chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient stated that she had redness and swelling at the injection site and that it also felt hard. She stated that after approximately two weeks she developed a rash on her face and around her eye.  She said that she was seen at a local Urgent Treatment center where she was told that she had shingles and received a Toradol injection and  scripts for acyclovir and a prednisone pack. She said that she was also seen at Optical store where she was given a sample of a wetting drops to prevent dry eye. She also said that she had a constant headache which finally went away today December 6, 2017. She came in today to pick up a refill for another rx and that is when she told me about her reaction to the vaccination.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis
Clinical narrative: Patient states vaccine " gave her bronchitis".
Age: 27.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: Headaches, myalgias, fatigue, palpitations, dizziness, lightheadedness, mild shortness of breath, normal PE.
Age: 27.0
Sex: M
Vaccine: YF
Symptoms: Myalgia, Palpitations
Clinical narrative: Headaches, myalgias, fatigue, palpitations, dizziness, lightheadedness, mild shortness of breath, normal PE.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Cough, Retching, Throat tightness
Clinical narrative: Symptoms: patient complained of feeling like her "throat was closing up" 20 minutes after  injection patient started coughing and gagging in office, vital signs taken and reported to provider who advise patient to high point of care. Patient wheelchaired to emergency department. Patient was given methylPREDNISolone sod succ (Solu-MEDROL) Inj 125 mg ,diphenhydrAMINE (BENADRYL) 50mg/mL Inj 50 mg ONCE , famotidine (PEPCID) Inj 20 mg, monitored with normal vital signs and sent home with  epiNEPHrine (EPIPEN 2-PAK) 0.3mg/0.3mL Kit (2 Pens), and prednISONE (DELTASONE) 20mg Tab prescription. Patient returned to emergency department on 12/06/17 Care Timeline  0041   Arrived 0054   Sodium Chloride 2000 mL 0102   RaNITidine HCl 50 mg 0106   DiphenhydrAMINE HCl 25 mg 0110   MethylPREDNISolone Sodium Succ 125 mg 0801   Discharged
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: SWELLING, BLEEDING, BUMP ON INJECTION SITE.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Breast pain, Breast swelling, Breast tenderness, Chest discomfort
Clinical narrative: Patient was seen on 11/30/17 had a flu shot and PNEUMOVAX, on 11/30/17 patient started running a fever of 101 x 3 days. Also developed severe muscle aches mostly on left, joint pain in left hip, fatigue, tightness in chest toward left side, cough, hoarseness in voice, ear pain, headaches, nausea, and anorexia, but no diarrhea, and no difficulty swallowing, some lightheadedness but no syncope. Also some light and sound sensitivity. The cough, hoarseness persist. Muscle ache, joint pain improved but still has some in neck and head. Developed welts and rash at injection site, the rash spread to armpit about the size of a melon, but is decreasing today. No fever today. She noted swollen lymph nodes left axilla but not the right for about 2 days only, and some left breast pain and tenderness and swelling that has resolved.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cough, Decreased appetite, Dizziness, Dysphonia, Ear pain
Clinical narrative: Patient was seen on 11/30/17 had a flu shot and PNEUMOVAX, on 11/30/17 patient started running a fever of 101 x 3 days. Also developed severe muscle aches mostly on left, joint pain in left hip, fatigue, tightness in chest toward left side, cough, hoarseness in voice, ear pain, headaches, nausea, and anorexia, but no diarrhea, and no difficulty swallowing, some lightheadedness but no syncope. Also some light and sound sensitivity. The cough, hoarseness persist. Muscle ache, joint pain improved but still has some in neck and head. Developed welts and rash at injection site, the rash spread to armpit about the size of a melon, but is decreasing today. No fever today. She noted swollen lymph nodes left axilla but not the right for about 2 days only, and some left breast pain and tenderness and swelling that has resolved.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Headache, Hyperacusis, Injection site rash, Injection site reaction
Clinical narrative: Patient was seen on 11/30/17 had a flu shot and PNEUMOVAX, on 11/30/17 patient started running a fever of 101 x 3 days. Also developed severe muscle aches mostly on left, joint pain in left hip, fatigue, tightness in chest toward left side, cough, hoarseness in voice, ear pain, headaches, nausea, and anorexia, but no diarrhea, and no difficulty swallowing, some lightheadedness but no syncope. Also some light and sound sensitivity. The cough, hoarseness persist. Muscle ache, joint pain improved but still has some in neck and head. Developed welts and rash at injection site, the rash spread to armpit about the size of a melon, but is decreasing today. No fever today. She noted swollen lymph nodes left axilla but not the right for about 2 days only, and some left breast pain and tenderness and swelling that has resolved.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Lymphadenopathy, Myalgia, Nausea, Neck pain, Photophobia
