chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLUX, HIBV, IPV, MMRV, UNK
Symptoms: Injection site pruritus, Injection site swelling, Local reaction, Rash, Swelling face
Clinical narrative: general rash; hives on unspecified areas of the patient's body; the patient had some facial swelling; patient had a local reaction such as itching, swelling in the left arm; patient had a local reaction such as itching, swelling in the left arm; This spontaneous report was received from a nurse prescriber via company representative referring to a 4-year-old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were unknown by the reporter.  On 03-JAN-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), hib conj vaccine (unspecified carrier) (manufacturer unknown) and poliovirus vaccine inactivated (unspecified) (manufacturer unknown) in different injection sites of the left arm; and with influenza virus vaccine (unspecified) (manufacturer unknown) in the right arm (dosage schedule, route of administration, lot number and expiration date were not reported for any of the vaccines).  On the same day (also reported as: "shortly after the patient left the office"), the patient's parent called the office reporting that the boy experienced a local reaction such as itching (injection site pruritus) and swelling (vaccination site swelling) in the left arm. On 04-JAN-2020 (also reported as: "24 hours later"), the patient had some general rash, hives on unspecified areas of the body (urticaria) and some facial swelling (swelling face). The patient was taken to an unspecified urgent care, where he was administered epinephrine hydrochloride (EPIPEN) and an unspecified dose of diphenhydramine hydrochloride (BENADRYL). The patient was sent to an unspecified emergency room (ER) to be monitored since he was administered epinephrine hydrochloride (EPIPEN) and he was discharged on the same day. It was unknown if laboratory studies/diagnostics were performed to the patient. On an unspecified date in January 2020, the patient recovered from injection site pruritus, swelling face, urticaria, rash and vaccination site swelling.   The causality assessments between the adverse events and the suspect therapies were not provided.  Upon internal review, the events injection site pruritus, swelling face, urticaria, rash and vaccination site swelling were considered to be medically significant.
Age: 4.0
Sex: M
Vaccine: FLUX, HIBV, IPV, MMRV, UNK
Symptoms: Urticaria
Clinical narrative: general rash; hives on unspecified areas of the patient's body; the patient had some facial swelling; patient had a local reaction such as itching, swelling in the left arm; patient had a local reaction such as itching, swelling in the left arm; This spontaneous report was received from a nurse prescriber via company representative referring to a 4-year-old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were unknown by the reporter.  On 03-JAN-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), hib conj vaccine (unspecified carrier) (manufacturer unknown) and poliovirus vaccine inactivated (unspecified) (manufacturer unknown) in different injection sites of the left arm; and with influenza virus vaccine (unspecified) (manufacturer unknown) in the right arm (dosage schedule, route of administration, lot number and expiration date were not reported for any of the vaccines).  On the same day (also reported as: "shortly after the patient left the office"), the patient's parent called the office reporting that the boy experienced a local reaction such as itching (injection site pruritus) and swelling (vaccination site swelling) in the left arm. On 04-JAN-2020 (also reported as: "24 hours later"), the patient had some general rash, hives on unspecified areas of the body (urticaria) and some facial swelling (swelling face). The patient was taken to an unspecified urgent care, where he was administered epinephrine hydrochloride (EPIPEN) and an unspecified dose of diphenhydramine hydrochloride (BENADRYL). The patient was sent to an unspecified emergency room (ER) to be monitored since he was administered epinephrine hydrochloride (EPIPEN) and he was discharged on the same day. It was unknown if laboratory studies/diagnostics were performed to the patient. On an unspecified date in January 2020, the patient recovered from injection site pruritus, swelling face, urticaria, rash and vaccination site swelling.   The causality assessments between the adverse events and the suspect therapies were not provided.  Upon internal review, the events injection site pruritus, swelling face, urticaria, rash and vaccination site swelling were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster related conditions (the dosage regimen information was not reported). Subsequently, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: M
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: the patient is 62 years old and he received a dose of GARDASIL 9 six months ago; This spontaneous report was received from a consumer as a 62 year old male patient. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  In approximately July 2019 (reported as 6 months ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot/batch # and expiration date were not provided)  for prophylaxis (product administered to patient of inappropriate age).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Balance disorder, Brain scan normal, Dizziness, Feeling abnormal
