chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: An adult female, age unknown, reported to MassBiologics by telephone on March 30, 2018 that she received a Td vaccine (NDC 13533-131), lot number unknown, in response to a cat scratch at her primary care provider's office approximately two weeks prior. The patient indicated that she was experiencing persistent arm pain, which started the same day as Td administration, on the arm that was vaccinated. She did not contact a medical professional for her arm pain. The patient did not want to disclose any additional information about the adverse event or her healthcare provider during the phone call but requested information about the Td vaccine be mailed to her. Follow-up with the patient was attempted by postal mail on May 3, 2018; no response was received and her recovery status remains unknown. Sender's Comments: The adverse event was assessed as non-serious and labeled.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Biopsy skin, Blister, Peripheral swelling, Pruritus, Scar
Clinical narrative: On October 31, 2018 a 43 year old male received an IM injection of MassBiologics' Td vaccine (Lot #A112A1) as a routine booster in his left arm. One to two days post administration, the patient developed itchiness in both hands and blisters on both hands, primarily around his knuckles and the joints of his fingers. The patient contacted his PCP on November 5 to report the reaction and was instructed by a nurse to monitor it at home. Between November 5 - 8, the blisters increased in size and developed a bullseye appearance and the patient's fingers began to swell. On November 8, the patient went to a dermatologist that took a biopsy of the blisters; the patient reported that the results were inconclusive. The dermatologist prescribed Prednisone 80mg with decreasing doses for three weeks. The patient reported the adverse event to MassBiologics on November 14, 2018 and he reported that the itchiness on both hands had resolved but still had callous-like scarring on his hands that resembled blood blisters. Follow-up performed on January 3, 2019: The patient confirmed that he had finished his prescription of Prednisone and that his reactions had completely resolved by the end of his treatment (about one month after Td administration). The patient indicated at least 4 visits to the dermatologist and his primary care physician (dates not provided) from November 8, 2018 through January 3, 2019 due to his reactions. Sender's Comments: All adverse events reported in this case were assessed as non-serious. Peripheral swelling is described in the Td vaccine package insert. The reported itchiness and blisters on both hands are unexpected events.
Age: 56.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Joint stiffness
Clinical narrative: A 56 year old male reported to MassBiologics on December 3, 2018 that he received a Td vaccine (Lot #A113A) approximately 14 days prior at his primary healthcare provider's office in response to a knife cut while deer hunting. He did not receive any other vaccinations that same day. The patient reported that 3 days after Td administration he experienced dizziness, headaches, joint pain / stiffness, and body weakness / not feeling well. He visited his healthcare provider approximately 1 week after the onset of his reactions. His physician provided him with the Td lot number and contact information for FDA. In addition, a brain MRI was ordered for the patient and scheduled for December 3, 2018 at 6PM due to the worsening of his dizziness. The patient contacted FDA who recommended that he contact the manufacturer of the Td vaccine since the symptoms he described are listed on the Td package insert.  When the patient called MassBiologics on December 3, 2018 to report the adverse event, he indicated that his symptoms were the same but had worsened from initial onset. MassBiologics attempted follow-up with the patient via telephone on December 28, 2018 and January 3, 2019 but no response was received; the patient's recovery status remains unknown. Sender's Comments: All adverse events reported in this case were assessed as non-serious and labeled.
