chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 05-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a child patient received only the dtap/ipv component of PENTACEL vaccine (batch number, route and site of administration not reported) on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique. 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 document held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited case received from a nurse on 05 Jun 2018. This case involves a patient (age and gender not reported) who was vaccinated expired dose of PENTACEL (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. It was an actual medication error case due to Expired vaccine used. 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 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: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from a Nurse (LPN) on 05-Jun-2018. This case involves a patient (age and gender was not reported), who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used one patient, received dose that had expired. 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.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left thigh 2 days after vaccines. Seen at ER, then follow-up with me. Responding well to antibiotics.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Localized discomfort and stiffness at site, redness and warmth and slight swelling below injection area (Deltoid) to elbow X4 days, reported by phone to clinic staff on 6/14/18 at 10:00 P.M. He was instructed by Dr. to take BENADRYL 25MG PO and apply ice pack to site for 10-15 minutes. Patient reported redness is improving and has no discomfort 6/15/18 at 9:45 A.M.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Localized discomfort and stiffness at site, redness and warmth and slight swelling below injection area (Deltoid) to elbow X4 days, reported by phone to clinic staff on 6/14/18 at 10:00 P.M. He was instructed by Dr. to take BENADRYL 25MG PO and apply ice pack to site for 10-15 minutes. Patient reported redness is improving and has no discomfort 6/15/18 at 9:45 A.M.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Influenza virus test negative, Local reaction, Pyrexia
Clinical narrative: Fever 102-105. Associated local reaction.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Patient developed a fever within 6 hours of receiving GARDASIL 9 vaccination. He was lethargic and lost appetite. The fever was lingering around 101 to 102 degree range for several hours. ADVIL in 400 mg dose was given at bedtime. Upon awakening the next morning at approximately 7 AM, the patients temperature was lingering around 101 and additional 400 mg dose of ibuprofen was given. At approximately 11:45 patient's temperature was registering in the range of 103.2 to 104.3 and he was placed in a tepid bath. At approximately 12:15 he was given additional 400 mg ibuprofen and subsequently had a reduction of his temperature when measured again at the doctor's office. At approximately 1:45 his registered temperature was 99.4.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chest discomfort, Fatigue, Pain in extremity, Rash
Clinical narrative: Major: Tightness in Chest (started around dinnertime approx. 7 pm). Minor: rash, tired, sore arm   (all evening into next day). Patient requested 2 shots in same arm (left) due to previous mastectomy on right side.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, headache, severe back pain.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial 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 concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, the patient was treated by the same physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In March 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. On or about 01-JUL-2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In July 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. On or about 05-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist who reported for her daughter. A 1-year-old female patient received the fourth dose of PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the pharmacist was pretty sure the baby had pneumonia (pneumonia was not yet diagnosed). Clinical outcome was unknown at time of this report. The information on the lot number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy (pneumonia occurred after the vaccination schedule with pneumococcal 13-valent conjugate vaccine) in this patient cannot be completely excluded.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Induration, Injection site erythema, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (physician's assistant). A 65 year-old female patient received the first dose of PREVNAR 13, (lot S74424) via an unspecified route of administration on 01Jun2018 at 0.5 ml single in the right deltoid for routine vaccination. Medical history included ongoing allergy to penicillin and irritable bowel syndrome from an unknown date and unknown if ongoing. Concomitant vaccine administered on 01Jun2018 for immunization included the first dose of SHINGRIX, (lot XC534) in the left deltoid. The patient had previously received for immunization another varicella zoster vaccine in 2016 without any adverse event. The patient experienced red, bumpy, itchy area around injection site on an unspecified day in Jun2018, she also experienced rash on left neck, arm, and knee on 08Jun2018. Clinical course was as follows: the patient reported induration after the vaccine and she had a red, bumpy area around the injection site. The patient was visited on 07Jun2018, she had a worsening red, bumpy area around the injection site, her arm was sore, and the itchy area which started out as the size of a 50 cent piece was getting bigger. The rash got bigger and was warm to the touch. The reporter was not sure when these symptoms first started for the patient. The patient was prescribed with BACTRIM and KEFLEX in case of infection.  