chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAP, RV1
Symptoms: Communication disorder, Regressive behaviour, Unresponsive to stimuli
Clinical narrative: I noticed that gradually my son was not grasping things as often he would not grasp the swing to hold on when I would push him, he would hand flap. He would zone out and he became very quiet. Babbling stopped. What was most concerning that he would not respond to his name, it seemed that he had checked out and I worried that his communication was not developing. The changes were subtle but often times I would be concerned because he would not respond to his name. He is now 15 months and the hand flapping continues, babbling has started again but no words. The zoning out still happens occasionally. He now uses his hands well but it feels like he is behind especially with the lack of speech and unable to communicate his needs.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: 6-7 hours after injection my upper left arm was extremely red, swollen, warm and painful. I could not lift my arm without a great deal of effort and pain. I took liquid BENADRYL at that time and then again before bedtime.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: 6-7 hours after injection my upper left arm was extremely red, swollen, warm and painful. I could not lift my arm without a great deal of effort and pain. I took liquid BENADRYL at that time and then again before bedtime.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Abdominal X-ray, Constipation, Diarrhoea, Vomiting
Clinical narrative: Had vomiting 4 hours after vaccine, had constipation then diarrhea.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient said she is experiencing severe pain in her upper arm and shoulder even 6 days after the immunization.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Diet refusal, Muscle rigidity, Opisthotonus, Pyrexia
Clinical narrative: About 4 hours following vaccines child began arching back and screaming/crying. He was inconsolable for 4 hours straight and refused to breastfeed or be held. He became rigid and developed a fever around 101 degrees F.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Screaming
Clinical narrative: About 4 hours following vaccines child began arching back and screaming/crying. He was inconsolable for 4 hours straight and refused to breastfeed or be held. He became rigid and developed a fever around 101 degrees F.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Blood electrolytes normal, Blood test normal, Gait disturbance, Gait inability, Impaired work ability
Clinical narrative: Pt received Anthrax vaccine in rt arm around 1322. Pt stated later that evening he started noticing a little swelling and on 01/19/2018 he was limping and on 01/20/2018 he could not walk and called into work. Pt was seen at ER for swelling in rt leg and muscle spasms.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Muscle spasms, Nuclear magnetic resonance imaging, Peripheral swelling, Swelling, Ultrasound scan normal
Clinical narrative: Pt received Anthrax vaccine in rt arm around 1322. Pt stated later that evening he started noticing a little swelling and on 01/19/2018 he was limping and on 01/20/2018 he could not walk and called into work. Pt was seen at ER for swelling in rt leg and muscle spasms.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: Patient came into the pharmacy on 1/24/18 and said her arm was extremely sore on Monday evening after the administration of the vaccine. She said she couldn't sleep at all on Monday night because she was in so much pain. Today she said she cannot move her arm forward or up and cannot do daily activities like showering or changing. She is going to the doctor's office tomorrow.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Constipation, Pain, Screaming
Clinical narrative: Mom in our clinic with patient to receive 4 month vaccines. Mom states after receiving 2 month vaccines her baby ended up hospitalized. He was unable to have a bowel movement and was screaming in pain. Took patient to ER and spent 5 days at the hospital. Negative for suspected Hirschsprung's. Upon following up with her pediatrician after discharge pediatrician states it could have been a possible adverse reaction related to ROTARIX vaccination.
Age: 56.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain, Blood urine present, Constipation, Dysuria
Clinical narrative: After the first pill, my stomach was a little upset. A few hours after the second pill (taken 23 Dec 2017 at 8am), I started to feel symptoms similar to a urinary tract infection: burning on urination, frequent urge to urinate, abdominal pain. I treated with plenty of juice and water. I noticed some blood spotting in the late afternoon. It progressively increased. By midnight I was in horrible pain and there were copious amounts of blood in my urine. I decided to ride it out at home rather than going to the ER where I wouldn't be in the comfortable and familiar surroundings of my home. By morning, the blood began to subside. The intense abdominal pain continued several hours. The burning and pain on urination continued until Jan 10, 2018, gradually decreasing daily. I took the third dose on Dec 25, 2017 at 8am. I started to feel achy all over around 1030 am. I ran a fever of 99-100 and had some constipation. I took the fourth dose with no further symptoms. On Jan 2, 2018 I noticed dark brown spots on my teeth which went away a week later.