Clinical narrative: Meniere's disease; off balance; vertigo; memory loss; dizzy; feels brain fog; This case was reported by a consumer via call center representative and described the occurrence of meniere's disease in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 2 days after receiving Shingrix, the patient experienced meniere's disease (serious criteria GSK medically significant), balance disorder, vertigo, memory loss, dizziness and foggy feeling in head. On an unknown date, the outcome of the meniere's disease, vertigo, memory loss, dizziness and foggy feeling in head were resolved with sequelae and the outcome of the balance disorder was recovering/resolving.   It was unknown if the reporter considered the meniere's disease, balance disorder, vertigo, memory loss, dizziness and foggy feeling in head to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated in early October 2019. Two days after vaccination, the patient felt off balance, vertigo, dizzy, brain fog, and memory loss.  The patient was seen by an ear, nose throat physician and had a brain scan, which was normal.   The physician diagnosed meniere's disease.   The symptoms were becoming worse. In December 2019, the patient received 2nd dose of Shingrix. The events were still present at the time of 2nd vaccination.  The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Meniere's disease, Vertigo
Clinical narrative: Meniere's disease; off balance; vertigo; memory loss; dizzy; feels brain fog; This case was reported by a consumer via call center representative and described the occurrence of meniere's disease in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 2 days after receiving Shingrix, the patient experienced meniere's disease (serious criteria GSK medically significant), balance disorder, vertigo, memory loss, dizziness and foggy feeling in head. On an unknown date, the outcome of the meniere's disease, vertigo, memory loss, dizziness and foggy feeling in head were resolved with sequelae and the outcome of the balance disorder was recovering/resolving.   It was unknown if the reporter considered the meniere's disease, balance disorder, vertigo, memory loss, dizziness and foggy feeling in head to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated in early October 2019. Two days after vaccination, the patient felt off balance, vertigo, dizzy, brain fog, and memory loss.  The patient was seen by an ear, nose throat physician and had a brain scan, which was normal.   The physician diagnosed meniere's disease.   The symptoms were becoming worse. In December 2019, the patient received 2nd dose of Shingrix. The events were still present at the time of 2nd vaccination.  The reporter did not consent to follow up.
Sex: F
Vaccine: UNK
Symptoms: Erythema, Rash macular
Clinical narrative: Fore arm blotchy; Fore arm red; This is a spontaneous case, initially received from other non-health professional on 17-Jan-2019, concerning a female patient of unspecified age.  The patient previously received flu vaccine when she was pregnant.  On an unspecified date (two years ago as reported), the patient was administered INN Flu Vaccine Seasonal [influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacture: not reported] for active immunization against influenza.  On an unspecified date, a few hours after vaccination, the patient's arm became red and blotchy. No treatment was given, and the symptoms were subsided after 2 days.  The outcome of the events was recovered on an unspecified date.  The reporter assessed this case as non-serious.  The reporter did not provide the consent to follow-up. Hence this case was considered as lost to follow-up.; Reporter's Comments: A female patient of unspecified age developed redness and blotchy, a few hours after administration of INN Flu vaccine seasonal. The company assessed the causality of the events as related to the suspect vaccine, due to plausible temporal relationship between the event and suspect vaccine.
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Had flu vaccine/pregnant; This is a non-serious spontaneous case, initially received from other non-health professional (consumer) on 17-Jan-2019, concerning a female pregnant patient of an unspecified age.  On an unspecified date, the pregnant patient was administered INN Flu Vaccine Seasonal [influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacture: not reported] for an unknown indication (explicitly coded as vaccine exposure during pregnancy).  The patient had not experienced any adverse events.  This case is linked to 201900685 due to the same reporter and patient. ; Reporter's Comments: A female pregnant patient of unspecified age was administered INN Flu vaccine seasonal (vaccine exposure during pregnancy). The company assessed the causality for the event as not related to the suspect vaccine considering it as a special case scenario.
