chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt stated that the day after receiving the vaccine she had a 103.5 degree fever that did not break for 16 hours, pt self treated with otc medication.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Bruising, very swollen, red, hard as a rock and soar. Expected to be mildly soar and a bruise but the swelling is the diameter of a baseball, hard and very soar. Have had a headache everyday since receiving shot and have had to take more pain relievers in the last few days then over the last 10 years. Site is very soar, red and swollen, not what I would consider a "mild" reaction. Received a tetanus with whooping cough vaccine, not sure what it was called or who manufactured it.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling
Clinical narrative: Bruising, very swollen, red, hard as a rock and soar. Expected to be mildly soar and a bruise but the swelling is the diameter of a baseball, hard and very soar. Have had a headache everyday since receiving shot and have had to take more pain relievers in the last few days then over the last 10 years. Site is very soar, red and swollen, not what I would consider a "mild" reaction. Received a tetanus with whooping cough vaccine, not sure what it was called or who manufactured it.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Sore arm reported by patient via phone on 6/9/18 at 9am. Sore to the point can't lay on side. TOLD PATIENT SORE ARM IS TYPICAL SIDE EFFECT FOR 3-4 DAYS AND TOLD PATIENT I WOULD CHECK BACK WITH THEM THE NEXT DAY. ON 6/10/18 I LEFT A VOICEMAIL FOR PATIENT AT 11 AM. I HEARD  BACK FROM PATIENT AT 2PM. SHE STATED HER INJECTION SITE REACTION HAD GOTTEN WORSE. IT IS RED AND RAISED AND IS ALSO CAUSING A SPASM-TYPE PAIN WHEN SHE RAISES HER ARM. SHE DESCRIBED IT AS A CHARLIE-HORSE-LIKE PAIN. EARLIER TODAY, SHE CALLED HER PCP AND SPOKE WITH AN ON-CALL NURSE. SHE WAS TOLD BY THE NURSE TO TAKE OVER THE COUNTER IBUPROFEN AND GO TO THE ER IF THE ISSUE WORSENS. I TOLD PATIENT THAT I AGREE WITH THAT AND THAT WE WILL BE REPORTING THIS AD VERSE EVENT TO THE VACCINE ADVERSE EVENT REPORTING SYSTEM. I ALSO TOLD HER WE WOULD CALL HER BACK TOMORROW TO CHECK ON HER AGAIN.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Pt reports that her L deltoid is sore after receiving the vaccine, two days later she developed a red rash in the area that is tender. Pt presented the day the rash developed.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Peripheral swelling, Rash
Clinical narrative: Presents for acute visit. On Monday, she got the first SHINGRIX vaccine in her left arm, at pharmacy. Later that night it was swollen and tender. The next 2 days it gradually got worse. The swelling and redness at the injection. She had chills for two nights but did not check her temp. Yesterday she developed a rash on her abdomen, today it is better after she took BENADRYL. She never had trouble breathing.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Presents for acute visit. On Monday, she got the first SHINGRIX vaccine in her left arm, at pharmacy. Later that night it was swollen and tender. The next 2 days it gradually got worse. The swelling and redness at the injection. She had chills for two nights but did not check her temp. Yesterday she developed a rash on her abdomen, today it is better after she took BENADRYL. She never had trouble breathing.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: 6/4/2018 SHINGRIX - Fever, nausea, severe pain and heat in left arm and left side, redness and swelling up to 6 inches diameter around injection site. Lasted for 5 days, now left with discoloration and nerve pain in upper left arm. Called doctor on 6/7/2018, told me to rest and take TYLENOL and not to get second dose. I was not initially told there was a second dose.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nausea, Neuralgia, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: 6/4/2018 SHINGRIX - Fever, nausea, severe pain and heat in left arm and left side, redness and swelling up to 6 inches diameter around injection site. Lasted for 5 days, now left with discoloration and nerve pain in upper left arm. Called doctor on 6/7/2018, told me to rest and take TYLENOL and not to get second dose. I was not initially told there was a second dose.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Swelling
Clinical narrative: 6/4/2018 SHINGRIX - Fever, nausea, severe pain and heat in left arm and left side, redness and swelling up to 6 inches diameter around injection site. Lasted for 5 days, now left with discoloration and nerve pain in upper left arm. Called doctor on 6/7/2018, told me to rest and take TYLENOL and not to get second dose. I was not initially told there was a second dose.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: Patient noticed some what she thought was normal injection site redness and tenderness but after a week she noticed "it was not healing" and a lump had formed. Today she has a 13mm erythematous and very tender area surrounding a 7mm nodule with rounded edges and a central punctum. Lesion is 15cm from the head of the humerus.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, CSF glucose increased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count negative
