chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Pyrexia, Rash, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 63-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For tolerance to the 1st dose received on 28th February 2018, refer case US2018GSK111463). On 11th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash, injection site pain, stomach pain, headache, chills and injection site warmth. The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site rash and injection site warmth were not recovered/not resolved and the outcome of the injection site pain, stomach pain, headache and chills were recovered/resolved. The reporter considered the injection site rash, injection site pain, stomach pain, headache and chills to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The next day, the patient experienced pain at the injection site, rash at the injection site, headache, chills and stomach pain. The reporter stated that, the rash was the size of the palm of the patient's hand and it was warm to the touch. The patient took Advil for the pain on the day before reporting. The reporter stated that the rash after the second dose was much larger than the rash the patient experienced after the first dose.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site pain, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 63-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For tolerance to the 1st dose received on 28th February 2018, refer case US2018GSK111463). On 11th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash, injection site pain, stomach pain, headache, chills and injection site warmth. The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site rash and injection site warmth were not recovered/not resolved and the outcome of the injection site pain, stomach pain, headache and chills were recovered/resolved. The reporter considered the injection site rash, injection site pain, stomach pain, headache and chills to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The next day, the patient experienced pain at the injection site, rash at the injection site, headache, chills and stomach pain. The reporter stated that, the rash was the size of the palm of the patient's hand and it was warm to the touch. The patient took Advil for the pain on the day before reporting. The reporter stated that the rash after the second dose was much larger than the rash the patient experienced after the first dose.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Similar reaction on previous exposure to drug
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 63-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For tolerance to the 1st dose received on 28th February 2018, refer case US2018GSK111463). On 11th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash, injection site pain, stomach pain, headache, chills and injection site warmth. The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site rash and injection site warmth were not recovered/not resolved and the outcome of the injection site pain, stomach pain, headache and chills were recovered/resolved. The reporter considered the injection site rash, injection site pain, stomach pain, headache and chills to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The next day, the patient experienced pain at the injection site, rash at the injection site, headache, chills and stomach pain. The reporter stated that, the rash was the size of the palm of the patient's hand and it was warm to the touch. The patient took Advil for the pain on the day before reporting. The reporter stated that the rash after the second dose was much larger than the rash the patient experienced after the first dose.
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized urticaria in a 86-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. Concomitant products included COREG, LIPITOR, NORVASC and ELIQUIS. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced generalized urticaria (serious criteria disability). On an unknown date, the outcome of the generalized urticaria was not recovered/not resolved. The reporter considered the generalized urticaria to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The reporter stated that the patient experienced hives all over his body.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site induration, Injection site mass, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. Her concurrent conditions included drug reaction/allergies to macrolides and ketolides. Her concomitant therapies included LAMICTAL. There were no pertinent medical history. On 29-MAY-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, with a lot # R000579, expiration date of 09-SEP-2019, intramuscularly (dose, dose number and vaccination site were not provided), for routine vaccination. On 30-MAY-2018, the patient called the pharmacy complaining of erythema, fever, and a lump at the injection site. Nevertheless, no treatment was provided and no lab diagnostics/studies were performed. Approximately in 2018, the pyrexia and injection site erythema had resolved, but the lump at the injection site still remained and was about the size of a golf ball. The reporter did not provide a causality assessment between PNEUMOVAX 23 and the events.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. Her concurrent conditions included drug reaction/allergies to macrolides and ketolides. Her concomitant therapies included LAMICTAL. There were no pertinent medical history. On 29-MAY-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, with a lot # R000579, expiration date of 09-SEP-2019, intramuscularly (dose, dose number and vaccination site were not provided), for routine vaccination. On 30-MAY-2018, the patient called the pharmacy complaining of erythema, fever, and a lump at the injection site. Nevertheless, no treatment was provided and no lab diagnostics/studies were performed. Approximately in 2018, the pyrexia and injection site erythema had resolved, but the lump at the injection site still remained and was about the size of a golf ball. The reporter did not provide a causality assessment between PNEUMOVAX 23 and the events.
