chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves patient who experienced flublok quadrivalent to a pediatric patient, while he/she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route. It was a case of actual medication error due to Inappropriate age at vaccine administration. The patient outcome is reported as Not Applicable for flublok quadrivalent to a pediatric patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Nausea, Palpitations, Tongue disorder, Vertigo
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 72 years old female patient who experienced heart was pounding, her tongue felt a little thick, started to feeling swirling in her head (not dizzy) then it spread through her whole body and nausea, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included has allergies with Sulfite, PCN and iodine. The patient's past vaccination included FLUZONE HD last year with no reaction. At the time of the event, the patient had ongoing diagnosis of Multiple Sclerosis. The patient took 2 BENADRYL before the injection. Concomitant medications included ZYRTEC every night. She takes Alprazolam prn for anxiety. On 25-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On 25-Sep-2018, the patient developed a non-serious heart was pounding two hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 25-Sep-2018, the patient developed a non-serious her tongue felt a little thick two hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 25-Sep-2018, the patient developed a non-serious started to feeling swirling in her head (not dizzy) then it spread through her whole body two hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 25-Sep-2018, the patient developed a non-serious nausea two hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient also has these symptoms but worse when patient ingests Sulfite. The symptoms were less in the AM. The patient still has a little of the tongue thickness. Lab data was not provided. Final diagnosis was nausea, started to feeling swirling in her head (not dizzy) then it spread through her whole body, her tongue felt a little thick and heart was pounding. It was not reported if the patient received a corrective treatment. Drinking water helps her. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for started to feeling swirling in her head (not dizzy) then it spread through her whole body, as Not Recovered / Not Resolved on an unknown date for her tongue felt a little thick, as Not Recovered / Not Resolved on an unknown date for nausea and as Not Recovered / Not Resolved on an unknown date for heart was pounding. List of documents held by sender- none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Body temperature increased, Diarrhoea, Flatulence
Clinical narrative: Pharmacy offered me a flu shot and I accepted. Wasn't told it was a new mixture. First two days had red, hot, swollen knot at injection site. Second night started severe vomiting, stomach cramps, gas, diarrhea and temp 100.3. Took the shot on Tuesday and to Sunday and still having awful diarrhea and temp. Today is Monday and feel very week. I will definitely never take this vaccine again.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Pharmacy offered me a flu shot and I accepted. Wasn't told it was a new mixture. First two days had red, hot, swollen knot at injection site. Second night started severe vomiting, stomach cramps, gas, diarrhea and temp 100.3. Took the shot on Tuesday and to Sunday and still having awful diarrhea and temp. Today is Monday and feel very week. I will definitely never take this vaccine again.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: SIGNIFICANT LEFT SHOULDER PAIN THAT HAS NOT IMPROVED OVER THE PAST 8 MONTHS PER PATIENT.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills
Clinical narrative: Patient experienced shivers and chills for 3 days despite doses of ADVIL.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Muscular weakness, Pain
Clinical narrative: Patient returned to the pharmacy on 10/07/18 to report adverse reaction after receiving FLUAD on 09/28/18. He states 12 hours after vaccination, he felt "painful on both sides of body" and when he tried to stand up from bed "both legs gave out". These symptoms lasted for estimated 7 days and today (10/07/18) has been the first time he has felt better and able to go out. Patient states he was at his doctor's office recently and was advised to let the pharmacy know what happened so we could report it. When asked if he had any current disease states or health problems he replied "No, nothing".  However, patient briefly mentioned he was scheduled for a radio nuclear assay and when asked for what reason he stated "I don't know, I guess I will ask my doctor". Patient appeared not to be in distress, was walking and speaking normally.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large redden area, most of upper arm at injection site. Patient describe area as "hot" and painful.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain, Swelling
