chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: headache; shivering; feel awful; Heart rate elevated last night to 93; myalgia; fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknwon date).   On 16th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache, shivering, feeling abnormal, heart rate increased, myalgia and fatigue. On an unknown date, the outcome of the headache, shivering, feeling abnormal, heart rate increased, myalgia and fatigue were unknown.   It was unknown if the reporter considered the headache, shivering, feeling abnormal, heart rate increased, myalgia and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient experienced headache, shivering, feeling awful, myalgia and fatigue after receiving 2nd dose of Shingrix. The patients heart rate elevated to 93 on the night before reporting. Further information was not reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Insomnia, Pyrexia
Clinical narrative: headache; fever; chivering; pain in joints; got very little sleep; This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 16th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced headache, fever, shivering, joint pain and sleeplessness. On an unknown date, the outcome of the headache, fever, shivering, joint pain and sleeplessness were unknown.   It was unknown if the reporter considered the headache, fever, shivering, joint pain and sleeplessness to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The reporter stated that the patient had got very little sleep, suffered from headache, fever, shivering and pain in joints after vaccination. The reporter stated that the patient had fibromyalgia but was not on immune suppressing drugs. The reporter asked what patient can do to reduce or treat the side effects.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite
Clinical narrative: chills/shivering; NO ENERGY; NO APPETITE; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix. On 16th January 2020, 8 hrs after receiving Shingrix, the patient experienced chills, loss of energy and appetite absent. On an unknown date, the outcome of the chills, loss of energy and appetite absent were unknown.   It was unknown if the reporter considered the chills, loss of energy and appetite absent to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The reporter stated that the patient developed chills, shivering, no energy, and no appetite after vaccination. The reporter asked how long does it take for the symptoms to go away.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Oral herpes
Clinical narrative: cold sores; ill; This case was reported by a nurse via sales rep and described the occurrence of cold sores in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received Shingrix .5 ml. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced cold sores and unwell. On an unknown date, the outcome of the cold sores and unwell were recovered/resolved.   It was unknown if the reporter considered the cold sores and unwell to be related to Shingrix.  Additional details were provided as follows: The patient felt cold sore and also felt ill for three days following that prevented her from going to work.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: slight headache; low grade fever; muscle pain at shot location; This case was reported by a consumer via call center representative and described the occurrence of headache in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache, fever and injection site muscle pain. On an unknown date, the outcome of the headache, fever and injection site muscle pain were unknown.   It was unknown if the reporter considered the headache, fever and injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced a slight headache, low grade fever, muscle pain at shot location. The patient reported that it was some listed side effect. The patient wanted to know what appear to be the listed side effects? The patient was advised to follow up with physician for side effects.
Sex: M
Vaccine: VARZOS
Symptoms: Blood group O, Herpes zoster
Clinical narrative: diagnosed with Shingles; This case was reported by a consumer and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included nonsmoker.   In 2019, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 57 or 58 years. The patient's blood type was O positive, body mass index was 24 and was active type. The patient was vaccinated last year and two weeks later was diagnosed with Shingles. The patient's yearly physical was due again. The patient was not sure if he should try the vaccine again as it seemed risky for his blood chemistry make up.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pruritus, Urticaria, Vaccination failure
Clinical narrative: Suspected vaccination failure; Mild case of shingles; Welts; Very uncomfortable; Very itchy; This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, welts, discomfort and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, welts, discomfort and pruritus were unknown.   The reporter considered the vaccination failure, shingles, welts, discomfort and pruritus to be possibly related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient age was in mid seventies. The patient had bad reaction to the shingles shot.  The patient had developed a mild case of shingles. The patient did not have pain, but welts, very uncomfortable, very itchy. This case was considered as suspected vaccination failure as details regarding full vaccination schedule, laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The permission to follow up was denied.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Hepatic steatosis, Magnetic resonance imaging liver abnormal, Vision blurred
