chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Amnesia, Asthenia, Blood glucose normal, Blood test normal, Computerised tomogram head normal
Clinical narrative: Vaccine received 4:30 pm day before. Felt fine until 8:30 am next morning. Became extremely sleepy, could not stay awake, amnesia of events that followed. Husband took me to clinic when I said I was seeing double. Clinic called ambulance. I remember very little of this. Spent 5 hours in ED of which I remember very little. Had CT of head....negative. All blood work WNL. Urine WNL. Discharged with diagnosis of 'weakness of unknown origin'. Left arm very sore for 5 days. No induration or redness at injection site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Diplopia, Pain in extremity, Somnolence, Urine analysis normal
Clinical narrative: Vaccine received 4:30 pm day before. Felt fine until 8:30 am next morning. Became extremely sleepy, could not stay awake, amnesia of events that followed. Husband took me to clinic when I said I was seeing double. Clinic called ambulance. I remember very little of this. Spent 5 hours in ED of which I remember very little. Had CT of head....negative. All blood work WNL. Urine WNL. Discharged with diagnosis of 'weakness of unknown origin'. Left arm very sore for 5 days. No induration or redness at injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: All symptoms below lasted approximately 48 hours: Pain, redness and swelling at injection site about 80mm Myalgia - significant pain at rest, which prevented normal everyday activities Fatigue  Headache  Shivering   Fever ? oral 99.3F Nausea
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Myalgia, Nausea, Pyrexia
Clinical narrative: All symptoms below lasted approximately 48 hours: Pain, redness and swelling at injection site about 80mm Myalgia - significant pain at rest, which prevented normal everyday activities Fatigue  Headache  Shivering   Fever ? oral 99.3F Nausea
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Pediarix, PCV13 and Hepatitis B on 11/22/13, He received 2 doses of hepatitis B, patient should have received Pediarix, PCV 13 and Hib. Patient had no adverse reaction to getting two Hepatitis B, local health department was contacted on 11/25/19 and advice to enter incident on VAERS. Provider spoke with patient's parents on 11/26/19 and informed them of vaccine error. Parents will bring child back to office to receive Hib vaccine.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Skin discolouration, Skin irritation, Tenderness, Yellow skin
Clinical narrative: You experienced a bruise the size of a baseball that was yellow/brown in color and tender/irritating.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on his torso/Rash on stomach; This case was reported by a consumer via call center representative and described the occurrence of rash in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2019, the patient received the 1st dose of Shingrix. On 18th November 2019, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash on his torso at the time of reporting. The patient clarified that the rash did not itch. The rash was on his torso, on the side of his stomach. The reporter did not consent to follow up.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: PATIENT COMPLAIN WITH SORE ARM SINCE 10-29. SHE EXPERIENSE PAIN WHILE SHE CHANGE CLOTHING.  I RECOMENTED MOTRIN AND TO CALL PRIMARY.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus, Tenderness, Urticaria
Clinical narrative: Hives, itching.  Started 11/28 behind knees and under armpits, spread to under breasts, buttocks; now on arms, across stomach, and still spreading.  Intense all over the body itching (despite daily Claritin, and, prn Benadryl), and point tenderness behind knees and other joints.  Slightly swollen hands.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Skin warm
Clinical narrative: arm still feels warm to touch and some discomfort in the area since shortly after injection
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Pyrexia
Clinical narrative: Fever- 101.6F, 3 days Chest Pain
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Peripheral swelling, Pruritus, Pyrexia, Rash
Clinical narrative: Feverish, heated rash developed within 24 hours of vaccine in the arm vaccine given in. Extreme itching and swelling initially. Originally the rash was the whole arm from shoulder to hand. Now it is resolving and just affecting the bicep area.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Feverish, heated rash developed within 24 hours of vaccine in the arm vaccine given in. Extreme itching and swelling initially. Originally the rash was the whole arm from shoulder to hand. Now it is resolving and just affecting the bicep area.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Diarrhoea, Headache, Pain in extremity
Clinical narrative: Pain radiating up and down my right arm, severe headache, diarrhea, joint pain.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received an improperly stored RECOMBIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided.  On 05-NOV-2019, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thimerosal-free, lot # R031052, expiration date 06-MAR-2019, injection (dose, site and route of administration were not provided) for prophylaxis. No adverse effect was reported. The vaccine experienced the temperature 47.1 Fahrenheit degrees for 30 minutes. There was previous temperature excursion 32.9 Fahrenheit degrees for 24 hours. Data logger was involved.  The outcome of the event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: NO adverse effect reported; patient was administered a dose of improperly stored PROQUAD; Route of administration: "intramuscular"; This spontaneous report as received from a medical assistant refers to a patient of unknown age. No information on patient's pertinent medical history and drug reaction or allergies was provided. Concomitant medication included sterile diluent.      