chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Food allergy, Gastrointestinal disorder, Urinary tract infection, Vomiting
Clinical narrative: alpha gal syndrome; This spontaneous report was received from a consumer (Patient's husband) referring his wife of an approximately 52-year-old. The patient's concurrent conditions included meniere's disease, colorectal cancer and chronic obstructive pulmonary disorder. Patient's medical history included chemotherapy and radiation. The patient had drug reaction/ allergies for mammalian byproducts. Concomitant therapies included fluorouracil, leucovorin calcium, unknown antiemetic, oxaliplatin, loratadine, chlorpromazine, diphenhydramine hydrochloride (BENADRYL), oxybutynin, albuterol sulfate (PROAIR), famotidine (PEPCID) and fluticasone propionate, salmeterol xinafoate (ADVAIR). On 08-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, anatomical location, lot and expiry dates were not provided) via intramuscular route for prevention of pneumonia (defaulted to prophylaxis). The reporter stated that his wife visited unspecified emergency rooms on 3 different occasions on unspecified dates for "extreme intestinal agony, along with vomiting and diarrhea. On an unknown date in September 2019 (reported as around September 2019), the patient experienced symptoms of food allergy. On 11-DEC-2019, unspecified test was performed and diagnosed as Alpha Gal syndrome (food allergy). On an unknown date, the patient was treated with antibiotics for urinary tract infection. The patient sought medical attention. The outcome of the event was not recovered. The causality assessment was not provided.
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Varicella post vaccine
Clinical narrative: the vaccine the patient received went without being refrigerated; chickenpox; This spontaneous report was received from a nurse refers to a 5 year old male patient. The patient's historical conditions, past drugs, drug allergies and concomitant therapies were not provided. Concurrent conditions included asthma and seasonal allergy. On an unspecified date in October 1998, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, lot# and expiration date was not provided) for prophylaxis. On an unspecified date in October 1998, patient developed chickenpox (varicella) within a couple weeks of receiving the vaccine. Nurse reported patient took an unspecified dose of benadryl (manufacturer, dose, lot and expiry unknown by reporter) on unspecified dates for treatment of itching associated with chickenpox. On an unspecified date after patient received the vaccine stating the refrigerator was unplugged and the vaccine the patient received went without being refrigerated for an unspecified period of time prior to the patient receiving the vaccine (product storage error). Product quality complaint and overdose was not involved in the case. The event chickenpox (varicella) was not related to cancer. Outcome of the event chickenpox (varicella) was reported as recovered/resolved. Causality of the event chickenpox (varicella) was not provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient did not experience any symptoms; A unspecified patient was administered a dose of expired ROTATEQ; This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 23-JAN-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # R005869, expiration date 23-OCT-2019 (strength and dose were not provided) for prophylaxis. The patient did not experience any symptoms.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: got a large red spot at injection site; trace of the irritation site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 31st December 2019, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced injection site erythema and injection site irritation. On an unknown date, the outcome of the injection site erythema and injection site irritation were unknown.   It was unknown if the reporter considered the injection site erythema and injection site irritation to be related to Shingles vaccine.  Additional details were received as follows: The patient after vaccination got a large red spot at the injection site and saw a faint trace of irritation site.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. A day before reporting, the patient received a dose of Shingrix. The patient experienced headache after vaccination. The patient asked what to take to relieve headache.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Shivers; Headache; This case was reported by a consumer via call center representative and described the occurrence of shivers in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shivers and headache. The patient was treated with cough cold preparations nos (Tylenol Plus Cold & Cough (Nos)). On an unknown date, the outcome of the shivers and headache were unknown.   It was unknown if the reporter considered the shivers and headache to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient receved Shingrix and experienced shivers and headache.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden
Clinical narrative: She and I were both in bed for Thanksgiving; This case was reported by a nurse and described the occurrence of bedridden in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received Shingrix. On 28th November 2019, 2 days after receiving Shingrix, the patient experienced bedridden. On an unknown date, the outcome of the bedridden was unknown.   It was unknown if the reporter considered the bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient was in bed. This case was linked with case US2020AMR007083, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Headache; This case was reported by a physician via sales rep and described the occurrence of nausea in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced nausea, vomiting and headache. On an unknown date, the outcome of the nausea, vomiting and headache were unknown.   It was unknown if the reporter considered the nausea, vomiting and headache to be related to Bexsero.  Additional details were provided as follows: The age at administration was not reported. The patient received Bexsero and experienced nausea, vomiting and headache. The reporter wants to know if he should give the second dose
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: tiredness/ fatigue; muscle ache; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in an unspecified number of patient's who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness and muscle pain. On an unknown date, the outcome of the tiredness and muscle pain were unknown.   It was unknown if the reporter considered the tiredness and muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that 20 to 30 percent of their patients have the common side effects of tiredness, fatigue and muscle ache post vaccination. The reporter consented to follow up. This case is linked to case US2020007421 reported by the same reporter for different patient.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pyrexia
Clinical narrative: feverish; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and woozy. On an unknown date, the outcome of the fever and woozy were unknown.   It was unknown if the reporter considered the fever and woozy to be related to Shingles vaccine.  Additional details were received as follows: The case was reported by patient's cousin. The age at vaccination was not reported. The reporter stated that the patient felt feverish and woozy after vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown 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 details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced side effects. The caller did not want to provide demographics and did not want to provide any adverse event information. For tolerances of 2nd dose, refer case US2020008243, reported by same reporter for the same patient.
