chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Dysarthria, Feeling abnormal, Feeling cold, Head injury, Headache
Clinical narrative: Patient started to feel weird a little bit after receiving shot. Patient said it sting where the shot went in. Then patient words started to slur, patient lost consciousness, fell to her left side and onto the floor. Patient hit her left side of her head on the bench as she was going down.  This all happened within a couple minutes of getting the shot. Patient came back to consciousness within 1 minute of passing out. Patient knew what had happened. Kept patient laying on the floor for 5-10 minutes until patient feel ok (seeing no stars and not dizzy). Patient then got cold and shaky but also feel sweaty. Helped patient up onto a chair and after patient feel ok, have patient drink water and GATORADE slowly. After 1 hour, patient feel slightly better and was driven home by a coworker. Checked on the patient at 7:15PM later that night, patient said the cold and shakiness had resolved. She is still experiencing a major headache from where she hit her head. She was advice to monitor for signs/symptoms of concussions (alter mental status, nausea and vomiting, eye issues, etc).
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Hyperhidrosis, Injection site pain, Loss of consciousness, Nervousness
Clinical narrative: Patient started to feel weird a little bit after receiving shot. Patient said it sting where the shot went in. Then patient words started to slur, patient lost consciousness, fell to her left side and onto the floor. Patient hit her left side of her head on the bench as she was going down.  This all happened within a couple minutes of getting the shot. Patient came back to consciousness within 1 minute of passing out. Patient knew what had happened. Kept patient laying on the floor for 5-10 minutes until patient feel ok (seeing no stars and not dizzy). Patient then got cold and shaky but also feel sweaty. Helped patient up onto a chair and after patient feel ok, have patient drink water and GATORADE slowly. After 1 hour, patient feel slightly better and was driven home by a coworker. Checked on the patient at 7:15PM later that night, patient said the cold and shakiness had resolved. She is still experiencing a major headache from where she hit her head. She was advice to monitor for signs/symptoms of concussions (alter mental status, nausea and vomiting, eye issues, etc).
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. In May 2018, the patient experienced injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The same day of vaccination, in the afternoon and through the next day she had fly like symptoms. The patient also experienced soreness at the injection site which lasted for 3 days.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a female patient who received SHINGRIX. On 22nd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain and fatigue. On an unknown date, the outcome of the pain and fatigue were recovered/resolved. It was unknown if the reporter considered the pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting physician did not have lot number or expiration date, as it was administered at another facility. The patient received her dose of SHINGRIX with her husband. This case was linked with US2018096041, reported by the same reporter for the patient's husband.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were not reported and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered nurse via email. The age at the vaccination was not reported. The nurse had a question since this was the second time this had come to her attention in the clinic. The patient was given SHINGRIX vaccine and might had been given it not exactly in the deltoid muscle might be a few inches away from the site, which led to vaccine administered at inappropriate site. The reaction was massive which included erythema, swelling, site pain. The reporter was trying to figure out if this was just a side effect or was it because they were not getting it to the muscle exactly. The reporter had a question as would like to know was intramuscular had to absolutely go in the muscle all the way which was the right way but what if it was given a few inches away would that cause this side effect. The sales representative had not spoken with the reporter. Therefore, no additional details was provided other than what was on the email.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a elderly female patient who received SHINGRIX. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, pain in arm and swelling arm. On 29th May 2-18, the outcome of the erythema of extremities, pain in arm and swelling arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, pain in arm and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting healthcare professional was the patient. She is a researcher or investigator and a retired registered nurse (RN) practitioner. After receiving SHINGRIX, the patient experienced arm redness, swelling and soreness that lasted for 4 to 5 days. The patient reported that the reaction was more significant than what she expected. The patient was in a rush and did not provide too much information. The patient did not want to provide her address.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Influenza like illness, Lethargy, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, simvastatin and metoprolol. In March 2018, the patient received the 1st dose SHINGRIX. In March 2018, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, feeling hot, lethargy and muscle pain. On an unknown date, the outcome of the influenza-like symptoms, chills, feeling hot, lethargy and muscle pain were recovered/resolved. The reporter considered the influenza-like symptoms, chills, feeling hot, lethargy and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX on the right arm on Thursday in the beginning of March. The exact date was unknown. The patient described the symptoms as feeling like had the flu. The patient was lethargic and had muscles aches. The patient described the fever as feeling feverish but not actually having a fever. The events presented the day after the vaccination and he felt the symptoms on Friday, Saturday and Sunday and were totally resolved by the fourth day. The patient had denied permission to contact their physician.