On 08Jun2018 the patient had a similar rash on her left neck, arm, and knee. The rash on the left side of the patient's body did show up after she took sulfamethoxazole, trimethoprim. The reporter was not sure if the patient was scratching, and that also contributed to the rash or not. The patient was not recovered from red, bumpy, itchy area around injection site and rash on left neck, arm, and knee that were reported as worsened; outcome of other events was unknown. The events red, bumpy, itchy area around injection site and rash on left neck, arm, and knee were assessed as related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (physician's assistant). A 65 year-old female patient received the first dose of PREVNAR 13, (lot S74424) via an unspecified route of administration on 01Jun2018 at 0.5 ml single in the right deltoid for routine vaccination. Medical history included ongoing allergy to penicillin and irritable bowel syndrome from an unknown date and unknown if ongoing. Concomitant vaccine administered on 01Jun2018 for immunization included the first dose of SHINGRIX, (lot XC534) in the left deltoid. The patient had previously received for immunization another varicella zoster vaccine in 2016 without any adverse event. The patient experienced red, bumpy, itchy area around injection site on an unspecified day in Jun2018, she also experienced rash on left neck, arm, and knee on 08Jun2018. Clinical course was as follows: the patient reported induration after the vaccine and she had a red, bumpy area around the injection site. The patient was visited on 07Jun2018, she had a worsening red, bumpy area around the injection site, her arm was sore, and the itchy area which started out as the size of a 50 cent piece was getting bigger. The rash got bigger and was warm to the touch. The reporter was not sure when these symptoms first started for the patient. The patient was prescribed with BACTRIM and KEFLEX in case of infection.  On 08Jun2018 the patient had a similar rash on her left neck, arm, and knee. The rash on the left side of the patient's body did show up after she took sulfamethoxazole, trimethoprim. The reporter was not sure if the patient was scratching, and that also contributed to the rash or not. The patient was not recovered from red, bumpy, itchy area around injection site and rash on left neck, arm, and knee that were reported as worsened; outcome of other events was unknown. The events red, bumpy, itchy area around injection site and rash on left neck, arm, and knee were assessed as related to pneumococcal 13-val conj vac (dipht crm197 protein).
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable Nurse via a Pfizer sales representative. A 16-year-old female patient received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme arm pain immediately after dose was given.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Fatigue, Headache, Impaired work ability, Injected limb mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient receive PREVNAR 13, intramuscular in left arm on 11Jun2018 09:00 at single dose at the physician office for pneumonia prevention. Medical history was none. There were no concomitant medications. On 11Jun2018, around 13:00 the patient left arm, where the injection occurred she experienced arm pain. Also at 13:00 on 11Jun2018 she began to have a horrible, pounding headache. Then at 14:30 she had to leave work because of the headache and went home to bed. The next day, 12Jun2018 around 06:00, she experienced body aches and fatigue. A couple hours later round 10:00-11:00 she experienced dizziness and nausea. On 13Jun2018 the patient was finally feeling better. Her headache was minor and she barely notices it. Her left arm pain has since improved as well, before she couldn't lift her arm above her head but now she can, she just can't touch her arm still. Before she could barely get out of bed but on 13Jun2018 the fatigue, dizziness, nausea, and body aches have subsided. The patient started feeling better at around 06:30 on 13Jun2018. The outcome of the events horrible, pounding headache and Left arm pain/where the injection occurs she experienced arm pain/couldn't lift her arm above her head was recovering. The outcome of the event fatigue was recovered with sequel on 13Jun2018. The outcome of other reported events was recovered on 13Jun2018. The information on the batch number has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Nausea, Pain, Pain in extremity, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient receive PREVNAR 13, intramuscular in left arm on 11Jun2018 09:00 at single dose at the physician office for pneumonia prevention. Medical history was none. There were no concomitant medications. On 11Jun2018, around 13:00 the patient left arm, where the injection occurred she experienced arm pain. Also at 