chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called and reported inadvertent administration of VARIVAX after a temperature excursion that occurred on 31JAN2025.; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2231763. The previous case ID: 2502USA001424. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report.  This spontaneous report has been received from a nurse concerning to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 31-JAN-2025 and 03-FEB-2025, multiple patients were vaccinated with a improperly storage doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot # involved Y014182 (valid lot number, expiration date reported and validated as 20-AUG-2026) and Y003891 (valid lot number, expiration date reported and validated as 06-FEB-2026) reconstituted with sterile diluent (lot # and expiration date were not reported) administered as prophylaxis (strengths, doses, routes and anatomical locations of administration were not provided). The doses were administered after undergoing a temperature excursion of 21 Fahrenheit (F) for 2 hours, 12 minutes, o seconds and 14.3 F for 1 hour 5 minutes 0 seconds. It was reported a previous temperature excursion of 31 F for 4 hours 0 minutes 0 seconds (product storage error). No additional adverse event was reported.  Follow up information has been received from the nurse on 06-FEB-2025. The reported stated that previously provided temperature excursion was incorrect. The vaccine was reevaluated, however no details where reported. The nurse stated that the varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered to patients after providing the previously incorrect temperature excursion.  Follow-up was received on 10-APR-2025 from a registered nurse. The patient details were updated. On 03-FEB-2025, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX). On the same date, the patient was vaccinated with measles, mumps and rubella (Wistar RA 27-3) virus vaccine (MMR II) subcutaneously on right thigh with lot # Y010046 with second dose and was vaccinated with Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (DTAP/DVP) intramuscularly on left thigh with lot # 47838AA.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :, Index date : 2025-04-14 , MNSC number : 02747559 , CLIC number : , ESTAR number : , IRMS number :, Central date : 2025-04-10 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : US-009507513-2231763
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 28-Mar-2025, the patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) Injection (0.5ML, lot #X022981, expiration date: 21-May-2026, strength unknown), administered by Intramuscular route for the treatment of Prophylaxis after a temperature excursion (Product storage error). Operator Of Device: Health Professional  Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) experienced the temperature excursion below 54.19 Fahrenheit degrees (F) for 2 hours 45 minutes. No previous temperature excursions. No other information provided. No product quality complaints reported.
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Caller reported PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 28-Mar-2025, the patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) Injection (0.5ML, lot #X022981, expiration date: 21-May-2026, strength unknown), administered by Intramuscular route for the treatment of Prophylaxis after a temperature excursion (Product storage error). Operator Of Device: Health Professional  Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) experienced the temperature excursion below 54.19 Fahrenheit degrees (F) for 2 hours 45 minutes. No previous temperature excursions. No other information provided. No product quality complaints reported. This is one of five reports from the same reporter.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: female patient was administered 2 doses of  GARDASIL in her teens/ indicates that the patient *may* be  vaccinated soon with a 3rd dose; Inbound transfer of an HCP calling. HCP reported that his 42 year old female patient was administered 2 doses of GARDASIL in her teens and has now tested positive for HPV. HCP refused to offer further information or to be contacted as he st; This spontaneous report was received from a physician and refers to a(n) 42-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown dates (when the patient was a teenager), the patient was vaccinated with the first and the second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for HPV prevention.  On an unknown exact day in April 2025 (estimated date, reported as: now), the patient experienced human papilloma virus test positive. It was indicated that the patient may be vaccinated soon with the third dose of vaccine (inappropriate schedule of vaccine administered). At the reporting time, the patient not recovered from the event human papilloma virus test positive.  The causal relationship between the event of human papilloma virus test positive and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was unknown/not reported/not provided.
