chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 58-year-old female patient who received SHINGRIX) (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 19th January 2019, the patient received SHINGRIX (intramuscular). On 24th January 2019, 5 days after receiving SHINGRIX, the patient experienced injection site blisters and injection site erythema. On an unknown date, the outcome of the injection site blisters and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient has developed a blister and redness at the injection site after getting SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX.  Additional details were reported as follows: The reporting nurse was the concerned patient. The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter did not have any additional details for this event. The reporter did not consent to follow-up.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Electromyogram, Flank pain, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness
Clinical narrative: (L) flank pain, leg and arm pain and weakness. Hospitalized 10/28/18 - 10/31/18. Dx with Guillain Barre Syndrome.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: (L) flank pain, leg and arm pain and weakness. Hospitalized 10/28/18 - 10/31/18. Dx with Guillain Barre Syndrome.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: Pt woke up Saturday morning and after taking a shower, she noticed her arm was red, hot and swollen. It is also painful to the touch. As of today, the injection site is improving but is still red, warm to the touch and sore.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Tenderness
Clinical narrative: Pt woke up Saturday morning and after taking a shower, she noticed her arm was red, hot and swollen. It is also painful to the touch. As of today, the injection site is improving but is still red, warm to the touch and sore.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Administered the SHINGRIX vaccine the wrong route.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Vaccination site cellulitis
Clinical narrative: Patient received smallpox at the site on Jan 08, 2019 to right arm, Presented this morning at the MC with multiple vesicles in various stages of break out and healing. Patient stated she removed dressing after smallpox was given and took a shower the day she received the vaccine. States she was not instructed not to remove dressing for 3 days or not to shower with smallpox vaccine site uncovered. Patient noted with cellulitis around vaccinated area. Seen by PA was placed on antibiotics. I instructed her on proper cleaning and dressing technique. Importance of keeping area clean and dry and proper hand washing.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Severe shivering starting about 9 hours after vaccine and lasting 6 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersomnia
Clinical narrative: Vaccine received 10 AM. At 9 PM the same day had terrible shivers for about 3 hours. Slept until 7 AM the next day, had juice, went back to bed and slept until 4:30 PM without waking. After that, I was fine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The next day my arm hurt very badly and started to get red. Today the site is very hot, red 4" diameter and hurts and raised.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: The next day my arm hurt very badly and started to get red. Today the site is very hot, red 4" diameter and hurts and raised.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Bedridden, Fatigue, Loss of personal independence in daily activities, Neck pain
Clinical narrative: My son received the meningitis vaccine for college requirements. The same evening the vaccine was administered, my son began having severe back and neck pain. In addition, he had a low grade fever, extreme tiredness and body aches. He was not ill before receiving the vaccine. These symptoms lasted for almost a week. He was bedridden for that  week and could not go about his normal activities. He did recover, but had lingering aches and tiredness for a few weeks afterwards.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: My son received the meningitis vaccine for college requirements. The same evening the vaccine was administered, my son began having severe back and neck pain. In addition, he had a low grade fever, extreme tiredness and body aches. He was not ill before receiving the vaccine. These symptoms lasted for almost a week. He was bedridden for that  week and could not go about his normal activities. He did recover, but had lingering aches and tiredness for a few weeks afterwards.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Rash, Somnolence
Clinical narrative: Patient began running fever within 2 hours following immunizations on 1/30/19. Initially was 101. Fever was off and on, max was 103.5. Patient also developed a rash following the immunization on 1/30/19 on the trunk and back that gradually worsened. Mom reports that following patient's 6 month vaccines (PEDIARIX, HIB, PREVNAR) they took her to the ER because the patient would not wake up. The ER was unable to find anything wrong with her per mom.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Lymph node pain, Lymphadenopathy, Musculoskeletal stiffness, Neck pain
