chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: PNC20
Symptoms: Erythema, Injection site swelling, Rash, Skin warm, Swelling
Clinical narrative: Swelling; Redness; Rash/rash with warmth; Rash/rash with warmth; swelling at the injection site; This is a spontaneous report and received from Consumer or other non HCPs.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Lot number: LJ5284) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown"; ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; RASH (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "Rash/rash with warmth"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling at the injection site".
Sex: M
Vaccine: RSV
Symptoms: Rash
Clinical narrative: My immune system reacts to the RSV Pfizer with a large rash; This is a spontaneous report received from a Consumer or other non HCP.  An elderly male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "My immune system reacts to the RSV Pfizer with a large rash".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Investigation, Rash
Clinical narrative: 3 weeks later he started a rash; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: RASH (non-serious) with onset Nov2021, 3 weeks after the suspect product(s) administration, outcome "not recovered", described as "3 weeks later he started a rash". The event "3 weeks later he started a rash" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: The reporter's husband received his 1st covid booster 22Oct2021. 3 weeks later he started a rash. 4 doctors, numerous ointments, light box treatments and then medication orally, the rash was not only still there, but was spreading. Doctors had taken various tests and punch biopsies, and no one knew what the rash was. Ruled out various common skin disorders, all negative. Reporter stated that need your help to see if this was a bad reaction to a chemical in the booster shot he received.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Dyspnoea, Haemophilus infection, Nausea
Clinical narrative: Haemophilus influenza; trouble breathing; felt dizziness; nausea; Initial information received on 24-Jun-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 16 year old female patient who had haemophilus influenza, patient is still experiencing felt dizziness, nausea and trouble breathing after receiving vaccine Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Jun-2025, at 11:00 hours the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection standard strength frequency-once (lot number and expiry date-unknown) via unknown route in unknown administration site for Immunization.  Information on the batch number was requested corresponding to the one at time of event occurrence.  On 22-Jun-2025 the patient developed haemophilus influenza (haemophilus infection) (latency-2 days)  On 20-Jun-2025 at 02:00 hours the patient developed felt dizziness (dizziness), nausea, trouble breathing (dyspnoea) (latency- 11 hours).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events of (dizziness), nausea, trouble breathing (dyspnoea) and haemophilus infection).  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.  Seriousness Criteria-The patient was hospitalized for the event of haemophilus infection.; Sender's Comments: Sanofi company comment dated 26-JUN-2024: This case involves a 16 year old female patient who had haemophilus influenza, patient is still experiencing felt dizziness, nausea and trouble breathing after receiving vaccine Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Further information regarding regarding allergic history, medical history, concomitant medication and tolerance,  laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 5.0
Vaccine: DTP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 5-year old twins received ADACEL instead of DTaP with no reported AE; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5 years old and unknown gender patient who experienced 5-year old twins received adacel instead of dtap with no reported ae (adverse event) while receiving vaccines diphtheria, tetanus and nos pertussis vaccine and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 5-year old twins received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine; Suspension for injection for Immunization and received an unknown dose of suspect diphtheria, tetanus and nos pertussis vaccine produced by unknown manufacturer with unknown formulation for Prophylactic vaccination (Immunisation) and both (lot number, strength and expiry date not reported) via unknown route in unknown administration site with no reported ae (wrong product administered) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  No follow-up is possible as Reporter cannot be contacted by Sanofi.  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.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received PENTACEL out of sequence, got it one-month early and now she is due for the 15-month dose with no reported AE; Initial information received on 26-Jun-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves Infant female patient who had received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] out of sequence, got it one-month early and now she is due for the 15-month dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, (lot number, strength and expiry date not reported) frequency: once via unknown route in unknown administration site for immunisation, out of sequence, got it one-month early and now she is due for the 15-month dose with no reported ae (inappropriate schedule of product administration) (latency: same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  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: 1.5
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: It was a extra dose of Polio that was given to pt. He had no reaction to this.
