chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Myelodysplastic syndrome, Thrombocytopenia
Clinical narrative: fluctuating thrombocytopenia (platelet counts between 35,000-60,000/µL); Myelodysplastic Syndromes (MDS); This spontaneous case was reported by a patient and describes the occurrence of MYELODYSPLASTIC SYNDROME (Myelodysplastic Syndromes (MDS)) and THROMBOCYTOPENIA (fluctuating thrombocytopenia (platelet counts between 35,000-60,000/µL)) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 030M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In September 2024, the patient experienced MYELODYSPLASTIC SYNDROME (Myelodysplastic Syndromes (MDS)) (seriousness criterion medically significant). In January 2025, the patient experienced THROMBOCYTOPENIA (fluctuating thrombocytopenia (platelet counts between 35,000-60,000/µL)) (seriousness criterion medically significant). At the time of the report, MYELODYSPLASTIC SYNDROME (Myelodysplastic Syndromes (MDS)) and THROMBOCYTOPENIA (fluctuating thrombocytopenia (platelet counts between 35,000-60,000/µL)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: platelet counts between 35,000-60,000/µL (low) since Jan-2025.         No concomitant medications were reported.  The patient was diagnosed with Myelodysplastic Syndromes (MDS) in September 2024, and had been monitoring his health closely, particularly his thrombocytopenia (low platelet counts), which had fluctuated between 35,000 and 60,000/AµL since January 2025. His healthcare team guided his ongoing treatment decisions, which included exploring RUNX1-targeted clinical trials due to his genetic mutations (PHF6, BCOR, RUNX1). The patient was exploring all possible factors that might had influenced the patient's condition, including the vaccines that the patient received in 2021.; Reporter's Comments: The patient's genetic mutations (PHF6, BCOR, RUNX1) remain as confounders for the events. The benefit-risk relationship of the product is not affected by this report.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site paraesthesia, Injection site warmth
Clinical narrative: Within about an hour after shot area around arm began to feel hot, prickly on fire; This spontaneous case, initially received on 09-Apr-2025, was reported by a non health professional and concerns an elderly female patient.  Past medical history included Latex allergy. Historical vaccine include: Comirnaty((2023-2024), syringe, 0.3 ml, right arm)  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 23-Jul-2024, the patient received Fluad (TIV) for Indication flu vaccine, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatomical location: Left arm, Lot number: No batch number available, and would be requested on follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 23-Jul-2024, the patient experienced Within about an hour after shot area around arm began to feel hot, prickly on fire (outcome: Recovered / Resolved).  It was reported that flu shot was given in left arm and Covid shot, Comirnaty was injected in right arm. Within 2 days right arm had a similar reaction but much less than the flu shot. Patient had never had a reaction to either the flu or covid shots in the past and these were very much like latex reactions and therefore it started my search for ingredients. The pharmacy swore that they did not use latex in gloves, bandages and the only place a latex could have been found would have been something that would cause a latex-like reaction, but it couldn't be proved as many people have a latex allergy.  Fluad (TIV) action taken: Not Applicable Treatment medication: Triamcinolone  Reporter's assessment:  The reporter did not provide a seriousness or causality assessment.; Reporter's Comments: The causality of events was assessed related to the administration of Fluad (TIV)
Vaccine: UNK
Symptoms: Respiratory distress
Clinical narrative: Respiratory distress; This spontaneous case initially received on 10-Apr-2025, was reported by a health professional and concerns a patient of unknown age/gender.  At the time of the event the patient had alpha gal, other allergies.  Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for an Indication not reported., Dose regimen, route of administration, and anatomical location: Not Reported, Lot number: No batch number available and would be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Respiratory distress (Medically Significant, outcome: Not Reported).  Case was upgraded to serious upon company assessment of the reported event clinical significance  Reporter shared that a patient received Flucelvax and had respiratory distress. The reporter told that the patient had alpha gal and other allergies.   Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide the seriousness and causality assessment of the event Respiratory distress.