chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: On 3-1-18 pt seen with 13.5 cm x 12 cm wide of redness and mild swelling from bottom of shoulder to just above left elbow, pt started on AUGMENTIN ES-600 600-42.9 mg/5ml give 3.5 ml BID for 10 days. Pt seen for follow up on 3-2-18 with 16.5 cm  x 12.5 cm wide of redness and mild swelling from bottom of shoulder to just above left elbow, non-tender, full strength and ROM, SL warm. SL redness extended from marked line only by less than 1 cm. Slight increase in circumference of arm from yesterday. However looks like more local reaction than cellulitis. However would continue AUGMENTIN. Start BENADRYL - can do Q6H for next 24 hours - 5 mls. Warm compresses. Monitor site. Fever, pain, increase swelling - mom aware to call back.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction, Increased tendency to bruise, Injection site pain
Clinical narrative: Pain at injection site immediately with vaccine administration- progressing to severe pain radiating down arm to wrist. Diffuse limb pain persists with intermittent focal pain and exacerbation at wrist/forearm often localized to site of old healed fracture. Continues with current pain x >4 weeks. Dizziness and lightheadness started within 10 minutes of injection and lasted 15-20 minutes from onset of symptom, no syncope. Paresthesia and sensory pain, exquisite pain to light touch, pallor, numbness and tingling in hand and fingers started within 12 hours of injection and continues with intermittent exacerbation x > 4 weeks. Weakness intermittent starting within 12 hours of injection.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Pallor, Paraesthesia, X-ray limb
Clinical narrative: Pain at injection site immediately with vaccine administration- progressing to severe pain radiating down arm to wrist. Diffuse limb pain persists with intermittent focal pain and exacerbation at wrist/forearm often localized to site of old healed fracture. Continues with current pain x >4 weeks. Dizziness and lightheadness started within 10 minutes of injection and lasted 15-20 minutes from onset of symptom, no syncope. Paresthesia and sensory pain, exquisite pain to light touch, pallor, numbness and tingling in hand and fingers started within 12 hours of injection and continues with intermittent exacerbation x > 4 weeks. Weakness intermittent starting within 12 hours of injection.
Age: 66.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Pain at injection sites, soreness, headache, muscle aches, chills, fatigue.
Age: 66.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Pain
Clinical narrative: Pain at injection sites, soreness, headache, muscle aches, chills, fatigue.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Neuritis, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Severe left shoulder pain and decreased ROM - diagnosed on 3/6/18 by orthopedist as left axillary neuritis following vaccination.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan normal, X-ray
Clinical narrative: Severe left shoulder pain and decreased ROM - diagnosed on 3/6/18 by orthopedist as left axillary neuritis following vaccination.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chest discomfort, Dizziness, Erythema, Feeling hot
Clinical narrative: Immediate following injection - dizzy, chest tightened, throat closed, weak, face turned red and felt hot. Nurse called in doctor who stayed with me until I felt OK leaving. Headaches, weakness lasted 4 or 5 days afterwards.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Immediate post-injection reaction, Throat tightness
Clinical narrative: Immediate following injection - dizzy, chest tightened, throat closed, weak, face turned red and felt hot. Nurse called in doctor who stayed with me until I felt OK leaving. Headaches, weakness lasted 4 or 5 days afterwards.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at injection site and along right upper arm. Pain and warmth noted by patient.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Pain, Pruritus, Rash, Swelling
Clinical narrative: Patient had minor pain and swelling and then in about 3 days a rash started that developed into small blisters and is improving but has been present for over 2 weeks. The rash is also itching her. The symptoms are improving but not gone after two weeks
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash erythematous
Clinical narrative: Red rash developed the next day on her upper chest (below neck and above breast) along with headache at the back of her neck/head. The following day it subsided but is still noticebably red.
Age: 32.0
Sex: F
Vaccine: ANTH, JEV1, TYP
Symptoms: Chest pain, Chills, Malaise, Myalgia, Nausea
Clinical narrative: She reports on 15 February she reports she was in her usual state of health and received Anthrax (dose 6), Typhoid (ViCPs dose 1), and Japanese Encephalitis (dose 1). The following day she noted onset of fever/chills, malaise, myalgia's, nausea, and chest pain. She presented to the ER where she was noted to have fever (102.5 F) and treated with TYLENOL. Her symptoms lasted for two days and then resolved. She denies URI symptoms, cough, and sore throat. She denies rash and local swelling, redness, or pain at vaccination site. She denies sick contacts. She denies prior adverse vaccine reactions.