Age: 62.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Administered an MMRV, was scheduled for MMR
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient came back to pharmacy to report adverse reaction to vaccine. Starting the day after receiving vaccine, patient experienced general pain in the arm vaccine was administered in. She later noticed redness and warmth. When she came in on 6/17/25, arm was red in the area well below administration site and spread towards the front of the arm, almost reaching elbow. Patient later reported seeing provider on 6/17/25 and received prednisone 20 mg BID for 5 days, then QD for 5 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, 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, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: numbness between right shoulder and spine area
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: unsuitable product administered with no reported adverse event; Initial information received on 26-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown age and gender who was administered to unsuitable 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 an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization and unsuitable product was administered with no reported adverse event (poor quality product administered) (latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.   Reportedly, the duration of temperature excursion: 48 hours and maximum/minimum temperature reached: 5°C but the reported stated that she was not sure for the temperature. It was not related to human error.  Action taken was not applicable.  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: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Dyspnoea, Hyporesponsive to stimuli, Loss of consciousness, Syncope
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient complained after shot of feeling light headed, went to go get water for her, by the time I got back with it my tech said she passed out in the chair. She was slightly resposive when I checked her, called 911 who sent paramedics and she was taken to the hospital from here. Bp was 80/60 when they checked. Patient's husband came later to report she recovered, relayed she had a semiglutide injection recently and was fasting for her blood draw that morning. , Other Vaccines:  VaccineTypeBrand: heplisav-b; Manufacturer: dynavax; LotNumber: 946063; Route: IM; BodySite: left arm; Dose: 1; VaxDate: 06/20/2025, VaccineTypeBrand: Varivax; Manufacturer: merck; LotNumber: 2004455; Route: IM; BodySite: left arm; Dose: ; VaxDate: 06/20/2025
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: RASHES APPEARED ON UPPER ARMS YESTERDAY WITH ITCHING
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient somewhat fainted for about 5 seconds after receiving the injection of Gardasil 9. His father was there, so the patient did not fall off of the chair. 911 was called. Patient seemed to be ok. The medics checked him out and he seemed to be ok. His dad said this has happened in the past with other vaccines., Other Vaccines:  VaccineTypeBrand: Gardasil 9; Manufacturer: Merck; LotNumber: x020725; Route: im; BodySite: arm; Dose: ; VaxDate: UNKNOWN
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Mobility decreased
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: Pt does take 2 benadryl at night as a routine medication and she took on wed,thr and fri but sysmtomps did not get better. Pt does have difficulty raising arm or no tingling running towards finger. Advised patient to seek medical attention either with PCP or urgent care or immediate care due to weekend. Per pt, if it continues she will contatct her PCP on monday or seek medical attention sooner. , Other Vaccines:  VaccineTypeBrand: Boostrix TDAP; Manufacturer: GSK; LotNumber: 793PT; Route: IM; BodySite: Right Deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Arexvy; Manufacturer: GSK; LotNumber: 4F45Z; Route: IM; BodySite: Right Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Patient had a "hamburger sized" injection site swelling, that decreased day after. (06/21/25). Patient started developing rash starting 06/21/25 evening rash from her upper thigh towards the glute. Started spraeding with bumps not blistering. Patient woke up at 06/22/25 and devleoped another rash across abdomin with same features. Patinet has been taking tylenol 500mg by mouth once daily since day of injection 06/20/25. Patient has been counselled to seek further medical help and advise., Other Vaccines:  VaccineTypeBrand: Shingrix (Shingles); Manufacturer: Glaxosmithkline; LotNumber: 39H2S; Route: IM; BodySite: Right Arm; Dose: ; VaxDate: UNKNOWN
