chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Asthenia
Clinical narrative: feeling "a little weak"; The patient was inadvertently administered one dose of Pneumovax23; Pneumovax23 for allergy medication; This spontaneous report as received from a pharmacist refers to a 55 year old female patient with unspecified allergies. The patient did not have any pertinent medical history, drug reactions or allergies. Concomitant medication included an unspecifed allergy medication.   The pharmacist reported that on 26-OCT-2019, the patient was inadvertently administered one dose of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R006465 and expiration date 24-OCT-2019, one unspecified dose, intramuscular in the left deltoid, for prophylaxis (also reported as "due to allergies") (product use in unapproved indication). Pharmacist noted that on the same day, the patient was also administered one dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid(BOOSTRIX).   The following morning, on 27-OCT-2019, the patient felt a little weak (asthenia), however she felt ''better" by the afternoon of the same day (recovered). It was reported that the patient called pharmacist, but no treatment was given for the adverse event, and no laboratory diagnostic or studies were performed. Causality assessment regarding asthenia and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; irnproperly stored MMR II was inadvertently administered; This spontaneous report as received from a medical assistant refers to a 12-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-OCT-2019, the patient was inadvertently vaccinated with one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) lot # R028003, expiration date 01-OCT-2020 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted in properly stored sterile diluent. There was no adverse event reported. The administered dose of vaccine experienced temperature excursion of above 47 degrees Fahrenheit (F) (52 F) for 10 hours. There was no previous temperature excursion The data logger was involved.
Age: 17.0
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Broken out in hives; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 17-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number J9F97, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, 15 min after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that the patient after vaccination have broken out in hives. The reporter consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 13.0
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Broken out in hives; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 13-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number J9F97, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, 15 min after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that the patient after vaccination have broken out in hives. The reporter consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Injection site pain, Injection site pruritus, Loss of personal independence in daily activities
Clinical narrative: Had a low grade fever; Felt worn out; It really incapacitates me; When I had those low grade temps, my husband had to push me around in a wheelchair; Injection site itchy; It was only very slightly tender; This case was reported by a consumer and described the occurrence of multiple sclerosis exacerbation in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple sclerosis and heat sensitivity.   On 18th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced multiple sclerosis exacerbation (serious criteria GSK medically significant), injection site itching, injection site tenderness and activities of daily living impaired. On 18th October 2019, the patient experienced low grade fever and worn out. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the multiple sclerosis exacerbation, injection site itching, injection site tenderness, low grade fever, worn out and activities of daily living impaired were unknown.   It was unknown if the reporter considered the multiple sclerosis exacerbation, injection site itching, injection site tenderness, low grade fever, worn out and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received the Shringrix vaccine on Friday. The patient was cautioned that the patient's arm would be extremely painful for 2 to 3 days afterwards.  The injection site was initially itchy, but after that the patient noticed no difference, unless pushed on the site and it was only very slightly tender.  It was reported that on the same day in the evening less than a day after vaccination and for 3 days afterward (and day before reporting) the patient had a low grade fever and patient felt worn out.  The patient had MS and therefore the patient was very sensitive to heat - fever or increased weather temperatures.  The patient could get around quite well with a walker, but when had those low grade temperatures, the patient's husband had to push her around in a wheelchair.  The patient reported that It really incapacitates her. The patient had been taking Ibuprofen and Tylenol and that seems to help. But she did not like to take too much of that due to liver/kidney concerns.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Multiple sclerosis relapse, Pyrexia, Wheelchair user
