chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-JAN-2012, at age 66, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, and economic losses. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not reported. On an unspecified date in 2017 (reported as: "2 years ago"), the patient was vaccinated with the first VAQTA (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis and on 27-MAR-2019, the patient was vaccinate with a second dose of VAQTA (lot # R022983 and expiration date: 09-AUG-2019) (dose, frequency, route of administration were not reported) for prophylaxis.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction, Myosclerosis
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a 25 year old female patient. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On 11-DEC-2018, the patient was vaccinated with the third dose of GARDASIL 9 for prophylaxis, lot # N035957 and expiration date 10-OCT-2020 (dose, strength, frequency, and route of administration were unknown). On the same day, following the injection, the muscle at the injection site felt extremely hard in a three inch by three inch area (injection site reaction). The outcome of injection site reaction was reported as recovered after 4-6 weeks (January 2019). It was unknown if the patient sought medical attention. Causal relationship between injection site reaction and GARDASIL 9 was unknown.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 27-MAR-2019, the patient was vaccinated with a dose of the pediatric formulation of VAQTA, 25/ 0.5 ml for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects reported. It was also reported that, the patient had received a pediatric dose of HAVRIX vaccine. The outcome of the event product use issue was not reported.
Sex: U
Vaccine: RV5
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. The patient's pertinent concurrent conditions, medical history and drug reactions or allergies, if any, were not provided. The nurse reported that, on 25-MAR-2019, the patient was inadvertently vaccinated with one dose of ROTATEQ orally (dose number and anatomical locations of administration were not provided; with lot number R017932 and expiration date on 01-MAY-2020) for prophylaxis. On an unspecified date, the dose of ROTATEQ was exposed to a temperature excursion from 36 degrees Fahrenheit to 46 degrees Fahrenheit (46.4 degrees Fahrenheit) for a time frame of 6 minutes, which was detected by the Digital Data Logger. There was no previous temperature excursion. No adverse effects or product quality complaints were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA012097.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 27-MAR-2019 the patient was vaccinated with VAQTA lot # R010369 for prophylaxis. On 27-MAR-2019, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A spontaneous report has been received from a consumer. The report concerns a female patient (age 13 years, height 59 in, weight 76 lbs). No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown. Concomitant medication included sertraline for anxiety (since 2017). The patient received FLUMIST QUADRIVALENT (live, attenuated) 0.2 ml once/single administration, via nasal route, for prevention of influenza during 2007. On 27-FEB-2019, the patient experienced flu (preferred term: Influenza). At the time of reporting, the event was ongoing. The event was considered non-serious.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Back pain, Dysstasia, Fatigue, Feeling cold
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX 23 for prophylaxis. Previously administered products included PREVNAR (1st dose received in 2002) and PREVNAR (2nd dose received in 9th March 2008). On 11th March 2019, the patient received SHINGRIX and PNEUMOVAX 23. On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, fatigue, feeling cold, nerve pain, back pain, pain in thigh and weakness. On an unknown date, the outcome of the influenza-like symptoms, headache, fatigue, feeling cold, nerve pain, back pain and pain in thigh were recovering/resolving and the outcome of the weakness was unknown. It was unknown if the reporter considered the influenza-like symptoms, headache, fatigue, feeling cold, nerve pain, back pain, pain in thigh and weakness to be related to SHINGRIX. Additional details were provided as follows: Within 24 hrs after vaccination, the patient had flu like symptom headache, fatigue, feeling freezing cold, brief sharp nerve pain in her mid thigh and mid back radiating to the front body aches. The worst part was profound weakness where she could barely stand could not even make it to be seen at physician's office. The events was worst on 12th March 2019 into 13th March 2019. By 14th March 2019, the patient felt somewhat better. On 15th March 2019, the patient was seen in office day 5 back to herself. The reporter agree to follow up from GlaxoSmithKline.