chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site extravasation, Injection site pain, Injection site rash
Clinical narrative: Rash on the injection site; Developed soreness [and a rash] on the injection site/had soreness; Some of the vaccine came out afterwards/a couple of drops came out; Some of the vaccine came out afterwards/couple of drops came out; This spontaneous case, initially received from a pharmacist on 03-Oct-2018, concerns a 66-year-old, elderly female patient.  The patient's current conditions included abnormal blood pressure and breathing problems (reported as medical history). The patient's concomitant medications included Norvasc (amlodipine besilate), lisinopril, metoprolol, simvastatin, isosorbide, Symbicort (budesonide, formoterol fumarate) and Ventolin (salbutamol) for unknown indications.  On 02-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: reported as 0.5 ml but few drops came out (explicitly coded as injection site leaking), route of administration: intramuscular, anatomical location: deltoid, batch number: 01944611A and expiry date: 24-May-2019] (explicitly coded as incomplete dose administered) for active immunization against influenza.  On the same day (reported as the end of the day), the patient developed soreness and rash on the injection site. The patient used Tylenol (paracetamol) and applied ice packs as treatment.  On an unspecified date in Oct-2018 (reported as after 3 or 4 days), the patient had recovered from the events.  The reporter assessed this case as non-serious.  Follow-up received from the pharmacist on 30-Oct-2018: Expiry date of the product was changed from 14-May-2019 to 24-May-2019 in the product tab. Treatment drug Tylenol was added in the product tab. Stop date (unspecified date in Oct-2018) was added and outcome of the events injection site rash and injection site pain was updated from not recovered to recovered in the event tab. Narrative was amended accordingly.; Reporter's Comments: A 66-year-old, female patient developed soreness and a rash on the injection site, on the same day after administration of an incomplete dose of the suspect vaccine Afluria Quadrivalent (incomplete dose administered) since a couple of drops of vaccine came out (injection site leaking). The company assessed the causality of the events injection site soreness and injection site rash as related due to plausible temporal relationship between the events and suspect vaccine. The company assessed the causality of the events incomplete dose administered and injection site leaking as not related, considering the events as accidental nature of the events.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Headache, Hypersensitivity, Lip swelling, Nasal congestion
Clinical narrative: Swollen lips/lips became swollen; Nasal congestion; Extremely tired; Allergic reaction to the Aflluria vaccine; Progressed to head ached; Feelings of nausea; This spontaneous case, initially received from other non-health professional on 02-Oct-2018, concerns a 50-year-old, adult male patient.  The patient had no historical condition. The patient did not receive any concomitant medication.  On 26-Sep-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 01944621A (reported as 019446218) and expiry date: 25-May-2018] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On the same day, within 3-4 hours after the vaccination, the patient developed allergic reaction to the suspect vaccine. The patient felt extremely tired, then progressed to head ache, then feeling of nausea. The patient's lips became swollen with nasal congestion. The events lasted for around 20 hours.  On 27-Sep-2018 (reported as within 24 hrs), the patient recovered from the events.  The reporter assessed the case as non-serious and the causality as related.  Follow-up received from other health professional on 01-Nov-2018: Dose, route of administration and anatomical location of the suspect vaccine was added in the product tab. The event weight fluctuation' was deleted from the event tab as the reporter clarified it to be "extremely tired" instead of "extreme weight". Narrative and case comment were amended accordingly.; Reporter's Comments: A 50-year-old, male patient developed allergic reaction to the suspect vaccine that included tiredness, headache, nausea, swollen lips and nasal congestion, 3-4 hours after the administration of Afluria Quadrivalent. The company assessed the causality as related due to plausible temporal relationship between the events and the suspect vaccine.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Swollen lips/lips became swollen; Nasal congestion; Extremely tired; Allergic reaction to the Aflluria vaccine; Progressed to head ached; Feelings of nausea; This spontaneous case, initially received from other non-health professional on 02-Oct-2018, concerns a 50-year-old, adult male patient.  The patient had no historical condition. The patient did not receive any concomitant medication.  