Clinical narrative: Had a low grade fever; Felt worn out; It really incapacitates me; When I had those low grade temps, my husband had to push me around in a wheelchair; Injection site itchy; It was only very slightly tender; This case was reported by a consumer and described the occurrence of multiple sclerosis exacerbation in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple sclerosis and heat sensitivity.   On 18th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced multiple sclerosis exacerbation (serious criteria GSK medically significant), injection site itching, injection site tenderness and activities of daily living impaired. On 18th October 2019, the patient experienced low grade fever and worn out. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the multiple sclerosis exacerbation, injection site itching, injection site tenderness, low grade fever, worn out and activities of daily living impaired were unknown.   It was unknown if the reporter considered the multiple sclerosis exacerbation, injection site itching, injection site tenderness, low grade fever, worn out and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received the Shringrix vaccine on Friday. The patient was cautioned that the patient's arm would be extremely painful for 2 to 3 days afterwards.  The injection site was initially itchy, but after that the patient noticed no difference, unless pushed on the site and it was only very slightly tender.  It was reported that on the same day in the evening less than a day after vaccination and for 3 days afterward (and day before reporting) the patient had a low grade fever and patient felt worn out.  The patient had MS and therefore the patient was very sensitive to heat - fever or increased weather temperatures.  The patient could get around quite well with a walker, but when had those low grade temperatures, the patient's husband had to push her around in a wheelchair.  The patient reported that It really incapacitates her. The patient had been taking Ibuprofen and Tylenol and that seems to help. But she did not like to take too much of that due to liver/kidney concerns.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Immediate post-injection reaction
Clinical narrative: Fatigue; Headache; Shivering; Fever; Gastrointestinal symptoms; Burning during the injection; Stiffness in her right arm /  Arm was stiff in the muscle; This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. In September 2019, immediately after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site burning and limbs stiffness. On an unknown date, the patient experienced fatigue, headache, shivering, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the injection site burning, fatigue, headache, shivering, fever and gastrointestinal symptom nos were unknown and the outcome of the limbs stiffness was not recovered/not resolved.   It was unknown if the reporter considered the injection site burning, limbs stiffness, fatigue, headache, shivering, fever and gastrointestinal symptom nos to be related to Shingrix. It was unknown if the reporter considered the fatigue, headache, shivering, fever and gastrointestinal symptom nos 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 received the first dose of Shingrix five weeks ago in left arm and she experienced stiffness in her right arm and burning during the injection.  The day after the shot, her arm was stiff in the muscle.  The patient also reported that she received the flu shot in her left arm which was the senior flu shot on the same date.  The patient had concerned that she was still experiencing stiffness after 5 weeks and she wonders if it was because this was the first time she had received a shot in her right arm. The reporter consent to follow up.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fatigue; Headache; Shivering; Fever; Gastrointestinal symptoms; Burning during the injection; Stiffness in her right arm /  Arm was stiff in the muscle; This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. In September 2019, immediately after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site burning and limbs stiffness. On an unknown date, the patient experienced fatigue, headache, shivering, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the injection site burning, fatigue, headache, shivering, fever and gastrointestinal symptom nos were unknown and the outcome of the limbs stiffness was not recovered/not resolved.   It was unknown if the reporter considered the injection site burning, limbs stiffness, fatigue, headache, shivering, fever and gastrointestinal symptom nos to be related to Shingrix. It was unknown if the reporter considered the fatigue, headache, shivering, fever and gastrointestinal symptom nos 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 received the first dose of Shingrix five weeks ago in left arm and she experienced stiffness in her right arm and burning during the injection.  The day after the shot, her arm was stiff in the muscle.  The patient also reported that she received the flu shot in her left arm which was the senior flu shot on the same date.  The patient had concerned that she was still experiencing stiffness after 5 weeks and she wonders if it was because this was the first time she had received a shot in her right arm. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Fever; Sore arm/ Sore Injection Site; Nausea; Vomiting; Headache; Shivers; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 15th August 2019, refer case US2019190825). Concurrent medical conditions included postnasal drip.   On 20th October 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st October 2019, 1 days after receiving Shingrix, the patient experienced fever, injection site pain, nausea, vomiting, headache and shivers. Rechallenge with Shingrix was positive. On 21st October 2019, the outcome of the injection site pain, nausea, vomiting, headache and shivers were recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever, injection site pain, nausea, vomiting, headache and shivers to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 57 or 58 years. On 21st October 2019, the patient woke up in the early AM with a sore injection site, nausea, vomiting, fever, headache and shivers. Several hours later, these symptoms had resolved. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Fever; Sore arm/ Sore Injection Site; Nausea; Vomiting; Headache; Shivers; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 15th August 2019, refer case US2019190825). Concurrent medical conditions included postnasal drip.   