chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Joint swelling, Lymphadenopathy, Pain in extremity
Clinical narrative: pain; swelling/ swelling of knuckles/ blueberry on knuckle; Joint pain/ pain on knuckles / knee pain/ Pain ankle; swelling of hand; swollen lymph node on the left side of neck (midway between the front and back); flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2018, the patient received the 1st dose of Shingrix. In February 2019, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and enlargement of lymph nodes. On 10th March 2019, the patient experienced pain in hand, swollen joints, pain in joint involving hand and hand swelling. The patient was treated with prednisone and steroids nos (Steroids). On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the pain in hand, swollen joints, enlargement of lymph nodes, pain in joint involving hand and hand swelling were recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the pain in hand, swollen joints, enlargement of lymph nodes, pain in joint involving hand and hand swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had 1st dose of Shingrix on left arm without any symptoms.  In late February 2019 she had flu like symptoms and a swollen lymph node on the left side of her neck (midway between the front and back) which resolved.   On 10th March 2019, 82 days after receiving Shingrix vaccine the patient experienced pain and swelling of her hand and knuckles.   The patient's knuckles looked liked she had a blueberry on each knuckle. The size of a blueberry not the color.   The color of her skin was normal. Later that day the pain and swelling traveled to her knee and ankles and then to all joints all over her body.  The patient was treated with prednisone for 10 days and the pain and swelling subsided.   As soon as the prednisone was withdrawn, the symptoms came back.  The patient was treated with steroids again and the symptoms resolved.   The patient took her last dose day before reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: pain; swelling/ swelling of knuckles/ blueberry on knuckle; Joint pain/ pain on knuckles / knee pain/ Pain ankle; swelling of hand; swollen lymph node on the left side of neck (midway between the front and back); flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2018, the patient received the 1st dose of Shingrix. In February 2019, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and enlargement of lymph nodes. On 10th March 2019, the patient experienced pain in hand, swollen joints, pain in joint involving hand and hand swelling. The patient was treated with prednisone and steroids nos (Steroids). On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the pain in hand, swollen joints, enlargement of lymph nodes, pain in joint involving hand and hand swelling were recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the pain in hand, swollen joints, enlargement of lymph nodes, pain in joint involving hand and hand swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had 1st dose of Shingrix on left arm without any symptoms.  In late February 2019 she had flu like symptoms and a swollen lymph node on the left side of her neck (midway between the front and back) which resolved.   On 10th March 2019, 82 days after receiving Shingrix vaccine the patient experienced pain and swelling of her hand and knuckles.   The patient's knuckles looked liked she had a blueberry on each knuckle. The size of a blueberry not the color.   The color of her skin was normal. Later that day the pain and swelling traveled to her knee and ankles and then to all joints all over her body.  The patient was treated with prednisone for 10 days and the pain and swelling subsided.   As soon as the prednisone was withdrawn, the symptoms came back.  The patient was treated with steroids again and the symptoms resolved.   The patient took her last dose day before reporting. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea
Clinical narrative: nausea; tiredness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received Shingrix. On 19th April 2019, less than a day after receiving Shingrix, the patient experienced tiredness. On 22nd April 2019, the patient experienced nausea. On 21st April 2019, the outcome of the tiredness was recovered/resolved. On an unknown date, the outcome of the nausea was recovering/resolving.   It was unknown if the reporter considered the tiredness and nausea to be related to Shingrix.  Additional details were provided as follows: The patient experienced extreme tiredness which continued until the date of reporting. On the date of reporting, 3 days after receiving the Shingrix, she was experiencing nausea. Consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching at injection site; Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KF37, expiry date 14th April 2020) for prophylaxis.   Concurrent medical conditions included allergic reaction to antibiotics (Allergy to Biaxin (clarithromycin)).   On 18th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were unknown.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in left deltoid. The patient experienced baseball sized area of redness. The patient experienced itching at the injection site a couple days later, over the weekend The redness had improved and the area was now pink.  The patient denied rash and denied pain.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle aches; Not feeling well; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis.   