chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB
Symptoms: Grunting, Hypotonia, Injection site erythema, Injection site mass, Lethargy
Clinical narrative: 2 month-old healthy baby boy received his 2 months shots, Hep B, PCV13 in the right leg, PENTACEL in the left and oral Rotavirus at 10:00am. He was fussy most of the day but feeding well and had wet diapers. By 11:00pm he had a fever of 100.7 axillary, was not feeding well and sleeping a lot/hard to wake. He was seen in our clinic on 9/8/2018 for evaluation. At that visit he had a rectal temperature of 98.9 and his exam revealed he had two areas of induration on the right thigh associated with his injection sites. No lethargy noted during that visit. One area was 1cm x 2.5cm and the other was smaller at < 0.3cm round induration. No fluctuance. Baby continued to have fever of this magnitude or lower for 3 days, have poor feeding and hard to wake. Parents describe him as "lethargic and could barely lift his head". He was treated with TYLENOL PRN and small frequent nursing. It took 1 week for him to fully recover, per parents, he did seem to recover fully. He has had 2 Well Child Checks since this event and he is growing, thriving and developing normally.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB
Symptoms: Poor feeding infant, Poor sucking reflex, Pyrexia
Clinical narrative: 2 month-old healthy baby boy received his 2 months shots, Hep B, PCV13 in the right leg, PENTACEL in the left and oral Rotavirus at 10:00am. He was fussy most of the day but feeding well and had wet diapers. By 11:00pm he had a fever of 100.7 axillary, was not feeding well and sleeping a lot/hard to wake. He was seen in our clinic on 9/8/2018 for evaluation. At that visit he had a rectal temperature of 98.9 and his exam revealed he had two areas of induration on the right thigh associated with his injection sites. No lethargy noted during that visit. One area was 1cm x 2.5cm and the other was smaller at < 0.3cm round induration. No fluctuance. Baby continued to have fever of this magnitude or lower for 3 days, have poor feeding and hard to wake. Parents describe him as "lethargic and could barely lift his head". He was treated with TYLENOL PRN and small frequent nursing. It took 1 week for him to fully recover, per parents, he did seem to recover fully. He has had 2 Well Child Checks since this event and he is growing, thriving and developing normally.
Sex: M
Vaccine: FLUC4
Symptoms: Influenza
Clinical narrative: This is serious spontaneous case, initially received on 26-Jan-2018 from a male patient (physician) of unspecified age. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after the vaccination (reported as later this season), the patient developed flu. This case was associated with product quality complaint, hence quality assurance investigation (QAIR) had been requested and the corresponding QAIR reference number was 1028319. It was reported that, as the batch information was unknown for the complaint, a detailed batch level review was not performed. A holistic review of the manufacturing process was performed and based on the investigation performed, it was concluded that, there were sufficient controls in place (in the manufacturing process of both multi-dose vials and pre-filled syringes) to ensure that FLUCELVAX vaccine was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the manufacturing process (fill finish and bulk). Therefore, no internal root cause was confirmed. At the time of this report, the outcome of the event flu was not reported. Non-significant follow-up received from quality assurance department on 01-Mar-2018: The QAIR number (1028319) was updated. Follow-up received from the quality assurance department on 12-Apr-2018: It was reported that, as the batch information was unknown for the complaint, a detailed batch level review was not performed. A holistic review of the manufacturing process was performed and based on the investigation performed, it was concluded that, there were sufficient controls in place (in the manufacturing process of both multi-dose vials and pre-filled syringes) to ensure that FLUCELVAX vaccine was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the manufacturing process (fill finish and bulk). Therefore, no internal root cause was confirmed.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Depression, Fatigue, General physical health deterioration, Mental disorder, Neurological symptom
Clinical narrative: Chronic pain (trying to get Fibromyalgia diagnosis), neurological problems, declining health, personality disorders,  fatigue, depression, various mental problems.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Personality disorder
Clinical narrative: Chronic pain (trying to get Fibromyalgia diagnosis), neurological problems, declining health, personality disorders,  fatigue, depression, various mental problems.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccines not put away after being transferred to Emergency back up facility all vaccines were bundled up from transport and a KINRIX was given to 4 month old. The CDC has been contacted and it will be counted as 2nd dose, and they suggested filling out a VAERS report. I called patient's mother and the patient had no reactions to the vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersomnia, Influenza like illness, Injection site erythema, Injection site pruritus
Clinical narrative: I had the vaccine on Friday morning and by Friday night, I started getting flu like symptoms. Aching and shivering. I slept most of the day on Saturday and Sunday. By Sunday night I felt like eating some food. Also, my arm, where the injection sight was, became red and hot. A red circle started getting bigger. Now it is more of a rectangle, approximately 3inches by 10. It is now Wednesday and it is still there and becoming itchy. I went to the clinic and they are going to have a doctor look at it this afternoon.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain
Clinical narrative: I had the vaccine on Friday morning and by Friday night, I started getting flu like symptoms. Aching and shivering. I slept most of the day on Saturday and Sunday. By Sunday night I felt like eating some food. Also, my arm, where the injection sight was, became red and hot. A red circle started getting bigger. Now it is more of a rectangle, approximately 3inches by 10. It is now Wednesday and it is still there and becoming itchy. I went to the clinic and they are going to have a doctor look at it this afternoon.
