chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 02-JUL-2018, the patient was vaccinated with a improperly stored dose of ROTATEQ orally, lot # N030175, expiration date 16-JUN-2019 (strength and vaccination site were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion at of above 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 84 hours. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA010994: US-009507513-1807USA010995: US-009507513-1807USA010304.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 02-JUL-2018, the patient was vaccinated with a improperly stored dose of ROTATEQ orally, lot # N030175, expiration date 16-JUN-2019 (strength and vaccination site were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion at or above 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 84 hours. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA010993: US-009507513-1807USA010995: US-009507513-1807USA010304.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 02-JUL-2018, the patient was vaccinated with a improperly stored dose of ROTATEQ orally, lot # N030175, expiration date 16-JUN-2019 (strength and vaccination site were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion at of above 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 84 hours. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA010993: US-009507513-1807USA010304: US-009507513-1807USA010994.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA182241, 2018SA182252, 2018SA182254, 2018SA182255 and 2018SA182256 (same reporter). This case involves a patient (age and gender not reported), who received a 0.5 mL dose of vaccine, which on 01-Jun-2018 reached to 52.8-degree F for 43 minutes and on 04-Jun-2018 product reached 48.2-degree F for more than 30 minutes, before patient received 0.5 ml dose of vaccine IPOL lot N1K921M, expiry date: 14-Nov-2019, via intramuscular route. 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 incorrect product storage (product storage error). It was not reported if the patient had any adverse event or not. 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 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: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA182241, 2018SA182252, 2018SA182253, 2018SA182255 and 2018SA182256 (same reporter). This case involves patient (age and gender not reported), who received a vaccine, which on 01-Jun-2018 reached to 52.8-degree F for 43 minutes and on 04-Jun-2018 product reached 48.2-degree F for more than 30 minutes, before patient received 0.5 ml dose of vaccine IPOL lot N1K931M via intramuscular route. 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 incorrect product storage. It was not reported if the patient had any adverse event or not. 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. Documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Nausea, Pain
Clinical narrative: Rash and soreness at the site of injection. Body aches and pains, nausea.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Presyncope
Clinical narrative: Pt received HPV9 and within 1 min of vaccine administration complained of dizziness. Pt was seated in a recumbent position chair. Pt. experienced a vasovagal response lasting less than 5 seconds. Pt's regained consciousness, was A&O x4 with stable vitals.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nerve compression, Neuralgia
Clinical narrative: Extreme pain from pinched nerve on left side of neck that has been dormant since physical and medicine therapy.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Movement disorder, Neck pain, Nerve compression
Clinical narrative: Extreme pain from pinched nerve on left side of neck that has been dormant since physical and medicine therapy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Malaise, Nausea, Pain
Clinical narrative: Rash and soreness at injection site, body aches and pain (moderate-severe), nausea, malaise.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test, Panic disorder
Clinical narrative: Approximately two weeks after administration of the above vaccine, I was notified by the patient (who was also a co-worker at the time) that she was struggling with numbness and tingling in her feet, legs, hands and face. That feeling continued to worsen, I encouraged her to go to the local hospital ER for a neurological evaluation for Guillian Barre. She was seen at the ER, discussed with that staff that she had previously had a vaccine, she was sent away with medication for panic/anxiety. After being seeing at the ER several times for worsening symptoms, she was seen by Dr. who diagnosed her with Guillian Barre Syndrome from previous influenza vaccine.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Approximately two weeks after administration of the above vaccine, I was notified by the patient (who was also a co-worker at the time) that she was struggling with numbness and tingling in her feet, legs, hands and face. That feeling continued to worsen, I encouraged her to go to the local hospital ER for a neurological evaluation for Guillian Barre. She was seen at the ER, discussed with that staff that she had previously had a vaccine, she was sent away with medication for panic/anxiety. After being seeing at the ER several times for worsening symptoms, she was seen by Dr. who diagnosed her with Guillian Barre Syndrome from previous influenza vaccine.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Somnolence
Clinical narrative: Shortly after last injection was administered patient slowly fell to what seem to be sleeping. Patient seemed very sleepy and would slightly open her eyes and would return to fall asleep. Per provider patient had good moro reflex, strong pulse and heartbeat on examination shortly after incident. Patient also good pupil reflex while sleeping. Provider/Staff monitored patient over 30 minutes, at that point patient woke up and was eating well.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Loss of consciousness, Presyncope
Clinical narrative: 2min after receiving the vaccines, pt complained of dizziness. Pt was placed in a recumbent position chair. Pt experienced a vasovagal episode and was unconscious for less than 5 seconds. Pt was then A&O x4 with stable vitals. Pt was observed for 30min and released.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Fever, chills, tiredness, malaise, abdominal pain and myalgia.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, tiredness, malaise, abdominal pain and myalgia.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Size of an orange red, inflamed, hot to the touch area on arm. I, RPh, recommended BENADRYL and ice pack.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Approx 10x12cm warmth, tenderness and induration on left anterior upper thigh. No streaking KEFLEX x10 days for treatment.