chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Blister, Eye pain, Herpes zoster, Hypoacusis
Clinical narrative: transient ischemic attacks; hives; loss of balance; hearing problems; blurred vision; eye pain; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not provided. On or around 24-OCT-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered constant and severe burning and blistering of her skin, resulting in scarring. The pt was diagnosed with herpes zoster. Subsequently, the pt experienced loss of balance, hearing problems, blurred vision and eye pain, as well as transient ischemic attacks. The pt also suffered a second outbreak of her skin and was diagnosed with hives. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt 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 pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt 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 pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was considered as not recovered. The lawyer considered all the events to be related to zoster vaccine live (ZOSTAVAX).     Transient ischemic attack, herpes zoster, urticaria, loss of balance, hearing problems, blurred vision and eye pain were considered to be disability. Upon internal review, transient ischemic attack was considerd to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scar, Skin burning sensation, Transient ischaemic attack, Urticaria
Clinical narrative: transient ischemic attacks; hives; loss of balance; hearing problems; blurred vision; eye pain; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not provided. On or around 24-OCT-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered constant and severe burning and blistering of her skin, resulting in scarring. The pt was diagnosed with herpes zoster. Subsequently, the pt experienced loss of balance, hearing problems, blurred vision and eye pain, as well as transient ischemic attacks. The pt also suffered a second outbreak of her skin and was diagnosed with hives. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt 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 pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt 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 pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was considered as not recovered. The lawyer considered all the events to be related to zoster vaccine live (ZOSTAVAX).     Transient ischemic attack, herpes zoster, urticaria, loss of balance, hearing problems, blurred vision and eye pain were considered to be disability. Upon internal review, transient ischemic attack was considerd to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: transient ischemic attacks; hives; loss of balance; hearing problems; blurred vision; eye pain; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not provided. On or around 24-OCT-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered constant and severe burning and blistering of her skin, resulting in scarring. The pt was diagnosed with herpes zoster. Subsequently, the pt experienced loss of balance, hearing problems, blurred vision and eye pain, as well as transient ischemic attacks. The pt also suffered a second outbreak of her skin and was diagnosed with hives. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt 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 pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt 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 pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was considered as not recovered. The lawyer considered all the events to be related to zoster vaccine live (ZOSTAVAX).     Transient ischemic attack, herpes zoster, urticaria, loss of balance, hearing problems, blurred vision and eye pain were considered to be disability. Upon internal review, transient ischemic attack was considerd to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone decreased, Incomplete course of vaccination, Malaise
Clinical narrative: did not feel weell; TSH had dropped / TSH level to drop.; This case was reported by a consumer and described the occurrence of malaise in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix and an unknown time after starting Levothyroxine, the patient experienced malaise and thyroid stimulating hormone decreased. The patient was treated with thyroxine sodium (Levothyroxine). On an unknown date, the outcome of the malaise and thyroid stimulating hormone decreased were unknown.   It was unknown if the reporter considered the malaise and thyroid stimulating hormone decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that the Shingrix vaccine caused TSH level to drop.  The patient received Shingrix and did not feel well and TSH had dropped and would not get the second one. The patient takes Levothyroxine for thyroid.  The week before the vaccine the level was good.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: arm pain/feeling like a sprain; The patient's blood pressure measured lower than is normal for him yesterday and; dizziness; Tingling was felt in the left arm/both feet, and bottom of the right foot; pain, redness, swelling and hot to touch at the injection site; redness, swelling and hot to touch at the injection site; hot to touch at the injection site; swelling and hot to touch at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2020, the patient received the 2nd dose of Shingrix .5 ml. On 23rd August 2020, 6 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site swelling. On 24th August 2020, the patient experienced tingling of extremity. On 26th August 2020, the patient experienced dizziness and blood pressure decreased. On 27th August 2020, the patient experienced pain in arm. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth and injection site swelling were recovering/resolving and the outcome of the dizziness was not recovered/not resolved and the outcome of the tingling of extremity was recovered/resolved and the outcome of the pain in arm and blood pressure decreased were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site swelling, dizziness, tingling of extremity, pain in arm and blood pressure decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had pain, redness, swelling and hot to touch at the injection site. The patient had Tingling was felt in the left arm, both feet, and bottom of the right foot and lasted a couple of hours.  