On 26th November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, muscle pain and feeling unwell. On an unknown date, the outcome of the fever, muscle pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, muscle pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows:  The patient noticed after dose 1 of Shingrix muscle aches, not feeling well, and fever. The healthcare professional reported events lasted 2 to 3 days after dose 1 and then completely resolved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Tenderness at injection site; Swelling at injection site; Fever; Body aches; Bedridden; This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number HM3NC, expiry date 13th April 2021) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site tenderness, injection site swelling, fever, general body pain and bedridden. In December 2018, the outcome of the bedridden was recovered/resolved. On an unknown date, the outcome of the injection site tenderness, injection site swelling, fever and general body pain were unknown.   It was unknown if the reporter considered the injection site tenderness, injection site swelling, fever, general body pain and bedridden to be related to Shingrix.  Additional case details were reported as follows: In December 2018, the patient experienced fever, full body aches, swelling at the injection site, tenderness at the injection site, and had to stay in bed for 3 days.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Rash pruritic, Rash vesicular
Clinical narrative: Red itchy rash; Red all over/ felt like a Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 27KF5, expiry date 10th June 2021) and (batch number 2RC9S, expiry date 10th June 2021) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced itchy rash and vesicular rash. The patient was treated with ibuprofen, cetirizine hydrochloride (Zyrtec) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the itchy rash and vesicular rash were recovered/resolved.   It was unknown if the reporter considered the itchy rash and vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient had a dose of Shingrix then for 5 days it was red all over from his back to his chest and up to his neck and ears and also on his scalp, visible since he is bald. It felt like a Shingles rash The patient saw a doctor and received for 5 days Zyrtec during the day and Benadryl at night.  The patient also had ibuprofen the day of the injection. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Musculoskeletal pain, Nausea, Neuralgia, Pain
Clinical narrative: pain in shoulder blades; coughing; nerve pain in palm and the soles of feet; nausea; body aches; arm soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in extremity in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   On 15th April 2019, the patient received Shingrix (intramuscular). On 15th April 2019, 12 hrs after receiving Shingrix, the patient experienced pain in extremity. On 16th April 2019, the patient experienced general body pain. On 17th April 2019, the patient experienced nausea. On 18th April 2019, the patient experienced neuralgia. On 19th April 2019, the patient experienced cough. On 20th April 2019, the patient experienced shoulder blade pain. On an unknown date, the outcome of the pain in extremity, general body pain, cough, shoulder blade pain and neuralgia were recovered/resolved and the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the pain in extremity, general body pain, nausea, cough, shoulder blade pain and neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient received an unspecified dose of Shingrix on left deltoid. Later the day of vaccination, the patient had arm soreness. The day after she experienced body aches, and the day after that she experienced nausea. The day after that she experienced nerve pain on her palms and the soles of her feet. The next day, she experienced coughing. The next day after that, she experienced pain in her shoulder blades. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in shoulder blades; coughing; nerve pain in palm and the soles of feet; nausea; body aches; arm soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in extremity in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   On 15th April 2019, the patient received Shingrix (intramuscular). On 15th April 2019, 12 hrs after receiving Shingrix, the patient experienced pain in extremity. On 16th April 2019, the patient experienced general body pain. On 17th April 2019, the patient experienced nausea. On 18th April 2019, the patient experienced neuralgia. On 19th April 2019, the patient experienced cough. On 20th April 2019, the patient experienced shoulder blade pain. On an unknown date, the outcome of the pain in extremity, general body pain, cough, shoulder blade pain and neuralgia were recovered/resolved and the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the pain in extremity, general body pain, nausea, cough, shoulder blade pain and neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient received an unspecified dose of Shingrix on left deltoid. Later the day of vaccination, the patient had arm soreness. The day after she experienced body aches, and the day after that she experienced nausea. The day after that she experienced nerve pain on her palms and the soles of her feet. The next day, she experienced coughing. The next day after that, she experienced pain in her shoulder blades. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm Soreness; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm and fatigue. On an unknown date, the outcome of the pain in arm and fatigue were unknown.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingrix.  Additional case details were reported as follows: The patient had fatigue and arm soreness. This case had been linked to the case US2019073321, reported by same reporter. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Erythema, Gait disturbance, Laboratory test normal, Pain