Clinical narrative: After receiving the Tdap - BOOSTRIX PFS from GlaxoSmithKline, I began having severe aching and stiffness in my neck and shoulders. The following day, I had noticeably enlarged lymph nodes along my collarbone, which were painful to touch. These symptoms lasted for close to 2 weeks. Since that time, I have had joint pain in my hips, knees, ankles and elbows off and on. I did not have these pains before, but did not think they could be related to the vaccine. Now, I'm not so sure.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Amnesia, Confusional state, Fatigue, Laboratory test normal
Clinical narrative: Patient experienced extreme fatigue the day of vaccination, confusion and persistent memory loss after vaccination.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Dizziness and light headed. Monitored patient for a few hours no meds given until recovery.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Per patient, itching started 5-6 hours post injection. When area was checked swelling and redness noted presenting like hives. Denies any fever/chills, pain and/or any other complain. Symptoms resolved in 2 days.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient states that her arm is still sore after receiving flu shot 4 months ago. The tricep in the vaccinated arm is sore and she reports it getting stiff.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Exposure via skin contact, Inflammation, Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 47 year old male patient with immunization. The patient's pertinent drug allergies, medical history and concomitant medications were not reported. On 04-JAN-2019, the patient was accidentally exposed to an unknown amount of M-M-R II route via topical for immunization(accidental exposure to product and exposure via skin contact). One week later, on 11-JAN-2019, 8 days after onset of therapy the patient developed an inflamed rash (rash and inflammation). The outcome of rash and inflammation was reported as not recovered. The patient had called his physician and sent pictures of the rash, but the treatment was known to have been provided yet. No other information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of white blood cell count increased in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 28 days after receiving SHINGRIX, the patient experienced white blood cell count increased. On an unknown date, the outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the white blood cell count increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported as an adverse event via click to chat. The patient had undergone a blood test four weeks after receiving SHINGRIX and 4 months later and the white blood cell count was elevated. The patient asked if the vaccination was responsible and also asked how long would the elevation last. The patient had an another test two months later and still the white blood cell count were elevated. Lab Comments: on an unknown date, the white blood cell count was increased.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX (batch number G2ZF2, expiry date 22nd March 2021) for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site blisters, injection site pain and fever. On an unknown date, the outcome of the injection site erythema, injection site blisters and injection site pain were recovered/resolved and the outcome of the fever was unknown. It was unknown if the reporter considered the injection site erythema, injection site blisters, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated the redness and blisters at the injection site were 3 inches by 5 inches in size in the shape of a band around the arm. The pain level was seven out of ten on a pain scale. This lasted for four weeks. Did not consent to follow up. The dose of the injection was what the pharmacist stated when the question was asked. The pharmacist did provide the name and address of the patient.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Laboratory test, Vomiting, X-ray normal
Clinical narrative: Two days after first vaccine set, vomiting prompted ER evaluation, and abdominal film read as possible intussusception, which spontaneously resolved after transfer to higher-level facility.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Exfoliative rash, Peripheral swelling, Rash generalised, Rash pruritic
Clinical narrative: Patient called pharmacy today (3 months after vaccine given). She states that 1 week after SHINGRIX was given, that she developed a bump on her arm. Not long after, she had a itchy, scaly rash develop on her face and head. It has now spread to her entire body, head to toe. She has no pain or neuropathy from the rash. She has seen two physicians and her doctor is now having her "detox".
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Exfoliative rash, Hypersensitivity, Pruritus, Rash generalised
Clinical narrative: Patient called pharmacy today (3 months after vaccine given). She states that 1 week after SHINGRIX was given, that she developed a bump on her arm. Not long after, she had a itchy, scaly rash develop on her face and head. It has now spread to her entire body, head to toe. She has no pain or neuropathy from the rash. She has seen two physicians and her doctor is now having her "detox".
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash generalised, Rash pruritic, Temperature intolerance
Clinical narrative: Patient called pharmacy today (3 months after vaccine given). She states that 1 week after SHINGRIX was given, that she developed a bump on her arm. Not long after, she had a itchy, scaly rash develop on her face and head. It has now spread to her entire body, head to toe. She has no pain or neuropathy from the rash. She has seen two physicians and her doctor is now having her "detox".