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Rash generalised, Urticaria
Clinical narrative: This spontaneous case, initially received on 17-Oct-2018 (combinedly processed with the follow-up received on 18-Oct-2018) reported by other healthcare professional (nurse), concerns a 15-year-old adolescent, male patient. On 14-Oct-2018 at 11 a.m., the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency unknown), route of administration: intramuscular, anatomical location: deltoid, batch number: 252670 and expiry date: 30-Jun-2019] (at pharmacy). On the same day (reported as Sunday) after vaccination, the patient broke out in hives. It was reported that at 2 o'clock (on the same day), 3 hours after vaccination, the patient's hands felt funny (considered as feeling abnormal) and he developed bumps on his arms (raised rash). it was reported by the patient's mother (nurse), who noticed at 5 o'clock, that the bumps were spreading to the patient's thighs, inner thighs, legs and everywhere, all over his body. The patient experienced no breathing difficulties or respiratory involvement. It was reported that the event kept recurring, due to which the patient was unable to attend school for a full day. The patient had missed a total of 3-5 days of school. On 15-Oct-2018, the patient had an appointment with his paediatrician and was prescribed steroids and antihistamine after which his events improved a little bit. On 16-Oct-2018 (reported as Tuesday morning), the events got worse again. The patient was taking prednisone 15 mg daily, at present. He was also taking diphenhydramine initially but later switched to ALLEGRA in the morning and ZYRTEC at night. It was reported that the events would improve with steroid but as the day went on, events would reoccur. It was reported that the symptoms went on for a week and then subsided. The patient took a total of 5 days of steroids and anti-histamines around the clock until all the symptoms disappeared. The patient was again back to school and had stopped the steroids and antihistamines. The patient had no further problems. On an unspecified date in 2018, the patient had recovered from the events. The reporter assessed this case as non-serious. Follow up received by other healthcare professional (nurse) on 01-Nov-2018: The start date of the product 14-Oct-2018 was confirmed. The outcome of the events was updated from not-recovered to recovered. It was reported that the symptoms went on for about a week and then subsided. The patient took a total of 5 days of steroids and anti-histamines around the clock until all the symptoms disappeared. The patient had missed a total of 3-5 days of school but on an unspecified date, the patient was again back to school and had stopped the steroids and antihistamines. The patient had no further problems. The narrative was amended accordingly.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Headache, Hypoaesthesia, Influenza, Malaise
Clinical narrative: This spontaneous case, initially received from a pharmacist on 17-Oct-2018, concerns a 24-year-old, adult female patient. The patient had no relevant medical history. The patient's concomitant medication included birth control pill. On 11-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252229 and expiry date: 31-May-2019). This was the first time the patient received the flu shot. On the same day, after vaccination, the patient experienced myalgia, running nose, spots on face, itchiness on her back and sore throat. The patient displayed an extreme migraine. Eight hours after vaccination, the patient got sick. The patient experienced nausea, extreme headache which displayed flu symptoms. On an unspecified date in 2018, the patient experienced rash on her back. The husband of the patient thought that she was going to get Guillain Barre syndrome. On an unspecified date in 2018, the patient was feeling numb and very weak and reported that she might have to sleep during the day. The patient had not taken any treatment measures for the events. At the time of this report, the patient was recovering from the events (reported as patient was ok). The reporter assessed this case as non-serious. Follow-up received from other health professional on 02-Nov-2018: Events migraine, flu symptoms, sickness, nausea, headache, rash, numbness, daytime sleepiness and weakness were added in the event tab. It was also confirmed that, the patient's concomitant medication included birth control pill. The narrative was amended accordingly.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Migraine, Myalgia, Nausea, Oropharyngeal pain, Pruritus
Clinical narrative: This spontaneous case, initially received from a pharmacist on 17-Oct-2018, concerns a 24-year-old, adult female patient. The patient had no relevant medical history. The patient's concomitant medication included birth control pill. On 11-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252229 and expiry date: 31-May-2019). This was the first time the patient received the flu shot. On the same day, after vaccination, the patient experienced myalgia, running nose, spots on face, itchiness on her back and sore throat. The patient displayed an extreme migraine. Eight hours after vaccination, the patient got sick. The patient experienced nausea, extreme headache which displayed flu symptoms. On an unspecified date in 2018, the patient experienced rash on her back. The husband of the patient thought that she was going to get Guillain Barre syndrome. On an unspecified date in 2018, the patient was feeling numb and very weak and reported that she might have to sleep during the day. The patient had not taken any treatment measures for the events. At the time of this report, the patient was recovering from the events (reported as patient was ok). The reporter assessed this case as non-serious. Follow-up received from other health professional on 02-Nov-2018: Events migraine, flu symptoms, sickness, nausea, headache, rash, numbness, daytime sleepiness and weakness were added in the event tab. It was also confirmed that, the patient's concomitant medication included birth control pill. The narrative was amended accordingly.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rhinorrhoea, Somnolence
