chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient stated she had a headache, fever, chills, swollen arm the day of the vaccine.  The next day she felt very sick went to the Dr and the Dr stated she had an infection and prescribed an antibiotic.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphonia, Vocal cord paralysis
Clinical narrative: Patient received first dose of Shingrix vaccine on 4/4/2019 and second dose on 6/26/2019.  In April after receiving first dose patient began experiencing hoarse voice.  In June patient followed up with otolaryngologist and diagnosed with vocal cord paralysis.  A potential diagnosis is neuritis that could be due to a viral infection or possibly the shingrix vaccination.
Age: 34.0
Sex: M
Vaccine: TYP, UNK
Symptoms: Confusional state, Dizziness, Vertigo
Clinical narrative: Veritgo, dizziness, confusion
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS NEAR INJECTION SITE
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: SWOLLEN INJECTION SITE, HIGH FEVER. PATIENT RECEIVED ANTIBIOTIC FROM THE URGENT CARE. ADVERSE EVENT GOT IMPROVED.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Tremor
Clinical narrative: Went to bed, was freezing.  My hands & arms were shaking so bad I couldn't hold the thermometer which was 97.  It lasted a half an hour & I got better.  I did go to hospital, but sat in car in parking lot with 80 degrees heater, heated seat & coat on.  My shaking calmed down.  No other symptoms.  I never had chicken pox & was reluctant to get this, but my doctor said to.  My husband also had a shot with me, but he just had a sore arm.  Afraid to get second shot!
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain; Injection site swelling; nausea; fever; chills; headache; Fatigue; This case was reported by a consumer and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2019 17:00, the patient received Shingrix. In January 2019, 7 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, nausea, fever, chills, headache and fatigue. The patient was treated with ibuprofen (Advil) and ondansetron (Zofran). On an unknown date, the outcome of the injection site pain, injection site swelling, nausea, fever, chills, headache and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, nausea, fever, chills, headache and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for herself. Approximately 7 hours later, increasing over next 9 hours, the patient experienced pain at injection site, swelling, nausea, fever, chills, headache, fatigue. The events were continued 10 hours later. The patient was treated with Advil and Zofran. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Injection site pain; Injection site swelling; nausea; fever; chills; headache; Fatigue; This case was reported by a consumer and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2019 17:00, the patient received Shingrix. In January 2019, 7 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, nausea, fever, chills, headache and fatigue. The patient was treated with ibuprofen (Advil) and ondansetron (Zofran). On an unknown date, the outcome of the injection site pain, injection site swelling, nausea, fever, chills, headache and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, nausea, fever, chills, headache and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for herself. Approximately 7 hours later, increasing over next 9 hours, the patient experienced pain at injection site, swelling, nausea, fever, chills, headache, fatigue. The events were continued 10 hours later. The patient was treated with Advil and Zofran. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Sex: F
Vaccine: MENB
Symptoms: Local reaction, Pain in extremity, Skin warm
Clinical narrative: arm pain; injection site warmth; localized reaction; This case was reported by a nurse via sales rep and described the occurrence of local reaction in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, less than a day after receiving Bexsero, the patient experienced local reaction, pain in arm and skin warm. On an unknown date, the outcome of the local reaction was recovered/resolved and the outcome of the pain in arm and skin warm were recovering/resolving.   It was unknown if the reporter considered the local reaction, pain in arm and skin warm to be related to Bexsero.  Additional details were provided as follows: This case was reported by the registered nurse (RN). The age at vaccination was not reported. For the first 24 to 48 hours after vaccination, the patient experienced a severe localized reaction that lasted a full week. The patient's arm was sore and warm to touch. Her arm was getting better each day. The reporter did not agree to follow up from GlaxoSmithKline (GSK). This case had been linked with case US2019AMR113752, reported by the same reporter.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: She developed a varicella-type rash to her torso and left jawline 13 days after the Varivax injection. No other symptoms.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Very high fever of 104.3 on Saturday, June 29, 2019 at 10pm. Gave 7.5 ml of Tylenol to reduce fever. Fever has continued from June 30th - today, July 1st, 2019. temperatures between 103 - 103.7. Continue to give 7.5 ml of Tylenol to reduce fever. Seeing Dr. today at 1:45pm.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Rash
Clinical narrative: Pt developed burning pain at the  right chest wall and then developed typical shingle rash next day
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Generalised vaccinia
Clinical narrative: generalized vaccinia.  pt otherwise well, non-toxic.
