chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Dizziness postural
Clinical narrative: Patient came to employee health for flu vaccine. Patient states she has had a flu vaccine before and has not had any previous reaction. She denies having COVID or being exposed to COVID. Patient received vaccine and approximately 5 minutes later she complained of lightheadedness and dizziness. I had her sit down in a chair. About 15 minutes later, I had her try to stand up and walk along the hallway, using the wall for stability. She was able to get up and walk, but felt wobbly whenever she took her hand off the wall and took a few steps. She sat back down and was told to keep waiting it out to see if it gets better. About 45 minutes after the flu shot, I gave her a bottle of water. 1 hour and 15 minutes after the shot we had her try to get up and walk again, and she still used the wall for stability. Still feeling dizzy. 1 hour and 20 minutes after flu shot, she said she is feeling a little bit better. She drank her whole bottle of water, and at 1130, her supervisor told her to go ahead and go home since she has to stand for her whole shift and is not able to stand for the whole shift.   After complaining of initial symptoms, patient did note that she had episodes of vomiting on 9/28, which she says is possible food poisoning since the fridge has not been working correctly lately. No vomiting episodes since then. She has had only cereal and coffee for breakfast. Also, she says she has a PMH of anxiety.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Pharyngeal swelling
Clinical narrative: Throating swelling, numb tongue
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE EFFECTS, PT RECIEVED THE HD FLU SHOT WHEN NOT QUITE 65 YEARS OLD
Age: 43.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Injection site pain
Clinical narrative: Patient reports aching in the left upper arm since vaccination. He also reports left thigh aching/myalgias as well that is dull. No numbness/tingling. This has been ongoing since 06/2020
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site haemorrhage
Clinical narrative: Vaccine was given in upper left deltoid. Upon withdrawal of the needle the patient started bleeding heavily. We cleaned him up and band aid was applied and he left. Patient seemed coherent and lucid when he left from the clinic. He is concerned that the vaccine came out when he was bleeding. He wants to get another Flu vaccination.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: in evening after vaccines administration, patient started vomiting and became febrile ( 102F). Multiple emesis episodes  til 3:00am next day. Taken to local emergency room by parent for evaluation. Treated w/ Zofran and fever reducers. Discharged home. As per parent's report , still febrile after 24 hours.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Limb discomfort, Mobility decreased, Paraesthesia, Peripheral swelling
Clinical narrative: Patient experienced swelling halfway to his elbow, tingling and discomfort.  He was unable to lift his arm from the shoulder. Mobility limited to below his elbow.  Patient visited his PCP,  who recommended ice and Aspirin treatment for the next few days. Patient is to follow up with prescriber in 3 additional days.
Sex: U
Vaccine: FLUC4
Symptoms: Eye pain, Swelling, Swelling of eyelid
Clinical narrative: Approx. 6 hours after injection I started feeling soreness in my R eye. Mild swelling developed and has persisted. Feels like I have a black eye. Swelling mostly above the eye on the inside-side. There is no excess mucus production or fluid being produced by the eye.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Myalgia, Nausea, Vomiting
Clinical narrative: patient described chills, muscle aches and nausea/vomitting that lasted approximately 4 hours.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Nausea
Clinical narrative: Child was given vaccines and waited in room for 5 minutes. Child walked to waiting room where he reported he was feeling nauseated and sat down. Nurse was called and with father's assistance he was escorted to room. Child was placed on table, legs elevated, Blood pressure taken, given popcycle and physician was called. Monitored for 20 minutes. Able to walk out of facility on own
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Joint injection, Joint range of motion decreased, Vaccination site pain
Clinical narrative: pain; a decrease in range of motion; should have been IM but was placed into the shoulder joint as opposed to the deltoid muscle; should have been IM but was placed into the shoulder joint as opposed to the deltoid muscle; should have been IM but was placed into the shoulder joint as opposed to the deltoid muscle; This spontaneous report was received from a medical student referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 03-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliters administered into the shoulder joint (joint injection and injected limb mobility decreased) as opposed to the deltoid muscle (strength, route of administration, lot #, and expiration date were not reported) for another health condition.      On the same day, the patient experienced pain (vaccination site pain) and a decrease in range of motion initially, but her status was improving.  It was unknown by the reporter if the patient received any treatment, or if any laboratory diagnostics or studies were performed to the patient due to this event.  The outcome of vaccination site pain, joint injection, injected limb mobility decreased and joint range of motion decreased was reported as resolving.   The causal relationship between the events and pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Scar
