chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: reported reactions at the site; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for 2 patients on behalf of physician. This is the second of two reports.  An adult patient of an unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), 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.  It was reported that a patient reported reactions at the site. She did the reassuring thing, like to take Advil, and put ice on it, and told them to call back if it didn't improve. Outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019164501 same reporter, same product, same events, different patients
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: redness, rash, hot to touch and pain at injection site; redness, rash, hot to touch and pain at injection site; redness, rash, hot to touch and pain at injection site; redness, rash, hot to touch and pain at injection site; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; NDC number: 0005197102, lot number: X39679 and expiration date: 30Oct2020), intramuscular on 04Apr2019 at 17:40 at 0.5 ml, single on the left arm at the pharmacy/drug store for vaccination. Medical history included high blood pressure. Concomitant medication included unspecified high blood pressure medication. The patient experienced redness, rash, hot to touch and pain at injection site in Apr2019. Outcome of the events was not recovered. Events were assessed as non-serious and related to suspect drug.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is the first of 3 reports. A patient of unspecified age and gender received first dose of TRUMENBA, at single dose and second dose of MENACTRA, both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms on an unspecified date for 3 days with outcome of unknown. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2019170863 Same reporter/products/events, different patients; US-PFIZER INC-2019170864 Same reporter/products/events, different patients.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 22 year-old female patient received the first dose of TRUMENBA (Batch/lot number: AA9699, NDC number of TRUMENBA: 00005010001, Expiry Date: 30Apr2020) at the age of 21-year-old intramuscularly in the right arm on 05Apr2019 at 0.5 cc, once for scheduled vaccine. The patient had no medical history and concomitant medications. The patient received the product in the office on 05Apr2019 and that evening, a fever began, with soreness in arm, bruising began to develop and between Friday and Saturday morning (06Apr2019) the mother had noticed the black and blue bruising and swelling spread from the deltoid muscle to above the elbow and by the next day, the black and blue bruising and swelling was on the underside of the arm. On 08Apr2019, it was reported to be getting better and gone by 09Apr2019. The nurse considered the event of fever as non-serious as the patient (also referred to as "child" by the nurse), did not take medication to treat the fever. The nurse considered the soreness, black and blue bruising and swelling as medically significant as the nurse had seen local redness but not like this one. No investigations were performed. The outcome of fever was recovered on an unspecified date in Apr2019 while recovered on 09Apr2019 for the rest of the events. The nurse considered the events of soreness, bruising began to develop, black and blue bruising and swelling spreading as related to meningococcal group b rlp2086. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable Nurse. A 18-years-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 mg, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headaches, chills and nausea on an unspecified date (the day after vaccination) with outcome of recovered after 2 days.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age and gender received first dose of TRUMENBA, at single dose and second dose of MENACTRA, both via an unspecified route of administration, on an unspecified date, for immunization. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms on an unspecified date for 3 days with outcome of unknown. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2019166742 Same reporter/products/events, different patients; US-PFIZER INC-2019170864 Same reporter/products/events, different patients.
Sex: M
Vaccine: MENB
Symptoms: Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A 17-year-old male patient started to receive TRUMENBA, (Lot number and expiration date were not reported), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had low grade fever and malaise. The outcome of the events, low grade fever and malaise, was unknown. Information on the batch/lot number has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Allergy to vaccine
Clinical narrative: Allergies: Pneumococcal Vaccines/Drug Allergies: Pneumovax; This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer-sponsored program; this report regards an event part of the medical history of the patient. A currently 73-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown manufacturer), at single dose and pneumococcal vaccine polysacch 23v (PNEUMOVAX), both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history included allergy to Sulfa Drugs and latex. Concomitant medications were not reported. The patient experienced allergies: pneumococcal vaccines/drug allergies: pneumovax on an unspecified date with outcome of unknown.   Information on the batch number has been requested. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein)  in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein)  has submitted the same report to the regulatory authorities.
