chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Borrelia test, Gait inability, Nausea, Pain in extremity
Clinical narrative: This spontaneous report has been received from a consumer who is the patient's mother referring to a 19 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies, or concurrent conditions. She was taking no concomitant medications. In June 2016, the patient was vaccinated with the first dose of GARDASIL by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. She received the vaccine three times at 0, 2 and 6 months. She received her third dose on January 2017. In January 2017, the patient developed strep throat. She also experienced joint pain and could not walk on her legs and had to use crutches. The patient also had tingling and pain in her extremities and sporadic waves of nausea. Additionally, the patient's mother mentioned that "she may have chronic fatigue syndrome." The patient was treated with pain killers and was seen by a pain management doctor. She was tested for Lyme disease (results not specified). At the reporting time, the outcome of all the events was not recovered. The mother felt GARDASIL caused her daughter's health issues. She indicated she had contacted an attorney. Could not walk on her legs, had to use crutches was considered disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Pharyngitis streptococcal, Walking aid user
Clinical narrative: This spontaneous report has been received from a consumer who is the patient's mother referring to a 19 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies, or concurrent conditions. She was taking no concomitant medications. In June 2016, the patient was vaccinated with the first dose of GARDASIL by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. She received the vaccine three times at 0, 2 and 6 months. She received her third dose on January 2017. In January 2017, the patient developed strep throat. She also experienced joint pain and could not walk on her legs and had to use crutches. The patient also had tingling and pain in her extremities and sporadic waves of nausea. Additionally, the patient's mother mentioned that "she may have chronic fatigue syndrome." The patient was treated with pain killers and was seen by a pain management doctor. She was tested for Lyme disease (results not specified). At the reporting time, the outcome of all the events was not recovered. The mother felt GARDASIL caused her daughter's health issues. She indicated she had contacted an attorney. Could not walk on her legs, had to use crutches was considered disabling. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Gastric disorder
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stomach issues on an unspecified date. The outcome of the event was unknown. The consumer also asked if there had been previous reports of patients having "undigested lactose products in their stool" after receiving pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and if the vaccine could produce allergic reactions in lactose intolerant patients.
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Body temperature increased, Fatigue, Induration, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable nurse. An 18-year-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for Meningitis B. The patient's medical history and concomitant medications were not reported. The patient had no known history of allergies. On an unspecified date, the patient had adverse effect reported as left deltoid was swollen; the complete deltoid was swollen with an approximate size of 3 inches wide and 5 inches tall. Extremely hard to touch and it was very tender he was unable to raise his left arm at 90 degrees. The patient denied headache. The patient had feeling fatigue, very weak and was very tired. Vital signs on an unspecified date included temperature of 99.1, blood pressure 137/66 (units were not provided). The outcome of the events was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: MENB
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: This is a spontaneous report from a contactable nurse. An 18-year-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for Meningitis B. The patient's medical history and concomitant medications were not reported. The patient had no known history of allergies. On an unspecified date, the patient had adverse effect reported as left deltoid was swollen; the complete deltoid was swollen with an approximate size of 3 inches wide and 5 inches tall. Extremely hard to touch and it was very tender he was unable to raise his left arm at 90 degrees. The patient denied headache. The patient had feeling fatigue, very weak and was very tired. Vital signs on an unspecified date included temperature of 99.1, blood pressure 137/66 (units were not provided). The outcome of the events was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: PNC13
Symptoms: Burning sensation, Erythema, Induration, Pain, Skin warm
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (physician assistant). A patient of unspecified age, ethnicity and gender started to receive PREVNAR 13, (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patient experienced erythema indurated, very burning and very warm. The reporter also described erythema as red and indurated, very hard, burning and very painful. The reporter wanted to give hydralazine and was querying if there was anything else that can be given to the patient and hydralazine and ice pack. The outcome of the events was unknown. The following information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Asthenia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of an unspecified age (reported age: over 65, unit: unknown) and ethnicity received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced weakness for a few days on an unspecified date after the injection of PREVNAR 13. Outcome of the event was unknown. Information on batch and lot numbers has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypersensitivity, Pain, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report received from a contactable pharmacist. A 77-year-old female patient received PREVNAR 13 (NDC number of PREVNAR 13: 0005-1971-02, lot number: S74424, expiry date: Dec2019), via an unspecified route of administration on 02Jan2018 at 0.5 ml, single in the left arm for routine vaccination. There were no reported medical history and concomitant medications. On 03Jan2018 the day after vaccination, the patient reported an allergic reaction - left arm swelled up, itched, and was red. The events lasted for 3-4 days and then she recovered completely and the dull pain started a week after the administration in Jan2018. The outcome of the event dull pain was recovering; all other events recovered in Jan2018. The reporter stated that these events may have been caused by the PREVNAR 13 as the patient did not receive any other vaccines that day.
