chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Weak; Felt depleted like she had been hit by a truck / it took everything out of me; sickness.; Not sleeping; Hives; Itching; This case was reported by a consumer via call center representative and described the occurrence of hives in a 38-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 947BS, expiry date 30th June 2020) for prophylaxis.   Previously administered products included Flu vaccine (had flu shot and did not had a problem previously). Concurrent medical conditions included shellfish allergy and iodine allergy.   On 1st October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced weakness, exhaustion and sickness. In October 2019, the patient experienced hives, generalized pruritus and insomnia. On 22nd October 2019, the outcome of the weakness, insomnia, exhaustion and sickness were recovered/resolved. On an unknown date, the outcome of the hives and generalized pruritus were recovered/resolved.   It was unknown if the reporter considered the hives, generalized pruritus, weakness, insomnia, exhaustion and sickness to be related to Fluarix Quadrivalent 2019-2020 season.Additional details were provided as follows: The reporter was the patient. The patient received dose of Fluarix Quadrivalent 2019-2020 season in left deltoid at the pharmacy. Less than 3 weeks, the patient experienced hives, generalized pruritus and insomnia.  The patient at 1st stated that, 24 hours later got sick, but later stated that in the afternoon on the day of vaccination, started feeling symptoms. The patient felt depleted like she had been hit by a truck. The patient did not go to the work on thursday 3rd October 2019 and Friday, 4th October 2019. The patient reported that not sleeping because of itching all over the body,  The patient had hives and itching for 4 days. By saturday 5th October, the patient was not fully recovered. On 22nd October 2019, the patient called to GlaxosmithKline response center and stated that, all events were recovered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold sore outbreak on lips, nose, and inside of mouth; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 2E4SZ, expiry date 26th November 2021) and (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On 16th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In September 2019, less than a week after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was recovered/resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Within 3 days after vaccination, the patient developed a severe outbreak of cold sores on her lips, nose, inside of her mouth, which had resolved. The reporter consented to follow up. The lot number and expiry date given was for the 1st dose vials of the powder and the diluent. This case has been linked with US2019192861, reported by the same reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Consumer continues to have injection site pain from second Shingrix dose shot; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 31st December 2019) for prophylaxis.   On 4th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had injection site pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Injection site haemorrhage, Injection site pain, Underdose
Clinical narrative: PAIN at the injection site; Injection site bleeding; UNDERDOSE; Inadvertent exposure to vaccine; exposure via skin contact; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd October 2019, immediately after receiving Shingrix, the patient experienced injection site pain, injection site bleeding, underdose, inadvertent exposure to vaccine and exposure via skin contact. The patient was treated with ibuprofen, ibuprofen (Motrin) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain and injection site bleeding were recovered/resolved and the outcome of the underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site pain and injection site bleeding to be related to Shingrix.  Additional details were provided as follows: The patient reported pain at the injection site when injected and her arm hurt that evening. She treated with motrin and benadryl and the pain resolved by the next day. She also said that after receiving the injection, blood and some liquid dripped down her arm and she was not certain if she received the entire dose.  The injection was given in the upper shoulder area of the deltoid muscle. The reporter did not consent to follow up. The reporter was a nurse and was also the patient.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Rash erythematous
Clinical narrative: rash; rough rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, couple of days after receiving Shingrix, the patient experienced red rash and skin rough. On an unknown date, the outcome of the red rash and skin rough were unknown.   It was unknown if the reporter considered the red rash and skin rough to be related to Shingrix.  Additional details were provided as follows: The patient experienced a rash on the back of his left calf muscle, 3 spots that are red and rough about the size of a dime or smaller.  The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood pressure increased, Burning sensation, Dizziness, Erythema
