chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Facial paralysis
Clinical narrative: This case was reported in a literature article and described the occurrence of facial palsy in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed facial palsy. Serious criteria included GSK medically significant. The outcome of facial palsy was unknown. It was unknown if the investigator considered the facial palsy to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of idiopathic facial nerve palsy in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and HPV (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, between 1-21 days after vaccination, the patient developed idiopathic facial nerve palsy. The case met the definition of Brighton level 1. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event idiopathic facial nerve palsy and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Facial paralysis
Clinical narrative: This case was reported in a literature article and described the occurrence of facial palsy in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed facial palsy. Serious criteria included GSK medically significant. The outcome of facial palsy was unknown. It was unknown if the investigator considered the facial palsy to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of idiopathic facial nerve palsy in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and HPV (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, between 1-21 days after vaccination, the patient developed idiopathic facial nerve palsy. The case met the definition of Brighton level 2. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event idiopathic facial nerve palsy and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a subject who received Meningococcal ACWY-CRM vaccine. The subject's past medical history included anaphylaxis (immediately following receipt of an unknown vaccine 6 years earlier). On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and other: Serious per reporter. The subject was treated with epinephrine. The outcome of anaphylaxis was unknown. It was unknown if the investigator considered the anaphylaxis to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of anaphylaxis in a patient of aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. The patient had a history of anaphylaxis immediately following receipt of an unknown vaccine 6 years earlier. No information on patient's family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and HPV (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, 24 hours or more after the vaccination, the patient developed anaphylaxis. The case met the definition of Brighton level 1. This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). The patient was treated with epinephrine. The outcome of the event was not reported. The authors did not comment on the relationship between the event of anaphylaxis and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Decreased appetite, Dizziness, Pain in extremity
Clinical narrative: LIGHT HEADED, MY RIGHT ARM WAS VERY SORE, FELT WEAK, NO APPETITE.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Muscle spasms, Neuralgia
Clinical narrative: Spasms and nerve pain in upper left arm and shoulders.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Mobility decreased, Nausea, Pain, Pain in extremity
Clinical narrative: Can not move arm at all without help. Can not touch it or move it without being in excruciating pain. Nausea. Light headed.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Can not move arm at all without help. Can not touch it or move it without being in excruciating pain. Nausea. Light headed.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Underdose
Clinical narrative: Partial dose administered in error.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 04-DEC-2014, the patient was vaccinated with his first dose of GARDASIL (lot number, expiration date and route and site of administration were not reported). On 25-FEB-2016, the patient was vaccinated with second dose of GARDASIL 9, lot number L045711, expiration date 08-MAY-2017 (route and site of administration were not reported) and on 02-MAR-2017 the patient was vaccinated with third dose GARDASIL 9 lot number M041212, expiration date 21-JUN-2019, (route and site of administration were not reported). No adverse effects were reported. No further information was provided. Additional information is requested.
Sex: U
Vaccine: MNQ
Symptoms: Stevens-Johnson syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of Stevens Johnson syndrome in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed Stevens Johnson syndrome. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of Stevens Johnson syndrome was unknown. It was unknown if the investigator considered the Stevens Johnson syndrome to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of Steven Johnson syndrome in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed Steven Johnson syndrome. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of Steven Johnson syndrome and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Few hours after vaccination, had multiple episodes of vomiting (12 to 15) which lasted for over few hours. Was re-examined in the office same day.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure fluctuation, Injection site erythema, Injection site pain
Clinical narrative: Eight hours after receiving the vaccine, the patient reported extreme pain around the injection site; injection site red, circumference of 8 X 3 inches; on 3/12, patient reported mild pain; on 3/13 pt reported BP fluctuations between 133/72 and 185/84 over a 3 hour period; on 3/14, his BP fluctuated 133/72 - 176/84 over a 3 hour period. Patient reported feeling better on 3/15 and has an appointment with his physician tomorrow to possibly adjust his blood pressure medications.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Blood pressure decreased, Hyperhidrosis, Mydriasis, Pallor, Slow speech
Clinical narrative: Patient was talking, speech became slow, began sweating and pale. RN came into room- I went to get water. Upon return his pupils were very dilated and large and he was not verbally responsive though he could follow verbal command. He took drink of water and in a few seconds was able to speak again- stating he could hear us the whole time but could not see or respond. No difficulty breathing, NO loss of consciousness. Eyes went back to normal- he was able to see, ate cookie and drank more water. Monitored in clinic 15-20 minutes after episode occured. BP during episode 78/43 before left clinic it was back to 118/72.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was talking, speech became slow, began sweating and pale. RN came into room- I went to get water. Upon return his pupils were very dilated and large and he was not verbally responsive though he could follow verbal command. He took drink of water and in a few seconds was able to speak again- stating he could hear us the whole time but could not see or respond. No difficulty breathing, NO loss of consciousness. Eyes went back to normal- he was able to see, ate cookie and drank more water. Monitored in clinic 15-20 minutes after episode occured. BP during episode 78/43 before left clinic it was back to 118/72.