The dizziness started day before reporting and still present but not as bad. The patient's blood pressure measured lower than was normal and had increased slightly. The arm pain present was described feeling like a sprain. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: arm pain/feeling like a sprain; The patient's blood pressure measured lower than is normal for him yesterday and; dizziness; Tingling was felt in the left arm/both feet, and bottom of the right foot; pain, redness, swelling and hot to touch at the injection site; redness, swelling and hot to touch at the injection site; hot to touch at the injection site; swelling and hot to touch at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2020, the patient received the 2nd dose of Shingrix .5 ml. On 23rd August 2020, 6 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site swelling. On 24th August 2020, the patient experienced tingling of extremity. On 26th August 2020, the patient experienced dizziness and blood pressure decreased. On 27th August 2020, the patient experienced pain in arm. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth and injection site swelling were recovering/resolving and the outcome of the dizziness was not recovered/not resolved and the outcome of the tingling of extremity was recovered/resolved and the outcome of the pain in arm and blood pressure decreased were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site swelling, dizziness, tingling of extremity, pain in arm and blood pressure decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had pain, redness, swelling and hot to touch at the injection site. The patient had Tingling was felt in the left arm, both feet, and bottom of the right foot and lasted a couple of hours.  The dizziness started day before reporting and still present but not as bad. The patient's blood pressure measured lower than was normal and had increased slightly. The arm pain present was described feeling like a sprain. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Dizziness, Fall, Hyperhidrosis, Loss of consciousness
Clinical narrative: Passed out several times; he got up to go to the bathroom and on his way back to bed he got dizzy; fell down on the floor; sweating; belly pain; Initial information received on 27-Aug-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional.  This case involves a 74-years-old male patient who experienced sweating (hyperhidrosis), he got up to go to the bathroom and on his way back to bed he got dizzy (dizziness) and fell down to the floor (fall) due to which he passed out several times (loss of consciousness) and belly pain (abdominal pain), while he received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included sinus infection (sinusitis) in 2019 for which doctor had gave him antibiotics, and he got dizzy (dizziness) and passed out (loss of consciousness).  The patient's past medical treatment, concomitant medication, vaccination and family history were not provided.  The patient had ongoing medical history of Type 2 Diabetes Mellitus.  On 26-Aug-2020 at 3:00 to 4:00 PM, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number, expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 27-Aug-2020 at 3:00 to 4:00 AM, the patient experienced sweating (hyperhidrosis), he got up to go to the bathroom and on his way back to bed he got dizzy (dizziness) and fell down to the floor (fall) due to which he passed out several times (loss of consciousness) (few hours) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  On 27-Aug-2020 at 3:00 to 4:00 AM, the patient developed a non-serious belly pain (abdominal pain) (few hours) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   He does not check his blood sugar because he said it is managed well. It normally runs about 140.  It was not reported if the patient received any corrective treatment.  The events outcome was not reported.  Information on the batch number was requested.; Sender's Comments: This case involves a 74-years-old male patient who experienced hyperhidrosis, dizziness and fall which was associated with loss of consciousness and also experienced abdominal pain, same day after vaccination with FLUZONE HIGH DOSE. The time to onset is compatible. Medical history, previous exposure to any vaccine, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: TDAP
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: a rash in the under arm area on the same arm,rash is itching and with redness; a rash in the under arm area on the same arm,rash is itching and with redness; Initial information received on 31-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves male patient (with unknown demographics) who had a rash in the under arm area on the same arm (rash pruritic) (rash erythematous), while he received vaccine ADACEL.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiration date not reported) via unknown route in the arm as prophylactic vaccination.  On an unknown date, the patient developed a non-serious rash in the under arm area on the same arm (rash pruritic) (rash erythematous) that began either on the same day or the day after the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome were unknown for all the events at the time of reporting.  There will be no information on the batch number for this case.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Migraine, Pyrexia, Vomiting
Clinical narrative: Migraine, diarrhea, vomiting, low grade fever
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Patient had redness down injection arm but not at injection site.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Headache, Hypoaesthesia, Pruritus, Rash
Clinical narrative: numbness, dizziness, headache, itching, rash on the belly
Age: 67.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Cyanosis, Dizziness, Dyspnoea, Eye movement disorder, Loss of consciousness
Clinical narrative: Gave Shingrix vaccine in right arm with patient standing up, asked patient to sit for flu shot as she said she felt 'woozy'.  After giving the flu shot, I caught her head in my hand as she had passed out. Her eyes were rolling around and she appeared to be gasping for breath. I removed her mask and her lips were blue/white. Her husband was on the other side of her and we were both trying to wake her up. She finally came to and didn't remember passing out but was very dizzy/nauseated. It lasted maybe 30 seconds-1 minute