On 20th October 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st October 2019, 1 days after receiving Shingrix, the patient experienced fever, injection site pain, nausea, vomiting, headache and shivers. Rechallenge with Shingrix was positive. On 21st October 2019, the outcome of the injection site pain, nausea, vomiting, headache and shivers were recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever, injection site pain, nausea, vomiting, headache and shivers to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 57 or 58 years. On 21st October 2019, the patient woke up in the early AM with a sore injection site, nausea, vomiting, fever, headache and shivers. Several hours later, these symptoms had resolved. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area little colder like a lack of circulation; Swelling presented in the area under arm lower than the armpit area and midway between that area and right breast; Tenderness presented in the area under arm lower than the armpit area and midway between that area and right breast; Feel like nerve pain; Muscle aches; Low grade fever; Chills; Heat; Redness at the injection site; Swelling at the injection site; Tenderness at the injection site; This case was reported by a nurse via call center representative and described the occurrence of myalgia in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced localized feeling of warmth, injection site erythema, injection site swelling and injection site tenderness. On 16th October 2019, the patient experienced myalgia, fever and chills. On 18th October 2019, the patient experienced local swelling, tenderness and nerve pain. On 21st October 2019, the patient experienced coldness of skin. On an unknown date, the outcome of the myalgia, fever, chills and localized feeling of warmth were recovered/resolved and the outcome of the local swelling, tenderness, nerve pain and coldness of skin were not recovered/not resolved and the outcome of the injection site erythema, injection site swelling and injection site tenderness were unknown.   It was unknown if the reporter considered the myalgia, fever, chills, local swelling, tenderness, localized feeling of warmth, nerve pain, coldness of skin, injection site erythema, injection site swelling and injection site tenderness to be related to Shingrix.  Additional information received were as follows: The reporting nurse was the concerned patient. The patient received Shingrix on the right arm. The patient experienced redness, swelling and tenderness at the injection site. She was not sure if it presented the night of vaccination or the next morning following the vaccination.  One day after vaccination, she woke up on Wednesday morning with a low grade fever of 99.6 degree F, muscle aches and chills. The symptoms lasted through the day and night and seemed to resolve. Thursday morning and then later in the day, they presented again and resolved by Friday morning.  Three days after vaccination, on Friday morning, a new event of swelling and tenderness presented in the area under her arm lower than the armpit area and midway between that area and her right breast.  The tenderness and swelling had improved but it now felt more like nerve pain in that area and it also feels a little colder like a lack of circulation.  The patient reported the tenderness in the area turned into nerve pain after her son hugged her and squeezed that area. The reporter consented to follow up. The outcome of events reported in the Argus was not recovered while in structured field it was reported as recovering.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neuralgia, Peripheral coldness, Pyrexia, Swelling
Clinical narrative: Area little colder like a lack of circulation; Swelling presented in the area under arm lower than the armpit area and midway between that area and right breast; Tenderness presented in the area under arm lower than the armpit area and midway between that area and right breast; Feel like nerve pain; Muscle aches; Low grade fever; Chills; Heat; Redness at the injection site; Swelling at the injection site; Tenderness at the injection site; This case was reported by a nurse via call center representative and described the occurrence of myalgia in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced localized feeling of warmth, injection site erythema, injection site swelling and injection site tenderness. On 16th October 2019, the patient experienced myalgia, fever and chills. On 18th October 2019, the patient experienced local swelling, tenderness and nerve pain. On 21st October 2019, the patient experienced coldness of skin. On an unknown date, the outcome of the myalgia, fever, chills and localized feeling of warmth were recovered/resolved and the outcome of the local swelling, tenderness, nerve pain and coldness of skin were not recovered/not resolved and the outcome of the injection site erythema, injection site swelling and injection site tenderness were unknown.   It was unknown if the reporter considered the myalgia, fever, chills, local swelling, tenderness, localized feeling of warmth, nerve pain, coldness of skin, injection site erythema, injection site swelling and injection site tenderness to be related to Shingrix.  Additional information received were as follows: The reporting nurse was the concerned patient. The patient received Shingrix on the right arm. The patient experienced redness, swelling and tenderness at the injection site. She was not sure if it presented the night of vaccination or the next morning following the vaccination.  One day after vaccination, she woke up on Wednesday morning with a low grade fever of 99.6 degree F, muscle aches and chills. The symptoms lasted through the day and night and seemed to resolve. Thursday morning and then later in the day, they presented again and resolved by Friday morning.  