Age: 55.0
Sex: M
Vaccine: PNC21
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; This spontaneous report was received from a nurse and referred to a 55-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 16-Apr-2025, the patient was vaccinated with a single dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot# 2002626 was invalid, expiration date reported as 04-Sep-2026; dose considered as 1 dosage form; strength was not reported) via intramuscular route as vaccination by a health professional.  About 36-48 hours after receiving Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), on an unknown date in April 2025, the patient developed very swollen, reddened area that was painful touch and limits his mobility in his left arm at the injection site. No other symptoms reported. The patient had sought medical attention. No treatment was provided at this time. No lab diagnostics/ studies were reported. Outcome of all events was not recovered.  The causal relationship between Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) and all the events was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: not feeling well; fever; chills; This spontaneous report was received from an office manager and referred to a currently 21-year-old female patient. The patient's medical history included paracetamol (TYLENOL) allergy. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) injection, administered by intramuscular route for vaccination (dose, strength, anatomical site, lot # and expiration date were not reported).  On an unknown date (reported as following the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9)), the patient experienced fever and  chills. The patient was not given any treatment for the fever and chills and had resolved on an unknown date (reported as by the time that the patient had called the office to report the side effects). On an unknown date, the patient experienced not feeling well. The patient had been the 3rd dose in the series and was declined due to the patient not feeling well. The 3rd dose had been scheduled on 21-MAR-2025. The outcome of not feeling well was not reported. The action taken with the suspect vaccine was withdrawn.    The causal relationship between all events and suspect vaccine was not reported.    The reporter considered all events to be life-threatening.   Lot # is being requested and will be submitted if received.
Vaccine: PNC21
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: They administered the product  PCV-21/capvaxive to a baby.; Capvaxive, was being labeled as Prevnar 21.; This spontaneous report was received from a consumer or other non-health professional, via Pfizer and refers to an infant patient (reported as baby) of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, dose number, frequency, vaccination scheme, anatomical location, route of administration, lot number, expiration date was not provided) as prophylaxis (product administered to patient of inappropriate age). Caller reported that Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was being labeled as Prevnar 21 (product label issue).
Age: 1.0
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; HCP calling to report expired MMR-II administered on 03/17/25.; This spontaneous report was received from a medical assistant on 24-Apr-2025 and refers to a 1-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-Mar-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #W029541, expiration date: 15-Sep-2024), administered for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date not provided) (Expired product administered). The patient was not symptomatic. Unsupported outcome was delivered. Confirmed no temperature excursion (TE). No other information. No additional adverse event (no adverse event).
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Bexsero below the age of 10 years; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: received Bexsero below the age of 10 years). The outcome of the inappropriate age at vaccine administration 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: 17-APR-2025 The reporter stated that pediatric patients in large national health system received Bexsero that are below the age of 10 years which led to inappropriate age at vaccine administration. The reporter stated that this was off label use.  The Health Care Professional estimated that over 30 patients in the previous year and some had received one dose and others have received more than one dose.  As Per Health Care Professional, recommendations appear to be coming from Pediatric Infectious Disease providers or Pediatric Oncology providers.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: She has not yet received her second; This non-serious case was reported by a consumer 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 (received 1st dose of vaccine in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: She has not yet received her second). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 23-APR-2025 Reporter stated that the patient only received her first dose of Shingrix in 2018.  She has not yet received her second. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2025049321:Same reporter,Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: spots that look like chickenpox; This non-serious case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-APR-2025, the patient received Shingrix (intramuscular, left arm). On 22-APR-2025, 18 days after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: spots that look like chickenpox). The outcome of the varicella-like rash was not resolved.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.     It was unknown if the company considered the varicella-like rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-APR-2025 The spots that look like chickenpox on right arm, axilla and lower abdomen. The reporter stated that she received her second dose of Shingrix in her left arm.   Consumer reported that on 22nd April 2025 she noticed a spot resembling chickenpox on her right arm, one on her axilla, and one or two on her abdomen.   Consumer reported that this morning she noticed that she has 7 spots on her abdomen.   No other information was provided/obtained.