Age: 63.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Erythema, Local swelling
Clinical narrative: Bump in both arms lasting PCV13 3wk. TD still not gone. Red swelling both arms-lasting 3wk. Size 3" in roundness.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Neurological examination normal, Paraesthesia
Clinical narrative: Patient in office 2/28/17 reporting ongoing tingling in her back x approximately 1 1/2 wks. (paresthesia). (No tingling elsewhere. No weakness. Neurologic exam NL here).
Age: 1.25
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Computerised tomogram head normal, Febrile convulsion, Full blood count normal, Influenza virus test negative, Metabolic function test normal
Clinical narrative: Pt received DTaP and Flu vax on 2-15-17-went to ER on 2-16-17 in febrile seizure, convulsing, abated after took 45 to 1 hr to acknowledge his mom. 3-13-17 in AM convulsed 2-3 minutes. All episodes pt febrile. None lasted >5 min no multiple episodes same day.
Age: 1.25
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Respiratory syncytial virus test negative, Streptococcus test negative
Clinical narrative: Pt received DTaP and Flu vax on 2-15-17-went to ER on 2-16-17 in febrile seizure, convulsing, abated after took 45 to 1 hr to acknowledge his mom. 3-13-17 in AM convulsed 2-3 minutes. All episodes pt febrile. None lasted >5 min no multiple episodes same day.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Eye swelling, Injection site swelling, Local reaction, Pruritus, Swelling face
Clinical narrative: Itchy hives, swelling of face and eyes. Local reaction at injection site, raised area.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Urticaria
Clinical narrative: Itchy hives, swelling of face and eyes. Local reaction at injection site, raised area.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Anaphylactic reaction, Eye swelling, Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: Itchy hives, swelling of face and eyes. Local reaction at injection site, raised area.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Lip swelling, Swelling face, Swollen tongue
Clinical narrative: Itchy hives, swelling of face and eyes. Local reaction at injection site, raised area.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Anaphylactic reaction, Eye swelling, Hypersensitivity, Injection site induration, Injection site swelling
Clinical narrative: Itchy hives, swelling of face and eyes. Local reaction at injection site, raised area.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Injection site urticaria, Laryngeal oedema, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: Itchy hives, swelling of face and eyes. Local reaction at injection site, raised area.
Age: 64.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event administration error.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Burning sensation, Erythema, Paraesthesia, Rash vesicular
Clinical narrative: Initial tingling and burning of low back to leg then rash with blisters on a red base from about L4 to the anterior thigh.
