chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rash
Clinical narrative: Rash and swelling to left arm measuring 5x5 1/2 in.; abrupt onset of severe body aches, chills and fever started approx. 8 hrs after injection; duration of fever and body aches from 1am on Feb 15 until the morning of Feb 17; rash to left arm improved with diphenhydramine but as not resolved completely at this writing.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Influenza like illness, Influenza virus test negative, Injection site erythema, Injection site nodule
Clinical narrative: Rash and swelling to left arm measuring 5x5 1/2 in.; abrupt onset of severe body aches, chills and fever started approx. 8 hrs after injection; duration of fever and body aches from 1am on Feb 15 until the morning of Feb 17; rash to left arm improved with diphenhydramine but as not resolved completely at this writing.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Rash and swelling to left arm measuring 5x5 1/2 in.; abrupt onset of severe body aches, chills and fever started approx. 8 hrs after injection; duration of fever and body aches from 1am on Feb 15 until the morning of Feb 17; rash to left arm improved with diphenhydramine but as not resolved completely at this writing.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema
Clinical narrative: Pt's arm was red and she wanted to know what to do. RPh on duty, saw it and suggested she go to dr to get a steroid shot. Pt went to MD office.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Patient reported swelling, redness, tenderness next morning after shot, that seemed to grow worse.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Patient received PREVNAR vaccine on 02/07/18. Patient called the pharmacy on 2/15/18 stating that she was experiencing local pain. Patient did not report any other side effects. We followed up with patient on 2/16/18 and patient stated she was feeling better and the pain has diminished. We followed up with patient again today (2/19/18). Patient stated that she experienced some radiating over the weekend but the pain has diminished and she is feeling better today.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Blood culture, C-reactive protein, Chest X-ray, Culture urine, Full blood count
Clinical narrative: Fever 103. Seizure, presumed febrile x 1 occurred 4-6 hours after vaccine administered.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Influenza virus test, Polymerase chain reaction, Pyrexia, Seizure, Streptococcus test
Clinical narrative: Fever 103. Seizure, presumed febrile x 1 occurred 4-6 hours after vaccine administered.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Urine analysis
Clinical narrative: Fever 103. Seizure, presumed febrile x 1 occurred 4-6 hours after vaccine administered.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Apnoea, Atelectasis, Chest X-ray abnormal, Dyspnoea, Human rhinovirus test positive
Clinical narrative: (1400) Patient received PCV23 vaccine at around 10 AM in clinic. About 4 hr. later developed fever and was given TYLENOL. Remained febrile, so received 2nd dose of TYLENOL at 18:00. Around 19:00, increased WOB and received alb neb. Around that time, dad found that she was apneic, and was given CPR at home, and EMS arrived and transferred to hosp. where she was admitted, and discharged on 1/17/18. Found to have positive RSV type B and Rhinovirus on VRP testing. Mother felt like this is unusual for her previous resp time infections and want to report. Description of reaction as attached/written in front page. Mother concerned that the event might be related to the PNEUMOVAX vaccine that was given. Personally, I think it is less likely a vaccine allergy is most likely from her respiratory illness that led to increased work of breathing, hypoxemia and apnea. She was found to have RSV infection during hospitalization. She was a complex medical problem with frequent respiratory illness, critical hypoventilation, Beckwith-Wiedemann Syndrome, chromosome 2 deletion, bronchopulmonary dysplasia tracheostomy. This is reported per the mother's request as she was concerned that patient's clinical course of illness was more rapid and severe than her previous respiratory illnesses. MD, 2-14-2018.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Hypoxia, Influenza virus test negative, Pyrexia, Respiratory disorder, Respiratory syncytial virus infection
Clinical narrative: (1400) Patient received PCV23 vaccine at around 10 AM in clinic. About 4 hr. later developed fever and was given TYLENOL. Remained febrile, so received 2nd dose of TYLENOL at 18:00. Around 19:00, increased WOB and received alb neb. Around that time, dad found that she was apneic, and was given CPR at home, and EMS arrived and transferred to hosp. where she was admitted, and discharged on 1/17/18. Found to have positive RSV type B and Rhinovirus on VRP testing. Mother felt like this is unusual for her previous resp time infections and want to report. Description of reaction as attached/written in front page. Mother concerned that the event might be related to the PNEUMOVAX vaccine that was given. Personally, I think it is less likely a vaccine allergy is most likely from her respiratory illness that led to increased work of breathing, hypoxemia and apnea. She was found to have RSV infection during hospitalization. She was a complex medical problem with frequent respiratory illness, critical hypoventilation, Beckwith-Wiedemann Syndrome, chromosome 2 deletion, bronchopulmonary dysplasia tracheostomy. This is reported per the mother's request as she was concerned that patient's clinical course of illness was more rapid and severe than her previous respiratory illnesses. MD, 2-14-2018.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory syncytial virus test positive, Resuscitation
