chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine / The redness extended from the injection site up to the elbow; The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine.; The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine.; The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine.; The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine.; The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine.; This spontaneous report was received from a consumer, reporting on herself, a 71-years-old female patient. The patient's pertinent medical history included high cholesterol, high blood pressure, osteoarthritis, bypass surgery, gastric bypass. Drug allergies and reactions to Ampicilin and ACE inhibitors.   Concomitant therapies included: levothyroxine sodium (LEVOTHYROXINE SODIUM), clopidogrel bisulfate (PLAVIX), alendronate sodium (FOSAMAX), metoprolol (METOPROLOL), atorvastatin (ATORVASTATIN) and losartan (LOSARTAN).  On 26-AUG-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one single dose shot, in the left arm, for prophylaxis (strength, rout of administration, lot number and expiration date were not provided). After vaccination, the patient experienced pain (injection site pain), swelling (injection site swelling), redness (injection site erythema), soreness (injection site pain), tiredness (fatigue) and hardening at the injection site (injection site induration), and the redness extended from the injection site up to the elbow (erythema).  The patient performed a routine blood work; however, the results were not reported.  Causality assessment for the events were not provided by the reporter and the outcome was reported as not recovered/not resolved.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine / The redness extended from the injection site up to the elbow; The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine.; The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine.; The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine.; The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine.; The patient experienced pain, swelling, redness, soreness, tiredness, and hardening at the injection site after receiving PNEUMOV AX 23 Vaccine.; This spontaneous report was received from a consumer, reporting on herself, a 71-years-old female patient. The patient's pertinent medical history included high cholesterol, high blood pressure, osteoarthritis, bypass surgery, gastric bypass. Drug allergies and reactions to Ampicilin and ACE inhibitors.   Concomitant therapies included: levothyroxine sodium (LEVOTHYROXINE SODIUM), clopidogrel bisulfate (PLAVIX), alendronate sodium (FOSAMAX), metoprolol (METOPROLOL), atorvastatin (ATORVASTATIN) and losartan (LOSARTAN).  On 26-AUG-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one single dose shot, in the left arm, for prophylaxis (strength, rout of administration, lot number and expiration date were not provided). After vaccination, the patient experienced pain (injection site pain), swelling (injection site swelling), redness (injection site erythema), soreness (injection site pain), tiredness (fatigue) and hardening at the injection site (injection site induration), and the redness extended from the injection site up to the elbow (erythema).  The patient performed a routine blood work; however, the results were not reported.  Causality assessment for the events were not provided by the reporter and the outcome was reported as not recovered/not resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Nonspecific reaction, Peripheral swelling
Clinical narrative: Big reaction; Bottom of arm gets inflamed; This case was reported by a pharmacist via call center representative and described the occurrence of nonspecific reaction in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced nonspecific reaction and swelling arm. On an unknown date, the outcome of the nonspecific reaction and swelling arm were unknown.   It was unknown if the reporter considered the nonspecific reaction and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that she had people with a big reaction and the whole bottom of their arm got inflamed. The reporter consented to follow up. The reporter granted permission to follow up but declined to provide a mailing address. The pharmacist was not at work at the time of this call and no further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Erythema, Herpes zoster, Injection site pain, Insomnia
Clinical narrative: shingles; pain on left chest and under arm; redness on chest; lack of sleep; tingling feeling on left chest; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) (batch number 5JT9C, expiry date 28th August 2021) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th August 2019, the patient experienced tingling sensation. On 17th August 2019, the patient experienced chest pain, localized erythema and sleep loss. On 21st August 2019, the patient experienced shingles. On an unknown date, the outcome of the injection site pain and tingling sensation were recovered/resolved and the outcome of the chest pain, localized erythema, shingles and sleep loss were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tingling sensation, chest pain, localized erythema, shingles and sleep loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had injection site pain, tingling sensation, chest pain, localized