chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 30-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; a male patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.    On 19-JUN-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # R030612, expiration date 23-OCT-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion from -14 to -10 degrees Celsius (-13.3 degrees Celsius) for 30 minutes and from 9 to 25 degrees Celsius (17.8 degrees Celsius, multiple) for 32 minutes. The data logger was involved. There were no previous excursions reported. There were no adverse effects reported  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008340: US-009507513-1906USA008121:
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Neck pain, Pain, Pain in extremity
Clinical narrative: radiating pain in chest; radiating pain in left arm; radiating pain in neck; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced neck pain. On an unknown date, the patient experienced chest pain and pain in arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the neck pain, chest pain and pain in arm were unknown.   It was unknown if the reporter considered the neck pain, chest pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine 72 hrs from the date of reporting. The patient expereinvced pain raidiating around neck, chest, left a arm minor relief with 400mg Ibuprofen q6, but seems to be getting a little worse.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Hives/ round welps; warmth to touch; Chills/Shivers; feeling cold; Soreness; Redness; Redness; Itchiness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site rash and injection site itching. On 12th June 2019, the patient experienced chills and feeling cold. On 13th June 2019, the patient experienced hives and skin warm. The patient was treated with benadryl (nos) (Benadryl) and hydrocortisone. On 13th June 2019, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site rash, injection site itching and hives were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved and the outcome of the skin warm was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site rash, injection site itching, chills, feeling cold, hives and skin warm to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received 1st dose Shingrix in right arm experienced soreness, itchiness and redness (rash) at the injection site.  The pharmacist reported that chills occurred the next day and lasted for that day. Chills described as shivers and getting cold. Itchiness reported as occurring on and off.  It was reported that 2 days after vaccination patient developed hives that went down his arm. The pharmacist described hives as a good sized, round welps that is raised and extends to his wrist and they are warm to touch.  The pharmacist debates if patient should receive 2nd dose and wants to discuss with PCP. The pharmacist advised the patient to use Benadryl and topical like hydrocortisone.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Skin warm, Urticaria
Clinical narrative: Hives/ round welps; warmth to touch; Chills/Shivers; feeling cold; Soreness; Redness; Redness; Itchiness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site rash and injection site itching. On 12th June 2019, the patient experienced chills and feeling cold. On 13th June 2019, the patient experienced hives and skin warm. The patient was treated with benadryl (nos) (Benadryl) and hydrocortisone. On 13th June 2019, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site rash, injection site itching and hives were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved and the outcome of the skin warm was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site rash, injection site itching, chills, feeling cold, hives and skin warm to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received 1st dose Shingrix in right arm experienced soreness, itchiness and redness (rash) at the injection site.  The pharmacist reported that chills occurred the next day and lasted for that day. Chills described as shivers and getting cold. Itchiness reported as occurring on and off.  It was reported that 2 days after vaccination patient developed hives that went down his arm. The pharmacist described hives as a good sized, round welps that is raised and extends to his wrist and they are warm to touch.  The pharmacist debates if patient should receive 2nd dose and wants to discuss with PCP. The pharmacist advised the patient to use Benadryl and topical like hydrocortisone.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pleurisy
Clinical narrative: pleurisy; This case was reported by a other health professional via call center representative and described the occurrence of pleurisy in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 12th June 2019, the patient received the 2nd dose of Shingrix. On 14th June 2019, 2 days after receiving Shingrix, the patient experienced pleurisy. On an unknown date, the outcome of the pleurisy was unknown.   It was unknown if the reporter considered the pleurisy to be related to Shingrix.  Additional details were reported as follows: This case was reported by the pharmacy intern. Forty-eight hours after vaccination, the patient experienced pleurisy. The emergency room visit required. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Peripheral swelling, Pruritus