Clinical narrative: This spontaneous case, initially received from a pharmacist on 17-Oct-2018, concerns a 24-year-old, adult female patient. The patient had no relevant medical history. The patient's concomitant medication included birth control pill. On 11-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252229 and expiry date: 31-May-2019). This was the first time the patient received the flu shot. On the same day, after vaccination, the patient experienced myalgia, running nose, spots on face, itchiness on her back and sore throat. The patient displayed an extreme migraine. Eight hours after vaccination, the patient got sick. The patient experienced nausea, extreme headache which displayed flu symptoms. On an unspecified date in 2018, the patient experienced rash on her back. The husband of the patient thought that she was going to get Guillain Barre syndrome. On an unspecified date in 2018, the patient was feeling numb and very weak and reported that she might have to sleep during the day. The patient had not taken any treatment measures for the events. At the time of this report, the patient was recovering from the events (reported as patient was ok). The reporter assessed this case as non-serious. Follow-up received from other health professional on 02-Nov-2018: Events migraine, flu symptoms, sickness, nausea, headache, rash, numbness, daytime sleepiness and weakness were added in the event tab. It was also confirmed that, the patient's concomitant medication included birth control pill. The narrative was amended accordingly.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Influenza B virus test positive, Product quality issue, Vaccination failure
Clinical narrative: This spontaneous case, initially received on 13-Sep-2018 was reported by other health professional and concerns a 25-year-old adult female patient. The patient's medical history and concomitant medications were unknown. On 12-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195250, expiry date: 30-Jun-2018). On 12-Sep-2018, 11 months after vaccination, the patient developed flu (considered as vaccination failure). On an unspecified date, the patient visited physician and was tested positive for influenza B strain. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QAI reference number was 1033366. At the time of this report, the patient had recovered from the event flu without any problems and was back to work. The reporter assessed this case as non-serious. Non-significant follow up received from Quality Assurance Department on 20-Sep-2018: The QAI reference number (1033366) was added in additional information tab. The narrative was amended accordingly. Follow up received from the reporter on 27-Sep-2018: The outcome of the event flu was changed from not reported to recovered. The patient's medical history and concomitant medications were unavailable (reported as refused). The narrative was amended accordingly.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Influenza B virus test positive, Product quality issue, Vaccination failure
Clinical narrative: This is a serious spontaneous case, initially received from other health professional on 31-Jan-2018, concerning a 57-year-old adult female patient. The patient's historical vaccine included FLUCELVAX QIV (administered on 16-Nov-2016, dose: 0.5 mg, route of administration: intramuscular, anatomical location: right deltoid, batch number: 185246 and expiry date: 30-Apr-2018). On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195210, expiry date: 31-Mar-2018). On 23-Jan-2018, 3 months 28 days after vaccination, nasal swab was performed, and the patient was tested positive for influenza B virus (considered as, vaccination failure). This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QA (Quality assurance) investigation reference number was 1027753. Based on the investigation performed, it was concluded that FLUCELVAX 195210 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the fill finish or bulk manufacturing process and no trend was identified for the batch. Therefore, no internal root cause was confirmed. The patient had recovered from the event (flu). It was reported that patient did not require any hospitalization. Non-significant follow up received from the reporter on 10-Feb-2018: QAIR reference number (1027753) was added. Narrative amended accordingly. Follow-up QA (Quality assurance) investigations report received on 26-Mar-2018: Added expiry date 31-Mar-2018 in the product tab. Based on the investigation performed, it was concluded that FLUCELVAX 195210 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the Fill Finish or Bulk manufacturing process and no trend was identified for the batch. Therefore, no internal root cause could be confirmed. The narrative was amended accordingly. Follow up report received on 02-Apr-2018: The patient's date of birth was added. The patient's historical vaccine (FLUCELVAX QIV) was added. The dose, route of administration, anatomical location of the suspect vaccine was added. The patient's lab data (nasal swab test) was added and reported that, influenza type B was confirmed. The outcome of the event influenza was updated from not reported to recovered. The narrative was amended accordingly. Update on 04-Jul-2018: Non-significant case correction was performed 26-Mar-2018: Case comment was corrected. No changes were made in the narrative.