On 26-Sep-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 01944621A (reported as 019446218) and expiry date: 25-May-2018] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On the same day, within 3-4 hours after the vaccination, the patient developed allergic reaction to the suspect vaccine. The patient felt extremely tired, then progressed to head ache, then feeling of nausea. The patient's lips became swollen with nasal congestion. The events lasted for around 20 hours.  On 27-Sep-2018 (reported as within 24 hrs), the patient recovered from the events.  The reporter assessed the case as non-serious and the causality as related.  Follow-up received from other health professional on 01-Nov-2018: Dose, route of administration and anatomical location of the suspect vaccine was added in the product tab. The event weight fluctuation' was deleted from the event tab as the reporter clarified it to be "extremely tired" instead of "extreme weight". Narrative and case comment were amended accordingly.; Reporter's Comments: A 50-year-old, male patient developed allergic reaction to the suspect vaccine that included tiredness, headache, nausea, swollen lips and nasal congestion, 3-4 hours after the administration of Afluria Quadrivalent. The company assessed the causality as related due to plausible temporal relationship between the events and the suspect vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Red circle of 5 cm; This spontaneous case, initially received from other health professional (nurse) on 05-Oct-2018, concerning a female patient of unspecified age.  On 04-Oct-2018, the patient was administered Afluria Quadrivalent vaccine [influenza vaccine, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 01344611A (reported as 03144611A) and expiry date: 30-Jun-2019] for active immunization against influenza.  On the same day, 6 hours after vaccination, the patient developed a red circle of 5 cm in area.   At the time of this report, the patient had not recovered from the event (redness).  The reporter assessed the case as non-serious.  This case was linked to 201804327 due to same reporter.  Update received on 02-Nov-2018: Non-significant case correction (IRD: 05-Oct-2018)- The area of red circle in the narrative was changed from 5 m to 5 cm and amended accordingly.; Reporter's Comments: A female patient of unspecified age developed erythema, 6 hours after vaccination with Afluria Quadrivalent vaccine. The company assessed the causality of the event as related to the suspect vaccine, due to plausible temporal relationship between the event and suspect vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Got a red circle of 5 cm; This spontaneous case, initially received on 05-Oct-2018, reported by other healthcare professional (nurse), concerns a female patient of unspecified age.  The patient's medical history and concomitant medications were not reported.  On 03-Oct-2018, the patient was administered Afluria Quadrivalent [influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00344611A (reported as 03144611A) and expiry date: 30-Jun-2019] for active immunization against influenza.   On 04-Oct-2018, 1 day after vaccination, the patient developed a red circle of 5 cm. On 05-Oct-2018, red circle reduced to 4 cm. The patient's treatment medications were not reported.  It was reported that, the patient was not hospitalized.  At the time of this report, the patient had not yet recovered from the event.  The reporter assessed this case as non-serious.  This case 201804329 was cross-linked to the case 201804327 due to the same reporter.; Reporter's Comments: A female patient of unspecified age developed redness, 1 day after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related due to plausible temporal relationship between the event and suspect vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Skin reaction, Skin warm
Clinical narrative: Area is warm to touch; Got a red circle of 5 cm on 04-Oct-2018/05-Oct-2018 the circle has gone from 5 cm to 6 cm; This spontaneous case, initially received on 05-Oct-2018, reported by other healthcare professional (nurse), concerns a female patient of unspecified age.  On 03-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00344611A (reported as 03144611A) and expiry date: 30-Jun-2019] for active immunization against influenza.  On 04-Oct-2018, 1 day after vaccination, the patient developed a red circle of 5 cm. On 05-Oct-2018, 2 days after vaccination, the red circle was enlarged from 5 cm to 6 cm, which was warm to touch.  It was reported that, the patient was not hospitalized.   At the time of this report, the patient had not yet recovered from the events.  The reporter assessed this case as non-serious.  This case was cross-linked to case 201804327 due to the same reporter.; Reporter's Comments: A female patient of unspecified age developed erythema, 1 day after vaccination and skin warm 2 days after vaccination with Afluria Quadrivalent. The company assessed the causality of the events as related due to plausible temporal relationship between the events and suspect vaccine.
