chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, 4 days after receiving SHINGRIX, the patient experienced weakness, headache and tiredness. On an unknown date, the outcome of the weakness, headache and tiredness were not recovered/not resolved. It was unknown if the reporter considered the weakness, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient declined to provide any demographics. The patient received 2nd dose of SHINGRIX on 10th August 2018 and reported that about four days later she experienced feeling weak, tired and headache and that those symptoms were still persisting at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had gotten her two dose series with SHINGRIX and the healthcare professional said the patient had a sore arm after each injection, but the soreness seemed to be more pronounced after the 2nd dose. These symptoms only lasted a few days. For tolerance after 2nd dose refer case US2018GSK159923.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Myalgia, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of foggy feeling in head in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included celiac disease. 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 foggy feeling in head, myalgia and pain. On an unknown date, the outcome of the foggy feeling in head, myalgia and pain were unknown. It was unknown if the reporter considered the foggy feeling in head, myalgia and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting physician was a gastroenterologist. The healthcare professional reported that patient got some symptoms similar to gluten exposure (foggy head, aches and myalgia). The patient received the dose at her primary care office. This information was collected via chat so this was all the information that was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, malaise and headache. On an unknown date, the outcome of the injection site pain, malaise and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, malaise and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported via Medical Science Liaison (MSL). The age at vaccination was not reported. The reporting physician was the patient. In 2018, the events were resolved.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Hypersomnia, Loss of consciousness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (at an age of 30 years). On 17th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, 8 days after receiving SHINGRIX, the patient experienced shingles and blister. On 17th August 2018, the patient experienced pain in arm. On 18th August 2018, the patient experienced loss of consciousness (serious criteria GSK medically significant) and sleep excessive. On 19th August 2018, the outcome of the sleep excessive was recovered/resolved. On an unknown date, the outcome of the loss of consciousness and pain in arm were recovered/resolved and the outcome of the shingles and blister were unknown. It was unknown if the reporter considered the loss of consciousness, shingles, blister, pain in arm and sleep excessive to be related to SHINGRIX. Additional details were provided as follows: The patient experienced soreness in her arm and the next day she was knocked out. She slept for about 25 hours. She had shingles appeared, it began with 3 at her belly button and they have almost resolved completely. Then she had 1 in the middle of her back toward the right side and that was subsiding. At the time of reporting, she had 3 coming up on her left side further down her back. She was encouraged to consult her physician, as she had not notified them. The patient reported having 3 shingles blisters on her stomach 8 to 9 days after vaccination with an additional 3 blisters appearing on her back 12 days after vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX. On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The case was reported by a pharmacy intern. The age at vaccination was not reported. The patient broke out in hives for 24 hours. The patient was just wondering how effective it would be against shingles because she probably would not get a 2nd shot due to how bad her reaction was to the 1st one. Pharmacy intern stated that she did fill out a form and sent it to the manufacturer already when asked for vaccine and the patient information. This might have already been reported as an adverse event (no duplicate case was identified). She stated that this reporting was done just in case it had not already been reported.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and joint pain. On an unknown date, the outcome of the fever and joint pain were unknown. It was unknown if the reporter considered the fever and joint pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. Caller heard from the physician that he had seen three patients who after receiving 1st dose of SHINGRIX, experienced low grade fever and joint aches. This case has been linked with cases US2018157969 and US2018157978, reported by the same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of swelling arm in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 13th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th August 2018, 2 hrs after receiving SHINGRIX, the patient experienced swelling arm, pain in arm, erythema of extremities and tenderness. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown and the outcome of the pain in arm was recovering/resolving and the outcome of the tenderness was not recovered/not resolved. It was unknown if the reporter considered the swelling arm, pain in arm, erythema of extremities and tenderness to be related to SHINGRIX. Additional deatils were provided as follows: The patient reported that after vaccination left arm swelled significantly and was red and tender to the touch for at least a week afterwards. Gentle touches to her arm were painful and even after 2 weeks out at the reporting time it was hurting when pressed, but it took a firmer touch. The contact details of the physician was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for 1st dose refer case US2018156103). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had gotten her two dose series with SHINGRIX and the healthcare professional said the patient had a sore arm after each injection, but the soreness seemed to be more pronounced after the 2nd dose. These symptoms only lasted a few days.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 29-Aug-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case 17 years old male patient who was vaccinated with a 0.5 ml expired dose of vaccine MENACTRA (Batch number: U5416AB, expiration date: 20-Oct-2017), via intramuscular route in Left arm 28-Aug-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. No AE symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial unsolicited report received from nurse on 29-Aug-2018. This case involves a seven years old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH DOSE (Batch number: UI981AB, expiration date: 16-Mar-2019, route: Intramuscular and site of administration was Left Arm) on 29-Aug-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration (FLUZONE HD given to pediatric patients). No adverse event symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Aug-2018 regarding an unsolicited valid non-serious case received from Other health professional. This case involves a 13 years old female patient who was inadvertently administered FLUBLOK QIV. The patients past medical history, concomitant medication and family history were not provided. On 29-Aug-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAAA103, expiry date 31 May 2019 via unknown route and unknown site of administration. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that patient was female patient who was inadvertently administered vaccine FLUBLOK QIV. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 30-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 6 months old male patient who was vaccinated with a 0.5 ml third dose of PENTACEL (Batch number: C55458A and expiry date: 10-Jun-2019) via intramuscular route (site of administration not reported) on 24-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate reconstitution technique because the Pentacel Hib lyophilized powder portion with sterile diluent water was given instead of the actual DTAP diluent to. No reaction was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: None.