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events considered related for reporting purposes. There is insufficient information regarding the event for a meaningful causal assessment (event onset date, temporality, unclear etiology, relevant medical history). Of note, underlying condition of alpha gal can be considered as contributing factor.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Ingredients of vaccine following possible allergic reaction; This spontaneous case, initially received on 22-Apr-2025, was reported by a non health professional and concerns a female patient.  Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for Influenza prophylaxis, dose: not reported, route of administration: not reported, anatomical location: not reported, Lot number: 946615.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Ingredients of vaccine following possible allergic reaction (outcome: Not Reported).  Consumer called to inquire about ingredients of vaccine following possible allergic reaction after her daughter was given the vaccine in October, specific type of reaction not provided. Covid vaccine was also mentioned as a suspected source of allergy, although product information was not specified. Caller refused to provide patient information.   Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the events Ingredients of vaccine following possible allergic reaction related to the administration of Flucelvax (TIV) and seriousness was not provided.; Reporter's Comments: Event is related
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: received the diluent without the adjuvant; received the diluent without the adjuvant; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number FJ9A7, expiry date 16-JUL-2026) for prophylaxis.   Concurrent medical conditions included cholesterol. Concomitant products included atorvastatin calcium (Lipitor).   On 02-MAY-2025, the patient received the 1st dose of Shingrix (left deltoid). On 02-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received the diluent without the adjuvant) and inappropriate dose of vaccine administered (Verbatim: received the diluent without the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 09-MAY-2025 The physician reported that the patient received the diluent without the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain in extremity
Clinical narrative: The first shot made me really sick; nauseous; arm hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: The first shot made me really sick), nausea (Verbatim: nauseous) and pain in arm (Verbatim: arm hurts). The outcome of the sickness, nausea and pain in arm were not reported.   It was unknown if the reporter considered the sickness, nausea and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the sickness, nausea and pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2025AMR058760   Additional Information: GSK Receipt Date : 10-MAY-2025 This case was reported by a patient via interactive digital media. The first shot made him/her really sick. Arm hurts and a lil nauseous but not as bad as the first one by far. For tolerance of second shot refer case US2025AMR058760.; Sender's Comments:  US-GSK-US2025AMR058760:same patient, 1st dose case
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: had received only the adjuvant portion of Shingrix; received only the adjuvant portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9L944, expiry date 30-MAR-2027) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: had received only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 09-MAY-2025 Other HCP reported that there were 5 patients involved in an incident where they didn't know which of them had received only the adjuvant portion of Shingrix. Also, reporter mentioned that they were investigating this incident, but that it may be possible that they readministered the doses to the patients, leading to a potential 3rd dose administered to any of these patients, as some of them had already received the 1st dose of Shingrix. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2025057630:SAME REPORTER US-GSK-US2025057623:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1 out of 2 of the shots back in 2020, and never got the 2nd one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 02 November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received 1 out of 2 of the shots back in 2020, and never got the 2nd one). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 09-MAY-2025 The registered pharmacist reported that one of the patients received 1 out of 2 of the Shingrix shots back in 2020 on 02nd November 2020, and she never got the 2nd one which led to incomplete course of vaccination. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Asthenia, Axillary pain, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Tightness around injection site while trying to sleep approx 12 hours after administration. Pt reports warm to touch with pain also under the arm.  