Menveo CYW-135 diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case is linked with US2023021303, reported by same reporter different patient.; Sender's Comments:  US-GSK-US2023021303:Same reporter
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 8th February 2023, the patient received Havrix. On 8th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The pharmacist reported that the patient received the dose of Havrix which was already expired. The reporter consented to follow up by email. Additional Supportive Information: The use of Havrix, which was already expired on 16th December 2022, which led to expired vaccine used.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Dose reconstituted with diluent from MMR vaccine; Dose reconstituted with diluent from MMR vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 10-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA761A, expiry date 30th November 2023) for prophylaxis.   On 2nd February 2023, the patient received Menveo. On 2nd February 2023, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comments: The clinic supervisor reported that the patient was administered a dose of Menveo. The dose was reconstituted with the diluent from MMR vaccine and not with the supplied Menveo CYW-135 diluent. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. Reporter consented to follow up. Additional supportive information: As dose was reconstituted with the diluent from MMR vaccine and not with the supplied Menveo CYW-135 diluent which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. This case is linked with US2023021184, reported by same reporter different patient.; Sender's Comments:  US-GSK-US2023021184:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Medication error, No adverse event
Clinical narrative: 1st dose 2018, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the first dose was received in 2018).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 09-FEB-2023 Reporter's comments: The caller was the patient. She reported that patient had not yet received the second dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination. Since it was a medication error case without any other AE and therefore outcome was not captured as not recovered based on the structured field value and kept as unknown only.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: Cluster of bumps (rash) on back and thigh.  Rash is not  itchy , red or painful . Patient describes as raised bumps
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine administered two days after the Beyond Expiration date of 02/13/2023.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Night sweats, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient reported feeling lightheaded within minutes of the shot.  She later reported 2 days later that she had experienced: sore throat, nausea, lightheadedness, night sweats, and a mild fever.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac function test normal, Disorientation, Disturbance in attention, Dyspnoea, Humidity intolerance
Clinical narrative: Anytime the temperature is above approximately 70/75 F and the humidity is high, I easily become severely short of breath and, at times lose focus to the point of disorientation.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder, Pulmonary function test abnormal, Temperature intolerance
Clinical narrative: Anytime the temperature is above approximately 70/75 F and the humidity is high, I easily become severely short of breath and, at times lose focus to the point of disorientation.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine administered two days after the Beyond Use date expiration of 02/13/2023.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine administered two days after the Beyond use expiration date of 02/13/2023.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called stating that arm of injection site has a large bump that is painful, red and warm to the touch. The bump occurred the same day as the injection was administered but it has gradually gotten worse over the course of 4 days. Patient has tried cold compresses, benadryl and nsaids with no relief or improvement. Patient denies fevers or other symptoms. Recommended that the patient be seen by doctor as symptoms have been getting worse.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I?ve had headaches ever since my initial vaccination.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Botulinum toxin injection, Headache, Hypertension, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Hypertension, severe neck pain and headache for 5 days requiring emergency care.  Have continued neck pain and loss of mobility of neck muscles requiring multiple physician visits and subsequent physical therapy, cortisone injections and now receiving botox injections every 3 months to manage pain and mobility.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Hypertension, severe neck pain and headache for 5 days requiring emergency care.  Have continued neck pain and loss of mobility of neck muscles requiring multiple physician visits and subsequent physical therapy, cortisone injections and now receiving botox injections every 3 months to manage pain and mobility.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine administered two days after the Beyond use expiration date of 02/13/2023.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect product formulation administered, Medication error, No adverse event
Clinical narrative: Medication error occurred. Patient received bivalent 5-11 years Pfizer vaccine as second dose to primary series. Patient was supposed to receive monovalent 5-11 years Pfizer as a second dose vaccine. No adverse reaction.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine administered one day after the Beyond Use expiration date of 02/13/2023.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus bilateral
Age: 18.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse reaction to vaccination. Patient received extraneous dose of flu vaccine on 01/27/2023, had already been vaccinated on 10/31/2022. Patient received unnecessary dose of Menveo vaccine on 01/27/2023, patient had previously received first and second dose of Menveo on 08/20/2015 and 03/30/2021.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram pulmonary abnormal, Computerised tomogram thorax abnormal, Embolism, Muscle spasms, Pulmonary thrombosis
Clinical narrative: Cramps in both legs for two days after receiving booster. One week later, blood clots in right leg migrating to both lungs. PE in both lungs.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Thrombosis
Clinical narrative: Cramps in both legs for two days after receiving booster. One week later, blood clots in right leg migrating to both lungs. PE in both lungs.
