chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 30-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal
Clinical narrative: chills; feeling crappy; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included headache, sinus congestion, rhinorrhea and influenza like illness.   On 9th May 2019, the patient received the 2nd dose of Shingrix. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced chills. In May 2019, the patient experienced feeling bad. On an unknown date, the outcome of the chills and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the chills and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient had been worked out in the yard and the pollen around the air and given some issues with headaches and sinus was being stuffy and runny and just feeling like the flu. The patient experienced extreme chills last night of reporting and it could be combination of the weather and the shingles and the patient felt pretty crappy.
Sex: M
Vaccine: VARZOS
Symptoms: Ill-defined disorder, Parkinson's disease
Clinical narrative: Parkinson's disease; This case was reported by a other health professional via patient support programs and described the occurrence of parkinson's disease in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced parkinson's disease (serious criteria GSK medically significant). On an unknown date, the outcome of the parkinson's disease was unknown.   It was unknown if the reporter considered the parkinson's disease to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date for Shingrix were unknown to the reporter. The patient experienced Parkinson's disease and had difficulty in receiving the 2nd dose of Shingrix for him and his wife. The patient asked for help as he had illness and was due for the 2nd dose of Shingrix in June 2019. The reporter did not agree to have GSK's safety team to follow up via postal mail.
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Pulmonary mass
Clinical narrative: autoimmune diseases; nodules in my lungs; This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a year after receiving Shingrix, the patient experienced autoimmune disorder (serious criteria GSK medically significant) and lung nodule. On an unknown date, the outcome of the autoimmune disorder and lung nodule were unknown.   It was unknown if the reporter considered the autoimmune disorder and lung nodule to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was due for 2nd dose and wanted to make sure whether it was good time or if would have to wait. The specialist advised not take dose.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: chicken pox; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received Shingrix. In May 2019, 1 day 12 hrs after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: The patient experienced two rounds of chicken pox since receiving the Shringrix vaccination. The first chicken pox started about 36 hours after the injection. The second round of chicken pox began 2 days ago from the date of reporting. The patient asked, have you heard of this type of side effect before.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose and Menveo at an unknown dose. On an unknown date, unknown after receiving Bexsero and Menveo, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Bexsero and Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that there was the patient that received both Menveo and Bexsero on the same day. The patient went to the emergency room and same to the physician's office twice with flu like symptoms, but these symptoms resolved and the patient was fine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dry eye, Dry mouth, Injection site erythema, Injection site swelling
Clinical narrative: dry mouth; worsening of dry eyes; swollen left arm; arm  feels hot; red mark at injection site; nausea; malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included dry mouth (after using another medication). Concurrent medical conditions included eye dryness.   On 25th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced malaise, dry eyes aggravated, injection site swelling, injection site warmth, injection site erythema and nausea. On 25th May 2019, the patient experienced dry mouth. On an unknown date, the outcome of the malaise and nausea were recovered/resolved and the outcome of the dry mouth, dry eyes aggravated, injection site swelling, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the malaise, dry mouth, dry eyes aggravated, injection site swelling, injection site warmth, injection site erythema and nausea to be related to Shingrix.  Additional case details were provided as follows: The patient reported the case. The patient did not provide the name of that medication which she used in the past and experienced dry mouth. The patient received the 1st dose of Shingrix in the left arm deltoid.  Within 30 minutes of receiving the vaccine, she developed extreme dry mouth.  A little while later, the patient experienced worsening of her dry eye condition. Her left arm was swollen and felt hot. She had a red mark at the injection site that was approximately 2 to 3 inches wide.  After receiving the vaccine, the patient also experienced nausea and malaise.  The patient gave consent to follow up as well as to contact the physician and provided contact details for the same. There is a discrepancy with respect to the outcome of the events dry mouth, dry eyes aggravated, injection site swelling, injection site warmth and injection site erythema. In source document, the outcome is reported as recovering/ resolving for all, however as per narrative description it is not recovered/ not resolved. The outcome of all the symptoms retains as per the narrative description.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Nausea