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Electrocardiogram abnormal, Influenza like illness, Laboratory test normal, Loss of consciousness, Malaise
Clinical narrative: This is a spontaneous report from a contactable nurse. This report was received via a Pfizer sales representative. A male patient of an unspecified age received TRUMENBA, (lot number and expiration date were unknown), via an unspecified route of administration on 13Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The meningococcal group B rlp2086 vaccine was given on 13Jun2018. Patient felt fine afterwards. Later that evening of 13Jun2018, around 0830-0900 felt like had a fever with flu like symptoms which progressively got worse throughout that evening. The next morning on 14Jun2018, have body aches as well. Around 1100 AM up to the bathroom and was standing at sink. Next thing knew he woke up on the floor. The patient did not remember falling on the bathroom floor. The patient went back to bed X11 hr and then ate a little food. He called family and ended up being taken to ER around 0130 PM to get checked out from passing out in the bathroom. The outcome of the events was unknown. The information on the lot number and expiration date had been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Neurological examination normal, Pain, Pyrexia, Syncope, Tachycardia
Clinical narrative: This is a spontaneous report from a contactable nurse. This report was received via a Pfizer sales representative. A male patient of an unspecified age received TRUMENBA, (lot number and expiration date were unknown), via an unspecified route of administration on 13Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The meningococcal group B rlp2086 vaccine was given on 13Jun2018. Patient felt fine afterwards. Later that evening of 13Jun2018, around 0830-0900 felt like had a fever with flu like symptoms which progressively got worse throughout that evening. The next morning on 14Jun2018, have body aches as well. Around 1100 AM up to the bathroom and was standing at sink. Next thing knew he woke up on the floor. The patient did not remember falling on the bathroom floor. The patient went back to bed X11 hr and then ate a little food. He called family and ended up being taken to ER around 0130 PM to get checked out from passing out in the bathroom. The outcome of the events was unknown. The information on the lot number and expiration date had been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Fall, Influenza like illness, Loss of consciousness, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. This report was received via a Pfizer sales representative. A male patient of an unspecified age received TRUMENBA, (lot number and expiration date were unknown), via an unspecified route of administration on 13Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The meningococcal group B rlp2086 vaccine was given on 13Jun2018. Patient felt fine afterwards. Later that evening of 13Jun2018, around 0830-0900 felt like had a fever with flu like symptoms which progressively got worse throughout that evening. The next morning on 14Jun2018, have body aches as well. Around 1100 AM up to the bathroom and was standing at sink. Next thing knew he woke up on the floor. The patient did not remember falling on the bathroom floor. The patient went back to bed X11 hr and then ate a little food. He called family and ended up being taken to ER around 0130 PM to get checked out from passing out in the bathroom. The outcome of the events was unknown. The information on the lot number and expiration date had been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Cerebrovascular accident, Chills, Headache, Malaise
Clinical narrative: I suffered a stroke on June 1st - less than 48 hrs. after this injection. I am a healthy person with no prior risks for stroke - never smoked, no diabetes, no family history, low blood pressure, acceptable cholesterol levels. While I have physically recovered, in that I demonstrate no residual deficits - my right arm was affected - I am suffering from anxiety and fear that this will happen again. It was so unexpected and out of the blue and seemingly, coincidental with the timing of the shot. The morning after I had the headache and chills that could perhaps be expected, but then shortly thereafter this much more serious event. So, as for the question have I recovered - no, not emotionally.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram, Anxiety, Cerebrovascular accident, Chills, Computerised tomogram
Clinical narrative: I suffered a stroke on June 1st - less than 48 hrs. after this injection. I am a healthy person with no prior risks for stroke - never smoked, no diabetes, no family history, low blood pressure, acceptable cholesterol levels. While I have physically recovered, in that I demonstrate no residual deficits - my right arm was affected - I am suffering from anxiety and fear that this will happen again. It was so unexpected and out of the blue and seemingly, coincidental with the timing of the shot. The morning after I had the headache and chills that could perhaps be expected, but then shortly thereafter this much more serious event. So, as for the question have I recovered - no, not emotionally.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Echocardiogram, Electrocardiogram, Fear, Headache, Nuclear magnetic resonance imaging
Clinical narrative: I suffered a stroke on June 1st - less than 48 hrs. after this injection. I am a healthy person with no prior risks for stroke - never smoked, no diabetes, no family history, low blood pressure, acceptable cholesterol levels. While I have physically recovered, in that I demonstrate no residual deficits - my right arm was affected - I am suffering from anxiety and fear that this will happen again. It was so unexpected and out of the blue and seemingly, coincidental with the timing of the shot. The morning after I had the headache and chills that could perhaps be expected, but then shortly thereafter this much more serious event. So, as for the question have I recovered - no, not emotionally.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Headache, Lethargy
Clinical narrative: Terrible headache, chills, excessive shivering, thigh/leg pain, nausea, no appetite, lethargic, brief diarrhea. This is day 4 and I am stil sick.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain in extremity
Clinical narrative: Terrible headache, chills, excessive shivering, thigh/leg pain, nausea, no appetite, lethargic, brief diarrhea. This is day 4 and I am stil sick.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash generalised, Rash vesicular
Clinical narrative: Daughter received chickenpox vaccine on the 15 of June this year. On Saturday June 23, she developed a fever, with a rash on her face. Sunday June 24, the rash began to spread over her body, with what looks like the beginning of chickenpox. Fever has continued, and rash is spreading. She went to her pediatrician June 25, and the doctor also believes it can be a section the vacation.