Clinical narrative: Bright red, swollen, itchy on the inside, looks like there is water ( for lack of another word) still in my left arm.  This arm is now larger than my right.  Seems to have settled near my elbow joint.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Retching
Clinical narrative: Severe Dizziness, sweating, dry heaves
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: diffuse arthralgias & myalgias x 12 days
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal disorder
Clinical narrative: redness developed from around site to within an inch or two of elbow, pain and swelling followed  The redness faded over a week but the soreness remains to the extent of limiting normal use of the arm to this date
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Pain in extremity
Clinical narrative: redness developed from around site to within an inch or two of elbow, pain and swelling followed  The redness faded over a week but the soreness remains to the extent of limiting normal use of the arm to this date
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Pallor
Clinical narrative: Soon after the vaccine were given the patient's body became stiff, his eyes rolled into the back of his head, and he became very pale. This episode lasted for approximately 2 minutes.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site discolouration, Injection site pain, Injection site swelling, Oropharyngeal pain
Clinical narrative: soreness, swelling and discoloring at site of injection, redness just below site of injection, headache, fever, body aches, sore throat
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: soreness, swelling and discoloring at site of injection, redness just below site of injection, headache, fever, body aches, sore throat
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Hypersomnia, Influenza like illness
Clinical narrative: severe flu like symptoms.  joint pain, upset stomach, chills, body aches, slight fever, lethargy.  Could not get out of bed for more than a few minutes.  Could not read or watch TV, could not sit up for more than a few minutes.  Slept most of the 24 hr period between 11 am on the 22 to 10 am on the 23rd.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: severe flu like symptoms.  joint pain, upset stomach, chills, body aches, slight fever, lethargy.  Could not get out of bed for more than a few minutes.  Could not read or watch TV, could not sit up for more than a few minutes.  Slept most of the 24 hr period between 11 am on the 22 to 10 am on the 23rd.
Age: 59.0
Sex: M
Vaccine: MENB
Symptoms: Induration, Myalgia, Rash erythematous
Clinical narrative: 2 days after vaccine given, patient had red rash, induration, myalgia
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: woke up with rash on chest Friday morning after receiving the vaccine Thursday morning, still has rash 6/24 (Monday) and has been putting hydrocortisone on it. red bumpy rash
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: I have a fever of 100.5, general malaise, tired and want to go back to bed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site urticaria, Lethargy
Clinical narrative: My arm was a bit sore the evening after the shot but I expected that. Within 18 hours, I was feeling achy and sore all over. I didn't want to go out on Friday night but just stay in. It was only then that I looked at the injection site. I have a raised red welt approximately 3 inches in diameter. It has not subsided in the interim. I am now in day 4. I was achy again on the afternoon of the second day after injection. Yesterday, I was also lethargic.  I am not currently achy, but that has occurred in the afternoon not morning. My arm itches at the injection site, and is still somewhat painful. There is a lump on my arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain
Clinical narrative: My arm was a bit sore the evening after the shot but I expected that. Within 18 hours, I was feeling achy and sore all over. I didn't want to go out on Friday night but just stay in. It was only then that I looked at the injection site. I have a raised red welt approximately 3 inches in diameter. It has not subsided in the interim. I am now in day 4. I was achy again on the afternoon of the second day after injection. Yesterday, I was also lethargic.  I am not currently achy, but that has occurred in the afternoon not morning. My arm itches at the injection site, and is still somewhat painful. There is a lump on my arm.
Age: 67.0
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash vesicular
Clinical narrative: On the morning of the fourth day after the vaccination, I woke up with a chicken pox like rash on my trunk (abdomen). This spread and got worse the following day. The itching was minimal (cortisone.10 took away all itch; the rash then started to get less red on the third day. Day four- still there, but fading.