On 11-OCT-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S006835, expiration date 02-SEP-2020 (dose and anatomical location were not provided) intramuscularly for prophylaxis. The vaccine was diluted with sterile diluent that did not experience a temperature excursion. The vaccine underwent a temperature excursion in range of 15 Fahrenheit degrees (F) to 46 F (20.7F) for 2 hours and 8 minutes. There was a previous excursion in range 6 F to 14 F (13.8 F) for 32 minutes. The call was because of data logger.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; The patient was administered improperly stored PROQUAD.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and drug allergies/reactions was not provided. On 20-MAR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (strength, dose, schedule, anatomical location, route of administration was not reported) (lot# R020678, expiry date: 15-JAN-2020) for prophylaxis (product storage error). The vaccine was reconstituted with a properly stored sterile diluent. The vaccine underwent a temperature excursion of 15 degree Fahrenheit to 46 degree Fahrenheit (32.57 Fahrenheit) for a duration of 22 hours. There was an involvement of data logger. There was no previous temperature excursion. No additional adverse effects reported. There was no associated product quality complaint.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; on 11/22/2019 a patient was administered a VAQTA vaccine that expired on 11/15/2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.       On 22-NOV-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # R025518, expiration date 15-NOV-2019, dosage detail, strength and route were not reported) for prophylaxis (expired vaccine used). No adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling; Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling 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 injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe reaction of pain and swelling at the injection site following first dose at an undisclosed date or time frame. The reporter declined to provide further demographic information. There was a discrepancy with respect to the primary reporter type, whether the primary reporter was a pharmacist or a consumer, the clarification was raised to confirm the type, however no clear information available for the same hence the clarification has been raised to seek more information regarding that the primary reporter type.
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient arm often hurts for 2 week after getting the flu Shot. The reporter did not consent to follow-up. This case was linked to case US2019203765 same reporter same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: general sense of malaise; This case was reported by a pharmacist via sales rep and described the occurrence of malaise 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, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patients stated a general sense of malaise after vaccination. The reporter did not agree to follow-up from GlaxoSmithKline. For tolerance to 2nd dose, please refer case US2019AMR204464.
Sex: U
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a physician via sales rep and described the occurrence of pain in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that her patients experienced more pain with Fluarix Quadrivalent 2019-2020 season than Sanofi flu vaccine. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Joint swelling, Peripheral swelling, Swelling
Clinical narrative: swelling; swelling in her left axilla/swelling on left side of her chest; swelling in left hand; This case was reported by a physician and described the occurrence of swollen joints in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, immediately after receiving Shingrix, the patient experienced swollen joints, local swelling and hand swelling. On an unknown date, the outcome of the swollen joints, local swelling and hand swelling were not recovered/not resolved.   It was unknown if the reporter considered the swollen joints, local swelling and hand swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix about 6 weeks ago. The vaccine was administered in the patient's left arm.  The patient almost immediately developed swelling in her shoulder, left axilla, left side of her chest and the left hand.  The physician saw the patient recently maybe and the patient still had some swelling in the left arm. Additional information not available.  The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity, Tearfulness
Clinical narrative: Right upper arm pain; Shoulder pain; her arm was stiil painfull with movement; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 5MM97, expiry date 30th June 2020) for prophylaxis.   On 25th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 2 months after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced pain in arm, shoulder pain and pain upon movement. The patient was treated with steroids nos (Steroid Pack (Nos)). On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the shoulder pain and pain upon movement were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain and pain upon movement to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by the Nurse Practitioner (NP) for an employee. The patient received Fluarix vaccine in her right arm and she reported that she was feeling right upper arm and shoulder pain and was still hurting on 18th October 2019. Hence the NP treated the patient with a six day steroid pack and she had no relief at all.  On 15th November 2019, the NP contacted the patient and her arm was still painful with movement that it would bring her to tears.  The NP consented to follow up. The patient can follow up with the reporter directly.  The patient had a scheduled appointment with their Primary Care Physician (PCP) this week. This case linked with US2019209636 and US2019209638, reported by same reporter.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Neuralgia, Pain in extremity