Age: 56.0
Sex: M
Vaccine: TD
Symptoms: Malaise, Nuclear magnetic resonance imaging brain
Clinical narrative: A 56 year old male reported to MassBiologics on December 3, 2018 that he received a Td vaccine (Lot #A113A) approximately 14 days prior at his primary healthcare provider's office in response to a knife cut while deer hunting. He did not receive any other vaccinations that same day. The patient reported that 3 days after Td administration he experienced dizziness, headaches, joint pain / stiffness, and body weakness / not feeling well. He visited his healthcare provider approximately 1 week after the onset of his reactions. His physician provided him with the Td lot number and contact information for FDA. In addition, a brain MRI was ordered for the patient and scheduled for December 3, 2018 at 6PM due to the worsening of his dizziness. The patient contacted FDA who recommended that he contact the manufacturer of the Td vaccine since the symptoms he described are listed on the Td package insert.  When the patient called MassBiologics on December 3, 2018 to report the adverse event, he indicated that his symptoms were the same but had worsened from initial onset. MassBiologics attempted follow-up with the patient via telephone on December 28, 2018 and January 3, 2019 but no response was received; the patient's recovery status remains unknown. Sender's Comments: All adverse events reported in this case were assessed as non-serious and labeled.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 24 years old female patient who received an expired dose of vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 10-Jan-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5746AC (expiry date: Oct-2018) via unknown route in unknown administration site. It was a case of actual medication error due to expired vaccine used. At the time of this report, it is unknown to reporter if the MENACTRA is continuing or if it is discontinued. It was unknown whether any adverse event occurred. No additional information was available at the time of this report. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 16-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old male patient received vaccine ACT-HIB. The patient's past vaccination(s) included PENTACEL in MAR-2018 with ACTHIB in it. The patient's past medical history and family history were not provided. Concomitant medications included PROQUAD, PREVNAR 13 and VAQTA on unknown dates. On 16-Jan-2019, the patient received a fourth dose in series, 0.5ml of suspect HIB (PRP/T) VACCINE lot UI819AA, expiry date 17-Nov-2018 via intramuscular route in the right thigh. It was an actual medication error due to expired vaccine used. It was reported that patient was given an expired dose (expiry date 17-Nov-2018) of ACT-HIB vaccine on 16-Jan-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 16-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 69 years old male patient who received vaccine MENACTRA. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 15-Jan-2019, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5746AC, expiry date 14-Oct-2018 via intramuscular route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient was given an expired dose (expiry date 14-Oct-2018) of MENACTRA vaccine on 15-Jan-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 16-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a nine months old female patient and reported that the second dose was given too early of vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No other vaccines were given at the time of FLUZONE QUADRIVALENT. On 01-Nov-2018 at day time, the patient received a 1st dose of suspect 0.25 ml INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ005AD and expiry date: 30-Jun-2019) (route and site of administration was not reported). On 12-Nov-2018 she also received a 2nd dose of the same vaccine. It was a case of actual medication error due to drug dose administration interval too short. It was not reported if any adverse event experienced by the patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Lethargy, Pain, Pyrexia
Clinical narrative: High fever and uncontrollable shaking for about two hours beginning at 3:30 in the morning, after administration of vaccine at 4:00 PM (approximately) the previous day. General lethargy, achiness, and headache for about two days afterward. Soreness at injection site for three days.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: High fever and uncontrollable shaking for about two hours beginning at 3:30 in the morning, after administration of vaccine at 4:00 PM (approximately) the previous day. General lethargy, achiness, and headache for about two days afterward. Soreness at injection site for three days.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling of body temperature change, Impaired driving ability, Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: After receiving my flu vaccine on 10/15 in my left shoulder I started to experience excruciating shoulder pain. The pain progressed and continue to worsen for weeks. I could not even lift my arm at all. I could not remove my clothing without assistance. I could not lift that arm enough to grab the steering wheel to drive, I could not lift the arm enough to open my car door. There was a constant hot/cold burning sensation in the injection site. I went to see my Occupational Health Department (as the shot was given to me at work). They assessed and stated they had never seen anyone have such an issue with the flu shot. I saw ARNP on 10/30. She ordered an Xray of left shoulder and I was given Prednisone. Follow up appt. on 11/6 where I was