chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 12-OCT-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose # and route not specified) for the long-term prevention of shingles and zoster-related conditions (prophylaxis). At the time of the patient's vaccination, the patient relied on the warning label affixed to vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare providers that vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced the patient to be vaccinated. On the same date, the patient's healthcare provider relied in the warning label affixed to the vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risk of adverse effects. Subsequent to the patient's vaccine live (ZOSTAVAX) vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had and will continue ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other loses and damages, and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 31-MAY-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose # and route not specified) for the long-term prevention of shingles and zoster-related conditions (prophylaxis). At the time of the patient's vaccination, the patient relied on the warning label affixed to vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare providers that vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced the patient to be vaccinated. On the same date, the patient's healthcare provider relied in the warning label affixed to the vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risk of adverse effects. Subsequent to the patient's vaccine live (ZOSTAVAX) vaccination, the patient was treated for shingles and other-related conditions by various healthcare provides. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had and will continue ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other loses and damages, and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around September 2016, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose; the prevention of shingles (herpes zoster) (prophylaxis).Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles. As a direct and proximate results of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations do not present prior to using zoster vaccine live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Also, the patient sustained severe and permanent personal injuries. Therefore, 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. Also, suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event was not recovered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose # and route not specified) for the long-term prevention of shingles and zoster-related conditions (prophylaxis). At the time of the patient's vaccination, the patient relied on the warning label affixed to vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare providers that vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced the patient to be vaccinated. On the same date, the patient's healthcare provider relied in the warning label affixed to the vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risk of adverse effects. Subsequent to the patient's vaccine live (ZOSTAVAX) vaccination, the patient was treated for shingles. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had and will continue ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other loses and damages, and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: significant pain in the arm where the vaccines were administered; chills; extreme fatigue; experienced low grade fever; This spontaneous report as received from a consumer refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter, intramuscularly (anatomical location, lot # and expiration date were not provided) as pneumonia prevention and influenza virus vaccine (unspecified) dose 0.5 ml (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On the same date, she experienced low grade fever, chills, extreme fatigue and significant pain in the arm where the vaccines were administered. The patient recovered from the events on 25-SEP-2020.  Causality assessment was not provided.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: chickenpox; This spontaneous report was received from a female pharmacy technician of unknown age who was also the patient via a company representative. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On an unknown date (also reported as "it was many, many years ago"), the patient was vaccinated with varicella virus vaccine (manufacturer unknown) (formulation, strength, exact dose, route of administration, lot # and expiration date were not reported), 1 dosage form (1 injection), for prophylaxis. On an unknown date, the patient developed chickenpox. It was unknown which specific varicella vaccine the patient received as this was many years ago. The outcome of the event was unknown. It was unknown whether the patient sought medical attention, received treatment or had lab diagnostics performed.  The relatedness between the suspect therapy and the event was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Heartrate increase; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was unknown.   The reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced heart rate increases from Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient had a sore arm for about a week after 1st Shingrix shot.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: low grade fever; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2020, the patient received Shingrix. On 2nd October 2020, 1 days after receiving Shingrix, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was unknown.   It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient got a Shingrix shot and had a low grade fever at the time of reporting.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: ice to heat
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Rash
Clinical narrative: slight rash and redness on right arm
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Electrocardiogram, Feeling hot, Pharyngeal paraesthesia, Skin warm