Clinical narrative: elevated blood pressure; red cheeks; rash; peeling of skin; sizzling; upset stomach; burning; lightheaded; achy; tingling; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix. On 12th October 2019, 5 days after receiving Shingrix, the patient experienced increased blood pressure and red face. In October 2019, the patient experienced injection site rash, skin peeling, tingling, extremities hot feeling of, upset stomach, burning sensation, light headedness and general body pain. On 18th October 2019, the outcome of the increased blood pressure and red face were recovered/resolved. On an unknown date, the outcome of the injection site rash and skin peeling were not recovered/not resolved and the outcome of the tingling, upset stomach, burning sensation, light headedness and general body pain were recovered/resolved and the outcome of the extremities hot feeling of was unknown.   The reporter considered the injection site rash, skin peeling, tingling, upset stomach, burning sensation, light headedness, general body pain, increased blood pressure and red face to be related to Shingrix. It was unknown if the reporter considered the extremities hot feeling of to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. Less than 3 weeks after receiving Shingrix, within days of the first injection, the patient developed a rash around the injection site which had just started to fade at the reporting date. The skin was peeling off.  The patient also experienced tingling going down her left leg, almost like a sizzling.  The patient had an upset stomach, some burning and lightheartedness as well as body aches. All symptoms with the exception of the rash and tingling resolved within a few days. The tingling down her leg went away about a week and a half after the shot.  The patient called back later to add her blood pressure went as high as 156/84 mm Hg and her facial cheeks were red. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site rash, Pain, Paraesthesia, Skin exfoliation
Clinical narrative: elevated blood pressure; red cheeks; rash; peeling of skin; sizzling; upset stomach; burning; lightheaded; achy; tingling; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix. On 12th October 2019, 5 days after receiving Shingrix, the patient experienced increased blood pressure and red face. In October 2019, the patient experienced injection site rash, skin peeling, tingling, extremities hot feeling of, upset stomach, burning sensation, light headedness and general body pain. On 18th October 2019, the outcome of the increased blood pressure and red face were recovered/resolved. On an unknown date, the outcome of the injection site rash and skin peeling were not recovered/not resolved and the outcome of the tingling, upset stomach, burning sensation, light headedness and general body pain were recovered/resolved and the outcome of the extremities hot feeling of was unknown.   The reporter considered the injection site rash, skin peeling, tingling, upset stomach, burning sensation, light headedness, general body pain, increased blood pressure and red face to be related to Shingrix. It was unknown if the reporter considered the extremities hot feeling of to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. Less than 3 weeks after receiving Shingrix, within days of the first injection, the patient developed a rash around the injection site which had just started to fade at the reporting date. The skin was peeling off.  The patient also experienced tingling going down her left leg, almost like a sizzling.  The patient had an upset stomach, some burning and lightheartedness as well as body aches. All symptoms with the exception of the rash and tingling resolved within a few days. The tingling down her leg went away about a week and a half after the shot.  The patient called back later to add her blood pressure went as high as 156/84 mm Hg and her facial cheeks were red. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: & SWELLING SUPPLY
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: pain at injection site (still a little sore to the touch), headache, muscle pain, tiredness and fever 101 (highest)  all lasted 1 day except for injection site tenderness
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: pain, redness and swelling at injection site and streaking towards axillary and then turned into red patches 6inX6in on left arm, patient was monitored over the course of a week, no treatment given
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Middle insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Extremely sore arm--enough to wake me up multiple times every night. Swollen red puffy arm, approx. 4" x 2 1/2 inch.  Got worse on the 2nd and worse still on the 3rd night.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient experience severe throbbing pain in the right arm. She stated that it started later that evening. When she came in to the report the reaction her left arm was red and warm to touch. The right arm was not affected.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abdominal pain lower, Body temperature increased, Chills, Erythema, Hyperaesthesia
Clinical narrative: 10/7/19-Vomiting, nausea, chills, shiver, 104F temperature 10/8/19- marginally better, arm very red and sensitive to touch 10/9/19-nausea, lower gut pain,  arm still swollen with redness
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nausea, Peripheral swelling, Vomiting
Clinical narrative: 10/7/19-Vomiting, nausea, chills, shiver, 104F temperature 10/8/19- marginally better, arm very red and sensitive to touch 10/9/19-nausea, lower gut pain,  arm still swollen with redness
