chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Lethargy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 72-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 8th August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea. On an unknown date, the outcome of the chills, fever, feeling bad, diarrhea, tiredness and lethargy were unchanged and the outcome of the nausea was unknown. It was unknown if the reporter considered the chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was linked with US2018GSK150533, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 72-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 8th August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea. On an unknown date, the outcome of the chills, fever, feeling bad, diarrhea, tiredness and lethargy were unchanged and the outcome of the nausea was unknown. It was unknown if the reporter considered the chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was linked with US2018GSK150533, reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 15th May 2018, the patient received the 1st dose of SHINGRIX. On 15th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 16th May 2018, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had her shot of SHINGRIX in the left arm in the morning. The patient felt soreness at the injection site. The next day she had pain in her arm and could not raise it. In May 2018, the pain and soreness lasted approximately for 24 hours. For tolerance to next dose, refer case US2018GSK150386.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 17th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, mobility decreased and difficulty sleeping. On an unknown date, the outcome of the pain in arm, mobility decreased and difficulty sleeping were recovered/resolved. It was unknown if the reporter considered the pain in arm, mobility decreased and difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows: At the reporting time, the patient was in very good health. The age at vaccination was not reported but could be 75 years or 76 years. The patient experienced extremely painful reaction. Pain was so bad in the patient's right arm. The patient could not move or use it for two days and it was hard to sleep due to the pain. The patient was uneasy about going through such excruciating pain again. The patient was asking if it was necessary to have the 2nd dose or it was possible she would still get some protection from just one dose.
Sex: F
Vaccine: MENB
Symptoms: Arthralgia
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in joint involving shoulder region in a female patient who received BEXSERO for prophylaxis. In August 2018, the patient received the 2nd dose of BEXSERO. In August 2018, 7 days after receiving BEXSERO, the patient experienced pain in joint involving shoulder region. On an unknown date, the outcome of the pain in joint involving shoulder region was not recovered/not resolved. It was unknown if the reporter considered the pain in joint involving shoulder region to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter's daughter (patient) received 2nd injection of the menengitis vaccine a week before the date of reporting and was having severe joint pain in her shoulder at the time of reporting. The reporter said it was getting worse. The reporter was enquiring about how long did the joint pain last and what should be done about it, whether this would be a permanent problem or require extensive measures such as physical therapy.
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of taste metallic in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced taste metallic. On an unknown date, the outcome of the taste metallic was recovered/resolved. The reporter considered the taste metallic to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient presented onset of metallic taste right after the SHINGRIX shot that lasted 5 days and went away after that. The reporter did not agree to follow up. This case was linked with US2018GSK150528, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chest discomfort, Palpitations
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of weakness in a 56-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included dyslipidemia and overweight. On an unknown date, the patient received the 1st dose of SHINGRIX. On 16th June 2018, less than a year after receiving SHINGRIX, the patient experienced weakness (serious criteria hospitalization), palpitation (serious criteria hospitalization) and chest discomfort (serious criteria hospitalization). On an unknown date, the outcome of the weakness, palpitation and chest discomfort were unknown. It was unknown if the reporter considered the weakness, palpitation and chest discomfort to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. However, it could be 55 or 56 years old. The patient received SHINGRIX vaccine at an unknown pharmacy. The reporter was notified that the patient had weakness, palpitations and intermediate chest discomfort after receiving SHINGRIX. The patient went to emergency room and was admitted.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash (Erythematous rash and Pruritus after receiving 1st dose on 3rd May 2018, see case US2018139576). Concomitant products included amlodipine, biotin, folic acid, thyroxine sodium (Levothyroxine), metformin hydrochloride (Metformin), pravastatin sodium (Pravastatin), ramipril, cyanocobalamin (Vitamin B12), pyridoxine hydrochloride (Vitamin B6), colecalciferol (Vitamin D3), cetirizine hydrochloride (Zyrtec), glimepiride and ubidecarenone (Coq10). On 5th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 5th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the wife of patient.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (fever and injected limb mobility experienced after receiving 1st dose on 15th May 2018, case US2018145493).  