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Injection site mass, Injection site pruritus, Pyrexia
Clinical narrative: Still don't feel back to myself; Had an Afluria shot and it was like there was a golf ball under my skin; Start itching like crazy; Fever of 102.7; This spontaneous case, reported by other non-health professional (consumer) and initially received on 09-Oct-2018, concerns a male patient of an unspecified age.  On an unspecified date (reported as few weeks ago), the patient was administered Afluria Quadrivalent (influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication.  On an unspecified date, after vaccination, the patient felt it was like there was a golf ball under her skin and about 10 minutes later, it started itching like crazy. The next day the patient woke up with fever of 102.7 and she still didn't feel back to herself.   The outcome of the events was not reported.  Update received on 02-Nov-2018: Significant case correction (09-Oct-2018): The listedness of the event injection site mass was changed from unlisted to listed in the event assessment tab. No changes made in the narrative.; Reporter's Comments: A male patient of unspecified age, the patient felt like it was like there was a golf ball under his skin and experienced itching like crazy, fever of 102.7 and didn't feel back to herself, after unspecified days of vaccination. The causality of the events injection site lump, feeling abnormal, itching and pyrexia were assessed as related due to the site-specific reaction (injection site) and plausible temporal relationship between the events and the suspect vaccine.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Vomiting
Clinical narrative: Vomiting; Chills; This spontaneous case, initially received from a pharmacist on 08-Oct-2018, concerns a 29-year-old, adult, female patient.   On 08-Oct-2018, the patient was administered Afluria QIV [influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF40408, expiry date: 30-Jun-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.   On 08-Oct-2018, within 15-20 minutes of vaccination, the patient experienced a reaction which included vomiting with chills. The patient took two doses of Emetrol (fructose, glucose, phosphoric acid) but continued to vomit. Subsequently, the pharmacist referred the patient to the emergency room (ER). On the same day, the patient went to the emergency room. The next day, on 09-Oct-2018, the patient was resting at home. And the day after that, on 10-Oct-2018, the patient went back to work again and was feeling well.  On 10-Oct-2018, the patient had recovered from the event vomiting and the outcome of the event chills was not reported.  The reporter assessed this case as non-serious.  The reporter assessed this case as non-serious and considered the causality of the events as related to the suspect vaccine.  Follow up received by the pharmacist on 02-Nov-2018: The outcome of the event vomiting was changed from not recovered to recovered. The stop date (10-Oct-2018) of the event vomiting was added in the event tab. It was reported that on the same day, the patient went to the emergency room. The next day, on 09-Oct-2018, the patient was resting at home. And the day after that, on 10-Oct-2018, the patient went back to work again and was feeling well. The narrative was amended accordingly.; Reporter's Comments: A 29-year-old, female patient, experienced chills and vomiting, within 15-20 minutes of vaccination with Afluria Quadrivalent. The company assessed the causality of the events as related considering the plausible temporal relationship between events and suspect vaccine.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Exposure during pregnancy, Malaise
Clinical narrative: Six months pregnant received the Afluria Quadrivalent vaccine; Sick before receiving the vaccine/accentuated after receiving the vaccine; This spontaneous case, initially received from the other health professional (nurse) on 08-Oct-2018, concerns a 37-year-old, adult pregnant patient.  The patient's historical condition included diabetes. The maternal medical history relevant to pregnancy included diabetes and the paternal medical history relevant to pregnancy included cancer and diabetes. The patient had miscarriage in her first pregnancy and premature delivery in the second pregnancy. The historical drug prior pregnancy included ortho tri-cyclen for birth control. The medication taken by the patient's husband prior conception was omeprazole. On an unspecified date, the patient underwent prenatal test and there was no evidence of defect or adverse finding.  The patient's current condition included sickness (reported as sick). The patient's concomitant medications included Effexor (venlafaxine hydrochloride) and Prenatal vitamins (minerals nos, vitamins nos) both for unknown indications.   The patient's last menstrual period date was 30-Mar-2018.  On 08-Oct-2018, the pregnant patient (27-week gestation period) was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 02444611A and expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy) for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On an unspecified date in Oct-2018, the patient's sickness accentuated (coded as condition aggravated). The patient administered Tylenol (paracetamol) for the treatment of sickness. On 09-Oct-2018, the patient was home sick.  At the time of this report, the outcome of the event condition aggravated was not reported.  The expected delivery date of the patient was 02-Feb-2019.  The reporter assessed the case as non-serious.  Non-significant case amendment (08-Oct-2018): The indication for the historical drug (ortho Tri-Cyclen) was corrected from indication not reported' to birth control'. The narrative was amended accordingly.  Non-significant follow up received from other health professional on 04-Feb-2019: Three unsuccessful attempts were made to reach the patient. Hence the case was considered lost to follow up. Med info number was added in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 37-year-old, pregnant patient's sickness accentuated (coded as condition aggravated) after the administration of Afluria Quadrivalent (explicitly coded as vaccine exposure during pregnancy). The company assessed the causality of the event condition aggravated as related to the suspect vaccine due to plausible temporal relationship between the events and suspect vaccine. The causality of the event vaccine exposure during pregnancy was assessed as not related considering it as a special situation.