Clinical narrative: Acute Immune Demyelinating Polyneuropathy; symptoms of distal paresthesias started the evening after vaccine administration, eventually developed distal weakness and facial diplegia with cytoalbuminologic dissociation. He was admitted to Hospital for IVIG therapy then discharged to acute rehab.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Diplegia, Immunoglobulin therapy, Paraesthesia
Clinical narrative: Acute Immune Demyelinating Polyneuropathy; symptoms of distal paresthesias started the evening after vaccine administration, eventually developed distal weakness and facial diplegia with cytoalbuminologic dissociation. He was admitted to Hospital for IVIG therapy then discharged to acute rehab.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Memory impairment
Clinical narrative: Patient came in stating that received the SHINGRIX on Wednesday and on Friday was driving to a place he has gone to before and knew where it was but couldn't remember how to get there and this happened again the next day. He stated that this has never happened before he received the immunization.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: PT IS ONLY 18. SHOULD HAVE RECEIVED PEDIATRIC DOSE. NO ADVERSE EVENTS REPORTED BY PATIENT.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Peripheral swelling, Tremor
Clinical narrative: 1ST dose experienced SWOLLEN PAINFUL arm for about 4 DAYS; 2ND DOSE HAD CHILLS AND SHAKING AND VERY EXHAUSTED. Patient stated after 48 hours he felt fine.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip dry, Lip swelling, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Her arm felt sore and was swollen when she woke on 6/7/18 (the day after the shot) but that went away the following day. She had myalgia on 6/7/18 and felt achy all over which was also better on 6/8/18. She had swollen, tight upper lip on 6/7/18 which later in the day spread to her bottom lip. Today (6/10/18) the swelling has gone down in both lips but she still has an odd sensation in them and they are very dry now.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: Joint pain that would travel from one part of the body to another (groin area, left knee, right knee, right hand, etc). It would stay in one place for a few days before moving to the next area.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: PT IS 18 YRS OLD AND WAS GIVEN ADULT DOSE OF HAVRIX INSTEAD OF PEDIATRIC DOSE.  NO ADVERSE EFFECTS REPORTED.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Feeling abnormal, Gait disturbance, Pain
Clinical narrative: Dizziness, fogginess, chills, unstable gait, soreness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient complained that her left arm hurt, the injection site was red and warm to touch. She also had a knot where the injection was. Her whole arm hurt. She also said that she felt like she had the flu. She had body aches and felt weak for 3 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient complained that her left arm hurt, the injection site was red and warm to touch. She also had a knot where the injection was. Her whole arm hurt. She also said that she felt like she had the flu. She had body aches and felt weak for 3 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Vertigo
Clinical narrative: Extreme fatigue, red raised patch on arm (3"x4") & serious vertigo.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain, Rash
Clinical narrative: Pt got cellulitis pt came in and said she got cellulitis, pain, rash pt came 5:30pm 6/10/2018.
Age: 27.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: There is a large circular area around where I receive the typhoid shot that is extremely painful, swollen, itchy, hot to the touch and very hard (it's a firm raised circular spot that is visibly swollen and red). I've felt very tired and my arm and joints hurt.
Age: 27.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: There is a large circular area around where I receive the typhoid shot that is extremely painful, swollen, itchy, hot to the touch and very hard (it's a firm raised circular spot that is visibly swollen and red). I've felt very tired and my arm and joints hurt.
Age: 1.67
Sex: F
Vaccine: DTAP
Symptoms: Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood calcium normal, Blood glucose decreased, Blood glucose increased
Clinical narrative: Child woke up completely lethargic, sweaty, trembling and with eyes rolling in the back of her head.  She was rushed to the ED where it was immediately indicated that she was in a hypoglycemic state       (with a blood sugar of 39). She had mild metabolic acidosis on presentation. Preliminary blood work was done, however doctor never thought to test the insulin level. Dextrose bolus was administered and blood sugar spiked to 357. Child was placed on a 12 hour fast, as per the endocrinologist, and was intermittently tested for blood sugar. It never dropped again during the fast. All remaining blood work was unremarkable. Child was discharged the following day. Doctors claim that the sequence of events were idiopathic.