Age: 48.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Patient developed a fine pin point rash to her whole body. It started on the right arm, but then spread to the back and down the legs. The rash is skin colored. It is itchy.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: 12 hours after receiving the shot, he developed sudden onset of chills and fever; Tmax 101.5; + headache, body aches, fatigue and general myalgias; the arm did not get erythematous or warm but was tender; 24 hours later symptoms resolved; no residual symptoms today
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tenderness
Clinical narrative: 12 hours after receiving the shot, he developed sudden onset of chills and fever; Tmax 101.5; + headache, body aches, fatigue and general myalgias; the arm did not get erythematous or warm but was tender; 24 hours later symptoms resolved; no residual symptoms today
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: patient developed autism after M-M-R II was administered; This spontaneous report was received from a nurse via company representative, and refers to a 7-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, after measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered, the patient developed autism. The patient did not recover from the event.  The causality assessment between autism and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  Upon internal review, the event of autism  was considered to be medically significant.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Low grade fever right around 100 degrees Fahrenheit; Fatigue; Chills; Flu-like symptoms; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), at 0.5 mg, single for prevention of meningococcal disease caused by serogroup B, and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) at an unknown dose for immunization (Prevention of meningococcal disease serogroups A, C, W or Y); both via an unspecified route of administration on 18Jun2019 02:45. The patient's medical history and concomitant medications were not reported. The patient was administered his second dose of meningococcal vaccine a/c/y/w conj (dip tox) and first dose of meningococcal group b rlp2086 2:45pm on 18Jun2019. The patient's mother reported today, 19Jun2019, that the patient had a low grade fever right around 100 degrees Fahrenheit, feeling fatigue, chills and flu-like symptoms on an unspecified date. The administered dose of meningococcal group b rlp2086 was first dose in a 2 dose series. The outcome of the events was unknown.  Information on the batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient presented with minor swelling and redness; Patient presented with minor swelling and redness; Warm to the touch; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age and gender received 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. On an unspecified date, the patient presented with minor swelling and redness and warm to the touch. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Skin reaction
Clinical narrative: patient's arm was red and painful; patient's arm was red and painful; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm was red and painful. The outcome of the events was unknown.
Age: 1.75
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 5/17/19 and was administered on 6/5/19.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Diarrhoea, Erythema, Pain
Clinical narrative: Arm soreness on day 1, Chills, fever and worsening arm soreness on day 2. Diarrhea and redness, bruising, swelling, and pain on day 3 and 4. An area of about 5 square inches total was swollen and painful. Swelling is somewhat reduced on day 5, but it is still very painful.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: Arm soreness on day 1, Chills, fever and worsening arm soreness on day 2. Diarrhea and redness, bruising, swelling, and pain on day 3 and 4. An area of about 5 square inches total was swollen and painful. Swelling is somewhat reduced on day 5, but it is still very painful.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; a patient received two doses of VAQTA less than six months apart; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-MAY-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1 dose (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 09-JUN-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1 dose, lot # S001832, expiration date 12-MAY-2020 (exact dose and route of administration were not reported) for prophylaxis. There was less than six months apart between two doses of vaccination. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Musculoskeletal pain, Paraesthesia, Post herpetic neuralgia
Clinical narrative: suffered sharp, tingling and burning pain on her left shoulder and was diagnosed with herpes zoster, post herpetic polyneuropathy and vertigo; suffered sharp, tingling and burning pain on her left shoulder and was diagnosed with herpes zoster, post herpetic polyneuropathy and vertigo; suffered sharp, tingling and burning pain on her left shoulder and was diagnosed with herpes zoster, post herpetic polyneuropathy and vertigo; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 28-DEC-2016, the pt was inoculated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly") after receiving zoster vaccine live(ZOSTAVAX), the pt suffered sharp, tingling and burning pain on her left shoulder and was diagnosed with herpes zoster, post herpetic polyneuropathy and vertigo. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations, which not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition.
