chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria
Clinical narrative: chronic spontaneous urticaria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose number unknown (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: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: CHRONIC SPONTANEOUS URTICARIA (non-serious) with onset 12Nov2022, outcome "unknown".  Additional information: It was reported that was just speaking to an agent and got disconnected.  She was reporting an adverse reaction she has had since 12Nov2022 since she took Pfizer booster shot. Clarified product as Pfizer Covid Booster Shot. The reaction was that she has been suffering from hives since she took booster. She was doing search on internet. She did a search and she came across something about a guy this happened to. It comes and go and it was long term urticaria which was hives. They called it chronic spontaneous urticaria after the covid19 vaccine. It was an article and it sounded classic to what she is going through. Caller declines report for the guy that had long term urticaria. She only has the website. It was through.  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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 at 16:30 as dose 1, single (Batch/Lot number: unknown), in right arm and in Apr2021 at 16:30 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2022 at 16:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and in Oct2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Mar2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included from 23Jan2023 to 28Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Gastritis, Rash
Clinical narrative: a little rash appeared on her upper right arm; burning sensation in the abdomen; gastritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2nd, Manufacturer unknown), for COVID-19 Immunization; Bnt162b2 (Dose: 3rd), for COVID-19 Immunization.  The following information was reported: GASTRITIS (non-serious) with onset Oct2022, outcome "recovering"; RASH (non-serious), outcome "unknown", described as "a little rash appeared on her upper right arm"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "burning sensation in the abdomen".  Additional information: Caller provided that she was diagnosed with gastritis in fall of Oct2022 and provided that the burning sensation she was feeling "seemed to have gone away." Caller provided that her gastritis has "somewhat resolved itself." Caller stated that she was "diagnosed with COVID this past Monday, however on Sunday (when she was not COVID positive), a little rash appeared on her upper right arm, in which she assumed it was shingles or a staph infection." Caller stated that she was taking Valacyclovir but she "took herself off of it upon starting Paxlovid yesterday morning." Caller provided that she is vaccinated with "2 Pfizer boosters and was on route to getting her bivalent" until she came down with the rash and exposure to COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she was diagnosed with Covid this past Monday; she was diagnosed with Covid this past Monday; 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 60-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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) all with onset Jan2023, outcome "unknown" and all described as "she was diagnosed with Covid this past Monday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was diagnosed with Covid this past Monday. Patient realized that she came in contact with Covid from a contractor she was around while she was checking on a property. Stated that she did a virtual visit with her doctor. Patient was vaccinated with "2 Pfizer boosters and was on route to getting her bivalent" until she came down with the rash and exposure to Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Loss of personal independence in daily activities, SARS-CoV-2 test
Clinical narrative: He can't stand or speak; He can't stand or speak; Multiple Strokes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76-year-old male patient received BNT162b2 (BNT162B2), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (COVID19 Vaccine, dose 2, manufacturer unknown, Lot number unknown, not bivalent), for Covid-19 immunization; Covid-19 vaccine (COVID19 Vaccine, dose 1, manufacturer unknown, Lot number unknown, not bivalent), for Covid-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (caused and prolonged hospitalization, disability, life threatening) with onset Sep2021, outcome "not recovered", described as "Multiple Strokes"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant), APHASIA (medically significant), outcome "unknown" and all described as "He can't stand or speak". The event "multiple strokes" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of cerebrovascular accident. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (PRIVATE). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: MYOCARDITIS (medically significant), outcome "unknown".  Clinical course : Caller said that he just got the Pfizer vaccine and is experiencing myocarditis. He was wondering why we were doing that to our vaccines. Created manual AE form since the caller had myocarditis after taking the covid 19 vaccine. Caller also stated that he wanted to talk to someone in (city name). Resolution: - The call was transferred from our location (Name and number withheld) - While reading the opening spiel, caller hang-up - No action was made - Submitted manual AE form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune pancreatitis, Blood immunoglobulin G, Immunoglobulins increased, Pancreatic disorder