Clinical narrative: dry mouth; worsening of dry eyes; swollen left arm; arm  feels hot; red mark at injection site; nausea; malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included dry mouth (after using another medication). Concurrent medical conditions included eye dryness.   On 25th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced malaise, dry eyes aggravated, injection site swelling, injection site warmth, injection site erythema and nausea. On 25th May 2019, the patient experienced dry mouth. On an unknown date, the outcome of the malaise and nausea were recovered/resolved and the outcome of the dry mouth, dry eyes aggravated, injection site swelling, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the malaise, dry mouth, dry eyes aggravated, injection site swelling, injection site warmth, injection site erythema and nausea to be related to Shingrix.  Additional case details were provided as follows: The patient reported the case. The patient did not provide the name of that medication which she used in the past and experienced dry mouth. The patient received the 1st dose of Shingrix in the left arm deltoid.  Within 30 minutes of receiving the vaccine, she developed extreme dry mouth.  A little while later, the patient experienced worsening of her dry eye condition. Her left arm was swollen and felt hot. She had a red mark at the injection site that was approximately 2 to 3 inches wide.  After receiving the vaccine, the patient also experienced nausea and malaise.  The patient gave consent to follow up as well as to contact the physician and provided contact details for the same. There is a discrepancy with respect to the outcome of the events dry mouth, dry eyes aggravated, injection site swelling, injection site warmth and injection site erythema. In source document, the outcome is reported as recovering/ resolving for all, however as per narrative description it is not recovered/ not resolved. The outcome of all the symptoms retains as per the narrative description.
Age: 53.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash
Clinical narrative: side and back rash; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number C7734, expiry date 14th June 2021) for prophylaxis.   Concomitant products included vitamins nos (Vitamins).   On 21st May 2019, the patient received Shingrix and Boostrix. On 26th May 2019, 5 days after receiving Shingrix and Boostrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix and Boostrix.  Additional details were provided as follows: The case was reported by the office manager. The Health care professionals described rash as very large on the patients side and back. The patient was taking vitamins, but the health care professionals could not provide identifying details.
Sex: M
Vaccine: VARZOS
Symptoms: Eye pruritus, Insomnia, Lacrimation increased
Clinical narrative: itchy eyes; watery eyes; inability to sleep; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received Shingrix. On 29th May 2019, less than a day after receiving Shingrix, the patient experienced sleeplessness. On 30th May 2019, the patient experienced eye pruritus and watering eyes. On an unknown date, the outcome of the sleeplessness, eye pruritus and watering eyes were unknown.   It was unknown if the reporter considered the sleeplessness, eye pruritus and watering eyes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The reporter did not consent to follow-up. The reporter did not wished to participate in safety report or provide demographics
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy kidney abnormal, Glomerulonephritis minimal lesion, Swelling
Clinical narrative: Minimal Change Disease; swelling; This case was reported by a consumer via call center representative and described the occurrence of minimal change disease in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number XC972, expiry date 29th August 2021) for prophylaxis.   On 16th February 2019, the patient received Shingrix. On 18th February 2019, 2 days after receiving Shingrix, the patient experienced minimal change disease (serious criteria hospitalization and GSK medically significant) and swelling (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the minimal change disease was not recovered/not resolved and the outcome of the swelling was unknown.   It was unknown if the reporter considered the minimal change disease and swelling to be related to Shingrix.  Additional details were provided as follows: The patient was very healthy and active prior to receiving Shingrix. Around 18th February 2019 to 20th February 2019 after receiving shingrix vaccine, the patient suddenly experienced swelling all over body. On 1st march 2019, 13 days after shingrix vaccine, kidney biopsy was performed and minimal change disease was diagnosed. The patient had been treated with high doses of steroids but 12 weeks after initiating treatment, the symptoms had not improved at all.  Steroids were usually very effective in treating this condition, so his physician was trying to find a new treatment protocol.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Oedema