Age: 67.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Nausea, Pallor
Clinical narrative: Gave Shingrix vaccine in right arm with patient standing up, asked patient to sit for flu shot as she said she felt 'woozy'.  After giving the flu shot, I caught her head in my hand as she had passed out. Her eyes were rolling around and she appeared to be gasping for breath. I removed her mask and her lips were blue/white. Her husband was on the other side of her and we were both trying to wake her up. She finally came to and didn't remember passing out but was very dizzy/nauseated. It lasted maybe 30 seconds-1 minute
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Pyrexia, Rash macular, Skin warm
Clinical narrative: Within 20 minutes of receiving the vaccine, he developed red, hot cheeks, with red splotches around mouth and neck. Low-grade fever.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Hip pain; sweats, fever of 100.4, chills, joint pain. These symptoms lasted 12 hours. After that I had a headache and 99 degree fever that persisted for a day. No other symptoms after 2 days.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt felt dizzy and passed out. Lowered to chair, mom on site, given water and cool cloth. B/P Taken 92/68 Within normal limits.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: rash developed on face.  After taking Hydroxyzine, rash lessened.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness, Discomfort and tingling
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine was given on 9/2/2020, but the vaccine was one day expired with expiration date  9/1/2020.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Warm, hot to touch raised area at injection site. Redness at injection site. It is itching. Site was marked with marker and redness has grown in size to outside of the original boarder. She used a warm compress and has taken 25 mg of Benadryl.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine was given on 9/2/2020 but the vaccine was 1 day expired with expiration date of 9/1/2020.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash maculo-papular
Clinical narrative: Full body rash, raised, maculopapular noticed several hours after vaccination.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 5 hours after administration pt reported pain/discomfort in injection site and throughout left arm.  states injection site is 'hot' and 'swollen'  and 'reddened'  states she was not able to sleep last night due to the discomfort.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: 5 hours after administration pt reported pain/discomfort in injection site and throughout left arm.  states injection site is 'hot' and 'swollen'  and 'reddened'  states she was not able to sleep last night due to the discomfort.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: I woke up this AM with a stomach ache. I normally dont have one and I thought it was gas. By lunch I felt very Nauseated and my stomach hurts.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex test positive, Lumbar puncture abnormal, Meningoencephalitis herpetic
Clinical narrative: Herpes Encephalitis - began July 24, 2020. Treated with 14 days IV Acyclovir. Relapsed 1 week later, currently receiving anoter 14 day course of IV Acyclovir.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: unknown number of patients received improperly stored VARIVAX on unspcified date; No additional adverse effect reported; This spontaneous report was received from a nurse and refers to an unknown number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S036636, expiration date 14-NOV-2021 (dose and route of administration were not provided) for prophylaxis. Administered doses of the suspect vaccine experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (7.97F) for 2 hours. There was no previous temperature excursion. Digital data logger was involved. Varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No additional adverse effects reported.  This is a non-valid report due to the lack of the patients identifiers.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A nursing assistant reported temperature excursion for vaccines that were administered to patients after excursion occurred; This spontaneous report was received from a nursing assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 03-AUG-2020, the patient was vaccinated with improperly stored dose of VARIVAX 1 dose (dosage regimen and route of administration were not reported) lot # T000341, expiration date 05-JAN-2022, for prophylaxis. The improperly stored dose experienced a temperature of -10.2 degree Celsius for 1 hour and 53 minutes. There was no previous temperature excursion. The call was because a digital data logger. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2009USA000117: US-009507513-2008USA014705: US-009507513-2008USA014798: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000132: US-009507513-2008USA014757: US-009507513-2008USA014767: US-009507513-2008USA014697: US-009507513-2008USA014803: US-009507513-2008USA014820: US-009507513-2008USA014825: US-009507513-2008USA014869: US-009507513-2008USA014871: US-009507513-2008USA014937: US-009507513-2008USA015018: US-009507513-2009USA000112: US-009507513-2008USA014803:AE Case # 01697206 US-009507513-2009USA000113:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Temperature excursion involving Proquad; This spontaneous report as received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.       On 28-JUL-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) began experiencing intermittent temperature excursion.  On 17-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) 0.5 ml, Lot # T009929, expiration date 16-SEP-2021, and Lot # S031882, expiration date 07-APR-2021 for prophylaxis (Frequency and patient route of administration were not reported). The storage temperature reported was between -14°C to -10°C, being the maximum temperature at -9..5 °C for a period of 38 hours and 30 minutes.     