chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of general body pain in a 51-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (on an unspecified date 1st dose received, for tolerance see case US2018GSK112756). On 13th June 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In June 2018, less than a month after receiving SHINGRIX, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain was unknown and the outcome of the fever was recovered/resolved. The reporter considered the general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that after the second dose, the patient of 102 degree F. The reporter stated that the onset time and exact duration of these symptoms were unknown. The reporter did not have any additional details. This case has been linked with case US2018GSK112756, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: DTAP, HEPA, VARZOS
Symptoms: Chills, Disturbance in attention, Feeling abnormal, Hyperhidrosis, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of attention concentration difficulty in a 60-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. Co-suspect products included Hepatitis A vaccine for prophylaxis and DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. Concomitant products included clindamycin (Clindamycin Gel), estradiol (Estradiol Vaginal) and colecalciferol (Vitamin D3). On 21st May 2018, the patient received the 1st dose of SHINGRIX, Hepatitis A vaccine and dTpa vaccine. On 21st May 2018, less than a day after receiving SHINGRIX, Hepatitis A vaccine and dTpa vaccine, the patient experienced attention concentration difficulty. On 22nd May 2018, the patient experienced chills, sweating, injection site rash and injection site pain. On an unknown date, the outcome of the attention concentration difficulty, chills, sweating, injection site rash and injection site pain were recovered/resolved. The reporter considered the attention concentration difficulty, chills, sweating, injection site rash and injection site pain to be possibly related to SHINGRIX. It was unknown if the reporter considered the attention concentration difficulty, chills, sweating, injection site rash and injection site pain to be related to Hepatitis A vaccine and dTpa vaccine. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. On the day of vaccination, later that evening, the patient had difficulty in focusing while watching the television. The patient stated, she knew she was watching television but could not focus or did not know what she was watching and that this felt weird. The next day after receiving SHINGRIX, the patient experienced chills, sweats, rash around the arm injection site and pain at the injection site. The manufacturer of concomitant vaccines were not asked during the phone consultation.
Age: 60.0
Sex: F
Vaccine: DTAP, HEPA, VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of attention concentration difficulty in a 60-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. Co-suspect products included Hepatitis A vaccine for prophylaxis and DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. Concomitant products included clindamycin (Clindamycin Gel), estradiol (Estradiol Vaginal) and colecalciferol (Vitamin D3). On 21st May 2018, the patient received the 1st dose of SHINGRIX, Hepatitis A vaccine and dTpa vaccine. On 21st May 2018, less than a day after receiving SHINGRIX, Hepatitis A vaccine and dTpa vaccine, the patient experienced attention concentration difficulty. On 22nd May 2018, the patient experienced chills, sweating, injection site rash and injection site pain. On an unknown date, the outcome of the attention concentration difficulty, chills, sweating, injection site rash and injection site pain were recovered/resolved. The reporter considered the attention concentration difficulty, chills, sweating, injection site rash and injection site pain to be possibly related to SHINGRIX. It was unknown if the reporter considered the attention concentration difficulty, chills, sweating, injection site rash and injection site pain to be related to Hepatitis A vaccine and dTpa vaccine. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. On the day of vaccination, later that evening, the patient had difficulty in focusing while watching the television. The patient stated, she knew she was watching television but could not focus or did not know what she was watching and that this felt weird. The next day after receiving SHINGRIX, the patient experienced chills, sweats, rash around the arm injection site and pain at the injection site. The manufacturer of concomitant vaccines were not asked during the phone consultation.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 13th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site inflammation and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site inflammation and injection site erythema were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site inflammation and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient experienced extensive swelling of vaccinated limb, inflammation, swelling and redness at the injection site, and these symptoms were large and almost down to her elbow. No further information was provided.