Clinical narrative: reports before Engerix his CAT scan showed a perfect liver and a recent MRI shows fatty liver; reports blurry vision; This case was reported by a consumer via call center representative and described the occurrence of fatty liver in a 53-year-old male patient who received HBV (Engerix B adult) (batch number 4795H, expiry date unknown) for prophylaxis.   On 8th October 2018, the patient received Engerix B adult. On an unknown date, less than 2 years after receiving Engerix B adult, the patient experienced fatty liver and blurred vision. On an unknown date, the outcome of the fatty liver and blurred vision were unknown.   It was unknown if the reporter considered the fatty liver and blurred vision to be related to Engerix B adult.  Additional details were provided as follows: The patient was received Engerix B adult on below the belt on the right side of leg. The reporter reported that before Engerix B adult the patients Computerised tomogram scan showed a perfect liver and a recent Magnetic resonance imaging shows fatty liver. The patient experienced blurry vision after the Engerix B adult vaccine. Consent to follow up was denied.      Lab Comments: On an unknown date lab test were performed.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Nausea, Pain in extremity
Clinical narrative: woke up with nausea; woke up with malaise; experienced chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced arm soreness, refer case US2020AMR010349).   On 16th January 2020, the patient received the 2nd dose of Shingrix. On 16th January 2020, less than a day after receiving Shingrix, the patient experienced chills. On 17th January 2020, the patient experienced nausea and malaise. On an unknown date, the outcome of the chills was resolved with sequelae and the outcome of the nausea and malaise were recovering/resolving.   It was unknown if the reporter considered the chills, nausea and malaise to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient experienced chills that caused her to fall out of bed. The patient was assessed at home and helped back to bed. The patient also had nausea and malaise after vaccination. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Injection site pain, Pain, Pain in extremity
Clinical narrative: had shooting pains from her hips to her knees and from her knees to her ankles/ pain in other parts of her body; Pain in hip; had pain in her arm where she got the injection; not want to lift her arm or other parts of her body due to the pain; she had other symptoms commonly experienced with Shingrix /but she does not remember what those were specifically; herpes; This case was reported by a consumer via call center representative and described the occurrence of herpes zoster in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix. On 27th December 2019, 58 days after receiving Shingrix, the patient experienced herpes zoster. On an unknown date, the patient experienced shooting pain, pain in hip, injection site pain, pain in extremity and adverse event. On an unknown date, the outcome of the herpes zoster and adverse event were unknown and the outcome of the shooting pain was recovered/resolved and the outcome of the pain in hip, injection site pain and pain in extremity were not recovered/not resolved.   It was unknown if the reporter considered the herpes zoster, shooting pain, pain in hip, injection site pain, pain in extremity and adverse event to be related to Shingrix.  Additional details were provided as follows: The patient experienced shooting pains from her hips to her knees and from her knees to her ankles within 1 week of getting the vaccine. The patient had pain in her arm where she got the injection, and pain in other parts of her body. The shooting pains was resolved, but she still had the pain in her arm and other areas of her body. The patient did not want to lift her arm or other parts of her body due to the pain. 3 weeks ago the patient broke out with herpes, which she not had in many years. The patient had other symptoms commonly experienced with Shingrix directly after the vaccination, but she did not remember those were specifically.  Consented to follow up was provided. Descripancy: As per narrative TTO of shooting pain is within week but in XML sheet it 1week. Please confirm if it is1 week or within week.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Immunisation, Incorrect route of product administration
Clinical narrative: Student Administrator accidently administered PROQUAD dose intramuscularly instead of subcutaneously. Dose was readministered subcutaneously.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Corneal erosion, Eye pain, Malaise, Photopsia, Pyrexia
Clinical narrative: Fever of 99 plus degrees that started evening of vaccination.   Felt "il" for 24 hours.  Three days after vaccination developed eye pain in right eye and flashes of light in right eye.  Flashes were worse upon waking and opening eyes.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Migraine
Clinical narrative: Headache described as migraine that started in the afternoon of the day of vaccination (exact time unknown), resolved by the following day. On 1/23/20 developed redness and swelling of injection site on LEFT arm which persisted unchanged until 1/26/20. Was seen in clinic on 1/27/20 and redness and swelling were diminished but not yet resolved.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: The following day after administration (January 11), she said she broke out in hives and itching along her back and both shoulders in the evening. She says that every night since, she breaks out in hives and experiences itching along those areas and her scalp. But it resolves in the daytime.
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: Joint range of motion decreased, Musculoskeletal pain, X-ray normal
Clinical narrative: Pain in shoulder. Limited range of movement in shoulder.  X-rays negative.  Currently in week 4 of physical therapy.