Clinical narrative: auto immune pancreatitis; IGG4 shot up to 280; my pancreas shut down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 73-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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: Covid-19 vaccine (Dose: 1st, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd, Manufacturer unknown), for Covid-19 immunization. The following information was reported: AUTOIMMUNE PANCREATITIS (medically significant), outcome "unknown", described as "auto immune pancreatitis"; IMMUNOGLOBULINS INCREASED (non-serious), outcome "unknown", described as "IGG4 shot up to 280"; PANCREATIC DISORDER (non-serious), outcome "unknown", described as "my pancreas shut down". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: my IGG4 shot up to 280, notes: develop Auto immune pancreatitis (AIP) and my IGG4 shot up to 280 after the third shot i was sick for a very long time. Therapeutic measures were taken as a result of autoimmune pancreatitis, immunoglobulins increased, pancreatic disorder. Clinical information: After taking 3rd shot of Pfizer vaccine (1st booster), patient developed Auto immune pancreatitis (AIP) and IGG4 shot up to 280 after the third shot, patient was sick for a very long time, patient never was diabetic, patient's pancreas shut down and now have to take Creon which is very expensive forever.  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: COVID19
Symptoms: Renal disorder
Clinical narrative: I have also had kidney issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rapid eye problems." (Unspecified if ongoing), notes: I feel that Covid was the beginning of my rapid eye problems.; "Covid" (unspecified if ongoing), notes: I feel that Covid was the beginning of my rapid eye problems. The patient's concomitant medications were not reported. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "I have also had kidney issues". Additional information: Description of Event Outcome: The patient feel that Covid was the beginning of my rapid eye problems. The patient had an adverse reaction with first vaccine. The patient was advice to take number 2 and a booster. However, the patient had 4 cases of Covid. The patient has also had kidney issues. The patient would like to speak to someone. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Gastric ischaemia
Clinical narrative: I had an a stomach stroke 7 weeks after receiving the Pfizer final booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: GASTRIC ISCHAEMIA (medically significant), 7 weeks after the suspect product(s) administration, outcome "unknown", described as "I had an a stomach stroke 7 weeks after receiving the Pfizer final booster shot".  Clinical course: Patient had a stomach stroke 7 weeks after receiving the Pfizer final booster shot. And asked if there was someone patient should inform regarding this as there may be a connection. Forwarded to N/A, no medical inquiry asked.  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: COVID19
Symptoms: Pain in extremity
Clinical narrative: My finger has been hurting since my last vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My finger has been hurting since my last vaccine".  Additional information: My finger has been hurting since my last vaccine. I would like to talk with someone about my pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen, red arm/Local site reaction 10cm x 10 cm; swollen, red arm/Local site reaction 10cm x 10 cm; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (medically significant), VACCINATION SITE ERYTHEMA (medically significant), outcome "unknown" and all described as "swollen, red arm/Local site reaction 10cm x 10 cm" after administration for 5 days. Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible causal association between administration of PREVNAR 20 and the onset of both events swollen, red arm/Local site reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product 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: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Had covid 2 times; Had covid 2 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had covid 2 times".  Clinical course: The patient got vaccinated with all 3 vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: FLUR3
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site pain, Pain
Clinical narrative: right knee pain; he experienced bilateral shoulder pain; Parkinson-Turner Syndrome; acute pain; weakness; fatigue; Initial information received on 01-Feb-2023 regarding an unsolicited valid serious case received from a consumer.  This case involves a 63 years old male patient who experienced right knee pain, he experienced bilateral shoulder pain, parkinson-turner syndrome, acute pain, weakness and fatigue after receiving vaccine Influenza Quadrivalent Recombinant Vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Interferon Alfa (Interferon Alfa).  On an unknown date, the patient received 0.5 ml 1x dose of suspect Influenza Quadrivalent recombinant vaccine (strength, lot number and expiry date: not reported) via intramuscular route in the right deltoid as Immunization.  On 03-Nov-2022, the patient developed a serious right knee pain (arthralgia), bilateral shoulder pain (arthralgia), parkinson-turner syndrome (turner's syndrome), acute pain (pain), weakness (asthenia) and fatigue (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine. This event was assessed as medically significant.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event right knee pain and was Not Recovered / Not Resolved for rest of the events.; Sender's Comments: Sanofi company comment dated 01-Feb-2023: This case involves a 63 years old male patient who experienced right knee pain, he experienced bilateral shoulder pain, parkinson-turner syndrome, acute pain, weakness and fatigue after receiving vaccine Influenza Quadrivalent Recombinant Vaccine [Flublok]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 63.0
Sex: M
Vaccine: FLUR3
Symptoms: Turner's syndrome