Age: 51.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient, also a medical assistant) on behalf of a nurse practitioner. A 51-year-old female patient received the first dose of PREVNAR 13, (lot number: S58704 and expiration date: 31Oct2019) intramuscular in the left deltoid, given around 13:00, at 0.5 ml, single and the first dose of SHINGRIX, (lot number: P3777 and expiration date: 30Jan2020) intramuscular in the right deltoid at unknown dose, both on 13Mar2018 for immunization (reported as over 50 and she wanted it). The patient's medical history and concomitant medications were unknown. The patient administered both vaccines then on an unspecified date in Mar2018, experienced significant soreness in arms at injection site, the left arm is worse than the right arm. She had a fever of 102 degrees Fahrenheit, a bad headache, and muscle aches. Therapeutic measures were taken as a result of the events. The patient took ADVIL and put ice on it. It is unknown if any other vaccinations were received within four weeks prior to the administration of the suspect vaccines. The patient did not undergo any relevant tests. The reporter did not know the seriousness criteria of any of the adverse events. Outcome of the events was unknown. Event relatedness for fever of 102 degrees Fahrenheit, bad headaches, and muscle aches was reported as unknown for both PREVENAR 13 and SHINGRIX.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Anxiety, Crying, Hypophagia, Irritability, Ultrasound abdomen
Clinical narrative: Patient had increased irritability, excessive crying, breathing worrisome, decreased PO intake. Had US to R/O intussusception 3/10/18.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Herpes simplex test negative, Polymerase chain reaction positive, Rash vesicular, Varicella virus test positive
Clinical narrative: Vesicular lesions on (L) scalp, forehead, periorbital area.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Anxiety, Asthenia, Condition aggravated, Depression, Dizziness
Clinical narrative: Felt like fainting, rash, eyes and ears hurt, anxiety worse, tired and weak. Dizzy, depression worse, sensitives worse.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Eye pain, Fatigue, Rash
Clinical narrative: Felt like fainting, rash, eyes and ears hurt, anxiety worse, tired and weak. Dizzy, depression worse, sensitives worse.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injected limb mobility decreased, Insomnia, Lymph node pain, Lymphadenopathy
Clinical narrative: 24 hours after injection lymph node in left armpit became tender and swelling. Unable to sleep on that side due to pain. At 72 hours (plus) later there is a baseball size swelling in left armpit. Very tender and unable to bring arm to body. No fever. May be having a few hot flashes.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: 24 hours after injection lymph node in left armpit became tender and swelling. Unable to sleep on that side due to pain. At 72 hours (plus) later there is a baseball size swelling in left armpit. Very tender and unable to bring arm to body. No fever. May be having a few hot flashes.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX (batch number P3777, expiry date 20th January 2020) On 21st December 2017, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills and tremor to be related to SHINGRIX. Additional details were reported as follows: The event lasted about a day. No further information was provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 72-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 31st January 2020). The patient's past medical history included respiratory disorder and infection (in an out of hospital with unspecified infections). Concomitant products included SINGULAIR, Diltiazem, DUONEB, NORCO, PROAIR HFA, XANAX, ZANAFLEX, ZOCOR and hydrochlorothiazide + losartan. On 6rh March 2018, the patient received SHINGRIX. On 7th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site mass, injection site pain and injection site erythema. The patient was treated with BACTRIM and MEDROL. On an unknown date, the outcome of the injection site mass, injection site pain and injection site erythema were unknown. The reporter considered the injection site mass, injection site pain and injection site erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient reported that soreness and pain at the injection site of the SHINGRIX injection, which was the left arm. The patient also reported a knot on the injection site and redness. The patient went to the physician, and was given BACTRIM and MEDROL dose pack.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity, Peripheral coldness
Clinical narrative: Arm pain, nausea, cold hands, myalgia.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Blood test, Dyspnoea, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Patient developed fever, shortness of breath, back pain and tingling in left leg. Had to be carried to ER by his mother.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient developed fever, shortness of breath, back pain and tingling in left leg. Had to be carried to ER by his mother.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Swelling, Tenderness
Clinical narrative: Patient complains of bilateral neck swelling and tenderness to touch in addition to soreness to injection site (right arm).