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache, Influenza like illness, Neuralgia, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX 23 for prophylaxis. Previously administered products included PREVNAR (1st dose received in 2002) and PREVNAR (2nd dose received in 9th March 2008). On 11th March 2019, the patient received SHINGRIX and PNEUMOVAX 23. On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, fatigue, feeling cold, nerve pain, back pain, pain in thigh and weakness. On an unknown date, the outcome of the influenza-like symptoms, headache, fatigue, feeling cold, nerve pain, back pain and pain in thigh were recovering/resolving and the outcome of the weakness was unknown. It was unknown if the reporter considered the influenza-like symptoms, headache, fatigue, feeling cold, nerve pain, back pain, pain in thigh and weakness to be related to SHINGRIX. Additional details were provided as follows: Within 24 hrs after vaccination, the patient had flu like symptom headache, fatigue, feeling freezing cold, brief sharp nerve pain in her mid thigh and mid back radiating to the front body aches. The worst part was profound weakness where she could barely stand could not even make it to be seen at physician's office. The events was worst on 12th March 2019 into 13th March 2019. By 14th March 2019, the patient felt somewhat better. On 15th March 2019, the patient was seen in office day 5 back to herself. The reporter agree to follow up from GlaxoSmithKline.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, 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 55-year-old patient who received SHINGRIX for prophylaxis. On 14th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm and axillary pain. The patient was treated with non-drug therapy (Heat Therapy). On an unknown date, the outcome of the pain in arm and axillary pain were unknown. It was unknown if the reporter considered the pain in arm and axillary pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain in arm that slided down into the armpit. The patient wondered if that was normal and can just keep moving it and putting heat on it like before. The patient's doctor did not have any doses to administer and did not found anyone else in trouble.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was past the 6 month interval for the second dose, which led to incomplete course of vaccination. The patient recently presented with shingles in the face and head area. The reporter did not provide any further information and did not refuse to be contacted about the case.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 86-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX 6 months and 3 weeks ago before the date of reporting. After the first dose of SHINGRIX he had a little soreness that went away after about 1 day. The reporter did not consent to follow-up. This case has been linked to the case US2019050309, reported for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of myalgia in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of myalgia (1st dose received on an unknown date, refer case US2019050460). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced myalgia, influenza-like symptoms and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the myalgia, influenza-like symptoms and chills were unknown. It was unknown if the reporter considered the myalgia, influenza-like symptoms and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The health care professional mentioned that the patient mentioned having worse myalgia, flu-like symptoms,including chills. Did not consent to follow up.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 86-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (For tolerance to 1st dose please refer case US2019GSK055877). On 18th March 2019, the patient received the 2nd dose of SHINGRIX. On 18th March 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On 19th March 2019, the patient experienced fatigue and influenza-like symptoms. On an unknown date, the outcome of the fatigue was not recovered/not resolved and the outcome of the influenza-like symptoms and drug dose administration interval too long were unknown. It was unknown if the reporter considered the fatigue and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: At the date of reporting the patient felt very fatigued, like he had the flu. The patient delayed in receiving the second dose, which led to the lengthening of vaccination schedule between 1st and 2nd dose. The reporter did not consent to follow-up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (received 1st dose 8 months ago, refer case US2019GSK055998). On 18th March 2019, the patient received the 2nd dose of SHINGRIX. On 18th March 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On 19th March 2019, the patient experienced fatigue and upset stomach. On an unknown date, the outcome of the fatigue and upset stomach were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the fatigue and upset stomach to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the husband who reported for her wife. The patient received SHINGRIX and the day of reporting she felt very fatigued, and had an upset stomach. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of myalgia in a adult 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 myalgia, influenza-like symptoms and chills. On an unknown date, the outcome of the myalgia, influenza-like symptoms and chills were unknown. It was unknown if the reporter considered the myalgia, influenza-like symptoms and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The health care professional mentioned that the patient mentioned having worse myalgia, flu-like symptoms, including chills. The reporter did not consent to follow up. For tolerance to 2nd dose, refer case US2019GSK055935.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 14th March 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 20th March 2019, 6 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and pain in arm were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the injection on Thursday. On 20th March 2019, in the morning, when patient woke up, her arm was hurting, swollen and red from the injection site down to the elbow.