Age: 1.67
Sex: F
Vaccine: DTAP
Symptoms: Blood magnesium normal, Blood phosphorus normal, Blood prolactin normal, Cortisol normal, Eye movement disorder
Clinical narrative: Child woke up completely lethargic, sweaty, trembling and with eyes rolling in the back of her head.  She was rushed to the ED where it was immediately indicated that she was in a hypoglycemic state       (with a blood sugar of 39). She had mild metabolic acidosis on presentation. Preliminary blood work was done, however doctor never thought to test the insulin level. Dextrose bolus was administered and blood sugar spiked to 357. Child was placed on a 12 hour fast, as per the endocrinologist, and was intermittently tested for blood sugar. It never dropped again during the fast. All remaining blood work was unremarkable. Child was discharged the following day. Doctors claim that the sequence of events were idiopathic.
Age: 1.67
Sex: F
Vaccine: DTAP
Symptoms: Hyperhidrosis, Hypoglycaemia, Lethargy, Metabolic acidosis, Tremor
Clinical narrative: Child woke up completely lethargic, sweaty, trembling and with eyes rolling in the back of her head.  She was rushed to the ED where it was immediately indicated that she was in a hypoglycemic state       (with a blood sugar of 39). She had mild metabolic acidosis on presentation. Preliminary blood work was done, however doctor never thought to test the insulin level. Dextrose bolus was administered and blood sugar spiked to 357. Child was placed on a 12 hour fast, as per the endocrinologist, and was intermittently tested for blood sugar. It never dropped again during the fast. All remaining blood work was unremarkable. Child was discharged the following day. Doctors claim that the sequence of events were idiopathic.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Disturbance in attention, Erythema, Feeling abnormal
Clinical narrative: PAIN IN INJECTION SITE FOR 6 DAYS. A LARGE PART OF UPPER ARM SWOLLEN AND HOT ONSET 24 HOURS, CONTINUING FOR 4 DAYS. APPROXIMATELY 24 HOURS AFTER INJECTION CHILLS, FEVER, NAUSEA, HEADACHE, LETHARGIC, FUZZY HEADED, COULD NOT CONCENTRATE. REACTION CONTINUED FOR 72 HOURS. I MISSED 1.5 DAYS WORK BEFORE FEELING BETTER. I PUT ICE ON MY UPPER ARM, TOOK IBUPROFEN, DRANK LOTS OF WATER, DID NOT EAT FOOD, SLEPT A LOT.  I TRIED NEOSPORIN AND LAVENDER OIL ON MY ARM BUT IT STILL HAS A LARGE RED PATCH ALMOST A WEEK LATER BUT SWELLING IS GONE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Impaired work ability, Injection site pain, Lethargy
Clinical narrative: PAIN IN INJECTION SITE FOR 6 DAYS. A LARGE PART OF UPPER ARM SWOLLEN AND HOT ONSET 24 HOURS, CONTINUING FOR 4 DAYS. APPROXIMATELY 24 HOURS AFTER INJECTION CHILLS, FEVER, NAUSEA, HEADACHE, LETHARGIC, FUZZY HEADED, COULD NOT CONCENTRATE. REACTION CONTINUED FOR 72 HOURS. I MISSED 1.5 DAYS WORK BEFORE FEELING BETTER. I PUT ICE ON MY UPPER ARM, TOOK IBUPROFEN, DRANK LOTS OF WATER, DID NOT EAT FOOD, SLEPT A LOT.  I TRIED NEOSPORIN AND LAVENDER OIL ON MY ARM BUT IT STILL HAS A LARGE RED PATCH ALMOST A WEEK LATER BUT SWELLING IS GONE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: PAIN IN INJECTION SITE FOR 6 DAYS. A LARGE PART OF UPPER ARM SWOLLEN AND HOT ONSET 24 HOURS, CONTINUING FOR 4 DAYS. APPROXIMATELY 24 HOURS AFTER INJECTION CHILLS, FEVER, NAUSEA, HEADACHE, LETHARGIC, FUZZY HEADED, COULD NOT CONCENTRATE. REACTION CONTINUED FOR 72 HOURS. I MISSED 1.5 DAYS WORK BEFORE FEELING BETTER. I PUT ICE ON MY UPPER ARM, TOOK IBUPROFEN, DRANK LOTS OF WATER, DID NOT EAT FOOD, SLEPT A LOT.  I TRIED NEOSPORIN AND LAVENDER OIL ON MY ARM BUT IT STILL HAS A LARGE RED PATCH ALMOST A WEEK LATER BUT SWELLING IS GONE.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever 102.2 plus chills, nausea, headache. Pt self medicated with TYLENOL and finally went away next day. By the 24th felt better.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm was red, swollen, warm to touch Md gave patient KEFLEX 500 mg one twice a day for 5 days. Md told patient it could be infected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On or about 08-NOV-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2014, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neuralgia