Age: 72.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Oral disorder, Oral mucosal eruption
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash mouth in a 72-year-old male patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). Concomitant products included PREVNAR 13. On 6th March 2018 19:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGIRX, the patient experienced rash mouth and mouth bump. On an unknown date, the outcome of the rash mouth and mouth bump were not recovered/not resolved. It was unknown if the reporter considered the rash mouth and mouth bump to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in unknown deltoid and experienced rash around the mouth as well as lump on the inside of their cheek. On 6th March 2018, the patient received PREVNAR 13 in another arm, in deltoid. The healthcare professional did not know when the reaction started. The healthcare professional reported that the patient had been on all their medications longstanding and did not have anything pertinent to this situation in their medical history.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding 3 patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient received a dose of ZOSTAVAX 19400 PFU lot# M03697 with expiry date of 13-MAR-2018, intramuscularly for prophylaxis (dosing details not reported). The pharmacist reported that he believes at least 2 other unspecified patients received doses of ZOSTAVAX by intramuscular route on unspecified dates. The pharmacist was unable to provide the lot numbers and expiration dates for the sterile diluent that was used to reconstitute the vaccines. No adverse effects were reported.  Follow up information has been received on 10-AUG-2017. All telephone attempts to obtain follow-up information have been unsuccessful.   Additional information has been requested.  Lot number M03697 is an invalid lot number for Zoster Vaccine Live.
Age: 0.33
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 4 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-MAR-2018, the patient was inadvertently administered M-M-R II lot# N045392 with expiry date of 14-NOV-2018, VARIVAX lot# N009768 with expiry date of 24-MAR-2019 and VAQTA lot# N020689 with expiry date of 22-OCT-2018 earlier than the recommended age for prophylaxis. No adverse effects were reported. No product quality complaint was present.
Age: 29.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site pruritus, 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 swelling in a 29-year-old male patient who received TWINRIX (batch number 3HG77, expiry date June 2020). Concomitant products included ibuprofen and Clobetasol ointment. On 12th March 2018 17:00, the patient received the 3rd dose of TWINRIX (intramuscular). On 13th March 2018, 1 days after receiving TWINRIX, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site itching were not recovered/not resolved and the outcome of the injection site erythema was unknown. The reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site itching to be almost certainly related to TWINRIX. Additional details were provided as follows: The pharmacist reported that the patient received his 3rd injection for TWINRIX and on the next day he noticed redness and swelling at the injection site. The symptoms had continued to get worse and the area was also itchy and hot to the touch. The pharmacist described the redness as being an area about the size of a baseball.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to her son who is 11 year old. The Patient's pertinent medical history, concurrent conditions, concomitant medications, were not reported. No previous drug reactions or allergies were reported. On an unknown date, the patient was vaccinated with adult dose of VAQTA (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis. No adverse effects were reported. No product quality complaint involved.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia, fatigue and fever. The patient was treated with medication unknown (Fluids) and Acetaminophen and Ibuprofen. On an unknown date, the outcome of the myalgia, fatigue and fever were recovered/resolved. It was unknown if the reporter considered the myalgia, fatigue and fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The physician administered the SHINGRIX vaccination and the patient had an adverse albeit expected reaction of myalgia, fatigue and fever that resolved in a few days with fluids, rest and acetaminophen and ibuprofen (no Emergency visit or hospitalization). No lot number or expiration date or patient details were provided.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a adult female patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was recovered/resolved. It was unknown if the reporter considered the allergic reaction to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 1998, the patient received a flu vaccine of unknown manufacturer and had an allergic reaction. The patient called to see if she would have an allergic reaction to SHINGRIX based on this previous reaction. The caller was transferred to medical information.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 71-year-old female patient who received SHINGRIX (batch number P3777, expiry date unknown). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included CARAFATE. On 9th March 2018, the patient received SHINGRIX .5 ml. On 9th March 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness and pain in arm. On 10th March 2018, the patient experienced injection site pain. On an unknown date, the outcome of the tiredness, pain in arm and injection site pain were recovered/resolved. The reporter considered the tiredness, pain in arm and injection site pain to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included vitamins (nos). The patient reported that after receiving the SHINGRIX vaccine she had soreness at the injection site and the patient was also tired and her arms were sore and achy. At the time of reporting, the side effect of the patient had fully resolved. The patient went to bed at 7:20 pm after that weekend but her tiredness has since resolved and she was back to exercising.