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; This is a non-serious spontaneous case, initially received from other non-health professional on 22-Jan-2019, concerning a 14-year-old, adolescent male patient.  On 05-Jan-2019, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication.  On an unspecified date in Jan-2019, after vaccination, the patient experienced pain in his arm.  The outcome of the event was not reported.  The reporter did not provide consent to follow up, hence the case is lost to follow up.; Reporter's Comments: A 14-year-old, male patient experienced pain in arm, unspecified date after the administration of INN Flu Vaccine Seasonal. The company assessed the causality of the event as related due to plausible temporal relationship between the event and the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash; This is a non-serious spontaneous case initially received from other non-health professional (consumer), concerning a female patient of an unspecified age.  The patient's medical history and concomitant medications were unknown.  On an unspecified date (reported as 10 or 20 years ago), the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for protection against seasonal flu.  On an unspecified date, after vaccination, the patient developed a rash.  The outcome of the event was recovered on an unspecified date.  The case was considered as lost to follow up as the reporter did not provide consent for follow up.; Reporter's Comments: A female patient of an unspecified age developed a rash, on an unspecified date after vaccination with INN Flu Vaccine Seasonal. The causality of the event was unassessable due to the lack of information regarding the onset latency of the event.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Infusion related reaction, Lip swelling, Urticaria
Clinical narrative: Infusion realred reaction; Hives; Lips were swelling; This is a spontaneous case initially received from a pharmacist on 24-Jan-2019, concerning a 22-year-old, adult female patient.  The patient had no pertinent medical history and no drug reactions or allergies. The patient had not received any concomitant medications.  On 07-Jan-2019, the patient was administered a high dose INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication. On the same day, the patient received a non-company suspect infusion Renflexis [infliximab abda, dose: 100 mg, route of administration, anatomical location, batch number and expiry date: not reported] for rheumatoid arthritis.  On the same day after vaccination, the patient experienced an infusion-related reaction which was described as hives and swollen lips 25 minutes inti infusion with Renflexis. It was reported that the infusion was stopped after an unknown amount of drug had been infused. The patient sought medical attention and was treated with unspecified medication. No lab tests or diagnosis were performed.  The outcome of the events was recovered on an unspecified date.  The reporter assessed the case as non-serious.; Reporter's Comments: A 22-year-old, female patient experienced an infusion-related reaction as hives and swollen lips, on the same day after administration with INN Flu Vaccine Seasonal and Renflexis infusion. The company assessed the causality of the event as related to the suspect vaccine due to plausible temporal relationship between event and suspect vaccine and the causal role of the suspect vaccine cannot be ruled out completely.
Sex: F
Vaccine: UNK
Symptoms: Herpes zoster
Clinical narrative: Had shingles; This is a non-serious spontaneous case initially received from other non-health professional (consumer) on 30-Jan-2019, concerning a female patient of an unspecified age.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication.  On an unspecified date, 2 weeks after vaccination, the patient developed shingles.  The outcome of the event was not reported.  Non-significant follow up received from the reporter on 11-Feb-2019: The Med info number (SEQ19-00706) was added in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A female patient of an unspecified age experienced shingles, 2 weeks after vaccination with INN Flu Vaccine Seasonal. The company assessed the causality of the event as related to the suspect vaccine due to plausible temporal relationship between event and suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This is a serious spontaneous case, initially received from other non-health professional via pharmaceutical manufacturer (Merck) on 14-Feb-2019, concerning a female patient of unspecified age.  On an unspecified date (reported as about 10 years ago), the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication.  On an unspecified date, after vaccination, the patient experienced an anaphylactic reaction.  At the time of the report, the outcome of the event was not reported.; Reporter's Comments: A female patient of unspecified age experienced anaphylactic reaction, unspecified period of time after receipt of INN Flu vaccine seasonal. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. Despite the lack of temporal relationship, considering the plausible biological mechanism and acute presentation of the event, the causal role of suspect vaccine cannot be ruled out. Hence, causality of anaphylactic reaction assessed as related to suspect vaccine. The company assessed the event (anaphylactic reaction) as serious (medically significant).