Pt  was given Tylenol 500mg  the next morning  and then again 6 hours later, pt reports during the time of OTC medication pt reports reduced pain to the area, but reports pain after meds have worn off.  Pt reports waking up to pain to the Left arm around the middle of the night and pain was located to the same areas as before.  Friday morning pt reported that injection site was red and warm to touch from deltoid to bicep and reports swelling to the area as well, pt was given additional medication doxycycline and pt reports after taking the doxy the swelling had reduced.  Pt reports while at the gym they have decreased strength during workouts however only to the left arm. Pt reports receiving Motrin and Tylenol for the strength symptoms and pts reports itching around the injection site.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Skin tightness, Skin warm
Clinical narrative: Tightness around injection site while trying to sleep approx 12 hours after administration. Pt reports warm to touch with pain also under the arm.  Pt  was given Tylenol 500mg  the next morning  and then again 6 hours later, pt reports during the time of OTC medication pt reports reduced pain to the area, but reports pain after meds have worn off.  Pt reports waking up to pain to the Left arm around the middle of the night and pain was located to the same areas as before.  Friday morning pt reported that injection site was red and warm to touch from deltoid to bicep and reports swelling to the area as well, pt was given additional medication doxycycline and pt reports after taking the doxy the swelling had reduced.  Pt reports while at the gym they have decreased strength during workouts however only to the left arm. Pt reports receiving Motrin and Tylenol for the strength symptoms and pts reports itching around the injection site.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Sleep disorder
Clinical narrative: Tightness around injection site while trying to sleep approx 12 hours after administration. Pt reports warm to touch with pain also under the arm.  Pt  was given Tylenol 500mg  the next morning  and then again 6 hours later, pt reports during the time of OTC medication pt reports reduced pain to the area, but reports pain after meds have worn off.  Pt reports waking up to pain to the Left arm around the middle of the night and pain was located to the same areas as before.  Friday morning pt reported that injection site was red and warm to touch from deltoid to bicep and reports swelling to the area as well, pt was given additional medication doxycycline and pt reports after taking the doxy the swelling had reduced.  Pt reports while at the gym they have decreased strength during workouts however only to the left arm. Pt reports receiving Motrin and Tylenol for the strength symptoms and pts reports itching around the injection site.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Flu-like symptoms-Medium, Systemic: Headache-Medium
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pneumonia, Respiratory disorder
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Upper Respiratory, breathing, "pneumonia"-Medium
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Pneumonia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Difficulty breathing, "pneumonia"-Medium
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: pain/discomfort around shoulder area-Medium
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess, Injection site pain, Injection site swelling, Nausea, 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: Nausea-Medium
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Severe, Additional Details: swelling happened 1 day after immunization
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Systemic: Patient says he got infected with COVID-19 in October 2024.-Medium, Additional Details: Patient says he got infected with COVID-19 in October 2024.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Hyperhidrosis, Injection site swelling, Pyrexia
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Malaise, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Fever-Mild, Systemic: Patient stated she felt sick and had a fever of 101-Medium, Additional Details: Patient did not complain of site reactions, system would not let me continue until I chose one.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Loss of consciousness, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: Patient recieved a HepB shot and lost conciousness about a minute after receiving the vaccination. Patient was caught by vaccinator and regained concisiosness in about 30 seconds. We immediately called 911. Patient did not appear to hit her head when falling. She did seem to jerk slightly while passed out. EMTs arrived and our assessing patient.