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus that ZOSTAVAX is intended to prevent. In 2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 04-DEC-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a severe vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-SEP-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sinus infection in a 60-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) for prophylaxis. On 31st January 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 21 days after receiving SHINGRIX, the patient experienced sinus infection. On an unknown date, the outcome of the sinus infection was unknown. It was unknown if the reporter considered the sinus infection to be related to SHINGRIX. Additional details were provided as follows: Three weeks after vaccination, the patient experienced a sinus infection. The healthcare professional was not sure if the sinus infection was associated with the SHINGRIX. The healthcare professional called medical information for efficacy data after only receiving the 1st dose.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Peripheral swelling, Pyrexia, Skin warm, Thrombosis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of thrombosis leg in a 77-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, 5 days after receiving SHINGRIX, the patient experienced thrombosis leg (serious criteria GSK medically significant), fever, fatigue, swelling of legs and skin warm. On an unknown date, the outcome of the thrombosis leg, fever, fatigue, swelling of legs and skin warm were recovering/resolving. It was unknown if the reporter considered the thrombosis leg, fever, fatigue, swelling of legs and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm. The pharmacist stated that the patient developed a blood clot in her left leg 5 days after receiving the shot. The patient's leg was swollen and hot. The patient also experienced fatigue and fever after receiving the shot. The pharmacist stated that patient did visit her doctor, and her doctor said the blood clot might also have been due to the fatigue and she was in the bed the whole time. No further details were provided. All questions were asked. The reported batch number C523J for SHINGRIX does not exist in sales database and was updated as C523T as per sales database.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pulmonary embolism, Scan abnormal, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of thrombosis leg in a 77-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, 5 days after receiving SHINGRIX, the patient experienced thrombosis leg (serious criteria GSK medically significant), fever, fatigue, swelling of legs and skin warm. On an unknown date, the outcome of the thrombosis leg, fever, fatigue, swelling of legs and skin warm were recovering/resolving. It was unknown if the reporter considered the thrombosis leg, fever, fatigue, swelling of legs and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm. The pharmacist stated that the patient developed a blood clot in her left leg 5 days after receiving the shot. The patient's leg was swollen and hot. The patient also experienced fatigue and fever after receiving the shot. The pharmacist stated that patient did visit her doctor, and her doctor said the blood clot might also have been due to the fatigue and she was in the bed the whole time. No further details were provided. All questions were asked. The reported batch number C523J for SHINGRIX does not exist in sales database and was updated as C523T as per sales database.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Thrombosis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of thrombosis leg in a 77-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, 5 days after receiving SHINGRIX, the patient experienced thrombosis leg (serious criteria GSK medically significant), fever, fatigue, swelling of legs and skin warm. On an unknown date, the outcome of the thrombosis leg, fever, fatigue, swelling of legs and skin warm were recovering/resolving. It was unknown if the reporter considered the thrombosis leg, fever, fatigue, swelling of legs and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm. The pharmacist stated that the patient developed a blood clot in her left leg 5 days after receiving the shot. The patient's leg was swollen and hot. The patient also experienced fatigue and fever after receiving the shot. The pharmacist stated that patient did visit her doctor, and her doctor said the blood clot might also have been due to the fatigue and she was in the bed the whole time. No further details were provided. All questions were asked. The reported batch number C523J for SHINGRIX does not exist in sales database and was updated as C523T as per sales database.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Product storage error, Swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 12th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced pain and swelling. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the pain and swelling were recovering/resolving and the outcome of the incorrect storage of drug was unknown. It was unknown if the reporter considered the pain and swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by an office manager. The patient received SHINGRIX which was frozen, which led to incorrect storage of vaccine. The only side effect the patient experienced was pain, soreness & swelling but was better after 3 days.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a 17-year-old male patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019) for prophylaxis. On 30th March 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site pain to be related to BEXSERO. Additional details were provided as follows: The patient experienced pain and swelling at injection site. In 2018, the events were resolved. This is 1 of 2 cases, reported by the same reporter for the same patient.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA182241, 2018SA182253, 2018SA182254, 2018SA182255 and 2018SA182256 (same reporter). This case involves patient (age and gender not reported), who received a 0.5 mL dose of vaccine, which on 01-Jun-2018 reached to 52.8-degree F for 43 minutes and on 04-Jun-2018 product reached 48.2-degree F for more than 30 minutes, before patient received 0.5 ml dose of vaccine IPOL lot N1K921M, expiry date: 14-Nov-2019, via intramuscular route. 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 incorrect product storage (product storage error). It was not reported if the patient had any adverse event or not. 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 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
Clinical narrative: Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This two month old patient who was vaccinated with an expired dose of PENTACEL (batch number, expiry date 24-JUN-2018, route and site of administration were not reported) on 11 July 2018. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was 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 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: TDAP
Symptoms: Adverse reaction