Clinical narrative: Pain, chill, swelling.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Dehydration, Nausea, Pain, Pain in extremity
Clinical narrative: I do not have the information regarding the manufacturer, or lot number. The nurse at my employer's clinic said it was a FLUZONE QUADRIVALENT preservative free flu shot.  She said some were with the preservative. By 7pm on the day I got the vaccine, I had severe pain in my entire left arm. I alternated TYLENOL and ibuprofen and used a heating pad to help soothe the pain. I vomited at midnight and 3am. I had full body aches and nausea all day on Saturday, 10/6. On Sunday, 10/7, I felt better but still couldn't eat much and was dehydrated. I also felt like I broke a fever Saturday night, although I never took my temperature prior to that.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: I do not have the information regarding the manufacturer, or lot number. The nurse at my employer's clinic said it was a FLUZONE QUADRIVALENT preservative free flu shot.  She said some were with the preservative. By 7pm on the day I got the vaccine, I had severe pain in my entire left arm. I alternated TYLENOL and ibuprofen and used a heating pad to help soothe the pain. I vomited at midnight and 3am. I had full body aches and nausea all day on Saturday, 10/6. On Sunday, 10/7, I felt better but still couldn't eat much and was dehydrated. I also felt like I broke a fever Saturday night, although I never took my temperature prior to that.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Seizure
Clinical narrative: Generalized seizure.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Electroencephalogram normal, Generalised tonic-clonic seizure, Incontinence, Nuclear magnetic resonance imaging normal, Postictal state
Clinical narrative: Generalized seizure.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Unresponsive to stimuli
Clinical narrative: Generalized seizure.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient's arm is red and and hot only below the injection site. He saw his PCP who presribed KEFLEX and told him it was due to depth of vaccination. Our facility uses 1-inch needles for this vaccination  No pain was reported. This is the second year in a row he has reported a red reaction days afterward.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Injection site pain and tenderness; severe rigors, chills and fever.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Pain, Swelling
Clinical narrative: Patient received a dose of his seasonal flu shot. Was fine that day but the next day noticed soreness, redness,and minor swelling. Patient saw on-site nurse and nurse felt that there was some possible "extravisation" of the vaccine into the skin. Felt that patient did not need medical attention.  Patient will just watch and wait to make sure does not get worse. He is using benadryl, ibuprofen for discomfort.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Joint contracture, Swelling face
Clinical narrative: Pt got routine BOOSTRIX vaccine at his request due to hand laceration when working on his lawnmower (time approx 11am). Pt was requested to wait in store for at least 20 minutes. After approximately 10 minutes (time approx 11:10-11:15), pt returned to pharmacy, stated he was starting to have trouble breathing. Rph had pt lie on floor and had technician call 911. Pt breathing became more labored and face had some swelling and hands were drawing closed. Rph administered at dose of epinephrine 0.3mg via pen in right thigh (through clothing) at 11:22am. Epinephrine worked quickly, pt breathing began to slow and hands began to relax. EMS arrived and took over with patient and recommended pt go to hospital. Pt was alert and oriented when he was taken away.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left arm, treated with KEFLEX and resolved.
Age: 62.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT STATING NEXT DAY SHE DEVELOPED REDNESS, SWELLING AND BURNING EFFECT AT THE INJECTIONS SITE ON HER RIGHT ARM (WHERE SHINGRIX GIVEN). TODAY IS DAY 7 TH, AND HER REDNESS AND SWELLING GOING DOWN BUT BURNING EFFECT IS NOW SPREADING TO HER ARM AND NECK AREA.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Feeling abnormal, Malaise
Clinical narrative: Generalized malaise, fatigue, and dizziness that has progressively worsened. She did take the "high dose" flu shot late last week and has felt "horrible" since then.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Patient called a few days later and reported that arm was red below injection site. It is not red around or above - only below. No pain was reported.
