chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: No adverse symtoms reported; "about a week later", the patient received a second dose of GARDASIL 9 in his foot; The patient received GARDASIL 9 by the recommendations of his dermatologist, received second dose one week after first dose,; A patient that was 61 years old received GARDASIL 9 by the recommendations of his dermatologist; This spontaneous report has been received from a medical assistant, concerning to a 61 year old male patient.      The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 26-SEP-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number, anatomical location and expiration date were not reported) as prophylaxis by recommedations of his dermatologist. The patient was 61-year--old when he was vaccinated (product administered to patient of inappropriate age).  On approximately 03-OCT-2019 (also reported as "about a week later"), the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number and expiration date not reported) in his foot (incorrect route of product administration and inappropriate schedule of product administration). No adverse symptoms reported.
Age: 82.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: shivering; This case was reported by a consumer via interactive digital media and described the occurrence of shivers in a 82-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shivers. On an unknown date, the outcome of the shivers was unknown.   It was unknown if the reporter considered the shivers to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had significant shivering in the night following the injection. The reporter wanted to know was it safe for her to receive 2nd dose of Shingrix.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect route of product administration, Injection site discomfort, Injection site erythema
Clinical narrative: Injection site redness; Injection site discomfort; Menveo vaccination that was administered subcutaneously instead of intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA153A, expiry date 31st March 2020) for prophylaxis.   On 18th October 2019, the patient received Menveo (subcutaneous). On 18th October 2019, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The nurse administered the Menveo vaccine subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up.   Follow up information was received from the nurse on 19th November 2019: The patient's demographic details were updated. On 18th October 2019 received DTPa (Reduced antigen) (Boostrix) via intramuscular on the left deltoid. The patient was very anxious and the nurse was giving the shots too quickly.   Less than week after vaccination, the patient experienced injection site erythema and injection site discomfort. The event were resolved. It was unknown if the reporter considered the injection site erythema and injection site discomfort to be related to Menveo and Boostrix. This case was considred as medication error with adverse event. The VAERS details were updated.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Erythema, Hypoaesthesia, Musculoskeletal pain, Myalgia
Clinical narrative: thumb numbness; thumb tingling; rash developing on the bicep, tricep, and shoulder; patch of redness on her elbow area; sore arm; pain in the pectoral area of the chest; bicep and tricep pain; shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cervical disc disease.   On 4th November 2019, the patient received the 1st dose of Shingrix. On 4th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, chest pain, muscle pain and shoulder pain. On 15th November 2019, the patient experienced numbness in fingers, tingling, rash and skin red. On an unknown date, the outcome of the pain in arm, chest pain, muscle pain, shoulder pain, numbness in fingers, tingling, rash and skin red were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chest pain, muscle pain, shoulder pain, numbness in fingers, tingling, rash and skin red to be related to Shingrix.  Additional details were provided as follows: The patient reports that she received dose of Shingrix and experienced a sore arm and soreness radiated to the bicep and tricep.  The patient is also reporting pain in the pectoral area of the chest. The patient has a history of cervical disk issues and the physician felt that the soreness was due to the cervical disks.  The patient, 4 days before the time of reporting,, reports a rash developing on the bicep, tricep, and shoulder, patch of redness and rash on her elbow area, about 4 inches down from the injection site.  The patient also reports numbness and tingling of the thumb.  This report will be cloned. The husband, patient one, is the reporter for himself and for patient 2, his wife. The follow up consent was not granted. This case has been linked with case US2019209364, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Rash, X-ray normal
Clinical narrative: thumb numbness; thumb tingling; rash developing on the bicep, tricep, and shoulder; patch of redness on her elbow area; sore arm; pain in the pectoral area of the chest; bicep and tricep pain; shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cervical disc disease.   On 4th November 2019, the patient received the 1st dose of Shingrix. On 4th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, chest pain, muscle pain and shoulder pain. On 15th November 2019, the patient experienced numbness in fingers, tingling, rash and skin red. On an unknown date, the outcome of the pain in arm, chest pain, muscle pain, shoulder pain, numbness in fingers, tingling, rash and skin red were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chest pain, muscle pain, shoulder pain, numbness in fingers, tingling, rash and skin red to be related to Shingrix.  Additional details were provided as follows: The patient reports that she received dose of Shingrix and experienced a sore arm and soreness radiated to the bicep and tricep.  The patient is also reporting pain in the pectoral area of the chest. The patient has a history of cervical disk issues and the physician felt that the soreness was due to the cervical disks.  The patient, 4 days before the time of reporting,, reports a rash developing on the bicep, tricep, and shoulder, patch of redness and rash on her elbow area, about 4 inches down from the injection site.  The patient also reports numbness and tingling of the thumb.  This report will be cloned. The husband, patient one, is the reporter for himself and for patient 2, his wife. The follow up consent was not granted. This case has been linked with case US2019209364, reported by same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: migraine headache; This case was reported by a other health professional via call center representative and described the occurrence of migraine headache in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number F9YH3, expiry date 7th December 2021) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2019, 1 days after receiving Shingrix, the patient experienced migraine headache. On an unknown date, the outcome of the migraine headache was unknown.   It was unknown if the reporter considered the migraine headache to be related to Shingrix.  Additional information was received as follows: One day later after receiving first dose of Shingrix, the patient experienced migraine headache.