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Brain stem stroke, Fatigue, Lethargy, Pollakiuria
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Urinary frequency-Medium, Systemic: Stroke-Severe, Additional Details: Pt stayed overnight in hospital and then 10 days in rehab recovering. Pt states that stroke was in lower left Pons., Other Vaccines:  VaccineTypeBrand: Fluzone High-Dose; Manufacturer: Sanofi-Pasteur; LotNumber: U8489DA; Route: Intramuscular; BodySite: Right Arm; Dose: 1; VaxDate: 09/13/2024
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Headache-Medium, Additional Details: "Flu-like symptoms", Other Vaccines:  VaccineTypeBrand: Influenza FLUAD TRIVALENT; Manufacturer: FLUAD; LotNumber: 388494; Route: IM; BodySite: Left arm; Dose: 1; VaxDate: 09/24/2024
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient reports that the injection site hurt for 3 days after receiving the shingles vaccine. She said that she hasn't experienced this with any other vaccine but the pain was mild. Her arm no longer hurts unless she presses the area.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Migraine, Nasopharyngitis
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient stated that he always gets reactions like the possible side effects (Mild Cold symptoms- Migraines and extreme fatigue)
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Tachycardia
Clinical narrative: Systemic: Tachycardia-Mild, Additional Details: She said it made her heart race for 1.5 hours and then went away on its own.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: 5/14/25: Immediately after recieving the priorix, pt fainted and fell to floor. She woke up right away. Mentally alert. Pt stated she had not eaten much today and was dehyrated. Pt was given water and observed for 30 mins. Monitored Blood pressue 3X (bp:98/76 80 @3:56p, bp106/80 83 @4:05p, bp 104/80 83 at 4:17p). pt was counseled on side effects, instruct to go to er/urgent care if condition worsen, stay hyrated, let pcp know what had happened. pt left pharmacy alert and was fine., Other Vaccines:  VaccineTypeBrand: gardasil; Manufacturer: merck; LotNumber: y015180; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: varivax; Manufacturer: merck; LotNumber: y017063; Route: subcutaneous; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: heplisav b; Manufacturer: dynavax; LotNumber: 946062; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details:  Patient reports arm was really red and swollen for several days; went back to pharmacy and was advised to f/u with doctor - event did result in patient needing to visit the doctor - flu shot was also administered at the same time, Other Vaccines:  VaccineTypeBrand: Fluzone High-Dose Triv; Manufacturer: Sanofi-Pasteur; LotNumber: UT8454CA; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 08/31/2024
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Lethargy
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Additional Details: Patient received all 3 vaccines together and experienced flu-like symptoms., Other Vaccines:  VaccineTypeBrand: Arexvy; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Flubok 2024-2025; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Additional Details: Patient received all 3 vaccines together and experienced flu-like symptoms., Other Vaccines:  VaccineTypeBrand: Arexvy; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Flubok 2024-2025; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 52.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Additional Details:  bad flu like symptoms , Other Vaccines:  VaccineTypeBrand: Arexvy RSV; Manufacturer: ; LotNumber: 9sb34; Route: IM; BodySite: LA; Dose: ; VaxDate: 04/13/2025, VaccineTypeBrand: Boostrix Tdap; Manufacturer: ; LotNumber: 39LB7; Route: IM; BodySite: LA; Dose: ; VaxDate: 04/13/2025
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Tinnitus
Clinical narrative: Systemic: Neurological Disorder (diagnosed by MD)-Medium, Systemic: Tinnitus-Medium, Other Vaccines:  VaccineTypeBrand: Fluad Trivalent - Flu; Manufacturer: Seqirus, Inc.; LotNumber: 388497; Route: IM; BodySite: Left Deltoid; Dose: 1; VaxDate: 12/16/2024
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Other Vaccines:  VaccineTypeBrand: SHINGRIX; Manufacturer: GLAXOSMITHKLINE; LotNumber: 55TH4; Route: IM; BodySite: LEFT DELTOID; Dose: 1; VaxDate: 05/09/2025, VaccineTypeBrand: BOOSTRIX TDAP; Manufacturer: GLAXOSMITHKLINE; LotNumber: PG3RP; Route: IM; BodySite: LELT DELTOID; Dose: 1; VaxDate: 05/09/2025
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy
Clinical narrative: Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, COVID-19, Cough, Fatigue, Headache
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Cough, Breast cancer diagnosis-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient says she was diagnosed with Breast cancer after her COVID vaccine. Patient also says she was infected with COVID-19 two months (around April 2024) after her Moderna 2023-2024 covid vaccine that was given on 02/26/2024.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Tachycardia
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Cough, Breast cancer diagnosis-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient says she was diagnosed with Breast cancer after her COVID vaccine. Patient also says she was infected with COVID-19 two months (around April 2024) after her Moderna 2023-2024 covid vaccine that was given on 02/26/2024.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash, Skin warm
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Rash on arms 4 inches-Mild, Additional Details: Rash on arm was 4 inches and left arm was warm to the touch.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Pain at arm subsided but returned after few days. She said this happened before to tdap vaccine. if doesn't resolve in next few days, report to md
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Imaging procedure abnormal, Paraesthesia
Clinical narrative: After administration patient reported tingling and numbness. Unknown exactly how fast for symptoms to start. Symptoms have mostly resolved but some tingling in finger tips are still reported.
