chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19-2, HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; She states that the MA gave a dose (0.25 ml) today 3Aug2023 of the Moderna bivalent (lot number 215K22A) for babies with pink cap, but it was the one that was supposed to be given for dose 3; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states that the MA gave a dose (0.25 ml) today 3Aug2023 of the Moderna bivalent (lot number 215K22A) for babies with pink cap, but it was the one that was supposed to be given for dose 3) and NO ADVERSE EVENT (No adverse event) in a 19-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product HEPATITIS A VACCINE (HEPATITIS A) for an unknown indication.    The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient had  no COVID19 vaccination history.    On 03-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter and dose of HEPATITIS A VACCINE (HEPATITIS A) (unknown route) 1 dosage form. On 03-Aug-2023, the patient experienced WRONG PRODUCT ADMINISTERED (She states that the MA gave a dose (0.25 ml) today 3Aug2023 of the Moderna bivalent (lot number 215K22A) for babies with pink cap, but it was the one that was supposed to be given for dose 3). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states that the MA gave a dose (0.25 ml) today 3Aug2023 of the Moderna bivalent (lot number 215K22A) for babies with pink cap, but it was the one that was supposed to be given for dose 3) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (She states that the MA gave a dose (0.25 ml) today 3Aug2023 of the Moderna bivalent (lot number 215K22A) for babies with pink cap, but it was the one that was supposed to be given for dose 3).    No concomitant medication was reported. No treatment medication was reported.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pediatric dose was given instead of adult dose
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Breakthrough Covid-19 Infection
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After receiving HPV injection he became lightheaded and became unconscious for 25-30 seconds and sat on floor. Color pink, skin warm and dry. When became alert again , he stood up and was seated in a chair. Given a snack of juice and gummies.  Denied any further feelings of light-headedness and received remainder of vaccine's with no other  adverse symptoms. Observed for another 15 - 20 minutes. Ambulated from clinic with no assistance. Gait steady.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: No adverse event
Clinical narrative: No adverse reaction noted at time of administration.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, SUBSEQ
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Breakthrough Covid-19 infection
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The 12+ Pfizer COVID vaccine was given 5 days after the 10 week expiration date in the fridge. The 10 week expiration date out of the freezer was 7/19/23 and the vaccine was given on 7/24/2023.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angina unstable
Clinical narrative: UNSTABLE ANGINA ACUTE NON ST ELEVATION MI
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Acute coronary syndrome, Myocarditis
Clinical narrative: ACUTE CORONARY SYNDROME, UNSPECIFIED MYOCARDITIS
Age: 11.0
Sex: F
Vaccine: COVID19-2, HPV9, MNQ, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administration error: pt. given Pfizer Bivalent dosage for adult.    Pt. didn't have any adverse signs or symptoms.   Attempted to reach parent by phone ( 08/08/23) to notify them or the error.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given past beyond use date. No adverse effects to patient noted
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear haemorrhage, Skin haemorrhage
Clinical narrative: Per patient, light blood coming through her skin and sometimes ears.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 3/11/2022,  8/21/2022,  11/21/2022,  11/29/2022,  3/14/2023,  2/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: 12+ Pfizer COVID vaccine was given 6 days after the 10 week expiration in the fridge. The 10 week expiration out of the freezer was 7/19/23 and the vaccine was given on 7/25/23.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine was taken out of cold storage 04/06/23 and is good refrigerated for 70 days. The vaccine was given 74 days after taken out of cold storage thus was given after the beyond use date. Pfizer was notified. Discussed situation with Dr. Patients who received the vaccine after the beyond use date will be recommended to be revaccinated.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine was taken out of cold storage 04/06/23 and is good refrigerated for 70 days. The vaccine was given 74 days after taken out of cold storage thus was given after the beyond use date. Pfizer was notified. Discussed situation with Dr. Patients who received the vaccine after the beyond use date will be revaccinated.
