chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Oropharyngeal pain
Clinical narrative: MILD SORE THROAT; NOT FEELING WELL/ ICKY; FEELING EXTRA RUN DOWN; MILD HEADACHES; HER STOMACH FELT FUNNY; NAUSEOUS; This spontaneous case report (PVX2019-2632) was received from a consumer on 22-Oct-2019. It described a female consumer who "felt nauseous" (PT: Nausea), had been feeling extra run down (PT: Fatigue), not feeling well/icky (PT: Malaise), had mild sore throat (PT: Oropharyngeal pain), her stomach felt funny (PT: abdominal discomfort) and had mild headaches (PT: Headache) while being on oral Vivotif (company suspect) in every other day.  Case report: The consumer completed all four doses of Vivotif either on 14-Oct-2019 or 15-Oct-2019. She stated that she felt nauseous only during the day of her second dose and fourth dose. Since then, had been feeling extra run down, not feeling well and icky and just wanted to sit down and take a nap. The consumer also reported a mild sore throat, but she was not coughing, and it was not unbearable. She was not eating a lot and not eating heavily, since her stomach felt funny. She also had mild headaches for which she was not worried about and thought maybe she just needed more sleep. She would take Aleve for her headache.  The consumer's medical history included occasional back aches and takes muscle relaxer.  Action taken with Vivotif with respect to the events was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: In this case, it was reported that a female consumer "felt nauseous", had been feeling extra run down, not feeling well/icky, her stomach felt funny and had mild headaches while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Owing to the nature of the event the causality of the event "had mild sore throat" has been assessed as unlikely.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer "felt nauseous", had been feeling extra run down, not feeling well/icky, her stomach felt funny and had mild headaches while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Owing to the nature of the event, the causality of the event "had mild sore throat" has been assessed as unlikely.
Sex: U
Vaccine: VARZOS
Symptoms: Hernia, Inguinal hernia repair, Injection site pain, Laparoscopic surgery
Clinical narrative: I had Robotic Inguinal laporoscopic surgery for two hernias; tenderness @ injection site lasting 48 hrs.; This case was reported by a consumer and described the occurrence of injection site tenderness in a 82-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included enlarged prostate.   On 25th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site tenderness and hernia. On an unknown date, the outcome of the injection site tenderness was recovered/resolved and the outcome of the hernia was unknown.   It was unknown if the reporter considered the injection site tenderness and hernia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 81 or 82 years. The patient experienced tenderness at injection site lasting 48 hrs. The patient was in good health.  The patient took medication for enlarged prostate daily. Two months prior to the reporting, the patient had Robotic Inguinal laparoscopic surgery for two hernias. First surgery ever. The patient when should I take the second dose
Age: 73.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Cough, Rash
Clinical narrative: rash; cough; This case was reported by a nurse via call center representative and described the occurrence of rash in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included shingles.   On 23rd October 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced rash and cough. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the cough was unknown.   The reporter considered the rash to be related to Shingrix. It was unknown if the reporter considered the cough to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The 1st shot was given intramuscularly in his right deltoid. The flu shot [brand name unspecified] was given in his left arm at the same time. Reporter was not at home therefore the Shingrix paperwork was not available to look for the lot number or expiry date however reporter did provide the name or location of the pharmacy where the shot was administered. Caller stated that husband developed a rash on the same arm where the Shingrix was injected.  The rash was not at the injection site (deltoid) but it was down by his elbow. It resolved.  About 3 weeks ago the patient had his second shot of Shingrix.  The second injection was given intramuscularly in the left arm. He received the injection even though he had a cough at the time. (The reporter was said she does not know the cough may have been Covid-19 related as he has not been tested). The cough has since resolved. [The patient did NOT experience a rash after the second Shingrix shot].  Negative history of live shingles vaccine (Zostavax). The reporter consented to follow up. This is 1 out of 3 cases reported by the same reporter.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: nothing
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Myalgia, Pain in extremity
Clinical narrative: Very sore arm and overall sore musculature throughout body starting the evening of the vaccine. Patient reported feeling very bad but didn't have a fever
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Shoulder injury related to vaccine administration