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: Head cold; This is a non-serious spontaneous case, initially received from other health professional on 19-Feb-2019, concerning a 49-year-old, adult female patient.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication.  On an unspecified date, after vaccination, the patient experienced head cold.  The outcome of the event was not reported.; Reporter's Comments: A 49-year-old, female patient experienced head cold, on an unspecified date after vaccination with INN Flu Vaccine Seasonal. The causality of the event was unassessable due to the lack of information regarding the vaccination date and onset latency of the event.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to Influenza vaccine; This is a non-serious spontaneous case, initially received from physician on 20-Feb-2019, concerning a 69-year-old, elderly, female patient.   On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [influenza vaccine, influenza virus vaccine polyvalent, dose, frequency, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication.  On an unspecified date, the patient experienced allergy due to influenza vaccine.   The outcome of the event was not reported.  Case re-opened for completion of full data entry: 20-Feb-2019.; Reporter's Comments: A 69-year-old female patient developed an allergy to vaccine on an unspecified day after administration of INN flu vaccine seasonal. The company assessed the causality of the event as unassessable due to lack of information regarding onset latency.
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling
Clinical narrative: Arm swelling; This is a non-serious spontaneous case, initially received from the pharmacist on 20-Oct-2018, concerning a female patient of an unspecified age.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported] for an unknown indication.  On an unspecified date, after vaccination, the patient developed swelling in arm.  The outcome of the event was not reported.   This case was cross-linked to the original case: 201804744 (same patient).; Reporter's Comments: A female patient of an unspecified age developed swelling in arm unspecified days after the administration of INN Flu Vaccine Seasonal. The causality of the event was unassessable due to lack of information regarding onset latency.
Sex: M
Vaccine: UNK
Symptoms: Epistaxis
Clinical narrative: Epistaxis; This is a non-serious spontaneous case, initially received from a physician on 20-May-2019, concerning a male elderly patient of unspecified age.   On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number, frequency, expiry date, trade name and manufacturer: not reported] for an unknown indication.  On an unspecified date, after vaccination, the patient consistently experienced epistaxis for the last 3 years.  The outcome of the event was not reported.  This case is linked to 201903515 (same patient).; Reporter's Comments: A male patient of unspecified age, consistently experienced epistaxis for the last 3 years on an unspecified period of time after administration of INN Flu Vaccine Seasonal. The causality of the event was unassessable due to lack of information regarding the vaccination date and onset latency  of the event.
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This is a spontaneous case, initially received from other non-health professional via Med Communications (reference number: SEQ19-02824) on 17-Sep-2019, concerning a female pregnant patient of an unknown age.  The patient's medical history and concomitant medications were not provided.  On unspecified date during her first trimester, the patient was administered INN Flu Vaccine [Influenza vaccine, brand name, dose, route of administration, batch number, expiry date and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy')  for an unknown indication.  It was unknown if the patient experience any adverse event after administration of Flu vaccine.
Sex: M
Vaccine: FLUX
Symptoms: Headache, Pyrexia, Sinus disorder
Clinical narrative: Sinuses are messed up; Severe headache; 102+F fever; 101 fever; This is a spontaneous case reported by consumer to agency (reference number: SEQ19-03173) and initially received on 24-Sep-2019, concerning an 81-year-old, male patient.   The patient's medical history and concomitant medications were not provided.   On 20-Sep-2019, on Friday, the patient was administered INN Flu Vaccine [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiration date: not reported] for influenza prophylaxis.  On 22-Sep-2019, two days after vaccination, the patient had fever, at 101 Fahrenheit.  On 23-Sep-2019, the third day after vaccination, the patient had fever with 102+ Fahrenheit.  On 24-Sep-2019, four days after vaccination, the patient had a severe headache and reported that his sinuses were messed up. Additionally, the patient reported that his life was horrible.  At the time of initial reporting, the outcome for the events was not reported.  The reporter did not provide seriousness and causality criteria.  Non-significant follow up received by other non-health professional (consumer) on 08-Oct-2019: Reference number (SEQ19-03930) added. No changes were made in the narrative.  Company Comment: The patient experienced sinus disorder, headache and pyrexia after vaccination with the suspect product INN Flu Vaccine. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The patient experienced sinus disorder, headache and pyrexia after vaccination with the suspect product INN Flu Vaccine. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This is a spontaneous case, initially reported by other non-health professional via Med Communications (reference number: SEQ19-03596) on 30-Sep-2019, concerning a pregnant female patient of unspecified age.  The patient's medical history was not provided.  The patient's concomitant medications were not reported.  On an unknown date, the pregnant patient was administered unspecified Flu vaccine [influenza vaccine, anatomical location: left arm; dose, route of administration, batch number, expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza prophylaxis.  On 24-Oct-2019, at unknown gestational age, the patient delivered a normal, male neonate who was full term. The neonate was healthy and did not have problems at birth or since. The patient stated he was doing really well.   The patient did not experience any adverse event after vaccination.  Company comment: Event Vaccine exposure during pregnancy is considered as not related to unspecified Flu vaccine.  Follow up received from other non-health professional on 03-Dec-2019: Patient's date of birth added; Pregnancy outcome information provided. Indication and anatomical location for vaccine added. It was confirmed that the patient did not experience any adverse event after vaccination. Narrative was amended accordingly. ; Sender's Comments: Event Vaccine exposure during pregnancy is considered as not related to unspecified Flu vaccine.