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 14th March 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 20th March 2019, 6 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and pain in arm were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the injection on Thursday. On 20th March 2019, in the morning, when patient woke up, her arm was hurting, swollen and red from the injection site down to the elbow.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a six years old patient who received 0.5 ml ADACEL (lot: C5556AA, expiry date: 12-Mar-2020) via unknown route in the right deltoid, on 22-Mar-2020. The ADACEL PI stated that it is indicated for ages 10 to 64 years. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error inappropriate age at vaccine administration. 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 documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Blood urine present, Haemorrhage urinary tract
Clinical narrative: Blood & clotted blood in urine, at every urination since vaccination. All documented with time-stamped photos 03/28/2019: 3:49 pm ? 4:29 pm ? 5:29 pm ? 6:19 pm ?. 11:57 pm 03/29/2019: 5:14 am ? 8:09 am.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Blood glucose, Burning sensation, Depression
Clinical narrative: Redness, swelling, burning in the arm. Following after...I had burning in the joints all throughout my body. My muscles felt very heavy and extremely fatigued, I saw spots, ringing in the ears, vertigo, depression, I thought I had bone cancer. I became pregnant with my second son in June 2016. I had very low white blood cell  count the entire pregnancy. At the 19 month checkup they found that my son had VUR. He was born 3 weeks early with stage 5 VUR. My pain and muscle fatigue has gotten worse. The littlest things can put me down for days. I have to completely change everything in order to get the energy and movement back that I had before the vaccine through plant based nutrition and detoxes. With my first pregnancy I had no complications and was full of energy. With my second after the vaccine I had insomnia along with all the other complications.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Foetal disorder, Insomnia, Maternal exposure before pregnancy
Clinical narrative: Redness, swelling, burning in the arm. Following after...I had burning in the joints all throughout my body. My muscles felt very heavy and extremely fatigued, I saw spots, ringing in the ears, vertigo, depression, I thought I had bone cancer. I became pregnant with my second son in June 2016. I had very low white blood cell  count the entire pregnancy. At the 19 month checkup they found that my son had VUR. He was born 3 weeks early with stage 5 VUR. My pain and muscle fatigue has gotten worse. The littlest things can put me down for days. I have to completely change everything in order to get the energy and movement back that I had before the vaccine through plant based nutrition and detoxes. With my first pregnancy I had no complications and was full of energy. With my second after the vaccine I had insomnia along with all the other complications.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Muscle fatigue, Pain, Peripheral swelling, Tinnitus
Clinical narrative: Redness, swelling, burning in the arm. Following after...I had burning in the joints all throughout my body. My muscles felt very heavy and extremely fatigued, I saw spots, ringing in the ears, vertigo, depression, I thought I had bone cancer. I became pregnant with my second son in June 2016. I had very low white blood cell  count the entire pregnancy. At the 19 month checkup they found that my son had VUR. He was born 3 weeks early with stage 5 VUR. My pain and muscle fatigue has gotten worse. The littlest things can put me down for days. I have to completely change everything in order to get the energy and movement back that I had before the vaccine through plant based nutrition and detoxes. With my first pregnancy I had no complications and was full of energy. With my second after the vaccine I had insomnia along with all the other complications.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Vertigo, Visual impairment, White blood cell count decreased
Clinical narrative: Redness, swelling, burning in the arm. Following after...I had burning in the joints all throughout my body. My muscles felt very heavy and extremely fatigued, I saw spots, ringing in the ears, vertigo, depression, I thought I had bone cancer. I became pregnant with my second son in June 2016. I had very low white blood cell  count the entire pregnancy. At the 19 month checkup they found that my son had VUR. He was born 3 weeks early with stage 5 VUR. My pain and muscle fatigue has gotten worse. The littlest things can put me down for days. I have to completely change everything in order to get the energy and movement back that I had before the vaccine through plant based nutrition and detoxes. With my first pregnancy I had no complications and was full of energy. With my second after the vaccine I had insomnia along with all the other complications.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Electrocardiogram abnormal, Injection site pain, Osteoarthritis, Rotator cuff syndrome
