chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Lethargy, Mobility decreased
Clinical narrative: I started to feel lethargic about 4 hours after receiving the vaccine.  About 8 hours later, I needed to urinate.  I was unable to walk to bathroom.  I tried crawling but my lower appendages would not move. At this point I urinated on myself & seemed to have passed out.  While sitting on floor, I tried to remove clothing but I was unable to lift my core .  Eventually, I was able to creep back into bed.  For the next 12 hours I felt very lethargic.   I continued to improve from that point on.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased
Clinical narrative: I started to feel lethargic about 4 hours after receiving the vaccine.  About 8 hours later, I needed to urinate.  I was unable to walk to bathroom.  I tried crawling but my lower appendages would not move. At this point I urinated on myself & seemed to have passed out.  While sitting on floor, I tried to remove clothing but I was unable to lift my core .  Eventually, I was able to creep back into bed.  For the next 12 hours I felt very lethargic.   I continued to improve from that point on.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: High fever, chills, nausea, tiredness, body aches (likely from tensed muscles from the chills).
Age: 33.0
Sex: F
Vaccine: COVID19, MMR
Symptoms: Pain
Clinical narrative: Extreme soreness lasting >7 days
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Headache, Malaise, Pain in extremity, Pallor
Clinical narrative: Pallor, fatigue, malaise, headache, sore arm
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: The patient received Prevnar 20 on 5/2/2024, and received the same vaccine Prevnar 20 on 5/3/2025
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Hyperhidrosis, Injection site pain, Loss of consciousness, Syncope
Clinical narrative: patient said vaccine was very painful and then fainted. Patient got sweaty, passed out on chair. I rubbed patients sternum and she woke up. patient refused help from 911. She accepted water and a cookie. Patient's son said she has fainted before during blood work. I checked her blood pressure and put on a fan to give her fresh air. She left after 45 minutes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse reaction,  she was given a 3rd dose of shingrix vaccine, she had the first 2 doses in 2019 and 2020.  patient had no adverse reaction
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient received the vaccine and a few days later she was having pain and difficulty raising her left arm
Age: 38.0
Sex: M
Vaccine: HEPAB, TYP, YF
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: The 3 above vaccines were administered. Patient experienced what appeared to be syncope with tonic-clonic movement <1 hour after vaccine administration. Patient started to fall as exiting Immunization room and was supported to floor and monitored until EMS arrived and took over supporting patient.  Patient did leave with EMS and it is thought that he visited the ER but the outcome once leaving  pharmacy is unknown. Called patient to check in on 5/4 and was unable to reach. Left voicemail to return pharmacy call if desired.
Age: 54.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received Prevnar20 on 2/28/24 therefore this is a second (duplicate) dose.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: red, hot, swollen, rash
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Pain in extremity, Paraesthesia
Clinical narrative: Received the vaccine and a few days later while laying in bed noticed tingling in her feet, the tingling progressed to painful stabbing pain which made it hard to walk. This went on for months as it slowly got better. Her doctor suspects it was a milder case of Guillain-Barré Syndrome.
Age: 47.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reported pain and loss of motion that began day after immunization in left arm. Unsure when but patient reported she sought treatment at ED and was treated successfully for cellulitis.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Pt developed redness, pain and erythema at site, then cellulitis at the site and in the arm
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Mass, Skin warm
Clinical narrative: Bruising with lump underneath, warmth that dissipated after 1 week
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS AND SWEELING AT INJECTION SITE. INJECTION SITE IS TENDER TO TOUCH. (RECOMEND BENADRYL AND WAIT AND SEE)
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis, Pericarditis
Clinical narrative: Pericarditis with slight myocarditis, treated with Prednisone.
