chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 97.0
Sex: M
Vaccine: VARZOS
Symptoms: Agitation, Confusional state, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 97-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dementia. On 7th November 2018, the patient received the 1st dose of SHINGRIX. On 7th November 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, pain and agitation. On 9th November 2018, the patient experienced influenza-like symptoms. On 10th November 2018, the patient experienced confusion and forgetfulness. On an unknown date, the outcome of the tiredness was not recovered/not resolved and the outcome of the pain, agitation and influenza-like symptoms were unknown and the outcome of the confusion and forgetfulness were recovered/resolved. It was unknown if the reporter considered the tiredness, pain, agitation, influenza-like symptoms, confusion and forgetfulness to be related to SHINGRIX. Additional details were provided as follows: The patient with dementia received a dose of SHINGRIX on left deltoid at 11:30 pm and as soon as he was injected the vaccine, he was agitated and said that the injection was really sore. The patient's wife told the pharmacy that because of his dementia he could not distinguish between discomfort and pain. On 7th November 2018 and 8th November 2018, he was tired. On 9th November 2018, he was agitated and started flu like symptoms. The patient was confused and forgot how to brush his teeth, wash his face and swallow medications. The patient at the time of reporting remembered how to brush his teeth, wash his face and swallow his medications again. The reporter consented to follow up.
Age: 97.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Memory impairment, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 97-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dementia. On 7th November 2018, the patient received the 1st dose of SHINGRIX. On 7th November 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, pain and agitation. On 9th November 2018, the patient experienced influenza-like symptoms. On 10th November 2018, the patient experienced confusion and forgetfulness. On an unknown date, the outcome of the tiredness was not recovered/not resolved and the outcome of the pain, agitation and influenza-like symptoms were unknown and the outcome of the confusion and forgetfulness were recovered/resolved. It was unknown if the reporter considered the tiredness, pain, agitation, influenza-like symptoms, confusion and forgetfulness to be related to SHINGRIX. Additional details were provided as follows: The patient with dementia received a dose of SHINGRIX on left deltoid at 11:30 pm and as soon as he was injected the vaccine, he was agitated and said that the injection was really sore. The patient's wife told the pharmacy that because of his dementia he could not distinguish between discomfort and pain. On 7th November 2018 and 8th November 2018, he was tired. On 9th November 2018, he was agitated and started flu like symptoms. The patient was confused and forgot how to brush his teeth, wash his face and swallow medications. The patient at the time of reporting remembered how to brush his teeth, wash his face and swallow his medications again. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown) for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness and injection site swelling. The patient was treated with Antihistamines and Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the injection site erythema, injection site tenderness and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site tenderness and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The patient experienced excessive redness, tenderness, and swelling in the same arm where she received her SHINGRIX vaccine. There was no fever. The symptoms were began the next day, worsened by 2 days after administration, and started to improve starting 4 days after administration. The symptoms was resolved since then, but the exact date was not known. The patient was advised to take antihistamines, and was also prescribed antibiotics in case of infection. The patient was out of state and therefore did not visit doctor's office, and all post-vaccination follow-up was done over the phone. The reporter was consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Needle issue, Pain in extremity, Underdose
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 19th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th November 2018, unknown after receiving SHINGRIX, the patient experienced accidental underdose. On 20th November 2018, the patient experienced pain in arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the accidental underdose was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient noticed in the morning of reporting date that his left arm was sore. The patient stated that he took Ibuprofen for the soreness. The patient stated that while he was getting the vaccine, the pharmacist told him that something happened with the needle and 2 or 3 drops of the vaccine did not get injected. The patient stated that the pharmacist checked with someone else there at the pharmacy and determined that the patient should be okay although the 2 or 3 drops did not get injected, which led to accidental underdose. The reporter gave consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of malaise in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved. It was unknown if the reporter considered the malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The vaccine had been administered at several local pharmacies. The physician reported that approximately 3 patients reported that after receiving 1st dose of SHINGRIX they experienced malaise which lasted 2 to 3 days. The patients reported symptoms to the doctor over the last few months from the date of reporting. The physician did not keep a log of patient information and had no access to product details. It was possible (but not verifiable) that these patients had previously been reported.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 75-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date 8th February 2021) for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was recovered/resolved. It was unknown if the reporter considered the localized erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right deltoid. The reporter stated that patient developed a red area across the stomach and naval area after receiving the SHINGRIX.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 18th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 19th November 2018, the patient experienced injection site erythema, injection site swelling and injection site warmth. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in left deltoid. The patient was presented with injection site hurt after receiving SHINGRIX. This injection site was swollen, warm to the touch, and red. The redness was spreading down to elbow. The patient described the area of the redness to be the size of two dollar coins side by side in diameter. The patient took BENADRYL on the day before reporting and on the day of reporting reported that the reaction had stabilized and was not getting worse.