Clinical narrative: (1400) Patient received PCV23 vaccine at around 10 AM in clinic. About 4 hr. later developed fever and was given TYLENOL. Remained febrile, so received 2nd dose of TYLENOL at 18:00. Around 19:00, increased WOB and received alb neb. Around that time, dad found that she was apneic, and was given CPR at home, and EMS arrived and transferred to hosp. where she was admitted, and discharged on 1/17/18. Found to have positive RSV type B and Rhinovirus on VRP testing. Mother felt like this is unusual for her previous resp time infections and want to report. Description of reaction as attached/written in front page. Mother concerned that the event might be related to the PNEUMOVAX vaccine that was given. Personally, I think it is less likely a vaccine allergy is most likely from her respiratory illness that led to increased work of breathing, hypoxemia and apnea. She was found to have RSV infection during hospitalization. She was a complex medical problem with frequent respiratory illness, critical hypoventilation, Beckwith-Wiedemann Syndrome, chromosome 2 deletion, bronchopulmonary dysplasia tracheostomy. This is reported per the mother's request as she was concerned that patient's clinical course of illness was more rapid and severe than her previous respiratory illnesses. MD, 2-14-2018.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: Given influenza vaccine in left arm. Vaccine was painful. 1 week later had increased pain in deltoid. 2 weeks later had large bump and bruise on deltoid. Still have residual pain in shoulder and decreased range of motion.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Given influenza vaccine in left arm. Vaccine was painful. 1 week later had increased pain in deltoid. 2 weeks later had large bump and bruise on deltoid. Still have residual pain in shoulder and decreased range of motion.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Dizziness, Drooling, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: Patient in her bedroom sitting on floor, everything went black, felt "dizzy". Stood up, called out to Mom, lost consciousness. Mom ran in, pt leaning against closet doors, very pale; face contorted, then arms, drooled, arms shaking. Mom held her. Patient moved her arms to support her head, apparently to get more comfortable. Then arms down to sides and head turned to side; head rhythmically hit floor few times. Shaking lasted 1.5 to 2 minutes. Eyes open, breathing but still unresponsive 5 minutes or less gradually came back. Slow to answer to mom, not confused no weakness. EMS arrived. Woke up felt dizzy, nauseated, vision black blur. To ER.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Nuclear magnetic resonance imaging brain, Pallor, Tremor, Unresponsive to stimuli
Clinical narrative: Patient in her bedroom sitting on floor, everything went black, felt "dizzy". Stood up, called out to Mom, lost consciousness. Mom ran in, pt leaning against closet doors, very pale; face contorted, then arms, drooled, arms shaking. Mom held her. Patient moved her arms to support her head, apparently to get more comfortable. Then arms down to sides and head turned to side; head rhythmically hit floor few times. Shaking lasted 1.5 to 2 minutes. Eyes open, breathing but still unresponsive 5 minutes or less gradually came back. Slow to answer to mom, not confused no weakness. EMS arrived. Woke up felt dizzy, nauseated, vision black blur. To ER.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Visual impairment
Clinical narrative: Patient in her bedroom sitting on floor, everything went black, felt "dizzy". Stood up, called out to Mom, lost consciousness. Mom ran in, pt leaning against closet doors, very pale; face contorted, then arms, drooled, arms shaking. Mom held her. Patient moved her arms to support her head, apparently to get more comfortable. Then arms down to sides and head turned to side; head rhythmically hit floor few times. Shaking lasted 1.5 to 2 minutes. Eyes open, breathing but still unresponsive 5 minutes or less gradually came back. Slow to answer to mom, not confused no weakness. EMS arrived. Woke up felt dizzy, nauseated, vision black blur. To ER.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Strabismus
Clinical narrative: Acute left esotropia one week after vaccine.
Sex: M
Vaccine: RAB
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to RABAVERT. Additional details were provided as follows: It was unknown if the patient received RABAVERT vaccination for pre or post exposure prophylaxis. The age at the vaccination was not reported. The reporter stated RABAVERT caused pain in the gluteus maximus of the patient. The reporter was not willing to provide any further details. The reporter was unable to confirm if they were a health care professional. The reporter refused to answer questions regarding complaint of the patient with pain in the gluteus maximus and was unable to provide any other adverse event information. Initials was the same as that of the reporter.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: Localized swelling at injection site, the size of a tennis ball. C/O redness, itching, hot to the touch. Used BENADRYL and cool compresses. Swelling x 5 days.
Age: 1.83
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Medical Assistant administered adult dose of Hep A vaccine to pediatric patient.
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Blood folate normal, Haemoglobin normal, Pancytopenia, Platelet count decreased, Reticulocyte count normal
Clinical narrative: Hemoglobin was obtained on 12/5/17 as part of this patient's well child check. She had influenza shot #2 at the appropriate time interval 11/27/17. Hemoglobin was 10.3 g/dL. I subsequently added a CBC to the same blood draw and this patient had a pancytopenia: WBC = 3.6 K, and plts = 132 K/uL. The patient was not sick at the time and was not exhibiting any adverse reactions otherwise. Follow up CBC with reticulocyte count, Vitamin B12 and Folate were normal one week later.
