chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: On 03/07/2018 patient had a visible red rash in the form a large ring, the size of a palm, around the injection site (left thigh). It was hot to the touch and felt hard. I notified the Dr and they did advised to give benadryl. On 03/10/18, the redness increased and a new rash had developed on right ankle. While in Urgent care, small hives started showing up on his neck, chest, legs and arms. The Dr confirmed it was hives and an allergic reaction. The dr prescribed him prednisone. His symptoms persisted to large red spots covering head to toe, even his scalp area. It was itchy and hot to the touch, We did apply calamine lotion to soothe the itching. The redness did decrease but hive are still visible. Patient does not have any other symptoms except a minor cough along with the itchiness.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site injury, Lipoma, Loss of personal independence in daily activities
Clinical narrative: Per MD note, 2/28/18: 10/12/17 left shoulder injury after vaccination. She is a disabled MD and has done some investigating believes this to be: SIRVA (shoulder injury related to vaccine administration). She reports immediately at the time of administration, she felt the vaccine had been placed too high on the arm and actually felt intra-articular. Worsening pain, dysfunction and limited motion followed subsequently. H/O remote FOOSH injury 1995-6 injuries bilateral shoulders, no other trauma, can't even make the bed. Started feeling slightly better in the last 2-4 weeks. Doing diclofenac BID. Heating pad BID. ROM exercises started within a few days. Pain even just with dependency as the arm hangs at rest. Lipoma on same shoulder non new. Review of previous records 4x5 cm -- unchanged.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Per MD note, 2/28/18: 10/12/17 left shoulder injury after vaccination. She is a disabled MD and has done some investigating believes this to be: SIRVA (shoulder injury related to vaccine administration). She reports immediately at the time of administration, she felt the vaccine had been placed too high on the arm and actually felt intra-articular. Worsening pain, dysfunction and limited motion followed subsequently. H/O remote FOOSH injury 1995-6 injuries bilateral shoulders, no other trauma, can't even make the bed. Started feeling slightly better in the last 2-4 weeks. Doing diclofenac BID. Heating pad BID. ROM exercises started within a few days. Pain even just with dependency as the arm hangs at rest. Lipoma on same shoulder non new. Review of previous records 4x5 cm -- unchanged.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site dermatitis, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Pain at injection site and then maculopapular rash developed anterior to injection a few days later exam: Skin: non-icteric erythematous, maculopapular, patchy dermatitis over left upper arm anterior to site of injection. Mildly indurated, warm and tender.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash maculo-papular
Clinical narrative: Pain at injection site and then maculopapular rash developed anterior to injection a few days later exam: Skin: non-icteric erythematous, maculopapular, patchy dermatitis over left upper arm anterior to site of injection. Mildly indurated, warm and tender.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Was inadvertently provided MMR-V (proquad) instead of MMR, in addition to Varicelle single component vaccine. No adverse events reported as of 3/12 by mother.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Mobility decreased, Pyrexia
Clinical narrative: Patient said she felt chills and fever, very severe flu like symptoms. She felt she could barely walk or lift her arms, and wasn't sure if she would "make it through the night." By morning symptoms were starting to subside.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient complaints of soreness and redness on her right arm. I advised patient to take ibuprofen and if he soreness isn't get better in the next few days, then give us a call back. I explained to her that it's very common side effect and it will go away in few days.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild swelling approximately 1.5x1.5 with light redness to right bicep area. Reaction was reported to our clinic on 3/9/18.  Ice applied x20min. with instructions to continue ice at home. Acetaminophen 650mg po given and Ibuprofen 400mg given. On 3/12/18 employee returned to clinic and was given Loradamed and a Prednisone dose pack.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dysstasia, Erythema, Hypersensitivity, Hypotension