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Chest discomfort, Headache, Pyrexia, Tachycardia
Clinical narrative: Fever of 102.8 deg F,  Headache,  Tachy at 108 bpm,  left sided chest discomfort at 4/10.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Rapid spike in fever . Febrile seizure.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site movement impairment, Injection site pain
Clinical narrative: Immediately after receiving the immunization, she had pain in the left upper arm at the injection site (like she normally has after an immunization).  However, the pain has persisted in the left upper arm and shoulder.  Abducting the left shoulder is painful.  Range of motion of the left  shoulder has decreased due to the pain.  Pain has worsened in the past week.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Flu like symptoms, joint pain, fever, nausea
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Eyelid function disorder, Facial paralysis, Herpes zoster oticus, Hypoacusis
Clinical narrative: Ramsey Hunt Syndrome; Bell's palsy; Shingles in ear; Trigeminal neuralgi; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   On 22-SEP-2009, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date and as a result of vaccination, the pt suffered shingles in her ear, Ramsey Hunt syndrome, Bell's palsy and trigeminal neuralgia, which resulted in severe injuries including pain, hearing and balance problems, facial paralysis which caused one eye to close, and problems with eating and drinking and other ordinary functions. The pt's symptoms have resulted in physical limitations not present prior to using the vaccine; she also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The pt sustained severe and permanent personal and emotional injuries and loss of consortium. Further, she 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 result of the pt's injuries, her husband has suffered loss of services and society and asserts a loss of consortium claim.   The reporter stated that these injuries were caused by zoster vaccine live (ZOSTAVAX) and were continued by the time of this report.   Upon internal review, Ramsey Hunt syndrome and Bell's palsy were considered to be medically significant event. Moreover, all the reported events were considered to be disabling,
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain, Trigeminal neuralgia
Clinical narrative: Ramsey Hunt Syndrome; Bell's palsy; Shingles in ear; Trigeminal neuralgi; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   On 22-SEP-2009, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date and as a result of vaccination, the pt suffered shingles in her ear, Ramsey Hunt syndrome, Bell's palsy and trigeminal neuralgia, which resulted in severe injuries including pain, hearing and balance problems, facial paralysis which caused one eye to close, and problems with eating and drinking and other ordinary functions. The pt's symptoms have resulted in physical limitations not present prior to using the vaccine; she also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The pt sustained severe and permanent personal and emotional injuries and loss of consortium. Further, she 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 result of the pt's injuries, her husband has suffered loss of services and society and asserts a loss of consortium claim.   The reporter stated that these injuries were caused by zoster vaccine live (ZOSTAVAX) and were continued by the time of this report.   Upon internal review, Ramsey Hunt syndrome and Bell's palsy were considered to be medically significant event. Moreover, all the reported events were considered to be disabling,
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Whole arm was swollen and red; Whole arm was swollen and red; Low grade fever; This is a spontaneous report from a contactable physician via a sales representative.  A male patient of an unspecified age (reported as Age: 66, Unit: Unknown)  received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)and concomitant medications were not reported. It was reported that the patient experienced his whole arm was swollen and red, low grade fever on an unspecified date.  Outcome of the events were unknown.  Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Headache, Injection site induration, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: have a 3" raised hot circle at the injection site; have a 3" raised hot circle at the injection site; Running a low grade fever; irritable; bad headache; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration o 20Jan2020 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient received the Prevnar 13 pneumonia shot on Monday (20Jan2020) and on is Wednesday (22Jan2020), the patient had a 3" raised hot circle at the injection site, and it was hard. The patient was running a low grade fever, irritable and bad headache for two days on an unspecified date in Jan2020. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: have a 3" raised hot circle at the injection site; have a 3" raised hot circle at the injection site; Running a low grade fever; irritable; bad headache; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration o 20Jan2020 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient received the Prevnar 13 pneumonia shot on Monday (20Jan2020) and on is Wednesday (22Jan2020), the patient had a 3" raised hot circle at the injection site, and it was hard. The patient was running a low grade fever, irritable and bad headache for two days on an unspecified date in Jan2020. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Pain
