chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia
Clinical narrative: PHN; residual nerve damage; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications.  On 22-SEP-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided) On an unknown date in 2009, reported as less than one month after receiving zoster vaccine live (ZOSTAVAX), the patient suffered debilitating injuries including painful and debilitating outbreaks of shingles as well as postherpetic neuralgia (PHN), significant throbbing pain, itching and residual nerve damage, which continued at the reporting time and have required medical treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events of herpes zoster, postherpetic neuralgia (PHN) and residual nerve damage was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of herpes zoster, postherpetic neuralgia (PHN) and residual nerve damage were considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: PHN; residual nerve damage; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications.  On 22-SEP-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided) On an unknown date in 2009, reported as less than one month after receiving zoster vaccine live (ZOSTAVAX), the patient suffered debilitating injuries including painful and debilitating outbreaks of shingles as well as postherpetic neuralgia (PHN), significant throbbing pain, itching and residual nerve damage, which continued at the reporting time and have required medical treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events of herpes zoster, postherpetic neuralgia (PHN) and residual nerve damage was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of herpes zoster, postherpetic neuralgia (PHN) and residual nerve damage were considered to be disabling.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Pneumonia, Pyrexia
Clinical narrative: pneumonia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 65-year-old female patient. Medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 13-NOV-2016, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot # and expiration date were not provided) by a pharmacist.  On unknown dates, the patient suffered the following injuries as a result of zoster vaccine live (ZOSTAVAX): suffered shortness of breath, fever, chest pain and on 13-DEC-2016, the patient was diagnosed with pneumonia. The patient claimed damages as a result of: injury to themselves. The outcome of the event was not provided. The lawyer felt the event was related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of pneumonia was considered to be medically significant.
Age: 19.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; an expired dose of properly stored VARN AX was inadvertently administered to a Patient; This spontaneous report was received from a nurse concerning a 19-year-old patient of unknown gender.   The patient's concurrent conditions and medical history were not reported.  The Nurse stated that on 28-JAN-2020, an expired dose of properly storedvirus vaccine live (oka/merck) (VARIVAX) (lot # R002056 and expiration date 22-JAN-2020) was inadvertently administered (dose and route were not reported) to the patient for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # and expiration date were unknown by the reporter). No additional adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cerebrovascular accident, Herpes zoster
Clinical narrative: shingles; debilitating stroke; This spontaneous report was received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.   On 06-AUG-2010 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength, batch/lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).         In approximately October 2010, reported as approximately two months after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a debilitating stroke and eventually experienced outbreaks of shingles, all caused by the zoster vaccine live (ZOSTAVAX). As a direct and proximate result of Merck's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and caused by the zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Merck's wrongful conduct. the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Aa direct and proximate result of Defendants' conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of debilitating stroke and shingles was not resolved. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).  The reporter considered the debilitating stroke and shingles to be serious due to disability.  Upon internal review, the event stroke was determined to be medically significant.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain, Vocal cord paralysis
Clinical narrative: vocal cord paralysis; second outbreak of shingles; outbreak of painful shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 25-MAY-2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately August 2016 (reported as approximately two and one-half months after vaccination), the patient suffered debilitating injuries including an outbreak of painful shingles. Patient subsequently experienced a second outbreak of shingles and vocal cord paralysis (dates unknown) which had required extensive medical treatment and would require surgery. These injuries were caused by the zoster vaccine live(ZOSTAVAX) vaccine.  As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical injuries and limitations not present prior to using the product. Patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX). Patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of events was not recovered. The lawyer considered the events to be related to zoster vaccine live(ZOSTAVAX).   Upon internal review, two times outbreak of shingles and vocal cord paralysis were determined to be disable.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Postherpetic Neuralgia; shingles; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On 13-DEC-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 07-FEB-2012 (reported as eight weeks after vaccination), the patient suffered debilitating and painful injuries including shingles and postherpetic neuralgia(PHN), which was first diagnosed five (5) months after the zoster vaccine live (ZOSTAVAX). These injuries were caused by zoster vaccine live (ZOSTAVAX) and the injuries and problems associated therewith continue today. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical injuries and limitations not present prior to using the vaccine and caused by the zoster vaccine live (ZOSTAVAX). As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The lawyer considered the events shingles and PHN to be disability.