Age: 44.0
Sex: F
Vaccine: FLU4, HEP, HEPA
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: Patient came in 2/16/23 for Boostrix vaccine and prior to administration, complains of radiating, left arm soreness that she states originated from her previous 3 vaccines she received on 8/27/22. She states she experiences pain when elevating her left arm and is unable to sleep in certain positions on her left side.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient is a 60 years old man who was here for his 1st Moderna Bivalent Booster vaccine. However, he inadvertently received 0.2 mL of Moderna Bivalent booster for 6 month - 5 years old (Lot# 216K22A). Patient left the office in stable condition, no adverse effect. Around 3 pm CDC was contacted and per CDC recommendation, patient returned to the clinic on the same day and received the Moderna Bivalent Booster (18 years old- up) 0.5 mL (Lot# 049D22A). Patient was notified of the adverse event and the CDC recommendation before receiving the correct vaccine. He left the office in stable condition.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Anticoagulant therapy, Atrial fibrillation, Cardiac monitoring abnormal, Feeling abnormal, Heart rate increased
Clinical narrative: The night of Sunday, November 6th, 2022, I did not sleep well at all.  The effect knocked me on my ass and lasted two days. I had never had a reaction to anything my entire life! But this shot was very different. On Friday the 11th, I went in for a nuclear stress test, and my heart was beating a constant 135. They sent me to the ER, and my heart miraculously went back into normal rhythm. That issue put me on a heart monitor for 30 days, and it confirmed that I now suffer from afib when I did not suffer from anything before the shot on the 6th. Two weeks into the monitor, my heart started racing at about 200 bpm. I was sweating profusely, and I knew something was wrong. I went to the ER again and spent the night under observation. I am now on Eliquis and Flecanaid and am on a trial of Digoxin. I am scheduled for an ablation soon. I am not confident that it will do any good.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Hyperhidrosis, Palpitations, Poor quality sleep, Scan myocardial perfusion
Clinical narrative: The night of Sunday, November 6th, 2022, I did not sleep well at all.  The effect knocked me on my ass and lasted two days. I had never had a reaction to anything my entire life! But this shot was very different. On Friday the 11th, I went in for a nuclear stress test, and my heart was beating a constant 135. They sent me to the ER, and my heart miraculously went back into normal rhythm. That issue put me on a heart monitor for 30 days, and it confirmed that I now suffer from afib when I did not suffer from anything before the shot on the 6th. Two weeks into the monitor, my heart started racing at about 200 bpm. I was sweating profusely, and I knew something was wrong. I went to the ER again and spent the night under observation. I am now on Eliquis and Flecanaid and am on a trial of Digoxin. I am scheduled for an ablation soon. I am not confident that it will do any good.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: C-reactive protein increased, Polymyalgia rheumatica, Red blood cell sedimentation rate increased, Synovitis
Clinical narrative: pMr  symptoms, synovitis
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Immunizing technician incorrectly administered the Bivalent vaccine instead of the monovalent vaccine for pts. 1st dose of primary series. Tech did not document Lot and Expiration date on the database prior to administration and only realized error was made after the fact. Pt was notified. Pt feels fine and does not want to pursue further action. RPH contacted Pfizer and CDC. Per Pfizer- do not repeat 1st dose. Per CDC: ok to give bivalent as 1st dose of primary series. Subsequently CDC recommended to give monovalent vaccine as 2nd dose followed by bivalent vaccine in 2 months as booster dose.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt given 3rd Dose of monovalent Moderna Vaccine in Error. Pt was due for Bivalent dose. Per pt mother, pt had no side effects. Patient was scheduled for Bivalent Moderna Dose in 2 months.
Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Pt received 2nd Bivalent booster by request. Staff unaware this was a 2nd bivalent booster. Pt had no side effects.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac monitoring, Cerebellar stroke, Computerised tomogram, Intensive care, Laboratory test
Clinical narrative: Cerebellar stroke, ICU at Hospital from 12/18 until 12/24/2022. Still in follow up protocol.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: Cerebellar stroke, ICU at Hospital from 12/18 until 12/24/2022. Still in follow up protocol.
Age: 70.0
Sex: M
Vaccine: PNC20
Symptoms: Blood urine present
Clinical narrative: About an hours after receiving vaccine, patient calls pharmacy complaining blood in the urine
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: no reported adverse effects other than sore left deltoid (as a result of the needle) during phone conversation Feb 17, 2023 4:50PM
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt received Bivalent dose as 2nd of series. Pt had no side effects. Pt given 2nd Monovalent dose as 3rd of series to complete series 2/15/2023. While given out of order, Pt received 2 monovalent doses and one bivalent dose.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was due for Hep B vaccine.  Hep A was given in error.  Patient denies any adverse symptoms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Vaccination site discolouration, Vaccination site pain
Clinical narrative: Patient has white spot near the area where the vaccine was adiministerd with some pain at times.  The area does not itch.   She also state that she has has headaches since recieveing the vaccine and "just does not feel right"
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Echocardiogram abnormal
Clinical narrative: The patient reported having arrhythmia verified by echocardiogram the day following her second dose
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Peripheral swelling
Clinical narrative: severe pain and swelling in entire deltoid, redness lasting through today, which is 4 days
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Small fibre neuropathy
Clinical narrative: Small fiber neuropathy  Burst dose of predisone - 9 days - symptoms resolved when taking but returned a couple days later Celecoxib 100 mg - 2 daily for 2 weeks - symptoms resolved while taking but returned a few days later
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Computerised tomogram head abnormal, Dyspnoea, Electroencephalogram, Magnetic resonance imaging head abnormal
Clinical narrative: First day received the booster 01/06/23 left leg swelled up a couple of days later blood clots in my left hand , constant migraines and weakness , shortness of breath .  02/07/23 admitted to hospital for TIA
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Migraine, Peripheral swelling, Thrombosis, Transient ischaemic attack
Clinical narrative: First day received the booster 01/06/23 left leg swelled up a couple of days later blood clots in my left hand , constant migraines and weakness , shortness of breath .  02/07/23 admitted to hospital for TIA
Age: 33.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Epistaxis, Fall, Loss of consciousness, Pallor, Speech disorder
Clinical narrative: Patient received the sub-q vaccines first.  The Adacel was administered and then the Twinrix.  Patient was talking immediately prior to the Twinrix being given and during administration she began to make a strange sound.  After administration was complete, patient then became unconscious and fell out of  her chair.  She was unconscious for at least 1 minute.  She was moved to her back.  She did have a bloody nose and was still not talking normal and had released her bladder. She was pale.  Paramedics arrived and took her blood pressure and pulse.  They put her back in the chair.  They were going to perform her blood pressure again and were unable because the patient began to seize. The paramedics took her to the ER.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: UNKNOWN spoke with mom she said no side effects have been reported yet
Age: 0.5
Sex: M
Vaccine: COVID19-2, FLU4, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: none
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Impaired driving ability, Memory impairment, Musculoskeletal disorder