Clinical narrative: unable to abduct left arm due to deltoid area muscular pain; injection to the left deltoid area, a moderate pain developed while at rest/deltoid area muscular pain; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on arm left on 22Jan2020 20:30 at a single dose for immunization. The patient's medical history and  concomitant medications were not reported. On 22Jan2020 21:30, approximately 1 hour after the injection to the left deltoid area, a moderate pain developed while at rest. No redness or heat or swelling or bruising was noted. No systemic symptoms noted. On 23Jan2020 15:30, 19 hour after receiving the injection, the patient was unable to abduct left arm due to deltoid area muscular pain. However, no acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDS) were used. As of today, while arm is at rest, there is no pain. There is only pain with attempting to abduct left arm. Flexion and extension of the left arm is without any pain, but only mild deltoid muscle area pain upon internal and external rotation of the left arm. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever on an unspecified date. Outcome of the event was unknown.  The following information on the batch number has been requested.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: pain through entire left arm muscles. pain is close to having a cramp Sometimes the pain is at upper left arm and then travels down toward wrist
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, Diarrhea, Nausea Vomiting
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Injection site pruritus, Skin warm
Clinical narrative: Arm is red, inflammed, and hot to touch. Patient said the area of injection also is itchy.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Blood test, Joint stiffness, Muscle tightness, Myalgia
Clinical narrative: Muscle tightness and soreness. Started in buttock area and thighs then moved into joints, shoulders and calves. Has lasted nearly 3 months and have been on prednisone for 2 months. They are doing test but haven't figured out what is going on
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: About 5 - 6 hours post injection patient complained of very sore arm he felt as though he could barely lift it up. It was in a lot of pain for a full 24 hour period before resolving.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Bruxism, Cold sweat, Erythema, Fall, Head injury
Clinical narrative: Patient came to get her flu shot.  Asked if she had ever had a reaction to a vaccine before and she stated no.  Said she gets a flu shot every year.  Gave shot and she sat on bench.  Was about to give shot to her friend and he asked her to hold his hand.  She got up and stood next to him and held his hand as I administered the vaccine.  As I was about to put his band aid on she fainted.  I tried to catch her as she fell, but she fell face first on to the ground and bumped her head against the fall.  I immediately kneeled down to her side and called her name.  With the help of friend we rolled her on to her back.  She was breathing normally and not convulsing, but was stiff and her skin felt clammy and her eyes were wide.  She was not bleeding from anywhere I could see.  I again asked her name and she said her name and then asked where she was.  I replied pharmacy and asked if anything hurt.  She said no.  I had her lay down until she felt ok to sit up.  I again asked her if she knew what happened and she said she got a flu shot.  I asked if she felt dizzy or if she felt like she was going to throw up and she said no.  I asked if she felt like her tongue was swelling or if she was having trouble breathing and she said no.  I asked her if she wanted me to call 911 and she said no.  When she felt ok she moved from the floor to the bench in the room and sat with her head between her knees.  I offered water or a cool compress and she declined.  She appeared to have a bright red mark on her right shoulder and another mark on her right cheek from the fall.  She stated that her teeth hurt as she clenched her mouth shut when she fell.  After about 10 minutes she was feeling better and we walked to the pharmacy waiting room.  She was steady and did not want assistance walking.  I had her sit in the waiting room for about 5 more minutes.  She knew the correct answers to her name, dob, what day it was, who our president was.  She could follow my finger with her eyes and had equal strength in both hand when I asked her to squeeze my hands with hers.  I again offered to call EMS and she declined and said she was feeling better.  Her friend who was with her said he'd be with her all night.  I told her if she started to feel like she was going to throw up or had a severe headache she should go to the doctor and also let us know.  I asked her to sit until she felt comfortable to move around and to let me know if she needed anything.  I told patient that I would be calling her the next morning to check in on her. She sat for a few more minutes and then her and her friend decided they were good to go.  9/25/2019 approx. 8-8:30pm
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Syncope, Toothache