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Vitamin B12 normal, White blood cell count decreased
Clinical narrative: Hemoglobin was obtained on 12/5/17 as part of this patient's well child check. She had influenza shot #2 at the appropriate time interval 11/27/17. Hemoglobin was 10.3 g/dL. I subsequently added a CBC to the same blood draw and this patient had a pancytopenia: WBC = 3.6 K, and plts = 132 K/uL. The patient was not sick at the time and was not exhibiting any adverse reactions otherwise. Follow up CBC with reticulocyte count, Vitamin B12 and Folate were normal one week later.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Bursitis, Hypoaesthesia, Injected limb mobility decreased, Local reaction, Pain
Clinical narrative: Patient went to ER with pain, swelling of Left arm-was unable to move left arm-pain medication was no helping with pain Also was having numbness distally in fingers. ER report stated that thought it was Deltoid bursitis. Was seen by primary physician on 2-2-18, primary physician thought it was more of an severe localized reaction to injection and not bursitis.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Peripheral swelling
Clinical narrative: Patient went to ER with pain, swelling of Left arm-was unable to move left arm-pain medication was no helping with pain Also was having numbness distally in fingers. ER report stated that thought it was Deltoid bursitis. Was seen by primary physician on 2-2-18, primary physician thought it was more of an severe localized reaction to injection and not bursitis.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient had a rash mainly on the injection site on thighs. Top part of legs, neck, underneath the breast. Is using a hydrating lotion and was given a cortisone shot and MEDROL DOSE pack and hydroxyzine tablets.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Pain
Clinical narrative: Pt said she developed a rash with pain a few hours after the injection. Rash is on left deltoid. Pt stated painful for several days. Pt saw MD today and nothing prescribed. MD stated rash will go away. Pt in less pain now as well.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: Pt said she developed a rash with pain a few hours after the injection. Rash is on left deltoid. Pt stated painful for several days. Pt saw MD today and nothing prescribed. MD stated rash will go away. Pt in less pain now as well.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Erythema multiforme
Clinical narrative: Developed Erythema multiforme minor 7 days after receiving PROQUAD and PREVNAR 13. Tx: systemic steroid, Antihistamine, Ranitidine.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Electromyogram, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Shot was given wrong. Couldn't move my arm went to general practitioner got prednisone, it didn't help. Saw a neurologist who ordered MRI, it shows Rotator cuff tear. EMG is scheduled. Going to physical therapy 3x a week. Still no relief from pain, constant since shot given.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test normal, Lip swelling, Swelling face, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 19-Jan-2018. This case involves a 50-year-old female patient who was vaccinated with single 0.1 ml dose of FLUZONE INTRADERMAL via intradermal route (batch number: UI826AD, expiry date: 30-Jun-2018, dose in series and site of administration were not reported) on 28-Sep-2017. The patient medical history and concomitant medications were not reported. On 01-Dec-2017, 64 days following the vaccination the patient experienced hives off and on over body. The patient required emergency room or doctor visit. Laboratory investigations and corrective treatment was not reported. The patient was not yet recovered from the event at the time of reporting. Follow up information received from a consumer (patient herself) on 06-Feb-2018. This patient was vaccinated first dose FLUZONE on 29-Sep-2017. The past medication included oxycodone hydrochloride/paracetamol (PERCOCET) from unknown date and patient had allergy to it. The patient did not have any other allergies. The patient did not have any other medical history other than sore throat on an unspecified date of May-2017. The patient's concomitant medications include 2.5 mg of estrogens conjugated/medroxyprogesterone acetate (PREMPRO) from 2009, 15 mg of MELOXICAM in 2012 and 50 mg of SUMATRIPTAN (IMITREX) as needed from 2017. On 02-Dec-2017, 63 days following the vaccination the patient experienced hives on wrist and on 03-Dec-2017, 64 days following the vaccination (Reported as next day) the patient woke up with her lips swollen half of her face was swollen, chronic hives on and off, swollen lips, eyes and face. The patient visited in allergists on 15-Dec-2017. Infection disease physician on 05-Jan-2018 and allergists' again on 10-Jan-2018. The patient's corrective treatment included FEXOFENADINE HYDROCHLORIDE (ALLEGRA 150), BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE), Zantac (RANITIDINE HYDROCHLORIDE), SINGULAIR (MONTELUKAST), DOXEPIN and OMALIZUMAB (XOLAIR). The patient's lab test included on 01-May-2018 rheumatoid arthritis factor, quantiferon-TB Gold, Cold agglutinin titre, Immunoglobulin E, hbsag screening, HEPATITIS ABC test, comprehensive metabolic panel and ANA test, cryslobullin test and HCV test and result of all test was negative. The patient was not yet recovered from the event. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Antinuclear antibody negative, Blood immunoglobulin E normal, Cold agglutinins negative, Cryoglobulins absent, Eye swelling