Sex: U
Vaccine: TYP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: preparing to give the PPD vaccine but instead gaveTyphim Vi/ no reactions noted; Initial information received on 18-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves adult patient of unknown demographics who was administered with 0.1 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (batch number: P1D631M and expiry date: 07-Sep-2020) via intradermal route on an unknown date instead of TUBERCULIN TEST [TUBERCULIN PPD].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  There were no concomitant vaccines given   It was a case of actual medication error due to wrong vaccine administered.  No reactions were noted.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Follow-up information was received from a nurse by phone on 23-Apr-2019.  Suspect vaccine dosage information, concomitant medication details and information about adverse event was updated and changes made in the field and narrative accordingly.  Documents held by the sender: none.
Age: 20.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: 20 year old female given expired Tenivac vaccine; Initial information received on 19-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 20 years old female patient who was vaccinated with 0.5 ml first dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U5525AA and expiry date: 07-Apr-2019) in the right deltoid on 19-Apr-2019.  The patient's past vaccination(s) included first dose of TDAP.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was reported that all the other expired vaccines in the refrigerator were removed except the Tenivac and there were a total of 4 including the one given.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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 the sender: None.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel was administered; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that expired Daptacel was administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included IPV and MMR vaccine.  On 19-Apr-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: 65169AA and expiry date: 16-Mar-2019) via intramuscular route in the right thigh.  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.  List of documents held by sender: none.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMR, TD
Symptoms: Incorrect dose administered
Clinical narrative: Adult Hepatitis B vaccine given to a pediatric client.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: Patient said her arm got red and hard around the injection site and got to the size of a baseball. She chose to use a heating pad on it after (instead of a cold compress) and it took 6 days to resolve. She also told me that because it burned when she got it and it was sore after that she didn't remove the band aid for 3 days. She said when she did remove the band aid brown liquid oozed out. It did not continue to ooze after the initial removal of band aid. It is totally resolved now with no lingering issues.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Developed extreme pain in injection site several hours after injection. Became worse the next day with a hot, red circle around it.  The red circle became even larger today (More than 48 hours later. It is hot to the touch and hard.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Fever to 102, fatigue, HA, malaise, dizziness,  injection site tenderness
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever to 102, fatigue, HA, malaise, dizziness,  injection site tenderness
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Injection site discomfort, Pain
Clinical narrative: Soreness at injection site, severe headache, fatigue, Body aches, chills
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: One week after first SHINGRIX dose, I developed about 5-6 fluid-filled vesicles on the mucous membrane lining the inside of my mouth. As of today, (April 25), the vesicles are slowly resolving but are still present.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Patient complaining of itchiness on immunization starting the same evening as vaccine administered. On 4/24/2019 patient had large urticaria on left arm.
Age: 15.0
Sex: F
Vaccine: FLU4, HEPA, TYP
Symptoms: Abdominal pain, Feeling hot, Nausea, Vital signs measurement
Clinical narrative: After receiving last vaccine patient complaint of nausea, abdominal pain and feeling warm. VS observed 89/50 pulse 59 r 16. continued to monitor for 30 minutes, patient vs. stable at 101/64 p 64 and no further reaction. Dr saw patient and discharged patient with no further treatment.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pyrexia, Urticaria
Clinical narrative: Patient broke out in hives day after shot, also ran slight fever and complained of some dizziness.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red, swelling, warm to the touch, and itching to left upper arm at injection site.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Left arm pain and neck pain.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Fever 100.3, chills, nausea, dizziness, headache, muscle pain, joint pain, skin hurt (like pins & needles).
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pain of skin, Paraesthesia, Pyrexia
Clinical narrative: Fever 100.3, chills, nausea, dizziness, headache, muscle pain, joint pain, skin hurt (like pins & needles).
