chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with COVID; diagnosed with COVID; The initial case was made invalid due to No adverse effect. Upon receipt of follow-up report on 15Feb2024, this case now contains all required information to be considered valid.  This is a spontaneous report and received from Consumer or other non HCPs, Program ID. A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: high blood pressure; "asthmatic" (unspecified if ongoing); "different forrns of Arthritis" (unspecified if ongoing); "neuropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Feb2024, outcome "unknown" and all described as "diagnosed with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as patient being treated with Paxlovid. Clinical course: The patient was just diagnosed this past Tuesday with COVID (13Feb2024). It was her first time having it, she's one of the patients that have underlying conditions such as high blood pressure (hypertension), asthmatic and diabetes. She have been getting the Covid Shots up until her insurance ran out in October of last year (Oct2023). The patient stated,"I have asthma, I have diabetes, and I have hypertension. I do have a form of Arthritis. Some Arthritis, (inaudible) it's called neuropathy(inaudible), so I'm all messed up with those (inaudible)".
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Paraesthesia
Clinical narrative: headache and left side of face started to tingle
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Gave first dose of Rotavirus at 4months old. No adverse events.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient did not have any adverse reactions to the vaccine.  Patient was given a dose that had a BUD of 02/14/2025 and the vaccine was given on 02/17/2025.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Bradycardia, Burning sensation, Dizziness, Immediate post-injection reaction, Pain in jaw
Clinical narrative: Patient felt a burning sensation upon  receiving the vaccine immediately after felt dizziness, bradycardia & jaw felt sore & locked - patient felt better after being monitored by MA & Provider after 1hr of monitoring vitals & EKG- patient was given water & a Ammonia ampule was used due to patient feeling faint.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Trismus
Clinical narrative: Patient felt a burning sensation upon  receiving the vaccine immediately after felt dizziness, bradycardia & jaw felt sore & locked - patient felt better after being monitored by MA & Provider after 1hr of monitoring vitals & EKG- patient was given water & a Ammonia ampule was used due to patient feeling faint.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Bladder discomfort, Culture urine negative, Cystitis interstitial, Dysuria, Urine analysis normal
Clinical narrative: Bladder discomfort, painful urination at the end of stream, no other symptoms.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt did not have any adverse reactions to the vaccine. Pt was given a vaccine that had a BUD: 02/14/2025 and vaccine was given on 02/19/2025.
Age: 65.0
Sex: F
Vaccine: TDAP, UNK, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PATIENT REPORTED REDNESS, SWELLING AND TENDER TO TOUCH AT INJECTION SITE. PATIENT WENT TO A CLINIC AND WAS PRESCRIBED ANTIBIOTICS.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and body aches.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received an extra dose. 1st dose was received in November of 2022 and then just received another dose on 3/10/25.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt did not have any adverse reactions. Pt was given a dose with BUD: 02/14/2025 on 02/19/2025.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: None, injected childs vaccine instead of adult vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: none, given child vaccine instead of adult vaccine
Age: 69.0
Sex: F
Vaccine: MMR
Symptoms: Respiratory tract infection, Urinary tract infection
Clinical narrative: PATIENT STATES THAT BOTH HER AND HER HUSBAND RECEIVED THE VACCINE THE SAME DAY AND TIME AND SUBSEQUENTLY DEVELOPED A RESPIRATORY INFECTION AND UTI'S.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Headache, Pain, Swelling
Clinical narrative: PT'S HUSBAND CALLED AND INDICATED THAT THEY THOUGHT SHE WAS HAVING AN ALLERGIC REACTION.  PT WAS ACHEY AND HAD HEADACHE, BUT ALSO HAD SWELLING AND A BIT OF DIFFUCLTY SWALLOWING.  REACTION WAS ALREADY STARTING TO SUBSIDE ON 3-10-25
Age: 72.0
Sex: M
Vaccine: MMR
Symptoms: Respiratory tract infection, Urinary tract infection
Clinical narrative: PATIENT AND HIS WIFE BOTH DEVELOPED UTI AND RESPIRATORY INFECTION SUBSEQUENTLY TO TAKING VACCINE. THOUGHT IT WAS ODD THEY BOTH DEVELOPED THEM.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Muscular weakness, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Both hands/ fingers became red and swollen, with pain and paresthesia; weakness in hands.  Pain, paresthesia, weakness still present after four years.  Rx- Gabapentin; results inconclusive
Sex: F
