chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: DTAP, FLUX, HEPA, MMR, VARCEL
Symptoms: Rash, Seizure, Vaccination site induration
Clinical narrative: Had multiple eye rolling upward episodes that appeared to be seizures; Indurated; Large bruise at site of injection; Petechiae; Rash on arms, legs, and trunk; Patient under 4 years of age received Influenza; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2015US047488).   This spontaneous report was received from an other healthcare professional and refers to a 1-year-old male patient. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 08-DEC-2014, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown), 1 dosage form (exact date, route of administration, anatomical location, lot # and expiration date were not reported). On the same day the patient also received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), 1 dosage form (exact date, route of administration, anatomical location, lot # and expiration date were not reported), varicella virus vaccine live (oka/merck)(manufacturer unknown), 1 dosage form (exact date, route of administration, anatomical location, lot # and expiration date were not reported), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid; 1 dosage form (exact date, route of administration, anatomical location, lot # and expiration date were not reported) and unspecified influenza virus vaccine, 1 dosage form (DF) (exact date, route of administration, anatomical location, lot # and expiration date were not reported). The reporter informed, that the influenza vaccine should not be administered to the patient under 4 years of age (drug use in unapproved population). All the vaccines were administered for immunization.   On 24-DEC-2014, the patient experienced multiple episodes of eye rolling upward that appeared to be seizures, petechiae, vaccination site induration (reported as indurated) and had a large bruise at the injection site and rash on his arms, legs and trunk. Additionally, the reporter informed that on an unknown date the patient had electroencephalogram (EEG) with the result reported as normal. The outcome of the events was unknown.  The relatedness between the event of multiple eye rolling upward episodes that appeared to be seizures and unspecified influenza virus vaccine was reported as suspected. The relatedness between the events of vaccination site induration, large bruise at site of injection, drug use in unapproved population, petechiae, rash and unspecified influenza virus vaccine were reported as not assessable. The causality assessment between the events and the other suspect therapies was not provided by the reporter.   The Agency considered all the events to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: they had many complaints from the shot'; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the unspecified number of patient had adverse drug reaction after vaccination. This case has been linked with case US2019AMR237655, reported for same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2020, the patient received the 1st dose of Shingrix. On 21st January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. In January 2020, the outcome of the pain in arm was resolved with sequelae.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine on left arm and she experienced arm soreness for a couple of days following the shot. The reporter consented to follow up. This case has been linked with US2020014925, reported by same reporter.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Running fever of 100.3; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on an unspecified day. For tolerance of 1st dose refer case US2020AMR023953).   On 9th February 2020, the patient received the 2nd dose of Shingrix. On 10th February 2020, 1 days after receiving Shingrix, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient had side effects of running fever of 100.3 degrees Fahrenheit.  The patient inquired if this was common and if could attend a funeral in the evening of the day of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: experienced side effects with the first dose, Pretty much the same; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had fever post vaccination.  The patient stated side effects were pretty much the same after both the doses. This case is linked to case US2020AMR023947 reported by the same reporter (2nd dose).
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: redness at the right of the shingled vaccine; it's a little itchy; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were recovered/resolved.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had redness at the right of the shingrix vaccine for a week and it was a little itchy.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Compression fracture, Syncope
Clinical narrative: compression fracture; Patient fainted; This case was reported by a nurse via sales rep and described the occurrence of faint in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and Flu vaccine at an unknown dose. On 4th February 2020, unknown after receiving Shingrix and Flu vaccine, the patient experienced faint (serious criteria GSK medically significant) and compression fracture (serious criteria hospitalization). On an unknown date, the outcome of the faint and compression fracture were unknown.   It was unknown if the reporter considered the faint and compression fracture to be related to Shingrix and Flu vaccine.  Additional details were provided as follows The age at vaccination not provided. The patient experienced fainted and subsequently hospitalized with a compression fracture. The reporter gave consent for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: otc medicine for pain after shingles shot; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were received as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient experienced pain after vaccination. The patient was asking about best otc medicine for pain after shingles shot. The patient was going for second shot and wanted to know if ibuprofen or aleve is best after the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: having issues with sinus infection; This case was reported by a consumer via call center representative and described the occurrence of sinus infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced sinus infection. On an unknown date, the outcome of the sinus infection was not recovered/not resolved.   It was unknown if the reporter considered the sinus infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient received the shot for the shingles vaccine and was hoping to get the 2nd shot this week, but patient still had issues with sinus infection. The patient inquired that would it be safe to get the second shot now.