Sex: F
Vaccine: MMR, UNK
Symptoms: Measles antibody positive, Mumps antibody test, Rubella antibody positive
Clinical narrative: Titers were drawn and patient is immune to measles and rubella and not immune to mumps; This spontaneous report was received from a registered nurse and refers to a currently 26 year old female patient. The patient's medical history, concurrent condition, concomitant medications were unknown to the reporter. On 03-SEP-1992, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot# and expiry date unknown) for prophylaxis. Other suspect therapies included sterile diluent (lot# and expiry date was not reported). On an unknown date, titers were drawn, and it showed that the patient was immune to measles and rubella and was not immune to mumps (mumps antibody test negative). The patient sought medical attention. No treatment was provided for the event. The outcome of the event was reported as not recovered. The causality assessment was not provided. No product quality complaint was involved.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity, Swelling
Clinical narrative: R side - neck feels swollen / numb, arm sore, medial leg to knee painful starting on 4/23 am. Provider recommended NSAIDS.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL, DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Wrong product administered
Clinical narrative: injected pediarix instead of dtap
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL, DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: injected pediarix instead of dtap
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: I had prior episode with shingles in rt. knee about 10 years ago. A week after shot started with burning pain in same knee. I have started the anti-viral. Hope it keeps it from full blown attack.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Burning sensation, Herpes zoster, Nausea, Pain
Clinical narrative: I had prior episode with shingles in rt. knee about 10 years ago. A week after shot started with burning pain in same knee. I have started the anti-viral. Hope it keeps it from full blown attack.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Urticaria
Clinical narrative: Patient developed urticaria over body within 12 hours of vaccination. Patient is also complaining of lightheadedness.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Fluctuance, Pain, Skin warm
Clinical narrative: Cellulitis appeared less than 12 hrs after vaccination- redness, swelling about the size of golf ball. Patient called about 5 days later reporting and reported to office 8 days after event with continued erythema, heat and underlying fluctuation about 3.5cm in width. Reports improved and no longer painful.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Cellulitis appeared less than 12 hrs after vaccination- redness, swelling about the size of golf ball. Patient called about 5 days later reporting and reported to office 8 days after event with continued erythema, heat and underlying fluctuation about 3.5cm in width. Reports improved and no longer painful.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Erythema
Clinical narrative: On 4/25/19, patient reports experiencing external pain on side of stomach (states nerve like pain) with redness in the area, but no rash. Patient stated that this happened about 7 to 10 days following SHINGRIX vaccination. Patient had only received first dose of vaccination. Patient reported that the reaction lasted for about 2 weeks before it fully resolved.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Sensory disturbance
Clinical narrative: Patient complains of localized "tightness" to right arm where she received the vaccine.  Patient states she experiences the tightness when she keeps her arm up for extended periods of time. Patient states that when she keeps it up for extended periods of time, it also goes numb.  Patient does not report tightness, numbness, pain, or other discomfort while using her arm for other activities. When the symptoms occur, the patient states that putting her arm down or moving her arm around relieves her of her symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperhidrosis, Skin warm
Clinical narrative: Patient called 4/25/2019 saying that the night before she noticed her back turning red from her neck all the way down to her lower back. She said she was not in pain but it felt warm and she was sweating. Since it was such a large area I recommended she have a doctor look at it. Later that day she was seen and given Prednisone.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Injection site pain, Injection site swelling, Pain
Clinical narrative: Rash and burning sensation in the left arm, joint pain all over body, pain and swelling in the left clavicle/shoulder area lasting approximately 1 week.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Rash and burning sensation in the left arm, joint pain all over body, pain and swelling in the left clavicle/shoulder area lasting approximately 1 week.