Age: 12.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event;  Client received Dtap rather than Tdap for age
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Breakthrough Covid-19 Infection
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine was taken out of cold storage 04/06/23 and is good refrigerated for 70 days. The vaccine was given 74 days after taken out of cold storage thus was given after the beyond use date. Pfizer was notified. Discussed situation with Dr. Patients who received the vaccine after the beyond use date will be recommended to be revaccinated.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Pt was inadvertently given a Menveo vaccine on 8/8/23 after having her required dose on 8/4/23, she was given two full doses of the vaccine  4 days apart.  She was due for her booster dose on 8/4/23 and had that dose, however she received a second dose 4 days later. Pt had previously received a Menactra dose on 2017.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine was taken out of cold storage 04/06/23 and is good refrigerated for 70 days. The vaccine was given 74 days after taken out of cold storage thus was given after the beyond use date. Pfizer was notified. Discussed situation with Dr. Patients who received the vaccine after the beyond use date were recommended to be revaccinated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pulmonary embolism
Clinical narrative: NEUROPATHY ACUTE PULMONARY EMBOLISM
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Pruritus, Skin warm, Swelling
Clinical narrative: Soreness, turned to localized swelling, warm to touch and itchy. Area turned larger and more painful (6x4" area) itchiness increased. Patient reports icing. 6 days after event area still swollen, warm to touch, and itching. Recommended anti-inflammatories, continuing ice packs and hydrocortisone.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine was taken out of cold storage 04/06/23 and is good refrigerated for 70 days. The vaccine was given 74 days after taken out of cold storage thus was given after the beyond use date. Pfizer was notified. Discussed situation with Dr. Patients who received the vaccine after the beyond use date was recommended to be revaccinated.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Breakthrough Covid Infection
Age: 49.0
Sex: F
Vaccine: PNC15
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: site is hot to the touch, swollen has a burning feeling and is painful-from patient
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode without loss of conciousness
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 64.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had received a Prevnar20 vaccination on 6/13/23. This did not display on his sheet at the time of his next clinic appointment, and the patient was given an additional vaccination of Prevnar20 again on 7/25/23.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Eye swelling, Injection site reaction, Injection site swelling, Rash
Clinical narrative: Child was given kinrix and proquad at approx. 09:50 am, child was walking with mom to car and said his tongue was itching and  child was scratching himself.  Mom brought back into clinic around 10:00 am, by this time  his face and eyes were swollen, he had a flat rash/welts on his face and body. At the proquad inj site he had welts the size of a BB all around site and the kinrix site has small bumps  around it.  Child was frantically scratching himself,  crying.  At 10:04 am I gave child epi 0.2ml to the right deltoid IM.  And at 10:07am  I gave him benadryl 2.5ml  by mouth. as ordered. by 10:30 child had calmed down, was still scratching, at 10:48 Swelling to face and eyes and significantly decreased.  At 11:00 am the provider had discharged the child to moms care.  No further swelling was noted and rash and subsided.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling face, Tongue pruritus, Urticaria
Clinical narrative: Child was given kinrix and proquad at approx. 09:50 am, child was walking with mom to car and said his tongue was itching and  child was scratching himself.  Mom brought back into clinic around 10:00 am, by this time  his face and eyes were swollen, he had a flat rash/welts on his face and body. At the proquad inj site he had welts the size of a BB all around site and the kinrix site has small bumps  around it.  Child was frantically scratching himself,  crying.  At 10:04 am I gave child epi 0.2ml to the right deltoid IM.  And at 10:07am  I gave him benadryl 2.5ml  by mouth. as ordered. by 10:30 child had calmed down, was still scratching, at 10:48 Swelling to face and eyes and significantly decreased.  At 11:00 am the provider had discharged the child to moms care.  No further swelling was noted and rash and subsided.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: On 08/02/2023 I injected my Patient, varicella in the deltoid instead of subcutaneously.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 12/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO REACTION, PATIENT WAS GIVEN SHOT BEFORE RECOMMENDED AGE.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: HYPOXIA 1/15/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site induration, Injection site warmth
Clinical narrative: Assessment 3" x 3" area of cellulitis and induration, and warm to the touch  noted in left deltoid. Limited motion of left arm also noted. Referred to Pediatrician or ER for further evaluation. Telephone call to client's mom to follow up regarding swelling and limited motion left arm, mom stated child is much improved and that it went away using warm compresses and Tylenol.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT TIBIAL VEIN ACUTE DVT OF LEFT PERONEAL VEIN