Sex: M
Vaccine: MMR
Symptoms: Swelling, Urticaria
Clinical narrative: This spontaneous report was received from an office manager referring to a male patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unspecified date in 2015, the patient was vaccinated with a dose of M-M-R II for prophylaxis (route of administration, lot number and expiration date were not reported). On an unknown date, the patient broke out into hives (urticaria) and was swollen (swelling) and, due to this, he was monitored in the clinic and treated with unspecified medications. The outcome of these events was reported as resolved on unknown dates. Causality relationship between the events and M-M-R II) was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report concerning a 81 year old female patient was received from the patient herself. The patient's medical history included cancer. The patient did not had drug reactions or allergies. Concomitant therapies included gabapentin. On an unknown date in 2007, the patient was vaccinated with ZOSTAVAX) 1 time vaccine in the arm (dose, route, lot number and expiration date were not reported) to prevent the shingles. The patient reported that in 2013, she got the shingles. An now, she had post herpetic neuralgia because of the shingles she had. Additionally, despite the fact that the patient in the past had cancer, she received ZOSTAVAX (product use issue). The patient seek for medical attention and received treatment for the events. Every year she had blood tests performed (results not provided). The outcome of post herpetic neuralgia and herpes zoster was not reported. No product quality complain was reported. The causal relationship between the events and the suspect therapy ZOSTAVAX was not provided.    Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Chest X-ray abnormal, Condition aggravated, Dyspnoea, Hypoxia, Interstitial lung disease
Clinical narrative: The initial case was missing the following minimum criteria: the suspect product and event were not reported or specified. Upon receipt of follow-up information on 06Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program, by contactable consumer and a contactable physician. A 68-year-old male patient of an unspecified race/ethnicity received PREVNAR 13 (Lot# N16562, Exp Oct2017), intramuscular at single dose in the upper arm on 26Sep2016 08:47 AM for immunisation. Medical history included ongoing chronic obstructive pulmonary disease, ongoing pulmonary fibrosis, ongoing pulmonary embolism, ongoing cardiac failure, ongoing neuropathy peripheral. Concomitant medication included FLUZONE (Lot# U1682AC) intramuscular in the upper arm on 26Sep2016 for immunization, metoprolol at 50 mg 1x/day, prednisone oral 10 mg 1x/day for COPD, pulmonary fibrosis. On 26Sep2016, the patient experienced (SOB) shortness of breath, fever, increased hypoxia, myalgias that required hospitalization. The final outcome of the events was unknown. The patient was hospitalized for the events from 26Sep2016 to 28Sep2016. The patient underwent lab tests and procedures which included Chest X-ray showed bilateral interstitial thickening and no acute pneumonia (Sep2016). Therapeutic measures were taken as a result of (SOB) shortness of breath. Hospital Course: The patient was admitted with increased hypoxia (oxygen saturationin the 60's; usually in the mid 80's on room air) with aching (myalgias). He had received a Prevnar 13 injection earlier on the day of admission. He denied worse cough or colored phlegm. He had a history of prior pulmonary emboli but had refused anticoagulation in the past. On coming to the ER he was started on 02 at 6 liters/minute with improvement in the oxygenation. Chest X-ray showed bilateral interstitial thickening and no acute pneumonia. He was started on IV steroids and antibiotics in the ER. He felt much better by the 2nd hospital day without fever and his O2 needs were back to baseline with oxygen saturation of 96%. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. The Company however considers the presence of underlying/pre-existing conditions an important confounder in the independent assessment of the causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Myalgia, Pyrexia
Clinical narrative: The initial case was missing the following minimum criteria: the suspect product and event were not reported or specified. Upon receipt of follow-up information on 06Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program, by contactable consumer and a contactable physician. A 68-year-old male patient of an unspecified race/ethnicity received PREVNAR 13 (Lot# N16562, Exp Oct2017), intramuscular at single dose in the upper arm on 26Sep2016 08:47 AM for immunisation. Medical history included ongoing chronic obstructive pulmonary disease, ongoing pulmonary fibrosis, ongoing pulmonary embolism, ongoing cardiac failure, ongoing neuropathy peripheral. Concomitant medication included FLUZONE (Lot# U1682AC) intramuscular in the upper arm on 26Sep2016 for immunization, metoprolol at 50 mg 1x/day, prednisone oral 10 mg 1x/day for COPD, pulmonary fibrosis. On 26Sep2016, the