Age: 75.0
Sex: F
Vaccine: HEPAB, PNC21
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Patient called on 5/14/25 saying that she had fever, redness in arm, arm pain into shoulder blade; she said that she had taken some tylenol; I told her if doesn't resolve symptoms to contact her primary care physician
Age: 30.0
Sex: F
Vaccine: COVID19, MMR, VARCEL
Symptoms: Injection site mass, Injection site pain
Clinical narrative: painful, palpable lump at injection site of MMR II in Right arm
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Injection site rash, Rash, Tenderness
Clinical narrative: DEVELOPED RASH ON BOTH CHEEKS  OVER TO THE EAR, SOMEWHAT SORE TO TOUCH, RASH ON LEFT MORE THAN RIGHT SIDE. NO REACTION/ RASH AT INJECTION SITE. ONLY ON FACE. DEVELOPED BY 5/17/25 MORNING AND SEEMED WORSE SATURDAY AFTERNOON.  PATIENT REPORTS RASH GETTING BETTER (5/19/25). PATIENT MAY GO TO DERMATOLOGIST
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Lymphadenopathy, Muscle mass
Clinical narrative: Knot in muscle, vasculature surrounding appears inflamed/redness developed, lymph node involvement and accumulation.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: She has a sore arm that cannot feel her hand.  It feels numb and dead like
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient with a history of vaso vagal reaction to vaccines and needles. Mom asked that vaccine be given because they do not have a PCP. Patient verbally and visually extremely nervous before vaccine given. Agreeable to vaccine. About 30 seconds after vaccine given, patient lost consciousness. She was easily roused, given water and placed ice packs on her neck. She stayed in the office for about 30 minutes and stated that she felt fine to go back to class. Mom was advised of the incident.
Age: 45.0
Sex: F
Vaccine: HEPAB, PNC21, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: redness and itching and rash that is spreading.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm, Blood iron decreased, Computerised tomogram thorax abnormal, Death, Faecal occult blood negative
Clinical narrative: Passed away
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Iron binding capacity total normal, Scan with contrast abnormal, Transferrin saturation decreased
Clinical narrative: Passed away
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: None. It was intended to have a Meningitis Vaccine.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Blindness unilateral, Blood test, COVID-19, Electrocardiogram
Clinical narrative: pt states in Sept of 2021 he developed covid.  In 2023 both eyes began to get blurry.  April 25th, 2024, out of nowhere he lost vision in the right eye for about a minute and a half. It came back but was still blurry but began to get more blurry. On May 17th, 2024, he went to Dr. He was diagnosed with central retinal vein occlusion with macula edema of the right eye. He was given a shot in the eye and continues to get shots in the eyes every 2 months depending on how the eyes looks. He now gets them every 3 months. The last shot was on March 28th, 2025.  He will go back for next visit in June 30th, 2025.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Macular oedema, Retinal vein occlusion, Vision blurred
Clinical narrative: pt states in Sept of 2021 he developed covid.  In 2023 both eyes began to get blurry.  April 25th, 2024, out of nowhere he lost vision in the right eye for about a minute and a half. It came back but was still blurry but began to get more blurry. On May 17th, 2024, he went to Dr. He was diagnosed with central retinal vein occlusion with macula edema of the right eye. He was given a shot in the eye and continues to get shots in the eyes every 2 months depending on how the eyes looks. He now gets them every 3 months. The last shot was on March 28th, 2025.  He will go back for next visit in June 30th, 2025.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Asthenia, Fatigue, Headache
Clinical narrative: Per the patient. Felt weak, tired and had a headache in the late afternoon after getting the vaccine. Then the next day has barely any memory of the entire day, apparently went to a remote location (that she owns) and forgot her husband wasn't with her and sent out a family search party for him even though he was at home the whole time.  Patient does state that she feels perfectly fine now.