Age: 56.0
Sex: F
Vaccine: TYP
Symptoms: Micturition urgency, Pain, Pyrexia, Tooth discolouration, Urinary tract infection
Clinical narrative: After the first pill, my stomach was a little upset. A few hours after the second pill (taken 23 Dec 2017 at 8am), I started to feel symptoms similar to a urinary tract infection: burning on urination, frequent urge to urinate, abdominal pain. I treated with plenty of juice and water. I noticed some blood spotting in the late afternoon. It progressively increased. By midnight I was in horrible pain and there were copious amounts of blood in my urine. I decided to ride it out at home rather than going to the ER where I wouldn't be in the comfortable and familiar surroundings of my home. By morning, the blood began to subside. The intense abdominal pain continued several hours. The burning and pain on urination continued until Jan 10, 2018, gradually decreasing daily. I took the third dose on Dec 25, 2017 at 8am. I started to feel achy all over around 1030 am. I ran a fever of 99-100 and had some constipation. I took the fourth dose with no further symptoms. On Jan 2, 2018 I noticed dark brown spots on my teeth which went away a week later.
Age: 56.0
Sex: F
Vaccine: TYP
Symptoms: Vaginal haemorrhage
Clinical narrative: After the first pill, my stomach was a little upset. A few hours after the second pill (taken 23 Dec 2017 at 8am), I started to feel symptoms similar to a urinary tract infection: burning on urination, frequent urge to urinate, abdominal pain. I treated with plenty of juice and water. I noticed some blood spotting in the late afternoon. It progressively increased. By midnight I was in horrible pain and there were copious amounts of blood in my urine. I decided to ride it out at home rather than going to the ER where I wouldn't be in the comfortable and familiar surroundings of my home. By morning, the blood began to subside. The intense abdominal pain continued several hours. The burning and pain on urination continued until Jan 10, 2018, gradually decreasing daily. I took the third dose on Dec 25, 2017 at 8am. I started to feel achy all over around 1030 am. I ran a fever of 99-100 and had some constipation. I took the fourth dose with no further symptoms. On Jan 2, 2018 I noticed dark brown spots on my teeth which went away a week later.
Age: 61.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: At around 7pm on day of shot I got a rash across my lower back and it itched. This lasted about an hour then the whelps and itching subsided.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient began experiencing a fever at 12 noon the following day. Patient was advised to treat fever with TYLENOL.
Age: 21.0
Sex: M
Vaccine: FLUX, HEPA, HPV9, MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse and an office manager (also reported as clerk) regarding a 21-year-old male patient. It was reported that there was no illness at the time of vaccination and patient was without pre-existing physician-diagnosed allergies, birth defects and medical conditions. No information was provided regarding the patient's pertinent medical history. On 04-JAN-2018, the patient was vaccinated with first dose of improperly stored GARDASIL 9 (exact dose, dose number, lot # M034780 with the expiration date of 15-APR-2019) intramuscularly for prophylaxis. The patient's concomitant medication included meningococcal vaccine (unspecified), hepatitis a virus vaccine inactivated, and influenza virus vaccine inactivated (unspecified). The patient was vaccinated in a public health clinic/hospital. The patient did not have prior vaccination within 4 weeks prior to 04-JAN-2018. This event was not previously reported. The administered dose of GARDASIL 9 underwent a temperature excursion at or above 32 Fahrenheit degrees (F) up to 35 F (35.4 F) for 7 hours and 15 minutes. Previous temperature excursions were at or above 32 F up to 35 F (35.1 F) for 2 days, 1 hour and 37 minutes, and at or above 32 F up to 35 F (35.4 F) for 7 hours and 15 minutes. Digital data logger was involved to capture the temperature excursions. No adverse effects were reported. This vaccine was stored at the clinic where the temperature excursion (also reported as for a few moments). It was reported that the office manager made contact with all manufacturers who stated vaccine did not need to be pulled from inventory and the office manager received follow up stating GARDASIL 9 given to the patient was supported through expiry.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates between 03-NOV-2017 and 02-JAN-2018, the patients were vaccinated with VARIVAX lot # N019127, expiration date 22-JUN-2019 and with PROQUAD (albumin status: rHA) Lot# N014950, expiration date 11-NOV-2018, (route, dose and frequency were unknown) both for prophylaxis, which had a temperature excursion of 6F to 14F for 13 hours on an unspecified date. It was reported that the vaccines did not have previous temperature excursion and it was detected by a data logger. Concomitant therapies included sterile diluent (manufacturer unknown).
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history or concomitant medications were unknown by the reporter. On an unspecified date, the patient was vaccinated with ZOSTAVAX, 1 dose for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Other suspect therapies included sterile diluent, for an unknown indication (dose, frequency, lot number and expiration date were not reported). On an unspecified date, 8 days after receiving ZOSTAVAX, the patient developed a rash. It was unknown by the reporter if the patient seek medical attention, if treatment was given for the adverse events or if laboratory tests were performed. No product quality complaint was involved. The outcome of the event of rash and the causal relationship between the event and therapy with ZOSTAVAX were not reported.