patient experienced (SOB) shortness of breath, fever, increased hypoxia, myalgias that required hospitalization. The final outcome of the events was unknown. The patient was hospitalized for the events from 26Sep2016 to 28Sep2016. The patient underwent lab tests and procedures which included Chest X-ray showed bilateral interstitial thickening and no acute pneumonia (Sep2016). Therapeutic measures were taken as a result of (SOB) shortness of breath. Hospital Course: The patient was admitted with increased hypoxia (oxygen saturationin the 60's; usually in the mid 80's on room air) with aching (myalgias). He had received a Prevnar 13 injection earlier on the day of admission. He denied worse cough or colored phlegm. He had a history of prior pulmonary emboli but had refused anticoagulation in the past. On coming to the ER he was started on 02 at 6 liters/minute with improvement in the oxygenation. Chest X-ray showed bilateral interstitial thickening and no acute pneumonia. He was started on IV steroids and antibiotics in the ER. He felt much better by the 2nd hospital day without fever and his O2 needs were back to baseline with oxygen saturation of 96%. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. The Company however considers the presence of underlying/pre-existing conditions an important confounder in the independent assessment of the causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: MENB
Symptoms: Generalised tonic-clonic seizure, Seizure
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-year-old male patient of unspecified race received first dose of TRUMENBA at single dose for immunization via unspecified route in May2016. Medical history and concomitant medication were unknown. The patient experienced grand mal primary generalized epilepsy and seizure on 16Jul2016. The outcome of  the events was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: PNC13
Symptoms: Anaemia, Asthenia, Ataxia, C-reactive protein increased, Erythema nodosum
Clinical narrative: This is a spontaneous report from a contactable physician and other healthcare professional. A patient of unspecified age and gender received a single dose of PREVNAR 13 , on an unspecified date for pneumonia vaccination. The patient medical history and concomitant medications were not reported. On an unknown date the patient was diagnosed with fever of unknown origin, hyponatremia, elevated sedimentation rate and CRP, anemia, elevated LFTs and erythema nodosum, due to which was hospitalized. Hospital discharge summary on 01Feb2017 also stated that the patient was admitted with weakness and ataxia. A diagnosis of UTI was suspected. The outcome of all the events was unknown and patient was discharged on 01Feb2017. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the events. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: PNC13
Symptoms: Hyponatraemia, Liver function test increased, Pyrexia, Red blood cell sedimentation rate increased, Urinary tract infection
Clinical narrative: This is a spontaneous report from a contactable physician and other healthcare professional. A patient of unspecified age and gender received a single dose of PREVNAR 13 , on an unspecified date for pneumonia vaccination. The patient medical history and concomitant medications were not reported. On an unknown date the patient was diagnosed with fever of unknown origin, hyponatremia, elevated sedimentation rate and CRP, anemia, elevated LFTs and erythema nodosum, due to which was hospitalized. Hospital discharge summary on 01Feb2017 also stated that the patient was admitted with weakness and ataxia. A diagnosis of UTI was suspected. The outcome of all the events was unknown and patient was discharged on 01Feb2017. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the events. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient). A 84 year old female patient of an unspecified race and ethnicity received, on 22Aug2015, PREVNAR 13 in the arm, at single dose, for immunization. The vaccine was administered at the physician's office. Relevant medical history included hypertension. Concomitant medication included metoprolol succinate from an unspecified date, 50 mg, once daily, for hypertension. On an unspecified date, in the second week of Sep2015, the patient had itching like crazy on her legs and rash. She saw two different dermatologist. She went to the first dermatologist in 12Nov2015 and said she had too much sun. She went back on 25Nov2015 and was put on prednisone. She took all of it but the rash never left and it got worse on her arms, back, and neck. It was very itchy. She also used Gold Bond itch cream. The patient reported that she stopped her blood pressure medication (metoprolol succinate) to see if that had anything to do with the reactions but no difference was noted. The patient did not recover from the events at time of this report.
Age: 45.0
Sex: F
Vaccine: FLU4, HEP, TD
Symptoms: Asthenia, Fatigue, Injection site reaction, Malaise, Nausea
Clinical narrative: Weak, sick, nausea, fatigue, vertigo, and eruptions of yellow, itchy papules, rash on right shoulder.