Age: 32.0
Sex: F
Vaccine: ANTH, JEV1, TYP
Symptoms: Pyrexia
Clinical narrative: She reports on 15 February she reports she was in her usual state of health and received Anthrax (dose 6), Typhoid (ViCPs dose 1), and Japanese Encephalitis (dose 1). The following day she noted onset of fever/chills, malaise, myalgia's, nausea, and chest pain. She presented to the ER where she was noted to have fever (102.5 F) and treated with TYLENOL. Her symptoms lasted for two days and then resolved. She denies URI symptoms, cough, and sore throat. She denies rash and local swelling, redness, or pain at vaccination site. She denies sick contacts. She denies prior adverse vaccine reactions.
Age: 0.0
Sex: F
Vaccine: FLUX
Symptoms: Wrong drug administered
Clinical narrative: DO NOT have completed information regarding of Flu Shot. Given new born a flu shot instead of Hep. B vaccine. Unknown outcome at this time. Delay treatment on Hep. B vaccine.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Erythema, Influenza like illness, Injection site erythema, Injection site vesicles
Clinical narrative: This was for Occ health. The employee reported feeling as though she had the flu the evening before, she developed several irregular fluid filled blisters on her L deltoid muscle along with mild redness in the morning and these gradually increased, there were more developing on her L wrist  as she spoke with me. The employee was referred to Occupational Health. I also contacted GSK and reported this event.
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Mobility decreased
Clinical narrative: Sore arm, per patient it was hard to move the arm after injection.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain
Clinical narrative: PNEUMOVAX 23 syr. A few hours later I had pain redness hard lump and it has continued for three days but not that bad.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Seen at ER on 3/1/18. 9 x 10 cm erythema on upper Rt arm. Smooth, no induration.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Immediate post-injection reaction, Investigation noncompliance, Neck pain, Pain
Clinical narrative: Patient called into our office on 2/19/2018 in regards to arm pain -- patient was seen in office by PA. Patient voiced to PA that right arm hurt immediately after injection, was swollen, red, and hot to the touch immediately. Nurse that had given the injection stated the patients injection site looked normal after injection. Did not even bleed. Patient did not voice to any office staff that her arm was in pain or swollen before leaving. Patient did not call into our office to inform us of this until 02/19/2018. PA discussed with her in office the side effects of this vaccination and sent her in prednisone 20 mg. Take one tablet PO daily for 5 days. Patient called back in after that please see documentation attached. I spoke with both the patient and her daughter in regards to your recommendations. Patient is not able to afford an ultrasound at this time due to finances being tight and being on a fixed income. Patient declined to schedule us at this time, but is aware that the order is pending and may be scheduled at a later date if she so desires. Both patient and her daughter expressed continued frustration with this matter. Patient asked what treatment would consist of it ultrasound findings were abnormal? I advised the patient that would depend on the results and explained to her that imaging was important in order to give a clearer picture to what's going on with her right arm. Patient still declined to schedule ultrasound. Patient is planning on calling to report adverse reaction. Ok for her to call to report adverse reaction/side effect to injection. We can get ultrasound of soft tissue to rule out abscess IR fluid collection in that area due to shot. Order placed. Patient called in, states she continues to have excruciating pain in right arm. Patient believes this pain to be related to PREVNAR that was administered on 2/8/18. Patient reports that the right arm pain is centralized to the upper arm and will radiate into the right side of her neck at times. Patient notes small amount of swelling, but states she is much more concerned with the pain than the swelling. Patient states since being seen in office on 2/19/18 she has taken all prescribed medications without any benefit. Patient admits to taking NORCO QID for back pain. But the NORCO is not helping to alleviate the right arm pain at all. Patient states she was reviewing the VIS and is highly considering calling to report an injury related to PREVNAR. Please advise.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient called into our office on 2/19/2018 in regards to arm pain -- patient was seen in office by PA. Patient voiced to PA that right arm hurt immediately after injection, was swollen, red, and hot to the touch immediately. Nurse that had given the injection stated the patients injection site looked normal after injection. Did not even bleed. Patient did not voice to any office staff that her arm was in pain or swollen before leaving. Patient did not call into our office to inform us of this until 02/19/2018. PA discussed with her in office the side effects of this vaccination and sent her in prednisone 20 mg. Take one tablet PO daily for 5 days. Patient called back in after that please see documentation attached. I spoke with both the patient and her daughter in regards to your recommendations. Patient is not able to afford an ultrasound at this time due to finances being tight and being on a fixed income. Patient declined to schedule us at this time, but is aware that the order is pending and may be scheduled at a later date if she so desires. Both