Age: 51.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Joint range of motion decreased, Limb discomfort, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Discomfort in right arm after vaccination turned to muscle soreness and weakness. Neck muscles were stiff and sore as well. The arm weakness continues. He is unable to put weight on arm. States range of motion was limited as well, that has return to some extent but not fully. He has not seen a doctor. Plans to give it a little more time before doing so. Recommended he see a doctor.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Diffuse red patches over most of upper arm centered around the injection site.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Approximately 5 minutes after receiving the vaccine the donor started to feel dizzy, lightheaded, nauseated, upset stomach, hot and diaphoretic, pale in color. donor was brought back into a medical office and observed.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor
Clinical narrative: Approximately 5 minutes after receiving the vaccine the donor started to feel dizzy, lightheaded, nauseated, upset stomach, hot and diaphoretic, pale in color. donor was brought back into a medical office and observed.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Depression, Injection site pain, Lethargy
Clinical narrative: Tenderness around injection site. Extreme lethargy and depression for ~ 48 hours after injection.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: PATIENT CALLED ON 09/04/18 STATING THAT HIS ARM WAS STILL HURTING AFTER HE GOT THE FLU SHOT ON 01/17/18. HE SAID THE PAIN NEVER TOTALLY WENT AWAY BUT IT FLARES UP EVERY ONCE IN A WHILE. HE SAID HE DID NOT CHECK HIS DR AS YET ABOUT THIS.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Chills, Headache
Clinical narrative: Headache, severe chills the same day. Took ibuprofen. Felt better following day.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Joint stiffness, Paraesthesia
Clinical narrative: Tingling up and down his left arm, a rash occurred around injection site, left shoulder pain, and stiffening of the right knee.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, Injection site rash, Joint stiffness, Musculoskeletal pain, Paraesthesia
Clinical narrative: Tingling up and down his left arm, a rash occurred around injection site, left shoulder pain, and stiffening of the right knee.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product preparation error
Clinical narrative: Tingling up and down his left arm, a rash occurred around injection site, left shoulder pain, and stiffening of the right knee.