Clinical narrative: Occurred while driving. Difficulty keeping car on road while driving lane. Eventually ran off road. Unable to talk or move right arm but otherwise uninjured in crash. Ambulance called by motorist following my vehicle and taken immediately to hospital emergency room. Unable to speak to nurses/doctor at ER. Unable to remember cell phone access code. Recall making noises but not speaking. ER staff contacted neurologist, and were told to administer Alteplase 100 mg SOLR (In 63 and 30 doses) and send by ambulance to hospital for follow-up treatment. In ambulance en route, I began to be able to speak about 1 hour into 2-hour trip and was able to access my cell phone. Able to respond very normally to hospital personnel at hospital upon arrival there. I have been subscribed to V-Safe since my initial Pfizer Injections (1 & 2) but the form doesn't allow information about results from respondent about conditions or reactions. Birthdate on form should be: XX/XX/XXXX (not 9th.... number changes when I moved on to the next item). Health department clinic where Pfizer booster ws given: 1st dose was administered 1/15/21 (FL3249 5/21); second dose was administered 2/5/21 (EM9810). Final booster in this series was the one administered 10/14/21. My personal physician is a DO. She and I have discussed the unusual nature of my having a stroke since I don't have any of the usual illnesses/conditions, am not a smoker and maintain a healthy lifestyle. All hospital test records and reports go to her for any hospitalizations or medical visits.  Please find a enclosed copy of my VAERS Adverse Reaction form related to a seizure I experienced in 2021, 10 days after receiving a Pfizer COVID booster at a local health department vaccination session. I have tried to send this document on-line but apparently have a problems/conflict with the form and my PDF/Adobe applications. Should you have any questions about the form, please contact me or any of the medical personnel listed in the report. I do not believe this seizure incident has been previously reported since none of the hospital involved were aware of the COVID vaccination and its proximity to the seizure. Thank you for your work on behalf of COVID information gathering and sharing! P.S. I did not mention in the form that I have not had COVID since its inception.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Road traffic accident, Seizure
Clinical narrative: Occurred while driving. Difficulty keeping car on road while driving lane. Eventually ran off road. Unable to talk or move right arm but otherwise uninjured in crash. Ambulance called by motorist following my vehicle and taken immediately to hospital emergency room. Unable to speak to nurses/doctor at ER. Unable to remember cell phone access code. Recall making noises but not speaking. ER staff contacted neurologist, and were told to administer Alteplase 100 mg SOLR (In 63 and 30 doses) and send by ambulance to hospital for follow-up treatment. In ambulance en route, I began to be able to speak about 1 hour into 2-hour trip and was able to access my cell phone. Able to respond very normally to hospital personnel at hospital upon arrival there. I have been subscribed to V-Safe since my initial Pfizer Injections (1 & 2) but the form doesn't allow information about results from respondent about conditions or reactions. Birthdate on form should be: XX/XX/XXXX (not 9th.... number changes when I moved on to the next item). Health department clinic where Pfizer booster ws given: 1st dose was administered 1/15/21 (FL3249 5/21); second dose was administered 2/5/21 (EM9810). Final booster in this series was the one administered 10/14/21. My personal physician is a DO. She and I have discussed the unusual nature of my having a stroke since I don't have any of the usual illnesses/conditions, am not a smoker and maintain a healthy lifestyle. All hospital test records and reports go to her for any hospitalizations or medical visits.  Please find a enclosed copy of my VAERS Adverse Reaction form related to a seizure I experienced in 2021, 10 days after receiving a Pfizer COVID booster at a local health department vaccination session. I have tried to send this document on-line but apparently have a problems/conflict with the form and my PDF/Adobe applications. Should you have any questions about the form, please contact me or any of the medical personnel listed in the report. I do not believe this seizure incident has been previously reported since none of the hospital involved were aware of the COVID vaccination and its proximity to the seizure. Thank you for your work on behalf of COVID information gathering and sharing! P.S. I did not mention in the form that I have not had COVID since its inception.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Discomfort, Fatigue, Headache
Clinical narrative: Day 1 Arm Pain; shivering (8)                              Pain Scale (1-10) " 2 Body aches; fatigue (10) " 3 fatigue, headache (4) " 4 fatigue; Day 5 scalp pain as pressure (5) " 6 fatigue " 7 back pain (8) " 8 back pain (6)
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pain of skin
Clinical narrative: Day 1 Arm Pain; shivering (8)                              Pain Scale (1-10) " 2 Body aches; fatigue (10) " 3 fatigue, headache (4) " 4 fatigue; Day 5 scalp pain as pressure (5) " 6 fatigue " 7 back pain (8) " 8 back pain (6)
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cardiac disorder, Catheter placement, Condition aggravated, General physical health deterioration