Clinical narrative: On 03/21/19, 73 yo F presented to clinic for scheduled visit. During this visit, pt was ordered and administered Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23). At 1548, 0.5 mL was injected in left deltoid (NDC: 0006-4837-01, Lot #R033342, Exp: 8/3/2020). Pt was then discharged with no noted adverse effects. On 03/22, pt presented to Urgent Care reporting that ~2 hours after injection she developed left shoulder pain "not so much at the vaccination site" which worsened to become 9/10 pain overnight. Pt self-medicated with diphenhydramine 50 mg PO on 03/21 at 2200, ibuprofen 600 mg PO on 03/21 at 2200 and 03/22 at 0800 and a "muscle relaxant" on 03/21 at 2300. Pt denied any numbness or tingling in the area or distally to left forearm /hands/fingers, but endorsed vomiting and feeling light headed around 0100 and again around 0300. Due to continued pain, pt came to urgent care on 03/22. Physical exam found no skin irritation at injection site. MD concluded "the pain/reaction appears to be deeper inside the shoulder than at the injection site per se. Since this requires services beyond what is available in current UC setting, advised patient to transfer care to ED. Patient agrees and opts to go to [ED]". On presentation to ED, pt had no fever or chills, but left deltoid was "tender on examination". MD documented "no redness or other sig changes on exam. MD diagnosed "Degenerative changes at the shoulder and Small calcific or ossific focus associated with the inferior aspect of the glenohumeral joint". Pt was discharged home with warm compresses. On 03/27, pt returned to clinic with continued c/o 5/10 pain . Pt reported use of acetaminophen extra strength 2 tabs TID and topical lidocaine with some relief. MD diagnosed Impingement syndrome of left shoulder with no evidence of frozen shoulder. Pt provided with prescriptions for methylprednisolone Dosepak, hydrocodone/acetaminophen 5-325 mg Q6H PRN for pain and Ambulatory Referral to Physical Therapy. No resolution at this time.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting, X-ray limb abnormal
Clinical narrative: On 03/21/19, 73 yo F presented to clinic for scheduled visit. During this visit, pt was ordered and administered Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23). At 1548, 0.5 mL was injected in left deltoid (NDC: 0006-4837-01, Lot #R033342, Exp: 8/3/2020). Pt was then discharged with no noted adverse effects. On 03/22, pt presented to Urgent Care reporting that ~2 hours after injection she developed left shoulder pain "not so much at the vaccination site" which worsened to become 9/10 pain overnight. Pt self-medicated with diphenhydramine 50 mg PO on 03/21 at 2200, ibuprofen 600 mg PO on 03/21 at 2200 and 03/22 at 0800 and a "muscle relaxant" on 03/21 at 2300. Pt denied any numbness or tingling in the area or distally to left forearm /hands/fingers, but endorsed vomiting and feeling light headed around 0100 and again around 0300. Due to continued pain, pt came to urgent care on 03/22. Physical exam found no skin irritation at injection site. MD concluded "the pain/reaction appears to be deeper inside the shoulder than at the injection site per se. Since this requires services beyond what is available in current UC setting, advised patient to transfer care to ED. Patient agrees and opts to go to [ED]". On presentation to ED, pt had no fever or chills, but left deltoid was "tender on examination". MD documented "no redness or other sig changes on exam. MD diagnosed "Degenerative changes at the shoulder and Small calcific or ossific focus associated with the inferior aspect of the glenohumeral joint". Pt was discharged home with warm compresses. On 03/27, pt returned to clinic with continued c/o 5/10 pain . Pt reported use of acetaminophen extra strength 2 tabs TID and topical lidocaine with some relief. MD diagnosed Impingement syndrome of left shoulder with no evidence of frozen shoulder. Pt provided with prescriptions for methylprednisolone Dosepak, hydrocodone/acetaminophen 5-325 mg Q6H PRN for pain and Ambulatory Referral to Physical Therapy. No resolution at this time.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Impaired work ability, Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vertigo in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced vertigo and inability to work. On an unknown date, the outcome of the vertigo and inability to work were unknown. It was unknown if the reporter considered the vertigo and inability to work to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient spent two days (day 2 and 3 following injection) physically unable to do anything but cautiously move to bathroom with debilitating vertigo.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Gastrointestinal disorder, Oral herpes, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cold sores. On 27th February 2019, the patient received the 1st dose of SHINGRIX. On 28th February 2019, 1 days after receiving SHINGRIX, the patient experienced diarrhea, gastrointestinal disorder and pain in arm. In March 2019, the patient experienced cold sores lip. The patient was treated with acyclovir. On an unknown date, the outcome of the diarrhea, gastrointestinal disorder, pain in arm and cold sores lip were unknown. It was unknown if the reporter considered the diarrhea, gastrointestinal disorder, pain in arm and cold sores lip to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a sore arm and gastrointestinal (GI) issues, mostly diarrhea. A couple of days after that, the patient experienced cold sores on her upper and lower lips. The patient went to her physician and was treated with acyclovir. The patient had a history of cold sores but not this severe. The pharmacist did not had access to the batch number and expire date at the time of reporting as she was at home.