Age: 0.75
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Laboratory test
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 10 month old male patient. The patient's pertinent medical history included umbilical hernia and cardiac murmur functional (reported as: "PPF functional heart murmur"). The patient did not have any concomitant medications and drug reactions or allergies. On 08-JAN-2018, the patient was vaccinated with a first dose of ROTATEQ vial, orally, lot # N014980; expiry date 16-NOV-2018 (dose was not reported) for prevention of rotavirus. On 08-JAN-2018, the patient was vaccinated with the second dose of ROTATEQ vial, orally, lot # N009962; expiry date 15-NOV-2018 (dose was not reported) for prevention of rotavirus. On 17-JAN-2018, the patient was admitted to the hospital with a diagnosis of intussusception. Unspecified treatment was given for the event. On an unknown date, intussusception was reduced but re-occurred at the time of the report. Unspecified lab diagnostic and studies were performed (reported as: " whatever was completed in the hospital"). At the time of the report, the patient was hospitalized. Re-reduction of intussusception was being attempt. The outcome of the event was reported as not recovered. The relatedness between the event and ROTATEQ was not reported. The reported considered the event to be life threatening and causing the patient a significant disability or incapacity. Upon internal review, the event of intussusception was considered to be medically significant.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Fall, Head injury, Lip injury
Clinical narrative: Initial unsolicited report received from a nurse via other company Pfizer (Manufacturer Report Number: 2017399532) on 07 Nov 2017. This case involves a 16-year-old male patient who was vaccinated with 0.5 ml dose of MENACTRA (expiry date: 17-Mar-2018) at right deltoid and TRUMENBA (expiry date: 31-Jan-2019) at left deltoid via intramuscular route (batch number, dose in series were not reported for both the vaccines) both on 22-Jun-2017 at 18:25 hours. Patient's medical history included scoliosis started on 24-Jun-2015. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of vaccinations. On 22-Jun-2017 at 18:28 hours, 3 minutes after the administration of the vaccination, the patient experienced syncope. It was reported that patient fell from exam table, experienced loss of consciousness, loss unconsciousness, head injury, increased lip and arm or shoulder pain. The patient was referred to emergency department. Patient was previously vaccinated with first dose of MENACTRA on 19-Jul-2012. Lab data included on 22-Jun-2017, neurological exam, CT scan of head, X-ray of left shoulder and EKG were performed, and results were negative. Corrective treatments were not reported. It was reported that patient was advised for reevaluation of vital signs. The events outcome were recovered for all the events on 22-Jun-2017. Follow up information received from a nurse via other company Pfizer on 09-Jan-2018. Patient received 0.5 ml dose of MENACTRA and TRUMENBA intramuscularly and Batch were reported as G7LSL2, U5514AC respectively. MENACTRA was given in right arm. Patient was not hospitalized. It was reported that patient was not deceased. List of documents held by sender: none.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness, Musculoskeletal pain, Neurological examination normal, Pain in extremity, Syncope
Clinical narrative: Initial unsolicited report received from a nurse via other company Pfizer (Manufacturer Report Number: 2017399532) on 07 Nov 2017. This case involves a 16-year-old male patient who was vaccinated with 0.5 ml dose of MENACTRA (expiry date: 17-Mar-2018) at right deltoid and TRUMENBA (expiry date: 31-Jan-2019) at left deltoid via intramuscular route (batch number, dose in series were not reported for both the vaccines) both on 22-Jun-2017 at 18:25 hours. Patient's medical history included scoliosis started on 24-Jun-2015. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of vaccinations. On 22-Jun-2017 at 18:28 hours, 3 minutes after the administration of the vaccination, the patient experienced syncope. It was reported that patient fell from exam table, experienced loss of consciousness, loss unconsciousness, head injury, increased lip and arm or shoulder pain. The patient was referred to emergency department. Patient was previously vaccinated with first dose of MENACTRA on 19-Jul-2012. Lab data included on 22-Jun-2017, neurological exam, CT scan of head, X-ray of left shoulder and EKG were performed, and results were negative. Corrective treatments were not reported. It was reported that patient was advised for reevaluation of vital signs. The events outcome were recovered for all the events on 22-Jun-2017. Follow up information received from a nurse via other company Pfizer on 09-Jan-2018. Patient received 0.5 ml dose of MENACTRA and TRUMENBA intramuscularly and Batch were reported as G7LSL2, U5514AC respectively. MENACTRA was given in right arm. Patient was not hospitalized. It was reported that patient was not deceased. List of documents held by sender: none.