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Injection site swelling; Injection site hardening; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site swelling and injection site induration. On an unknown date, the outcome of the injection site swelling and injection site induration were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site induration to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced swelling and hardness at the injection site for five days after the administration of Bexsero.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: fatigue; chills; slept 12 hours that night / On the second night she slept 11 hours; pain at the injection site; swelling at the injection site; redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received in October 2019, refer case US2020021626.).   On 3rd February 2020, the patient received the 2nd dose of Shingrix .5 ml. On 3rd February 2020, less than a day after receiving Shingrix, the patient experienced fatigue, chills, sleep excessive, injection site pain, injection site swelling and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue, chills, injection site pain, injection site swelling and injection site erythema were recovering/resolving and the outcome of the sleep excessive was recovered/resolved.   It was unknown if the reporter considered the fatigue, chills, sleep excessive, injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows:  After receiving 2nd dose of Shingrix that evening the patient experienced fatigue and chills. The patient was slept 12 hours that night but was able to function the next day.  On the second night she slept 11 hours and the chills were reduced. The patient also experienced pain, swelling and redness at the injection site the first night. The injection site reactions were worst the 1st night and started to reduce in intensity by the second night. The 2nd day injection site area experiencing these symptoms increased in size but the pain, swelling and redness reduced in intensity. Consent to follow up was denied.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Vaccine positive rechallenge
Clinical narrative: fatigue; chills; slept 12 hours that night / On the second night she slept 11 hours; pain at the injection site; swelling at the injection site; redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received in October 2019, refer case US2020021626.).   On 3rd February 2020, the patient received the 2nd dose of Shingrix .5 ml. On 3rd February 2020, less than a day after receiving Shingrix, the patient experienced fatigue, chills, sleep excessive, injection site pain, injection site swelling and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue, chills, injection site pain, injection site swelling and injection site erythema were recovering/resolving and the outcome of the sleep excessive was recovered/resolved.   It was unknown if the reporter considered the fatigue, chills, sleep excessive, injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows:  After receiving 2nd dose of Shingrix that evening the patient experienced fatigue and chills. The patient was slept 12 hours that night but was able to function the next day.  On the second night she slept 11 hours and the chills were reduced. The patient also experienced pain, swelling and redness at the injection site the first night. The injection site reactions were worst the 1st night and started to reduce in intensity by the second night. The 2nd day injection site area experiencing these symptoms increased in size but the pain, swelling and redness reduced in intensity. Consent to follow up was denied.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: heavy, pervasive skin rash on his abdomen, torso, back and his shoulder; This case was reported by a nurse via call center representative and described the occurrence of rash in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   On 31st January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st February 2020, 1 days after receiving Shingrix, the patient experienced rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: 24 hours after receiving Shingrix, the patient experienced a heavy, pervasive skin rash on his abdomen, torso, back and his shoulder where he received the vaccination. No information as to whether the rash resolved or improved after treatment. Consent to follow up was provided.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Incomplete course of vaccination, Pain, Rash
Clinical narrative: inappropriate schedule of vaccine; painful blisters; Right arm was red; Right arm was warm; Looks like shingles/ blisters rash/ rash on his right elbow and forearm; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (when the patient was young) and shingles (on his back when he was older). Previously administered products included Zostavax (many years before the time of reporting).   On 16th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On 17th May 2019, the patient experienced vesicular rash and pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the vesicular rash, pain and incomplete course of vaccination were unknown and the outcome of the erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, erythema of extremities, skin warm and pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix vaccine on right arm. Less than a week after vaccination, the patient's right arm was red and warm which resolved later. The patient experienced painful blisters and rash on his right elbow and forearm. The pharmacist stated it looked like shingles. This was not confirmed by his physician. The blisters (mosquito bite like) resolved in 4 to 5 days. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Skin warm