Age: 28.0
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Migraine, Urticaria
Clinical narrative: Within 1 hour of vaccination, chest broke out in hives, severe migraine started along with trouble breathing.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Fatigue, Malaise, Pyrexia
Clinical narrative: After receiving the second dose of the Shingrix vaccine, the patient started feeling unwell that night. The next morning he was experiencing shortness of breath, fatigue, fever, chills, and overall malaise. At home he used duonebs and Tylenol to help with symptoms. The patient's daughter called his primary care physicians office who instructed her to take him to the local ED because he was experiencing shortness of breath. Upon follow up on 8/28, patient reported that he did not go to ED for symptoms, and that symptoms lasted for 5-6 days before resolving. He had raised his home oxygen from 2L to 4L. All symptoms had resolved completely after 6 days. He had no current complaints at the time of follow up.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Migraine
Clinical narrative: Approx 1 hour post immunization became warm and developed a migraine headache took 2 Tylenol approx. 5 hour post onset. Laid prone in darken room which started to relive symptoms.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: After vaccination, about 5 min after and sitting on our bench patient fainted. A technician caught her and kept her from hurting herself. Patient came to within 5 seconds and we gave her some water and she knew she had fainted. Had a store manager come and ask her questions and after sitting 10 more minutes she wanted to go. A technician escorted her out to a car waiting for her with a relative.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Chills, Decreased appetite, Injection site pain
Clinical narrative: Fever 102.4 decreased appetite all day. Had pain at injection site and low back ache but did not take anything for it. Started getting chills at work, (nurse), checked temp x3, consistently 102.4 Took Advil. 40" later temp 101.9 aches and pain gone. Took Tylenol and ate. Temp continues to decrease. Advised by pharmacist to fill out this report. Pretty sure I'm fine. I think I took Advil for pain with the first dose of this vaccine a couple months ago so never noticed a fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 102.4 decreased appetite all day. Had pain at injection site and low back ache but did not take anything for it. Started getting chills at work, (nurse), checked temp x3, consistently 102.4 Took Advil. 40" later temp 101.9 aches and pain gone. Took Tylenol and ate. Temp continues to decrease. Advised by pharmacist to fill out this report. Pretty sure I'm fine. I think I took Advil for pain with the first dose of this vaccine a couple months ago so never noticed a fever.
Age: 26.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Approx 2 days after administering both vaccinations the patients arm experienced increased soreness and red swelling at site of injections. Patient went to doctor and was prescribed a steroid dose pack to help with redness and swelling.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states that the right arm (site of PNEUMOVAX 23 injection) became red, swollen and painful after injection on 8/30/18. She did not seek treatment and was still experiencing symptoms today 9/5/18.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Nausea, Sluggishness
Clinical narrative: Chills, nausea, achy joints.  Sluggish feeling on day 2.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Pallor, Seizure like phenomena, Somnolence, Syncope
Clinical narrative: Injection given per above description and immediately patient fainted with seizure-like episode that lasted seconds. Sleepy after event and pale but Fully recovered later.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: MA discussed egg allergy w/Dr and was given ok to go ahead and give immunization as pt has been able to eat egg baked in things and also had no previous reaction to two prior flu shots. Immunizations were given by MA. About 5 minutes later parent notice rash developing on legs R greater than L. Hive like rash noted around right thigh flu shot injection site. Dr was alerted and evaluated patient. RN gave oral liquid BENADRYL to patient without difficulty. Parents were instructed on as needed BENADRYL dosing. Patient left with parents w/o further concerns.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Sleep disorder
Clinical narrative: The vaccination was the most painful I have ever received. Within one hour the muscle started becoming sore and overnight it disturbed my sleep. By the next morning the area was extremely sore and I couldn't raise my arm above shoulder height. I canceled an event I was to attend and I would estimate loss of 80% use of that arm due to pain. That decreased very slowly over the next week and was down to 20% in three weeks. This morning 6 weeks after the event I still felt slight twinges in that area.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Myalgia, Sleep disorder
Clinical narrative: The vaccination was the most painful I have ever received. Within one hour the muscle started becoming sore and overnight it disturbed my sleep. By the next morning the area was extremely sore and I couldn't raise my arm above shoulder height. I canceled an event I was to attend and I would estimate loss of 80% use of that arm due to pain. That decreased very slowly over the next week and was down to 20% in three weeks. This morning 6 weeks after the event I still felt slight twinges in that area.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: Patient returned to clinic the day after having received his vaccine. He had redness and warmth to site as well as rash with itching to area of injection. Hive type rash around the injection site.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Patient returned to clinic the day after having received his vaccine. He had redness and warmth to site as well as rash with itching to area of injection. Hive type rash around the injection site.