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt received Arexvy vaccine on Thursday 6/19/25. Pt came to pharmacy on Sunday 6/22/25 and reported redness, swelling, and pain in arm below injection site that has lasted for 3 days. Recommended pt take ibuprofen and diphenhydramine to alleviate symptoms. Will follow up with pt the next day., Other Vaccines:  VaccineTypeBrand: Arexvy; Manufacturer: GSK; LotNumber: XA53Y; Route: IM; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Additional Details: Pt said that his all extremites are very painful and he is not able to sleep on left side at all., Other Vaccines:  VaccineTypeBrand: Heplisav B; Manufacturer: dynavax; LotNumber: 947931; Route: intramusular; BodySite: right arm; Dose: 1; VaxDate: 06/16/2025
Age: 56.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Severe, Additional Details: patient reported to pharmacy to today with severe bruising of large area of right arm. patient was advised to see a doctor immediately by rph both in person when in the pharmacy and later on phone. patient has refused to see doctor or go to the emergency room , Other Vaccines:  VaccineTypeBrand: boostrix; Manufacturer: ; LotNumber: pd324; Route: intramuscular; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: pfizer comirnity; Manufacturer: ; LotNumber: md3414; Route: intramuscular; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: patient said the injection site turned red and swelling after a few days, patient went to the doctor to get it check out, and doctor said it was infected, and prescribed patient oral antibiotics, no other symtoms specified, patient called to let us know, no other complaints.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Flushing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Dyskinesia, Facial pain, Fall, Headache
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient got MENACWY vaccine in his left arm. In 5 min patient got HPV vaccine in right arm, was doing well for 2 minutes, and was talking. Suddenly fell face forward and was unconscious. Had a couple second episode of jerking movements, SBP 150, patient was diaphoretic, in a couple of minutes started talking and was oriented to self, situation and place, was complaining of face pain due to trauma to the lip from falling and right knee pain, as well as headache.  Was thirsty and was drinking, Other Vaccines:  VaccineTypeBrand: HPV; Manufacturer: merck; LotNumber: z005469; Route: IM; BodySite: right deltoid; Dose: 1; VaxDate: 06/24/2025
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Lip injury, Loss of consciousness, Syncope, Thirst
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient got MENACWY vaccine in his left arm. In 5 min patient got HPV vaccine in right arm, was doing well for 2 minutes, and was talking. Suddenly fell face forward and was unconscious. Had a couple second episode of jerking movements, SBP 150, patient was diaphoretic, in a couple of minutes started talking and was oriented to self, situation and place, was complaining of face pain due to trauma to the lip from falling and right knee pain, as well as headache.  Was thirsty and was drinking, Other Vaccines:  VaccineTypeBrand: HPV; Manufacturer: merck; LotNumber: z005469; Route: IM; BodySite: right deltoid; Dose: 1; VaxDate: 06/24/2025
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient got MENACWY vaccine in his left arm. In 5 min patient got HPV vaccine in right arm, was doing well for 2 minutes, and was talking. Suddenly fell face forward and was unconscious. Had a couple second episode of jerking movements, SBP 150, patient was diaphoretic, in a couple of minutes started talking and was oriented to self, situation and place, was complaining of face pain due to trauma to the lip from falling and right knee pain, as well as headache.  Was thirsty and was drinking, Other Vaccines:  VaccineTypeBrand: HPV; Manufacturer: merck; LotNumber: z005469; Route: IM; BodySite: right deltoid; Dose: 1; VaxDate: 06/24/2025
Age: 66.0
Sex: F
Vaccine: PNC21
Symptoms: Infection, Injection site abscess
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: Husband reports patient was seen for an infection, treated with short term course of kefelx, dispensed from pharmacy
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site bruising, Injection site pain, Lethargy, Pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient received 2nd dose of Shingles vaccine on 6/6/2025. His first dose was in 2024. He does not recall if he had any reactions after the 1st dose. He complained for arm soreness, pain, and upper extremity rash. Those symptoms started 2 days after the vaccine. He visited the ER. The ER did X-rays and scans, which all came back normal. They prescriber stated patient may have possible reaction from vaccine. Pt will follow up with PCP.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Scan normal, X-ray normal
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient received 2nd dose of Shingles vaccine on 6/6/2025. His first dose was in 2024. He does not recall if he had any reactions after the 1st dose. He complained for arm soreness, pain, and upper extremity rash. Those symptoms started 2 days after the vaccine. He visited the ER. The ER did X-rays and scans, which all came back normal. They prescriber stated patient may have possible reaction from vaccine. Pt will follow up with PCP.
