chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Asthenia, Headache, Productive cough, Secretion discharge
Clinical narrative: coughing and bringing up mucus; headache; weak; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of productive cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced productive cough (Verbatim: coughing and bringing up mucus), headache (Verbatim: headache) and weakness (Verbatim: weak). The outcome of the productive cough and weakness were not reported and the outcome of the headache was resolved.   It was unknown if the reporter considered the productive cough, headache and weakness to be related to Arexvy.     It was unknown if the company considered the productive cough, headache and weakness to be related to Arexvy.   Additional Information: GSK receipt date: 23-NOV-2024 The patient reported that he/she got the RSV vaccine and he/she was not sick when he/she got but had been coughing and bringing up mucus, and he/she did had a headache for a few days and he/she was weak. The patient asked what should he/she did.
Age: 0.33
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month-old patient received Flulaval vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 724L5, expiry date 02-JUN-2025) for prophylaxis.   On 01-NOV-2024, the patient received FluLaval 2024-2025 season. On 01-NOV-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 month-old patient received Flulaval vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2024 The other health professional reported that a 4 month-old patient received Flulaval vaccine which led to inappropriate age at vaccine administration.  The other health professional asked for recommendations on this situation.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: reconstitute with MMR vaccine diluent (sterile water); reconstitute with MMR vaccine diluent (sterile water); This non-serious 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 patient who received Herpes zoster (Shingrix) (batch number 3ZT24, expiry date 21-APR-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstitute with MMR vaccine diluent (sterile water)) and inappropriate dose of vaccine administered (Verbatim: reconstitute with MMR vaccine diluent (sterile water)). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-DEC-2024 Health care provider (HCP) reported that a patient received Shingrix vaccine that was reconstitute with MMR vaccine diluent (sterile water), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Patient who received this dose had not been identified. Did not consent to follow-up. This was 1 of 8 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130284:SAME REPORTER US-GSK-US2023118651:SAME REPORTER US-GSK-US2022185136:SAME REPORTER US-GSK-US2022120159:SAME REPORTER US-GSK-US2021001301:SAME REPORTER US-GSK-US2019215421:SAME REPORTER US-GSK-US2018228581:SAME REPORTER
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: received only adjuvant without the powder portion of the Shingrix vaccine; received only adjuvant without the powder portion of the Shingrix vaccine; This non-serious case was reported by a nurse via call center representative 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, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only adjuvant without the powder portion of the Shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: received only adjuvant without the powder portion of the Shingrix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-DEC-2024 The reporter stated that she was completing inventory and this morning he/she noticed our Shingrix vaccine had one more of the component and one less adjuvant portion, someone wasn't aware that had to mix and just gave the one without the component. The specialist clarified with nurse that one patient received only adjuvant without the powder portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Nurse also stated that immediately afterward, the staff member who administered the dose realized the error and proceeded to give a properly reconstituted dose on the same day. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not have any patient details or lot information available at the time of the call.  The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a late second dose of TWINRIX administered to a female patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On 05-JUN-2024, the patient received Twinrix. On 05-JUN-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: a late second dose of TWINRIX administered to a female patient). The outcome of the drug dose administration interval too long 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: 05-DEC-2024 Pharmacist called asking about a late second dose of Twinrix administered to a patient.  The reporter asked if they would need to Reinitiate the patient´s schedule. The vaccination date and patient demographics were retrieved from the pharmacist´s end during this call.  No vaccine detail was provided from the pharmacist´s end during this call.  No further information was obtained during this call. The reporter consented to follow up. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: significantly delayed 3rd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 2 dose in 2020).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: significantly delayed 3rd dose). The outcome of the incomplete course of vaccination 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: 05-DEC-2024 The reporter was reaching out for clarification on how to proceed with a significantly delayed 3rd dose of Twinrix.  Based on the information he/she was given, a patient received 2 doses following the schedule in 2020. The patient had returned in December 2024 looking for the third dose.  The reporter asked if they proceed with the 3rd dose or they need to restart the series since it had been 4 years.  The Vaccine Administration Facility is the same as Primary Reporter. No other information provided. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2019079208:SAME REPORTER