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of myalgia in a 54-year-old male patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. Concurrent medical conditions included diabetes and hyperlipidemia. Concomitant products included Atorvastatin, Metformin and glimepiride. On 13th June 2018, the patient received SHINGRIX. On 13th June 2018, several hours after receiving SHINGRIX, the patient experienced myalgia, fever, chills and general body pain. The patient was treated with ibuprofen, TYLENOL and BENADRYL. On an unknown date, the outcome of the myalgia, fever, chills and general body pain were recovering/resolving. The reporter considered the myalgia, fever, chills and general body pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced myalgia, body aches, fever, and chills the night after vaccination.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of bronchitis (Refer case US2018107612). Concomitant products included vitamin D and hydrochlorothiazide. On 14th June 2018, the patient received the 2nd dose of SHINGRIX. On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, headache, pain in hand, fever, feeling bad, influenza-like symptoms and swelling of fingers. On an unknown date, the outcome of the muscle pain was recovered/resolved and the outcome of the headache, pain in hand and swelling of fingers were unknown and the outcome of the fever, feeling bad and influenza-like symptoms were not recovered/not resolved. The reporter considered the muscle pain, headache, pain in hand, fever, influenza-like symptoms and swelling of fingers to be related to SHINGRIX. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient did not want to get the 2nd dose, but upon instructions by her health care professional she received it on 14th June 2018. That evening she started experiencing muscle pain, a violent headache, a 99 F temperature, pain in her hands, and swelling in her fingers. The symptoms got worse over in the night and at the time of reporting she felt terrible like she had the flu. She had put in a call to her health care professional. The patient had denied permission to contact their physician. This case has been linked to case US2018107612 reported by the same reporter for the same patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of bronchitis (Refer case US2018107612). Concomitant products included vitamin D and hydrochlorothiazide. On 14th June 2018, the patient received the 2nd dose of SHINGRIX. On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, headache, pain in hand, fever, feeling bad, influenza-like symptoms and swelling of fingers. On an unknown date, the outcome of the muscle pain was recovered/resolved and the outcome of the headache, pain in hand and swelling of fingers were unknown and the outcome of the fever, feeling bad and influenza-like symptoms were not recovered/not resolved. The reporter considered the muscle pain, headache, pain in hand, fever, influenza-like symptoms and swelling of fingers to be related to SHINGRIX. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient did not want to get the 2nd dose, but upon instructions by her health care professional she received it on 14th June 2018. That evening she started experiencing muscle pain, a violent headache, a 99 F temperature, pain in her hands, and swelling in her fingers. The symptoms got worse over in the night and at the time of reporting she felt terrible like she had the flu. She had put in a call to her health care professional. The patient had denied permission to contact their physician. This case has been linked to case US2018107612 reported by the same reporter for the same patient.
Sex: M
Vaccine: PNC13
Symptoms: Biopsy bone marrow normal, Computerised tomogram normal, Histiocytosis haematophagic, Neutropenia, Neutrophil count decreased
Clinical narrative: This is a spontaneous report from a contactable consumer. A 56-year-old male patient received PREVNAR 13 on an unspecified date in 2018 at single dose for immunisation. Medical history included autologous bone marrow transplant and ongoing T-cell lymphoma diagnosed in late 2016 or early 2017 and treated by chemotherapy. The patient's concomitant medications were not reported. On Jun2018, after receiving pneumococcal 13-val conj vaccine, patient experienced hemophagocytic lymphohistiocytosis (HLH). On an unknown date in 2018 elevated ferritin level and neutropenia occurred which was consistent with HLH (unknown if recovered). The patient was hospitalized for hemophagocytic lymphohistiocytosis from 11Jun2018 to an unknown date. CT scan and Bone marrow biopsy done on Jun2018 revealed no re-occurrence of the lymphoma. Unspecified therapeutic measures were taken as a result of hemophagocytic lymphohistiocytosis.Outcome of hemophagocytic lymphohistiocytosis was recovering. Information on the batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Serum ferritin increased
