chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: knot at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RR52, expiry date 7th December 2021) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 20th August 2019, less than a day after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist reporting that the patient experienced a knot at the site of the injection about the size of a dime and had not resolved.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Orange sized hot, painful, red, and hard injection site; Injection site hot; Injection site painful; Injection site hard; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 227FL, expiry date 26th November 2021) for prophylaxis.   On 14th September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th September 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site pain and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site pain and injection site induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site pain and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, after vaccination with dose of Shingrix, the patient had orange sized hot, painful, red, and hard injection site. The reporter consented to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Erythema of eyelid, Herpes zoster, Injection site pruritus, Ocular hyperaemia
Clinical narrative: Shingles; Redness with itching all over her body / redness of her face, eyes, eyelids, inside of her thumbs, right side torso; Itching all over her body / Itching at right ankle, back of right leg, upper back, and it may have come around to her front shoulder blade area, and right side torso; Rash on upper back and shoulder blade; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2018, the patient received the 1st dose of Shingrix (intramuscular). On 31st July 2018, 10 days after receiving Shingrix, the patient experienced shingles, generalized erythema, generalized pruritus and rash. The patient was treated with cetirizine hydrochloride (Cetrizine). Shingrix was discontinued. On an unknown date, the outcome of the shingles was unknown and the outcome of the generalized erythema, generalized pruritus and rash were resolved with sequelae.   The reporter considered the shingles, generalized erythema, generalized pruritus and rash to be related to Shingrix.  Additional details were provided as follows: The patient stated that had redness with itching all over her body. The patient specifically mentioned redness of her face, eyes, eyelids, inside of her thumbs, right side torso. The patient also mention itching at injection site, right ankle, back of right leg, upper back, and it may have come around to her front shoulder blade area, and right side torso. The patient also had rash on upper back and shoulder blade. The patient had not received the second dose of shingrix because her healthcare professional told her she is not a candidate for the second dose due to the reaction she experienced with the first dose. The patient had 2 outbreaks of shingles after receiving the first dose. The patient did not consent to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Shingles; Redness with itching all over her body / redness of her face, eyes, eyelids, inside of her thumbs, right side torso; Itching all over her body / Itching at right ankle, back of right leg, upper back, and it may have come around to her front shoulder blade area, and right side torso; Rash on upper back and shoulder blade; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2018, the patient received the 1st dose of Shingrix (intramuscular). On 31st July 2018, 10 days after receiving Shingrix, the patient experienced shingles, generalized erythema, generalized pruritus and rash. The patient was treated with cetirizine hydrochloride (Cetrizine). Shingrix was discontinued. On an unknown date, the outcome of the shingles was unknown and the outcome of the generalized erythema, generalized pruritus and rash were resolved with sequelae.   The reporter considered the shingles, generalized erythema, generalized pruritus and rash to be related to Shingrix.  Additional details were provided as follows: The patient stated that had redness with itching all over her body. The patient specifically mentioned redness of her face, eyes, eyelids, inside of her thumbs, right side torso. The patient also mention itching at injection site, right ankle, back of right leg, upper back, and it may have come around to her front shoulder blade area, and right side torso. The patient also had rash on upper back and shoulder blade. The patient had not received the second dose of shingrix because her healthcare professional told her she is not a candidate for the second dose due to the reaction she experienced with the first dose. The patient had 2 outbreaks of shingles after receiving the first dose. The patient did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but as per indication of the vaccine the age group was captured as adult. The patient received Shingrix and developed cellulitis at the injection site. No patient information was provided.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site mass, Malaise, Pain
Clinical narrative: Headache; Was achy; Lump on her arm at the injection site; Not feeling well /  feeling awfully sick; She was tired / She feels exhausted; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 2nd dose of Shingrix. On 17th September 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell and tiredness. On 18th September 2019, the patient experienced headache, pain and injection site lump. On an unknown date, the outcome of the feeling unwell, tiredness, headache, pain and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, tiredness, headache, pain and injection site lump to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm.  The patient received her second dose of Shingrix, on day before reporting and last night she was not feeling well and she was tired and she felt exhausted.  The patient described her experience as feeling awfully sick on day of reporting. The patient went to bed at 8:30 PM and she awake with a headache and was achy.  