Clinical narrative: Patient states that immediately upon injection it was extremely painful. He states he has had constant pain and reduced range of motion since injection. He is a health care provider and is stating he believes this is a shoulder injury due to injection.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report was received from a Vaccine Coordinator, referring to a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.    It was reported that between 03 3-OCT-2019 and 28-OCT-2019, the patients might have inadvertently administered with an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot# S000961 had been verified to be valid lot number; expiration date 19-OCT-2020).  The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours, and not had previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This case was determined as non-valid due to lack of patients identifiers.  Follow up information was received from Vaccine Coordinator on 27-APR-2020: This spontaneous report refers to a 6 month old male patient. On 09-OCT-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ).   This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA008135: US-009507513-2004USA008139: US-009507513-2004USA008136: US-009507513-2004USA008137: US-009507513-2004USA008138:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Facial bones fracture, Fall, Syncope
Clinical narrative: when the patient stood up she fainted, fell forward onto the floor and broke her nose; when the patient stood up she fainted, fell forward onto the floor and broke her nose; fell forward; This spontaneous report was received from an office manager via a company representative regarding a 14-year-old female patient. The patient's medical history, concurrent conditions or concomitant therapies were not reported.   On an unspecified day, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot number, expiration dated, dose, frequency, route of administration were not reported) for prophylaxis. The patient was sitting in a chair post vaccination for 5 minutes and then stood up to be taken to the reception area of the office to do another 10 minutes of waiting. When she stood up she fainted, fell forward onto the floor and broke her nose. The outcome of the events was not reported.  The relatedness between the events and the suspect vaccine was not reported.  Upon internal review, the events of syncope and facial bones fracture were determined to be medically significant.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report as received from a Vaccine Coordinator refers to a 9 week old female patient.  The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.   On 11-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot #S000961 had been verified to be valid lot number; expiration date 19-OCT-2020) (product storage error). The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours. There were no previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA016835:
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report as received from a Vaccine Coordinator refers to a 7 month old female patient.  The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.   On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot #S000961 had been verified to be valid lot number; expiration date 19-OCT-2020) (product storage error). The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours. There were no previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA016835:
Age: 0.75
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report as received from a Vaccine Coordinator refers to a 9 month old female patient.  The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.   On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot #S000961 had been verified to be valid lot number; expiration date 19-OCT-2020) (product storage error). The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours. There were no previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA016835:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report as received from a Vaccine Coordinator refers to a 9 week old female patient.  The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.   On 22-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot #S000961 had been verified to be valid lot number; expiration date 19-OCT-2020) (product storage error). The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours. There were no previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA016835:
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report as received from a Vaccine Coordinator refers to a 12 week old female patient.  The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.   On 28-OCT-2019 , the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot #S000961 had been verified to be valid lot number; expiration date 19-OCT-2020) (product storage error). The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours. There were no previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA016835:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected Vaccination failure; is it possible to get shingles after getting the vaccine?; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and less than 9 months 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 and Shingrix.  Additional case details were reported as follows: This case was reported by patient himself or herself. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient enquired was it possible to get shingles after receiving Shingrix. The call center nurse replied that it was possible as the vaccine was not 100 percent effective and compared with placebo, Shingrix significantly reduced the risk of developing herpes zoster by 97.2 percent in patients 50 years and older. This case was considered as suspected vaccination failure as details regarding time to onset and lab test confirming varicella zoster virus infection was unknown at the time of reporting.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Pain, Sensitive skin