Age: 2.0
Sex: U
Vaccine: DTAPIPV, HEP, HEPA, PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 2 years old patient who experienced received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; PNEUMOCOCCAL CONJUGATE VACCINE; and HEPATITIS A VACCINE. On 08-Mar-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA via unknown route in the left thigh. It was a case of actual medication error due to Inappropriate age at vaccine administration. It was reported that no adverse effects have been 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.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Chills, Dizziness, Fatigue, Hot flush, Mobility decreased
Clinical narrative: Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 36 years old female patient who cannot move her arm parallel to her shoulder, hot flashes, nauseous, dizzy, lightheaded, her arm hurts, like she pulled a muscle or was punched, she feels like she moves in and out of being really tired and then will feel ok, chills and low grade fever of 98.9 f, while she received vaccine TENIVAC. The patients past medical history, concomitant medication and family history were not provided. On 18-Mar-2019, the patient received a 0.5ml dose of suspect TENIVAC lot U6091AA, expiry date 12-Oct-2020 via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious she cannot move her arm parallel to her shoulder (mobility decreased) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious hot flashes (hot flush) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious nauseous (nausea) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious dizzy, lightheaded (dizziness) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious her arm hurts, like she pulled a muscle or was punched (pain in extremity) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious she feels like she moves in and out of being really tired and then will feel ok (fatigue) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious chills with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious low grade fever of 98.9 f (pyrexia) with unknown latency following the administration of TENIVAC. The patient visited a Clinic. Lab data was not provided. Final diagnosis was low grade fever of 98.9 f, chills, she feels like she moves in and out of being really tired and then will feel ok, her arm hurts, like she pulled a muscle or was punched, dizzy, lightheaded, nauseous, hot flashes and she cannot move her arm parallel to her shoulder. The patient was treated with IBUPROFEN and TYLENOL. The patient outcome is reported as Unknown for dizzy, lightheaded, as Unknown for nauseous, as Unknown for low grade fever of 98.9 f, as Unknown for chills, as Unknown for hot flashes, as not recovered for her arm hurts, like she pulled a muscle or was punched, as not recovered for she cannot move her arm parallel to her shoulder and as Unknown for she feels like she moves in and out of being really tired and then will feel ok. List of documents held by sender- none.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 36 years old female patient who cannot move her arm parallel to her shoulder, hot flashes, nauseous, dizzy, lightheaded, her arm hurts, like she pulled a muscle or was punched, she feels like she moves in and out of being really tired and then will feel ok, chills and low grade fever of 98.9 f, while she received vaccine TENIVAC. The patients past medical history, concomitant medication and family history were not provided. On 18-Mar-2019, the patient received a 0.5ml dose of suspect TENIVAC lot U6091AA, expiry date 12-Oct-2020 via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious she cannot move her arm parallel to her shoulder (mobility decreased) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious hot flashes (hot flush) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious nauseous (nausea) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious dizzy, lightheaded (dizziness) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious her arm hurts, like she pulled a muscle or was punched (pain in extremity) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious she feels like she moves in and out of being really tired and then will feel ok (fatigue) with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious chills with unknown latency following the administration of TENIVAC. On an unknown date, the patient developed a non-serious low grade fever of 98.9 f (pyrexia) with unknown latency following the administration of TENIVAC. The patient visited a Clinic. Lab data was not provided. Final diagnosis was low grade fever of 98.9 f, chills, she feels like she moves in and out of being really tired and then will feel ok, her arm hurts, like she pulled a muscle or was punched, dizzy, lightheaded, nauseous, hot flashes and she cannot move her arm parallel to her shoulder. The patient was treated with IBUPROFEN and TYLENOL. The patient outcome is reported as Unknown for dizzy, lightheaded, as Unknown for nauseous, as Unknown for low grade fever of 98.9 f, as Unknown for chills, as Unknown for hot flashes, as not recovered for her arm hurts, like she pulled a muscle or was punched, as not recovered for she cannot move her arm parallel to her shoulder and as Unknown for she feels like she moves in and out of being really tired and then will feel ok. List of documents held by sender- none.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves a 57 years old female patient who was vaccinated with 0.5 ml twice dose of FLUZONE QUADRIVALENT (lot number: UJ041AA and expiry date: 30-Jun-2019, dose in series and route of administration were not reported) in left arm on 26-Sep-2018 and 21-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were reported as none. It was a case of actual medication error due to extra dose administered. 