Age: 30.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Differential white blood cell count, Full blood count, Hypoaesthesia, Local reaction, Skin warm
Clinical narrative: Patient came to ED on 10-4-2018. Treated for either local reaction vs cellulitis at site where vaccines were given on 10-1-2018. Put on Doxycycline 100mg BID, 20 caps. Also given Hydrocodone 5-325mg for pain. Next visit was today, 10-8-2018-continues with treatment. Arm still warm to touch and very tender. Some numbness in fingers.
Age: 30.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Tenderness, Vaccination site cellulitis, White blood cell count increased
Clinical narrative: Patient came to ED on 10-4-2018. Treated for either local reaction vs cellulitis at site where vaccines were given on 10-1-2018. Put on Doxycycline 100mg BID, 20 caps. Also given Hydrocodone 5-325mg for pain. Next visit was today, 10-8-2018-continues with treatment. Arm still warm to touch and very tender. Some numbness in fingers.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Laboratory test abnormal, Pain, Product administered at inappropriate site
Clinical narrative: The nurse practitioner was standing and I was seated when the vaccine was administered. It was given extremely high -- practically directly atop the acromion process. About 1.5 weeks post-administration I began experiencing pain when moving my arm in certain angles, lifting my arm, and upon palpating my shoulder. The pain has not abated and I have limited range of motion of my arm. I am unable to lift it higher than shoulder level without prohibitive pain.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Myalgia
Clinical narrative: Fever (102.2) Fever, Fatigue, Chills, Myalgias, Arthralgias. Right arm is swollen, tender and erythematous.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Fever (102.2) Fever, Fatigue, Chills, Myalgias, Arthralgias. Right arm is swollen, tender and erythematous.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Woke up with severe chills, shaking hard all over and my teeth chattering uncontrollably.  My husband got blankets and a heating pad.  Realized I had fever and took a reading, 101.5. Normal temperature is somewhat below 98.6 usually. Took some Tylenol and after about 45 minutes my fever came down and the chills subsided.  Continued taking Tylenol through the night every 4 hours, and all the next day until about 5:00 when the fever didn't seem to creep back up any longer.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased
Clinical narrative: Patient said later that night/overnight she experienced a severe drop in her blood pressure.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Blood test, Diarrhoea, Mobility decreased, Myalgia
Clinical narrative: Fever, severe body aches and joint pain, unable to left my arm up. Ache in all my muscles, joints difficult lifting arm. Throwing up ALL food, and than loose bowels.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia, Urine analysis, Vomiting
Clinical narrative: Fever, severe body aches and joint pain, unable to left my arm up. Ache in all my muscles, joints difficult lifting arm. Throwing up ALL food, and than loose bowels.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea, Erythema, Panic attack
Clinical narrative: Patient became bright red in her face and neck about 10 seconds after receiving her FLUZONE HD vaccine on 10/08/2018 at around 11:40 am. She complained of being unable to breath and was gasping for air. She also complained of a lower back pain that was a level 3 out of 10. Due to her inability to breath/taking a full breath, patient went into a panic-attack like mode. After about a couple minutes of gasping for air, the pharmacist decided to inject an epinephrine pen into the left thigh of the patient. The pharmacy called 911 and paramedics came and took patient to Medical Center. Patient seemed to improve in color and especially in her ability to breath post epinephrine pen injection. By the time paramedics arrived, patient seemed to have mostly recovered.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: SEVERE PAIN IN THE ARM. THE DAY AFTER, REDNESS AND PAIN.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Injection site erythema, Injection site pain, Rash
Clinical narrative: Per diagnosis of medical center on 10/7/18 and Dr. on 10/8/18 patient was diagnosed with an outbreak of shingles. Painful rash is present on both sides of abdomen/torso and legs, and per patient has worsened in the last few days. Patient also said he experienced 24 to 48 hours post-vaccination fatigue and pain/redness at the injection site.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Injection site pain, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: Per diagnosis of medical center on 10/7/18 and Dr. on 10/8/18 patient was diagnosed with an outbreak of shingles. Painful rash is present on both sides of abdomen/torso and legs, and per patient has worsened in the last few days. Patient also said he experienced 24 to 48 hours post-vaccination fatigue and pain/redness at the injection site.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced swelling, pain, and itching at the injection site.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Crying, Hypoaesthesia, Muscular weakness
Clinical narrative: After HPV and MCV vaccines were given in the left upper arm, patient started crying and complaining of numbness and weakness in left arm, he had weakness and numbness only for 10 min, he was observed in the office for 30 - 40 min after all the vaccines were given. At the time of the d/c he was able to move his left arm well, ROM was nl, normal strength, normal sensation; he denied H/A, dizziness. The reaction to vaccines will be reported to VAERS, the message was left today. We followed up with the family within 48 hrs, patient didn't have any numbness, had full strength  in his left arm. Per MD notes.