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Shingrix on 2018 but she never came back for the second dose, can she get the second dose now; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 89-year-old female patient who received Herpes zoster (Shingrix) (expiry date 11-JUN-2019) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of Shingrix on 2018 but she never came back for the second dose, can she get the second dose now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-DEC-2024 The reporter called to ask if a patient received the first dose of Shingrix on 2018 but she never came back for the second dose, if she could get the second dose now or she need to start over the series. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received 1 vaccine but then she didn't get any other vaccine since June 10th; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 10th June 2024).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient received 1 vaccine but then she didn't get any other vaccine since June 10th). The outcome of the incomplete course of vaccination 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: 05-DEC-2024 The reporter called to inform that patient received 1 vaccine but then she did not get any other vaccine since 10th June 2024, she's behind. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: PENTACEL was given in error to a patient Liquid component was administered to the patient but not the HIB component with no adverse event; Initial information received on 13-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] in error only liquid component was administered to the patient but not the hib component with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) both for Immunisation.   On 05-Dec-2024, the patient received dose 2, 0.5 ml, 1X (once) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UK023AA and expiry 30-Apr-2025) (strength: unknown) in error only liquid component was administered to the patient but not the hib component with no adverse event (single component of a two-component product administered) (latency same day) via intramuscular route in the left vastus lateralis 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: 22.0
Sex: F
Vaccine: JEV1
Symptoms: Headache, Vision blurred
Clinical narrative: 24 hours post vaccine administration, Dec 18th, pt experienced blurry vision and headache.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Intellectual disability, Mass, Pain, Skin warm
Clinical narrative: It has been 2 1/2 mo since vaccine given and pt comes today complaining of still having a lump, itchiness and mild pain. To my exam there is still about a 6 cm (-) lump, warm to touch, no erythema, mildly painful to palpation. Recommended Benadryl q 6 hrs with ice f/u 2 wks or earlier if needed
Age: 68.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dry skin, Pruritus, Rash, Rash pruritic, Skin exfoliation
Clinical narrative: Age 68, For convenience, I decide to have both Covid/flu shots given at same time @ hospital. Side effects started a few days like an "attack by immune system?" I started suffering from upper body extreme-dryness. My Extreme dry-flaking-peeling skin -itching started on my face; then over a week spread with small bumpy rash-itching on my neck, arms, front/back torso. The lack of any "internal oils" symptoms began to ease gradually, starting with no peeling/flaking/itching on my face. Now, over the course of a month, there is no more drying/flaking face or neck only mild itching/rash are on arms-back torso remain. My self-treatment: topical hydrocortsone, vaseline, aquaphor, E-oil, benadyril, mild soap, infrequent showering.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Fall, Pyrexia, Syncope, Vomiting
Clinical narrative: patient received 2 vaccines Shingrix (GSK) and Fluzone HD (sanofi), developed fever, vomiting once, weakness, and syncope (several hours after vaccines). She then fell and was subsequently hospitalized due to fall. Patient reported event to pharmacy stating they medical providers are unsure which vaccine/or both caused reaction.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Urticaria
Clinical narrative: Patient reports she took covid shot got sick ,three weeks later, patient reports she took skyrizi injection, three weeks later she got hives. No additional information provided patient does consent to be contacted
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RVX
Symptoms: Botulism, Bradycardia, Culture stool positive, Endotracheal intubation, Hypotonia
Clinical narrative: 4mo infant who presented with confirmed (positive stool) infantile botulism. Admitted to ICU with profound cephalocaudal hypotonia, experienced bradycardic arrest on 12/17 requiring sedation and intubation. Received routine 4-month vaccines (DTaP, HepB, HiB, IPV, PCV20, Rotavirus) on 12/12 and started new Enfamil neuropro canned formula three weeks prior to presentation. Reportedly began to develop acute symptoms on 12/12, which has progressively worsening until current medical state in ICU. positive stool botulism, awaiting serotyping.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RVX
Symptoms: Intensive care
Clinical narrative: 4mo infant who presented with confirmed (positive stool) infantile botulism. Admitted to ICU with profound cephalocaudal hypotonia, experienced bradycardic arrest on 12/17 requiring sedation and intubation. Received routine 4-month vaccines (DTaP, HepB, HiB, IPV, PCV20, Rotavirus) on 12/12 and started new Enfamil neuropro canned formula three weeks prior to presentation. Reportedly began to develop acute symptoms on 12/12, which has progressively worsening until current medical state in ICU. positive stool botulism, awaiting serotyping.