Clinical narrative: Patient came to get her flu shot.  Asked if she had ever had a reaction to a vaccine before and she stated no.  Said she gets a flu shot every year.  Gave shot and she sat on bench.  Was about to give shot to her friend and he asked her to hold his hand.  She got up and stood next to him and held his hand as I administered the vaccine.  As I was about to put his band aid on she fainted.  I tried to catch her as she fell, but she fell face first on to the ground and bumped her head against the fall.  I immediately kneeled down to her side and called her name.  With the help of friend we rolled her on to her back.  She was breathing normally and not convulsing, but was stiff and her skin felt clammy and her eyes were wide.  She was not bleeding from anywhere I could see.  I again asked her name and she said her name and then asked where she was.  I replied pharmacy and asked if anything hurt.  She said no.  I had her lay down until she felt ok to sit up.  I again asked her if she knew what happened and she said she got a flu shot.  I asked if she felt dizzy or if she felt like she was going to throw up and she said no.  I asked if she felt like her tongue was swelling or if she was having trouble breathing and she said no.  I asked her if she wanted me to call 911 and she said no.  When she felt ok she moved from the floor to the bench in the room and sat with her head between her knees.  I offered water or a cool compress and she declined.  She appeared to have a bright red mark on her right shoulder and another mark on her right cheek from the fall.  She stated that her teeth hurt as she clenched her mouth shut when she fell.  After about 10 minutes she was feeling better and we walked to the pharmacy waiting room.  She was steady and did not want assistance walking.  I had her sit in the waiting room for about 5 more minutes.  She knew the correct answers to her name, dob, what day it was, who our president was.  She could follow my finger with her eyes and had equal strength in both hand when I asked her to squeeze my hands with hers.  I again offered to call EMS and she declined and said she was feeling better.  Her friend who was with her said he'd be with her all night.  I told her if she started to feel like she was going to throw up or had a severe headache she should go to the doctor and also let us know.  I asked her to sit until she felt comfortable to move around and to let me know if she needed anything.  I told patient that I would be calling her the next morning to check in on her. She sat for a few more minutes and then her and her friend decided they were good to go.  9/25/2019 approx. 8-8:30pm
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain upper, Crying, Diarrhoea, Fatigue
Clinical narrative: Less than one day after my first dose, I experienced very uncomfortable and prolonged stomach cramps and fatigue. I felt them off and on for about day. Then when I was feeling better, I took the second dose as directed hoping it was a fluke. The day after my second dose, I experienced the worst pain I've ever felt. Severe stomach cramping, which cause my whole body to tense up badly. I couldn't do anything but cry and lie down. I also had diarrhea and fatigue, but it felt like my entire intestine was cramping. It hurt my whole lower torso and was really intense, sharp pain. I have never experienced this before. I was not able to finish taking the pills. The following day I was fatigued and my whole lower torso was sensitive to pressure and uncomfortable, but not nearly as bad as the previous day. Today I'm feeling fine but I still have diarrhea.
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Pain, Tension
Clinical narrative: Less than one day after my first dose, I experienced very uncomfortable and prolonged stomach cramps and fatigue. I felt them off and on for about day. Then when I was feeling better, I took the second dose as directed hoping it was a fluke. The day after my second dose, I experienced the worst pain I've ever felt. Severe stomach cramping, which cause my whole body to tense up badly. I couldn't do anything but cry and lie down. I also had diarrhea and fatigue, but it felt like my entire intestine was cramping. It hurt my whole lower torso and was really intense, sharp pain. I have never experienced this before. I was not able to finish taking the pills. The following day I was fatigued and my whole lower torso was sensitive to pressure and uncomfortable, but not nearly as bad as the previous day. Today I'm feeling fine but I still have diarrhea.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Lacrimation increased, Pharyngeal swelling
Clinical narrative: Employee had constantly watering eyes, cough and felt like throat was swollen.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Dark circles under eyes, Fatigue, General physical health deterioration, Skin discolouration
Clinical narrative: Within 24 hrs of the injections, I noticed the color in my daughter's face change and a darkness under her eyes.  I didn't think much of it, knowing that vaccinations often challenge the immune system and cause an internal battle.  However, over the following months, I noticed that the color in her face didn't improve.  It worsened until she had dark circles under her eyes.  She began to complain of stomach aches and fatigue.  Over time, she was diagnosed with Type 1 Diabetes.  My daughter was in perfect health before this set of immunizations.  I witnessed her health decline with these immunizations.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Within 24 hrs of the injections, I noticed the color in my daughter's face change and a darkness under her eyes.  I didn't think much of it, knowing that vaccinations often challenge the immune system and cause an internal battle.  However, over the following months, I noticed that the color in her face didn't improve.  It worsened until she had dark circles under her eyes.  She began to complain of stomach aches and fatigue.  Over time, she was diagnosed with Type 1 Diabetes.  My daughter was in perfect health before this set of immunizations.  I witnessed her health decline with these immunizations.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Chills, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: Flu shot given - Dec. 10, 2019 Sick Dec. 24th, 2019, went to Doc. Dec. 26, 2019 Very tired, Fever of 102, raw sore throat, weak, chills for 12 days. Had to go on amoxicillin for 10 days, because my throat was so raw.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Throat irritation