Clinical narrative: Patient was seen on 11/30/17 had a flu shot and PNEUMOVAX, on 11/30/17 patient started running a fever of 101 x 3 days. Also developed severe muscle aches mostly on left, joint pain in left hip, fatigue, tightness in chest toward left side, cough, hoarseness in voice, ear pain, headaches, nausea, and anorexia, but no diarrhea, and no difficulty swallowing, some lightheadedness but no syncope. Also some light and sound sensitivity. The cough, hoarseness persist. Muscle ache, joint pain improved but still has some in neck and head. Developed welts and rash at injection site, the rash spread to armpit about the size of a melon, but is decreasing today. No fever today. She noted swollen lymph nodes left axilla but not the right for about 2 days only, and some left breast pain and tenderness and swelling that has resolved.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Patient was seen on 11/30/17 had a flu shot and PNEUMOVAX, on 11/30/17 patient started running a fever of 101 x 3 days. Also developed severe muscle aches mostly on left, joint pain in left hip, fatigue, tightness in chest toward left side, cough, hoarseness in voice, ear pain, headaches, nausea, and anorexia, but no diarrhea, and no difficulty swallowing, some lightheadedness but no syncope. Also some light and sound sensitivity. The cough, hoarseness persist. Muscle ache, joint pain improved but still has some in neck and head. Developed welts and rash at injection site, the rash spread to armpit about the size of a melon, but is decreasing today. No fever today. She noted swollen lymph nodes left axilla but not the right for about 2 days only, and some left breast pain and tenderness and swelling that has resolved.
Age: 64.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Arthralgia, Inflammation, Pain in extremity
Clinical narrative: After 4-5 days of the immunization, both of her wrists and fingers started aching with nightly inflammation. She feels it may be getting better but she saw Nurse Practitioner on 12/5/17. Upon consulting Nurse Practitioner's office, I was informed that she could not rule out immunizations as causes for her symptoms but may not be related since both of her hands/wrists are in pain. Patient is taking 2 ibuprofen 200mg 3-4 times daily for her pain. Inflammation worse during night and subsides in the AM.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Injection site haematoma
Clinical narrative: Pt had hemotoma at injection site and saw dr. I got a call from the doctor asking why we gave them PREVNAR-13 because she had gotten it in august...we were promted to give her her PREVNAR at production when we ran a flu shot by her part B insurance, so i gave her PREVNAR and a high dose flu shot. Md asked why we gave her PREVNAR when she had just gotten it.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site discolouration, Injection site swelling, Rash
Clinical narrative: Left arm is swollen and yellowish in color at site of injection. Also had spotted rash on arm. Patient went to the walk-in to have her arm checked after presenting to pharmacy and the doctor stated she was in fact having an allergic reaction  to the vaccine but felt no treatment was needed.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Antibody test, Blood test, Exposure during pregnancy, Foetal heart rate abnormal
Clinical narrative: Patient was given flu shot on 8/24/2017. She says she went to the Emergency room on 9/22/2017 for watery discharge and bleeding. At this time, she was told that their was no heartbeat found on ultrasound. She had a miscarriage. They gave her options to either remove the baby then or allow the baby to naturally come out (in labor). She went into labor (had surgery) on 9/24/2017. After her surgery, patient says she started having feet and leg pain/soreness with some instances of hand pain/soreness.. She says she is still experiencing some pain/soreness post-surgery. She presented this information to me tonight on 12/06/2017. She is currently looking for a PCP.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Surgery, Ultrasound antenatal screen abnormal, Vaginal haemorrhage
Clinical narrative: Patient was given flu shot on 8/24/2017. She says she went to the Emergency room on 9/22/2017 for watery discharge and bleeding. At this time, she was told that their was no heartbeat found on ultrasound. She had a miscarriage. They gave her options to either remove the baby then or allow the baby to naturally come out (in labor). She went into labor (had surgery) on 9/24/2017. After her surgery, patient says she started having feet and leg pain/soreness with some instances of hand pain/soreness.. She says she is still experiencing some pain/soreness post-surgery. She presented this information to me tonight on 12/06/2017. She is currently looking for a PCP.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: PATIENT NOTICED PAIN SOON AFTER WENT HOME ON 12/4/2017. FELT TENDER MUSCLE, HOT TO TOUCH SKIN. TOADY 12/06/2017 AT ABOUT 4:00PM SHE NOTICED RED PATCHES AND PAIN EXTENDING TO BACK SHOULDER, PALM NUMBNESS.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: PATIENT NOTICED PAIN SOON AFTER WENT HOME ON 12/4/2017. FELT TENDER MUSCLE, HOT TO TOUCH SKIN. TOADY 12/06/2017 AT ABOUT 4:00PM SHE NOTICED RED PATCHES AND PAIN EXTENDING TO BACK SHOULDER, PALM NUMBNESS.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red warm swollen injection site.