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 19-Jan-2018. This case involves a 50-year-old female patient who was vaccinated with single 0.1 ml dose of FLUZONE INTRADERMAL via intradermal route (batch number: UI826AD, expiry date: 30-Jun-2018, dose in series and site of administration were not reported) on 28-Sep-2017. The patient medical history and concomitant medications were not reported. On 01-Dec-2017, 64 days following the vaccination the patient experienced hives off and on over body. The patient required emergency room or doctor visit. Laboratory investigations and corrective treatment was not reported. The patient was not yet recovered from the event at the time of reporting. Follow up information received from a consumer (patient herself) on 06-Feb-2018. This patient was vaccinated first dose FLUZONE on 29-Sep-2017. The past medication included oxycodone hydrochloride/paracetamol (PERCOCET) from unknown date and patient had allergy to it. The patient did not have any other allergies. The patient did not have any other medical history other than sore throat on an unspecified date of May-2017. The patient's concomitant medications include 2.5 mg of estrogens conjugated/medroxyprogesterone acetate (PREMPRO) from 2009, 15 mg of MELOXICAM in 2012 and 50 mg of SUMATRIPTAN (IMITREX) as needed from 2017. On 02-Dec-2017, 63 days following the vaccination the patient experienced hives on wrist and on 03-Dec-2017, 64 days following the vaccination (Reported as next day) the patient woke up with her lips swollen half of her face was swollen, chronic hives on and off, swollen lips, eyes and face. The patient visited in allergists on 15-Dec-2017. Infection disease physician on 05-Jan-2018 and allergists' again on 10-Jan-2018. The patient's corrective treatment included FEXOFENADINE HYDROCHLORIDE (ALLEGRA 150), BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE), Zantac (RANITIDINE HYDROCHLORIDE), SINGULAIR (MONTELUKAST), DOXEPIN and OMALIZUMAB (XOLAIR). The patient's lab test included on 01-May-2018 rheumatoid arthritis factor, quantiferon-TB Gold, Cold agglutinin titre, Immunoglobulin E, hbsag screening, HEPATITIS ABC test, comprehensive metabolic panel and ANA test, cryslobullin test and HCV test and result of all test was negative. The patient was not yet recovered from the event. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hepatitis A virus test, Hepatitis B surface antigen negative, Hepatitis B test negative, Hepatitis C test negative, Hepatitis viral test negative
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 19-Jan-2018. This case involves a 50-year-old female patient who was vaccinated with single 0.1 ml dose of FLUZONE INTRADERMAL via intradermal route (batch number: UI826AD, expiry date: 30-Jun-2018, dose in series and site of administration were not reported) on 28-Sep-2017. The patient medical history and concomitant medications were not reported. On 01-Dec-2017, 64 days following the vaccination the patient experienced hives off and on over body. The patient required emergency room or doctor visit. Laboratory investigations and corrective treatment was not reported. The patient was not yet recovered from the event at the time of reporting. Follow up information received from a consumer (patient herself) on 06-Feb-2018. This patient was vaccinated first dose FLUZONE on 29-Sep-2017. The past medication included oxycodone hydrochloride/paracetamol (PERCOCET) from unknown date and patient had allergy to it. The patient did not have any other allergies. The patient did not have any other medical history other than sore throat on an unspecified date of May-2017. The patient's concomitant medications include 2.5 mg of estrogens conjugated/medroxyprogesterone acetate (PREMPRO) from 2009, 15 mg of MELOXICAM in 2012 and 50 mg of SUMATRIPTAN (IMITREX) as needed from 2017. On 02-Dec-2017, 63 days following the vaccination the patient experienced hives on wrist and on 03-Dec-2017, 64 days following the vaccination (Reported as next day) the patient woke up with her lips swollen half of her face was swollen, chronic hives on and off, swollen lips, eyes and face. The patient visited in allergists on 15-Dec-2017. Infection disease physician on 05-Jan-2018 and allergists' again on 10-Jan-2018. The patient's corrective treatment included FEXOFENADINE HYDROCHLORIDE (ALLEGRA 150), BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE), Zantac (RANITIDINE HYDROCHLORIDE), SINGULAIR (MONTELUKAST), DOXEPIN and OMALIZUMAB (XOLAIR). The patient's lab test included on 01-May-2018 rheumatoid arthritis factor, quantiferon-TB Gold, Cold agglutinin titre, Immunoglobulin E, hbsag screening, HEPATITIS ABC test, comprehensive metabolic panel and ANA test, cryslobullin test and HCV test and result of all test was negative. The patient was not yet recovered from the event. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Lip swelling, Metabolic function test normal, Mycobacterium tuberculosis complex test negative, Rheumatoid factor negative, Swelling face
