chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Product administered at inappropriate site
Clinical narrative: vaccine determinded to have been administered too high and ito the joint. pt had shooting/tingling pain. pt took ibuprofen with no relief. pt went to urgent care the next morning and received prednisone, zofran, lidocaine patch, cyclobenzaprine, and norco.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Patient reported pain during the administration of the vaccine, and later during the day she developed redness in the administration area, as well as a "bump" and the area feeling warm to the touch. She used cold compresses for the symptoms, but it didn't help. The symptoms lasted for more than 5 days.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased, Nausea, Vomiting
Clinical narrative: Patient reported he started with nausea and vomiting at home  and went to the ER . he said he was admitted for 24 hours due to a low heart rate .
Age: 62.0
Sex: F
Vaccine: PNC15
Symptoms: Arthralgia, Erythema, Headache, Induration, Myalgia
Clinical narrative: Generalized myalgias, arthralgias, headache, low grade fever x 48 hours with redness and swelling of 10 x 7 cm induration for 72 hours.
Age: 62.0
Sex: F
Vaccine: PNC15
Symptoms: Pyrexia, Swelling
Clinical narrative: Generalized myalgias, arthralgias, headache, low grade fever x 48 hours with redness and swelling of 10 x 7 cm induration for 72 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Patient received both Shingrix (1st dose) and Capvaxive (NDC: 00006-4347-02, lot: Z002626, Exp: 09/04/2026) on left deltoid muscle on 7/2/25, On 7/3/25, patient reported the following symptoms: 1. Fever/tired/slight stomach pain/weak/dizziness that last for 3 days.  2. Rashes/bumpiness/itching  on  both legs around the knees area, lower 1/3 part of her thighs, and upper 1/3 part of her calves area--- according to patient there is no change in food or  medications and she strongly believed those bumps/itchiness are caused by the vaccine(s). 3. Primary concern are the  Pain, Redness, firm, inflame,  and warm to touch of the injection site and the surrounding area (about the size of a golf ball).  Patient was recommend to apply ice pack to the area 20 min every hours and taking tylenol 500mg (2 tab Q6-8HPRN PAIN), loratadine,  hydrocortisone 1% cream. Patient will try to get in contact with her primary provider to assess/resolve the reaction and potentially get some steroid.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Patient received both Shingrix (1st dose) and Capvaxive (NDC: 00006-4347-02, lot: Z002626, Exp: 09/04/2026) on left deltoid muscle on 7/2/25, On 7/3/25, patient reported the following symptoms: 1. Fever/tired/slight stomach pain/weak/dizziness that last for 3 days.  2. Rashes/bumpiness/itching  on  both legs around the knees area, lower 1/3 part of her thighs, and upper 1/3 part of her calves area--- according to patient there is no change in food or  medications and she strongly believed those bumps/itchiness are caused by the vaccine(s). 3. Primary concern are the  Pain, Redness, firm, inflame,  and warm to touch of the injection site and the surrounding area (about the size of a golf ball).  Patient was recommend to apply ice pack to the area 20 min every hours and taking tylenol 500mg (2 tab Q6-8HPRN PAIN), loratadine,  hydrocortisone 1% cream. Patient will try to get in contact with her primary provider to assess/resolve the reaction and potentially get some steroid.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient received both Shingrix (1st dose) and Capvaxive (NDC: 00006-4347-02, lot: Z002626, Exp: 09/04/2026) on left deltoid muscle on 7/2/25, On 7/3/25, patient reported the following symptoms: 1. Fever/tired/slight stomach pain/weak/dizziness that last for 3 days.  2. Rashes/bumpiness/itching  on  both legs around the knees area, lower 1/3 part of her thighs, and upper 1/3 part of her calves area--- according to patient there is no change in food or  medications and she strongly believed those bumps/itchiness are caused by the vaccine(s). 3. Primary concern are the  Pain, Redness, firm, inflame,  and warm to touch of the injection site and the surrounding area (about the size of a golf ball).  Patient was recommend to apply ice pack to the area 20 min every hours and taking tylenol 500mg (2 tab Q6-8HPRN PAIN), loratadine,  hydrocortisone 1% cream. Patient will try to get in contact with her primary provider to assess/resolve the reaction and potentially get some steroid.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Computerised tomogram, Ear pain, Headache, Hemiparesis
Clinical narrative: Pain from right arm to the back of the right side of head to the ear. Massive headache, face swelling, vomiting and right side weakness with neurological symptoms
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Magnetic resonance imaging, Neurological symptom, Pain in extremity, Swelling face, Vomiting
Clinical narrative: Pain from right arm to the back of the right side of head to the ear. Massive headache, face swelling, vomiting and right side weakness with neurological symptoms
Age: 0.17
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the HPV vaccine by mistake.  Provider notified parent that the wrong shot was given Later in the afternoon and the physician was on call this weekend and didn't have any calls from the parent to say that anything had developed.