The patient also reported a lump on her arm at the injection site. The reporter consented to follow up. In the XML document outcome of events was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: injection site redness; Whelps; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax.   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 injection site erythema, injection site wheal and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site wheal and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site wheal and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness, whelps and swelling at the injection site of her first dose.  The patient could not recall the date of the initial dose, but she added she never had issues with the Zostavax. The reporter consented to follow up. The case has been linked with the case US2019AMR170622, reported for the dose 2 of the same patient.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose increased, Malaise
Clinical narrative: Sugar starting spiking and overnight it got up into the 500s; Not feel well; This case was reported by a nurse via call center representative and described the occurrence of blood sugar increased in a 46-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 9579P, expiry date 30th June 2020) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 17th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. In September 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced feeling unwell. On 17th September 2019, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was not recovered/not resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the blood sugar increased and feeling unwell to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The employee health nurse on the line with a type I diabetic employee who received a dose of FluLaval, pre-filled syringe, a day before reporting date. By 7:00 pm, less than a day after receiving Shingrix, the patient's sugar starting spiking and overnight it got up into the 500s (his monitor can not monitor levels higher than what it reached). The employee took 12 extra units of insulin, which brought their glucose into range, but it was wearing off this morning and his glucose was now back into the 300s and the employee does not felt well The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Contusion
Clinical narrative: Pain after injection in underarm; Bruising; This case was reported by a physician via call center representative and described the occurrence of axillary pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced axillary pain and contusion. On an unknown date, the outcome of the axillary pain and contusion were unknown.   It was unknown if the reporter considered the axillary pain and contusion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter sated that, the patient had bruising and pain after injection in underarm.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Headache; Hurt; Fever; Nausea; Joint Pain; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2019, the patient received Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced headache, pain in arm, fever, nausea and joint pain. On an unknown date, the outcome of the headache, pain in arm, fever, nausea and joint pain were recovered/resolved.   It was unknown if the reporter considered the headache, pain in arm, fever, nausea and joint pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received the Shingrix vaccine and the night after receiving the vaccine he began to experience a severe headache, arm hurt, nausea, fever, and joint pain.  These symptoms resolved after 1 to 2 days. The patient gave consent to contact the physician and provided contact details for the same. The case has been linked to the case US2019170041, reported by same reporter. There was discrepancy in the outcome of the events, in the source document outcome was reported as recovered/ resolved with sequel and in the narrative outcome reported as recovered/resolved.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Blister, Burning sensation, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: aching lymph nodes; burning sensation inside of body; blisters all over right side of body; swollen lymph nodes; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 34-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included factor v leiden mutation.   On 4th September 2019, the patient received the 1st dose of Boostrix (intramuscular). On 4th September 2019, less than a day after receiving Boostrix, the patient experienced injection site swelling. On 9th September 2019, the patient experienced blister, enlargement of lymph nodes, lymph node pain and burning sensation. On 9th September 2019, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the blister, enlargement of lymph nodes, lymph node pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, blister, enlargement of lymph nodes, lymph node pain and burning sensation to be related to Boostrix.  Additional details were provided as follows: The patient received a dose of Boostrix in the right arm. On 9th September 2019, 5 days after receiving a dose of Boostirx the patient experienced blister, enlargement of lymph nodes, lymph node pain and burning sensation. The patient planned to continue follow-up with his physician on an unknown date. The reporter consented to follow up. The case was linked with the case US2019170062, reported by same reporter. There was discrepancy in the outcome of the events blister, enlargement of lymph nodes, lymph node pain and burning sensation, in the source document outcome was reported as recovering/ resolving and in the database outcome reported as not recovered/not resolved.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: shivers; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ethanol (Alcoholic Beverage) for an unknown indication.   Concurrent medical conditions included weight loss diet.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Alcoholic Beverage at an unknown dose and frequency. In September 2019, less than a day after receiving Shingrix, the patient experienced shivers. On an unknown date, the outcome of the shivers was not recovered/not resolved.   