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 19-Jan-2018. This case involves a 50-year-old female patient who was vaccinated with single 0.1 ml dose of FLUZONE INTRADERMAL via intradermal route (batch number: UI826AD, expiry date: 30-Jun-2018, dose in series and site of administration were not reported) on 28-Sep-2017. The patient medical history and concomitant medications were not reported. On 01-Dec-2017, 64 days following the vaccination the patient experienced hives off and on over body. The patient required emergency room or doctor visit. Laboratory investigations and corrective treatment was not reported. The patient was not yet recovered from the event at the time of reporting. Follow up information received from a consumer (patient herself) on 06-Feb-2018. This patient was vaccinated first dose FLUZONE on 29-Sep-2017. The past medication included oxycodone hydrochloride/paracetamol (PERCOCET) from unknown date and patient had allergy to it. The patient did not have any other allergies. The patient did not have any other medical history other than sore throat on an unspecified date of May-2017. The patient's concomitant medications include 2.5 mg of estrogens conjugated/medroxyprogesterone acetate (PREMPRO) from 2009, 15 mg of MELOXICAM in 2012 and 50 mg of SUMATRIPTAN (IMITREX) as needed from 2017. On 02-Dec-2017, 63 days following the vaccination the patient experienced hives on wrist and on 03-Dec-2017, 64 days following the vaccination (Reported as next day) the patient woke up with her lips swollen half of her face was swollen, chronic hives on and off, swollen lips, eyes and face. The patient visited in allergists on 15-Dec-2017. Infection disease physician on 05-Jan-2018 and allergists' again on 10-Jan-2018. The patient's corrective treatment included FEXOFENADINE HYDROCHLORIDE (ALLEGRA 150), BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE), Zantac (RANITIDINE HYDROCHLORIDE), SINGULAIR (MONTELUKAST), DOXEPIN and OMALIZUMAB (XOLAIR). The patient's lab test included on 01-May-2018 rheumatoid arthritis factor, quantiferon-TB Gold, Cold agglutinin titre, Immunoglobulin E, hbsag screening, HEPATITIS ABC test, comprehensive metabolic panel and ANA test, cryslobullin test and HCV test and result of all test was negative. The patient was not yet recovered from the event. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 19-Jan-2018. This case involves a 50-year-old female patient who was vaccinated with single 0.1 ml dose of FLUZONE INTRADERMAL via intradermal route (batch number: UI826AD, expiry date: 30-Jun-2018, dose in series and site of administration were not reported) on 28-Sep-2017. The patient medical history and concomitant medications were not reported. On 01-Dec-2017, 64 days following the vaccination the patient experienced hives off and on over body. The patient required emergency room or doctor visit. Laboratory investigations and corrective treatment was not reported. The patient was not yet recovered from the event at the time of reporting. Follow up information received from a consumer (patient herself) on 06-Feb-2018. This patient was vaccinated first dose FLUZONE on 29-Sep-2017. The past medication included oxycodone hydrochloride/paracetamol (PERCOCET) from unknown date and patient had allergy to it. The patient did not have any other allergies. The patient did not have any other medical history other than sore throat on an unspecified date of May-2017. The patient's concomitant medications include 2.5 mg of estrogens conjugated/medroxyprogesterone acetate (PREMPRO) from 2009, 15 mg of MELOXICAM in 2012 and 50 mg of SUMATRIPTAN (IMITREX) as needed from 2017. On 02-Dec-2017, 63 days following the vaccination the patient experienced hives on wrist and on 03-Dec-2017, 64 days following the vaccination (Reported as next day) the patient woke up with her lips swollen half of her face was swollen, chronic hives on and off, swollen lips, eyes and face. The patient visited in allergists on 15-Dec-2017. Infection disease physician on 05-Jan-2018 and allergists' again on 10-Jan-2018. The patient's corrective treatment included FEXOFENADINE HYDROCHLORIDE (ALLEGRA 150), BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE), Zantac (RANITIDINE HYDROCHLORIDE), SINGULAIR (MONTELUKAST), DOXEPIN and OMALIZUMAB (XOLAIR). The patient's lab test included on 01-May-2018 rheumatoid arthritis factor, quantiferon-TB Gold, Cold agglutinin titre, Immunoglobulin E, hbsag screening, HEPATITIS ABC test, comprehensive metabolic panel and ANA test, cryslobullin test and HCV test and result of all test was negative. The patient was not yet recovered from the event. List of documents held by sender: none.
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Anxiety, Cold sweat, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Initial unsolicited report received from a consumer on 05-Feb-2018. This case involves a 40-year-old female patient who was vaccinated with a single dose of YF-VAX (Batch number, expiration date, dose in series, route and site of administration were not reported) on 05-Jan-2018. Patient's medical history and concomitant medications were not reported. On 06 Jan 2018, (Reported as next day Saturday) one day post vaccination, she began to have a low grade fever that persisted for 2 days (Saturday and Sunday). On 8 Jan 2018 (Monday), three days post vaccination she felt muscle weakness, and a buzzy sensation in arms, legs, and head, accompanied with nausea. On 09 Jan 2018 (Tuesday) four days post vaccination she got out of bed, and was cold and clammy, and had a near syncopal episode, and went to the Emergency Room. These symptoms persisted through the week, along with loss of appetite, low blood pressure and headache. Laboratory investigation and corrective treatment were not reported. Urgent care taken on 14 Jan 2018 and healthcare professional again on 18 Jan 2018. It was stated that follow up lab tests are scheduled on 08 Feb 2018. Patient was recovering from events. Symptoms persisted until January 20, and then they began to gradually resolve. List of documents held by sender: none.