Clinical narrative: Pain at the injection / Described it as tender and sensitive and hurt; Pain at the injection / Described it as tender and sensitive and hurt; hurt if someone brushed up against; felt like pure cement was in her arm.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 93JN5, expiry date 27th March 2022) for prophylaxis.   On 26th February 2020, the patient received the 1st dose of Shingrix. On 26th February 2020, 3 hrs after receiving Shingrix, the patient experienced injection site pain, sensitive skin, pain upon movement and feeling abnormal. On an unknown date, the outcome of the injection site pain, sensitive skin, pain upon movement and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the injection site pain, sensitive skin, pain upon movement and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient reported feeling pain at the injection site 3 hours after administration.  She described it as tender and sensitive and hurt if someone brushed up against her.   The patient said it felt like pure cement was in her arm.   It lasted 3 to 4 days before resolving.   The patient did Yoga the second day after receiving the vaccine.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Pain in extremity, Prenatal screening test
Clinical narrative: Sore arm; Afluria Quad aministered to pregnant woman; This spontaneous case, initially received from other non-health professional (together processed with follow-up received on 27-Sep-2018) on 26-Sep-2018, concerns a 31-year-old, adult pregnant patient.  The patient had no relevant maternal and paternal medical history. The patient did not use any contraceptives. The patient had no birth defects and congenital anomalies were occurred in previous pregnancies.   The patient's husband did not take any medications prior to conception. The concomitant medications included Prenatal vitamins (ascorbic acid, biotin, minerals nos, nicotinic acid, retinol, tocopherol, vitamin b nos, vitamin d nos), Claritin (clarithromycin) and ranitidine for unknown indications. This was the patient's first pregnancy.  The patients last menstrual period (LMP) date was 09-Jun-2018.  On 25-Sep-2018, the pregnant patient (15-week gestation period) was administered Afluria (TIV) (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical site: deltoid, batch number: YT38207B and expiry date: 30-Jun-2019) (coded as vaccine exposure during pregnancy) as active immunization against influenza disease [explicitly reported as Afluria Quadrivalent]. The reported batch number (YT38207B), does not match Afluria Quadrivalent batch numbers, however, the batch number was mapped to Afluria (TIV). Hence, the suspect vaccine was coded as Afluria (TIV).  On the same day after vaccination, the patient experienced a sore arm.  There was no evidence of defect or adverse finding from a prenatal test.  The patient's estimated date of delivery was on 16-Mar-2019.  At the time of this report, the outcome of the event was not reported.  The reporter assessed the case as non-serious.  Non-significant follow up received from the reporter on 08-Jan-2019: It was reported that, the patient was not enrolled in the pregnancy registry. The reporter also confirmed that, the attempts to reach the patient had exhausted and no further follow up would be conducted. Hence, this case was considered as lost to follow up.  Non-significant follow up received from the reporter on 19-Feb-2019: It was reported that the patient was tried to reach on 19-Nov-2018, 20-Nov-2018 and 03-Dec-2018 but no information was obtained. Reference number (Med info number:SEQ18-06663) was updated in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 31-year-old, pregnant patient experienced a sore arm on the same day after the administration of Afluria TIV (coded as vaccine exposure during pregnancy). The company assessed the causality as related for the event pain in arm' due to plausible temporal relationship between the event and the suspect vaccine. The causality of event vaccine exposure during pregnancy' was assessed as not related considering it as a special situation.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site [went tall and swollen, bigger than half a dollar, red and] 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; Injection site went [tall and swollen, bigger than half a dollar, red and hot to the touch,] sore/ the area is also tender to the touch and very painful; This spontaneous case, initially received from other healthcare professional (nurse) on 28-Sep-2018, concerning a 49-year-old, adult, female patient.  The patient had no historical conditions. The patient was not taking any medication at the time of vaccination.  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: 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 27-Sep-2018, one day after vaccination, the patient's injection site went tall and swollen, bigger than half a dollar. It was red, hot and tender to the touch as well as very painful. The patient used ice therapy for the events.   On an unspecified date in 2018, within one week after vaccination, the patient had recovered from the events. At the time of this report, the patient felt better.  