Vaccine: RSV
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: fever; body aches; throwing up; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: fever), general body pain (Verbatim: body aches), vomiting (Verbatim: throwing up) and headache (Verbatim: headache). The outcome of the fever, general body pain, vomiting and headache were resolved (duration 1 week).   It was unknown if the reporter considered the fever, general body pain, vomiting and headache to be related to Arexvy.     It was unknown if the company considered the fever, general body pain, vomiting and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-APR-2025 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient just got the shot and reactions were more severe, fever, body aches, throwing up, headache for a week.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had not completed the series yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose anywhere between 2 to 5 years ago).   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: had not completed the series yet). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 16-APR-2025 An office manager informed that a patient had gotten the first dose of Shingrix vaccine anywhere between 2 to 5 years ago and had not completed the series yet at the moment of the call. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.33
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number J5T9Z, expiry date 06-JUN-2025) for prophylaxis.   On 17-APR-2025, the patient received FluLaval 2024-2025 season. On 17-APR-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). The outcome of the inappropriate age at vaccine administration 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: 18-APR-2025 Registered nurse called to report an Adverse Event regarding an underage administration and they just gave out a dose to a four month old patient, which led to inappropriate age at vaccine administration. The registered nurse wanted to have Medical Information advise on this situation.  The vaccination date, vaccine detail and patient demographics were obtained in this call.  No further detail was obtained in this call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Vaccination Schedule (less than 6 months after first dose); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received HAV (Havrix) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 12th December 2024, batch number : 4T93R and expiry date:11-JUL-2026 00:00).   On 22-APR-2025, the patient received the 2nd dose of Havrix. On 22-APR-2025, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate Vaccination Schedule (less than 6 months after first dose)). The outcome of the drug dose administration interval too short 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:22-APR-2025 Pharmacist called to report a patient was vaccinated for the second dose on month four after the first dose instead of sixth month after the first dose.  The reporter asked if they need to revaccinate. The vaccination date (first and second dose), vaccine detail (first and second dose) and patient demographics were obtained in this call.  No further information was obtained in this call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient received 2nd dose of Havrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 45-year-old female patient who received HBV (Engerix B) (batch number AX2D5, expiry date 07-DEC-2024) for prophylaxis.   On 21-APR-2025, the patient received Engerix B. On 21-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B expired dose administration). 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:23-APR-2025 Medical Assistant wanted to know how to proceed after administering an expired dose of Engerix-B to a patient, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired drug administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number H54F9, expiry date 11-APR-2025) for prophylaxis.   On 22-APR-2025, the patient received Pediarix. On 22-APR-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired drug administered). 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: 23-APR-2025 Nurse reported that Pediarix was administered to a baby but the dose was expired, which led to expired vaccine used. HCP was going to consider this dose valid and proceed with the regular schedule. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was supposed to receive Pediarix but instead he received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 23-APR-2025, the patient received the 1st dose of Kinrix. On an unknown date, the patient did not receive Pediarix. On 23-APR-2025, immediately after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Patient was supposed to receive Pediarix but instead he received Kinrix). The outcome of the wrong vaccine administered 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: 23-APR-2025 The clinic had called because they had mistakenly administered the Kinrix vaccine to a four-month-old, even though it was indicated for children four years and older.  As a result, they had a few questions regarding the situation. The patient was supposed to have received Pediarix, but instead, had been given Kinrix, which led to wrong vaccine administered. They had consented to a follow-up.