Age: 67.0
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: On the morning of the fourth day after the vaccination, I woke up with a chicken pox like rash on my trunk (abdomen). This spread and got worse the following day. The itching was minimal (cortisone.10 took away all itch; the rash then started to get less red on the third day. Day four- still there, but fading.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: 9 hours later headache and fatigue started. Slept for 11 hours. Had headache, fatigue, fever, joint aches, loss of appetite  that last 5-7 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain, Pyrexia
Clinical narrative: 9 hours later it woke you up with joint pain and body aches.   Did not take any medicine.  At 7am, took some  ibuprofen. Felt sleep again and woke up with slight fever 99.4.  Took Motrin to reduce fever. Patient has not called doctor yet since it is similar to adverse events after 1st dose which took a couple of days to resolve.  Currently has pain at injection site.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: SHE DEVELOPED BIG RASHES ON ON HER ABDOMEN WHICH LASTED ABOUT 3 DAYS
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Woke up at 4am, 6/24/2019  to notice running fever 0f 100F together with tiredness headache
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Electrocardiogram abnormal, Sleep disorder
Clinical narrative: Atrial fibrillation.  Afib occurs in the night preventing sleep. Afib confirmed with a personal monitor. I haven?t had significant incidence of afib in 6 months prior.  Afib started the night after the injection and the following 2 nights so far.  Periods of afib have increased in length (day 1 - 1 hour, day 2 - 3 hours, day 3 - 4+ hours).  Other effects were previously reported on this site. I didn?t initially make the afib connection since it wasn?t listed as an effect until I really looked for it specifically.  My afib is vagal type.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: HIS EYE SHAKES AND HE HAS AN APPOINTMENT WITH EYE DOCTOR IN 2 WEEKS
Sex: M
Vaccine: VARZOS
Symptoms: Retinal tear
Clinical narrative: torn retina; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around In or around 21-JUL-2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2017 [reported as shortly after receiving zoster vaccine live (ZOSTAVAX)], the patient suffered from a torn retina. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the retinal tear was considered to be not recovered.  Retinal tear was considered to be disabling.  Upon internal review retinal tear was considered to be a medically significant event.   Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse effects reported; improperly stored dose of PEDVAX HIB was administered to the patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 19-JUN-2019, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R027328 with expiration date 12-JUL-2021 (dose detail and route were not reported) for prophylaxis.  The vaccine experienced improperly stored and was stored above 47 Fahrenheit degrees/ 9 degree Celsius (47.4 Fahrenheit degrees) for 1 hour and 30 minutes. There was no previous temperature excursion and the call was because of a data logger involved. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Immune system disorder, Joint stiffness, Joint swelling, Musculoskeletal stiffness, Pain
Clinical narrative: stiff knees/ stiff elbows; COULD NOT CURLE MY FINGERS; SOME REACTION WITH MY IMMUNE SYSTEM; PAIN/ hurt; hands swollen/ fingers swollen; wrists swollen; This case was reported by a consumer via call center representative and described the occurrence of hand swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced hand swelling, swelling of wrists, stiff knees, stiff fingers, immune system disorder and pain. On an unknown date, the outcome of the hand swelling, swelling of wrists and pain were recovered/resolved and the outcome of the stiff knees, stiff fingers and immune system disorder were unknown.   It was unknown if the reporter considered the hand swelling, swelling of wrists, stiff knees, stiff fingers, immune system disorder and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix injection at physician office. The patient stated that next day the patient wrists hands and fingers were swollen, they hurt.  The patient knees and elbows were stiff and the pain and swelling lasted to 1 week, and the swelling lasted for 2 weeks. The patient could not curle fingers to make a fist. The patient asked that will this happen again with the 2nd injection. The patient stated that this must be some reaction with immune system. The reporter can be contacted by phone.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: stiff knees/ stiff elbows; COULD NOT CURLE MY FINGERS; SOME REACTION WITH MY IMMUNE SYSTEM; PAIN/ hurt; hands swollen/ fingers swollen; wrists swollen; This case was reported by a consumer via call center representative and described the occurrence of hand swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced hand swelling, swelling of wrists, stiff knees, stiff fingers, immune system disorder and pain. On an unknown date, the outcome of the hand swelling, swelling of wrists and pain were recovered/resolved and the outcome of the stiff knees, stiff fingers and immune system disorder were unknown.   It was unknown if the reporter considered the hand swelling, swelling of wrists, stiff knees, stiff fingers, immune system disorder and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix injection at physician office. The patient stated that next day the patient wrists hands and fingers were swollen, they hurt.  The patient knees and elbows were stiff and the pain and swelling lasted to 1 week, and the swelling lasted for 2 weeks. The patient could not curle fingers to make a fist. The patient asked that will this happen again with the 2nd injection. The patient stated that this must be some reaction with immune system. The reporter can be contacted by phone.