Clinical narrative: sustained scarring; painful rash outbreak across her back and was diagnosed with shingles / continues to have rash outbreaks; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 18-MAY-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a painful rash outbreak across her back and was diagnosed with shingles. The pt sustained scarring and continued to have rash outbreaks. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events of herpes zoster and scar to be related to zoster vaccine live (ZOSTAVAX) (reported as injuries caused by zoster vaccine live (ZOSTAVAX)).  The events of herpes zoster and scar were considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: herpes zoster with ophthalmic complications; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster with ophthalmic complications. As a result of these symptoms, the pt had been seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter considered the event of herpes zoster with ophthalmic complications to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster with ophthalmic complications was considered to be disabling. Upon internal review, the event of herpes zoster with ophthalmic complications was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Experience swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional information was provided as follows: The patients experienced injection site swelling after receiving the dose of Shingrix. Follow up has been requested.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR044343:same reporter
Age: 64.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: upset stomach; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 18th September 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 21st September 2020, 3 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was not recovered/not resolved.   It was unknown if the reporter considered the upset stomach to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were as follows: The case was reported by the wife for her husband. After receiving dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced upset stomach. The reporter reported that, could it be from the vaccine. The reporter wanted to know how long after a Shingrix vaccine side effects could take place. The reporter consented to follow.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Soreness; Stiffness; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 2nd dose of Shingrix. On 22nd September 2020, 1 days after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pain, stiffness and headache. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain, stiffness and headache were unknown.   It was unknown if the reporter considered the pain, stiffness and headache to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  After receiving 2nd dose of Shingrix, the experienced pain, stiffness and headache. The patient was asking is it safe to take aspirin if necessary. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female 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 week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that patient experienced a sore arm for about a week after receiving the 1st dose of Shingrix. No further information was available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Heart rate increased
Clinical narrative: after / first dose / took 24 hours / rapid heartbeat and called paramedics; This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included premature ventricular contractions (has metoprolol for PVC.) and heartbeats increased (has metoprolol for slight rapid heartbeat.).   On an unknown date, the patient received the 1st dose of Shingrix (intraparietal). On an unknown date, 24 hrs after receiving Shingrix, the patient experienced heartbeats increased. On an unknown date, the outcome of the heartbeats increased was unknown.   It was unknown if the reporter considered the heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient herself. After receiving 1st dose of Shingrix, the patient experienced rapid heartbeat and called paramedics. The reporter did not consent to follow-up. This case has been linked with US2020190519, reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190519:same patient
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Rash erythematous, Rash papular
Clinical narrative: papulo-vesicular grouped red hypereresthetic rash; papulo-vesicular grouped red hypereresthetic rash; right scapular pain begins; burning right scapular pain begins; This case was reported by a other health professional via sales rep and described the occurrence of scapula pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix. On 17th September 2020, 16 days after receiving Shingrix, the patient experienced scapula pain and burning sensation. On 22nd September 2020, the patient experienced papular rash and erythema. On an unknown date, the outcome of the scapula pain, burning sensation, papular rash and erythema were unknown.   It was unknown if the reporter considered the scapula pain, burning sensation, papular rash and erythema to be related to Shingrix.  Additional details were provided as follows: The over 50th years old patient received Shingrix and experienced burning right scapular, right scapular pain, papulo-vesicular grouped red hyperarithmetic rash on left scapula and papulo-vesicular grouped red hyperarithmetic rash on left lateral breast. The patient asks about 2nd dose of Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via interactive digital media 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. On 24th September 2020 20:43, 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 received Shingrix and on 24-SEP-2020 20:43:01 experienced fever. The age group was not reported but was captured as adult as per vaccine indication.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Something that people are allergic to in a regular flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported.  After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic to vaccine. The reporter did not consent to follow up. This case has been linked with US2020AMR193688, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR193688:grandson's case
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: All symptoms of the flu; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported.  After receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced symptoms of the flu. The reporter reported that, reporter would tell the doctor but they didn't believe me and one day reporter mentioned it to a nurse friend of mine and she told reporter what it was and to ask for the flu shot without that ingredient in it. The reporter reported that, after that patient had no problems with any flu shots.  The reporter did not consent to follow up. This case has been linked with US2020AMR193682, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR193682:people's case
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, 2 days 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 patient was vaccinated with 1st dose of Shingrix and experinced side effcts. The patient had fever after vaccination. The patient was inquired about 2nd dose.