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site bruising, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX. Concomitant products included Metformin, PREVACID, simvastatin, VENTOLIN, TRADJENTA and TRAVATAN. On 28th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th May 2018, 1 days after receiving SHINGRIX, the patient experienced fever, breathing rate increased, influenza-like symptoms, injection site erythema, injection site swelling and injection site bruising. On an unknown date, the outcome of the fever, breathing rate increased, influenza-like symptoms, injection site erythema, injection site swelling and injection site bruising were not recovered/not resolved. The reporter considered the fever, breathing rate increased, influenza-like symptoms, injection site erythema, injection site swelling and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced fever of 100 degree F, breathing faster than normal, and flu like syndrome. The patient was unable to provide full demographics for the pharmacy or his prescriber. The contact details of the physician was provided.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX. Concomitant products included Metformin, PREVACID, simvastatin, VENTOLIN, TRADJENTA and TRAVATAN. On 28th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th May 2018, 1 days after receiving SHINGRIX, the patient experienced fever, breathing rate increased, influenza-like symptoms, injection site erythema, injection site swelling and injection site bruising. On an unknown date, the outcome of the fever, breathing rate increased, influenza-like symptoms, injection site erythema, injection site swelling and injection site bruising were not recovered/not resolved. The reporter considered the fever, breathing rate increased, influenza-like symptoms, injection site erythema, injection site swelling and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced fever of 100 degree F, breathing faster than normal, and flu like syndrome. The patient was unable to provide full demographics for the pharmacy or his prescriber. The contact details of the physician was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On 23rd May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and erythematous rash. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the erythematous rash was not recovered/not resolved. It was unknown if the reporter considered the injection site pain and erythematous rash to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The adverse reactions experienced by the patient, after vaccination was minor. For two days the patient had injection site soreness. On the second day of the vaccination she noticed a square red rash with size about 2 and half inch by 2 and half inch. It was still there on the day of reporting (day 3rd of vaccination), but noticeably lighter and the pain was greatly diminished.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site discolouration, Pain
Clinical narrative: I ached all over my body as though I had the Flu. My Left arm turned purple where the shot was given. My breathing was fine, so I didn't seek a doctor. I was in pain for about four days. This was my second shot-the first one was given one yr. ago.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Pt came in days after vaccine complaining of redness covering most of his upper arm and still suffered from soreness from the injection. Rph recommended NSAIDS and to call Dr if anything got worse. Arm did not look infected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a 78-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to the 1st dose, refer case US2018GSK096993). Concomitant products included LOVAZA and vitamin D. On 25th May2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 25th May 2018, 2 hrs after receiving SHINGRIX, the patient experienced unwell, fever and confusion. On 26th May 2018m the patient experienced sweating. On 26th May 2018m the outcome of the unwell, sweating, fever and confusion were recovered/resolved. The reporter considered the unwell, sweating, fever and confusion to be related to SHINGRIX. Additional details were provided as follows: The case was reported by GlaxoSmithKline employee who reported for her mother. The patient was receiving blood pressure medication concomitantly. At around 4:00 pm, the patient received SHINGRIX on the left arm. At around 6:00 pm, the patient became ill and had a fever of 101.5 degree F. The patient's normal body temperature was 97.6 degree F. The patient's fever broke by 5:00 and all of the side effects have since resolved and she felt better by Saturday, 26 May 2018. The patient had denied permission to contact their physician.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site vesicles, Local reaction, Swelling
Clinical narrative: Localized reaction to Left arm including redness and swelling. Now with distinct vesicles at site.
Age: 21.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Chills, Myalgia, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Within 1 hour of vaccine, pt developed chills myalgias and sore throat. The symptoms grow worse over the day. Pt denies localized redness. Denies fever. Seen in office 6/5 to rule out tonsilair abcess. throat swelling.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Generalised oedema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of generalized edema in a 54-year-old male patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th May 2018, 5 days after receiving SHINGRIX, the patient experienced generalized edema. On an unknown date, the outcome of the generalized edema was unknown. It was unknown if the reporter considered the generalized edema to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient experienced generalized edema, especially in the hands, arms, feet and face.