Clinical narrative: Flu shot given - Dec. 10, 2019 Sick Dec. 24th, 2019, went to Doc. Dec. 26, 2019 Very tired, Fever of 102, raw sore throat, weak, chills for 12 days. Had to go on amoxicillin for 10 days, because my throat was so raw.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus & Itching of head
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Back pain
Clinical narrative: Lower back ache
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Chills Body Aches Headach Soreness Fever Tiredness Pain on left side of head nausea diarrhea
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Chills Body Aches Headach Soreness Fever Tiredness Pain on left side of head nausea diarrhea
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Induration, Mass, Pain in extremity, Skin warm
Clinical narrative: Warth; Lump Hard Red swollen, about 2 inches Round ARM soreness
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Warth; Lump Hard Red swollen, about 2 inches Round ARM soreness
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: got pneumooccocal booster on thursday, then yesterday, growing beyond mark; hurt yesterday but not today; no fevers, not tender to touch
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Neurological symptom
Clinical narrative: Neurological reaction; Drug allergy; This spontaneous report was received from a physician via Pfizer refers to a patient of unknown age and gender. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dosing details, lot# and expiry date not reported). On an unknown date, the patient experienced neurological symptom and drug hypersensitivity. Outcome of neurological symptom and drug hypersensitivity was unknown. The reporter considered neurological symptom and drug hypersensitivity to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Follow-up information was received from a physician via Pfizer (2019169966) refers to a female patient of currently 69 year old. Upon follow up this case was considered as valid due to availability of patient identifier.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Inappropriate schedule of vaccine administered; Information has been received from a registered nurse, concerning a female patient of unknown age. The patien''s pertinent medical history, concurrent conditions, and concomitant medications were not provided.  On unspecified dates (reported as in the second dose schedule), the patient was vaccinated with the first and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dosage, route, lot number and expiration date were not provided) for prophylaxis.   It was reported that on 23-JAN-2020, the patient was inadvertently vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R029507, expiration date on 10-JUL-2021, dosage and route were not provided) (Inappropriate schedule of product administration), for prophylaxis. No additional adverse events were reported.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient reports a baseball sized raised area at injection site 3 days after vaccine administration. Rash and itching present at site.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: On going diarrhea for 6 weeks.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash papular, Rash pruritic
Clinical narrative: Itchy papular rash covering upper part of patient's left shoulder.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: BELLS PALSY GAVE STEROIDS FOR 1 WEEK AND STARTED TAKING VALTREX  ON 01/23/2020
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: rash appeared on 1/26/2020, swelling and redness and soreness on 1/25/2020, localized to left shoulder 3 inches below injection site.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Neuralgia
Clinical narrative: Patient has said he has burning in his feet. He has nerve pain when he is sleeping.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal disorder, Pain in extremity
Clinical narrative: The patient states they have pain in the hand and wrist of the left arm and has lost use in that hand. They are now doing physical therapy to try to regain use.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Patient complained on significant injection site pain and difficulty moving her arm/hand.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: SORE ARM/SHOULDER ONLY UPON CERTAIN MOVEMENTS
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: VACCINE WAS SHINGRIX, 2ND DOSE. HAD HEADACHE,CHILLS,FEVER BODY ACHES.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Both MMRV (Proquad) and Varivax were administered to patient.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: "flu " like symptoms-fatigue, lethargic, feverish, body aches,  chills pain at site, with redness,warmth
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Lethargy, Pain, Pyrexia
Clinical narrative: "flu " like symptoms-fatigue, lethargic, feverish, body aches,  chills pain at site, with redness,warmth
Age: 32.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: My co-worker who is 32 wanted MMR and Varicella, and I gave her MMRV inadvertently. No adverse outcomes.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: patient 29 weeks pregnant and not followed by our facility for OB care. RN performed PPD reading and noticed patient was not immune to varicella due to recent titers drawn for nursing school. checked with another resident to see if okay to give immunization. Varicella administered without verifying pregnancy status. Manufacturer contacted for outcome and patient contacted and counseled on low risk of fetal abnormalities. Attending and supervisor also notified, No reaction noted.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Coccydynia, Headache, Mobility decreased, Myalgia