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: suffered sharp, tingling and burning pain on her left shoulder and was diagnosed with herpes zoster, post herpetic polyneuropathy and vertigo; suffered sharp, tingling and burning pain on her left shoulder and was diagnosed with herpes zoster, post herpetic polyneuropathy and vertigo; suffered sharp, tingling and burning pain on her left shoulder and was diagnosed with herpes zoster, post herpetic polyneuropathy and vertigo; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 28-DEC-2016, the pt was inoculated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly") after receiving zoster vaccine live(ZOSTAVAX), the pt suffered sharp, tingling and burning pain on her left shoulder and was diagnosed with herpes zoster, post herpetic polyneuropathy and vertigo. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations, which not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Route of Administration: "Intramuscular."; No adverse effects reported; This spontaneous report was received from a medical assistant on behalf of the physician concerning a currently 4 years old child of unknown gender and race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On unknown date, the patient was vaccinated with one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA), intramuscular (incorrect route of product administration), lot number R020815 with expiration date on 16-JAN-2020. It was reported that the patient missed the following, future doses. No adverse effects reported.   The outcome of incorrect route of product administration was unknown.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Local reaction
Clinical narrative: flu like symphtoms; localized reaction; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, less than a day after receiving Bexsero, the patient experienced influenza-like symptoms and local reaction. On an unknown date, the outcome of the influenza-like symptoms and local reaction were unknown.   It was unknown if the reporter considered the influenza-like symptoms and local reaction to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Registered Nurses (RN). The age at vaccination was not reported. The patients experienced severe localized reactions as well as flu like symptoms for the first 24 to 48 hours. The reporter stated that when they were first providing Bexsero, they received a lot more calls, because they were not educating parents and patients about the side effects. This case has been linked with cases US2019AMR113762, US2019AMR113769, reported by the same reporter. The RN did not agree to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: flu like symphtoms; injection site pain; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female 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 influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Registered Nurses (RN). The age at vaccination was not reported. The patient experienced flu like symptoms for a 1/2 day and injection site pain. The RN did not agree to be followed up. This case has been linked with cases US2019AMR113762, US2019AMR113752, reported by the same reporter.
Sex: F
Vaccine: MENB
Symptoms: Abdominal discomfort, Condition aggravated, Decreased immune responsiveness, Dizziness, Food allergy
Clinical narrative: passing out; swollen arms; gastrointestinal distress; weakened immune system; dizzinesss; Food allergy; Condition aggravated; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included food allergy.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced passed out (serious criteria GSK medically significant), swelling arm, distress gastrointestinal, decreased immune responsiveness, dizziness, food allergy and condition aggravated. On an unknown date, the outcome of the passed out, swelling arm, distress gastrointestinal, decreased immune responsiveness and dizziness were recovered/resolved and the outcome of the food allergy and condition aggravated were unknown.   It was unknown if the reporter considered the passed out, swelling arm, passed out, distress gastrointestinal, decreased immune responsiveness, dizziness, food allergy and condition aggravated to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero and experienced swollen arm, gastrointestinal distress decreased immune responsiveness, dizziness, and food allergy increased. This case has been linked with US2019AMR110932, reported by same reporter.
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Peripheral swelling
Clinical narrative: passing out; swollen arms; gastrointestinal distress; weakened immune system; dizzinesss; Food allergy; Condition aggravated; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included food allergy.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced passed out (serious criteria GSK medically significant), swelling arm, distress gastrointestinal, decreased immune responsiveness, dizziness, food allergy and condition aggravated. On an unknown date, the outcome of the passed out, swelling arm, distress gastrointestinal, decreased immune responsiveness and dizziness were recovered/resolved and the outcome of the food allergy and condition aggravated were unknown.   It was unknown if the reporter considered the passed out, swelling arm, passed out, distress gastrointestinal, decreased immune responsiveness, dizziness, food allergy and condition aggravated to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero and experienced swollen arm, gastrointestinal distress decreased immune responsiveness, dizziness, and food allergy increased. This case has been linked with US2019AMR110932, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: redness around injection site; hot injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female 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 a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced injection site erythema and injection site warmth but went away after the first 1 to 2 days. This case has been linked with case US2019AMR113921, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: felt feverish; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a female 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 a year after receiving Shingrix, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient stated that after receiving a dose of Shingrix, she had flu like symptoms that lasted for 2 days. The patient stated that she felt feverish following the dose. The call was disconnected and agent was not able to capture additional information. Attempted call back and left voicemail for the patient to call back to provide additional details. The request has been placed to the Agency for creation of additional case for the same patient who experienced an adverse event after 2nd dose as well.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Abdominal Rash; This case was reported by a physician via call center representative and described the occurrence of rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced rash. 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: The patient received Shingrix in the left deltoid. The patient experienced abdominal rash.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Immediate post-injection reaction
Clinical narrative: herpes outbreak; This case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included acyclovir.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was unknown.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix in few months before the date of reporting, and experienced outbreak of herpes shortly thereafter.  The patient was not sure if it was related to the vaccine as she got herpes flare ups anyway.  The reporter did not consent to follow-up.