Age: 17.0
Sex: F
Vaccine: FLUX, MEN
Symptoms: Chills, Vomiting
Clinical narrative: chills; throwing up; This case was reported by a consumer via call center representative and described the occurrence of chills in a 17-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 22nd September 2020 09:30, the patient received Influenza vaccine Quadrivalent unspecified season and Meningococcal B vaccine. On 22nd September 2020, less than a day after receiving Influenza vaccine Quadrivalent unspecified season and Meningococcal B vaccine, the patient experienced chills and vomiting. On an unknown date, the outcome of the chills and vomiting were unknown.   The reporter considered the chills and vomiting to be related to Influenza vaccine Quadrivalent unspecified season and Meningococcal B vaccine.  Additional detaails were provided as follows: The reporter was patients mother. The patient was vaccinated with Meningitis B and Flu vaccine morning around 9:30. The patient was throwing up and had chills at time of reporting. The reporter did not known the brand name of products. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia
Clinical narrative: Arm where received the injection was numb; This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper arm in an elderly female 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 day after receiving Shingrix, the patient experienced numbness of upper arm. On an unknown date, the outcome of the numbness of upper arm was recovered/resolved.   It was unknown if the reporter considered the numbness of upper arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that the patient after receiving the 1st dose of Shingrix, the arm where received the vaccination was numb, it happened on the same day and lasted for less than 24 hours. No further information was available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site bruising, Injection site pain
Clinical narrative: it burnt when the injection went in; huge bruise at the injection site; could not move her arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 14th September 2020, the patient received the 1st dose of Shingrix. On 14th September 2020, immediately after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site burning. In September 2020, the patient experienced injection site bruising and injected limb mobility decreased. On an unknown date, the outcome of the injection site burning was unknown and the outcome of the injection site bruising was not recovered/not resolved and the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injection site burning, injection site bruising and injected limb mobility decreased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, but the patient was in her 50's. On 14th September 2020, the patient received Shingrix vaccine at left arm and reported that it burnt when the injection went in, which led to injection site burning and on the same day, the patient also received the flu shot and did not experienced pain, redness or swelling at the injection site, right arm. Patient also reported that she could not move her arm for several days, which led to injected limb mobility decreased . Pharmacist reported that five days later the patient had a huge bruise at the injection site and the vaccine appeared to had been administered higher up the left arm upper deltoid muscle, which led to injection site bruising. The reporter did not consented to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise, Pain in extremity, Rash macular, Rash pruritic
Clinical narrative: itching in the mid torso area but it was a flat rash; didn't feel great; arm hurt; felt under the weather; flat macular rash all over the trunk of her body; This case was reported by a nurse via call center representative and described the occurrence of macular rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, 2 days after receiving Shingrix and an unknown time after starting Zyrtec, the patient experienced macular rash. On an unknown date, the patient experienced itchy rash, feeling abnormal, pain in arm and feeling unwell. The patient was treated with cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the macular rash, itchy rash, feeling abnormal, pain in arm and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the macular rash, itchy rash, feeling abnormal, pain in arm and feeling unwell to be related to Shingrix.  Additional details were reported as follows: In August 2020, patient received 1st dose of Shingrix and 2 to 3 days after receiving Shingrix, the patient experienced rash (on 10th August 2020 or somewhere around there). Nurse stated that It was not hives but a flat macular rash all over the trunk of her body and was not exactly sure how long it lasted, but patient took Zyrtec and had mild itching in the mid torso area but it was a flat rash and it resolved after taking Zyrtec. The patient also experienced some mild reactions (didn't feel great, arm hurt, felt under the weather) for about 24 to 36 hour period then resolved. Physician did not want patient to receive the 2nd dose of Shingrix. The reporter consented to follow-up. This case is linked with US2020190518 and US2020190562, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190518:same reporter US-GLAXOSMITHKLINE-US2020190562:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: didn't feel good; she felt fatigued; flu-ey; arm felt sore; This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dermatomyositis and systemic lupus erythematosus.   