Sex: M
Vaccine: VARZOS
Symptoms: Labyrinthitis, Neuritis, Vertigo
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vertigo in in a male pharmacist who administered the SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vertigo, neuritis, inner ear infection, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the vertigo, neuritis and inner ear infection were recovered/resolved and the outcome of the inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the vertigo, neuritis and inner ear infection to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The healthcare professional stated that, he developed vertigo, neuritis and an inner ear infection for 1 week following repeated administration of SHINGRIX to patients. The reporter gave consent to follow up. The healthcare professional stated that, he might have had some exposure to the SHINGRIX on his left hand, which led to inadvertent exposure to vaccine and exposure via skin contact.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 54-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number 92XR5, expiry date 30th June 2019) for prophylaxis. On 18th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 19th October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced fatigue, fever, chills, headache and general body pain. On an unknown date, the outcome of the fatigue, fever, chills, headache and general body pain were recovered/resolved. It was unknown if the reporter considered the fatigue, fever, chills, headache and general body pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The day after receiving FLUARIX, the patient experienced extreme fatigue, occasional fever, chills, headaches and body aches which lasted for 4 to 5 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 2nd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On 19th March 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The anatomical location for vaccination was left deltoid. The patient was vaccinated with the 1st dose of SHINGRIX and experienced soreness at the vaccination site, that lasted for a week. The reporter gave consent to follow up. This case was linked to case US2018214129 (2nd dose), reported by the same reporter for the same patient.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of passed out in a 65-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovered/resolved. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were received as follows: This case was reported by the office manager. After vaccination with SHINGRIX, the patient arrived at home and reported to the physician that he passed out and became unconscious. The patient noted that the event lasted for 6 hours. The representative was not sure, but believed the patient's initials were TV, but couldn't verify the last initial of V.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on arms by injection sites. MMR and DTaP were both given in each arm. Not sure which arm was which. Given BENADRYL and went away. Later showed back up on belly by ribs. This morning showed back up on ribs.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HEP, PPV, RVX
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider order vaccines for patient: Dtap-HIB-IPV, Hepatitis B, PCV13, and Rotavirus. I got vaccines from VFC fridge went over to RN to verify my vaccines, she gave the go ahead to proceed with vaccines. Patient waited in room with mom for 15 min, no reaction went home. Later that day around 3 PM I had the same order different patient got vaccines ready went to the Dr. to verify vaccines there Dr. identify I had KINRIX instead of PENTACEL. I went back to the fridge got the PENTACEL vaccine. Dr. verified the vaccines went ahead and did the administration of the vaccines. Once I was done with the vaccines I went back to the chart of my patient I administered vaccines and there I found I administered KINRIX on this patient instead of the PENTACEL. I informed my  lead, RN, Provider, supervisor. I called mother at 6 PM to inform her patient had received only DTAP-IPV only not with HIB; no reaction from patient per mother. RN was present when call was made. Mother scheduled to come in to clinic Monday. Monday morning appointment was cancelled. Called mother once again to schedule a follow up appointment was set and was a no-show. Next appointment set for patient now is 1/18/2019.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash generalised
Clinical narrative: Rash from toes to neck. Swelling at injection site.