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Arrhythmia, Headache, Influenza like illness, Pain
Clinical narrative: heart arrhythmia; flu like symptoms; body aches; headache; This case was reported by a consumer via call center representative and described the occurrence of cardiac arrhythmia in a 62-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included heart disorder and animal bite (Possum bite).   On 11th December 2019, the patient received the 1st dose of RabAvert. On 12th December 2019, 1 days after receiving RabAvert, the patient experienced cardiac arrhythmia (serious criteria GSK medically significant), influenza-like symptoms, general body pain and headache. On 14th December 2019, the outcome of the cardiac arrhythmia, influenza-like symptoms, general body pain and headache were recovered/resolved.   It was unknown if the reporter considered the cardiac arrhythmia, influenza-like symptoms, general body pain and headache to be related to RabAvert.  Additional details were provided as follows: The patient received Rabavert vaccination for post- exposure prophylaxis. The patient experienced flu like symptoms described as body aches and headaches and heart arrhythmia.   The patient's events were resolved in the morning of 14th December 2019. The reporter consented to follow up. For tolerance of 2nd dose refer linked case US2020009056, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced arm soreness after receiving Shingrix. The nurse did not have any of the patient information available at the time of the report.  The reporter would provide that information when the (2nd line) agent called her back. Consented to follow up was provided. This case has been linked with case  US2020009073, US2020AMR009402 and US2020009080, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced arm soreness after receiving Shingrix. The nurse did not have any of the patient information available at the time of the report. The reporter would provide that information when the (2nd line) agent called her back. Consented to follow up was provided. This case has been linked with case  US2020009073, US2020AMR009401 and US2020009080, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Pyrexia, Sleep disorder
Clinical narrative: headache; got very little sleep-suffering; fever; shivering; pain in joints; This case was reported by a consumer and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 16th January 2020, the patient received the 1st dose of Shingrix. On 16th January 2020, less than a day after receiving Shingrix, the patient experienced headache, sleep disturbance, fever, shivering and arthralgia. On an unknown date, the outcome of the headache, sleep disturbance, fever, shivering and arthralgia were not recovered/not resolved.   It was unknown if the reporter considered the headache, sleep disturbance, fever, shivering and arthralgia to be related to Shingrix.  Additional details were reported as follows: Patient had fibromyalgia but was not on immune suppressing drugs. The patient received Shingrix and had very little sleep-suffering from headache, fever, shivering, pain in joints. Patient wants to know what should do to reduce or treat these side effects.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: redness from her shoulder to her elbow; Redness was hot to the touch; This case was reported by a nurse via sales rep and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had redness from her shoulder to her elbow. Redness was hot to the touch and lasted for about a week.