Three days after vaccination, on Friday morning, a new event of swelling and tenderness presented in the area under her arm lower than the armpit area and midway between that area and her right breast.  The tenderness and swelling had improved but it now felt more like nerve pain in that area and it also feels a little colder like a lack of circulation.  The patient reported the tenderness in the area turned into nerve pain after her son hugged her and squeezed that area. The reporter consented to follow up. The outcome of events reported in the Argus was not recovered while in structured field it was reported as recovering.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Area little colder like a lack of circulation; Swelling presented in the area under arm lower than the armpit area and midway between that area and right breast; Tenderness presented in the area under arm lower than the armpit area and midway between that area and right breast; Feel like nerve pain; Muscle aches; Low grade fever; Chills; Heat; Redness at the injection site; Swelling at the injection site; Tenderness at the injection site; This case was reported by a nurse via call center representative and described the occurrence of myalgia in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced localized feeling of warmth, injection site erythema, injection site swelling and injection site tenderness. On 16th October 2019, the patient experienced myalgia, fever and chills. On 18th October 2019, the patient experienced local swelling, tenderness and nerve pain. On 21st October 2019, the patient experienced coldness of skin. On an unknown date, the outcome of the myalgia, fever, chills and localized feeling of warmth were recovered/resolved and the outcome of the local swelling, tenderness, nerve pain and coldness of skin were not recovered/not resolved and the outcome of the injection site erythema, injection site swelling and injection site tenderness were unknown.   It was unknown if the reporter considered the myalgia, fever, chills, local swelling, tenderness, localized feeling of warmth, nerve pain, coldness of skin, injection site erythema, injection site swelling and injection site tenderness to be related to Shingrix.  Additional information received were as follows: The reporting nurse was the concerned patient. The patient received Shingrix on the right arm. The patient experienced redness, swelling and tenderness at the injection site. She was not sure if it presented the night of vaccination or the next morning following the vaccination.  One day after vaccination, she woke up on Wednesday morning with a low grade fever of 99.6 degree F, muscle aches and chills. The symptoms lasted through the day and night and seemed to resolve. Thursday morning and then later in the day, they presented again and resolved by Friday morning.  Three days after vaccination, on Friday morning, a new event of swelling and tenderness presented in the area under her arm lower than the armpit area and midway between that area and her right breast.  The tenderness and swelling had improved but it now felt more like nerve pain in that area and it also feels a little colder like a lack of circulation.  The patient reported the tenderness in the area turned into nerve pain after her son hugged her and squeezed that area. The reporter consented to follow up. The outcome of events reported in the Argus was not recovered while in structured field it was reported as recovering.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Erythema, Myalgia, Pruritus
Clinical narrative: Days 1-5 Soreness in arm muscle. Evening of day 2: shivering chills/temperature of 99.8 (resolved after OTC advil) Day 5 & 6: itchy and redness/warmth of left arm (3-4 inches)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Days 1-5 Soreness in arm muscle. Evening of day 2: shivering chills/temperature of 99.8 (resolved after OTC advil) Day 5 & 6: itchy and redness/warmth of left arm (3-4 inches)
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Blister, Dizziness, Neck pain, Peripheral swelling
Clinical narrative: patient presents for a visit today stating he had a reaction yesterday at his work an hour after receiving the flu vaccine. He states he received the flu vaccine (first time getting flu shot), and then an hour later he experienced increased neck pain, and swelling in his bilateral hands and small "water bumps" on his hands, dizziness and lightheadedness. His manager gave him a Benadryl. He stated they offered to send him to the ER but he refused and went home to sleep instead. Since then he has taken another dose of Benadryl and states he feels much better, however still is experiencing small amount of swelling in his hands, no localized reaction to his right arm or neck pain. He denies any shortness of breath, dizziness or further symptoms.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: Patient describes stronger than normal pain, described as nerve pain. Says entire arm is sore and tingling
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Inflammation, Mobility decreased, Pain in extremity
Clinical narrative: Patient said her arm was sore and she had difficulty raising it after a few days.   After 11 days she went to an urgent care and was prescibed meloxicam for inflammation.  Over time she said it is feeling better, but not 100 %.
Age: 27.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pruritus
Clinical narrative: Patient had a raised lump at the injection site along with redness, itching, it also was inflamed
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Rash, Rash erythematous
Clinical narrative: Patient came in with large, red rash on arm.  Patient stated rash developed where she received the shot and eventually grew larger down towards her elbow. Patient also stated that it feels hard to the touch. Advised pt to see their PCP.