Age: 81.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patients left arm was red around injection site. Patient also complain of pruritis at site of injection.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Feeling of body temperature change, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of fever in a elderly male patient who received Influenza vaccine Quadrivalent. Co-suspect products included fluticasone propionate, ADVAIR inhalation powder for asthma. In October 2017, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started ADVAIR 250/50 ug 250 mg at an unknown frequency. In November 2017, less than a year after receiving Influenza vaccine Quadrivalent and unknown after starting ADVAIR, the patient experienced fever, feeling hot and cold, cough, sneezing, nasal congestion and nasal discharge. The action taken with ADVAIR was unknown (Dechallenge was unknown). Rechallenge with ADVAIR was unknown. On an unknown date, the outcome of the fever, feeling hot and cold, cough, sneezing, nasal congestion and nasal discharge were unknown. It was unknown if the reporter considered the fever, feeling hot and cold, cough, sneezing, nasal congestion and nasal discharge to be related to Influenza vaccine Quadrivalent and ADVAIR. Additional information was reported as follows: This case was received from the consumer (spouse) via the patient assistance program. The age at vaccination was not reported. The patient was taking ADVAIR from 20 years for asthma. The patient and his wife went outside for dinner. That evening the patient started feeling feverish, hot and cold at the same time, developed cough, sneezing, congestion and drainage. The patient has not seen doctor yet. The patient was taking over the counter remedies for the symptoms. This case was not associated with product complaint.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Sneezing
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of fever in a elderly male patient who received Influenza vaccine Quadrivalent. Co-suspect products included fluticasone propionate, ADVAIR inhalation powder for asthma. In October 2017, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started ADVAIR 250/50 ug 250 mg at an unknown frequency. In November 2017, less than a year after receiving Influenza vaccine Quadrivalent and unknown after starting ADVAIR, the patient experienced fever, feeling hot and cold, cough, sneezing, nasal congestion and nasal discharge. The action taken with ADVAIR was unknown (Dechallenge was unknown). Rechallenge with ADVAIR was unknown. On an unknown date, the outcome of the fever, feeling hot and cold, cough, sneezing, nasal congestion and nasal discharge were unknown. It was unknown if the reporter considered the fever, feeling hot and cold, cough, sneezing, nasal congestion and nasal discharge to be related to Influenza vaccine Quadrivalent and ADVAIR. Additional information was reported as follows: This case was received from the consumer (spouse) via the patient assistance program. The age at vaccination was not reported. The patient was taking ADVAIR from 20 years for asthma. The patient and his wife went outside for dinner. That evening the patient started feeling feverish, hot and cold at the same time, developed cough, sneezing, congestion and drainage. The patient has not seen doctor yet. The patient was taking over the counter remedies for the symptoms. This case was not associated with product complaint.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient reports skin rash 2 days after flu shot.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Abdominal distension, Peripheral swelling
Clinical narrative: Pt's mother stated child was getting swelling on bilateral feet, legs and on stomach.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Mood altered, Rash vesicular
Clinical narrative: Rash around the injection site, Rash described by parent as "Pox like". Mom noted some "moodiness".
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Flank pain, Nervousness
Clinical narrative: Pt. had flu shot at about 145PM. Returned 30 mins later with left side sharp pain, same side as flu shot. No SOB, lightheadness, clamminess, pain lasted 5-6 mins. Heart sounds, lung sounds-NL. BP may have been elevated 2 degree nervousness. Pt. told to call MD or go to ER if returns.