Clinical narrative: Drug Allergies: Pneumococcal Vaccine - Edema; Drug Allergies: Pneumococcal Vaccine - Edema; This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer-sponsored program Pfizer RXPathways. A 54-year-old female patient received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced drug allergies: pneumococcal vaccine - edema on an unspecified date with outcome of unknown.    Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Carditis, Dyspnoea, Heart rate increased, Hypersensitivity
Clinical narrative: inflammation of her lungs; shortness of breath; inflammation of her heart; allergic reaction; low grade temperature; rapid heartbeat; could not lift her arm; Initial information received on 31-May-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 53 years old female patient who experienced inflammation of her lungs, inflammation of her heart, allergic reaction, rapid heartbeat, low-grade temperature, could not lift her arm and shortness of breath, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the right arm.  On 16-Oct-2018, the patient developed a non-serious rapid heartbeat (heart rate increased), low grade temperature (pyrexia), could not lift her arm (Mobility decreased) and shortness of breath (dyspnoea) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity), following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient began to experience shortness of breath that got progressively worse and diagnosed with inflammation of her lungs (pneumonitis) and inflammation of her heart (carditis), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized a month later in November 2018 for these events for 7 days. (hospitalization during 7 days).  (Other relevant tests included no lab data.)  Final diagnosis was shortness of breath, could not lift her arm, low-grade temperature, rapid heartbeat, allergic reaction, inflammation of her lungs and inflammation of her heart.  She received IV steroids and antibiotics while hospitalized.  On an unknown date, the patient was recovered from the events.  Information on the batch number was requested.  Documents held by sender: none.; Sender's Comments: This case concerns a 53 years old female patient who presented with pneumonitis, carditis, hypersensitivity, heart rate increased, pyrexia, Mobility decreased and dyspnea after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible with the role of vaccine. Additional information regarding patient's past medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pneumonitis
Clinical narrative: inflammation of her lungs; shortness of breath; inflammation of her heart; allergic reaction; low grade temperature; rapid heartbeat; could not lift her arm; Initial information received on 31-May-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 53 years old female patient who experienced inflammation of her lungs, inflammation of her heart, allergic reaction, rapid heartbeat, low-grade temperature, could not lift her arm and shortness of breath, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the right arm.  On 16-Oct-2018, the patient developed a non-serious rapid heartbeat (heart rate increased), low grade temperature (pyrexia), could not lift her arm (Mobility decreased) and shortness of breath (dyspnoea) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity), following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient began to experience shortness of breath that got progressively worse and diagnosed with inflammation of her lungs (pneumonitis) and inflammation of her heart (carditis), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized a month later in November 2018 for these events for 7 days. (hospitalization during 7 days).  (Other relevant tests included no lab data.)  Final diagnosis was shortness of breath, could not lift her arm, low-grade temperature, rapid heartbeat, allergic reaction, inflammation of her lungs and inflammation of her heart.  She received IV steroids and antibiotics while hospitalized.  On an unknown date, the patient was recovered from the events.  Information on the batch number was requested.  Documents held by sender: none.; Sender's Comments: This case concerns a 53 years old female patient who presented with pneumonitis, carditis, hypersensitivity, heart rate increased, pyrexia, Mobility decreased and dyspnea after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible with the role of vaccine. Additional information regarding patient's past medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Swelling at injection site, fever, Nausea
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, VARCEL
Symptoms: Body temperature increased, Crying, Generalised tonic-clonic seizure, Influenza virus test negative, Irritability
Clinical narrative: 6/5/19 fussy 9 pm Tylenol 6/6/19 3 AM tonic clonic seizure - 4 - 5 min Called EMT  T  103.9  O2 or duonebs given - postictal - no cough  330 ED - 105.8  O2 98%  HR 142 crying  neg flu  neg RSV  Tylenol (R) Discharged 7 AM 6/6/19
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, VARCEL
Symptoms: Oxygen saturation normal, Postictal state, Respiratory syncytial virus test negative