Age: 59.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood glucose increased, Dizziness, Malaise
Clinical narrative: Patient received two vaccines on Monday 4/22/19 for Pneumovax 23 and Boostrix. After the vaccine the patient stayed in the pharmacy for more 10-15 minutes and everything was fine and the patient said bye and left the pharmacy. The patient did say he felt fine and everything was good before leaving the pharmacy.  The patient came in today claiming he felt dizzy that night after receiving the vaccines. The patient went to the ER last night on 4/24/19. Spoke to the patient and he is a diabetic and said his blood sugar has been running 390-400 for the past 3 weeks. He went to the ER last night because he felt really dizzy. He was in the ER for about 4 hours and they let him go. The patient said the ER checked everything but his blood sugar is still about 300 and he is not feeling well but they still let him go. The patient wants to go back to the ER because he does not feel good and still feels really dizzy. The patient filled and picked up a prescription for meclizine. Recommended to the patient to have someone drive him to the ER today since he is not feeling well and he said his son will bring him as soon as he gets home. The patient said he is fine to drive home from the pharmacy today. Called the ER and spoke to PA that saw the patient. PA said he does not think this is related to the vaccines. PA recommended MRI for the patient but the patient refused and PA thinks there is something else that is going on.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: Pt started having malaise and headache about 4-5 hours after getting shot, she took ibuprofen and went to bed at 19:30, slept through the night, felt ok in the AM. As today progressed she started getting fevers and bad headache while at work with shivers/ chills, feeling lousy, nausea, flu like syndrome, T-max of 103, was still 101.5 when she called in today ~ 4 PM. Her physician, Dr was contacted, she suggested TYLENOL Ibuprofen, oral hydration, rest. Report if doesn't improve by tomorrow so she can be seen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Pt started having malaise and headache about 4-5 hours after getting shot, she took ibuprofen and went to bed at 19:30, slept through the night, felt ok in the AM. As today progressed she started getting fevers and bad headache while at work with shivers/ chills, feeling lousy, nausea, flu like syndrome, T-max of 103, was still 101.5 when she called in today ~ 4 PM. Her physician, Dr was contacted, she suggested TYLENOL Ibuprofen, oral hydration, rest. Report if doesn't improve by tomorrow so she can be seen.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Erythema, Pain in extremity
Clinical narrative: Pt stated he had soreness the day after vaccine, then the second day after (4/25) his arm got red from the shoulder to the elbow. He said it no longer hurt and it was not warm to the touch. It did not seem to be bothering him but he wanted to make sure it was a normal reaction.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling, Irritability, Lethargy, Pyrexia
Clinical narrative: Minor Swelling at right injection site for 1 day,  fussiness and lethargy for 2-3 days, low grade fever was instructed to give Tylenol.  Lasted a few hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Oedema peripheral, Pyrexia
Clinical narrative: Fever and chills for about 12 hours starting 9 pm on the day of the vaccination (Tuesday 4/9/2019). Edema of the left arm pit (vaccination arm) starting Thursday morning (4/11/2019) and lasting for 3 days.
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Irritability
Clinical narrative: Rt thigh-> erythema( 6x3.5 cm, warmth, ttp at injection site->pt amble to ambulate and move limbs Lt thigh-> 2 small area about 5 cm of erythema at sites of injection This was noticed by parents on 4.25 but they did note after vaccination, pt was fussy and di not want her legs touch
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: Tingling in arm and then "feels like shingles in her mouth and all throughout her body".
