chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient inadvertently received 2 doses of ipol with no reported adverse event; Initial information was received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA338108.  This case involves a 4 months old female patient who inadvertently received 2 doses of 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 pneumococcal vaccine 13v (pneumococcal 13 valent vaccine) and rotavirus vaccine (rotavirus vaccine) for prophylactic vaccination.  On 25-Oct-2023, the patient received a 0.5 ml, once dose of suspect IPV (VERO) (Suspension for injection) (lot VIB901M, expiry date: 02- Jun-2024, strength: standard) via intramuscular route in the left thigh for Immunisation and patient inadvertently received 2 doses of ipol with no reported adverse event (extra dose administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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: 0.33
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: receiving an extra dose of PENTACEL with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 4 months old female patient who was receiving an extra dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] 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 rotavirus vaccine for Prophylactic vaccination.  On 25-Oct-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot- UJ877AA and expiration date- 22-Mar-2024) via intramuscular route in the right thigh (strength: not provided) for Immunisation (extra dose administered) (latency- same day).  Patient inadvertently received 2 doses of IPOL and 2 doses of PENTACEL. All 4 doses received on the same day.   Action taken- not applicable.  At time of reporting, the outcome was Unknown for the 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: 0.67
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired acthib was given to a consumer with no reported adverse event; Initial information was received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 8 months old male patient to whom expired HIB (PRP/T) vaccine [ACT-HIB] was given 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 diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix), pneumococcal vaccine 13v (pneumococcal 13 valent vaccine) and influenza vaccine (influenza) for prophylactic vaccination.  On 30-Oct-2023, the patient received a 0.5 ml, (once) dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot UJ836AA, expiry date: 28-Oct-2023, strength: standard) via intramuscular route in the left thigh for Immunisation and expired acthib was given to a consumer with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a dose of fluzone high dose qiv at their pharmacy and later was informed by patient's daughter that the patient had already received a flu vaccine this season with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a Pharmacist.  This case involves a 76 years old female patient where she received a dose of influenza quadrival a-b high dose hv vaccine [Fluzone high-dose Quadrivalent] at their pharmacy and later was informed by patient's daughter that the patient had already received a flu vaccine this season 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 elasomeran (spikevax) and rsv vaccine (respiratory syncytial virus vaccine) for Prophylactic vaccination.  On 27-Oct-2023, the patient received 0.7 ml dose of suspect influenza quadrival a-b high dose hv vaccine (lot- UT8150AA and expiration date- 30-Jun-2024) via intramuscular route in the right arm (formulation, strength, lot/batch number and expiration date: not provided) for Immunisation (extra dose administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the 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: 0.58
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of Pentacel was accidentally administered to a 7 month-old child with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient to whom an expired dose of pentacel was accidentally administered 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 POLYSACCH (PNEUMOVAX VACCIN) for Prophylactic vaccination.  On 30-Oct-2023, the patient received a  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection lot UJ794AB, expiry- 08-Oct-2023 via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (latency same day).  Action taken: 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: 71.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently administered Fluzone qiv instead of the intended Fluzone high dose qiv with no reported adverse event; Initial information was received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 71 years old female patient who received inadvertently administered influenza quadrival a-b vaccine (fluzone qiv) instead of the intended influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Oct-2023, the patient received a unknown dose of suspect influenza quadrival a-b high dose hv vaccine (strength, expiry date, formulation, lot number not reported) via unknown route in unknown administration site and also received a dose of 0.5 ml of suspect influenza quadrival a-b vaccine (Suspension for injection) (lot U8041CA, Expiry date : 30-Jun-2024, strength was unknown) via intramuscular route in the arm not otherwise specified for all Immunization and inadvertently administered fluzone qiv instead of the intended fluzone high dose qiv with no reported adverse event (wrong product administered) (latency : same day). The information on batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered fluzone qiv instead of the intended fluzone high dose qiv 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.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: patient only received the liquid dtap-ipv portion with no reported adverse event; Initial information was received on 31-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who received the liquid dtap-ipv portion of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received who received the liquid dtap-ipv portion of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Suspension for injection (lot, dose, strength, and expiry date: unknown) (single component of a two-component product administered, latency same day) via unknown route in unknown administration site for prophylactic vaccination (immunization).  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: 68.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A second Spikevax vaccine was administered instead of a flu shot. No symptoms occured