On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and fever. On 8th August 2018, the patient experienced injected limb mobility decreased. Rechallenge with SHINGRIX was positive. On 7th August 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and fever to be related to SHINGRIX. Additional details were provided as follows: The patient had her shot of SHINGRIX in the unknown arm. The patient experienced those same two symptoms which experienced after the 1st dose (felt soreness at the injection site and the next day she had pain in her arm and could not raise it), with the same time frame. The patient also felt little feverish after the 2nd shot like a very low grade fever. The patient had shot in the morning and felt feverish in the afternoon and it was resolved by bedtime. This case has been linked with case US2018145493, for same patient reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose, refer case US2018145428). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient's friend reported this case. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient experienced flu like symptoms that lasted a day or two. This reporter had not yet received the vaccine. The reporter denied permission to contact their physician. The reporter declined to provide any additional information and said she would tell her friends to call the global response center (GRC). The reporter declined follow up contact. This case has been linked to US2018GSK150389 and US2018GSK150390, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient's friend reported this case. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient experienced flu like symptoms that lasted a day or two. For tolerance of 2nd dose of SHINGRIX, refer case US2018GSK150390 for same patient. This reporter had not yet received the vaccine. The reporter denied permission to contact their physician. The reporter declined to provide any additional information and said she would tell her friends to call the global response center (GRC). The reporter declined follow up contact. This case has been linked to US2018145428 and US2018GSK150388, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose, refer case US2018GSK150389). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient's friend reported this case. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient experienced flu like symptoms that lasted a day or two. This reporter had not yet received the vaccine. The reporter denied permission to contact their physician. The reporter declined to provide any additional information and said she would tell her friends to call the global response center (GRC). The reporter declined follow up contact. This case has been linked to US2018GSK150388 and US2018145428, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of taste metallic in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of dysgeusia (1st dose received on an unknown date (see case:US2018GSK146267)). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced taste metallic. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the taste metallic was recovered/resolved. The reporter considered the taste metallic to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient presented onset of metallic taste right after the SHINGRIX shot that lasted 5 days and went away after that. The reporter did not agree to follow up. This case was linked with US2018GSK146267, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Lethargy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea. On an unknown date, the outcome of the chills, fever, feeling bad, diarrhea, tiredness and lethargy were unchanged and the outcome of the nausea was unknown. It was unknown if the reporter considered the chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per product indication. The pharmacist reported that she had some patients presented with the reported events but she did not know how many or have other information. This case was linked with US2018145480, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea. On an unknown date, the outcome of the chills, fever, feeling bad, diarrhea, tiredness and lethargy were unchanged and the outcome of the nausea was unknown. It was unknown if the reporter considered the chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per product indication. The pharmacist reported that she had some patients presented with the reported events but she did not know how many or have other information. This case was linked with US2018145480, reported by the same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration in 2015 at a single dose for immunization; and PNEUMOVAX 23, via an unspecified route of administration in 2014 at an unknown dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received 13-valent conjugate vaccine (diphtheria crm197 protein) 11 months after receiving PNEUMOVAX 23, one month shy of the one year recommendation (inappropriate schedule of vaccine administered). Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional. A 2-month-old patient of an unspecified gender received PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization. The patient's medical history concomitant medications were not reported. On an unspecified date, the patient experienced a fever of 102.5 F and also developed a red knot and swelling on leg. The child was brought to emergency room for treatment. Outcome of the events was unknown. Information on batch and lot numbers has been requested.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 16-year-old female patient received TRUMENBA, intramuscular in the deltoid at a single dose for the prevention of meningococcal B disease and MENACTRA via an unspecified route of administration at unknown dose  for immunization both administered on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced fainting. It was also reported that in the morning of the event, the patient did not eat. The outcome of the event was recovered on an unspecified date. Information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient aged 17-18 years old received TRUMENBA (lot number and expiration date not reported) via an unspecified route of administration, on an unspecified date, single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, within 1.5 hours of injection, the patient developed headache. Outcome of the event was unknown. Information on the batch number has been requested.