Vaccine: FLUN4, HEPA, HPV9, MMRV, MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; Improper storage of PROQUAD; This spontaneous report was received from a Registered Nurse and refers to a(n) 11-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9), Flumist (Influenza vaccine live reassort 3v), Havrix (Hepatitis a vaccine inact) .  On 21-Nov-2024, the patient started therapy with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (lot #Y008284, expiration date: 21-Oct-2025), dose number 2, administered by Subcutaneous route in Left Arm for prophylaxis (dose not reported) (improper storage of product in use). No adverse event was reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :, Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 03/01/2013 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: FLUN4, HEPA, HPV9, MMRV, MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improper storage of PROQUAD; This spontaneous report was received from a Registered Nurse and refers to a(n) 11-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9), Flumist (Influenza vaccine live reassort 3v), Havrix (Hepatitis a vaccine inact) .  On 21-Nov-2024, the patient started therapy with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (lot #Y008284, expiration date: 21-Oct-2025), dose number 2, administered by Subcutaneous route in Left Arm for prophylaxis (dose not reported) (improper storage of product in use). No adverse event was reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :, Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 03/01/2013 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: No adverse effects reported; Improper storage of proquad; This spontaneous report was received from a Registered Nurse and refers to a(n) 5-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Kinrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid), Havrix (Hepatitis a vaccine inact) .  On 14-Nov-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (rHA) (Oka-Merck) Virus Vaccine Live (lot #Y008284, expiration date: 21-Oct-2025), dose number 1, administered by Subcutaneous route in Left Thigh, for  prophylaxis (improper storage of product in use). No adverse effects reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/28/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Improper storage of proquad; This spontaneous report was received from a Registered Nurse and refers to a(n) 5-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Kinrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid), Havrix (Hepatitis a vaccine inact) .  On 14-Nov-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (rHA) (Oka-Merck) Virus Vaccine Live (lot #Y008284, expiration date: 21-Oct-2025), dose number 1, administered by Subcutaneous route in Left Thigh, for  prophylaxis (improper storage of product in use). No adverse effects reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/28/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 3.0
Sex: M
Vaccine: DTPPVHBHPB, FLUN4, HEPA, MMRV, MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: No adverse effects reported; Improper storage of proquad; This spontaneous report was received from a Registered Nurse and refers to a(n) 3-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included  dtap ipv hep b hib vaccine Injection (manufacturer unknown) Havrix (Hepatitis a vaccine inact), Flumist (Influenza vaccine live reassort 3v) .  On 20-Nov-2024, the patient started therapy with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y013583), dose number 1, administered by Subcutaneous route in Left Thigh (expiration date was not reported) for prophylaxis (improper storage of product in use). No adverse effects reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 03/08/2021 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 3.0
Sex: M
Vaccine: DTPPVHBHPB, FLUN4, HEPA, MMRV, MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Improper storage of proquad; This spontaneous report was received from a Registered Nurse and refers to a(n) 3-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included  dtap ipv hep b hib vaccine Injection (manufacturer unknown) Havrix (Hepatitis a vaccine inact), Flumist (Influenza vaccine live reassort 3v) .  On 20-Nov-2024, the patient started therapy with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y013583), dose number 1, administered by Subcutaneous route in Left Thigh (expiration date was not reported) for prophylaxis (improper storage of product in use). No adverse effects reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 03/08/2021 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Bone pain, Impaired work ability, Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Sleep disorder, X-ray limb
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Fall
Clinical narrative: ended up with COVID; ended up with COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTERS)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "unknown" and all described as "ended up with COVID". Clinical course: the patient stated he ended up with COVID after he came back from (Withheld) and "got sick." The patient went to an urgent care the next day, and he was prescribed nirmatrelvir; ritonavir (PAXLOVID). The patient stated, he "had all the shots and all the boosters. I've had Pfizer shots for COVID, and I've had all the boosters and everything, and my only concern is I know it doesn't keep you from getting it; it just keeps you from dying from it." Therapeutic measures were taken as a result of drug ineffective, COVID-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: ended up with COVID; ended up with COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTERS)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "unknown" and all described as "ended up with COVID". Clinical course: the patient stated he ended up with COVID after he came back from (Withheld) and "got sick." The patient went to an urgent care the next day, and he was prescribed nirmatrelvir; ritonavir (PAXLOVID). The patient stated, he "had all the shots and all the boosters. I've had Pfizer shots for COVID, and I've had all the boosters and everything, and my only concern is I know it doesn't keep you from getting it; it just keeps you from dying from it." Therapeutic measures were taken as a result of drug ineffective, COVID-19.