Clinical narrative: intermittent pain; redness; Purple spot under the nail of her second toe on her left foot; walks with a limp; This case was reported by a consumer via call center representative and described the occurrence of pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 16th May 2018, refer case US2019GSK078466).   On 12th September 2018, the patient received the 2nd dose of Shingrix. On 14th September 2018, 2 days after receiving Shingrix, the patient experienced pain, erythema, skin discoloration and limping. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the erythema and limping were unknown and the outcome of the skin discoloration was not recovered/not resolved.   It was unknown if the reporter considered the pain, erythema, skin discoloration and limping to be related to Shingrix.  Additional details were provided as follows: Two days after receiving Shingrix vaccine she developed a purple spot under the nail of her second toe on her left foot. Also, the skin around the nail and at the tip of the toe was red. She has intermittent pain that she reports was at in 8 on a scale from 1 to 10. An X ray was taken and blood was taken to test for gout. Everything came back negative. She has had other tests performed since them, all negative results. She indicated that the pain occurs when she was standing only. She does describe that the redness and purple spot have faded but she still has this intermittent pain.  The physician reported that the patient walks with a limp when she was experiencing the pain.  The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter was unable to provide any additional information.      Lab Comments: Everything came back negative. She has had other tests performed since them, all negative results.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, X-ray normal
Clinical narrative: intermittent pain; redness; Purple spot under the nail of her second toe on her left foot; walks with a limp; This case was reported by a consumer via call center representative and described the occurrence of pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 16th May 2018, refer case US2019GSK078466).   On 12th September 2018, the patient received the 2nd dose of Shingrix. On 14th September 2018, 2 days after receiving Shingrix, the patient experienced pain, erythema, skin discoloration and limping. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the erythema and limping were unknown and the outcome of the skin discoloration was not recovered/not resolved.   It was unknown if the reporter considered the pain, erythema, skin discoloration and limping to be related to Shingrix.  Additional details were provided as follows: Two days after receiving Shingrix vaccine she developed a purple spot under the nail of her second toe on her left foot. Also, the skin around the nail and at the tip of the toe was red. She has intermittent pain that she reports was at in 8 on a scale from 1 to 10. An X ray was taken and blood was taken to test for gout. Everything came back negative. She has had other tests performed since them, all negative results. She indicated that the pain occurs when she was standing only. She does describe that the redness and purple spot have faded but she still has this intermittent pain.  The physician reported that the patient walks with a limp when she was experiencing the pain.  The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter was unable to provide any additional information.      Lab Comments: Everything came back negative. She has had other tests performed since them, all negative results.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Peripheral sensory neuropathy
Clinical narrative: Sensory neuropathy; Balance issues; This case was reported by a physician via call center representative and described the occurrence of sensory neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included triamcinolone acetonide (Kenalog).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 122 days after receiving Shingrix, the patient experienced sensory neuropathy and balance disorder. On an unknown date, the outcome of the sensory neuropathy and balance disorder were unknown.   The reporter considered the sensory neuropathy and balance disorder to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Four months after vaccination, the patient developed sensory neural and balance issues.  The physician stated that he did not believe the neural issue was related to the vaccine.  No additional details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Autoimmune disorder, Blood creatine phosphokinase increased, Inflammation, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of autoimmune disorder in a 80-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included heart disease, unspecified and polymyalgia rheumatica.  In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced autoimmune disorder (serious criteria GSK medically significant), arthralgia, myalgia, creatine phosphokinase increased, peripheral edema, inflammatory reaction and synovial disorder. SHINGRIX was discontinued. On an unknown date, the outcome of the autoimmune disorder, arthralgia, myalgia, creatine phosphokinase increased, peripheral edema, inflammatory reaction and synovial disorder were unknown. It was unknown if the reporter considered the autoimmune disorder, arthralgia, myalgia, creatine phosphokinase increased, peripheral edema, inflammatory reaction and synovial disorder to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX at a local pharmacy. The reporter did not know the product details or exact date of immunization. The reporter thought, this was the 1st dose of SHINGRIX vaccine for patient. After vaccination, the patient experienced as an adverse reaction with autoimmune symptoms. The patient further described it as a diffuse inflammatory reaction, involving arthralgia's, myalgia's, increase in creatine phosphokinase (CPK), synovial fluid retention and peripheral edema. The reporter did not have patient's chart with him. The patient had seen two physician, including a rheumatologist, regarding this reaction. The patient told did not get the 2nd dose of SHINGRIX. The reporter consented to follow up. Lab Comments: On an unknown date, the creatine phosphokinase was increased.