There was digital data logger involved and  no previous temperature excursion was reported.; Sender's Comments:  US-009507513-2008USA014709:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion/VARIVAX administered doses; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On an unknown date, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002843 with expiration date of 23-JAN-2022, and lot # S032357 with expiration date of 14-OCT-2021, 0.5 milliliter (strength, dose, route, frequency and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range between -14°C to -10°C, during a time frame of 38 hours and 30 minutes which was called by a data logger. No previous temperature excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: vaccines that were administered to patients after excursion occurred; This spontaneous report as received from a nursing assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.      On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number: T002846, expiration date: 23-JAN-2022, dose and route of administration were not provided). The vaccine was stored in temperature -10.2 degree Celsius for 1 hour and 53 minutes. There was no previous temperature excursion. Digital data lodger was involved.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014798: US-009507513-2008USA014951: US-009507513-2008USA014697: US-009507513-2008USA014705: US-009507513-2008USA014757: US-009507513-2008USA014767: US-009507513-2008USA014803: US-009507513-2008USA014806: US-009507513-2008USA014820: US-009507513-2008USA014825: US-009507513-2008USA014869: US-009507513-2008USA014871: US-009507513-2008USA014888: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA015018: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000117:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2015, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue 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. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Cough, Herpes zoster, Sneezing
Clinical narrative: herpes zoster; Pain in the lower right chest upon coughing or sneezing intermittent stabbing pain on the right, midback; Pain in the lower right chest upon coughing or sneezing intermittent stabbing pain on the right, midback; Information has been received regarding a case in litigation from a lawyer and the pt on 01-SEP-2020, referring to a male pt of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-MAR-2008, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for routine health maintenance and prevention of shingles (herpes zoster). The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: pain in the lower right chest upon coughing (cough) or sneezing and intermittent stabbing pain on the right, midback and was diagnosed with herpes zoster; symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) vaccine and seriousness of his conditions. The outcome of cough, sneezing and Herpes zoster was reported as not revolved. The causality assessment between cough, sneezing and Herpes Zoster with zoster vaccine live (ZOSTAVAX) was reported as related.  Cough, sneezing and herpes Zoster were considered disabling events.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further AE information provided; administration of improperly stored vaccines; This spontaneous report as received from a certified medical assistant refers to a 14-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose and route of administration were not reported, lot # T002848, expiration date 23-JAN-2022), for prophylaxis. The vaccine was reconstituted with a sterile diluent (STERILE DILUENT). Previously, the vaccine had experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. The current temperature excursion was from 4 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Digital data logger was used. No adverse event was reported.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Abdominal discomfort, Erythema, Headache, Inflammation, Pain
Clinical narrative: large red inflamed area; large red inflamed area; severe pain; upset stomache; headache; What would I expect if it was subQ and not into muscle; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema, inflammation, pain, upset stomach, headache and intramuscular formulation administered by other route. On an unknown date, the outcome of the erythema, inflammation, pain, upset stomach, headache and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the erythema, inflammation, pain, upset stomach and headache to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient never had much of rection to a until patient's last dose of Shingrix and a flu shot. The patient reported that, the people who gave them did it very slowly and patient wasn't sure if they even got into the muscle.  The patient was ever supposed to but have never had them given so slowly (and more painfully because of that). The patient experinced large red inflamed area, severe pain 2 days out, upset stomache and headache. The patient asked, what would expect if it was subcutaneous and not into muscle. The patient asked, can Shingrix and the Flu vaccine be receive at the same time.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache
Clinical narrative: was experiencing headaches; fatigue; This case was reported by a consumer and described the occurrence of headache in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Bexsero. On 25th August 2020, less than a day after receiving Bexsero, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were unknown.   It was unknown if the reporter considered the headache and fatigue to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Bexsero and experienced headaches and fatigue. The reporter asked how long should side affects from Bexsero last.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: this is an allergic reaction.; itchy scalp; This case was reported by a consumer via interactive digital media and described the occurrence of itchy scalp in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced itchy scalp and allergic reaction. On an unknown date, the outcome of the itchy scalp and allergic reaction were unknown.   It was unknown if the reporter considered the itchy scalp and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient experienced an itchy scalp for about 2 hours the night of Shingrix vaccination. The patient asked did like to take the 2nd dose, but suppose this was an allergic reaction.  Should be hesitant.