Age: 35.0
Sex: M
Vaccine: YF
Symptoms: Dysphagia, Oropharyngeal discomfort, Throat tightness
Clinical narrative: Throat "felt funny".  Difficulty swallowing and tightness.  He was advised to take an antihistamine and go to the ER.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Shortness of breath and coughing since Nov 1
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Hypotension, Seizure like phenomena, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient was given both the flu and the covid in left arm felt dizzy and fell to the ground seemed to have a very short seizure may have hit head when fell patient was then awake and coherent medics were called and patient was take to hospital. Protocol was followed rph stayed with patient until taken by medics , Other Vaccines:  VaccineTypeBrand: covid; Manufacturer: pfizer; LotNumber: lm2224; Route: im; BodySite: left arm; Dose: 00; VaxDate: 12/14/2024
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient was given both the flu and the covid in left arm felt dizzy and fell to the ground seemed to have a very short seizure may have hit head when fell patient was then awake and coherent medics were called and patient was take to hospital. Protocol was followed rph stayed with patient until taken by medics , Other Vaccines:  VaccineTypeBrand: covid; Manufacturer: pfizer; LotNumber: lm2224; Route: im; BodySite: left arm; Dose: 00; VaxDate: 12/14/2024
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Dizziness postural, Fatigue, Hypotension
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypotension-Medium, Additional Details: Patient began feeling dizzy and lightheaded after vacccination with C-19 and influenza vaccines around 4pm 12/14/24 in pharmacy. We advised patient to sit with feet elevated. Blood pressure was checked several times while being monitored by pharmacist. Emergency kit was provided by technician just in case patient symptoms deteriorated. Patient recovered from dizzy spell within 10-15 minutes. Parents provided her some juice as well. Checked patient's blood pressure before left pharmacy building., Other Vaccines:  VaccineTypeBrand: Flucelvax Trivalent; Manufacturer: Seqirus; LotNumber: 946639; Route: IM; BodySite: L deltoid; Dose: n/a; VaxDate: 12/14/2024
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lethargy
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypotension-Medium, Additional Details: Patient began feeling dizzy and lightheaded after vacccination with C-19 and influenza vaccines around 4pm 12/14/24 in pharmacy. We advised patient to sit with feet elevated. Blood pressure was checked several times while being monitored by pharmacist. Emergency kit was provided by technician just in case patient symptoms deteriorated. Patient recovered from dizzy spell within 10-15 minutes. Parents provided her some juice as well. Checked patient's blood pressure before left pharmacy building., Other Vaccines:  VaccineTypeBrand: Flucelvax Trivalent; Manufacturer: Seqirus; LotNumber: 946639; Route: IM; BodySite: L deltoid; Dose: n/a; VaxDate: 12/14/2024
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: Flulaval; Manufacturer: GSK-ID BIODMEDIC; LotNumber: A555J; Route: Intramuscular; BodySite: Right Deltoid; Dose: ; VaxDate: 10/30/2024, VaccineTypeBrand: Prevnar 20; Manufacturer: WYETH/PFIZER; LotNumber: LG5576; Route: Intramuscular; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Joint swelling
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, Additional Details: injection site reaction, 5in by 5in, red, puffy, swollen, tender and itchy. treated with benadryl and ibuprofen, went away after 5 days
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient went to doctor after receiving injection because of redness and swelling at injection site, was told it was cellulitis and prescribed antibitoic
Age: 29.0
Sex: M
Vaccine: FLUC4
Symptoms: Flushing, Hyperhidrosis, Pallor
Clinical narrative: Systemic: Flushed / Sweating-Mild, Additional Details: Pt became pale and diaphoretic after administration of flu vaccine. Pt denies previous history of vasovagal episodes. Denies allergy. Vital signs stable  BP 103/70. HR 86. Temp 97.2. O2 98% on RA. Symptoms resolved after 15 minutes of observation. Pt ambulate out of the clinic unassisted without any issue.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Systemic: Patient reports being really sick (sick to her stomach) for a couple days after receiving COVID vaccine.-Medium
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Malaise, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Malaise & other flu like symptoms-Severe
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Lethargy, Pyrexia
Clinical narrative: Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: this was a trivalent high dose flu vaccine.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Cough
Clinical narrative: Systemic: cough-Mild, Additional Details: Patient stated after he received his vaccines, he began to experience a cough that has been going on for about 1 month.  He says he complete one entire bottle of over the counter store brand cough syrup with no resolution. Patient advised to speak with prescriber to advise on next steps.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Injection site bruising, Syncope, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: fainting and dizziness. consconciousness, responsiveness-Mild, Systemic: Vomiting-Mild, Additional Details: 3 vaccines given for the patient. after administering, the patient fainted and lie down on floor. The patient is consciousness and responsiveness. The 911 was called. Medic came over and take him to the Medic car for monitoring and taking him to hospital., Other Vaccines:  VaccineTypeBrand: Prevnar 20; Manufacturer: Pfizer; LotNumber: LJ5280; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 946625; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Cough, Decreased appetite, Dysphonia, Eye discharge