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 feeling unwell, fatigue, influenza-like symptoms and pain in arm. On an unknown date, the outcome of the feeling unwell, fatigue, influenza-like symptoms and pain in arm were recovered/resolved.   It was unknown if the reporter considered the feeling unwell, fatigue, influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were provided as follow: The age vaccination was not reported. The patient was vaccinated with Shingrix within the last 3 months. After vaccination patient did not feel good, felt flu, srm sore and fatigued. The symptoms were resolved within 24 hours. The reporter did not sure if the symptoms started the night of vaccination with Shingrix or the next day. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190518:same reporter US-GLAXOSMITHKLINE-US2020190557:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: left arm and hand pain; Left arm numbness; Left arm / tingling; Left elbow joint pain; This case was reported by a consumer via call center representative and described the occurrence of pain in hand in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 15th September 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In September 2020, less than 2 weeks after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in hand, numbness of upper extremities, tingling of extremity and pain in elbow. On an unknown date, the outcome of the pain in hand, numbness of upper extremities, tingling of extremity and pain in elbow were unknown.   It was unknown if the reporter considered the pain in hand, numbness of upper extremities, tingling of extremity and pain in elbow to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. Patient reported that he received a dose of GSK flu vaccine on 15th sepember 2020 and after that experienced events like left arm and hand pain, left arm numbness and tingling, and left elbow joint pain.      The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Pain, Pain in extremity
Clinical narrative: Nausea; Soreness; Arm became sore with pressure; Redness; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced erythema. On 22nd September 2020, the patient experienced pain and pain in arm. On 24th September 2020, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the erythema, pain and pain in arm were unknown.   It was unknown if the reporter considered the nausea, erythema, pain and pain in arm to be related to Shingrix.  Additional details were as follows: The patient received 1st dose of Shingrix intramuscularly in right arm. After receiving 1st dose of Shingrix, the patient experienced redness, soreness, nausea and arm became sore with pressure. The patient had some medicine. The reporter reported that, all information was not available. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood immunoglobulin G increased, Blood immunoglobulin M increased, Blood pressure increased, Dizziness
Clinical narrative: Malaise; Shakiness; Dizziness; Increased blood pressure; Fast heartbeat; Difficulty breathing; Headache; Extreme tiredness; Muscle Pain; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles last october and november 2019 (last October and November 2019.). Concurrent medical conditions included immune disorder (nos).   On 15th September 2020, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 15th September 2020, less than a day after receiving Shingrix, the patient experienced headache, tiredness, muscle pain and upset stomach. On 17th September 2020, the patient experienced tremor, dizziness, increased blood pressure, heartbeats increased and difficulty breathing. On an unknown date, the patient experienced malaise. On 18th September 2020, the outcome of the headache, tiredness, muscle pain and upset stomach were recovered/resolved. On an unknown date, the outcome of the tremor, dizziness, increased blood pressure, heartbeats increased and difficulty breathing were not recovered/not resolved and the outcome of the malaise was unknown.   It was unknown if the reporter considered the tremor, dizziness, increased blood pressure, heartbeats increased, difficulty breathing, malaise, headache, tiredness, muscle pain and upset stomach to be related to Shingrix.  Additional details were as follows: The caller shared the patient received weekly infusions of IgM due to an unspecified immune disorder. On 17th September 2020, the patient underwent fast heartbeat test which result increased and increased blood pressure which results 143/76 and highest blood pressure seen since onset of increase was170/92. On unknown date the patient underwent blood test for varicella zoster antibodies IgG and IgM which results was 4000. After receiving 1st dose of Shingrix, the patient experienced upset stomach, muscle pain, extreme tiredness, headache, difficulty breathing, fast heartbeat, increased blood pressure, dizziness and shakiness. The consumer reports her physician changed blood pressure to see if it helped decrease blood pressure however, blood pressure still varies. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Headache, Heart rate increased, Malaise