Sex: M
Vaccine: HPV4, MENB
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: The initial case was missing the following minimum criteria (unspecified adverse event). Upon receipt of follow-up information on 13Aug2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. An 18-year-old male patient received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose; and GARDASIL, via an unspecified route of administration on an unspecified date at an unspecified dose, both for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was given the first dose of meningococcal group b rlp2086 along with another vaccine HPV (Non-Pfizer product) on the same date and had a severe reaction. The patient experienced high fever of 103, chills, severe headaches, and shaking on an unspecified date. Outcome of the events was unknown. The physician wanted to know if she can give the vaccine again as she would hate to compromise the dosing and stop giving the GARDASIL. The reporter presumed that meningococcal group b rlp2086 was causing the reaction since GARDASIL was given at the office. He had to be sent to another office location on the same day to receive meningococcal group b rlp2086 at least 15-20 minutes later. He started to have the reaction about an hour after the initial GARDASIL vaccine was administered which is why she was presuming meningococcal group b rlp2086 caused the reaction. Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient) via a sales representative. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient had no concomitant medications, other medical conditions, or relevant investigations. The patient reported that she herself received the injection of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) years ago when it first came out and experienced arm pain on an unspecified date reported as over two years ago. Outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Abscess, Injection site scab, Rash
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-month-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. Patient developed a rash and returned to doctor 2 days later. Then 1 week later returned and it was diagnosed as an abscess. Patient had refused band aid after the dose was administered. Nurse reported patient had been picking at the scab bc there was no band aid. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: It cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role in triggering the occurrence of rash on the vaccination site later diagnosed as abscess. 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: Erythema, Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician. A female patient of an unspecified age (reported as "82") received PREVNAR 13 via an unspecified route of administration on 06Aug2018 at single dose in the left deltoid for immunisation. Relevant medical history and concomitant medications were not reported. On 09Aug2018, three days after the vaccination, the patient experienced increased erythema and heat extending down the upper arm. The outcome of the events was unknown.
Sex: U
Vaccine: HPVX, MENB
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a contactable family medicine physician. This report was received via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA, (lot number and expiration date not reported) and HPV vaccine (manufacturer unknown), both via unspecified routes of administration from unspecified dates at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date. The outcome of seizure was unknown. Information on the batch/lot number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer-sales representative. A patient of unspecified age and gender started to receive TRUMENBA (Lot number and Expiration date: Unknown), via an unspecified route of administration in the arm, single dose, from an unspecified date for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tingling in upper thigh as a result of receiving meningococcal group b rlp2086 in upper arm. The outcome of the event was unknown. Information on the lot number and expiration date has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable Physician via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The doctor stated that she received body aches as an adverse reaction from her patient. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Skin warm, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales Representative. A male patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling and hot to the touch on an unspecified date. The outcome of both events was unknown. Information on batch number has been requested.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site swelling, Wrong drug administered
Clinical narrative: This is a spontaneous report from a contactable Licensed Vocational Nurse. A 12-year-old male patient received TRUMENBA (lot number: S58895, expiry date: Jun 2019), intramuscular on 14Aug2018 at 0.5 ml, single(0.5ml intramuscular injection) for immunization. The patient's medical history and concomitant medications were not reported. The patient administered meningococcal group b rlp2086 by accident on 14Aug2018, the patient was supposed to receive the MCV 4 vaccine instead. He is 12 years old. He was in an express care complaining of headache and swelling at the injection site on unknown date in 2018. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient in her 70's received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tender to touch for 2 weeks in area below arm around armpit on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: HPV9, MENB