erythema and sleep loss and shingles. The wife of the patient reported that her husband planned to continue follow up with his physician on an unknown date. The reporter consented to follow up. This case linked with US2019157548, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: shingles; pain on left chest and under arm; redness on chest; lack of sleep; tingling feeling on left chest; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) (batch number 5JT9C, expiry date 28th August 2021) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th August 2019, the patient experienced tingling sensation. On 17th August 2019, the patient experienced chest pain, localized erythema and sleep loss. On 21st August 2019, the patient experienced shingles. On an unknown date, the outcome of the injection site pain and tingling sensation were recovered/resolved and the outcome of the chest pain, localized erythema, shingles and sleep loss were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tingling sensation, chest pain, localized erythema, shingles and sleep loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had injection site pain, tingling sensation, chest pain, localized erythema and sleep loss and shingles. The wife of the patient reported that her husband planned to continue follow up with his physician on an unknown date. The reporter consented to follow up. This case linked with US2019157548, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Myalgia; Sore arm; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and myalgia. On an unknown date, the outcome of the pain in arm and myalgia were recovered/resolved.   It was unknown if the reporter considered the pain in arm and myalgia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The nurse reported that the patient experienced sore arm for a week, and a day of myalgia. The reporter did not agree to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Immediate post-injection reaction
Clinical narrative: high blood sugar; This case was reported by a other health professional via sales rep and described the occurrence of blood sugar increased in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was recovered/resolved.   It was unknown if the reporter considered the blood sugar increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not known. The patient was type 2 diabetic with controlled diabetes. The patient reported high blood sugar immediately after receiving Shingrix injection. Her blood sugar remained high for several days after Shingrix injection.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Mammogram, Pain, Pyrexia, Ultrasound scan
Clinical narrative: prominent lymph node on left side; fever; body aches; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes, fever and general body pain. On an unknown date, the outcome of the enlargement of lymph nodes, fever and general body pain were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: On Friday, the patient received Shingrix vaccine and had fever and body aches over the weekend.  The patient had scheduled annual mammogram on Monday.  The patient was called to come in for an ultrasound because of a prominent lymph node that the patient had on left side, the same side of vaccination.  The patient asked, whether this could be due to the Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased appetite, Dysgeusia, Fatigue, Feeling hot, Hypersensitivity
Clinical narrative: allergic reaction; feel overall achy; overall Weariness; lack of appetite; heat in my cheek and jawline of the same side of the injection; bitter taste; tongue becoming slightly numb; prickling feeling in my throat; injection site sore; injection site swollen; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 27th August 2019, the patient experienced feeling of warmth facial, taste bitter, numbness of tongue and throat irritation. On 28th August 2019, the patient experienced pain, weariness and appetite absent. On an unknown date, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction, feeling of warmth facial, taste bitter, numbness of tongue and throat irritation were recovered/resolved and the outcome of the injection site pain, injection site swelling, pain, weariness and appetite absent were unknown.   It was unknown if the reporter considered the allergic reaction, injection site pain, injection site swelling, feeling of warmth facial, taste bitter, numbness of tongue, throat irritation, pain, weariness and appetite absent to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Within seconds of being injected with the vaccine before the date of reporting the patient experienced heat in my cheek and jawline of the same side of the injection, along with a bitter taste in my mouth, followed by the tip of my tongue becoming slightly numb and a prickling feeling in my throat. These symptoms slowly dissipated perhaps 2 minutes, though the attending nurse said 5 minutes. The patient doctor contends that it was too soon for it to have been an allergic reaction, yet has determined it best if I did not receive the 2nd required injection. The patient asked could the injection have hit a blood vessel and been directly injected into my blood stream rather than my muscle, thus resulting in the unusual symptoms and what type of effectiveness would there be against shingles since I would not be able to receive the second injection. At the time of reporting the patient feel overall achy and a complete feeling of overall weariness and lack of appetite. The injection site was very sore and swollen.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Injection site pain, Injection site swelling, Pain, Throat irritation