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Hyperhidrosis, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain, sweating and weakness. On an unknown date, the outcome of the muscle pain, sweating and weakness were unknown. It was unknown if the reporter considered the muscle pain, sweating and weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient received first dose of SHINGRIX and experienced muscle pain, weakness and sweating. The reporter was a pharmacist at call center who did not have access to patient information or vaccine information. The reporting pharmacist was not the administering health care professional and did not work at the administering medical office. No information was available other than the documented side effects.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were unknown. It was unknown if the reporter considered the fever and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Monday at 17:00 pm (no exact date provided), the patient received SHINGRIX. On Tuesday (no exact date provided), the patient experienced intractable vomiting wished described as she could not stop vomiting. The patient went to an emergency care facility for treatment. The patient did not provide any additional information outside of what has been documented in this report. The patient had denied permission to contact their physician. The reporter did not wish to complete adverse report, she felt that GlaxoSmithKline would be getting more from her, than she would be getting from them. No lot or expiry date of SHINGRIX was provided. The patient did not wish to provide a street address.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site reaction in a female patient who received SHINGRIX. Previously administered products included ZOSTAVAX. 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 injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was at a public Food and Drug Administration (FDA) hearing on the time of reporting and one of the speakers noted that the patient had ZOSTAVAX previously and after the a dose of SHINGRIX injection developed a fairly significant injection site reaction (she said half her upper arm). She saw from the label that swelling and redness was quite common. She actually read the label very carefully and noted that patients with ZOSTAVAX were excluded from the trials, and wanted to know if there was any data on risk of such reactions in patients with previous ZOSTAVAX (as Centers for Disease Control (CDC) does recommend SHINGRIX even with prior ZOSTAVAX). She also wanted to know about getting the 2nd injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash pustular, Skin hyperpigmentation
Clinical narrative: R/t KINRIX since RXN in deloid. Skin hyperpigmented, no induration NTT. Few pustules.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Injection site pain, Injection site rash, Presyncope
Clinical narrative: Near syncope. Patient reports being very disoriented at home. He reports walking into walls and nearly fainting. He also reports pain and rash at injection sites. Still present on 3/19/2018.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: When the patient came in today to pick up one of her prescription, I inquired how she is doing on the SHINGRIX vaccine that was administered on 03/17/2018. She said that she had headache, fever, loss of appetite, pain redness, soreness and swelling at the site of injection. She also said that she saw her provider. When I examined her arm this morning, her left arm is still swollen and red at the site of injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: When the patient came in today to pick up one of her prescription, I inquired how she is doing on the SHINGRIX vaccine that was administered on 03/17/2018. She said that she had headache, fever, loss of appetite, pain redness, soreness and swelling at the site of injection. She also said that she saw her provider. When I examined her arm this morning, her left arm is still swollen and red at the site of injection.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Rash with hives, not localized starting day vaccine was received.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Blood test, Computerised tomogram, Dysstasia, Hypoaesthesia, Impaired work ability
Clinical narrative: Shot was administered on 11/3/17. On 12/10/17 noticed numbness in right thigh. numbness continued to progress down leg. Saw my oncologist on 12/13/17 who sent me to a neurologist that same day. Neurologist set up MRIs and CATs for following Tuesday (12/19/17) and told me to go to ER if there was weakness (which there wasn't, just a numb sensation). On Friday 12/15 the numb sensation had covered my entire right leg and was beginning on my left. Called neurologist up and told him. He restated that as long as there was no weakness to continue daily activities and wait for Tuesdays tests. On Tuesday morning, 12/19/2017, I woke up unable to move my right leg and barley able to stand on the left. Went to ER and was admitted to hospital that day. Stayed in hospital from 12/19/17 to 12/30/17 when I was moved to a rehabilitation facility where I remained until 1/19/2018. Neurologist diagnosed me with Neuromyelitis Optima in January. I left rehab in a wheelchair and am currently going to therepy 2 times a week to learn how to walk again. I have not been able to go to work since 12/19/17.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Lumbar puncture, Mobility decreased, Neuromyelitis optica spectrum disorder, Nuclear magnetic resonance imaging, Wheelchair user