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Angina pectoris, Arteriosclerosis, Catheterisation cardiac abnormal, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: developed angina 2 days later diagnosed as microvascular cardiac disease -- see above
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Microvascular coronary artery disease, Pain in jaw, Positron emission tomogram abnormal, Stress
Clinical narrative: developed angina 2 days later diagnosed as microvascular cardiac disease -- see above
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died the next morning after vaccine was given, unknown cause of death at this time.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient already received a flu shot this season. Patient was wanting to received the latest moderna shot ( spikevax), but the flu shot was incorrectly billed and administered.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Pain in extremity, Skin discolouration
Clinical narrative: patient states that they have a discolored bicep and arm pain as eel as light headedness for the following day. followed up with patient several times patient now is feeling fine and the reddish yellow coloration that he states as on his arm is now gone. patient states that is was painful and alarming.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Brain fog, Cognitive disorder, Discomfort, Panic attack
Clinical narrative: Originally came on as extreme brain fog with discomfort under left arm pit. Slowly progressed to tingling in lips, teeth and right hand thumb. Two weeks after the vaccine I experienced a panic attack. Prior to the vaccine I had never had a panic attack. In the coming weeks Cognitive thinking was a lot harder. I also experienced blurred vision in the inability to focus on any task. I also a sensation like Novacaine coming into my mouth over the course of a couple days. After the advisement of two of my doctors, I went ahead and got the second shot . Two days after the second shot, I experienced TMJ in my jaw that was so severe I could hardly chew for a month. This sensations in around the face neck, chest area in increased, and are prevalent every single day since the vaccination. I have gone to every doctor I could think of. These doctors include primary care, neurologist,  MS clinic, long, Covid clinic, cardiology, psychologist, and infectious disease. I keep being diagnosed with anxiety and stress. I have taken numerous SSRI?s, and other anti-anxiety and depression drugs. I?ve never taken any of these prior to vaccine. None of them have ever taken away any of the symptoms. I?ve also tried acupuncture and holistic purchase, such as breathing exercises and meditation.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Sensory disturbance, Stress, Temporomandibular joint syndrome
Clinical narrative: Originally came on as extreme brain fog with discomfort under left arm pit. Slowly progressed to tingling in lips, teeth and right hand thumb. Two weeks after the vaccine I experienced a panic attack. Prior to the vaccine I had never had a panic attack. In the coming weeks Cognitive thinking was a lot harder. I also experienced blurred vision in the inability to focus on any task. I also a sensation like Novacaine coming into my mouth over the course of a couple days. After the advisement of two of my doctors, I went ahead and got the second shot . Two days after the second shot, I experienced TMJ in my jaw that was so severe I could hardly chew for a month. This sensations in around the face neck, chest area in increased, and are prevalent every single day since the vaccination. I have gone to every doctor I could think of. These doctors include primary care, neurologist,  MS clinic, long, Covid clinic, cardiology, psychologist, and infectious disease. I keep being diagnosed with anxiety and stress. I have taken numerous SSRI?s, and other anti-anxiety and depression drugs. I?ve never taken any of these prior to vaccine. None of them have ever taken away any of the symptoms. I?ve also tried acupuncture and holistic purchase, such as breathing exercises and meditation.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Originally came on as extreme brain fog with discomfort under left arm pit. Slowly progressed to tingling in lips, teeth and right hand thumb. Two weeks after the vaccine I experienced a panic attack. Prior to the vaccine I had never had a panic attack. In the coming weeks Cognitive thinking was a lot harder. I also experienced blurred vision in the inability to focus on any task. I also a sensation like Novacaine coming into my mouth over the course of a couple days. After the advisement of two of my doctors, I went ahead and got the second shot . Two days after the second shot, I experienced TMJ in my jaw that was so severe I could hardly chew for a month. This sensations in around the face neck, chest area in increased, and are prevalent every single day since the vaccination. I have gone to every doctor I could think of. These doctors include primary care, neurologist,  MS clinic, long, Covid clinic, cardiology, psychologist, and infectious disease. I keep being diagnosed with anxiety and stress. I have taken numerous SSRI?s, and other anti-anxiety and depression drugs. I?ve never taken any of these prior to vaccine. None of them have ever taken away any of the symptoms. I?ve also tried acupuncture and holistic purchase, such as breathing exercises and meditation.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Vomiting 4 times without other symptoms. Occurred 5-6 hours after vaccine given
Age: 91.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two doses of Spikevax.  No signs of adverse reaction.  Pt was monitored for 30 mintues and continues be monitored by facility.
