chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX and then developed shingles two weeks later. Further patient identifiers, lot number, expiry date or any further details regarding event were unknown.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX, the patient had pain in her arm at the injection site and felt tired. This is 1 of the 5 cases, reported by the same reporter. The gender of the patient was captured as male as per narrative, whereas it is reported as female in the file.
Sex: F
Vaccine: RV1
Symptoms: Oral administration complication, Underdose, Vomiting
Clinical narrative: a vomiting; Underdose; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number Y7352, expiry date 15th September 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation. On an unknown date, 5 min after receiving Rotarix lyophilized formulation, the patient experienced vomiting and accidental underdose. On an unknown date, the outcome of the vomiting and accidental underdose were unknown.   It was unknown if the reporter considered the vomiting and accidental underdose to be related to Rotarix lyophilized formulation.  Additional details were provided as follows:  The age at vaccination was not reported. The patient was given 1st dose of Rotarix and 5 minutes later the patient vomited about 2 to 3 ounces of vomit. The vaccine might had been lasted, which led to accidental underdose.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy legs in a 77-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included hypertension and diabetes.  On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 6th March 2019, 281 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced itchy legs. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the itchy legs was not recovered/not resolved and the outcome of the product supply issue was unknown.  It was unknown if the reporter considered the itchy legs to be related to SHINGRIX. Additional case details were reported as follows: The patient experienced itching on both legs. The patient reported that she had been unable to get her second dose since 29th November 2018.
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a adult male patient who received 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 cold sores. On an unknown date, the outcome of the cold sores was unknown. It was unknown if the reporter considered the cold sores to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The healthcare professional did not have information about patient nor lot or expiry of vaccine available. After vaccination with SHINGRIX the patient experienced cold sores. The reporter did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 56-year-old female patient who received SHINGRIX (batch number 0727D ?, expiry date 24th January 2020) for prophylaxis. The patient had a Family History of shingles (to the patient's husband). On 15th March 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 17th March 2019, 2 days after receiving SHINGRIX, the patient experienced chickenpox. The patient was treated with VALTREX. On an unknown date, the outcome of the chickenpox was unknown. It was unknown if the reporter considered the chickenpox to be related to SHINGRIX. Additional details were provided as follows: The reported batch number 0727D seems to be adjuvant's batch number was not available in sales data base, however it was captured as 0727D ?. After about two days of SHINGRIX shot, the patient developed chickenpox. Therefore, the pharmacist was suspicious that the patient got the chickenpox from her husband. However, the event occurred after getting SHINGRIX. The patient visited her physician and her physician confirmed that she had chickenpox. The physician prescribed VALTREX.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 25th March 2019, the patient received SHINGRIX (intramuscular). On 26th March 2019, 1 days 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 not recovered/not resolved. 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: On Monday, the patient received the SHINGRIX dose in the left arm. The patient experienced 2 inch by 2 inch patch of redness at the injection site and the area of redness was hot to touch. The patient put some ice on the affected area and it helped. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received SHINGRIX (batch number GZ29L, expiry date 23rd May 2021) for prophylaxis. On 15th January 2019, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness and soreness at injection site after SHINGRIX vaccine. The reported batch number g729L was corrected to GZ29L as per sales data review.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: patient was vaccinated with Pentacel that had been diluted with a diluent made by Merck; Initial information received on 02-Apr-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a three months old female patient who received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL] lot UJ065AA, expiration date: 16-Oct-2020 via intramuscular route in the left thigh on 26-Mar-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.   It was an actual medication error due to inappropriate reconstitution technique. Pentacel that had been diluted with a diluent made by Merck.  It was unknown whether patient experienced any adverse event following 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.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling and erythema approximately 10X12 cm over left deltoid; Localized swelling and erythema approximately 10X12 cm over left deltoid; Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional/ consumer via Health Authorities under reference .  This case involves a 4 years old female patient who experienced localized swelling and erythema approximately 10x12 cm over left deltoid, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2018, the patient received a single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot uj041aa via intramuscular route in the left deltoid (LA).  On 24-Oct-2018, the patient developed a non-serious localized swelling and erythema approximately 10x12 cm over left deltoid (injection site erythema) and (injection site swelling) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included No lab data reported.)  Final diagnosis was localized swelling and erythema approximately 10x12 cm over left deltoid.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for localized swelling and erythema approximately 10x12 cm over left deltoid.