Sex: M
Vaccine: MENB, MNQ
Symptoms: X-ray normal
Clinical narrative: Initial unsolicited report received from a nurse via other company Pfizer (Manufacturer Report Number: 2017399532) on 07 Nov 2017. This case involves a 16-year-old male patient who was vaccinated with 0.5 ml dose of MENACTRA (expiry date: 17-Mar-2018) at right deltoid and TRUMENBA (expiry date: 31-Jan-2019) at left deltoid via intramuscular route (batch number, dose in series were not reported for both the vaccines) both on 22-Jun-2017 at 18:25 hours. Patient's medical history included scoliosis started on 24-Jun-2015. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of vaccinations. On 22-Jun-2017 at 18:28 hours, 3 minutes after the administration of the vaccination, the patient experienced syncope. It was reported that patient fell from exam table, experienced loss of consciousness, loss unconsciousness, head injury, increased lip and arm or shoulder pain. The patient was referred to emergency department. Patient was previously vaccinated with first dose of MENACTRA on 19-Jul-2012. Lab data included on 22-Jun-2017, neurological exam, CT scan of head, X-ray of left shoulder and EKG were performed, and results were negative. Corrective treatments were not reported. It was reported that patient was advised for reevaluation of vital signs. The events outcome were recovered for all the events on 22-Jun-2017. Follow up information received from a nurse via other company Pfizer on 09-Jan-2018. Patient received 0.5 ml dose of MENACTRA and TRUMENBA intramuscularly and Batch were reported as G7LSL2, U5514AC respectively. MENACTRA was given in right arm. Patient was not hospitalized. It was reported that patient was not deceased. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: 12/29/17- Between 5-6pm- left deltoid became very inflamed and painful-took some 200mg Ibuprofen before bedtime; 12/30/17- left deltoid -3"x21/2" inflamed area-1/4" swollen area; 12noon began joint muscle pain-entire body and severe headache. At 330pm I took 1 Oxy/acet 5-325 and went to sleep. Upon awakening-headache gone/muscle-joint pain much improved. Overnite-symptoms became less-however deltoid remained swollen and itching on Monday. Weakness and "fatigue and chills".
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: 12/29/17- Between 5-6pm- left deltoid became very inflamed and painful-took some 200mg Ibuprofen before bedtime; 12/30/17- left deltoid -3"x21/2" inflamed area-1/4" swollen area; 12noon began joint muscle pain-entire body and severe headache. At 330pm I took 1 Oxy/acet 5-325 and went to sleep. Upon awakening-headache gone/muscle-joint pain much improved. Overnite-symptoms became less-however deltoid remained swollen and itching on Monday. Weakness and "fatigue and chills".
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Erythema, Injection site induration, Injection site mass, Swelling
Clinical narrative: Patient called 48 hours after receiving the vaccination complaining of a swollen red area about 6 inches in diameter and feels like a hard lump on the injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema of (L) upper arm.
Age: 54.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Diarrhoea, Full blood count, Headache, Injection site erythema, Injection site pain
Clinical narrative: PPSV23 in (R) deltoid-developed pain, redness warmth at site followed by diarrhea and headache.
Age: 54.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site warmth
Clinical narrative: PPSV23 in (R) deltoid-developed pain, redness warmth at site followed by diarrhea and headache.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Condition aggravated, Synovial cyst
Clinical narrative: Patient's left wrist ganglion cyst grew in size. Both the patient and his mother are convinced that he woke up the morning after the 2nd HPV shot with a notable increase in the size of his ganglion cyst. They also stated that they are convinced that the ganglion cyst originated after having received the first dose of HPV vaccine on 6/27/17, but they did not bring him to see me for his ganglion cyst until 12/12/17. The ganglion cyst has always been asymptomatic: no pain, no limit in his range of motion. He saw an orthopedic hand specialist for it on 12/14/17, who recommended monitoring it clinically. He again saw me for it on 1/23/18, after it had increased in size, and it is now approximately 1 cm in size but still painless, nontender, and without any limit of his ROM, so I recommended continuing to monitor it and to return if it causes pain or limited range of motion or continues to grow. I also told them I would file this VAERS report but felt that it was not related to the HPV vaccine.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Anger, Asthenia, C-reactive protein increased, Condition aggravated, Cutaneous lupus erythematosus