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Vaccine positive rechallenge
Clinical narrative: Sick; Activities of daily living impaired; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received in August 2019, refer case US2020009077).   On 14th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced feeling unwell and activities of daily living impaired. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and activities of daily living impaired to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported but it could be 50 to 51 years. The patient experienced very sick, after vaccination. For about 3 days he could not function well. The reporter Consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Rash has spread to her abdomen and buttocks; tching in arm spread to her back, chest and under arm; burning on her arm; This case was reported by a consumer via call center representative and described the occurrence of rash in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash, pruritus and burning sensation. On an unknown date, the outcome of the rash, pruritus and burning sensation were unknown.   It was unknown if the reporter considered the rash, pruritus and burning sensation to be related to Shingrix.  Additional details were reported as follows: The patient after vaccination experienced itching and burning on her arm and it began to spread to her back, chest and under arm. The patient also had rash that spread to her abdomen and buttocks. The reporter consented to follow up. This case has been linked to US2020006503, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin reaction
Clinical narrative: Skin rash; Skin reaction; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and skin reaction. On an unknown date, the outcome of the rash and skin reaction were unknown.   It was unknown if the reporter considered the rash and skin reaction to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that patient had a skin rash after receiving the vaccine. No other information was able to be obtained. The reporter did not consent to follow up. This case has been linked to US2020006493, reported by the same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: knee pain that made it difficult to get up/wrist pain; This case was reported by a consumer via call center representative and described the occurrence of knee pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2020, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, less than a week after receiving Shingrix, the patient experienced knee pain. On an unknown date, the outcome of the knee pain was unknown.   It was unknown if the reporter considered the knee pain to be related to Shingrix.  Additional details were received as follows: This case was reported by patient's wife. The patient experienced knee pain that made it difficult to get up and also had left wrist pain. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm still sore; Shoulder still sore; Soreness at the injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number NY749, expiry date 4th December 2021) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix .5 ml. On 27th September 2019, 1 days after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient reported soreness at the injection a day following the administration. The patient arm and shoulder are still sore. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Blister on leg; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 227FL, expiry date 30th November 2021) 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 blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The patient developed blister on leg at some time after receiving first dose of Shingrix.  The patient did not see a physician, no diagnosis. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth, Tuberculin test
Clinical narrative: Injection site of the Bexsero was warm to touch; Injection site of the Bexsero was red; Blister just below where the band aid was covering the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Flu unspecified (Flu vaccine).   On 8th January 2020, the patient received the 2nd dose of Bexsero (intramuscular). In January 2020, 2 days after receiving Bexsero and not applicable after receiving Flu vaccine, the patient experienced injection site warmth, injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site blisters were unknown.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site blisters to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and a flu shot unknown brand to have tuberculin skin test red and it was noted that the injection site of the Bexsero was warm to touch, red and the presence of a blister just below where the band aid was covering the injection site
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a nurse via call center representative and described the occurrence of rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash that the patient think was related to Shingles.  The reporter requested information regarding the timing of the 2nd dose of Shingrix in patient who developed Shingles after the first dose The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: she had a lump at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number EG55L, expiry date 7th December 2021) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was not recovered/not resolved.   It was unknown if the reporter considered the injection site lump to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had lump at the injection site within a week that was still unresolved. The reporter consented to follow up for additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: fever; chills; myalgia; headache; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2020, the patient received Shingrix (intramuscular). On 13th January 2020, 1 days after receiving Shingrix, the patient experienced fever, chills, myalgia, headache and influenza-like symptoms. On an unknown date, the outcome of the fever, chills, myalgia, headache and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever, chills, myalgia, headache and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The day before report the patient received Shingrix and reports fever, chills, myalgia and headache, flu like symptoms.   Reporter did not consent to follow-up.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site swelling, Rash
Clinical narrative: Immediate reaction at the injection site of redness; Immediate reaction at the injection site of swelling; Immediate reaction at the injection site of rash; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 31-year-old female patient who received HBV (Engerix B adult) (batch number BG92Z, expiry date 4th July 2022) for prophylaxis.   On 10th January 2020, the patient received Engerix B adult. On 10th January 2020, immediately after receiving Engerix B adult, the patient experienced injection site erythema, injection site swelling and injection site rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site rash were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site rash to be related to Engerix B adult.  Additional details were provided as follows: The patient Engerix B adult in morning and had an immediate reaction at the injection site of redness, swelling and rash. The rash spreads across her chest.
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: convulsions; This case was reported by a pharmacist via call center representative and described the occurrence of convulsion in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th January 2020, 1 days after receiving Shingrix, the patient experienced convulsion (serious criteria GSK medically significant). On an unknown date, the outcome of the convulsion was unknown.   It was unknown if the reporter considered the convulsion to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in an unknown deltoid. At night, the patient started to have convulsions. The patient did not seek medical attention. Caller did not have full patient demographics or lot information at the time of the call.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: felt really cold; Shivering; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2020 18:30, the patient received the 1st dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced feeling cold and shivering. On an unknown date, the outcome of the feeling cold was recovering/resolving and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the feeling cold and shivering to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient's wife. The patient received of Shingrix on the day before reporting at around 6:30 PM in his right arm. On 16th January 2020 in morning the patient felt really cold and then began shivering for approximately 20 minutes. No other information was provided.