patient and her daughter expressed continued frustration with this matter. Patient asked what treatment would consist of it ultrasound findings were abnormal? I advised the patient that would depend on the results and explained to her that imaging was important in order to give a clearer picture to what's going on with her right arm. Patient still declined to schedule ultrasound. Patient is planning on calling to report adverse reaction. Ok for her to call to report adverse reaction/side effect to injection. We can get ultrasound of soft tissue to rule out abscess IR fluid collection in that area due to shot. Order placed. Patient called in, states she continues to have excruciating pain in right arm. Patient believes this pain to be related to PREVNAR that was administered on 2/8/18. Patient reports that the right arm pain is centralized to the upper arm and will radiate into the right side of her neck at times. Patient notes small amount of swelling, but states she is much more concerned with the pain than the swelling. Patient states since being seen in office on 2/19/18 she has taken all prescribed medications without any benefit. Patient admits to taking NORCO QID for back pain. But the NORCO is not helping to alleviate the right arm pain at all. Patient states she was reviewing the VIS and is highly considering calling to report an injury related to PREVNAR. Please advise.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Diarrhoea, Vomiting
Clinical narrative: After receiving the vaccines, the patient had 2 occurrences of vomiting and 4 occurrences of diarrhea. His parent contacted the patient's allergist who advised that he may be allergic to the gelatin in the Varicella vaccine and will test him for this at his next visit. They were advised to give BENADRYL every 6 hours until symptoms resolve.
Age: 1.92
Sex: M
Vaccine: HEPA
Symptoms: Injection site mass
Clinical narrative: Small 2 cm lump in upper outer right thigh, not tender to touch, mobile.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Arm is tender at injection site, with redness and swelling in the upper deltoid.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Computerised tomogram, Contusion, Dyspnoea, Erythema, Headache
Clinical narrative: Pain in arm got worse, severe, lump in arm, swelling, headache. Couldn't move arm. Arm warm and red. Shortness of breath, throat closing. Went to ER. Received Benadryl shot and observed. Pain didn't subside for a long time, lump descreased to a small knot. Bruising. Currently has knot in left side (size of grapefruit), waiting for results of CAT scan.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Limb mass, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain in arm got worse, severe, lump in arm, swelling, headache. Couldn't move arm. Arm warm and red. Shortness of breath, throat closing. Went to ER. Received Benadryl shot and observed. Pain didn't subside for a long time, lump descreased to a small knot. Bruising. Currently has knot in left side (size of grapefruit), waiting for results of CAT scan.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Throat tightness
Clinical narrative: Pain in arm got worse, severe, lump in arm, swelling, headache. Couldn't move arm. Arm warm and red. Shortness of breath, throat closing. Went to ER. Received Benadryl shot and observed. Pain didn't subside for a long time, lump descreased to a small knot. Bruising. Currently has knot in left side (size of grapefruit), waiting for results of CAT scan.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy, Headache, Migraine, Nausea
Clinical narrative: Initial unsolicited pregnancy report received from a nurse on 15-Dec-2017. This case involves a 25-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (Batch number, expiry date, dose in series and site of administration were not reported) intramuscularly instead of FLUZONE QIV (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 15-Dec-2017 while she was 61 days pregnant. Pregnancy information including patient's last menstrual period was 01-Oct-2017 and estimated delivery date were not reported. It was also reported that the patient was delayed in knowing she was pregnant (irregular) so there was no available due date at this time but, they were guessing somewhere in the first trimester. Patient's ongoing illness, risk factors, medical history and concomitant medications were reported as unknown. It was also a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event occurred following the vaccination. It was also reported that the nurse would prepare the patient for the possible common issues following FLUZONE HD and give her medicine advice if needed. 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 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. Follow up information received from a nurse on 21-Feb-2018 FLUZONE HIGH-DOSE (Lot number: u1877AB, expiry date: 17-May-2018) was given intramuscularly at right deltoid. Patient's menstrual cycles were normal. LMP date was 10-May-2017. Patient's estimated delivery date is 13-JUL-2018. Patient had a history of depression, headaches. Hypertension and migraine. On an unknown date, post vaccination, patient developed c/o nausea, c/o HA x 1 week and had history of migraines. It was also a case of overdose. On an unknown date, patient recovered from the events. List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Overdose, Wrong drug administered