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ACTHIB being given to children 6 to 7 weeks of age with no reported AE; Initial information received on 27-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Infant and unknown gender patient for whom HIB (PRP/T) vaccine [ACT-HIB] being given to children 6 to 7 weeks of age with no reported ae (adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine;  Powder and solvent for solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization; being given to children 6 to 7 weeks of age with no reported ae (product administered to patient of inappropriate age) (latency: same day).   Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  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: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Feeling faint, laid on the floor to recover
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Rash, Rash pruritic
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient states approx 48 hrs after vaccination she experienced an "intensely itchy rash" on upper right arm and right ankle
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient stated she feels itchy at the site of injection and swelling was there but does not bother her. She wants some itching symptom relief. Advice her to get benadryl tablet to take, also she can use benadryl cream for itching. Recommended ice pack or warm compression on arm. Patient stated she will monitor and seek for medical help if needed.
Age: 73.0
Sex: F
Vaccine: PNC21
Symptoms: Blood disorder, Deep vein thrombosis
Clinical narrative: Systemic: Blood Disorder  (diagnosed by MD)-Medium, Additional Details: Patient developed a DVT in her right leg, has had a history of 3 previous DVTs in the right leg
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Systemic: felt hot and redness on neck and arms-Mild, Additional Details: patient feels hot and redness on arms and neck
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Lymphadenopathy, Pruritus
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: had some itching on wrist and says lympth node on that side swollen-Mild, Other Vaccines:  VaccineTypeBrand: boostrix; Manufacturer: glaxosmith; LotNumber: hr4279; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: gardasil; Manufacturer: merck; LotNumber: 2005055; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 87.0
Sex: M
Vaccine: PNC21
Symptoms: Dizziness, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild
Age: 66.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 0.25
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Additional Details: pt said they had itching reaction when asked if they wanted to finish the series. i asked patient if she wanted me to report she said yes.  i can't view any of the other info in rx system
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Blister, Erythema, Injection site erythema, Pruritus
Clinical narrative: Site: Redness at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Additional Details: patient states that he gets several blisters, patches of red spots with fluids all over the body including back of hair and butt. symptoms goes away after 7-8 days and comes back. this is 3rd time having these symptoms after second dose of shingrix... 1st dose was fine..., Other Vaccines:  VaccineTypeBrand: prevnar 20; Manufacturer: wyeth Pharmaceuticals LLC; LotNumber: LJ5281; Route: IM; BodySite: right arm; Dose: 00; VaxDate: 02/28/2025
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Site: Redness at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Additional Details: patient states that he gets several blisters, patches of red spots with fluids all over the body including back of hair and butt. symptoms goes away after 7-8 days and comes back. this is 3rd time having these symptoms after second dose of shingrix... 1st dose was fine..., Other Vaccines:  VaccineTypeBrand: prevnar 20; Manufacturer: wyeth Pharmaceuticals LLC; LotNumber: LJ5281; Route: IM; BodySite: right arm; Dose: 00; VaxDate: 02/28/2025
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, 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
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Crying, Diarrhoea haemorrhagic, Food refusal
Clinical narrative: Inconsolable crying, decreased PO intake, developed bloody diarrhea on day 3 after vaccine
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Injection site pain
Clinical narrative: The patient received an expired vaccine at his appointment. On 06/12/2025 he received a COVID 19 vaccine that expired 06/11/1025. He had soreness at injection site for 3 days. Has not had any new symtoms since.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a COVID vaccine on 06/13/2025, this vaccine expired on 06/11/3025. Patient did not experience any adverse reactions from this injection.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a COVID 19 vaccine on 6/17/2025 that expired on 6/11/2025. I spoke to parents and patient did not experience any adverse resctions to this vaccine.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea and spit up for 7 days