Sex: F
Vaccine: FLUX, HPV9, MNQ
Symptoms: Crying
Clinical narrative: The patient experienced excessive crying; This spontaneous report was received from a physician concerning a 15-year-old female patient. Information regarding the patient's pertinent medical history, concomitant medications or previous drug reactions/allergies was unknown by reporter.  On an unknown date in January 2020 reported as, (last week), the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dosage schedule, anatomical location, route of administration, lot number and expiration date were unknown by reporter), unspecified flu vaccine as vaccination (dosage schedule, anatomical location, route of administration, lot number and expiration date were not reported) and meningococcal ACYW conj vaccine (CRM197) (MENVEO) as vaccination (dosage schedule, anatomical location, route of administration, lot number and expiration date were not reported). Subsequently, the patient experienced excessive crying. In addition, the patient did not sought medical attention and it was unknown by reporter if any laboratory diagnostics or studies were performed.  The outcome of crying and the causal relationship between the event and all the aforementioned suspect therapies were not reported.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: chest tightness; shortness of breath; This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix .5 ml. In October 2019, 24 hrs after receiving Shingrix, the patient experienced chest tightness and shortness of breath. On an unknown date, the outcome of the chest tightness and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the chest tightness and shortness of breath to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 24 hours after developed chest tightness and shortness of breath.  These symptoms lasted for 24 hours before going away.  The patient had to sleep sitting up with four pillows because of the breathing problems that she was experiencing.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In December 2019, between 2 and 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The patient received their first Shingrix in September and was diagnosed with Shingles in December. The patient did not receive the vaccine at the reporting pharmacy. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient was sick for 4 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness at injected arm, shoulder, arm and hand; This case was reported by a pharmacist via call center representative and described the occurrence of limbs stiffness in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number F49L5, expiry date 1st December 2021) for prophylaxis.   On 12th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced limbs stiffness. On an unknown date, the outcome of the limbs stiffness was not recovered/not resolved.   It was unknown if the reporter considered the limbs stiffness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. After receiving Shingrix, the patient experienced stiffness at the injected arm, it started on the shoulder and went down the arm and hand.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: large red "circle" at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 5JX9Z, expiry date 5th November 2021) for prophylaxis.   On 20th January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd January 2020, 2 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix on the left deltoid. The patient developed a large red circle at her injection site after vaccination. The reporter consented to follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: some spotting throughout the arm in which he received the injection.; not very red but lighter in appearance; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 227FL, expiry date 26th November 2021) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th October 2019, 21 days after receiving Shingrix, the patient experienced rash and red rash. On an unknown date, the outcome of the rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the rash and red rash to be related to Shingrix.  Additional details were provided as follows: The batch number was updated from 227FX to 227FL, as per sales data sheet. About three weeks after receiving Shingrix, the patient noticed some spotting throughout the arm in which he received the injection.   It was not very red but lighter in appearance. The pharmacist was transferred to medical information for information on this possible side effect and if it had been previously reported by other patients.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash on the back of neck; Itching on her lower right arm; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 12th May 2022) for prophylaxis.   On 23rd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd January 2020, 2 hrs after receiving Shingrix, the patient experienced rash and itchy upper limbs. On an unknown date, the outcome of the rash and itchy upper limbs were unknown.   It was unknown if the reporter considered the rash and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at 11 AM and approximately 2 hours later, the patient reported a rash on the back of her neck and itching on her lower right arm. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling at injection site; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2020, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, less than a week after receiving Shingrix, 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 not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingirx and experienced swelling and pain at the injection site that has improved but has not resolved. The reporter did not consent to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got sick - unspecified; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) for prophylaxis.   On 4th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced sickness (serious criteria hospitalization). On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be unrelated to Shingrix.  Additional details were reported as follows: The patient had history of unknown medical condition. The pharmacist reported that after receiving vaccination, the patient got sick due to an unknown medical condition and was hospitalized. This delayed the 2nd dose of Shingrix. The reporter did not know the symptoms experienced by patient but he knewthat those symptoms were related to her medical condition. The reporter did not have any information about the hospitalization.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, Paralysis
Clinical narrative: Paralysis, GBS, CIDP
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Headache, Influenza virus test, Pain
Clinical narrative: Mom reports that the child developed 103.5F temperature, bodyaches, chills, and a headache the evening of the same date he received the vacicne
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Inflammation, Pain, Pruritus, Skin warm
Clinical narrative: RED, INFLAMED, ITCHING, AND PAINFUL. OSLO WARM TO TOUCH
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count normal, Hypoaesthesia, Metabolic function test normal, Paraesthesia, Urine analysis normal
Clinical narrative: numbness and tingling in stocking and glove pattern, both lower extremities to mid calf and both arms to mid forearm. symptoms started the evening of the vaccination, and were maximal at 48-hours after vaccination. At 96 hours after vaccination, the symptoms were less, only in ulnar aspects of both hands (not in forearm) and feet, not above ankles. No treatment was instituted. CBC, CMP and UA were normal at 48 after vaccination.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Joint noise, Pain, Peripheral swelling, Sleep disorder
Clinical narrative: The actual injection was very painful, more so than any other I've experienced. Within a few hours,  the injection site was extremely sore.  I at first assumed that it may be a similar reaction to how one feels after a flu-shot (tenderness, etc.) but this pain went well beyond tenderness. My arm was swollen, it clicked on the inside when I moved it and I could not raise it over my head without it taking my breath away.  I called/contacted/visited the doctor several times. He administered steroid shots which helped but the pain returned as soon as the shot wore off. It is now constant. It affects everything that I do. It never goes away.  I wake from it.  I dream about it.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 31-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number  S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No aditional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The patient was administered improperly stored VARIVAX; This spontaneous report was received from an Office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 09-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (product storage error) with lot # R034394 and expiry date 27-NOV-2020, 1 dosage form for prophylaxis (strength, route, anatomical location not reported). The patient did not experience any symptoms. Doses of suspect vaccines experienced temperature excursion from 6 Fahrenheit (°F) to 14 Fahrenheit (°F) for 20 minutes. It was reported as no previous temperature excursion was done. Data logger was involved. No product quality complaint was involved in this report.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness, Nausea, Pain
Clinical narrative: bad flu like symptoms; we had the first shot in April; nausea; aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type 2 diabetes mellitus.   On 8th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, pain and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms and incomplete course of vaccination were unknown and the outcome of the nausea and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, nausea and pain to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of shingrix at age of 58 years old and experienced bad flu like symptoms, nausea and pain. Nausea and pain was resolved in 5 days. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The patient wanted to know whether he can receive 2nd dose of vaccine as soon as possible. The case was considered as medication error with adverse drug reaction. This case has been linked with US2020AMR011890 , reported by same reporter. All the information from case US2020AMR011890 will be merged into case US2020AMR011213 and case US2020AMR011890 will be deleted as it was created in error (created separately for medication error).