Sex: M
Vaccine: FLUC4
Symptoms: Drug ineffective, Influenza
Clinical narrative: This serious spontaneous case, initially received from physician on 30-Oct-2018, concerns a male patient of unspecified age. On an unspecified date, the patient received FLUCELVAX QIVc [dose, batch number, expiry date, route of administration and anatomical location: not reported]. On an unspecified date after vaccination, the patient developed flu. The patient claimed that, the vaccine gave him flu (coded as lack of drug effect). This case was considered as lost to follow up, since the reported had not given the consent to follow up.
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Cough, Decreased appetite, Influenza, Oropharyngeal pain
Clinical narrative: This is serious spontaneous case, initially received on 26-Jan-2018, reported by other non-health professional, concerning a patient of unspecified age and gender. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (batch number: 195210, expiry date: 31-Mar-2018, dose, route of administration, anatomical location: not reported). On 23-Jan-2018, the patient experienced fever (temperature between 103-104), sore throat, cough, loss of energy or appetite. On 25-Jan-2018, after 3 months 27 days of vaccination, the patient was diagnosed with type A Influenza [considered as vaccination failure (lack of efficacy)]. This case was associated with product quality assurance investigation report (QAIR) and the corresponding reference number was 1027573. The QA investigation was performed, and it was concluded that FLUCELVAX 195210 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE (lack of efficacy) complaint was the result of the fill finish or bulk manufacturing process and no trends were identified for the batch, or any other FLUCELVAX QIV batches from the 2017-2018 FLUCELVAX commercial season. Therefore, no internal root cause was confirmed. At the time of this report, the outcome of the event influenza was not reported. Non-significant follow up received from Quality Assurance department on 05-Feb-2018: QAIR reference number 1027573 was added. Amended narrative accordingly. Follow-up received from the quality assurance (QA) department on 13-Mar-2018: The QA investigation was performed, and it was concluded that FLUCELVAX 195210 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE (lack of efficacy) complaint was the result of the fill finish or bulk manufacturing process and no trends were identified for the batch, or any other FLUCELVAX QIV batches from the 2017-2018 FLUCELVAX Commercial season. Therefore, no internal root cause was confirmed. The expiry date (31-Mar-2018) of the suspect vaccine was added in the product tab. Narrative was amended accordingly. Update 04-Jul-2018: Non-significant case correction with IRD 26-Jan-2018: The case comment was corrected. No changes were done in the narrative.
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia, Vaccination failure
Clinical narrative: This is serious spontaneous case, initially received on 26-Jan-2018, reported by other non-health professional, concerning a patient of unspecified age and gender. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (batch number: 195210, expiry date: 31-Mar-2018, dose, route of administration, anatomical location: not reported). On 23-Jan-2018, the patient experienced fever (temperature between 103-104), sore throat, cough, loss of energy or appetite. On 25-Jan-2018, after 3 months 27 days of vaccination, the patient was diagnosed with type A Influenza [considered as vaccination failure (lack of efficacy)]. This case was associated with product quality assurance investigation report (QAIR) and the corresponding reference number was 1027573. The QA investigation was performed, and it was concluded that FLUCELVAX 195210 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE (lack of efficacy) complaint was the result of the fill finish or bulk manufacturing process and no trends were identified for the batch, or any other FLUCELVAX QIV batches from the 2017-2018 FLUCELVAX commercial season. Therefore, no internal root cause was confirmed. At the time of this report, the outcome of the event influenza was not reported. Non-significant follow up received from Quality Assurance department on 05-Feb-2018: QAIR reference number 1027573 was added. Amended narrative accordingly. Follow-up received from the quality assurance (QA) department on 13-Mar-2018: The QA investigation was performed, and it was concluded that FLUCELVAX 195210 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE (lack of efficacy) complaint was the result of the fill finish or bulk manufacturing process and no trends were identified for the batch, or any other FLUCELVAX QIV batches from the 2017-2018 FLUCELVAX Commercial season. Therefore, no internal root cause was confirmed. The expiry date (31-Mar-2018) of the suspect vaccine was added in the product tab. Narrative was amended accordingly. Update 04-Jul-2018: Non-significant case correction with IRD 26-Jan-2018: The case comment was corrected. No changes were done in the narrative.