Age: 24.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Arm/shoulder has been in pain and I cannot move it within its entire range, I get really bad pain if I try to scratch my back or reach up.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: The provider ordered Hepatitis B, and as a result the medical assistant administered Hepatitis A.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blister, Blood immunoglobulin G, Dermatitis, Eosinophilia
Clinical narrative: onset of serology positive bullous pemphigoid 10 days following vaccine administration
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pathology test
Clinical narrative: onset of serology positive bullous pemphigoid 10 days following vaccine administration
Age: 25.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Arexvy RSV Vaccine given to pregnant patient instead of Abrysvo. 33 weeks and 3d days pregnant at time of vaccination.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: Swelling where vaccine was given. Patient was prescribed an antibiotic for 3 days. Mom states patient is doing better.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: end of life
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Three to four hours after the injection, my arm began to hurt. By six hours after the injection the pain radiated from shoulder to finger tips. The following morning, the paid had lessened but was was still present. The following morning (approximately seventeen hours after the injection), I began to experience muscle aches and chills. This worsened over the following twelve hours as I experienced severe muscle aches and low grade fever. The following day (approximately 30 hours after the injection), I am experiencing mild muscle aches and fatigue but no fever. My arm still hurts, but not as severely as it did the evening after the injection. The injection site is mildly swollen and warm to the touch.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site discomfort, Injection site swelling
Clinical narrative: SWELLING ON LT ARM VACCINE SITE WITH MILD DISCOMFORT ZYRTEC GIVEN AND COLD COMPRESS QID WITH MOTRIN PRN
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: look like allergic reaction to vaccine. pt had rash red and swollen at the injection site
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: look like allergic reaction to vaccine. pt had rash red and swollen at the injection site
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pain in jaw, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Sharp, radiating, shooting pain on rotating sides of jaw-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient called pharmacy 04/21/2025 to report a reaction suspected to be related to recent vaccination with Moderna 2024-25 Spikevax vaccine. Patient reported radiating, shooting pain starting the day after vaccination localized mainly to lower jaw (rotating sides). Patient described pain as similar to a toothache with symptoms worsening with hot and cold drinks / food. Patient reported having strong immune reactions to Moderna vaccinations in past, but these symptoms are new.
Age: 61.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Blood disorder, Central venous catheterisation, Chills
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Severe, Systemic: Blood Disorder  (diagnosed by MD)-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Received vaccine tuesday 04/1@11:44AM.Felt fine & mowed lawn later that day.Around 4-5Pm began to have stomach pain,itching on legs.later that night, chills and leg pain.Did not feel better and eventually went to ER on thursday.  Developed blood clot in stomach, started on eliquis, Currently has PICC line x6 weeks for abx due to blood infection. Not sure if caused by vaccine or other external factor, but wanted to document timeline.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Gastrooesophageal reflux disease, Haematological infection, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Severe, Systemic: Blood Disorder  (diagnosed by MD)-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Received vaccine tuesday 04/1@11:44AM.Felt fine & mowed lawn later that day.Around 4-5Pm began to have stomach pain,itching on legs.later that night, chills and leg pain.Did not feel better and eventually went to ER on thursday.  Developed blood clot in stomach, started on eliquis, Currently has PICC line x6 weeks for abx due to blood infection. Not sure if caused by vaccine or other external factor, but wanted to document timeline.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Thrombosis mesenteric vessel
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Severe, Systemic: Blood Disorder  (diagnosed by MD)-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Received vaccine tuesday 04/1@11:44AM.Felt fine & mowed lawn later that day.Around 4-5Pm began to have stomach pain,itching on legs.later that night, chills and leg pain.Did not feel better and eventually went to ER on thursday.  Developed blood clot in stomach, started on eliquis, Currently has PICC line x6 weeks for abx due to blood infection. Not sure if caused by vaccine or other external factor, but wanted to document timeline.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Mouth ulceration, Oral mucosal eruption, Paraesthesia, Stomatitis
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient stated developed Mouth sores/ulcers in gum and pain on left side of face. feel tingling sensation and rash inside of mouth in only 1 side of the face (left side). went to dentist and gave peridex mouthwash.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Systemic: Chills-Medium
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Systemic: Chills-Medium
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Asthenia, Chills, Condition aggravated
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: arthritis flare up-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Severe
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pain, Pyrexia, Tremor
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: arthritis flare up-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Severe
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Fatigue, Lethargy, Pain, Sluggishness
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Weakness-Medium, Additional Details: Feeling very tired, very weak, sluggish, and barely stay awake and slept under multiple covers
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site paraesthesia, Limb injury, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Tingling/electrical pulses at shoulder and around injection site. Difficulty raising arm.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Mouth swelling, Oral herpes, Swelling face
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: On day of vaccination, All questions reviewd and patient was healthy and confirmed that no immune system issues & managed for 15 minutes after getting the shot. I recieved a call from ED, patient admited to hospital on 04/21/2025 getting facial swelling, fever blisters on her mouth & both eyes shut down. Symptoms managed by  Prescriber & she is responding to medications.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling of eyelid, Swollen tongue
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: On day of vaccination, All questions reviewd and patient was healthy and confirmed that no immune system issues & managed for 15 minutes after getting the shot. I recieved a call from ED, patient admited to hospital on 04/21/2025 getting facial swelling, fever blisters on her mouth & both eyes shut down. Symptoms managed by  Prescriber & she is responding to medications.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Injection site pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient experienced rash on the leg and eye itching . referred patient to her provider for treatment .