Clinical narrative: Patient arm from elbow to shoulder turned red and swollen. Patient experienced low blood pressure and dizziness to the point she could not stand. She was taken to the hospital by ambulance. The hospital gave her oral BENADRYL and IV Steroids and after about 20 minutes she began to feel better. The hospital doctor told the patient she was having an allergic reaction to the shot.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient arm from elbow to shoulder turned red and swollen. Patient experienced low blood pressure and dizziness to the point she could not stand. She was taken to the hospital by ambulance. The hospital gave her oral BENADRYL and IV Steroids and after about 20 minutes she began to feel better. The hospital doctor told the patient she was having an allergic reaction to the shot.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Patient received the influenza vaccine around 11 AM in her left arm. At around 3 PM, she began developing a hive-like rash in her left armpit, along her left bra line. The rash quickly spread all over her body and was quite itchy. She did not have any swelling of her mouth, tongue, or airway. She called the clinic at 5 PM, was told to take BENADRYL. The patient has continued to have severe flares of all-over hives (at least through Saturday 3/10/18). BENADRYL helped but she had to take large doses on a regular basis to keep the rash under control. She was advised to go back to the health clinic to be examined but she said she was unable to due to work demands.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pruritus, Skin warm
Clinical narrative: Pt stated she noticed some itchiness and redness in her arm the day after the immunization was given. Then she noticed the arm was warm to touch. Pt called and made an appt with the provider. Provider evaluated the patient and decided it was cellulitis. Provider then treated with cold compresses and a Anti-biotic.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Sudden onset of nausea and vomiting.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV1, UNK
Symptoms: Diarrhoea, Influenza, Pallor, Pyrexia, Rash
Clinical narrative: Unable to wake up for more than two minutes. Pale and couldn't tell if she was breathing or not. Was rushed in the ER upon visit they said everything came back normal. And they didn't want to keep her because they thought it would only stress her out. She also got a rash, high fever, diarrhea and cold a flu symptoms that lasted for 4-5 days after the vaccines. She still has a "rash" that comes and goes on her face. She was also seen by Local urgent care and her pediatrician.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV1, UNK
Symptoms: Somnolence
Clinical narrative: Unable to wake up for more than two minutes. Pale and couldn't tell if she was breathing or not. Was rushed in the ER upon visit they said everything came back normal. And they didn't want to keep her because they thought it would only stress her out. She also got a rash, high fever, diarrhea and cold a flu symptoms that lasted for 4-5 days after the vaccines. She still has a "rash" that comes and goes on her face. She was also seen by Local urgent care and her pediatrician.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Sweating, chills, local site pain and swelling, body aches, patient says felt like flu but did not check the temperature, no vomiting.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Sweating, chills, local site pain and swelling, body aches, patient says felt like flu but did not check the temperature, no vomiting.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness at injection site the evening of the injection, the next day increased soreness, swelling and redness at site. On second day after, increased area of redness, increased discomfort enough to cause difficulty in raising arm. Warmth at injection site started the next day and continued for 3 days. By third day after injection, redness and swelling the size of a tennis ball. Painful  to move arm.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pain
Clinical narrative: Soreness at injection site the evening of the injection, the next day increased soreness, swelling and redness at site. On second day after, increased area of redness, increased discomfort enough to cause difficulty in raising arm. Warmth at injection site started the next day and continued for 3 days. By third day after injection, redness and swelling the size of a tennis ball. Painful  to move arm.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Rash, Rash erythematous
Clinical narrative: The patient came to the pharmacy on 3/12 and complained of a red rash on his arm with a little pain still around the injection site.