Clinical narrative: Initial information received on 13-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an adult patient (age and gender not reported) who experienced patient complaining about issues after administration, while he/she received vaccine ADACEL. 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 DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (dose, dose in series, lot number, expiry date, route and site of administration was not reported). On an unknown date ¸the patient developed a non-serious issues (administration related reaction) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. No lab test reported. Final diagnosis was issues after administration. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for the event. List of documents held by sender: none.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Arthralgia, Head banging, Injection site pain, Injection site reaction, Irritability
Clinical narrative: Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a non-health professional. This case involves a 13 months old male patient who experienced fever, had severe right rash after receiving PENTACEL, swelling, fussiness and banging head, joint pain, screaming and has skin lesions that are tender on right thigh, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Jul-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE (lot number: C5437AA) (expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious fever following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious had severe right rash after receiving PENTACEL following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious swelling following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious fussiness, banging head following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious joint pain following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious screaming following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious has skin lesions that are tender on right thigh following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. Other relevant tests included No lab data was reported. Final diagnosis was has skin lesions that are tender on right thigh, screaming, joint pain, fussiness and banging head, swelling, had severe right rash after receiving PENTACEL and fever. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for fever, as Unknown for had severe right rash after receiving PENTACEL, as Unknown for swelling, as Unknown for fussiness and banging head, as Unknown for joint pain, as Unknown for screaming and as Unknown for has skin lesions that are tender on right thigh. List of documents held by the sender: None.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Rash, Screaming, Skin lesion, Swelling
Clinical narrative: Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a non-health professional. This case involves a 13 months old male patient who experienced fever, had severe right rash after receiving PENTACEL, swelling, fussiness and banging head, joint pain, screaming and has skin lesions that are tender on right thigh, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Jul-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE (lot number: C5437AA) (expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious fever following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious had severe right rash after receiving PENTACEL following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious swelling following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious fussiness, banging head following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious joint pain following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious screaming following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. On an unknown date, the patient developed a non-serious has skin lesions that are tender on right thigh following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. Other relevant tests included No lab data was reported. Final diagnosis was has skin lesions that are tender on right thigh, screaming, joint pain, fussiness and banging head, swelling, had severe right rash after receiving PENTACEL and fever. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for fever, as Unknown for had severe right rash after receiving PENTACEL, as Unknown for swelling, as Unknown for fussiness and banging head, as Unknown for joint pain, as Unknown for screaming and as Unknown for has skin lesions that are tender on right thigh. List of documents held by the sender: None.
Age: 1.58
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 months old patient who experienced received an expired dose, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 18-Jul-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5390AA (expiry date: 17-Jul-2018) via intramuscular route in the right thigh. It was a case of actual medication error due to expired vaccine used. It was unknown if adverse event occurred or not. 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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Fatigue, Haematochezia, Intussusception, Vomiting
Clinical narrative: Intussusception, vomiting, blood in stool, fatigue.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: Vaccine site red, inflamed, hot.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called reported injection site is red and slightly swollen, advised patient to monitor and seek medical attention if continues to worsen or shows signs of infection.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Hypotonia, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Immediatly after giving 4th injection (GARDASIL) client passed out...becoming unresponsive, limp, pale and jerking slightly. Was lowered from sitting position to floor with help of his mother. Became responsive very quickly after being laid down. Cool compress applied to forehead. 1:26 B/P 120/72 and apical pulse 72. Patient states the last thing he remembers was getting the last shot and then waking up on floor. 1:33  104/64  apical pulse 72 and regular, color had returned. 1:40 discharged in care of mother who is a Nurse Practitioner.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Immediatly after giving 4th injection (GARDASIL) client passed out...becoming unresponsive, limp, pale and jerking slightly. Was lowered from sitting position to floor with help of his mother. Became responsive very quickly after being laid down. Cool compress applied to forehead. 1:26 B/P 120/72 and apical pulse 72. Patient states the last thing he remembers was getting the last shot and then waking up on floor. 1:33  104/64  apical pulse 72 and regular, color had returned. 1:40 discharged in care of mother who is a Nurse Practitioner.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Oral mucosal erythema, Screaming, Vomiting
Clinical narrative: Received DTaP in the left thigh, later mom noticed redness and swelling in the same area. No fever. Was screaming nonstop for many hours and mom noticed redness in the mouth. Denies any lip swelling. No breathing problems. No generalized rash or hives. No vomiting today. Vomited 2 times yesterday. No diarrhea. No seizure activity.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: Soreness, redness at injection site and underneath injection site, achy, nausea, headache and fever.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness, redness at injection site and underneath injection site, achy, nausea, headache and fever.