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Exfoliative rash, Peripheral swelling, Rash generalised, Rash pruritic
Clinical narrative: Within 5 days developed itchy spot on right arm. Rash spread to skull/hairline. Rash scaly, itchy, burning rash. About 5 weeks ago, rash spread to entire body except for face and feet. It feels like if it was poison ivy all over body. Went to Dr. (dermatologist), who specified it was an allergic reaction but was not sure to what; medication given did not work at all. On 2/2, since other doctor was not available, went to Dr. (dermatologist). She specific that rash was related to vaccine, gave a shot to detox liver and Reishi Immune. Went back to doctor today since there was no improvement; received another shot today. Pt has follow-up appt on 2/9. Rash consuming because it itches constantly. Patient delaying cancer follow-up testing until immune system is back to normal.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Exfoliative rash, Hypersensitivity, Pruritus, Rash generalised
Clinical narrative: Within 5 days developed itchy spot on right arm. Rash spread to skull/hairline. Rash scaly, itchy, burning rash. About 5 weeks ago, rash spread to entire body except for face and feet. It feels like if it was poison ivy all over body. Went to Dr. (dermatologist), who specified it was an allergic reaction but was not sure to what; medication given did not work at all. On 2/2, since other doctor was not available, went to Dr. (dermatologist). She specific that rash was related to vaccine, gave a shot to detox liver and Reishi Immune. Went back to doctor today since there was no improvement; received another shot today. Pt has follow-up appt on 2/9. Rash consuming because it itches constantly. Patient delaying cancer follow-up testing until immune system is back to normal.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash generalised, Rash pruritic, Temperature intolerance
Clinical narrative: Within 5 days developed itchy spot on right arm. Rash spread to skull/hairline. Rash scaly, itchy, burning rash. About 5 weeks ago, rash spread to entire body except for face and feet. It feels like if it was poison ivy all over body. Went to Dr. (dermatologist), who specified it was an allergic reaction but was not sure to what; medication given did not work at all. On 2/2, since other doctor was not available, went to Dr. (dermatologist). She specific that rash was related to vaccine, gave a shot to detox liver and Reishi Immune. Went back to doctor today since there was no improvement; received another shot today. Pt has follow-up appt on 2/9. Rash consuming because it itches constantly. Patient delaying cancer follow-up testing until immune system is back to normal.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Influenza like illness
Clinical narrative: Moderate pain at site injection. Flu like symptoms: chills, body aches, joint pain, dizziness, tired,    Also got a few itchy small red bumps above the knee on upper legs and a couple on the right breast. The symtoms built up over 3 days and are beginning to subside on 4th day but I am still not normal. I am basically a very healthy person who walks 2-3 miles a day, works on our farm, and rides my horse. I am considering NOT taking the second shot.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Moderate pain at site injection. Flu like symptoms: chills, body aches, joint pain, dizziness, tired,    Also got a few itchy small red bumps above the knee on upper legs and a couple on the right breast. The symtoms built up over 3 days and are beginning to subside on 4th day but I am still not normal. I am basically a very healthy person who walks 2-3 miles a day, works on our farm, and rides my horse. I am considering NOT taking the second shot.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: Left arm - red, swollen, positive for itching and rash 2 cm raised erythematous. Patient instruction: Apply ice to area and prednisone also take BENADRYL.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediately following administration all sites appeared very red and swollen. Mother was advised to take child to ER.
Age: 27.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Blood test, Burning sensation, Computerised tomogram, Eyelid function disorder
Clinical narrative: 10/24/18 made appointment because I had flu like symptoms. Was told I had viral syndrome, and that the virus would clear within a couple days. The doctor put in an order in the immunization department for me to receive the HPV vaccine. 10/26/18 I was in ER with new symptoms. My entire body felt like it was on fire, explosive headache, my face hurt to touch. I was told its just the virus. 10/28/18 I was back in the ER with more symptoms. Pain still intensely burning through my body, I felt pins and needles in my hands, feet and head, face still hurt and I could close my right eye. I asked for an MRI, but was given a CT scan instead. Still I was told it's the virus. 10/29/18 I went in for a visit with the entire right side of my face paralyzed, lost a lot of strength in my legs I, was diagnosed with Bells Palsy. And was also told my bodily symptoms were jus the virus, which should have been gone by then. 11/1/18 office visit for worsening symptoms. I asked if I Should see a neurologist, and was told that I should wait a month before he'd write me a referral for one. 11/3-5 phone appointments for explosive headaches. Pain, and not being able to move. I was stuck in bed most of the day, I couldn't sit up without assistance. Was told virus. 11/6/2018 I went to ER because I hadn't been able to sleep. Was given morphine throughout the night, still it didn't take away all the pain and I could sleep. The ER doctor said he didn't believe I had Bells Palsy, but that I had GBS. Next morning I was given a lumbar puncture, and admitted in the hospital and immediately assigned to a neurologist. Tests confirmed GBS. I was given an MRI, and a five day treatment of IVig. I was hospitalized from 11/6/18-11/14/18. I lost majority of mobility in legs. Walked with cane up until last month. Im currently taking Lyrica for nerve pain. My face is still healing, and my eye still won't close. I spoke to a surgeon 1/30/2019 about surgical options for my eye.