Age: 64.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Discomfort, Throat irritation, Throat tightness
Clinical narrative: Patient reported Discomfort , Scratchy throat and closing up 30 minutes after immunization. Epipen was administered and Patient stabilized by emergency personnel.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Discomfort, Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: Significant shoulder pain including soreness and inability to move arm for several weeks after vaccine administration.  After that the pain continued to persist though some limited range of motion has returned. Pain continues to be a dull ache almost 4 months post administration with some numbness and also inability to sleep on left side due to pain. Continued issue with range of motion, pain and discomfort even when not moving arm. Pain could be described as numb ache but sometimes increase to sharp pain radiating down arm
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Significant shoulder pain including soreness and inability to move arm for several weeks after vaccine administration.  After that the pain continued to persist though some limited range of motion has returned. Pain continues to be a dull ache almost 4 months post administration with some numbness and also inability to sleep on left side due to pain. Continued issue with range of motion, pain and discomfort even when not moving arm. Pain could be described as numb ache but sometimes increase to sharp pain radiating down arm
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper
Clinical narrative: abdominal pain times 4 years from 3/10 to 10/10, nausea, dizzy and liver enzymes ALT and AST are abnormal at times.  no treatments have helped.  I was perfectly healthy, I competed in volleyball in high school on a national level.  Since June 19, I have been sick with abdominal pain every day for 4 years with no diagnosis nor successful treatment.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Alanine aminotransferase abnormal, Aspartate aminotransferase abnormal, Blood test normal, Borrelia test negative
Clinical narrative: abdominal pain times 4 years from 3/10 to 10/10, nausea, dizzy and liver enzymes ALT and AST are abnormal at times.  no treatments have helped.  I was perfectly healthy, I competed in volleyball in high school on a national level.  Since June 19, I have been sick with abdominal pain every day for 4 years with no diagnosis nor successful treatment.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cholecystectomy, Computerised tomogram normal, Dizziness, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: abdominal pain times 4 years from 3/10 to 10/10, nausea, dizzy and liver enzymes ALT and AST are abnormal at times.  no treatments have helped.  I was perfectly healthy, I competed in volleyball in high school on a national level.  Since June 19, I have been sick with abdominal pain every day for 4 years with no diagnosis nor successful treatment.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test normal, Nausea, Thyroid function test normal
Clinical narrative: abdominal pain times 4 years from 3/10 to 10/10, nausea, dizzy and liver enzymes ALT and AST are abnormal at times.  no treatments have helped.  I was perfectly healthy, I competed in volleyball in high school on a national level.  Since June 19, I have been sick with abdominal pain every day for 4 years with no diagnosis nor successful treatment.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: HCP called regarding GARDASIL and/or GARDASIL 9. It's reported that the patient was "in her 20's at the time of the first vaccination" and missed her 2nd and 3rd dose in the GARDASIL series (HCP unclear whether it was GARDASIL or GARDASIL 9) and on; No other AE/No PQC.; This spontaneous report was received from a/an Pharmacist and refers to a(n) Adult 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 date between 2014 and 2016 also reported when the patient was in her 20's, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), administered by Unknown route (lot # and expiration date were not reported) however, the reporter was unclear whether it was GARDASIL or GARDASIL 9.   On an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), administered by Unknown route (lot # and expiration date were not reported). The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), for the treatment of Prophylaxis.  The HCP stated that they would be administering the remaining Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) series "starting where they left off", they had not yet received the 2nd and 3rd dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9). No adverse event reported.   Lot # is being requested and will be submitted if received.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other information provided.  No additional AEs/PQC reported.; Caller reported VAQTA administered after expiration date.; Information has been received from Business Partner/CRO on 08-Apr-2025.  This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with . On an unknown date, the patient started therapy with Hepatitis A Vaccine, Inactivated (lot #X024966, expiration date: 23-Mar-2025) 1 mL administered by Intramuscular route. The patient started therapy with Hepatitis A Vaccine, Inactivated for the treatment of Prophylaxis.  On 25-Mar-2025, the patient experienced Caller reported VAQTA administered after expiration date.. On an unknown date, the patient experienced No other information provided.  No additional AEs/PQC reported..   At the reporting time, the outcome of Caller reported VAQTA administered after expiration date. and No other information provided.  No additional AEs/PQC reported. was unknown.   The action taken with Hepatitis A Vaccine, Inactivated was reported as not applicable.