Sex: M
Vaccine: UNK
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: Suspected vaccination failure; Type A flu; This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, less than 2 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced influenza a virus infection. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza a virus infection was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza a virus infection to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had type A flu. This case was considered as suspected vaccination failure as details regarding time to onset for the event was unknown at the time of reporting. Limited information was available. This is 1 of the 2 linked cases reported by the same reporter.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Flank pain, Herpes zoster
Clinical narrative: atypical shingles on right flank; redness on right flank; pain on right flank; tiredness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2019, 25 days after receiving Shingrix, the patient experienced shingles, localized erythema, flank pain and tiredness. On an unknown date, the outcome of the shingles, localized erythema, flank pain and tiredness were recovering/resolving.   It was unknown if the reporter considered the shingles, localized erythema, flank pain and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient reported for herself. The patient received Shingrix in her left arm. The patient went to the emergency room as advised by her physician on 6th November 2019. The patient planned to continue follow-up with her physician on an unknown date. The patient consented to follow up. There is discrepancy in the reported event outcome in XML file and narrative. However it was captured as per XML file.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix. On 26th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was received as follows: The patient experienced injection site pain which lasted for about 3 days and then resolved. The reporter did not consent to follow-up. This case is linked to the case US2019210496 by same reporter. The outcome of injection site pain as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequel.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza
Clinical narrative: like having the flu; feel horrible; This case was reported by a consumer via call center representative and described the occurrence of influenza in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza and feeling bad. On an unknown date, the outcome of the influenza and feeling bad were unknown.   It was unknown if the reporter considered the influenza and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and it made him feel horrible, like having the flu. The caller declined to provide more information for safety report. Limited details were provided.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain; This case was reported by a pharmacist via call center representative and described the occurrence of myalgia of lower extremities in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced myalgia of lower extremities. On an unknown date, the outcome of the myalgia of lower extremities was recovered/resolved.   It was unknown if the reporter considered the myalgia of lower extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced muscle pain in his legs. The reporting pharmacist would like to know if there are any issues with the patient getting the 2nd dose.  The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had shingles after the first dose of Shingrix was given on 28Aug2019; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient experienced shingles after the first dose of Shingrix. The reporter stated that she does not know how soon after receiving Shingrix the patient had shingles, but she could obtain this information from the patient upon follow up from safety. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection red,swollen,warm and sore
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: Temp of 102, nausea, red swollen site, ache in legs and arms
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, X-ray
Clinical narrative: - gradually worsening and disabling shoulder pain with most, even slight,  movements - motrin with some improvement - now 10 weeks out with continued severe pain and severe impairment
Age: 72.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Feeling cold
Clinical narrative: Dizziness and extremely cold began within 15 minutes and persisted for 4 hours
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: client given pediatric dose of Engerix-B.  no adverse reaction was noted. Medical Director was notified and he advised to give adult dose of vaccine. client called and made aware of error and agreed to come in for adult dose.