Clinical narrative: 6/5/19 fussy 9 pm Tylenol 6/6/19 3 AM tonic clonic seizure - 4 - 5 min Called EMT  T  103.9  O2 or duonebs given - postictal - no cough  330 ED - 105.8  O2 98%  HR 142 crying  neg flu  neg RSV  Tylenol (R) Discharged 7 AM 6/6/19
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cold sweat, Fatigue, Nausea, Night sweats, Pain in extremity
Clinical narrative: Arm Pain; Heating pad; Little help. Fever (101.7); Ibuprofen; Reduced fever. Nausea; no treatment; broke into cold sweat. Tired; Sleep; Felt better next day. Night sweats 1st & 2nd nights
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Arm Pain; Heating pad; Little help. Fever (101.7); Ibuprofen; Reduced fever. Nausea; no treatment; broke into cold sweat. Tired; Sleep; Felt better next day. Night sweats 1st & 2nd nights
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Swelling
Clinical narrative: extreme swelling
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Malaise, Pyrexia, Rash
Clinical narrative: Fever and Chills, joint pain and rash on the torso. My husband had the shot the same day and broke out with a rash at the same time as me, but did not get sick. He had the same rash pattern: Left nipple a few spots then across the back and a few spots on the stomach. My rash is much MUCH, worse and developed into pustules. I had to go on an anti-viral medication : Valacyclovir. I still don't feel well and it's been five days. After starting on the Valacyclovir the joint pain and fever left in 24 hours but the rash continued to spread. I asked the technician if I should get this shot since I have RA and Leukemia. He said I couldn't get sick because it's not a "live vaccine".
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: Fever and Chills, joint pain and rash on the torso. My husband had the shot the same day and broke out with a rash at the same time as me, but did not get sick. He had the same rash pattern: Left nipple a few spots then across the back and a few spots on the stomach. My rash is much MUCH, worse and developed into pustules. I had to go on an anti-viral medication : Valacyclovir. I still don't feel well and it's been five days. After starting on the Valacyclovir the joint pain and fever left in 24 hours but the rash continued to spread. I asked the technician if I should get this shot since I have RA and Leukemia. He said I couldn't get sick because it's not a "live vaccine".
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Glossodynia, Headache, Pain
Clinical narrative: Extreme fatigue and soreness in my right arm came on within a few hours of the Tdap Vaccine. I got the shot on Monday, June 3rd. It is now June 5th and I've had high fever and chills each day. Horrible headache. And I woke up this morning with a painful sore on the bottom left of my tongue. My arm has swollen to the size of a egg (upper arm only). My fever is typically 101.8 and Advil lowers it to 100. I am still waiting to feel better. My body feels achy and it hurts to raise my head. Prior to the shot, I felt absolutely fine and energetic.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Tongue ulceration
Clinical narrative: Extreme fatigue and soreness in my right arm came on within a few hours of the Tdap Vaccine. I got the shot on Monday, June 3rd. It is now June 5th and I've had high fever and chills each day. Horrible headache. And I woke up this morning with a painful sore on the bottom left of my tongue. My arm has swollen to the size of a egg (upper arm only). My fever is typically 101.8 and Advil lowers it to 100. I am still waiting to feel better. My body feels achy and it hurts to raise my head. Prior to the shot, I felt absolutely fine and energetic.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug hypersensitivity, Pyrexia, Rash, Rash vesicular, Secretion discharge
Clinical narrative: Patient was put on Amoxicillin on 5/2 -- patient then broke out in a rash.  Amoxil was stopped and parent's started with Benadryl Patient then started on Friday/Saturday with blister like lesions/bubbles all over her body - clear drainage.  Patient with fever up to 100F today.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dry mouth, Fatigue, Headache
Clinical narrative: Extremely severe headache, chills, fever, weakness, tiredness, dry mouth
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Extremely severe headache, chills, fever, weakness, tiredness, dry mouth
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurse drew up 0.5ml of vaqta from adult 1.0ml formulation; no adverse effect; This spontaneous report was received from a registered pharmacist referred to a child patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the nurse drew up to 0.5 ml of hepatitis a vaccine, inactivated (VAQTA) from adult 1.0 ml formulation and administered to the patient via intramuscular route for prophylaxis (dose: 0.5 ml, lot # and expiry date were not reported) (Product administered to patient of inappropriate age). No adverse effects were reported.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. On 15th May 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The patient experienced pain at the injection site, but it went away fairly quickly.  