given FLEXERIL and LIDODERM patches. Very minimal relief came from the medications given. Did Physical Therapy which was barely tolerated and made the pain intensely worse. MRI Results are stated as follows: Nonspecific marrow edema in the posterior humeral head/neck junction. Some adjacent edema is seen in the subdeltoid bursa. The exact etiology of this marrow edema is uncertain. Was referred to Orthopedic Dr and was seen on 1/3/19. Dr. stated that there was nothing he could do for me and declared me at Maximum Medical Improvement. Referred me to see Infectious Disease Dr. I saw Dr. on 1/21/19. He said he has seen this in extremely rare case on two other times. He ordered another MRI so that he can compare to the last MRI. My next MRI is scheduled for 2/13/19. As of today, It has been 14 weeks and 3 days since I received the vaccination without resolve.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Oedema, X-ray limb
Clinical narrative: After receiving my flu vaccine on 10/15 in my left shoulder I started to experience excruciating shoulder pain. The pain progressed and continue to worsen for weeks. I could not even lift my arm at all. I could not remove my clothing without assistance. I could not lift that arm enough to grab the steering wheel to drive, I could not lift the arm enough to open my car door. There was a constant hot/cold burning sensation in the injection site. I went to see my Occupational Health Department (as the shot was given to me at work). They assessed and stated they had never seen anyone have such an issue with the flu shot. I saw ARNP on 10/30. She ordered an Xray of left shoulder and I was given Prednisone. Follow up appt. on 11/6 where I was given FLEXERIL and LIDODERM patches. Very minimal relief came from the medications given. Did Physical Therapy which was barely tolerated and made the pain intensely worse. MRI Results are stated as follows: Nonspecific marrow edema in the posterior humeral head/neck junction. Some adjacent edema is seen in the subdeltoid bursa. The exact etiology of this marrow edema is uncertain. Was referred to Orthopedic Dr and was seen on 1/3/19. Dr. stated that there was nothing he could do for me and declared me at Maximum Medical Improvement. Referred me to see Infectious Disease Dr. I saw Dr. on 1/21/19. He said he has seen this in extremely rare case on two other times. He ordered another MRI so that he can compare to the last MRI. My next MRI is scheduled for 2/13/19. As of today, It has been 14 weeks and 3 days since I received the vaccination without resolve.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Occult blood negative
Clinical narrative: Pt started 1 day after vaccine with diarrhea and developed blood in stool on day 2. Stool was tested previously for blood after report of single bloody stool following 2 month visit which was guiac negative.
Age: 61.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site dryness, Injection site rash, Rash
Clinical narrative: Patient reports she had a rash at the site of injection (left arm) and on a small area on the left side of her chest. Rash resolved after three days. Patient is currently left with a dry, circular patch of skin at the site of injection. Denies any other issues.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Axonal neuropathy, Blood test normal, CSF test normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram normal
Clinical narrative: October 24, 2018, received the flu shot (Fluvcelvax, Seqirus) as part of the employee vaccination program. November 10, 2018, right pinky developed tingling and numbness that lasted for a few hours before back to normal; November 26, 2018, peroneal nerve palsy on left leg with foot drop and loss of dorsiflexion; November 29, treated with one-week oral steroid. December 8, 2018, right hand (4th and 5th finger) developed tingling, numbness, cramp, weakness and pain. The palm of the affected fingers also developed numbness and pain. Between December 8-13, hospitalized and treated with 5-day IVIG for suspected GBS or CIDP. Jan 2, 2019, received a nerve conduction test and EMG test, showing axonal loss. The diagnosis is mononeuritis multiplex. Jan 3, 2019, left hand (4th and 5th finger) developed tingling and numbness. The palm of the affected fingers also developed numbness. The extent was less severe than the right hand. So far, all the tests (e.g. blood work, spinal fluid, MRIs, x-ray, CT, urine test) showed normal results, ruling out malignancy, hematologic, rheumatologic, and infectious reasons. The patient is otherwise healthy, non-smoker, non-drinker, without any chronic diseases, and has not been taking any medications prior. The patient is currently taking gabapentin for controlling nerve pain. The patient's symptoms have been improving, limping of left leg/foot is less noticeable, gained some dorsiflexion, gained some strength back in the leg/foot, and hands.