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash vesicular, Skin lesion, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles rash; neuralgia; lession in left axilla; Shingles rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mepolizumab (Nucala) unknown for eosinophilic asthma.   Concurrent medical conditions included eosinophilic asthma. Concomitant products included valaciclovir hydrochloride (Valtrex).   In June 2018, the patient received the 1st dose of Shingrix. In October 2018, the patient received the 2nd dose of Shingrix. In February 2017, the patient started Nucala at an unknown dose and frequency. On an unknown date, less than a year after receiving Shingrix and Shingrix and an unknown time after starting Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, neuralgia, skin lesion and varicella-like rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, neuralgia, skin lesion and varicella-like rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, neuralgia, skin lesion and varicella-like rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, neuralgia, skin lesion and varicella-like rash to be related to Nucala.  Additional details were provided as follows: The age at vaccination was not reported but it could be 79 or 80 years. The patient was diagnosed with eosinophilic asthma receiving Nucala every 4 weeks since February 2017, her last dose of Nucala was the 6th June 2018 and she did not have the batch number and expiration date but did provide the phone number for the infusion center.  The patient developed neuralgia before she broke out with Shingles rash, 4 or 5 days later she found a lesion in left axilla and went to an urgent care center where the physician confirmed her Shingles diagnosis.  The patient was currently has areas up and down left axilla area to wrist and was on day 6 of Valtrex. The reporter had consented to follow up. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and was not provided.
Sex: U
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: had gotten GBS; This is a spontaneous report from a contactable consumer. This female consumer reported similar events for five patients. This is 2nd of five reports. 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 immunization. The patient's medical history and concomitant medications were not reported. The patient had gotten GBS (guillain-barre syndrome) on an unspecified date with outcome of unknown.  In reporter city of 30,000 people, 4 people have gotten GBS. One person was still in a wheelchair.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019264899 Same reporter/products/events, different patients
Sex: U
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: had gotten GBS; This is a spontaneous report from a contactable consumer. This female consumer reported similar events for five patients. This is 3rd of five reports. 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 immunization. The patient's medical history and concomitant medications were not reported. The patient had gotten GBS (guillain-barre syndrome) on an unspecified date with outcome of unknown.  In reporter city of 30,000 people, 4 people have gotten GBS. One person was still in a wheelchair.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019264899 Same reporter/products/events, different patients
Sex: U
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: had gotten GBS; This is a spontaneous report from a contactable consumer. This female consumer reported similar events for five patients. This is 4th of five reports. 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 immunization. The patient's medical history and concomitant medications were not reported. The patient had gotten GBS (guillain-barre syndrome) on an unspecified date with outcome of unknown.  In reporter city of 30,000 people, 4 people have gotten GBS. One person was still in a wheelchair.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019264899 Same reporter/products/events, different patients
Sex: U
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: had gotten GBS; This is a spontaneous report from a contactable consumer. This female consumer reported similar events for five patients. This is 5th of five reports. 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 immunization. The patient's medical history and concomitant medications were not reported. The patient had gotten GBS (guillain-barre syndrome) on an unspecified date with outcome of unknown.  In reporter city of 30,000 people, 4 people have gotten GBS. One person was still in a wheelchair.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019264899 Same reporter/products/events, different patients
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Exposure during pregnancy
Clinical narrative: None but patient is pregnant. EDD is Nov. 9, 2019. Patient shouldn't have received this Men B vaccine.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injected limb mobility decreased, Muscle tightness, Myalgia, Pain in extremity
Clinical narrative: Muscle pain/tension all over, jaw tightness/soreness, severe headache, fever (100.1), limited range of motion (left arm) Pt started having symptoms morning after administration. By the next day symtoms other than headache subsided and the next day just arm soreness remained.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Pyrexia
Clinical narrative: Muscle pain/tension all over, jaw tightness/soreness, severe headache, fever (100.1), limited range of motion (left arm) Pt started having symptoms morning after administration. By the next day symtoms other than headache subsided and the next day just arm soreness remained.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient stated redness and soreness at injection site. informed this is common side effect listed in literature. Stated since she didn't experience this with first shot of series wanted adverse effect reported.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: PATIENT HAS RAISED RED BUMP THAT IS HOT TO TOUCH AND GETTING LARGER, SHE IS MARKING WITH A PEN