Age: 27.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Facial pain, Facial paralysis, Guillain-Barre syndrome, Headache, Immunoglobulin therapy
Clinical narrative: 10/24/18 made appointment because I had flu like symptoms. Was told I had viral syndrome, and that the virus would clear within a couple days. The doctor put in an order in the immunization department for me to receive the HPV vaccine. 10/26/18 I was in ER with new symptoms. My entire body felt like it was on fire, explosive headache, my face hurt to touch. I was told its just the virus. 10/28/18 I was back in the ER with more symptoms. Pain still intensely burning through my body, I felt pins and needles in my hands, feet and head, face still hurt and I could close my right eye. I asked for an MRI, but was given a CT scan instead. Still I was told it's the virus. 10/29/18 I went in for a visit with the entire right side of my face paralyzed, lost a lot of strength in my legs I, was diagnosed with Bells Palsy. And was also told my bodily symptoms were jus the virus, which should have been gone by then. 11/1/18 office visit for worsening symptoms. I asked if I Should see a neurologist, and was told that I should wait a month before he'd write me a referral for one. 11/3-5 phone appointments for explosive headaches. Pain, and not being able to move. I was stuck in bed most of the day, I couldn't sit up without assistance. Was told virus. 11/6/2018 I went to ER because I hadn't been able to sleep. Was given morphine throughout the night, still it didn't take away all the pain and I could sleep. The ER doctor said he didn't believe I had Bells Palsy, but that I had GBS. Next morning I was given a lumbar puncture, and admitted in the hospital and immediately assigned to a neurologist. Tests confirmed GBS. I was given an MRI, and a five day treatment of IVig. I was hospitalized from 11/6/18-11/14/18. I lost majority of mobility in legs. Walked with cane up until last month. Im currently taking Lyrica for nerve pain. My face is still healing, and my eye still won't close. I spoke to a surgeon 1/30/2019 about surgical options for my eye.
Age: 27.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Insomnia, Lumbar puncture abnormal, Mobility decreased, Musculoskeletal disorder, Nerve conduction studies
Clinical narrative: 10/24/18 made appointment because I had flu like symptoms. Was told I had viral syndrome, and that the virus would clear within a couple days. The doctor put in an order in the immunization department for me to receive the HPV vaccine. 10/26/18 I was in ER with new symptoms. My entire body felt like it was on fire, explosive headache, my face hurt to touch. I was told its just the virus. 10/28/18 I was back in the ER with more symptoms. Pain still intensely burning through my body, I felt pins and needles in my hands, feet and head, face still hurt and I could close my right eye. I asked for an MRI, but was given a CT scan instead. Still I was told it's the virus. 10/29/18 I went in for a visit with the entire right side of my face paralyzed, lost a lot of strength in my legs I, was diagnosed with Bells Palsy. And was also told my bodily symptoms were jus the virus, which should have been gone by then. 11/1/18 office visit for worsening symptoms. I asked if I Should see a neurologist, and was told that I should wait a month before he'd write me a referral for one. 11/3-5 phone appointments for explosive headaches. Pain, and not being able to move. I was stuck in bed most of the day, I couldn't sit up without assistance. Was told virus. 11/6/2018 I went to ER because I hadn't been able to sleep. Was given morphine throughout the night, still it didn't take away all the pain and I could sleep. The ER doctor said he didn't believe I had Bells Palsy, but that I had GBS. Next morning I was given a lumbar puncture, and admitted in the hospital and immediately assigned to a neurologist. Tests confirmed GBS. I was given an MRI, and a five day treatment of IVig. I was hospitalized from 11/6/18-11/14/18. I lost majority of mobility in legs. Walked with cane up until last month. Im currently taking Lyrica for nerve pain. My face is still healing, and my eye still won't close. I spoke to a surgeon 1/30/2019 about surgical options for my eye.