Age: 75.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Asthenia, Balance disorder, Pyrexia
Clinical narrative: Patient reported "roaring fever, and was weak and wobbly" the night follow the vaccine administration. He presented to the ER where he was admitted for observation for 2 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypotension, Loss of consciousness, Neurological examination normal, Syncope, Tonic clonic movements
Clinical narrative: 5 minutes after receiving vaccines, while sitting in my office, patient passed out and had a few seconds of tonic clonic movements. Patient regained consciousness within seconds. No neurologic findings on exam. Blood pressure was low. Patient diagnosed with vasovagal syncopal event.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Pyrexia, Swelling
Clinical narrative: Patient complained of soreness/pain on right arm on FLUZONE injection site and also reported fever. I advised patient to use ice/cold compress to help the swelling and soreness and to take TYLENOL by mouth for fever and pain. I checked with patient after a few hours and they confirmed the fever/pain/soreness had improved. They decided not to go see their physician. I informed the physician of the reaction to flu shot and they advised patient come see them if symptoms do not resolve.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash, grows to the size of about 2.5 inches in diameter. No itchiness, just red and painful.  Patient was treated in urgent care with antibiotic and topical steroid cream.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immunology test, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site bright red, swollen and painful, approx. 5" in diameter; slight dizziness, ill feeling & nausea. By today, redness has lessened and other symptoms have finally gone. Two days after the injection, the doctor prescribed cortisone-type cream for injection area.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: Injection site bright red, swollen and painful, approx. 5" in diameter; slight dizziness, ill feeling & nausea. By today, redness has lessened and other symptoms have finally gone. Two days after the injection, the doctor prescribed cortisone-type cream for injection area.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Injection site was red but no pain or itchiness.
Age: 93.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site warmth
Clinical narrative: Patient experienced large bruising at injection site involving whole upper outer arm, with some warmth. Bruise is starting to dissipate with some dark spots and yellowing. Patient is going to his dr to have his arm evaluated.
Age: 19.0
Sex: F
Vaccine: HPV9, MMR
Symptoms: Dyspnoea, Peak expiratory flow rate abnormal
Clinical narrative: No complication noted after 15 minutes wait. Patient returned about 20 minutes after vaccines stating some difficulty breathing. No rash/angioedema symptoms.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Had syncope episode after injections response immediate.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Evening of 8/31/2018: Pt experienced pain at injection site and fever of 101 F. Over the weekend (9/1/2018-9/2/2018), pt continued to experience fever and chills. Pt took Tylenol for symptoms. As of 9/5/2018, upper arm area surrounding injection site is red, warm, tender, and inflamed.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Evening of 8/31/2018: Pt experienced pain at injection site and fever of 101 F. Over the weekend (9/1/2018-9/2/2018), pt continued to experience fever and chills. Pt took Tylenol for symptoms. As of 9/5/2018, upper arm area surrounding injection site is red, warm, tender, and inflamed.
Age: 38.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient has headache, nausea and vomiting since the day she got vaccination (09/02/18) until the day she saw the doctor (09/05/18) but she stated that symptoms are getting better.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Influenza like illness
Clinical narrative: Patient reports flu like symptoms- mild HA, cough, chills (no fever).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient received vaccine from Pharmacist- the following day she reports arm pain and fatigue which slowly improved until day 5 she complained of increased arm swelling, pain and redness at site of injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Developed rash on both lower arms with no itchiness or redness.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Bed rest, Chills, Crying
Clinical narrative: Mild pain at site of injection during the day. When I got home from work I noticed my entire arm had swollen. I had to take off my watch and wedding band. The next day I felt tired, achy, joint pain at work. I got home and felt like I had the flu with chills and hot flashes. Took Advil and Tylenol intermittently. The entire holiday weekend I felt very tired, achy and sick. Laid in bed the whole 3 days. started having odd right lower back pain that made me cry on Saturday. Went back to work on Tuesday although I did not still feel well due to intense back pain. Used menthol cream and Advil and Tylenol which did not help much. Today is the sixth day after the injection and I still have back pain although it has lessened.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hot flush, Influenza like illness, Injection site pain, Pain