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: generalized red rash on arm. Does not itch, but warm to the touch-Mild, Additional Details: Pt exhibited a generalized red rash on the right arm. Said it presented approximately 4 days after vaccine administration. I did tell her that that is a common side effect with any vaccine, to apply ice and cortisone to area and observe. If it continues to spread, contact dr, Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: GSK; LotNumber: 9l5p2; Route: IM; BodySite: right arm; Dose: 1; VaxDate: 04/18/2025
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: HORRIBLE HEADACHE, FATIGUE, WHITE STOOL-Severe, Systemic: Headache-Severe, Systemic: Weakness-Medium
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: HORRIBLE HEADACHE, FATIGUE, WHITE STOOL-Severe, Systemic: Headache-Severe, Systemic: Weakness-Medium
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient reported that he experiences pain at injection site after all vaccination. Pain usually last 2 days , Other Vaccines:  VaccineTypeBrand: Fluzone High-Dose; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 10/08/2024
Age: 74.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Hyperhidrosis, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Mild, Additional Details: sweating
Age: 74.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Mild, Additional Details: sweating
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: covid-19 commirnaty; Manufacturer: pfizer pharm; LotNumber: MD3414; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC20
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received a Hep A outside of recommended dosing time frame by accident. Child was kept in office for 15 minute shot time, during that time no signs or symptoms of reactions noted. Nurse did inform child's mother immediately and incident and the provider.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse reaction. The vaccine expired 04/24/2025 and was given the morning of 04/25/2025
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: The vaccine expired on April 24th 2025 and was given the morning of April 25th 2025. No adverse reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt came in 04/28/25 reporting redness, swelling, itching, pain at injection site that had spread bilatterally.  It is currently subsiding but still red at injection site
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: CLIENT ADMINISTERED 0.25 ML DOSE OF MODERNA VACCINE. CLIENT WAS NOTIFIED PER PC WHEN DISCOVERED DOSE ADMINISTERED IS A NON COUNTABLE DOSE. PT INFORMED AND MADE AWARE OF RECOMMENDATION TO REPEAT MODERNA VACCINE WITH 0.5 ML DOSE TO ENSURE EFFICACY AND ADEQUATE PROTECTION. CLIENT DENIES ADVERSE EFFECTS, VERBALIZED UNDERSTANDING, AND INTENT TO REPEAT IN FUTURE.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Rash, Rash macular
Clinical narrative: Patient developed a small rash around the injection site. A day later her face broke out in a red, spotty rash. The rash continued to spread to her upper arms and legs, progressing down her arms and legs over the next 24-48  hours. Patient now has small spotty rashes breaking out on her chest and back.  -- Patient received MMRV 4/10/25 and DTAP/IPV 4/22/25
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient called on 4/24/25 reported that her arm was still sore, red, hot to touch and swollen. Patient asked if she could take Ibuprofen and ice the area which patient was told ok. If no improvement instructed patient to go see PCP and have them look at area. Asked patient to call us back 4/25/25 to let us know how she was doing and if any improvement
Age: 0.5
Sex: F
Vaccine: PNC15
Symptoms: Dermatitis, Injection site rash
Clinical narrative: Persistent rash at vaccine injection site. Area of dermatitis still present at 9 month well child examination. No topicals trialed, other than moisturizer.