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure increased, Chest discomfort, Headache, Nausea, Pain
Clinical narrative: Patient presented to the clinic w/chest discomfort, nausea, headache, and body aches 2 hrs post vaccination. Patient had elevated BP temporarily.
Age: 0.5
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Crying, Decreased eye contact, Dyskinesia, Grunting, Insomnia
Clinical narrative: Mother of child states the following: that child was irritable in the evening and through the night on 11/30/18. Child awoke with a fever of 102 on 12/1/18 and was irritable and crying or sleeping through the day of 12/1/18. Child cried all night 12/1-12/2 and mom had to hold her all night. Around 5 AM 12/2/18 she noticed that child had difficulty holding her head up, she does not make eye contact, she is grunting and mouth is crooked. She stated the child no longer had fever 12/2 to the present. She took child to her PCP today and there was a discussion about a neurologist referral but the referral wasn't made. Per mom the PCP "didn't know what else to do". This RN informed her to call PCP back for guidance for neurologist consult or guidance to go to ER. She is planning to take the child to the ER. Mother states that the PCP informed her to no longer get any vaccines.
Age: 0.5
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Irritability, Posture abnormal, Pyrexia, Somnolence
Clinical narrative: Mother of child states the following: that child was irritable in the evening and through the night on 11/30/18. Child awoke with a fever of 102 on 12/1/18 and was irritable and crying or sleeping through the day of 12/1/18. Child cried all night 12/1-12/2 and mom had to hold her all night. Around 5 AM 12/2/18 she noticed that child had difficulty holding her head up, she does not make eye contact, she is grunting and mouth is crooked. She stated the child no longer had fever 12/2 to the present. She took child to her PCP today and there was a discussion about a neurologist referral but the referral wasn't made. Per mom the PCP "didn't know what else to do". This RN informed her to call PCP back for guidance for neurologist consult or guidance to go to ER. She is planning to take the child to the ER. Mother states that the PCP informed her to no longer get any vaccines.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient presented to the pharmacy 12/4/18 to pick up prescription for Valacyclovir and reported outbreak of shingles post SHINGRIX vaccination.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blood iron decreased, Blood test, Electroencephalogram normal, Fall
Clinical narrative: While at school two hours after her shot, her teacher noticed her leaning towards her left side, she couldn't stand up straight at the playground, and kept falling down, then standing back up and then would fall again. Her teacher ran to her and that is when patient stated her legs were numb and she couldn't walk. However, the way she was saying it wasn't making sense. Just that her leg wasn't working. They brought her in, she had patient lean against the wall so she could get the rest of her class and when she got back in patient was on the floor again, her left side kept jilting, like shaking back and forth. Her entire left side only and she was spacing out. They called an ambulance and when I got there, the ambulance was there and her left side was still jilting. We took it to the hospital and while in the ambulance she said she couldn't lay down as it hurt her back badly and her legs so they had to sit her up and the pain got better. When we got to hospital, they stated she needed an x-ray on her leg and that she may have had a grand mal seizure. However after the x-ray was clear they just sent us home saying she had three random seizures and to schedule an app with a neurologist and her primary despite me stating it was abnormal for her to have seizures and no reason besides her just having her flu shot that morning. They sent us home anyways, we got home and noticed the leaning again she was doing it with her right side again and was spacey. Though she was moving and what not she was not making sense and was again just not talking and it was like she was looking beyond. Again we had her lay down and she continued to do that and then the tingling in her legs and back came back and she became overwhelmed with pain and I sat next her to and she stated I was sitting on her foot and I wasn't I was sitting next to her tummy and not on her foot. Then I asked her what hurt and noticed her right shoulder jolting again like her previous seizures and she stuttered IDK loudly due to pain, frustration and I'm sure the seizure. She ended up sleeping a lot like 20 hrs the next day it continued. I took her to the ER where they admitted her, did an MRI and EEG but didn't see anything and we saw Dr., a children's neurologist who stated her iron levels were on the low side and that he felt the drug (the shot) could have done it but they weren't sure what caused it, despite me providing a video of her behavior after we were sent home the first time from the ER. We have diazepam on hand for when the seizures last longer than 5mins. Her sleep patterns are off, her mood swings are awful now, and she gets frustrated and tired WAY easier than ever before and she's been having issues communicating with us even more. We won't know more until she gets older on how extensive the damage is.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Feeling abnormal, Frustration tolerance decreased, Gait inability, Hypersomnia