Clinical narrative: Shot was administered on 11/3/17. On 12/10/17 noticed numbness in right thigh. numbness continued to progress down leg. Saw my oncologist on 12/13/17 who sent me to a neurologist that same day. Neurologist set up MRIs and CATs for following Tuesday (12/19/17) and told me to go to ER if there was weakness (which there wasn't, just a numb sensation). On Friday 12/15 the numb sensation had covered my entire right leg and was beginning on my left. Called neurologist up and told him. He restated that as long as there was no weakness to continue daily activities and wait for Tuesdays tests. On Tuesday morning, 12/19/2017, I woke up unable to move my right leg and barley able to stand on the left. Went to ER and was admitted to hospital that day. Stayed in hospital from 12/19/17 to 12/30/17 when I was moved to a rehabilitation facility where I remained until 1/19/2018. Neurologist diagnosed me with Neuromyelitis Optima in January. I left rehab in a wheelchair and am currently going to therepy 2 times a week to learn how to walk again. I have not been able to go to work since 12/19/17.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal disorder, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient had arm pain after vaccine. MD believes injection could have been in bursa sac. Arm function limited. Improving but still not fully normal.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Immunodeficiency, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Had severe swelling and redness at injection point. Entire left upper arm and curved part of shoulder stuck out about two inches. Area was very sore to the touch. All of my muscles ached and I was completely wore out (fatigued) for three days, My pain increased similar to when I had my back surgery. I did nothing but stay in my recliner for the three days. On the 17th of March when I woke up the swelling and redness had almost totally gone away, my pain became tolerable and the only other change is that I felt nausea for the first 4 to five hours of the day. Having lived thru necrotizing pancreatitis, Kyrle's and cythro cytosis I have a compromised immune system.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Nausea, Pain
Clinical narrative: Had severe swelling and redness at injection point. Entire left upper arm and curved part of shoulder stuck out about two inches. Area was very sore to the touch. All of my muscles ached and I was completely wore out (fatigued) for three days, My pain increased similar to when I had my back surgery. I did nothing but stay in my recliner for the three days. On the 17th of March when I woke up the swelling and redness had almost totally gone away, my pain became tolerable and the only other change is that I felt nausea for the first 4 to five hours of the day. Having lived thru necrotizing pancreatitis, Kyrle's and cythro cytosis I have a compromised immune system.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Patient states she got a rash over the body.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: Patient states that a few hours after injection, her left deltoid became swollen, sore and hot, and she had body aches. She states that lasted a few days, but now the swelling has gone down and her arm is itching. There is not any signs of rash, and she did not experience any breathing difficulties.  Her pain was moderate, but was relieved by TYLENOL. Patient states that she does not want the second shot in this series.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Dermatitis, Erythema, Immune system disorder, Injection site dryness, Injection site scab
Clinical narrative: 26 yo primary vacinee received SPV vaccine 17 days prior to developing a pruritic macular/papular erythematous dermatitis to both arms and legs. There were no vesicles or pustules or lesions to his hands. He states he feels well no fever, chills, malaise, arthralgias or myalgias. He self treated with BENADRYL which has alleviated the pruritus and was overall much better. The site was dry and still had a scab. Dermatitis resolved three days later at followup. Diff Dx NVP vs. immune mediated. Lesion onset was late and more macular than typical for NVP.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Skin lesion
Clinical narrative: 26 yo primary vacinee received SPV vaccine 17 days prior to developing a pruritic macular/papular erythematous dermatitis to both arms and legs. There were no vesicles or pustules or lesions to his hands. He states he feels well no fever, chills, malaise, arthralgias or myalgias. He self treated with BENADRYL which has alleviated the pruritus and was overall much better. The site was dry and still had a scab. Dermatitis resolved three days later at followup. Diff Dx NVP vs. immune mediated. Lesion onset was late and more macular than typical for NVP.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Back pain, Body temperature increased, Injection site erythema, Injection site pain
Clinical narrative: PAIN AT INJECTION SITE, WITH IRREGULAR SHAPED REDNESS. PAIN IN BACK, TEMP 100.1. EVALUATED BY MD, GIVEN ZYRTEC. DOCUMENTED AS MILD ADVERSE REACTION.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given 1 single dose of varicella vaccine and 1 single dose of proquad on the same day.  3/16/18 As of 3/19/18 there have been no report of side effects from patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: I woke up with a 100.2 F fever with aches and pains the morning after getting the injection. The second day, my arm got very sore and felt hot and swollen around the injection site. The red area was about 5 inches long and 3 inches wide. The redness has all resolved now, but I still have a little pain in my arm more than a week later. It is improving, so I suppose it will completely go away in a few days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I woke up with a 100.2 F fever with aches and pains the morning after getting the injection. The second day, my arm got very sore and felt hot and swollen around the injection site. The red area was about 5 inches long and 3 inches wide. The redness has all resolved now, but I still have a little pain in my arm more than a week later. It is improving, so I suppose it will completely go away in a few days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Very painful at time of shot. Arm pain after shot. Arm and shoulder pain remaining of day and one day after shot. Next day felt Malaise muscle pain. Felt ok on the second day.