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Therapeutic response unexpected, Vaccination failure
Clinical narrative: Suspected vaccination failure; had it twice; Postherpetic neuralgia; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included psoriasis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had it twice) and post herpetic neuralgia (Verbatim: Postherpetic neuralgia). The outcome of the vaccination failure was not reported and the outcome of the shingles and post herpetic neuralgia were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-APR-2025 This case was reported by a patient via interactive digital media. The patient had it twice  after the shot also had Postherpetic neuralgia  which was twice as bad as the shingles, but when it all went away no longer had psoriasis on elbows ever again.  The patient reported this observation to the because was not an physician they were not interested. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Kinrix out of the recommended age administration; Kinrix as fourth instead of fifth DTaP-IPV dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 16-APR-2025, the patient received Kinrix. On 16-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix out of the recommended age administration) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as fourth instead of fifth DTaP-IPV dose administration). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-APR-2025 Certified Medical Assistant wanted to know if a Kinrix administration in a 3 years-old patient was considered an error and how to proceed, inappropriate age at vaccine administration. Also, agent asked in which number dose in the series for DTaP-IPV immunization Kinrix was given and the health care provider mentioned that was the fourth (instead of being the fifth, as recommended in the prescribing information), which led to inappropriate schedule of vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: PNC21, TTOX
Symptoms: Abdominal pain, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Experienced sore, tight/stiff arm, and inject site soreness; Experienced sore, tight/stiff arm, and inject site soreness; tight/stiff arm; This spontaneous report was received from a consumer, referring to herself, a 50-year-old female patient. The patient's concomitant drugs included breast cancer medication. The patient's medical history, historical drugs, past drug reactions or allergies, and concurrent conditions were not reported.   On an unknown date, the patient was vaccinated with Pneumococcal 21v conj vaccine (CRM197) (CAPVAXIVE) (dose, strength, route of administration, lot#, and expiration date were not reported) for prophylaxis by a Health Professional; together with Tetanus vaccine (dose, strength, route of administration, lot#, and expiration date were not reported).  On 29-APR-2025, the patient experienced sore, tight/stiff arm, and inject site soreness. At the time of reporting, the outcome of the events above was unknown. The causal relationship between the events above and the suspected vaccines was not reported.   Lot# is being requested and will be submitted if received.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Eye haemorrhage, Injection site pain, Vomiting
Clinical narrative: Vomiting; Diarrhea; Pain injection site; broke an eye blood vessel/ my left eye broke a blood vessels in the eye and the white part is totally red; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. In APR-2025, less than a week after receiving Shingrix, the patient experienced broken blood vessel in eye (Verbatim: broke an eye blood vessel/ my left eye broke a blood vessels in the eye and the white part is totally red). On 25-APR-2025, the patient experienced injection site pain (Verbatim: Pain injection site). On 26-APR-2025, the patient experienced vomiting (Verbatim: Vomiting) and diarrhea (Verbatim: Diarrhea). The outcome of the injection site pain was unknown and the outcome of the vomiting and diarrhea were resolved and the outcome of the broken blood vessel in eye was not resolved.   It was unknown if the reporter considered the injection site pain, vomiting, diarrhea and broken blood vessel in eye to be related to Shingrix.     It was unknown if the company considered the injection site pain, vomiting, diarrhea and broken blood vessel in eye to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2025 The patient self reported this case for herself. The patient reported an adverse event for the Shingrix vaccine on 30th April 2025.  She stated that she had received the first dose of Shingrix on 24th April 2025, in her left arm at a local pharmacy.  The lot/expiration details were unknown.  She mentioned that she had experienced pain at the injection site on the next day.  On 26th April 2025, she reported vomiting and diarrhea.  The patient stated that she had recovered from these symptoms but noted, the vomiting was so bad that her left eye broke a blood vessel, and the white part was totally red.
Age: 42.0
Vaccine: VARCEL, VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE; HCP calling to report T/E. HCP stated VARIVAX was administered.ved (including lot/exp): VARIVAX Y013347 8/08/2026; This spontaneous report was received from a nurse and refers to a 42-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 unspecified dates, varicella virus vaccine live (oka-merck) (VARIVAX) lot #Y013347 underwent temperature excursions (13 minutes in -14.0 degrees Celsius and 36 minutes in -7.8 degrees Celsius).  On 07-APR-2025, the patient was vaccinated with varicella virus vaccine live (oka-merck) (VARIVAX), injection, lot #Y013347, expiration date was reported as 08-AUG-2026, however upon internal validation determined as 02-AUG-2026, for prophylaxis (dose, route of administration and anatomical location were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiry date were not reported). The vaccine underwent temperature excursion described above (Product storage error). No additional adverse event was reported.