Clinical narrative: inappropriate schedule of vaccine; painful blisters; Right arm was red; Right arm was warm; Looks like shingles/ blisters rash/ rash on his right elbow and forearm; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (when the patient was young) and shingles (on his back when he was older). Previously administered products included Zostavax (many years before the time of reporting).   On 16th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On 17th May 2019, the patient experienced vesicular rash and pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the vesicular rash, pain and incomplete course of vaccination were unknown and the outcome of the erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, erythema of extremities, skin warm and pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix vaccine on right arm. Less than a week after vaccination, the patient's right arm was red and warm which resolved later. The patient experienced painful blisters and rash on his right elbow and forearm. The pharmacist stated it looked like shingles. This was not confirmed by his physician. The blisters (mosquito bite like) resolved in 4 to 5 days. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Bronchitis, Influenza, Malaise, Vaccination failure
Clinical narrative: had bronchitis; became sick; suspected vaccination failure; had the flu that last lasted 1.5 months; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included antibiotics nos for bronchitis.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, the patient started antibiotics nos at an unknown dose and frequency. On 20th December 2019, less than 2 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the patient experienced bronchitis and feeling unwell. The action taken with antibiotics nos was unknown. On an unknown date, the outcome of the vaccination failure and feeling unwell were unknown and the outcome of the influenza and bronchitis were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza, bronchitis and feeling unwell to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by patient herself. The patient received an unknown manufacturer of the flu vaccine,  The patient become sick and had the flu that lasted 1.5 months and   the patient had bronchitis and had to take antibiotics.  This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. In February 2020, more than 2 years after receiving Shingrix and between 1 and 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had both doses of Shingrix in 2018, six months apart. A week before time of reporting, the patient was diagnosed with shingles. The reporter consented to follow up. The patient asked if there were times the vaccine did not work. The patient also wanted to know should he get another round of the vaccine.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Bacterial infection, Dysphagia, Infection, Intensive care, Mechanical ventilation
Clinical narrative: couldn't swallow; Sore throat; Provisional diagnosis is infection/ metastatic infection; Provisional diagnosis is infection; Provisional diagnosis is infection; Swelling on the neck area; This case was reported by a pharmacist via call center representative and described the occurrence of infection in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix. On 31st January 2020, less than a day after receiving Shingrix, the patient experienced neck swelling (serious criteria hospitalization). On 9th February 2020, the patient experienced infection (serious criteria hospitalization), bacterial infection (serious criteria hospitalization), viral infection (serious criteria hospitalization) and sore throat (serious criteria hospitalization). On 10th February 2020, the patient experienced unable to swallow (serious criteria hospitalization). The patient was treated with prednisone and antibiotics nos. On an unknown date, the outcome of the infection, bacterial infection, viral infection, sore throat and unable to swallow were unknown and the outcome of the neck swelling was recovering/resolving.   It was unknown if the reporter considered the infection, bacterial infection, viral infection, neck swelling, sore throat and unable to swallow to be related to Shingrix.  Additional information was provided as follows: The patient started experiencing swelling on the neck area on the same night of receiving vaccine which was visible to the registered pharmacist on 10th February 2020. After 9 days of receiving vaccine, the patient expereinced  a sore throat. The patient consulted urgent care on 9th February 2020 where they did a strep swab which came back negative. The patient was prescribed prednisone 20mg twice a day for 5 days but couldn't swallow it. On 10th February 2020, the patient went to the emergency room and was admitted to hospital. On 11th February 2020 the patient was hospitalized in the intensive care unit (ICU) with respiratory mechanical support.  The provisional diagnosis was infection. The patient was on vent. The reporter was not sure if it was a metastatic infection, viral infection, bacterial infection or what it was. The patient was on a short course of antibiotics at the time of reporting. The reporter consented to follow up. This case is linked with US2020024281, reported by same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Streptococcus test negative, Swelling, Viral infection