Age: 33.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Pain
Clinical narrative: Location where flu vaccine was administered still hurts two weeks after administration. Painful to exert deltoid muscle.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Eye movement disorder, Fatigue, Musculoskeletal stiffness, Seizure, Speech disorder
Clinical narrative: 03/11/2018, my daughter had a seizure after arriving home from a long drive. She tensed up and was stiff, all leaning toward the left but tremoring and shaking violently. She couldn't talk or move her eyes. It lasted a few minutes and when it was over she was fatigued a little and then was normal again. A few days prior she was also experiencing tremors in her leg for a while. After less than a week of having her hepatitis A vaccine.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Tension, Tremor
Clinical narrative: 03/11/2018, my daughter had a seizure after arriving home from a long drive. She tensed up and was stiff, all leaning toward the left but tremoring and shaking violently. She couldn't talk or move her eyes. It lasted a few minutes and when it was over she was fatigued a little and then was normal again. A few days prior she was also experiencing tremors in her leg for a while. After less than a week of having her hepatitis A vaccine.
Age: 36.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Eye pruritus, Nasal pruritus, Pruritus
Clinical narrative: Client sated that within a few minutes of receiving vaccines, she started itching-mostly in face, but also in nose and eyes.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Irritability, Rash, Skin warm, Urticaria
Clinical narrative: 30 min after above immunization and given Similac sensitive (pro) pt got hives, red, fussy felt hot. Pt returned to office about 1 hour after rash got BENADRYL, DECADRON observed. Much improved.
Age: 75.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Fever (highest temp=101) started on 03/09/18. Generalized rash, small red bumps, not itchy, started last night, 03/11/18. Bilateral wrist pain.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Antinuclear antibody, Biopsy skin, C-reactive protein, Full blood count, Metabolic function test
Clinical narrative: Patient has a papular rash on UE and trunk that developed 8 hives after HPV vaccine given. Pt does not have any itchiness to the sites. Pt had been referred to allergy and dermatology for further testing. Pt currently still has the rash.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash papular, Urticaria
Clinical narrative: Patient has a papular rash on UE and trunk that developed 8 hives after HPV vaccine given. Pt does not have any itchiness to the sites. Pt had been referred to allergy and dermatology for further testing. Pt currently still has the rash.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash pruritic, Urticaria
Clinical narrative: Developed pruritic rash approximately 12 hours after administ. Band-like around (R) upper arm, scattered hives 1-3" diameter on scalp, face, neck, and upper.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 61-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 2nd March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced headache, fatigue, shivering, muscle pain and fever. On an unknown date, the outcome of the headache, fatigue, shivering, muscle pain and fever were recovering/resolving. The reporter considered the headache, fatigue, shivering, muscle pain and fever to be related to SHINGRIX. Additional details were reported as follows: The patient experienced a headache, muscle aches, fever, shivering, and fatigue. The patient's symptoms were described as severe on Saturday and were not resolved but improving at the time of the reporting. The patient did not require any intervention, physician's visit, hospitalization and the symptoms were not considered disabling or life threatening.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a elderly male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. The reporter considered the feeling unwell to be probably related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. Reporter was the daughter of the patient. No concomitant vaccine was reported. Reporter was not aware of any concomitant medications. The reporter noted that the patient received SHINGRIX injection and began feeling sick. The patient's event fully resolved the next morning, no additional information provided. No vaccine administration facility information was provided. The reporter did not have lot number or expiration date of the product. Date of injection and dose of injection were unknown. Start date and stop date of event were unknown. Reporter denied hospitalization or need for hospitalization to treat this event. The patient had denied permission to contact their physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 70-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included Atorvastatin and vitamin D. On 23rd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th March 2018, 12 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The pharmacist reported that the patient experienced rash around her eye. It was unknown which eye was involved. Limited information was provided by the pharmacist.