Clinical narrative: Mild pain at site of injection during the day. When I got home from work I noticed my entire arm had swollen. I had to take off my watch and wedding band. The next day I felt tired, achy, joint pain at work. I got home and felt like I had the flu with chills and hot flashes. Took Advil and Tylenol intermittently. The entire holiday weekend I felt very tired, achy and sick. Laid in bed the whole 3 days. started having odd right lower back pain that made me cry on Saturday. Went back to work on Tuesday although I did not still feel well due to intense back pain. Used menthol cream and Advil and Tylenol which did not help much. Today is the sixth day after the injection and I still have back pain although it has lessened.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Mild pain at site of injection during the day. When I got home from work I noticed my entire arm had swollen. I had to take off my watch and wedding band. The next day I felt tired, achy, joint pain at work. I got home and felt like I had the flu with chills and hot flashes. Took Advil and Tylenol intermittently. The entire holiday weekend I felt very tired, achy and sick. Laid in bed the whole 3 days. started having odd right lower back pain that made me cry on Saturday. Went back to work on Tuesday although I did not still feel well due to intense back pain. Used menthol cream and Advil and Tylenol which did not help much. Today is the sixth day after the injection and I still have back pain although it has lessened.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Hypersomnia, Injection site erythema
Clinical narrative: 10 1/2 hrs after vaccination (during the night) - Chills, sweating, fever. 1 day after vaccination - Chills, sweating, 101.5 fever, neck ache, EXTREME fatigue, nausea; Slept almost all day and night, and could hardly get out of bed. 2 days after vaccination - Nausea, fatigue. Injection site - redness, pain & swelling - grew to the width of about three quarters (the coin); maybe one quarter width high.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea, Neck pain, Pyrexia
Clinical narrative: 10 1/2 hrs after vaccination (during the night) - Chills, sweating, fever. 1 day after vaccination - Chills, sweating, 101.5 fever, neck ache, EXTREME fatigue, nausea; Slept almost all day and night, and could hardly get out of bed. 2 days after vaccination - Nausea, fatigue. Injection site - redness, pain & swelling - grew to the width of about three quarters (the coin); maybe one quarter width high.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient developed large blisters on arms, legs, and ankles.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site swelling, Paraesthesia
Clinical narrative: Swelling on injection site, some numbness/tingling on left cheek. No hives or itching, no breathing problem.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Polyarthritis
Clinical narrative: Patient reported within an hour of vaccine strange shooting pains, arthritis in all of his joints, and a shooting pain in his head to his ear that would come and go.  It lasted for 24 hours after it began.
Age: 51.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Influenza like illness, Loss of personal independence in daily activities, Myalgia, Nausea
Clinical narrative: Nausea, muscle pain, redness, swelling, flu-like symptoms/feelings starting with nausea the evening of the shot and still occurring now but has improved. Has missed 2 days of work.
Age: 51.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Swelling
Clinical narrative: Nausea, muscle pain, redness, swelling, flu-like symptoms/feelings starting with nausea the evening of the shot and still occurring now but has improved. Has missed 2 days of work.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypertension, Nausea, Tachycardia, Vomiting
Clinical narrative: Apx. 1.5 hours after administration, Pt experienced N/V, headache, tachycardia, HTN. Pt was admitted to ER. Unsure of receiving hospital. Symptoms escalated.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT HAD REDNESS AND SORENESS, AND SOME WARMTH AT SITE OF INJECTION AND AROUND SITE OF INJECTION. PT INFORMED ME ON 08/31 & I CALLED THE DR THE SAME DAY. HE SAID HE SAID PT CAN USE ICE PACKS, BUT SHE CAN COME SEE HIM SO HE CAN LOOK IT. AFTER PT SAW DR SHE TOLD ME DR SAID TO USE ICE PACKS TO HELP WITH REDNESS/SORENESS. SAW PT AT WORK ON 09/05, REDNESS/SORENESS CLEARED AT SITE OF INJECTION AND AROUND INJECTION, BUT NOW PT HAD REDNESS BELOW AND INTERIOR SIDE OF ARM. SHE SAID SHE FELT A LITTLE WARMTH IN THE AREA. PT CALLED ME IN THE AFTERNOON AND SAW THE DR. SHE SAID DR WAS BUSY WITH PATIENTS, SO SHE WAS TOLD TO RELAY INFORMATION TO ME. SHE SAID DR SAID HE IS NOT CONCERNED OF AN INFECTION & PT HAD A POSSIBLE REACTION TO THE SHOTS. SHE SAID HE TOLD HER TO MONITOR THE AREA AND I BELIEVE SHE SAID HE CALLED HER IN SOME PROPHYLACTIC MEDICATIONS TO HER PHARMACY.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Patient received injection in right deltoid on 8/28/18 and complained of pain and inflammation approx. two days later on opposite arm. She visited an immedi center that told her to take a NSAI and apply heat to the site. She came to the pharmacy (where she received the injection) to inform us of the situation on 9/3/2018 and again on 9/5/2018 to inform us that all of her symptoms resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Injection site pain, Injection site reaction, Joint swelling, Mobility decreased
Clinical narrative: Patient received injection in right deltoid on 8/28/18 and complained of pain and inflammation approx. two days later on opposite arm. She visited an immedi center that told her to take a NSAI and apply heat to the site. She came to the pharmacy (where she received the injection) to inform us of the situation on 9/3/2018 and again on 9/5/2018 to inform us that all of her symptoms resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms, Pain in extremity, Skin warm
Clinical narrative: Patient received injection in right deltoid on 8/28/18 and complained of pain and inflammation approx. two days later on opposite arm. She visited an immedi center that told her to take a NSAI and apply heat to the site. She came to the pharmacy (where she received the injection) to inform us of the situation on 9/3/2018 and again on 9/5/2018 to inform us that all of her symptoms resolved.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Activated partial thromboplastin time normal, Contusion, Dehydration, Differential white blood cell count normal, Epistaxis