Clinical narrative: PT did state she had been a decline since she received her last Covid vaccine Feb/March of 2021. PT has been using a Cane since that last Covid vaccine and has also cardiac issues with heart palpitations. She is now seeing a Cardiologist. She has also lost mobility of her left arm when she received her Covid vaccine for longer distance walks PT uses 2 sticks. She did loose her balance once in the last month when she took a step, doesn't consider it to be a fall and she didn't hurt herself. PT stated she gets relapses but she has not been diagnoses with Relapsing remitting since she has Neuromyelitis optica. PT has had a decline with her bladder retention due to a car accident October of 2022. She is self-cathering and stated has issues with retention. She did get Botox injection in Jan and it created more retention that before. She has an appt with a Urologist in April. PT was sick for a week starting Feb 1st 2023 and didnt' test herself for Covid, no lingering effects (possible had covid since her husband has it). She has missed a few doses of the medication for being sick and not being able to keep up with the every 12 hour window and going off schedule. She asked if that was okay but declined counsel and expressed the importance of Q12H. No concerns with the missed doses. PT pushes herself to do things around the house, goes to physical therapy once in a hwile and pelvic floor therapy about every 2 weeks. Intially to her Dx she had impaired vision and doesn't think there has been any changes since, stable.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Multiple sclerosis relapse, Neuromyelitis optica spectrum disorder, Palpitations
Clinical narrative: PT did state she had been a decline since she received her last Covid vaccine Feb/March of 2021. PT has been using a Cane since that last Covid vaccine and has also cardiac issues with heart palpitations. She is now seeing a Cardiologist. She has also lost mobility of her left arm when she received her Covid vaccine for longer distance walks PT uses 2 sticks. She did loose her balance once in the last month when she took a step, doesn't consider it to be a fall and she didn't hurt herself. PT stated she gets relapses but she has not been diagnoses with Relapsing remitting since she has Neuromyelitis optica. PT has had a decline with her bladder retention due to a car accident October of 2022. She is self-cathering and stated has issues with retention. She did get Botox injection in Jan and it created more retention that before. She has an appt with a Urologist in April. PT was sick for a week starting Feb 1st 2023 and didnt' test herself for Covid, no lingering effects (possible had covid since her husband has it). She has missed a few doses of the medication for being sick and not being able to keep up with the every 12 hour window and going off schedule. She asked if that was okay but declined counsel and expressed the importance of Q12H. No concerns with the missed doses. PT pushes herself to do things around the house, goes to physical therapy once in a hwile and pelvic floor therapy about every 2 weeks. Intially to her Dx she had impaired vision and doesn't think there has been any changes since, stable.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Road traffic accident, Urinary retention, Visual impairment, Walking aid user
Clinical narrative: PT did state she had been a decline since she received her last Covid vaccine Feb/March of 2021. PT has been using a Cane since that last Covid vaccine and has also cardiac issues with heart palpitations. She is now seeing a Cardiologist. She has also lost mobility of her left arm when she received her Covid vaccine for longer distance walks PT uses 2 sticks. She did loose her balance once in the last month when she took a step, doesn't consider it to be a fall and she didn't hurt herself. PT stated she gets relapses but she has not been diagnoses with Relapsing remitting since she has Neuromyelitis optica. PT has had a decline with her bladder retention due to a car accident October of 2022. She is self-cathering and stated has issues with retention. She did get Botox injection in Jan and it created more retention that before. She has an appt with a Urologist in April. PT was sick for a week starting Feb 1st 2023 and didnt' test herself for Covid, no lingering effects (possible had covid since her husband has it). She has missed a few doses of the medication for being sick and not being able to keep up with the every 12 hour window and going off schedule. She asked if that was okay but declined counsel and expressed the importance of Q12H. No concerns with the missed doses. PT pushes herself to do things around the house, goes to physical therapy once in a hwile and pelvic floor therapy about every 2 weeks. Intially to her Dx she had impaired vision and doesn't think there has been any changes since, stable.