Clinical narrative: She presented to me nearly in tears, using a cane on 12/12/17. She has been in terrific pain, to the point of not being able to move since she was discharged from the hospital. She has required more of her medications (which she had previously been on very low doses) and has required prednisone just to be able to move. She is very angry and upset that she was forced to have the flu shot and the pneumonia (PREVNAR 13) at the same time and feels the combination has caused a prolonged flare of her discoid lupus which had previously been very stable. She felt better on 12/18/17 and was walking without her cane on this date. She was doing much better. However she was taking prednisone. On 1/24/17, pt presents to the office again for terrible pain and she is incredibly frustrated with her pain and lack of mobility, she does not want to be on any more medications, but she can't move without pain unless she is on prednisone. She would like me to report this to the vaccine administration personnel. She has been in pain now for 4.5 months, only able to move if she is taking the prednisone. She is very weak, she continues have limited movement and pain. Hospital could not tell me which flu vaccine the pt received. I have scanned in the information provided. There were 2 Seqirus vaccines options in the drop down menu on this site. I chose the quadrivalent AFLURIA. The other was one I had not heard of in this area, which is why I did not chose it. My nurse spoke with staff at hospital and she could not provide us with the information we asked for.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Emotional distress, Gamma-glutamyltransferase increased, Glomerular filtration rate, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: She presented to me nearly in tears, using a cane on 12/12/17. She has been in terrific pain, to the point of not being able to move since she was discharged from the hospital. She has required more of her medications (which she had previously been on very low doses) and has required prednisone just to be able to move. She is very angry and upset that she was forced to have the flu shot and the pneumonia (PREVNAR 13) at the same time and feels the combination has caused a prolonged flare of her discoid lupus which had previously been very stable. She felt better on 12/18/17 and was walking without her cane on this date. She was doing much better. However she was taking prednisone. On 1/24/17, pt presents to the office again for terrible pain and she is incredibly frustrated with her pain and lack of mobility, she does not want to be on any more medications, but she can't move without pain unless she is on prednisone. She would like me to report this to the vaccine administration personnel. She has been in pain now for 4.5 months, only able to move if she is taking the prednisone. She is very weak, she continues have limited movement and pain. Hospital could not tell me which flu vaccine the pt received. I have scanned in the information provided. There were 2 Seqirus vaccines options in the drop down menu on this site. I chose the quadrivalent AFLURIA. The other was one I had not heard of in this area, which is why I did not chose it. My nurse spoke with staff at hospital and she could not provide us with the information we asked for.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Hepatitis viral test negative, Mobility decreased, Pain, Red blood cell sedimentation rate normal, Tearfulness
Clinical narrative: She presented to me nearly in tears, using a cane on 12/12/17. She has been in terrific pain, to the point of not being able to move since she was discharged from the hospital. She has required more of her medications (which she had previously been on very low doses) and has required prednisone just to be able to move. She is very angry and upset that she was forced to have the flu shot and the pneumonia (PREVNAR 13) at the same time and feels the combination has caused a prolonged flare of her discoid lupus which had previously been very stable. She felt better on 12/18/17 and was walking without her cane on this date. She was doing much better. However she was taking prednisone. On 1/24/17, pt presents to the office again for terrible pain and she is incredibly frustrated with her pain and lack of mobility, she does not want to be on any more medications, but she can't move without pain unless she is on prednisone. She would like me to report this to the vaccine administration personnel. She has been in pain now for 4.5 months, only able to move if she is taking the prednisone. She is very weak, she continues have limited movement and pain. Hospital could not tell me which flu vaccine the pt received. I have scanned in the information provided. There were 2 Seqirus vaccines options in the drop down menu on this site. I chose the quadrivalent AFLURIA. The other was one I had not heard of in this area, which is why I did not chose it. My nurse spoke with staff at hospital and she could not provide us with the information we asked for.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Walking aid user
Clinical narrative: She presented to me nearly in tears, using a cane on 12/12/17. She has been in terrific pain, to the point of not being able to move since she was discharged from the hospital. She has required more of her medications (which she had previously been on very low doses) and has required prednisone just to be able to move. She is very angry and upset that she was forced to have the flu shot and the pneumonia (PREVNAR 13) at the same time and feels the combination has caused a prolonged flare of her discoid lupus which had previously been very stable. She felt better on 12/18/17 and was walking without her cane on this date. She was doing much better. However she was taking prednisone. On 1/24/17, pt presents to the office again for terrible pain and she is incredibly frustrated with her pain and lack of mobility, she does not want to be on any more medications, but she can't move without pain unless she is on prednisone. She would like me to report this to the vaccine administration personnel. She has been in pain now for 4.5 months, only able to move if she is taking the prednisone. She is very weak, she continues have limited movement and pain. Hospital could not tell me which flu vaccine the pt received. I have scanned in the information provided. There were 2 Seqirus vaccines options in the drop down menu on this site. I chose the quadrivalent AFLURIA. The other was one I had not heard of in this area, which is why I did not chose it. My nurse spoke with staff at hospital and she could not provide us with the information we asked for.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Vomiting. Occurred within a few hours after the shot. Child acting normal all day before the vaccination. Late that night we called the hospital to see if he should be brought in. We decided on the phone to see if it got any worse before doing so.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Hyperhidrosis, Influenza A virus test positive, Pyrexia, Vaccination failure