Age: 37.0
Sex: U
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Generalized swelling, no itchiness. Onset approximately 12am.
Age: 1.5
Sex: F
Vaccine: DTAP, MMR
Symptoms: Wrong drug administered
Clinical narrative: Patient inadvertently received MMR vaccine when Hepatitis A vaccine was ordered.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Rash pruritic
Clinical narrative: Patient received PREVENAR-13 in left deltoid on Wednesday. She developed itchy rash on Sunday, 4 days after vac. Pt called the pharmacy on Monday and got instructions to see MD if rash not resolved. Pt saw PCP on Tuesday and received diag: -local injection reaction, no infection. Medications: ZYRTEC tbl., BENADRYL tbl. and Fluocinonide cream.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Mom called 11/9/17 to report that patient had large hives on his face last night at dinner. Gave BENADRYL and did clear up some. Mom also gave Benadryl today as well. Mom reports no problems breathing, swallowing or itching.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Erythemic maculopapular rash trunk and face < 30 minutes after administration of vaccines. Given P.O. BENADRYL-rash faded, but did not resolve in clinic. Family sent home with BENADRYL and precautions.
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Eye pruritus, Lacrimation increased, Musculoskeletal pain, Pleurisy
Clinical narrative: This serious initial spontaneous case, was received from other non-health professional (consumer) on 27-NOV-2017, concerning a female patient of an unspecified age. On an unspecified date, the patient was administered with INN (dose, batch number, expiry date, manufacturer, trade name, route of administration, anatomical location; not reported) for an unknown indication. On an unspecified date, after the vaccination, the patient woke up in middle of the night with sharp pain in right shoulder into chest and was diagnosed with pleurisy. The patient also had watery and itchy eyes. The outcome of the events was not reported. Case comment: Considering the limited information regarding the vaccination date, onset date of the event, the temporal latency, treatment received and any other contributory factors, the company assessed causal role of the vaccine as unassessable. The assessed the event pleurisy as serious (medically significant).
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Pt complains of sore/painful arm since receiving vaccine.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Varicella rash 2 wks after vaccine given.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Aspiration bursa, Impaired work ability, Injection site discolouration, Injection site pain, Insomnia
Clinical narrative: Participant reported incident on 11/6/17 stated that when she had her flu shot on 10/25/17 at around 1:00 PM later that night she started experiencing severe pain in her left arm where shot was given. The area became black and blue and she had to see her primary physician for the pain. Patient stated that she is going for and xray and ultrasound. Patient continues to have severe pain and is unable to sleep at night. 12/7/17 spoke with patient regarding which arm flu shot was given in she stated it was definitely the left arm. Sign consent was for right deltoid. Participant claims she had her bursa drained and is taking cortisone shots and is out of work.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Ultrasound scan, X-ray
Clinical narrative: Participant reported incident on 11/6/17 stated that when she had her flu shot on 10/25/17 at around 1:00 PM later that night she started experiencing severe pain in her left arm where shot was given. The area became black and blue and she had to see her primary physician for the pain. Patient stated that she is going for and xray and ultrasound. Patient continues to have severe pain and is unable to sleep at night. 12/7/17 spoke with patient regarding which arm flu shot was given in she stated it was definitely the left arm. Sign consent was for right deltoid. Participant claims she had her bursa drained and is taking cortisone shots and is out of work.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on (L) thigh at site of DTAP and Flu shot 12/4/17. Warm compress and prescribed cephalexin 125mg 3x a day for 10 days and Diphenhydramine 25ml PO TID.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bone pain, Nausea, Pyrexia, Tenderness
Clinical narrative: Fever 101, achy bones, arm tenderness, nausea.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain, Pleurisy
Clinical narrative: Pt. states severe soreness, lite "pleurisy". Says when pulls arm up feels like yanking right out of socket. Cannot sleep on left side of arm. Pt got shot on 11/6/17. Notified pharmacy on 12/4/17. Pt using TYLENOL.