Clinical narrative: Malaise; Shakiness; Dizziness; Increased blood pressure; Fast heartbeat; Difficulty breathing; Headache; Extreme tiredness; Muscle Pain; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles last october and november 2019 (last October and November 2019.). Concurrent medical conditions included immune disorder (nos).   On 15th September 2020, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 15th September 2020, less than a day after receiving Shingrix, the patient experienced headache, tiredness, muscle pain and upset stomach. On 17th September 2020, the patient experienced tremor, dizziness, increased blood pressure, heartbeats increased and difficulty breathing. On an unknown date, the patient experienced malaise. On 18th September 2020, the outcome of the headache, tiredness, muscle pain and upset stomach were recovered/resolved. On an unknown date, the outcome of the tremor, dizziness, increased blood pressure, heartbeats increased and difficulty breathing were not recovered/not resolved and the outcome of the malaise was unknown.   It was unknown if the reporter considered the tremor, dizziness, increased blood pressure, heartbeats increased, difficulty breathing, malaise, headache, tiredness, muscle pain and upset stomach to be related to Shingrix.  Additional details were as follows: The caller shared the patient received weekly infusions of IgM due to an unspecified immune disorder. On 17th September 2020, the patient underwent fast heartbeat test which result increased and increased blood pressure which results 143/76 and highest blood pressure seen since onset of increase was170/92. On unknown date the patient underwent blood test for varicella zoster antibodies IgG and IgM which results was 4000. After receiving 1st dose of Shingrix, the patient experienced upset stomach, muscle pain, extreme tiredness, headache, difficulty breathing, fast heartbeat, increased blood pressure, dizziness and shakiness. The consumer reports her physician changed blood pressure to see if it helped decrease blood pressure however, blood pressure still varies. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Tremor
Clinical narrative: Malaise; Shakiness; Dizziness; Increased blood pressure; Fast heartbeat; Difficulty breathing; Headache; Extreme tiredness; Muscle Pain; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles last october and november 2019 (last October and November 2019.). Concurrent medical conditions included immune disorder (nos).   On 15th September 2020, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 15th September 2020, less than a day after receiving Shingrix, the patient experienced headache, tiredness, muscle pain and upset stomach. On 17th September 2020, the patient experienced tremor, dizziness, increased blood pressure, heartbeats increased and difficulty breathing. On an unknown date, the patient experienced malaise. On 18th September 2020, the outcome of the headache, tiredness, muscle pain and upset stomach were recovered/resolved. On an unknown date, the outcome of the tremor, dizziness, increased blood pressure, heartbeats increased and difficulty breathing were not recovered/not resolved and the outcome of the malaise was unknown.   It was unknown if the reporter considered the tremor, dizziness, increased blood pressure, heartbeats increased, difficulty breathing, malaise, headache, tiredness, muscle pain and upset stomach to be related to Shingrix.  Additional details were as follows: The caller shared the patient received weekly infusions of IgM due to an unspecified immune disorder. On 17th September 2020, the patient underwent fast heartbeat test which result increased and increased blood pressure which results 143/76 and highest blood pressure seen since onset of increase was170/92. On unknown date the patient underwent blood test for varicella zoster antibodies IgG and IgM which results was 4000. After receiving 1st dose of Shingrix, the patient experienced upset stomach, muscle pain, extreme tiredness, headache, difficulty breathing, fast heartbeat, increased blood pressure, dizziness and shakiness. The consumer reports her physician changed blood pressure to see if it helped decrease blood pressure however, blood pressure still varies. The reporter consented to follow up.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Eye was swollen; Eye was swollen and red; This case was reported by a other health professional via call center representative and described the occurrence of eye swelling in a infant male patient who received DTPa-HBV-IPV (Pediarix) (batch number 23YL4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, less than a day after receiving Pediarix, the patient experienced eye swelling and eye red. On an unknown date, the outcome of the eye swelling and eye red were recovered/resolved.   It was unknown if the reporter considered the eye swelling and eye red to be related to Pediarix.  Additional details were reported as follows: Reporter was medical assistant. The age at vaccination was not reported. Reporter stated that the patient received a dose of Pediarix, and on the same day, the patient developed eye swelling and redness. Reporter stated that the patient's mother reportedly did not had to intervene at all, and the patient's eye was swollen and red for about 4 hours before resolving. The reporter consented to follow-up.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, UNK