Sex: U
Vaccine: VARZOS
Symptoms: Acne, Rash, Rash erythematous
Clinical narrative: small rash on my upper right / few small red dots; pimple; This case was reported by a consumer via call center representative and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced red rash and pimples. On an unknown date, the outcome of the red rash and pimples were recovered/resolved.   It was unknown if the reporter considered the red rash and pimples to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced small rash on my upper right chest area with a few small red dots and one of these patches got like a big pimple. The patient stated that the events disappeared several days later. The patient was wondering if can get the second dose or not.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Lethargy, Malaise, Pain
Clinical narrative: lethargic; achy; chills; arm soreness; felt bad/she felt pretty bad/not feeling right; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of lethargy (received 1st dose 2months ago, refer case US2019215519.).   In November 2019, the patient received the 2nd dose of Shingrix (intramuscular). In November 2019, 4 hrs after receiving Shingrix, the patient experienced lethargy, pain, chills, pain in arm, feeling bad and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the lethargy, pain, chills, pain in arm, feeling bad and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the lethargy, pain, chills, pain in arm, feeling bad and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix one week ago in her right arm and experienced lethargy, achiness, chills, not feeling right, arm soreness and she felt bad and did not feel well.  She claims that the side effects all lasted for two whole days and then resolved. The reporter consented to follow up. The reporter can follow up with the patient directly and the pharmacy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: lethargic; achy; chills; arm soreness; felt bad/she felt pretty bad/not feeling right; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of lethargy (received 1st dose 2months ago, refer case US2019215519.).   In November 2019, the patient received the 2nd dose of Shingrix (intramuscular). In November 2019, 4 hrs after receiving Shingrix, the patient experienced lethargy, pain, chills, pain in arm, feeling bad and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the lethargy, pain, chills, pain in arm, feeling bad and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the lethargy, pain, chills, pain in arm, feeling bad and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix one week ago in her right arm and experienced lethargy, achiness, chills, not feeling right, arm soreness and she felt bad and did not feel well.  She claims that the side effects all lasted for two whole days and then resolved. The reporter consented to follow up. The reporter can follow up with the patient directly and the pharmacy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Blister / Injection site blisters /Blister below injection site; Redness at Injection Site; Pain at the Injection Site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 47XJ3, expiry date 20th April 2022) for prophylaxis.   On 16th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 19th November 2019, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters and injection site erythema were not recovered/not resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site blisters, injection site erythema and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. Just underneath the injection site the patient noticed a blister on day of reporting. The patient also mentioned redness and pain at the injection site and that the patient still had a Band-Aid covering injection site. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood pressure increased, Dizziness, Headache, Injection site pain
Clinical narrative: Blood pressure had increased; Felt lightheaded; Bilateral shoulder pain; Neck pain; Pain also involving the joints in neck and shoulders; headache; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension and hypercholesterolemia. Concomitant products included nebivolol hydrochloride (Bystolic), losartan and atorvastatin.   On 18th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th November 2019, couple of hours after receiving Shingrix, the patient experienced injection site pain, shoulder pain, neck pain, arthralgia and headache. On 20th November 2019, the patient experienced increased blood pressure and dizziness. On an unknown date, the outcome of the injection site pain and headache were recovered/resolved and the outcome of the increased blood pressure, dizziness, shoulder pain, neck pain and arthralgia were unknown.   It was unknown if the reporter considered the injection site pain, increased blood pressure, dizziness, shoulder pain, neck pain, arthralgia and headache to be related to Shingrix.  Additional details were provided as follows: The patient stated that as of recently before taking the Shingrix his regular blood pressure had been 135/85 for which he was on two anti-hypertensive medications, Bystolic 5 mg and losartan 100 mg, both once a day. He was also on atorvastatin 40 mg for preexisting hypercholesterolemia. The patient states after the Shingrix vaccine, later that day, the patient was experiencing bilateral shoulder and neck pain also involving the joints in his neck and shoulders. On 20 November 2019, at work he felt lightheaded and was seen by the nurse at the work place who took three blood pressure readings which were 170/90, 180/90 and 190/90. He was instructed to go to the Urgent care. About 1.5 hours later at the Urgent care, his blood pressure was reported as 154/86, which was considered normal for him. On 21 November 2019, the customer states his blood pressure has been normal. The reporter was consented to follow up.      Lab Comments: On unkown date, blood pressure was 135/85