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Gait disturbance, Pain in extremity
Clinical narrative: extreme confusion/ She had no idea where she was; her legs were painful; she woke up and it took her 13 minutes to walk from the bed to the toilet/ hardly walk; This case was reported by a consumer via call center representative and described the occurrence of confusion in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of somnolence (1st dose received on an unknown date, refer case US2020011308). Concurrent medical conditions included hip discomfort and sulfonamide allergy.   On 14th January 2020, the patient received the 2nd dose of Shingrix. On 15th January 2020, 1 days after receiving Shingrix, the patient experienced confusion, leg pain and walking difficulty. On an unknown date, the outcome of the confusion, leg pain and walking difficulty were recovered/resolved.   It was unknown if the reporter considered the confusion, leg pain and walking difficulty to be related to Shingrix.  Additional details were provided as follows: After the 2nd dose of Shingrix, the patient had extreme confusion. The confusion lasted from about 9 am until noon the next day of the vaccine. The next morning of having the vaccine, patient woke up and it took her 13 minutes to walk from the bed to the toilet.she had no idea where she was. The patient husband said she looked like a zombie. The patient legs were painful and she could hardly walk. The patient did not have this symptom anymore. Consent to follow up was provided.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: skin rash, to collar area, chest; This case was reported by a nurse via call center representative and described the occurrence of rash in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2020, the patient received the 2nd dose of Shingrix. On 20th January 2020, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine on sunday and on monday developed skin rash, to collar area, chest. The patient tried to determine what in vaccine he/she may have reacted to.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site bump; Injection site erythema; injection site pruritis; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA190A, expiry date 30th September 2020) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix) and Gardasil.   On 18th December 2019, the patient received Menveo. In December 2019, 2 days after receiving Menveo and not applicable after receiving Boostrix, the patient experienced injection site swelling, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site itching to be related to Menveo.  Additional details were provided as follows: The patient received Menveo and he also received Boostrix and Gardasil at another injection site. Two days after he developed a good sized 30 mm red bump with severe itching at the Menveo injection site. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever (higher than 101 F); This case was reported by a physician via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. Post vaccination the patient experienced fever (higher than 101 fahrenheit) during 48 hours. The event resolved in 48 hours. The reporter consented to follow up.
Age: 3.0
Sex: F
Vaccine: RAB
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever 100.2 F; sore arm; This case was reported by a nurse via call center representative and described the occurrence of fever in a 3-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA51YA, expiry date 31st March 2023) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of RabAvert. In January 2020, less than a week after receiving RabAvert, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were unknown.   It was unknown if the reporter considered the fever and pain in arm to be related to RabAvert.  Additional details were provided as follows: The patient developed a fever of 100.2 degree fahrenheit and a sore arm.  It was unknown if the events were ongoing at the time of this report. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 227FL, expiry date 26th November 2021) for prophylaxis.   The patient's past medical history included shingles (had shingles prior receiving 1st dose). Previously administered products included Shingrix (1st dose was administered in October 2019).   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient had shingles prior to the first dose and after receiving the 2nd dose, had shingles a week later. She provided 2 lot number and the 2nd one provided did not pull up a valid Shingrix dose in the batch finder. It was unclear which lot number goes with which administration date. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Feeling abnormal, Influenza like illness, Lethargy
Clinical narrative: rash on upper right-hand side of back between spine and shoulder blade; redness around rash has a branching effect; rash as bleeding and scabbing over, in a small area, and the redness around rash has a branching effect.; rash as scabbing; not eating much; Severe flu-like symptoms; Lethargy; Chills; feeling off; Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 7th January 2020, the patient experienced influenza-like symptoms, lethargy, chills, feeling abnormal and decreased appetite. On 18th January 2020, the patient experienced rash, red rash, rash hemorrhagic and scab. On 8th January 2020, the outcome of the lethargy and chills were recovered/resolved. On 9th January 2020, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the pain in arm, feeling abnormal, rash hemorrhagic, scab and decreased appetite were recovered/resolved and the outcome of the rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, lethargy, chills, feeling abnormal, rash, red rash, rash hemorrhagic, scab and decreased appetite to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in upper left arm and had pain in vaccinated arm. The patient had severe flu-like symptoms described as severe lethargy, chills, and feeling off. The caller reported eventually staying in bed remainder of that day to be underneath covers and stay warm. Caller describes flu-like symptoms escalating and not eating much, and then going to bed early. The caller reported still feeling off but flu-like symptoms clearly diminishing and getting better.  