Age: 0.17
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given the HPV vaccine by mistake.  Provider notified parent that the wrong shot was given Later in the afternoon and the physician was on call this weekend and didn't have any calls from the parent to say that anything had developed.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pruritus, Injection site rash
Clinical narrative: Rash around injection site, flushing and itchiness.; flushing; itchiness; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-JUN-2025, the patient received the 1st dose of Shingrix (left deltoid). On 20-JUN-2025, 2 days after receiving Shingrix, the patient experienced injection site rash (Verbatim: Rash around injection site, flushing and itchiness.), flushing (Verbatim: flushing) and pruritus (Verbatim: itchiness). The outcome of the injection site rash, flushing and pruritus were not resolved.   The reporter considered the injection site rash, flushing and pruritus to be related to Shingrix.     The company considered the injection site rash, flushing and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2025 The Medical assistant reported that a female patient received the first dose of Shingrix vaccine and experienced rash around injection site, flushing and itchiness
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Nausea, Retching
Clinical narrative: Nausea; Gagging; Diarrhea; Fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-MAR-2025, the patient received the 1st dose of Shingrix. On 28-MAR-2025, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), gagging (Verbatim: Gagging), diarrhea (Verbatim: Diarrhea) and fatigue (Verbatim: Fatigue). The outcome of the nausea, gagging, diarrhea and fatigue were resolved.   It was unknown if the reporter considered the nausea, gagging, diarrhea and fatigue to be related to Shingrix.     It was unknown if the company considered the nausea, gagging, diarrhea and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2025 This report was submitted via the online direct entry reporting system. Reporter was the patient, who received her first dose of SHINGRIX on March 27. She stated that a day later, she experienced nausea, gagging, diarrhea, and fatigue. Symptoms resolved for a day and a half.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got first Shingrix shot 2 years ago but forgot to get 2nd shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (shot 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got first Shingrix shot 2 years ago but forgot to get 2nd shot). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 27-JUN-2025 This case was reported by a patient via (chatbot) interactive digital media. The patient got first Shingrix shot 2 years ago but forgot to get 2nd shot.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first shot seven years ago, but did not get the second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (shot seven years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received first shot seven years ago, but did not get the second shot). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 27-JUN-2025 This case was reported by a patient via (chatbot) interactive digital media. The patient received a Shingrix shot seven years ago, but did not get the second shot. Now his/her doctor wanted to get the second shot. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Maladministration After the Expiration Date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis.   On 25-JUN-2025, the patient received Infanrix. On 25-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Maladministration After the Expiration Date). The outcome of the expired vaccine used was not applicable.   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: 25-JUN-2025 A Registered nurse called to report that a patient had been administered an expired dose of Infanrix, which led to Expired vaccine used. and inquired whether it needed to be repeated.