Age: 34.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Oral lichen planus
Clinical narrative: Oral Lichen Planus
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient woke up morning after immunization with redness and hives on the arm and itching.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Lip swelling, Mouth swelling
Clinical narrative: pt had minor injection arm swelling, and started to have lip and mouth swelling.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, red arm around injection site.  Redness size of baseball. No fever.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Swelling down the whole arm, red hot to the touch.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Myalgia
Clinical narrative: One day of severe muscle ache and slept for 30 hours
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenitis
Clinical narrative: Swelling from bottom of Left arm pit to top side of breast.  "Fits in palm of hand - soft, feels like fluid".  Not warm or red.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: pain and redness to left arm , under injection site that night 10/25/2019. Swelling and warmth 10/26/2019 morning. Continued to get worse. no fever, no headache. No rash.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fatigue
Clinical narrative: Patient called to say he received the vaccine on 10/26/19, and he started having some dizziness, fatigue, and  feeling lightheaded on 10/30/19. He just wasn't sure if this could have been related to the vaccine. He has not went to see a provider about the symptoms though.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: After receiving the vaccination, the patient's leg immediately began itching, turned red and developed a hive next to the injection site. The patient was treated with 12.5 mg of oral Benadryl. Per mom, the redness went away by the evening hours. The patient woke up with a bruise where the hive was and the patient had pain in the affected leg all day. 48 hours later, he is feeling well.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Injection site urticaria
Clinical narrative: After receiving the vaccination, the patient's leg immediately began itching, turned red and developed a hive next to the injection site. The patient was treated with 12.5 mg of oral Benadryl. Per mom, the redness went away by the evening hours. The patient woke up with a bruise where the hive was and the patient had pain in the affected leg all day. 48 hours later, he is feeling well.
Age: 48.0
Sex: M
Vaccine: FLUR4, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: The day after the immunization, the patient experienced itching and a rash developed around the site of injection. The rash has persisted from 10/26-10/31.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Lethargy, Oropharyngeal pain, Productive cough, Pyrexia, Sputum discoloured
Clinical narrative: Sore Throat first , reaction 8:00pm the day of receiving vaccination. Adverse events started 10/21/2019 Sore Throat, Lethargic, Fever and Productive Cough yellow/white sputum.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Mass, Peripheral swelling, Tenderness
Clinical narrative: redness and swelling from the shoulder to the elbow on inner and outer arm; Areas with hard lumps; severe tenderness to the touch
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Dehydration, Fatigue, Pyrexia
Clinical narrative: fever, extreme fatigue, dehydration, generally resolved after 36 hours
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Feeling hot, Presyncope
Clinical narrative: Patient stated prior to vaccination that she becomes light headed with every immunization she receives. Approximately three minutes after vaccination, patient began to experience vasovagal symptoms. She stated she was lightheaded,dizzy, and feeling hot. Patient did not lose consciousness, remained laying down for approximately 25 minutes, drank juice, BP at time of occurrence was 98/76 and HR 78. After 25 minutes, patient slowly sat up, BP re-checked and was 100/76. After approximately one hour of observation, patient stated she felt much better and ready to leave. All symptoms resolved.
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal
Clinical narrative: Unknown if related to vaccine but was fine day of event.  Woke up with nausea and headache.  Passed out while going to bathroom.  Hit head on tile floor.  Still headache and weakness.  No sign of stroke, heart event or abnormal blood work.  Admitted to hospital as continued dizziness and nausea.
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: Head injury, Headache, Loss of consciousness, Nausea
Clinical narrative: Unknown if related to vaccine but was fine day of event.  Woke up with nausea and headache.  Passed out while going to bathroom.  Hit head on tile floor.  Still headache and weakness.  No sign of stroke, heart event or abnormal blood work.  Admitted to hospital as continued dizziness and nausea.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: patient left arm have sign and symptoms of redness, with little bit of swollen and mild pain.   pt does not have fever, shortness of breath or anything else.   Patient had been advise to take Tylenol and Benadryl to relieve the symptoms.    Patient had been advise by RPH that if thing get worse then seek medical treatment with MD or go to hospital.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pallor, Injection site swelling
Clinical narrative: Redness and swelling down the arm from injection site for 3 or more inches. White spot at injection site.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphonia, Dyspnoea, Headache, Pain, Pharyngeal swelling