Sex: U
Vaccine: VARZOS
Symptoms: Joint swelling, Musculoskeletal stiffness
Clinical narrative: severe lower body joint swelling; stiffness; This case was reported by a consumer via interactive digital media and described the occurrence of swollen joints 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, 5 days after receiving Shingrix, the patient experienced swollen joints and stiffness. The patient was treated with ibuprofen. On an unknown date, the outcome of the swollen joints and stiffness were unknown.   It was unknown if the reporter considered the swollen joints and stiffness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient received first Shingrix injection about 5 weeks ago and have had severe lower body joint swelling and stiffness starting about 5 days after the vaccine and it has not gotten better.  The patient take ibuprofen.  The patient asked how much longer would it last.
Sex: M
Vaccine: RAB
Symptoms: Abnormal behaviour, Anger, Asthenia, Feeling abnormal, Gait disturbance
Clinical narrative: He still has  weakness; pain and tingling in the arm; tingling in the arm; started to behaved different, he felt mad, crazy and in rage.; his shoulder were he received the doses hurt; So weak he almost could not walk for 2 days after injection; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 64-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Concurrent medical conditions included animal bite.   On 17th July 2020, the patient received RabAvert. On an unknown date, less than 2 months after receiving RabAvert, the patient experienced shoulder pain, walking difficulty, weakness of arms, pain in arm, tingling of extremity and behavior abnormal. On an unknown date, the outcome of the shoulder pain, weakness of arms, pain in arm, tingling of extremity and behavior abnormal were unknown and the outcome of the walking difficulty was recovered/resolved.   It was unknown if the reporter considered the shoulder pain, walking difficulty, weakness of arms, pain in arm, tingling of extremity and behavior abnormal to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The patient started with the post exposure schedule for RabAvert after being bitten by a bat and started to develop different side effects.  The patient shoulder where he received the doses hurt, that felt so weak he could hardly walk for 2 days after the vaccine was administered. The patient had weakness, pain and tingling in the arm and reported that after receiving the vaccine he started to behave different, he felt mad, crazy and in rage. The reporter consented to follow up. The Patient was worried and concern about the symptoms.
Sex: M
Vaccine: RAB
Symptoms: Injection site pain, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: He still has  weakness; pain and tingling in the arm; tingling in the arm; started to behaved different, he felt mad, crazy and in rage.; his shoulder were he received the doses hurt; So weak he almost could not walk for 2 days after injection; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 64-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Concurrent medical conditions included animal bite.   On 17th July 2020, the patient received RabAvert. On an unknown date, less than 2 months after receiving RabAvert, the patient experienced shoulder pain, walking difficulty, weakness of arms, pain in arm, tingling of extremity and behavior abnormal. On an unknown date, the outcome of the shoulder pain, weakness of arms, pain in arm, tingling of extremity and behavior abnormal were unknown and the outcome of the walking difficulty was recovered/resolved.   It was unknown if the reporter considered the shoulder pain, walking difficulty, weakness of arms, pain in arm, tingling of extremity and behavior abnormal to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The patient started with the post exposure schedule for RabAvert after being bitten by a bat and started to develop different side effects.  The patient shoulder where he received the doses hurt, that felt so weak he could hardly walk for 2 days after the vaccine was administered. The patient had weakness, pain and tingling in the arm and reported that after receiving the vaccine he started to behave different, he felt mad, crazy and in rage. The reporter consented to follow up. The Patient was worried and concern about the symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: local reaction; long read area; which was also warm.; This case was reported by a pharmacist via call center representative and described the occurrence of local reaction in a adult patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date 28th March 2022) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than 2 weeks after receiving Shingrix, the patient experienced local reaction, erythema and skin warm. On an unknown date, the outcome of the local reaction, erythema and skin warm were unknown.   It was unknown if the reporter considered the local reaction, erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The Shingrix applied ten days ago and patient had a local reaction with a long read area which was also warm. The reporter consented to follow up. No patient's identifiers were provided.  Requested to follow up.