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Loss of consciousness, Pallor
Clinical narrative: Patient had gotten the menvo vaccine in the left deltoid. I ask him if he was ok and he said yes that that was not bad at all. I told him i would be back in a few minutes. I was gone maybe 5 minutes and mom had the little brother open the door, mom yelled out nurse he is going to pass out. When I go into the room he was laying down on the bed. He was very pale in color and clammy. I went to grab the nurse, because the doctor was not around. Our nurse went in while I grabbed the blood pressure cuff and pulse ox. His pressure, pulse and oxygen were fine. The nurse put a cool towel on his forehead and I got him popsicle and he laid down for a while.  Then he was fine and was able to get up and walk.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Condition aggravated, Deep vein thrombosis, Gastrooesophageal reflux disease, Haematology test
Clinical narrative: Patient developed non-cardiac chest pain after first COVID vaccine which was determined to be GERD. He then developed DVT approximately 1 year after his second COVID vaccination.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Patient developed non-cardiac chest pain after first COVID vaccine which was determined to be GERD. He then developed DVT approximately 1 year after his second COVID vaccination.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: PT was administered a DTAP today instead of a TDAP that was due.
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was scheduled on nurse visit and Medical Assistant looked at note in chart for order to give vaccines. Medical assistant  misread the providers previous note as the note for current visit and inadvertently gave repeat of previous vaccines.  Patient received Tdap, varicella on 7/27/23 and again on 8/5/23. In addition patient did receive HPV which was correct as ordered. No adverse reaction has occurred at this time and provider disclosed information with patient and family.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Breakthrough Covid-19 Infection
Age: 7.0
Sex: F
Vaccine: MMRV, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was on nurse visit schedule. Medical assistant read providers note in chart as order to give vaccine today which was actually note from previous visit. Nurse inadvertently gave same vaccines as previous visit. On July 27, 2023 patient received MMRV and Tdap. Patient returned on 8/7 and received another dose of MMRV andTdap. No adverse effects have resulted.
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Mobility decreased, Pain
Clinical narrative: 2 days later got worsening shoulder pain, Hard to move without pain medications including tylenol #3. It continues till this day 8/8/23 I had to prescribe her Naproxen 500 BID.
Age: 4.0
Sex: M
Vaccine: MMRV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given Tdap in error.  No  known adverse event
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Patient DID NOT receive a Moderna COVID vaccine on 11/02/2021 as listed in data. The vaccine was entered into the computer system incorrectly by a source outside the System. Spoke with patient directly and reviewed his COVID vaccinations with him. Patient had his COVID card listing all COVID vaccines. Patient reports receiving 5 COVID vaccines in total. Patient's COVID vaccination record is as follows:                  1st dose=02/24/2021 Moderna monovalent 0.5mL Lot#001A21A, received                  2nd dose=03/25/2021 Moderna monovalent 0.5mL Lot#047A21A, received                  3rd dose=10/25/2021 Moderna monovalent 0.25mL Lot#026D21A, received at pharmacy                 4th dose=05/07/2022 Moderna monovalent 0.25mL Lot#004M21A, received at pharmacy                 5th dose=10/01/2022 Moderna bivalent 0.25mL Lot#057F22A, received at pharmacy.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Spoke with the pt short after talking (supervisor). Informed the pt that the COVID vaccine, she received on 3/20/23 was invalid. The vaccine went pass the end date. The pt was understanding about the situation. She doesn't want to talk to my supervisor and don't want to write an incident report to supervisor. Would like to repeat the COVID shot later. Pt had no adverse reactions.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Condition aggravated, Tremor
Clinical narrative: Chills, shaking and terrible chest pain on the day after injection.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Patient came in forn a well child check and I was advised to give the patient vaccines. When I checked the container in the fridge that holds tha vaccines I could not find a box of tdap vaccines for children. Another MA that I work with was there because i asked her to confirm that I had the correct vaccines and she stated that she had used the last tdap vaccine and had not put a new box in the vaccine container. She then handed me a new box of tdap vaccines which we both looked at and thought that it was the appropriate vaccine. I gave the vaccine to the patient in the left thigh. I tried calling the company of the vaccine but they were closed. I also tried calling the patient's guardian and left a message asking them to call the office. There were no immediate adverse reactions noted after I gave the vaccine.