Age: 24.0
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: . No additional AE /PQC reported; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX was administered.  Permission was given to contact HCP.  No additional AE /PQC reported.           ?    Names of vaccines involved (including lot/exp): VARIVAX Y013347 8/08/20; This spontaneous report was received from an other health professional and refers to a(n) 24-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 27-MAR-2025, the patient was vaccinated with improperly stored dose of varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE), Injection, lot #Y013347, expiration date 02-AUG-2026 for prophylaxis (exact dose, dose number, route and site of administration were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The excursion lasted for 36 minutes in temperature -7.8 Celsius degrees. There was previous excursion that lasted 13 minutes in temperature -14.0 Celsius degrees (-14.4°C up to -10.4°C) (improper storage of product in use). No additional adverse events were reported.
Age: 55.0
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE /PQC reported.; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX was administered.  Permission was given to contact HCP.  No additional AE /PQC reported.           ?    Names of vaccines involved (including lot/exp): VARIVAX Y013347 8/08/20; This spontaneous report was received from an other health professional and refers to a(n) 55-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 18-MAR-2025, the patient was vaccinated with improperly stored dose of varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE), Injection, lot #Y013347, expiration date 02-AUG-2026 for prophylaxis (exact dose, dose number, route and site of administration were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The excursion lasted for 36 minutes in temperature -7.8 Celsius degrees. There was previous excursion that lasted 13 minutes in temperature -14.0 Celsius degrees (-14.4°C up to -10.4°C) (improper storage of product in use). No additional adverse events were reported.
Age: 10.0
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX  were administered. Permission was given to contact HCP.  No additional AE/PQC reported.              ?    Names of vaccines involved (including lot/exp): VARIVAX Y015557 09/1; no adverse event; This spontaneous report was received from a nurse and regarding a 10-year-old patient of unknown gender.   The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 24-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection, as prophylaxis (lot #Y015557, expiration date: 16-Sep-2026) (dose, anatomical location, and route of administration were not reported), reconstituted with sterile diluent (MERCK STERILE DILUENT), solution for injection (dose, indication, route of administration, expiration date, and lot # were not reported). It was stated that this vaccine, underwent a temperature excursion (TE) at -7.8 °C, during 36 minutes. A previous temperature excursion had occurred at -14.4°C (up to -10.4°C) and 14.0 °C  during 13 minutes.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; the patient was administered this dose via a feeding tube (nasogastric); patient received their first dose of ROTATEQ on 4/11/2025 at the age of 18 weeks and 4 days.; This spontaneous report was received from a Nurse (registered nurse [RN]) and refers to an 18-week-old female patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 11-Apr-2025 (at the age of 18 weeks and 4 days), the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral solution, dose number 1, administered via a feeding tube (nasogastric) (exact dose, lot # and expiration date were not reported) for prophylaxis at Clinic (inappropriate schedule of product administration, incorrect route of product administration). No additional adverse event (AE) was reported (no adverse event).   Lot # is being requested and will be submitted if received.
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; temperature excursion evaluation and stated that the product was administered.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 09-Apr-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (formulation, strength, dose, vaccination scheme, and anatomical site of vaccination were not reported, lot numbers Y010373, which had been verified to be valid, expiration date was reported as 06-Jun-2026 and validated as 05-Jun-2026; and Y015108 which had been verified to be valid, expiration date was reported and validated as 06-Sep-2026), as prophylaxis. The vaccine administered was stored at temperature of 12.9 degrees Celsius (C) for a time frame of 5 hours and 12 minutes (improper storage of product in use). There was no previous temperature excursion. No additional AE details were reported.