Age: 0.33
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4-month-old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with PROQUAD injection, lot # N022973 with expiration date on 19-FEB-2019 (dose and route of administration) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager, refers to an unspecified number of patient whose age and gender were unknown. The patients' pertinent medical history and drug reactions or allergies, if any, were not provided. Concomitant therapies included sterile diluent. The office manager reported that, on unspecified dates, the unspecified patients were inadvertently vaccinated with unspecified doses of VARIVAX (lot number N021317, expiration date 07-AUG-2019); and, PROQUAD (lot number N020012, expiration date 03-JAN-2019) that had been improperly stored (product storage error) on unspecified dates, for prophylaxis (dose numbers, route and anatomical locations of administration were not provided). The doses of both VARIVAX; and, PROQUAD were exposed to a temperature excursion of 5.5 degrees Fahrenheit (°F) for a time frame of 30 minutes, which was detected by the Digital Data Logger. There was not a previous temperature excursion. In addition, the office manager stated that all lots of VARIVAX and PROQUAD were reconstituted with properly stored sterile diluent (lot number and expiration date were unknown by reporter). No adverse effects or product quality complaints were reported. Further information was not provided. This case has been considered to be non-valid, since patients' identifiers were not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a healthcare administrator referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. Concomitant therapies included sterile diluent. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of VARIVAX lot # N031001 with expiration date: 03-NV-2019 (strength, dose, route and anatomical location were not provided) for prophylaxis. The temperature excursion occurred between 6° F and 14° F (5.8° F) with a time frame of 8 hours. The call was given by a data logger and there were no previous temperature excursions reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 19 year old male patient. In January 2018, the patient was vaccinated with a first dose of GARDASIL 9 for prophylaxis. On 13-JUN-2018, the patient was vaccinated with a second dose of GARDASIL 9 lot # N023828, expiration date 25-JUN-2020. No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, PNC, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from an Administrator/Office Manager refers to a 1 year old patient. The patient's concurrent conditions and medical history were not reported. On 12-JUN-2018, the patient was vaccinated with a dose of PROQUAD (strength, dose and route of administration were unknown) with lot # N020620 and expiration date of 22-JAN-2019 and with VARIVAX (strength, dose and route of administration were unknown) with lot number N030571 and expiration date of 31-OCT-2019; both for prophylaxis. Concomitant therapies included sterile diluent (MRK) and PREVNAR. The patient was supposed to received M-M-R II (strength, dose, lot number, expiration date and route of administration were unknown) instead of measles, mumps, rubella and PROQUAD. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-MAY-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, strength, route, anatomical location, lot # and expiration date were not reported). On 13-JUN-2018, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, strength, route, anatomical location, lot # and expiration date were not reported). There were no known adverse effects.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated one dose of an improperly stored one dose of PROQUAD (concentration, vaccination site and dose number were not provided) with lot # N021724, expiration date 06-FEB-2019, for prophylaxis, diluted with properly stored sterile diluent. The vaccine was exposed to a temperature excursion of -14 degrees Celsius (degree C) to -10 degree C during a time frame of 90 minutes which was detected by the data logger. There was no prior temperature excursion. No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-JUN-2018, the patient was vaccinated with an expired dose of M-M-R II, lot # M025185 and expiration date on 18-MAY-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). It was reported that the vaccine was appropriately stored and there was no adverse effect reported.