Clinical narrative: right knee pain; he experienced bilateral shoulder pain; Parkinson-Turner Syndrome; acute pain; weakness; fatigue; Initial information received on 01-Feb-2023 regarding an unsolicited valid serious case received from a consumer.  This case involves a 63 years old male patient who experienced right knee pain, he experienced bilateral shoulder pain, parkinson-turner syndrome, acute pain, weakness and fatigue after receiving vaccine Influenza Quadrivalent Recombinant Vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Interferon Alfa (Interferon Alfa).  On an unknown date, the patient received 0.5 ml 1x dose of suspect Influenza Quadrivalent recombinant vaccine (strength, lot number and expiry date: not reported) via intramuscular route in the right deltoid as Immunization.  On 03-Nov-2022, the patient developed a serious right knee pain (arthralgia), bilateral shoulder pain (arthralgia), parkinson-turner syndrome (turner's syndrome), acute pain (pain), weakness (asthenia) and fatigue (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine. This event was assessed as medically significant.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event right knee pain and was Not Recovered / Not Resolved for rest of the events.; Sender's Comments: Sanofi company comment dated 01-Feb-2023: This case involves a 63 years old male patient who experienced right knee pain, he experienced bilateral shoulder pain, parkinson-turner syndrome, acute pain, weakness and fatigue after receiving vaccine Influenza Quadrivalent Recombinant Vaccine [Flublok]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: receiving an expired dose of pentacel yesterday with no reported adverse event; Initial information received on 02-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1-year-old male patient and it reported that he received an expired dose of Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] yesterday with no reported adverse event.  The patient's past vaccination(s) included Pediarix on 30-Jun-2021, Pentacel on 22-Sep-2021, HIB on 30-Jun-2021, HIB on 22-Sep-2021 and HIB on 30-Nov-2021.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine, measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (varicella vaccine) all for Prophylactic vaccination.  On 01-Feb-2023, the patient received 0.5 ml (milliliter) (dose 4), 1x (once) of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot number: UJ634AA, expiry date: 28-Jan-2023) (with unknown strength and route) in the right thigh for prophylactic vaccination (immunization).  On 01-Feb-2023, the reporter reported that patient received an expired dose of pentacel yesterday with no reported adverse event (expired product administered) (latency; same day).  No lab data were reported.  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: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of fluzone high-dose quadrivalent was administered to a patient with no reported adverse event; Initial information was received on 02-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 79 years old male patient who experienced expired dose of fluzone high-dose quadrivalent was administered to a patient with no reported adverse event while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Feb-2023, the patient received a Dose 1 dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine lot UJ765AB via intramuscular route in the left deltoid for Immunization.  On 02-Feb-2023 the patient developed a non-serious event of expired dose of fluzone high-dose quadrivalent was administered to a patient with no reported adverse event (expired product administered) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event (expired dose of fluzone high-dose quadrivalent was administered to a patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event expired dose of fluzone high-dose quadrivalent was administered to a patient 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: 29.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired TENIVAC was administered (with no reported adverse event); Initial information was received on 02-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 29 years old female patient who experienced an expired tenivac was administered (with no reported adverse event) while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Feb-2023, the patient received a Dose 1 dose of 0.5 ml suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT lot U6831AA of expiry date 08-Oct-2022 via intramuscular route in the deltoid not otherwise specified for Immunization.  On 02-Feb-2023 the patient developed a non-serious event of an expired tenivac was administered (with no reported adverse event) (expired product administered) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (an expired Tenivac was administered (with no reported adverse event)).  At time of reporting, the outcome was Not Recovered for the event an expired tenivac was administered (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: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus, Vertigo
Clinical narrative: Ringing in ears and vertigo started 6 days after 3rd booster
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cardiac discomfort, Chest discomfort
Clinical narrative: Heart and chest pressure and discomfort
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Arm itches; This case was reported by a consumer via interactive digital media and described the occurrence of itchy upper limbs in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced itchy upper limbs. On an unknown date, the outcome of the itchy upper limbs was unknown.   It was unknown if the reporter considered the itchy upper limbs to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 28-Jan-2023. Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter stated that it's been 5 days since vaccine and arm itches. Additional Supportive Information: Follow-up would not possible as no contact details were available. Note: As it was not clear if event occurred after 5 days or its been 5 days since vaccination. Conservatively 5 days were captured as latency based upon discrepant information in narrative