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; HCP reports multiple patients may have received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freeze; This spontaneous report has been received from a nurse, regarding a 7-year-old female patient.  The patient's concomitant therapies included polio vaccine inact 3v (vero) (IPOL) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid) (BOOSTRIX). The patient's pertinent medical history, concurrent conditions, and previous drug reactions or allergies were not reported. On 08-JAN-2025, the patient was vaccinated with an improperly stored second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (rHA [recombinant human albumin]) (PROQUAD) administered subcutaneously on the left arm as prophylaxis (Lot No. Y013579 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection], expiration date was not reported but upon internal validation established as 03-FEB-2026) (strength and vaccination scheme frequency were not reported) (product storage error) after a temperature excursion with  a range of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) (-9 degree Celsius to 8 degree Celsius during a time frame of 1344 (time units not provided).  No previous temperature excursion was reported.  No additional information or adverse events were provided (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 04/12/2017 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A HCP (pharmacist) called to inquire about whether the GARDASIL 9 vaccine was indicated for use in women greater than 45 years of age.  The HCP stated she had a 62 or 63 year old consumer/patient presently at the pharmacy who requested to receive her; No additional AE.; This spontaneous report was received from a Pharmacist and refers to an Adult (62 or 63 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 03-SEP-2024, the patient was vaccinated with the first dose of human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route, lot #, expiration date and anatomical location were not provided), then on 04-NOV-2024, the patient received the second dose of human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route, lot #, expiration date and anatomical location were not provided) for prophylaxis (Inappropriate age at vaccine administration). The patient presented at the pharmacy who requested to receive her third dose of human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) vaccine on 07-MAR-2025.  No adverse event reported. It was also mentioned that the patient had an article with her that recommended healthcare workers who had been exposed to "fumes" should get the human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) vaccine to prevent throat cancer (captured in case#: 2263369)
Sex: F
Vaccine: TD
Symptoms: Anxiety, Chest discomfort, Condition aggravated, Hypermetabolism, Hypoglycaemia
Clinical narrative: syncope; constellation of atypical symptoms after the reaction chest vibrations; tachycardia; hypermetabolism; phonophobia; insomnia; severe anxiety; weight loss; hypoglycemic symptoms; Initial information received on 06-Mar-2025 regarding an unsolicited valid  serious case received from Health Care Professional.  This case involves Adult female patient who experienced syncope, constellation of atypical symptoms after the reaction chest vibrations, tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety, weight loss and hypoglycemic symptoms after receiving Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  The patient's past medical history included Post-traumatic stress disorder as she describes as PTSD and general anxiety at one point history consistent with agoraphobia, (Anxiety and Agoraphobia). The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 07-Jul-2024, the patient received unknown dose of suspect Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (lot U8021BA; strength and expiry date not reported) via unknown route in unknown administration site for vaccination.  On 07-Jul-2024 (15 mins after vaccination) the patient developed a serious syncope. This event was assessed as medically significant. She went to ED and emergency room physician felt she had vasovagal reaction. She had on 07-Jul-2024 constellation of atypical symptoms after the reaction chest vibrations (chest discomfort), tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety (anxiety), weight loss (weight decreased) and hypoglycemic symptoms (hypoglycaemia) on  same day.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events. These symptoms slowly resolved over 2 months. She feels she is better now.  No other information was able to be gathered from the HCP.; Sender's Comments: Sanofi Company Comment dated 11-MAR-2025: This case involves Adult female patient who experienced syncope, constellation of atypical symptoms after the reaction chest vibrations, tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety, weight loss and hypoglycemic symptoms after receiving Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. Post-traumatic stress disorder and general anxiety at one point history consistent with agoraphobia could also paly confounding role Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: TD