Age: 67.0
Sex: F
Vaccine: HEP, HEPA, HEPA
Symptoms: Underdose
Clinical narrative: pediatric dose of Hep A (720 720 EL.U.) vaccine was inadvertently administered  instead of adult Hep A (1440 EL.U.)
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Cyanosis, Infantile apnoea
Clinical narrative: Baby was noted blue on lips and not breathing for a few seconds
Age: 0.92
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine coordinator called manufacture they stated nothing else needs to be done just watch for side affects and patient can remain on schedule as usual
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: pateint states she got shingles outbreak from the vaccine
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Bloody stool with a lot of mucus
Age: 72.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Injection site pain
Clinical narrative: Patient developed diffuse erythema, tenderness at injection site lasting longer than 3 days
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Patient developed diffuse erythema, tenderness, hard "lump", itching and stiffness of the limb at injection site lasting longer than 3 days-- Also experienced generalized chills which resolved 05/05/2025. Advised by medical team to apply intermittent cold compress.
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient developed diffuse erythema, tenderness, hard "lump", itching and stiffness of the limb at injection site lasting longer than 3 days-- Also experienced generalized chills which resolved 05/05/2025. Advised by medical team to apply intermittent cold compress.
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient developed diffuse erythema, tenderness at injection site lasting longer than 3 days
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Inflammation, Rash
Clinical narrative: PT CALLED AND STATED THAT AFTER 2 DAYS OF VACCINATION, SHE WENT TO THE POOL AND SHE NOTICED THAT  SHE HAS RASH/INFLAMED AREA ON HER BACK. SHE STATED THAT THE AREA WAS COVERED BY HER SWIMMING SUIT, AND SHE HAD SOME DISCOMFORT FEELING AT THIS AREA. SHE THINKS THAT IT MIGHT BE A REACTION FROM THE VACCINE, BECAUSE THE DISCOMFORT FEELING SEEMED SIMILAR TO THE FEELING WHEN SHE HAD SHINGLES IN THE PAST, BUT IT IS LESS SEVERE. THIS HAS BEEN LASTING FOR 10 DAYS
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bundle branch block right, Cardiac pacemaker insertion, Dyspnoea, X-ray abnormal
Clinical narrative: I was sitting down and then all of sudden it felt like my heart stopped and it took the breathe out of me. And i felt weird i went to the ER and they did an XRay and they found right branch block and i had to get a pace maker put in.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Left thigh with bruising and redness after Dtap vaccine on 5/16/25. Saturday morning it was red and hot to touch, 101 fever, swollen. Fever continued through Sunday. Parents gave Tylenol & Ibuprofen and at visit on 5/19/25, report that Patient is improving and have pictures which show that he is improving. At office visit on 5/19/25, physician advised mom to do the following: Start 1/4 tsp Zyrtec daily, local compress. Call if fever returns, does not bear weight, and/or for other concerns.