Vaccine: DTAPHEPBIP
Symptoms: Incorrect route of product administration
Clinical narrative: possibly administered subcutaneously; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix (subcutaneous). On an unknown date, an unknown time after receiving Pediarix, the patient experienced intramuscular formulation administered by other route (Verbatim: possibly administered subcutaneously). The outcome of the intramuscular formulation administered by other route was not applicable.   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: 30-JUN-2025 The clinic supervisor for a pediatric primary care clinic reported that while the medical assistant administered Pediarix was sure it was given intramuscular and the parent who worked in healthcare thought it was given subcutaneously instead, which led to intramuscular formulation administered by other route. The reporter asked was there concern if this is the case.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Administered Shingrix liquid without mixing the powder; Administered Shingrix liquid without mixing the powder;  This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUN-2025, the patient received Shingrix. On 11-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administered Shingrix liquid without mixing the powder) and inappropriate dose of vaccine administered (Verbatim: Administered Shingrix liquid without mixing the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 01-JUL-2025 The registered nurse reported that a nurse gave Shingrix liquid without mixing the powder to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter had 2 different lot numbers for Shingrix on the date of administration, and they did not know which one was administered to the patients, it could be 3J2S2 with expiration date of 27th March, 2027, or 2HJ99 with expiration date of 4th April, 2027. This case has been linked with US2025082620, by same reporter for different patient; Sender's Comments:  GSK-US2025082620:Same reporter/Diffrent patient
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Administered Shingrix liquid without mixing the powder; Administered Shingrix liquid without mixing the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUN-2025, the patient received Shingrix. On 11-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administered Shingrix liquid without mixing the powder) and inappropriate dose of vaccine administered (Verbatim: Administered Shingrix liquid without mixing the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 01-JUL-2025 The registered nurse reported that a nurse gave Shingrix liquid without mixing the powder to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter had 2 different lot numbers for Shingrix on the date of administration, and they did not know which one was administered to the patients, it could be 3J2S2 with expiration date of 27th March, 2027, or 2HJ99 with expiration date of 4th April, 2027. This case has been linked with US2025082618, by same reporter for different patient; Sender's Comments:  US-GSK-US2025082618:Same reporter/Diffrent patient
Age: 5.0
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 5-year-old twins who received ADACEL instead of DTaP, with no reported adverse event; Initial information received on 02-Jul-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves 5 years old and unknown gender patient who received diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of diphtheria, tetanus and acellular pertussis vaccine 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 AC pertussis vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for immunization instead of diphtheria, tetanus and acellular pertussis vaccine with no reported adverse event (wrong product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence.  No follow-up is possible as Reporter cannot be contacted by Sanofi.  Reportedly, Immunization medical director states that he was made aware of a situation where there were 5-year old twins who received ADACEL instead of DTaP.  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.; Sender's Comments:  US-SA-2025SA184064:
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: but never got the second; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: but never got the second). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 26-JUN-2025 This case was reported by a patient via (Shingrix GRC Chatbot) interactive digital media. Patient got the first dose of Shingrix but never got the second dose. The patient wanted to know did he/she now need one more dose or did he/she need two. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 29-year-old female patient who received HBV (Engerix B pediatric) (batch number 9237Y, expiry date 27-OCT-2025) for prophylaxis.   On 22-MAY-2025, the patient received Engerix B pediatric. On 22-MAY-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose administered to adult patient) and underdose (Verbatim: Pediatric dose administered to adult patient). The outcome of the adult use of a child product and underdose were not applicable.   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: 27-JUN-2025 The Licensed Practical Nurse explained that a patient was about to start her adult series of Engerix B vaccine, but instead they gave pediatric dose which led to adult use of a child product and underdose.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Antisynthetase syndrome, Electromyogram abnormal, Interstitial lung disease, Myopathy
Clinical narrative: I received two Moderna shots the initial and the booster. The first was around Jan/Feb 2021. The second was around April 2021. Both were at different pharmacies. Had a rash and symptoms appear in Sept 2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test abnormal, Rash, Ventilation/perfusion scan
Clinical narrative: I received two Moderna shots the initial and the booster. The first was around Jan/Feb 2021. The second was around April 2021. Both were at different pharmacies. Had a rash and symptoms appear in Sept 2021.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint injury
Clinical narrative: Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: TDap; Manufacturer: ; LotNumber: ; Route: IM; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Muscle spasms, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Patient reports severe burning pain when she wakes up in the morning. Sometimes it wakes her up in the middle of the night. The pain is in her hands, palms, fingers. Fingers tend to cramp/curl up and causes her pain.  She hs gotten an xray which showed it could be nerve damage or arthritis, but she states it cannot be arthritis.  She has taken gabapentin but can only take it at night since it makes her drowsy.  She has a hard time driving and carrying things.  She is diabetic.