Sex: M
Vaccine: YF
Symptoms: Blister, Injection site discolouration, Injection site erythema, Injection site vesicles, Skin hyperpigmentation
Clinical narrative: Initial unsolicited report received from the literature on 24-Oct-2017. This case is linked with: 2017SA207244, 2017SA207248, 2017SA207251, 2017SA207263, 2017SA207267, 2017SA207271, 2017SA207273, 2017SA207275, 2017SA207277, 2017SA207279, 2017SA207282. (same literature). Abstract: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. This case involves a 24-year-old male patient, who was vaccinated with a first dose of YF-VAX via subcutaneous route (batch number: UF734AA, expiry date not reported) in left arm on 25-May-2010. Patient's medical history was not reported. Patient had no current illness was reported as none. Patient's concomitant medication was not reported. Other medication was reported as none. On an unknown date, seven days after the vaccination, patient developed a large bulla with circumferential hyperpigmentation. On 31-May-2010, six days following the vaccination (also reported as 7 days after receiving vaccination), patient presented with a large oval blistered area at the injection site, red and purple colored around the blister. No swelling noted. No c/o discomfort from this. Patient required ER (emergency room) visit. No laboratory was not performed. Corrective treatment was not reported. Outcome of the event large bulla with circumferential hyperpigmentation was not reported. Patient recovered from other events. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthralgia
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 18-Oct-2017 and additional information was received on 25-Oct-2017. This case involves a 70-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number, expiry date, site, dose series were not reported) via intramuscularly on 08-Sep-2017 for Immunization. The patient medical history and concomitant medications were not reported. On 08-Sep-2017 evening, same day after the vaccination, the patient experienced shoulder and neck pain which progressed to traveling across her shoulders and down both arms. The pain was in her wrists and hands and make normal things like driving difficult. Patient said that she knows it was not from the injection, but rather the pain was from the shot itself. As lab tests, patient underwent blood work which was negative. As Corrective measures, patient was prescribed PT but, she stopped that as she has better equipment at home. She was packing herself in Himalayan salt and sitting in her sauna. She returned to the Doctor again after stopping PT and he gave her steroids and she felt fine but, she only took them for 5 days. Patient has an appointment with her primary physician tomorrow and she wants more blood tests and referrals to specialists. Outcome pf event was not recovered. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 18-Oct-2017 and additional information was received on 25-Oct-2017. This case involves a 70-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number, expiry date, site, dose series were not reported) via intramuscularly on 08-Sep-2017 for Immunization. The patient medical history and concomitant medications were not reported. On 08-Sep-2017 evening, same day after the vaccination, the patient experienced shoulder and neck pain which progressed to traveling across her shoulders and down both arms. The pain was in her wrists and hands and make normal things like driving difficult. Patient said that she knows it was not from the injection, but rather the pain was from the shot itself. As lab tests, patient underwent blood work which was negative. As Corrective measures, patient was prescribed PT but, she stopped that as she has better equipment at home. She was packing herself in Himalayan salt and sitting in her sauna. She returned to the Doctor again after stopping PT and he gave her steroids and she felt fine but, she only took them for 5 days. Patient has an appointment with her primary physician tomorrow and she wants more blood tests and referrals to specialists. Outcome pf event was not recovered. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthralgia, Blood test normal, Impaired driving ability, Musculoskeletal pain, Neck pain
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 18-Oct-2017 and additional information was received on 25-Oct-2017. This case involves a 70-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number, expiry date, site, dose series were not reported) via intramuscularly on 08-Sep-2017 for Immunization. The patient medical history and concomitant medications were not reported. On 08-Sep-2017 evening, same day after the vaccination, the patient experienced shoulder and neck pain which progressed to traveling across her shoulders and down both arms. The pain was in her wrists and hands and make normal things like driving difficult. Patient said that she knows it was not from the injection, but rather the pain was from the shot itself. As lab tests, patient underwent blood work which was negative. As Corrective measures, patient was prescribed PT but, she stopped that as she has better equipment at home. She was packing herself in Himalayan salt and sitting in her sauna. She returned to the Doctor again after stopping PT and he gave her steroids and she felt fine but, she only took them for 5 days. Patient has an appointment with her primary physician tomorrow and she wants more blood tests and referrals to specialists. Outcome pf event was not recovered. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 18-Oct-2017 and additional information was received on 25-Oct-2017. This case involves a 70-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number, expiry date, site, dose series were not reported) via intramuscularly on 08-Sep-2017 for Immunization. The patient medical history and concomitant medications were not reported. On 08-Sep-2017 evening, same day after the vaccination, the patient experienced shoulder and neck pain which progressed to traveling across her shoulders and down both arms. The pain was in her wrists and hands and make normal things like driving difficult. Patient said that she knows it was not from the injection, but rather the pain was from the shot itself. As lab tests, patient underwent blood work which was negative. As Corrective measures, patient was prescribed PT but, she stopped that as she has better equipment at home. She was packing herself in Himalayan salt and sitting in her sauna. She returned to the Doctor again after stopping PT and he gave her steroids and she felt fine but, she only took them for 5 days. Patient has an appointment with her primary physician tomorrow and she wants more blood tests and referrals to specialists. Outcome pf event was not recovered. List of documents held by sender: none.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Cough, Urticaria, Wheezing
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of anaphylactic reaction in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). The patient was treated with epinephrine. On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The case was linked with US2017GSK185577, reported by the same reporter.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of anaphylactic reaction in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). The patient was treated with epinephrine. On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The case was linked with US2017GSK185577, reported by the same reporter.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Axillary pain, Injection site induration, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 77 year old nurse who was referring to herself. The patient concurrent condition was hypertension. The patient had no allergies. The patient's concomitant therapies included atenolol, olmesartan medoxomil (+) hydrochlorothiazide (manufacturer unknown), amiodarone and rivaroxaban (XARELTO). On 28-NOV-2017, the patient was vaccinated with PNEUMOVAX 23, subcutaneously in the right deltoid for prophylaxis (lot number and expiration date were not provided). On 29-NOV-2017, the patient experienced redness and severe inflammation in the biceps area from her armpit to a little bit below her elbow which covered a 5 to 6 inch area around the biceps. There was no laboratory diagnostic studies performed. Treatment included applying ice to the area and taking diphenhydramine (BENADRYL) and ibuprofen (ADVIL), however it did not help. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rash, Tenderness
Clinical narrative: This spontaneous report was received from a 77 year old nurse who was referring to herself. The patient concurrent condition was hypertension. The patient had no allergies. The patient's concomitant therapies included atenolol, olmesartan medoxomil (+) hydrochlorothiazide (manufacturer unknown), amiodarone and rivaroxaban (XARELTO). On 28-NOV-2017, the patient was vaccinated with PNEUMOVAX 23, subcutaneously in the right deltoid for prophylaxis (lot number and expiration date were not provided). On 29-NOV-2017, the patient experienced redness and severe inflammation in the biceps area from her armpit to a little bit below her elbow which covered a 5 to 6 inch area around the biceps. There was no laboratory diagnostic studies performed. Treatment included applying ice to the area and taking diphenhydramine (BENADRYL) and ibuprofen (ADVIL), however it did not help. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Inflammation
Clinical narrative: This spontaneous report was received from a 77 year old nurse who was referring to herself. The patient concurrent condition was hypertension. The patient had no allergies. The patient's concomitant therapies included atenolol, olmesartan medoxomil (+) hydrochlorothiazide (manufacturer unknown), amiodarone and rivaroxaban (XARELTO). On 28-NOV-2017, the patient was vaccinated with PNEUMOVAX 23, subcutaneously in the right deltoid for prophylaxis (lot number and expiration date were not provided). On 29-NOV-2017, the patient experienced redness and severe inflammation in the biceps area from her armpit to a little bit below her elbow which covered a 5 to 6 inch area around the biceps. There was no laboratory diagnostic studies performed. Treatment included applying ice to the area and taking diphenhydramine (BENADRYL) and ibuprofen (ADVIL), however it did not help. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: Upon waking up the morning of 12/06/2017 my daughter had slightly swollen eyes. They continued to bother her for the day. The morning of 12/07/2017 they are still slightly swollen and are still bothering her but a bit better.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Pain, Pallor, Pyrexia
Clinical narrative: The morning of 12/06/2017 she developed a slight fever (99.7), achy, tired and very pale. The morning of 12/07/2017 she was doing better. No fever but still not 100%.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Present to the clinic at 12:30am on 12/6/17 with complaints of redness, swelling, and pain in her right upper arm at the injection site. Site assessed. 8cm by 8cm erythema, edematous, tender areas, with slight tightness of the skin. I obtain an xray of her upper arm and placed her on BACTRIM. She is to return to the clinic in 2 days.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Skin tightness, X-ray limb normal
Clinical narrative: Present to the clinic at 12:30am on 12/6/17 with complaints of redness, swelling, and pain in her right upper arm at the injection site. Site assessed. 8cm by 8cm erythema, edematous, tender areas, with slight tightness of the skin. I obtain an xray of her upper arm and placed her on BACTRIM. She is to return to the clinic in 2 days.