Clinical narrative: This is a spontaneous report from a contactable consumer. A 56-year-old male patient received PREVNAR 13 on an unspecified date in 2018 at single dose for immunisation. Medical history included autologous bone marrow transplant and ongoing T-cell lymphoma diagnosed in late 2016 or early 2017 and treated by chemotherapy. The patient's concomitant medications were not reported. On Jun2018, after receiving pneumococcal 13-val conj vaccine, patient experienced hemophagocytic lymphohistiocytosis (HLH). On an unknown date in 2018 elevated ferritin level and neutropenia occurred which was consistent with HLH (unknown if recovered). The patient was hospitalized for hemophagocytic lymphohistiocytosis from 11Jun2018 to an unknown date. CT scan and Bone marrow biopsy done on Jun2018 revealed no re-occurrence of the lymphoma. Unspecified therapeutic measures were taken as a result of hemophagocytic lymphohistiocytosis.Outcome of hemophagocytic lymphohistiocytosis was recovering. Information on the batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Histiocytosis haematophagic
Clinical narrative: This is a spontaneous report from a contactable physician, via Medical Information Team. A 56-year-old male patient receive PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included T-cell malignancy and stem cell transplant. The patient's concomitant medications were not reported. On unspecified date, after receiving the vaccine the patient developed a rare complication of HLH (hemophagocytic lymphohistiocytosis). The outcome of the event was unknown. Information on the batch number has been requested. Sender's Comments: Currently there is no plausible mechanism to implicate the suspect vaccine to the occurrence of the serious event "HLH (hemophagocytic lymphohistiocytosis)" due to insufficient information. The event more likely represents an intercurrent medical condition. 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: MENB
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after use of the product, the patient experienced headache, fatigue, and nausea. Outcome of the events was unknown. Information on the batch and lot numbers has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of an unspecified age, reported as probably over 65, received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cellulitis at injection site. Clinical outcome of the event was unknown. Information on batch and lot numbers has been requested. Sender's Comments: Based on the information currently available, the vaccination with PREVNAR 13 might play a contributory role in triggering the occurrence of vaccination site cellulitis. 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, PPV
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, (Call Center for HCPs), received from a contactable nurse. A patient of unspecified age and gender receive PREVNAR 13, and PNEUMOVAX 23; both 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 had an allergic reaction on an unspecified date. The reporter wanted to know if the patient had an allergic reaction to PNEUMOVAX 23 or the PREVNAR 13. The outcome of the event was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative and via Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A female patient of an unspecified age received the 1st dose of TRUMENBA, 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 stated that pain experiencing was much different than when had gotten the 1st dose of trumenba on an unspecified date with outcome of unknown. She had to take Motrin that helped with the pain. The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018247760 Same patient, same event in different timeframe;US-PFIZER INC-2018247760 same patient, different event in different time frame.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Mobility decreased, Swelling
Clinical narrative: This is a spontaneous report from a contactable Nurse. This report was received via a Pfizer sales representative. A 16-year-old female patient received TRUMENBA (lot number and expiration date were unspecified), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and swelling that measured 3 1/2" in diameter on an unspecified date. The patient also could hardly move her arm on an unspecified date. The events took place after use of the vaccine. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable nurse received via Pfizer sales representative. A 18-year-old male patient received TRUMENBA on an unspecified date, at single dose, in arm, for immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced redness and swelling at injection site and could not raise arm. Events outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 13-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves nine patients (age and gender not reported) who were vaccinated with a dose of DAPTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that 9 adults were vaccinated with wrong vaccine. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 13-Jun-2018 regarding an unsolicited valid non-serious case received from a office person medical assistant. This case involves a patient (age and gender was not reported), who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used because a dose expired which was hoping to be in a grace period. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 14-Jun-2018 in the United States regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 12-month-old patient (gender was not reported), who was vaccinated with a dose of ACT-HIB (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. It was a case of actual medication error due to expired vaccine used because expired dose given to a 1 year old patient. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 13-Jun-2018 regarding an unsolicited valid non-serious case received from a physician. This case 18 year old patient who received two doses of MENACTRA (batch number, expiry date, route and site of administration were not reported) on the same night at two different offices when she supposed to get MENINGOCOCCAL VACCINE B "meningitis B". It was a case of actual medication error due to Wrong vaccine administered and Extra dose administered. No adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 14-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a adult patient who was vaccinated with PENTACEL (batch number, expiry date, route and site of administration were not reported) who need Tdap. It was a case of actual medication error due to Wrong vaccine administered and inappropriate age at vaccine administration as PENTACEL was administered to an adult who needed a TDaP. No adverse event were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 14-Jun-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 12 months old patient who was vaccinated with a dose of QUADRACEL (batch number, expiry date, route and site of administration were not reported) instead of PENTACEL (batch number and expiry date were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a office person medical assistant on 15-Jun-2018. This case involves a patient of an unknown demographics who was vaccinated with a dose of ACT-HIB (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to wrong solution used in drug reconstitution. It was reported that ACTHIB mixed with sterile water and given to the patient. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 15-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (gender not reported) who was vaccinated with a DTaP/IPV component without HIB component of PENTACEL (batch number, expiry date, dose, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 15-Jun-2018 regarding an unsolicited valid non-serious case received from a Medical assistant (health care professional). This case involves a patient (age and gender not reported) who was vaccinated with expired dose of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Expired vaccine used. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dysphagia, Lymphadenopathy, Mononucleosis heterophile test negative, Odynophagia, Streptococcus test negative
Clinical narrative: School requires two doses of meningococcal vaccine MCV4 (8 weeks apart) prior to beginning of senior year. Patient received 1st dose on 6/14/2018 and that night found one of her lymph nodes swollen. Over the next few days, it progressed to very swollen lymph nodes all throughout neck. She found it painful and hard to swallow.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site rash
Clinical narrative: Rash/site reaction (erythema ~3cm x 3cm).
Age: 52.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Feeling cold, Headache
Clinical narrative: I started getting upset stomach around 6pm - cramps and diarrhea. That continued until about 10:30pm. I then went to bed and woke up about 1:30am with chills & shaking - I could not get warm but had a fever. I then started again with diarrhea and vomiting also started. This lasted until about 3:30am. Throughout this, I had a headache and body aches as well which went well into Saturday during the day.
Age: 52.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Muscle spasms, Pain, Pyrexia, Tremor, Vomiting
Clinical narrative: I started getting upset stomach around 6pm - cramps and diarrhea. That continued until about 10:30pm. I then went to bed and woke up about 1:30am with chills & shaking - I could not get warm but had a fever. I then started again with diarrhea and vomiting also started. This lasted until about 3:30am. Throughout this, I had a headache and body aches as well which went well into Saturday during the day.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Erythema, Pain, Skin irritation, Swelling
Clinical narrative: Reports signs of severe pain, redness, swelling, irritation and discomfort. Had called primary care physician for further care.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Fatigue, Pyrexia, Swelling
Clinical narrative: Reports signs of severe pain, redness, swelling, irritation and discomfort. Had called primary care physician for further care.