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: Patient received vaccination at external clinic and could not confirm Brand on flu vaccine received. Experienced cough, sneezing, runny nose, loss of appetite, sleeplessness, weakness, runny eyes, and hoarseness
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Insomnia, Lethargy, Rhinorrhoea, Sneezing
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: Patient received vaccination at external clinic and could not confirm Brand on flu vaccine received. Experienced cough, sneezing, runny nose, loss of appetite, sleeplessness, weakness, runny eyes, and hoarseness
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Systemic: a-fib-Medium, Additional Details: a-fib, Other Vaccines:  VaccineTypeBrand: fluad; Manufacturer: seqirus; LotNumber: 388494; Route: im; BodySite: r-deltoid; Dose: ; VaxDate: UNKNOWN
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac disorder, Hypertension
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Hypertension-Severe
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Anxiety, Dizziness, Flushing, Loss of consciousness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Concerned for shaking, unsure if seizure as patient reported no PMH-Medium, Additional Details: Patient received both Boostrix and Priorix, patient had adverse event only after receiving Priorix. Patient became very flush and lightheaded immediately, followed by passing out. After catching from falling forward, had visible body shaking for 5-10 sec, and then came back to very anxious. No other symptoms. Patient reported no allergies, side effects from previous vaccines, or past medical history. No signs of allergic reaction (i.e. SOB, hives, etc). Had patient stay and boyfriend picked up.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Concerned for shaking, unsure if seizure as patient reported no PMH-Medium, Additional Details: Patient received both Boostrix and Priorix, patient had adverse event only after receiving Priorix. Patient became very flush and lightheaded immediately, followed by passing out. After catching from falling forward, had visible body shaking for 5-10 sec, and then came back to very anxious. No other symptoms. Patient reported no allergies, side effects from previous vaccines, or past medical history. No signs of allergic reaction (i.e. SOB, hives, etc). Had patient stay and boyfriend picked up.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient reporting still having pain near site of injection in upper right arm. She says it hurts when she lies down or touches the upper arm. She feels something is wrong.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient visited doctor and was prescribed cephalexin for cellulitis. Complained of pain at injection site and redness on left arm
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Weakness-Medium
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: paitent reports severe pain at shoulder and arm at injection site
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: patient is complaining of pain on the injection arm up til date 12/17/24
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient called the pharmacy on 12/19/24 to report that she has had difficulty moving her shoulder every since getting the vaccine on 09/19/24.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: extreme pain and trouble lifting arm
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Anaphylactic reaction, Asthenia, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Unable to Sleep-Mild, Systemic: Weakness-Mild, Additional Details: General malaise like some one sick
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site swelling, Insomnia, Malaise
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Unable to Sleep-Mild, Systemic: Weakness-Mild, Additional Details: General malaise like some one sick
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient said arm was in pain after getting boostrix shot. Went to MD and thought it was in rotator cuff. Prescribed steroids. Said if pain does not get better will have to do PT.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: PATIENT REPORTS EXPEREIENCING FEVER, CHILLS AND PAIN AT INJECTION SITE AS A RESULT OF LAST COVID SHOT.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site infection, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient was hospitalized from infection at site.  Patient received 3 vaccinations in the right arm. , Other Vaccines:  VaccineTypeBrand: Flucelvax Trival; Manufacturer: ; LotNumber: 388523; Route: IM; BodySite: Right arm; Dose: 1; VaxDate: 09/23/2024, VaccineTypeBrand: Arexvy; Manufacturer: Glaxosmithkline; LotNumber: 97M99; Route: IM; BodySite: Right arm; Dose: ; VaxDate: 09/23/2024
