chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Influenza like illness, Injection site pain, Nausea
Clinical narrative: Pain at Injection Site; Low-grade fever; Nausea; Headache; Generalized Aches and Pain; Redness; pain down neck; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms. The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The patient received 1st and 2nd dose of Shingrix doses in left deltoid over a period of 3 months. After receiving 1st dose, the patient experienced pain at injection site, redness, low grade fever, nausea, headache, generalized aches and pain down neck (flu-like symptoms), which lasted approximately one week until fully resolved. The reporter consented to follow up reports taking Tylenol and Advil intermittently . This was 1 of the 2 cases reported by same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: Pain at Injection Site; Low-grade fever; Nausea; Headache; Generalized Aches and Pain; Redness; pain down neck; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms. The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The patient received 1st and 2nd dose of Shingrix doses in left deltoid over a period of 3 months. After receiving 1st dose, the patient experienced pain at injection site, redness, low grade fever, nausea, headache, generalized aches and pain down neck (flu-like symptoms), which lasted approximately one week until fully resolved. The reporter consented to follow up reports taking Tylenol and Advil intermittently . This was 1 of the 2 cases reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm sore; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-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, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. For tolerability of 2nd dose, refer case US2019117673.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental underdose, Chills, Exposure via skin contact, Pain, Pain in extremity
Clinical narrative: fever; body aches; chills; shaking; underdose; exposure via skin contact; Inadvertent exposure to vaccine; arm is still sore; This case was reported by a nurse via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for 1st dose, refer case US2019135644).   On 22nd July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On 22nd July 2019, the patient experienced fever, general body pain, chills, tremor, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, general body pain, chills and tremor were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the fever, general body pain, chills, tremor and pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was a nurse. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient had the injection during morning. By night the patient was experiencing fever, chills, shaking, body aches. The patient did not have those symptoms anymore but her arm was sore.  Fluid ran out of her arm after she received the Shingrix so she was concerned about not getting the complete vaccine. The reporter did not give consent to follow up. This case has been linked with US2019135644, reported for the dose 1 of the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: fever; body aches; chills; shaking; underdose; exposure via skin contact; Inadvertent exposure to vaccine; arm is still sore; This case was reported by a nurse via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for 1st dose, refer case US2019135644).   On 22nd July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On 22nd July 2019, the patient experienced fever, general body pain, chills, tremor, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, general body pain, chills and tremor were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the fever, general body pain, chills, tremor and pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was a nurse. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient had the injection during morning. By night the patient was experiencing fever, chills, shaking, body aches. The patient did not have those symptoms anymore but her arm was sore.  Fluid ran out of her arm after she received the Shingrix so she was concerned about not getting the complete vaccine. The reporter did not give consent to follow up. This case has been linked with US2019135644, reported for the dose 1 of the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm is still swollen; Arm painful to touch; arm itches; Allergy; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced swelling arm, pain in arm, itchy upper limbs and allergy. On an unknown date, the outcome of the swelling arm, pain in arm, itchy upper limbs and allergy were unknown.   It was unknown if the reporter considered the swelling arm, pain in arm, itchy upper limbs and allergy to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm. The patient arm was still swollen and not directly near the injection site but a large portion of patient upper arm, and it was painful to touch and itches. The reporter enquired does that indicate allergy. The reporter did not give permission to follow up.
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: Felt like her throat was swolen; couldn't breathe; This case was reported by a consumer via interactive digital media and described the occurrence of throat 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, 10 hrs after receiving Bexsero, the patient experienced throat swelling and difficulty breathing. On an unknown date, the outcome of the throat swelling and difficulty breathing were unknown.   It was unknown if the reporter considered the throat swelling and difficulty breathing to be related to Bexsero.  Additional case details were reported as follows: This case was reported by the consumer for his/her daughter. The age at vaccination was not reported. The patient just got the vaccine. The patient did not have any reaction to any other ones but this one bothered her. About 10 hours later the patient felt like her throat was swollen and she couldn't breathe. The reporter still has to take patient back for a booster in a month.  The reporter going to but, was little nervous why the patient would have such a delayed reaction. The reporter did not give permission to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Genital rash, Pain in extremity, Pruritus, Rash macular
Clinical narrative: iching; red flat spots in her pubic area, several on her breast, and belly as well as   a couple on her spine; sore left arm; genital rash; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and genital rash. On 24th June 2019, the patient experienced erythromacular rash. On 27th June 2019, the patient experienced pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the erythromacular rash, pruritus and genital rash were unknown.   It was unknown if the reporter considered the pain in arm, erythromacular rash, pruritus and genital rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on left deltoid. Several hours after the injection in her left arm, the patient developed red flat spots in her pubic area, several on her breast, and belly as well as a couple on her spine. The spots were flat and not itchy, and area a one fourth inch in size. The patient was a quick healer but that these are not healing. The patient stated on night the day before reporting, she noticed she was itching and mentioned that she thought she had lice as her head was itching. The patient took a Benadryl. The patients left arm was also sore for days after having the injection in her left deltoid. The patient reported previously having the older Shingrix vaccine and developing swelling in her arm. The patient stated the older vaccine caused her arm to swell to three times its normal size. The patient asked if she should have second dose. The reporter gave consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable Physician via Pfizer sales representative.  A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA) , 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 fever, leading to patient's hospitalization,  on an unspecified date with outcome of recovered.  The information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 (TRUMENBA) contributed to the development of the reported event fever.