Age: 27.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Neuralgia, Nuclear magnetic resonance imaging, Paraesthesia, Walking aid user
Clinical narrative: 10/24/18 made appointment because I had flu like symptoms. Was told I had viral syndrome, and that the virus would clear within a couple days. The doctor put in an order in the immunization department for me to receive the HPV vaccine. 10/26/18 I was in ER with new symptoms. My entire body felt like it was on fire, explosive headache, my face hurt to touch. I was told its just the virus. 10/28/18 I was back in the ER with more symptoms. Pain still intensely burning through my body, I felt pins and needles in my hands, feet and head, face still hurt and I could close my right eye. I asked for an MRI, but was given a CT scan instead. Still I was told it's the virus. 10/29/18 I went in for a visit with the entire right side of my face paralyzed, lost a lot of strength in my legs I, was diagnosed with Bells Palsy. And was also told my bodily symptoms were jus the virus, which should have been gone by then. 11/1/18 office visit for worsening symptoms. I asked if I Should see a neurologist, and was told that I should wait a month before he'd write me a referral for one. 11/3-5 phone appointments for explosive headaches. Pain, and not being able to move. I was stuck in bed most of the day, I couldn't sit up without assistance. Was told virus. 11/6/2018 I went to ER because I hadn't been able to sleep. Was given morphine throughout the night, still it didn't take away all the pain and I could sleep. The ER doctor said he didn't believe I had Bells Palsy, but that I had GBS. Next morning I was given a lumbar puncture, and admitted in the hospital and immediately assigned to a neurologist. Tests confirmed GBS. I was given an MRI, and a five day treatment of IVig. I was hospitalized from 11/6/18-11/14/18. I lost majority of mobility in legs. Walked with cane up until last month. Im currently taking Lyrica for nerve pain. My face is still healing, and my eye still won't close. I spoke to a surgeon 1/30/2019 about surgical options for my eye.
Age: 27.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Blood test abnormal, Burning sensation, Computerised tomogram, Eyelid function disorder
Clinical narrative: 10/24/18 made appointment because I had flu like symptoms. Was told I had viral syndrome, and that the virus would clear within a couple days. The doctor put in an order in the immunization department for me to receive the HPV vaccine. 10/26/18 I was in ER with new symptoms. My entire body felt like it was on fire, explosive headache, my face hurt to touch. I was told its just the virus. 10/28/18 I was back in the ER with more symptoms. Pain still intensely burning through my body, I felt pins and needles in my hands, feet and head, face still hurt and I could close my right eye. I asked for an MRI, but was given a CT scan instead. Still I was told it's the virus. 10/29/18 I went in for a visit with the entire right side of my face paralyzed, lost a lot of strength in my legs I, was diagnosed with Bells Palsy. And was also told my bodily symptoms were jus the virus, which should have been gone by then. 11/1/18 office visit for worsening symptoms. I asked if I Should see a neurologist, and was told that I should wait a month before he'd write me a referral for one. 11/3-5 phone appointments for explosive headaches. Pain, and not being able to move. I was stuck in bed most of the day, I couldn't sit up without assistance. Was told virus. 11/6/2018 I went to ER because I hadn't been able to sleep. Was given morphine throughout the night, still it didn't take away all the pain and I could sleep. The ER doctor said he didn't believe I had Bells Palsy, but that I had GBS. Next morning I was given a lumbar puncture, and admitted in the hospital and immediately assigned to a neurologist. Tests confirmed GBS. I was given an MRI, and a five day treatment of IVig. I was hospitalized from 11/6/18-11/14/18. I lost majority of mobility in legs. Walked with cane up until last month. Im currently taking Lyrica for nerve pain. My face is still healing, and my eye still won't close. I spoke to a surgeon 1/30/2019 about surgical options for my eye.