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 10/7/19- chills, shivering, nausea, painful to touch injection site, swelling and redness, fever 10/8/19- better, arm still very red and sensitive to touch 10/9/19- vomiting, nausea, chills, shivering, 104F temperature
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: 10/7/19- chills, shivering, nausea, painful to touch injection site, swelling and redness, fever 10/8/19- better, arm still very red and sensitive to touch 10/9/19- vomiting, nausea, chills, shivering, 104F temperature
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Disturbance in attention, Fatigue, Lymphadenopathy
Clinical narrative: Swollen glands, extreme fatigue and unable to concentrate
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: pt received vaccine on 10/15 at pt home
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Bladder discomfort, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: About 9 hours later I experienced fever and muscular pain.  Symptoms were partially alleviated by ibuprofen. By the next morning I experienced significant pressure in my bladder consistent with urinary tract infection. I was alarmed enough by this to make a drs appointment. Fortunately this subsided in about an hour and a half and I cxld the appt. The remainder of this day I felt tired and achy. At about 4 pm I took another dose of ibuprofen as I started to feel feverish again.  By the morning of Nov 1 I was feeling back to normal.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: About 9 hours later I experienced fever and muscular pain.  Symptoms were partially alleviated by ibuprofen. By the next morning I experienced significant pressure in my bladder consistent with urinary tract infection. I was alarmed enough by this to make a drs appointment. Fortunately this subsided in about an hour and a half and I cxld the appt. The remainder of this day I felt tired and achy. At about 4 pm I took another dose of ibuprofen as I started to feel feverish again.  By the morning of Nov 1 I was feeling back to normal.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: EXCESSIVE CRYING 4-5 HOURS AFTER VACCINATIONS WITH FEVER (100 DEGREE), REDNESS AND SWOLLEN AT INJECTION SITE.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: left arm pain persistent 3 weeks after vaccine given
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: patient reports a rash on her arms and upper torso
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: student presented to center with red, swollen , painful right deltoid at site of injection about 2cm or more in diameter
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Within the same week as receiving the PNEUMOVAX 23 the patient experienced cellulitis; This initial spontaneous report was received from a pharmacist, referring to a 66-year-old female patient. Her pertinent medical history included hypertension and diabetes mellitus. Her concomitant therapies included unspecified medications as treatment for hypertension and diabetes. The patient's historical conditions were not reported. The patient had no, previous drug reactions or allergies.  On 10-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered intramuscularly (dose/frequency reported as 25mcg/5.5ml) , lot number R018735 expiration date 06-APR-2020, as prophylaxis (reported as "routine") (anatomical injection site was not reported).         Afterwards, on an unspecified day in September 2019 (also reported as "within the same week as receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)") the patient experienced cellulitis. It was reported that 2 days after the cellulitis appeared, the patient sought medical attention, went to a walk-in clinic and was prescribed cephalexin 500mg and prednisone 5mg, as treatment for the event. No laboratory diagnostics or studies were performed to the patient.  On an unspecified date in 2019, the patient fully recovered from the event of cellulitis.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and cellulitis occurrence was not provided.  It was reported that cellulitis was not a disabling, life-threatening, cancer or overdose event. The patient did not required hospitalization due to this event. Upon internal review, the event of cellulitis was determined to be medically significant.  By request of the reporting pharmacist, an investigation was started for the reported lot number.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Product supply issue
Clinical narrative: Inappropriate schedule of vaccine; A little sore at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose 1 year before the date of reporting and experienced influenza like ilness and felt unwell,refer case US2019AMR192685).   On 23rd October 2019, the patient received the 2nd dose of Shingrix. On 23rd October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information received were as follows: The patient experienced injection site soreness after receiving Shingrix. Because of shortages the patient received his second dose late.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Injection site haemorrhage