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient was hospitalized from infection at site.  Patient received 3 vaccinations in the right arm. , Other Vaccines:  VaccineTypeBrand: Flucelvax Trival; Manufacturer: ; LotNumber: 388523; Route: IM; BodySite: Right arm; Dose: 1; VaxDate: 09/23/2024, VaccineTypeBrand: Arexvy; Manufacturer: Glaxosmithkline; LotNumber: 97M99; Route: IM; BodySite: Right arm; Dose: ; VaxDate: 09/23/2024
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, 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-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pruritus, Pruritus allergic, Rash
Clinical narrative: Site: Bruising at Injection Site-Medium, 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-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Weakness-Medium, Additional Details: Patient is experiencing weakness and sharp pain in vaccination location with certain movements for over 2 months after shingles vaccine
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: On 12/20/24 I administered a fluarix vaccine after asking patient the 2 questions I ask of every patient #1- Have you had the flu vaccine this year at any other doctor's office or pharmacy (he replied no) and #2- Do you have Charity care (he replied yes). I then had him sign the vaccine forms explaining what he is signing (which I do with every patient). I administered vaccine and provided the patient with the VIS.  Today (clinical supervisor) was checking all the forms against site and noticed that this patient had the flu vaccine at a Pharmacy on 12/10/24. She called the pharmacy to confirm the patient received flu vaccine. They confirmed he received the flu vaccine in addition to 2 other vaccines. Clinical Supervisor then called the patient, and he confirmed that he did get vaccines at the Pharmacy. When she notified him that he had already received the flu vaccine on 12/10/24 but when he was asked by the nurse on 12/20/24 he answered no he had not. The patient then stated to the Clinical Superivor that he has gotten so many vaccines and blood work that he is confused. Patient denied having any symptoms or adverse effects from receiving the second flu vaccine.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: RSV is only a one time shot. However, Patient received shot on 10/14/2023, and then again on 12/22/24. Have placed call out to patient for them to call back. Shot was given outside current guidelines. Patient hasn't reported any symptoms, and we only recognized the incident this morning.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Fatigue, SARS-CoV-2 test
Clinical narrative: Fatigue, cough
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Patient has adverse event of 'hallucinations' listed in EMR related to COVID-19 vaccine. No additional information available in the chart. Patient did complete a 3 series vaccination with Pfizer COVID vaccine. Vaccination dates were 4/7/21, 4/30/21,and 11/20/21. Unable to find information related to vaccination and hallucination event.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given incorrect vaccine based on age. Patient received Pfizer 12+ COVID vaccine and should have received Pfizer 5-11yr COVID vaccine due to age. No adverse effects reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Postural orthostatic tachycardia syndrome
Clinical narrative: Worsening of POTS
Age: 56.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Nausea
Clinical narrative: nausea and vomiting 12/20 , fever 12/20-current, continues at night, erythema, tenderness, firmness, and warmth at site 12/20-current.
Age: 56.0
Sex: M
Vaccine: PNC20
Symptoms: Pyrexia, Vomiting
Clinical narrative: nausea and vomiting 12/20 , fever 12/20-current, continues at night, erythema, tenderness, firmness, and warmth at site 12/20-current.
Age: 0.25
Sex: M
Vaccine: RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events. Vaccine was given at age 15 weeks 2 days
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Laboratory test abnormal, Spasmodic dysphonia
Clinical narrative: Was ultimately diagnosed with Abductor Spasmodic Dysphonia. It was barely perceptible when I first noticed it, on August 1st, as it would only manifest while I was performing voice over work. I thought it might be allergy related. Until one day, in July of 2022, I was unable to perform at all (I sounded like I was whispering) while recording (speaking voice is fine, though can disappear when I?m nervous).  I took Trazadone, which helps, it?s used in clinical trials for the condition, but I?ve had to let go of 90% of my clients, since I?m not able to perform as I used to.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Chest pain, Condition aggravated, Headache
Clinical narrative: 2 events. 1- Dec 17-24. At night b/p elevated, paine in lt. Side head. Morning of the 18, pain in lt. Chest, lt. Head, lt. Shoulder and neck. Lasted most of 12-18-24 . event 2 on Dec 22 morning lt side head, shoulder and neck pain lasted till pm. Then it was gone. With both events I had gas like indigestion.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: 2 events. 1- Dec 17-24. At night b/p elevated, paine in lt. Side head. Morning of the 18, pain in lt. Chest, lt. Head, lt. Shoulder and neck. Lasted most of 12-18-24 . event 2 on Dec 22 morning lt side head, shoulder and neck pain lasted till pm. Then it was gone. With both events I had gas like indigestion.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second Arexvy Vaccine but had no reaction.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: 2ND DOSE: SWELLING (GOLF BALL TO BASEBALL SIZE) PER CUSTOMER.