Clinical narrative: Initial unsolicited pregnancy report received from a nurse on 15-Dec-2017. This case involves a 25-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (Batch number, expiry date, dose in series and site of administration were not reported) intramuscularly instead of FLUZONE QIV (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 15-Dec-2017 while she was 61 days pregnant. Pregnancy information including patient's last menstrual period was 01-Oct-2017 and estimated delivery date were not reported. It was also reported that the patient was delayed in knowing she was pregnant (irregular) so there was no available due date at this time but, they were guessing somewhere in the first trimester. Patient's ongoing illness, risk factors, medical history and concomitant medications were reported as unknown. It was also a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event occurred following the vaccination. It was also reported that the nurse would prepare the patient for the possible common issues following FLUZONE HD and give her medicine advice if needed. 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 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. Follow up information received from a nurse on 21-Feb-2018 FLUZONE HIGH-DOSE (Lot number: u1877AB, expiry date: 17-May-2018) was given intramuscularly at right deltoid. Patient's menstrual cycles were normal. LMP date was 10-May-2017. Patient's estimated delivery date is 13-JUL-2018. Patient had a history of depression, headaches. Hypertension and migraine. On an unknown date, post vaccination, patient developed c/o nausea, c/o HA x 1 week and had history of migraines. It was also a case of overdose. On an unknown date, patient recovered from the events. List of documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy test positive, Angioedema, Epinephrine
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of angioedema in a female patient who received SHINGRIX. On 7th February 2018, the patient received SHINGRIX. In February 2018, less than a month after receiving SHINGRIX, the patient experienced angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the angioedema was unknown. It was unknown if the reporter considered the angioedema to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient experienced numerous angioedema attacks which required her to be transported by ambulance to the emergency room. The patient also had laser attacks where she was able to medicate herself.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of angioedema in a female patient who received SHINGRIX. On 7th February 2018, the patient received SHINGRIX. In February 2018, less than a month after receiving SHINGRIX, the patient experienced angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the angioedema was unknown. It was unknown if the reporter considered the angioedema to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient experienced numerous angioedema attacks which required her to be transported by ambulance to the emergency room. The patient also had laser attacks where she was able to medicate herself.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site pain, Injection site swelling, Local reaction, Pain
Clinical narrative: Onset of pain and swelling in left arm around injection site several hours after injection. Patient was seen in ER on 8/31/17 for pain and local reaction. She continues to have intermittent pain and discomfort with reported intermittent swelling at site of injection for months following for which she made office visit in 2/2018. At that time topical LIDODERM patch and or cream were offered to help with reported ongoing intermittent pain at former injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan normal
Clinical narrative: Onset of pain and swelling in left arm around injection site several hours after injection. Patient was seen in ER on 8/31/17 for pain and local reaction. She continues to have intermittent pain and discomfort with reported intermittent swelling at site of injection for months following for which she made office visit in 2/2018. At that time topical LIDODERM patch and or cream were offered to help with reported ongoing intermittent pain at former injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: The pharmacist was advised that the patient reported warmness to the touch, soreness, redness, and hard to touch at injection site. The patient also reported dizziness and a headache. It is unclear when the actual adverse events started as the pharmacist was unable to reach the patient again after being notified on March 6th.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: The pharmacist was advised that the patient reported warmness to the touch, soreness, redness, and hard to touch at injection site. The patient also reported dizziness and a headache. It is unclear when the actual adverse events started as the pharmacist was unable to reach the patient again after being notified on March 6th.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a physician assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 22-FEB-2018, the patient was vaccinated with one dose of M-M-R II injection, lot M029230, expiration date 08-JUN-2018, for prophylaxis (anatomical location were not provided). This dose was reconstituted with an unspecified sterile diluent (manufacturer, lot # and expiration date were not provided) that was not the recommended sterile diluent to be used for reconstitution as per the prescribing information. No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report as received from a 41 years old female patient referring herself. The patient was not pregnant. The patient had no medical history, concurrent conditions and concomitant medications. On an unknown date in January 2018 (reported as about two months ago), the patient was vaccinated with first dose of GARDASIL 9 intramuscularly for prophylaxis. On an unknown date in January 2018, the patient experienced severe arm pain at the site lasting 3 to 4 days and had very limited range of motion. Unspecified treatment was given for the adverse events. There was no lab tests performed. The outcome of vaccination site pain and joint range of motion decreased was reported as recovered/resolved. The reporter did not provide the causality assessment for the events. There was no product quality complaint involved.