Symptoms: Insomnia, Phonophobia, Presyncope, Syncope, Tachycardia
Clinical narrative: syncope; constellation of atypical symptoms after the reaction chest vibrations; tachycardia; hypermetabolism; phonophobia; insomnia; severe anxiety; weight loss; hypoglycemic symptoms; Initial information received on 06-Mar-2025 regarding an unsolicited valid  serious case received from Health Care Professional.  This case involves Adult female patient who experienced syncope, constellation of atypical symptoms after the reaction chest vibrations, tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety, weight loss and hypoglycemic symptoms after receiving Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  The patient's past medical history included Post-traumatic stress disorder as she describes as PTSD and general anxiety at one point history consistent with agoraphobia, (Anxiety and Agoraphobia). The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 07-Jul-2024, the patient received unknown dose of suspect Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (lot U8021BA; strength and expiry date not reported) via unknown route in unknown administration site for vaccination.  On 07-Jul-2024 (15 mins after vaccination) the patient developed a serious syncope. This event was assessed as medically significant. She went to ED and emergency room physician felt she had vasovagal reaction. She had on 07-Jul-2024 constellation of atypical symptoms after the reaction chest vibrations (chest discomfort), tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety (anxiety), weight loss (weight decreased) and hypoglycemic symptoms (hypoglycaemia) on  same day.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events. These symptoms slowly resolved over 2 months. She feels she is better now.  No other information was able to be gathered from the HCP.; Sender's Comments: Sanofi Company Comment dated 11-MAR-2025: This case involves Adult female patient who experienced syncope, constellation of atypical symptoms after the reaction chest vibrations, tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety, weight loss and hypoglycemic symptoms after receiving Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. Post-traumatic stress disorder and general anxiety at one point history consistent with agoraphobia could also paly confounding role Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: TD
Symptoms: Weight decreased
Clinical narrative: syncope; constellation of atypical symptoms after the reaction chest vibrations; tachycardia; hypermetabolism; phonophobia; insomnia; severe anxiety; weight loss; hypoglycemic symptoms; Initial information received on 06-Mar-2025 regarding an unsolicited valid  serious case received from Health Care Professional.  This case involves Adult female patient who experienced syncope, constellation of atypical symptoms after the reaction chest vibrations, tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety, weight loss and hypoglycemic symptoms after receiving Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  The patient's past medical history included Post-traumatic stress disorder as she describes as PTSD and general anxiety at one point history consistent with agoraphobia, (Anxiety and Agoraphobia). The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 07-Jul-2024, the patient received unknown dose of suspect Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (lot U8021BA; strength and expiry date not reported) via unknown route in unknown administration site for vaccination.  On 07-Jul-2024 (15 mins after vaccination) the patient developed a serious syncope. This event was assessed as medically significant. She went to ED and emergency room physician felt she had vasovagal reaction. She had on 07-Jul-2024 constellation of atypical symptoms after the reaction chest vibrations (chest discomfort), tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety (anxiety), weight loss (weight decreased) and hypoglycemic symptoms (hypoglycaemia) on  same day.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events. These symptoms slowly resolved over 2 months. She feels she is better now.  