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This serious spontaneous case, initially received from other health professional on 15-Jan-2018, concerning a 17-year-old, female adolescent patient. On 01-Nov-2017, the patient was administered with FLUCELVAX QIV (anatomical location: right deltoid, indicated for 4 years old and above, batch number: 195250, expiry date: 30-Jun-2018, dose and route of administration: not reported). On 13-Jan-2018, 2 months 13 days after vaccination, nasal swab was performed, and the patient diagnosed with type A flu (Influenza), considered as vaccination failure. The patient was treated with TAMIFLU (reported that, first dose taken within 48 hours of event). This case was associated with QA (Quality Assurance) reference number: 1027392. Based on the investigation performed, it was concluded that FLUCELVAX 195250 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE (lack of efficacy) complaint was the result of the fill finish or bulk manufacturing process and no trends were identified for the batch (195250), or any other FLUCELVAX QIV batches from the 2017-2018 FLUCELVAX commercial season. Therefore, no internal root cause was confirmed. It was reported that, the patient recovered from the event (type A flu) within 72-96 hours of symptom onset (36-50 hrs post TAMIFLU treatment). Non-significant follow-up received from other health professional on 25-Jan-2018: Added QA reference number: 1027392 in the additional information tab. The narrative was amended accordingly. Follow-up received from other health professional on 08-Feb-2018: The age of patient (17), anatomical location (right deltoid) and expiry date of vaccine (Jun-2018) were updated. Nasal swab confirmed type A influenza. Treatment drug (TAMIFLU) added. It was reported that, the patient recovered from the event (type A flu) within 72-96 hours of symptom onset (36-50 hrs post TAMIFLU treatment). Narrative amended accordingly. QA investigation report received from QA (Quality Assurance) on 08-Mar-2018: Based on the investigation performed, it was concluded that FLUCELVAX 195250 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the fill finish or bulk manufacturing process and no trends were identified for the batch (195250), or any other FLUCELVAX QIV batches from the 2017-2018 FLUCELVAX commercial season. Therefore, no internal root cause was confirmed. The narrative was amended accordingly. Update 04-Jul-2018: Non-significant case correction received 15-Jan-2018: The case comment was corrected. No changes were done in the narrative.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Influenza, Influenza B virus test positive, Laboratory test abnormal, Oropharyngeal pain
Clinical narrative: This serious spontaneous case, initially received from other health professional on 12-Jan-2018, concerns a 27-year-old, adult, female patient. The patient's current conditions included seasonal allergy for which no treatment was taken and knee pain (since unspecified dates). The patient was not taking any concomitant medications. It was reported that patient did not receive any flu vaccine in past and had no flu symptoms prior to vaccination. On 09-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195249 and expiry date: 30-Jun-2018). On the same day (09-Jan-2018), after vaccination, the patient had no flu symptoms. On 10-Jan-2018, 2 days after vaccination, the patient had cough, felt itchy and aching throat. On 12-Jan-2018, the swab was taken, and it showed positive for influenza virus B infection. The patient was treated with TAMIFLU. On an unspecified date, the patient's lab test showed positive for maxillary sinusitis. At the time of this report, the patient had recovered from the events, Influenza virus B infection and maxillary sinusitis. Follow-up received from other health professional (nurse) on 31-Jan-2018: The new events maxillary sinusitis and knee pain were added. The treatment drug TAMIFLU was added. The reporter confirmed that patient did not receive any flu vaccines in past and patient visit was for knee pain. It was reported that patient had no flu symptoms prior to vaccination. Narrative amended accordingly. Follow-up received from other health professional (nurse) on 12-Feb-2018: The reporter confirmed that, the event knee pain occurred before vaccination, hence added knee pain as current condition and deleted from the event section. The outcome of the event influenza virus B was changed from not reported to recovered. Narrative was amended accordingly. Non-significant follow-up received from other health professional (nurse) on 09-Apr-2018: As there was no new information in the source document, no changes were made in narrative.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Sinusitis
Clinical narrative: This serious spontaneous case, initially received from other health professional on 12-Jan-2018, concerns a 27-year-old, adult, female patient. The patient's current conditions included seasonal allergy for which no treatment was taken and knee pain (since unspecified dates). The patient was not taking any concomitant medications. It was reported that patient did not receive any flu vaccine in past and had no flu symptoms prior to vaccination. On 09-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195249 and expiry date: 30-Jun-2018). On the same day (09-Jan-2018), after vaccination, the patient had no flu symptoms. On 10-Jan-2018, 2 days after vaccination, the patient had cough, felt itchy and aching throat. On 12-Jan-2018, the swab was taken, and it showed positive for influenza virus B infection. The patient was treated with TAMIFLU. On an unspecified date, the patient's lab test showed positive for maxillary sinusitis. At the time of this report, the patient had recovered from the events, Influenza virus B infection and maxillary sinusitis. Follow-up received from other health professional (nurse) on 31-Jan-2018: The new events maxillary sinusitis and knee pain were added. The treatment drug TAMIFLU was added. The reporter confirmed that patient did not receive any flu vaccines in past and patient visit was for knee pain. It was reported that patient had no flu symptoms prior to vaccination. Narrative amended accordingly. Follow-up received from other health professional (nurse) on 12-Feb-2018: The reporter confirmed that, the event knee pain occurred before vaccination, hence added knee pain as current condition and deleted from the event section. The outcome of the event influenza virus B was changed from not reported to recovered. Narrative was amended accordingly. Non-significant follow-up received from other health professional (nurse) on 09-Apr-2018: As there was no new information in the source document, no changes were made in narrative.