Age: 0.5
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: I gave pt vaccine on the left thigh and when I was done I went to enter in the system and realize I gave her the wrong vaccine immediately let the provider know of what occur. No symptoms and no signs of threat to patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Chills, lethargy, pain and swelling at injection site.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood potassium decreased, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: On Tuesday, June 19th, at approx. 10 am, patient came into the office for a PPD, and Men B #2 for college forms. Pt seemed fine in the office before, and after administration. She received the PPD and Men B at approx. 10:10 am. Approx 10:30 am, the front desk staff received a phone call from patient's mother, stating that "she passed out, or had a seizure". I grabbed a wheelchair, and went outside. Patient was lying back in passenger seat of mom's car. Car was turned off. It was hot in the vehicle. On my assessment, patient was pale, and diaphoretic, lying with her eyes closed. Pulse and respirations normal. When I spoke to her, she was responsive to my questioning. I attempted to sit her up, to transfer her to the wheelchair. At that time, she told me "I am going to pass out". I laid her back down at this time. There was an initial period of approx. 5-10 seconds where her eyes rolled back, and her arms stiffened. At this time, I called 911. While I was on the phone with 911 at the car, the physician came out to the vehicle, and assessed the patient as well. We continued to monitor patient while awaiting EMS arrival. EMS arrived, and report was given to paramedic. Patient was responsive to sternal rub. She was able to get out of the car, with assistance, and ambulate to the gurney. Ambulance left to take her to Hospital for further evaluation and treatment. Mom followed behind in her vehicle.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pallor, Seizure, Syncope
Clinical narrative: On Tuesday, June 19th, at approx. 10 am, patient came into the office for a PPD, and Men B #2 for college forms. Pt seemed fine in the office before, and after administration. She received the PPD and Men B at approx. 10:10 am. Approx 10:30 am, the front desk staff received a phone call from patient's mother, stating that "she passed out, or had a seizure". I grabbed a wheelchair, and went outside. Patient was lying back in passenger seat of mom's car. Car was turned off. It was hot in the vehicle. On my assessment, patient was pale, and diaphoretic, lying with her eyes closed. Pulse and respirations normal. When I spoke to her, she was responsive to my questioning. I attempted to sit her up, to transfer her to the wheelchair. At that time, she told me "I am going to pass out". I laid her back down at this time. There was an initial period of approx. 5-10 seconds where her eyes rolled back, and her arms stiffened. At this time, I called 911. While I was on the phone with 911 at the car, the physician came out to the vehicle, and assessed the patient as well. We continued to monitor patient while awaiting EMS arrival. EMS arrived, and report was given to paramedic. Patient was responsive to sternal rub. She was able to get out of the car, with assistance, and ambulate to the gurney. Ambulance left to take her to Hospital for further evaluation and treatment. Mom followed behind in her vehicle.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest pain, Cough, Crying, Glossodynia, Injection site erythema
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 6 year old female patient. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a first dose of VARIVAX (strength, route of administration, lot# and expiration date were not reported). After the vaccination the patient had no adverse reactions. On 31-MAY-2018 the patient was vaccinated with a second dose of VARIVAX injection, 0.5 ml (route of administration, lot# and expiration date were not reported) for prophylaxis. By the time they got to the car, the patient started crying. The patient's chest was burning and she started coughing. The patient's throat, mouth, tongue and throat hurt and the patient started holding her throat. Pain in throat lasted for 20 minutes and then resolved. The patient also had an injection site reaction, that was a hard red circle, that was about 3/4 of an inch across. The patient's mother stated, that the injection site reaction has resolved but she didn't say when it resolved. The outcome of the other events was reported as recovered/resolved (on an unknown date in 2018). Causality assessment was not provided.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Oral pain, Oropharyngeal pain
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 6 year old female patient. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a first dose of VARIVAX (strength, route of administration, lot# and expiration date were not reported). After the vaccination the patient had no adverse reactions. On 31-MAY-2018 the patient was vaccinated with a second dose of VARIVAX injection, 0.5 ml (route of administration, lot# and expiration date were not reported) for prophylaxis. By the time they got to the car, the patient started crying. The patient's chest was burning and she started coughing. The patient's throat, mouth, tongue and throat hurt and the patient started holding her throat. Pain in throat lasted for 20 minutes and then resolved. The patient also had an injection site reaction, that was a hard red circle, that was about 3/4 of an inch across. The patient's mother stated, that the injection site reaction has resolved but she didn't say when it resolved. The outcome of the other events was reported as recovered/resolved (on an unknown date in 2018). Causality assessment was not provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Headache, shivering, fever of 100.4, nausea and vomiting (perhaps related to the fever), fatigue, significant pain at injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache, shivering, fever of 100.4, nausea and vomiting (perhaps related to the fever), fatigue, significant pain at injection site.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site nodule