Clinical narrative: "shocky sensation" (pharmacist described it as nerve pain); soreness / soreness from her left deltoid injection site; Wrist pain; This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced nerve pain, pain in arm and wrist pain. On an unknown date, the outcome of the nerve pain, pain in arm and wrist pain were unknown.   It was unknown if the reporter considered the nerve pain, pain in arm and wrist pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The vaccine lot number was not available. The patient had experiencing soreness and a shocky sensation (pharmacist described it as nerve pain) from her left deltoid injection site to her wrist. The symptoms began at an unspecified time during the week of administration. The permission to follow up was denied.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: pain in neck; intermttent pain in fingers while sleeping; This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th September 2019, less than a day after receiving Shingrix, the patient experienced neck pain and pain in fingers. On an unknown date, the outcome of the neck pain and pain in fingers were unknown.   It was unknown if the reporter considered the neck pain and pain in fingers to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The patient received Shingrix, and experienced pain in neck and also when she sleeps at night she sometimes gets pain in fingers. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Musculoskeletal pain
Clinical narrative: headaches; shoulder pain; feeling lousy; This case was reported by a pharmacist via call center representative and described the occurrence of headache in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, shoulder pain and feeling bad. On an unknown date, the outcome of the headache, shoulder pain and feeling bad were unknown.   It was unknown if the reporter considered the headache, shoulder pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: This case was reported by the reporter on behalf of for his neighborhood. The patients had been complaining about bad headaches, shoulder pain and felt lousy following Shingrix administration. They were really laid up. The reporter did not consent to follow-up.
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Influenza, Pharyngitis streptococcal
Clinical narrative: Came down with type A flu; Strep throat; This case was reported by a consumer via sales rep and described the occurrence of influenza a virus infection in a female 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, immediately after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced influenza a virus infection and streptococcal sore throat. On an unknown date, the outcome of the influenza a virus infection and streptococcal sore throat were unknown.   It was unknown if the reporter considered the influenza a virus infection and streptococcal sore throat 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 flu vaccine last month and shortly afterwards she came down with type A flu and streptococcal throat. Limited information was available. The reporter denied permission to follow up. This is 2 of the 2 linked cases reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Lower respiratory tract congestion, Myalgia
Clinical narrative: Patient states started having muscle ache, cough and chest congestion a day after the vaccine was administered, no fever was reported. Patient called to the office on 11/27, he was encouraged to come to the office for a check up, which he refused stating that he was feeling better than Monday 11/25 when everything started.   Patient was advised of how to treat the mild symptoms he was experiencing with over the counter medications, and go to the emergency room if symptoms worsen.  Patient has been called today 12/2 for follow up on symptoms and he states feeling well except for a little cough and chest tightness.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, X-ray limb
Clinical narrative: Immediate pain in left shoulder and bicep.  Unable to move arm for 2 days.  After 1 month of no relief, contact primary doctor's office.  Talked to the nurse who advised I should see a specialist as I would be referred to one.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Patient reported at time of second shot, 11.24, that he received swelling under armpit after first dose (8.23).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Hypoaesthesia, Swelling
Clinical narrative: Patient states she had bruising and swelling to left shoulder area which covered top of shoulder to mid deltoid area.  Pt also states numbness to right middle finger.  While swelling has resolved, numbness of right middle finger still persists.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury, Headache, Syncope, Vomiting
Clinical narrative: Patient experienced a syncopal event about 5 minutes after influenza vaccination.  She fell backwards and hit her head. C/o headache at the back of her head.  Vomited about 10-15 minutes after the fall.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: was given adult dose instead of pediatrics
Age: 14.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Headache
Clinical narrative: Mild headache
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Woke at 3 a.m. (approx. 12 hours post-injection) with flu-like symptoms: nausea, chills, body aches, headache. No fever (37.1 C). I had the flu vaccine in September, so this seems unlikely to be influenza. Awake until 6:30, back to sleep until 7. Took 600 mg Ibuprofen at approx. 8:30 a.m.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Mouth ulceration, Myalgia
Clinical narrative: Severe Lupus flareup - flu-like symptoms including fever and body aches, open mouth ulcers in roof of mouth, severe joint and muscle pain especially in feet and hands, and fatigue.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Systemic lupus erythematosus
Clinical narrative: Severe Lupus flareup - flu-like symptoms including fever and body aches, open mouth ulcers in roof of mouth, severe joint and muscle pain especially in feet and hands, and fatigue.