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous case, initially received from pharmacist via Communications (reference number: SEQ19-03530) on 30-Sep-2019, concerning a male patient of an unknown age.   The patient's medical history and concomitant medications were not provided.  On the unknown date, the patient was administered unspecified Flu vaccine [Influenza vaccine, dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.  On the unknown date, after vaccination, the patient developed an allergic reaction.   At the time of initial reporting, the outcome for the event of allergic reaction was not reported.  The case was assessed as non-serious and reporter did not provide causality assessment.  No new information reported by pharmacist to Communications [reference number: SEQ19-04362] on 06-Nov-2019: Additional Communications number added. No changes in narrative.  Follow up received on 10-Oct-2019: Report type was changed from invalid to spontaneous as it was confirmed that the patient administered unspecified Flu vaccine instead of egg-based Flucelvax Quad. Narrative was updated accordingly.; Sender's Comments: Event of allergic reaction is considered as related to Flu vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Vaccine exposure during pregnancy; This is a spontaneous case initially received from agency (case ID: SEQ19-03793) by pharmacist on 03-Oct-2019, concerning a pregnant female patient of unknown age.  The patient's current medical conditions, concomitant medications and pregnancy information were not provided.   On 03-Oct-2019, the patient was administered Flu vaccine (influenza vaccine, dose, anatomical location, route of administration, batch number and expiration date: not provided) (explicitly coded as 'Vaccine exposure during pregnancy) for influenza prophylaxis.  At the time of the report, there was no adverse event described.  Event's causality was assessed as not related to the suspect product per company.; Sender's Comments: Event's causality was assessed as not related to the suspect product per company.
Sex: F
Vaccine: FLUX
Symptoms: Incorrect dose administered
Clinical narrative: The patient was administered high dose of vaccine; This is a spontaneous case, initially received from pharmacist via Communications (reference number: SEQ19-04364) and initially received on 10-Oct-2019, concerning an adult female patient.  The patient's relevant medical history and concomitant medications were not provided.  On an unspecified date in 2018, the patient was administered unspecified flu vaccine [Influenza vaccine, dose reported as: 'high dose', anatomical location, route of administration, batch number and expiration date: not reported] (explicitly coded as 'Inappropriate dose of vaccine administered') for an unknown indication.   It was unknown if the patient experienced any adverse event after vaccination.  This case is linked to case 201905210 (the same patient).  Non-significant follow-up reported by Communications (reference number: SEQ19-05385) on 23-Oct-2019: Additional Communications reference number added. No changes in narrative.; Sender's Comments: Reportedly, incorrect dose administered occurred during vaccination with the suspect product unspecified flu vaccine. Chronology is plausible. It was not reported if the patient experienced any adverse event. Causal role of the suspect product is assessed as not related per company conventions.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to 'adult flu shots' and can only take a child flu shot; This is spontaneous case initially reported by consumer via Patient Assistance Program to Communications (reference number: SEQ19-04829) on 16-Oct-2019, concerning an unknown age female patient.  The patient's medical history and concomitant medications were not reported.  On an unknown date the patient was administered INN Flu Vaccine [Influenza vaccine; route of administration: injection; batch number, expiration date, dose and anatomical location not reported] to prevent contracting Influenza.   On an unknown date the patient developed allergy to adult flu shots. It was reported that she can only take child flu shot.  The outcome of the event allergy to adult flu shots was not provided, at the time of this event.  The reporter didn't provide causality and seriousness assessment.  The patient refused to provide any additional information and didn't give permission to be contacted.  Event's causality was assessed as related to the suspect product per company.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Injection site stays hot; Injection site swells; This is a spontaneous case, reported by consumer to Communications (reference number: SEQ19-04825) and initially retrieved on 16-Oct-2019, concerning 8-year-old, female patient.  Patient's medical history and concomitant medications were not reported.  