13:00 on 11Jun2018 she began to have a horrible, pounding headache. Then at 14:30 she had to leave work because of the headache and went home to bed. The next day, 12Jun2018 around 06:00, she experienced body aches and fatigue. A couple hours later round 10:00-11:00 she experienced dizziness and nausea. On 13Jun2018 the patient was finally feeling better. Her headache was minor and she barely notices it. Her left arm pain has since improved as well, before she couldn't lift her arm above her head but now she can, she just can't touch her arm still. Before she could barely get out of bed but on 13Jun2018 the fatigue, dizziness, nausea, and body aches have subsided. The patient started feeling better at around 06:30 on 13Jun2018. The outcome of the events horrible, pounding headache and Left arm pain/where the injection occurs she experienced arm pain/couldn't lift her arm above her head was recovering. The outcome of the event fatigue was recovered with sequel on 13Jun2018. The outcome of other reported events was recovered on 13Jun2018. The information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. A 16-year-old female patient received first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after administration of first dose, the patient experienced sore arm. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: MENB
Symptoms: Injection site bruising
Clinical narrative: This is a spontaneous report from a contactable healthcare professional via a Pfizer-sales representative. A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bruise at the injection site on an unspecified date. The outcome of the event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Local reaction, Skin warm
Clinical narrative: This is a spontaneous report received from a contactable nurse. A female patient of an unspecified age received PREVNAR, via an unspecified route of administration in the morning of 12Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 12Jun2018 the patient went to the urgent care due to local reaction. It was further described as about 6 or 7 cm kind of firm area. It was also reported that the patient was warm and red however was not having any problems breathing and she doesn't have a fever. The outcome of the events was unknown.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MMR given inadvertently to 12 week old patient.
Age: 18.0
Sex: M
Vaccine: HEPAB
Symptoms: Asthenia, Feeling cold, Headache, Pyrexia, Vaccination site rash
Clinical narrative: Rash around point of entry of vaccination, weakness, high fever, headache and cold body.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash, Rash erythematous, Vertigo
Clinical narrative: Bright red flat rash over chest noticed after taking shower approximately 24 hours after receiving vaccine. Approximately 40 hours after receiving vaccine began to itch all over body. Took CLARITIN. After shower approximately 48 hours after vaccine noticed flat rash over chest, up to neck. Light rash on arms and thighs. After 56 hours, experienced vertigo on standing. Rash on arms and legs gone and chest rash became lighter in color. After 72 hours rash mostly gone. Vertigo gone.  Itching remaining on chest for one week.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Muscle aches all over/ chills/ nausea/ weakness/ fatigue. Started within 8 hours of shot/extreme muscle aches nausea started at mid night.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Pt reported a headache and chills (unsure if she was febrile) the same night as receiving the vaccine earlier that day. Pt reported it last a few hours until she went to bed. She called this morning and stated that she is feeling back to normal.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Invalid dose, pediatric dose administered to an adult. No adverse reaction occurred however patient will need to be revaccinated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient experienced redness, inflammation, pain and hot to the touch at site of injection. Patient sought treatment 5 days after receiving immunization and was prescribed KEFLEX and Prednisone. Patient 1 month out is completely recovered and does not have any of the above signs of redness, inflammation, pain or warmth to the touch at site of injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Pt reported a bad headache and a fever that started the evening of the same day as receiving the vaccine. The symptoms resolved by the next morning.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Mouth haemorrhage, Mouth injury, Syncope
Clinical narrative: Pt was given all 3 vaccines at the end of his physical-approx. 10:10 am. He tolerated them well.  He then watched his cousin get her imm and tb skin test. I asked how he was feeling and he said fine. I asked if he had breakfast this morning and he said yes. At about 10:20 the family was at checkout and pt fainted. Pt placed in supine position with legs elevated and BP and pulse taken. He was awake and oriented and able to answer question. He had some blood on front tooth as he hit his forehead/mouth on wall. He was placed in sitting position and vitals taken again-normal. Pt was moved to a room and given apple juice and rested for 10 more minutes. Vital retaken and pt seen by NP who had done his physical this morning and was released to his guardian with instructions to call us if he has any other sx's or concerns.