Clinical narrative: PATIENT HAD NEVER HAD A FLU SHOT. NURSE HAD HER WAIT 20 MINUTES , AT 20 MINUTES SHE CAME TO NURSE SAYING ARM WAS HOT,TINGLING,AND TICKLE IN THROAT. GIVEN BENADRYL-10 ML. SHE BECAME HOT AND DIZZY. NO RELIEF FROM BENADRYL. VITALS STABLE. 911 CALLED. SENT TO ER. EKG AND OBSERVATION FOR 1 HOUR. SENT HOME. SJEHE WAS CALLED 10/08/20 TO CHECK ON HER STATUS. HEADING TO WORK AND DOING FINE.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: PATIENT HAD NEVER HAD A FLU SHOT. NURSE HAD HER WAIT 20 MINUTES , AT 20 MINUTES SHE CAME TO NURSE SAYING ARM WAS HOT,TINGLING,AND TICKLE IN THROAT. GIVEN BENADRYL-10 ML. SHE BECAME HOT AND DIZZY. NO RELIEF FROM BENADRYL. VITALS STABLE. 911 CALLED. SENT TO ER. EKG AND OBSERVATION FOR 1 HOUR. SENT HOME. SJEHE WAS CALLED 10/08/20 TO CHECK ON HER STATUS. HEADING TO WORK AND DOING FINE.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Fall, Head injury
Clinical narrative: Pt had brief LOC episode lasting 20--30 seconds.  Pt with previous Hx of syncope  had a flu vaccine at 11:45 am and felt dizzy at 11:50  as she was standing while waiting for her mother to get d/c paperwork and was observed to fall backwards hitting back of her head on the carpet covered floor.  Mother states that pt's arms stiffened for 1--3 seconds.  I heard the sound of pt falling and got to pt right away and observed pt's hands to be clenched and elbows to be stiffened for 3--5 seconds.  Episode lasted 20--30 seconds. Pt was immediately alert right after and stated "I fainted."  Pt dines any headache or pain. No loss of bladder or bowel control.  Was able to walk to stretcher. Vitals wnl.  Denies dizziness, nausea.  911 was called and pt was sent to Hospital ER for evaluation
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Joint contracture, Joint stiffness, Loss of consciousness, Musculoskeletal stiffness, Neurological examination normal
Clinical narrative: Pt had brief LOC episode lasting 20--30 seconds.  Pt with previous Hx of syncope  had a flu vaccine at 11:45 am and felt dizzy at 11:50  as she was standing while waiting for her mother to get d/c paperwork and was observed to fall backwards hitting back of her head on the carpet covered floor.  Mother states that pt's arms stiffened for 1--3 seconds.  I heard the sound of pt falling and got to pt right away and observed pt's hands to be clenched and elbows to be stiffened for 3--5 seconds.  Episode lasted 20--30 seconds. Pt was immediately alert right after and stated "I fainted."  Pt dines any headache or pain. No loss of bladder or bowel control.  Was able to walk to stretcher. Vitals wnl.  Denies dizziness, nausea.  911 was called and pt was sent to Hospital ER for evaluation
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Pt had brief LOC episode lasting 20--30 seconds.  Pt with previous Hx of syncope  had a flu vaccine at 11:45 am and felt dizzy at 11:50  as she was standing while waiting for her mother to get d/c paperwork and was observed to fall backwards hitting back of her head on the carpet covered floor.  Mother states that pt's arms stiffened for 1--3 seconds.  I heard the sound of pt falling and got to pt right away and observed pt's hands to be clenched and elbows to be stiffened for 3--5 seconds.  Episode lasted 20--30 seconds. Pt was immediately alert right after and stated "I fainted."  Pt dines any headache or pain. No loss of bladder or bowel control.  Was able to walk to stretcher. Vitals wnl.  Denies dizziness, nausea.  911 was called and pt was sent to Hospital ER for evaluation
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Vomiting
Clinical narrative: About 3 hours after getting the vaccine, he developed a severe headache, followed by vomiting an hour later.  He had several episodes of vomiting, and received IV fluids at the hospital
Age: 68.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Injection site pain, Malaise, Nausea, Neck pain
Clinical narrative: neck pain injection site pain nausea general malaise
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There has not yet been an adverse event. The MA gave the incorrect vaccine.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: patient  started to experience some soreness in the left arm a couple hours after her immunizations,  She noted a fever up to 100.1 last night, using Tylenol, she is currently on an antibiotic for an infection in her foot, today her left arm is very sore and has redness. Doctor advised to use a topical cortisone cream to left upper arm. More pink the erythematous and no red streaks and no axillary lymphadenopathy per her office notes. We will check on patient tomorrow to f/u.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Muscular weakness, Pain in extremity
Clinical narrative: Loss of push/pull strength in arm x 3 days.  Weak push/pull x next 2 days.  Painful push/pull x next 3 days.  Continues with slight pain at day 10.  Injection site itself was never tender.  Prodromal s/s x 10 days.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient called pharmacy around 530PM evening of 10/5/20 stating she could not move her arm.  She had movement in hand and fingers.  She came if for me to look at injection, but I could not tell where injection was given (no sign of blood droplet and unsure if bandage had been moved). I suggested she be seen by provider for full assessment.  Patient was talked to by other pharmacist on evening of 10/6/20 and she stated she had contacted provider, but had not been seen yet.  She reported improvement in movement of arm.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abdominal pain upper, Injection site mass, Injection site pain, Injection site urticaria, Pain in extremity
Clinical narrative: Patient states on the evening of receiving vaccine, patient broke out in hives around area of the injection. The following day, patient reported having a "big red water balloon" on the medial side of her upper right arm with pain and without fever.  Patient states she was seen by a provider but was not prescribed medication and was told to monitor for fever. Patient states a few days later, she had stomach pain and cramps with the pain and aches extending to thighs. Patients states after 6 days, symptoms resolved completely.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abdominal pain upper, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Patient states on the evening of receiving vaccine, patient broke out in hives around area of the injection. The following day, patient reported having a "big red water balloon" on the medial side of her upper right arm with pain and without fever.  Patient states she was seen by a provider but was not prescribed medication and was told to monitor for fever. Patient states a few days later, she had stomach pain and cramps with the pain and aches extending to thighs. Patients states after 6 days, symptoms resolved completely.