Clinical narrative: couldn't swallow; Sore throat; Provisional diagnosis is infection/ metastatic infection; Provisional diagnosis is infection; Provisional diagnosis is infection; Swelling on the neck area; This case was reported by a pharmacist via call center representative and described the occurrence of infection in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix. On 31st January 2020, less than a day after receiving Shingrix, the patient experienced neck swelling (serious criteria hospitalization). On 9th February 2020, the patient experienced infection (serious criteria hospitalization), bacterial infection (serious criteria hospitalization), viral infection (serious criteria hospitalization) and sore throat (serious criteria hospitalization). On 10th February 2020, the patient experienced unable to swallow (serious criteria hospitalization). The patient was treated with prednisone and antibiotics nos. On an unknown date, the outcome of the infection, bacterial infection, viral infection, sore throat and unable to swallow were unknown and the outcome of the neck swelling was recovering/resolving.   It was unknown if the reporter considered the infection, bacterial infection, viral infection, neck swelling, sore throat and unable to swallow to be related to Shingrix.  Additional information was provided as follows: The patient started experiencing swelling on the neck area on the same night of receiving vaccine which was visible to the registered pharmacist on 10th February 2020. After 9 days of receiving vaccine, the patient expereinced  a sore throat. The patient consulted urgent care on 9th February 2020 where they did a strep swab which came back negative. The patient was prescribed prednisone 20mg twice a day for 5 days but couldn't swallow it. On 10th February 2020, the patient went to the emergency room and was admitted to hospital. On 11th February 2020 the patient was hospitalized in the intensive care unit (ICU) with respiratory mechanical support.  The provisional diagnosis was infection. The patient was on vent. The reporter was not sure if it was a metastatic infection, viral infection, bacterial infection or what it was. The patient was on a short course of antibiotics at the time of reporting. The reporter consented to follow up. This case is linked with US2020024281, reported by same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Alopecia
Clinical narrative: alopecia; This case was reported by a other health professional via call center representative and described the occurrence of alopecia in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 20th January 2020, 17 days after receiving Shingrix, the patient experienced alopecia. On an unknown date, the outcome of the alopecia was recovering/resolving.   It was unknown if the reporter considered the alopecia to be related to Shingrix.  Additional details were reported as follows: The patient was a veterinarian. The patient received Shingrix vaccine in right arm  and suffered from alopecia. She saw general practitioner who referred her to a dermatologist. The Emergency room  visit was required. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Alopecia, Alopecia areata, Blood iron normal, Blood thyroid stimulating hormone decreased, Full blood count normal
Clinical narrative: alopecia; This case was reported by a other health professional via call center representative and described the occurrence of alopecia in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 20th January 2020, 17 days after receiving Shingrix, the patient experienced alopecia. On an unknown date, the outcome of the alopecia was recovering/resolving.   It was unknown if the reporter considered the alopecia to be related to Shingrix.  Additional details were reported as follows: The patient was a veterinarian. The patient received Shingrix vaccine in right arm  and suffered from alopecia. She saw general practitioner who referred her to a dermatologist. The Emergency room  visit was required. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Iron binding capacity total normal, Liver function test normal, Platelet count normal, Serum ferritin normal, Transferrin saturation
Clinical narrative: alopecia; This case was reported by a other health professional via call center representative and described the occurrence of alopecia in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 20th January 2020, 17 days after receiving Shingrix, the patient experienced alopecia. On an unknown date, the outcome of the alopecia was recovering/resolving.   It was unknown if the reporter considered the alopecia to be related to Shingrix.  Additional details were reported as follows: The patient was a veterinarian. The patient received Shingrix vaccine in right arm  and suffered from alopecia. She saw general practitioner who referred her to a dermatologist. The Emergency room  visit was required. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site arm pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, but it could be 68 or 69 years. The patient received a dose of Shingrix approximately 4 months ago from  reporting date in the left arm and was still experienced injection site arm pain. The reporter consented to follow up. This is 1 of the 2 cases, reported by same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills overnight; reported experiencing a fever of 101; This case was reported by a consumer via call center representative and described the occurrence of chills in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020, the patient received the 2nd dose of Shingrix. On 11th February 2020, less than a day after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and experienced a fever and chills overnight. The fever had come down today. The follow up consent was granted.