Age: 0.08
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Foetal exposure during pregnancy, Nasal congestion, Pyrexia, Upper respiratory tract infection
Clinical narrative: This is a serious spontaneous case, initially received from other non-health professional (consumer) on 25-Mar-2019, concerning a 05-weeks-old infant male patient. The patient's mother was a 33-year-old, female patient. The patient's mother had 4 previous pregnancies in which two were miscarriages. The patient's mother had no maternal or paternal medical history. The patient's mother last menstrual period (LMP) date was 16-May-2018. The current condition of the patient's mother included hypothyroidism and concomitant medication included levothyroxine. The mother had not used any contraceptives. At approximately 22 weeks of gestation, on 17-Oct-2018, the patient's mother received FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for active immunization against influenza. The patient was exposed to the vaccine via transplacental route (explicitly coded as foetal exposure during pregnancy). The estimated date of delivery (EDD) was reported as 20-Feb-2019. On an unspecified date, the mother delivered a male neonate. On an unspecified date after vaccination, the patient experienced fever, cough and nasal congestion and was diagnosed with an upper respiratory tract infection at 5 weeks. The patient had no other conditions and had not received any treatment/ medication for this infection. The outcome of the event fever was recovered on an unspecified date (reported as lasted for less than 24 hours), the outcome of the events cough, nasal congestion was not recovered, and upper respiratory tract infection was recovering. This case is linked to 201804617 (mother-baby case). Reporter's Comments: A 05-week-old male infant experienced fever, cough and nasal congestion and was diagnosed with an upper respiratory tract infection at 5 weeks, on an unspecified day after receipt of FLUCELVAX QIV vaccine administered to mother at approximately 22 weeks of gestation (explicitly coded as foetal exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event, inactivated nature of the suspect vaccine and infectious aetiology of the reported event, the causal role of suspect vaccine was assessed as not related. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the event 'upper respiratory tract infection' as serious (medically significant).
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Nausea, Pyrexia
Clinical narrative: Severe flu like symptoms within 4-6 hrs with chills high fever nausea injection site pain rating 8-10 symptoms lasting 4 days confined to bed.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise, Myalgia, Nausea
Clinical narrative: Malaise days 3-5; nausea days 4-5, painful injection site days 1-5,  muscle aches days 2-5, headaches days 2-5.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Face especially and other parts of my body got really red, started itching,  felt a little quaesy, left arm swollen. Later that day and through today a headache that won?t go away and queasiness occasionally.
Age: 71.0
Sex: M
Vaccine: TD
Symptoms: Angioedema
Clinical narrative: Angioedema
Age: 68.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt. states on 4/4/19 when he awoke he noticed a mild rash over his torso, front and back, that was itchy. He states he believes it is a reaction to the vaccine due to literature he has read. He states rash better today.