Clinical narrative: While at school two hours after her shot, her teacher noticed her leaning towards her left side, she couldn't stand up straight at the playground, and kept falling down, then standing back up and then would fall again. Her teacher ran to her and that is when patient stated her legs were numb and she couldn't walk. However, the way she was saying it wasn't making sense. Just that her leg wasn't working. They brought her in, she had patient lean against the wall so she could get the rest of her class and when she got back in patient was on the floor again, her left side kept jilting, like shaking back and forth. Her entire left side only and she was spacing out. They called an ambulance and when I got there, the ambulance was there and her left side was still jilting. We took it to the hospital and while in the ambulance she said she couldn't lay down as it hurt her back badly and her legs so they had to sit her up and the pain got better. When we got to hospital, they stated she needed an x-ray on her leg and that she may have had a grand mal seizure. However after the x-ray was clear they just sent us home saying she had three random seizures and to schedule an app with a neurologist and her primary despite me stating it was abnormal for her to have seizures and no reason besides her just having her flu shot that morning. They sent us home anyways, we got home and noticed the leaning again she was doing it with her right side again and was spacey. Though she was moving and what not she was not making sense and was again just not talking and it was like she was looking beyond. Again we had her lay down and she continued to do that and then the tingling in her legs and back came back and she became overwhelmed with pain and I sat next her to and she stated I was sitting on her foot and I wasn't I was sitting next to her tummy and not on her foot. Then I asked her what hurt and noticed her right shoulder jolting again like her previous seizures and she stuttered IDK loudly due to pain, frustration and I'm sure the seizure. She ended up sleeping a lot like 20 hrs the next day it continued. I took her to the ER where they admitted her, did an MRI and EEG but didn't see anything and we saw Dr., a children's neurologist who stated her iron levels were on the low side and that he felt the drug (the shot) could have done it but they weren't sure what caused it, despite me providing a video of her behavior after we were sent home the first time from the ER. We have diazepam on hand for when the seizures last longer than 5mins. Her sleep patterns are off, her mood swings are awful now, and she gets frustrated and tired WAY easier than ever before and she's been having issues communicating with us even more. We won't know more until she gets older on how extensive the damage is.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Mood swings, Nuclear magnetic resonance imaging normal, Pain in extremity, Posture abnormal
Clinical narrative: While at school two hours after her shot, her teacher noticed her leaning towards her left side, she couldn't stand up straight at the playground, and kept falling down, then standing back up and then would fall again. Her teacher ran to her and that is when patient stated her legs were numb and she couldn't walk. However, the way she was saying it wasn't making sense. Just that her leg wasn't working. They brought her in, she had patient lean against the wall so she could get the rest of her class and when she got back in patient was on the floor again, her left side kept jilting, like shaking back and forth. Her entire left side only and she was spacing out. They called an ambulance and when I got there, the ambulance was there and her left side was still jilting. We took it to the hospital and while in the ambulance she said she couldn't lay down as it hurt her back badly and her legs so they had to sit her up and the pain got better. When we got to hospital, they stated she needed an x-ray on her leg and that she may have had a grand mal seizure. However after the x-ray was clear they just sent us home saying she had three random seizures and to schedule an app with a neurologist and her primary despite me stating it was abnormal for her to have