It was unknown if the reporter considered the shivers to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The reporter's wife received dose 1 of Shingrix and later had some alcohol beverages. The reporter stated that the patient had been in bed since last night shivering. The reporter did not consent to follow-up. The reporter did not have vaccine information. The reporter declined HCP follow up and declined to provide any further information. It was unknown if the reporter considered the shivers to be related to Alcoholic Beverage.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: headache; sore throat; swollen lymph nodes; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received Shingrix (intramuscular). On 11th September 2019, 1 days after receiving Shingrix, the patient experienced headache, sore throat and lymphadenopathy cervical. On an unknown date, the outcome of the headache, sore throat and lymphadenopathy cervical were unknown.   It was unknown if the reporter considered the headache, sore throat and lymphadenopathy cervical to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient experienced headache, sore throat, and swollen lymph nodes on the neck. The patient was seen by her physician who noted the swelling was unremarkable. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Lymphadenopathy, Myalgia, Oropharyngeal pain, Ultrasound scan abnormal
Clinical narrative: headache; sore throat; swollen lymph nodes; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received Shingrix (intramuscular). On 11th September 2019, 1 days after receiving Shingrix, the patient experienced headache, sore throat and lymphadenopathy cervical. On an unknown date, the outcome of the headache, sore throat and lymphadenopathy cervical were unknown.   It was unknown if the reporter considered the headache, sore throat and lymphadenopathy cervical to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient experienced headache, sore throat, and swollen lymph nodes on the neck. The patient was seen by her physician who noted the swelling was unremarkable. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: rash; itchy rash; bump; soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number J225D, expiry date 22nd October 2021) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced pain. On 18th September 2019, the patient experienced red rash, itchy rash and local swelling. On an unknown date, the outcome of the pain, red rash, itchy rash and local swelling were unknown.   It was unknown if the reporter considered the pain, red rash, itchy rash and local swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced soreness after receiving the first Shingrix vaccination.  The patient also experienced  red, bumpy and itchy rash. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus, Scratch, Skin haemorrhage
Clinical narrative: Itching; This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th August 2019, 2 days after receiving Shingrix, the patient experienced itchy upper limbs. The patient was treated with hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the itchy upper limbs was unknown.   It was unknown if the reporter considered the itchy upper limbs to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced itching on the front of the right arm closer to her shoulder. On the reporting date, the patient's left arm had started to itch closer to her shoulder.  The itching felt like stabbing 2 inches deep into the skin.  The itching was like poison oak and felt like a lightning bolt. Due to increased scratching, the patient had started tobleed.  The patient had used hydrocortisone cream and it did not help.  The patient had applied band aid over her area where she was bleeding.  The reporter did not consent to follow-up.  No further details were provided.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache; Nausea; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 7 days after receiving Shingrix, the patient experienced fever, headache and nausea. On an unknown date, the outcome of the fever, headache and nausea were recovered/resolved.   It was unknown if the reporter considered the fever, headache and nausea to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The reporter unsure if vaccine administered intramuscularly, the volume, and lot number, expiry date of vaccine. The patient complains of 103 degree Fahrenheit fever that developed a week later that lasted approximately 5 days.  The reporter also reported less than 2 weeks after vaccination headache and nausea. The patient not considering for receiving 2nd dose. The reporter consented to follow up.
Sex: U
Vaccine: UNK
Symptoms: Exposure via breast milk
Clinical narrative: drug exposure via breast milk; This case was reported by a nurse via call center representative and described the occurrence of drug exposure via breast milk in a 2-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number 99CA4, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2019-2020 season. On an unknown date, unknown after receiving Fluarix Tetra 2019-2020 season, the patient experienced drug exposure via breast milk. On an unknown date, the outcome of the drug exposure via breast milk was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient demographic details were not provided. The nurse reported that, the Fluarix vaccine was administered to the patient who was breastfeeding to child. The reporter provided the details of the patients' monther who was breastfeeding to child.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: flu symptoms; This case was reported by a physician via sales rep and described the occurrence of flu symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was unknown.   It was unknown if the reporter considered the flu symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported via request that the patient had Shingrix vaccine and experienced flu symptoms. The reporter consented to follow up. Other details were not provided.  It was unknown if the reporter filed an adverse event based on physician's request.