Age: 19.0
Sex: F
Vaccine: HEP, MENB
Symptoms: Malaise, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Within 12hr developed feeling of being "not well", progressed to 24hr of fever and then what patient describes as severe myalgias and neck stiffness. Reporting to VAERS because required doctor visit. Also had Hep B on the same day, but do not suspect symptoms are from Hep B. Hep B GlaxoSmithKlein, intramuscular.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache
Clinical narrative: Dizzy, headache, fatigue, shivering.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Pt reported local rash reaction at injection site on left arm which was red in color, baseball size diameter, tender, and painful. Verified no body aches, no fever, or other symptoms. Symptoms first noticed the morning after getting vaccine. Pt has reported it hasn't gotten better since. RPh counselled to monitor site and use OTC ibuprofen for pain relief as well as local ice pack at site if needed.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient states fever and redness/tenderness at injection site.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient had rash on neck and upper chest after the vaccination that she says "hurts." Its red and elevated. It is still not completely gone July 25, 2018.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Hypersomnia, Injection site erythema, Injection site induration
Clinical narrative: Aches,chills,slept for 18 hours. Very uncomfortable. Shot sight red and about the size of a baseball. Site felt hot, hard and itched for one week. Took ADVIL (2 doses).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth, Pain
Clinical narrative: Aches,chills,slept for 18 hours. Very uncomfortable. Shot sight red and about the size of a baseball. Site felt hot, hard and itched for one week. Took ADVIL (2 doses).
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Epistaxis, Influenza like illness, Influenza virus test negative, Oropharyngeal pain
Clinical narrative: This 55 year old male presents for Reaction to vaccine. Had SHINGRIX last week. Fever 104 that night. Then on weekend felt achy, cough, flu like symptoms,- sore thoat, and bloody nose from coughing so hard. Coughing yesterday. Started on DAYQUIL yesterday. Patient had full work up and workup was negative for cold/flu.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Viral test negative
Clinical narrative: This 55 year old male presents for Reaction to vaccine. Had SHINGRIX last week. Fever 104 that night. Then on weekend felt achy, cough, flu like symptoms,- sore thoat, and bloody nose from coughing so hard. Coughing yesterday. Started on DAYQUIL yesterday. Patient had full work up and workup was negative for cold/flu.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Erythema and edema, significant and requiring urgent care and ER visit.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Patient reported that she started to get vertigo the day after the vaccination. She claims that her symptoms come and go but she is still feeling the effects of the vertigo now, which is weeks later.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Varicella
Clinical narrative: Approximately 2 weeks after vaccination patient reports breaking out in chicken pox. Red bumps on her arm and upper body.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient has a large round red injection site reaction about 7 inches in diameter. It is sore to the touch and hurts.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site reaction, Nausea, Rash erythematous
Clinical narrative: Patient called explaining she experienced nausea, headache, and chills the day after receiving her second SHINGRIX dose. She is now 5 days post immunization and explains from raised, itchy red bumps right below the injection site. Patient went to urgent care, where she was advised to apply topical antihistamine cream and take oral BENADRYL as needed for itching. I further advised her to apply cold compress and take ibuprofen as needed for comfort. Patient is aware vaccine is not live, and patient is not worried reaction is due to herpes zoster virus itself.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient called explaining she experienced nausea, headache, and chills the day after receiving her second SHINGRIX dose. She is now 5 days post immunization and explains from raised, itchy red bumps right below the injection site. Patient went to urgent care, where she was advised to apply topical antihistamine cream and take oral BENADRYL as needed for itching. I further advised her to apply cold compress and take ibuprofen as needed for comfort. Patient is aware vaccine is not live, and patient is not worried reaction is due to herpes zoster virus itself.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness, Neck pain, Pain