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Injection site pain, Injection site swelling, Product complaint
Clinical narrative: product complaint; injection site pain; Vaccination site swelling; trouble driving; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 30th September 2021) for prophylaxis. This case was associated with a product complaint.  On an unknown date, the patient received the 1st dose of Shingrix. On 25th February 2019, less than a year after receiving Shingrix, the patient experienced injection site pain, injection site swelling and driving ability disturbed. On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the injection site pain, injection site swelling, driving ability disturbed and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling and driving ability disturbed to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the right deltoid and felt injection site pain as the product was being administered and she pulled away from the pharmacist.  The site became swollen and had trouble driving home.  The patient might had gotten physical therapy to deal with the pain. She did not want to get the 2nd dose. The reporter consented to follow up. The eight other patients pulled back when the vaccine was administering from the same box. The pharmacist did not administer the 10th dose and it was available for return to GlaxoSmithKline for analysis.
Age: 1.67
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: adacel that was given expired/ none symptoms; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse (reporters herself) by phone.  This case involves a 20 months old female patient who was vaccinated with 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5202AA and expiry date: 16-May-2019) via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  No symptoms were reported.  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.   Documents held by the sender: none.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Daptacel was administered to an 11 year old patient; patient was administered Daptacel instead of Adacel; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (formulation: unknown, lot: C5307AA via intramuscular route in the right deltoid) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 13-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. This would have been dose 6 in the series.  It was unknown if the patient had any adverse event.  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 document held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Urticaria
Clinical narrative: hives; minor transient numbness in 1 leg with the last shot; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA170185 (same reporter).  This case involves a male patient who experienced hives and minor transient numbness in 1 leg with the last shot, while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported.  On an unknown date, The patient developed a non-serious hives (urticaria) and minor transient numbness in 1 leg with the last shot (hypoaesthesia) following the administration of RABIES (HDC) VACCINE.  No lab test reported.  Final diagnosis was minor transient numbness in 1 leg with the last shot and hives.   An unknown antihistamines corrective treatment was received.  The patient outcome was not reported.  Information on the batch number was requested.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was inadvertently administered to a patient/no AE; Initial information received on 18-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 36 months old female patient who was inadvertently vaccinated with an expired second dose of 0.5 mL suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5206AA, expiry date: 17-May-2019) via intramuscular route in the right thigh on 18-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.  It was a case of actual medication error case due to expired vaccine used.  No adverse event was reported.  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.
Sex: F
Vaccine: MEN, MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient received Menactra today and then later it was realized that she already received Menactra in Apr2018.; patient was to receive a meningococcal B vaccine, patient received Menactra today; Initial information received on 19-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female patient who received 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (formulation: unknown, lot: U6015AA, expiry date: 06-Oct-2019, via unknown route in unknown administration site), on 19-Jun-2019 and she was already received Menactra in Apr-2018 and was supposed to receive Meningococcal B vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to extra dose administered and Wrong vaccine administered.  It was unknown whether the patient had any adverse event.  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 document held by sender: none.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: Patient did state she had not eaten breakfast before coming to the office this morning but had done well with the 1st Gardasil vaccine.  She did drink 4 oz orange juice before the vaccine.  She was put in a semi-reclined position afterward.  After 5 minutes I checked on patient and she stated she felt dizzy and slightly nauseated.  She was given additional orange juice, cool compress was applied to her forehead, and placed in reclining position.  BP was  122/79 and HR was 97; about 20 minutes later BP 119/80 and HR 109.  Continued to monitor her, vital signs remained stable.  She remained in the office for 45 minutes total, during which time she was able to transition to sitting which was well-tolerated, she was seen by Dr. before being discharged from office, at time of discharge BP was 118/75 and HR 93.  Left office in good condition with both parents, parents aware to call back to office if symptoms worsening or additional concerns or questions.