This case is linked to case 201804181 (same reporter).  The reporter assessed this case as non-serious.  Follow-up received other health professional on 26-Oct-2018 (combinedly processed with follow-up 1 received on 24-Oct-2018): The batch number (02444611A) and expiry date (06-Jun-2019) of the suspect vaccine were updated in the product tab. The outcome of the events was changed from not recovered to recovered (within one week after vaccination). It was reported that, the patient felt better. The narrative was amended accordingly.  Significant case amendment (24-Oct-2018): Treatment received for all the events was corrected from 'unk to 'yes' in event tab. No changes were done in narrative.; Reporter's Comments: A 49-year-old female patient experienced injection site warmth, pain, swelling and redness, one day after the administration of Afluria Quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship and localized injection site reaction.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Lethargy
Clinical narrative: Felt slightly lethargic; 18 weeks, 5 days pregnant and received the Afluria inactivated flu vaccine; This non-serious spontaneous case, initially received from other non-health professional (consumer), on 02-Oct-2018, concerning a 24-year-old, adult, female pregnant patient.  The patient had one previous pregnancy. No still birth or miscarriage and no birth defect or congenital anomaly occurred during the previous pregnancy. The patient's current condition included depression and post-traumatic stress disorder (PTSD). The patient's concomitant medications included Wellbutrin (bupropion hydrochloride) and Prenatal vitamins (minerals nos, vitamins nos) for unknown indications. The patient did not use any contraceptive.   The patient's last menstrual period (LMP) date was unknown.  On 02-Oct-2018, at gestational age of 18 weeks and 5 days, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: right deltoid, batch number: YF40408, expiry date: 30-Jun-2019 and route of administration: not reported) (explicitly coded as vaccine exposure during pregnancy) for protection against seasonal influenza.  On the same day, after the vaccine administration, the patient felt slightly lethargic and quickly resolved from the event.   The estimated date of delivery (EDD) was reported on 01-Mar-2019.  Update received on 30-Oct-2018: Non-significant case correction (IRD: 02-Oct-2018): The phrase and felt' was changed to experienced' in the case comment. The phrase ' The causality of the event lethargic was changed to ' The causality of the event lethargy' in the case comment.  No changes were made in the narrative.  Non-significant follow up received from the reporter on 08-Jan-2019: It was reported that, the patient was not enrolled in the pregnancy registry. The reporter also confirmed that, the attempts to reach the patient had exhausted and no further follow up would be conducted. Hence, this case was considered as lost to follow up.; Reporter's Comments: A 24-year-old female pregnant patient was administered Afluria Quadrivalent (vaccine exposure during pregnancy) and experienced slightly lethargic on the same day after vaccination with suspect vaccine Afluria Quadrivalent. The company assessed the causality of the event lethargy as related due to the plausible temporal relationship between the event and suspect vaccine. The company assessed the causality of the event vaccine exposure during pregnancy as not related to the suspect vaccine considering the event as special situation.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Limits on movements of the arm; Pain in the arm; Swelling in the arm; Redness in the arm; This is a spontaneous case, initially received from a pharmacist on 12-Oct-2018, concerning a 56-year-old, adult, female patient.  The patient's medical history and concomitant medications were unknown.   On 28-Sep-2018 (reported as two weeks ago), the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: YF39207 and expiry date: 30-Jun-2019] for protection against seasonal influenza.  On 28-Sep-2018, same day after vaccination, the patient experienced swelling, redness and pain in the arm. The patient did not receive any of the treatment measures associated with the events. It was reported that, two weeks after vaccination, the patient was still experiencing swelling, redness and pain in the arm. On an unspecified date, the patient also experienced limits on movement of the arm. The patient confirmed that she wants to seek a second opinion with a new doctor.  On an unspecified date, the outcome of the events swelling arm and redness was resolved and the events (pain in arm and mobility decreased) was not recovered.  The reporter assessed the case as non-serious.  Non-significant case amendment (12-Oct-2018): The onset latency was added in the case comment. No changes were made in the narrative.  Follow-up received from the reporter on 29-Nov-2018: The patient's initials and age (56 years) were added in the patient tab. The vaccination date (28-Sep-2018), route of administration (intramuscular), anatomical location (left arm), batch number (YF39207) and expiry date (30-Jun-2019) of the vaccine were added in the product tab. The event onset date of the was added (28-Oct-2018). The outcome of the events peripheral swelling and erythema was changed from not recovered' to recovered'. The new event mobility decreased' was added in the event tab. The narrative was amended accordingly.  Significant case amendment (29-Nov-2018): Event onset date was deleted for the event mobility decreased from the event tab.  