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Diffuse rash started approximately 7 days after immunizations.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Decreased appetite, Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: PATIENT HAD A SEVERE INJECTION SITE REACTION. THE PATIENT COMPAINED OF THE DELTOID REGION WAS RED, WARM AND SWOLLEN AND EXTENDED ABOUT 10 CENTIMETRS GOING UP TO HER SHOULDER, TO THE BEND OF HER ELBOW AND THE BACK OF HER ARM. THIS HAPPENDED THE FIRST DAY OF HER VACCINE AND SHE TOOK BENADRYL WHICH LASTED FOR A COUPLE DAYS. THE SECOND DAY SHE WAS FATIGUED AND NOT EATING. SHE COULD NOT USE HER ARM FOR ABOUT A WEEK.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site warmth
Clinical narrative: PATIENT HAD A SEVERE INJECTION SITE REACTION. THE PATIENT COMPAINED OF THE DELTOID REGION WAS RED, WARM AND SWOLLEN AND EXTENDED ABOUT 10 CENTIMETRS GOING UP TO HER SHOULDER, TO THE BEND OF HER ELBOW AND THE BACK OF HER ARM. THIS HAPPENDED THE FIRST DAY OF HER VACCINE AND SHE TOOK BENADRYL WHICH LASTED FOR A COUPLE DAYS. THE SECOND DAY SHE WAS FATIGUED AND NOT EATING. SHE COULD NOT USE HER ARM FOR ABOUT A WEEK.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Adverse reaction
Clinical narrative: PATIENT HAD A SEVERE INJECTION SITE REACTION. THE PATIENT COMPAINED OF THE DELTOID REGION WAS RED, WARM AND SWOLLEN AND EXTENDED ABOUT 10 CENTIMETRS GOING UP TO HER SHOULDER, TO THE BEND OF HER ELBOW AND THE BACK OF HER ARM. THIS HAPPENDED THE FIRST DAY OF HER VACCINE AND SHE TOOK BENADRYL WHICH LASTED FOR A COUPLE DAYS. THE SECOND DAY SHE WAS FATIGUED AND NOT EATING. SHE COULD NOT USE HER ARM FOR ABOUT A WEEK.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: At first the area around the injection site felt a little sore, and might have been swollen, but didn't bother me, until a 3 or 4 hours later when I noticed my arm was noticeably swollen, and the swelling had gone down to my elbow; he said as long as it doesn't go down my arm he didn't think it was serious and told me what to watch out for. But it did go down my arm, was a light red, and a little itchy. the next day I went to urgent care and was told to take Benadryl, which only helped slightly. On tues. Went to my doctor & was told to ice it, and keep it uplifted which I did, and she prescribe 3 prednisone pills to take by Fri. if it got worse or not better. After 6 days the swelling subsided.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Pain, Sluggishness
Clinical narrative: Unusual sluggishness and confusion the next morning.  Also, unusual levels of aches and pains.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pustular
Clinical narrative: 2 days after injection broke out in a rash on both sides of stomach. Chest and under breast. Rash had small pustule bump filled w/clear fluid. Rashes still present as of 4/5/19. Taking VALTREX.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 17-JUL-2015, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles. On approximately 20-JUL-2015 (reported as three days after receiving ZOSTAVAX, the patient suffered a rash from his back to his abdomen on his right side. He was diagnosed with shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses (considered to mean he received treatment); the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was not recovered/not resolved. Causality assessment was related. The lawyer considered the shingles to be disabling.
Sex: F
Vaccine: HPVX
Symptoms: Feeling abnormal, Incomplete course of vaccination, Muscular weakness, Tic
Clinical narrative: This spontaneous report was received from a nurse who was the female patient of unknown age, reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On an unknown date in 2011, reported as 8 years ago, the patient was vaccinated with the first dose of GARDASIL 9 or with GARDASIL (route, anatomical location, lot # and expiration date were not provided) for prophylaxis. In approximately 2011, 4 days after vaccination, the patient developed weakness in the legs, "just not clear headed", and eventually she experienced a tic. The patient reported, these adverse events lasted about 8 months. Additionally, the patient reported, she never got the second dose of the vaccine. The outcome of muscular weakness and tic was resolved. The causality between the events and therapy with GARDASIL or GARDASIL 9 was unknown. It was not verify if the suspect therapy was GARDASIL or GARDASIL 9.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered an improperly stored dose of PNEUMOVAX 23; No adverse effects; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported.  On 31-MAR-2019, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 vial, intramuscularly, lot number R022754, expiration date 17-JUL-2020 (site of administration was not reported) for prophylaxis. The administered vaccine was stored in temperature of 66.9 Fahrenheit degrees (F) for 8.5 hours. Digital data logger was involved. No previous temperature excursion was provided. No adverse effects were reported.