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Arrhythmia, Headache, Hot flush, Influenza like illness, Night sweats
Clinical narrative: heart arrhythmia; hot flashes; night sweats; nocturnal urinary incontinence; flu like symptoms; body aches; headache; This case was reported by a consumer via call center representative and described the occurrence of cardiac arrhythmia in a 62-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included heart disorder (Not specified) and animal bite. Previously administered products included Rabavert with an associated reaction of arrhythmia (1st dose received on 11th December 2019, refere linked case US2020AMR009367).   On 14th December 2019, the patient received the 2nd dose of RabAvert. On 15th December 2019, 1 days after receiving RabAvert, the patient experienced cardiac arrhythmia (serious criteria GSK medically significant), hot flashes, night sweat and urinary incontinence. In December 2019, the patient experienced influenza-like symptoms, general body pain and headache. Rechallenge with RabAvert was positive. On an unknown date, the outcome of the cardiac arrhythmia, influenza-like symptoms, general body pain, headache, hot flashes, night sweat and urinary incontinence were recovered/resolved.   It was unknown if the reporter considered the cardiac arrhythmia, influenza-like symptoms, general body pain, headache, hot flashes, night sweat and urinary incontinence to be related to RabAvert.  Additional details were provided as follows: The patient received Rabavert vaccination for post- exposure prophylaxis. The patient received 2nd dose on the afternoon of December 14, 2019. She experienced the flu like symptoms of body aches and headache. The patient also reported heart arrhythmia, hot flashes, night time sweating, and urinary incontinence at night after 2nd dose. All events had been resolved at time of report. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Urinary incontinence, Vaccine positive rechallenge
Clinical narrative: heart arrhythmia; hot flashes; night sweats; nocturnal urinary incontinence; flu like symptoms; body aches; headache; This case was reported by a consumer via call center representative and described the occurrence of cardiac arrhythmia in a 62-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included heart disorder (Not specified) and animal bite. Previously administered products included Rabavert with an associated reaction of arrhythmia (1st dose received on 11th December 2019, refere linked case US2020AMR009367).   On 14th December 2019, the patient received the 2nd dose of RabAvert. On 15th December 2019, 1 days after receiving RabAvert, the patient experienced cardiac arrhythmia (serious criteria GSK medically significant), hot flashes, night sweat and urinary incontinence. In December 2019, the patient experienced influenza-like symptoms, general body pain and headache. Rechallenge with RabAvert was positive. On an unknown date, the outcome of the cardiac arrhythmia, influenza-like symptoms, general body pain, headache, hot flashes, night sweat and urinary incontinence were recovered/resolved.   It was unknown if the reporter considered the cardiac arrhythmia, influenza-like symptoms, general body pain, headache, hot flashes, night sweat and urinary incontinence to be related to RabAvert.  Additional details were provided as follows: The patient received Rabavert vaccination for post- exposure prophylaxis. The patient received 2nd dose on the afternoon of December 14, 2019. She experienced the flu like symptoms of body aches and headache. The patient also reported heart arrhythmia, hot flashes, night time sweating, and urinary incontinence at night after 2nd dose. All events had been resolved at time of report. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Injection site pain, Pain, Pyrexia
Clinical narrative: fever; aches; tired; feels cold; injections site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2020, the patient received the 2nd dose of Shingrix. On 15th January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain (serious criteria clinically significant/intervention required). On 16th January 2020, the patient experienced fever (serious criteria clinically significant/intervention required), pain (serious criteria clinically significant/intervention required), tiredness (serious criteria clinically significant/intervention required) and feeling cold (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, fever, pain, tiredness and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, pain, tiredness and feeling cold to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in right arm. The patient had injection site soreness. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Encephalitis
Clinical narrative: Encephalitis; This case was reported by a pharmacist via call center representative and described the occurrence of encephalitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient received 1st dose of Shingrix a week prior to date of reporting and experienced encephalitis symptoms. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced arm soreness after receiving Shingrix. The nurse did not have any of the patient information available at the time of the report.  The reporter would provide that information when the (2nd line) agent called her back. Consented to follow up was provided. This case has been linked with case  US2020AMR009401, US2020AMR009402 and US2020009080, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Injection site pain, Swelling
Clinical narrative: swellling; redness; firmness; warmth; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received Shingrix (intramuscular). On 13th January 2020, immediately after receiving Shingrix, the patient experienced injection site pain. On 15th January 2020, the patient experienced swelling, erythema, induration and feeling of warmth. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, swelling, erythema, induration and feeling of warmth were recovering/resolving.   It was unknown if the reporter considered the injection site pain, swelling, erythema, induration and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain as the dose was being administered. Two days after receiving vaccination, the Wednesday night the patient developed swelling 3 inches below the injection site along with redness, firmness and warmth. She put ice on the area and the area was going down a little as of this morning. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Labelled drug-drug interaction medication error, Pain in extremity