Clinical narrative: Bleed a little on arm after injection; Unsure if complete dose received; Vaccine ran down arm of patient; Exposure via skin contact; This case was reported by a nurse via call center representative and described the occurrence of injection site hemorrhage in a 56-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 97S5T, expiry date 30th June 2020) for prophylaxis.   On 22nd October 2019, the patient received FluLaval Tetra 2019-2020 season. On 22nd October 2019, immediately after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site hemorrhage, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site hemorrhage, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The registered nurse called in to question that any information or recommendations when Flulaval vaccine ran down arm of patient. The healthcare professional was unsure if complete dose received because a small amount of vaccine seen running down patient's arm after Flulaval administration, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The healthcare professional stated that the patient did bleed a little on arm after injection. The adverse event was collected.  The reporter did not consent to follow-up.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Nausea, Pruritus, Rash
Clinical narrative: outbreaks that presented at alternating parts of her bodies, more often at the join; Itchy; nauseous; Rash; Injection site erythema; Heat below the injection site; Swelling (approximately a 4-5 inch width); This case was reported by a consumer via call center representative and described the occurrence of rash in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Benadryl for antihistamine therapy.   Previously administered products included BENADRYL with an associated reaction of nausea (She described that she has a known problem with taking Bendaryl her whole life - it has caused her to be nauseous when she as used it before prior to receiving vaccine.).   On 4th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th October 2019, the patient started Benadryl at an unknown dose and frequency. On 6th October 2019, 2 days after receiving Shingrix, the patient experienced rash, erythema of extremities, skin warm, extensive swelling of vaccinated limb, vesicular rash and itchy. In October 2019, the patient experienced nausea. The patient was treated with hydrocortisone. On an unknown date, the outcome of the rash, erythema of extremities, skin warm, extensive swelling of vaccinated limb and vesicular rash were resolved with sequelae and the outcome of the itchy and nausea were recovered/resolved.   It was unknown if the reporter considered the rash, erythema of extremities, skin warm, extensive swelling of vaccinated limb, vesicular rash, itchy and nausea to be related to Shingrix.  Additional details were received as follows: The patient two days after receiving the first dose of the Shingrix vaccine developed a rash, swellling, redness, and heat below the injection site. The area affected had approximately a 4-5 inch width.   The patient went to her physician the next day and was prescribed an antihistamine and hydrocortisone. The patient stated that she took Benadrayl as the antihistamine and it causes her to get nauseous and she threw up once. The patient also began to experience outbreaks that presented at alternating parts of her bodies, more often at the joints (ankles, knees, wrists, and elbows) but also on the tops of her hands, and her buttocks, too. The outbreaks was presenting as a red area with a pox in the middle and it is itchy. The have decreased in frequency and severity and she has not had any outbreaks. The patient consented to follow up. The patient gave permission for her physician to be contacted. The patient did not have the lot number for the Benadryl and indicated that it could have been the generic, diphenhydramine. The patient said that she only took one capsule daily when she took it.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin warm
Clinical narrative: outbreaks that presented at alternating parts of her bodies, more often at the join; Itchy; nauseous; Rash; Injection site erythema; Heat below the injection site; Swelling (approximately a 4-5 inch width); This case was reported by a consumer via call center representative and described the occurrence of rash in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Benadryl for antihistamine therapy.   Previously administered products included BENADRYL with an associated reaction of nausea (She described that she has a known problem with taking Bendaryl her whole life - it has caused her to be nauseous when she as used it before prior to receiving vaccine.).   On 4th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th October 2019, the patient started Benadryl at an unknown dose and frequency. On 6th October 2019, 2 days after receiving Shingrix, the patient experienced rash, erythema of extremities, skin warm, extensive swelling of vaccinated limb, vesicular rash and itchy. In October 2019, the patient experienced nausea. The patient was treated with hydrocortisone. On an unknown date, the outcome of the rash, erythema of extremities, skin warm, extensive swelling of vaccinated limb and vesicular rash were resolved with sequelae and the outcome of the itchy and nausea were recovered/resolved.   It was unknown if the reporter considered the rash, erythema of extremities, skin warm, extensive swelling of vaccinated limb, vesicular rash, itchy and nausea to be related to Shingrix.  