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administrations of VARIVAX following a temperature excursion; No other AE/PQC; This spontaneous report was received from a consumer or other non health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with unknown number of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y014939, expiration date: 04-Sep-2026, administered for prophylaxis (strength, dose and route of administration were not provided) following a temperature excursion (5.5°F up to 14.4°F (-14.4°C up to -10.4°C) 0 hours 50 minutes; 14.5°F up to 46.4°F (-10.5°C up to 8.4°C) 11 hours 30 minutes; 46.5°F to 77.4°F (8.5°C to 25.4°C) 0 hours 40 minutes; 77.5°F/25.5°C or warmer 0 hours 0 minutes) (Improper storage of product in use). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot and expiration date were not provided). No previous temperature excursion. No symptoms reported and no additional details provided. No other adverse event (AE) (No adverse event).  This is an invalid case due to lack of patient's identifiers.; Reporter's Comments:
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient given MMRV instead of MMR.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Received MMRV instead of MMR
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site swelling, Oedema peripheral, Tenderness
Clinical narrative: Employee states after receiving vaccination she got a headache within a few hours. The next morning she woke up with swelling to injection site, her underarm area and her breast were swollen as well and sore to the touch.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Most of L anterior thigh erythematous, warm, tender (14cm x 9.5cm). Rx Keflex issued, Benadryl PRN, warm sitz baths, cool compresses. Improvement noted within 24-48hrs.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Eye swelling, Periorbital swelling, Pyrexia, Rash
Clinical narrative: On day 6, It started with a small rash on the neck. By Day 8-9 it became a full body rash. Day 10 patient woke up with puffy/swollen eyes, a fever and diarrhea.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: none noted
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No additional AE/no; received half a dose of PROQUAD; This spontaneous report was received from a field-based employee (FBE) via physician and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 30-APR-2025, the patient was vaccinated with half a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) due to the child screaming and squirming and they lost control of the child, and the product was wasted during that time (underdose). The FBE states the physician wanted to know if the dose given was sufficient or is revaccination required. No adverse events reported.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Cyanosis, Irritability, Peripheral coldness, Pyrexia
Clinical narrative: Later in the evening after receiving his vaccine, mother says he "reacted" and developed fever, his hands looked "cold and purple" and he was fussy.  This was better, it sounds like, by the next day.  No ongoing concerns.  Family is concerned that this could have been related to the vaccines he had received, and wants this "reaction marked in his chart.".
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Hyperhidrosis, Immediate post-injection reaction, Pain in extremity
Clinical narrative: She immediately felt discomfort as the vaccine was being administered.  Her arm remained sore throughout the day and she began "freezing" later that night. The next morning (Friday) she woke up drenched in sweat as if her fever broke and she was extremely fatigued that day.  The fever and fatigue remained through Sunday (72 hours).  Her arm is still sore and swollen today, Monday.  She is taking ibuprofen to try and manage the symptoms.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Peripheral swelling, Pyrexia
Clinical narrative: She immediately felt discomfort as the vaccine was being administered.  Her arm remained sore throughout the day and she began "freezing" later that night. The next morning (Friday) she woke up drenched in sweat as if her fever broke and she was extremely fatigued that day.  The fever and fatigue remained through Sunday (72 hours).  Her arm is still sore and swollen today, Monday.  She is taking ibuprofen to try and manage the symptoms.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Dose provided was # 4 of 3 dose course.  Extra dose administered.   Given by Medical Assistant.  No adverse event was noted (no signs or symptoms of reaction)
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Heart rate increased
Clinical narrative: Was not informed she was given Tdap instead of Td. No VIS given. Has severe headache and rapid heart rate but not as severe  as yesterday.