Age: 56.0
Sex: M
Vaccine: FLU4, HEP, HEPA, TDAP, VARZOS, VARZOS
Symptoms: Asthenia, Headache, Loss of personal independence in daily activities, Malaise, Pain
Clinical narrative: Patient had reaction after receiving 5 vaccines at his workplace at 5:10pm. Patient started not feeling well around 7pm  and fainted at work at 8:40pm. He left his workplace to go home and couldn't finish his shift.  He is experiencing  overall body pain and weakness. He is also has pain at the base of his head and pain down his spine. Patient was not showing any signs of an allergic reaction (no hives, no trouble breathing). Patient has not received medical attention for his condition but I advised him to do so if need be.
Age: 56.0
Sex: M
Vaccine: FLU4, HEP, HEPA, TDAP, VARZOS, VARZOS
Symptoms: Spinal pain, Syncope
Clinical narrative: Patient had reaction after receiving 5 vaccines at his workplace at 5:10pm. Patient started not feeling well around 7pm  and fainted at work at 8:40pm. He left his workplace to go home and couldn't finish his shift.  He is experiencing  overall body pain and weakness. He is also has pain at the base of his head and pain down his spine. Patient was not showing any signs of an allergic reaction (no hives, no trouble breathing). Patient has not received medical attention for his condition but I advised him to do so if need be.
Age: 56.0
Sex: M
Vaccine: FLU4, HEP, HEPA, TDAP, VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Patient had reaction after receiving 5 vaccines at his workplace at 5:10pm. Patient started not feeling well around 7pm  and fainted at work at 8:40pm. He left his workplace to go home and couldn't finish his shift.  He is experiencing  overall body pain and weakness. He is also has pain at the base of his head and pain down his spine. Patient was not showing any signs of an allergic reaction (no hives, no trouble breathing). Patient has not received medical attention for his condition but I advised him to do so if need be.
Age: 56.0
Sex: M
Vaccine: FLU4, HEP, HEPA, TDAP, VARZOS, VARZOS
Symptoms: Asthenia, Headache, Loss of personal independence in daily activities, Malaise, Pain
Clinical narrative: MUSCULAR PAIN, ARTICULATIONS PAIN, HEADEACHE, FATIGUE
Age: 56.0
Sex: M
Vaccine: FLU4, HEP, HEPA, TDAP, VARZOS, VARZOS
Symptoms: Spinal pain, Syncope
Clinical narrative: MUSCULAR PAIN, ARTICULATIONS PAIN, HEADEACHE, FATIGUE
Age: 56.0
Sex: M
Vaccine: FLU4, HEP, HEPA, TDAP, VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: MUSCULAR PAIN, ARTICULATIONS PAIN, HEADEACHE, FATIGUE
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Low grade fever up to 100.9, lasting longer than 24 hours after injection.
Age: 54.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Lip swelling, Odynophagia, Rash, Swelling of eyelid
Clinical narrative: Broke out in a rash on the back, chest, buttocks. On the 28th, eyelids and upper lip had swelling. Had throat pain when swallowing. Afterwards requested steroids.
Age: 54.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Herpes zoster, Lip swelling, Papule, Rash papular, Rash pruritic
Clinical narrative: Broke out in a rash on the back, chest, buttocks. On the 28th, eyelids and upper lip had swelling. Had throat pain when swallowing. Afterwards requested steroids.
Age: 54.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: Broke out in a rash on the back, chest, buttocks. On the 28th, eyelids and upper lip had swelling. Had throat pain when swallowing. Afterwards requested steroids.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left arm from elbow to shoulder was swolen, tender to touch, and warm. Patient has taken claritin, and tylenol. Patient has been icing the arm for 2 days now. Symptoms are slowly going away after 2 days but it still irritates the patient
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Pain
Clinical narrative: About 2 minutes after the vaccine was administered, she began to experience a wash of pain all over from head to toe as she was walking. She did not have any other symptoms other than the pain (no fainting, no difficulty breathing, no vision changes, etc.). She was able to get to the walk-in urgent clinic in our store via a motorized shopping scooter to be examined by a provider and said the pain improved when she was able to hold still and not move. They prescribed her prednisone and diphenhydramine, but her symptoms had resolved by the time I followed up with her husband around 2:30 pm.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Pyrexia, Swelling face
Clinical narrative: Patient reports a low grade fever started the night of the vaccination and then facial swelling on the same side as the flu shot (right).
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER ON 9-3-2020 OF 102-103, VOMITTING 9-4-2020, NO REACTION AT INJECTION SITE. PRIMARY CARE VISIT SCHEDULED FOR 9-4-2020 @1:30 TO ASSESS IN CLINIC