Symptoms: Pain, Paraesthesia, Torticollis
Clinical narrative: Pain; Torticollis spastic; This is a spontaneous report from a contactable physician. This physician reported similar events for five patients. This is the third of five reports.   A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA lot number: AT1920) intramuscular on the left arm on 28Aug2020 11:28 at a single dose (reported as 1-1-1/2) for Men B/immunization; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA lot number: U6575AA) intramuscular on the right arm on 28Aug2020 at an unspecified dose for immunisation and hepatitis a vaccine (lot number: 7595K) intramuscular on the right arm on 28Aug2020 at an unspecified dose for immunisation. The patient had no medical history, concomitant medications and relevant test. On 30Aug2020 the patient experienced torticollis spastic. Patient still gets tingling with movement of neck. On an unspecified date, the patient experienced pain. The patient was not hospitalized due to the events. The events required a visit to the physician office. Patient was given Lorlatinib as treatment. Patient getting P.T. Outcome of the event Torticollis spastic was not recovered while unknown for the other event. It was reported that there was a reasonable possibility that the events were related to the suspect product.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020343033 Same reporter, similar drugs and events, different patient
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on unspecified date at single dose for immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced pain, the event took place after use of product. The patient outcome of the event was unknown.    No follow-up attempts are possible, information about Lot/ Batch number cannot be obtained.
Age: 5.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 5 year old patient was given FluBlok by mistake, no AE; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone   This case involves a five-years-old male patient who was vaccinated with a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (pre filled syringe, lot number QFAA2009 and expiration date was 03-Jun-2021) via an intramuscular route in the left deltoid on 16-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient was concomitantly vaccinated with a dose of  DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and POLIO VACCINE INACT (IPV) on for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency was same day).  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance. 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: 76.0
Sex: F
Vaccine: UNK
Symptoms: Syringe issue, Underdose
Clinical narrative: Some part of the vaccine spilled out from the plunger with no AE; Some part of the vaccine spilled out from the plunger with no AE; Initial information was received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 76 years old female patient whom while administrating 0.7 mL once suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Lot UJ467AB, expiration date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination (syringe issue) (vaccine underdose) some part of the vaccine spilled out from the plunger on 08-Sep-2020.  Medical history, past medical treatments, past vaccinations and family history were not provided.  This was actual medication error case due to vaccine underdose and Syringe issue.  Reporter reported that as soon as he started pushing down on the plunger, as he was pushing it into patient, the stuff came leaking out. He states that the liquid seemed to be coming from the syringe itself, a crack in the area of the 'shoulder' of the syringe (the barrel of the syringe, "2 or 3 centimeters from the needle") (syringe issue).  It was not reported whether the patient experienced any adverse event.  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.
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient who was back for second Imovax injection, the first being 24 days ago, no AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 18 years old female patient who was vaccinated with first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] vaccine and the patient came back for second dose after 24 days of first dose administration (PT:inappropriate schedule of product administration).  Medical history and concomitant medications were not reported.  On an unknown date, the patient received the first dose of RABIES (HDC) VACCINE  and on 31-Aug-2020, the patient also received 0.5 ml of the second dose of same vaccine (injection,lot number and expiration date were not reported for bot the regimens) via unknown route in unknown administration site for unknown indication.  It was an actual medication error case due to inappropriate schedule of vaccine administration .  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Immediate burning and soreness that developed into SIRVA