Age: 17.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: excursion could have been caused by someone tampering with the refrigerator/ IPOL exposed to temperatures between 315.5 farenheit and 32 farenheit for 10 minutes and out of range till 11 july; Initial information received on 25-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse by phone and additional information was received on 25-Jul-2019.  This case involves a 17 years old male patient who was vaccinated with a 0.5 ml dose of IPV (VERO) [IPOL] (Batch number: 979860 and expiry date: 26-Apr-2020) via unknown route in the right arm on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was a case of actual medication error due to product storage error temperature too high because IPOL exposed to temperatures between 315.5 Fahrenheit and 32 Fahrenheit for 10 minutes and out of range till 11 July.   It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received a booster of Menactra 20 days earlier on 03Jan2019 at a Vaccine Visit; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who vaccinated with 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6207AA via unknown route in the right deltoid on 03-Jan-2019.  It was a actual medication error case due to Inappropriate schedule of vaccine administered.  It was reported that received a booster of Menactra 20 days earlier on 03Jan2019 at a Vaccine Visit.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Dtap/IPV was given, Can they give the ActHIB part as a seperate injection.; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old female patient who received only DTap/IPV part of the vaccine Pentacel DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE , Pentacel- Lot number UI954AAA, Dtap IPV Lot number U6138AB, ActHIB- Lot number UI954AA (Expiry date 30-Jun-2020) on 12-Jun-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that DTap/IPV part of the Pentacel to a patient. She does not have the corresponding IPV vial anymore)  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: patient received an Adacel dose during her third trimester of pregnancy; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 19 years old female patient who was received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, dose, route of administration were unknown) in left shoulder on 30-Jul-2019, while she was pregnant (third trimester).  The date of last menstrual period was not reported.  The estimated due date is 02-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine exposure during pregnancy. The patient was pregnant (third trimester) when she received vaccine.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested.  List of documents held by sender- none.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: redness, swelling, remarkable itching, classified as a mild-moderate reaction
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Feeling abnormal, Injection site pain, Myalgia
Clinical narrative: 1.5 days after, terrible pain at site of injection, muscle aches, weakness, nausea, chills, body aches, brain fog
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pain
Clinical narrative: 1.5 days after, terrible pain at site of injection, muscle aches, weakness, nausea, chills, body aches, brain fog
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: High fever, 101F for 12 hours. Headache and flu-like symptoms, very achy body for 24 hours.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Condition aggravated, Seizure
Clinical narrative: Per mother (legal guardian) states had a seizure 7 days after the vaccine after being seizure free for over 10 years, not if related to the vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Within 12 hours my arm was sore/red/hot/rash at the injection site and well as a 1/2" band half way around my arm just below the injection site. During the night I experienced pain all the way down my arm and into my hand. My fingers felt numb/tingly. This continued for about 12 hours. My upper arm continued to be sore/red/hot/rash for another 5 days. As of today (8/7/19) there is still a slight rash on my upper arm
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Within 12 hours my arm was sore/red/hot/rash at the injection site and well as a 1/2" band half way around my arm just below the injection site. During the night I experienced pain all the way down my arm and into my hand. My fingers felt numb/tingly. This continued for about 12 hours. My upper arm continued to be sore/red/hot/rash for another 5 days. As of today (8/7/19) there is still a slight rash on my upper arm
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: On Monday 8/5/2019, pt presented with some redness immedately adjacent and below the injection site.  Pt called back 8/6/19 indicating that the redness/rash is spreading "down and around" arm.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles or herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 27-SEP-2012, pt was vaccinated with zoster vaccine live (ZOSTAVAX), prescribed and/or administered by the physician in the physician office (lot#, expiration date, dose, and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, pt experienced and was treated by the physician for shingles or herpes zoster. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Pyrexia
Clinical narrative: Client states she had  a headache, fever, and shivers.  Could not get warm all night.  Started around 10:00 p.m. and lasted all night.  Client called around 11:00 am 08/06/2019 and said that she just started feeling warm.  Headache was gone after she took something for it that morning.