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 78 year old male patient. The patient's concurrent conditions included hospitalization from an unknown date, due to a pre-existing unspecified condition. The patient's pertinent medical history and concomitant therapies were not reported. On 01-MAR-2018, during hospitalization, the patient was inadvertently vaccinated with PNEUMOVAX 23, intradermally into the left arm, for prevention (dose, lot number and expiration date were not reported). On 02-MAR-2018, the patient complained of pain and swelling at the injection site and was given acetaminophen (TYLENOL). On that same date, the patient was discharged home.  The patient was recovered from pain and swelling at the injection site by the time of the report. The reporter did not assess the causal relationship between vaccination with PNEUMOVAX 23 and the events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with an improperly dose of VARIVAX lot # N012618, expiration date 21-APR-2019 (also reported as 19-APR-2021), for prophylaxis (strength and route were not reported) which was reconstituted, concomitantly, with a properly stored Merck sterile diluent. The vaccine was improperly stored at a temperature between -14°C to -10°C during a time frame of 42 minutes and between -9°C to 8°C for 1 hour and 2 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.
Sex: F
Vaccine: HPV9
Symptoms: Accidental exposure to product, Exposure via skin contact, No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report as received from a female patient (also reported as office manager) of unknown age referring to herself. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, a drop of GARDASIL 9 (lot # N013698; expiry date: 19-DEC-2019) got onto her hand while she was reporting a product quality complaint (PQC) for a broken pre-filled syringe of GARDASIL 9 (occupational exposure to product, accidental exposure to product, product quality issue and exposure via skin contact). No known adverse effects were reported. A PQC was filed for the broken pre-filled syringe.
Age: 58.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Product storage error
Clinical narrative: This is a spontaneous report from a contactable office manager reporting on behalf of a physician. This office manager reported similar events for five patients. This is the third of five reports. This office manager reported that...Dates for Patient received vaccine after temperature excursion: (From: 22 Dec 2017 To: Unspecified). Is PREVNAR 13 a Pfizer product? Unspecified. PREVNAR 13 manufacturer: Wyeth. Dates for PREVNAR 13: (Start: 22 Dec 2017 Stop: Unspecified). NDC number of PREVNAR 13: Unknown. Expiry Date of PREVNAR 13: Dec 2019. PREVNAR 13: No change. Dates for Concomitant Products Lisinopril: (Start: Unknown Stop: Unspecified). Dates for Concomitant Products FLUARIX: (Start: Unspecified Stop: Unspecified). Additional Context: Report 3 of 5. Warm transfer from Pfizer Medical Information US18-002817 has a caller on the line who called her for PREVNAR 13 that was exposed to temperature excursion and was asking for the viability of product. Transfer agent states that agent provided caller that information, but found that there were 5 patients exposed to the PREVNAR 13 in question; Agent states she is an Office Manager. Temperature excursion went to 10.7 degrees Celsius for 50 minutes. Temperature Excursion details: Reporter clarified it was not at that temperature, 10.7 degrees Celsius for 50 minutes. That was the maximum temperature reached on the alert system they use and started coming back up as power back on. Patient 3 of 5: Information populated within this report. Other Medical Conditions: None. Denies any. Testing/Interventions/Treatment: None. VACCINE SUPPLEMENTAL FORM. Patient Age at Time of Vaccination in Years: 58 years old. Vaccine Lot Number: S74424. Vaccine Lot Expire Date: Dec 2019. Time the Vaccination was Given (24 hour clock): Unknown. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Deltoid Right. Vaccination Facility Type: Other: Physician's Clinic. Vaccine Administered at Military Facility? No. Additional Vaccines Administered on Same Date of the Pfizer Suspect Vaccine Name: FLUARIX. Lot Number/Expiry Date: G29412/30Jun2018. Route: Intramuscular. Anatomical Location: Deltoid Right. Number of Previous Doses: Unknown. Adverse Event: Patient received vaccine after temperature excursion. Time of Onset (24 hour clock): Unknown. Additional Information. Did any AE(s) require a visit to: Emergency Room: No Physician Office: No. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine(s)): None. Patient's Medical History: None. Family Medical History Relevant to AE(s): None. Relevant Tests: None. Sender's Comments: Linked Report(s): US-PFIZER INC-2018017647 same reporter, different patient, same drug/event.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Back pain, Headache, Pyrexia
Clinical narrative: 1 day after vaccination patient developed fever 103, headache, back pain; ran fever for 6 days over 101.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: EDD 09/27/2018-  Live MMR vaccine given to pt prior to us knowing of pregnancy.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain at the injection site, redness, burning, huge knot.