Age: 73.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Rash
Clinical narrative: 5/15/18 clinic note: Ptt has #1 of new shingles shot 21 days ago- 4/26. 7 days ago developed rash on right scrotum and groin, denies any preceding malaise, low grade fever, feeling ill. etc. Pt has lesions on right groin/upper medial thigh close to groin, states these aren't painful. Surrounding skin isn't painful he states some early cellulitis scrotal area- KEFLEX Rx given for 7 days.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Fall, Pulse absent, Resuscitation, Syncope
Clinical narrative: Patient received the Hep A vaccine and came up to the front window. While the patient was waiting the patient fell forward and fainted. During this time the patient was pulseless for a second where Dr. had to perform CPR. The Paramedic came and took her to the ER for future evaluation.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blister
Clinical narrative: 12 small vesicles on body suggestive of vaccine induced varicella infection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included Wegener's granulomatosis. Concomitant products included folic acid, methotrexate and vitamin D. In February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue, injection site pain, weight loss, injection site erythema, fever and appetite lost. On an unknown date, the outcome of the influenza-like symptoms, fatigue, injection site pain, weight loss, injection site erythema, fever and appetite lost were recovered/resolved. The reporter considered the influenza-like symptoms, fatigue, injection site pain, weight loss, injection site erythema, fever and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient stated that the next day after receiving the SHINGRIX vaccine, she experienced flu like symptoms that lasted approximately 48 hours. She also experienced a fever that peaked at 101.6 F. The patient also experienced extreme fatigue and loss of appetite that resulted in a weight loss of approximately 2-3 pounds. The patient experienced redness and soreness in her arm that started at the injection site and spread down her arm. Patient stated that the red, sore arm lasted longer than 2 days. The patient had denied permission to contact their physician. The patient did not wish to provide her own address. She did not visit the doctor's office, but simply called to report her symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Weight decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included Wegener's granulomatosis. Concomitant products included folic acid, methotrexate and vitamin D. In February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue, injection site pain, weight loss, injection site erythema, fever and appetite lost. On an unknown date, the outcome of the influenza-like symptoms, fatigue, injection site pain, weight loss, injection site erythema, fever and appetite lost were recovered/resolved. The reporter considered the influenza-like symptoms, fatigue, injection site pain, weight loss, injection site erythema, fever and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient stated that the next day after receiving the SHINGRIX vaccine, she experienced flu like symptoms that lasted approximately 48 hours. She also experienced a fever that peaked at 101.6 F. The patient also experienced extreme fatigue and loss of appetite that resulted in a weight loss of approximately 2-3 pounds. The patient experienced redness and soreness in her arm that started at the injection site and spread down her arm. Patient stated that the red, sore arm lasted longer than 2 days. The patient had denied permission to contact their physician. The patient did not wish to provide her own address. She did not visit the doctor's office, but simply called to report her symptoms.
Age: 1.42
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient is doing fine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: The patient states that shortly after the immunization they developed pain, her arm became swollen and red from her upper arm to her elbow and it was warm to touch for 1 week. No treatment mentioned.
Age: 0.17
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Diet refusal, Insomnia
Clinical narrative: Had intense crying for 1 wk-started within an hour of receiving vaccines. Intense crying without sleep. Did not eat well during that time-acted like he was in pain.
Age: 0.17
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Decreased appetite, Insomnia, Pain
Clinical narrative: Had intense crying for 1 wk-started within an hour of receiving vaccines. Intense crying without sleep. Did not eat well during that time-acted like he was in pain.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Axillary pain, Fatigue, Feeling abnormal, Headache, Loss of personal independence in daily activities
Clinical narrative: Patient described extreme arm pain at site of injection, as well as bruising around injection site, under the axilla, and running along the breast. This lasted for 72 hours per the patient.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lymphadenopathy, Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: Patient described extreme arm pain at site of injection, as well as bruising around injection site, under the axilla, and running along the breast. This lasted for 72 hours per the patient.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Patient described extreme arm pain at site of injection, as well as bruising around injection site, under the axilla, and running along the breast. This lasted for 72 hours per the patient.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Contusion, Injection site bruising, Injection site pain
Clinical narrative: Patient described extreme arm pain at site of injection, as well as bruising around injection site, under the axilla, and running along the breast. This lasted for 72 hours per the patient.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Erythematous macules with areas of coalescence on legs and abdomen, involving most of body including palms and soles, but starting to clear face. Slight lacy appearance on abdomen and trunk. Blanch with pressure, nontender.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pallor, Rash, Rash macular