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: 2 inch area erythema/local reaction at the site of injection; This spontaneous case, initially received on 11-Oct-2018, reported by other healthcare professional (nurse) concerns a patient of an unspecified gender and age.  On an unspecified date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00844621A (reported as 02844621A), expiry date: 25-Jun-2019] for an unknown indication.   On an unspecified date after vaccination, the patient developed erythema of size 2 inches in area at the site of injection.  At the time of this report, the outcome of the event was not reported.  The reporter assessed this case as non-serious.  This case was linked to case 201804405 owing to the same reporter.  Non-significant case amendment (11-Oct-2018): The sentence 'On an unspecified date after vaccination, the patient developed erythema of size 2 inches' in narrative was changed to 'On an unspecified date after vaccination, the patient developed erythema of size 2 inches in area at the site of injection'.; Reporter's Comments: A patient of unspecified gender and age developed injection site erythema after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related to the suspect vaccine due to site-specific occurrence of the event.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local reactions at the site of injections/2 inch area erythema; This spontaneous case, initially received from other healthcare professional (nurse) on 11-Oct-2018, concerning a patient of unspecified gender and age.  On an unspecified date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00844621A (reported as 02844621A) and expiry date: 25-Jun-2019] for an unknown indication.   On an unspecified date after vaccination, the patient developed erythema of 2 inches in the area at the site of injection which was considered as a local reaction.  At the time of this report, the outcome of the event was not reported.  The reporter assessed this case as non-serious.  This case: 201804408 was cross-linked to case 201804405 owing to the same reporter.  Non-significant case amendment (11-Oct-2018): The sentence On an unspecified date after vaccination, the patient developed erythema of 2 inches in area' was changed from to On an unspecified date after vaccination, the patient developed erythema of 2 inches in the area at the site of injection' in the narrative.; Reporter's Comments: A patient of an unspecified gender and age developed injection site erythema on an unspecified date after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related to the suspect vaccine due to site-specific occurrence of the event.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Expired product administered
Clinical narrative: Diarrhea; Expired vaccine given; This spontaneous, initially received from other health professional on 12-Oct-2018, concern a 39-year-old, adult, female patient.   On 10-Oct-2018, the patient was administered expired Afluria Quadrivalent (Influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 01344611A (reported as 0134461A) and expiry date: 30-Jun-2018) for influenza prophylaxis (explicitly coded as expired vaccine used).    On 12-Oct-2018, 2 days after vaccination, the patient experienced diarrhoea. The patient did not receive any treatment medications.  The reporter confirmed that the event of diarrhea lasted only for few days.   The reporter assessed this case as non-serious.  The reporter confirmed that the event of diarrhea was not related to the vaccine because it was prevalant around the office (reported as evet had been going around the office).   This case: 201804450 was crosslinked to the case: 201804449 due to same reporter.  Follow-up received from the reporter on 29-Oct-2018: The onset date of the event diarrhea was updated from Oct-2018 to 12-Oct-2018. The outcome of the event diarrhea was updated from not reported to recovered. The stop date was updated as Oct-2018. The reporter causality of the event diarrhea was updated from 'not reported' to 'not related'. The narrative and case comment were amended accordingly.; Reporter's Comments: A 39-year-old female patient experienced diarrhoea, 2 days after receiving expired Afluria Quadrivalent (explicitly coded as expired vaccine used). The company assessed the causality of the event expired vaccine used as not related to the suspect vaccine, considering the accidental nature of the event. The company assessed the causality of the event diarrhoea as not related to the suspect vaccine as the event was prevalant around the office during the specified period.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Bone pain, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Aching joints; Bone [muscle] ache; Feeling very bad; High fever of 103 F; Muscle ache; This spontaneous case, initially received on 12-Oct-2018 from other health professional (nurse), concerns a 38-year-old, adult male patient.  The patient had no historical condition and concomitant medication.  On 11-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 02644611A and expiry date: 18-Jun-2019) for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.  On the same day, about 8 hours after vaccination, the patient developed high fever of 103 F, aching joints, bone pain and muscle ache. Overnight, the patient felt very bad. The patient felt much better the next morning, when he woke up.  On 12-Oct-2018, the patient had recovered from the events.  The reporter assessed the case as non-serious.; Reporter's Comments: A 38-year-old, male patient developed high fever, aching joints, bone and muscle ache, about 8 hours after the administration of suspect vaccine Afluria Quadrivalent. The patient also felt abnormal overnight, on the same day after vaccination. The company assessed the causality of the events as related due to plausible temporal relationship between the events and suspect vaccine.