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Blood pressure had increased; Felt lightheaded; Bilateral shoulder pain; Neck pain; Pain also involving the joints in neck and shoulders; headache; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension and hypercholesterolemia. Concomitant products included nebivolol hydrochloride (Bystolic), losartan and atorvastatin.   On 18th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th November 2019, couple of hours after receiving Shingrix, the patient experienced injection site pain, shoulder pain, neck pain, arthralgia and headache. On 20th November 2019, the patient experienced increased blood pressure and dizziness. On an unknown date, the outcome of the injection site pain and headache were recovered/resolved and the outcome of the increased blood pressure, dizziness, shoulder pain, neck pain and arthralgia were unknown.   It was unknown if the reporter considered the injection site pain, increased blood pressure, dizziness, shoulder pain, neck pain, arthralgia and headache to be related to Shingrix.  Additional details were provided as follows: The patient stated that as of recently before taking the Shingrix his regular blood pressure had been 135/85 for which he was on two anti-hypertensive medications, Bystolic 5 mg and losartan 100 mg, both once a day. He was also on atorvastatin 40 mg for preexisting hypercholesterolemia. The patient states after the Shingrix vaccine, later that day, the patient was experiencing bilateral shoulder and neck pain also involving the joints in his neck and shoulders. On 20 November 2019, at work he felt lightheaded and was seen by the nurse at the work place who took three blood pressure readings which were 170/90, 180/90 and 190/90. He was instructed to go to the Urgent care. About 1.5 hours later at the Urgent care, his blood pressure was reported as 154/86, which was considered normal for him. On 21 November 2019, the customer states his blood pressure has been normal. The reporter was consented to follow up.      Lab Comments: On unkown date, blood pressure was 135/85
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Neuralgia
Clinical narrative: bleeding at injection site right after administration; nerve pain in her skin along her back and side; This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 93-year-old female patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date 15th November 2021) for prophylaxis.   The patient's past medical history included shingles (4 years prior to the date of reporting).   On 19th November 2019, the patient received Shingrix (intramuscular). In November 2019, less than a week after receiving Shingrix, the patient experienced nerve pain. On 19th November 2019, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the nerve pain and injection site hemorrhage were unknown.   It was unknown if the reporter considered the nerve pain and injection site hemorrhage to be related to Shingrix.  Additional case details were reported as follows: The patient experienced bleeding at injection site immediately after vaccination. The patient also had nerve pain in her skin along her back and side, at the same places where she prior had a shingles outbreak.
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: blister near the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 25th November 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 25th November 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was not recovered/not resolved.   It was unknown if the reporter considered the injection site blisters to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The patient received the vaccine at the hospital and that same day in the evening the patient noticed a blister near the injection site, left upper arm. Vaccine was administered intramuscularly in the left upper arm, 0.5 ml. The patient states the blister was starting to improve at the time of reporting. No additional information was provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Lethargy, Malaise, Pain
Clinical narrative: lethargic; achy; chills; arm soreness; felt bad/not feeling right; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced lethargy, pain, chills, pain in arm, feeling bad and feeling unwell. On an unknown date, the outcome of the lethargy, pain, chills, pain in arm and feeling bad were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the lethargy, pain, chills, pain in arm, feeling bad and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix over two months ago in her left arm and experienced lethargy, achiness, chills, not feeling right, arm soreness and she felt bad and did not feel well.   She claims that the side effects all lasted for two whole days and then resolved. The reporter consented to follow up. The reporter can follow up with the patient directly and the pharmacy.  