Age: 71.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Shingles rash on his back; Shingles rash on his back; Pain; Itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HIGH DOSE) for prophylaxis.   Previously experienced adverse reactions included shingles (30 years ago).   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received FLUZONE HIGH DOSE (intramuscular). In September 2019, couple of days after receiving Shingrix, the patient experienced shingles, rash, pain and pruritus. On an unknown date, the outcome of the shingles, rash, pain and pruritus were unknown.   It was unknown if the reporter considered the shingles, rash, pain and pruritus to be related to Shingrix.  Additional information received were as follows: The caller was wife of the patient, and patient also came on the line to provide information for the report. A couple days after receiving Shingrix, the patient experienced shingles rash on his back with associated pain and itching. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Rash, Rash pruritic, Swelling, Urticaria
Clinical narrative: swelling; rash "moved and he felt it move from shoulder to stomach to legs; generalized rash / rash "moved and he felt it move from shoulder to stomach to legs; extremely itchy; pain in bone; hives; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced generalized rash, itchy rash, bone pain, hives, swelling and rash. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the generalized rash and rash were recovered/resolved and the outcome of the itchy rash, bone pain, hives and swelling were unknown.   It was unknown if the reporter considered the generalized rash, itchy rash, bone pain, hives, swelling and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced generalised rash, for about 5 days after vaccination. The patient was treated with over the counter calamine lotion. The reporter stated that, the rash was extremaly itchy, and moved from shoulder to stomach to legs and had pain all over through the bone. The pharmacist stated that, the pain, hives and swelling lasted for 4 days. The patient was seen in his physician's office, but the rash was resolved by the time he had his appointment.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Gait inability, Pain in extremity, Plantar fasciitis
Clinical narrative: Discomfort; couldn't walk; Plantar fasciitis; sore arm / foot pain; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, immediately after receiving Shingrix, the patient experienced pain in extremity. On 15th September 2019, the patient experienced discomfort, unable to walk and plantar fasciitis. On an unknown date, the outcome of the pain in extremity, discomfort and unable to walk were recovered/resolved and the outcome of the plantar fasciitis was unknown.   It was unknown if the reporter considered the pain in extremity, discomfort, unable to walk and plantar fasciitis to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient's arm was sore right after the injection.  Two days later, on 15th September 2019, the patient woke up with discomfort in the instep of his right foot. By the end of the day his foot was so painful that he couldn't walk on it.  The patient started off it for a couple days and the pain resolved.  The patient stated it felt like plantar fasciitis, which he has never had before. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: muscle aches; headache; weakness; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 61-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   On 4th September 2019, the patient received the 4th dose of RabAvert. In September 2019, less than 3 weeks after receiving RabAvert, the patient experienced muscle pain, headache, weakness and fatigue. On an unknown date, the outcome of the muscle pain, headache, weakness and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, headache, weakness and fatigue to be related to RabAvert.  Additional information received were as follows: It was unknown, whether the patient received RabAvert for preexposure or post exposure prophylaxis. The patient experienced muscle aches, headache, weakness and fatigue. The symptoms improved for a time and on the reporting date, the patient had them again.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Gastrointestinal disorder, Injection site swelling, Pyrexia
Clinical narrative: Fever; Chills; Swelling; GI symptoms; This case was reported by a physician via call center representative and described the occurrence of fever in an unspecified number 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 fever, chills, injection site swelling and gastrointestinal symptom nos. On an unknown date, the outcome of the fever, chills, injection site swelling and gastrointestinal symptom nos were unknown.   It was unknown if the reporter considered the fever, chills, injection site swelling and gastrointestinal symptom nos to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not applicable for this report. The physician reported side effects for approximately 30 percent of his patients seen over several clinics. After receiving Shingrix, the patient complain of fever, chills swelling at injection site and gastrointestinal symptoms. The reporter consented to follow up. The doctor stated that he believes it is 30 percent of 30 patient administered the vaccine which were approximately 9 patients. No specific data was given at the time of call.