Age: 27.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Influenza like illness, Insomnia, Lumbar puncture, Magnetic resonance imaging, Mobility decreased
Clinical narrative: 10/24/18 made appointment because I had flu like symptoms. Was told I had viral syndrome, and that the virus would clear within a couple days. The doctor put in an order in the immunization department for me to receive the HPV vaccine. 10/26/18 I was in ER with new symptoms. My entire body felt like it was on fire, explosive headache, my face hurt to touch. I was told its just the virus. 10/28/18 I was back in the ER with more symptoms. Pain still intensely burning through my body, I felt pins and needles in my hands, feet and head, face still hurt and I could close my right eye. I asked for an MRI, but was given a CT scan instead. Still I was told it's the virus. 10/29/18 I went in for a visit with the entire right side of my face paralyzed, lost a lot of strength in my legs I, was diagnosed with Bells Palsy. And was also told my bodily symptoms were jus the virus, which should have been gone by then. 11/1/18 office visit for worsening symptoms. I asked if I Should see a neurologist, and was told that I should wait a month before he'd write me a referral for one. 11/3-5 phone appointments for explosive headaches. Pain, and not being able to move. I was stuck in bed most of the day, I couldn't sit up without assistance. Was told virus. 11/6/2018 I went to ER because I hadn't been able to sleep. Was given morphine throughout the night, still it didn't take away all the pain and I could sleep. The ER doctor said he didn't believe I had Bells Palsy, but that I had GBS. Next morning I was given a lumbar puncture, and admitted in the hospital and immediately assigned to a neurologist. Tests confirmed GBS. I was given an MRI, and a five day treatment of IVig. I was hospitalized from 11/6/18-11/14/18. I lost majority of mobility in legs. Walked with cane up until last month. Im currently taking Lyrica for nerve pain. My face is still healing, and my eye still won't close. I spoke to a surgeon 1/30/2019 about surgical options for my eye.
Age: 27.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nerve conduction studies abnormal, Pain, Paraesthesia, Viral infection, Walking aid user
Clinical narrative: 10/24/18 made appointment because I had flu like symptoms. Was told I had viral syndrome, and that the virus would clear within a couple days. The doctor put in an order in the immunization department for me to receive the HPV vaccine. 10/26/18 I was in ER with new symptoms. My entire body felt like it was on fire, explosive headache, my face hurt to touch. I was told its just the virus. 10/28/18 I was back in the ER with more symptoms. Pain still intensely burning through my body, I felt pins and needles in my hands, feet and head, face still hurt and I could close my right eye. I asked for an MRI, but was given a CT scan instead. Still I was told it's the virus. 10/29/18 I went in for a visit with the entire right side of my face paralyzed, lost a lot of strength in my legs I, was diagnosed with Bells Palsy. And was also told my bodily symptoms were jus the virus, which should have been gone by then. 11/1/18 office visit for worsening symptoms. I asked if I Should see a neurologist, and was told that I should wait a month before he'd write me a referral for one. 11/3-5 phone appointments for explosive headaches. Pain, and not being able to move. I was stuck in bed most of the day, I couldn't sit up without assistance. Was told virus. 11/6/2018 I went to ER because I hadn't been able to sleep. Was given morphine throughout the night, still it didn't take away all the pain and I could sleep. The ER doctor said he didn't believe I had Bells Palsy, but that I had GBS. Next morning I was given a lumbar puncture, and admitted in the hospital and immediately assigned to a neurologist. Tests confirmed GBS. I was given an MRI, and a five day treatment of IVig. I was hospitalized from 11/6/18-11/14/18. I lost majority of mobility in legs. Walked with cane up until last month. Im currently taking Lyrica for nerve pain. My face is still healing, and my eye still won't close. I spoke to a surgeon 1/30/2019 about surgical options for my eye.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: 12 days of arm soreness- no redness - when she presses on site of injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pain, Palpitations
Clinical narrative: Day 1 after: Shortness of breath, achiness. Day 2 after: Shortness of breath/palpitations. Patient went to ER on Day 2 after palpitations started.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Dizziness, Malaise, Mobility decreased, Muscular weakness
Clinical narrative: Severe muscle weakness, could not life my head off the pillow, nausea, dizziness, muscle pain. High fever, 104 °F, within 4 hours after vaccine. Within 6 months began having severe joint pain, muscles felt on fire occasionally. Began getting sick a lot.  After many different ER and doctor visits and then seeing a rheumatologist I was eventually diagnosed with lupus.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Nausea, Pyrexia, Systemic lupus erythematosus
Clinical narrative: Severe muscle weakness, could not life my head off the pillow, nausea, dizziness, muscle pain. High fever, 104 °F, within 4 hours after vaccine. Within 6 months began having severe joint pain, muscles felt on fire occasionally. Began getting sick a lot.  After many different ER and doctor visits and then seeing a rheumatologist I was eventually diagnosed with lupus.