Sex: U
Vaccine: HEPAB
Symptoms: Blood test, Hepatitis A, Hepatitis A virus test positive
Clinical narrative: Hepatitis A was reactive; This case was reported by a physician via call center representative and described the occurrence of hepatitis a in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st two doses on unknown dates).   On an unknown date, the patient received the 3rd dose of Twinrix. On an unknown date, 1 week after receiving Twinrix, the patient experienced hepatitis a. On an unknown date, the outcome of the hepatitis a was unknown.   It was unknown if the reporter considered the hepatitis a to be related to Twinrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received three doses of Twinrix. One week after 3rd dose, the patient had blood work done and a Hepatitis panel was drawn and result was found as Hepatitis A reactive. No other information was reported. The reporter consented to follow up.      Lab Comments: on an unknown date lab tests was performed
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm pain/persistent pain in arm; This is a spontaneous case, initially received on 25-Sep-2018 (combinedly processed), reported by other non-health professional, concerning a 25-year-old, adult, female patient.  On an unspecified date in 2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml (reported as full dose administered), route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date not reported) for influenza prophylaxis.  On an unspecified date in 2018 after the vaccination, the patient experienced prolonged arm pain (more than the normal 24 to 48 hours) with no warmth, swelling or redness for 10 days. The patient had no systemic, anaphylactic, nor local swelling and redness, just the persistent pain in arm. The pain was not extreme, nor life style altering.  On an unspecified date in 2018, the patient was treated with Advil (ibuprofen) which made a little difference in reducing or eliminating the degree of pain nor the length of time it had persisted.  At the time of the report, the time length of the pain was reported as greater than 10 days, and hence the patient had not recovered from the event.  The reporter assessed the case as non-serious.  This case was considered as lost to follow up, since the reported had not given the consent to follow up.; Reporter's Comments: A 25-year-old female patient developed persisting arm pain on an unspecified day after receiving the suspect vaccine Afluria Quadrivalent. The company assessed the causality of the event as related due to the plausible temporal relationship.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Rash
Clinical narrative: Developed a rash; Allergic reaction to Afluria Quadrivalent; This spontaneous case, initially received from a pharmacist on 27-Sep-2018, concerns a 9-year-old, male child patient.   The patient had no relevant medical history. The patient had not received any concomitant medications.   On 15-Nov-2017, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported] for influenza prophylaxis.  On an unspecified date in Nov-2017, 2-3 days after vaccination, the patient developed a rash. Reporter stated that, it was an allergic reaction to the vaccine and thought it was due to Neosporin. The patient was treated with hydrocortisone (reported as hidrocortisone) (hydrocortisone acetate).  The patient had recovered from the events.  The reporter assessed this case as non-serious and the causality as related to the suspect vaccine.  Update received on 02-Nov-2018: Non-significant case correction (27-Sep-2018): The sentence in the narrative was changed from 'the patient was treated with hydrocortisone (hydrocortisone acetate)' to ' the patient was treated with hydrocortisone (reported as hidrocortisone) (hydrocortisone acetate)'.  Update received on 05-Nov-2018: Non-significant case correction (27-Sep-2018): Treatment received for the event 'allergy to vaccine' was changed from 'unknown' to yes' in the event tab. No changes were made in the narrative.; Reporter's Comments: A 9-year-old, male patient developed a rash considering as allergic reaction, 2-3 days after vaccination with the suspect vaccine Afluria Quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between events and suspect vaccine.