Age: 0.58
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details provided; VARIVAX was administered after a TE; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-JUN-2023, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters once as prophylaxis (W024552, which was determined to be valid, with an expiration date on 31-JAN-2024) (strength, route of administration and anatomical location of administration were not reported), in combination with a sterile diluent.  The administered dose underwent a temperature excursion via digital data logger of 12.84 degrees Fahrenheit for 25 minutes. There was a no previous temperature excursion reported. No further adverse event details provided.   Follow-up information has been received from the nurse on 25-JUL-2023. This case has been become valid as concerns to a 7-month-old male patient. On 22-MAY-2023, the freezer door was opened for scraping ice off-sides, but the door was left open too long. Then, temperature excursion occurred and was improperly stored. Consequently, it was confirmed that the 7-month-old child was vaccinated on 14-JUN-2023, with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U028164 with expiration date 09-SEP-2023) administered subcutaneously in the left tight for prophylaxis. The vaccine was used according to the instruction leaflet. It was reported that the patient was given the vaccinate without reporting to the manufacturer to verify if the vaccine was safe to use. On 11-JUL-2023, the vaccine was properly reported to the manufacturer with temperature excursion; however. The vaccine was no available for return/evaluation. Manufacturer reported that the vaccine was safe to use. The child received the last dose of the vaccine in stock at that time and no other stock was administered. The patient had not had medical events occurred due to the administered vaccine. This temperature excursion did not occur as a result of a reading from a digital data logger.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2307USA002368: US-009507513-2307USA002154: US-009507513-2308USA001000:
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; an expired dose of MMR II was administered to a patient.; This spontaneous report was received from a medical assistant concerning a 12 month old female patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 03-AUG-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (the dose expired on 22-JUL-2023) (dose, frequency, route, anatomical location and lot# were not reported). The reporter stated that the patient had no symptoms. No additional adverse event or product quality complaint were reported. The vaccine never had a temperature excursion.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 prophylaxis.     Medical History or Condition were not reported.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding.  Concomitant product use was not provided by the reporter.  Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 1st out of 8 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735647, US-MODERNATX, INC.-MOD-2023-735653, US-MODERNATX, INC.-MOD-2023-735657, US-MODERNATX, INC.-MOD-2023-735666, US-MODERNATX, INC.-MOD-2023-735674, US-MODERNATX, INC.-MOD-2023-735682, US-MODERNATX, INC.-MOD-2023-735693 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735666:5 out of 8 patients US-MODERNATX, INC.-MOD-2023-735657:4 out of 8 patients US-MODERNATX, INC.-MOD-2023-735647:2 out of 8 patients US-MODERNATX, INC.-MOD-2023-735653:3 out of 8 patients US-MODERNATX, INC.-MOD-2023-735674:6 out of 8 patients US-MODERNATX, INC.-MOD-2023-735682:7 out of 8 patients US-MODERNATX, INC.-MOD-2023-735693:8 out of 8 patients
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Patient received covid a few months after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient received covid a few months after receiving the vaccine) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient received covid a few months after receiving the vaccine). At the time of the report, COVID-19 (Patient received covid a few months after receiving the vaccine) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   The patient had covid a few months after receiving the vaccine. Not sure of when the events started and was not able to locate the card for when she received the vaccine.  Treatment medication not reported.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Vaccination site pain