Age: 99.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Rash erythematous, Tenderness, Vaccination site reaction
Clinical narrative: On 11/5/23 the patient reported having several days of severe chills and presented with 3 red round bumps on his arm in the area of the vaccination. They were approximately 1/4-inch and looked like bug bites. He said they had appeared 2 to 3 days prior and that they were sore to the touch. He said it seemed like maybe they were getting better, not worse. He was not concerned about needing treatment, he just wanted to report the reaction.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pneumonia aspiration, Vomiting
Clinical narrative: Spikevax COVID vaccine was administered to the patient on 11-2-2023. The patient's daughter called and reported that the patient had developed severe vomiting beginning on the night of 11-5-2023.  She offers the patient had been to several birthday parties in which she was exposed to over 100 people that particular weekend presenting a potential confound in her opinion. Symptoms of vomiting resolved  within 24 hour. However, the patient developed an aspiration pneumonia secondary to vomiting, to which she was admitted to the hospital for treatment. Daughter reports the patient is now stable and recovering with no further complications at this time.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: HIV antibody negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative
Clinical narrative: The subject of this report is actually the pharmacy technician who was giving a vaccine to another patient. She administered the vaccine to the patient and then accidentally dropped the syringe, giving herself a needle stick in her left leg. This report is to document the needle stick.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Injury associated with device
Clinical narrative: The subject of this report is actually the pharmacy technician who was giving a vaccine to another patient. She administered the vaccine to the patient and then accidentally dropped the syringe, giving herself a needle stick in her left leg. This report is to document the needle stick.
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Immediate metal of chemical taste in mouth
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Heart rate increased
Clinical narrative: Patient complained that her heart rate went up and she went to emergency room and was high for 3 weeks
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: Patient came in for a flu shot. When I announced the name of the patient for the next vaccine to enter the room, she stepped in thinking that it was for her. She received the covid vaccine when she did not ask for it.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Injected limb mobility decreased, Rash
Clinical narrative: Patient states that they experienced redness and a rash on the left arm and know she is not able to move her left arm above her head.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received the incorrect dose of the 2023-2024 Pfizer Covid Vaccine. Patient is 4 years old on the day of vaccination. Patient received the 5?11year dose instead of the 6 months- 4 years dose.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site rash, Menstruation irregular
Clinical narrative: Rash near injection site Menstrual irregularities
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient came in for vaccines, consent form was handed to immunizer with Shingles and Flu HD written on consent form, immunizer administered both vaccines, after administration patient mentioned that they received flu shot a month prior, no adverse reaction reported on site
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: Patient experienced dizziness and wanting to faint.   Patient sat down for awhile.  Patient left the pharmacy on her own will.  Followed up with patient at 7:49 pm and patient stated she was fine.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Blindness unilateral, Blood test normal, Computerised tomogram normal, Magnetic resonance imaging
Clinical narrative: Complete loss of vision in right eye  3 days after vaccine
Age: 0.17
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect vaccine given by new staff member. No known side effects have occurred to date.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Gait disturbance, Gait inability, Hypoaesthesia, Muscular weakness
Clinical narrative: weakness, numbness, tingling and pain of both legs, falling, progressive difficulty and inability to walk
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: weakness, numbness, tingling and pain of both legs, falling, progressive difficulty and inability to walk
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Loss of consciousness, Nausea, Seizure, Vomiting
Clinical narrative: 6 month pregnant. adverse reaction: nausea, vomiting, >30 second seizure, loss of conscious. patient had reported no history of allergies or any severe side effects before she was given the vaccination and also marked "no" on her consent form for any serious reactions in the past from a vaccination. she regained conscious within 30 seconds. after emergency services arrived she mentions that she had similar reaction in the past to pfizer vaccine but had thought she would be okay now.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Out of date, No longer approved for usage
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Out of date, No longer approved for usage
Age: 97.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Out of date, No longer approved for usage
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Out of date, No longer approved for usage
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Out of date, No longer approved for usage
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Out of date, No longer approved for usage
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Out of date, No longer approved for usage
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Spontaneous nosebleed, right nostril of approx. 20 min duration
Age: 12.0
Sex: F
Vaccine: FLUN4, MNQ, PNC20, TDAP
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine administered. Gardasil was ordered but PCV20 was administered. No harm to patient. Patient mom, provider and clinic manager are aware. No further action is needed.