Clinical narrative: allergic reaction; feel overall achy; overall Weariness; lack of appetite; heat in my cheek and jawline of the same side of the injection; bitter taste; tongue becoming slightly numb; prickling feeling in my throat; injection site sore; injection site swollen; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 27th August 2019, the patient experienced feeling of warmth facial, taste bitter, numbness of tongue and throat irritation. On 28th August 2019, the patient experienced pain, weariness and appetite absent. On an unknown date, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction, feeling of warmth facial, taste bitter, numbness of tongue and throat irritation were recovered/resolved and the outcome of the injection site pain, injection site swelling, pain, weariness and appetite absent were unknown.   It was unknown if the reporter considered the allergic reaction, injection site pain, injection site swelling, feeling of warmth facial, taste bitter, numbness of tongue, throat irritation, pain, weariness and appetite absent to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Within seconds of being injected with the vaccine before the date of reporting the patient experienced heat in my cheek and jawline of the same side of the injection, along with a bitter taste in my mouth, followed by the tip of my tongue becoming slightly numb and a prickling feeling in my throat. These symptoms slowly dissipated perhaps 2 minutes, though the attending nurse said 5 minutes. The patient doctor contends that it was too soon for it to have been an allergic reaction, yet has determined it best if I did not receive the 2nd required injection. The patient asked could the injection have hit a blood vessel and been directly injected into my blood stream rather than my muscle, thus resulting in the unusual symptoms and what type of effectiveness would there be against shingles since I would not be able to receive the second injection. At the time of reporting the patient feel overall achy and a complete feeling of overall weariness and lack of appetite. The injection site was very sore and swollen.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Influenza, Myalgia
Clinical narrative: Headache; Muscle ache; Mild flu symptons; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced headache, muscle pain and flu symptoms. On an unknown date, the outcome of the headache, muscle pain and flu symptoms were unknown.   It was unknown if the reporter considered the headache, muscle pain and flu symptoms to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient reported that, had headache, muscle pain and mild flu symptoms after vaccination with dose of Shingrix. The patient asked, if over the counter drugs was ok to take.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site discoloration; The area became itchy; Large red area the size of a grapefruit presented at the injection site; hot to touch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix. On 4th May 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. In May 2019, the patient experienced injection site discoloration and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site discoloration and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in her left arm. Two days after receiving the 1st dose, the patient had a large red area the size of a grapefruit at the injection site.  It was hot to touch.   It resolved after 8 days but there was still some slight discoloration in the area.  Two weeks following the injection, the area became itchy and it lasted for 4 or 5 days.   The patient did not consent to follow up. The patient received 2nd dose and had some adverse events, refer case US2019157518.
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: tinnitus; This case was reported by a physician via sales rep and described the occurrence of tinnitus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician reported to the sales representative the patient in the late 50s to early 60s developed tinnitus after receiving their 2nd dose of Shingrix. No additional information was available regarding the patients. The reporter was consented to follow up. This case has been linked with US2019157521, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache; Muscle pain; Shaking; Tiredness; Nausea; Fever; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On 27th August 2019, less than a day after receiving Shingrix, the patient experienced headache, muscle pain, tremor, tiredness, nausea and fever. On an unknown date, the outcome of the headache, muscle pain, tremor, tiredness, nausea and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscle pain, tremor, tiredness, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the day before reporting date, the patient received the 1st of two doses of Shingrix.  The patient had muscle pain, headache, tiredness, nausea, fever and was shaking. These reactions were very extreme that, these not resolved even 24 hours later and the patient was not sure about taking a 2nd shot due to the severity of reactions.