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Sleep disorder, X-ray abnormal
Clinical narrative: Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Patient reports severe burning pain when she wakes up in the morning. Sometimes it wakes her up in the middle of the night. The pain is in her hands, palms, fingers. Fingers tend to cramp/curl up and causes her pain.  She hs gotten an xray which showed it could be nerve damage or arthritis, but she states it cannot be arthritis.  She has taken gabapentin but can only take it at night since it makes her drowsy.  She has a hard time driving and carrying things.  She is diabetic.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Medium, Additional Details: She fainted in the front of the store collapsing on her cart and to the floor.  She was responsive to the staff and they got her a chair.  She sat in the chair then vomited on the floor.  I recieved a phone call from the front store after this happened and went up front to check on her.  They had called an ambulance and it was arriving while I was up front.  Patient was saying she didn't want to go to the doctor but we recommended she get checked out.  She left with the ambulance.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Asthenia, Confusional state, Decreased appetite, Diarrhoea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Loss of appetite-Severe, Systemic: Weakness-Medium, Additional Details: According to the patient, She had these symptoms developed 2 days after receiving her vaccine on 6/25/2025. She stated that her confusion was more of realizing that she is experiencing side effects after vaccine because she had never experienced such reactions in the past and described as "I talked my self into believing this because I was very confused." On 6/25/2025, she felt really tired, had diarrhea and no appetite. However, she feels much better, improved today 6/28/2025
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Injection site pain, Lethargy, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Loss of appetite-Severe, Systemic: Weakness-Medium, Additional Details: According to the patient, She had these symptoms developed 2 days after receiving her vaccine on 6/25/2025. She stated that her confusion was more of realizing that she is experiencing side effects after vaccine because she had never experienced such reactions in the past and described as "I talked my self into believing this because I was very confused." On 6/25/2025, she felt really tired, had diarrhea and no appetite. However, she feels much better, improved today 6/28/2025
Age: 77.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Additional Details: Patient reports itching and tenderness near injection site. Near injection site is red
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Unable to Sleep-Mild, Additional Details: pt describes pain and burning up and down her injection arm from wrist to shoulder making it difficult to sleep and function after 1st dose. has md appt on 6/30/2025
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Unable to Sleep-Mild, Additional Details: pt describes pain and burning up and down her injection arm from wrist to shoulder making it difficult to sleep and function after 1st dose. has md appt on 6/30/2025
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: warm to touch the area-Mild, Additional Details: This was a delayed reaction, but was at the actual injection site, so her primary dr told her to have us report it.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Vaccination given and patient discharged to waiting room.  Patient came back saying she felt like was going to pass out.  Patient was laid down on exam table and BP taken was 82/50.  Water given to patient and she said that she was feeling better and BP was 94/68.  Waiting a few more minutes after and BP was checked again with patient sitting on edge of bed and was 102/76.  Symptoms resolved and patient discharged.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Still having muscular pain in left deltoid. Has trouble reaching behind to her back as well as lifting her arm up. She states that this has continued ever since she got the vaccine. She has not spoken to her doctor about this issue. Recommended that she reach out to doctor to discuss the problem and to get a workup to determine severity of issue, Other Vaccines:  VaccineTypeBrand: Comirnaty; Manufacturer: Pfizer; LotNumber: LN0589; Route: Intramuscular; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Face injury, Syncope, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Additional Details: pt recived vaccine and sat down after gave both parents two vaccines each thereafter so good 5 minutes time lapsed. mom asked pt to come in and change out the bandage. bandaged changed out by rxist and thats when pt fainted forward hitting door with face and went down face down. called 911 immediately.  while waiting for them pt was alert and aware. first responders came and assessed pt and refused to go to hospital citing she was ok, aware, coherent and cognizant of what happened. pt and parent
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient reports having a red swollen arm and visited the urgent care to receive antibiotics in order to help in case there is an infection on top of the allergic reaction.  Patient states that the injection was given lower than usual and started having an allergic reaction a day or so later.  The arm is red and swollen.