Additional details were received as follows: The patient two days after receiving the first dose of the Shingrix vaccine developed a rash, swellling, redness, and heat below the injection site. The area affected had approximately a 4-5 inch width.   The patient went to her physician the next day and was prescribed an antihistamine and hydrocortisone. The patient stated that she took Benadrayl as the antihistamine and it causes her to get nauseous and she threw up once. The patient also began to experience outbreaks that presented at alternating parts of her bodies, more often at the joints (ankles, knees, wrists, and elbows) but also on the tops of her hands, and her buttocks, too. The outbreaks was presenting as a red area with a pox in the middle and it is itchy. The have decreased in frequency and severity and she has not had any outbreaks. The patient consented to follow up. The patient gave permission for her physician to be contacted. The patient did not have the lot number for the Benadryl and indicated that it could have been the generic, diphenhydramine. The patient said that she only took one capsule daily when she took it.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Muscle pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 28th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The pharmacist reported that the patient was continue to have muscle pain at the injection site of Shingrix vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: achy; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2019, the patient received Shingrix. On 12th October 2019, 1 days after receiving Shingrix, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain was resolved with sequelae and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's daughter. The reporter stated that, the patient felt achy and tired the day after the injection. The patient stayed in her pajamas all day and rested. The next day she felt much better. The reporter did not consent to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Contusion
Clinical narrative: bruise in left arm above elbow; This is a spontaneous report from a non-contactable pharmacist.   A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), on 02Oct2019, at single dose, for immunization. Relevant medical history was unknown. Concomitant medication included influenza vaccine, received on an unspecified date, in 2019, for immunization. On an unspecified date, in 2019, the patient experienced bruise in left arm. It was specified that the patient an influenza shot in left arm, and on 02Oct2019 received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) in right arm. Has a large bruise in left arm above elbow.   No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Borrelia test negative, Computerised tomogram normal, Dizziness, Dysgeusia, Headache
Clinical narrative: About 30 min after receiving shot, she called and reported symptoms of bilateral facial tingling, numbness in upper teeth and lip, and metallic taste in her mouth. I asked her to report back to my office and she was there almost immediately. As I was questioning her, the symptoms persisted and as I was about to check vitals, she stated she felt like she was "going to pass out." She sat for another minute or two and was able to walk assisted by me to the ER. Once in the ER vitals were stable and symptoms of facial tingling, and numbness in teeth and upper lip persisted, and she developed an headache. An IV was started and she was then given IV steroid, The Dr. verbalized was not concerned about analphylactic reaction. She was monitored and then released to home after a few hours of monitoring. The next day she reported new symptoms of delayed speech, which was evident when I saw her in person. She came to work and I took her to the ED to be evaluated once again. She had CT scan and was tested for Lyme Disease. CT was negative and Lyme test was unequivocal. She followed up with provider the next day (10/3). Symptoms of delayed speech persisted, and she was referred to neuro. 10/4 she had MRI and neurologist stated this was all due to Lyme and not related to Flu shot. Follow-up with PCP the following week it was revealed to patient she did not have Lyme, and symptoms were due to flu shot. It remains under investigation by Agency to determine if this was caused by flu shot or reaction to something else.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Magnetic resonance imaging, Paraesthesia, Speech disorder
Clinical narrative: About 30 min after receiving shot, she called and reported symptoms of bilateral facial tingling, numbness in upper teeth and lip, and metallic taste in her mouth. I asked her to report back to my office and she was there almost immediately. As I was questioning her, the symptoms persisted and as I was about to check vitals, she stated she felt like she was "going to pass out." She sat for another minute or two and was able to walk assisted by me to the ER. Once in the ER vitals were stable and symptoms of facial tingling, and numbness in teeth and upper lip persisted, and she developed an headache. An IV was started and she was then given IV steroid, The Dr. verbalized was not concerned about analphylactic reaction. She was monitored and then released to home after a few hours of monitoring. The next day she reported new symptoms of delayed speech, which was evident when I saw her in person. She came to work and I took her to the ED to be evaluated once again. She had CT scan and was tested for Lyme Disease. CT was negative and Lyme test was unequivocal. She followed up with provider the next day (10/3). Symptoms of delayed speech persisted, and she was referred to neuro. 