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site reaction
Clinical narrative: Patient had pain and redness around injection site after shot was given (4/9/2019) for few days. Patient was in the pharmacy today (4/25/2019). She still has mild pain in the same arm as per patient. Injection site skin looks wrinkly. Primary care office was close today. We will call primary care tomorrow and provide details about allergic reaction.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash generalised
Clinical narrative: 05/31/2019: Per reporter, patient was later seen by PCP and assessed as Rocky Mountain Spotted Fever (RMSF). PCP information not available.   Pt received vaccine 4/8 and had no issues until 4/13, she stated in the evening on 4/13, she started to get fever/chills. Pt stated that the fever and chills continued and she had a full body rash on 4/18. She called dr office and the covering physician told her to take ZYRTEC 10mg otc. She has taken that with no change. When I spoke with her on 4/25, I urged her to contact her physician again as something more may be going on.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Lymphadenopathy, Photophobia, Pyrexia, Rash generalised
Clinical narrative: Fever the lasted for three days. Temperature fluctuating between 100.4 and 103.3. Headache, eye sensitivity. When fever subsided small rash over body. Swollen glands.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Chills, fever, muscle aches, headache, very sore, red, swollen  arm at injection site, queasy stomach, swollen lymph nodes left armpit. Four days and counting. Symptoms slowly getting resolved.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, fever, muscle aches, headache, very sore, red, swollen  arm at injection site, queasy stomach, swollen lymph nodes left armpit. Four days and counting. Symptoms slowly getting resolved.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Pyrexia, Swelling
Clinical narrative: bright red, feverish, itching and swollen, golf ball size red area
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Adverse event following immunisation, Diarrhoea, Flatulence, Gait disturbance
Clinical narrative: Blisters appeared on 4/9 on left thigh, by the evening there was a lump on the thigh surrounding the original blisters that was approximately 1.5 inches in diameter. By the next morning it was close to 2 inches across and the initial blisters were weeping. I contacted the pediatrician's office and they recommended packing with Bentonite clay, Epsom salt bath, soothing essential oils. They helped to reduce how the depth/height of the swelling, but did not stop it from growing in diameter initially. It grew to approximately 4 inches in diameter. Patient was limping and cried if the area was touched, even just to sit down on the couch. Continued use through the day finally slowed the spread in all directions and started to reduce it by the evening. We were seen by NP the next morning, 4/11. The swelling had started shrinking. She measured it at approximately 3x3 inches and diagnosed it as a vaccine reaction and requested that I report it here. Blisters continued to show up through the 16th, but didn't all weep. The bruise took about 2 weeks to go away and there is still some small scars (not sure that's an appropriate word, I'm sure they will continue to fade) from the "pox"/blisters. She has also complained of tummy pain, had loose stools, and foul gas since the event, but we haven't gotten to talk to the doctor about those symptoms yet, so I don't know if they are related. We will follow up with the practice on 4/29/19.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discharge, Injection site pain, Injection site vesicles, Scar
Clinical narrative: Blisters appeared on 4/9 on left thigh, by the evening there was a lump on the thigh surrounding the original blisters that was approximately 1.5 inches in diameter. By the next morning it was close to 2 inches across and the initial blisters were weeping. I contacted the pediatrician's office and they recommended packing with Bentonite clay, Epsom salt bath, soothing essential oils. They helped to reduce how the depth/height of the swelling, but did not stop it from growing in diameter initially. It grew to approximately 4 inches in diameter. Patient was limping and cried if the area was touched, even just to sit down on the couch. Continued use through the day finally slowed the spread in all directions and started to reduce it by the evening. We were seen by NP the next morning, 4/11. The swelling had started shrinking. She measured it at approximately 3x3 inches and diagnosed it as a vaccine reaction and requested that I report it here. Blisters continued to show up through the 16th, but didn't all weep. The bruise took about 2 weeks to go away and there is still some small scars (not sure that's an appropriate word, I'm sure they will continue to fade) from the "pox"/blisters. She has also complained of tummy pain, had loose stools, and foul gas since the event, but we haven't gotten to talk to the doctor about those symptoms yet, so I don't know if they are related. We will follow up with the practice on 4/29/19.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red and warm around injection site.