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: October 24, 2018, received the flu shot (Fluvcelvax, Seqirus) as part of the employee vaccination program. November 10, 2018, right pinky developed tingling and numbness that lasted for a few hours before back to normal; November 26, 2018, peroneal nerve palsy on left leg with foot drop and loss of dorsiflexion; November 29, treated with one-week oral steroid. December 8, 2018, right hand (4th and 5th finger) developed tingling, numbness, cramp, weakness and pain. The palm of the affected fingers also developed numbness and pain. Between December 8-13, hospitalized and treated with 5-day IVIG for suspected GBS or CIDP. Jan 2, 2019, received a nerve conduction test and EMG test, showing axonal loss. The diagnosis is mononeuritis multiplex. Jan 3, 2019, left hand (4th and 5th finger) developed tingling and numbness. The palm of the affected fingers also developed numbness. The extent was less severe than the right hand. So far, all the tests (e.g. blood work, spinal fluid, MRIs, x-ray, CT, urine test) showed normal results, ruling out malignancy, hematologic, rheumatologic, and infectious reasons. The patient is otherwise healthy, non-smoker, non-drinker, without any chronic diseases, and has not been taking any medications prior. The patient is currently taking gabapentin for controlling nerve pain. The patient's symptoms have been improving, limping of left leg/foot is less noticeable, gained some dorsiflexion, gained some strength back in the leg/foot, and hands.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Mononeuropathy multiplex, Muscle spasms, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: October 24, 2018, received the flu shot (Fluvcelvax, Seqirus) as part of the employee vaccination program. November 10, 2018, right pinky developed tingling and numbness that lasted for a few hours before back to normal; November 26, 2018, peroneal nerve palsy on left leg with foot drop and loss of dorsiflexion; November 29, treated with one-week oral steroid. December 8, 2018, right hand (4th and 5th finger) developed tingling, numbness, cramp, weakness and pain. The palm of the affected fingers also developed numbness and pain. Between December 8-13, hospitalized and treated with 5-day IVIG for suspected GBS or CIDP. Jan 2, 2019, received a nerve conduction test and EMG test, showing axonal loss. The diagnosis is mononeuritis multiplex. Jan 3, 2019, left hand (4th and 5th finger) developed tingling and numbness. The palm of the affected fingers also developed numbness. The extent was less severe than the right hand. So far, all the tests (e.g. blood work, spinal fluid, MRIs, x-ray, CT, urine test) showed normal results, ruling out malignancy, hematologic, rheumatologic, and infectious reasons. The patient is otherwise healthy, non-smoker, non-drinker, without any chronic diseases, and has not been taking any medications prior. The patient is currently taking gabapentin for controlling nerve pain. The patient's symptoms have been improving, limping of left leg/foot is less noticeable, gained some dorsiflexion, gained some strength back in the leg/foot, and hands.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Neuralgia, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: October 24, 2018, received the flu shot (Fluvcelvax, Seqirus) as part of the employee vaccination program. November 10, 2018, right pinky developed tingling and numbness that lasted for a few hours before back to normal; November 26, 2018, peroneal nerve palsy on left leg with foot drop and loss of dorsiflexion; November 29, treated with one-week oral steroid. December 8, 2018, right hand (4th and 5th finger) developed tingling, numbness, cramp, weakness and pain. The palm of the affected fingers also developed numbness and pain. Between December 8-13, hospitalized and treated with 5-day IVIG for suspected GBS or CIDP. Jan 2, 2019, received a nerve conduction test and EMG test, showing axonal loss. The diagnosis is mononeuritis multiplex. Jan 3, 2019, left hand (4th and 5th finger) developed tingling and numbness. The palm of the affected fingers also developed numbness. The extent was less severe than the right hand. So far, all the tests (e.g. blood work, spinal fluid, MRIs, x-ray, CT, urine test) showed normal results, ruling out malignancy, hematologic, rheumatologic, and infectious reasons. The patient is otherwise healthy, non-smoker, non-drinker, without any chronic diseases, and has not been taking any medications prior. The patient is currently taking gabapentin for controlling nerve pain. The patient's symptoms have been improving, limping of left leg/foot is less noticeable, gained some dorsiflexion, gained some strength back in the leg/foot, and hands.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Peroneal nerve palsy, Urine analysis normal, X-ray normal
Clinical narrative: October 24, 2018, received the flu shot (Fluvcelvax, Seqirus) as part of the employee vaccination program. November 10, 2018, right pinky developed tingling and numbness that lasted for a few hours before back to normal; November 26, 2018, peroneal nerve palsy on left leg with foot drop and loss of dorsiflexion; November 29, treated with one-week oral steroid. December 8, 2018, right hand (4th and 5th finger) developed tingling, numbness, cramp, weakness and pain. The palm of the affected fingers also developed numbness and pain. Between December 8-13, hospitalized and treated with 5-day IVIG for suspected GBS or CIDP. Jan 2, 2019, received a nerve conduction test and EMG test, showing axonal loss. The diagnosis is mononeuritis multiplex. Jan 3, 2019, left hand (4th and 5th finger) developed tingling and numbness. The palm of the affected fingers also developed numbness. The extent was less severe than the right hand. So far, all the tests (e.g. blood work, spinal fluid, MRIs, x-ray, CT, urine test) showed normal results, ruling out malignancy, hematologic, rheumatologic, and infectious reasons. The patient is otherwise healthy, non-smoker, non-drinker, without any chronic diseases, and has not been taking any medications prior. The patient is currently taking gabapentin for controlling nerve pain. The patient's symptoms have been improving, limping of left leg/foot is less noticeable, gained some dorsiflexion, gained some strength back in the leg/foot, and hands.
Sex: F