On unspecified date, the patient was administered INN Flu Vaccine [influenza vaccine, dose, route of administration, anatomical location, batch number, expiration date: not reported] for unknown indication.   On unspecified date, the patient developed vert bad injection site warmth and swelling. Reporter stated that it lasts for several weeks and looks like she was hit by a baseball. It was also reported that patient has been getting her dose from a multi-dose vile at the paediatrician and that these events have been happening for last couple of years.  The outcome of the events was not reported, at the time of the initial reporting.  The reported did not provide seriousness and causality.  Company comment: The patient developed vaccination site warmth and vaccination site swelling, associated with unspecified Influenza vaccine. The patient developed mentioned events on an unspecified day after vaccination. Chronology needs more clarification. More information regarding medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Nausea, Pain, Pyrexia
Clinical narrative: I was achy; Ran a fever; Felt nauseous; I was up all night feeling miserable; This is a spontaneous case, initially received from other non-health professional (consumer) via Communication (reference number: SEQ19-06120) on 04-Nov-2019, concerning a patient, of an unspecified age and gender.   The patient's relevant medical history was not reported.  The patient's concomitant medications were not reported.  On an unspecified date in 2019, the patient was administered with INN influenza vaccine [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 259814, route of administration, anatomical location and expiration date: not reported] for an unknown indication.  On an unspecified date in 2019, reported as on the following night, the patient was achy, ran a fever and felt nauseous. The patient was up all night feeling miserable. It was reported that this year was the first time the patient got a reaction.  The outcome of the events of ache, fever, nausea and feeling miserable was resolved, on an unspecific date.  The reporter did not provide seriousness or causality assessment to Flucelvax Quadrivalent.  Non-significant follow up received from other non-health professional (consumer) on 13-Nov-2019: Reference number (SEQ19-06574) added. No changes were made to the narrative.  Company comment: The patient experienced pain, pyrexia, nausea and feeling abnormal after vaccination with the suspect product INN influenza vaccine. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced pain, pyrexia, nausea and feeling abnormal after vaccination with the suspect product INN influenza vaccine. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Influenza like illness, Injection site pain, Lymph node pain
Clinical narrative: 1.  flu-like symptoms (chills, fever, muscle aches) kept me out of work the day after the shot- took Tylenol and alka selzer plus as often as allowed - symptoms ended after 48 hours 2.  a very painful injection site - no treatment - ended after 72 hours 3.  painful swollen lymph nodes  (neck, armpit and shoulder on the side of the injection) - no treatment - painful for 72 hours - almost resolved now, and no longer painful, but still somewhat swollen, and this is 5 days later -please note, he refused to report, but similar side effects also happened to my husband, 53 years old, who was vaccinated on the same day (58160-0823-11 ), but he did not have swollen nodes and did additionally have stomach pain and diarrhea  ***these side effects are unacceptable and had I known how bad it would be, I probably would not have been vaccinated.  I think you need to improve this vaccine, if you expect people to be immunized***
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: 1.  flu-like symptoms (chills, fever, muscle aches) kept me out of work the day after the shot- took Tylenol and alka selzer plus as often as allowed - symptoms ended after 48 hours 2.  a very painful injection site - no treatment - ended after 72 hours 3.  painful swollen lymph nodes  (neck, armpit and shoulder on the side of the injection) - no treatment - painful for 72 hours - almost resolved now, and no longer painful, but still somewhat swollen, and this is 5 days later -please note, he refused to report, but similar side effects also happened to my husband, 53 years old, who was vaccinated on the same day (58160-0823-11 ), but he did not have swollen nodes and did additionally have stomach pain and diarrhea  ***these side effects are unacceptable and had I known how bad it would be, I probably would not have been vaccinated.  I think you need to improve this vaccine, if you expect people to be immunized***
Age: 29.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Anxiety, Hyperacusis, Injection site pain, Injection site swelling, Migraine
Clinical narrative: Anxiety. Increased migraines. Hypersensitivity to sunlight, noise. Swelling and pain at injection site.