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: A nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: A nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 01-NOV-2023 The nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients. They gave partial information about the event, vaccine and asked for specific data.
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: A nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: A nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 01-NOV-2023 The nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients. They gave partial information about the event, vaccine and asked for specific data.
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Blood pressure increased, Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: A nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: A nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 01-NOV-2023 The nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients. They gave partial information about the event, vaccine and asked for specific data.
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: A nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: A nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 01-NOV-2023 The nurse contacted GSK via phone on 11/02/2023 inquiring about Arexvy and what information is available about the use of Arexvy in pregnant patients. They gave partial information about the event, vaccine and asked for specific data.
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: all 32-36 weeks gestation, receiving Arexvy off-label; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in an unspecified number of female patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patients received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: all 32-36 weeks gestation, receiving Arexvy off-label). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 02-NOV-2023 A pharmacist reported multiple incidents of maternal patients, all 32-36 weeks gestation, receiving Arexvy off-label.  No specific adverse events had been reported and vaccine was approved for non-pregnant, older adults (60 years and older). The patients who were pregnant were received Arexvy vaccine, which led to vaccine exposure during pregnancy. The reporter was GSK/ViiV field staff employee. The reporter agree to follow up from GSK.
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: all 32-36 weeks gestation, receiving Arexvy off-label; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in an unspecified number of female patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patients received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: all 32-36 weeks gestation, receiving Arexvy off-label). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 02-NOV-2023 A pharmacist reported multiple incidents of maternal patients, all 32-36 weeks gestation, receiving Arexvy off-label.  No specific adverse events had been reported and vaccine was approved for non-pregnant, older adults (60 years and older). The patients who were pregnant were received Arexvy vaccine, which led to vaccine exposure during pregnancy. The reporter was GSK/ViiV field staff employee. The reporter agree to follow up from GSK.
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Blood pressure increased, Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: all 32-36 weeks gestation, receiving Arexvy off-label; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in an unspecified number of female patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patients received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: all 32-36 weeks gestation, receiving Arexvy off-label). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 02-NOV-2023 A pharmacist reported multiple incidents of maternal patients, all 32-36 weeks gestation, receiving Arexvy off-label.  No specific adverse events had been reported and vaccine was approved for non-pregnant, older adults (60 years and older). The patients who were pregnant were received Arexvy vaccine, which led to vaccine exposure during pregnancy. The reporter was GSK/ViiV field staff employee. The reporter agree to follow up from GSK.
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: all 32-36 weeks gestation, receiving Arexvy off-label; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in an unspecified number of female patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patients received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: all 32-36 weeks gestation, receiving Arexvy off-label). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 02-NOV-2023 A pharmacist reported multiple incidents of maternal patients, all 32-36 weeks gestation, receiving Arexvy off-label.  No specific adverse events had been reported and vaccine was approved for non-pregnant, older adults (60 years and older). The patients who were pregnant were received Arexvy vaccine, which led to vaccine exposure during pregnancy. The reporter was GSK/ViiV field staff employee. The reporter agree to follow up from GSK.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; Caller is a nurse who reports VARIVAX that experienced excursion 10/20/2023 was administered to one patient that same day; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 20-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection after a temperature excursion of -10 Celsius degree (C) for 1 hour and 57 minutes, that occurred on that same date (product storage error) (lot number W025277 has been verified to be a valid lot number, expiration date reported and validated as 10-AUG-2024) administered for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) . There was no previous temperature excursion and no additional adverse event.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HCP calling to report AE for patient that received expired dose of PNEUMOVAX 23.  No adverse effects reported.  No additional AE.  No PQC.; This spontaneous report was received from a pharmacist, referring to a 17-year-old male patient.  The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 24-OCT-2023, the patient was vaccinated with a dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, single dose, lot #W019533, expiration date: 30-SEP-2023, for prophylaxis (strength, dose and route of administration were not provided) (Expired product administered). No adverse effects and no additional adverse event (AE) were reported.