No other information was able to be gathered from the HCP.; Sender's Comments: Sanofi Company Comment dated 11-MAR-2025: This case involves Adult female patient who experienced syncope, constellation of atypical symptoms after the reaction chest vibrations, tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety, weight loss and hypoglycemic symptoms after receiving Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. Post-traumatic stress disorder and general anxiety at one point history consistent with agoraphobia could also paly confounding role Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of adacel to a patient less than 10 years of age with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves 4 years old female patient less than 10 years of age who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Polio vaccine inact (IPV), measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (varicella vaccine) for prophylactic vaccination (Immunisation).   On 05-Mar-2025, a less than 10 years of age patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection (lot U8115AA and expiry date 31-Mar-2026) (frequency: once, strength: standard) via intramuscular route in the right thigh for Immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired vaccine with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who had received an expired IPV (VERO) [IPOL] with no reported adverse event.  This case is linked to US-SA-2025SA070267  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine; mumps vaccine; rubella vaccine; varicella zoster vaccine, Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), and Hepatitis B vaccine (hepatitis B vaccine) all for Immunisation.  On 06-Mar-2025 at 11:00 am, the patient received an expired 0.5ml dose of suspect IPV (VERO) Suspension for injection (strength-standard, frequency-once, lot W1A191M, expiry date-16-Feb-2025) via intramuscular route in the left deltoid for Immunization, with no reported adverse event (expired product administered) (latency- same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA070267:2nd patient
Age: 10.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 10 years old male patient who had inappropriate use due to administration of an expired vaccine IPV (VERO) [IPOL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B vaccine (Hepatitis B vaccine) and Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for prophylactic vaccination (Immunisation).  On 06-Mar-2025 at 11:00 hours, the patient received a dose of 0.5 ml of suspect IPV (VERO), Suspension for injection (lot W1A191M and expiry date 16-Feb-2025) (frequency: once and strength: standard) via intramuscular route in the left deltoid for immunisation with no reported adverse event (expired product administered) (Latency: same day).  Reportedly, Medical Assistant called to ask the validity of the administered expired IPOL to 2 patients.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA070402:2nd patient
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: they were supposed to administer Boostrix but administered TENIVAC instead with no reported AE; Initial information received on 07-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown age and gender who was supposed to get  Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid [Boostrix] but Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered instead with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, patient was supposed to get  Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid [Boostrix] but Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection (lot number, expiry date not reported) for immunisation was administered instead with no reported adverse event (wrong product administered) (latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence   Action taken was not applicable.  Reportedly, the nurse was confirmed with the brand names of the vaccines afterwards and  informed that Boostrix is not a Sanofi product and advised them to call the manufacturer of Boostrix directly regarding their inquiry.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever 103 degrees, headache, nausea.
Vaccine: VARZOS
Symptoms: Antibody test
Clinical narrative: patient vaccinated with shingrix, and after 1 year shows no immunity for titers; This non-serious case was reported by a other health professional via sales rep and described the occurrence of therapy non-responder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced therapy non-responder (Verbatim: patient vaccinated with shingrix, and after 1 year shows no immunity for titers). The outcome of the therapy non-responder was not applicable.   Additional Information: GSK Receipt Date : 06-MAR-2025 Healthcare professional reported that a patient vaccinated with shingrix, and after 1 year shows no immunity for titers.