Sex: M
Vaccine: VARZOS
Symptoms: Oedema peripheral, Synovial disorder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of autoimmune disorder in a 80-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included heart disease, unspecified and polymyalgia rheumatica.  In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced autoimmune disorder (serious criteria GSK medically significant), arthralgia, myalgia, creatine phosphokinase increased, peripheral edema, inflammatory reaction and synovial disorder. SHINGRIX was discontinued. On an unknown date, the outcome of the autoimmune disorder, arthralgia, myalgia, creatine phosphokinase increased, peripheral edema, inflammatory reaction and synovial disorder were unknown. It was unknown if the reporter considered the autoimmune disorder, arthralgia, myalgia, creatine phosphokinase increased, peripheral edema, inflammatory reaction and synovial disorder to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX at a local pharmacy. The reporter did not know the product details or exact date of immunization. The reporter thought, this was the 1st dose of SHINGRIX vaccine for patient. After vaccination, the patient experienced as an adverse reaction with autoimmune symptoms. The patient further described it as a diffuse inflammatory reaction, involving arthralgia's, myalgia's, increase in creatine phosphokinase (CPK), synovial fluid retention and peripheral edema. The reporter did not have patient's chart with him. The patient had seen two physician, including a rheumatologist, regarding this reaction. The patient told did not get the 2nd dose of SHINGRIX. The reporter consented to follow up. Lab Comments: On an unknown date, the creatine phosphokinase was increased.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: body pain/ feeling like he was hit by a truck; This case was reported by a nurse via sales rep and described the occurrence of general body pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by nurse for himself. The age at vaccination was not reported. The patient felt like he got hit by a truck for a few days after getting the first dose of Shingrix. The symptoms he experienced were not enough to prevent him from getting the second dose of the Shingrix.  No additional details were reported. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: RAB
Symptoms: Extra dose administered, Serology abnormal
Clinical narrative: Patient was bitten by a raccoon on 2018. She did not seek medical attention at that time. 3 weeks later her doctor saw the wounds and started treatment with IG and Rabavert.  (Please see continuation page)          She received Rabies vaccine on 5/1/18,  5/4/18,  5/8/18,  5/22/18 and 5/29/18 at another provider. Her physician stated that she was on immunosuppressive  medication at that time. The physician did rabies titers in February 2019 and they were low. We administered rabies protocol for post-exposure of previously vaccinated. She received vaccine on 3/8/19 and3/11/19. Both doses had the same lot number and route of administration.  Additional information for Item 18:  She received Rabavert on: 05/01/2018 05/04/2018 05/08/2018 05/22/2018 05/29/2018 And Rabies IG on 05/01/2018 Patient was on immunosuppressive drugs at the time. Titers were done by the physician and because they were low she was give two more doses of rabies vaccine on 3/8/19 and 3/11/19.Both doses were the same lot number and route of administration as in #17. She was not on immunosuppressive drugs at this time.  3/19/2019 Patient called and said she was having a vaccine reaction. She states that after the vaccine on 03/08/2019 she "felt bad" and had a headache. Within 30 minutes of getting the shot she had a headache and was achy. She had the headache for 5 days.  After the second one on 03/11/2019 she almost passed out when leaving the building. She states she has a sound in her ear like "scratching." Has had a fever of 102 degrees that started 30  60 minutes after she received the vaccine. Has a scratching in her ear such that she can't hear anything over it. Has had a headache, and blisters in her throat. Her arm hurts when she tries to lift it. She reports a metal taste. She has had intermittent coughing that she states is not coming from her chest. She has used her entire inhaler in one week. She has taken Benadryl once a day for relief. She visited a house with cats and started feeling throat tightening. She stated she is allergic to cats. She was advised to see her physician. On 3/22/19 I spoke to Patient. She canceled her Dr. appt. because she was nauseous, had a fever and was too sick to go. She stated that she still had blisters in her throat. She said she was going to the doctor today or tomorrow. I asked her to send me a medication list and let me know what the Dr. said. I left 2 messages to see what the doctor said but she did not return any calls.  Has Lupus and take multiple medications. Plaquenil. She would not provide list of medications.