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Visual impairment
Clinical narrative: Visual disturbances; Dizziness; This spontaneous case, initially received from other health professional (pharmacist) on 28-Sep-2018, concerns a male patient of an unspecified age.  On 27-Sep-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: YF40408 and expiry date: 30-Jun-2019) for protection against seasonal influenza.  On 28-Sep-2018, one day after vaccination, the patient began to experience visual disturbance and dizziness. The patient had two episodes of it on the day of this report. It was reported that, the patient did not receive any treatment for the events.   At the time of this report the outcome of the events were unknown.  The reporter assessed the case as non-serious.; Reporter's Comments: A male patient of an unspecified age experienced visual disturbance and dizziness one day after the administration of Afluria Quadrivalent. The company assessed the causality as related due to plausible temporal relationship between the events and suspect vaccine.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Hot effect / hot to the touch; Injection site went tall and swollen, bigger than half a dollar; Injection site went [tall and swollen, bigger than half a dollar,] red; Tender to the touch; Severe headache; This spontaneous case, initially received from other health professional (nurse) on 28-Sep-2018, concerns a 56-year-old, adult, female patient.  The patient did not have any medical history and did not take any medications at the time of vaccination.  On 25-Sep-2018, the patient was administered Afluria (QIV) [(influenza vaccine), dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 02444611A and expiry date: 06-Jun-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.   On 26-Sep-2018, one day after vaccination, the patient's injection site went tall and swollen, bigger than half a dollar. The site was red and hot to the touch (for 24 hours), the area was also tender to the touch. The patient also reported severe headache, but not fever. On 27-Sep-2018, the patient had recovered from the event- injection site warmth. On an unspecified date in 2018 (reported as within one week of vaccine administration), the patient had recovered from the events injection site swelling, injection site redness, injection site tenderness and headache. It was reported that, the patient felt better.  The reporter assessed the case as non-serious.  Follow-up received from the other health professional on 24-Oct-2018 (combinedly processed with follow-up received on 26-Oct-2018): The expiry date of the vaccine was added. The outcome of the events (injection site swelling, injection site redness, injection site tenderness and headache) was changed from unknown to recovered (within one week after vaccination). It was reported that, the patient felt better. Narrative was amended accordingly.; Reporter's Comments: A 56-year-old female patient experienced injection site warmth, swelling, redness, tenderness and severe headache one day after the administration of suspect vaccine Afluria (QIV). The company assessed the causality of the events related to the suspect vaccine due to anatomical site-specific reaction and plausible temporal relationship between the suspect vaccine and the events.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Oral herpes
Clinical narrative: Weakness; Cold sore; This spontaneous case, initially received from other non-health professional on 15-Oct-2018, concerns a 32-year-old, adult male patient.   The patient's historical conditions included hyperthyroidism and sleep issues. The patient's concomitant medications included doxycycline and Zyrtec (cetirizine hydrochloride) for unknown indications.  On 10-Oct-2018, the patient was administered with Afluria Quadrivalent (Influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF39508, and expiry date: 30-Jun-2019) [explicitly reported as Afluria Trivalent] for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.   On 11-Oct-2018, 1 day after vaccination, the patient experienced cold sore and weakness. On an unspecified date, the patient made an emergency room visit for cold sore and was prescribed with Valtrex.  On 13-Oct-2018, the patient had recovered from the event weakness. On -25-Oct-2018, the patient had recovered from the event cold sore.  The reporter assessed this case as non-serious.  Follow-up received on 01-Nov-2018: Expiry date of the suspect vaccine was added in the product tab. Stop date of the event cold soar was added in the event tab and the outcome of the same was changed to recovered. Narrative was amended accordingly.; Reporter's Comments: A 32-year-old, male patient experienced cold sore and weakness, 1 day after vaccination with Afluria Quadrivalent. The company assessed the causality of the event weakness as related due to plausible temporal relationship between event and suspect vaccine and cold sore as not related, due to infectious nature of the event.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain at injection site/pain in her arm; This spontaneous case, initially received from a pharmacist on 16-Oct-2018, concerns a 49-year-old, adult female patient.  The patient had no relevant medical history and had not received any concomitant medications.  On 02-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF39908, expiry date: 30-Jun-2019] for influenza prophylaxis.  On the same day, immediately after vaccination, the patient experienced pain at the injection site for 2 weeks. It was reported that, the patient felt fine when she was vaccinated but from the moment she was vaccinated, she experienced pain in her arm. The patient was treated with ibuprofen.  On an unspecified date in 2018, the patient was feeling better (recovering).  The reporter assessed this case as non-serious.  Follow up received from the pharmacist on 02-Nov-2018: The treatment drug (ibuprofen) was added in the product tab. The outcome of the event injection site pain was changed from not recovered to recovering. The narrative was amended accordingly.  Non-significant case amendment (16-Oct-2018): The duration (2 weeks) of the event was removed in the event tab. No changes were done in the narrative.; Reporter's Comments: A 49-year-old, female patient experienced pain at the injection site, immediately after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related due to the site-specific reaction and plausible temporal relationship between event and suspect vaccine.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Muscle discomfort
Clinical narrative: Discomfort at the injection site [up to neck muscles]; Discomfort [at the injection site] up to neck muscles; This spontaneous case, initially received from a pharmacist on 17-Oct-2018, concerns a 41-year-old, adult female patient.  The patient's current condition included diabetes (since an unspecified date). The patient's concomitant medications included Metformin (metformin hydrochloride), glimepiride and Depo-provera (medroxyprogesterone acetate) for unknown indications.  On 10-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF40908 and expiry date: 30-Jun-2019) for influenza prophylaxis.  On the same day, two hours after vaccination, the patient experienced discomfort at the injection site up to neck muscles. There was no swelling or redness. The patient did not take any treatment measure. It was reported that, the patient would try analgesics and contact physician if no improvement.  On an unspecified date in Oct-2018 (12 to 14 days after administration of the vaccine), the patient had recovered from the events.  The reporter assessed the case as non-serious.  Follow-up report received from a pharmacist on 20-Nov-2018: The reporter confirmed that, the patient had recovered from events, 12 to 14 days after administration of the vaccine. The outcome of the events was changed from not recovered' to recovered'. The narrative was amended accordingly.; Reporter's Comments: A 41-year-old, female patient experienced discomfort at the injection site up to neck muscles, two hours after the administration of Afluria Quadrivalent. The causality of the event injection site discomfort and muscle discomfort as related to the suspect vaccine due to the plausible temporal relationship and site-specific reactions.