Age: 16.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Dermatitis contact, Eye swelling, Rash, Rash pustular
Clinical narrative: Patient stated he woke up on 06/22/2019 at 10:00AM with a rash on his arms, chest, and face.  Stated right eye was swollen as well.  Nurse Practitioner stated Patient has a pustular rash on anterior and posterior trunk of chest from waist up.  This rash is also on bilateral arms and face.  Patient's right eye is swollen as well.  She stated the rash looks like contact dermatitis.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Hyperacusis, Injected limb mobility decreased, Insomnia
Clinical narrative: By 6:30pm had fever (102); patient could not lower fever even with Percocet. Took aspirin and cool shower.    Up all night long, still have fever until now.  Fever is coming down; continues taking aspirin.   Patient has not called doctor yet.   Barely can lift arm and it is severely swollen.  Patient putting ice packs on area, area is hot to the touch. Patient vomiting and has light sensitivity like if had migraine.  The Percocet worsens the migraine patient is even wearing a mask to help.  Patient reports that hearing is sensitive and is hearing a high pitch. Patient is just throwing up green at this point since there is nothing in stomach.  Per patient, she is dizzy, everything hurts, and busted blood vessel onface. Patient is exhausted and fatiguedcannot even sleep. Patient continues with meds normally except for avoiding Percocet and adding the aspirinper nurse's instructions. Patient has a rash all over body
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Photophobia, Pyrexia, Rash generalised
Clinical narrative: By 6:30pm had fever (102); patient could not lower fever even with Percocet. Took aspirin and cool shower.    Up all night long, still have fever until now.  Fever is coming down; continues taking aspirin.   Patient has not called doctor yet.   Barely can lift arm and it is severely swollen.  Patient putting ice packs on area, area is hot to the touch. Patient vomiting and has light sensitivity like if had migraine.  The Percocet worsens the migraine patient is even wearing a mask to help.  Patient reports that hearing is sensitive and is hearing a high pitch. Patient is just throwing up green at this point since there is nothing in stomach.  Per patient, she is dizzy, everything hurts, and busted blood vessel onface. Patient is exhausted and fatiguedcannot even sleep. Patient continues with meds normally except for avoiding Percocet and adding the aspirinper nurse's instructions. Patient has a rash all over body
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Vascular injury, Vomiting
Clinical narrative: By 6:30pm had fever (102); patient could not lower fever even with Percocet. Took aspirin and cool shower.    Up all night long, still have fever until now.  Fever is coming down; continues taking aspirin.   Patient has not called doctor yet.   Barely can lift arm and it is severely swollen.  Patient putting ice packs on area, area is hot to the touch. Patient vomiting and has light sensitivity like if had migraine.  The Percocet worsens the migraine patient is even wearing a mask to help.  Patient reports that hearing is sensitive and is hearing a high pitch. Patient is just throwing up green at this point since there is nothing in stomach.  Per patient, she is dizzy, everything hurts, and busted blood vessel onface. Patient is exhausted and fatiguedcannot even sleep. Patient continues with meds normally except for avoiding Percocet and adding the aspirinper nurse's instructions. Patient has a rash all over body
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pain
Clinical narrative: Pain on movement for a period of five weeks after injection. One month after injection (and 4-1/2 months after implantation of two PP mesh surgical appliances) I have chronic fatigue. I'm unsure which event precipitated this, or if it was both.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Feeling hot, Influenza like illness
Clinical narrative: Flu-like Symptoms; aching; dizziness; nauseous; feeling hot; Shivering; muscle pain; joint pain; Welp great big welp near the injection site that is spreading; Vaccine Administered at Inappropriate Site; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd March 2019, refer case US2019108644).   On 13th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th June 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 14th June 2019, the patient experienced influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was nurse. Yesterday from the date of reporting after 5 PM, the patient received 2nd dose on an unknown deltoid and experienced influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema. The symptoms were lasting just prior to the call after waking up on the day of reporting  The patient also observed great big welp, near the injection site that was spreading. The patient also mentioned that vaccine was administered between her shoulder and elbow and after probing, it was determined that the vaccine was administered below deltoid region, which led to vaccine administered at inappropriate site. The reporter did not consent to follow-up. This call was transferred to medical information (MI) for further queries and the patient wanted to know the efficacy of Shingrix if not administered in the deltoid.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Myalgia, Nausea, Pain