Clinical narrative: Golf ball size knot at injection site.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Pityriasis rosea, Pruritus, Rash
Clinical narrative: On June 10 I started to develop itches and small red marks that appeared as mosquito bites. A couple days latter rashes and small red vesicles appeared on my torso, back, lower abdomen and thighs. On June 20, PAC, at Health Clinic, diagnosed the harsh as Pityriasis Rosea and prescribed BANOPHEN 25 mg and Hydrocortisone Cream USP 2.5%. As of today the hashes are still itching and seems that it is spreading.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Pain in extremity, Pityriasis rosea, Pruritus, Scar
Clinical narrative: On June 10 I started to develop itches and small red marks that appeared as mosquito bites. A couple days latter rashes and small red vesicles appeared on my torso, back, lower abdomen and thighs. On June 20, PAC, at Health Clinic, diagnosed the harsh as Pityriasis Rosea and prescribed BANOPHEN 25 mg and Hydrocortisone Cream USP 2.5%. As of today the hashes are still itching and seems that it is spreading.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion, Skin ulcer
Clinical narrative: On June 10 I started to develop itches and small red marks that appeared as mosquito bites. A couple days latter rashes and small red vesicles appeared on my torso, back, lower abdomen and thighs. On June 20, PAC, at Health Clinic, diagnosed the harsh as Pityriasis Rosea and prescribed BANOPHEN 25 mg and Hydrocortisone Cream USP 2.5%. As of today the hashes are still itching and seems that it is spreading.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash vesicular, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Provider concerned due to patient ended up with Shingles/Active Chicken pox 4 months after receiving 1st varicella vaccine. Patient came into clinic on 6/21/18 due to outbreak of rash, vesicles to left thigh and left buttock noted in clusters. Patient sent home on acyclovir suspension and topical cream for treatment. Patient had varicella titers drawn which came back active for chicken pox/shingles. Patient to follow up in clinic in 1 week.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain, Vaccination site pain
Clinical narrative: Pain in upper left arm in area of vaccination, but not just right after the vaccination, but lasting to this day, two months later, and actually inhibiting motion of the arm (as when swinging arm horizontally as part of exercise routine). The pain is only felt when I use the arm in the particular motion described. I have done nothing for it, hoping it would just go away; but it seems to be permanent, and not sure what could be done anyway. Now don't know whether to get second SHINGRIX shot. I would hate to be crippled in both arms!
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Patient had a rash. Site was warm to touch.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin discolouration, Skin exfoliation
Clinical narrative: Patient complained her arm was red, then purple, swollen and painful. This took 3 weeks before it heeled. The area eventually started peeling.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reports left arm is sore beginning day after administration. Has reduced slightly over time but arm still store four months later.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Myalgia, Nausea, Productive cough
Clinical narrative: Fever,chills, cough,muscle aches,phlegm,nausea.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever,chills, cough,muscle aches,phlegm,nausea.
Age: 19.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Received BEXSERO to left deltoid, the next morning noted inability to move left shoulder. Mild pain over injection site. No H/O injury. Pt doing home physical therapy.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Confusional state, Delirium, Malaise, Pyrexia, Vomiting
Clinical narrative: Thursday morning (6-21-18) patient reports severe vomiting, fever (unknown max) and delirium/confusion that persisted until Saturday 6-23-18. Pt denies any rashes, redness or soreness at injection site. Pt states "she was too sick to go to the ER".
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was inadvertently vaccinated with improperly stored dose of VARIVAX (lot # N015475, expiration date: 18-MAY-2019, dose, frequency and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK). Reporter stated that the vaccines were stored between -14 degrees Celsius to -10 degrees Celsius for 21 minutes prior to administration. There were no previous temperature excursions. The digital data logger was used. The patients did not experienced any adverse events. Product quality complaint was not involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031:US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009055: US-009507513-1806USA009056.