Sex: F
Vaccine: FLU4
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Ears were ringing; Felt like her ears needed to pop; This spontaneous case, initially received on 17-Oct-2018, reported by other healthcare professional (nurse), concerns a female patient of unspecified age.  The patient's historical condition and medication at the time of vaccination were unknown.  On 17-Oct-2018, the patient was administered Afluria (TIV) [Influenza Vaccine; dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported] for protection against seasonal influenza. It was reported that it was not clear if the vaccine administered was quadrivalent or trivalent formulation.  On the same day after vaccination, the patient experienced ringing in ears and felt like her ears needed to pop. Patient stated that she was not feeling this way before receiving the vaccine Afluria.   The patient did not take any treatment measures for the event.  At the time of this report, the patient had not recovered from the events.  The reporter assessed this case as non-serious.; Reporter's Comments: A female patient of unspecified age developed tinnitus and abnormal feeling, on an unspecified date after vaccination with Afluria (TIV). The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and reported events.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: C-reactive protein normal, Full blood count normal, Granulocyte count increased, Headache, Lymphocyte count decreased
Clinical narrative: Major headaches/headache is still really bad; Nausea; Granulocytes were high at 81.2; Lymphocyte number was low at 0.9; This spontaneous case, initially received on 18-Oct-2018, from other health professional, concerning a 64-year-old, adult female patient.  The patient had no medical history and the concomitant medications included aspirin, calcium carbonate and acetaminophen for unknown indications.  On 16-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: YF41508 and expiry date: 30-Jun-2019] for influenza prophylaxis.  On 17-Oct-2018, 1 day after vaccination, the patient experienced major headache and nausea. On the same day, the patient was taken to the emergency room (ER) and treated with normal saline (1000 ml intravenous), ketorolac (30 mg, intravenous) and Zofran (ondansetron, 4 mg injection). On the same day, at 14:30 pm, the patient received another injection of ketorolac. The complete blood tests (CBC) (CVC as reported), comprehensive metabolic panel (CMP) tests and C-reactive protein tests were performed and granulocytes were 81.2 (elevated) and lymphocytes were 0.9 (depressed) (units not reported). All other tests were found to be normal. On 18-Oct-2018, the patient was taken to ER again and treated with prochlorperazine (prochlorperazine maleate, 5 mg, intravenous), ketorolac (30 mg, intravenous) and Benadryl injection (diphenhydramine hydrochloride, 50 mg in 100 ml solution, intravenous). The patient also continued Zofran (orally). On the same day, computed tomography (CT) scan of head was ordered and the patient sent to home with a prescription of Phenergan 25 mg. It was reported that, the patient still felt really bad headache.    At the time of this report, the patient had not recovered from the event headache and outcome of the event nausea was not reported. The outcome of the events (granulocyte count high and lymphocyte count low) was unknown.  The reporter assessed the case as serious (medically significant).; Reporter's Comments: A 64-year-old, adult female patient experienced headache, nausea one day after receipt of Afluria QIV vaccine. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assesses the events as possibly related to suspect vaccine.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test normal, Nausea
Clinical narrative: Major headaches/headache is still really bad; Nausea; Granulocytes were high at 81.2; Lymphocyte number was low at 0.9; This spontaneous case, initially received on 18-Oct-2018, from other health professional, concerning a 64-year-old, adult female patient.  The patient had no medical history and the concomitant medications included aspirin, calcium carbonate and acetaminophen for unknown indications.  On 16-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: YF41508 and expiry date: 30-Jun-2019] for influenza prophylaxis.  