The patient did not experience any other side effects. The patient had same initials as reporter. There is a discrepancy with respect to the outcome of the events injection site pain. In core the outcome is reported as recovered/resolved, however in provided source document it is recovered/resolved with sequel. The outcome of these events retains as per the structural field.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Arthralgia/ Joint pain; Myalgia; pain in right and left arm.; This case was reported by a pharmacist via call center representative and described the occurrence of arthralgia in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   The patient's past medical history included shingles (2 mild outbreaks 6 month before to vaccination).   On 27th February 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced arthralgia, myalgia and pain in arm. The patient was treated with non-drug therapy (Physical Therapy (Nos)). Shingrix was discontinued. On an unknown date, the outcome of the arthralgia, myalgia and pain in arm were unknown.   It was unknown if the reporter considered the arthralgia, myalgia and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported arm pain in the right arm injection site that lasted for a month and moved to opposite arm, bilateral upper extremity joint pain, myalgia and arthralgia. The general practitioner discontinued vaccination therapy and patient was in physical therapy due to pain in joints. No additional information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pain; swelling; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: This case was reported through online chat. The age at vaccination was not reported. The patient experienced pain and swelling at the injection after receiving Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsey/ facial droop; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 273BZ, expiry date 15th May 2021) and (batch number 3393R, expiry date 15th May 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, 3 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was recovering/resolving.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. Three months before, the patient received a dose of Shingrix on her left arm and 3 days later she developed transient bell's palsey on her right side. The patient has minimal residual till the time of reporting. The health care professionals texted to MIS for discussion of potential other related reports. There is a discrepancy with respect to the outcome of the events Bell's palsy. In Argus core the outcome is reported as recovering/resolving, however in provided source document it is fatal. The outcome of these events retains as per the Argus structural field. As per global ales data sheet, the batch number was updated from L273BZ to 273BZ
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hive-like whelps/hives like rash; This case was reported by a other health professional via call center representative and described the occurrence of urticarial rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a month after receiving Shingrix, the patient experienced urticarial rash. On an unknown date, the outcome of the urticarial rash was recovered/resolved.   It was unknown if the reporter considered the urticarial rash to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in left deltoid. The patient had hive-like whelps (welts) around her trunk, on her shoulders and on the backs of both arms.   On 22nd May 2019, the patient called the reporter and stated, the whelps remained for at least a week.   The patient reported that, one and half months prior to getting the vaccine, she had returned from traveling and did not know if the hive-like rash was related to the Shingrix or something from traveling.  The reporter was unable to obtain additional information.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site rash, Mass, Pain in extremity
Clinical narrative: Patient woke with a fever the next day.  As progressed, she c/o feeling tired, chills, left arm sore with rash at injection site. This morning(06/06/2019) she noticed a lump on left clavicle.  Per her PCP, she was told that this is a reaction to the injection.  Pending outcome.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient woke with a fever the next day.  As progressed, she c/o feeling tired, chills, left arm sore with rash at injection site. This morning(06/06/2019) she noticed a lump on left clavicle.  Per her PCP, she was told that this is a reaction to the injection.  Pending outcome.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Full blood count, Injection site mass, Musculoskeletal pain, Myalgia
Clinical narrative: Patient had a lump at the injection site for about 4 days, then developed a rash about 2 weeks later w/intermittent elevated temperature, pain radiating into shoulder/arm, and myalgias.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: Patient had a lump at the injection site for about 4 days, then developed a rash about 2 weeks later w/intermittent elevated temperature, pain radiating into shoulder/arm, and myalgias.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Nothing , patient has had this vaccine before, just received 2nd dose early.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pruritus, Urticaria
Clinical narrative: Site of injection very red, hot & tender to touch; raised, itchy hives around patient's midsection (abdomen and middle back).