Age: 0.08
Sex: F
Vaccine: DTAP, PNC20, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given 4 days before recommended date of 5/12/25
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, COVID-19, Nasopharyngitis, Neck pain
Clinical narrative: pt says she started feeling like she was getting a cold. She was tested for Covid twice and both times were negative. By that following Monday, May 12th, she had a full blown cold and was tested again and she was Covid positive. She says her right shoulder and neck are sore and painful.  No fever or chills. Just has body aches and cold symptoms along with some weakness. She says she is still achy. She will contact her doctors office to let the know she is having symptoms.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: pt says she started feeling like she was getting a cold. She was tested for Covid twice and both times were negative. By that following Monday, May 12th, she had a full blown cold and was tested again and she was Covid positive. She says her right shoulder and neck are sore and painful.  No fever or chills. Just has body aches and cold symptoms along with some weakness. She says she is still achy. She will contact her doctors office to let the know she is having symptoms.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: Syringe adaptor became unattached while drawing up the dose, resulting in loss of product and inability to administer to patient.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Meningitis
Clinical narrative: Patient was hospitalized with meningitis.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product administration error
Clinical narrative: No adverse events, just vaccine administration error
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient had pain and redness at injection site 1-2 days after administration, diagnosed with cellulitis and treated with mupirocin and Cefdinir.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: patient received vaccine, left the immunization room and then husband was asking out loud for smelling salts
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Mom brought pt to clinic next day 5-13-25 at approx 3:15pm to report erythema, itching, and warmth to 1/3 of upper RUE, circumferential. Mom stated that pt began experiencing itching and redness approx 8-12h after administration of Menveo on 5-12-25. Encouraged cold pack, OTC antihistamine, and IBU/APAP; worsening s/s or SOB to go to the nearest emergency room or dial 911. Attempted to contact pt on 5-15-25, 5-16, and 5-19-25 and unable to reach. VM left for parent to contact clinic for f/u.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Injection site reaction, Scratch
Clinical narrative: Autistic patient who did not handle vaccinations well, once needle was inserted into skin, he pulled away and the needle came out and scratched his skin. Mother of patient wanted to continue 2nd vaccine, same incident happened again and mom demanded injection be given the rest of the way, CMA then administered the 2nd vaccine but did not change needle. No adverse effects noted other than injection site scratch.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: After administering vaccines client complained of pain to left deltoid where HPV was administered. Client remained sitting on chair while this nurse spoke with the mother. The mother asked if she could have some condoms for her other teenage son. This nurse went to get the condoms and when returned, was approached by mother outside of exam room. Was speaking to mother, when heard a thump/noise and turned around to find that client was on floor sitting with back against the wall, with head leaning to right side by door going out to waiting area of clinic. This nurse yelled for help, and clerks from front came to help. Went to client's side and examined him for injuries, with mother at side. Client was awake alert and oriented x4. Noticed that client had some redness by right eye. Client said that he got dizzy, fell, and hit his head. Client vital signs were taken, BP 125/86, heart rate 71, pulse 65, oxygen 95%-99% via room air. With the help of mother, helped client get up and was taken back to exam room. Mother was asked if she wanted us to call an ambulance and mother replied 'no." Client in exam room denied any dizziness or nausea. Client stated that his head hurt 7/10. Had client lie flat on back on the examination table with feet elevated. Ice pack was placed where client had the redness by right eye, no swelling was noted. No redness or swelling noted on areas of vaccine administration.  Client was given some orange juice and was conversing. Called Nurse Manager via phone call and informed her. Called Dr. via phone call to inform him and he advised that out of an abundance of precaution; mother should take client to the ER due to client stating that he hit his head. Mother agreed and said she would be taking client to ER. With the help of clerks and this nurse, client was transferred via wheelchair to mother's vehicle.  Client's mother was called later the evening of 5/16/2025 by Manager and mother stated that she had taken her son to the ER and that he was "fine."
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Provider ordered Engerix-B (Hep B).  Nurse prepared, had a second member of the team perform a second check, and administered the Pediatric variation, instead of the adult variation that was ordered.  She was made aware of the error when she was documenting, as the lot number was not available to select.  Nurse notified the provider who advised patient to return in a week to receive the adult dose.  Patient notified and scheduled to return.   The nurse advised that being new to primary care, was unaware that there was an adult and pediatric dose.  Noted that the syringe is not clearly marked as adult or pediatric, although the packaging does indicate which it is.
Age: 55.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Pyrexia, Swelling
Clinical narrative: Swelling, injection site pain, redness, fever > 101F, all beginning one day post injection. Fever has subsided, but injection site and surrounding areas are still red. Patient has been icing the area.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness 2 x 2 inches Right Arm. Mild swelling
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20
Symptoms: Injection site rash, Injection site reaction, Urticaria
Clinical narrative: Mom reported rash/welt appeared two days after vaccine on 5/17/25 on right anterior thigh. He had Hep A and Prevnar 20 in this thigh. Vaccines were administered on 5/15/25.  Mom reported on 5/19/25 that rash improved/resolved.