Age: 1.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: Patient presented to clinic for a 1 year well child check along with her 4 year old sister. While getting shots ready for each child we placed the shots on separate trays. However when entering the room the trays were placed side by side and one nurse removed 2 shots from one tray so we were left with 2 trays with 2 shots on them. The second nurse then picked up the incorrect 2 shots for the 1 year old and administered them. The parents, nursing supervisor and provider were notified right away and the CDC was called. They stated patient would be fine may just be sore at the site and to keep an eye on her. Following incident reports and VARES filed.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: runny nose; injection site pain; intermittent fever; malaise; aches and pains; inappropriate schedule of vaccine; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX794AZ, expiry date 31st August 2020) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 29th July 2019, the patient received the 2nd dose of Bexsero (intramuscular) .5 ml. On 29th July 2019, unknown after receiving Bexsero and 28 days after receiving Bexsero, the patient experienced drug dose administration interval too short. On 30th July 2019, the patient experienced injection site pain (serious criteria clinically significant/intervention required), intermittent fever (serious criteria clinically significant/intervention required), malaise (serious criteria clinically significant/intervention required) and pain (serious criteria clinically significant/intervention required). On 31st July 2019, the patient experienced runny nose (serious criteria clinically significant/intervention required). The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, intermittent fever, pain and runny nose were not recovered/not resolved and the outcome of the malaise was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain, intermittent fever, malaise, pain and runny nose to be related to Bexsero.  Additional details were reported as follows: The patient received Boostrix on right deltoid. The patient received Bexsero, and experienced fever of 101, malaise, aches, pains, and injection site pain. The nurse advised the patient to treat this with alternating Tylenol and Ibuprofen. Next day, the patient's fever was as high as 103 and he developed a runny noise. The nurse reported that the fever was responding to the interventions and had resolved at this time, all other symptoms continued. The batch number was reported as SKBABX794AZ, however it was corrected to ABX794AZ upon sales data sheet. The reporter consented for follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; injection site pain; intermittent fever; malaise; aches and pains; inappropriate schedule of vaccine; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX794AZ, expiry date 31st August 2020) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 29th July 2019, the patient received the 2nd dose of Bexsero (intramuscular) .5 ml. On 29th July 2019, unknown after receiving Bexsero and 28 days after receiving Bexsero, the patient experienced drug dose administration interval too short. On 30th July 2019, the patient experienced injection site pain (serious criteria clinically significant/intervention required), intermittent fever (serious criteria clinically significant/intervention required), malaise (serious criteria clinically significant/intervention required) and pain (serious criteria clinically significant/intervention required). On 31st July 2019, the patient experienced runny nose (serious criteria clinically significant/intervention required). The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, intermittent fever, pain and runny nose were not recovered/not resolved and the outcome of the malaise was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain, intermittent fever, malaise, pain and runny nose to be related to Bexsero.  Additional details were reported as follows: The patient received Boostrix on right deltoid. The patient received Bexsero, and experienced fever of 101, malaise, aches, pains, and injection site pain. The nurse advised the patient to treat this with alternating Tylenol and Ibuprofen. Next day, the patient's fever was as high as 103 and he developed a runny noise. The nurse reported that the fever was responding to the interventions and had resolved at this time, all other symptoms continued. The batch number was reported as SKBABX794AZ, however it was corrected to ABX794AZ upon sales data sheet. The reporter consented for follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: The patient developed a rash below the injection site several days after administration which continued to get larger.  After 4 days the patient presented to her primary care physician with a 2 inch diameter discoid rash that was warm to the touch.  The patient was subsequently started on a course of Antibiotics (Augmentin 875mg) twice a day for 7  days.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Discomfort, Dizziness, Fatigue
Clinical narrative: On the day I received the shot I ran five miles before I got the injection. The next morning I did a vigorous physical workout for two hours. During the workout I felt a little tired and weak. Later that day I began to feel worse. I felt tired, weak, feverish, and a little dizzy. I felt so tired, weak, feverish, and uncomfortable that I spent most of the afternoon amd night in bed. The next day I was able to run a few miles, but at a slower pace than normal. During the day I continued to feel weak and tired. The next couple of days I also felt weak and tired. In addition, I experienced diarrhea for a few days.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: On the day I received the shot I ran five miles before I got the injection. The next morning I did a vigorous physical workout for two hours. During the workout I felt a little tired and weak. Later that day I began to feel worse. I felt tired, weak, feverish, and a little dizzy. I felt so tired, weak, feverish, and uncomfortable that I spent most of the afternoon amd night in bed. The next day I was able to run a few miles, but at a slower pace than normal. During the day I continued to feel weak and tired. The next couple of days I also felt weak and tired. In addition, I experienced diarrhea for a few days.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Right arm only 7/27/19 itching & painful to touch,  7/28/19 itching & swelling & very red! 7/29/19 itching, swelling & red at least 5 inches wide 7/30/19 itching, still red little swelling 7/31/19 itching & red 8/01/19 itching & pink 8/02/19 itching & pink maybe about 3 in wide now