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Whole body soreness/fatigue, fever - severe for about 3 hours (6/4 11pm - 6/5 2am); overall about 36 hours
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: patient described injection site as red, swollen and hot. Also stated that she noticed her lymph node in under her arm was swollen. it has been 4 days since the vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Poor quality sleep, Rash generalised
Clinical narrative: - Rash all over entire body - not sleeping well - fussy Perscribed - Atarax on 6-5-19
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Hypersomnia, Influenza like illness
Clinical narrative: Flu like symptoms:  muscle aches -quads, bi-ceps & shoulders; chills; fatigue; headache, nausea Thursday May 30th.  Fatigue, muscle aches and loss of appetite Friday May 31st.  Fatigue and loss of appetite Saturday June 1 2019.  Treated as I would the flu - rest, warm liquids, gel advil for body aches.  Slept a lot over the course of the 3 days.  Did not call my doctor, just assumed it was the shot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Flu like symptoms:  muscle aches -quads, bi-ceps & shoulders; chills; fatigue; headache, nausea Thursday May 30th.  Fatigue, muscle aches and loss of appetite Friday May 31st.  Fatigue and loss of appetite Saturday June 1 2019.  Treated as I would the flu - rest, warm liquids, gel advil for body aches.  Slept a lot over the course of the 3 days.  Did not call my doctor, just assumed it was the shot.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Night sweats
Clinical narrative: Sweated all night and had chills, not severe, however. Still have slight chills at 10:00 a.m. the following day but again, not severe just noticeable.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: on 6/5/19 around 5 pm I started feeling sick to my stomach, extremely tired, headache and shivering. The site of the injection is red, has a hard lump and is hot to the touch
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site warmth, Nausea
Clinical narrative: on 6/5/19 around 5 pm I started feeling sick to my stomach, extremely tired, headache and shivering. The site of the injection is red, has a hard lump and is hot to the touch
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Oedema, Paraesthesia, Swelling face, Swelling of eyelid
Clinical narrative: he was vaccinated and within 45-60 min began to notice a tingling feeling in upper eyelid. He stated it looked like his left eye was half asleep with swelling of upper lid and sensation of fullness in jaw.  No problems with vision. No recall of eye redness, tearing, nasal congestion, cough, problems talking, swallowing or breathing, and no skin symptoms. He took Benadryl and symptoms persisted for 36-48 hrs. This was second episode. Had a previous episode with vaccination in 1999  Symptoms: EDEMA, UNSPECIFIED(R609).
Age: 21.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Rash, Vaccination complication
Clinical narrative: Multiple satellite lesions confined to dressing post SPV. >100 lesions.   Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: Fever and joint pain starting 6-1-19, Rash to neck on 6-3-19, Rash spreading to other areas on 6-4-19.
Age: 64.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema
Clinical narrative: AREA OF REDNESS DOWN AND AROUND INJECTION SITE EXTENDING TO JUST ABOVE THE ELBOW 19X9CM, NO INDURATION NO OTHER SYMPTOMS REPORTED
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Mother specifies that approximately 35 minutes after the vaccination of the baby, she observed a rash on the face, arms, back, and 1 foot.