Sex: F
Vaccine: HPVX
Symptoms: Cervical dysplasia, Vaccination failure
Clinical narrative: This spontaneous report was received from a physician and refers to an approximately 22 year old female patient (4-5 years older than her 17 year old sister). The patient's concurrent conditions included an immunocompromising condition of idiopathic autoimmune hearing loss, which is being treated with methotrexate. On unknowns dates, the patient was vaccinated with the three doses of  GARDASIL 9 or with GARDASIL (unidentified Merck hpv vaccine administered) since the reporter did not know which for prophylaxis (frequency, route, lot number and expiration date were not reported). On an unknown date, the patient developed cervical dysplasia with one of the Human Papillomavirus (HPV) serotypes that the HPV vaccination series protects against (vaccination failure). The outcome of cervical dysplasia and vaccination failure and the causal relationship between the aforementioned events and both vaccines were not reported.
Sex: M
Vaccine: HPV9
Symptoms: Condition aggravated, Fluid retention, Nephrotic syndrome, Rash
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 24 years old male patient. The patient's medical history included nephrotic syndrome, unspecified dates onset when he was a child. The patient had no concomitant medication or drug reactions/allergies. Information about concurrent condition was unknown. On 31-MAY-2018 the patient was vaccinated with the first dose of GARDASIL 9 (lot # N000326, Expiration Date: 14-OCT-2019, 0.5 ml, intramuscular) for HPV prevention. On 31-MAY-2018, three hours after the vaccination of GARDASIL 9, the patient experienced rash on both arms. On the same date, the patient took BENADRYL, and the rash went away (unknown date in 2018). On approximately 02-JUN-2018 (reported as two to three days after vaccination), the patient experienced nephrotic syndrome with symptoms of accumulating fluid (unknown where in the body the fluid was accumulated). The patient had seen by the physician. The patient received treatment for the events and no lab diagnostics/studies was performed. This was the first time the patient exhibited symptoms of nephrotic syndrome since he had it as a child. The outcome of nephrotic syndrome was unknown. The outcome of rash was reported as recovered. The causality between GARDASIL 9 with all the events was unknown. Upon internal review, the event of nephrotic syndrome was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 21-MAR-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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: F
Vaccine: VARZOS
Symptoms: Blister, 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 06-OCT-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also known as shingles and other complications. In 2016, the patient was treated at a medical center, for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-SEP-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 13-NOV-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed gabapentin and valacyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-AUG-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 13-OCT-2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 18-APR-2018, the patient received an improperly stored dose of VAQTA 50/1.0 U/mL, lot# N020503 and 04-SEP-2018 expiration date for prophylaxis (frequency and route of administration were not reported). The temperature excursion was reported as 47.6 °F for a time frame of 7 hours. Previous temperature excursion was reported as 47.6 °F for a time frame of 6 hours. No symptoms were reported. Data logger was reported. No product quality complain was reported.
Sex: F
Vaccine: HPV9, MENB, HPV4, MENB
Symptoms: Acute disseminated encephalomyelitis, Balance disorder, Computerised tomogram, Hemiparesis, Lumbar puncture
Clinical narrative: This initial spontaneous report was received from the father of a 17 year old female patient. Pertinent medical history and drug reactions/allergies were unknown by the reporter. No information was provided regarding concomitant medications. On 21-FEB-2018, the patient received GARDASIL 9 for "routine vaccination" (dose and route unknown; lot # M035486; expiration date 05-JUN-2019). That same day, she also received BEXSERO (route and dose unknown; lot # 166801; expiration date unknown). On 24-FEB-2018 (reported as three days later), the patient felt sick, the left side of her body felt weak, and she had loss of motion and balance. On an unspecified date, the patient was taken back to see her physician, who sent the patient home, thinking she had low iron. The patient did not improve after three more days, so she was taken back to see the physician, who then sent the patient to the hospital. The patient underwent computed tomography (CT) scans, magnetic resonance imaging (MRI), a spinal tap twice, and was given high doses of steroids. The patient was hospitalized for six days (dates not specified). The father reported that the diagnosis was either multiple sclerosis or acute disseminated encephalomyelitis (ADEM). The patient was "100% recovered" at the time of the report. The father did not rate causality. He was requesting compensation for his daughter's hospital and neurologist's bill. Upon internal review, multiple sclerosis and acute disseminated encephalomyelitis were considered medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9, MENB, HPV4, MENB