Clinical narrative: Patient has pain that is intermittent of the LEFT arm with radiation proximally to shoulder/neck and distally down the arm, forearm and to the thumb. He reports this is slowly getting better but did come in to get it checked since it has persisted for 2 weeks. Patient did do weight bearing exercise the day he received the SHINGRIX vaccine (6/28/18). His description of the numbness is more like a sensation of weakness in the arm when the tenderness occurs. This weakness and pain is described as following a dermatomal distribution. This is also intermittent.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient has pain that is intermittent of the LEFT arm with radiation proximally to shoulder/neck and distally down the arm, forearm and to the thumb. He reports this is slowly getting better but did come in to get it checked since it has persisted for 2 weeks. Patient did do weight bearing exercise the day he received the SHINGRIX vaccine (6/28/18). His description of the numbness is more like a sensation of weakness in the arm when the tenderness occurs. This weakness and pain is described as following a dermatomal distribution. This is also intermittent.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site reaction, Varicella post vaccine
Clinical narrative: One day after Varicella placement, client developed 3-4 chicken pox at injection site. By day 4, client had chicken pox covering multiple body surfaces. On 6/19/18, 3 months later, client develops shingles in the same leg that Varicella was placed. Treated by dermatology with anti-virals. Referred to Infectious Disease.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: Severe muscle pain and weakness, could hardly walk; severe chills; fever; tiredness; swelling and pain at injection site; stomach pain & nausea; headache; rash at injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Muscular weakness, Myalgia
Clinical narrative: Severe muscle pain and weakness, could hardly walk; severe chills; fever; tiredness; swelling and pain at injection site; stomach pain & nausea; headache; rash at injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Severe muscle pain and weakness, could hardly walk; severe chills; fever; tiredness; swelling and pain at injection site; stomach pain & nausea; headache; rash at injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Severe muscle pain and weakness, could hardly walk; severe chills; fever; tiredness; swelling and pain at injection site; stomach pain & nausea; headache; rash at injection site.
Age: 33.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 7x6 cm right upper arm; 3.5x2.5 cm left upper arm pink/red raised area at injection sites hot & tender to the touch VS T 99; P 88 R 20; BP 110/60.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacy intern concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 09-JUL-2018 the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 Lot R005344 with expiration date of 01-MAR-2020, (dose, route of administration and anatomical location were not reported) for prophylaxis which were stored in the range of 47 Fahrenheit degrees to 77 Fahrenheit degrees for 72 hours. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. The reporter inquired if the patient needed to be revaccinated.
Age: 32.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Headache, Injection site pain, Night sweats, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 32-year-old male patient who received BOOSTRIX (batch number X9YP3, expiry date October 2020) for prophylaxis. On 13th July 2018, the patient received BOOSTRIX. On 13th July 2018, less than a day after receiving BOOSTRIX, the patient experienced fever, night sweat, injection site pain, general body pain and headache. In July 2018, the patient experienced swelling. On an unknown date, the outcome of the fever, swelling, night sweat, injection site pain, general body pain and headache were unchanged. The reporter considered the fever, swelling, night sweat, injection site pain, general body pain and headache to be related to BOOSTRIX. Additional details were provided as follows: The report stated that the patient contacted her one day before the day of reporting to report the side effects. The patient received SHINGRIX on right deltoid. In July 2018, less than a week after receiving BOOSTRIX the patient experienced swelling. The patient explained that he had a fever of 102 degrees F since the past three days from the date of reporting. The pain and soreness experienced was at the injection site. The reporter had patients waiting for her to see, so the call was ended.
Age: 32.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 32-year-old male patient who received BOOSTRIX (batch number X9YP3, expiry date October 2020) for prophylaxis. On 13th July 2018, the patient received BOOSTRIX. On 13th July 2018, less than a day after receiving BOOSTRIX, the patient experienced fever, night sweat, injection site pain, general body pain and headache. In July 2018, the patient experienced swelling. On an unknown date, the outcome of the fever, swelling, night sweat, injection site pain, general body pain and headache were unchanged. The reporter considered the fever, swelling, night sweat, injection site pain, general body pain and headache to be related to BOOSTRIX. Additional details were provided as follows: The report stated that the patient contacted her one day before the day of reporting to report the side effects. The patient received SHINGRIX on right deltoid. In July 2018, less than a week after receiving BOOSTRIX the patient experienced swelling. The patient explained that he had a fever of 102 degrees F since the past three days from the date of reporting. The pain and soreness experienced was at the injection site. The reporter had patients waiting for her to see, so the call was ended.