Clinical narrative: Flu-like Symptoms; aching; dizziness; nauseous; feeling hot; Shivering; muscle pain; joint pain; Welp great big welp near the injection site that is spreading; Vaccine Administered at Inappropriate Site; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd March 2019, refer case US2019108644).   On 13th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th June 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 14th June 2019, the patient experienced influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was nurse. Yesterday from the date of reporting after 5 PM, the patient received 2nd dose on an unknown deltoid and experienced influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema. The symptoms were lasting just prior to the call after waking up on the day of reporting  The patient also observed great big welp, near the injection site that was spreading. The patient also mentioned that vaccine was administered between her shoulder and elbow and after probing, it was determined that the vaccine was administered below deltoid region, which led to vaccine administered at inappropriate site. The reporter did not consent to follow-up. This call was transferred to medical information (MI) for further queries and the patient wanted to know the efficacy of Shingrix if not administered in the deltoid.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Urticaria, Vaccine positive rechallenge
Clinical narrative: Flu-like Symptoms; aching; dizziness; nauseous; feeling hot; Shivering; muscle pain; joint pain; Welp great big welp near the injection site that is spreading; Vaccine Administered at Inappropriate Site; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd March 2019, refer case US2019108644).   On 13th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th June 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 14th June 2019, the patient experienced influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was nurse. Yesterday from the date of reporting after 5 PM, the patient received 2nd dose on an unknown deltoid and experienced influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain, joint pain and injection site erythema. The symptoms were lasting just prior to the call after waking up on the day of reporting  The patient also observed great big welp, near the injection site that was spreading. The patient also mentioned that vaccine was administered between her shoulder and elbow and after probing, it was determined that the vaccine was administered below deltoid region, which led to vaccine administered at inappropriate site. The reporter did not consent to follow-up. This call was transferred to medical information (MI) for further queries and the patient wanted to know the efficacy of Shingrix if not administered in the deltoid.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Feeling hot, Influenza like illness
Clinical narrative: Flu-like Symptoms; aching; dizziness; nauseous; feeling hot; Shivering; muscle pain; joint pain; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In March 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain and joint pain. In March 2019, the outcome of the influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was nurse. The patient  received a dose on left arm and experienced flu-like symptoms described as aching, dizziness, nauseous, feeling hot, shivering, and muscle and joint pain. The symptoms lasted about 3 days after the first dose. The reporter did not consent to follow-up. For tolerance for dose 2, refer case US2019GSK113363
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Flu-like Symptoms; aching; dizziness; nauseous; feeling hot; Shivering; muscle pain; joint pain; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In March 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain and joint pain. In March 2019, the outcome of the influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, dizziness, nausea, feeling hot, shivering, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was nurse. The patient  received a dose on left arm and experienced flu-like symptoms described as aching, dizziness, nauseous, feeling hot, shivering, and muscle and joint pain. The symptoms lasted about 3 days after the first dose. The reporter did not consent to follow-up. For tolerance for dose 2, refer case US2019GSK113363
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: the expiration date of the Daptacel was 16 May 2019 was given to a patient; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional by phone.  This case involves a 4 months old male patient who was vaccinated with 0.5 ml first expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5202BA and expiry date: 16-May-2019) (route and site of administration were not reported) on 03-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  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.   Documents held by the sender: none.