Sex: U
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Headache; Muscle pain; Shaking; Tiredness; Nausea; Fever; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On 27th August 2019, less than a day after receiving Shingrix, the patient experienced headache, muscle pain, tremor, tiredness, nausea and fever. On an unknown date, the outcome of the headache, muscle pain, tremor, tiredness, nausea and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscle pain, tremor, tiredness, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the day before reporting date, the patient received the 1st of two doses of Shingrix.  The patient had muscle pain, headache, tiredness, nausea, fever and was shaking. These reactions were very extreme that, these not resolved even 24 hours later and the patient was not sure about taking a 2nd shot due to the severity of reactions.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Malaise, Rash
Clinical narrative: fairly severe rash; shortness of breath; not feeling at my best; This case was reported by a consumer and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash, shortness of breath and feeling unwell. On an unknown date, the outcome of the rash, shortness of breath and feeling unwell were unknown.   It was unknown if the reporter considered the rash, shortness of breath and feeling unwell to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported  The patient had an adverse reaction to 1st dose of Shingrix. The patient nearly 3 weeks at the reporting date into a fairly severe rash shortness of breath generally not feeling at best since the injection. Any ideas as health care provider, the patient had seen and not witnessed this kind of reaction before. The only advice, the patient was getting is give it another two or three days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore Arm; Fatigue; Headache; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 19th April 2019, refer case US2019AMR158286).   On 3rd July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, fatigue and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid. The patient received Shingrix and had local sore arm for 2 days and fatigue, headache for 24 hours. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Fatigue; Headache; myalgia; Shivering; local Pain in arm; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm, fatigue, headache, myalgia and shivering. On an unknown date, the outcome of the pain in arm, fatigue, headache, myalgia and shivering were unknown.   It was unknown if the reporter considered the pain in arm, fatigue, headache, myalgia and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had local sore arm for 2 days and myalgia, fatigue, headache, shivering day after vaccination. For tolerances of 2nd dose refer case US2019AMR158281, reporter by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling in feet; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bone spur.   On 17th February 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 30 days after receiving Shingrix, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.  Additional details were reported as follows: The patient stated that he received dose 1 of Shingrix and felt a tingling in his feet one month later.  The reporter consented to follow up. The case has been linked to the case US2019156572, reported by same reporter for same patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Mammogram abnormal
Clinical narrative: swollen lymph node, same side of vaccine; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 27th August 2020) for prophylaxis.   On 16th August 2019, the patient received Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on an unknown arm. The day after vaccination, the patient had her scheduled mammogram done. The patient was then contacted and was told that the mammagram showed a swollen lymph node on the same side that she had the vaccine. The reporter did not consent to follow-up. No further information was available. The provided information regarding lymphadenitis to the intern from Shingrix prodcut information.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash pustular
Clinical narrative: Itches a little; pustule/shingles pox; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced itchy rash and pustular rash. On an unknown date, the outcome of the itchy rash and pustular rash were unknown.   It was unknown if the reporter considered the itchy rash and pustular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that the patient who was older than 65 years of age received the 1st dose of Shingrix. On 26th August 2019, the patient called the pharmacist to report that she had one shingles pox on the palm of her hand, which itches a little. The pharmacist stated the patient sent a picture and the area looks more like a bug bite or spider bite to the pharmacist, as there was a pustule in the middle.  The patient denied fever, pain, chills, and injection site reactions.  The reporter consented to follow up but declined to provide a mailing address. She requested if safety wants to follow up that they do so via email,the pharmacist was not at work at the time of this call, so patient age and additional details were not available.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling hot, Headache, Influenza like illness