Clinical narrative: Case number PHEH2017US000760, is an initial spontaneous report received from a consumer on 05 Jan 2017. This report is also associated with a Quality Assurance number (QA Reference number: 1018884). This report refers to a 15 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185327, expiry: Apr 2017) at a dose of 0.5 ml intramuscularly on 08 Oct 2016. On 03 Jan 2017 after vaccination, the patient came home with high fever, chills and sweats. On 04 Jan 2017, the patient was tested positive for A strain influenza. The patient received treatment with TAMIFLU. It was reported that symptoms were much improved with no more fever. The outcome of the events high fever, chills and sweats was reported as complete recovery on 05 Jan 2017 and outcome of the event tested positive for A strain influenza was not reported. The seriousness and causality of the events were not reported. The seriousness assessment of the events influenza A virus test positive and vaccination failure was upgraded (medically significant) based on the information available in the source document. Batch review report reference number [1018884] received from quality assurance department on 17 Feb 2017. Based on the document review, it was stated that the concerned FLUCELVAX QUADRIVALENT batch number [185327] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up information received from Quality assurance department on 17 Feb 2017: Added investigation summary.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Blister, Dyspnoea, Lip swelling, Pruritus, Rash generalised
Clinical narrative: This initial spontaneous case, was received from nurse on 25-Oct-2017, concerning a 63-year-old adult female patient. The patient's historical conditions included: had a titanium cobalt hip implant (about 3 years ago). The patient got a reaction and developed the asthmatic-like symptoms. She was treated but the treatment did not work and hence removal of implant was done. The history of asthma was only during the time she had the implant. All the asthmatic symptoms were resolved in 2015. It was reported that she never had any reactions to any other vaccine. The patient's current conditions included asthma and hypothyroidism (since an unspecified date). The patient's concomitant medications included Levothyroxine and EVISTA for an unknown indication. The patient did not have any known allergy. On 18-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195245, expiry date; Jun-2018, route of administration: intramuscular, anatomical location: deltoid). On the same day, about 1 hour after vaccination, the patient developed itching, rash, hives, swollen lip and went to the emergency room, she had also had shortness of breath and developed full body rash, which resolved with BENADRYL, SOLUMEDROL, Fluids via intravenous route and PEPCID, but she had little bit of rash left at bra line and patient was discharged home. It was reported that, she woke up and noticed full body rash again and areas of blisters over the entire body. At that point, she called the emergency room and started an unspecified oral steroids and antihistamines, which was completely resolved on an unspecified date. The reporter suspected that, she was allergic to metals and advised to stop using jewelry. The outcome of the events was recovered. The reporter assessed the report as serious (medically significant). Follow-up report received from the nurse on 13-Nov-2017: Outcome of the events "Generalized rash and blistering" was changed from recovering to recovered. It was reported that, the patient had no inpatient hospitalization but only emergency visit. The nurse did not know, if the patient had any previous allergic reactions. Amended narrative accordingly. Follow-up report received from the nurse on 29-Nov-2017: Updated medical history. The patient had a titanium cobalt hip implant (about 3 years ago). The patient got a reaction and developed asthmatic-like symptoms. She was treated but the treatment did not work and hence removal of implant was done. The history of asthma was only during the time she had the implant. All the asthmatic symptoms were resolved in 2015. It was reported that she never had any reactions to any other vaccine. The narrative was amended accordingly.