Age: 21.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Expired product administered
Clinical narrative: It was noted when charting the Varivax that the vaccine given was expired as of 1/4/25. Contacted Merck to inquire about potency and was told that they have in house data that supports the potency of the vaccine and they do not give recommendations on whether or not dose needs to be repeated. NP states that she will have titers drawn in a few months to see if he has immunity. patient notified and voiced understanding. Incident report filled out.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: redness below the area of injection- red banding around the arm-pooling of the serum? arm swelling and soreness. fever (102.6), chills, muscle/joint aches, tiredness, headache.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: redness below the area of injection- red banding around the arm-pooling of the serum? arm swelling and soreness. fever (102.6), chills, muscle/joint aches, tiredness, headache.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: SITE OF INJECTION: RED/HARD/HOT. NO ADDITIONAL SYMPTOMS
Age: 1.33
Sex: F
Vaccine: HEPA, MMR, PNC20
Symptoms: Product preparation error
Clinical narrative: Patient was due for Pentacel, they received 2 of 2 with was reconstituted with dilutian instead if being reconstituted with the Dtap- IPV component. Patients mouther was contacted and informed. We are bringing the patient back to get a repeat of the Pentacel Vaccines
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: A few hours after receiving the vaccines the injection site started to swell and become red.  Swelling worsened over the next 24 hours, mom took patient to the ER on 5/4/25.  Diagnosed with cellulitis and given clindymicin.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Bacterial infection, Blood creatine phosphokinase, Blood culture, C-reactive protein, Crying
Clinical narrative: A few hours after receiving the vaccines the injection site started to swell and become red.  Swelling worsened over the next 24 hours, mom took patient to the ER on 5/4/25.  Diagnosed with cellulitis and given clindymicin.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Differential white blood cell count, Full blood count, Gait disturbance, Injection site erythema, Injection site induration
Clinical narrative: A few hours after receiving the vaccines the injection site started to swell and become red.  Swelling worsened over the next 24 hours, mom took patient to the ER on 5/4/25.  Diagnosed with cellulitis and given clindymicin.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pain, Procalcitonin
Clinical narrative: A few hours after receiving the vaccines the injection site started to swell and become red.  Swelling worsened over the next 24 hours, mom took patient to the ER on 5/4/25.  Diagnosed with cellulitis and given clindymicin.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Screaming, Ultrasound scan
Clinical narrative: A few hours after receiving the vaccines the injection site started to swell and become red.  Swelling worsened over the next 24 hours, mom took patient to the ER on 5/4/25.  Diagnosed with cellulitis and given clindymicin.
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Erythema, Muscle rigidity, Pain, Peripheral vascular disorder, Rash
Clinical narrative: Muscle rigidity, pain, redness in left leg then 1 week later - hive, rash, blood vessel issue on thigh and calf
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Urticaria
Clinical narrative: Muscle rigidity, pain, redness in left leg then 1 week later - hive, rash, blood vessel issue on thigh and calf
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pain, Paralysis, Urticaria
Clinical narrative: Muscle rigidity, pain, redness in left leg then 1 week later - hive, rash, blood vessel issue on thigh and calf
Age: 1.25
Sex: M
Vaccine: MMR, MMR, UNK, MMR
Symptoms: Lacrimation increased, Ocular hyperaemia, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: PATIENT DEVELOPED A HEAD TO TOE RASH, HIGH FEVER, RED RUNNY EYES, RUNNY NOSE 9 DAYS AFTER GETTING VACCINE
Age: 1.25
Sex: M
Vaccine: MMR, MMR, UNK, MMR
Symptoms: Enterovirus infection, Herpangina, Morbillivirus test positive, Pyrexia, Rash morbilliform
Clinical narrative: PATIENT DEVELOPED A HEAD TO TOE RASH, HIGH FEVER, RED RUNNY EYES, RUNNY NOSE 9 DAYS AFTER GETTING VACCINE
Age: 1.25
Sex: M
Vaccine: MMR, MMR, UNK, MMR
Symptoms: Respiratory disorder
Clinical narrative: PATIENT DEVELOPED A HEAD TO TOE RASH, HIGH FEVER, RED RUNNY EYES, RUNNY NOSE 9 DAYS AFTER GETTING VACCINE
Age: 1.25
Sex: M
Vaccine: MMR, MMR, UNK, MMR
Symptoms: Conjunctivitis, Cough, Morbillivirus test positive, Pyrexia, Rash
Clinical narrative: PATIENT DEVELOPED A HEAD TO TOE RASH, HIGH FEVER, RED RUNNY EYES, RUNNY NOSE 9 DAYS AFTER GETTING VACCINE
Age: 1.25
Sex: M
Vaccine: MMR, MMR, UNK, MMR
Symptoms: Rash morbilliform, Respiratory viral panel, Rhinorrhoea
Clinical narrative: PATIENT DEVELOPED A HEAD TO TOE RASH, HIGH FEVER, RED RUNNY EYES, RUNNY NOSE 9 DAYS AFTER GETTING VACCINE
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness, swelling on vaccine site
Age: 78.0
Sex: F
Vaccine: PNC21
Symptoms: Myalgia, X-ray
Clinical narrative: Muscle pain for more than usual amount of time.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There is no adverse reaction instead of rabies vaccine 2nd dose. Pt was instead given Rabies Immune Globulin.