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 52 year old female patient. The patient did not have pertinent medical history, drug reactions/allergies and concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II as vaccination (dosing details, route, lot# and expiration date not reported). On an unknown date, post vaccination an unspecified test showed a low serologic titer. The patient sought medical attention and received treatment for the event. The event did not cause hospitalization or disability to the patient. The event was not life threatening. The outcome of the event viral titer decreased was unknown. The reporter's causality assessment was not provided. Product quality complaint not involved.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 08-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) and ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of muscle pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter had a patient who had muscle pain since the SHINGRIX shot that started 3 to 4 weeks afterward and had gotten worse. The shot was only thing the patient had done differently.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain in extremity, Peripheral swelling
Clinical narrative: 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 SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received in September 2018, refer case US2019005998). On 9th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, swelling arm, fever, headache and shivers. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, swelling arm, fever, headache and shivers were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, swelling arm, fever, headache and shivers to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Wednesday, the patient's arm started out sore not to bad but then got progressively worse. The patient's arm was swollen and got a fever with headaches and shivers like he had the flu. The reporter stated that he could not get out of bed for 2 days and just got back to his self this morning.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: 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 SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received in September 2018, refer case US2019005998). On 9th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, swelling arm, fever, headache and shivers. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, swelling arm, fever, headache and shivers were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, swelling arm, fever, headache and shivers to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Wednesday, the patient's arm started out sore not to bad but then got progressively worse. The patient's arm was swollen and got a fever with headaches and shivers like he had the flu. The reporter stated that he could not get out of bed for 2 days and just got back to his self this morning.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain, Rash, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. Co-suspect products included AFLURIA (batch number 03044611A, expiry date 30th June 2019) for prophylaxis. On 5th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd November 2018, the patient received AFLURIA (intramuscular). In November 2018, 5 days after receiving SHINGRIX, the patient experienced joint pain and general body pain. On 3rd December 2018, the patient experienced rash and itchy rash. On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the joint pain, general body pain and muscle pain were recovered/resolved and the outcome of the rash and itchy rash were unknown. It was unknown if the reporter considered the joint pain, general body pain, rash, itchy rash and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient began to experience joint pain at the knee five days after receiving her first dose of the SHINGRIX vaccine on left deltoid. Seven days after receiving the vaccine, the patient developed body aches all over her body. On 3rd December 2018, the patient developed a rash across her back consisting of five itchy, annoying bumps. The patient indicated that these were not painful. It took three weeks for the joint and muscle pain to resolve. Unknown the status of the rash. The patient received AFLURIA QUADRIVALENT in right deltoid at the same time she received the SHINGRIX vaccination. The reporter was unable to provide additional information. Because the patient indicated that had not had the symptoms evaluated by her physician, the reporter was trying to determine if the second dose of SHINGRIX should be administered. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 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 SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient's arm was sore and achy for a day or two. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK012893.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Headache, body aches, chronic fatigue, dizziness, blurry vision, stomach ache.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Headache, body aches, chronic fatigue, dizziness, blurry vision, stomach ache.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Pt stated she had left shoulder pain, was treated by Orthopaedic for SIRVA.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: 7.5 x 8.5 area of pinkness at area of shot. No fever, drainage or pain.