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Rash erythematous
Clinical narrative: ER Note 8-6-19 HPI Patient is a 65 year old male who is here complaining of a burning somewhat painful rash on both legs that developed within the last hour.  He had been waiting in the lake and some shorts and a T-shirt and was right after this that he noticed it.  He was in the water up to his mid abdomen.  The rash is from his mid thighs down and nothing higher.  He did not think there was anything unusual in the water.  He was not waiting through a lot of weeds.  No bites or stings that he can recall.  Cannot think of any thing else that could cause any type of allergic reaction such as new medication or change in medication.  No new foods or soaps or detergents.  He went and showered and cleaned it off and he felt that the hot water actually made it a bit worse.  He has numerous raised red areas that are somewhat tender.  He has not noticed any new areas developing since this first began.   Clinic notes 8-7-91 Patient presents to the clinic for hives that turned into red bumps. Patient states the bumps started yesterday and was burning and itching so bad he went into the ER where they gave him a shot of benadryl and prednisone.  Notes from provider not in chart yet, patient relates that she thinks it cold be chicken pox as progressed to wheals/hives and then pustules. Treated with triamcinolone cream and diphenhydramine cream. Possible differential diagnosis could be swimmers's itch since rash is only in areas that were immersed in water
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pustular, Swelling, Tenderness, Urticaria
Clinical narrative: ER Note 8-6-19 HPI Patient is a 65 year old male who is here complaining of a burning somewhat painful rash on both legs that developed within the last hour.  He had been waiting in the lake and some shorts and a T-shirt and was right after this that he noticed it.  He was in the water up to his mid abdomen.  The rash is from his mid thighs down and nothing higher.  He did not think there was anything unusual in the water.  He was not waiting through a lot of weeds.  No bites or stings that he can recall.  Cannot think of any thing else that could cause any type of allergic reaction such as new medication or change in medication.  No new foods or soaps or detergents.  He went and showered and cleaned it off and he felt that the hot water actually made it a bit worse.  He has numerous raised red areas that are somewhat tender.  He has not noticed any new areas developing since this first began.   Clinic notes 8-7-91 Patient presents to the clinic for hives that turned into red bumps. Patient states the bumps started yesterday and was burning and itching so bad he went into the ER where they gave him a shot of benadryl and prednisone.  Notes from provider not in chart yet, patient relates that she thinks it cold be chicken pox as progressed to wheals/hives and then pustules. Treated with triamcinolone cream and diphenhydramine cream. Possible differential diagnosis could be swimmers's itch since rash is only in areas that were immersed in water
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Abdominal pain upper, Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site, chills/shivers, high fever, headache, stomach ache. Given Ibuprofen, Tylenol, cold compress, rest, Epsom salt bath
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: raised, red, swollen area 4 inches
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Blister, Dizziness, Myalgia, Pain in extremity
Clinical narrative: dizziness, unsteadiness, muscle soreness and pain in legs, small blisters and rash down injection arm
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: dizziness, unsteadiness, muscle soreness and pain in legs, small blisters and rash down injection arm
Sex: M
Vaccine: TDAP
Symptoms: Allergy to vaccine, Dyspnoea, Pertussis, Vaccination failure
Clinical narrative: Suspected vaccination failure; Whooping cough; allergies to the Pertussis part of the DPT shot; could not catch breath; This case was reported by a contact via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), allergy to vaccine and shortness of breath. On an unknown date, the outcome of the vaccination failure, whooping cough, allergy to vaccine and shortness of breath were unknown.   It was unknown if the reporter considered the vaccination failure, whooping cough, allergy to vaccine and shortness of breath to be related to DTPa vaccine.  Additional case details were reported as follows: This case was reported by the patient's parents. The age at vaccination was not reported. The patient was allergic to the pertussis part of the DPT shot. After vaccination, the patient got whooping cough, which was also passed on to reporter's younger son who had a less serious bout with it. The whooping cough was so scary because the patient would cough so hard he could not catch his breath, if terrified to the patient's parent to be away from him at all.  This case was considered as suspected vaccination failure as details regarding time to onset for target disease, completion of primary vaccination schedule and laboratory confirmation of disease were unknown at the time of reporting. The reporter advised that, get the kids vaccinated, if the parents were able to and whooping cough was nothing to act as if it was no big deal, it was very much so a big deal.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 12 days 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 case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient developed rash 12 days after the 1st vaccine. The patient enquired whether the vaccine was failed, and should he/she receive 2nd dose of vaccine. The reporter did not give permission to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: health issues; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The lot number of Shingrix was unavailable. The patient wanted to delay the 2nd dose of Shingrix even longer due to health issues and was having to go in for surgery. The reporting pharmacist had no further details regarding health issues or surgery. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash generalised