On 17-Oct-2018, 1 day after vaccination, the patient experienced major headache and nausea. On the same day, the patient was taken to the emergency room (ER) and treated with normal saline (1000 ml intravenous), ketorolac (30 mg, intravenous) and Zofran (ondansetron, 4 mg injection). On the same day, at 14:30 pm, the patient received another injection of ketorolac. The complete blood tests (CBC) (CVC as reported), comprehensive metabolic panel (CMP) tests and C-reactive protein tests were performed and granulocytes were 81.2 (elevated) and lymphocytes were 0.9 (depressed) (units not reported). All other tests were found to be normal. On 18-Oct-2018, the patient was taken to ER again and treated with prochlorperazine (prochlorperazine maleate, 5 mg, intravenous), ketorolac (30 mg, intravenous) and Benadryl injection (diphenhydramine hydrochloride, 50 mg in 100 ml solution, intravenous). The patient also continued Zofran (orally). On the same day, computed tomography (CT) scan of head was ordered and the patient sent to home with a prescription of Phenergan 25 mg. It was reported that, the patient still felt really bad headache.    At the time of this report, the patient had not recovered from the event headache and outcome of the event nausea was not reported. The outcome of the events (granulocyte count high and lymphocyte count low) was unknown.  The reporter assessed the case as serious (medically significant).; Reporter's Comments: A 64-year-old, adult female patient experienced headache, nausea one day after receipt of Afluria QIV vaccine. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assesses the events as possibly related to suspect vaccine.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Feeling abnormal, Feeling hot, Hypersensitivity
Clinical narrative: Felt extreme heat through body; Face and neck were bright red; Felt dizzy; Right side of body felt strange; Having a stroke; Nasty allergic reaction; This spontaneous case, initially received from other non-health professional via Merck (00986633) on 24-Oct-2018, concerns a female patient of an unspecified age.  The patient's historical vaccine included Afluria vaccine on an unspecified date in 2015 and 2016 (reported as past three years) for unknown indications.  On an unspecified date in 2017, the patient was administered Afluria (TIV) (influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication.  On the same day, within 20 minutes after vaccination, the patient experienced extreme heat through her body and her face and neck were bright red. The patient felt dizzy and the right side of her body felt strange. The patient experienced nasty allergic reaction which she described as having a stroke (coded as post procedural stroke). The patient sat on her car until the symptoms had resolved.  At the time of this report, the outcome of the events was recovered.; Reporter's Comments: A female patient of an unspecified age experienced allergic reaction, sensation of heat, redness of face and neck, dizziness, right side of her body felt strange and had post procedural stroke, within 20 minutes after the administration of Afluria (TIV). The compnay assessed the causality as related due to plausible temporal relationship between the events and suspect vaccine.
Sex: F
Vaccine: FLU3
Symptoms: Post procedural stroke
Clinical narrative: Felt extreme heat through body; Face and neck were bright red; Felt dizzy; Right side of body felt strange; Having a stroke; Nasty allergic reaction; This spontaneous case, initially received from other non-health professional via Merck (00986633) on 24-Oct-2018, concerns a female patient of an unspecified age.  The patient's historical vaccine included Afluria vaccine on an unspecified date in 2015 and 2016 (reported as past three years) for unknown indications.  On an unspecified date in 2017, the patient was administered Afluria (TIV) (influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication.  On the same day, within 20 minutes after vaccination, the patient experienced extreme heat through her body and her face and neck were bright red. The patient felt dizzy and the right side of her body felt strange. The patient experienced nasty allergic reaction which she described as having a stroke (coded as post procedural stroke). The patient sat on her car until the symptoms had resolved.  At the time of this report, the outcome of the events was recovered.; Reporter's Comments: A female patient of an unspecified age experienced allergic reaction, sensation of heat, redness of face and neck, dizziness, right side of her body felt strange and had post procedural stroke, within 20 minutes after the administration of Afluria (TIV). The compnay assessed the causality as related due to plausible temporal relationship between the events and suspect vaccine.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Attention deficit hyperactivity disorder, Disturbance in attention, Dizziness
Clinical narrative: Within an hour I became pale, lethargic, weak and dizzy which only lasted 2-3 hours. The next several days I developed extreme joint pain in all joints, similar to flu like joint pain, however I never became sick. Joint pain lasted 2 months. Developed daily headaches, brain fog that caused ADD like symptoms. Difficulty concentrating, speaking, reading, writing, poor memory retention.