Age: 72.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Influenza, Influenza B virus test positive, Nausea, Pyrexia
Clinical narrative: This is a serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 72-year-old, elderly female patient. On an unspecified date in 2017 (reported as last year), the patient was administered FLUCELVAX QIVc (dose, route of administration, anatomical location, batch number and expiry date: not reported). On the same day after vaccination (reported as later), the patient developed fever and had nausea, vomiting and diarrhoea for 1 day. On an unspecified date, 4 months after vaccination, the patient developed flu. The lab test performed confirmed influenza virus B strain. At the time of this report, the outcome of the events was not reported.
Age: 72.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: This is a serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 72-year-old, elderly female patient. On an unspecified date in 2017 (reported as last year), the patient was administered FLUCELVAX QIVc (dose, route of administration, anatomical location, batch number and expiry date: not reported). On the same day after vaccination (reported as later), the patient developed fever and had nausea, vomiting and diarrhoea for 1 day. On an unspecified date, 4 months after vaccination, the patient developed flu. The lab test performed confirmed influenza virus B strain. At the time of this report, the outcome of the events was not reported.
Age: 1.25
Sex: F
Vaccine: DTAP, DTAPHEPBIP, HEPA
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Diffuse erythematous maculo-papular rash.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Cardiac disorder, Dizziness, Electrocardiogram, Headache, Loss of personal independence in daily activities
Clinical narrative: Patient had a lot of pain after the GARDASIL shot. She started to get headaches and dizzy spells causing her to miss a lot of school. On 10/29/14, I took Patient to see Dr. because she had been dizzy and nauseous for 3 days. He referred us to an ENT. The ENT did a tilt table test and determined her dizziness to be a cardiac issue. On 10/31/14, patient was diagnosed with POTS by Dr., a pediatric cardiologist. She did not have problems like this before. Patient was an elite soccer player.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Pain, Postural orthostatic tachycardia syndrome, Tilt table test positive, Ultrasound scan
Clinical narrative: Patient had a lot of pain after the GARDASIL shot. She started to get headaches and dizzy spells causing her to miss a lot of school. On 10/29/14, I took Patient to see Dr. because she had been dizzy and nauseous for 3 days. He referred us to an ENT. The ENT did a tilt table test and determined her dizziness to be a cardiac issue. On 10/31/14, patient was diagnosed with POTS by Dr., a pediatric cardiologist. She did not have problems like this before. Patient was an elite soccer player.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Breath sounds abnormal, Death, Dysphagia, Resuscitation, Unresponsive to stimuli
Clinical narrative: The following is history obtained from family after the event: The patient left the office, went for breakfast, developed difficulty swallowing in the restaurant and was making sounds in her chest when breathing, was driven home by family, was not answering her family verbally, then EMS was called and they could not revive her, she was sent to the ER.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Breath sounds abnormal, Cardiac arrest, Choking, Death
Clinical narrative: The following is history obtained from family after the event: The patient left the office, went for breakfast, developed difficulty swallowing in the restaurant and was making sounds in her chest when breathing, was driven home by family, was not answering her family verbally, then EMS was called and they could not revive her, she was sent to the ER.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyskinesia, Dysphagia, Dyspnoea, Eye movement disorder, Mouth breathing
Clinical narrative: The following is history obtained from family after the event: The patient left the office, went for breakfast, developed difficulty swallowing in the restaurant and was making sounds in her chest when breathing, was driven home by family, was not answering her family verbally, then EMS was called and they could not revive her, she was sent to the ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: LEFT ARM SWELLING UP INTO SHOULDER AND BACK (SCAPULA AND NECK) WITH REDNESS AND HEAT. TREATED WITH ORAL BENADRYL AND CREAM.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Swelling
Clinical narrative: LEFT ARM SWELLING UP INTO SHOULDER AND BACK (SCAPULA AND NECK) WITH REDNESS AND HEAT. TREATED WITH ORAL BENADRYL AND CREAM.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles outbreak on 01/20/2019. She received both doses of SHINGRIX, 1st dose 5/2018 and 2nd dose 7/2018, at a pharmacy. Patient is requesting that this be reported to CDC as an adverse reaction.