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Malaise, Pain, Product administration error, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received Shingrix for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. In September 2018, the patient received the 1st dose of Shingrix .5 ml and Influenza vaccine Quadrivalent 2018-2019 season. In September 2018, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced general body pain, chills, fever, feeling unwell and drug administration error. In September 2018, the outcome of the general body pain, chills, fever and feeling unwell were recovered/resolved. On an unknown date, the outcome of the drug administration error was unknown. It was unknown if the reporter considered the general body pain, chills, fever and feeling unwell to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient received Shingrix and flu vaccine at the same time in the left deltoid, which led to drug administration error. Both vaccines were administered about three weeks ago from the date of reporting but the patient could not provide a specific date. The night when the patient received vaccines, the patient developed the chills, aches and fever. When the patient woke the next day, she did not feel well but the chills and fever were gone and she went to work. All events were resolved within 2 days. The patient does not recall the name of the flu vaccine but she told it was for those over 65 as it was a bit stronger.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Musculoskeletal pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 53-year-old female patient who received Shingrix for prophylaxis. On 19th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 20th September 2018, 1 days after receiving Shingrix, the patient experienced general body pain, headache, pain in joint involving hand, fever and chills. On 25th September 2018, the patient experienced shoulder pain. On an unknown date, the outcome of the general body pain, headache, pain in joint involving hand, fever and chills were recovered/resolved and the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the general body pain, headache, pain in joint involving hand, shoulder pain, fever and chills to be related to Shingrix. Additional details were provided as follows: On 19th September 2018 at 16:30 hours , the patient received Shingrix on left arm. After receiving Shingrix, the patient experienced severe body aches, severe headache, fever, chills and joint pain in her fingers. The headache only lasted about 1 day and the other symptoms resolved after 3 days. The patient experienced pain in her right shoulder and it had been getting worse. The patient could not move her arm without pain.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 53-year-old female patient who received Shingrix for prophylaxis. On 19th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 20th September 2018, 1 days after receiving Shingrix, the patient experienced general body pain, headache, pain in joint involving hand, fever and chills. On 25th September 2018, the patient experienced shoulder pain. On an unknown date, the outcome of the general body pain, headache, pain in joint involving hand, fever and chills were recovered/resolved and the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the general body pain, headache, pain in joint involving hand, shoulder pain, fever and chills to be related to Shingrix. Additional details were provided as follows: On 19th September 2018 at 16:30 hours , the patient received Shingrix on left arm. After receiving Shingrix, the patient experienced severe body aches, severe headache, fever, chills and joint pain in her fingers. The headache only lasted about 1 day and the other symptoms resolved after 3 days. The patient experienced pain in her right shoulder and it had been getting worse. The patient could not move her arm without pain.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 71-year-old male patient who received Shingrix (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 23rd August 2018, the patient received the 1st dose of Shingrix (intramuscular). In September 2018, 21 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unchanged. It was unknown if the reporter considered the rash to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. Three weeks after receiving Shingrix, the patient experienced a rash on both legs below their knees.