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Alopecia, Asthma, Eczema, Erythema, Food allergy
Clinical narrative: Patient had been drinking almond milk after she turned 1 for 8 months leading to her vaccinations. She had no issues with nuts, no asthma, no allergies, and no skin conditions. After receiving her first dose of vaccines, she began to develop allergies to foods she had eaten before, severe eczema, and asthma. She has been suffering for the last 5 years. She has been on an alternative vaccine schedule however after each vaccine her symptoms have gotten progressively worse. She now  is unable to eat gluten, takes multiple medications and suffers daily from hair loss and skin rashes. Most recently, she went in for her next set of vaccines and now has been dealing with redness in her face, severe allergies and severe eczema.
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Gluten sensitivity, Milk allergy, Rash
Clinical narrative: Patient had been drinking almond milk after she turned 1 for 8 months leading to her vaccinations. She had no issues with nuts, no asthma, no allergies, and no skin conditions. After receiving her first dose of vaccines, she began to develop allergies to foods she had eaten before, severe eczema, and asthma. She has been suffering for the last 5 years. She has been on an alternative vaccine schedule however after each vaccine her symptoms have gotten progressively worse. She now  is unable to eat gluten, takes multiple medications and suffers daily from hair loss and skin rashes. Most recently, she went in for her next set of vaccines and now has been dealing with redness in her face, severe allergies and severe eczema.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported redness, swelling, and  warmth around injection site starting the next morning after vaccination. The redness was approximately 3x5 inch with a 2x2 inch induration centered around injection site. Patient also reported joint pain in the left shoulder radiating up neck. Also, patient reports swelling of left axial lymphth nodes. Patient took ibuprofen for 3 days, and pain, swelling, redness, and induration  were all significantly improved. One week after injection, patient still has a small amount of redness and warmth around injection site, but says she is "significantly better".
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Lymphadenopathy, Neck pain, Pain
Clinical narrative: Patient reported redness, swelling, and  warmth around injection site starting the next morning after vaccination. The redness was approximately 3x5 inch with a 2x2 inch induration centered around injection site. Patient also reported joint pain in the left shoulder radiating up neck. Also, patient reports swelling of left axial lymphth nodes. Patient took ibuprofen for 3 days, and pain, swelling, redness, and induration  were all significantly improved. One week after injection, patient still has a small amount of redness and warmth around injection site, but says she is "significantly better".
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient came in for a HPV9 (Gardasil 9) vaccine but received a HepB (Heplisav-b) vaccine instead. The patient did not have any side effects or symptoms. This was discovered when the patient came in for their physical on 4/16/25.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: none
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Keratosis pilaris, Rash, Tenderness
Clinical narrative: Keratosis Pilaris like rash  on arm with mild tenderness. No swelling or decreased range of motion
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: pt developed a red itchy rash 2 inches below the injection site.
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: N/A No adverse side effects
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea, Infant irritability, Vomiting
Clinical narrative: vomiting, diarrhea, irritability since receiving vaccine 13 days ago. Infant otherwise had normal VSD, no PMH and pleasant baby.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose instead of an adult dosenone
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Lethargy
Clinical narrative: Patient had allergic reaction and lethargy - wife got concerned and took him to ER - Got discharged for ER and he is doing ok - I called on Friday evening and  Monday morning to check up on him - and wife stated that he is okay.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Hypotonia, Tremor
Clinical narrative: Approx 5 hours after vaccines were given, mom reports he was shaking all over and then went limp.  She called 911 and was taking to Hospital.  He was found to be afebrile with normal exam; no further testing was done.  Note documents possibility of being connected to vaccines (pertussis?) given earlier that day.  Mom was told to follow up with neurology but no appointment was ever given.  Now he is doing well