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: 13-year-old 1 Dose of Engerix-B Peds, Received HEPLISAV-B Instead of Dose 2 of Engerix-B Peds; 13-year-old 1 Dose of Engerix-B Peds, Received HEPLISAV-B Instead of Dose 2 of Engerix-B Peds; Initial Report Received on 09-Jun-2023.  Additional information was received on 16-Jun2023.  A physician reported that a 13-year-old (gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization instead of a second dose of Engerix-B Peds.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unknown date, the patient received a dose of Engerix-B Peds.  On an unspecified date, the patient received a dose of HEPLISAV-B (route, lot #, expiration date and NDC # not reported) instead of the second scheduled dose of Engerix-B Peds.  The reporter advised to count this as a valid dose and to proceed with the 6-month dose of Engerix-B Peds.  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Pyrexia
Clinical narrative: Myocarditis; Fever; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (Myocarditis) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant) and PYREXIA (Fever). At the time of the report, MYOCARDITIS (Myocarditis) had resolved and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient had 2 shots of the Moderna vaccine and experienced some fever. Then, the patient had a first booster with Moderna and ended up with myocarditis. The patient reported it was extremely painful, but only lasted 8-10 hours.  No treatment medications were reported.    Company Comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the serious (due to medically significant) expected event of Myocarditis and the non-serious expected event of Pyrexia. The event Myocarditis occurred after the third (booster) dose of mRNA-1273 vaccine administration and the event Pyrexia occurred after the first and second dose of mRNA-1273 vaccine administration. Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the event Myocarditis was reported as resolved.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: severe vertigo/almost could not walk; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (severe vertigo/almost could not walk) in a 60-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032089) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: pfizer (Dose 1) on 18-Mar-2021, pfizer (Dose 2) on 14-Apr-2021, pfizer (Dose 3) on 04-Jan-2022, pfizer (Dose 4) on 03-Jan-2023 and Influenza vaccine on 12-Sep-2023. Past adverse reactions to the above products included No adverse event with Influenza vaccine, pfizer, pfizer, pfizer and pfizer.    On 02-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 05-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced VERTIGO (severe vertigo/almost could not walk). At the time of the report, VERTIGO (severe vertigo/almost could not walk) was resolving.            No concomitant medication was reported. On 05-Nov-2023, the patient developed severe vertigo. The patient almost could not walk but could walk when holding onto a railing. The patient feels 20% better today. This was the first time the patient received a Moderna vaccine. The patient regularly drinks coffee, had a protein shake with creatine, collagen, and whey protein every day but did not have this on 3NOV2023 or 4NOV2023. The patient did have it yesterday 5NOV2023. The symptoms started almost immediately after drinking the smoothie. Normally also does cold plunges, did one 2NOV2023. The patient did not had it for a couple days then did try it again on 5NOV2023. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: 4/34 aSOTRs experienced breakthrough infection between 3-6 months post D3; breakthrough infection; This is a literature report for the following literature source(s).  An adolescent patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Adolescent solid organ transplant recipients" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "4/34 aSOTRs experienced breakthrough infection between 3-6 months post D3"; COVID-19 (medically significant), outcome "unknown", described as "breakthrough infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown result; Positive, notes: 6 months following D3, indicating antibody durability among aSOTRs.  The reporter considered "4/34 asotrs experienced breakthrough infection between 3-6 months post d3" and "breakthrough infection" related to bnt162b2.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: 4/34 aSOTRs experienced breakthrough infection between 3-6 months post D3; 4/34 aSOTRs experienced breakthrough infection between 3-6 months post D3; This is a literature report.  An adolescent patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Adolescent Solid Organ Transplant Recipients" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "4/34 aSOTRs experienced breakthrough infection between 3-6 months post D3". The patient underwent the following laboratory tests and procedures: Antibody test: Positive; Positive, notes: 6 months following D3, indicating antibody durability among aSOTRs; SARS-CoV-2 antibody test: Unknown results.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded. ,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Chemotherapy, Fatigue, Full blood count, Pyrexia
Clinical narrative: My daughter had a fever following the vaccine. She took Tylenol. The next several days she was tired but did not have a fever. She presented with a fever and stomach pain on July 18. She had vomiting so we took her to urgent care. They gave her anti nausea meds and said to go to another clinic to get blood tests if she didn?t start to feel better. We took her to get her blood checked on July 28 because she was still sick. Her WBC was incredibly high. We were sent to ER where they confirmed leukemia. We then took a life flight to hospital the same day, where they confirmed T-cell acute lymphoblastic leukemia. She began chemo therapy the following day, July 29.