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Laboratory test, Muscle spasms, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 73-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) and (batch number 97H72, expiry date 8th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 24th July 2018, the patient received the 2nd dose of SHINGRIX. On 24th July 2018, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, cramp, headache and diarrhea. The patient was treated with metronidazole. On an unknown date, the outcome of the general body pain, cramp and headache were unknown and the outcome of the diarrhea was recovered/resolved. It was unknown if the reporter considered the general body pain, cramp, headache and diarrhea to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The patient received 1st dose of SHINGRIX on 25th April 2018. The healthcare professional reported that after receiving 2nd dose, the patient developed a very severe reaction. She had severe body aches, diarrhea for about 48 hours, severe cramping, and a severe headache. She did end up going to the doctor and they gave her Metronidazole for 2 weeks for the diarrhea and cramping, and did additional tests for irritable bowel syndrome (IBS). She said she had a reaction to the first shot, but it was much more severe with the 2nd dose and she had just gotten back from a trip. On the first one she thought that was the underlying reason. Lab Comments: In 2018, the test for IBS was performed.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Shingrix for prophylaxis. On 14th June 2018, the patient received the 1st dose of Shingrix. On 14th June 2018, less than a day after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on the left arm. The patient stated that, he had left arm pain which lingered with limited mobility in arm, since the day of vaccine administration, for 3 months at the time of reporting. The patient would like information on this adverse event.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix. Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient had redness at the injection site and the injection site was warm to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) stated that, many of her patients complained of injection site reactions, such as pain, redness and swelling after the administration of Shingrix vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction, Drug hypersensitivity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a patient who received Flu Seasonal TIV Dresden for prophylaxis. Concurrent medical conditions included egg allergy. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced adverse reaction and documented hypersensitivity to administered drug. On an unknown date, the outcome of the adverse reaction and documented hypersensitivity to administered drug were unknown. It was unknown if the reporter considered the adverse reaction and documented hypersensitivity to administered drug to be related to Flu trivalent vaccine. Additional details were reported as follows: The age at vaccination was not reported. In 1996, the patient received unknown brand of flu vaccine. In 1996 after vaccination, the patient experienced severe reaction due to an egg allergy, which led to documented hypersensitivity to administered drug.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Immune system disorder, Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feels awful in a 56-year-old male patient who received Shingrix (batch number P3777, expiry date 30th January 2020) for prophylaxis. Co-suspect products included Shingrix for prophylaxis. On 14th February 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced feels awful, immune system disorder and incomplete course of vaccination. On an unknown date, the outcome of the feels awful and immune system disorder were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the feels awful and immune system disorder to be related to Shingrix. Additional details were provided as follows: The healthcare professional reported that the patient experienced a horrible reaction after their first dose of Shingrix. All he know that the patient felt awful and it messed with their immune system. The healthcare professional believed the patient was recovered at that point. The patient had not received 2nd dose at the time of reporting, which led to incomplete course of vaccination. The healthcare professional did not know if the patient would receive the 2nd dose. The healthcare professional provided lot number (A5X5B) and expiration date (7th March 2021), if the patient would receive the 2nd dose this would be what he receives.
Age: 56.0
Sex: U
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old patient who received Shingrix for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 26th September 2018, the patient received Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. On 27th September 2018, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient reported that he he received the Shingrix vaccine as well as the flu shot a day before the reporting date. At the time of reporting, the patient experienced flu-like symptoms and fever.