Clinical narrative: Erythematous macules with areas of coalescence on legs and abdomen, involving most of body including palms and soles, but starting to clear face. Slight lacy appearance on abdomen and trunk. Blanch with pressure, nontender.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of skin red in a 60-year-old female patient who received SHINGRIX. On 26th May 2018, the patient received the 1st dose of SHINGRIX. On 27th May 2018, 1 days after receiving SHINGRIX, the patient experienced skin red, muscle pain, skin warm and pain. On an unknown date, the outcome of the skin red, muscle pain, skin warm and pain were not recovered/not resolved. The reporter considered the skin red, muscle pain, skin warm and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The patient reported to the pharmacy that after receiving SHINGRIX, there was redness on skin and was warm to the touch. The patient also had severe muscle ache. The reporting pharmacist was not the pharmacist that administered the injection. This pharmacist saw the patient and noticed that the redness of the skin was not at the injection site but below it. She believed that the redness started about 2 inches below from the injection site down to her elbow. The patient had not reached out to her healthcare professional to report the incident.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Myalgia, Pain, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of skin red in a 60-year-old female patient who received SHINGRIX. On 26th May 2018, the patient received the 1st dose of SHINGRIX. On 27th May 2018, 1 days after receiving SHINGRIX, the patient experienced skin red, muscle pain, skin warm and pain. On an unknown date, the outcome of the skin red, muscle pain, skin warm and pain were not recovered/not resolved. The reporter considered the skin red, muscle pain, skin warm and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The patient reported to the pharmacy that after receiving SHINGRIX, there was redness on skin and was warm to the touch. The patient also had severe muscle ache. The reporting pharmacist was not the pharmacist that administered the injection. This pharmacist saw the patient and noticed that the redness of the skin was not at the injection site but below it. She believed that the redness started about 2 inches below from the injection site down to her elbow. The patient had not reached out to her healthcare professional to report the incident.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash pruritic
Clinical narrative: Shortly after receiving Vaccine pt was treated for Shingles.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shortly after receiving Vaccine pt was treated for Shingles.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: 2nd dose of SHINGRIX injection given 5/21/18. AE reported by pt 5/24/18. Swelling, redness and inflammation at injection site. Pt reported is improving. She also developed 'lumps' on same arm...a few inches below where injection was given; Not itchy or painful. Today 5/25/18, pt said lumps are improving. She also reports tiredness.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site inflammation, Injection site mass, Injection site swelling
Clinical narrative: 2nd dose of SHINGRIX injection given 5/21/18. AE reported by pt 5/24/18. Swelling, redness and inflammation at injection site. Pt reported is improving. She also developed 'lumps' on same arm...a few inches below where injection was given; Not itchy or painful. Today 5/25/18, pt said lumps are improving. She also reports tiredness.
Age: 18.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Dizziness, Dysarthria, Nausea, Syncope
Clinical narrative: Dizziness, fainting, slurred speech, nauseous. Happened 13 hours after shot. Treated with cold compress and water and rest. Outcome feeling better at the moment.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Insomnia, Middle insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient experience shoulder pain for more than 3 days that made it difficult to sleep or would even wake her up at night. Also made her limit use of that arm. She took ibuprofen. She will be calling to inform her doctor and will call back to the pharmacy in regards to the outcome.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Patient experience shoulder pain for more than 3 days that made it difficult to sleep or would even wake her up at night. Also made her limit use of that arm. She took ibuprofen. She will be calling to inform her doctor and will call back to the pharmacy in regards to the outcome.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 84 year old male patient. The patient's pertinent medical history included: diabetes mellitus, hypothyroidism and benign prostatic hyperplasia.He had no drug reactions or allergies.Concomitant therapies included bupropion, nifedipine, glipizide, carvedilol, metformin, lisinopril (manufacturer unknown), levothyroxine sodium(manufacturer unknown) pioglitazone and tamsulosin hydrochloride. On 23-MAY-2018, the patient was vaccinated with pneumococcal PNEUMOVAX 23 lot # N031947 (expiration date:12-SEP-2019) intramuscular for vaccination(strength, dose, anatomical location and frequency were not reported). On 24-MAY-2018 (reported as the following day), the patient woke up and his entire upper arm was red (erythema) and warm (Feeling hot). He called his physician and was given unknown advice. It was reported that patient received treatment for the events. There were no lab diagnostics performed. The outcome of the events was reported as not resolved. At the time of the report the causality assessment between the events and PNEUMOVAX 23 was not reported.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (L.P.N), referring to a 2 year old male patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 03-APR-2018, the patient was vaccinated with a dose of improperly stored Oka/Merck VARIVAX (strength, dose, dose number and administration route were not reported) lot number N015477, expiration date 18-MAY-2018, for prophylaxis. Concomitant therapies included a properly stored sterile diluent used for reconstitution (lot number and expiration date were not reported). The vaccine was exposure to a temperature excursion; the data logger registered a temperature range between 6 grades Fahrenheit (°F) and 14°F for 15 hours. The previous temperature excursion registered was 6°F to 14°F for 48 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1805USA012575.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Herpes zoster, Sudden hearing loss