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: PATIENT STATES THAT A DAY OR TWO AFTER RECEIVING HPV VACCINE SHE BROKE OUT IN A SEVERE RASH TO THE ARM SHE RECEIVED THE VACCINE IN (RIGHT) AND TO THE TRUNK OF HER BODY. SHE WAS SEEN BY PMD AND WAS TOLD THAT SHE HAD A SEVERE REACTION TO THE VACCINE AND SHE IS STILL BEING TREATED FOR THE REACTION AT THIS TIME.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Patient had swelling at lower injection site (meq site). Swelling got bigger throughout the day. Ibuprofen was administered. Swelling still present 2 days after noticing.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Muscular weakness, Pain
Clinical narrative: States soreness, limited ROM, muscles weakness at times x 10 days
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient recieved dtap-hep b-ipv vaccine instead of recommended dose of dtap-hib-ipv (pentacel), after patient received incorrect dose patient was acting his normal self. RN placed call to parent to inform of incorrect vaccine no answer, RN left message to have parent call clinic back.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Headache, Injected limb mobility decreased, Pain, Pyrexia
Clinical narrative: Beginning around four hours after the injection I had limited to no mobility in my arm. A couple more hours into the evening, I developed a really bad fever, had an immense headache, and severe chills. My teeth were chattering, and I could not stop shaking.  It was about 10:30pm when I had to take some Aleve, as the pain was so intense.  I was finally able to go to sleep, as the fever broke and stopped shaking. It has taken about three days for my arm to be at 90% of full range of motion.  I have never experienced that fever or shaking before, as I don't ever get sick.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Tremor
Clinical narrative: Beginning around four hours after the injection I had limited to no mobility in my arm. A couple more hours into the evening, I developed a really bad fever, had an immense headache, and severe chills. My teeth were chattering, and I could not stop shaking.  It was about 10:30pm when I had to take some Aleve, as the pain was so intense.  I was finally able to go to sleep, as the fever broke and stopped shaking. It has taken about three days for my arm to be at 90% of full range of motion.  I have never experienced that fever or shaking before, as I don't ever get sick.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Lacrimation increased, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: At 0730 resident BP was 167/81 T 100.3 vital placed in vitals section in PCC, face was flushed has running nose and watery eyes, lip was red and slightly swollen. Resident stated it possibly could be related having the covid vaccine yesterday. Writer updated NP on call had given one time order Benadryl 25 mg and Tylenol 650 mg q 4 hours prn for fever/pain. Resident said he does not want to go to the hospital. Nursing staff will continue to monitor resident.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Welts near site of injection
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Rash, Rash pruritic
Clinical narrative: PATIENT IS EXPERIENCING A ITCHY AND PAINFUL RASH. SHE IS ALSO HAVING DIARRHEA
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt has injection site rash with erythema, swelling and pain
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Tdap inadvertently given too soon. Patient did not suffer any adverse effects after inadvertent administration of Tdap.
Age: 22.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was given Poliovirus intradermally instead of TB. No symptoms at time of injection
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Seizure
Clinical narrative: Per pt's mother, pt had a seizure and was taken to the hospital. Per mother, she states the ER physician told her it was a reaction to the meningitis vaccine.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Chills, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: Mild SOB; dizziness, chills, body aches, joints pain, nausea, fever, loss of appetite.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Mild SOB; dizziness, chills, body aches, joints pain, nausea, fever, loss of appetite.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dementia, Dizziness, Dysstasia, Gait disturbance
Clinical narrative: patient experience nerve pain in shoulder; nerve pain in lower extremities(butt, lower back & legs); difficulty thinking, memory decline; difficulty standing, walking and strength decline; vertigo; pain when attempting to stand; dizzyness; within 1st year after Vaccine and  Inpatient hospitalization, prolongation of existing hospitalization, persistent and significant incapacity, substantial disruption of the ability to conduct normal life functions diagnosed to have osteoporosis & dementia declared incompetent all within 36 months after receiving Pfizer Vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Memory impairment, Mental impairment, Neuralgia, Osteoporosis