Clinical narrative: RECURRENCE OF MOD SEVERE HERPETIC PAIN RIGHT T7-8 DERMATOME, WITHOUT RASH.  REQUIRING LYRICA FOR SX RELIEF. PREVIOUS H/O SHINGLES IN THAT DERMATOME.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: RECURRENCE OF MOD SEVERE HERPETIC PAIN RIGHT T7-8 DERMATOME, WITHOUT RASH.  REQUIRING LYRICA FOR SX RELIEF. PREVIOUS H/O SHINGLES IN THAT DERMATOME.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: RECURRENCE OF MOD SEVERE HERPETIC PAIN RIGHT T7-8 DERMATOME, WITHOUT RASH.  REQUIRING LYRICA FOR SX RELIEF. PREVIOUS H/O SHINGLES IN THAT DERMATOME.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Condition aggravated, Decreased activity, Neuralgia, Pain
Clinical narrative: RECURRENCE OF MOD SEVERE HERPETIC PAIN RIGHT T7-8 DERMATOME, WITHOUT RASH.  REQUIRING LYRICA FOR SX RELIEF. PREVIOUS H/O SHINGLES IN THAT DERMATOME.
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blindness unilateral, Corneal oedema, Eye pain, Slit-lamp examination, Vision blurred
Clinical narrative: Below report to Manufacturer: Possible side effect with SHINGRIX vaccine: I will BRIEFLY outline. I am writing to you as a patient. I'm an 87 year old retired pharmacist and believe I have a serious side effect from the first dose of SHINGRIX vaccine. One day after receiving the vaccine at Pharmacy I lost most of my vision in my left eye. I have a history of glaucoma and blepharitis (Rosacea) so I treated the symptoms as I previously did for the itchy, scratchy symptoms expecting the symptoms to disappear. However, the symptoms only got worse. My left eye became painful and extremely uncomfortable. I went to see my ophthalmologist. He was on vacation at the time, so I saw the optometrist who did not know why my vision was so blurry. I couldn't read the largest letter on the chart with the left eye. I reported that I got the SHINGRIX vaccine--after that I saw another ophthalmologist, and other eyes doctors until regular Dr. returned from vacation and I saw him several times. He did not know what caused my condition. I reported that the SHINGRIX was the only change in my medication. He referred me to a cornea specialist. He saw me three times--once with the swollen cornea, another time when I was off my glaucoma drops for a week as recommended by my regular eye doctor and Dr. said I needed a cornea transplant. I agreed and saw him a third time. He examined me and reconsidered. He said a transplant would not help me and may make my glaucoma worse. I went back to my regular eye doctor who disagreed somewhat and referred me to another cornea specialist. I have an appointment with him on 30 July. I would like to know if you have any reported side effects with SHINGRIX that relate to my condition. I don't believe any signs of herpes or rosacea was seen in my eyes when examined with a slit lamp. I spoke to one of my primary care doctors who was concerned and he added that I wouldn't be protected from Shingles without the second shot. I only briefly outlined the circumstances here. All this transpired over the past few months beginning the day after my SHINGRIX vaccine. My left eye doesn't appear to be getting worse at this time but I can't see through it. If you have any questions please contact me. I'll report my experience to other agencies in the event my symptoms may have been reported by others.