Age: 56.0
Sex: U
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old patient who received Shingrix for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 26th September 2018, the patient received Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. On 27th September 2018, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient reported that he he received the Shingrix vaccine as well as the flu shot a day before the reporting date. At the time of reporting, the patient experienced flu-like symptoms and fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 14th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st September 2018, 7 days after receiving SHINGRIX, the patient experienced shingles and skin lesion. On an unknown date, the outcome of the shingles and skin lesion were unknown. It was unknown if the reporter considered the shingles and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The reporter received SHINGRIX vaccine on left deltoid. The patient noted a lesion on her right forearm. On 24th September 2018, the patient was diagnosed with Shingles. Transferred to medical information.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pain in extremity, Rash macular
Clinical narrative: This case was reported by a dentist via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Shingrix for prophylaxis. The patient's past medical history included bone marrow transplant (in 2009 from a 21 year old person). In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, injection site erythema, blotchy rash and injection site rash. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the injection site erythema, blotchy rash and injection site rash were recovered/resolved. It was unknown if the reporter considered the pain in arm, injection site erythema, blotchy rash and injection site rash to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient was not on any medications since 2011. The patient experienced sore arm and had rash below the injection site, which was described as red, blotchy and not itchy. The patient stated that he felt like he was hit with a ton of bricks. In October 2018, the patient scheduled his second dose of Shingrix. The patient wanted to know the efficacy after vaccination with the first dose of Shingrix. The patient stated that more likely he would not receive the 2nd dose of Shingrix based on the reactions experienced. The questions were forwarded to Monitoring-Evaluation System (MES) for efficacy guidelines. No additional information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (Arm soreness after receiving 1st dose on April 2018, see case US2018GSK181307). On 9th September 2018, the patient received the 2nd dose of Shingrix. On 9th September 2018, immediately after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site warmth to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient felt as if she had been kicked in the arm by a horse. The site was warm and very swollen and sore. This developed the same evening and it took three to four days to go away. For tolerance after 2nd dose of Shingrix, refer US2018GSK181307.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 26th March 2018, for tolerance refer, US2018GSK181073). On 24th September 2018, the patient received the 2nd dose of Shingrix. On 24th September 2018, less than a day after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The patient received the Shingrix on the right arm. The patient stated that, he sat down and pharmacist stood when he received the shot. The patient experienced pain and soreness at the injection site which lasted for 4 days, although it was 50 percent better in the last 24 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Rash papular, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced pain, feeling unwell, swelling arm and skin warm. On an unknown date, the outcome of the pain, feeling unwell, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pain, feeling unwell, swelling arm and skin warm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had the injection at around 5 PM and did not notice anything that evening or the next day but on the second day her arm became swollen, bumpy and hot to the touch. The patient did not feel well for a few days. All symptoms were resolved within seven days. The patient did not want to provide personal information. An event was reported as whelp, clarification has been requested for the same.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced pain, feeling unwell, swelling arm and skin warm. On an unknown date, the outcome of the pain, feeling unwell, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pain, feeling unwell, swelling arm and skin warm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had the injection at around 5 PM and did not notice anything that evening or the next day but on the second day her arm became swollen, bumpy and hot to the touch. The patient did not feel well for a few days. All symptoms were resolved within seven days. The patient did not want to provide personal information. An event was reported as whelp, clarification has been requested for the same.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Thirst
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of pain in arm in a 67-year-old female patient who received Shingrix for prophylaxis. Concurrent medical conditions included scoliosis (severe) and arthritis. Concomitant products included meloxicam. On 25th September 2018 13:30, the patient received the 1st dose of Shingrix (intramuscular). On 25th September 2018, less than a day after receiving Shingrix, the patient experienced thirst. On 25th September 2018 16:30, the patient experienced pain in arm and injected limb mobility decreased. The patient was treated with Tylenol and tramadol. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the thirst was recovering/resolving and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the pain in arm, thirst and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The patient stated that, she received the Shingrix on left deltoid at 01:30 PM and at 04:30 PM, the same day she started to feel the pain in her left arm. The patient stated that, the pain was so severe that she can not move her arm. The patient stated that, she went to urgent care and was taking extra-strength Tylenol and Tramadol. The patient stated that, she was using a heating pad and cold compress for the pain. The patient stated that, she called her doctor and her doctor prescribed Tylenol-3 for the pain. The patient stated that even though she was taking pain medication, the pain was still very severe at the time of reporting. The patient also reported that she experienced extreme thirst that was getting better, but had not completely gone away. This case has been linked to the case US2018176529, reported by same reporter. On 26th September 2018, caller originally left afterhours voicemail with details of this event. An outbound call was placed, to the patient to obtain additional adverse event details.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Immediate post-injection reaction, Injection site bruising, Injection site swelling
Clinical narrative: Immediate swelling at injection site.  No discoloration at first.  Severe discomfort in lifting the arm for 48 hours. Bruise still at injection site today.