Age: 1.83
Sex: M
Vaccine: MMR, UNK
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event, Underdose
Clinical narrative: No adverse effect reported.; some of the vaccine "sprayed back out" of the injection site and onto the patient's forearm, resulting in a partial dose of M-M-R II and topical exposure/he feels that she pulled the needle out too soon and got some on the dad; Information has been received from a medical assistant referring to a 22 month old male patient. Concomitant therapies included hepatitis a virus vaccine (unspecified) and pneumococcal conj vaccine (unspecified). The patient had no illness at the time of the vaccination and had no pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient had no adverse event following a prior vaccination.  On 06-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R028002, expiration date was 01-OCT-2020, subcutaneous in the left thigh (LT); strength and dose were not reported) for prophylaxis. Other suspect therapies included sterile diluent (Merck manufactured) (lot # was reported as R032351, expiration date was 02-JUN-2021, subcutaneous in the left thigh; strength, dose and indication were not reported).  On the same day, the medical assistant reported that during administration of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), some of the vaccine "sprayed back out" of the injection site and onto the patient's forearm, resulting in a partial dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and topical exposure (Accidental exposure to product). No adverse effect was reported. There has no temperature excursion occur as a result of a reading from a Digital Data Logger. The reporter reported according to the patient's dad, while the medical assistant was giving the shot he feels that she pulled the needle out too soon and got some on the dad. The doctor spoke with the dad and felt that he received enough of the medication and told him it was up to the parents if they want to revaccinate the child or wait. At the reporting time they were waiting.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects; adult patient was inadvertently administered a pediatric dose of VAQTA; adult patient was inadvertently administered a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant regarding an adult patient of unknown age and gender. The patient's concomitant conditions, medical history, past drugs, allergies and reactions were not reported. On 31-MAY-2019, the patient was inadvertently vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) vial 25/0.5 unspecified units (lot # R009822 and expiry date 12-JUN-2019) via intramuscular route for prophylaxis (product administered to patient of inappropriate age) (incorrect dosage administered). No adverse effects was reported.The outcome of the events was unknown.
Age: 4.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: no adverse effect; less than 1 full dose of proquad was administered to 4 year old child(patient); less than 1 full dose of proquad was administered to 4 year old child(patient) via IM; This spontaneous report was received from a nurse coordinator referring to a 4-year-old patient. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were unknown. On 31-MAY-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (dose number, anatomical location, therapy type, lot number and expiration date unknown) that was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (lot number and expiration date unknown) intramuscularly for prophylaxis, which was administered with less than 1 full dose (product administered at inappropriate site and incorrect dose administered). It was also reported that, the "patient pulled arm away and needle of vaccine went out of the patient's arm". No adverse effect was reported. No product quality complaints (PQC) were involved.
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, No adverse event, Underdose
Clinical narrative: No adverse effects; The patient was re vaccinated with ZOSTAVAX because the one she received in 2005 was under filled; The patient was re vaccinated with ZOSTAVAX because the one she received in 2005 was under filled; This spontaneous report was received from a female patient of unknown age concerning to herself. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date in 2005, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) 19400 Plaque Forming Units (PFU) (dose, frequency, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis, which was underfilled (product quality issue, incorrect dose administered). For this reason, the patient was told on an unspecified date in 2019, that she had to be re vaccinated with Zoster Vaccine Live (ZOSTAVAX). No adverse effects were reported. At the reporting time, the outcome of the product quality issue was unknown.    The causality between the event of product quality issue and Zoster Vaccine Live (ZOSTAVAX) was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a nurse via sales rep and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported fever 99.9 to 100 degrees F, duration from recollection was days. The reporter did not had additional details and would be try and get more details. This case has been linked with case US2019AMR097312, US2019AMR097190 reported by the same reporter.      Lab Comments: On unknown date, body temperature was measured.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tiredness; This case was reported by a nurse via sales rep and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient was co-worker of reporter. The age at vaccination was not reported. The patient reported that after immunization they were tired for 1 to 2 days. This case has been linked with case US2019AMR097312, US2019AMR097048reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tiredness; This case was reported by a nurse via sales rep and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: Patient was employee at practice. The age at vaccination was not reported. The patient reported that after immunization they were tired for 1 to 2 days. This case has been linked with case US2019AMR097190, US2019AMR097048reported by the same reporter.