Clinical narrative: Flu like symptoms; hot; pain from the shot in his muscle/ muscle ache; fatigue; weakness; feverish; didn't feel well; headache; pain; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019 15:30, the patient received the 1st dose of Shingrix (intramuscular). On 21st August 2019 23:00, 7 hrs 30 min after receiving Shingrix, the patient experienced influenza-like symptoms, feeling hot, muscle pain, fatigue, weakness, fever, feeling unwell, headache and pain. On an unknown date, the outcome of the influenza-like symptoms, feeling hot, muscle pain, fatigue, weakness, fever, feeling unwell, headache and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling hot, muscle pain, fatigue, weakness, fever, feeling unwell, headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine at 3:30 PM on a Wednesday. At 11:00 PM that evening, he was hot, had pain from the shot in his muscle, had weakness, fatigue, was feverish, had muscle aches with not much of a headache. By 24th August 2019, he still did not feel well but his symptoms resolved by that Sunday 25th August 2019. The patient did not consent to follow-up and refused to provide any demographic information or name. No additional details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: Flu like symptoms; hot; pain from the shot in his muscle/ muscle ache; fatigue; weakness; feverish; didn't feel well; headache; pain; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019 15:30, the patient received the 1st dose of Shingrix (intramuscular). On 21st August 2019 23:00, 7 hrs 30 min after receiving Shingrix, the patient experienced influenza-like symptoms, feeling hot, muscle pain, fatigue, weakness, fever, feeling unwell, headache and pain. On an unknown date, the outcome of the influenza-like symptoms, feeling hot, muscle pain, fatigue, weakness, fever, feeling unwell, headache and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling hot, muscle pain, fatigue, weakness, fever, feeling unwell, headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine at 3:30 PM on a Wednesday. At 11:00 PM that evening, he was hot, had pain from the shot in his muscle, had weakness, fatigue, was feverish, had muscle aches with not much of a headache. By 24th August 2019, he still did not feel well but his symptoms resolved by that Sunday 25th August 2019. The patient did not consent to follow-up and refused to provide any demographic information or name. No additional details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis contact, Eczema, Hypersensitivity, Local reaction, Rash
Clinical narrative: allergic reaction; contact dermatitis; Local reaction; Rash; widespread body skin eruption; eczema; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 1 day after receiving Shingrix, the patient experienced rash, widespread rash and eczema. On an unknown date, the patient experienced allergic reaction, contact dermatitis and local reaction. On an unknown date, the outcome of the allergic reaction, widespread rash, eczema, contact dermatitis and local reaction were unknown and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the allergic reaction, rash, widespread rash, eczema, contact dermatitis and local reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was 50 years old at the time of reporting. The reporter reported that, the patientb experienced widespread body skin eruption (rash, eczema) the day after, which was unmanaged and uncontrolled. The reporter stated that, the patient had pretty impressive local reaction after vaccination which they figured was expected. Less than 5 months, the patient experienced allergic reaction, contact dermatitis and local reaction. The reporter did not suspect the rash to be shingles but, rather a spongiotic dermatitis or contact dermatitis, as the patient never had rashes in the past. The patient stated that, has been misdiagnosed with Scabies and treated unsuccessfully. The patient reported that, did not have chickenpox as a kid and was inquiring if this could make a difference with him getting the vaccine. The patient asked, if tghis was an allergic reaction and how long would the symptoms last. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Erythema, Extensive swelling of vaccinated limb, Paraesthesia
Clinical narrative: Swelling; burning sensation; redness; tingling; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 8th November 2021) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMOCOCCAL VACCINE. On 21st August 2019, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, burning sensation, erythema of extremities and tingling of extremity. On an unknown date, the outcome of the extensive swelling of vaccinated limb, burning sensation, erythema of extremities and tingling of extremity were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, burning sensation, erythema of extremities and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient received dose of pneumococcal vaccine on the same day on same arm (left arm) from doctor's office. The pharmacist repoprted that, patient had redness from the injection site of the left arm up to the elbow. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash
Clinical narrative: reactivation of herpes zoster; Rash; This case was reported by a other health professional via call center representative and described the occurrence of herpes zoster reactivation in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster and rash.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced herpes zoster reactivation and rash. On an unknown date, the outcome of the herpes zoster reactivation and rash were unknown.   It was unknown if the reporter considered the herpes zoster reactivation and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient's herpes zoster was reactivated after getting the first dose of Shingrix. The patient experienced a rash. The reporter consented to follow up. The reporter thinks this has already been reported to GlaxoSmithKline. Product details (lot number, expiration date) and other details are not available at the time of reporting.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills; fever; muscle soreness; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 19th November 2021) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced chills, fever and muscle soreness. On an unknown date, the outcome of the chills, fever and muscle soreness were unknown.   