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Nausea, Skin warm
Clinical narrative: Felt warm, dizzy  & nauseated.  Gave cold pac, elevated legs, & fanned.  Recovered within 20 min.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Ear discomfort, Headache, Hypoacusis
Clinical narrative: Upon waking up the morning after receiving the SHINGRIX vaccine, I had significant pressure in my left ear, somewhat degraded hearing in that ear, tinnitus, and a headache. This continued for several days. The headache went away after the 1st day, but the pressure in my ear remained, the tinnitus sounds varied, and my hearing in that ear remained degraded. On April 8, 2019, I was completely deaf in my left ear when I woke up. I contacted an Otolaryngologist by phone and he was able to see me that same morning. In his examination, he found no fluid in either ear, nor was there any wax buildup. He gave me a hearing test, and the only sounds my left ear were able to hear were a few high frequency tones. He prescribed an 11-day course of Methylprednisolone, 4 mg, a 7-day course of Cephalexin 500 mg, a baby aspirin, and 2 over-the-counter medicines to keep my nasal passages open. 48 hours after waking up with essentially no hearing in my left ear, I woke up and had some degraded hearing in my left ear. The pressure was gone but the tinnitus remained. Over the next 24 hours, my hearing improved substantially and no longer seemed degraded. The tinnitus diminished.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Upon waking up the morning after receiving the SHINGRIX vaccine, I had significant pressure in my left ear, somewhat degraded hearing in that ear, tinnitus, and a headache. This continued for several days. The headache went away after the 1st day, but the pressure in my ear remained, the tinnitus sounds varied, and my hearing in that ear remained degraded. On April 8, 2019, I was completely deaf in my left ear when I woke up. I contacted an Otolaryngologist by phone and he was able to see me that same morning. In his examination, he found no fluid in either ear, nor was there any wax buildup. He gave me a hearing test, and the only sounds my left ear were able to hear were a few high frequency tones. He prescribed an 11-day course of Methylprednisolone, 4 mg, a 7-day course of Cephalexin 500 mg, a baby aspirin, and 2 over-the-counter medicines to keep my nasal passages open. 48 hours after waking up with essentially no hearing in my left ear, I woke up and had some degraded hearing in my left ear. The pressure was gone but the tinnitus remained. Over the next 24 hours, my hearing improved substantially and no longer seemed degraded. The tinnitus diminished.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Aphasia, Balance disorder, Headache, Infantile back arching, Pyrexia
Clinical narrative: fever, lost of balance, vomiting, headache, arching his back,  baby stopped saying words he used to say fora 1 week after vaccine was given, no reaction or interaction on outside world for a week.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: fever, lost of balance, vomiting, headache, arching his back,  baby stopped saying words he used to say fora 1 week after vaccine was given, no reaction or interaction on outside world for a week.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Lethargy, Nausea
Clinical narrative: Nausea and stomach cramping. Colon cramping. Lethargy. I'm tired.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Fever, HA, chills, fatigue, pain at site, rash, abd. pain, nausea. OTC pain meds, warm compress, rest x 4 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Rash
Clinical narrative: Fever, HA, chills, fatigue, pain at site, rash, abd. pain, nausea. OTC pain meds, warm compress, rest x 4 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous, Rash generalised
Clinical narrative: Received both immunizations on 4-15-19, then on 4-21-10 pt. complained of injection site itching. (Right thigh) when mom looked she could see red rash all over thigh, that then spread over body.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Patient experienced an itchy, whole body, red, raised rash 2 to 3 days after getting the first dose of SHINGRIX. The patient did not self-treat the reaction with anything. The patient then received the second SHINGRIX vaccination approximately 3 months after the first vaccine, and there is no reaction noted to the second vaccine. Skin rash, rash and urticaria pruritus.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Call 4/18/2019, pt came by office to look @ site 4/18/19 449pm 7x 7.5 cm area of localized redness (Left Det) warmth (only localized to inj. site), firmness/induration No streaking, no Fever/chills, "itches", not painful No decreased ROM, no shoulder/joint involved 4/19/19 Reported ER visit, treated for cellulitis (cephalexin) 4/22/19 F/U ER visits @ our clinic - improved
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Influenza like illness
Clinical narrative: headache chills Flu like feeling
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid rash, Ophthalmic herpes zoster, Rash, Rash vesicular, Viral test
Clinical narrative: On 4/17/19 rash broke out on left forehead. Painful rash, blistery, new rash around eyelids. Shingles on left eyelid. Erythromycin ophthalmic ointment prescribed. Valacyclovir prescribed. VALTREX 1gm one tid x 7 days. Rash also on scalp as of 4/24/19 started Bacitracin ointment 2% twice daily.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthroscopic surgery, Condition aggravated, Injection site erythema, Injection site infection, Injection site pain