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Eczema
Clinical narrative: Eczema. Cut out gluten and dairy which May have helped a little but not much. Stopped giving DTaP and eventually the eczema went away. Now he eats gluten, dairy, etc and has no dietary restrictions and no more eczema.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Tenderness
Clinical narrative: Patient noticed soreness in the arm the evening of the vaccination. The next day the soreness increased to where it was very tender to the touch. The area bacame red, swollen, and gave off heat. The affected area was not around the injection site. The affected area was below the injection site near the bicep. Patient does not remember any insect bites/stings and had limited exposure to the outdoors.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Low grade fever, swollen/red/hot left upper deltoid/arm, LA-sore/painful, cellulitis. Seen and treated pt prescribed antibiotics to treat cellulitis.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Low grade fever, swollen/red/hot left upper deltoid/arm, LA-sore/painful, cellulitis. Seen and treated pt prescribed antibiotics to treat cellulitis.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction
Clinical narrative: Immediate redness with SHINGRIX vaccine - 8 days later redness.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, via the subcutaneous route (dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. No known adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis.  On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that friend of hers, who was also the physician's assistant, told her they were getting a lot of patients in the emergency room with extreme shoulder pain after receiving SHINGRIX. This is 1 of 3 cases, reported by the same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The vaccine was administered in the left arm. The reporter indicated that her husband received the SHINGIRX vaccine sometime at the end of April or early May, 2018.  He experienced a sore arm that lasted for a day or two. The patient had denied permission to contact their physician.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th June 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills and rash. On 5th June 2018, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the fever and chills were recovering/resolving. The reporter considered the fever, chills and rash to be possibly related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, the patient received first dose of SHINGRIX on Monday around 5:55 pm.  On the same day of vaccination, the patient experienced a little fever and chills as well as a rash on her feet. The rash resolved the next day, after the vaccination while the fever and chills were still present, but were mild. Since then the healthcare professional was unsure if the events had resolved. The healthcare professional was unsure whether an emergency room or doctor visit was required, the patient was hospitalized or not, it was disabling or life-threatening or whether it jeopardized the patient or intervention was required, (other than the discontinuation of the drug) to prevent one of the listed outcomes. The reporter stated that the patient was exposed to someone with a cold so she was unsure if the symptoms could be related to that instead. Other pharmacist at pharmacy, administered the SHINGIRX vaccine.
Sex: F
Vaccine: MENB
Symptoms: Abdominal discomfort, Altered state of consciousness, Lymph node pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer for a female patient (daughter). A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration on 01Jun2018 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. In the past, 1-2 years ago, the patient previously took HPV vaccine for immunisation and experienced golf ball lymph nodes under her arms. The patient experienced swollen lymph nodes and upset stomach on unspecified date in Jun2018 with outcome of unknown. Per reporter: When her Dr. pressed on the golf ball sized lymph nodes my daughter almost passed out. The lymph nodes were really tender. Do you have any links between HPV vaccine and meningococcal group b rlp2086?