Clinical narrative: pain at injection site; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  An adult male patient received meningococcal group b Rlp2086 (TRUMENBA), on 27Jul2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Meningococcal vaccine (PRIMARY IMMUNIZATION SERIES, MANUFACTURER UNKNOWN ), for immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Jul2023, outcome "recovering", described as "pain at injection site". It was unknown if therapeutic measures were taken as a result of vaccination site pain. Additional information: Physician shared personal experience with pain at injection site after receiving booster dose of meningococcal group b Rlp2086 last week on 27Jul2023.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got all four doses of the vaccine. The initial two ad then two boosters. Why do I have COVID-19 again? The vaccine doesn't work.; I got all four doses of the vaccine. The initial two ad then two boosters. Why do I have COVID-19 again? The vaccine doesn't work.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got all four doses of the vaccine. The initial two ad then two boosters. Why do I have COVID-19 again? The vaccine doesn't work.".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: myelitis transversal (thoracic level); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 28May2021 as dose 1, single (Batch/Lot number: unknown) and on 21Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (disability, medically significant) with onset Jun2021, outcome "unknown", described as "myelitis transversal (thoracic level)". Clinical course: Patient was struggling with a disease that came about approximately 2 years ago, myelitis Transversal. He since had a disability on his right foot. He was in crisis. He had to go to the hospital where he was given morphine because he was hurting and hurting. It calmed for a while, but then it started again. He had been in and out of the hospital. He was now in a wheel chair. He needed to be going to the hospital. He was now limited on things he can do. He needs to go to the hospital because he needs treatment for his myelitis transversal. The injections made him be in a wheelchair. He was looking for assistance because the doctor at the emergency room at the nearest hospital is not capable of helping him with his condition that is in the thoracic level.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Patient had cardiac reaction; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious) with onset Feb2023, outcome "unknown", described as "Patient had cardiac reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Covid RAT positive on 09Jul2022; Covid RAT positive on 09Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), on 07Nov2021 as dose 1 (orange cap), single (Lot number: FK5127) intramuscular, in arm and on 21Nov2021 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 9 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "unknown" and all described as "Covid RAT positive on 09Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (09Jul2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300247428 same patient/drug/event, different dose;US-PFIZER INC-PV202300134420 same patient/drug, different event/dose;
Sex: U
Vaccine: PNC20
Symptoms: Rash, Rash erythematous
Clinical narrative: red like rash on my arm, on my left arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Jul2023 as dose number unknown, 0.5 ml, single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 05Aug2023, outcome "unknown", described as "red like rash on my arm, on my left arm". Additional information: the patient woke up with a red like rash on left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, SARS-CoV-2 test
Clinical narrative: muscle pain; prolonged weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 1, single (Lot number: FH8030) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; GABAPENTINE. Past drug history included: Valtrex, reaction(s): "known allergies: Valtrex". No other vaccine in four weeks. The following information was reported: MYALGIA (disability) with onset 23Nov2021, outcome "not recovered", described as "muscle pain"; ASTHENIA (disability) with onset 23Nov2021, outcome "not recovered", described as "prolonged weakness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Negative, notes: Nasal swab. Therapeutic measures were not taken as a result of myalgia, asthenia.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Myalgia, Asthenia  and the use of suspect product cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: massive rash on her face; swole up to 2-3 times its size; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), 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: 3), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization; Bnt162b2 (DOSE: 1), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "massive rash on her face"; SWELLING FACE (non-serious), outcome "unknown", described as "swole up to 2-3 times its size". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: MEN
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16-year-olds (adolescent) and up patient who experienced flu like symptoms after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for prophylactic vaccination (Immunisation).  On an unknown date, the patient received unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (lot number and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested.  On an unknown date the patient developed flu like symptoms (influenza like illness) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event flu like symptoms.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Contraindicated product administered, Medication error, No adverse event