Sex: F
Vaccine: PPV
Symptoms: Reaction to preservatives
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. The patient's medical history included unspecified adverse events, associated with the usage of unspecified eye drops that contained benzalkonium chloride. No information regarding the patient's concurrent conditions, allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, site, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had an unspecified reaction to vaccine. Patient stated that it was a reaction to the benzalkonium chloride in the vaccine, even though this was not listed as an ingredient of PNEUMOVAX 23 in the patient's information (PI). No treatment was given for the adverse events. The outcome of the event was unknown. Reporter stated that the event was related to PNEUMOVAX 23. No product quality complaint (PQC) was involved.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash macular
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-NOV-2017, the patient was vaccinated with a dose of GARDASIL 9 intramuscular injection (dose, lot number and expiration date were not reported). On 17-NOV-2017, the patient experienced red splotches with itching above his eyebrow, along his cheek and on his neck. The patient was applied diphenhydramine hydrochloride (BENADRYL) cream to the affected area by his mother and was given diphenhydramine hydrochloride (BENADRYL) 50 mg orally once by the nurse as a treatment. The patient did not recover from the events at the time of the report. The relatedness between the events and GARDASIL 9 was not reported.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Culture urine positive, Exposure during pregnancy, Flank pain, Pregnancy test positive, Urinary tract infection
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner, and refers to a 37 year old female patient. The patient's concurrent conditions included hypothyroidism. Medical history included abortion spontaneous (reported as "miscarriages"). Concomitant medications included levothyroxine 25 micrograms (mcg).The patient had no allergies or drug reactions. On 04-OCT-2017, the patient was vaccinated with a dose of VARIVAX for prophylaxis (route of administration, lot number and expiration date were not provided) and it was diluted with sterile diluent (manufacturer unknown). On 20-NOV-2017, the patient found out that she was pregnant because she did a home pregnancy test, and the result was positive; therefore she went to the physician's office. Her last menstrual period was reported as 11-OCT-2017. The estimated date of delivery was 18-JUL-2018. The trimester of exposure was 1 and the gestation period was 5 weeks. The pregnancy outcome was pending. The patient was referred to an obstetrician/gynecologist physician. The patient also reported having bilateral flank pain, a urine culture was done and the result was consistent with urinary tract infection (UTI). The patient did not received treatment for the event and there was no intervention to prevent a serious criteria. At the time of this report, it was unknown if the patient recovered from the event urinary tract infection. The reporter did not assess the causal relationship between therapy with VARIVAX, sterile diluent (manufacturer unknown) and the event.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 15-NOV-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot number L029113, expiration date 27-MAR-2017, intramuscularly (dose was not reported) for prophylaxis (expired product administered).