Significant case amendment (29-Nov-2018): The description to be coded for the event verbatim 'Limits on movements of the arm' was changed from 'mobility decreased' to 'joint range of motion decreased' in the event tab. The narrative and case comment was amended accordingly.; Reporter's Comments: A 56-year-old, female patient experienced swelling arm, redness and pain in arm on the same day after administration of suspect vaccine Afluria Quadrivalent. The patient also experienced Joint range of motion decreased on an unspecified date after vaccination. The causality of the events assessed as related to the suspect vaccine due to the plausible temporal relationship between the events and the suspect vaccine.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Muscular weakness, Myalgia, Paraesthesia
Clinical narrative: Weakness in arms; Muscle aches; Tingling in arms and legs; This is a spontaneous case from, initially received from other non-health professional on 19-Oct-2018, concerning a 39-year-old, adult, female patient.  The patient had seasonal allergy and cat allergy.   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: YF38907, 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 07-Oct-2018, 4 days after the vaccination, the patient developed muscle aches and tingling in arms and legs. On 08-Oct-2018, 5 days after the vaccination, the patient visited the primary care physician and lab tests were performed which came back normal. On the same day, the patient began to experience weakness in her arms. The patient reported had been scheduled with neurologist consultation for further evaluation as the events persisted till day 16.   On an unspecified date in Oct-2018, the patient had recovered from muscle aches. The patient had not recovered from the events tingling in arms and legs and weakness in arms.   The reporter assessed this case as non-serious.  Non-significant follow up received from the reporter on 24-Jan-2019: Info number (SEQ18-07585) was added in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 39-year-old female patient experienced muscle ache and tingling of extremity, 4 days after vaccination with suspect vaccine Afluria Quadrivalent. The patient also developed weakness of arms, 5 days after vaccination with suspect vaccine. The company assessed the causality of the events as related considering the plausible temporal relationship between events and suspect vaccine.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: [Swelling of arm the size of a small plum with] bruising at injection site; Swelling of arm the size of a small plum; This spontaneous case, initially received from pharmacist on 21-Oct-2018, concerns a 30-year-old, adult, female patient.   The patient's current condition included shortness of breath and concomitant medication included Ventolin.   On 20-Oct-2018, the patient was administered Afluria QIV (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF37806A, expiry date: 18-Jun-2019) for influenza prophylaxis.   On 21-Oct-2018, one day after vaccination, the patient experienced swelling of the arm which was of the size of a small plum (coded as injection site swelling) with bruising at the injection site. The patient did not administer any treatment measure for the events.  At this time of the report, the outcome was not reported.   The reporter assessed the event as non-serious.  Non-significant follow up received from the pharmacist on 27-Nov-2018: The current condition (shortness of breath) and concomitant medication (ventolin) was added. The narrative was amended accordingly.  Significant case amendment (21-OCT-2018): The description to be coded for the event verbatim 'swelling of arm the size of a small plum' was changed to 'injection site swelling' from 'swelling arm'. The narrative and case comment was amended accordingly.; Reporter's Comments: A 30-year-old, male patient experienced injection site swelling and injection site bruising, one day after vaccination with Afluria QIV. The company assessed the causality of the events injection site swelling and injection site bruising as related considering the plausible temporal relationship and due to site specific reaction.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed hives; This is a spontaneous case, initially received from a pharmacist on 22-Oct-2018, concerning a 63-year-old, adult female patient.  On an unspecified date in 2017 (reported as some time last year), the patient was administered Afluria Quadrivalent [influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported] for active immunization against influenza.  On an unspecified date after vaccination, the patient developed hives. The patient did not administered any treatment for the event.  On an unspecified date, the hives went away on their own (recovered).  The reporter assessed this case non-serious.  Follow up received from the reporter on 20-Dec-2018: The pharmacist was contacted but no information was obtained. Info number (SEQ18-06670) was added in the additional information tab.; Reporter's Comments: A 63-year-old, female patient developed hives on an unspecified date after vaccination with Afluria Quadrivalent. The company assessed the causality of the event with the suspect vaccine as unassessable due to lack of information regarding the onset latency of the event.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to Afluria Quadrivalent; This is a non-serious spontaneous case from, initially received from other health professional (nurse) on 22-Oct-2018, concerning a female patient of an unspecified age.  