chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering an expired dose of tenivac to patients with no reported adverse event; Initial information received on 08-Aug-2024 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 54 years old male patient who was administered expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Jan-2024, the patient received an expired dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection (expired product administered) (latency: same day) (lot: U7183AA, Expiry date: 24-Sep-2023) via intramuscular route in unknown administration site for immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: menquadfi following its administration to a patient,after it has expired with no reported adverse event; Initial information received on 09-Aug-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who received Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] following its administration to a patient,after it has expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 09-Aug-2024, the patient received a  dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (Solution for injection) (lot U7373AB , Expiry date: 06-Aug-2024, strength was unknown) via intramuscular route in the left deltoid for Immunization and menquadfi following its administration to a patient, after it has expired with no reported adverse event (expired product administered) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administration of expired MENQUADFI to a patient."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Aphasia, No adverse event
Clinical narrative: fluzone high dose due to suspected given post expiration with no reported adverse event; Initial information received on 09-Aug-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 83 years old female patient who got Influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] due to suspected given post expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Aug-2024, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (lot- HE6174) via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation (expired product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to administration of IPOL which has already been punctured after an excursion with no reported adverse event; Initial information received on 09-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 12 years old male patient where patient had inappropriate use due to administration of IPV (VERO) [Ipol] which has already been punctured after an excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (tdap)and hepatitis a vaccine (hepatitis A) for Prophylactic vaccination.  On 29-Jul-2024, the patient received 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot- W1C831M) via intramuscular route in the left deltoid (strength and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, MMRV, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse event (so far). I am reporting a vaccine administration error that occurred 4 days ago, before the expected time frame for a possible reaction due to 2 MMR vaccines (that is MMR and MMRV)
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported; Improper storage of product in use; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 14-JUN-2024, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # X019625, expiration date: 23-APR-2025 underwent a temperature excursion (TE) at a temperature of 51 degrees Fahrenheit (F) for time frame of 446 hours. On 27-JUN-2024, the patient was vaccinated with improperly stored vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # X019625, expiration date reported and confirmed as 23-APR-2025 (also mentioned that the initial lot reported was provided incorrectly [2019414, expiry date: 22-DEC-2025]), administered for prophylaxis (strength, exact dose, route of administration, and anatomical location were not provided) (Product storage error). The healthcare professional did not have patient information at the time of the call. In addition, no adverse side effects were reported (no adverse event).   This is one of several reports that were received from the same reporter. ; Sender's Comments:  US-009507513-2407USA010455: US-009507513-2407USA015892: US-009507513-2407USA010431:02637628 US-009507513-2407USA016011: US-009507513-2407USA015997: US-009507513-2407USA015998: US-009507513-2408USA000111: US-009507513-2408USA002567: US-009507513-2408USA000111:
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered a dose of Infanrix to a 21 year old female patient who was supposed to be receiving a Tdap vaccine; administered a dose of Infanrix to a 21 year old female patient who was supposed to be receiving a Tdap vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 21-year-old female patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   Previously administered products included Tdap vaccine (on 7th April 2014 received ).   On 05-AUG-2024, the patient received Infanrix. On 05-AUG-2024, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: administered a dose of Infanrix to a 21 year old female patient who was supposed to be receiving a Tdap vaccine) and inappropriate age at vaccine administration (Verbatim: administered a dose of Infanrix to a 21 year old female patient who was supposed to be receiving a Tdap vaccine). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 05-AUG-2024 A nurse reported that a staff member administered a dose of Infanrix to a 21 year old female patient who was supposed to be receiving a Tdap vaccine which led to Wrong vaccine administered and Inappropriate age at vaccine administration.  The patient's last prior Tdap was on 07 Apr 2014.  The vaccine administration facility was the same as primary reporter.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired FLUZONE High Dose vaccine,with no reported adverse event; Initial information received on 09-Aug-2024 regarding an unsolicited valid non-serious case received via consumer/non-healthcare professional.  This case involves a 83-year-old female patient was given an expired Influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone High Dose], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 01-Aug-2024, the patient received an unknown dose of suspect influenza USP TRIVAL A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe (strength, expiry date: unknown) (lot: HE6174) via unknown route in unknown administration site as prophylactic vaccination (immunistaion) and patient was given an expired fluzone high dose vaccine,with no reported adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Injection site swelling, Mass, Skin warm
Clinical narrative: Swelling L upper arm, redness, warmth, hard lump Cephalexin 250mg/5ml 10mL BID x 7 days Dexamethasone sodium phosphate 4mg/ml - 1.5ml prally x 1 dose
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Accidental administration of meningococcal B instead of meningococcal conjugate ACWY
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Intercepted product selection error
Clinical narrative: Employee came to get peds vaccines for her patient after looking at the patient record I pulled a DTap for patient. I did not administer this vaccine.