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired product with no reported adverse event; Initial information received on 07-Mar-2025 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 14 months old male patient who had  administration of  an expired  Hib (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) and Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3)  On 06-Mar-2025, the patient received an expired  dose  3 of 0.5 ml dose of suspect HIB (PRP/T) Vaccine,Powder and solvent for solution for injection,(Frequency: once, strength=standard, expiry date: 28-feb-2025, lot UJ995AA) via intramuscular route in the left thigh for Immunization, with no reported adverse event. (expired product administered) (latency:same day).  Action taken  was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Pain
Clinical narrative: The day after I had the flu vaccine I woke up with a very sore shoulder and I was having trouble moving my arm into a certain position ..I thought at first that I slept on it wrong. Finally I decided after almost 4 months to see my general practitioner. My doctor thought I should try physical therapy. The physical therapist on 3/3/25 evaluated me and thought I might have tendinitis and is treating me for that. I have had 3 sessions so far. After 5 or so sessions PT will refer me to an orthopedist if I don't show improvement. So far I don't see any change. It is painful to try and  move my arm while removing a jacket and trying to move my arm up  behind my back (which I cannot do.)I am doing exercises given to me by the physical therapist at home in between PT sessions. No tests have been recommended yet. If I need to see an orthopedist I'm sure tests will be done:
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Swelling , redness, rash feeling warm to the touch, itching.  Some better but still occurring.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Weakness-Medium
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: Local injection site reaction. Patient came back after 10 minutes without any symptoms. I asked patient to sit at the vaccination area for addtion 10-15 minutes to monitor for futher reaction. No reaction per patient, no shortness of breath, no pupil dilation, or any reaction. Injection site was reduced and not as red. Checked back again after 5 more minutes and patient is doing fine with no symptoms. Instructed patient to go home and will call back to check on patient in about 2-3 hours.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 60.0
Sex: M
Vaccine: HEPAB
Symptoms: Flushing, Hyperhidrosis, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Flushed / Sweating-Medium, Other Vaccines:  VaccineTypeBrand: prevnar20; Manufacturer: ; LotNumber: lk6650; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN
Age: 60.0
Sex: M
Vaccine: HEPAB
Symptoms: Pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Flushed / Sweating-Medium, Other Vaccines:  VaccineTypeBrand: prevnar20; Manufacturer: ; LotNumber: lk6650; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN
Age: 62.0
Sex: M
Vaccine: PNC21
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: faint-Mild, Additional Details: patient fainted for about 5 seconds
Age: 69.0
Sex: F
Vaccine: PNC21
Symptoms: Asthenia, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient came back 4 days after vaccine and reported redness, swelling, pain, and feeling weak after the vaccine
Age: 69.0
Sex: F
Vaccine: PNC21
Symptoms: Pain, Swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient came back 4 days after vaccine and reported redness, swelling, pain, and feeling weak after the vaccine
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Lymphadenopathy, Pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: 3/1/25 patient reported redness and itchiness on site of vaccine administration, she also said lymph nodes felt swollen, recommened she take zyrtec/benadryl and ibu and to moniter and report worsening sx to md.
Age: 98.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Systemic: change in taste and smell-Mild, Additional Details: pickles taste soapy, sweet smells and citrus can be smelled, no earthy smells. , Other Vaccines:  VaccineTypeBrand: fluzone trivalent; Manufacturer: sanofi; LotNumber: ut8506na; Route: IM; BodySite: Right arm; Dose: 1; VaxDate: 11/09/2024
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 64.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient states they have lasting muscle/joint pain from the vaccine. Reported having this start shortly after vaccine and lasting. Stated he had no other issues with any of his other vaccines, just this one. Vaccine administration was correct and in the correct location, not placed in too high or too low. Side effects are reported from the vaccine itself
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Hypertension, Pain
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Hypertension-Medium
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site erythema, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium
Age: 81.0
Sex: M
Vaccine: PNC20
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient had syncope episode resulting in patinet being unresponsive for about 2 to 3 minutes appeared to have also stopped breathing momentarily but pulse was present-after rubbing patients chest he regained breathing and EMT's arrived to transport patient to ER. Spoke with patient this evening 5 hours post event-states he was released by ER and is doing well.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Rash
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
Age: 57.0
Sex: M
Vaccine: PNC20
Symptoms: Eye swelling, Lip swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Swelling of lips. No other symptoms
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Systemic: Diarrhea-Medium, Additional Details: PATIENT RECEIVED SHINGRIX YESTERDAY, 3/4. TODAY HE REPORTS HAVING DIARRHEA + STOMACH UPSET. HE HASNT HAD TO TAKE ANY MEDICATION.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: EMT arrived states not from vaccine more from panic nervousness. after resting bp came back up and face color came back from pale, Other Vaccines:  VaccineTypeBrand: heplisav-b; Manufacturer: ; LotNumber: 945659; Route: im; BodySite: right; Dose: ; VaxDate: UNKNOWN