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be probably related to SHINGRIX. Additional details were reported as follows: This case was not previously reported to anyone. This case was reported by the patient's daughter who is also GlaxoSmithKline employee. The age at vaccination was not reported. No concomitant vaccines were reported and the reporter was not aware of any concomitant medications. The patient received SHINGRIX on an unknown arm. The reporter could not provide which arm was affected. The patient described the pain as her arm hurted for two days and the pain resolved two days after the vaccination. No vaccine admin facility information was provided. The reporter did not have lot number or expiry date of the vaccine. The reporter had denied hospitalization or need for hospitalization to treat this event. The patient denied permission to contact their physician.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Chest X-ray normal, Crying, Diarrhoea, Dyskinesia, Febrile convulsion
Clinical narrative: Patient had a febrile seizure on 3/11/2018 at 3 AM. Mom described him waking up suddenly and screaming and crying then staring off and having bilateral upper and lower extremity jerking. He then fell asleep. He was seen in an ED and was diagnosed with a LOM and started on AUGMENTIN. On 3/12 he began having episodes of vomiting and diarrhea. He has had fever since 3/11 - Mom is alternating TYLENOL and MOTRIN and says the fever comes back before he is due for the next dose of anti-pyretic.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Influenza virus test negative, Otitis media acute, Pyrexia, Screaming, Staring
Clinical narrative: Patient had a febrile seizure on 3/11/2018 at 3 AM. Mom described him waking up suddenly and screaming and crying then staring off and having bilateral upper and lower extremity jerking. He then fell asleep. He was seen in an ED and was diagnosed with a LOM and started on AUGMENTIN. On 3/12 he began having episodes of vomiting and diarrhea. He has had fever since 3/11 - Mom is alternating TYLENOL and MOTRIN and says the fever comes back before he is due for the next dose of anti-pyretic.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient had a febrile seizure on 3/11/2018 at 3 AM. Mom described him waking up suddenly and screaming and crying then staring off and having bilateral upper and lower extremity jerking. He then fell asleep. He was seen in an ED and was diagnosed with a LOM and started on AUGMENTIN. On 3/12 he began having episodes of vomiting and diarrhea. He has had fever since 3/11 - Mom is alternating TYLENOL and MOTRIN and says the fever comes back before he is due for the next dose of anti-pyretic.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pain, Rash
Clinical narrative: Patient called pharmacy 3/3/18 2 PM to report AE. She stated she had pain/soreness starting 5:30 PM on 3/1. Also, she noticed redness above injection site which partially wrapped around arm. Less pain on 3/3. On 3/4 - Rash resolving, pain only when pressing on site.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Chills, aches, nausea, back pain on spine, headache, severe pain in arm.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain
Clinical narrative: Chills, aches, nausea, back pain on spine, headache, severe pain in arm.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, Pyrexia
Clinical narrative: Bulging fontanel (anterior) x 1 day. Clinically stable. Observed and by 48 hrs and was back to flat/normal. Infant was fussy with sl. fever but never in acute distress.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Crying, Rash macular, Throat irritation, Urticaria
Clinical narrative: Within less than 5 min child began coughing and crying a lot. He then started to attempt to clear his throat and was wheezing. About 5-10 min after the vaccine started getting red blotchy skin and developed a small hive at R lower eyelid. Respiratory symptoms improved within 3-5 min of starting albuterol. He did get a dose of BENADRYL orally 10 ml that was given 1 min after albuterol was started but was too fast to have caused his respiratory symptoms to improve. He had never had an anaphylactic reaction to vaccines prior and had received all regular immunizations before (excluding influenza).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Within less than 5 min child began coughing and crying a lot. He then started to attempt to clear his throat and was wheezing. About 5-10 min after the vaccine started getting red blotchy skin and developed a small hive at R lower eyelid. Respiratory symptoms improved within 3-5 min of starting albuterol. He did get a dose of BENADRYL orally 10 ml that was given 1 min after albuterol was started but was too fast to have caused his respiratory symptoms to improve. He had never had an anaphylactic reaction to vaccines prior and had received all regular immunizations before (excluding influenza).