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 5 year old male patient. Information about concurrent condition, concomitant therapies, drug reactions/allergies and medical history was not provided. On 29-NOV-2014, the patient was administered his first dose of VAQTA (1 dose, lot # and route unknown) for prophylaxis. On 19-NOV-2015, the patient was administered his second dose of hepatitis a vaccine, inactivated (VAQTA) (lot # unknown). On 17-NOV-2017, the patient was inadvertently vaccinated with his third dose of VAQTA (25/0.5 ml, 1 dose, lot # unknown) (extra dose administered). No adverse effect reported.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unspecified dates, the patient was vaccinated with the first and the second dose of GARDASIL (dose, route, lot # and expiration date were not reported) for prevention of human papillomavirus (HPV) infection. Approximately in 2012 (reported as 5 years ago), the patient was vaccinated with the third dose of GARDASIL (dose, route, lot # and expiration date were not reported) for prevention of human papillomavirus (HPV) infection. On an unknown date, the patient had an abnormal Papanicolaou (PAP) smear which showed that she was positive for high-risk HPV, one of the strains covered by GARDASIL. The previous information was reported approximately in 2017 (stated as several months ago, late summer or early fall). No additional information was provided. The outcome of the patient was unknown. The causality between the event Papanicolaou smear positive and GARDASIL was not reported.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced cellulitis at unspecified location an unspecified amount of time after administration of PNEUMOVAX 23. The reporter stated that he had reported this adverse event to Vaccine Adverse Event Reporting System (VAERS) (no VAERS number was provided). At the time of the report, the outcome of cellulitis was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with PNEUMOVAX 23.  Upon internal review, cellulitis was determined to be medically significant. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA001550:
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced cellulitis at unspecified location an unspecified amount of time after administration of PNEUMOVAX 23. The reporter stated that he had reported this adverse event to Vaccine Adverse Event Reporting System (VAERS) (no VAERS number was provided). At the time of the report, the outcome of cellulitis was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with PNEUMOVAX 23. Upon internal review, cellulitis was determined to be medically significant. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA000894:
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain, Injection site reaction, Insomnia, Loss of personal independence in daily activities
Clinical narrative: 10/10/17 Employee called to notify that she is continuing to have left shoulder bursitis type pain after receiving her flu shot 3 weeks ago. She said the pain started within 2 hours of receiving the flu shot. She has been using OTC pain tablets/ice for some relief. Advised to f/u with PCP if symptoms worsen or if no improvement in near future. 11/7/17 F/U with employee states difficulty getting shirt on and off over her head and having difficulty sleeping as usually tucks arm under pillow but cannot due to pain in shoulder. Encouraged to f/u with PCP. 11/28/17 F/u email to employee with following response: Still having difficulty when sleeping as bringing arm up under pillow produces pain in shoulder. Getting shirt on and off over head has improved. Saw PCP with no new recommendations. This is an employee who gets her flu shot every year and has not had any symptoms like this in the past.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Patient complained of redness in the left arm where vaccine was given, described it as dark red and descended down the arm. Patient did not complain of any fever or real pain. We were advised that it was no longer in the left arm. Patient states she had history of breast cancer in left side and some lymph nodes were removed. Patient did recover.
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt was 5 months old at the time of vaccination. No adverse effect.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Flushing, Palpitations
Clinical narrative: After administering the flu shot, patient was fine. She was invited to stay around for a few minutes to make sure she was okay. She said she walked about 10 feet and she started feeling flushed, red, and heart racing. I gave her 10 mls of BENADRYL and waited a few seconds and she started feeling better. Her redness went away, she started to relax, and walked away fine.
Age: 28.0
Sex: M
Vaccine: FLU4, HEPA, TDAP
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: 9:55 AM - Following administration of 3rd vaccine (Hepatitis A), client became pale, sweaty, put head back (was seated in chair) - near syncopal - no loss of consciousness. Nurse Practitioner applied sternal rub. Client laid down on exam table with feet elevated, cool compresses to head. Vitals: 94/60 (BP), 68 (pulse), 20 (respirations). By 10:00 AM was alert, oriented. At that time was given juice to drink - had not had anything to eat or drink prior to coming for vaccines. Had client wait additional 20 minutes. Had no further complaints. Client declined any further assistance - left the clinic at 10:20 AM.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On 12/6 developed redness, itching at site on left thigh at site of GARDASIL vaccine. Progressed to about 5" swollen area, no drainage or pustule, no fluctuance. Seen in office 12/7, area warm and mild erythema, mild tenderness but mostly itchy. Felt to be local allergic reaction and not cellulitis.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Local reaction
Clinical narrative: On 12/6 developed redness, itching at site on left thigh at site of GARDASIL vaccine. Progressed to about 5" swollen area, no drainage or pustule, no fluctuance. Seen in office 12/7, area warm and mild erythema, mild tenderness but mostly itchy. Felt to be local allergic reaction and not cellulitis.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist who referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # N021571 with expiration date 29-APR-2020 or lot# N021475 with expiration date: 31-JAN-2020 (dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of -1 degree Celsius (C) or colder (-10 C) for 6 days, through 6 cycles multiple temperature excursions were involved. The temperature excursion was detected by a digital data logger. No adverse event was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA002441: US-009507513-1712USA002499: US-009507513-1712USA002527: US-009507513-1712USA002540: US-009507513-1712USA002556: US-009507513-1712USA003006: US-009507513-1712USA003166: US-009507513-1712USA003175: US-009507513-1712USA003176: US-009507513-1712USA003170.