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Feeling cold, Hyperhidrosis, Muscular weakness, Nausea, Peripheral coldness
Clinical narrative: Initial unsolicited report received from a consumer on 05-Feb-2018. This case involves a 40-year-old female patient who was vaccinated with a single dose of YF-VAX (Batch number, expiration date, dose in series, route and site of administration were not reported) on 05-Jan-2018. Patient's medical history and concomitant medications were not reported. On 06 Jan 2018, (Reported as next day Saturday) one day post vaccination, she began to have a low grade fever that persisted for 2 days (Saturday and Sunday). On 8 Jan 2018 (Monday), three days post vaccination she felt muscle weakness, and a buzzy sensation in arms, legs, and head, accompanied with nausea. On 09 Jan 2018 (Tuesday) four days post vaccination she got out of bed, and was cold and clammy, and had a near syncopal episode, and went to the Emergency Room. These symptoms persisted through the week, along with loss of appetite, low blood pressure and headache. Laboratory investigation and corrective treatment were not reported. Urgent care taken on 14 Jan 2018 and healthcare professional again on 18 Jan 2018. It was stated that follow up lab tests are scheduled on 08 Feb 2018. Patient was recovering from events. Symptoms persisted until January 20, and then they began to gradually resolve. List of documents held by sender: none.
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Presyncope, Pyrexia, Sinus disorder
Clinical narrative: Initial unsolicited report received from a consumer on 05-Feb-2018. This case involves a 40-year-old female patient who was vaccinated with a single dose of YF-VAX (Batch number, expiration date, dose in series, route and site of administration were not reported) on 05-Jan-2018. Patient's medical history and concomitant medications were not reported. On 06 Jan 2018, (Reported as next day Saturday) one day post vaccination, she began to have a low grade fever that persisted for 2 days (Saturday and Sunday). On 8 Jan 2018 (Monday), three days post vaccination she felt muscle weakness, and a buzzy sensation in arms, legs, and head, accompanied with nausea. On 09 Jan 2018 (Tuesday) four days post vaccination she got out of bed, and was cold and clammy, and had a near syncopal episode, and went to the Emergency Room. These symptoms persisted through the week, along with loss of appetite, low blood pressure and headache. Laboratory investigation and corrective treatment were not reported. Urgent care taken on 14 Jan 2018 and healthcare professional again on 18 Jan 2018. It was stated that follow up lab tests are scheduled on 08 Feb 2018. Patient was recovering from events. Symptoms persisted until January 20, and then they began to gradually resolve. List of documents held by sender: none.
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Dizziness, Headache, Pyrexia, Syncope
Clinical narrative: Initial unsolicited report received from a consumer on 05-Feb-2018. This case involves a 40-year-old female patient who was vaccinated with a single dose of YF-VAX (Batch number, expiration date, dose in series, route and site of administration were not reported) on 05-Jan-2018. Patient's medical history and concomitant medications were not reported. On 06 Jan 2018, (Reported as next day Saturday) one day post vaccination, she began to have a low grade fever that persisted for 2 days (Saturday and Sunday). On 8 Jan 2018 (Monday), three days post vaccination she felt muscle weakness, and a buzzy sensation in arms, legs, and head, accompanied with nausea. On 09 Jan 2018 (Tuesday) four days post vaccination she got out of bed, and was cold and clammy, and had a near syncopal episode, and went to the Emergency Room. These symptoms persisted through the week, along with loss of appetite, low blood pressure and headache. Laboratory investigation and corrective treatment were not reported. Urgent care taken on 14 Jan 2018 and healthcare professional again on 18 Jan 2018. It was stated that follow up lab tests are scheduled on 08 Feb 2018. Patient was recovering from events. Symptoms persisted until January 20, and then they began to gradually resolve. List of documents held by sender: none.
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Cold sweat, Decreased appetite, Headache, Hypotension, Muscular weakness
Clinical narrative: Initial unsolicited report received from a consumer on 05-Feb-2018. This case involves a 40-year-old female patient who was vaccinated with a single dose of YF-VAX (Batch number, expiration date, dose in series, route and site of administration were not reported) on 05-Jan-2018. Patient's medical history and concomitant medications were not reported. On 06 Jan 2018, (Reported as next day Saturday) one day post vaccination, she began to have a low grade fever that persisted for 2 days (Saturday and Sunday). On 8 Jan 2018 (Monday), three days post vaccination she felt muscle weakness, and a buzzy sensation in arms, legs, and head, accompanied with nausea. On 09 Jan 2018 (Tuesday) four days post vaccination she got out of bed, and was cold and clammy, and had a near syncopal episode, and went to the Emergency Room. These symptoms persisted through the week, along with loss of appetite, low blood pressure and headache. Laboratory investigation and corrective treatment were not reported. Urgent care taken on 14 Jan 2018 and healthcare professional again on 18 Jan 2018. It was stated that follow up lab tests are scheduled on 08 Feb 2018. Patient was recovering from events. Symptoms persisted until January 20, and then they began to gradually resolve. List of documents held by sender: none.