Age: 64.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Ventricular extrasystoles
Clinical narrative: After vaccination, he had PVCs for the remainder of the day, through the next 12 hours before complete resolution.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Nausea
Clinical narrative: This was a 2nd dose of shingles vaccination.  No reaction to first dose.  2nd dose was Shingrix.  Not sure about 1st dose.  Reaction was as follows:  1) shivering in middle of night (2 or 3am); 2) early morning stomach pain; 3) woke to fever of 101.3, which remained for 6 to 8 hours, along with strong headache, heavy fatigue, and nausea.   Began to feel better around 3 or 4pm on Sat., Nov. 23.  Felt close to normal by bedtime that evening, and felt fine the next day.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This was a 2nd dose of shingles vaccination.  No reaction to first dose.  2nd dose was Shingrix.  Not sure about 1st dose.  Reaction was as follows:  1) shivering in middle of night (2 or 3am); 2) early morning stomach pain; 3) woke to fever of 101.3, which remained for 6 to 8 hours, along with strong headache, heavy fatigue, and nausea.   Began to feel better around 3 or 4pm on Sat., Nov. 23.  Felt close to normal by bedtime that evening, and felt fine the next day.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; dose of Proquad that had been improperly stored was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 05-NOV-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA (recombinant human albumin) albumin status) injection, lot # S008574, expiration date 16-SEP-2020 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15.4 degrees Fahrenheit for 1 hour. There was no previous temperature excursions. Data logger was involved.
Sex: M
Vaccine: HEP
Symptoms: Therapeutic response unexpected
Clinical narrative: The patient thought his skin reaction went down after receiving hepatitis B shot; This spontaneous report was received from a 70-year-old male patient reporting on himself. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug allergies.   On an unknown date, the patient was vaccinated with an hepatitis b vaccine (manufacturer unknown) for prophylaxis (dosage schedule, route of administration, lot number and expiration date were not reported). Furthermore, the patient thought his skin reaction went down after receiving hepatitis B (manufacturer unknown) shot (therapeutic response unexpected).       The outcome of therapeutic response unexpected and the causal relationship between the event and therapy with hepatitis b vaccine (manufacturer unknown) were not reported.; Sender's Comments:  US-009507513-1610USA004936:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix was inadvertantly administered earlier than the 2month interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 15th November 2019, the patient received Shingrix. On 15th November 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: Additional details were provided as follows: The pharmacist called to report that Shingrix was inadvertantly administered earlier than the 2month interval. First dose was 8th October 2019, second dose was 15th November 2019, which led to drug dose administration interval too short. The reporter was consented to follow up.  The Lot and expiration date was from 2nd dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: 6 itchy blisters on right hand, arm, wrist, and bicep/ look like large mosquito bite; blister itch; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7F33X, expiry date 11th December 2021) for prophylaxis.   On 14th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th November 2019, 1 days after receiving Shingrix, the patient experienced blister and pruritus. On an unknown date, the outcome of the blister and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in  left deltoid. The patient developed 6 blisters on the right arm (opposite of injection site) on the wrist, arm, bicep and hand. The patient stated, these blister itch and look like large mosquito bites and had not resolved at the time of reporting. The reporter consented to follow up. The reporter was unsure if this was related to Shingrix vaccine.