On an unspecified date in 2018 (reported as a couple of weeks ago), the patient was administered Afluria quadrivalent [influenza vaccine, batch number: YF37506 (reported as YF35706), expiry date: 06-Jul-2019, dose, route of administration and anatomical location: not reported] for active immunization against influenza.  On an unspecified date after vaccination, the patient experienced an allergic reaction to the vaccine.  The outcome of the event was not reported at the time of this report.  The reporter assessed this case as related to the suspect product.  Non-significant case amendment (22-Oct-2018): Code (+1) was added for fax number in the general tab. No changes were made in the narrative.  Non-significant follow up received on 26-Dec-2018: This case was considered as lost to follow up as the reporter could not be contacted to gather further information Added reference number (Med Info Number: SEQ18-06870) in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A female patient of an unspecified age experienced an allergic reaction to the vaccine, on an unspecified date after vaccination with Afluria quadrivalent. The causality of the event was taken as unassessable due to the lack of information regarding the onset latency of the event.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; Stuffy nose; Runny nose; Sore throat; Cough; Muscle aches; Headache; Chills; Fever; This is a spontaneous case from, initially received from other non-health professional on 24-Oct-2018, concerning an adult female patient of unspecified age.  The patient's current condition included bipolar disorder. The patient's concomitant medication included Lithium (lithium carbonate).  On 14-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml route of administration: intramuscular, batch number: YF38407 (reported as YF3H407), anatomical location and expiry date: not reported) for influenza prophylaxis.  On an unspecified date in Oct-2018, 3 days after the vaccination (reported as exact time frame not known), the patient experienced systemic fever, chills, sore throat, muscle aches, fatigue, cough, headache, runny nose and stuffy nose. The patient administered Nyquil (dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol) as a treatment measure for the events.  At the time of this report, the patient was recovering from the events.  This case is linked with 201804858 due to same reporter.  The reporter assessed the case as non-serious.  Follow up report received from the reporter on 27-Nov-2018: The reporter confirmed that the exact onset dates could not be obtained. The outcome for all the events was updated from not recovered' to recovering'. The narrative was amended accordingly.  Non-significant follow up received from the reporter on 03-Jan-2019: The reporter reported that the consumer started that saying the information requested was not related to the AE itself, it was inappropriate and that she didn't know the reporter and to never call again. Med info number (SEQ19-00036) was updated in the additional information tab. No changes were made in the narrative.  Follow-up received from the med communications on 26-Feb-2019: The reference number (Med Info Number: SEQ19-00111) was added in the additional information tab. It was stated that, the reporter refused to provide any further information for the case. Hence this case was considered as lost to follow up. No changes were made in the narrative.  Case re-opened for completion of full data entry: 26-Feb-2019; Reporter's Comments: An adult female patient of unspecified age experienced fever, chills, sore throat, muscle aches, fatigue, cough, headache, runny nose and stuffy nose, 3 days after vaccination of Afluria Quadrivalent. The causality of the events was assessed as related due to plausible temporal relationship between the events and suspect vaccine.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fatigue; Stuffy nose; Runny nose; Sore throat; Cough; Muscle aches; Headache; Chills; Fever; This is a spontaneous case from, initially received from other non-health professional on 24-Oct-2018, concerning an adult female patient of unspecified age.  The patient's current condition included bipolar disorder. The patient's concomitant medication included Lithium (lithium carbonate).  On 14-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml route of administration: intramuscular, batch number: YF38407 (reported as YF3H407), anatomical location and expiry date: not reported) for influenza prophylaxis.  On an unspecified date in Oct-2018, 3 days after the vaccination (reported as exact time frame not known), the patient experienced systemic fever, chills, sore throat, muscle aches, fatigue, cough, headache, runny nose and stuffy nose. The patient administered Nyquil (dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol) as a treatment measure for the events.  At the time of this report, the patient was recovering from the events.  This case is linked with 201804858 due to same reporter.  The reporter assessed the case as non-serious.  Follow up report received from the reporter on 27-Nov-2018: The reporter confirmed that the exact onset dates could not be obtained. The outcome for all the events was updated from not recovered' to recovering'. The narrative was amended accordingly.  