Age: 5.0
Sex: F
Vaccine: FLUR4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Myalgias, Fever, Neck Pain Headache, Arthralgias, Chills, Diarrhea
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Neck pain, Pyrexia
Clinical narrative: Myalgias, Fever, Neck Pain Headache, Arthralgias, Chills, Diarrhea
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Fatigue, Headache, Rash, Rash pruritic
Clinical narrative: Day after flu shot, had an upset stomach, headache, and noticeable fatigue. She then noted a rash that started on her left hand and went up her arm. Stomach upset, headache and fatigue have resolved. Rash is still there, and very itchy, but seems to be resolving. She is treating with Caladryl cream. Suggested Benedryl tabs orally if available.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient did not received 2nd dose two months after initial dose; No further AE reported; This spontaneous report has been received from a pharmacist referring to a 21 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unspecified date in 2017, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The patient did not received the second dose (inappropriate schedule of product administration and no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Myalgia, Pain, Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown  age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In or around 01-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, lot # and expiration date were not reported) for routine health maintenance and for it's intended purpose the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), Plaintiff suffered an abrupt onset of arthralgias and myalgias with aching, burning, excruciating and intermittent pain located in shoulders, hips, and knees bilaterally. Plaintiff was diagnosed with polymyalgia rheumatica. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), Plaintiff's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result Plaintiff sustained severe and permanent personal injuries. Plaintiff 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 Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, polymyalgia rheumatica was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received on from a lawyer and a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On or about 14-FEB-2017, the pt was inoculated, by a healthcare provider, with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date (reported as "subsequent to inoculation"), the pt was treated by a healthcare provider for herpes zoster. As a direct and proximate result of the Zoster Vaccine Live (ZOSTAVAX) the pt suffered ongoing injuries including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the reporting time, the outcome of the event was not recovered and the causality was related.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: herpes zoster ophthalmicus; Information has been received on from a lawyer and a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On or about 12-FEB-2012, the pt was inoculated, by a healthcare provider, with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date (reported as "subsequent to inoculation"), the pt was treated by a healthcare provider for herpes zoster ophthalmicus. As a direct and proximate result of the Zoster Vaccine Live (ZOSTAVAX) the pt suffered ongoing injuries including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the reporting time, the outcome of the event was not recovered and the causality was related.  Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: zoster related vision loss; zoster related vision loss; Information has been received regarding a case in litigation from a lawyer and the pt on 02-OCT-2020, referring to a pt of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unknown date in 2011, the pt was vaccinated by a health care provider with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions (lot# and route unknown). The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: vision loss (blindness) and herpes zoster, requiring hospitalization. The outcome of blindness and herpes zoster was reported as ongoing. The causality assessment between blindness and herpes zoster with zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, blindness was determined to be a medically significant event.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and the pt on 02-OCT-2020, referring to a 65 year old pt of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On November 2018, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown). The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: shingles on an unknown date in December 2018, that was permanent and lasting in nature. The outcome of shingles was reported as not resolved. The causality assessment between shingles with zoster vaccine live (ZOSTAVAX) was reported as related.  The adverse event of shingles was considered a disabled event.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and the pt on 02-OCT-2020, referring to a 70 year old pt of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unknown date in April 2018, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for prophylaxis. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: shingles on 02-OCT-2018, reported as permanent and lasting in nature. The outcome of shingles was reported as not resolved. The causality assessment between shingles with zoster vaccine live (ZOSTAVAX) was reported as related. The adverse event of shingles was considered a disabled event.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Deafness