For tolerances of 2nd dose, refer case US2019AMR217074, reported by same reporter for the same patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: lethargic; achy; chills; arm soreness; felt bad/not feeling right; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced lethargy, pain, chills, pain in arm, feeling bad and feeling unwell. On an unknown date, the outcome of the lethargy, pain, chills, pain in arm and feeling bad were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the lethargy, pain, chills, pain in arm, feeling bad and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix over two months ago in her left arm and experienced lethargy, achiness, chills, not feeling right, arm soreness and she felt bad and did not feel well.   She claims that the side effects all lasted for two whole days and then resolved. The reporter consented to follow up. The reporter can follow up with the patient directly and the pharmacy.  For tolerances of 2nd dose, refer case US2019AMR217074, reported by same reporter for the same patient.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Pruritus
Clinical narrative: rash at site of injection  and c/o diffuse itching all over the body but no other lesions found elsewhere
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given immunization subcutaneously in the right upper arm and developed redness, swelling, warmth, tenderness, and firmness of the area.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Cardiac monitoring normal, Chills, Culture, Dysstasia
Clinical narrative: Pt received Shingrix dose on 12/2/19 at approx. 7pm.  Pt developed extreme weakness and could not stand by 12noon on 12/3/19.  Pt was transported by ambulance to local hospital and presented with extreme weakness, inability to stand, 101 degree fever, chills, and headache.  Tests were done, with no other obvious explanation for symptoms. As of this morning, lab values had not been returned yet, everything on heart monitor is O.K., his blood pressure is within a normal range.  The hospitalist is running cultures to attempt to identify any other possible infectious source.  Pt. is still in observation unit of hospital, but is much improved, is able to walk, but headache still remains.  Pt's PCP told pt that a small number of patients react negatively to Shingrix.  All this info was relayed to me by pt's wife, on 12/4/19 at about 08:30 am.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Laboratory test, Pyrexia
Clinical narrative: Pt received Shingrix dose on 12/2/19 at approx. 7pm.  Pt developed extreme weakness and could not stand by 12noon on 12/3/19.  Pt was transported by ambulance to local hospital and presented with extreme weakness, inability to stand, 101 degree fever, chills, and headache.  Tests were done, with no other obvious explanation for symptoms. As of this morning, lab values had not been returned yet, everything on heart monitor is O.K., his blood pressure is within a normal range.  The hospitalist is running cultures to attempt to identify any other possible infectious source.  Pt. is still in observation unit of hospital, but is much improved, is able to walk, but headache still remains.  Pt's PCP told pt that a small number of patients react negatively to Shingrix.  All this info was relayed to me by pt's wife, on 12/4/19 at about 08:30 am.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose normal, Clonus, Computerised tomogram head normal, Dizziness, Face injury
Clinical narrative: 10 minutes after receiving the Bexsero vaccine the patient was in the exam room with her mother when she became nauseous and dizzy. Per the mother she then fell forward from the exam table and impacted her face on the floor sustaining an abrasion to her upper lip. Subsequently she had several episodes of clonic tremulous activity of her upper extremities lasting approximately 15 seconds each time within a period of 15 minutes. This patient was transported to the emergency room where she had one additional episode of the tremulous upper extremity activity. She continued to breath through these events and had immediate return to baseline mentation.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fall, Haemoglobin normal, Nausea, Pregnancy test urine negative, Skin abrasion
Clinical narrative: 10 minutes after receiving the Bexsero vaccine the patient was in the exam room with her mother when she became nauseous and dizzy. Per the mother she then fell forward from the exam table and impacted her face on the floor sustaining an abrasion to her upper lip. Subsequently she had several episodes of clonic tremulous activity of her upper extremities lasting approximately 15 seconds each time within a period of 15 minutes. This patient was transported to the emergency room where she had one additional episode of the tremulous upper extremity activity. She continued to breath through these events and had immediate return to baseline mentation.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Toxicologic test normal, Tremor
Clinical narrative: 10 minutes after receiving the Bexsero vaccine the patient was in the exam room with her mother when she became nauseous and dizzy. Per the mother she then fell forward from the exam table and impacted her face on the floor sustaining an abrasion to her upper lip. Subsequently she had several episodes of clonic tremulous activity of her upper extremities lasting approximately 15 seconds each time within a period of 15 minutes. This patient was transported to the emergency room where she had one additional episode of the tremulous upper extremity activity. She continued to breath through these events and had immediate return to baseline mentation.