Sex: M
Vaccine: HPV9
Symptoms: Apathy, Fatigue
Clinical narrative: Information has been received from a physician via a field employee referring to a 14 year old male patient. Information about medical history, concurrent condition and concomitant medication was not provided. On 24-JAN-2018 the patient was vaccinated with a dose of GARDASIL 9 (intramuscular; lot#, dose and frequency unspecified) for human papillomavirus (HPV) prevention. On an unspecified date in 2018 the patient experienced unspecified fatigue and apathy towards school and sports. No treatment was given for the events. The physician reported that patient was doing much better on 26-FEB-2018. The outcome of the events was reported as recovering. The causality was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot # N010246, subcutaneously (strength and dose was not reported). Sterile diluent used for reconstitution was properly stored. No adverse effect was reported. The vaccines were stored between 6 degrees Fahrenheit (F) and 10 F for 54 minutes. There was no previous excursion reported. Data logger was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 05-MAR-2018, the patient was vaccinated with one shot of PEDVAXHIB (lot # N034006; expiry date: 01-FEB-2020) injection which had undergone a temperature excursion and was not supported. Dosing details were not reported. The temperature excursion occurred at 28.8 degrees Fahrenheit (°F) on an unknown date for a time frame of 35 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA002448.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 26 year and 10 months old female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient started GARDASIL 9 series for prophylaxis (dosing details were not reported). No adverse effect reported. No product quality complaint was present.
Age: 1.0
Sex: M
Vaccine: FLU4, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site induration, Irritability, Product storage error, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 1 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were reported as none. On 16-FEB-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N023960 with expiration date on 01-SEP-2019, subdermaly as prevention of varicella virus (strength, dose and anatomical location were not reported) reconstituted with a properly stored diluent (manufacturer unknown) lot number N026288 with expiration date on 08-FEB-2020. On the same day, the patient also received one dose of PREVNAR 13 (lot number S58703 with expiration date on 31-OCT-2019) and one dose of an unspecified flu shot influenza virus vaccine, manufactured by Sanofi (lot number UT5949JA expiration date on 30-JUN-2018). The administered dose of the vaccine experienced a temperature excursion in the range between 6°F to 14°F with a time frame of 30 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. On 19-FEB-2018, the patient's mother call the physician office and stated that on an unspecified date in February 2018, the patient developed fever, was fussy, and was vomiting, therefore she was told by the staff at the physician office to push fluids and keep the patient hydrated, however, later on the same day the patient was at the emergency room due to the aforementioned events, the patient was not admitted to the hospital and was sent home from the emergency room that same day with the instruction to push fluids and keep the patient hydrated. Additionally, it was reported that he patient recovered from the events pyrexia, irritability and vomiting on an unspecified date. On 23-FEB-2018, the patient was seen at physician office and was diagnosed with Roseola. On approximately 02-MAR-2018, reported as "approximately two weeks after", the patient developed a hardened dark spot at the injection site. The outcome of the events injection site induration and injection site discoloration was not reported and the reporter did not provided the causality assessment between the aforementioned events and therapy with VARIVAX.
Age: 1.0
Sex: M
Vaccine: FLU4, PNC13, VARCEL
Symptoms: Roseola, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 1 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were reported as none. On 16-FEB-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N023960 with expiration date on 01-SEP-2019, subdermaly as prevention of varicella virus (strength, dose and anatomical location were not reported) reconstituted with a properly stored diluent (manufacturer unknown) lot number N026288 with expiration date on 08-FEB-2020. On the same day, the patient also received one dose of PREVNAR 13 (lot number S58703 with expiration date on 31-OCT-2019) and one dose of an unspecified flu shot influenza virus vaccine, manufactured by Sanofi (lot number UT5949JA expiration date on 30-JUN-2018). The administered dose of the vaccine experienced a temperature excursion in the range between 6°F to 14°F with a time frame of 30 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. On 19-FEB-2018, the patient's mother call the physician office and stated that on an unspecified date in February 2018, the patient developed fever, was fussy, and was vomiting, therefore she was told by the staff at the physician office to push fluids and keep the patient hydrated, however, later on the same day the patient was at the emergency room due to the aforementioned events, the patient was not admitted to the hospital and was sent home from the emergency room that same day with the instruction to push fluids and keep the patient hydrated. Additionally, it was reported that he patient recovered from the events pyrexia, irritability and vomiting on an unspecified date. On 23-FEB-2018, the patient was seen at physician office and was diagnosed with Roseola. On approximately 