Sex: U
Vaccine: TDAP
Symptoms: Asthenia, Pain
Clinical narrative: Weakness; aching; This case was reported by a consumer via call center representative and described the occurrence of feelings of weakness in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 27th March 2019, the patient received Boostrix. In March 2019, less than a week after receiving Boostrix, the patient experienced feelings of weakness and general body pain. On an unknown date, the outcome of the feelings of weakness and general body pain were unknown.   It was unknown if the reporter considered the feelings of weakness and general body pain to be related to Boostrix.  Additional details were provided as follows: The patient received booster dose of Boostrix vaccine. The patient was not willing to provide mailling address. The patient provide only contact details to reporter. Follow up could not be pursued.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (prior to getting the vaccine she had several outbreaks of shingles.). Concurrent medical conditions included tremor (essential diagnosed when she was 30 years old). On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). 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 unknown. 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. The patient has experienced a little soreness in her arm. The reporter consented to follow up. For tolerance to the 2nd dose of SHINGRIX, refer case US2019057139.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult male patient who received SHINGRIX for prophylaxis. On 22nd March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 23rd March 2019, 1 days after receiving SHINGRIX, the patient experienced tiredness and headache. On 25th March 2019, the patient experienced dizziness. On an unknown date, the outcome of the tiredness and headache were recovering/resolving and the outcome of the dizziness was not recovered/not resolved. It was unknown if the reporter considered the tiredness, headache and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left deltoid. 3 days after receiving SHINGRIX, the patient felt better, but when he got out of bed later that night he felt dizzy. The patient did not stand up immediately, but just sat on the end of the bed for a few moments. On the day of reporting, the patient felts a little dizzy. The reporter gave consent to follow up.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Acne, Pruritus, Rash
Clinical narrative: Patient states rash on back of neck, looks like pimples, ithcy
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: 4.5 cm diameter red knot on Right bicep red, painful to touch.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Injection site warmth, Neck pain
Clinical narrative: Patient notified me by telephone that during the night after her injection, she woke up with throbbing pain to her right arm and neck. Injection site was red and hot. The next day the area was bruised. When the bruising and pain went away, a rash started at the injection site and she described it as small raised bumps that itched. All symptoms have gone away today except there are still some raised bumps.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash pruritic
Clinical narrative: Patient notified me by telephone that during the night after her injection, she woke up with throbbing pain to her right arm and neck. Injection site was red and hot. The next day the area was bruised. When the bruising and pain went away, a rash started at the injection site and she described it as small raised bumps that itched. All symptoms have gone away today except there are still some raised bumps.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Throat irritation
Clinical narrative: Patient complained of throat itching moments after receiving the vaccine. Patient was given BENADRYL and monitored until feeling better patient was then discharged.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Slight Fatigue in late afternoon & Evening. Got out of bed to brush teeth and had chills bad enough that while attempting to brush teeth, my hands were shaking making brushing difficult and decided to skip flossing till morning. Took Simvastatin & aspirin at that time. Tossed and turned during the night, but didn't think to take my temperature. Fatigue lasted for two days, only walking to Public for groceries.  Injection site was pink, somewhat swollen, & sore to the touch. By today, just tender to touch. Forgot to mention I also take a less-costly version of eye drops (label is worn off) which is taken roughly at 10:30 am & 10:30 pm.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep, Tremor
Clinical narrative: Slight Fatigue in late afternoon & Evening. Got out of bed to brush teeth and had chills bad enough that while attempting to brush teeth, my hands were shaking making brushing difficult and decided to skip flossing till morning. Took Simvastatin & aspirin at that time. Tossed and turned during the night, but didn't think to take my temperature. Fatigue lasted for two days, only walking to Public for groceries.  Injection site was pink, somewhat swollen, & sore to the touch. By today, just tender to touch. Forgot to mention I also take a less-costly version of eye drops (label is worn off) which is taken roughly at 10:30 am & 10:30 pm.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Rash developed within 48 hours. Rash spread slightly as time lapsed and was hot to the touch. Patient was advised to take Benadryl and have it checked by medical doctor as soon as possible.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Patient received pneumovax 23 2 days ago and noticed symptoms yesterday. Reports 3-4 areas of red blotching around the site of injection with pain and warmth to touch. States she feels like it is worsening. Denies itching, difficulty breathing or fever. Patient received prevnar 13 on  8/16/17 without a reaction.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Anxiety, Asthenia, Body temperature increased, Chills