Age: 42.0
Sex: F
Vaccine: FLUN4
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Started with sore throat and headache approx 2:30 pm.  Shortness of breath and trouble taking a deep breath at 3:00pm.  3:30 pm increase in shortness of breath.  Patient called Employee health and then PCP and directed to go to ED.  Patient short of breath just talking while on the way to the ED.  Light headed and dizzy while in the ED.  Heaviness in chest and feeling of throat constricting.  Treated in ED with Benadryl po and albuterol inhaler.  No EPI Pen given.  EKG and CXR and Blood work and UA done and were negative.  Patient sent home with Albuterol inhaler and told to use Benadryl PRN.  Patient still using inhaler and Benadryl today.
Age: 42.0
Sex: F
Vaccine: FLUN4
Symptoms: Electrocardiogram normal, Headache, Oropharyngeal pain, Throat tightness, Urine analysis normal
Clinical narrative: Started with sore throat and headache approx 2:30 pm.  Shortness of breath and trouble taking a deep breath at 3:00pm.  3:30 pm increase in shortness of breath.  Patient called Employee health and then PCP and directed to go to ED.  Patient short of breath just talking while on the way to the ED.  Light headed and dizzy while in the ED.  Heaviness in chest and feeling of throat constricting.  Treated in ED with Benadryl po and albuterol inhaler.  No EPI Pen given.  EKG and CXR and Blood work and UA done and were negative.  Patient sent home with Albuterol inhaler and told to use Benadryl PRN.  Patient still using inhaler and Benadryl today.
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Bursitis, Impaired driving ability, Injected limb mobility decreased, Injection site reaction, Pain
Clinical narrative: The individual administering the vaccine injected it into the bursa of the left shoulder, causing bursitis. Driving was difficult and certain shoulder motions were painful or unable to be performed. Mobic anti-inflammatory was given to me by my PCP which alleviated the symptoms.
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: The individual administering the vaccine injected it into the bursa of the left shoulder, causing bursitis. Driving was difficult and certain shoulder motions were painful or unable to be performed. Mobic anti-inflammatory was given to me by my PCP which alleviated the symptoms.
Age: 41.0
Sex: M
Vaccine: FLUR4
Symptoms: Musculoskeletal pain
Clinical narrative: Intense and intermittent solder pain that was persisted for the 6 weeks sine
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Pain, Pyrexia
Clinical narrative: Severe Diarrhea, Fever, Body aches, Flu like symptoms
Sex: U
Vaccine: MMR, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the highest temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 12-month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA (lot # S004120 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 11-JAN-2021, but upon internal validation established as 11-FEB-2021) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 1 hour. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the highest temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA (lot # S004120 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 11-JAN-2021, but upon internal validation established as 11-FEB-2021) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 1 hour. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 18-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the highest temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: Within about 4-5 hours after the shot the site became very sore and continued to increase in intensity, dull intense soreness. This is unusual for me as I do not get sore arms of any note for other vaccines and also did the usual series of pushups to ward that off.   More concerning was around 10pm or later when going to bed I developed shivers without even feeling cold. No temperature that I could find with the IR thermometer. The shivers went on until I fell asleep, maybe 20-30 minutes. Covering with a blanket seemed to lessen it. Again I never felt cold, just started shivering.  Shivers were completely gone when I awoke the next morning. The arm soreness had decreased and as I used it throughout the day lessened. Soreness was gone by late the following evening.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: redness and swelling  went to doctor feeling better put on doxycycline
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Extreme shivering
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Body temperature decreased, Feeling cold, Raynaud's phenomenon, Tremor
Clinical narrative: PATIENT CALLED THE PHARMACY ON 12/4/19 AND TOLD US SHE HAD A SEVERE RAYNAUD'S REACTION (SHE HAS HAD THEM IN THE PAST) AND HER CORE TEMPERATURE WAS VERY LOW.  SHE REPORTED BEING EXTREMELY COLD AND SHAKING
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Nodule, Peripheral swelling, Tenderness
Clinical narrative: Right arm swelling, tenderness, redness, formation of nodule