Clinical narrative: they had a patient who was accidentally administered with ACTHIB and VAXELIS at the same with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 months old male patient who was accidentally administered with hib (prp/t) vaccine [ACT-HIB] and vaxelis at the same with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (Rotateq) for Prophylactic vaccination.  On 31-Jul-2023, the patient received a dose 1 of 0.5 ml of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot U7374BA, strength and expiry date unknown) via intramuscular route in right vastus lateralis for Immunization and they had a patient who was accidentally administered with acthib and vaxelis at the same with no reported adverse event (contraindicated product administered) (latency : same day).   It is unknown if there were lab data/results available.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event they had a patient who was accidentally administered with acthib and vaxelis at the same with no reported adverse event.  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: 16.0
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: on 28jun2023 patient received a dose on menquadfi, then on 28jul2023, patient received another dose of menquadfi with no reported adverse event; Initial information was received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who received meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] on 28-Jun-2023, then on 28-Jul-2023, patient received another dose of menquadfi with no reported adverse event.  The patient's past vaccination(s) included Menquadfi in 2018. The patient's past medical history, medical treatment(s) and family history were not provided.  On 28-Jun-2023 the patient received a dose of meningococcal a-c-y-w135 (t conj) vaccine Solution for injection at dose of 0.5 ml (strength: standard, frequency: 2, lot number: U7595AA, expiration date: 11-Mar-2025) via intramuscular route in the right deltoid for Immunization (immunisation) and on 28-Jul-2023, the patient received a dose of same vaccine at dose of 0.5 ml (strength: standard, lot U7643AA, expiration date: 27-Jun-2025) via intramuscular route in the right deltoid for Immunization (immunisation) with no reported adverse event (inappropriate schedule of product administration) (latency: same day).   No lab data reported.  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event on 28jun2023 patient received a dose on menquadfi, then on 28jul2023, patient received another dose of menquadfi with no reported adverse event.  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: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 month old received quadracel instead of the intended pentacel with no reported adverse event; 15 month old received quadracel instead of the intended pentacel with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse).  This case involves a 15 month old female patient who received Diphtheria-15/Tetanus/5 Hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] instead of the intended Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] 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 Pneumococcal Vaccine CONJ 15V (CRM197) (Vaxneuvance) in the right thigh for Prophylactic vaccination.  On 25-Jul-2023, the 15 month old patient received a dose of 0.5 ml (Frequency: once) of standard strength dose 4 of suspect Diphtheria-15/Tetanus/5 Hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] suspension for injection (lot: U7656AA, Expiry date: 08-Mar-2025) via intramuscular route in the left thigh for prophylactic vaccination (Immunisation) instead of the intended Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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: 15.0
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: a patient was administered a booster dose of MENACTRA at 15 and half years old. The patient was previously administered the first dose of MENACTRA at 11 years, 8 months and 3 days old with no reported adverse event; Initial information was received on 02-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 years old patient of unknown gender who received a booster dose of meningococcal a-c-y-w135 (d conj) vaccine [menactra], the patient was previously administered the first dose of menactra at 11 years, 8 months and 3 days old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, a patient was administered a booster dose of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (dose, strength, lot number, route, administration site, expiration date: Unknown) for Immunization (immunisation) at 15 and half years old. the patient was previously administered the first dose of menactra at 11 years, 8 months and 3 days old with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event a patient was administered a booster dose of menactra at 15 and half years old. the patient was previously administered the first dose of menactra at 11 years, 8 months and 3 days old with no reported adverse event  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.