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This initial spontaneous case, was received from nurse on 25-Oct-2017, concerning a 63-year-old adult female patient. The patient's historical conditions included: had a titanium cobalt hip implant (about 3 years ago). The patient got a reaction and developed the asthmatic-like symptoms. She was treated but the treatment did not work and hence removal of implant was done. The history of asthma was only during the time she had the implant. All the asthmatic symptoms were resolved in 2015. It was reported that she never had any reactions to any other vaccine. The patient's current conditions included asthma and hypothyroidism (since an unspecified date). The patient's concomitant medications included Levothyroxine and EVISTA for an unknown indication. The patient did not have any known allergy. On 18-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195245, expiry date; Jun-2018, route of administration: intramuscular, anatomical location: deltoid). On the same day, about 1 hour after vaccination, the patient developed itching, rash, hives, swollen lip and went to the emergency room, she had also had shortness of breath and developed full body rash, which resolved with BENADRYL, SOLUMEDROL, Fluids via intravenous route and PEPCID, but she had little bit of rash left at bra line and patient was discharged home. It was reported that, she woke up and noticed full body rash again and areas of blisters over the entire body. At that point, she called the emergency room and started an unspecified oral steroids and antihistamines, which was completely resolved on an unspecified date. The reporter suspected that, she was allergic to metals and advised to stop using jewelry. The outcome of the events was recovered. The reporter assessed the report as serious (medically significant). Follow-up report received from the nurse on 13-Nov-2017: Outcome of the events "Generalized rash and blistering" was changed from recovering to recovered. It was reported that, the patient had no inpatient hospitalization but only emergency visit. The nurse did not know, if the patient had any previous allergic reactions. Amended narrative accordingly. Follow-up report received from the nurse on 29-Nov-2017: Updated medical history. The patient had a titanium cobalt hip implant (about 3 years ago). The patient got a reaction and developed asthmatic-like symptoms. She was treated but the treatment did not work and hence removal of implant was done. The history of asthma was only during the time she had the implant. All the asthmatic symptoms were resolved in 2015. It was reported that she never had any reactions to any other vaccine. The narrative was amended accordingly.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Allergy to vaccine, Anaphylactic reaction, Erythema, Injection site erythema, Injection site pruritus
Clinical narrative: This serious initial spontaneous case, was received from a pharmacist on 13-Nov-2017, concerning a 36-year-old, female patient. The patient's medical history was not reported. The patient was allergic to soy. The patient's concomitant medication included imipramine for unknown indication. On 09-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195239, expiry date: May-2018). On the same day, after 30 minutes of vaccination, the patient experienced swelling in tongue, itching and redness at the site of injection and throughout her arm. The patient had an allergy to vaccine. The patient went to the emergency room (ER) in fear of anaphylactic reaction as she was allergic to soy and thought that soy could be in vaccine. It was confirmed that the patient had an anaphylactic reaction. The patient was treated with steroids, BENADRYL at ER and MEDROL dose pack, hydroxyzine once at home. The outcome of the events was reported as recovered on 09-Nov-2017. Follow up received on 29-Nov-2017: It was reported that patient had an anaphylactic reaction. The narrative was amended accordingly.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swollen tongue
Clinical narrative: This serious initial spontaneous case, was received from a pharmacist on 13-Nov-2017, concerning a 36-year-old, female patient. The patient's medical history was not reported. The patient was allergic to soy. The patient's concomitant medication included imipramine for unknown indication. On 09-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195239, expiry date: May-2018). On the same day, after 30 minutes of vaccination, the patient experienced swelling in tongue, itching and redness at the site of injection and throughout her arm. The patient had an allergy to vaccine. The patient went to the emergency room (ER) in fear of anaphylactic reaction as she was allergic to soy and thought that soy could be in vaccine. It was confirmed that the patient had an anaphylactic reaction. The patient was treated with steroids, BENADRYL at ER and MEDROL dose pack, hydroxyzine once at home. The outcome of the events was reported as recovered on 09-Nov-2017. Follow up received on 29-Nov-2017: It was reported that patient had an anaphylactic reaction. The narrative was amended accordingly.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This initial serious spontaneous case, was received on 03-Nov-2017, reported by other non-health professional and concerns a 32-year-old adult female patient. The patient's historical drug included SINGULAIR for an unknown indication. It was reported that, the patient stopped oral contraceptive pills on an unspecified date in May 2017. The patient did not have any maternal medical history and paternal medical history (hereditary disease). The patient's last menstrual period date was 02-Aug-2017 and estimated date of delivery was 09-May-2018. There was no evidence of defect/adverse finding from a prenatal test. It was reported that, no medications were taken by father prior to conception. The patient's concomitant medications included Acyclovir for cold sores. On 03-Nov-2017, at gestational age of 13-weeks (first trimester), the patient was administered with FLUCELVAX QIV (dosage: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). It was reported that no adverse event was reported in the patient and fetus. The reporter assessed the report as serious (medically significant).