Symptoms: Malaise, Mobility decreased, Multiple sclerosis, Nuclear magnetic resonance imaging
Clinical narrative: This initial spontaneous report was received from the father of a 17 year old female patient. Pertinent medical history and drug reactions/allergies were unknown by the reporter. No information was provided regarding concomitant medications. On 21-FEB-2018, the patient received GARDASIL 9 for "routine vaccination" (dose and route unknown; lot # M035486; expiration date 05-JUN-2019). That same day, she also received BEXSERO (route and dose unknown; lot # 166801; expiration date unknown). On 24-FEB-2018 (reported as three days later), the patient felt sick, the left side of her body felt weak, and she had loss of motion and balance. On an unspecified date, the patient was taken back to see her physician, who sent the patient home, thinking she had low iron. The patient did not improve after three more days, so she was taken back to see the physician, who then sent the patient to the hospital. The patient underwent computed tomography (CT) scans, magnetic resonance imaging (MRI), a spinal tap twice, and was given high doses of steroids. The patient was hospitalized for six days (dates not specified). The father reported that the diagnosis was either multiple sclerosis or acute disseminated encephalomyelitis (ADEM). The patient was "100% recovered" at the time of the report. The father did not rate causality. He was requesting compensation for his daughter's hospital and neurologist's bill. Upon internal review, multiple sclerosis and acute disseminated encephalomyelitis were considered medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9, MENB, HPV4, MENB
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Balance disorder, Computerised tomogram, Discomfort
Clinical narrative: This initial spontaneous report was received from the father of a 17 year old female patient. Pertinent medical history and drug reactions/allergies were unknown by the reporter. No information was provided regarding concomitant medications. On 21-FEB-2018, the patient received GARDASIL 9 for "routine vaccination" (dose and route unknown; lot # M035486; expiration date 05-JUN-2019). That same day, she also received BEXSERO (route and dose unknown; lot # 166801; expiration date unknown). On 24-FEB-2018 (reported as three days later), the patient felt sick, the left side of her body felt weak, and she had loss of motion and balance. On an unspecified date, the patient was taken back to see her physician, who sent the patient home, thinking she had low iron. The patient did not improve after three more days, so she was taken back to see the physician, who then sent the patient to the hospital. The patient underwent computed tomography (CT) scans, magnetic resonance imaging (MRI), a spinal tap twice, and was given high doses of steroids. The patient was hospitalized for six days (dates not specified). The father reported that the diagnosis was either multiple sclerosis or acute disseminated encephalomyelitis (ADEM). The patient was "100% recovered" at the time of the report. The father did not rate causality. He was requesting compensation for his daughter's hospital and neurologist's bill. Upon internal review, multiple sclerosis and acute disseminated encephalomyelitis were considered medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9, MENB, HPV4, MENB
Symptoms: Full blood count, Gait disturbance, Joint range of motion decreased, Lumbar puncture, Multiple sclerosis
Clinical narrative: This initial spontaneous report was received from the father of a 17 year old female patient. Pertinent medical history and drug reactions/allergies were unknown by the reporter. No information was provided regarding concomitant medications. On 21-FEB-2018, the patient received GARDASIL 9 for "routine vaccination" (dose and route unknown; lot # M035486; expiration date 05-JUN-2019). That same day, she also received BEXSERO (route and dose unknown; lot # 166801; expiration date unknown). On 24-FEB-2018 (reported as three days later), the patient felt sick, the left side of her body felt weak, and she had loss of motion and balance. On an unspecified date, the patient was taken back to see her physician, who sent the patient home, thinking she had low iron. The patient did not improve after three more days, so she was taken back to see the physician, who then sent the patient to the hospital. The patient underwent computed tomography (CT) scans, magnetic resonance imaging (MRI), a spinal tap twice, and was given high doses of steroids. The patient was hospitalized for six days (dates not specified). The father reported that the diagnosis was either multiple sclerosis or acute disseminated encephalomyelitis (ADEM). The patient was "100% recovered" at the time of the report. The father did not rate causality. He was requesting compensation for his daughter's hospital and neurologist's bill. Upon internal review, multiple sclerosis and acute disseminated encephalomyelitis were considered medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9, MENB, HPV4, MENB