Symptoms: Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 19-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration, on 15Aug2018, at single dose, for immunisation and HPV9, via an unspecified route of administration, on 15Aug2018, at unspecified dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took HPV9 for immunisation. The patient experienced fever of 101 on 15Aug2018 with outcome of unknown and chills on 15Aug2018 with outcome of unknown, both within 3 hours of vaccines administration. The physician told her to take a fever reducer and come back in to see her. No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 13.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 13 years old female patient who received instead of Tdap vaccine, single DTaP injection by accident, while she received vaccines ADACEL and DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Aug-2018, the patient received a once dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. It was a case of actual medication error due to wrong vaccine administered. The patient has not experienced any side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp from Other manufacturer Novartis under the reference number-PHEH2018US015045. This case involves a 57 years old female patient who experienced allergy to tetanus toxoid, while she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route. The patient developed a non-serious allergy to tetanus toxoid (allergy to vaccine) following the administration of TETANUS TOXOID. (Other relevant tests included No lab test.) Final diagnosis was allergy to tetanus toxoid. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus toxoid.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction (R) thigh.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia, Rash papular
Clinical narrative: Fever a few hours after vaccines given to 102.3 degree - a fine popular rash on head and upper trunk.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Developed headache and fever, temp max 103.8 the evening after having been vaccinated in the am. Temp down to 100 by the next am, headache resolved. No long-term effect. Temperature just seems high for a vaccine reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat, body aches, fever, tiredness.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient received vaccination on 8/13/18 and 2-3 days later had a large red area form on her shoulder that was warm to touch and was very itchy. She came in 8/2018 asking if that was a normal reaction but only the redness remained, itchiness and warmness to touch had dissipated. She otherwise felt fine, denied difficulty breathing or any other symptoms of more severe allergic reaction. She was advised to wait another 48 hours to see if redness cleared before reaching out to her primary unless symptoms worsened and did not improve to be checked just in case something underlying happened.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site bruising, Injection site urticaria, Poor quality sleep
Clinical narrative: Woke up at 1 am will chills and rigors. Didn't take her temperature but took TYLENOL. Had a mild headache and didn't sleep well. Took temperature in the morning when she got up and it was 100.0. Had a reported golf ball sized welt on her arm at the site of the injection the am of 8/17, not red or hot, bruised by the end of 8/17. Temp gone by end of day 8/17. Welt gone by 8/17.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: Large area of swelling at injection site with redness, fever, muscle ache, severe lethargy, headache, dizziness.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Large area of swelling at injection site with redness, fever, muscle ache, severe lethargy, headache, dizziness.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Nodule, Peripheral swelling
Clinical narrative: Mother called to report that her daughter's right arm is "red, swollen, and has a knot in it". Encouraged to apply warm and called compress alternately, take Ibuprofen, and keep arm moving. Advised to call the doctor if it gets worse. RN followed up the call the next day. Mother stated that it "has been better".
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: On July 19 my left forearm where I got vaccine was very red/hard and swollen. Was told by Dr. that I can't ever have this vaccine.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Myalgia
Clinical narrative: Soreness and slight rash at area of injection for 3 days. Then symptoms subsided & disappeared. Severe general muscle soreness in legs and arms for 3 days. Then symptoms subsided & disappeared.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: Soreness and slight rash at area of injection for 3 days. Then symptoms subsided & disappeared. Severe general muscle soreness in legs and arms for 3 days. Then symptoms subsided & disappeared.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Decreased appetite, Irritability, Rash
Clinical narrative: Rash located to the trunk; fussiness and decreased appetite.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV9, MENB
Symptoms: Wrong drug administered
Clinical narrative: Dtap was given in place of tdap.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia, Rash macular, Skin discolouration, Urticaria
Clinical narrative: Per patient report via e-mail on 8/6/2018 at 7pm, a potential allergic reaction occurred the night of vaccination. Patient reports face broke out in hives and a bad fever was experienced. Her arm is still sore on Monday after getting the shot on 8/3/18, Fever is gone on 8/6/18, but face is still very splotchy. Client reports did not seek health care for this concern "because I'm stubborn". She reports that her face doesn't hurt or itch, but "looks terrible". Client is not sure what to call this "rash" as she doesn't believe it to be hives. She describes them as "tiny mosquito bites or acne everywhere, but its just color, There is no actual bump. Just splotches of color everywhere and has spread to legs as of 8/7/18 at 3:15pm. At this time client reports that they are not able to be felt and are not causing pain.  As of 8/15/18, per an email to Public Health Nurse, client reports that splotches on face stopped spreading and faded a "few days ago".