Sex: M
Vaccine: VARZOS
Symptoms: Depression, Herpes zoster, Malaise
Clinical narrative: Information was received on 02-MAR-2018 from a 39 year old male patient referring to himself. He had no pertinent medical history, no allergies, and was taking no concomitant medications. In September 2017, the patient was vaccinated with ZOSTAVAX for "shingles" (lot # not provided).  He stated "1 shot administered in my arm". The patient reported that ZOSTAVAX "really messed me up and did no good." He also mentioned that ZOSTAVAX made his health situation "real bad." He reported that the adverse events occurred on 05-DEC-2017. He felt depressed and was currently experiencing a shingles breakout. The patient visited the Emergency Room (ER) three times (unable to confirm whether he was admitted). While at the ER, the patient was prescribed an unknown medication to treat the shingles outbreak. The patient felt the events were related to ZOSTAVAX. The events were not resolved at the time of the report. The patient stated he wants "settlement" for the adverse reactions he experienced and was planning to launch a lawsuit against Merck because of ZOSTAVAX. The patient did not provide consent to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Limb discomfort, Ophthalmic herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 69-year-old male patient who received SHINGRIX. The patient's past medical history included shingles and ophthalmic herpes zoster (it reoccurred again in 15th June 2017). Concurrent medical conditions included lymphoplasmacytic type lymphoma (Kiel classification) (In partial remission since Dec 2014). On 21st December 2017 16:52, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th January 2018, 29 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved and the outcome of the injection site pain was unknown. The reporter considered the ophthalmic herpes zoster to be unrelated to SHINGRIX. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: In March of 2017, the patient was first diagnosed with shingles on his forehead. With medication, it resolved but on 7th April 2017 it returned and was in patient left eye. The patient took medication and it resolved, so was titrated off the medication. Then on 15th June 2017, shingles came back in his left eye and was again treated. On 13th November 2017, the patient doctor said he was clear of shingles. After receiving vaccines, on 19th January 2018, after receiving vaccination, the patient broke out again with shingles in his left eye. Less than a year after receiving vaccination, the patient experienced sore arm. No information was gathered for the sore arm other than they assumed the shot was given intramuscularly as both he and his wife had sore arms. This case was linked to the case US2018032694 (case reported for patient's wife).
Age: 55.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Cardiovascular evaluation, Palpitations
Clinical narrative: On the day of vaccination started having palpations around 7 pm while playing video games, called 911 and seen in ER. Had card..w/o. No rash, no SOB, no lips swelling, no choking. HR was around 130's. Had flu vaccines in the past.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Injection site swelling
Clinical narrative: On evening of vaccination, developed swelling, itching, with some pain at site with swelling involving much of arm. Felt dizzy. Fell twice without injury. Itching has resolved. Overall symptoms improved 65%.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Hypopnoea, Pallor
Clinical narrative: After receiving vaccines child cried incessantly, then suddenly became quiet with pallor and shallow breathing - after approximately 20-30 sec infant became alert but remained pale. POX-99% P-130 RR-30 NAD After 15-20 mins infant back to normal state.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Vaccination complication
Clinical narrative: 2/12/18-Pt seen by a different provider for diaper rash but reported that some "new bite-like spots" had appeared that morning. Rx DIFLUCAN and LAMISIL and told to F/U in 1wk. 2/15/18-Pt seen by yet a different provider and DIFLUCAN refilled and Clotrimazole Rx. Told to F/U with PCP as Derm referral may be necessary. 2/21/18-PT saw PCP Dx w/reaction to vaccines. Rx Acyclovir and Cetirizine. Advised to stop fungal Tx and referred to Derm which is not yet scheduled per parent request.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Vaccine administered to left arm (sq) at 10:10am. At 10:22am a rash appeared across face. Dr. examined patient 10:23 1.5 ml of ZYRTEC was given. Patient monitored for 20 mins. Rash disappeared. Patient was stable with no wheezing nor discharge.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Injection site erythema