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy, Weight bearing difficulty
Clinical narrative: No weight bearing, pain, tender to touch, redness, swelling from groin to toes measuring upper thigh 25.5 cm. - middle thigh 28.3 cm. - lower thigh 23 cm. - lymph nodes x 2 swollen right groin.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Patient reported redness and swelling on arm 4 inches past injection site 2 days after the injection was given. Myself the pharmacist told patient she should discuss with doctor if he should examine for possible cellulitis. Did not hear from patient until today (6 days after injection). She said the redness and swelling had continued to spread to her torso and trunk of body up to her breast area. The redness and swelling subsided on its own before she reached an on call nurse. The nurse stated that she believes it was an allergic reaction to the vaccine.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Malaise, Personality change, Pyrexia
Clinical narrative: After vaccination pt got a very high fever and became very ill. His attitude and behavior was indifferent after the vaccination.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anal incontinence, Blood test, CSF protein increased, Diplegia, Electrocardiogram
Clinical narrative: Tingling, numbness in Rt. Leg below knee onset 10:00pm 10/11/18, by next morning Tingling, numbness and paralysis of both legs by 10:00am. Saw Physician at Dr. office who then sent me to ER. They did two MRI of spine and head which showed no significant issues. Paralysis spread up to waist. Incontinent of urine and feces. Admitted trans ICU with diagnosis of Guillain Barre Syndrome. Had Lumbar puncture (3 times) finally showed elevated Protein of 63.0 and a series of 5 five rounds of Mechanical separation of plasma from opening blood (36514) was completed during a ten(10) day hospital stay. Discharged to Rehabilation Hospital for 9 day stay to help me walk.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Laboratory test, Lumbar puncture
Clinical narrative: Tingling, numbness in Rt. Leg below knee onset 10:00pm 10/11/18, by next morning Tingling, numbness and paralysis of both legs by 10:00am. Saw Physician at Dr. office who then sent me to ER. They did two MRI of spine and head which showed no significant issues. Paralysis spread up to waist. Incontinent of urine and feces. Admitted trans ICU with diagnosis of Guillain Barre Syndrome. Had Lumbar puncture (3 times) finally showed elevated Protein of 63.0 and a series of 5 five rounds of Mechanical separation of plasma from opening blood (36514) was completed during a ten(10) day hospital stay. Discharged to Rehabilation Hospital for 9 day stay to help me walk.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal, Paraesthesia, Pulmonary function test, Urinary incontinence
Clinical narrative: Tingling, numbness in Rt. Leg below knee onset 10:00pm 10/11/18, by next morning Tingling, numbness and paralysis of both legs by 10:00am. Saw Physician at Dr. office who then sent me to ER. They did two MRI of spine and head which showed no significant issues. Paralysis spread up to waist. Incontinent of urine and feces. Admitted trans ICU with diagnosis of Guillain Barre Syndrome. Had Lumbar puncture (3 times) finally showed elevated Protein of 63.0 and a series of 5 five rounds of Mechanical separation of plasma from opening blood (36514) was completed during a ten(10) day hospital stay. Discharged to Rehabilation Hospital for 9 day stay to help me walk.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Local reaction
Clinical narrative: Local reaction at injeciton site started with bumps about 4 days after. Increased in size with redness, swelling or induration. No fevers or pain.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Crying, Dizziness, Fear
Clinical narrative: Patient was crying and scared during vaccinations. She felt dizziness after last shot of HPV. Had patient lie down and within 5 minutes dizziness went away and stated felt better.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Patient describes local site pain/redness/irritation that has lingered on for a longer duration of time than typical. He still complains of injection site pain and irritation (it has been 7 days since the injection).