Age: 45.0
Sex: F
Vaccine: FLU4, HEP, TD
Symptoms: Rash papular, Rash pruritic, Vertigo
Clinical narrative: Weak, sick, nausea, fatigue, vertigo, and eruptions of yellow, itchy papules, rash on right shoulder.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Induration, Injection site erythema, Skin warm
Clinical narrative: Had firmness, heat, redness in arm. Had 100.1 fever. Had difficulty breathing that night (felt like she couldn't take in a full breath)  This was followed by a red strip below the injection site, from one side of the muscle to the other.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Redness and swelling from shoulder to halfway to the elbow. Area is warm and itchy.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Arm soreness, chills, muscle aches.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Contusion, Erythema, Pain
Clinical narrative: Red and sore with bruise.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (RN) concerning an unspecified number of patients. The RN reported that improperly stored PNEUMOVAX 23 (lot # L019835; expiration 23-MAR-2017) doses were administered were administered to unspecified patient on unspecified dates. Temperature: 9 degrees Celsius to 25 degrees Celsius. Time frame: 22 hours. When asked if there was a previous temperature excursion, the RN reported "yes" (49 degrees Celsius for 15 minutes, 1.16 degrees Celsius for unspecified time frame). The RN called because of a "data logger". No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning 10 unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, via intramuscular, lot # M033583, expiration date: 14-APR-2019, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 2 hours. There were previous temperature excursions. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Haemophilus infection, Malaise, Pneumonia streptococcal, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 4-month-old female patient of an unspecified race and ethnicity received the first dose of PREVNAR 13 on an unknown date, at the age of at 2 months, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the first vaccination and before the second shot, the patient experienced illness and fever. She was diagnosed with streptococcal Pneumonia and haemophilus influenzae. Clinical outcome was unknown at time of this report.; Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
Sex: F
Vaccine: PNC13
Symptoms: Seizure, Tremor
Clinical narrative: This is a spontaneous report received from a contactable consumer via a Pfizer sales representative. A roughly 18-month-old (infant) female patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. 12 hours after vaccination the patient experienced seizures which lasted for an hour (recovered) with no corresponding fever or additional symptoms, and tremors with outcome of unknown.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: C-reactive protein increased, Cutaneous lupus erythematosus, Erythema, Erythema nodosum, Liver function test increased
Clinical narrative: This is a spontaneous report from a contactable physician. A 63-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on 10Jan2016 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient admitted with B symptoms, fever of unknown origin (FUO), and elevated liver function test (LFTs)  that required hospitalization. On an unspecified date, the patient also experienced a new rash following that vaccination and red, raised plaques of her skin involving both the upper and lower extremities. Differential dignosis included erythema nodosum and discoid lupus. It was reported that on an unspecified date CRP was 19.4. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: onset date of the events. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash, Skin plaque
Clinical narrative: This is a spontaneous report from a contactable physician. A 63-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on 10Jan2016 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient admitted with B symptoms, fever of unknown origin (FUO), and elevated liver function test (LFTs)  that required hospitalization. On an unspecified date, the patient also experienced a new rash following that vaccination and red, raised plaques of her skin involving both the upper and lower extremities. Differential dignosis included erythema nodosum and discoid lupus. It was reported that on an unspecified date CRP was 19.4. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: onset date of the events. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Injection site nodule, Injection site pruritus, Syncope
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13 (Lot # R33239, Expiry Date Mar2018, NDC # 0005-1971-02, UPC # 30005-197105) via an unspecified route of administration at single dose at left arm on 02Mar2017 for immunization. The patient medical history was not reported. Concomitant medication included BOOSTRIX at right arm on an unknown date for immunization. Seven days later, on 09Mar2017, she had a knot at the injection site and it started to itch, with outcome not recovered, and she was dizzy, with outcome unknown, and on an unspecified date she got kind of fainted, with outcome unknown. The pharmacist mentioned he/she did not know that's associated with anything having to do with immunization or not, but it did happened and she was questioning. Pharmacist in response to causality mentioned "On injection site reactions yes it was due to PREVNAR 13 as far as dizziness he/she called to ask that question, so I don't know if it was or it isn't, the patient also in her other arm received the BOOSTRIX.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Reports flu like symptoms such as muscle aches and fever. Nothing at injection site.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomited twice within 24 hours of Rota vaccine, diarrhea for 72 hours.