Sex: F
Vaccine: FLU4
Symptoms: Caesarean section, Exposure during pregnancy, Hypothyroidism
Clinical narrative: Vaccine exposure during pregnancy; Hypothyroidism; This is a spontaneous case from, initially received from other health professional on 10-Feb-2020 with additional information received on 12-Feb-2020, being processed together, concerning a pregnant female patient (Race and Ethnicity: not reported) of unspecified age.  The patient's medical history and concomitant medication included were not provided.   The patient's obstetrical history, history of offspring with major congenital malformation (MCM) and relevant maternal and paternal medical history were not reported. It was not reported if mother used tobacco, alcohol or illicit drugs during pregnancy.   The patient's last menstrual period (LMP) date was not reported. The patient's estimated delivery date (EDD) was reported and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.  On 25-Sep-2019, approximately at 28 weeks of gestation, the patient was administered Afluria QIV [influenza vaccine; batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an unknown indication.   On an unspecified date in 2019, the patient developed hypothyroidism, reported as pregnancy complication.  Approximately at 37.1 weeks of gestation, the patient delivered live birth female neonate by caesarean method. The neonate's birth weight was 3430 g, length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 (one minute) and 9 (five minutes). There was no APGAR score data for 10 minutes reported. No MCMs were identified at birth.  At the time of this report, the outcome of the event hypothyroidism was not reported.  The event of hypothyroidism was considered as serious due to the criterion of medical significance, per company.  The causality assessment was not provided.  Company comment: It is unknown when the patient developed hypothyroidism therefore the causal relationship between Afluria and this adverse event is considered unassessable. Vaccine exposure during pregnancy is causally unrelated to Afluria.; Sender's Comments: It is unknown when the patient developed hypothyroidism therefore the causal relationship between Afluria and this adverse event is considered unassessable. Vaccine exposure during pregnancy is causally unrelated to Afluria.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Madarosis
Clinical narrative: The patient noticed loss of eyelashes on 12-20-19 when she tried to put mascara on for a Christmas party when she noticed her top and bottom lashes were missing.  As of 2-12-20 the top lashes have grown back but the bottom lashes are still missing.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: The patient had a hot rash at the site of injection, started 1 day after  having  mild fever, rash did not worsen
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: The next morning, I had a very large rectangular, raised patch of skin (approximately 4" long x 3" wide) on my injected arm, it was very hot to the touch but the worst issue was needle-like pain radiating UP from the skin which hurt quite a lot.  This remained for 4-5 days then the pain subsided and the rash/swelling disappeared after a week.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Pain and swelling around injection site. The swelling seems to be moving down the arm as days pass, not being swollen at the injection site now (day 5), instead being swollen further down.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient reported cellulitis in her arm
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Nodule, Pain in extremity
Clinical narrative: upper arm pain/knot
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Vaccination complication
Clinical narrative: After getting the SECOND dose of the shingrix on 2/1, she developed fever blisters on 2/3 that the Dr identieifed on 2/18 to be "Vaccine-associated zoster", to which they prescribed Valtrex and Gabapentin
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Muscle tightness, Myalgia, Peripheral swelling, Pruritus
Clinical narrative: Pt arm began to turn red and swell . patients arm was itching and the muscle felt tight and painful .