Age: 8.0
Sex: F
Vaccine: MMRV
Symptoms: Muscle twitching
Clinical narrative: Muscle twitching -involuntary
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia, Nausea
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 YEAR OLD WAS GIVEN TDAP INSTEAD OF DTAP.  NO TREATMENT. PT DID NOT EXPERIENCE ANY ADVERSE REACTIONS IN CLINIC.
Age: 47.0
Sex: M
Vaccine: HEPA, MMR, TDAP
Symptoms: Hypersomnia, Injection site induration, Injection site ulcer, Injection site vesicles, Malaise
Clinical narrative: 4/10/19 Patient came to clinic. Reports that after vaccines he wasn't feeling well. Last evening he went to be at 5 pm and slept till this morning. He has an open area on back of right arm approximately 1/4 in wide and 1 inch long. Posterior to that their is a blister about the same size. Circular area around that is firm but not hot. Applied antibacterial ointment and covered with a 2 x 2 gauze. Patient called the next day and said he went to urgent care and they said it was a reaction to Hep A. The blisters were where the MMR was given.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Headache, Pain, Petechiae, Skin discolouration
Clinical narrative: Pt reports washing her face the night of receiving her first dose of Shingrix vaccine and noticed a "reddish/purple" discoloration to the right side of her face and purple bruise-like discoloring inside of the right outter ear. The patient states that she had some body aches and headaches throughout the day but nothing significant at the time of discovering the discoloration other than it also feeling a little tight but denies noticing any swelling. Pt reports also having an acupuncture session earlier that morning prior to receiving the vaccine at about 10AM to facilitate sinus drainage. The acupuncture needles had been placed inside of her ears, in her maxillary sinus areas, and on her scalp. Pt reports that this is about her 6th or 7th weekly acupuncture session out of 10. She has never noticed any bruising or any other adverse reactions after acupuncture before but sometimes after the needle is removed, the provider will have to dab away a small amount of blood. Pt called the ER that night after the discovery of the discoloration to express her concern and inquire if she needed to be seen. ER nurse advised her that the discoloration/bruising was likely from acupuncture not likely a vaccine reaction as pt denied any localized issue at injection site or swollen buccal tissue, difficulty breathing, rashes, etc. Pt had taken Tylenol throughout the day for generalized body aches. Today as patient is reporting incident, the right deltoid inspected; no erythema, edema or any abnormal presentation observed. Tympanic membrane of both ears intact and within normal limits, marked petechial bruising noted inside of the right outter ear, normal presentation to left ear. Facial discoloration not present at time of assessment, pt reports that it was present last night and showed RN pictures. Advised to report incident to her cancer doctor, to continue Tylenol for any discomfort as needed, increase water intake and monitor for any changes or worsening. Also advised that VAERS report would be submitted on her behalf.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin tightness
Clinical narrative: Pt reports washing her face the night of receiving her first dose of Shingrix vaccine and noticed a "reddish/purple" discoloration to the right side of her face and purple bruise-like discoloring inside of the right outter ear. The patient states that she had some body aches and headaches throughout the day but nothing significant at the time of discovering the discoloration other than it also feeling a little tight but denies noticing any swelling. Pt reports also having an acupuncture session earlier that morning prior to receiving the vaccine at about 10AM to facilitate sinus drainage. The acupuncture needles had been placed inside of her ears, in her maxillary sinus areas, and on her scalp. Pt reports that this is about her 6th or 7th weekly acupuncture session out of 10. She has never noticed any bruising or any other adverse reactions after acupuncture before but sometimes after the needle is removed, the provider will have to dab away a small amount of blood. Pt called the ER that night after the discovery of the discoloration to express her concern and inquire if she needed to be seen. ER nurse advised her that the discoloration/bruising was likely from acupuncture not likely a vaccine reaction as pt denied any localized issue at injection site or swollen buccal tissue, difficulty breathing, rashes, etc. Pt had taken Tylenol throughout the day for generalized body aches. Today as patient is reporting incident, the right deltoid inspected; no erythema, edema or any abnormal presentation observed. Tympanic membrane of both ears intact and within normal limits, marked petechial bruising noted inside of the right outter ear, normal presentation to left ear. Facial discoloration not present at time of assessment, pt reports that it was present last night and showed RN pictures. Advised to report incident to her cancer doctor, to continue Tylenol for any discomfort as needed, increase water intake and monitor for any changes or worsening. Also advised that VAERS report would be submitted on her behalf.