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: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician via phone. This case is linked to cases 2019SA082205, 2019SA082208, 2019SA082209 and 2019SA082210 (same reporter). This case involves a 2 months old male patient who experienced fussiness and 101.9 F fever within 4 hours, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 and ROTATEQ on an unknown date. On 14-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ095AA in the thigh NOS. On an unknown date, the patient developed a non-serious fussiness and 101.9 F fever within 4 hours following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Relevant laboratory test results included: Body temperature on an unknown date: [result: 101.9 Fahrenheit]. Final diagnosis was fussiness and 101.9 F fever within 4 hours. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for fussiness and 101.9 F fever within 4 hours. Documents held by the sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from a non HCP. This case involves a female patient of unknown age was exposed to vaccine ADACEL lot number, Exp. Date, dose, route and site of administration were not reported on 22 Mar 2019 while she was pregnant of 36 weeks and also received same vaccine few months ago. Data for this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The gestation period was 36 weeks. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The data regarding previous pregnancy/ies not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was also an actual medication error case due to extra dose administered. It was unknown whether the patient experienced any adverse event. At the time of reporting, pregnancy outcome was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' 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: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant). This case involves a 15 months old female patient who received vaccine DAPTACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ACTHIB and PREVNAR 13 on 21-Mar-2019. On 21-Mar-2019, the patient received a fourth dose 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5169AA, expiry date 16-Mar-2019 via intramuscular route in the right thigh. It was an actual medication error due to expired vaccine used. It was reported that Expired DAPTACEL vaccine (expiry date 16-Mar-2019) was given to child on 21-Mar-2019. The patient did not experience 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: 40.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain
Clinical narrative: Pt reported R sided chest pain that started around 5 PM after receiving the vaccine the same day. She did not seek medical advice. She went to bed and when she woke up the pain was gone. She came into the health center to report it the next day.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Crying, Headache, Lethargy, Middle insomnia
Clinical narrative: Child began waking during the night, grabbing at his head and crying inconsolably. Child developed a light rash on his torso, arms and legs. Child was lethargic and overall not acting normally for those 4 days following the vaccine. This began the night after his vaccine and continued for the next 4 nights. Child was taken back to pediatrician 2 times that week in which they could not find any reason why he was acting in such a way. The pediatrician acknowledged that the child may be having a "slight" reaction to the MMR vaccine he received earlier in the week but did not see the need to report the reaction.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Child began waking during the night, grabbing at his head and crying inconsolably. Child developed a light rash on his torso, arms and legs. Child was lethargic and overall not acting normally for those 4 days following the vaccine. This began the night after his vaccine and continued for the next 4 nights. Child was taken back to pediatrician 2 times that week in which they could not find any reason why he was acting in such a way. The pediatrician acknowledged that the child may be having a "slight" reaction to the MMR vaccine he received earlier in the week but did not see the need to report the reaction.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperhidrosis, Muscle swelling, Pain, Pyrexia
Clinical narrative: Very Painful, Hurt to wash hair, get dressed. Muscle is swollen, red, hot. She felt feverish and was sweating last night (3/28/19) but the feeling is better today.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Very Painful, Hurt to wash hair, get dressed. Muscle is swollen, red, hot. She felt feverish and was sweating last night (3/28/19) but the feeling is better today.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Cough, Diarrhoea, Pyrexia, Rash generalised, Rash papular
Clinical narrative: Vaccines given on 3/4/19. Child developed cough, vomiting, diarrhea on approx. 3/6 (suspect incidental). This illness resolved after a couple days. Developed fever on 3/17 for 2 days. Developed rash on 3/19 and evaluated in the office on 3/21. Rash was discrete erythematous papules, some vesicular, some crusted lesions. Rash consistent with varicella. Rash was all over body, not limited to site of vaccine. Rash resolved after about 1 week according to mom (child was not seen in the office again)
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash vesicular, Scab, Vomiting
Clinical narrative: Vaccines given on 3/4/19. Child developed cough, vomiting, diarrhea on approx. 3/6 (suspect incidental). This illness resolved after a couple days. Developed fever on 3/17 for 2 days. Developed rash on 3/19 and evaluated in the office on 3/21. Rash was discrete erythematous papules, some vesicular, some crusted lesions. Rash consistent with varicella. Rash was all over body, not limited to site of vaccine. Rash resolved after about 1 week according to mom (child was not seen in the office again)