Age: 28.0
Sex: M
Vaccine: FLUR4
Symptoms: Pruritus, Rash, Throat irritation, Urticaria
Clinical narrative: 30 MINUTES after receiving flu vaccine he had hives to arms, neck,face, itching, and slight itchy feeling to his throat. No SOB/chest pain or nausea/vomitting. He works in ED so he was seen there. received 1 liter normal saline IV fluids. 1 gram of tylenol, benadryl 50mg IV push. Pepcid 20mg IV push. solumedrol 125mg IV push. Had improvement of rash/itchiness and was released home with. Rx for benadryl/prednisone/H2 blocker.   Was re-evaluated by me the following morning, and had not filled Rx. Still with multi form wheels to arms with itching. NO angioedema, respiratory sx, No nausea vomiting. Reinforced the importance of continuing RX for sx resolution. Has appointment followup scheduled on 9/30/19.  Patient notes that last year he received the flu blok on 10/10/18 without any issues. Previous 10/10/2017 regular influenza IIV vaccine he also experienced hives.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme pain at injection site at time of injection. Within 2 hours vomiting and flu-like symptoms, swelling, redness at injection site.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medication Error:  Incorrectly given to a 57 year old.  No treatment, symptoms from patient currently.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Medication Error:  Incorrectly given to a 57 year old.  No treatment, symptoms from patient currently.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Medication Error:  Incorrectly given to a 57 year old.  No treatment, symptoms from patient currently.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash stomach, back
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient called pharmacy to report having a slight fever (100.2) the night she received the vaccine (9/25/19) and injection site swelling as well as redness of her entire arm from shoulder down to elbow that presented 9/25/19 in the left arm (the arm in which she received Shingrix). The redness got progressively worse that day, and has subsided and appears to be resolving today (9/27).  She works in a facility with a nurse available who evaluated her and advised her to contact us so that we could report reaction.  She'd had several shots before but never had a reaction.  We called her PCP to advise as well, though the patient didn't think that was necessary.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Influenza like illness
Clinical narrative: Flu-like illness for 72 hours, followed by extreme weakness and dizziness. Latter has not gone away six weeks later.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: Patient started having chills around 6:30pm, approx 4 hours after receiving vaccine. She had a fever, aches, headache, and was very cold. Patient recovered within one day.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: patient called on 9/27/19 stating she received the flu vaccine on 9/12/19 and that now her arm is sore. In the patient profile it shows that shingrix was administered on that date and no flu vaccine was received. The form filled out by the patient has the vaccine you would like to receive today area blank. I explained to the patient that she received the shingrix vaccine according to our records and that pain at the injection would be normal for the shingrix vaccine. She reiterated that she thought the vaccine was the flu shot. I also informed her that she was due for the shingrix and that now that she has had the first on she would be due for the booster in 2 months.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Neurological examination normal, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Neuro exam non focal. Etiology unclear however low concern for a demyelinating polyneuropathy, myopathy, or other acute CNS process at this point. UA positive for UTI which could be contributing
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Arm numbness that progressed to numbness in fingers and legs (intermittent, tingling); headache and light-headedness. Pt was recommended to f/u with neurology. Still at home recuperating
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye discharge, Headache, Pain, Periorbital swelling
Clinical narrative: Had my shot at 11:33. By 4:00 pm. I was having difficulty breathing, swelling in my throat. I took an antihistamine. After awhile that went away. Then that night around 8. My skin around my eyes started puffing up. And a white then yellow mucus started in my eyes. Later that night I started to have a horrible headache. In the morning I called my Dr. I was told to take Alive, I did.  I was out of pain around 11 the next day.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal swelling
Clinical narrative: Had my shot at 11:33. By 4:00 pm. I was having difficulty breathing, swelling in my throat. I took an antihistamine. After awhile that went away. Then that night around 8. My skin around my eyes started puffing up. And a white then yellow mucus started in my eyes. Later that night I started to have a horrible headache. In the morning I called my Dr. I was told to take Alive, I did.  I was out of pain around 11 the next day.