Clinical narrative: Woke up 12/13/18 in the morning w/ more limited range of motion in left shoulder than usual. Reports temp. approximately 100.9 F 12/13/18 around 10:30 AM. Continued having issues w/ left deltoid (redness, swelling, pain). Admitted to hospital 12/18/18, elevated WBC count. Said she had arthroscopic drainage and given IV antibiotics in hospital from 12/18 - 12/22, then discharged and continued on IV antibiotics until 1/16/19. Patient noted that the treating provider thought infection was likely there prior to vaccination.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Joint fluid drainage, Joint range of motion decreased
Clinical narrative: Woke up 12/13/18 in the morning w/ more limited range of motion in left shoulder than usual. Reports temp. approximately 100.9 F 12/13/18 around 10:30 AM. Continued having issues w/ left deltoid (redness, swelling, pain). Admitted to hospital 12/18/18, elevated WBC count. Said she had arthroscopic drainage and given IV antibiotics in hospital from 12/18 - 12/22, then discharged and continued on IV antibiotics until 1/16/19. Patient noted that the treating provider thought infection was likely there prior to vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Tic
Clinical narrative: New onset simple motor tics about 3 weeks post-injection.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Patient came to the pharmacy today 4/25/2019 to report an adverse event she experienced after receiving her 2nd dose of SHINGRIX vaccine. She stated six hours after receiving the vaccination she experienced an extremely rapid heart beat. She said it felt like a jackhammer. She said this lasted for 10 minutes and then went away. She did not seek medical attention but wanted to report it today. I told her I would document the event and I recommended that she call her PCP to report it to them for further evaluation.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Heart rate increased, Syncope, Tonic clonic movements
Clinical narrative: Heart rate decreased; Syncope; Tonic clonic movements; This spontaneous report as received from an Agency refers to a 12-year-old female patient. Her medical history and current illnesses were reported as none. There was no information regarding prior vaccinations. On 01-SEP-2017, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N010497, expiration date: 15-JAN-2020) dose 3 (exact dose was not provided) , intramuscular in the left arm for prophylaxis. Other medications included fluticasone propionate(FLONASE) and cetirizine hydrochloride. On 01-SEP-2017, the patient experienced syncope with tonic clonic activity. The patient was taken into a supine position and oxygen was administered via face mask at 5L/min. Vitals were taken, heart rate dropped to 52 beats per minute. Heart rate then raised to a normal level and the patient was given juice and crackers & observed for 25 min. The outcome of the eventswas reported as recovered on the same day. The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow up information was received from a health care professional on 25-FEB-2019.  The patient was non pregnant, White, Hispanic or Latino. She had food allergy to peanuts, eggs, grass and dirt. The patient was vaccinated in a public health clinic on 01-SEP-2017 at 16:30. The events occurred on the same day at 16:32. Additionally details of the patient's vaccination were provided and details of other medications were updated.  Follow up information has been received via telephone call on 24-APR-2019 The reporter was unable to identify the patient. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; itching; rash; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th April 2019, 9 days after receiving Shingrix, the patient experienced pruritus, rash and local swelling. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the pruritus and rash were not recovered/not resolved and the outcome of the local swelling and shingles were unknown.   It was unknown if the reporter considered the pruritus, rash, local swelling and shingles to be related to Shingrix.  Additional details were provided as follows: The patient experienced itching on back and could feel some bumps when she touched it and also had small rash after receiving 1st dose of Shingrix vaccine. The rash had spread in line and looked like shingles rash. The patient visited physician and physician daignosed it as shingles outbreak.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Swelling
Clinical narrative: shingles; itching; rash; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th April 2019, 9 days after receiving Shingrix, the patient experienced pruritus, rash and local swelling. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the pruritus and rash were not recovered/not resolved and the outcome of the local swelling and shingles were unknown.   It was unknown if the reporter considered the pruritus, rash, local swelling and shingles to be related to Shingrix.  Additional details were provided as follows: The patient experienced itching on back and could feel some bumps when she touched it and also had small rash after receiving 1st dose of Shingrix vaccine. The rash had spread in line and looked like shingles rash. The patient visited physician and physician daignosed it as shingles outbreak.