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Product administered at inappropriate site, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient reports having a red swollen arm and visited the urgent care to receive antibiotics in order to help in case there is an infection on top of the allergic reaction.  Patient states that the injection was given lower than usual and started having an allergic reaction a day or so later.  The arm is red and swollen.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Chest discomfort, Chest pain, Condition aggravated, Dyspnoea
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: SHORTNESS OF BREATH    MUSCLE ACHES-Medium, Systemic: Nausea-Severe, Additional Details: SHORTNESS OF BREATH AND CHEST PAIN HAD BEEN PRESENT PRIOR TO VACCINE, Other Vaccines:  VaccineTypeBrand: COVID; Manufacturer: PFIZER; LotNumber: ME6072; Route: INTRAMUSCULAR; BodySite: RIGHT ARM; Dose: UNKNOWN; VaxDate: 06/30/2025
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Lethargy, Myalgia, Nausea
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: SHORTNESS OF BREATH    MUSCLE ACHES-Medium, Systemic: Nausea-Severe, Additional Details: SHORTNESS OF BREATH AND CHEST PAIN HAD BEEN PRESENT PRIOR TO VACCINE, Other Vaccines:  VaccineTypeBrand: COVID; Manufacturer: PFIZER; LotNumber: ME6072; Route: INTRAMUSCULAR; BodySite: RIGHT ARM; Dose: UNKNOWN; VaxDate: 06/30/2025
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: passed out after receiving both vaccines
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: passed out after receiving both vaccines
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Other Vaccines:  VaccineTypeBrand: tdap; Manufacturer: GSK; LotNumber: h4279; Route: Intramuscular; BodySite: Right Arm; Dose: ; VaxDate: UNKNOWN
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: MD claimed patient had swelling on arm, shoulder, face, and MD insisted it was from vaccine and nothing else, patient experienced symtoms few days post vaccines. MD claims patient presented to pharmacy 6/12/25 and filling rph said symptoms were not due to vaccine.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling, Swelling face
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: MD claimed patient had swelling on arm, shoulder, face, and MD insisted it was from vaccine and nothing else, patient experienced symtoms few days post vaccines. MD claims patient presented to pharmacy 6/12/25 and filling rph said symptoms were not due to vaccine.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Medium
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Medium
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: On 7/7 during an outreach call, the patient stated that she experienced the most painful vaccine on 6/13/25. She stated that she had an approx 3 inch circle of swelling for approx 1 week and continues to have swelling and pain when lifting arm and an approx 1 and 3/4 inch hard swollen spot where administered. She alleges the vaccine was administered too low on the arm.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away
Age: 10.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Face injury, Tunnel vision, Unresponsive to stimuli
Clinical narrative: Patient was given two vaccines, one in each arm, given one at a time. Approximately 10 minutes after getting the vaccines, patient left the exam room and proceeded to the check out window.  She was trying to get to the chair and missed. They yelled for the RN and when she ran out to help, the patient had already dropped to the floor. It appeared she went down, landed on her chest, then the left side of her face hit the floor. When the RN got to her, her eyes were open wide, but, she did not seem super responsive. But, came back quickly. She was moved to the chair for a minute by Dr. and mom. We then took her to exam room one, She lied down, legs elevated, cool cloth on forehead, BP and pulse taken (WNL). Monitored her for 15 minutes till safe to leave. Patient said when she started to pass out, her vision became dark and tunnel like.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Hypotension, Nausea, Pallor, Syncope
Clinical narrative: Pt. had a syncopal episode shorty after injection at 11:29 am. This happened once to the patient in the past when he was getting his blood drawn. Pt. stayed in seat, but episode lasted around 10 seconds. Pt. came to and experienced clamminess, pale skin, low BP and nausea. Patient sat about 15 minutes and condition improved back to baseline.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave 7 days after the assigned expiration date. No adverse events were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave 7 days after the assigned expiration date, no adverse events reported.