Age: 29.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Photophobia
Clinical narrative: Anxiety. Increased migraines. Hypersensitivity to sunlight, noise. Swelling and pain at injection site.
Age: 0.17
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events noted
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Ecchymosis, Injection site haemorrhage
Clinical narrative: APPROXIMATELY 21 HOURS AFTER INJECTION (R) mid-thigh circumference=27 cm.; (L)= 28.5 cm. (site of injection is clean on the Left anterior thigh); there are spotty ecchymotic lesions on the same anterior thigh & few similar lesions on the (R) lower leg, suggesting a systemic reaction;
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Febrile convulsion, Intensive care, Pyrexia
Clinical narrative: patient began with fever which then resulted to febrile seizures, patient now hospitalized in ICU
Age: 56.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Fever, headache, arm soreness, general malaise persisted overnight into the next day
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Scar
Clinical narrative: scarring on her abdomen; shingles; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In or around March 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles. In or around January 2018, the patient was diagnosed by a physician with shingles. As a result of the shingles diagnosis, she now had a scarring on her abdomen. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of the events was reported as not recovered ("also reported as was diagnosed with shingles that lasted for several weeks"). The causality was related.  The event of shingles and scarring on abdomen were considered to be disabling.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse symptoms; patient received VARIVAX on 08-JAN-2020 after the patient received MMR II on 20-DEC-2019; This spontaneous report was received from a licensed practical nurse referred to a 5-year-old female patient. The patient's pertinent medical history, drug reactions/allergies were not reported. The concomitant medications included sterile diluent (STERILE DILUENT). On 20-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, indication, lot # and expiry date were not reported) for prophylaxis. On 08-JAN-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R002051, expiry date 22-JAN-2020, via subcutaneous route for prophylaxis (inappropriate schedule of product administration). The reporter stated that, it was too short of an interval between the doses. There was no adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and developed Shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in November 2019, refer case US2020002562.).   On 2nd January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had arm soreness which lasted 2 days and has resolved. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Transfusion
Clinical narrative: Required a blood transfusion; This case was reported by a pharmacist via call center representative and described the occurrence of blood transfusion in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th December 2021) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix. On 3rd October 2019, 16 days after receiving Shingrix, the patient experienced blood transfusion. On an unknown date, the outcome of the blood transfusion was unknown.   It was unknown if the reporter considered the blood transfusion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 3rd October 2019, the patient received three pints of blood. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Blood test normal, Discomfort, Dizziness
Clinical narrative: only exercise for 15 minutes and he has to go to bed and rest; Terrible pain; slight dizziness; feet felt heavy; muscle collapse; threw out his knee; Discomfort; This case was reported by a consumer via call center representative and described the occurrence of muscle disorder in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included sinus operation. Previously administered products included Shingrix with an associated reaction of discomfort (received 1st dose on an unknown date and experienced discomfort).   On 7th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, 6 days after receiving Shingrix, the patient experienced muscle disorder, knee pain and discomfort. On an unknown date, the patient experienced energy decreased, pain, dizziness and heaviness in extremities. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle disorder, knee pain, energy decreased, dizziness and heaviness in extremities were unknown and the outcome of the discomfort and pain were recovered/resolved.   It was unknown if the reporter considered the muscle disorder, knee pain, discomfort, energy decreased, pain, dizziness and heaviness in extremities to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received his second dose and experienced muscle collapse and he threw out his knee. The patient also experienced mild discomfort for about 3 days. The patient gone to 6 doctors and all of his blood tests come back as normal. The patient was very healthy and used to work out 5 days per week and go dancing regularly. After vaccination patient can only exercise for 15 minutes and he has to go to bed and rest. For 1 month he was in terrible pain, but it had passed. The patient began a mild exercise routine for 4 weeks, but developed slight dizziness and his feet felt heavy.      Lab Comments: On an unknown date blood test was done