Clinical narrative: soreness left arm; redness left arm; Labelled drug-drug interaction medication error; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included 10PN-PD-Dit (Pneumococcal vaccine) for prophylaxis.   On 9th October 2019, the patient received the 1st dose of Shingrix (intramuscular) and Pneumococcal vaccine. On 9th October 2019, unknown after receiving Shingrix and Pneumococcal vaccine, the patient experienced labeled drug-drug interaction medication error. On 10th October 2019, the patient experienced pain in arm and erythema of extremities. The patient was treated with antihistamine and cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved and the outcome of the labeled drug-drug interaction medication error was unknown.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix and Pneumococcal vaccine.  Additional details were provided as follows: The patient received Shingrix and Pneumococcal vaccine in left arm, which led to labelled drug-drug interaction medication error. The next day after vaccination the patient experienced sore and red left arm. The soreness and redness continued to get worse and eventually the redness spread from her shoulder to her elbow and was approximately 4 inches in size.  The reporter called physician and she recommended that the patient use an antihistamine. The patient used an antihistamine and cortisone cream for 2-3 days and this seemed to help with the symptoms.  The issue resolved after approximately 2-3 weeks. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months 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 dose of Shingrix and developed Shingles. The follow up consent was granted. As date of birth was future date which was discrepant hence clarification raised for DOB considering age group as adult.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain, Pain in extremity, Skin reaction, Skin warm
Clinical narrative: hard and painful to raise her arm; range of motion is painful; warmth and swelling; warmth and swelling; Skin reaction; This is a spontaneous report from a contactable nurse  A 58-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot CH3594, exp.date 28Feb2022) at 0.5 ml single dose via intramuscular route in the left deltoid on 09Dec2019 10:33.  On the same date the patient also received the second dose of varicella zoster vaccine rge (CHO) (SHINGRIX, lot YM74C, exp,date 08Mar2020) via intramuscular route in the right deltoid. The patient had received the first dose of shingrix on 05Jul2019. The patient had not medical history. On 09Dec2019 the patient experienced Skin reaction, warmth and swelling, hard and painful to raise her arm and range of motion is painful. The outcome of the events Skin reaction, Feeling hot and swelling was reported as recovered. The outcome of the other adverse events was reported as not recovered.  The events Skin reaction, hard and painful to raise her arm and range of motion is painful were assessed as serious.; Sender's Comments: The association between the events "skin reaction, hard and painful to raise her arm, and range of motion is painful" with pneumococcal 13-valent conjugate vaccine can not be fully excluded based on the close temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: hard and painful to raise her arm; range of motion is painful; warmth and swelling; warmth and swelling; Skin reaction; This is a spontaneous report from a contactable nurse  A 58-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot CH3594, exp.date 28Feb2022) at 0.5 ml single dose via intramuscular route in the left deltoid on 09Dec2019 10:33.  On the same date the patient also received the second dose of varicella zoster vaccine rge (CHO) (SHINGRIX, lot YM74C, exp,date 08Mar2020) via intramuscular route in the right deltoid. The patient had received the first dose of shingrix on 05Jul2019. The patient had not medical history. On 09Dec2019 the patient experienced Skin reaction, warmth and swelling, hard and painful to raise her arm and range of motion is painful. The outcome of the events Skin reaction, Feeling hot and swelling was reported as recovered. The outcome of the other adverse events was reported as not recovered.  The events Skin reaction, hard and painful to raise her arm and range of motion is painful were assessed as serious.; Sender's Comments: The association between the events "skin reaction, hard and painful to raise her arm, and range of motion is painful" with pneumococcal 13-valent conjugate vaccine can not be fully excluded based on the close temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased, Pain, Skin warm, Swelling
Clinical narrative: experienced redness swelling and warmth to touch; experienced redness swelling and warmth to touch; experienced redness swelling and warmth to touch; experiencing ongoing limitation of arm movement, with pain when trying to raise her arm above the head; experiencing ongoing limitation of arm movement, with pain when trying to raise her arm above the head; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received the pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (reported as: on 09Dec) at a single dose for immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: experienced redness swelling and warmth to touch, experiencing ongoing limitation of arm movement, with pain when trying to raise her arm above the head. The clinical outcome of the event, experienced redness swelling and warmth to touch, was recovered on an unspecified date. The clinical outcome of the event, experiencing ongoing limitation of arm movement, with pain when trying to raise her arm above the head, was not recovered.  The batch/lot numbers for the vaccine, pneumococcal 13-val conj vac (dipht crm197 protein), were not provided and will be requested during follow up.
Sex: U
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Pain after being administered by Trumenba; This is a spontaneous report from a contactable nurse.  A patient of unspecified age and gender 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 pain after being administered by TRUMENBA (non-serious) on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.