Age: 67.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Influenza virus test, Pain, Pruritus, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient stated he began to get congestion, fever as high as 102, general aches and pains, small amount of hives/itchy patches on arm that was vaccinated beginning 1 or 2 days after the vaccination and lasting 5 days so far.
Age: 67.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Streptococcus test, Urticaria
Clinical narrative: Patient stated he began to get congestion, fever as high as 102, general aches and pains, small amount of hives/itchy patches on arm that was vaccinated beginning 1 or 2 days after the vaccination and lasting 5 days so far.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Insomnia, Musculoskeletal pain, Myalgia
Clinical narrative: Aching muscles and joints. Ongoing since 12/22/2017. Shoulders, neck, lower back and hip joints. At times it makes sleep difficult.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Neck pain
Clinical narrative: Aching muscles and joints. Ongoing since 12/22/2017. Shoulders, neck, lower back and hip joints. At times it makes sleep difficult.
Age: 6.0
Sex: F
Vaccine: FLUC4, HEP, HEPA, VARCEL
Symptoms: Pyrexia, Rash, Rash papular, Rash pustular, Scab
Clinical narrative: Patient developed fever and rash on 3-17-18. Was examined by MD on 3-19-18. Aural temperature of 99.8. Has lesions consistent with chicken pox. Lesions in various stages (some scabbed, some red papules, some pustules on red base) on trunk, and a few on face and extremities. Rash began on back. As above, younger sister had similar rash 2 weeks ago, now resolved.
Age: 6.0
Sex: F
Vaccine: FLUC4, HEP, HEPA, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Patient developed fever and rash on 3-17-18. Was examined by MD on 3-19-18. Aural temperature of 99.8. Has lesions consistent with chicken pox. Lesions in various stages (some scabbed, some red papules, some pustules on red base) on trunk, and a few on face and extremities. Rash began on back. As above, younger sister had similar rash 2 weeks ago, now resolved.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash macular
Clinical narrative: 3/15/18 New onset this AM. Suspect this is related to the varicella vaccine that she got 10 days ago. She is without fever and only slight change to her baseline activity. I have educated mother about this and precautions for those who are older, immunocompromised and very young who have not been vaccinated. Will f/u closely in office tomorrow. Counselled to just use calamine lotion prn if needed. All questions answered. Skin: many small macular erythematous rash to extremities, trunk and face - NO PUSTULES. 3/16/18Grossly unchanged presentation from yesterday. Continue to wait/watch. Precautions discussed again with mother. Will call us next week with update. 3/19/18 Mother reports patient is doing much better, rash is almost gone(rash has disappeared/no scabbing).
Age: 28.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event per say just that FLUAD is meant for ages 65 and older but was mistakenly given to 29 year old male.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Neck pain, Pain, Palpitations
Clinical narrative: Patient had severe pain radiating up to his left neck, chills and body aches. He had severe palpitations. He went online and checked at website and read that the severe palpitation could happen to 1 in 50 people. He called his MD too.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Eye irritation, Headache, Influenza
Clinical narrative: Woke up 3:30 AM with splitting headache, red burning eyes, diffuse body aches. 9:00 AM ran a low grade fever of 99.6 most of the day (normal body temp is low at 95- 96 degrees) with headache, body aches, occ. shooting pains in knees and mild chills like a mild flu. Left arm soreness like a DPT shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Woke up 3:30 AM with splitting headache, red burning eyes, diffuse body aches. 9:00 AM ran a low grade fever of 99.6 most of the day (normal body temp is low at 95- 96 degrees) with headache, body aches, occ. shooting pains in knees and mild chills like a mild flu. Left arm soreness like a DPT shot.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema, Pain, Skin warm
Clinical narrative: Linear area 5 cm of erythema, warmth, edema, pain.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain. Initially it was swollen and hurt. The arm pain has continued (without swelling); discomfort is daily and is temporarily relieved by rubbing my arm.