seizures and no reason besides her just having her flu shot that morning. They sent us home anyways, we got home and noticed the leaning again she was doing it with her right side again and was spacey. Though she was moving and what not she was not making sense and was again just not talking and it was like she was looking beyond. Again we had her lay down and she continued to do that and then the tingling in her legs and back came back and she became overwhelmed with pain and I sat next her to and she stated I was sitting on her foot and I wasn't I was sitting next to her tummy and not on her foot. Then I asked her what hurt and noticed her right shoulder jolting again like her previous seizures and she stuttered IDK loudly due to pain, frustration and I'm sure the seizure. She ended up sleeping a lot like 20 hrs the next day it continued. I took her to the ER where they admitted her, did an MRI and EEG but didn't see anything and we saw Dr., a children's neurologist who stated her iron levels were on the low side and that he felt the drug (the shot) could have done it but they weren't sure what caused it, despite me providing a video of her behavior after we were sent home the first time from the ER. We have diazepam on hand for when the seizures last longer than 5mins. Her sleep patterns are off, her mood swings are awful now, and she gets frustrated and tired WAY easier than ever before and she's been having issues communicating with us even more. We won't know more until she gets older on how extensive the damage is.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure, Tremor, X-ray normal
Clinical narrative: While at school two hours after her shot, her teacher noticed her leaning towards her left side, she couldn't stand up straight at the playground, and kept falling down, then standing back up and then would fall again. Her teacher ran to her and that is when patient stated her legs were numb and she couldn't walk. However, the way she was saying it wasn't making sense. Just that her leg wasn't working. They brought her in, she had patient lean against the wall so she could get the rest of her class and when she got back in patient was on the floor again, her left side kept jilting, like shaking back and forth. Her entire left side only and she was spacing out. They called an ambulance and when I got there, the ambulance was there and her left side was still jilting. We took it to the hospital and while in the ambulance she said she couldn't lay down as it hurt her back badly and her legs so they had to sit her up and the pain got better. When we got to hospital, they stated she needed an x-ray on her leg and that she may have had a grand mal seizure. However after the x-ray was clear they just sent us home saying she had three random seizures and to schedule an app with a neurologist and her primary despite me stating it was abnormal for her to have seizures and no reason besides her just having her flu shot that morning. They sent us home anyways, we got home and noticed the leaning again she was doing it with her right side again and was spacey. Though she was moving and what not she was not making sense and was again just not talking and it was like she was looking beyond. Again we had her lay down and she continued to do that and then the tingling in her legs and back came back and she became overwhelmed with pain and I sat next her to and she stated I was sitting on her foot and I wasn't I was sitting next to her tummy and not on her foot. Then I asked her what hurt and noticed her right shoulder jolting again like her previous seizures and she stuttered IDK loudly due to pain, frustration and I'm sure the seizure. She ended up sleeping a lot like 20 hrs the next day it continued. I took her to the ER where they admitted her, did an MRI and EEG but didn't see anything and we saw Dr., a children's neurologist who stated her iron levels were on the low side and that he felt the drug (the shot) could have done it but they weren't sure what caused it, despite me providing a video of her behavior after we were sent home the first time from the ER. We have diazepam on hand for when the seizures last longer than 5mins. Her sleep patterns are off, her mood swings are awful now, and she gets frustrated and tired WAY easier than ever before and she's been having issues communicating with us even more. We won't know more until she gets older on how extensive the damage is.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Chest pain, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Swelling to site, red, pain, fever, nausea, myalgia, chest pain.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Nausea, Pyrexia
Clinical narrative: Swelling to site, red, pain, fever, nausea, myalgia, chest pain.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: During administration pt reached down to grab at needle. Full dose not administered.