Age: 60.0
Sex: M
Vaccine: TYP, YF
Symptoms: Arthralgia, Diarrhoea, Discomfort, Fatigue, Influenza A virus test negative
Clinical narrative: 01/31/2019: patient woke up with muscle aches, joint pain, facial pressure, fever 101 F. Seen in clinic 02/01/2019 and tested negative for Influenza. Provided rehydration solution, and instructed to take Ibuprofen as needed. 02/04/2019 Seen in clinic for diarrhea (6 x/day) for one day on 02/02/2019, with fever up to 101. On 02/04/2019, patient stated diarrhea only lasted one day, no other symptoms except fatigue and fever of 101 1 day ago. Feels much better today. Exam WNL. Provided Azithromycin 500 mg x 1 for diarrhea.
Age: 60.0
Sex: M
Vaccine: TYP, YF
Symptoms: Influenza B virus test, Influenza virus test negative, Myalgia, Pyrexia
Clinical narrative: 01/31/2019: patient woke up with muscle aches, joint pain, facial pressure, fever 101 F. Seen in clinic 02/01/2019 and tested negative for Influenza. Provided rehydration solution, and instructed to take Ibuprofen as needed. 02/04/2019 Seen in clinic for diarrhea (6 x/day) for one day on 02/02/2019, with fever up to 101. On 02/04/2019, patient stated diarrhea only lasted one day, no other symptoms except fatigue and fever of 101 1 day ago. Feels much better today. Exam WNL. Provided Azithromycin 500 mg x 1 for diarrhea.
Age: 1.17
Sex: F
Vaccine: VARCEL, FLU4, HEPA, VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Had Varicella vaccine 1/28. 2/3 developed vesicular rash- has spread all over body. No fever, + itchy. No known exposure to patient with varicella. Otherwise healthy girl. Acting fine. Eating and drinking fine [MD].
Age: 1.17
Sex: F
Vaccine: VARCEL, FLU4, HEPA, VARCEL
Symptoms: Asthenia, Blister, Fatigue, Rash pruritic, Varicella post vaccine
Clinical narrative: Had Varicella vaccine 1/28. 2/3 developed vesicular rash- has spread all over body. No fever, + itchy. No known exposure to patient with varicella. Otherwise healthy girl. Acting fine. Eating and drinking fine [MD].
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever x2 days.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and past drugs were unknown. Concomitant therapies included sterile diluent. On 23-JAN-2019 the patient was vaccinated with PROQUAD (Albumin status of rHA (recombinant human albumin)) (dose, frequency and route were unknown) (lot # N016994; expiration date: 29-NOV-2018) for prophylaxis, which was expired (expired product administered). No adverse effects (no adverse event) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Ear discomfort, Hypoacusis, Tinnitus
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 04-FEB-2016, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered a sudden and rapid decrease in hearing, sudden and constant ringing in ears, and ear pressure. Patient was diagnosed with sensorineural hearing loss and tinnitus. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of the ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, loss of accumulations, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, sensorineural hearing loss was determined to be medically significant. Sensorineural hearing loss and tinnitus were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injury associated with device, Scratch, Syringe issue
Clinical narrative: The initial case was missing the following minimum criteria: no adverse event, only reported product complaint. Upon receipt of follow-up information on 22Jan2019 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 2-month-old patient of an unspecified gender received PREVNAR 13, (lot number: X39675, expiry date: Oct2020), intramuscularly on an unspecified date at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported. The reporting nurse reported on 18Jan2019 that PREVNAR 13 syringe broke upon administration. She said that the same thing happened on 22Jan2019 again. The patient got scratched by the needle. This incident happened was from the same lot as the one she reported on 18Jan2019. The reporter said that they are freaking out and want to know if this has been reported before or is it just this lot number.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a contactable Physician. An 80-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergy "pneumonia vaccination" on an unspecified date with outcome of unknown. Pfizer is a Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Sex: M
Vaccine: PNC13
Symptoms: Decreased immune responsiveness, Ear infection, Ear tube insertion, Immunoglobulins abnormal, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative.  A 34-month-old male patient received PREVNAR 13 (lot #: R41774), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had multiple episodes of pneumonia and otitis after use of product on an unspecified date (eventually got tubes). The reporter discovered that his immune system didn't respond to the PCV 13 vaccine series. The patient was given a booster of PPV 23 and repeated his immunoglobulin levels which was much improved on an unspecified date. The outcome of all events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Sex: M