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Fever, headache, shivering, fatigue, muscle pain, losing energy, slight numbness in the top of some fingers.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, headache, shivering, fatigue, muscle pain, losing energy, slight numbness in the top of some fingers.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Blood test, Cold sweat, Dysstasia
Clinical narrative: 11/16/2018 Severe muscle aches, fever, cold sweats. 11/27/18 Severe pain in right shoulder, arm and hand as well as joints. Severe back pain, numbness and tingling on right side of body as well as loss of feeling. Symptoms continues through December that also included muscle weakness in legs, could not stand longer than 35 minutes. Symptoms migrated to left leg, including pain, muscle weakness, numbness and loss of feeling. Cold burning feeling on toes that has now included both feet up to my ankles. Now January, still experiencing pain, numbness and loss of feeling in legs as well as leg weakness. Cannot stand longer than 4o minutes, now walking with cane due to leg muscle weakness. Not sleeping due to leg cramping and numbness, tingling sensations.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Insomnia, Muscle spasms, Muscular weakness
Clinical narrative: 11/16/2018 Severe muscle aches, fever, cold sweats. 11/27/18 Severe pain in right shoulder, arm and hand as well as joints. Severe back pain, numbness and tingling on right side of body as well as loss of feeling. Symptoms continues through December that also included muscle weakness in legs, could not stand longer than 35 minutes. Symptoms migrated to left leg, including pain, muscle weakness, numbness and loss of feeling. Cold burning feeling on toes that has now included both feet up to my ankles. Now January, still experiencing pain, numbness and loss of feeling in legs as well as leg weakness. Cannot stand longer than 4o minutes, now walking with cane due to leg muscle weakness. Not sleeping due to leg cramping and numbness, tingling sensations.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain in extremity, Paraesthesia
Clinical narrative: 11/16/2018 Severe muscle aches, fever, cold sweats. 11/27/18 Severe pain in right shoulder, arm and hand as well as joints. Severe back pain, numbness and tingling on right side of body as well as loss of feeling. Symptoms continues through December that also included muscle weakness in legs, could not stand longer than 35 minutes. Symptoms migrated to left leg, including pain, muscle weakness, numbness and loss of feeling. Cold burning feeling on toes that has now included both feet up to my ankles. Now January, still experiencing pain, numbness and loss of feeling in legs as well as leg weakness. Cannot stand longer than 4o minutes, now walking with cane due to leg muscle weakness. Not sleeping due to leg cramping and numbness, tingling sensations.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Sensory loss, Spinal X-ray, Walking aid user, X-ray limb
Clinical narrative: 11/16/2018 Severe muscle aches, fever, cold sweats. 11/27/18 Severe pain in right shoulder, arm and hand as well as joints. Severe back pain, numbness and tingling on right side of body as well as loss of feeling. Symptoms continues through December that also included muscle weakness in legs, could not stand longer than 35 minutes. Symptoms migrated to left leg, including pain, muscle weakness, numbness and loss of feeling. Cold burning feeling on toes that has now included both feet up to my ankles. Now January, still experiencing pain, numbness and loss of feeling in legs as well as leg weakness. Cannot stand longer than 4o minutes, now walking with cane due to leg muscle weakness. Not sleeping due to leg cramping and numbness, tingling sensations.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Dyspnoea, Unresponsive to stimuli
Clinical narrative: Patient observed with difficulty of breathing, became unresponsive for 10 seconds after few drops of Rotavirus administered orally.
Age: 42.0
Sex: F
Vaccine: DTP
Symptoms: Asthenia, Chills, Decreased appetite, Euphoric mood, Headache
Clinical narrative: Patient received Tetanus/Diphtheria 0.5 ml IM was given 8/14 in Left Deltoid; Manufacturer: Sanofi Pasteur, Lot Number: U6021AA Exp: 27JUL20). Patient sent message on site to physician describing symptoms as follows "I basically had flu-like symptoms, to include chills (severe, couldn't sleep), fever (didn't check it often, but it was 101 at one point), very low energy, body was aching all over, no appetite (not even thirsty), and I felt "high". As expected, arm was a little sore too. Symptoms started 11 hours after I got the shot (about 10:30pm). I couldn't work or barely do anything. Today, I still have chills on and off and I have a slight headache." ADR entered.
Age: 42.0
Sex: F
Vaccine: DTP
Symptoms: Impaired work ability, Influenza like illness, Insomnia, Pain, Pain in extremity
Clinical narrative: Patient received Tetanus/Diphtheria 0.5 ml IM was given 8/14 in Left Deltoid; Manufacturer: Sanofi Pasteur, Lot Number: U6021AA Exp: 27JUL20). Patient sent message on site to physician describing symptoms as follows "I basically had flu-like symptoms, to include chills (severe, couldn't sleep), fever (didn't check it often, but it was 101 at one point), very low energy, body was aching all over, no appetite (not even thirsty), and I felt "high". As expected, arm was a little sore too. Symptoms started 11 hours after I got the shot (about 10:30pm). I couldn't work or barely do anything. Today, I still have chills on and off and I have a slight headache." ADR entered.