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Biopsy skin, Chills, Erythema multiforme, Nausea, Pain in extremity
Clinical narrative: Several hours after patient received vaccine, rash developed on both of the patient's lower extremities. Patient reported to the ED the next day (26 June)  where he was referred to the dermatology clinic. Clinic obtained biopsy of the rash sight and prescribed triamcinolone topical. Rash continued to spread rapidly over his entire body, bringing the patient back to the ED on 28 June. Patient also complained of N/V, subjective chills, itching, and pain in his feet. Patient diagnoses with erythema multiforme as a possible reaction to the anthrax vaccine.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Pruritus, Rash, Rash generalised, Vomiting
Clinical narrative: Several hours after patient received vaccine, rash developed on both of the patient's lower extremities. Patient reported to the ED the next day (26 June)  where he was referred to the dermatology clinic. Clinic obtained biopsy of the rash sight and prescribed triamcinolone topical. Rash continued to spread rapidly over his entire body, bringing the patient back to the ED on 28 June. Patient also complained of N/V, subjective chills, itching, and pain in his feet. Patient diagnoses with erythema multiforme as a possible reaction to the anthrax vaccine.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Blister, Erythema multiforme
Clinical narrative: Several hours after patient received vaccine, rash developed on both of the patient's lower extremities. Patient reported to the ED the next day (26 June)  where he was referred to the dermatology clinic. Clinic obtained biopsy of the rash sight and prescribed triamcinolone topical. Rash continued to spread rapidly over his entire body, bringing the patient back to the ED on 28 June. Patient also complained of N/V, subjective chills, itching, and pain in his feet. Patient diagnoses with erythema multiforme as a possible reaction to the anthrax vaccine.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Biopsy, Chills, Erythema multiforme, Nausea, Pain in extremity
Clinical narrative: Several hours after patient received vaccine, rash developed on both of the patient's lower extremities. Patient reported to the ED the next day (26 June)  where he was referred to the dermatology clinic. Clinic obtained biopsy of the rash sight and prescribed triamcinolone topical. Rash continued to spread rapidly over his entire body, bringing the patient back to the ED on 28 June. Patient also complained of N/V, subjective chills, itching, and pain in his feet. Patient diagnoses with erythema multiforme as a possible reaction to the anthrax vaccine.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Pruritus, Rash, Vomiting
Clinical narrative: Several hours after patient received vaccine, rash developed on both of the patient's lower extremities. Patient reported to the ED the next day (26 June)  where he was referred to the dermatology clinic. Clinic obtained biopsy of the rash sight and prescribed triamcinolone topical. Rash continued to spread rapidly over his entire body, bringing the patient back to the ED on 28 June. Patient also complained of N/V, subjective chills, itching, and pain in his feet. Patient diagnoses with erythema multiforme as a possible reaction to the anthrax vaccine.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Biopsy skin, Chills, Erythema multiforme, Nausea, Pain in extremity
Clinical narrative: Diffuse erythema multiforme with bullae
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Pruritus, Rash, Rash generalised, Vomiting
Clinical narrative: Diffuse erythema multiforme with bullae
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Blister, Erythema multiforme
Clinical narrative: Diffuse erythema multiforme with bullae
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Biopsy, Chills, Erythema multiforme, Nausea, Pain in extremity
Clinical narrative: Diffuse erythema multiforme with bullae
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Pruritus, Rash, Vomiting
Clinical narrative: Diffuse erythema multiforme with bullae
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site vesicles, Rash erythematous
Clinical narrative: developed erythematous rash with blistery lesions, area, was itching/burning/tender to touch about 1 inch below the injection site
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Blood test, Cardiac monitoring, Chest X-ray, Diarrhoea
Clinical narrative: fever, body aches, headache at base of skull, shortness of breath all beginning on Thursday. Went to ER and was given pain meds, chest xray, and bloodwork.  Diarrhea began Thursday afternoon and continued until Sunday, began feeling very weak, went back to ER and was given IV fluids.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: fever, body aches, headache at base of skull, shortness of breath all beginning on Thursday. Went to ER and was given pain meds, chest xray, and bloodwork.  Diarrhea began Thursday afternoon and continued until Sunday, began feeling very weak, went back to ER and was given IV fluids.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injection site rash, Myalgia, Nausea