It was unknown if the reporter considered the chills, fever and muscle soreness to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the female received first dose of Shingrix and within 24 hours on 24th August 2019, she was reporting fever, chills and muscle soreness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Muscle aches; Flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2019) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th April 2019, 1 days after receiving Shingrix, the patient experienced muscle pain and influenza-like symptoms. On 20th April 2019, the outcome of the muscle pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the muscle pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in the left arm. The pharmacist on the line reported that the patient experienced flu like symptoms and muscle aches, starting the day after the injection and then resolving two days later. The patient did not want to get the second dose. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle mass, Muscle neoplasm, Ultrasound scan normal
Clinical narrative: Muscle bulges; Muscle tumor; This case was reported by a pharmacist via call center representative and described the occurrence of muscle mass in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 7D9C3, expiry date 25th September 2021) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced muscle mass and muscle neoplasm. On an unknown date, the outcome of the muscle mass and muscle neoplasm were not recovered/not resolved.   It was unknown if the reporter considered the muscle mass and muscle neoplasm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist reported that, shortly after the vaccination, the patient developed two bulges in their muscle. An ultrasound was preformed which showed no liquid. There was one underneath the shoulder bone and one to the back of the arm, and almost looks like tumors, big muscle tumors. The patient develpoed muscle bulges shortly after the vaccination, but not right away, and are ongoing. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersensitivity, Injection site erythema, Rash
Clinical narrative: Rash all over body; redness at injection site; Slight Headache; Allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. On 24th August 2019, 1 days after receiving Shingrix, the patient experienced generalized rash, injection site erythema, headache and allergic reaction. On an unknown date, the outcome of the generalized rash and injection site erythema were not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the allergic reaction was unknown.   The reporter considered the generalized rash, injection site erythema, headache and allergic reaction to be possibly related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on left arm. On 24th August 2019. the patient woke up with a slight headache and a rash all over her body. The patient also has redness at the injection site. The patient went to see her physician on 28th August 2019 regarding the rash and the doctor gave her a steroid injection and some other medications to take. The patient stated that her physician thinks it was an allergic reaction to the vaccine. The reporter was consented to follow up Emergency room (ER) visit was required. The patient did not provide any additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Malaise; This case was reported by a pharmacist via call center representative and described the occurrence of malaise 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, less than 2 years after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The pharmacist reported that he received a dose of Shingrix and experienced malaise for a couple days afterwards. The case has been linked to the case US2019157513, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: Throat began to close; This case was reported by a consumer via call center representative and described the occurrence of throat constriction in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site reaction (received 1st dose, refer case US2019AMR158086).   On 22nd August 2019 10:00, the patient received the 2nd dose of Shingrix (intramuscular). In August 2019, 15 hrs after receiving Shingrix, the patient experienced throat constriction. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the throat constriction was recovered/resolved.   It was unknown if the reporter considered the throat constriction to be related to Shingrix.  Additional details were provided as follows: The Shingrix administered in the left arm. The patient received the 2nd dose of Shingrix and at 10:00 AM and 15 hours later, her throat began to close.   She was treated at the ER with a benadryl cocktail and the issue resolved 4 hours after receiving the treatment.   The reporter did not consent to follow up. Emergency room visit was required.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Eye pain, Injection site pain, Ocular hyperaemia, Visual impairment
Clinical narrative: burning feeling in eyes; redness in eyes; soreness in eyes; unable to see sharply; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 5JT9C, expiry date 28th August 2021) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 17th August 2019, the patient experienced burning sensation in eye, eye red, soreness in eyes and visual impairment. On an unknown date, the outcome of the injection site pain, burning sensation in eye, eye red and soreness in eyes were recovered/resolved and the outcome of the visual impairment was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, burning sensation in eye, eye red, soreness in eyes and visual impairment to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm. Three days after receiving Shingrix, the patient experienced burning feeling in eyes, redness in eyes, soreness in eyes and unable to see sharply. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up. The case has been linked to the case US2019157557, reported by same reporter.