Clinical narrative: patient experience nerve pain in shoulder; nerve pain in lower extremities(butt, lower back & legs); difficulty thinking, memory decline; difficulty standing, walking and strength decline; vertigo; pain when attempting to stand; dizzyness; within 1st year after Vaccine and  Inpatient hospitalization, prolongation of existing hospitalization, persistent and significant incapacity, substantial disruption of the ability to conduct normal life functions diagnosed to have osteoporosis & dementia declared incompetent all within 36 months after receiving Pfizer Vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vertigo
Clinical narrative: patient experience nerve pain in shoulder; nerve pain in lower extremities(butt, lower back & legs); difficulty thinking, memory decline; difficulty standing, walking and strength decline; vertigo; pain when attempting to stand; dizzyness; within 1st year after Vaccine and  Inpatient hospitalization, prolongation of existing hospitalization, persistent and significant incapacity, substantial disruption of the ability to conduct normal life functions diagnosed to have osteoporosis & dementia declared incompetent all within 36 months after receiving Pfizer Vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Patient came in to ask about whether she should receive another dose due to a reaction she had with the 1st dose in February. Patient reported itching started in the evening of injection. The next day she woke up with a red, swollen, itchy arm from the injection site to her wrist. She said the symptoms persisted until day 4 when they started to improve. By the 6th day the symptoms had resolved.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Patient woke up this morning with left eye swollen at 11:00 am on 06/27/2025.  Patient can still still see out of the eye, has no pain, or itching.  Patient reports that it is a lot of swelling but does not impede the vision and has not closed up the eye.   On 06/30/25 1:45 pm called patient and she reported that the left eye swelling has greatly improved with the use of allergy medications and did not require a doctor's visit.  She did have some itching in left eye and slight swelling and reported that she was going to continue to take the allergy medication for a little longer.  VACCINE WAS SUPPLIED BY VFC.
Age: 1.17
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Refusal of vaccination
Clinical narrative: mom declined flu vaccines to clinician.  MA failed to follow protocols as per company policies and an unwanted vaccine was given without parent consent. No abnormal symptoms reported per parents when follow up by office manager.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chest discomfort, Eye pruritus, Injection site erythema, Injection site swelling, Lacrimation increased
Clinical narrative: Patient was given Bexero vaccine in left Deltoid and approximately one hour after injection started with swelling of lips, Hives on arm and redness around injection site, itchy and watery eyes, wheezing and chest tightness.  Patient contacted her mother that advised her to take Benadryl, symptoms improved after a few minutes.  Patient was seen by the provider today in the office, no more hives, but still with swelling of the arm and at the injection site.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Lip swelling, Urticaria, Wheezing
Clinical narrative: Patient was given Bexero vaccine in left Deltoid and approximately one hour after injection started with swelling of lips, Hives on arm and redness around injection site, itchy and watery eyes, wheezing and chest tightness.  Patient contacted her mother that advised her to take Benadryl, symptoms improved after a few minutes.  Patient was seen by the provider today in the office, no more hives, but still with swelling of the arm and at the injection site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blood magnesium normal, Dizziness, Electrocardiogram normal, Full blood count normal, Metabolic function test normal
Clinical narrative: PATIENT RECEIVED BEXSERO IN OFFICE AROUND 11AM. AROUND 11PM SHE COMPLAINED TO HER PARENT THAT HER ARM HURT, SHE FAINTED, AND CONTINUED TO COMPLAIN OF DIZZINESS UNTIL SHE RECEIVED A FLUID BOLUS IN THE ED.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Syncope, Ultrasound scan normal
Clinical narrative: PATIENT RECEIVED BEXSERO IN OFFICE AROUND 11AM. AROUND 11PM SHE COMPLAINED TO HER PARENT THAT HER ARM HURT, SHE FAINTED, AND CONTINUED TO COMPLAIN OF DIZZINESS UNTIL SHE RECEIVED A FLUID BOLUS IN THE ED.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events -pt received 3rd vaccine when only supposed to get 2 to complete the series.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt reported arm pain and stated it was painful to move her arm up and down without any pain.