Clinical narrative: By 8 PM the day of the shot (6/29), my arm was very sore, and a little tender.  I started developing joint pain in my hips, knees, and ankles, as well as back pain later that night.  The next day (6/30) the arm and joint, and back pain worsened, treated with Tylenol.  Also got some minor muscle soreness, but the worst pain was in my joints.  Then at about 8PM I started to feel nausea.  Today (7/1) the pain has lessened but is still intermittent, and the nausea isn't as bad, but still comes and goes.  Also noticed rash at the spot of the injection this morning.  I've never had a reaction like this to any vaccines in the past, so it has thrown me off and worried me.  I looked up the side effects today and saw that this isn't abnormal and should be gone after today so I'll just grin and bear it.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: By 8 PM the day of the shot (6/29), my arm was very sore, and a little tender.  I started developing joint pain in my hips, knees, and ankles, as well as back pain later that night.  The next day (6/30) the arm and joint, and back pain worsened, treated with Tylenol.  Also got some minor muscle soreness, but the worst pain was in my joints.  Then at about 8PM I started to feel nausea.  Today (7/1) the pain has lessened but is still intermittent, and the nausea isn't as bad, but still comes and goes.  Also noticed rash at the spot of the injection this morning.  I've never had a reaction like this to any vaccines in the past, so it has thrown me off and worried me.  I looked up the side effects today and saw that this isn't abnormal and should be gone after today so I'll just grin and bear it.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Insomnia, Pain, Rash macular, Skin warm
Clinical narrative: Patient reports excruciating pain day after vaccination, could not sleep from the pain. Reports Pain, Swelling, Redness with red blotchy raised skin(resembling rash), Hot to touch
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient reports excruciating pain day after vaccination, could not sleep from the pain. Reports Pain, Swelling, Redness with red blotchy raised skin(resembling rash), Hot to touch
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: patient pain and soreness in arm
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: None. Patient received two Hep B vaccines on the same  day. Patient received Pediarix, Hep B and Prevnar 13  vaccines. Did not receive Hib vaccine that was due.  Should have been Pediarix, PedVax Hib, Prevnar 13.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; One dose of ROTATEQ was administered to patient outside of maximum age for first dose.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 27-JUN-2019, one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R034878, expiration 11-SEP-2020 for prophylaxis (dose and route of administration was not reported) was administered to the patient, who was outside of maximum age for first dose (product administered to patient of inappropriate age).    No adverse effects reported. The outcome of product administered to patient of inappropriate age was not reported.
Sex: U
Vaccine: RV5
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: the patient missed the second and third dose; no adverse effects; This spontaneous report was received from a physician refers to a patient of currently 8 months of age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength, lot number and expiration date unknown) orally for prophylaxis. On an unknown date, the patient missed the second and third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). No adverse effects were reported. No product quality complaints were involved.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient received improperly stored proquad; This spontaneous report was received from a pharmacist refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 24-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R028531, expiration date: 02-APR-2020, therapy type: rha) (dose, strength, frequency, route of administration not reported) for prophylaxis (product storage error). The vaccine was reconstituted with a properly stored sterile diluent. The vaccine underwent temperature excursion from 6 degree Fahrenheit to 14 degree Fahrenheit (9.5F) for 5 minutes and 15 degree Fahrenheit to 46 degree Fahrenheit (44.8 F) for 40 minutes. There was no previous temperature excursion. There was involvement of a data logger. No adverse effects were reported. No product quality complaints were involved.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011525:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema
Clinical narrative: Angioedema; This case was reported by a nurse via sales rep and described the occurrence of angioedema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the angioedema was unknown.   It was unknown if the reporter considered the angioedema to be related to Shingrix.  Additional details were provided as follows: The patient experienced angioedema after receiving 1st dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: redness around injection site about 3 inches long and 1.5 inches wide; hot injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on an unknown date).   On 18th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was complaining about redness around injection site about 3 inches long and 1.5 inches wide and injection site was hot to the touch. The reporter stated that the patient took Bendryl which seemed to minimally help. The patient stated that she forgot but this happened during the first shot but went away after the first 1 -2 days. This case has been linked with case US2019GSK118068, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on chest; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced rash. 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: The age at vaccination was not reported but it could be 63 years or 64 years. There were no adverse events associated with dose 1 of Shingrix. The patient had rash on the chest.  No other details were known.   The patient did not consent to follow-up.