Clinical narrative: At 24 hrs post vaccine, sudden large red welt at vaccine site, sore arm, fever, sweating, chills, fatigue, no appetite then after 12 hrs resolved. Rash resolved w.in 12 hrs.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash, Urticaria, Vaccination site reaction
Clinical narrative: At 24 hrs post vaccine, sudden large red welt at vaccine site, sore arm, fever, sweating, chills, fatigue, no appetite then after 12 hrs resolved. Rash resolved w.in 12 hrs.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Expired product administered
Clinical narrative: Vaccination expired.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Cardiac function test normal, Chest pain, Dysgeusia, Electrocardiogram
Clinical narrative: Numbness/Tingling in tongue/throat and part of mouth, Post nasal drip, metallic taste, Chest pain 20 minutes after vaccination. Patient went to Hospital. She had a cardiac workup; everything was normal. Given a dose of BENADRYL and Lidocaine PO.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia, Upper-airway cough syndrome
Clinical narrative: Numbness/Tingling in tongue/throat and part of mouth, Post nasal drip, metallic taste, Chest pain 20 minutes after vaccination. Patient went to Hospital. She had a cardiac workup; everything was normal. Given a dose of BENADRYL and Lidocaine PO.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Developed hives approximately 24 hours after receiving the vaccine. Treated with non-sedating anti-histamines.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: Awoke with left upper arm swelling, erythema, and mild ecchymosis at the injection site (approximately 16 hours after the injection).
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Coordination abnormal, Dizziness, Feeling hot, Flushing, Presyncope
Clinical narrative: FACIAL FLUSHING, LIGHT HEADED, LACK OF COORDINATION OF EXTREMITIES. AFTER VACCINE INJECTION PATIENT WAS SITTING IN EXAMROOM AND SHE STARED TO FEEL VERY WARM AND GOT UP TO LEAVE THE ROOM BEFORE STAFF WAS AVAILABLE DEVELOPED A VASO VAGEL RESPONSE WHEN SHE TRIED TO WALK OUT THE EXAM ROOM DOOR. STAFF IN IMMEDIATE AREA PREVENTED HER FROM FALLING LYING HER DOWN AND ELEVATING HER FEET, COLD FACECLOTH TO HER FORHEAD AND GAVE HER SIPPS OF H20. AFTER ABOUT 15 MINUTE THE PATIENT STOOD WITH ASSISTANCE AND WALKED WITH ASSISTANCE TO AN EXAM ROOM WHERE SHE WAITED FOR A TOTAL OF 40 MINUTES. VITAL SIGN WERE RE-CHECKED AND REVIEW BY HER PCP. AFTER SOME MORE H2O AND CRACKERS. PATIENT STATED SHE FELT BACK TO NORMAL AND WAS WALKED BY A STAFF MEMBER TO HER CAR AND STAFF MEMBER REPORTED THAT SHE WAS DRIVING NORMALLY. SHE WAS DIRECTED TO  ACTIVATE EMS IF SYMPTOMS RETURNED.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Musculoskeletal pain
Clinical narrative: Headache, fatigue, chills, heart palpitations, area around site red, extreme pain in shoulder.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Palpitations
Clinical narrative: Headache, fatigue, chills, heart palpitations, area around site red, extreme pain in shoulder.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Pain, Pain in extremity
Clinical narrative: Vaccine given at 1:25 PM. No issues with redness, swelling, or pain at site of injection at the time of the injection. Patient denied any redness or swelling at the site after injection, only stated, "The severe pain started at 8 pm at the site of the injection in my left deltoid muscle and radiates down to my wrist. When I palpate down my arm, the muscles "feel sore"." Denied numbness, redness, swelling or tingling in fingers or arm. Patient stated, "I have been taking TYLENOL, but it is only helping a little. When I move my arm the pain level is an 8, but when I keep my arm still the pain level is only a 2."
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Cardiac stress test normal, Chest X-ray, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Rapid heart beat. Went to ER at 11am, EKG, chest xray, shot of some drug to stop the rapid heart beat. Overnight observation. Cardiologist put me on sotalol, so had to stay in hospital 2 more days, echo, EKGs, stress test. Nothing found and no further occurrences.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased
Clinical narrative: Rapid heart beat. Went to ER at 11am, EKG, chest xray, shot of some drug to stop the rapid heart beat. Overnight observation. Cardiologist put me on sotalol, so had to stay in hospital 2 more days, echo, EKGs, stress test. Nothing found and no further occurrences.