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-MAY-2015, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient experienced sudden hearing loss in her left ear, leading to total hearing loss in her left ear. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Upon internal review, sudden hearing loss in her left ear leading to total hearing loss in her left ear was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 01-JUN-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # N034005 and expiration date 31-JAN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 32 Fahrenheit degree up to 35 Fahrenheit degree (33.8 Fahrenheit degree), time frame of 2 hours 30 minutes with no previous temperature excursions. Digital Data logger was involved.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from nurse on 14 May 2018. This was invalid case as no patient identifier reported. In this case expired dose of TENIVAC (Batch number was unknown, expiration date: 16 Mar 2018, dose, route and site of administration was not reported) on an unspecified date. It was an actual medication error due to expired dose administered. No adverse event 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 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: 3.0
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Irritability
Clinical narrative: Initial unsolicited report received from a consumer on 14 May 2018. This case involves a three-year-old female patient who was vaccinated with 0.5 ml intramuscular injection of TYPHIM VI (batch number and expiry date were not reported) on 04 May 2018. The patient's medical history and concomitant medications were not reported. On unspecified date after receiving the vaccine she was tired and generally whiny for a few days she did not have a fever at any point but, she may have had some body aches and she is better now. No Lab data were provided. No corrective measure was reported. On an unspecified date patient's outcome was reported as recovered for all events. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from a nurse on 15-May-2018. This case involves an adult patient (age and gender not reported) who was inadvertently vaccinated with an expired dose of MENACTRA (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any harm or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from an other healthcare professional on 15-May-2018. This case involves a patient (age and gender not reported) who was vaccinated with an expired dose of ACT-HIB (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. It was of actual medication error due to expired vaccine used. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Initial unsolicited report received from a physician on 14-May-2018. This case involves a 60 years old male patient who was vaccinated with a dose of ADACEL (batch number: U5656AA, expiration date, dose, dose in series, route and site of administration was not reported) on 13-Nov-2017. The patient's premedication, concomitant medication and previous therapy was not provided. On 13-Nov-2017 (reported as since then'), following the vaccination, the patient developed intermittent left deltoid muscle pain from the injection site. No rash or swelling was observed. The patient's laboratory investigations and corrective treatment were not reported. The patient was not recovered from the event. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 15-May-2018 regarding an unsolicited valid non-serious case from a nurse. This case involves a patient (Age and gender was not reported) who received a dose of ACT-HIB and PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date.  It was actual medication error due to extra dose administered (of HIB component). This was reported on 10 February 2017 that the patient had received ACTHIB and PENTACEL and staff was told to monitor the patient to report any adverse event that may occur. It was discussed that "we do not have any documentation that states that. Asked for reference number, case number for that call provided". No further questions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 1.75
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited report received from other health professional (office person medical assistant) on 17-May-2018. This case involves a 21-month old patient (gender not reported) who was vaccinated with a dose of ADACEL instead of 4th dose in the series of DTaP (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. No adverse event 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 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: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited information received from a nurse on 17-May-2018. This case involves a patient (age and gender not reported) who was administered with 0.4 percent diluent of ACT-HIB (batch number, expiry date, dose, route and site of administration were not reported). It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event 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 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: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a medical assistant on 17-May-2018. This case involves child patient who was vaccinated with only the PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of an actual medication error due to inappropriate reconstitution technique. No adverse event 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 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. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial unsolicited report received from a Nurse on 16-May-2018. This case involves a 34-year-old patient (gender was not reported) who was vaccinated with a fifth dose of ACT-HIB on an unspecified date. It was a case of actual medication error due to extra dose administered. No adverse event 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 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. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a nurse on 17 May 2018. This case involves a patient (age and gender unknown) who was vaccinated with PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event 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 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. Documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial unsolicited report received from a Nurse on 17-May-2018. This case involves an eight-year-old patient (gender was not reported) who was vaccinated with a fifth dose of QUADRACEL (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse event 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 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. Documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 18 May 2018. This case involves a patient who was vaccinated with ADACEL (batch number, expiry date, route and site of administration were not reported) instead of DTap vaccine on an unspecified date. It was a case of actual medication error due as product use in unapproved population, Inappropriate age at vaccine administration and Wrong vaccine administered as patient received Tdap vaccine when should had received Dtap vaccine. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.