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Nausea, Presyncope, Pyrexia, Sensory disturbance
Clinical narrative: Initial unsolicited report received from a consumer on 05-Feb-2018. This case involves a 40-year-old female patient who was vaccinated with a single dose of YF-VAX (Batch number, expiration date, dose in series, route and site of administration were not reported) on 05-Jan-2018. Patient's medical history and concomitant medications were not reported. On 06 Jan 2018, (Reported as next day Saturday) one day post vaccination, she began to have a low grade fever that persisted for 2 days (Saturday and Sunday). On 8 Jan 2018 (Monday), three days post vaccination she felt muscle weakness, and a buzzy sensation in arms, legs, and head, accompanied with nausea. On 09 Jan 2018 (Tuesday) four days post vaccination she got out of bed, and was cold and clammy, and had a near syncopal episode, and went to the Emergency Room. These symptoms persisted through the week, along with loss of appetite, low blood pressure and headache. Laboratory investigation and corrective treatment were not reported. Urgent care taken on 14 Jan 2018 and healthcare professional again on 18 Jan 2018. It was stated that follow up lab tests are scheduled on 08 Feb 2018. Patient was recovering from events. Symptoms persisted until January 20, and then they began to gradually resolve. List of documents held by sender: none.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Abnormal behaviour, Crying, Culture stool negative, Diarrhoea, Emotional distress
Clinical narrative: The patient developed a hard, red, warm to the touch and very sensitive, knot/welt at one of the injection sights on his left thigh by 4pm the afternoon of vaccination. The patient also experienced extreme fatigue, weakness, periods of inconsolable crying and screaming lasting more than a few hours, drastic behavioral and sleep changes, projectile vomiting, fever, diarrhea in a range of colors (the worst was milky white in color), a rash. He was eating baby food and table food with no issue for a few months prior to vaccination and immediately regressed to only being able to tolerate formula and small amounts of water for a week, he lost two pounds in that week because he was not able to keep any food down during that time. Following the day of vaccination, he would not stay asleep for more than 30 minutes to an hour at a time. He would just scream, a different kind of scream that I had never heard in that first year of his life, what you would describe as, "screaming bloody murder" and only wanted to be held. He had no interest in interacting with anybody or playing with anything. All of these symptoms but the projectile vomiting persisted for roughly 3 weeks.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Faeces pale, Parasite stool test negative, Poor quality sleep, Stool analysis normal, Streptococcus test negative
Clinical narrative: The patient developed a hard, red, warm to the touch and very sensitive, knot/welt at one of the injection sights on his left thigh by 4pm the afternoon of vaccination. The patient also experienced extreme fatigue, weakness, periods of inconsolable crying and screaming lasting more than a few hours, drastic behavioral and sleep changes, projectile vomiting, fever, diarrhea in a range of colors (the worst was milky white in color), a rash. He was eating baby food and table food with no issue for a few months prior to vaccination and immediately regressed to only being able to tolerate formula and small amounts of water for a week, he lost two pounds in that week because he was not able to keep any food down during that time. Following the day of vaccination, he would not stay asleep for more than 30 minutes to an hour at a time. He would just scream, a different kind of scream that I had never heard in that first year of his life, what you would describe as, "screaming bloody murder" and only wanted to be held. He had no interest in interacting with anybody or playing with anything. All of these symptoms but the projectile vomiting persisted for roughly 3 weeks.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Vomiting projectile
Clinical narrative: The patient developed a hard, red, warm to the touch and very sensitive, knot/welt at one of the injection sights on his left thigh by 4pm the afternoon of vaccination. The patient also experienced extreme fatigue, weakness, periods of inconsolable crying and screaming lasting more than a few hours, drastic behavioral and sleep changes, projectile vomiting, fever, diarrhea in a range of colors (the worst was milky white in color), a rash. He was eating baby food and table food with no issue for a few months prior to vaccination and immediately regressed to only being able to tolerate formula and small amounts of water for a week, he lost two pounds in that week because he was not able to keep any food down during that time. Following the day of vaccination, he would not stay asleep for more than 30 minutes to an hour at a time. He would just scream, a different kind of scream that I had never heard in that first year of his life, what you would describe as, "screaming bloody murder" and only wanted to be held. He had no interest in interacting with anybody or playing with anything. All of these symptoms but the projectile vomiting persisted for roughly 3 weeks.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Abnormal behaviour, Asthenia, Crying, Decreased interest, Diarrhoea