Age: 2.0
Sex: F
Vaccine: MMR, PNC20, VARCEL
Symptoms: Rash
Clinical narrative: Rash on torso.  Client was taken to acute care, no treatment given.  Physician referred to allergist to be tested for allergies.
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: (PRIVACY) speaking client with agency (PRIVACY) interpreter present at a school located vaccination clinic. This child came to the nurse. The nurse verified name/address/date of birth on the consent form with the parent/guardian present (through the interpreter), and this parent/guardian said "yes". This child was vaccinated. After this child left, another child, with the same name as the consent used for this child, showed up. Another consent form with Pt name was found (the first consent form was a different child's name/DOB but had the same parent/guardian signature on both consent forms. We are deducing that the family member gave us the wrong child's consent form when Pt came through (the original incorrect consent was for a 6 yr old child), so Pediarix was given. Once again, the nurse verified the name/DOB on the consent and the family (through an agency interpreter) said yes,, it was the correct child. The child that the nurse thought that they were vaccinating needed DTaP, Hep B and IPV and was 6 years old so eligible for Pediarix. After finding out the error in children's consent forms this child is actually 9 and inadvertently received Pediarix. No adverse effects have been reported back from the family.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Deafness unilateral, Lymphadenopathy, Metamorphopsia, Peripheral swelling, Swelling
Clinical narrative: Swollen lymph nodes on left side of face, hearing loss to left ear, vision distortion to left eye (patient stated that vision was blurry), swelling moved into left arm and hand (patient was unable to make a fist). Swelling to left side of face and neck (patient was unable to turn head).
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Swelling face, Vision blurred
Clinical narrative: Swollen lymph nodes on left side of face, hearing loss to left ear, vision distortion to left eye (patient stated that vision was blurry), swelling moved into left arm and hand (patient was unable to make a fist). Swelling to left side of face and neck (patient was unable to turn head).
Age: 41.0
Sex: F
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: The patient experienced swelling, itching and hardening of the skin on 08/13/2024 on the back of her right arm where the Varivax was administered.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at the injection site
Age: 0.83
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Per Patients Parent Child has Had No Adverse event
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Pt received pediatric dose of Hep B vaccine. No adverse side effects. Repeat of pediatric dose completed 8/2/24.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Four hours after receiving my RSV vaccine, I began to have ringing in my ears.  This is something I'd never experienced before.  I put off making a report because I thought it would stop.  It hasn't.  As I write this, it's worse than ever, to the point of keeping me awake at night.
Age: 48.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Local reaction, Skin warm, Urticaria
Clinical narrative: Pt had local reaction on right arm warm to touch, Red. Pt stated that she did not notice anything but when she was getting blood taken on 8-13-24 the person pointed out the welt on her arm. Pt was seen at clinic where she got the vaccine on 8-14-24.