Age: 0.17
Sex: M
Vaccine: DTAP, RV5
Symptoms: Body temperature increased, Croup infectious, Gastrointestinal disorder, Respiratory disorder
Clinical narrative: 105 temp and respiratory illness (croup) followed by prolonged gastro intestinal issues.  Treating with probiotics seems to helping but not as well as one would hope.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Asthenia, Feeling of body temperature change, Headache, Myalgia
Clinical narrative: Nausea vomiting shakes hot and cold weakness and muscle pain,  agitation, severe headache
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: Nausea vomiting shakes hot and cold weakness and muscle pain,  agitation, severe headache
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Arthralgia, Back pain, Brain oedema, Hypokinesia
Clinical narrative: This spontaneous report was received from social media "Revolution For Choice", via a vendor regarding a 16 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot # and date of expiry were unknown) for prophylaxis. On an unknown date, the patient experienced swollen brain (brain oedema), anxiety, no movement (hypokinesia), tingliness (paraesthesia), pain/extreme pain/body pain, constant nausea, worst start to hurt her knees and back (back pain and arthralgia. The outcome of anxiety, back pain, body pain, arthralgia, nausea, pain, paraesthesia, hypokinesia and brain oedema was unknown. On 12-OCT-2013, the patient had died suddenly on bed. The cause of death was not reported. It was not reported if autopsy was performed. The causality assessment was not reported. Upon internal review, event of brain oedema was considered to be medically significant. This is one of the several reports.; Reported Cause(s) of Death: sudden death.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Paraesthesia, Sudden death
Clinical narrative: This spontaneous report was received from social media "Revolution For Choice", via a vendor regarding a 16 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot # and date of expiry were unknown) for prophylaxis. On an unknown date, the patient experienced swollen brain (brain oedema), anxiety, no movement (hypokinesia), tingliness (paraesthesia), pain/extreme pain/body pain, constant nausea, worst start to hurt her knees and back (back pain and arthralgia. The outcome of anxiety, back pain, body pain, arthralgia, nausea, pain, paraesthesia, hypokinesia and brain oedema was unknown. On 12-OCT-2013, the patient had died suddenly on bed. The cause of death was not reported. It was not reported if autopsy was performed. The causality assessment was not reported. Upon internal review, event of brain oedema was considered to be medically significant. This is one of the several reports.; Reported Cause(s) of Death: sudden death.
Sex: M
Vaccine: HPV4
Symptoms: Death, Injury, Pain
Clinical narrative: This spontaneous report was received from social media, refers to unspecified number of young male patients. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with GARDASIL (dose, frequency, route of administration, expiry date and lot # were not specified) for prophylaxis. On an unknown date, the patients experienced injury (majority injuries) and pain (unfathomable pain). On an unknown date, the patients died due to unknown reason. It was also reported on an unknown date that, dangerous bills were passed to mandate the suspect GARDASIL (lethal injection)  and also allow the minors to receive without "Parental Consent" as prophylactic treatment to prevent STD's (sexually transmitted diseases) in millions of boys in more than 52 countries around the world. The outcome of pain and injury was unknown. The causality assessment was not reported. This was one of the several reports.