Age: 17.0
Sex: M
Vaccine: HPVX, MENB, MNQ
Symptoms: Dyskinesia, Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 17 year-old male patient received TRUMENBA at single dose, hpv vaccine (unspecified manufacturer) and MENACTRA, all on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. After the 3 injections the nurse asked the patient if he was okay. As he tried to answer her, he slid down onto the table, jerked, lost color and passed out. He was only out for a second and then tried to sit up. The nurse had him lay down for a few minutes and then she gave him crackers and water. He said he felt better. He did tell the nurse he should have eaten something before he came in. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect drug meningococcal group b rlp2086 contributed to the development of the reported event passed out.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable Nurse. This Nurse reported similar event for 2 patient. This is 1st of two reports. A 17-year-old female patient received TRUMENBA (NDC number: 0005-0100-10, Lot Number: S58896, Expiry date: 31Aug2019) at single dose on 07Jun2018 at 0.5ml single dose, via intramuscular route of administration into right arm for immunization. The patient had not medical history. The patient received first dose of the same vaccine at 16-year-old on 17Apr2017, via intramuscular route of administration into left arm from Lot number: R45100, Expiration date: 31Jul2018. On unknown date the patient also received GARDASIL (lot N026812, exp.date 22Jun2020) via intramuscular route. On 07Jun2018 the patient experienced severe arm pain in the injected arm and on unknown date she could not lift her arm. The outcome of the event severe arm pain was recovering because the patient had been taking Motrin for it, while the outcome of the other adverse event was unknown. The event severe arm pain was considered to be a serious important medical event.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect drug meningococcal group b rlp2086 contributed to the development of the reported event arm pain and could not lift her arm. ,Linked Report(s) : US-PFIZER INC-2018242439 same reporter/drug, similar event, different patient.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from a nurse on 06-Jun-2018. This case involves a two-month-old patient (gender not reported) who was vaccinated with a dose of PENTACEL (batch number: C5370AA, expiry date: 04-Jun-2018, dose, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used. 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: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited case received from a healthcare professional (office person medical assistant) on 07 Jun 2018. This case involves a patient (age and gender not reported) who was vaccinated expired dose of ACTHIB (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. It was an actual medication error case due to Expired vaccine used. 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: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional (office person, medical assistant). This case involves a patient (age not reported) who received an expired dose of ADACEL (batch number, expiration date, route and site of administration were not reported) on an unspecified date. It was actual medication error due to expired vaccine used. It was reported that ADACEL was kept at 58.5F for 6 hours "closed ok". "Open products discard explained says PPD covered her other products". It was not reported if the patient experienced any adverse event, following vaccination. Lab test and corrective treatment: not 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: Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult patient who experienced dose given to a pt on 03-Jun-2015 and on 22-Jun-2015. Too close together, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Jun-2015, the patient received a dose Primary dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. On 22-Jun-2015 he/she also received a dose Primary dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. It was a case of actual medication error because actual administration of vaccine at inappropriate schedule took place. (Other relevant tests included no lab data.) Final diagnosis was dose given to a pt on 03-Jun-2015 and on 22-Jun-2015. Too close together. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for dose given to a pt on 03-Jun-2015 and on 22-Jun-2015. Too close together. 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: Expired product administered, No adverse event
Clinical narrative: Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional (Medical assistant). This case involves an unknown age patient who received a dose of expired vaccine PENTACEL. On an unknown date, the patient received a dose of suspect PENTACEL Lot number, expiry date, dose, route and site of administration was not reported. It was a case of actual medication error due to expired vaccine used. 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: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from a health care professional on 07 June 2018. This case involves a patient (age and gender not reported) who was vaccinated with expired dose of 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 as expired vaccine used. 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: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial unsolicited report received from a nurse on 08-Jun-2018. This case involves a four-year-old patient (gender not reported) who was vaccinated with a dose of ADACEL (batch number, expiry date, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to 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.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Patient received SHINGRIX subcutaneously instead of the recommended IM injection site. Other than pain at injection site, patient appears to be in good health. In accordance with website, the dose has been shown to be immunogenic and does not need to be repeated.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Lethargy