Age: 16.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient has received one dose of Fluad Trivalent on 7/22/24. On 8/13/24, patient received another dose of Fluad Trivalent. No major reactions have occurred or reported by patient.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Herpes zoster, Neck pain, Pain in extremity, Rash
Clinical narrative: Patient received vaccine 07/16/2024.  The next morning he woke up and had severe neck pain then pain went down arm into fingers.  His arm and fingers are very sensitive to touch.  Patient broke out in several small spots on arm, face, neck and fingers.  He has been dealing with this for a month after he received his vaccine.  Patient went to md a week after vaccine and md diagnosed patient with shingles.  Patient is still in excruciating pain that he has had to increase his hydrocodone pain medication.  Patient also has had a ct scan due to pain being so severe.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: Patient received vaccine 07/16/2024.  The next morning he woke up and had severe neck pain then pain went down arm into fingers.  His arm and fingers are very sensitive to touch.  Patient broke out in several small spots on arm, face, neck and fingers.  He has been dealing with this for a month after he received his vaccine.  Patient went to md a week after vaccine and md diagnosed patient with shingles.  Patient is still in excruciating pain that he has had to increase his hydrocodone pain medication.  Patient also has had a ct scan due to pain being so severe.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Decreased appetite, Electrocardiogram normal, Headache, Pain, Painful respiration
Clinical narrative: approximately 2 1/2 hours after receiving the pneumonia vaccine, I developed a headache, body aches, decreased appetite  but more concerning was  when taking a deep breath in, I experienced pain at the lower right aspect of my breast bone. The pain under the breastbone occured each time I took a deep breath in and lasted 2 days. The pain was sharp and only occurred when I took a deep breath in.  I was not short of breath and my watch indicated a blood oxygenation level of 98-99%  and the watch EKG indicated a sinus rhythm. I treated with Tylenol and a BEN GAY rub application to the lower aspect of my breastbone. Also, hydated  with water, juice and gingerale.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Fatigue, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Ambulance called. Patient past out for 15 seconds. Assuming needle hit a nerve and she past out for 15 seconds. paramedic clear her to go home safely
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Lethargy, Loss of consciousness
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Ambulance called. Patient past out for 15 seconds. Assuming needle hit a nerve and she past out for 15 seconds. paramedic clear her to go home safely
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Ambulance called. Patient past out for 15 seconds. Assuming needle hit a nerve and she past out for 15 seconds. paramedic clear her to go home safely
Age: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Flushing, Headache, Hyperhidrosis, Hypertension, Tremor
Clinical narrative: Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GSK; LotNumber: c2979; Route: IM; BodySite: left ARM; Dose: 2/2; VaxDate: UNKNOWN, VaccineTypeBrand: prevnar; Manufacturer: pfizer; LotNumber: HN5978; Route: IM; BodySite: Right arm; Dose: 1; VaxDate: UNKNOWN, VaccineTypeBrand: arexvy; Manufacturer: pfizer; LotNumber: 3G55B; Route: IM; BodySite: Right arm; Dose: 1; VaxDate: UNKNOWN
Age: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Visual impairment
Clinical narrative: Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GSK; LotNumber: c2979; Route: IM; BodySite: left ARM; Dose: 2/2; VaxDate: UNKNOWN, VaccineTypeBrand: prevnar; Manufacturer: pfizer; LotNumber: HN5978; Route: IM; BodySite: Right arm; Dose: 1; VaxDate: UNKNOWN, VaccineTypeBrand: arexvy; Manufacturer: pfizer; LotNumber: 3G55B; Route: IM; BodySite: Right arm; Dose: 1; VaxDate: UNKNOWN
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test abnormal, Electric shock sensation, Fall, Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient felt severe tingling in his leg, "like electricity shooting in his legs" on the day after receiving vaccine. He tried to hold himself up against the wall to prevent falling,but he collapsed onto the floor and ended up staying on the floor for about 17 hours because he could not get up. his appartment manager helped pick him up the next day. Patient did not hit his head when he fell. On Tuesday morning he could walk again. Laboratory blood tests shows significant abnormalities.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild
Age: 40.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: prevnar 20; Manufacturer: pfizer; LotNumber: hp7364; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: right arm weakness, numbness several days painful to squeeze hand and could not make a fist, pt had f/u with md-Severe, Systemic: Weakness-Severe, Other Vaccines:  VaccineTypeBrand: heplisav b; Manufacturer: dynavax; LotNumber: 944906; Route: im; BodySite: right arm; Dose: 1; VaxDate: 04/23/2024