Sex: F
Vaccine: MENB
Symptoms: Concussion, Headache
Clinical narrative: severe headaches; Concussion; This is a spontaneous report obtained from a contactable Health Care Professional through a Pfizer sales representative.   A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced severe headaches and concussion. Clinical outcome of the adverse events was unknown at time of this report.   The information on the lot number has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Blood test abnormal, Chills, Inflammation, Joint swelling
Clinical narrative: swollen knee; Did not feel well; Fever; Chills; Achiness; joint pain in arms, wrists and fingers; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient started received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 17Oct2019 at a single dose for immunisation, and flu vaccine (influenza vaccine), via an unspecified route of administration on 17Oct2019 at a single dose for immunisation. There were no medical history and concomitant medications. The patient had fever, chills and achiness on 17Oct2019. She did not feel well on 18Oct2019. A week later on Oct2019, she developed joint pain in her arms, wrists and fingers and a swollen knee on 07Nov2019, but is still to be determined if that is part of this or something else going on. As a result, she has had cortisone injections in her shoulders and a prednisone pack for 5 days. She had cortisone injections on 31Oct2019 in her rotator cuffs on both sides due to joint pain. Then because everything snowballed, she was put on steroids (Prednisone dose pack) for 5 days which helped on 11Nov2019.  The same day of her last day of the steroid, the symptoms started coming back. She went to the ER yesterday because her knee was swollen and she hadn't been able to sleep due to prednisone. She had blood work done and it came back that she has an inflammatory issue. Outcome of the event of fever, chills and achiness was recovered on 18Oct2019, for the event of "did not feel well" was recovered on 19Oct2019, while for the remaining events was not recovered.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: swollen knee; Did not feel well; Fever; Chills; Achiness; joint pain in arms, wrists and fingers; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient started received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 17Oct2019 at a single dose for immunisation, and flu vaccine (influenza vaccine), via an unspecified route of administration on 17Oct2019 at a single dose for immunisation. There were no medical history and concomitant medications. The patient had fever, chills and achiness on 17Oct2019. She did not feel well on 18Oct2019. A week later on Oct2019, she developed joint pain in her arms, wrists and fingers and a swollen knee on 07Nov2019, but is still to be determined if that is part of this or something else going on. As a result, she has had cortisone injections in her shoulders and a prednisone pack for 5 days. She had cortisone injections on 31Oct2019 in her rotator cuffs on both sides due to joint pain. Then because everything snowballed, she was put on steroids (Prednisone dose pack) for 5 days which helped on 11Nov2019.  The same day of her last day of the steroid, the symptoms started coming back. She went to the ER yesterday because her knee was swollen and she hadn't been able to sleep due to prednisone. She had blood work done and it came back that she has an inflammatory issue. Outcome of the event of fever, chills and achiness was recovered on 18Oct2019, for the event of "did not feel well" was recovered on 19Oct2019, while for the remaining events was not recovered.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Mydriasis, Neurological examination normal, Pallor, Posture abnormal
Clinical narrative: Pt tolerated MCV4 well and was given TDaP approximately 1-2 minutes after the first vaccine. Pt was feeling a little nervous about getting vaccines. Pt started to slump over, convulsed approximately 5 seconds with eyes closed, arm extended and stiff.  Pt then abruptly sat up with eyes open and pupils dilated and then (what i think was purposefully) laid back down. Pt was immediately awake and alert. Speech was normal. neurological exam was normal, eyes- PERRLA. Pt was pale. We kept her here for 30 minutes and she recovered completely and left the office.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Seizure
Clinical narrative: Pt tolerated MCV4 well and was given TDaP approximately 1-2 minutes after the first vaccine. Pt was feeling a little nervous about getting vaccines. Pt started to slump over, convulsed approximately 5 seconds with eyes closed, arm extended and stiff.  Pt then abruptly sat up with eyes open and pupils dilated and then (what i think was purposefully) laid back down. Pt was immediately awake and alert. Speech was normal. neurological exam was normal, eyes- PERRLA. Pt was pale. We kept her here for 30 minutes and she recovered completely and left the office.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient received Fluzone HD on 10/21/19. Had typical pain at injection site the next day. Pain persisted and spread to entire arm. Pt state there is no redness or swelling of arm just the pain. pain is mainly between shoulder and elbow, hurts to push on arm or try to lift arm. Patient stated she called MD and he ran a course of steroids and pain went away. after completing steroids the pain came back. Patient is awaiting follow up with MD at this point.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Vaccine does was given too soon. It is considered an invalid dose. Patient is known for having Migraines. He did receive 2 vaccines that day Menveo and Fluzone by Sanofi.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy - both sides of neck
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No symptoms
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Myalgia, Paraesthesia, Swelling
Clinical narrative: Local muscle soreness occurring 11/18 to now. No other side effects??swelling, redness, paresthesias, weakness.