Age: 15.0
Sex: F
Vaccine: FLU4, HPVX
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Debilitating and radiating pain in upper arm (of injected arm) when movement of any kind of the hand, forearm, or shoulder. This pain was persistent on a daily basis until around two and a half months later then it lessened to finally dissipating.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: I was almost immediately struck with persistent debilitating pain that radiated throughout my upper left arm caused by any movement of hand, forearm, or shoulder. It finally lessened and dissipated in February 2017.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient had a fever of 102 and then had a presumed febrile seizure.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nausea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient started to feel very ill (fever, body aches, nauseous) on 03/12/2017.  On 03/14/2017 her arm that she received the vaccine in started to swell up and also started producing a rash.  Didn't see any sign of cellulitis.  Patient came into the pharmacy on 03/15/2017 with prescriptions for the swelling/rash in arm.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient started to feel very ill (fever, body aches, nauseous) on 03/12/2017.  On 03/14/2017 her arm that she received the vaccine in started to swell up and also started producing a rash.  Didn't see any sign of cellulitis.  Patient came into the pharmacy on 03/15/2017 with prescriptions for the swelling/rash in arm.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unspecified dates in 2016, the patient was vaccinated with the first and second dose of M-M-R II, and on 04-MAR-2017, the patient was inadvertently vaccinated with a third dose of M-M-R II "single dose", subcutaneous route (dose, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Axillary pain, Chills, Headache, Pain
Clinical narrative: SEVERE HEADACHE AND BODY, JOINT PAIN. VOMITING, CHILLS PAIN IN ARMPIT AND DOWN SIDE OF TORSO ONE SIDE.
Age: 66.0
Sex: F
Vaccine: DTAP
Symptoms: Vaccination complication, Vomiting
Clinical narrative: SEVERE HEADACHE AND BODY, JOINT PAIN. VOMITING, CHILLS PAIN IN ARMPIT AND DOWN SIDE OF TORSO ONE SIDE.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Adverse event
Clinical narrative: Event found 03/15/2017.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site paraesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Tingling and pain left shoulder radiating to left dorsal hand.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: PATIENT SAID THAT SHE HAD A SORE ARM, AND THERE WAS A SMALL, HOT CIRCLE AT THE INJECTION SITE.  WHEN SHE NOTIFIED US ON 3/15/17, THE CIRCLE WAS NOW APPROXIMATELY 6 INCHES IN DIAMETER.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Abscess, Atrophy, Induration, Injection site discharge, Injection site erythema
Clinical narrative: A week later her right arm where she had the pneumonia vaccine had a 50 cent piece sized area of erythema, swelling, yellow/greenish drainage, and pain. She developed an abscess and a lot of induration after the vaccine and was treated with antibiotics. She then used hot packs on the area and had a scab for a long time. Recently the scab fell off and she realized she has a hole in her arm. Its not really painful.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Scab
Clinical narrative: A week later her right arm where she had the pneumonia vaccine had a 50 cent piece sized area of erythema, swelling, yellow/greenish drainage, and pain. She developed an abscess and a lot of induration after the vaccine and was treated with antibiotics. She then used hot packs on the area and had a scab for a long time. Recently the scab fell off and she realized she has a hole in her arm. Its not really painful.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Headache, Nausea, Skin lesion
Clinical narrative: Patient presented to urgent care center with headache and nausea, and few skin lesions on face, chest, and back.  No fever, no CP, or other sxms.  She was subsequently admitted for supportive care overnight, and did well.  DHA Immunization team consulted and concurred with dx of probable NVP.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site pain, Pain, X-ray limb
Clinical narrative: Pt seen today with continued pain in left arm where got Men B and Flu shot- says hurt to lift arm above head- had pain since getting shot over 2.5 months ago and pain not going away.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test normal, Muscular weakness
Clinical narrative: At injection site: redness and swelling noted and tender to touch area ---then on 3/1/17 developed bilateral arm and leg weakness - went to ER for evaluation - then had Neurology evaluation 3/7/17.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: At injection site: redness and swelling noted and tender to touch area ---then on 3/1/17 developed bilateral arm and leg weakness - went to ER for evaluation - then had Neurology evaluation 3/7/17.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Limb discomfort, Muscular weakness, Pain
Clinical narrative: At injection site: redness and swelling noted and tender to touch area ---then on 3/1/17 developed bilateral arm and leg weakness - went to ER for evaluation - then had Neurology evaluation 3/7/17.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash generalised, Urticaria
Clinical narrative: Patient returned to Pharmacy on 3/14/2017 and returned that he broke in to hives and shown bumps similar to shave bumps in multiple locations all over his body, patient stated that allergy started 7 to 10 days after he got ZOSTAVAX vaccine. He thinks it was from the vaccine. Patient was given oral BENADRYL tablets to treat allergies. Advised patient to report his medical doctor and also told the patient we will follow up next day (3/15/2017) to see how he was doing after taking BENADRYL.