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Hypertension, Migraine, Treatment noncompliance
Clinical narrative: Systemic: Hypertension-Severe, Additional Details: My assessment was that shingrix may not have something to do with it. Posssible infammatory response.......She indicated that she had not been consistent with her amlodopine therapy ...Misses many doses.....He bp was 190 & complained to urgent care of terrible migraine. I counseled her on the importance of taking her hypertension medication
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Other Vaccines:  VaccineTypeBrand: Meningococcal Group B (Bexsero); Manufacturer: GSK; LotNumber: 95nj4; Route: IM; BodySite: Right Arm; Dose: 1; VaxDate: 08/04/2024, VaccineTypeBrand: Tdap (Boostrix); Manufacturer: GSK; LotNumber: z7l7h; Route: IM; BodySite: Right Arm; Dose: 1; VaxDate: 08/04/2024
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Nausea, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Medium, Additional Details: Patient recieved the shot around 2 pm and ended up in the ER at 6 pm with extreme arm pain and had to recieve medication. Pain is till strong and unable to use left arm. Believes pharmacist gave shot too high on the shoulder and said shot hurt going into the arm.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Medium, Additional Details: Patient recieved the shot around 2 pm and ended up in the ER at 6 pm with extreme arm pain and had to recieve medication. Pain is till strong and unable to use left arm. Believes pharmacist gave shot too high on the shoulder and said shot hurt going into the arm.
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Severe, Systemic: diagnosis was lue cellulitis-Severe
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Systemic: rash in the back-Mild, Additional Details: patientr reported had rash in her back
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Eye swelling, Flushing
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: spoke with patient, still feeling unwell, has not been able to keep food down, and will be attempting to see primary care physician next day
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Injection site swelling, Malaise, Mouth swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: spoke with patient, still feeling unwell, has not been able to keep food down, and will be attempting to see primary care physician next day
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Swelling face, Swollen tongue, Vomiting
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: spoke with patient, still feeling unwell, has not been able to keep food down, and will be attempting to see primary care physician next day
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Exposure during pregnancy, Hyperhidrosis, Tremor
Clinical narrative: Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: patient monitored by rph then layed pt on ground from seated position on left side as directed by EMS. Patient is 28 weeks pregnant. Saw OBG this morning who instructed her to come get vaccine for covIID.EMS arrived and checked vitals and blood sugar. pt taken to er for precautionary measures
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium
Age: 78.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: arexvy; Manufacturer: gsk; LotNumber: 29z7e; Route: im; BodySite: right arm; Dose: 1; VaxDate: 07/31/2024
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Dermatitis allergic, Discomfort, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient states injectioin site was hot and inflamed, red, then over the course of the next few days the welling and itching and bumps moved from injection site to elbow with intense itching and mild pain.  i spoke to her on day 7 and she applied bacitracin, took claritin, and applied ice and heat to the area, the discomfort is resolving but not completely gone at day 9
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient states injectioin site was hot and inflamed, red, then over the course of the next few days the welling and itching and bumps moved from injection site to elbow with intense itching and mild pain.  i spoke to her on day 7 and she applied bacitracin, took claritin, and applied ice and heat to the area, the discomfort is resolving but not completely gone at day 9
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient states injectioin site was hot and inflamed, red, then over the course of the next few days the welling and itching and bumps moved from injection site to elbow with intense itching and mild pain.  i spoke to her on day 7 and she applied bacitracin, took claritin, and applied ice and heat to the area, the discomfort is resolving but not completely gone at day 9
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Fever-Medium, Additional Details: red and painful
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Fever-Medium, Additional Details: red and painful