Age: 69.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called me on 03/18/2018 (4 days post vaccination) in morning hours after 10 am complaining of swelling, redness, pain and itching at site of injection. Upon questioning for more details, she said the swelling and redness on her arm at one point was 4 inches in radius. The site was painful and uncomfortable to the touch. Recommended treatment with BENDRYL and pain relievers. Followed up with patient on 03/19/2018 and the symptoms have significantly improved, including reduced swelling.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Confirmed shingles rash today by description of symptoms, physician exam by Dr.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient developed redness and a rash - hot to touch on left arm, 5 inches tall, 8 inches wide around arm. Some small red "spots". This was observed on 3/14/18 at doctors re-evaluation appointment.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Fatigue, Injection site swelling, Nausea
Clinical narrative: Shortness of breath, hives, nausea, vomiting, swelling of injection site, fever, chills, fatigue.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Shortness of breath, hives, nausea, vomiting, swelling of injection site, fever, chills, fatigue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Red, raised welt on upper arm. Patient reported she had swelling, redness and warmth from the shoulder to the elbow. Welt has been present for 3 days. Swelling of upper arm for 2 days. Warmth has been present for 3 days. She stayed quiet and rested over the weekend. She didn't try any medications, ice etc.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Fatigue, Skin warm, Swelling
Clinical narrative: Arm redness, more than expected. Transferred to her armpit which is where she noticed pain.  Swollen, hot and red. Patient taking ibuprofen and BENADRYL. Complained of excessive fatigue the following day.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hypoaesthesia, Injection site pain, Musculoskeletal disorder, Nausea
Clinical narrative: Patient experienced nausea, numbness in the arm to the point where she said she could not use it normally, pain at injection site and chills. I advised her to go to the ER if she felt necessary or if symptoms worsened and to call her doctor at a minimum in the morning if needed. I called her back later to check on her again and she was contemplating going to the ER. Nausea had begun but other symptoms remained the same. No trouble breathing reported.
Age: 56.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Blister, Immediate post-injection reaction, Musculoskeletal pain, Pruritus generalised, Pyrexia
Clinical narrative: Pt reports a rash with redness and pimple-like blisters from her hand to elbow (below injection site) starting approximately 2 days ago, shoulder pain and soreness that started yesterday, and general itching that started a week ago. The patient had fevers immediately after receiving vaccines. Pt was referred to seek medical attention to evaluate her symptoms.
Age: 56.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt reports a rash with redness and pimple-like blisters from her hand to elbow (below injection site) starting approximately 2 days ago, shoulder pain and soreness that started yesterday, and general itching that started a week ago. The patient had fevers immediately after receiving vaccines. Pt was referred to seek medical attention to evaluate her symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal disorder in a female patient who received SHINGRIX. On 12th March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced gastrointestinal disorder. On an unknown date, the outcome of the gastrointestinal disorder was unknown. It was unknown if the reporter considered the gastrointestinal disorder to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case was reported by the patient's husband. The patient received the SHINGRIX vaccine this past Monday and she was experiencing gastrointestinal issues.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Abnormal sensation in eye, Asthenia, Erythema, Nausea, Pallor
Clinical narrative: Pt. was given Tdap first in the right deltoid, MCV4 next in the right deltoid, then Hepatitis A was administered in the left deltoid. Pt. said his eyes "felt funny" and that he felt sick to his stomach. His skin then got white/pale and he started vomiting. Red blotchy spots popped up across his shoulders and he became very weak. I got him a cold wash cloth and wiped his face and on the back of his neck. After vomiting, his coloring started coming back and he stated he was ready for the last shot which would have been GARDASIL but I did not administer this vaccine. I gave him some cold water, a popsicle and mom requested a dose of BENADRYL. I gave him 25 m of BENADRYL. After the medication and a cold drink, the patient "felt" better. I did not see any immediate reactions locally where the vaccines were given nor did he seem to be in respiratory distress.