Age: 1.0
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Exactly 7-8 days after 12 months vaccine appt. fever came then the next morning red small bumps began appearing on stomach and very fast within a half an hour the rash covered the whole face, behind and inside ear, inside of mouth near eyes all the way down to toes lasted for several  days.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Vaccination site pain, X-ray limb normal
Clinical narrative: Severe pain at vaccine site upon receiving the vaccination. After 3 days of severe pain, range of motion in left arm/shoulder. Reported again on October 12th, 2018 visit to physician, x-ray of left shoulder was ordered and physical therapy was advised for treatment of loss of range of motion to left arm.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 09-OCT-2012, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 15-DEC-2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-SEP-2011, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 16-JAN-2014, the patient was treated by a physician for possible shingles outbreak. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-MAY-2013, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 08-SEP-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 02-JAN-2015, a healthcare provider administered ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries and conditions (dose, route, and lot number not provided). On or about 23-NOV-2016, the patient was treated by a healthcare professional for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 24-JUN-2014, a pharmacist administered ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot number not provided). On or about 29-DEC-2016, the patient was treated by a healthcare professional for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Heart rate decreased, Respiration abnormal, Respiratory arrest, Sleep apnoea syndrome
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (parent).  An infant male patient received, on an unspecified date, in 2014, at the age of 2 months, pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP); polio vaccine inact (IPV); hib vaccine (HIB); rotavirus vaccine and hepatitis b vaccine; all for immunization. Relevant medical history and concomitant medications were unknown. Her son received the vaccines and he had a breathing issue. He went to the hospital where they kept him overnight; they had to put him on an apnea monitor. At the age of 4 months, he received another vaccine (unspecified) and he stopped breathing, his heart rate went down, and he had to have a sleep apnea machine at home after the incident. Clinical outcome of the adverse event was unknown at time of this report. Pfizer is 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. No follow-up attempts are possible, information about lot numbers cannot be obtained.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Pain
Clinical narrative: Pain radiating up left collarbone.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Bacterial infection, Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Vaccine given on 11/19/18 at school flu clinic. Mom states child's arm became red and swollen, took to walk in clinic on Wednesday 11/21/18 and was diagnosed with cellulitis/bacterial infection and given antibiotics. Spoke with mom today, child has finished medication and is no longer symptomatic and is doing well.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Deafness unilateral, Dyspnoea, Hypoaesthesia, Injection site paraesthesia, Muscular weakness
Clinical narrative: Post vaccination onset of tingling in left deltoid progressing to tingling of entire left arm, sensation resolving upon leaving work. Individual was seen by onsite paramedic, obtained vitals within normal range, determined to be local swelling. While at store around 4:00 PM tingling progressed to back of head, weak leg muscles and hearing in right ear for 2 minutes. Drove home arrived at 4:30 then went to phone store, while there she called urgent care at 4:49, nurse hotline at 4:52. Referred by nurse hotline to hospital. Went to the hospital, arrival at 6:18 PM with symptoms of shortness of breath, nausea, hives around mouth and left arm numbness. Release from Emergency room around 11:30 PM.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Paraesthesia, Swelling, Urticaria
Clinical narrative: Post vaccination onset of tingling in left deltoid progressing to tingling of entire left arm, sensation resolving upon leaving work. Individual was seen by onsite paramedic, obtained vitals within normal range, determined to be local swelling. While at store around 4:00 PM tingling progressed to back of head, weak leg muscles and hearing in right ear for 2 minutes. Drove home arrived at 4:30 then went to phone store, while there she called urgent care at 4:49, nurse hotline at 4:52. Referred by nurse hotline to hospital. Went to the hospital, arrival at 6:18 PM with symptoms of shortness of breath, nausea, hives around mouth and left arm numbness. Release from Emergency room around 11:30 PM.
Age: 16.0
Sex: F
Vaccine: IPV, TD
Symptoms: Anxiety, Cold sweat, Pallor, Syncope
Clinical narrative: Patient fainted upon receiving Td and IPV vaccines. Looked pale, felt clammy and appeared anxious. Helped patient lay down, checked vital signs - BP 123/85, pulse 108. Offered patient a glass of water once the patient felt better. Patient left the clinic after 15 minutes of observation, denied any signs and symptoms of syncope at the time of departure. Encouraged parent and patient to follow up with their pediatrician.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child received vaccine out of age range.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site pain
Clinical narrative: L deltoid that caused pain/myalgia and subsequent.