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Painful shots; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's comments: This case was reported by the patient via interactive digital media. The reporter stated that, he/she had shingles vaccine some time ago. Painful shots but well worth it. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: today, breaks out with shingles; This case was reported by a pharmacist and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2023, the patient received the 1st dose of Shingrix. On 30th January 2023, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's comments: The pharmacist had given a patient a Shingrix vaccine (first dose) and at the time of reporting,  she breaks out with shingles.  The reporter had asked whether the vaccine could cause an outbreak or it was just coincidence.  The patient had called our pharmacy, and asked to speak, we had answered the phone unlike other pharmacies.  The reporter had consented to follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Expressive swelling arround injection site; Pain, worse than Covid vaccines; This case was reported by a consumer via sales rep and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date May 2024) for prophylaxis.   Previously administered products included Moderna covid vaccine with an associated reaction of pain (on an unknown date received vaccine).   On 29th January 2023, the patient received Shingrix (intramuscular) .5 ml. In January 2023, 1 day after receiving Shingrix, the patient experienced swelling arm and pain. On an unknown date, the outcome of the swelling arm and pain were unknown.   It was unknown if the reporter considered the swelling arm and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The patient experienced expressive swelling around injection site and had pain 1 day post injection.  The pain was worse than Moderna Covid vaccines.
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Kinrix as 4th dose of Dtap and 3rd of IPV; was suppose to receive flu vaccine and got Kinrix and flu vaccine; This case was reported by a other health professional and described the occurrence of inappropriate schedule of vaccine administered in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving INFLUENZA VACCINE, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023017376   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comments: The reporter reported that the patient received Kinrix was 4th dose of Dtap and 3rd dose of IPV. They receive it in error as HCP stated that they had the wrong shot of record. The patient was supposed to receive a flu vaccine only but got Kinrix and Flu vaccine. HCP did not provide information on what flu vaccine the patient received. Additional Supportive Information: The patient received Kinrix was 4th dose of Dtap and 3rd dose of IPV which led to Inappropriate schedule of vaccine administered The patient supposed to receive a flu vaccine only but got Kinrix and Flu vaccine, which led to Wrong vaccine administered. Additional Supportive Information: This case was linked with case US2023017376, reported by the same reporter for same patient.; Sender's Comments:  US-GSK-US2023017376:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness from neck to ear; Swelling from neck to ear; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2023, the patient received Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comments: Pharmacist left message on afterhours VM box. Reporter reported that she administered a Shingrix vaccine on last Thursday and the patient reported today (on the day of reporting) that she experienced redness and swelling all the way from her neck to her ear. At the time of adverse report no additional details regarding Shingrix lot and expiration date or patient demographics available. The reporter consented to follow up.
Age: 0.5
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given not at age 4-6, given at 6 months old; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comment: If a patient was given Kinrix earlier in the vaccination series, not at age 4-6, could you provide data if that was ok or did the office need to repeat the doses using Pediarix.  This office had patient from another health system that joined their practice that was administered Kinrix this way. The reporter noticed that one patient was given Kinrix at 6 months. Since we got no communication with healthcare professional other than through sales representative , no more information that the one on the description was provided (no Lot number, expiration date, patient's identifiers were provided). The reporter shared she had two patients that transferred to her office from two different offices. The reporter agreed to follow up from GlaxoSmithKline was not asked. Additional Supportive Information: The patient received Kinrix below than the recommended age, which led to inappropriate age at vaccine administration. The case had been linked to US2023015600, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023015600:Same reporter
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via media concerned a 38 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was a dad to a 3 year old boy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 21-AUG-2022 for covid-19 prophylaxis. Age at time of vaccination 4 decade old. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke from the vaccine and still at the time of reporting patient was not able to speak or fully use limbs. It was reported as "38 year old male/dad to a 3 year old boy - stroke from the vaccine in 8/21 and I still am not able to speak or fully use limbs" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230211299- stroke.. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site laceration, Malaise, Skin warm