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event happened.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient not experiencing additional symptoms.; patients received unspecified dose in ROTATEQ immunization series that was improperly stored; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-NOV-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # R017955, expiry date 05-MAY-2020) (exact dose was not reported) for prophylaxis. Storage temperature was 10.57 Celsius degrees (C) during the time frame of 15 minutes. Previous temperature excursions were: 9.94 C for 15 minutes, 10.1 C for 15 minutes and 13.29 C for 45 minutes. The digital data logger was involved. The patient did not experience additional symptoms. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported for the patient by the pharmacist.; administration of one dose of MMR II that was reconstituted by an expired STERILE DILUENT; administration of one dose of MMR II that was reconstituted by an expired STERILE DILUENT; This spontaneous report was received from a pharmacist and refers to an approximately 32-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-NOV-2019, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA))(M-M-R II) 0.5 milliliter (ml) (lot # R036583, expiry date 17-DEC-2020) (route of administration was not reported) for prophylaxis. The vaccine was reconstituted with one dose of expired sterile diluent 0.7 ml (lot# N012922, expiry date 15-OCT-2019) (route of administration was not reported). No adverse effects were reported. Both the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent were stored in the correct temperature. The outcome of expired product administered, no adverse event and product preparation issue was unknown.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: the patient received an improperly stored dose of RECOMBIVAX; This spontaneous report was received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 15-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) 5 microgram (mcg) per 0.5 milliliter (ml) (dose, route of administration and anatomical site of vaccination  were not reported; lot number R021372 has been verified to be a valid lot number, expiration date 25-MAY-2021) as prophylaxis (product storage error). The vaccine was stored at a temperature of 25 degrees Farenheit (°F) for 6 hours and 28 minutes, and at a temperature of 55 °F for 7 hours. There was no previous temperature excursion. The digital data logger was involved.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she is scared to get pneumovax23 in a year, though she is about 7 years too late but she took this one; This spontaneous report was received from a physician via Pfizer referring to a 72-year-old female patient. The patient's concurrent condition included chronic obstructive pulmonary disorder (COPD). The patient's concomitant medications were not provided. On an unknown date the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose #, route of administration, lot/batch # and expiry date were not reported) for prophylaxis. On an unknown date, the patient was scared to get Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX) within a year, though she is about 7 years too late but she took that one (inappropriate schedule of product administration). It was reported that, the patient was supposed to take that in a year which have the one with 23 different pneumonia things, but she was not sure whether she wants to do if this also happens with the 13.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Malaise
Clinical narrative: Aching, fatigue, chills, diarreha , upset stomach; Aching; Aching, fatigue, chills, diarreha , upset stomach; Aching, fatigue, chills, diarreha , upset stomach; Aching, fatigue, chills, diarreha , upset stomach; sick; This case was reported by a consumer via call center representative and described the occurrence of fatigue 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, less than 2 months after receiving Shingrix, the patient experienced fatigue, pain, chills, diarrhea, upset stomach and sickness. On an unknown date, the outcome of the fatigue, pain, chills, diarrhea, upset stomach and sickness were unknown.   The reporter considered the fatigue, pain, chills, diarrhea, upset stomach and sickness to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose two months ago and got sick with aching, fatigue, chills, diarrhea, upset stomach. The reporter wanted to know was it likely that would get sick again on the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Aching, fatigue, chills, diarreha , upset stomach; Aching; Aching, fatigue, chills, diarreha , upset stomach; Aching, fatigue, chills, diarreha , upset stomach; Aching, fatigue, chills, diarreha , upset stomach; sick; This case was reported by a consumer via call center representative and described the occurrence of fatigue 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, less than 2 months after receiving Shingrix, the patient experienced fatigue, pain, chills, diarrhea, upset stomach and sickness. On an unknown date, the outcome of the fatigue, pain, chills, diarrhea, upset stomach and sickness were unknown.   The reporter considered the fatigue, pain, chills, diarrhea, upset stomach and sickness to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose two months ago and got sick with aching, fatigue, chills, diarrhea, upset stomach. The reporter wanted to know was it likely that would get sick again on the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: When I looked it up it was the two potassium ingredients in it that I am allergic to; This case was reported by a consumer via call center representative and described the occurrence of allergy to vaccine in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced allergy to vaccine. On an unknown date, the outcome of the allergy to vaccine was unknown.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingrix.  Additional details were reported as follows: The patient was allergic to the two ingredients of Shingrix vaccine which included potassium dihydrogen phosphate and dipotassium phosphate. The patient had zince allergy, zinc makes red and gives trashy skin. The reporter wanted to know what should do if someone is allergic to some ingredients in Shingles shot.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction 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 adverse reaction. Shingrix was discontinued. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: This case was reported by the wife who reported for her husband. The patient had an adverse reaction to Shingrix and his doctor recommended he not get the second immunization. The reporter wanted to know what does your research show about the effectiveness of 1 of the 2 recommended does.
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: skin is still ashen/gray; This case was reported by a pharmacist via sales rep and described the occurrence of skin discoloration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix and after a couple weeks was still ashen/gray.
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: incidence of flu like symptoms after vaccination; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter mentioned an incidence of flu like symptoms in boys after Meningococcal B vaccination. When the office sees this, the reporter did not complete the series. The reporter consented to follow up.