The patient reported an additional 12 hours later still not quite feeling right but symptoms almost gone.  Symptoms reportedly lasted 48 hours to 2.5 days. Approximately 4-5 days ago, the caller noticing a rash on upper right-hand side of back between spine and shoulder blade.  The patient had no past dermatology history and no major history of health issues.  The caller describes rash as bleeding and scabbing over, in a small area, and the redness around rash has a branching effect.  The caller has pictures and suspects rash was a mild or healed version of shingles based upon shingles pictures observed online.  The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Purpura, Rash, Rash erythematous, Scab
Clinical narrative: rash on upper right-hand side of back between spine and shoulder blade; redness around rash has a branching effect; rash as bleeding and scabbing over, in a small area, and the redness around rash has a branching effect.; rash as scabbing; not eating much; Severe flu-like symptoms; Lethargy; Chills; feeling off; Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 7th January 2020, the patient experienced influenza-like symptoms, lethargy, chills, feeling abnormal and decreased appetite. On 18th January 2020, the patient experienced rash, red rash, rash hemorrhagic and scab. On 8th January 2020, the outcome of the lethargy and chills were recovered/resolved. On 9th January 2020, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the pain in arm, feeling abnormal, rash hemorrhagic, scab and decreased appetite were recovered/resolved and the outcome of the rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, lethargy, chills, feeling abnormal, rash, red rash, rash hemorrhagic, scab and decreased appetite to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in upper left arm and had pain in vaccinated arm. The patient had severe flu-like symptoms described as severe lethargy, chills, and feeling off. The caller reported eventually staying in bed remainder of that day to be underneath covers and stay warm. Caller describes flu-like symptoms escalating and not eating much, and then going to bed early. The caller reported still feeling off but flu-like symptoms clearly diminishing and getting better.  The patient reported an additional 12 hours later still not quite feeling right but symptoms almost gone.  Symptoms reportedly lasted 48 hours to 2.5 days. Approximately 4-5 days ago, the caller noticing a rash on upper right-hand side of back between spine and shoulder blade.  The patient had no past dermatology history and no major history of health issues.  The caller describes rash as bleeding and scabbing over, in a small area, and the redness around rash has a branching effect.  The caller has pictures and suspects rash was a mild or healed version of shingles based upon shingles pictures observed online.  The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities, Neck pain
Clinical narrative: pain in the right arm; having pain in the right arm that shoots up to her neck; pain affects her ability to sleep at night; decreases her range of motion when reaching backwards with the right arm /unable to left heavy things; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2019, the patient received the 1st dose of Shingrix. On 14th October 2019, immediately after receiving Shingrix, the patient experienced pain in arm, neck pain, difficulty sleeping and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and neck pain were not recovered/not resolved and the outcome of the difficulty sleeping and injected limb mobility decreased were recovering/resolving.   It was unknown if the reporter considered the pain in arm, neck pain, difficulty sleeping and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and immediately started having pain in the right arm that shoots up to her neck.  The reporter states this pain affects her ability to sleep at night, decreases her range of motion when reaching backwards with the right arm and she was unable to left heavy things.  The pain had constant since dose 1 and had not resolved at this time.  On 14th October 2019, less than a day after receiving Shingrix, the patient experienced difficulty sleeping, mobility decreased and activities of daily living impaired.  The follow up consent was granted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: pain in the right arm; having pain in the right arm that shoots up to her neck; pain affects her ability to sleep at night; decreases her range of motion when reaching backwards with the right arm /unable to left heavy things; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2019, the patient received the 1st dose of Shingrix. On 14th October 2019, immediately after receiving Shingrix, the patient experienced pain in arm, neck pain, difficulty sleeping and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and neck pain were not recovered/not resolved and the outcome of the difficulty sleeping and injected limb mobility decreased were recovering/resolving.   It was unknown if the reporter considered the pain in arm, neck pain, difficulty sleeping and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and immediately started having pain in the right arm that shoots up to her neck.  The reporter states this pain affects her ability to sleep at night, decreases her range of motion when reaching backwards with the right arm and she was unable to left heavy things.  The pain had constant since dose 1 and had not resolved at this time.  On 14th October 2019, less than a day after receiving Shingrix, the patient experienced difficulty sleeping, mobility decreased and activities of daily living impaired.  The follow up consent was granted.