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding a 14-month patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 14-JAN-2019, the patient was vaccinated with an improperly stored dose of VARIVAX (route of administration and dose were not reported) for prophylaxis (lots # and expiration dates: R018777, 01-JUL-2020; R017641, 20-JUN-2020; R013563, 13-MAY-2020), however, it was unknown which specific lots the patient received. The Sterile Diluent used to reconstitute the vaccines was stored properly. No adverse effects were reported. The vaccines were exposure to a temperature excursion of 9°C to 25°C (9.2°C) during 2 hours which was called by a data logger. There was not previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA005741: US-009507513-1901USA005740: US-009507513-1901USA005743: US-009507513-1901USA005739:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding a 1-year patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 14-JAN-2019, the patient was vaccinated with an improperly stored of VARIVAX (route of administration, indication and dose were not reported) for prophylaxis (lots # and expiration dates: R018777, 07-JUL-2020; R017641, 20-JUN-2020; R013563, 13-MAY-2020), however, it was unknown which specific lots the patient received. The sterile diluent used to reconstitute the vaccines was stored properly. No adverse effects were reported. The vaccines were exposure to a temperature excursion of 9°C to 25°C (9.2°C) during 2 hours which was called by a data logger. There was not previous temperature excursion. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA005742: US-009507513-1901USA005741: US-009507513-1901USA005740: US-009507513-1901USA005739: US-009507513-1901USA005573.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: 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 22-JAN-2019, the patient was vaccinated with improperly stored dose of VARIVAX (lot # R018931, expiration date: 02-JUL-2020, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of VARIVAX experienced temperature excursion between 15 and 46 Fahrenheit degrees for 1 hour 45 minutes. There was no previous temperature excursion reported. Digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Impaired work ability, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (fine after receiving the first dose on an unknown date.). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever and feels awful. On an unknown date, the outcome of the fever and feels awful were recovered/resolved. It was unknown if the reporter considered the fever and feels awful to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Registered Pharmacist (RPh) for herself. The age at vaccination was not reported. In 2018 last year from the reporting date, the patient received a dose of SHINGRIX, and she felt terrible with fever and missed work for an entire day. The patient said, she patient did not feel that great prior to receiving the vaccine. The patient received a dose of SHINGRIX on Wednesday (date unspecified) and felt better by Friday (date unspecified).
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who herself was the Nurse Practitioner. The age at vaccination was not reported. The patient stated, received the 1st dose of 2 doses given 2 to 6 months apart in unknown deltoid became swollen, red and hot. The pharmacy person seemed to have given the injection toward the back of the deltoid instead of the center. The shot did not hurt going in but the reaction started the next day. The size was 130cm by 110cm. The patient also stated no awareness of experiencing any other side effects. At the time of this report, minimum dosing interval for indicated 2nd dose had not been met, but the patient stated that she did not care about the adverse event, she just do not want shingles. The events were lasted approximately a week. The patient did believe the reaction was caused by SHINGRIX.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 65-year-old female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a month after receiving SHINGRIX, the patient experienced tiredness and difficulty breathing. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the difficulty breathing was not recovered/not resolved. It was unknown if the reporter considered the tiredness and difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The reporter has a patient that was so tired for three days after receiving the first dose of the SHINGRIX vaccine that she could not get out of bed. The symptoms resolved after three days. The patient also developed breathing issues after receiving the vaccination. She went to the Emergency room for these issues two weeks after receiving the vaccination. She was still having breathing issues. The reporter did not consent to follow up. The reporter was unable to provide additional information. She was transferred to Medical information.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site discolouration, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (did not have this type of reaction to the first dose). On an unknown date, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, injection site swelling, induration, skin warm and skin discoloration. On an unknown date, the outcome of the erythema of extremities, injection site swelling, induration, skin warm and skin discoloration were unknown. It was unknown if the reporter considered the erythema of extremities, injection site swelling, induration, skin warm and skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of SHINGRIX on Monday and their arm was red, hard, swollen, purple in the middle and warm to the touch. The swelling goes from the site to the arm pit.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced mild arm pain after dose 1 of SHINGRIX. The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: DTAP, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Instead of an MMR and Varicella vaccine, patient received MMRV and Varicella, no symptoms or side effects noted.