10/4 she had MRI and neurologist stated this was all due to Lyme and not related to Flu shot. Follow-up with PCP the following week it was revealed to patient she did not have Lyme, and symptoms were due to flu shot. It remains under investigation by Agency to determine if this was caused by flu shot or reaction to something else.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: Client presented for flu vaccination and was vaccinated without incident. No history of problems after a vaccine in the past. Immediately after being vaccinated she became very pale and complained of being lightheaded.  No rash, no hives or difficulty breathing. BP 80/50; HR 60. Cool compress given and orange juice to drink.  School nurse was brought in to sit with client and observe her. 10 minutes later BP repeated and was same at 80/50 and color had improved and client reported feeling better. Client was released to the care of her mother with instructions to seek medical help if symptoms reoccurred or worsened. Nurse also recommended client be vaccinated in the future at her family doctor.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Musculoskeletal disorder, Myalgia, Pain
Clinical narrative: Great pain began almost immediately and the arm became useless. Swollen, red, hot. The shoulder and back muscles ached. , Painful to even touch.. Can't use the arm. This is day 2, so symptoms remain.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Great pain began almost immediately and the arm became useless. Swollen, red, hot. The shoulder and back muscles ached. , Painful to even touch.. Can't use the arm. This is day 2, so symptoms remain.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Wife reported, described no pain at time of injection friday morning (10/25/19).  Pain started in both shoulders Sunday evening (10/27/19) and continued into Monday.  Right shoulder pain resolved Monday, but left shoulder pain continued into Tuesday.  Family went to ER to rule out cardiac issues, ER MD diagnosed shoulder impingement & prescribed Ibuprofen & hot/cold packs.  As of 10/31/19 wife reports patient continues to have severe left shoulder pain, can not lift left shoulder and can not sleep on it. She came to the pharmacy 10/31/19 to report and ask for advice. Recommended patient follow up with PCP for next steps
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Fatigue, Poor quality sleep
Clinical narrative: Starting the evening of Sept 26th , several hours after receiving the vaccine,  I felt very tired and totally out of energy.  Slept very restless that night .  The following two days I developed a low grade fever, had diarrhea  and stomach  cramps .  The symptoms finally went away on the 3rd day.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Starting the evening of Sept 26th , several hours after receiving the vaccine,  I felt very tired and totally out of energy.  Slept very restless that night .  The following two days I developed a low grade fever, had diarrhea  and stomach  cramps .  The symptoms finally went away on the 3rd day.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: Patient received vaccination with high doe flu shot and Pneumovax23 today in the morning, patient completed the rest of his tasks for the day, then about 1800 patient started to develop a high fever (unknown exact temp) and shaking chills, this proceeded through the night and patient stated he had such shaking chills and high fever through the night that he almost called an ambulance, patient went to work this morning and still has a fever and is tired but will monitor and call if symptoms worsen again.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Facial paralysis, Headache
Clinical narrative: Started out with a sever headache early in the morning on October 18,2019 by approximately 1030am my right side of my  face became numb, along with my tongue which affected my speech.  I then developed facial drooping . I went to the ER thought I was having a stroke.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Speech disorder
Clinical narrative: Started out with a sever headache early in the morning on October 18,2019 by approximately 1030am my right side of my  face became numb, along with my tongue which affected my speech.  I then developed facial drooping . I went to the ER thought I was having a stroke.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Musculoskeletal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, aching body, sore arm and shoulder
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: soreness and achiness in left upper arm on the posterior and medial aspects, not in the injection site.  Over the next few days pain increased and reduced ROM in left arm (could not raise arm much above shoulder level).  Physician exam on 10/31 demonstrated some soft tissue swelling in the posterior left upper arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: red bump/hard spot near injection site/hot spot
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vulvovaginal mycotic infection