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Heart rate increased, Injection site pain, Injection site swelling
Clinical narrative: patient described pain and swelling at injection site, rapid heartbeat requiring er visit and medications
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug abuse, Pyrexia, Rash, Rash pruritic
Clinical narrative: the patient received the second shingles shot on 6/24/25. she called the pharmacy on 7/7/5 to report that she had rash all over her body and her eyelid a eek after she received the second shingles shot. she also had a low grade fever. patient still having itchy rash on her body and she will see a doctor on 7/9/2025
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Blood test normal, Cyanosis, Electroencephalogram normal, Eye movement disorder, Gaze palsy
Clinical narrative: Patient had seizure like activity in pediatrician office after vaccine was administered (arms raised up and something "in her eye", lasted 15 seconds). Had second episode of seizure like activity at home (similar characteristics but eyes rolled back, lasted 3-5 seconds). Taken to ER. Normal exam in ER with Neurology consulted. Discharged home. Immediately after discharge, patient had third episode of seizure like activity (patient was back arching/eyes deviated to left, increase tone, color change (blue/purple), lasted 7 seconds). Went back into the ER. Fourth episode noted by ER provider (similar characteristics to above instances. Keppra load IV started and transfered to hospital. Hospitalized for 2 days. Imaging and workup done. Discharged home. Started on outpatient Keppra.  Set to see PCH Neurology on 7/8/25. Saw pediatrician for ER/Hospitalization follow up on 7/1/25.
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Hypertonia, Lumbar puncture normal, Opisthotonus, Seizure like phenomena, Ultrasound head normal
Clinical narrative: Patient had seizure like activity in pediatrician office after vaccine was administered (arms raised up and something "in her eye", lasted 15 seconds). Had second episode of seizure like activity at home (similar characteristics but eyes rolled back, lasted 3-5 seconds). Taken to ER. Normal exam in ER with Neurology consulted. Discharged home. Immediately after discharge, patient had third episode of seizure like activity (patient was back arching/eyes deviated to left, increase tone, color change (blue/purple), lasted 7 seconds). Went back into the ER. Fourth episode noted by ER provider (similar characteristics to above instances. Keppra load IV started and transfered to hospital. Hospitalized for 2 days. Imaging and workup done. Discharged home. Started on outpatient Keppra.  Set to see PCH Neurology on 7/8/25. Saw pediatrician for ER/Hospitalization follow up on 7/1/25.
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Urine analysis normal
Clinical narrative: Patient had seizure like activity in pediatrician office after vaccine was administered (arms raised up and something "in her eye", lasted 15 seconds). Had second episode of seizure like activity at home (similar characteristics but eyes rolled back, lasted 3-5 seconds). Taken to ER. Normal exam in ER with Neurology consulted. Discharged home. Immediately after discharge, patient had third episode of seizure like activity (patient was back arching/eyes deviated to left, increase tone, color change (blue/purple), lasted 7 seconds). Went back into the ER. Fourth episode noted by ER provider (similar characteristics to above instances. Keppra load IV started and transfered to hospital. Hospitalized for 2 days. Imaging and workup done. Discharged home. Started on outpatient Keppra.  Set to see PCH Neurology on 7/8/25. Saw pediatrician for ER/Hospitalization follow up on 7/1/25.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Cold sweat, Dizziness, Hypoacusis, Loss of consciousness, Nausea
Clinical narrative: Patient experienced a syncopal episode in her chair at 1:34 pm. Pt. regained consciousness around 5-10 seconds later but experienced dizziness, blurry vision, hearing impairment, nausea and clammy skin. Pt. recovered to baseline within 15 minutes. Grandparent and patient left facility with no difficulty.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope, Vision blurred
Clinical narrative: Patient experienced a syncopal episode in her chair at 1:34 pm. Pt. regained consciousness around 5-10 seconds later but experienced dizziness, blurry vision, hearing impairment, nausea and clammy skin. Pt. recovered to baseline within 15 minutes. Grandparent and patient left facility with no difficulty.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Seizure 15 seconds