Clinical narrative: The employee called on 8/27/18 and left a message re: an adverse reaction. A nurse returned the call and left a message. On 8/28/18, I spoke to the employee who stated about day 4-5 she had a rash near the injection site which now was throughout her body (described as red little dots) She also stated she just felt off and was having intermittent nosebleeds, and bruising. Denied fever, vomiting, diarrhea. She complained of headache and stiff neck as well. When I spoke to her, she stated she called the CDC about the rashes and was told it could be a reaction to the MMR vaccine that occurs 6-14 days after vaccine given and should have her platelets checked and be seen. She also told me she had a difficult time walking and felt terrible, and dehydrated She was seen and evaluated in the ER, on 8/28/18 had lab work done and was placed off of work for 2 days. Her platelet count and all labs were unremarkable. She was given IV fluids as well. The employee knew the vaccine was being reported to VAERS. I also made her a follow up appointment with our Occupational Health physician. She canceled the first one and will be seen on 9/6/18 for follow-up.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Full blood count normal, Gait disturbance, Headache, Metabolic function test normal
Clinical narrative: The employee called on 8/27/18 and left a message re: an adverse reaction. A nurse returned the call and left a message. On 8/28/18, I spoke to the employee who stated about day 4-5 she had a rash near the injection site which now was throughout her body (described as red little dots) She also stated she just felt off and was having intermittent nosebleeds, and bruising. Denied fever, vomiting, diarrhea. She complained of headache and stiff neck as well. When I spoke to her, she stated she called the CDC about the rashes and was told it could be a reaction to the MMR vaccine that occurs 6-14 days after vaccine given and should have her platelets checked and be seen. She also told me she had a difficult time walking and felt terrible, and dehydrated She was seen and evaluated in the ER, on 8/28/18 had lab work done and was placed off of work for 2 days. Her platelet count and all labs were unremarkable. She was given IV fluids as well. The employee knew the vaccine was being reported to VAERS. I also made her a follow up appointment with our Occupational Health physician. She canceled the first one and will be seen on 9/6/18 for follow-up.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Musculoskeletal stiffness, Platelet count normal, Prothrombin time normal, Rash generalised
Clinical narrative: The employee called on 8/27/18 and left a message re: an adverse reaction. A nurse returned the call and left a message. On 8/28/18, I spoke to the employee who stated about day 4-5 she had a rash near the injection site which now was throughout her body (described as red little dots) She also stated she just felt off and was having intermittent nosebleeds, and bruising. Denied fever, vomiting, diarrhea. She complained of headache and stiff neck as well. When I spoke to her, she stated she called the CDC about the rashes and was told it could be a reaction to the MMR vaccine that occurs 6-14 days after vaccine given and should have her platelets checked and be seen. She also told me she had a difficult time walking and felt terrible, and dehydrated She was seen and evaluated in the ER, on 8/28/18 had lab work done and was placed off of work for 2 days. Her platelet count and all labs were unremarkable. She was given IV fluids as well. The employee knew the vaccine was being reported to VAERS. I also made her a follow up appointment with our Occupational Health physician. She canceled the first one and will be seen on 9/6/18 for follow-up.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Eye swelling, Oral mucosal eruption, Rash, Somnolence
Clinical narrative: Hives, rash around mouth and face after shot and lollipop, swollen eyes, red ears and neck, vomited clear, sleepy.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria, Vomiting
Clinical narrative: Hives, rash around mouth and face after shot and lollipop, swollen eyes, red ears and neck, vomited clear, sleepy.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, MNQ, VARCEL
Symptoms: Paraesthesia, Rash generalised, Vomiting
Clinical narrative: 18 YO female Hx of PL. For college physical received vaccines 15-20 min. later developed "Tingling" in chest auscultation normal and body rash. After leaving office returned to office BP 105/60, HR 150, Sat 98% room air, chest normal. Given 25 mg BENADRYL. 1:1000 EPIPEN 0.3 mg given IM. 10-15 minutes of observation with office. Child vomited x 1 clear fluid. EMS called. Child chest "Tinglyness" and body rash (Hives). Improved vital signs BP 120/80, HR 120's, Sat 99% room air. Child transported to Hospital. I called 3-4 hours later at ED. Child D/C'd home. Nurse and MD who took care of child finished shift no update on child's condition.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site papule, Injection site reaction
Clinical narrative: Large local bilateral reaction at injection sites, quarter sized erythematous plaque bilateral legs with tenderness and subcutaneous induration, 1 papule each leg, no fluctuance, no lymphatic streaking.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Local reaction, Skin plaque
Clinical narrative: Large local bilateral reaction at injection sites, quarter sized erythematous plaque bilateral legs with tenderness and subcutaneous induration, 1 papule each leg, no fluctuance, no lymphatic streaking.