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Corneal oedema, Eye pain, Ocular discomfort, Slit-lamp tests normal, Vision blurred
Clinical narrative: Below report to Manufacturer: Possible side effect with SHINGRIX vaccine: I will BRIEFLY outline. I am writing to you as a patient. I'm an 87 year old retired pharmacist and believe I have a serious side effect from the first dose of SHINGRIX vaccine. One day after receiving the vaccine at Pharmacy I lost most of my vision in my left eye. I have a history of glaucoma and blepharitis (Rosacea) so I treated the symptoms as I previously did for the itchy, scratchy symptoms expecting the symptoms to disappear. However, the symptoms only got worse. My left eye became painful and extremely uncomfortable. I went to see my ophthalmologist. He was on vacation at the time, so I saw the optometrist who did not know why my vision was so blurry. I couldn't read the largest letter on the chart with the left eye. I reported that I got the SHINGRIX vaccine--after that I saw another ophthalmologist, and other eyes doctors until regular Dr. returned from vacation and I saw him several times. He did not know what caused my condition. I reported that the SHINGRIX was the only change in my medication. He referred me to a cornea specialist. He saw me three times--once with the swollen cornea, another time when I was off my glaucoma drops for a week as recommended by my regular eye doctor and Dr. said I needed a cornea transplant. I agreed and saw him a third time. He examined me and reconsidered. He said a transplant would not help me and may make my glaucoma worse. I went back to my regular eye doctor who disagreed somewhat and referred me to another cornea specialist. I have an appointment with him on 30 July. I would like to know if you have any reported side effects with SHINGRIX that relate to my condition. I don't believe any signs of herpes or rosacea was seen in my eyes when examined with a slit lamp. I spoke to one of my primary care doctors who was concerned and he added that I wouldn't be protected from Shingles without the second shot. I only briefly outlined the circumstances here. All this transpired over the past few months beginning the day after my SHINGRIX vaccine. My left eye doesn't appear to be getting worse at this time but I can't see through it. If you have any questions please contact me. I'll report my experience to other agencies in the event my symptoms may have been reported by others.
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Visual acuity tests abnormal
Clinical narrative: Below report to Manufacturer: Possible side effect with SHINGRIX vaccine: I will BRIEFLY outline. I am writing to you as a patient. I'm an 87 year old retired pharmacist and believe I have a serious side effect from the first dose of SHINGRIX vaccine. One day after receiving the vaccine at Pharmacy I lost most of my vision in my left eye. I have a history of glaucoma and blepharitis (Rosacea) so I treated the symptoms as I previously did for the itchy, scratchy symptoms expecting the symptoms to disappear. However, the symptoms only got worse. My left eye became painful and extremely uncomfortable. I went to see my ophthalmologist. He was on vacation at the time, so I saw the optometrist who did not know why my vision was so blurry. I couldn't read the largest letter on the chart with the left eye. I reported that I got the SHINGRIX vaccine--after that I saw another ophthalmologist, and other eyes doctors until regular Dr. returned from vacation and I saw him several times. He did not know what caused my condition. I reported that the SHINGRIX was the only change in my medication. He referred me to a cornea specialist. He saw me three times--once with the swollen cornea, another time when I was off my glaucoma drops for a week as recommended by my regular eye doctor and Dr. said I needed a cornea transplant. I agreed and saw him a third time. He examined me and reconsidered. He said a transplant would not help me and may make my glaucoma worse. I went back to my regular eye doctor who disagreed somewhat and referred me to another cornea specialist. I have an appointment with him on 30 July. I would like to know if you have any reported side effects with SHINGRIX that relate to my condition. I don't believe any signs of herpes or rosacea was seen in my eyes when examined with a slit lamp. I spoke to one of my primary care doctors who was concerned and he added that I wouldn't be protected from Shingles without the second shot. I only briefly outlined the circumstances here. All this transpired over the past few months beginning the day after my SHINGRIX vaccine. My left eye doesn't appear to be getting worse at this time but I can't see through it. If you have any questions please contact me. I'll report my experience to other agencies in the event my symptoms may have been reported by others.