Age: 32.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Breath holding, Dizziness, Feeling hot, Laboratory test normal, Loss of consciousness
Clinical narrative: Patient was very nervous to receive the vaccine and squeezed a pharmacist's hand while getting the vaccines. Patient was also holding their breath throughout. After getting the vaccines pat got dizzy, groggy, and pale. Also, she expressed that she felt very warm and she vomited. Rapid response was called and she was taken to the ED. Per ED report pt passed out, though she was never observed to have lost consciousness while at the immunization clinic  and was talking  from the time she got the shot until ED took her.
Age: 32.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Pallor, Somnolence, Vomiting
Clinical narrative: Patient was very nervous to receive the vaccine and squeezed a pharmacist's hand while getting the vaccines. Patient was also holding their breath throughout. After getting the vaccines pat got dizzy, groggy, and pale. Also, she expressed that she felt very warm and she vomited. Rapid response was called and she was taken to the ED. Per ED report pt passed out, though she was never observed to have lost consciousness while at the immunization clinic  and was talking  from the time she got the shot until ED took her.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Eye movement disorder, Tonic clonic movements, Vision blurred
Clinical narrative: Approximately 15 minutes after administration of vaccines in primary care clinic, parent and pt in lobby alerted staff that pt c/o blurred vision, then developed tonic-clonic movments of 4 limbs that lasted a few seconds as well as lateral eye movements. She did not fall or sustain injury. Pt then asked what had happened and remained alert and oriented.  Mother described the incident as a seizure. Given lack of hx of seizures, the parent was asked to take the pt to the Emergency Department for further evaluation (seizure vs syncope).
Age: 73.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt arm got red and a little raised at the injection site
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cerebrovascular accident, Electrocardiogram ambulatory
Clinical narrative: AFIB developed 1 month later which lead to a stroke.
Age: 33.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: One day after receiving vaccine, patient went to the gym and began to experience redness, warmth and swelling at injection site
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Feeling hot, Incoherent, Loss of consciousness, Vision blurred
Clinical narrative: Patient began feeling dizzy while sitting about 15 seconds after final vaccination and then made incoherent sounds and seemingly lost consciousness for about 5-10 seconds. Patient then was fully responsive but still feeling hot and dizzy. Patient was given water to drink and a lollipop because his father reported eating and drinking very little today. A fan was turned on and pointed at patient to help cool off and after 3-5 minutes was placed on a wheelchair to move to room with a bed to lay down. Patient states vision became blurry and dark while moving him to wheelchair. Patient was layed down on bed and vitals were taken at 03:22pm and B/P was 97/57, pulse 51, and o2 sat 95%. Patient was given snack and more water and reported feeling better. Pupils were equal and reactive to light. Vitals checked again at 3:29: BP 107/70, pulse 60, and o2 sat 97%. Vitals taken again at 3:35: BP 117/72, pulse 62, and o2 sat 95%. Patient stated feeling much better and was escorted down hallway with stable gait. Patient escorted to vehicle with dad driving.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Visual impairment
Clinical narrative: Patient began feeling dizzy while sitting about 15 seconds after final vaccination and then made incoherent sounds and seemingly lost consciousness for about 5-10 seconds. Patient then was fully responsive but still feeling hot and dizzy. Patient was given water to drink and a lollipop because his father reported eating and drinking very little today. A fan was turned on and pointed at patient to help cool off and after 3-5 minutes was placed on a wheelchair to move to room with a bed to lay down. Patient states vision became blurry and dark while moving him to wheelchair. Patient was layed down on bed and vitals were taken at 03:22pm and B/P was 97/57, pulse 51, and o2 sat 95%. Patient was given snack and more water and reported feeling better. Pupils were equal and reactive to light. Vitals checked again at 3:29: BP 107/70, pulse 60, and o2 sat 97%. Vitals taken again at 3:35: BP 117/72, pulse 62, and o2 sat 95%. Patient stated feeling much better and was escorted down hallway with stable gait. Patient escorted to vehicle with dad driving.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness postural, Nausea, Urticaria
Clinical narrative: pt reported dizziness when standing up, large welt that extended to the elbow, and nausea. pt was directed by MD to monitor symptoms, try HC cream, stay hydrated, and rest