Age: 0.75
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Urticaria
Clinical narrative: Hives coming and going from all over his body for 4 days consecutive after his vaccines.
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: My daughter ran a temperature of 102 degrees, injection site was hot to touch, there was a a hard bump under injection site for a week, site broke out in a red rash running in a vertical line with the injection site and runny nose.
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Rhinorrhoea
Clinical narrative: My daughter ran a temperature of 102 degrees, injection site was hot to touch, there was a a hard bump under injection site for a week, site broke out in a red rash running in a vertical line with the injection site and runny nose.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 28-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date when she was a child, the patient was vaccinated with an unspecified number of doses of M-M-R II reconstituted with sterile diluent and VARIVAX (for all dose, route of administration, lot# and expiration date were not reported) as pediatric immunizations. On 17-JAN-2018, the patient had negative titres for rubeola and varicella. There was no additional adverse events/reactions reported. The reporter inquired whether or not M-M-R II and VARIVAX could be given on the same day. The outcome of the events was reported as not recovered. The relatedness between the events and suspect therapies were not reported.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare business professional and refers to a non dialysis adult patient of an unknown 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 a dose of RECOMBIVAX HB dialysis formulation, injection (thimerosal status, route of administration, lot # and expiration date were not reported). There was no adverse event reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Delivery, Exposure during pregnancy, No adverse event, Pregnancy test
Clinical narrative: This spontaneous retrospective pregnancy report as received from a registered nurse refers to a 19-year-old female patient with no pertinent medical history, drug reactions/allergies or concomitant medications. On an unspecified date in 2017, the patient had her last menstrual period (LMP) and become pregnant. On 09-JAN-2018, during an unknown time of the pregnancy gestation, in approximately third trimester, she was vaccinated with a dose of GARDASIL 9 intramuscularly, lot # N020352, expiration date: 10-APR-2020 (dose, vaccination site and dose number in the human papilloma virus (HPV) vaccination series were not reported). On an unknown date, a pregnancy test was performed, however no results were provided. On 08-FEB-2018, the patient delivered a baby without any side effects. No other pregnancy, delivery and infant details were provided. The patient sought a medical attention. No treatment was given to the patient.
Sex: F
Vaccine: PNC13
Symptoms: Bed rest, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for herself. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the event and included bed rest, some antibiotics and other stuff. The information on the lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity receive PREVNAR 13, (Lot # S74423, Expiry Date Nov2019, NDC # 00005197101) via an unspecified route of administration at 0.5 ml, single into left deltoid on 24Feb2018 around 13:00 for immunisation, administered at pharmacy/drug store. No other vaccines were given the same day. The patient medical history, concomitant medications or investigations were not reported. The patient initially had a low grade fever the first day or two after the vaccination on 24Feb2018 and has gone away completely recovering in Feb2018. On 27Feb2018 also began experiencing nausea and diarrhea and had continued (outcome was unknown). She also experienced pain, significant swelling and tenderness, at the injection site and that it is warm to the touch, like elevated temperature in that arm, all on an unspecified date in Feb2018 with outcome of not recovered. Patient did not information the reporter of time of onset of the AEs reported and whether her symptoms had improved, worsened, or persisted. The reporter had already advised the patient to speak with her doctor. Information about lot number already provided.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity receive PREVNAR 13, (Lot # S74423, Expiry Date Nov2019, NDC # 00005197101) via an unspecified route of administration at 0.5 ml, single into left deltoid on 24Feb2018 around 13:00 for immunisation, administered at pharmacy/drug store. No other vaccines were given the same day. The patient medical history, concomitant medications or investigations were not reported. The patient initially had a low grade fever the first day or two after the vaccination on 24Feb2018 and has gone away completely recovering in Feb2018. On 27Feb2018 also began experiencing nausea and diarrhea and had continued (outcome was unknown). She also experienced pain, significant swelling and tenderness, at the injection site and that it is warm to the touch, like elevated temperature in that arm, all on an unspecified date in Feb2018 with outcome of not recovered. Patient did not information the reporter of time of onset of the AEs reported and whether her symptoms had improved, worsened, or persisted. The reporter had already advised the patient to speak with her doctor. Information about lot number already provided.