Clinical narrative: About sixteen hrs after vaccine given I developed severe muscular aches and chills, shivering, and a sore L arm where I was vaccinated. The upper deltoid where my vaccine was given became very red and sore as well, but has since resolved. Advil 200mg two tabs every six hrs were taken the day I started initially having symptoms and helped a little. The chills were on and off over the past 10 days , continued daily and I felt like I was coming down with the flu but never ran a fever. The highest my temp has been was 99.6 F. I have never felt like I was "burning up" as with flu in the past.  I began to feel very weak four days  post vaccine and now eleven days post vaccine I am continuing to feel weak, anxious as I am worried about the adverse effects, and the chills are still occurring about every four hrs lasting about an hour. I also have had an upset stomach with loose stools starting five days post vaccine. Unsure if related to vaccine or not. I have reported my symptoms to my physician who did not feel necessary to be seen. He said he is unfamiliar with the side effects of SHINGRIX. I had the vaccine administered by a pharmacist who was very nice and stated he wanted to make sure he gave the vaccine high enough in the deltoid muscle. My arm redness and swelling completely resided. I am concerned as I still have weakness and chills, and mild loss of appetite. I have also reported these side effects to Glaxo SK. I repeated a call to my doctor today who has told me to go to the ER if I get any worse. He was not able to see me today as he is fully booked. I am going to continue to monitor my symptoms, and if I develop a fever, rash or any new symptoms I will be calling my doctor again.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Diarrhoea, Influenza like illness, Injection site erythema, Myalgia
Clinical narrative: About sixteen hrs after vaccine given I developed severe muscular aches and chills, shivering, and a sore L arm where I was vaccinated. The upper deltoid where my vaccine was given became very red and sore as well, but has since resolved. Advil 200mg two tabs every six hrs were taken the day I started initially having symptoms and helped a little. The chills were on and off over the past 10 days , continued daily and I felt like I was coming down with the flu but never ran a fever. The highest my temp has been was 99.6 F. I have never felt like I was "burning up" as with flu in the past.  I began to feel very weak four days  post vaccine and now eleven days post vaccine I am continuing to feel weak, anxious as I am worried about the adverse effects, and the chills are still occurring about every four hrs lasting about an hour. I also have had an upset stomach with loose stools starting five days post vaccine. Unsure if related to vaccine or not. I have reported my symptoms to my physician who did not feel necessary to be seen. He said he is unfamiliar with the side effects of SHINGRIX. I had the vaccine administered by a pharmacist who was very nice and stated he wanted to make sure he gave the vaccine high enough in the deltoid muscle. My arm redness and swelling completely resided. I am concerned as I still have weakness and chills, and mild loss of appetite. I have also reported these side effects to Glaxo SK. I repeated a call to my doctor today who has told me to go to the ER if I get any worse. He was not able to see me today as he is fully booked. I am going to continue to monitor my symptoms, and if I develop a fever, rash or any new symptoms I will be calling my doctor again.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: About sixteen hrs after vaccine given I developed severe muscular aches and chills, shivering, and a sore L arm where I was vaccinated. The upper deltoid where my vaccine was given became very red and sore as well, but has since resolved. Advil 200mg two tabs every six hrs were taken the day I started initially having symptoms and helped a little. The chills were on and off over the past 10 days , continued daily and I felt like I was coming down with the flu but never ran a fever. The highest my temp has been was 99.6 F. I have never felt like I was "burning up" as with flu in the past.  I began to feel very weak four days  post vaccine and now eleven days post vaccine I am continuing to feel weak, anxious as I am worried about the adverse effects, and the chills are still occurring about every four hrs lasting about an hour. I also have had an upset stomach with loose stools starting five days post vaccine. Unsure if related to vaccine or not. I have reported my symptoms to my physician who did not feel necessary to be seen. He said he is unfamiliar with the side effects of SHINGRIX. I had the vaccine administered by a pharmacist who was very nice and stated he wanted to make sure he gave the vaccine high enough in the deltoid muscle. My arm redness and swelling completely resided. I am concerned as I still have weakness and chills, and mild loss of appetite. I have also reported these side effects to Glaxo SK. I repeated a call to my doctor today who has told me to go to the ER if I get any worse. He was not able to see me today as he is fully booked. I am going to continue to monitor my symptoms, and if I develop a fever, rash or any new symptoms I will be calling my doctor again.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Chills, Decreased appetite