Clinical narrative: hearing and vision loss; hearing and vision loss; Information has been received regarding a case in litigation from a lawyer and the pt on 02-OCT-2020, referring to a pt of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about April 2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: hearing and vision loss (deafness and blindness), reported as severe permanent injuries. The outcome of deafness and blindness was reported as not resolved. The causality assessment between deafness and blindness with zoster vaccine live (ZOSTAVAX) was reported as related.  The adverse events deafness and blindness were considered disabled events. Upon internal review, deafness and blindness were determined to be serious adverse events.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to an elderly patient of unknown gender who was at least 73 years old at the time of vaccination. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On 28-OCT-2013, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) at a physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider for shingles, resulting form the pt's use of zoster vaccine live (ZOSTAVAX). The outcome of the event was not reported. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: running a fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced fever after receiving the 2nd dose of Shingrix. The reporter was asking how long does the side effects last after the 2nd dose. No further information was provided.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pharmacist states that they were having an event and two patients ages 11,16 were inadvertently given the Flublok immunization; Initial information received on 03-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was issued in publication with one other linked case 2020SA273639 (cluster)  This case involves a 11 years old patient for whom pharmacist states that they were having an event and two patients ages 11,16 were inadvertently given the flublok immunization (Product administered to patient of inappropriate age) was reported while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ463AA, Expiry date:19-MAR-2021) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date (of unknown latency), the patient developed a non-serious pharmacist states that they were having an event and two patients ages 11,16 were inadvertently given the flublok immunization (reported to be wrong product administered) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No lab details were reported.   It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome was reported to be not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Visual impairment
Clinical narrative: Patient received flu shot and walked away to look at stuff in the store. Shortly the patient started to experience some dizziness and vision went black. Patient had to sit down and rest. Patient was also feeling hot. Patient had not eaten prior to receiving vaccine. Patient was able to get up and leave the store for home.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Magnetic resonance imaging abnormal, Neuritis, Oedema, Radial nerve palsy
Clinical narrative: left radial neuritis with wrist drop / finger weakness
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Urticaria
Clinical narrative: Patient described having hives over entire body for a few days after receiving vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Patient experienced tiredness, dizziness,  muscle pain, headache and fever.  Fever reached 101, then 99.9 then 97.4  on 10/08/2020.  Slept in for 1.5 days. Muscle pain still painful on 10/08/2020
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister rupture, Musculoskeletal pain, Scab, Wound
Clinical narrative: Pain noticed at the very top of buttocks. After several days, I was asked to look to see what it was because it "felt like a scab" - I took a photo that showed what appears to be two broken blisters that were open wounds.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site oedema, Injection site pain, Localised oedema, Neck pain
Clinical narrative: 24h after injection had induration at site; 48h after injection developed edema and severe pain extended from LUE to axilla, supraclavicular region and left neck
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Patient reported bruising that went around the circumference of the arm two days after vaccination was administered.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Urticaria, Vaccination site reaction
Clinical narrative: after about 3 days after vaccination; pt began to experience itchy hives around the vaccination area
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Malaise, Myalgia, Pyrexia
Clinical narrative: Patient called pharmacy the day after receiving the vaccine and reported feeling sick, muscle aches, fever, and redness around injection site the size of a baseball.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Nausea
Clinical narrative: The patient felt nausea and then passed out. We called 911 and they evaluated him. He was doing better and they said his blood pressure was normal.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 3 or more hours after administration of vaccine, patient started having warmth in site of shot and pain, she had a lump form on the opposite side of her arm ( inner arm about five inches below the arm pit area ) the lump was  about 3 inches in diameter and hard, she applied cold and hot compresses alternatively with the ice compress mostly ! swelling  and lump gone down about 75% already, the pain went to her shoulder and to her upper chest area above the breast she also had nausea but no vomiting Today patient called her doctor and informed them, she also called the pharmacy. I spoke to her as I am the one who administered the vaccine yesterday collected the above info, she doesn't have any other symptoms she says the nausea has gotten much better and the lump is getting better I told her to watch for worsening of symptoms and if it happens to contact her doctor or 911 if severe but very likely she will continue getting better as the symptoms are getting better by time I advised her to use Tylenol for pain and swelling as needed  and I will follow up on her with a call later this evening .