Age: 90.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second Arexvy vaccine. No reaction reported.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV9, TDAP
Symptoms: Asthenia, Nausea
Clinical narrative: Pt reported nausea feeling in lobby after vaccines were administered.  Pt showed signs of weakness in chair and carefully placed on ground with legs up.  After 10 mins and refreshments, pt reported to be okay.  VS WNL.  Pt reported that she did not eat before appointment.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second Arexvy Vaccine, but no reaction reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site scab, Pain in extremity
Clinical narrative: pt had scab on arm that crusted, fell off and then arm stayed red in a circle where shot was given even now 6 months out.  no heat.  no sign of infection. pt also said arm "hurts" and is sore and hes unable to lift shoulder past certain point.  referred to PCP.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Patient having pain in Right shoulder. Waiting or test results
Age: 56.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Back pain, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient daughter called due to patient speaks (redacted) only.. Reported on 12/23 that her mother started having fever, chills, body aches and arm soreness bilaterally the evening of the shots 12/16 and is still having these symptoms off and on and lower back pain.  Daughter reports mother had flu and Covid a month before these injections and had to get medications.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Oral candidiasis, Rhinorrhoea
Clinical narrative: Coughing, nasal discharge, headache, thrush on mouth. OTC medication until contacted telehealth Wednesday December 18th. Prescribed antibiotics and anti fungal meds for 5 days.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Patient went to Hospital with dizziness and numbness in legs. Headache for two days.   Patient stated he saw chiropractor 10-22 for adjustment and was in the woods and received vaccine 10/09.  Contacted hospital and was informed by NP that patient was diagnosed with GBS and given IVIG.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Patient received Bexsero when they should've received Menveo. Only side effect from immunization was sore arm per patient's mother
Age: 51.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Chills, Erythema, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, left arm pain, erythematic patches on left arm, warmth to site, distal patch with excoriation started day after receiving vaccine. Started on antibiotics on day 4 post vaccination after patient need in clinic again.
Age: 51.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Skin abrasion
Clinical narrative: Fever, chills, left arm pain, erythematic patches on left arm, warmth to site, distal patch with excoriation started day after receiving vaccine. Started on antibiotics on day 4 post vaccination after patient need in clinic again.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None reported
Age: 8.0
Sex: F
Vaccine: COVID19, DTAP, FLU3, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient presented to office with caregiver (Social Worker) for vaccines, No out of country imms record was available, so routine standard vaccines were to be given for age. Patient was given Dtap when she should have been given Tdap. Prior to drawing up vaccines I verified with social worker the vaccines that were to be given including the Tdap, and again at nurse station when drawing them up but somehow accidently pulled out Dtap vaccine from fridge instead of Tdap. Before administering in the exam room again I stated the vaccines with Tdap, did not notice I was given a Dtap until I went to chart the vaccines. Attempted to contact Agency and social worker, left VM for them to return my call to notify of the vaccine error. No reaction to vaccines in office.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3, PNC21
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness, Urticaria
Clinical narrative: Left arm was swollen, tender and red with hives and itchiness which started the day after the vaccines were received, and have so far lasted 9 days.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse s/s. Gave baby dose to adult
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Lichenoid keratosis
Clinical narrative: Lichen planus-like rash has developed, persisting for a few weeks on the trunk
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Bell's palsy
Clinical narrative: Patient seen in  ED for Bell's Palsy a few days after injection.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None at the time of injection.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I don't think my symptoms were from the shot at all I'm just reporting it I tested positive for COVID starting 12/14/2024. I am negative as of 12/21/2024. I believe I caught it from my husband, he had been very sick the week before, dealing this went through the employees at his work,  but did not test for COVID. I took Paxlovid, and my symptoms were mild. I'm all better.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Chills, headache, nausea. Less than 24 hour time course.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Discomfort, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Persistent pain in arm, pain upon receiving vaccine, pressure in shoulder, pain when moving arm/shoulder
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Impaired work ability, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: After the vaccination, that night my body ached and I felt chills and fever at the same time, I couldn't sleep, the next day the injection site turned red and swollen and spread further on my arm. It was very painful, I couldn't move my left arm above my head, I had to take half a day off work due to lack of sleep. The pain lasted for 5 days. Although the redness and pain have disappeared today, I still can't move my arm normally.
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site swelling, Insomnia, Pain, Pyrexia
Clinical narrative: After the vaccination, that night my body ached and I felt chills and fever at the same time, I couldn't sleep, the next day the injection site turned red and swollen and spread further on my arm. It was very painful, I couldn't move my left arm above my head, I had to take half a day off work due to lack of sleep. The pain lasted for 5 days. Although the redness and pain have disappeared today, I still can't move my arm normally.