Clinical narrative: Lethargy, chills, stomach upset, redness.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Disorientation, Dysarthria, Laboratory test, Musculoskeletal pain
Clinical narrative: Patient received the SHINGRIX Vaccine on 06/04/18. On 06/06/18 she began taking diclofenac 75mg DR tablets for shoulder pain. On 06/11/18 she presented to the clinic with a BP of 200/105, slurred speech, blurry vision, and was disoriented. An ambulance was called and patient was taken to the ER and diagnosed with an adverse reaction to diclofenac. I do not suspect the adverse reaction was to SHINGRIX, but due to the proximity of the immunization to the reaction I wanted to report it.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Patient received the SHINGRIX Vaccine on 06/04/18. On 06/06/18 she began taking diclofenac 75mg DR tablets for shoulder pain. On 06/11/18 she presented to the clinic with a BP of 200/105, slurred speech, blurry vision, and was disoriented. An ambulance was called and patient was taken to the ER and diagnosed with an adverse reaction to diclofenac. I do not suspect the adverse reaction was to SHINGRIX, but due to the proximity of the immunization to the reaction I wanted to report it.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patients entire back of arm became hot, red and hard.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Nausea, Palpitations, Pruritus
Clinical narrative: Hives: red rash over trunk, arms, legs, neck, face Felt like skin on fire, Nausea, Fever, Internally itchy. Felt like throat was closing up, Headache, Heart racing.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous, Skin burning sensation, Throat tightness
Clinical narrative: Hives: red rash over trunk, arms, legs, neck, face Felt like skin on fire, Nausea, Fever, Internally itchy. Felt like throat was closing up, Headache, Heart racing.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives: red rash over trunk, arms, legs, neck, face Felt like skin on fire, Nausea, Fever, Internally itchy. Felt like throat was closing up, Headache, Heart racing.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site induration, Injection site mass, Pain in extremity, Pyrexia
Clinical narrative: Patient had notable arm pain, erythema, and a fever of 101F by the following day of the vaccine. The reactions began to subside over the next couple of days. The only significant adverse reaction that remains is a hard lump about the size of a golf ball at the site of injection.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: Patient had notable arm pain, erythema, and a fever of 101F by the following day of the vaccine. The reactions began to subside over the next couple of days. The only significant adverse reaction that remains is a hard lump about the size of a golf ball at the site of injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain, Bone pain, Erythema, Fatigue
Clinical narrative: Worst flu symptoms I have ever had! Every bone in my body ached. Terrible headache, extremely tired. My arm has baseball reaction of redness, warmth and anything touching it feels like a boil.  Took TYLENOL every 4-6 hours, drank lots of fluids. Ate little as my stomach was a little upset.  Started about 20 hours after injection, couldn't get out of bed other than to go to bathroom for 24 hours. Today I feel somewhat better but still with aches in lower back and pelvic bones when I walk, still with headache but not as intense. Tired but better. Still taking TYLENOL every 4-6 hours. Getting better but know I had a reaction. Arm still sore to touch and red and warm. Same size has not grown further in size. Unable to go to work for two days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Influenza, Skin warm, Tenderness
Clinical narrative: Worst flu symptoms I have ever had! Every bone in my body ached. Terrible headache, extremely tired. My arm has baseball reaction of redness, warmth and anything touching it feels like a boil.  Took TYLENOL every 4-6 hours, drank lots of fluids. Ate little as my stomach was a little upset.  Started about 20 hours after injection, couldn't get out of bed other than to go to bathroom for 24 hours. Today I feel somewhat better but still with aches in lower back and pelvic bones when I walk, still with headache but not as intense. Tired but better. Still taking TYLENOL every 4-6 hours. Getting better but know I had a reaction. Arm still sore to touch and red and warm. Same size has not grown further in size. Unable to go to work for two days.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Blister
Clinical narrative: Patient reported small watery blisters, one behind ear, a couple on arm, on her back and under breast. Patient was seen by primary MD on 6/14/2018 and MD does not think reaction is caused by vaccine. Diagnosis unspecified angioedema. Patient prescribed Clobetasol Cream to apply as directed.