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Haemorrhage, Nausea, Pallor, Skin lesion
Clinical narrative: AFTER RECEIVING BOTH VACCINATIONS, PT STOOD FOR ABOUT 15 SECONDS TO ALLOW ANOTHER PERSON TO TAKE THE VACCINATION SEAT, AND FAINTED TO FLOOR. THERE WAS SOME LIGHT BLEEDING FROM A FOREHEAD LESION, AND PT CAME TO IN ABOUT 5 SECONDS, AND WAS ABLE TO TAKE A NEARBY CHAIR. PT THEN EXPERIENCED VOMITING, NAUSEA, DIZZINESS, AND WAS VERY PALE. AFTER RESTING FOR A COUPLE OF MINUTES, THE PT REPORTED BEING WELL ENOUGH TO LEAVE THE PHARMACY.
Vaccine: COVID19, FLU3
Symptoms: Syncope, Vomiting
Clinical narrative: AFTER RECEIVING BOTH VACCINATIONS, PT STOOD FOR ABOUT 15 SECONDS TO ALLOW ANOTHER PERSON TO TAKE THE VACCINATION SEAT, AND FAINTED TO FLOOR. THERE WAS SOME LIGHT BLEEDING FROM A FOREHEAD LESION, AND PT CAME TO IN ABOUT 5 SECONDS, AND WAS ABLE TO TAKE A NEARBY CHAIR. PT THEN EXPERIENCED VOMITING, NAUSEA, DIZZINESS, AND WAS VERY PALE. AFTER RESTING FOR A COUPLE OF MINUTES, THE PT REPORTED BEING WELL ENOUGH TO LEAVE THE PHARMACY.
Age: 15.0
Sex: M
Vaccine: DTAPHEPBIP, PNC20
Symptoms: Product preparation issue
Clinical narrative: Pt was receiving 2mth old vaccines including HIB. Verified vaccines and given to MA to administer. When MA returned from room, noted that HIB lyophilized antigen component vial was not reconstituted with Sterile Diluent. MA stated only administered syringe containing diluent but did not reconstitute. Upon verifying, syringe did not have any diluent and vial still noted with white powder. Dr. and DON made aware. Dr. advised can repeat HIB this visit. Parents decided to wait and return for a nurse visit for HIB vaccine since at this time pt had already received vaccines and was sleeping. HIB vaccines documented in chart as deferred and wasted. PM made aware
Age: 1.5
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Urticaria
Clinical narrative: urticaria - antihistamine, steriods
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: firm chestnut-sized swelling appeared on top of muscle below SQ injection site the day after injection. Site was swollen tender and erythematous x 1 week post-injection. The ?lump? persists 10 days post injection, redness and tenderness has resolved. No hx vaccine reactions in past.
Sex: F
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No additional  AE/No PQC reported.; HCP called to report a female patient, who is currently 15 years old, received her first dose of GARDASIL 9 on 01NOV2024 and will be receiving her second dose today on 01MAY2025.  Caller was unable to provide patient name or age at time of first admi; This spontaneous report was received from a Pharmacist and refers to currently 15 years old female.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 01-Nov-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route, anatomical ocation, lot #, expiration date were not reported) for prophylaxis. It was mentioned that the patient would be receiving her second dose today on 01-MAY-2025. No symptoms reported.  vide patient name or age at time of first admi. On an unknown date, the patient experienced No additional  AE/No PQC reported..   At the reporting time, the outcome of HCP called to report a female patient, who is currently 15 years old, received her first dose of GARDASIL 9 on 01NOV2024 and will be receiving her second dose today on 01MAY2025.  Caller was unable to provide patient name or age at time of first admi and No additional  AE/No PQC reported. was unknown.   The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Rash, Rash erythematous
Clinical narrative: 233: Returned to room 10 minutes after injection-Site red on the side with MMR and varicella. PCP in to review. She stated ok to put an ice pack on and check back in 10 minutes    245 Upon recheck PCP asked to check as well. Area to injection site, less red. Red rash to the left shoulder.  PCP wanted to give benadryl.   Benadryl given without incident. Patient tolerated well. Area drawn around the site with a skin marker.    Reassessed at 309 and redness decreased, rash less.   Reviewed with PCP-ok to send home. Benadryl every 8 hours x 3 doses 12.5 mg. Next dose due at 1030 pm.    Encouraged to call back if worsening or not improving.