Clinical narrative: Felt feverish, throat felt swollen and difficulty breathing and headache a few hours after flu shot was administered. Called my primary doctor?s office who recommended going to Urgent Care facility.  Doctor prescribed throat medication and recommended I take the rest of the day off.  I have been having headaches, body aches and throat hoarseness and have been home for the pass two days.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Felt feverish, throat felt swollen and difficulty breathing and headache a few hours after flu shot was administered. Called my primary doctor?s office who recommended going to Urgent Care facility.  Doctor prescribed throat medication and recommended I take the rest of the day off.  I have been having headaches, body aches and throat hoarseness and have been home for the pass two days.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Bladder catheterisation, Chills, Injection site pain, Lip swelling, Oedema genital
Clinical narrative: Patient developed very sore arm at injection site, lip swelling and labial swelling which was followed by fever, body aches, chills, followed by blisterin and erosion of mucosal  vaginal tissue.  Required IM steroids x 2,  PO steroids, Diphenhydramine, Pepcid, Percocet, Zytret, and indwelling  foley cath placement which patient wore for 2 weeks
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Vaginal erosion, Vaginal mucosal blistering
Clinical narrative: Patient developed very sore arm at injection site, lip swelling and labial swelling which was followed by fever, body aches, chills, followed by blisterin and erosion of mucosal  vaginal tissue.  Required IM steroids x 2,  PO steroids, Diphenhydramine, Pepcid, Percocet, Zytret, and indwelling  foley cath placement which patient wore for 2 weeks
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red, swollen spot on arm starting 2 inches below injection site. Spot is about the size of a hand.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Dizziness
Clinical narrative: Patient was administered Flu shot by writer of this report with father present in room. She was then dismissed to go to Check-out. At checkout patient stated to her father that she was feeling dizzy. Per dad he told her to sit on the floor. Staff seen her sitting on the floor and intervened to help. She was placed in a nearby room where she remained until she was feeling better. Given ice pack, and obtained vitals.  Pulse-82 B/p-92/60 O2 Sat-99%
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: By 7 pm was feeling achy all over, temp over 99.  About 4 am was having hard chills, temp  over 101.  This continued through the next day (Saturday).   By mid Sunday temp down to 99 and was feeling better.  Red area at injection site about 2 in itchy and very painful.  This continued for several more days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: By 7 pm was feeling achy all over, temp over 99.  About 4 am was having hard chills, temp  over 101.  This continued through the next day (Saturday).   By mid Sunday temp down to 99 and was feeling better.  Red area at injection site about 2 in itchy and very painful.  This continued for several more days.
Age: 55.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Fluid retention, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced extreme redness and swelling to outer and inner arm. Inner arm had a sack-like fluid buildup, possibly in lymph system, but was mostly reduced by the time they reported it to this Rph. Very painful, red, sore, came with excessive fever and headache. Patient will be reporting to MD's office in case cellulitis is suspected and/or antibiotics recommended. Patient experienced this within 12 hours after administration of vaccine by the following morning.
Age: 55.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient experienced extreme redness and swelling to outer and inner arm. Inner arm had a sack-like fluid buildup, possibly in lymph system, but was mostly reduced by the time they reported it to this Rph. Very painful, red, sore, came with excessive fever and headache. Patient will be reporting to MD's office in case cellulitis is suspected and/or antibiotics recommended. Patient experienced this within 12 hours after administration of vaccine by the following morning.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; improperly stored MMR II; This spontaneous report was received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's concurrent condition, pertinent medical history and drug reactions/allergies were unknown.  The patient's concomitant therapies included sterile diluent. On 17-OCT-2019, the patient was vaccinated inadvertently with dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: digital logger) (dose, frequency, route of administration, anatomical location unknown) (lot # R028003 and expiration date 01-OCT-2020) for prophylaxis (Product storage error). It was reported that there were no adverse effects. The temperature was above 47degree Fahrenheit (52 F) with time frame 10 hours as recorded by a data logger. The vaccine had no previous temperature excursion.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Skin reaction, Skin warm
Clinical narrative: painful, red and warm
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: About 1 hour after administration patient experienced hives, itching wide spread, and swelling of her lips
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Patient attended the Influenza Vaccination Clinic on 10/3/2019 at Health Fair. On 10/31/2019 Patient visited the Health Center and stated his left arm was still in discomfort since the Flu Vaccination. Had patient point to area of discomfort and patient pointed to left arm deltoid area.  Patient states most of time dull ache scales at #2 of 10 and if using left arm consistently or carrying his dull ache is #7 of 10. States the dull ache has some improvement but if he rotates left arm to posterior position the discomfort is #7 of ten and experiences the ache and numbness radiating down left arm to 5 th finger left hand Patient has had no intervention or used any OTC or treatment because he thought it would resolve, states used Icy/Hot one time, no relief. Referred Patient to ER or Urgent Care as he states he will not be able to obtain an appointment with PMD or 2 weeks. Patient usually takes Advil for any discomfort and was advised he could use Advil if unable to go to ER or Urgent Care today as soon as possible and can use heat application, but should see MD asap