Sex: M
Vaccine: VARCEL
Symptoms: Polymerase chain reaction positive, Rash generalised, Rash vesicular, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Information has been received from a literature article concerning an unidentified previously healthy male patient who was vaccinated with a dose of varicella virus vaccine live. "Five months after receipt of varicella vaccine the patient's 3 year old brother (WAES # 00080565) who was otherwise normal was noted to have thoracic zoster." Fourteen days after his brother developed thoracic zoster, the patient who had been immunized the same time as his brother was, developed a mild case of varicella. On the second day of his illness, he was observed to have 50 vesicular lesions in a generalized distribution on the trunk and scalp. He was playful and did not seem to be very ill. It was indicated that the patient's "mother had not had varicella during pregnancy" and the patient had "no known exposure to varicella except for contact three days before their immunization with a child who had the onset of rash three days later." Virus isolated from the patient was analyzed via polymerase  chain reaction and identified as "vaccine type." Subsequently the patient's experience was reported in a published literature article. It was reported that the patient developed a mild varicella-like rash from which vaccine strain varicella virus was isolated. This is an amended report. The event of secondary transmission was removed as the patient was vaccinated with VARIVAX and therefore the report does not meet the definition of "secondary transmission". No further information is expected.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous, non-valid report was received from a registered nurse and refers to seven unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. From 03-NOV-2017 to 20-NOV-2017, the patients were vaccinated with improperly stored ROTATEQ, orally, lot# reported as "N000592" , expiration date: 12-OCT-2018 (dose and frequency not reported). The vaccine underwent a temperature excursion between 9 to 25 Celsius degrees for 1 hours and 50 minutes. No previous excursions were reported. Digital data logger was involved in recording the excursion. No adverse effects were reported. The lot # M064719 has been verified to be not valid for ROTATEQ. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received for patients vaccinated with ROTATEQ vaccine that was involved in a data logger excursion. Follow up information has been received from registered nurse on 01-JUN-2018: This spontaneous report was received from a registered nurse and refers to 15 months old patient unknown gender. On 03-NOV-2017, the patient was vaccinated with improperly stored ROTATEQ, orally, lot# reported as "N000592" , expiration date: 12-OCT-2018 (dose and frequency not reported). This is one of several reports received from the same reporter (1806USA004013, 1806USA004061, 1806USA004062, 1806USA004063, 806USA004064 and 1806USA004065).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 1 year old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 24-MAY-2018, the patient was vaccinated with VARIVAX with lot # N030409 and expiration date 30-OCT-2019, subcutaneously for prophylaxis (dose not reported) and with PROQUAD recombinant Human albumin, with lot # N019249 with expiration date 20-DEC-2018, for prophylaxis (route and dose not reported) instead of M-M-R II. No adverse effects reported.
Sex: M
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Information has been received from a physician via a company representative, referring to a teenaged male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (strength, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. On an unspecified date, the teenaged patient developed Postural Orthostatic Tachycardia Syndrome (POTS). The outcome of postural orthostatic tachycardia syndrome was unknown.
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, referring to an unspecified infant patient whose age was approximately 2 to 3 months old, and gender was not specified. The patient's pertinent medical history, concomitant medications and information about any drug reactions or allergies experienced by the patient were not provided. The pharmacist reported that, on 25-MAY-2018, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23, for prophylaxis (drug administered to patient of inappropriate age) (concentration, dose number, frequency were not provided; route and anatomical location of administration, lot number and expiration date were unknown by the pharmacist). No adverse effects or product quality complains were reported by the pharmacist. Further information was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site reaction, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report has been received from a 66 years old female consumer, reporting on herself. The patient's pertinent medical history included, as current medical conditions, hypertension (reported as "high pressure"); asthma; and a nervous system disorder (reported as "unspecified neurological condition"). The concomitant medication the patient was taking included amlodipine; losartan potassium (manufacturer unknown) (reported as "losartan"); estradiol; gabapentin; calcium (unspecified) (reported as "calcium supplements"); and, omega-3 marine triglycerides (reported as "fish oil supplements"). The patient's drug reactions and allergies history included tramadol drug hypersensitivity and sulfonamide (reported as "sulfa drugs") allergy. In addition, the patient reported that on an unspecified date approximately in 2017 (reported as "about a year ago"), she "got a shot" of PREVNAR 13 and "it gave her like a 3 inch wide welt at the injection site". On 21-MAY-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 as prevention of pneumonia (prophylaxis) (concentration, dose, dose number were not provided; route and anatomical location of administration, lot number, expiration date were unknown by the patient; product circular number uspi-v110-i-1505r041). The patient stated that she was vaccinated at an unspecified "Pharmacy". The same day, about 4 or 5 hours later, the patient experienced a severe injection site reaction after being vaccinated. The patient stated that she had aching and stiffness in an unspecified arm (pain in extremity and musculoskeletal stiffness). Therefore, the patient mentioned she took TYLENOL and ADVIL as treatment. The patient stated that later, that night, "she could not feel comfortable while sleeping as it was very painful. The next day, on 22-MAY-2018, the patient reported that "it started swelling (peripheral swelling), and continued to do so over the next few days, along with the arm and up to her neck" (swelling). The patient mentioned that "it had started to slowly get better". When reporting, on 29-MAY-2018, the patient stated that day was "the first day she felt like it was back to normal", and that pain in extremity, injection site reaction, peripheral swelling, swelling and musculoskeletal stiffness had resolved. Further information was not provided and no product quality complains were reported. The patient did not provide any causality assessment for pain in extremity, injection site reaction, peripheral swelling, swelling and musculoskeletal stiffness in regards with PNEUMOVAX 23 vaccination.