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Headache, Hypotonia, Nausea
Clinical narrative: Pt. had all 3 immunizations while seated in a chair. Pt. did not appear anxious. After all shots were given, pt. remained looking at her phone and didn't report feeling any different. After approximately 2 minutes, pt. dropped the phone and began to slump out of the chair. Staff and pt.'s family caught her and lowered her to a seated position on the floor. Her eyes appeared to roll back and she went limp.  After about 10 seconds, she looked up and said, "What happened?" She felt dizzy and nauseous for the next few minutes and felt like she was going to vomit. She was given a cool wash cloth and had a fan on her. She stood up and was encouraged to sit in the chair for a few minutes. Pt. c/o headache. She was encouraged to lie down on the cot with her feet elevated slightly. She remained there for about 10 minutes and then felt well enough to leave with her family. Pt. reports she only had applesauce for breakfast that morning. Mom reported that this is the first time she has reacted to vaccinations like this.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt. had all 3 immunizations while seated in a chair. Pt. did not appear anxious. After all shots were given, pt. remained looking at her phone and didn't report feeling any different. After approximately 2 minutes, pt. dropped the phone and began to slump out of the chair. Staff and pt.'s family caught her and lowered her to a seated position on the floor. Her eyes appeared to roll back and she went limp.  After about 10 seconds, she looked up and said, "What happened?" She felt dizzy and nauseous for the next few minutes and felt like she was going to vomit. She was given a cool wash cloth and had a fan on her. She stood up and was encouraged to sit in the chair for a few minutes. Pt. c/o headache. She was encouraged to lie down on the cot with her feet elevated slightly. She remained there for about 10 minutes and then felt well enough to leave with her family. Pt. reports she only had applesauce for breakfast that morning. Mom reported that this is the first time she has reacted to vaccinations like this.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain upper, Blood test, Borrelia test, Dehydration, Headache
Clinical narrative: High fever, severe head aches, sensitivity to light, sever stomach pain, abnormal liver functions, low white blood cell count, numbness in legs, dehydration.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Hypoaesthesia, Liver function test abnormal, Mononucleosis heterophile test, Photophobia, Pyrexia
Clinical narrative: High fever, severe head aches, sensitivity to light, sever stomach pain, abnormal liver functions, low white blood cell count, numbness in legs, dehydration.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Streptococcus test, White blood cell count decreased
Clinical narrative: High fever, severe head aches, sensitivity to light, sever stomach pain, abnormal liver functions, low white blood cell count, numbness in legs, dehydration.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Headache, Pain
Clinical narrative: Headaches and stomach pain and aching all over body.
Age: 21.0
Sex: F
Vaccine: HPV9, TDAP, VARCEL
Symptoms: Arthralgia, Chills, Hot flush, Injection site pain, Nausea
Clinical narrative: Naseua, chills, hot flashes, body aches, joint pain, injection site pain (HPV and Tdap). Took 2 500 mil of Advil. Still have symptoms (9:35 am).
Age: 21.0
Sex: F
Vaccine: HPV9, TDAP, VARCEL
Symptoms: Pain
Clinical narrative: Naseua, chills, hot flashes, body aches, joint pain, injection site pain (HPV and Tdap). Took 2 500 mil of Advil. Still have symptoms (9:35 am).
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Nasopharyngitis, Sneezing
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 57 year old female patient. The patient's concomitant therapies were unknown by the reporter. The patient did not have any pertinent medical history. The patient's drug allergies/reaction included an unknown reaction to COMPAZINE. On 09-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, Lot # R002354, expiration date 17-DEC-2019, for vaccination (strength, dose and frequency were not reported). On 10-AUG-2018 (reported as "on the following day"), the patient experienced a cough, sneezing and other cold symptoms. The patient did take MUCINEX for these symptoms (also reported as "treatment: No") and recovered on 16-AUG-2018. The patient did not seek medical attention and diagnostic laboratories were not performed. The pharmacist requested a Lot check and stated it was time sensitive. Additionally, the causality assessment between Nasopharyngitis and PNEUMOVAX 23 was not provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA007466: US-009507513-1808USA008021.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Eye pruritus, Eye swelling, Facial pain, Influenza like illness