Age: 41.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Headache, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Fever, rash, itching, headache body aches.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Nausea, vom and headaches 2-3 hrs after immunizations. Sx better at 11:00am 9/5/18.
Age: 75.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chills, Erythema, Limb mass, Pain in extremity, Pruritus
Clinical narrative: Itchiness, pain, soreness, redness, fever, chills, development of lump all on left arm.
Age: 75.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pyrexia
Clinical narrative: Itchiness, pain, soreness, redness, fever, chills, development of lump all on left arm.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called office spoke with head nurse RN and verbalized redness/swelling at the injection site. Pt was encouraged to report to ED via nurse.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pruritus, Feeling cold, Feeling hot, Hyperhidrosis, Rash pruritic
Clinical narrative: Sweaty, hot/cold. Eyes itchy. Clustered rash on right hip, itchy. Rash formed 24 hr after vaccine administration. No treatment initiated.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3
Symptoms: Dyspnoea, Pain in extremity, Vomiting
Clinical narrative: Problem breathing, vomiting, right arm pain. Person who completed form called about 2:30 injections given around 10:30. Told pt to go to ER.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3
Symptoms: Muscle strain, Pain in extremity, Vomiting
Clinical narrative: Problem breathing, vomiting, right arm pain. Person who completed form called about 2:30 injections given around 10:30. Told pt to go to ER.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Redness and swelling and stiffness at injection site - extending around arm from shoulder to elbow. Slightly warm to the touch.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Fever, pain, redness, itchiness, soreness all on left arm.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Eye swelling, Swelling face
Clinical narrative: Pt had Pneumococcal 23 and SHINGRIX on 8/23/18. Back in today with swollen face and eyes. Denies SOA. Symptoms started yesterday. Dr. thinks from SHINGRIX.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb mass, Myalgia
Clinical narrative: Achy muscles. Big lump on arm.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Condition aggravated, Dizziness, Pyrexia, Upper respiratory tract infection
Clinical narrative: History of fever, weakness the night of receiving vaccines. Had URTI symptoms. Lightheaded. No weakness in legs or extremities. Lasted 3-4 days.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Peripheral swelling, Tenderness
Clinical narrative: Redness, swelling of arm, tenderness that developed into cellulitis and required abx treatment.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Autopsy, Death, Pyrexia, Sudden infant death syndrome
Clinical narrative: Death. Manner-could not be determined. Cause-consistent with SUID in infancy.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Autopsy, Death, Sudden infant death syndrome
Clinical narrative: Death. Manner-could not be determined. Cause-consistent with SUID in infancy.
Age: 19.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 19-year-old female patient. The patient had no pertinent medical history, concomitant medications, drug reactions and allergies. On 21-AUG-2018, the patient was vaccinated with PNEUMOVAX 23, intramuscularly in an unspecified hip, lot# R007722, expiration date 10-MAR-2020 (also reported as lot# N024717, expiration date: 30-APR-2019 but it was confirmed that lot# R007722 was administered to the patient) for prophylaxis. On an unknown date in August 2018, the patient developed swelling and erythema with a yellow cnter the size of "50 cent piece" at the injection site. The patient sought medical attention via an emergency room visit and was given an unspecified treatment for the events. No lab diagnostic testes were performed. The outcome of the events was reported as not recovered. The relatedness between the events and vaccination with PNEUMOVAX 23 was not reported.