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; one (1) dose of MMR II (lot unknown) with DILUENT was administered intramuscularly to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 30-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 1 dose, (lot# was not reported) intramuscularly for prophylaxis. The vaccine was reconstituted in sterile diluent. No adverse event was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 11th April 2019, 57 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy has the patient who got his 1st Shingrix 2 months ago, and was due for his 2nd dose on the date of reporting. The patient developed shingles 2 days before his 2nd dose was due. The pharmacy asked how should we proceed with the vaccination schedule given these circumstances.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: achiness in arm; arm rigidity/ unable to move the arm; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (experienced after 1st dose, refer linked case US2019GSK077075).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Almost immediately, after vaccination with 2nd dose, the patient experienced achiness. Over the course of days, the patient unable to move the arm. The patient was seen in office on 12th April 2019, Friday and was given with medicine for arm. The patient was going to be seen again on 15th April 2019 for follow up. The clinic was submitting the VAERS.
Sex: F
Vaccine: HPVX
Symptoms: Immune system disorder
Clinical narrative: immune system disorder; This case was reported by a consumer via interactive digital media and described the occurrence of immune system disorder in an unspecified number of female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, unknown after receiving HPV vaccine, the patient experienced immune system disorder. On an unknown date, the outcome of the immune system disorder was unknown.   It was unknown if the reporter considered the immune system disorder to be related to HPV vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received HPV vaccine and experienced damaged immune system. This case has been linked to case US2019AMR070839, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: tiredness; felt lousy; This case was reported by a nurse via sales rep and described the occurrence of tiredness in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix .5 ml. In April 2019, less than a week after receiving Shingrix, the patient experienced tiredness and feeling bad. On an unknown date, the outcome of the tiredness and feeling bad were unknown.   It was unknown if the reporter considered the tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix was unknown. The reporter did not agree to follow up. This case has been linked with the case US2019AMR071497, reported by the same reporter.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood pressure increased, Chills, Fatigue, Heart rate increased
Clinical narrative: Injection site erythema; Injection site swelling; arm pain; Increased pulse; Blood pressure increased; fatigue; sweating; Chills; Upset stomach; Achy; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number JE45P, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 29th January 2019,refer case US2019GSK078688).   On 16th April 2019, the patient received the 2nd dose of Shingrix. On 17th April 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, pain in arm, pulse increased, increased blood pressure, fatigue, sweating, chills, upset stomach and pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, pain in arm, pulse increased, increased blood pressure, fatigue, sweating, chills, upset stomach and pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, pain in arm, pulse increased, increased blood pressure, fatigue, sweating, chills, upset stomach and pain to be related to Shingrix.  Additional details were provided as follows: The day after the patient received 2nd dose, he had complaints of injection site redness (one fourth dollar size), swelling, pain throughout his arm, racing pulse, increased blood pressure, fatigue, sweating, chills, and upset stomach. The patient called the clinic and they encouraged him to see his primary care doctor of medicine. With 1st dose the patient was achy and had soreness in arm, but not as severe as with the 2nd dose.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Injection site erythema; Injection site swelling; arm pain; Increased pulse; Blood pressure increased; fatigue; sweating; Chills; Upset stomach; Achy; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number JE45P, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 29th January 2019,refer case US2019GSK078688).   On 16th April 2019, the patient received the 2nd dose of Shingrix. On 17th April 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, pain in arm, pulse increased, increased blood pressure, fatigue, sweating, chills, upset stomach and pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, pain in arm, pulse increased, increased blood pressure, fatigue, sweating, chills, upset stomach and pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, pain in arm, pulse increased, increased blood pressure, fatigue, sweating, chills, upset stomach and pain to be related to Shingrix.  