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypersomnia, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Patient reports after receiving her vaccines, her right arm where her PPSV23 was administered became very stiff and had a raised, round area the size of a baseball at the injection site. She reports her skin felt itchy because her skin was so tight. She reports later that evening a raised line spread from her injection site on her right arm, down to her forearm, across her neck, and across her chest. She reports the raised area was not red. She reports the next day she ran a fever but is unable to recall the temperature. She reports she felt unwell and slept for several hours. She reports the following day her shoulder was also hot to the touch. Patient reports she applied Thieves essential oil to the area for several days, which relieved the swelling and pain.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Injection site warmth, Malaise, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient reports after receiving her vaccines, her right arm where her PPSV23 was administered became very stiff and had a raised, round area the size of a baseball at the injection site. She reports her skin felt itchy because her skin was so tight. She reports later that evening a raised line spread from her injection site on her right arm, down to her forearm, across her neck, and across her chest. She reports the raised area was not red. She reports the next day she ran a fever but is unable to recall the temperature. She reports she felt unwell and slept for several hours. She reports the following day her shoulder was also hot to the touch. Patient reports she applied Thieves essential oil to the area for several days, which relieved the swelling and pain.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Client claimed she received the vaccines too high near her shoulder that is why she experience mild pain right away but ignore it then after 2 days the mild pain become moderate like 6-7 scale out of 10 but on and off it comes away then since 10/24 /19 up to present - pain worsen  and she had issues with limited mobility only on site where she got the immunization (left shoulders as per client) that opt her seek medical attention through her PCP and later diagnosed that it was flu vaccines related.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Urticaria
Clinical narrative: pt reported of welts after receiving dose the next day, then rashes that didn't go away quickly. she is ok now and thinks it will resolve by itself.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen area that was warm to touch. about 5 inches in diameter. recommended Benadryl every 6-8 hours, PRN and started patient on Keflex suspension BID x 7 days
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebral haemorrhage, Clavicle fracture, Syncope
Clinical narrative: Paintient Fainted after getting home causing broken clavicle and internal brain hemmorahging
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Clavicle fracture, Fall, Intensive care, Loss of consciousness, Skull fracture
Clinical narrative: Paintient Fainted after getting home causing broken clavicle and internal brain hemmorahging
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Patient reports that 3 hours after vaccination was given, her left arm began hurting from shoulder to elbow.  It became swollen and remained swollen at the time this report was taken.  Patient became nauseated and faint feeling approximately 6 hours post-vaccine, but had no vomiting.  At time of report, the nausea and faint feeling had passed, but arm remained swollen and sore upon movement.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Rash erythematous
Clinical narrative: 1 inch bruise with skin tone center with a pink (light red) oval rash descending below the bruised are approx 3 inches log by 2 inches across
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: 10/30/19 @ 15:33: Pneumovax 23 administered. Pt was concerned the vaccine was administered too high on arm. Administration was very painful, and later that evening her arm became immobile. She couldn't sleep, nor cover her arm due to the pain (level 10). There is a 4 to 5 inch red, swollen area at and surrounding injection site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Nasal congestion, Pain, Throat irritation
Clinical narrative: Body aches, stuffy nose, scratchy throat, warm feeling
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising
Clinical narrative: Patient complains of black and blue bruise mark on the site of injection which has progressively gotten worse since she first noticed it on the day of injection. She measured the size to be approximately 2 inches around. She is worried since she assumed the bruise would disappear in few days but only appeared to get worse since the bruise mark got much bigger in size. She has applied ice around the site of injection but has not used any medication to treat it. She does not report of any pain, burning, or itchiness, rash or any other side effect from the site of injection.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hypotension, Syncope
Clinical narrative: extremely low blood pressure 74/50 within an hour of vaccination.  Light headed and dizzy.  Fainted once.  Blood pressure remained low thru the next day 74/50 in the AM climbing back to 117/61 by 1am.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: The patient called the pharmacy 1.5 hours later to vaccination. She reported face red and hot and itchy arms. I recommeded her go to emergency room or call the doctor. She didn't go to emergency room instead she said that she had Benadryl and then she took 2 capsules. I called her today at 8:23am and she said that is ok, today she don't have any symptoms.