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Other Vaccines:  VaccineTypeBrand: mMENVEO; Manufacturer: GSK; LotNumber: JT347; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Weakness-Mild, Other Vaccines:  VaccineTypeBrand: MENQUADFI VIAL; Manufacturer: SANOFI-PASTEUR; LotNumber: U7949AB; Route: IM; BodySite: LEFT DELTOID; Dose: 1; VaxDate: 08/07/2024
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: arexvy; Manufacturer: glaxcosmithkline; LotNumber: z7km4; Route: im; BodySite: left arm; Dose: ; VaxDate: 07/18/2024
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Blood pressure decreased, Vision blurred
Clinical narrative: Systemic: blurry vision, decreased blood pressure-Mild
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient called pharmacy on Thursday, 08/08/2024 to discuss itching/redness around injection site of vaccinations administered on Monday, 08/05/2024. She has started experiencing itching and redness around the injection sites of the 2 vaccinations she received.  She asked what she should do to alleviate itching.  She is not having systemic issues such as breathing difficulty or swelling of airway. , Other Vaccines:  VaccineTypeBrand: Boostrix TDAP Vaccine Syringe; Manufacturer: Glaxosmithkline; LotNumber: 9L475; Route: Intramuscular; BodySite: Left Arm; Dose: 00; VaxDate: UNKNOWN
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Flushing, Hyperhidrosis, Syncope, Tremor
Clinical narrative: Systemic: vasovagal syncope-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient had same reaction during blood draw at urgent care(3 months ago)was diagnosis as a vaso-vagal syncope.  she "spaced" out, started mild shaking , responded to me calling her name, straightened up in the chair and responded to questions.  she was flushed. stayed with her for 15 minutes and walked her to boyfriend in car who was driving her home.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site hypoaesthesia, Injection site swelling, Peripheral swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient experienced some numbness in the local injection site on the left arm, sensation is still numb as of 8/9/2024 and arm feels like as if it big/swollen, but it is not preventing her from doing any daily activities. Patient also reporting that arm is still warm to the touch. Patient did go to clinic and prescriber ordered an antibiotic prescription and also administered a steroid injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient experienced some numbness in the local injection site on the left arm, sensation is still numb as of 8/9/2024 and arm feels like as if it big/swollen, but it is not preventing her from doing any daily activities. Patient also reporting that arm is still warm to the touch. Patient did go to clinic and prescriber ordered an antibiotic prescription and also administered a steroid injection.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient complained of right arm pain and left leg pain. Hurts when patient walks. Reported no swelling or redness in leg. Tylenol helps with the pain. Also reported pain radiating down from neck to fingertips. Recommended patient see doctor for further assessment
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling hot, Flushing, Hyperhidrosis
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: pt stated she started having a racing heart beat, sweating  and almost fainted 24 hours after the vaccine was administered. she still has the exhaustion but will contact her md if it continuess. the sweating/fainting sensation was acute and resolved-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: The patient  called and stated she had to take a nap after she came home from getting the vaccine. then  the next days she was shopping and the faitness/sweating and racing heart rate occured. she had to sit, drink water and use a fan to cool down before she went home. she stated she had to take another nap and this is unusual for her. , Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: GSK; LotNumber: 4n9pf; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Lethargy, Palpitations, Presyncope, Tachycardia
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: pt stated she started having a racing heart beat, sweating  and almost fainted 24 hours after the vaccine was administered. she still has the exhaustion but will contact her md if it continuess. the sweating/fainting sensation was acute and resolved-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: The patient  called and stated she had to take a nap after she came home from getting the vaccine. then  the next days she was shopping and the faitness/sweating and racing heart rate occured. she had to sit, drink water and use a fan to cool down before she went home. she stated she had to take another nap and this is unusual for her. , Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: GSK; LotNumber: 4n9pf; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: pt stated she started having a racing heart beat, sweating  and almost fainted 24 hours after the vaccine was administered. she still has the exhaustion but will contact her md if it continuess. the sweating/fainting sensation was acute and resolved-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: The patient  called and stated she had to take a nap after she came home from getting the vaccine. then  the next days she was shopping and the faitness/sweating and racing heart rate occured. she had to sit, drink water and use a fan to cool down before she went home. she stated she had to take another nap and this is unusual for her. , Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: GSK; LotNumber: 4n9pf; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Bubble at injection site, possibly fluid filled-Mild