Clinical narrative: full body rash; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th April 2019, immediately after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional information received were as follows: On the reporting date, the patient arrived for 2nd dose of Shingrix. The patient shared that when she received her 1st dose of Shingrix, she experienced full body rash that did not itch.  The reporter stated that this started shortly after her first dose that it lasted for couple of weeks. The reporter consented to follow up. The healthcare professional consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. In July 2019, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.  Additional details were provided as follows: The health care professional stated patient received the 1st dose of Shingrix and currently had Shingles. The pharmacist called in to questioned any information available how to proceed with 2nd dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported, but was selected adult as per vaccine indication. The nurse reported that she had heard that a number of patients reported flu-like symptoms after receiving the 2nd dose of Shingrix
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Loss of consciousness, Nausea
Clinical narrative: passed out; fever; shivers; sore arm; bad headache; nausea; vomiting; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of passed out in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2019, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), fever, shivers, pain in arm, headache, nausea, vomiting and fatigue. On 17th July 2019, the outcome of the passed out was recovered/resolved. On 18th July 2019, the outcome of the fever, shivers, pain in arm, headache, nausea, vomiting and fatigue were recovered/resolved.   It was unknown if the reporter considered the passed out, fever, shivers, pain in arm, headache, nausea, vomiting and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever, shivering, passed out briefly, sore arm, bad headache, nausea, vomiting, and fatigue within hours of this dose. These symptoms lasted for 24 hours and then resolved. The patient developed a bad headache and fatigue on 29th July 2019 that lasted for 24 hours and resolved on 30th July 2019. The reporter consented to follow up. The c consumer declines HCP follow up, but stated that safety may follow up with her if they wish. She declined to provide her full name. She did not have vaccine information for this case.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: passed out; fever; shivers; sore arm; bad headache; nausea; vomiting; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of passed out in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2019, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), fever, shivers, pain in arm, headache, nausea, vomiting and fatigue. On 17th July 2019, the outcome of the passed out was recovered/resolved. On 18th July 2019, the outcome of the fever, shivers, pain in arm, headache, nausea, vomiting and fatigue were recovered/resolved.   It was unknown if the reporter considered the passed out, fever, shivers, pain in arm, headache, nausea, vomiting and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever, shivering, passed out briefly, sore arm, bad headache, nausea, vomiting, and fatigue within hours of this dose. These symptoms lasted for 24 hours and then resolved. The patient developed a bad headache and fatigue on 29th July 2019 that lasted for 24 hours and resolved on 30th July 2019. The reporter consented to follow up. The c consumer declines HCP follow up, but stated that safety may follow up with her if they wish. She declined to provide her full name. She did not have vaccine information for this case.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that the patient received Shingrix vaccine and continues to experience arm pain.  The pharmacist did not provide any additional information. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Myocardial infarction, Peripheral coldness
Clinical narrative: Thought she was having a heart attack; flu like aches on half of her body; shivering/ teeth chattering and clanking; hands and feet being so cold; Flu like aches; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix. On 15th July 2019, 4 hrs after receiving Shingrix, the patient experienced heart attack (serious criteria GSK medically significant), feeling unwell, shivering, cold hands & feet and flu-like aching. On an unknown date, the outcome of the heart attack was unknown and the outcome of the feeling unwell, shivering, cold hands & feet and flu-like aching were recovered/resolved.   It was unknown if the reporter considered the heart attack, feeling unwell, shivering, cold hands & feet and flu-like aching to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and 4 hours later experienced not feeling well overall, shivering, hands and feet were freezing, and thought she was having a heart attack. Consented to follow up. As per reporter the events were completely resolved approximately 12 hours after initial injection. The event not feeling well overall described as flu like aches on half of her body. The event shivering described as her teeth chattering and clanking and hands and feet freezing described as hands and feet being so cold she had to be covered up. No additional details related to thinking she was having a heart attack.  The reporter consented for follow up.