Clinical narrative: About sixteen hrs after vaccine given I developed severe muscular aches and chills, shivering, and a sore L arm where I was vaccinated. The upper deltoid where my vaccine was given became very red and sore as well, but has since resolved. Advil 200mg two tabs every six hrs were taken the day I started initially having symptoms and helped a little. The chills were on and off over the past 10 days , continued daily and I felt like I was coming down with the flu but never ran a fever. The highest my temp has been was 99.6 F. I have never felt like I was "burning up" as with flu in the past.  I began to feel very weak four days  post vaccine and now eleven days post vaccine I am continuing to feel weak, anxious as I am worried about the adverse effects, and the chills are still occurring about every four hrs lasting about an hour. I also have had an upset stomach with loose stools starting five days post vaccine. Unsure if related to vaccine or not. I have reported my symptoms to my physician who did not feel necessary to be seen. He said he is unfamiliar with the side effects of SHINGRIX. I had the vaccine administered by a pharmacist who was very nice and stated he wanted to make sure he gave the vaccine high enough in the deltoid muscle. My arm redness and swelling completely resided. I am concerned as I still have weakness and chills, and mild loss of appetite. I have also reported these side effects to Glaxo SK. I repeated a call to my doctor today who has told me to go to the ER if I get any worse. He was not able to see me today as he is fully booked. I am going to continue to monitor my symptoms, and if I develop a fever, rash or any new symptoms I will be calling my doctor again.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Feeling abnormal, Myalgia, Peripheral swelling
Clinical narrative: About sixteen hrs after vaccine given I developed severe muscular aches and chills, shivering, and a sore L arm where I was vaccinated. The upper deltoid where my vaccine was given became very red and sore as well, but has since resolved. Advil 200mg two tabs every six hrs were taken the day I started initially having symptoms and helped a little. The chills were on and off over the past 10 days , continued daily and I felt like I was coming down with the flu but never ran a fever. The highest my temp has been was 99.6 F. I have never felt like I was "burning up" as with flu in the past.  I began to feel very weak four days  post vaccine and now eleven days post vaccine I am continuing to feel weak, anxious as I am worried about the adverse effects, and the chills are still occurring about every four hrs lasting about an hour. I also have had an upset stomach with loose stools starting five days post vaccine. Unsure if related to vaccine or not. I have reported my symptoms to my physician who did not feel necessary to be seen. He said he is unfamiliar with the side effects of SHINGRIX. I had the vaccine administered by a pharmacist who was very nice and stated he wanted to make sure he gave the vaccine high enough in the deltoid muscle. My arm redness and swelling completely resided. I am concerned as I still have weakness and chills, and mild loss of appetite. I have also reported these side effects to Glaxo SK. I repeated a call to my doctor today who has told me to go to the ER if I get any worse. He was not able to see me today as he is fully booked. I am going to continue to monitor my symptoms, and if I develop a fever, rash or any new symptoms I will be calling my doctor again.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills, Feeling cold, Pain in extremity
Clinical narrative: Between 4:30 and 5 PM I first had pain in my two wrists, ankles and heels followed shortly by awful chills (I had on a hoodie with the hood over my head wrapped in a quilt and was still cold). Then I started shaking, everywhere and hard. Got very thirsty and drank a bottle and one half of water. I decided to take my temperature and found I had a temp of 102 degrees. This lasted until about 8 PM when I started to feel better.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Thirst, Tremor
Clinical narrative: Between 4:30 and 5 PM I first had pain in my two wrists, ankles and heels followed shortly by awful chills (I had on a hoodie with the hood over my head wrapped in a quilt and was still cold). Then I started shaking, everywhere and hard. Got very thirsty and drank a bottle and one half of water. I decided to take my temperature and found I had a temp of 102 degrees. This lasted until about 8 PM when I started to feel better.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, No adverse event