Clinical narrative: The patient developed a hard, red, warm to the touch and very sensitive, knot/welt at one of the injection sights on his left thigh by 4pm the afternoon of vaccination. The patient also experienced extreme fatigue, weakness, periods of inconsolable crying and screaming lasting more than a few hours, drastic behavioral and sleep changes, projectile vomiting, fever, diarrhea in a range of colors (the worst was milky white in color), a rash. He was eating baby food and table food with no issue for a few months prior to vaccination and immediately regressed to only being able to tolerate formula and small amounts of water for a week, he lost two pounds in that week because he was not able to keep any food down during that time. Following the day of vaccination, he would not stay asleep for more than 30 minutes to an hour at a time. He would just scream, a different kind of scream that I had never heard in that first year of his life, what you would describe as, "screaming bloody murder" and only wanted to be held. He had no interest in interacting with anybody or playing with anything. All of these symptoms but the projectile vomiting persisted for roughly 3 weeks.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Faeces discoloured, Fatigue, Influenza virus test negative, Injection site erythema, Injection site induration
Clinical narrative: The patient developed a hard, red, warm to the touch and very sensitive, knot/welt at one of the injection sights on his left thigh by 4pm the afternoon of vaccination. The patient also experienced extreme fatigue, weakness, periods of inconsolable crying and screaming lasting more than a few hours, drastic behavioral and sleep changes, projectile vomiting, fever, diarrhea in a range of colors (the worst was milky white in color), a rash. He was eating baby food and table food with no issue for a few months prior to vaccination and immediately regressed to only being able to tolerate formula and small amounts of water for a week, he lost two pounds in that week because he was not able to keep any food down during that time. Following the day of vaccination, he would not stay asleep for more than 30 minutes to an hour at a time. He would just scream, a different kind of scream that I had never heard in that first year of his life, what you would describe as, "screaming bloody murder" and only wanted to be held. He had no interest in interacting with anybody or playing with anything. All of these symptoms but the projectile vomiting persisted for roughly 3 weeks.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Injection site nodule, Injection site pain, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: The patient developed a hard, red, warm to the touch and very sensitive, knot/welt at one of the injection sights on his left thigh by 4pm the afternoon of vaccination. The patient also experienced extreme fatigue, weakness, periods of inconsolable crying and screaming lasting more than a few hours, drastic behavioral and sleep changes, projectile vomiting, fever, diarrhea in a range of colors (the worst was milky white in color), a rash. He was eating baby food and table food with no issue for a few months prior to vaccination and immediately regressed to only being able to tolerate formula and small amounts of water for a week, he lost two pounds in that week because he was not able to keep any food down during that time. Following the day of vaccination, he would not stay asleep for more than 30 minutes to an hour at a time. He would just scream, a different kind of scream that I had never heard in that first year of his life, what you would describe as, "screaming bloody murder" and only wanted to be held. He had no interest in interacting with anybody or playing with anything. All of these symptoms but the projectile vomiting persisted for roughly 3 weeks.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Rash, Screaming, Sleep disorder, Stool analysis normal, Streptococcus test negative
Clinical narrative: The patient developed a hard, red, warm to the touch and very sensitive, knot/welt at one of the injection sights on his left thigh by 4pm the afternoon of vaccination. The patient also experienced extreme fatigue, weakness, periods of inconsolable crying and screaming lasting more than a few hours, drastic behavioral and sleep changes, projectile vomiting, fever, diarrhea in a range of colors (the worst was milky white in color), a rash. He was eating baby food and table food with no issue for a few months prior to vaccination and immediately regressed to only being able to tolerate formula and small amounts of water for a week, he lost two pounds in that week because he was not able to keep any food down during that time. Following the day of vaccination, he would not stay asleep for more than 30 minutes to an hour at a time. He would just scream, a different kind of scream that I had never heard in that first year of his life, what you would describe as, "screaming bloody murder" and only wanted to be held. He had no interest in interacting with anybody or playing with anything. All of these symptoms but the projectile vomiting persisted for roughly 3 weeks.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Urticaria, Vomiting projectile, Weight decreased
Clinical narrative: The patient developed a hard, red, warm to the touch and very sensitive, knot/welt at one of the injection sights on his left thigh by 4pm the afternoon of vaccination. The patient also experienced extreme fatigue, weakness, periods of inconsolable crying and screaming lasting more than a few hours, drastic behavioral and sleep changes, projectile vomiting, fever, diarrhea in a range of colors (the worst was milky white in color), a rash. He was eating baby food and table food with no issue for a few months prior to vaccination and immediately regressed to only being able to tolerate formula and small amounts of water for a week, he lost two pounds in that week because he was not able to keep any food down during that time. Following the day of vaccination, he would not stay asleep for more than 30 minutes to an hour at a time. He would just scream, a different kind of scream that I had never heard in that first year of his life, what you would describe as, "screaming bloody murder" and only wanted to be held. He had no interest in interacting with anybody or playing with anything. All of these symptoms but the projectile vomiting persisted for roughly 3 weeks.