Age: 93.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Injection site swelling, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Initial symptoms included redness with swelling 7 cm x 7cm, tender warm to touch, itchiness reported by patient. Symptoms progressed to right upper outer arm mildly swollen with no localized area- there is a diffuse red rash over the area of swelling down to the elbow-all of this on the outer upper arm.
Age: 93.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Swelling, Tenderness
Clinical narrative: Initial symptoms included redness with swelling 7 cm x 7cm, tender warm to touch, itchiness reported by patient. Symptoms progressed to right upper outer arm mildly swollen with no localized area- there is a diffuse red rash over the area of swelling down to the elbow-all of this on the outer upper arm.
Age: 93.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Initial symptoms included redness with swelling 7 cm x 7cm, tender warm to touch, itchiness reported by patient. Symptoms progressed to right upper outer arm mildly swollen with no localized area- there is a diffuse red rash over the area of swelling down to the elbow-all of this on the outer upper arm.
Age: 100.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Mild pinkish in appearance with some swelling.
Age: 100.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Mild pinkish in appearance with some swelling.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Cold sweat, Dizziness, Fatigue, Headache
Clinical narrative: Generalized weakness, severe pain in spine, severe headache, cold sweats, fatigue, stiff neck and dizziness. Was unable to hold my infant. Symptoms lasted for about 6 hrs. TYLENOL and MOTRIN provided no relief.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Musculoskeletal stiffness, Spinal pain
Clinical narrative: Generalized weakness, severe pain in spine, severe headache, cold sweats, fatigue, stiff neck and dizziness. Was unable to hold my infant. Symptoms lasted for about 6 hrs. TYLENOL and MOTRIN provided no relief.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: Feeling "under the weather" possible fever (didn't check), chills, malaise.
Age: 2.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Dysphemia
Clinical narrative: Within hours she started stuttering by Friday she couldn't get a word out without getting stuck on the word. By Monday it was getting better, it's gradually gotten better but she still stutters on words. Of course I called the doctor and he said it was not listed as a side effect and at her age because she's so advanced her brain is not being able to keep up with her vocabulary. But I don't believe that it just so happened.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest pain, Dyspnoea, Hyperaesthesia, Injected limb mobility decreased
Clinical narrative: After the vaccine was administered she went to work as a dishwasher, her work day was no different than other days. When she got off, she could not move her left arm. Her daughter applied BENGAY and she took 2 TYLENOL 500mg tablets with little improvement. Her pain was 10 out of 10. It started on the left side of her back, went down her arm and continues around to the left side of her chest. The injection site was sensitive to the touch. The next day her pain lessened to 4 or 5 out of ten with the same pain area. She took 2 more TYLENOL 500mg tablets. She also complain of shortness of breath and chest pain, which she claims was resolved with ALKA SELTZER. No abnormal changes to her diet and she does not normally have heartburn. Today she complains of the same pain area with her pain being a 4 or 5 out of ten. The injection site is red and is warm and sensitive to the touch. She has taken 1 TYLENOL 500mg tablet today. After discussing with a provider in the clinic, we recommend that she go the the ER to make sure that there is not something else going on.