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report has been received from a 66 years old female consumer, reporting on herself. The patient's pertinent medical history included, as current medical conditions, hypertension (reported as "high pressure"); asthma; and a nervous system disorder (reported as "unspecified neurological condition"). The concomitant medication the patient was taking included amlodipine; losartan potassium (manufacturer unknown) (reported as "losartan"); estradiol; gabapentin; calcium (unspecified) (reported as "calcium supplements"); and, omega-3 marine triglycerides (reported as "fish oil supplements"). The patient's drug reactions and allergies history included tramadol drug hypersensitivity and sulfonamide (reported as "sulfa drugs") allergy. In addition, the patient reported that on an unspecified date approximately in 2017 (reported as "about a year ago"), she "got a shot" of PREVNAR 13 and "it gave her like a 3 inch wide welt at the injection site". On 21-MAY-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 as prevention of pneumonia (prophylaxis) (concentration, dose, dose number were not provided; route and anatomical location of administration, lot number, expiration date were unknown by the patient; product circular number uspi-v110-i-1505r041). The patient stated that she was vaccinated at an unspecified "Pharmacy". The same day, about 4 or 5 hours later, the patient experienced a severe injection site reaction after being vaccinated. The patient stated that she had aching and stiffness in an unspecified arm (pain in extremity and musculoskeletal stiffness). Therefore, the patient mentioned she took TYLENOL and ADVIL as treatment. The patient stated that later, that night, "she could not feel comfortable while sleeping as it was very painful. The next day, on 22-MAY-2018, the patient reported that "it started swelling (peripheral swelling), and continued to do so over the next few days, along with the arm and up to her neck" (swelling). The patient mentioned that "it had started to slowly get better". When reporting, on 29-MAY-2018, the patient stated that day was "the first day she felt like it was back to normal", and that pain in extremity, injection site reaction, peripheral swelling, swelling and musculoskeletal stiffness had resolved. Further information was not provided and no product quality complains were reported. The patient did not provide any causality assessment for pain in extremity, injection site reaction, peripheral swelling, swelling and musculoskeletal stiffness in regards with PNEUMOVAX 23 vaccination.
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous report as received from a company representative refers to a male patient of unknown age. On 29-MAY-2018 the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On 30-MAY-2018, 2 days after onset of therapy the patient experienced feeling abnormal. The outcome of feeling abnormal was reported as not recovered/not resolved.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, via a company representative, referring to an unspecified 65 years old patient of unspecified gender. The patient's pertinent medical history, concomitant medications and information about any drug reactions or allergies experienced by the patient were not provided. The pharmacist reported to the company representative that, on unspecified dates, the unspecified patient had already received a dose of pneumococcal 13v conj vaccine (CRM197) (reported as "PCV13") for an unknown indication; and two previous doses of PNEUMOVAX 23 for prophylaxis (concentration, dose, route and anatomical location of administration, lot number and expiration date were unknown by the pharmacist) (extra dose administered). No adverse effects were reported. Further information was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 03-JUN-2008, 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, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 28-JAN-2010, the patient was inoculated 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 06-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX and TYLENOL for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-JAN-2016, the patient was inoculated 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 and the patient subsequently contracted a persistent strain of herpes zoster. Shortly after being vaccinated in January of 2011 (conflicting information; pt vaccinated in 2016), the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and. treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 06-JUN-2011, the patient was inoculated 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 and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-JUL-2016, the patient was treated at a Dermatology Office for the onset of a vesicular rash, which was diagnosed as shingles. The patient has been prescribed valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: 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. On or about 01-OCT-2015, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-JUN-2016, the patient was treated by a physician at a dermatology office for a vesicular outbreak, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: 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 12-JAN-2012, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided), administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-APR-2016, the patient was treated by a physician assistant certified, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. 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 27-NOV-2007, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided), at a health department facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 21-JUN-2016, the patient was treated by a nurse practitioner, for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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. In 2015, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a health care facility (by an unspecified health care professional) for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.