Additional details were provided as follows: The day after the patient received 2nd dose, he had complaints of injection site redness (one fourth dollar size), swelling, pain throughout his arm, racing pulse, increased blood pressure, fatigue, sweating, chills, and upset stomach. The patient called the clinic and they encouraged him to see his primary care doctor of medicine. With 1st dose the patient was achy and had soreness in arm, but not as severe as with the 2nd dose.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: soreness in arm; Achy; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number JE45P, expiry date unknown) for prophylaxis.   On 29th January 2019, 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 and pain. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: After 1st dose of Shingrix the patient was achy and had soreness in arm, but not as severe as with the 2nd dose. For tolerance of 2nd dose, refer case US2019AMR073972, reported by same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Contusion, Erythema, Pruritus, Rash papular
Clinical narrative: bruising; redness; itching; rash/bumps; This case was reported by a physician via call center representative and described the occurrence of contusion in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number T7E4A, expiry date 3rd June 2020) for prophylaxis.   On 15th April 2019, the patient received Kinrix. In April 2019, less than a week after receiving Kinrix, the patient experienced contusion, erythema, pruritus and papular rash. On an unknown date, the outcome of the contusion, erythema and pruritus were unknown and the outcome of the papular rash was recovering/resolving.   It was unknown if the reporter considered the contusion, erythema, pruritus and papular rash to be related to Kinrix.  Additional details were provided as follows: The patient's rash was getting better at the time of reporting, but the physician was concerned about administering additional doses.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Impaired work ability, Joint swelling, Malaise, Pain in extremity
Clinical narrative: ankle swelling; sick; back pain; back pain extending down to his legs; painful breathing; This case was reported by a pharmacist via call center representative and described the occurrence of back pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   The patient's past medical history included chickenpox (as a child).   On 16th April 2019, the patient received the 1st dose of Shingrix. On 16th April 2019, less than a day after receiving Shingrix, the patient experienced back pain, leg pain and painful respiration. On 18th April 2019, the patient experienced sickness. On 22nd April 2019, the patient experienced ankle swelling. On an unknown date, the outcome of the back pain, leg pain, painful respiration, ankle swelling and sickness were unknown.   It was unknown if the reporter considered the back pain, leg pain, painful respiration, ankle swelling and sickness to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced back pain extending down to his legs, painful breathing unrelated to anaphylaxis, and ankle swelling after 1st dose of Shingrix vaccination. On 17th April 2019, the patient went to work but called in sick on 18th April 2019. The pharmacist stated she saw the patient's left ankle swollen on 22nd April 2019.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Painful respiration
Clinical narrative: ankle swelling; sick; back pain; back pain extending down to his legs; painful breathing; This case was reported by a pharmacist via call center representative and described the occurrence of back pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   The patient's past medical history included chickenpox (as a child).   On 16th April 2019, the patient received the 1st dose of Shingrix. On 16th April 2019, less than a day after receiving Shingrix, the patient experienced back pain, leg pain and painful respiration. On 18th April 2019, the patient experienced sickness. On 22nd April 2019, the patient experienced ankle swelling. On an unknown date, the outcome of the back pain, leg pain, painful respiration, ankle swelling and sickness were unknown.   It was unknown if the reporter considered the back pain, leg pain, painful respiration, ankle swelling and sickness to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced back pain extending down to his legs, painful breathing unrelated to anaphylaxis, and ankle swelling after 1st dose of Shingrix vaccination. On 17th April 2019, the patient went to work but called in sick on 18th April 2019. The pharmacist stated she saw the patient's left ankle swollen on 22nd April 2019.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site swelling
Clinical narrative: Acute crying episode - cried almost 3 hours continuously after injection. Thigh (injection site) slightly swollen.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Agitation
Clinical narrative: Agitation.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Eye pain, Headache, Immediate post-injection reaction
Clinical narrative: Immediate malaise - Headache-Eyes aches-Joints-Very ill-Pain-Red-swelling-Injection site  Next day-Rash below injection site-Gradually moved almost-to elbow-Bone in site injection-very sore-aching & painful