Age: 39.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia, Muscle spasms, Peripheral swelling
Clinical narrative: Client reports that approx. 20 min after receiving the vaccine she developed muscle spasms in her right shoulder. Client states that her arm is now swollen and 3 of her right fingers are numb. States she was seen at Urgent Care and was told to massage and apply heat to right arm. In our phone conversation today client states blood clots run in her family and she is concerned. I advised patient to go to the ER.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Neck pain, Pain
Clinical narrative: He came back to the pharmacy around 10 minutes after the vaccine saying he had pain in his neck and lower back and down his sides (both). He said it came on slowly and got sharper. I offered to have him take a seat and called. I offered him an ambulance and/or to call his primary care doctor. As I was talking to him and others he said it was starting to subside. After about 30 minutes he said he felt pretty good and basically no pain any longer.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Tic
Clinical narrative: He had a new onset of tic starting 9 hours after vaccination. This required overnight admission to the hospital for evaluation for secondary causes of acute onset tic.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Cold sweat, Dyspnoea, Pain in extremity
Clinical narrative: Wife got her Fluzone HD shot first and then I gave her husband his Fluzone HD and his first Shingrix shot. Patient reported symptoms 10-15 minutes after receiving her Fluzone HD shot. Patient had some difficulty breathing, skin was clammy to touch, reported leg pain, back pain and chest pain. Before paramedics arrived she started feeling a little better with her leg pain and back pain. When husband notified of adverse event we contacted 911 immediately and asked paramedics to come to pharmacy to check patient. Patient's son arrived the same time paramedics came.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Patient reports chills and fever beginning a few hours after injection and continuing for 48 hours.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Redness around injection site, patient states are itches, she experienced a headache after injection
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Confusional state, Delirium, Malaise, Pyrexia
Clinical narrative: Wife called and reported patient sick in bed, weak, low grade fever,  acting confused and delirious.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient has red rash around neck area and feels reaction through out her body.  She had no adverse reaction to first injections.  They think possibly this is an allergic reaction to 2nd injection
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Feeling abnormal, Headache, Loss of personal independence in daily activities
Clinical narrative: Throat felt like I had something stuck in it, I couldn't gargle or drink it away. I called my sister who is a nurse and she said to take Benadryl.  I also had chills and some body aches. After taking the Benadryl I slept most of the night but woke a couple of times because of a migraine. I took 50mg Sumatriptan at 2 am and again at 6 am. The following day I felt poorly, could not eat much,  but the feeling in my throat was getting better so I just stayed home from work and rested. I still have a dull headache today, two days later. A little throat irritation, but easy to swallow.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Migraine, Pain, Sensation of foreign body, Throat irritation
Clinical narrative: Throat felt like I had something stuck in it, I couldn't gargle or drink it away. I called my sister who is a nurse and she said to take Benadryl.  I also had chills and some body aches. After taking the Benadryl I slept most of the night but woke a couple of times because of a migraine. I took 50mg Sumatriptan at 2 am and again at 6 am. The following day I felt poorly, could not eat much,  but the feeling in my throat was getting better so I just stayed home from work and rested. I still have a dull headache today, two days later. A little throat irritation, but easy to swallow.
Sex: M
Vaccine: MMR
Symptoms: Epilepsy, Febrile convulsion, Seizure
Clinical narrative: He developed febrile seizures / hospitalized many times at unspecified times due to seizures; Developed epilepsy at age of 4; This spontaneous report was received from a consumer (patient's mother) regarding a currently 5 years old male patient. Information on patient's current conditions, drug allergies/reactions were not reported.Concomitant medications included divalproex sodium (DEPAKOTE). On an unknown date, the patient was vaccinated with first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR), 1 regular injection, for prophylaxis (dose, route, lot# and expiry date was not reported).The consumer reported that the patient had received MMR (not  M-M-R II) vaccine around 12 to18 months of age. On an unknown date (reported as within 24 hours of vaccination), the patient developed febrile seizures (febrile convulsion). The consumer reported that her son had been hospitalized many times at unspecified hospitals at unspecified times due to seizures. On an unknown date (reported as at the age of 4), the patient developed epilepsy (also reported as pertinent medical history).The patient sought medical attention. The consumer stated that she was not anti-vaccine. She was against putting her son's life in danger. She also stated that she highly doubted her son would have had epilepsy if he had not gotten that first shot of MMR. The consumer stated that her son was up to date on all vaccines except MMR because he tolerated monovalent vaccines. The consumer wanted to speak to the person who made the decision to stop making MMR as a monovalent vaccine. There was no product quality complaint (PQC) was involved. The outcome of the event febrile seizures was reported as not recovered, however for epilepsy it was unknown.Causality of the events were not reported.   Upon internal review, the event febrile seizures and epilepsy were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Herpes zoster, Pneumonia, Skin lesion
Clinical narrative: pneumonia; COPD exacerbation; herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history and concomitant medications were not provided. Her concurrent condition included chronic obstructive pulmonary disease (COPD). In or around 28-MAY-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dosage, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving zoster vaccine live (ZOSTAVAX) (date unknown in 2017), the patient suffered from COPD exacerbation and pneumonia, which required hospitalization. Additionally, shortly after receiving zoster vaccine live (ZOSTAVAX) (date unknown in 2017), the patient also suffered from lesions and was diagnosed with herpes zoster.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the company wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   The events herpes zoster, COPD exacerbation and pneumonia were considered to be disabling. Upon internal review, the event pneumonia was determined to be medically significant.