Clinical narrative: cut where the needle went in; Got very ill; large red mark on my arm; large warm mark on arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site laceration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site laceration, unwell, erythema of extremities and skin warm. On an unknown date, the outcome of the injection site laceration, erythema of extremities and skin warm were not recovered/not resolved and the outcome of the unwell was unknown.   It was unknown if the reporter considered the injection site laceration, unwell, erythema of extremities and skin warm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received shingles vaccine and got very ill. The patient still had a large warm red mark on patients arm and cut where the needle went in. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Swelling at  injection point; Welt at injection point; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2023, the patient received the 1st dose of Shingrix. On 28th January 2023, 2 days after receiving Shingrix, the patient experienced injection site swelling and injection site wheal. On an unknown date, the outcome of the injection site swelling and injection site wheal were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site wheal to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received first dose of Shingrix on Thursday and today Saturday on the day of reporting, the patient had swelling and a welt at the injection point. The patient asked how long should this last. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: wheals/hives/wheals and that "it's all over my legs; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (wheals/hives/wheals and that "it's all over my legs) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    On 20-Dec-2022, the patient received 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 URTICARIA (wheals/hives/wheals and that "it's all over my legs). The patient was treated with PREDNISONE at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (wheals/hives/wheals and that "it's all over my legs) had not resolved.            No concomitant medications were reported.  The patient reported that, she had received a 3rd booster on 20-Dec-2022 and ended up breaking out with wheals or hives. She mentioned that she had been using prednisone, hydrocortisone cream and steroids shot but that she was still breaking out with wheals and that it all over her legs today. She did not know if that was normal reaction.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever (102.4 highest), aches, chills  Lasted approximately 36 hours  Treated with ibuprofen and acetaminophen (alternate doses)
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: Storage of vaccine was in refrigerator instead of the recommended location of the freezer and therefore out of temperature range 11/30/2022 and vaccine given 1/12/2023. Vaccine given intermuscular instead of subcutaneous.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: Storage of vaccine was in refrigerator instead of the recommended location of the freezer and therefore out of temperature range 11/30/2022 and vaccine given 1/12/2023. Vaccine given intermuscular instead of subcutaneous.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: Storage of vaccine was in refrigerator instead of the recommended location of the freezer and therefore out of temperature range 11/30/2022 and vaccine given 12/21/2022. Vaccine given intermuscular instead of subcutaneous.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Patient reports that since her vaccination last Wednesday woke up at 2 am on Thursday am with HA and fatigue began running fever, then Friday another HA, fever and fatigue, along with the HA, fever and fatigue, rash began on arms Saturday, Sunday the rash blistered, then Monday am called clinic for appt. And noticed lymph node swollen on side where she received vaccination on. The highest temperature was 101.0 which reduced with tylenol or motrin.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Sleep disorder
Clinical narrative: Patient reports that since her vaccination last Wednesday woke up at 2 am on Thursday am with HA and fatigue began running fever, then Friday another HA, fever and fatigue, along with the HA, fever and fatigue, rash began on arms Saturday, Sunday the rash blistered, then Monday am called clinic for appt. And noticed lymph node swollen on side where she received vaccination on. The highest temperature was 101.0 which reduced with tylenol or motrin.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Chills, Muscle Aches,
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus.   Never had the issue before.  Doesn't run in family.   Didn't notice so much early so I wasn't concerned, but by January, it was more pronounced.  Since it persists and I've found others attribute it to the vaccine, I decided to enter it into VAERS.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 1/5/21, 10/22/21, 5/17/22. Positive on 2/6/23
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: I received and tolerated the booster with no adverse effects. I started getting very tired and had a cough on 12/27/2022. I tested positive COVID-19 on 12/29/2022. I contacted my doctor and was given the prescription PAXLOVID. I took one dose and had to stop as it made me sick. I was really sick for eight days. I lost my sense of taste and smell. I also tested positive for COVID-19 on 01/09/2022. As of today, I will have a coughing spell for a day or two. I now use FLONASE daily.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: I received and tolerated the booster with no adverse effects. I started getting very tired and had a cough on 12/27/2022. I tested positive COVID-19 on 12/29/2022. I contacted my doctor and was given the prescription PAXLOVID. I took one dose and had to stop as it made me sick. I was really sick for eight days. I lost my sense of taste and smell. I also tested positive for COVID-19 on 01/09/2022. As of today, I will have a coughing spell for a day or two. I now use FLONASE daily.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/12/21, 3/12/21, 11/29/21. Positive on 2/6/23 (pos. on SNF)