Clinical narrative: MUSCLE ACHES, HEAD PAIN RADIATING TO BOTH SIDES OF HEAD, PAIN DOWN TO TAIL BONE, RINGING IN EARS, SHIVERING, DIFFICULTY MOVING ARM.  PATIENT STATES FINALLY FEELING BETTER TODAY (4 DAYS LATER)
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: MUSCLE ACHES, HEAD PAIN RADIATING TO BOTH SIDES OF HEAD, PAIN DOWN TO TAIL BONE, RINGING IN EARS, SHIVERING, DIFFICULTY MOVING ARM.  PATIENT STATES FINALLY FEELING BETTER TODAY (4 DAYS LATER)
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: pt reporting tingling, numbness in injection arm
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Child came to office for vaccines. after pulling record from the state immunization registry it indicated that several vaccines were needed. spoke with mother about needed vaccines. I began with rotarix. After infant had taken the oral vaccine mother states that infant had been seen in the Pediatrics Clinic early today and given vaccines. These were not reflective in the report from the immunization registry. I placed a call to that office and spoke with staff who confirmed that the infant indeed received immunization at that office and she has not had time to get them documented into the immunization registry. I informed her that I also had administered a rotarix.  I informed mother that infant had received and 'extra' dose. I informed our clinics Medical Director, and the state Immunization Nurse for guidance for followup. Medical Director did see patient and Immunization Nurse from the state gave instructions and the possible side effects. This information was relayed to mother.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia
Clinical narrative: Extreme headache, severe chills, extreme muscle pain, upset stomach lasted until Sunday (shot was on Friday)
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Skin lesion
Clinical narrative: Broke out in cluster of raised red nodular lesions near injection site 7 days after MMRV injection
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Skin warm, Urticaria
Clinical narrative: Patient came in next day with a large red, warm welt area above her elbow.  concerned on how low shot given and the intense site reaction.
Age: 48.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site swelling, Mass, Migraine
Clinical narrative: swelling on the right arm where he got injection Migraine like pain and headache and got lump for a little while and then lum got bigger
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site mass, Lymph node pain, Lymphadenopathy, Musculoskeletal chest pain
Clinical narrative: Swollen lymph node under right armpit (baseball size) and sore neck and ribs on right side.  Lymph node area sore as well.  Hard lump about 2in diameter on injection site.  Scratchy throat and night sweats.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Night sweats, Throat irritation
Clinical narrative: Swollen lymph node under right armpit (baseball size) and sore neck and ribs on right side.  Lymph node area sore as well.  Hard lump about 2in diameter on injection site.  Scratchy throat and night sweats.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: pt was given prevnar 13 when she was suppose to get pneumococcal 23
Age: 65.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Spoke with Pt on 1/21/20 to remind her to complete her Twinrix series.  It sounds like she is experiencing SIRVA.  Her arm is still hurting down to her elbow.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Pallor
Clinical narrative: 11 year old female received the HPV, TDaP, and Meningococcal vaccines. The patient became pale and complained of nausea. The Corpsmen and Nurse sat the patient in a chair with the patient's knew raised. The patient was given a cold pack and some water, while vitals were taken every few minutes. The vitals were as follows: B/P- 87/56, 90/58, 86/49: Pulse- 60bpm, 82bpm, 83bpm. The patient was allowed to leave with their guardian once they exhibited signs of improvement.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: Patient says she still feels the pain at the injection site after 3 month.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever 100.2 Chills Fatigue
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Rash, Rash vesicular, Varicella virus test negative
Clinical narrative: Began with left side low back pain which increased over several days to a week and spread toward left hip, mild raised rash evident on lower back moving toward left hip (a few lesions appearing blister like), visual light sensivity also. Pain (neuralgia) in lower back & left hip increased significantly throughout Dec, at some points becoming excrutiating, especially upon sitting.  Dr diagnosed case of Shingles at patient visit on 11Dec2019. Prescribed Lyrica, hydrocodone with acetaminophen and Voltarin for neuralgia, pain.  End of Jan 2020 patient's pain has improved, but not completely resolved.  Pain levels vary from day to day. Pt. has begun physical therapy to increase strength and endurance.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Shingrix vaccine was given subq, not IM. patient developed large, red, raised, itchy patch on arm that grew in size over a 3 day span.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Severe pain on the back of the head