Clinical narrative: Vaginal yeast infection; Soreness in my arm for a few days; This case was reported by a other health professional via interactive digital media and described the occurrence of vaginal yeast infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced vaginal yeast infection and pain in arm. On an unknown date, the outcome of the vaginal yeast infection was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the vaginal yeast infection and pain in arm to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received Shingrix a week before the date of reporting. The patient had the soreness in her arm for a few days but it was gone away.  Now she was experiencing symptoms of vaginal yeast infection for a few days. The patient asked if there were any chance the Shingrix shot could have triggered this or was just a coincidence.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; shingle out break; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provide as follows: The age at vaccination was not reported. The patient had another shingle out break. The patient wanted to know the shingle out break was normal or not. This case was considered as suspected vaccination failure as details regarding time to onset for target disease, and laboratory confirmation were unknown at the time of reporting.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Baseball size rash across R arm; Redness with purple center; Warm to touch; Red line at bottom of Rash; Pain when pressed; Nausea; Fever for two days; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number EE924, expiry date 29th January 2022) for prophylaxis.   On 18th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced rash, skin discolouration, skin warm, red rash, pain, fever and nausea. On an unknown date, the outcome of the rash, skin discolouration, skin warm, red rash, pain and nausea were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the rash, skin discolouration, skin warm, red rash, pain, fever and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy student. The patient received shingrix on the right arm. The patient experienced baseball size rash with purple center around injection site which was increased daily and that extends across the right arm. At the bottom of the rash, there was a red line. Warm to touch and pain when pressed. Fever lasted for 2 days. The reporter did not consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Skin warm
Clinical narrative: Baseball size rash across R arm; Redness with purple center; Warm to touch; Red line at bottom of Rash; Pain when pressed; Nausea; Fever for two days; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number EE924, expiry date 29th January 2022) for prophylaxis.   On 18th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced rash, skin discolouration, skin warm, red rash, pain, fever and nausea. On an unknown date, the outcome of the rash, skin discolouration, skin warm, red rash, pain and nausea were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the rash, skin discolouration, skin warm, red rash, pain, fever and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy student. The patient received shingrix on the right arm. The patient experienced baseball size rash with purple center around injection site which was increased daily and that extends across the right arm. At the bottom of the rash, there was a red line. Warm to touch and pain when pressed. Fever lasted for 2 days. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a other health professional via call center representative and described the occurrence of headache in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th 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 headache. On an unknown date, the outcome of the headache was recovered/resolved.   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, but it could be 55 or 56 years. The reporter stated that the patient had severe headache for 7 days after the first dose of Shingrix. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Arm Swelling; Decreased Mobility; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 23rd September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 7 days after receiving Shingrix, the patient experienced swelling arm (serious criteria hospitalization) and mobility decreased (serious criteria hospitalization). The patient was treated with non-drug therapy (Physiotherapy). On an unknown date, the outcome of the swelling arm and mobility decreased were unknown.   It was unknown if the reporter considered the swelling arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose Shingrix in right deltoid, and at an unknown time frame following vaccination the patient's arm became swollen and locked up with decreased mobility.  The patient reported to have been hospitalized approximately 1 week following vaccination for 5 days. The patient was undergoing physical therapy.
Sex: F
Vaccine: PNC13
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: Pneumonia vaccine (Both varieties)/ Neither vaccine prevented my contracting the disease; Pneumonia vaccine (Both varieties)/ Neither vaccine prevented my contracting the disease; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received pneumonia vaccines (both varieties) and neither vaccine prevented her from contracting the disease on an unspecified date. The outcome of the event was unknown. The reporter stated that the event might have been related to the drug.  Information on the batch number has been requested.