Vaccine: PNC13
Symptoms: Ear infection, Ear tube insertion, Therapy non-responder
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 26-month-old male patient received PREVNAR 13, (lot #: R41774), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had had multiple cases of otitis ending in tubes after use of product on an unspecified date. The patient saw an allergist and discovered that he did not respond to the PCV 13 series. He may or may not have an immunodeficiency. The reporter planned to give him a booster of PPV 23 and repeat immunoglobulin levels. The outcome of all events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical and concomitant medications were not reported. The patient experienced a burning sensation at the injection site after injection on an unspecified date. The outcome of the event was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported for a female patient of an unspecified age (Reported as Age: Over 65, unit: Unknown) received PREVNAR 13 (Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation, SHINGRIX, via an unspecified route of administration on an unspecified date at unspecified dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient received a pneumococcal vaccines and a SHINGRIX in different arms. The patient developed redness and swelling on the arm in the area where SHINGRIX was injected accompanied by pain. Pain was so great, the patient had to go to Urgent Care. Outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pain in extremity
Clinical narrative: Chills, fever up to 101 degrees, fatigue, muscle aches, light nausea, sore arm/muscle pain.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Chills, fever up to 101 degrees, fatigue, muscle aches, light nausea, sore arm/muscle pain.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, PNC13, RV1
Symptoms: Wrong product administered
Clinical narrative: Patient was given KINRIX instead of PENTACEL. PCP was notified and safety report done. Mother was notified. Per health dept this will count and should not be harmful to patient.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site nodule, Pruritus, Tenderness
Clinical narrative: Has a palpable subcutaneous linear nodule left upper arm. Mild tenderness. Seen in our office on 7/17/18 with persistent symptoms. Seen in our office again on 2/4/19 and 1.5 cm firm nodule still present. Mild tenderness and area is itchy on and off.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Injection site pain, Throat irritation
Clinical narrative: Patient was given a 2nd flu shot for the season, a 3rd MCV4, and the 3rd dose of HPV9 at 11.5 weeks instead of at the minimum 12 week interval. This miss-administration of these 3 vaccines was due to a technical error with immunization records not uploading from the clinic electronic medical record into the state record system. Patient reported sore injection sites on each arm and a scratchy throat. Provider believed the scratchy throat to be unrelated.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Experienced severe flu like symptoms for 2 days following 2nd shingles vaccine. I experienced the same symptoms after the 1st injection in May 2018. Headache, stomach ache, vomiting, total body ache, extreme fatigue. Needed to stay in bed for a day and half. This is someone who has no allergies, no medications except baby aspirin.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Experienced severe flu like symptoms for 2 days following 2nd shingles vaccine. I experienced the same symptoms after the 1st injection in May 2018. Headache, stomach ache, vomiting, total body ache, extreme fatigue. Needed to stay in bed for a day and half. This is someone who has no allergies, no medications except baby aspirin.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Migraine, Pain, Vomiting
Clinical narrative: Patient's headache started Friday morning after she got to school. I picked her up around 10 am.  Her headache got worse and worse throughout the day. She vomited 4 times. She has had 3-4 migraines in the last 3 years. At first I thought that was what this was, but after speaking to her, I discovered her symptoms were not the same as the other migraines. Her pain was in a different location and she did not have any eye sensitivity. Her pain has not gone away and today is day 4!
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported 2 to 3 hours post-injection, injection site reaction, localized to injection area being "large red and painful." Followed up with patient in 3 hours and patient reported there was no progression and that the patient was feeling OK.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Blood glucose increased, Enuresis, Pollakiuria, Thirst, Type 1 diabetes mellitus
Clinical narrative: Bed wetting at night, then constant thirst and urination for weeks. Brought to Pediatrician and then was referred to Hospital because of extremely high blood glucose levels. Hospital Endocrinology department diagnosed him with Type 1 Diabetes and he spent 3 days in the hospital.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: SWOLLEN LEG.