Clinical narrative: Patient was seen 8/16/2018 complaining of flu like symptoms and fever of 102. Facial pain and swelling and neck x 3 days. Associated symptoms include eye itching, eye redness and a rash. Pertinent negatives include no abdominal pain, chest pain, diarrhea, difficulty breathing, vomiting or wheezing. Swelling is present on the eyes and face. The patient had received the 2nd SHINGRIX vaccine on 8/10/2018. The first dose was given 6/8/2018 with no reported reaction. The patient was then treated on 8/16 with triamcinolone acetonide (KENALOG-40) injection 60 mg; Inject 1.5 mLs (60 mg total) into the muscle once. The patient was sent home with oral predniSONE (DELTASONE) 10 MG tablet; Use 4 tabs PO qAM for 3 days, then 3 tabs daily for 3 days, then 2 tabs daily for 3 days, then 1 tab daily for 3 days and triamcinolone (KENALOG) 0.5 % cream; Apply thin layer of cream over affected area 2 times daily until gone up to 2 weeks. The patient was also advised to take OTC Benadryl. Then the patient returned on 8/21/2018 stating that he is back because of nose swelling, can't sleep at night, the swelling moves all around face and head, and has throbbing and is very painful. No vision problems.  The patient was given Keflex today because his rash has turned into cellulitis. The patient was advised to finish the prednisone taper and was also given tramadol for pain. The patient will follow up with his family doctor Dr. within the next couple of days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Nasal congestion, Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: Patient was seen 8/16/2018 complaining of flu like symptoms and fever of 102. Facial pain and swelling and neck x 3 days. Associated symptoms include eye itching, eye redness and a rash. Pertinent negatives include no abdominal pain, chest pain, diarrhea, difficulty breathing, vomiting or wheezing. Swelling is present on the eyes and face. The patient had received the 2nd SHINGRIX vaccine on 8/10/2018. The first dose was given 6/8/2018 with no reported reaction. The patient was then treated on 8/16 with triamcinolone acetonide (KENALOG-40) injection 60 mg; Inject 1.5 mLs (60 mg total) into the muscle once. The patient was sent home with oral predniSONE (DELTASONE) 10 MG tablet; Use 4 tabs PO qAM for 3 days, then 3 tabs daily for 3 days, then 2 tabs daily for 3 days, then 1 tab daily for 3 days and triamcinolone (KENALOG) 0.5 % cream; Apply thin layer of cream over affected area 2 times daily until gone up to 2 weeks. The patient was also advised to take OTC Benadryl. Then the patient returned on 8/21/2018 stating that he is back because of nose swelling, can't sleep at night, the swelling moves all around face and head, and has throbbing and is very painful. No vision problems.  The patient was given Keflex today because his rash has turned into cellulitis. The patient was advised to finish the prednisone taper and was also given tramadol for pain. The patient will follow up with his family doctor Dr. within the next couple of days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Swelling, Swelling face
Clinical narrative: Patient was seen 8/16/2018 complaining of flu like symptoms and fever of 102. Facial pain and swelling and neck x 3 days. Associated symptoms include eye itching, eye redness and a rash. Pertinent negatives include no abdominal pain, chest pain, diarrhea, difficulty breathing, vomiting or wheezing. Swelling is present on the eyes and face. The patient had received the 2nd SHINGRIX vaccine on 8/10/2018. The first dose was given 6/8/2018 with no reported reaction. The patient was then treated on 8/16 with triamcinolone acetonide (KENALOG-40) injection 60 mg; Inject 1.5 mLs (60 mg total) into the muscle once. The patient was sent home with oral predniSONE (DELTASONE) 10 MG tablet; Use 4 tabs PO qAM for 3 days, then 3 tabs daily for 3 days, then 2 tabs daily for 3 days, then 1 tab daily for 3 days and triamcinolone (KENALOG) 0.5 % cream; Apply thin layer of cream over affected area 2 times daily until gone up to 2 weeks. The patient was also advised to take OTC Benadryl. Then the patient returned on 8/21/2018 stating that he is back because of nose swelling, can't sleep at night, the swelling moves all around face and head, and has throbbing and is very painful. No vision problems.  The patient was given Keflex today because his rash has turned into cellulitis. The patient was advised to finish the prednisone taper and was also given tramadol for pain. The patient will follow up with his family doctor Dr. within the next couple of days.
Age: 43.0
Sex: M
Vaccine: FLUX, PPV, TTOX, FLUX, PPV, TTOX
Symptoms: Electromyogram abnormal, Foreign travel, Gait inability, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Patient was vaccinated prior to trip. Approx 3-4 weeks later, upon return from trip developed pins/needle sensation which progressed to thighs; weakness of legs; unable to ambulate and presented to our facility.
Age: 43.0
Sex: M
Vaccine: FLUX, PPV, TTOX, FLUX, PPV, TTOX
Symptoms: Muscular weakness, Nerve conduction studies abnormal, Paraesthesia, Peripheral sensorimotor neuropathy, Plasmapheresis
Clinical narrative: Patient was vaccinated prior to trip. Approx 3-4 weeks later, upon return from trip developed pins/needle sensation which progressed to thighs; weakness of legs; unable to ambulate and presented to our facility.