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: 3 or more hours after administration of vaccine, patient started having warmth in site of shot and pain, she had a lump form on the opposite side of her arm ( inner arm about five inches below the arm pit area ) the lump was  about 3 inches in diameter and hard, she applied cold and hot compresses alternatively with the ice compress mostly ! swelling  and lump gone down about 75% already, the pain went to her shoulder and to her upper chest area above the breast she also had nausea but no vomiting Today patient called her doctor and informed them, she also called the pharmacy. I spoke to her as I am the one who administered the vaccine yesterday collected the above info, she doesn't have any other symptoms she says the nausea has gotten much better and the lump is getting better I told her to watch for worsening of symptoms and if it happens to contact her doctor or 911 if severe but very likely she will continue getting better as the symptoms are getting better by time I advised her to use Tylenol for pain and swelling as needed  and I will follow up on her with a call later this evening .
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: She was given 2 meningitis vaccines, Menveo and MenB, 1 in each arm but not sure which one was given in which arm. Was given at a different facility than reporting provider.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Loss of consciousness, Sensation of foreign body
Clinical narrative: patient said 2 hours after she went home she felt faint and passed out on the couch. She woke up and had a "ball" in her throat and a headache. Slept overnight then she woke with all effects gone except the headache but that left 2 hours after she woke up.
Age: 75.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: On 10/07/2020 patient called pharmacy reporting signs of significant redness, swelling and soreness in his left arm.  Patient was instructed to take Benadryl 25-50mg along with icing the area several times daily.  If no improvement  or worsening was noticed, he was to seek  medical help with his primary care physician. On 10/08/2020, pharmacist called patient  and patient reported significant improvement of symptoms.  He reported redness and swelling had decreased considerably.  He was instructed to  continue icing the area and to contact PCP as well as our pharmacy if worsening of symptoms took place.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: PATIENT FELT DIZZY FOR FEW MINUTES AND THEN SHE FAINTED AND REGAINED CONSCIOUSNESS ON AND OFF AND WAS SWEATING. WE CALLED 911 AND ASKED FOR EMS AS SOON AS POSSIBLE. SHE WAS BREATHING WELL WITH NO RESPITORY DISTRESS.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Amnesia
Clinical narrative: After receiving the flu vaccine, I experienced a lapse in memory. I was conscious, and actively working at my desk while at work, however I do not recall from around 10:30am-1pm. No medical attention was sought, and there are no accompanying symptoms. No history of any similar past episodes. No underlying health conditions.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: hot, swollen, redness at local site (right deltoid)
Age: 0.75
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pyrexia
Clinical narrative: fever 103.5 taking motrin/ Tylenol every 4-6 hours
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site, tiredness, fever, shivering
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Rash
Clinical narrative: Patient broke out in shingles-like rash on the arm that she received the vaccine in. Patient also reported experiencing nerve pain in that arm.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dyspnoea, Feeling cold, Immediate post-injection reaction, Tremor
Clinical narrative: Within moments after receiving  vaccinations, patient started exhibiting shortness of breath, shakiness and felt cold (subjective), patient was alert and responsive. Patient was asked to lay down and take slow/deep breathes until she felt calm. Patients vital signs were assisted and normal. Provider assisted patient, gave one 25 mg capsule of diphenhydramine which per patients mother; patient tolerates fine. Pt was asked to stay seated until calm and was released per Provider.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient reported a fever of 100.7 that began at 4am the morning following her vaccine.  Her temperature generally runs "low" so she said this was  relatively high for her.  It had been around this temperature for about two days at the time she reported to us.