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: This initial spontaneous report was received from the father of a 17 year old female patient. Pertinent medical history and drug reactions/allergies were unknown by the reporter. No information was provided regarding concomitant medications. On 21-FEB-2018, the patient received GARDASIL 9 for "routine vaccination" (dose and route unknown; lot # M035486; expiration date 05-JUN-2019). That same day, she also received BEXSERO (route and dose unknown; lot # 166801; expiration date unknown). On 24-FEB-2018 (reported as three days later), the patient felt sick, the left side of her body felt weak, and she had loss of motion and balance. On an unspecified date, the patient was taken back to see her physician, who sent the patient home, thinking she had low iron. The patient did not improve after three more days, so she was taken back to see the physician, who then sent the patient to the hospital. The patient underwent computed tomography (CT) scans, magnetic resonance imaging (MRI), a spinal tap twice, and was given high doses of steroids. The patient was hospitalized for six days (dates not specified). The father reported that the diagnosis was either multiple sclerosis or acute disseminated encephalomyelitis (ADEM). The patient was "100% recovered" at the time of the report. The father did not rate causality. He was requesting compensation for his daughter's hospital and neurologist's bill. Upon internal review, multiple sclerosis and acute disseminated encephalomyelitis were considered medically significant. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a adult patient of unknown age and gender. The patient concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient "inadvertently" received a pediatric dose of VAQTA (unknown lot and expiration date). No adverse effects were reported.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 17 year old patient. The patien's relevant medical history, concurrent conditions and concomitant medications were unknown. On 10-APR-2018, the patient was vaccinated with a dose of Oka-Merck PROQUAD for prophylaxis, lot # M044021, and expiration date 01-MAY-2018 (dose, strength, frequency, and route of administration were unknown). On 10-APR-2018, the patient received a second dose of  Oka-Merck PROQUAD for prophylaxis, lot # M044021, and expiration date 01-MAY-2018 (dose, strength, frequency, and route of administration were unknown). The Oka-Merck PROQUAD was administered to a patient of inappropriate age at the time of vaccine administration. No further adverse events were reported.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unspecified date in April 2016, at age 11 years old, the patient was vaccinated with first dose of GARDASIL injection, lot number K016966 with expiration date on 10-MAY-2017 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. On 22-JUN-2018, the patient was vaccinated with first dose of GARDASIL 9 injection, lot number N025428 with expiration date on 19-JUN-2020 (strength, dose, route of administration and anatomical location were not reported) as the second dose of Human papillomavirus (HPV) vaccine, for prophylaxis. No adverse effect were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 13-month-old patient of unknown gender. The patient concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient inadvertently administered together with PROQUAD lot # N029879 for prophylaxis and VARIVAX lot # M033907. No adverse effects reported. No product quality compliant (PQC) was reported.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 16-year-old female patient who received BEXSERO (batch number 166901A, expiry date 30th November 2018) for prophylaxis. Co-suspect products included MENVEO (batch number M17038, expiry date 31st March 2019) for prophylaxis. On 13th June 2018, the patient received BEXSERO (intramuscular) .5 ml and MENVEO (intramuscular) .5 ml. On 13th June 2018, less than a day after receiving BEXSERO and MENVEO, the patient experienced fever, headache, nausea and pain. On an unknown date, the outcome of the fever, headache, nausea and pain were not recovered/not resolved.  The reporter considered the fever, headache, nausea and pain to be related to BEXSERO and MENVEO. Additional details were provided as follows: The patient received MENVEO and BEXSERO in the reporting physician's office, a day before the reporting date. The patient complained about achiness, mild fever, headache and nausea. This case has been linked to case US2018107283, reported by the same reporter.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Insomnia, Pain, Restlessness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of flu like symptoms in a 58-year-old male patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. Concurrent medical conditions included spine issues. On 14th June 2018 15:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th June 2018, several hours after receiving SHINGRIX, the patient experienced flu like symptoms, exhaustion, sleeplessness, general body pain and restless. On an unknown date, the outcome of the flu like symptoms, exhaustion, sleeplessness, general body pain and restless were not recovered/not resolved. It was unknown if the reporter considered the flu like symptoms, exhaustion, sleeplessness, general body pain and restless to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that she gave a SHINGRIX shot yesterday afternoon. The patient called back this morning reporting last evening he experienced flu like symptoms with body aches, unable to sleep, restless and exhausted. The reporter reviewed the prescribing information and saw similar events reported. The reviewed duration of time of solicited local and general events and grade 3 events worse with dose 2. The referred her to have patient report to physician and for medical treatment if required.