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Lethargy, Paraesthesia
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Posture abnormal, Tension, Visual brightness
Clinical narrative: Within one minute after receiving vaccines listed above, the patient fell back onto the bed and tensed up. Patient came back to within 30 seconds and could only remember seeing brightness. Patient was monitored by provider for another 15 minutes, when she stated that she felt ok.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Vaccine administered subcutaneously instead of IM. Client observed for 15 minutes with no adverse reactions.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Vaccine not reconstituted, only diluent portion given.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: The wrong dose was given...too low for patient age
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Rash
Clinical narrative: RASH ON THIGHS, CONTINUED TO HAVE A RASH ON THIGHS AND GROIN AREA 08.14.24
Age: 24.0
Sex: F
Vaccine: DTAP, FLU4, MMR
Symptoms: Wrong product administered
Clinical narrative: Patient was provided a Dtap instead of a Tdap vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt was incorrectly given covid vaccine for 6 mo.- 11yrs. instead of covid vaccine 12yrs+. Mistake was discovered after the patient had left the clinic. Pt's provider and supervisor were notified. RN called pt to explain the error and offer to revaccinate with the appropriate dose as a walk-in visit. Pt verbalized understanding.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt inadvertently administered HPV (Gardasil) vaccine. No adverse side effects noted.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Haematochezia
Clinical narrative: bloody stool reported per mother
Age: 1.33
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: child was given the TDAP instead of Dtap. no reaction was seen.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Pt was here with MOC for vaccines for school. Per MOC he was due for a TDaP vaccine. I administered a TDaP for Patient. As I was looking at his vaccine record after the administration I realized that he received a TDaP last year (2023) at his last well visit. He was supposed to receive his Menquadfi vaccine for school. I explained to Mom that I had given the wrong vaccine without realizing but that he was going to be okay. Supervisors and Dr. were notified right away of the error. MOC was very understanding. Menquadfi was administered today as well.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Eye movement disorder, Incontinence, Syncope, Tremor
Clinical narrative: Patient given Menquadfi vaccine on 8/14/24. Patient initially tolerated the vaccination well without complaints.   However, about 10 minutes post vaccination, patient fainted while sitting in the waiting room chair- only witnessed by mom. The patient did not fall from the chair nor were any injuries reported by the patient or by mom. Patient was given a juice box and crackers. This writer waited with the patient and mom for 5 minutes to ensure patient was feeling better. Patient reports feeling better. Writer got up and left waiting room and immediately called DON of NCDOH to report the incident.   Writer was then called back to the waiting room by clerical about 5 minutes later. Mom reports to this writer that the patient had an episode of incontinence, that she began shaking, and that her eyes rolled back in her head. The episode was reported to have lasted 5-10 seconds and only witnessed by mom. Blood pressure and pulse were taken by this writer. Vitals WNL. Patient AxO x3. Patient was continuously monitored by writer for 30 minutes after this incident. DON and SPHN came to clinic to speak with mom and patient. SPHN called the patient's PMD and it was suggested by the PMD that the patient go to an ER for evaluation. This recommendation was relayed to mom and she is agreeable to taking the patient to Hospital ER.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC20
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Single Hep B vaccination was given to patient instead of Hib. Therefore patient received double dose of Hep B vaccination at one time since she also received Pediatrix on the same day.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received a dose of Covid 19 vaccine that was intended for patients ages 6 mo to 11 years v. the dose for 12 years and older.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Angiogram, Cerebral ischaemia, Electroencephalogram, Magnetic resonance imaging, Middle cerebral artery stroke
Clinical narrative: tics and twitching on L side starting 2 days after vaccinations, found to have ischemic R MCA with associated symptomatic seizures