Age: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Dry skin, Injection site erythema, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Patient called the pharmacy at 1:10pm on 10/8/2020, approximately 24 hours after receiving her Flublok immunization, that she had an oblong, orange-sized red area surrounding the injection site that was also slightly raised and rough. When asked, the patient reported soreness on the level of a normal intramuscular vaccination and the are being only slightly warmer to the touch. No reported itching or systemic reactions.
Age: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Skin warm
Clinical narrative: Patient called the pharmacy at 1:10pm on 10/8/2020, approximately 24 hours after receiving her Flublok immunization, that she had an oblong, orange-sized red area surrounding the injection site that was also slightly raised and rough. When asked, the patient reported soreness on the level of a normal intramuscular vaccination and the are being only slightly warmer to the touch. No reported itching or systemic reactions.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pallor
Clinical narrative: Donor received vaccination this morning IM to right deltoid. Presented at 3:10 pm complaining of feeling nauseated, and he appeared pale in his face. States nausea started as he was leaving for lunch at 1:30-1:45.  Called at 3:15 pm. Clinic recommends eating something,  however, client feel this will not be helpful at present, and knows how he feels when his blood sugar is low.  Requesting to go home at present.   3:48 pm client feels the nausea is subsiding,
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Urticaria
Clinical narrative: Had hives spread through out her body.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Erythema, Rash, Rash erythematous, Skin warm, Swelling
Clinical narrative: Skin very red, hot, 4 inch x4 inch area of erythema and swelling. Skin also bumpy Given oral diphenhydramine, topical ice pack and rest. After 2 hours, area less red and bumps gone, but still swollen.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Diffuse maculopapular rash to lower back and abdomen starting 3-4 hours after vaccine. No local site reaction. No fever or irritability. Rash slightly improved today.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Skin induration
Clinical narrative: patient had pain in the arm of flu shot the day of and the following day; then it became swollen and the skin in the area was hard-like as per patient- Able to move arm and no issue with mobility and feeling in the hand is okay
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Lip injury, Loss of consciousness, Tooth fracture
Clinical narrative: PATIENT RECEIVED FLUCELVAX. SHE WAS CHECKING OUT OF FLU CLINIC AND SHE PASSED OUT, CUT HER LOWER LIP WITH HER FRONT TEETH AND CHIPPED HER UPPER FRONT RIGHT TOOTH.  SHE QUICKLY REGAINED CONSCIOUSNESS BUT CONTINUED TO FEEL FAINT.  SHE WAS TRANSPORTED TO THE HOSPITAL FOR FOLLOW UP.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site swelling
Clinical narrative: Patient reported a dusty red color wityh swelling and hardness at injection site 2 days post immunization. Patient is a physician herself and believes that the injection site is infected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Intense injection site reaction with large swollen arm all the way from the shoulder down to the elbow. Hot to the touch. was counseled to monitor symptoms and take benadyrl as well as ice and ibuprofen. Was also told to follow up with provider especially not resolving after another 24-48 hours.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Muscle spasms, Pain in extremity
Clinical narrative: Patient reported having sore left arm and cramping which started within 24 hours.  Then it spread to both feet with pain and crampin.  Also experienced chest pain, tightness and shortness of breath.  Patient did report having rheumatoid arthritis and some other autoimmune issues as well as neuropathy.
Age: 25.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cyanosis, Dyspnoea
Clinical narrative: Patient started to have trouble breathing about 24 hours after receiving them. Couldnt breathe and was "turning blue" per sister. Was taken to the hospital for possible anaphylactic reaction.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Red man syndrome
Clinical narrative: In about 24-48h post flu shot - she developed a very diffuse sort of "red man" syndrome - called to say it started on her arm at the site of the flu shot then spread to her limbs and included her face. No rash just extreme redness, everywhere! We medicated w/ benadryl + pepcid and within 12 hours she was better and had no recurrence.
Age: 65.0
Sex: M
Vaccine: FLUR4
Symptoms: Urticaria
Clinical narrative: PATIENT REPORTS HIVES ON NECK AND CHEST AT AROUND 2:30PM. PATIENT TOOK SOME BENADRYL AND SHOWER AND THE HIVES SEEMED TO IMPROVE.