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient experienced no sympotms; improperly stored dose of Gadrasil 9 was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 29-JAN-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly, lot # R016970, expiration date 22-MAR-2021 (exact dose and dose number were not reported) for prophylaxis.   The temperature excursion was 48.6 degrees Fahrenheit (F) for 73 hours 9 minutes. There were no previous excursions reported. The digital data logger was involved. The patient experienced no symptoms.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Seizure
Clinical narrative: Started having convulsions; Fever; This case was reported by a physician via sales rep and described the occurrence of convulsion in a infant patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, unknown after receiving Pediarix, the patient experienced convulsion (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the convulsion and fever were unknown.   It was unknown if the reporter considered the convulsion and fever to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not reported. A baby patient received Pediarix and experienced fever and convulsions. The reporter declined consent for follow up.
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Headache that has persisted for seven months; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient received the second dose of meningococcal group b rlp2086 (TRUMENBA), 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 previously took the first dose of meningococcal group b rlp2086 (TRUMENBA) on an unknown date for immunization. The patient experienced headache that has persisted for seven months on an unspecified date within a week of the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: MENB, UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: high fever; vomiting; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), and meningococcal vaccine conjugate (MENINGOCOCCAL CONJUGATE), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced high fever and vomiting on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Vomiting
Clinical narrative: high fever; vomiting; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced high fever and vomiting on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Bacterial infection, Pneumococcal sepsis
Clinical narrative: Developed pneumococcal sepsis 2 days later; This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunisation .  The patient medical history  and concomitant medications were not reported.  The patient developed pneumococcal sepsis on an unspecified date two days after receiving vaccination  with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information current currently available, no LOE with PREVNAR 13 is clearly implied for the onset of Pneumococcal sepsis occurred two days after receiving vaccination, which most likely represents an intercurrent severe bacterial infection. 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 and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site vesicles, Lip blister, Lip swelling, Peripheral swelling
Clinical narrative: Rash up to the shoulder of injected arm; blistering of the skin near injection site; swelling of injected arm as well as lips; Rash up to the shoulder of injected arm, blistering of the skin near injection site as well as on the lips, swelling of injected arm as well as lips; Rash up to the shoulder of injected arm, blistering of the skin near injection site as well as on the lips, swelling of injected arm as well as lips; This is a spontaneous report from a contactable physician via Pfizer sales representative.   A 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot # CD0412), via an unspecified route of administration at single dose on 05Dec2019 for immunisation. Medical history included diabetes. Concomitant medications were not reported. After receiving the vaccine patient returned to physician's office several days later on 11Dec2019 with adverse effects. Patient experienced rash up to the shoulder of injected arm, blistering of the skin near injection site as well as on the lips, swelling of injected arm as well as lips on an unspecified date in Dec2019 with outcome of unknown.
Sex: M
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Days later developed cellulitis at and around the site of injection; This is a spontaneous report from a contactable physician received via Pfizer Sales Representative.  A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. Days later receiving the vaccine, patient developed cellulitis at and around the site of injection on an unspecified date with outcome of unknown.    The information on the lot number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Cough
Clinical narrative: She had a former patient complain of chronic cough after receiving Prevnar; This is a spontaneous report from a contactable consumer via Pfizer sales representative.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) () via an unspecified route of administration on an unspecified date at single dose for immunisation.   The patient medical history and concomitant medications were not reported.  The patient experienced she had a former patient complain of chronic cough after receiving PREVNAR 13on an unspecified date. The outcome of the event was unknown.  Information on the batch number has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: PATIENT RECIEVED THE VACCINE ON SATURDAY SHOWED NO SYMPTOMS. CAME IN MONDAY 2/17 STATING THAT HER ARM HAD MORE REDDNESS THAN USUAL. UPON EVALUATION. I COULD NOT TELL WHETHER IT WAS AN ALLERGIC REACTION OR CELLULITIS I SUGGESTED CONTACTING HER PROVIDER AND DREW A LINE AROUND THE AFFECTED AREA. MD SAW PHOTOS AND SUBMITTED FOR KEFLEX 500MG. PATIENT IS IN NO DISCOMFORT.
Age: 53.0
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given Varivax when she had MMR within the past 4 weeks. It was not reported to the pharmacy that she received MMR prior.
Age: 53.0
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given Varivax when she had MMR within the past 4 weeks. It was not reported to the pharmacy that she received MMR prior.