Age: 0.92
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Complex Febrile Seizures/Convulsions.
Age: 65.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Erythema, Injection site warmth, Mobility decreased, Skin discolouration, Swelling
Clinical narrative: Patient complained about warmth at the site of injection, decreased limb mobility (could not move her shoulder), swelling and redness. Also discoloration of the skin.
Age: 65.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Patient complained about warmth at the site of injection, decreased limb mobility (could not move her shoulder), swelling and redness. Also discoloration of the skin.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient reported to HR manager at school district that she had to go to the doctor for a sore arm from a flu shot. Patient stated that she felt the flu shot was given too high on the arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Myalgia, Pain, Paraesthesia
Clinical narrative: Patient states that approximately 3-4 weeks after receiving her PRVENAR 13 shot she realized she was having deep muscle pain due to her PREVNAR 13 shot after watching a lawyer commercial on TV. Patient admits when RPH asked how she was feeling approximately one week after her shot, patient stated she was fine. Now patient feels like she is having deep muscle pain that sometimes involves tingling and sometimes radiates up her right arm into her breast. Patient has increased pain when bending down to pick something up and when she puts on a seat belt when sitting in the passenger's side of a vehicle. Patient believes pain is increasing and has self treated with ibuprofen and VICODIN.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea
Clinical narrative: Patient states that in the evening after Shingrix vaccine he had chills to the point of putting on lots of layers in order to get comfortable.  He also says he had about 10-15 minutes where breathing was difficult.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Blood test abnormal, Deep vein thrombosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Very painful injection. Swelling at injection site. Redness and swelling of upper left arm. Oval shaped swelling that moved from upper arm to elbow to below elbow. Diagnosed with DVT in left brachial vein.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Ultrasound scan abnormal
Clinical narrative: Very painful injection. Swelling at injection site. Redness and swelling of upper left arm. Oval shaped swelling that moved from upper arm to elbow to below elbow. Diagnosed with DVT in left brachial vein.
Age: 1.83
Sex: F
Vaccine: VARCEL
Symptoms: Ophthalmic herpes zoster, Viral test positive
Clinical narrative: Shingles on her left eye to the tip of her nose. 3-4 times a year.
Age: 68.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Nausea, Oropharyngeal pain, Vomiting
Clinical narrative: She started with a sore throat on 10/6 late at night. She started with nausea 10/7. She was vomiting 10/8.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Violent Headache 3 plus days, fever for 2 days. Fatigue.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood lactic acid, Blood magnesium, Brain natriuretic peptide, Chest X-ray, Chills
Clinical narrative: The shot was received at Drug Store. State registry says shot given 10/1, but patient reports she received on 10/2/18. Report from ED: 71-year-old female states had a flu shot yesterday and felt slightly off after that last night started having chills and this morning she was coming down to have breakfast fell lightheaded nauseous diaphoretic and then had a syncopal episode. Husband took blood pressure at home and it was in the 70s. No associated chest pressure tightness or heaviness. She states she is feeling better now.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Dizziness, Fall, Feeling abnormal, Full blood count
Clinical narrative: The shot was received at Drug Store. State registry says shot given 10/1, but patient reports she received on 10/2/18. Report from ED: 71-year-old female states had a flu shot yesterday and felt slightly off after that last night started having chills and this morning she was coming down to have breakfast fell lightheaded nauseous diaphoretic and then had a syncopal episode. Husband took blood pressure at home and it was in the 70s. No associated chest pressure tightness or heaviness. She states she is feeling better now.