Clinical narrative: Physician drew titers to check patient's immunity from the recent community exposure to chicken pox/titers were negative for varicella; This spontaneous report was received from a physician and refers to a 12 year old male patient. The patient's medical history included an exposure to chicken pox from his community. His concurrent conditions and concomitant medications were not reported. The patient's vaccination history was unknown.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis. On an unknown date, a few days post vaccination, the reporting physician drew titers to check patient's immunity from the recent community exposure to chicken pox (and not due to recent vaccination) and then, the patient's titers were negative for varicella. It was also reported that "no adverse effects were reported" (discrepant information). At the reporting time, the outcome of varicella virus test negative was not reported. The reporter did not provide a causal relationship between the event and varicella virus vaccine live (oka/merck)(VARIVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 61-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, sweating and fever. On an unknown date, the outcome of the influenza-like symptoms, chills, sweating and fever were unknown. It was unknown if the reporter considered the influenza-like symptoms, chills, sweating and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Each time after receiving the shingle's shot, the patient experienced flu like symptoms including fever, chills and sweats. The patient's physician advised to report these symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia, Rash, Rash generalised
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of headache in a 51-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date without any adverse events). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced headache, general body pain, fever, generalized rash and patchy rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the headache, general body pain, fever, generalized rash and patchy rash were recovered/resolved. The reporter considered the headache, general body pain, fever, generalized rash and patchy rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not receive any concomitant vaccines. The pharmacist stated that the patient had headache, body aches, fever and rash over her entire body. Most symptoms had resolved within a few days but the rash took longer to resolve. The patient had remaining splotches of rash that lasted longer. The physician did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date at patient's medical care provider). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site lump, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site lump, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site lump, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient received 2nd dose vaccine at the pharmacy because the patient medical provider no longer provides the vaccine as it was hard to get. The patient experienced Knot on arm 1 inch x 2 inches red and warm to touch.
Age: 59.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Pruritus, Slow response to stimuli
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of slow response to stimuli in a 59-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included BOOSTRIX for prophylaxis. The patient's past medical history included shingles. On 13th March 2019, the patient received the 1st dose of SHINGRIX and the 1st dose of BOOSTRIX. On 13th March 2019, less than a day after receiving SHINGRIX and BOOSTRIX, the patient experienced slow response to stimuli, itching both hands, lip swelling, numbness facial and numb lips. On 16th March 2019, the outcome of the slow response to stimuli, itching both hands, lip swelling, numbness facial and numb lips were recovered/resolved. It was unknown if the reporter considered the slow response to stimuli, itching both hands, lip swelling, numbness facial and numb lips to be related to SHINGRIX and BOOSTRIX. Additional details were provided as follows: The reporter provided limited information.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (On an unknown date received 1st dose). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm, fever, malaise and pain. On an unknown date, the outcome of the pain in arm, fever, malaise and pain were unknown. It was unknown if the reporter considered the pain in arm, fever, malaise and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe pain in arm but not really unpleasant. For a day after patient's arm was sore, patient was feeling achy, feverish and had malaise. No further information provided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Fatigue, Injection site pain, Lymphoedema, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 22nd March 2019, the patient received the 1st dose of SHINGRIX. On 23rd March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain, contusion, muscle pain, fever and fatigue. On 24th March 2019, the patient experienced lymphedema. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the contusion was not recovered/not resolved and the outcome of the muscle pain, fever and fatigue were recovered/resolved and the outcome of the lymphedema was unknown. It was unknown if the reporter considered the injection site pain, contusion, muscle pain, fever, fatigue and lymphedema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX vaccine in left deltoid and had a pretty bad reaction. She had pain at the injection site, bruising, muscle aches, fever, and fatigue, she was really wiped out. These started on 23rd March 2019, and pretty much went away. The fever went away after one dose of TYLENOL, the muscle aches are pretty much gone, the pain at the injection site had gotten less and less. The fatigue was pretty much gone. The bruise was recovered. On 24th March 2019, she developed lymphedema of her arm and by 25th March 2019, the swelling in her armpit was really bad and it was not getting better. The lot number and expiry date was not known.