Age: 79.0
Sex: M
Vaccine: PNC21, RSV
Symptoms: Arthralgia, Injection site pain, Joint stiffness, Joint swelling, Pain in extremity
Clinical narrative: patient first experienced pain in the upper left arm, the arm the Capvaxive was administered in.  he stated the pain travelled further down that same arm and ended in the wrist area. patient's wrist was swollen and stiff.  patient was told to use ice on the swollen area of that wrist and present to his physician for further medical advice if deemed necessary.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Aphasia, Rash, Sluggishness
Clinical narrative: Patient did break out with a rash covering all of her back, legs, arm and chest.   She did move around sluggishly.   She did speak less/'l
Sex: M
Vaccine: COVID19
Symptoms: Apathy, Depressed mood, Dysgraphia, Hypogeusia, Hyposmia
Clinical narrative: pt says when someone had a positive comment for him he felt happy and good inside but since being vaccinated    when someone makes the same comments there is not feeling of being happy or feeling of anything anymore. He used to feel relaxed, a sense of enjoyment and at peace at the end of the day when listening to music or sports radio, but now he no longer has this feeling. Now he just feels numb. He hasn't had any sense of enjoyment for the most part but what he did have for the most part is gone since the vaccination. Post vaccine, he since has difficulty writing his signature, brushing his teeth, and is not as confident when to say thank you. Unmotivated to bathe and his sense of taste and smell has decreased. He has discussed this in the facility he was in with his therapist, social workers, and physiatrist.
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities
Clinical narrative: pt says when someone had a positive comment for him he felt happy and good inside but since being vaccinated    when someone makes the same comments there is not feeling of being happy or feeling of anything anymore. He used to feel relaxed, a sense of enjoyment and at peace at the end of the day when listening to music or sports radio, but now he no longer has this feeling. Now he just feels numb. He hasn't had any sense of enjoyment for the most part but what he did have for the most part is gone since the vaccination. Post vaccine, he since has difficulty writing his signature, brushing his teeth, and is not as confident when to say thank you. Unmotivated to bathe and his sense of taste and smell has decreased. He has discussed this in the facility he was in with his therapist, social workers, and physiatrist.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Rash, Rash macular
Clinical narrative: Significant redness and swelling at vaccine site in r thigh the day after vaccine. Parent went to an UC, pt was given antibiotics. No documentation of this available to me as was an outside facility. Sounds like a large local reaction. Did see her in office 5/5/23 for diffuse full body macular rash developed 5/3/25. No fever or other symptoms.
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: SECOND DOSE OF RSV VACCINE ADMINISTERED. NOT NEEDED UNDER CURRENT RECOMMENDATIONS. NO ADVERSE REACTION REPORTED.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: SECOND DOSE OF RSV VACCINE ADMINISTERED. NOT NEEDED UNDER CURRENT RECOMMENDATIONS. NO ADVERSE REACTION REPORTED.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient requested reporting of severe vomitting after covid vaccine administered 4/11/25. She was admitted to the hospital overnight for treatment.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: Capvaxive; Manufacturer: Merck; LotNumber: Y019158; Route: IM; BodySite: Right Arm; Dose: ; VaxDate: UNKNOWN
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthma, Cellulitis, Condition aggravated, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Pt said vaccine exacerbated her asthma and flared cellulitis on akles, legs and arms-Mild
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis, Condition aggravated, Dyspnoea, Pain in extremity
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Pt said vaccine exacerbated her asthma and flared cellulitis on akles, legs and arms-Mild
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthma, Cellulitis, Chronic obstructive pulmonary disease, Condition aggravated, Discomfort
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Pt said vaccine exacerbated her asthma and flared cellulitis on akles, legs and arms-Mild
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Pt said vaccine exacerbated her asthma and flared cellulitis on akles, legs and arms-Mild