Age: 62.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Cellulitis
Clinical narrative: cellulitis; pt was prescribed antibiotic on 4/27/25
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Rash, Rash erythematous, Urticaria
Clinical narrative: Patient came into office on 4/28 for Rash - Appeared on his arm 3 days ago after a physical exam where he had received Hep A - Worsened progressively, especially with heat - Treated with Benadryl and Tylenol  Skin: red round rash all over face, chest, back, arms and legs- urticaria multiforme
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test normal, Pain in extremity, Paraesthesia, X-ray normal
Clinical narrative: extreme pain in lower extremities,  both legs, and back of hips, - given pain medicines, needle sticks in legs, xrays and dozens of blood work....all tests were negative for muscle weakness
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal distension, Fatigue, Joint swelling
Clinical narrative: Reported to pharmacy on 04/28/20/25 ---Patient noticed that after receiving the RSV VACCINE on 12/11/2024  had bloating , started feel tired for next couple of days. Stated he started having swollen ankles after that.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Skin tightness
Clinical narrative: Patient has redness in right arm, some swelling and states arm feels tight. She was started on Levaquin 500 mg daily x 7 days, Prednisone 10 mg daily x 5 days on 4/26/25. She was given injection of Decadron 10 mg IM in left gluteus maximus on 4/28/25.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna Covid vaccine 6 months to 11 years given. It should have been Moderna Spikevax 12 years and older. The patient is 12
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Asthenia, Blood test, Computerised tomogram, Depression
Clinical narrative: Normal Pressure Hydrocephalus - gait disturbance, incontinence, pulsating and "whooshing" sensation in head; also persistent tinnitus; occasional stinging back pain; depression; lack of energy and motivation; diminished sex drive
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Incontinence, Libido decreased, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Normal Pressure Hydrocephalus - gait disturbance, incontinence, pulsating and "whooshing" sensation in head; also persistent tinnitus; occasional stinging back pain; depression; lack of energy and motivation; diminished sex drive
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Normal pressure hydrocephalus, Pain, Sensory disturbance, Tinnitus
Clinical narrative: Normal Pressure Hydrocephalus - gait disturbance, incontinence, pulsating and "whooshing" sensation in head; also persistent tinnitus; occasional stinging back pain; depression; lack of energy and motivation; diminished sex drive
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Pain, X-ray
Clinical narrative: Patient had sharp shooting pain immediately after vaccine administration that has continued four days after administration
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Product preparation issue
Clinical narrative: During a pillbox appointment, I administered 2nd dose of Shingles vaccine. While drawing up the diluent, I thought I had injected into the lyophilized vial to reconstitute but I believe I injected back into the same diluent vial. After that, I left the room to try and find a smaller needle for administration into the patient. I injected the diluent into the patient, who commented on a "burning sensation" which I attributed to a normal response to Shingles Vaccine. After patient left, I observed the un-reconstituted vial on the counter.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: PATIENT STATED THAT ARM HAS BEEN PAINFUL SINCE GETTING INJECTION. PATIENT UPPER ARM IS RED IN SPOTS AND WARM TO THE TOUCH. PATIENT STATES THAT IT IS HARD TO LIFT HER ARM. PATIENT IS IN CLINIC NOW SEEING PROVIDER
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient due for MMR, MenQuadfi administer invertedly. Suspect error originated at ordering phase. No adverse symptoms.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination, Exposure during pregnancy
Clinical narrative: MMR vaccination inadvertently administered to patient. EDD or birth weight unavailable.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Client experienced 2 miscarraiges  weeks after being vaccinated.  Was not aware she was pregnant at the time of being vaccinated.   The first loss was  at 15wks 0d shew she was vaccinated on 3/15/2021 loss the developing fetus on June 3 2021.   The second loss was she was vaccinated on 1/14/2025 the loss occurred on 4/19/2025 after being vaccinated on 1/14/2025 at 15wks 3d.    This is the only common denominator.  She has had 2 normal healthy at term pregnancies in 2015 and 2018.
Age: 50.0
Sex: F
Vaccine: PNC15
Symptoms: Erythema, Mass, Pain, Pruritus
Clinical narrative: Extreme soreness, baseball size lump and redness, itching
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: TM reports she got Heplisav B shot and a rash started on her torso that day.  It slowly progressed and spear to under her arms.  She denies shortness of breath.  Rash to upper truck and extremities only. Upon speaking with her she was 3 days post shot with a rash at that time, was improving.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and increase warmth   of the right thigh