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Influenza, Influenza A virus test positive, Pyrexia, Vaccination failure
Clinical narrative: This serious initial spontaneous case initially received on 29-Mar-2017 was reported by other health professional (nurse) and concerns a 26-year-old adult female patient. The patient had received flu shot (name of vaccine unspecified) which was given long ago. It was reported that prior to vaccination patient's immune status was normal. On 08-Oct-2016, the patient was administered with FLUCELVAX QIV (dosage: 0.5ml, form: solution, batch number: 185327, route of administration: intramuscular, expiration date: 30-Apr-2017). On 24-Mar-2017 after administration of FLUCELVAX QIV, the patient being diagnosed with Influenza Type A (Vaccination failure) and on an unspecified date patient experienced fever and chills. Relevant tests included nasal swab test, positive for influenza A. Batch review report (reference number: 1021160 received from quality assurance department on [02-Jun-2017]: Based on the document review, it was stated that the concerned [FLUCELVAX QIV] batch number [185327] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Outcome of the event influenza Type A was recovered / resolved on 29-Mar-2017. The reporter assessed the "lack of efficacy" and "Influenza Type A as non-serious. The reporter assessed the causality of the events as related. Follow-up report received on 25-Apr-2017: Patients age at vaccination was updated, relevant tests include nasal swab (positive for influenza A), fever and chills were added as symptoms. Follow up report received on 02-Jun-2017: Vaccine administered date was updated from 28-Sep-2016 to 08-Oct-2016. Expiration date was added as 30-Apr-2017, Batch review report was added. Follow up report received on 07-Jun-2017: Added historical vaccine details. Significant case correction received on 20 Jun 2017: Added follow up justification, coded flu shot as historical drug, lack of efficacy was coded to vaccination failure, first reference number added, confirmation of receipt was attached in additional information.
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This initial spontaneous case, received on 14-Apr-2017, which was reported by other health-professional (nurse) and concerns a male patient of an unspecified age. On 29-Sep-2016, the patient received FLUCELVAX QIV (dose: 0.5 ml, expiry date: 30-Apr-2017, batch number: 185327, route of administration: intramuscular and anatomical location: not reported). On 10-Apr-2017 (Monday), the patient was diagnosed with Influenza A virus infection. This was characterised as vaccination failure. The patient was treated with an anti-viral medication  for influenza. Batch review report (reference number: 1021320) received from quality assurance department on 08-Jun-2017, based on the document review, it was stated that, FLUCELVAX QIV was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The outcome of the events were not reported. The reporter did not provide the causality of the events in relation to the FLUCELVAX QIV. This case was serious (medically significant). Significant case correction received on 11-May-2017: Company causality was changed from unassessable to related. Batch review report (reference number 1021320) received from quality assurance department on 08-Jun-2017: Based on the document review, it was stated that the concerned FLUCELVAX QIV batch number 185327 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements.
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This Spontaneous case, initially received on 13-Apr-2017 was reported by other healthcare professional and concerns a female patient of unknown age. On 28-Sep-16, the patient was administered FLUCELVAX QIV (dosage: 0.5 ml, route of administration: intramuscular, batch number: 185327 and expiry date: 30-Apr-2017). On 05-Apr-17 after administration of FLUCELVAX QIV, the patient experienced type B influenza and vaccination failure. On 10-Apr-17 the event type B influenza has stopped. Batch review report 1021283 was received from quality assurance department on 08-Jun-2017. Based on the document review, it was stated that the concerned FLUCELVAX QIV batch number 185327 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The outcome of the event type B influenza was recovered/resolved and vaccination failure was unknown. The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This was a serious case (medically significant). Non-significant case correction received on 03-May-2017: The case comment and typo errors in narrative were corrected. Follow-up report was received from quality assurance department on 08-Jun-2017: Batch review report and expiry date were updated.
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Cough, Influenza, Oropharyngeal pain, Pyrexia
Clinical narrative: Case number PHEH2017US005138 is initial spontaneous report received from consumer on 15 Feb 2017. This report refers to 17-year-old female patient (weight-72.3 kg and height- 160.3 cm). The patient's medical history included: hematochezia, teratoma. FLUCELVAX QUADRIVALENT was administered on 08-Oct-2016 (Dosage: 0.5ml, route of administration: intramuscular, batch number: 185327, expiry date: 30-Apr-2017). After administration of FLUCELVAX QUADRIVALENT, on 15-Feb-2017 the patient experienced influenza (Seriousness criteria: Medically Significant), (Outcome - recovered), Associated Symptoms: cough, fever, chills, sore throat. It is reported that patient experienced flu because of vaccination failure. This was considered as vaccination failure (seriousness criteria: medically significant), (outcome - not reported). Batch review report (1021211) received from quality assurance department on 03-Jun-2017: Based on the document review, it was stated that the concerned FLUCELVAX QUADRIVALENT, batch number: 185327 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Treatment medications: TAMIFLU is administered for flu. The Consumer assessed the events as serious (medically significant) and the causality related (possibly) for vaccination failure and not related for Influenza. This case report was considered as serious (medically significant). Follow up received on 12-Apr-2017: Added reporter's details, updated patient details (height, weight and race), medical history (hematochezia, teratoma), added treatment drug (TAMIFLU), added events vaccination failure and influenza with symptoms (influenza with symptoms fever, chills and sore throat), updated outcome and causality for the events, accordingly updated narrative. Follow up received on 03-Jun-2017: Start date, batch number and expiry date of suspect vaccine was updated and batch review report (1021211) from quality assurance department was updated.