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Large red patch located below injection site of approximately 3" by 4".  Area hot to touch.  Syptoms began clearing on 6th day after vaccination.  Red patch still evident on 6th day but area only warm to touch.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Child was inadvertently given Bexsero instead of Trumenba as a second dose in the Men B vaccination series. Reviewed with client and parent. Offered a 6 m follow up to complete the series correctly. Supv reviewed and gave input to nurse who has done the error and has completed this form
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Pallor, Vision blurred
Clinical narrative: HPV was administered to patient's right deltoid at 1:00PM on Monday, 07/07/2025. Within 1 minute of administration, patient reported that she was experiencing "slightly blurry" vision and dizziness. She immediately drank some water offered by her guardian/mother. After resting for 1-2 minutes, she stood rapidly and walked 5 steps before reporting a worsening of her symptoms. Upon observation, she appeared pale. She was able to independently return to her chair immediately where she accepted a sugar lollipop. During this entire episode, patient was able to speak clearly and maintain eye contact.  Speaking with patient, she mentioned that the HPV dose made her feel "woozy". Calm affect, able to respond to stimuli and conversation appropriately. At 1:15PM, she appeared to have more color in her cheeks, observed by RNs, and confirmed by patient's guardian. Patient confirmed that her symptoms (dizziness, blurry vision) had resolved. Patient and her guardian were advised to seek medical evaluation if her symptoms returned, including but not limited to an ER visit and/or her pediatrician. Patient denied a wheelchair escort, stating that she felt "much better" and could walk on her own. Patient was able to ambulate independently from the chair, out of the clinic, and out of the facility. While observing her gait, she maintained a steady balance, walking in a straight line without guidance or assistance.
Age: 59.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient received vaccines Thursday afternoon 07/03/25, in the evening around 10pm her body started hurting. Friday morning the vaccine site was hot and red and she started with a fever. Saturday morning the vaccine site was still red and inflamed and patient was running a fever. Sunday morning the vaccine administration site was still red and inflamed and sensitive to the touch, patient decided to go to the urgent care and was diagnosed with Cellulitis and prescribed Cefadroxil. The patient experienced diarrhea with the  Cefadroxil, the Cefadroxil was changed to Augmentin and Septra DS by her PCP.
Age: 59.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient received vaccines Thursday afternoon 07/03/25, in the evening around 10pm her body started hurting. Friday morning the vaccine site was hot and red and she started with a fever. Saturday morning the vaccine site was still red and inflamed and patient was running a fever. Sunday morning the vaccine administration site was still red and inflamed and sensitive to the touch, patient decided to go to the urgent care and was diagnosed with Cellulitis and prescribed Cefadroxil. The patient experienced diarrhea with the  Cefadroxil, the Cefadroxil was changed to Augmentin and Septra DS by her PCP.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Nausea
Clinical narrative: Nausea, chills onset 2 hrs following immunization
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient was given a Prevnar20 shot on 7/1 around 4:15 in the afternoon. She experienced redness, swelling and itchiness in the days following. On 7/7, there is still redness and patient still expresses feeling itchy.
Age: 19.0
Sex: F
Vaccine: HEPA, HEPA, MENB
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric Hepatitis A was given during visit. After administration, it was noticed that the vaccine given was the pediatric dose, rather than the adult dose. About 10 minutes later, patient was given the adult dose of Hepatitis A. No symptoms noted so far. Patient was notified of signs and symptoms to look for, and to contact us if any symptoms occur.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: 2-3 hours after vaccination pt reported redness, swelling and bruising to site. Could not lift arm for a few days. Did not seek medical care. MOP administered Motrin 800mg x1 for 3 days.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diplopia, Electromyogram, Magnetic resonance imaging head, Muscular weakness
Clinical narrative: Binocular diplopia, leg muscle weakness and pain; 11/24-present
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Binocular diplopia, leg muscle weakness and pain; 11/24-present