02-MAR-2018, reported as "approximately two weeks after", the patient developed a hardened dark spot at the injection site. The outcome of the events injection site induration and injection site discoloration was not reported and the reporter did not provided the causality assessment between the aforementioned events and therapy with VARIVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 02-DEC-2011, the patient was inoculated with ZOSTAVAX by a physician (MD) at a medical clinic center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-MAR-2016, the patient was treated by the physician (same physician who administered the vaccine) at a medical clinic center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2010, the patient was inoculated with ZOSTAVAX at the internal medicine office, by a physician's assistant, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-APR-2016, he was treated by a physician at the internal medicine office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with complications. The patient has been prescribed VALTREX, LIDODERM, and acetaminophen, PERCOCET for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-JAN-2014, the patient was vaccinated at a community physicians clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2016 the patient was treated at physicians for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2011, the patient was inoculated at Physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-APR-2009, the patient was inoculated at a hospital with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-APR-2016, the patient was treated in emergency department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 14-MAY-2012, the patient was inoculated (by an unspecified person) with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-MAR-2016, she was treated (by an unspecified healthcare professional) at a medical group for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 30-DEC-2010, the patient was inoculated with ZOSTAVAX by a physician, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-MAR-2016, she was treated (by an unspecified healthcare professional) at a family care office, for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as chronic herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to be treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir and methylprednisolone (MEDROL) in attempt to curb her painful symptoms. On or about 28-MAR-2016, the patient received subsequent treatment from a physician for the diagnosis of post-herpetic polyneuropathy. The patient has been prescribed gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, post-herpetic polyneuropathy was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-JUN-2009, the patient was vaccinated with ZOSTAVAX, (lot # and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-APR-2016, the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-APR-2016 the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed prednisone, BACTROBAN and acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular, Vaccination failure
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-AUG-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-FEB-2015, the patient was treated at a hospital for persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed KEFLEX, ibuprofen, and oxycodone and PEROCET for management of her painful symptoms and chronic pain. On or about 27-MAR-2017, she sought subsequent treatment at a hospital for recurrent shingles treatment with baseline impaired vision that affected her left eye. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested. This spontaneous report as received from a lawyer refers to a female patient of unknown age with routine health maintenance. On 13-AUG-2014 the patient was vaccinated with ZOSTAVAX, unknown for routine health maintenance and prophylaxis. On 20-FEB-2015, 6 months 8 days after onset of therapy the patient experienced herpes zoster, immune system disorder and vaccination failure. On 27-MAR-2017 the patient experienced visual impairment. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of vaccination failure, visual impairment and immune system disorder is unknown. The reporter considered herpes zoster, visual impairment, immune system disorder and vaccination failure to be related to ZOSTAVAX. {Additional information has been requested. / Additional information is not expected.}
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-AUG-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-FEB-2015, the patient was treated at a hospital for persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed KEFLEX, ibuprofen, and oxycodone and PEROCET for management of her painful symptoms and chronic pain. On or about 27-MAR-2017, she sought subsequent treatment at a hospital for recurrent shingles treatment with baseline impaired vision that affected her left eye. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested. This spontaneous report as received from a lawyer refers to a female patient of unknown age with routine health maintenance. On 13-AUG-2014 the patient was vaccinated with ZOSTAVAX, unknown for routine health maintenance and prophylaxis. On 20-FEB-2015, 6 months 8 days after onset of therapy the patient experienced herpes zoster, immune system disorder and vaccination failure. On 27-MAR-2017 the patient experienced visual impairment. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of vaccination failure, visual impairment and immune system disorder is unknown. The reporter considered herpes zoster, visual impairment, immune system disorder and vaccination failure to be related to ZOSTAVAX. {Additional information has been requested. / Additional information is not expected.}