Non-significant follow up received from the reporter on 03-Jan-2019: The reporter reported that the consumer started that saying the information requested was not related to the AE itself, it was inappropriate and that she didn't know the reporter and to never call again. Med info number (SEQ19-00036) was updated in the additional information tab. No changes were made in the narrative.  Follow-up received from the med communications on 26-Feb-2019: The reference number (Med Info Number: SEQ19-00111) was added in the additional information tab. It was stated that, the reporter refused to provide any further information for the case. Hence this case was considered as lost to follow up. No changes were made in the narrative.  Case re-opened for completion of full data entry: 26-Feb-2019; Reporter's Comments: An adult female patient of unspecified age experienced fever, chills, sore throat, muscle aches, fatigue, cough, headache, runny nose and stuffy nose, 3 days after vaccination of Afluria Quadrivalent. The causality of the events was assessed as related due to plausible temporal relationship between the events and suspect vaccine.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Head pain on the left side of head; This is a spontaneous case from, initially received from a pharmacist on 30-Oct-2018, concerning a 62-year-old, adult female patient.  The patient did not have any medical history. The patient did not receive any concomitant medications.  On 26-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 03244611A and expiry date: 30-Jun-2019) for active immunization against influenza.   On an unspecified date in Oct-2018, after the vaccination, the patient experienced head pain on the left side of her head which was reported on 29-Oct-2018. It was reported that, the patient was not hospitalized.  As of 30-Oct-2018, the patient had not yet recovered from the event.  The reporter assessed the case as non-serious.   Significant case amendment (30-Oct-2018): The patient's initials was changed in patient tab. No changes were made in narrative.  Non-significant case amendment (30-Oct-2018): The statement "A 62-year-old, female patient experienced head pain on the left side of her head, unspecified date in Oct-2018 after administration of Afluria Quadrivalent" was changed to "A 62-year-old, female patient experienced head pain on the left side of her head, within a week after administration of Afluria Quadrivalent" in the case comment. No changes were made in the narrative.  Non-significant follow up received on 28-Jan-2019: An attempt was made to contact the reporter but was unsuccessful. The case was considered as lost to follow up. Med info number (SEQ19-07634) was added in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 62-year-old, female patient experienced head pain on the left side of her head, within a week after administration of Afluria Quadrivalent. The company assessed the causality of the event as related to the suspect vaccine due to the plausible temporal relationship between the event and suspect vaccine.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Decreased appetite, Hypoaesthesia, Malaise
Clinical narrative: Weakness; Loss of appetite; Sweating through the night; Chills; Not feeling well; Thumb, index finger, little bit of other finger tips and entire left hand was numb; This is a spontaneous case from  initially received from other non-health professional on 31-Oct-2018, concerning a 58-year-old, adult, female patient.   The patient's concomitant medications included Zocor (simvastatin), lisinopril and levothyroxine (levothyroxine sodium) for unknown indications.  On 25-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, batch number: 02844611A, expiry date: 25-Jun-2019, dose, route of administration, anatomical location: not reported] for unknown indication. It was reported that, the patient received the vaccine through in-house at her job.   On 27-Oct-2018 (reported as Saturday), 2 days after vaccination, the patient was not feeling well.   On 28-Oct-2018 (reported as Sunday), at the night, she started having chills, weakness, loss of appetite, sweating through the night. On 29-Oct-2018, the patient woke up feeling better.   On an unspecified, the patient reported that her thumb, index finger, little bit of other finger tips and entire left hand was numb. It was reported that the patient tried to get blood circulation, but the numbness persisted. Also, the patient reported that she hasn't had any excursing and thought it was because of new bra but realized it was not.   At the time of this report, the patient was recovering from the event (weakness, sweating, chills, loss of appetite and not feeling well) and had recovered from the event numbness in hand.  The reporter assessed the case as non-serious.  Significant case amendment (31-Oct-2018): The lowest level term (LLT) for the event 'sweating through the night' was changed from 'sweating' to 'night sweat' in the event tab. No changes were made in narrative.  Follow up received from reporter on 15-Jan-2019: It was reported that, one attempt had been made on 12-Dec-2018 in order to obtain additional information regarding this case, with no success. Hence this case was considered as lost to follow up. Med Info number (SEQ18-07356) was added in the additional information tab. Hence, no changes were made in the narrative.; Reporter's Comments: A 58-year-old, female patient experienced malaise two days after and weakness, loss of appetite, night sweat, chills three days after and numbness in hand on an unspecified date, after vaccination with Afluria quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to the plausible temporal relationship between events and suspect vaccine.