chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day 1: approx 12 hrs after receiving shot, started feeling "out of sorts" and developed a headache. Overnight got feverish, chills, body aches. Day 2: continuation of fevers, chills, body aches, fatigue, loss of appetite, injection site pain and swelling - took TYLENOL and ADVIL all day. Day 3: same as Day 2, only less severe "flu like" symptoms, injection sight swelling = size of softball, very hard, hot and painful to touch, arm stiffness. Day 4: symptoms lessening, called doctor's office to report reaction. Day 5: no chills or fever, body aches almost gone, still tired and no appetite, injection sight same except swelling size = baseball. Day 6: flu-like symptoms gone, developed headache and sore, stiff neck, injection sight swelling size = golf ball, pain and stiffness subsided.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pyrexia
Clinical narrative: Day 1: approx 12 hrs after receiving shot, started feeling "out of sorts" and developed a headache. Overnight got feverish, chills, body aches. Day 2: continuation of fevers, chills, body aches, fatigue, loss of appetite, injection site pain and swelling - took TYLENOL and ADVIL all day. Day 3: same as Day 2, only less severe "flu like" symptoms, injection sight swelling = size of softball, very hard, hot and painful to touch, arm stiffness. Day 4: symptoms lessening, called doctor's office to report reaction. Day 5: no chills or fever, body aches almost gone, still tired and no appetite, injection sight same except swelling size = baseball. Day 6: flu-like symptoms gone, developed headache and sore, stiff neck, injection sight swelling size = golf ball, pain and stiffness subsided.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Heart rate increased, Pyrexia, Respiration abnormal, Respiratory tract congestion, Seizure
Clinical narrative: Fever of 103, vomiting, convulsions, congestion, increased heart rate, abnormal breathing.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Fever of 103, vomiting, convulsions, congestion, increased heart rate, abnormal breathing.
Age: 1.67
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Urticaria- diffuse.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Periarthritis
Clinical narrative: Patients wife approached the pharmacy 4.5 weeks after immunization and said that he has a frozen shoulder after the flu shot administration. Patient can move his arm forward but not backwards and the injection site and arm are sore and painful. PCP office has been contacted and awaiting PCP response since he also takes some cholesterol medications/statins which can cause muscle pain/rhabdomyolysis but since this episode was triggered post- flu shot- reporting to VAERS. Pharmacy advised patient to follow up with PCP and left message with MD office as well to call back and suggest course of action for the patient.
Age: 53.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Needle issue, Nodule, Syringe issue
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 53.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: On 11/29/2018, patient received PNEUMOVAX 23 (administered on Right Arm), FLUZONE HD (administered on the left arm) and BOOSTRIX (administered on the left arm). On 11/30/2018 the patient returned with a red spotted, swollen right arm.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient states redness and tenderness on injection site. Redness started off as small area around injection site and slowly expanded. The redness/tenderness around injection  site went away. Patients still has small band of redness/purple area below injection week later. The site also itches from time to time and is tender.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient states redness and tenderness on injection site. Redness started off as small area around injection site and slowly expanded. The redness/tenderness around injection  site went away. Patients still has small band of redness/purple area below injection week later. The site also itches from time to time and is tender.
Age: 64.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Erythema, Inflammation, Needle issue, Nodule, Syringe issue
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 64.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Concussion, Eyelid injury, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient experienced a vasovagal event. I administered TRUMENBA first in the left deltoid, then HPV in the right deltoid. Patient had vasovagal event within 1 (one) minute of receiving vaccines. Patient fell from exam table, hit right side of head above eye on the providers desk, and fell to the floor. Patient experienced loss of consciousness for approx. 10-15 seconds. Patient remembers receiving vaccines, but does not recall falling down. Patient was assessed by C.F.N.P. in office. Patient has 3 small approx 0.5 cm superficial lacerations to the Right upper eye lid. Patient was diagnosed with a concussion, and is currently on concussion protocol. Patients blood pressure immediately following event was 88/65. Patients blood pressure was checked four more times in office in the following order: 90/65, 94/70, 97/70, 96/71. The adverse reaction occurred at 5:16 pm and the patient stayed in office until 7:20pm.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Presyncope, Visual acuity tests normal
Clinical narrative: Patient experienced a vasovagal event. I administered TRUMENBA first in the left deltoid, then HPV in the right deltoid. Patient had vasovagal event within 1 (one) minute of receiving vaccines. Patient fell from exam table, hit right side of head above eye on the providers desk, and fell to the floor. Patient experienced loss of consciousness for approx. 10-15 seconds. Patient remembers receiving vaccines, but does not recall falling down. Patient was assessed by C.F.N.P. in office. Patient has 3 small approx 0.5 cm superficial lacerations to the Right upper eye lid. Patient was diagnosed with a concussion, and is currently on concussion protocol. Patients blood pressure immediately following event was 88/65. Patients blood pressure was checked four more times in office in the following order: 90/65, 94/70, 97/70, 96/71. The adverse reaction occurred at 5:16 pm and the patient stayed in office until 7:20pm.
Age: 85.0
Sex: M
Vaccine: TDAP
Symptoms: Cardioversion, Pulse absent, Respiratory arrest, Resuscitation, Syncope
Clinical narrative: Tdap given per MD order to pt. Came to HD, immunization given - stayed in dept app 15 minutes talking with staff and RN. Pleasant alert and oriented. App 5 min. later wife runs into HD and states her husband was not responding. This RN ran down to car - no respiratory effort occurring. No pulse noted. Compressions performed - 3 agonal like breaths occurred. Deputy sheriff on scene - defib 2 shocks then ambulance arrived on scene and took over pt's care. Was transported to local hospital - heart rhythm came back as well as respiratory effort, but remained unresponsive. Transferred to another hospital. Had flu shot at clinic on 11/06/18. Pt received (.5mg) IV into (R) forearm (venous) during resuscitation (but doubt if this perfused to core) -> app 7 min into resuscitation efforts. Not completely sure vaccine was cause of collapse - had walked up 2 flights of stairs and down after receiving vaccine -> 85.5 yrs old.
Age: 85.0
Sex: M
Vaccine: TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Tdap given per MD order to pt. Came to HD, immunization given - stayed in dept app 15 minutes talking with staff and RN. Pleasant alert and oriented. App 5 min. later wife runs into HD and states her husband was not responding. This RN ran down to car - no respiratory effort occurring. No pulse noted. Compressions performed - 3 agonal like breaths occurred. Deputy sheriff on scene - defib 2 shocks then ambulance arrived on scene and took over pt's care. Was transported to local hospital - heart rhythm came back as well as respiratory effort, but remained unresponsive. Transferred to another hospital. Had flu shot at clinic on 11/06/18. Pt received (.5mg) IV into (R) forearm (venous) during resuscitation (but doubt if this perfused to core) -> app 7 min into resuscitation efforts. Not completely sure vaccine was cause of collapse - had walked up 2 flights of stairs and down after receiving vaccine -> 85.5 yrs old.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt came into office 12/4 with her mother on 11/30 pt. had two vaccines administered PENTACEL and PCV13 in her right thigh. Mother states pt. had fevers on/off from 11/30-12/2 TMAX 102 rectal. Friday (11/30) Pt leg had red spots all over. On 12/4 Pts leg was still swollen.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Cold sweat, Headache
Clinical narrative: Headache. Per dad patient called him he has a headache this morning and feels clammy advised dad as per vaccine reaction protocol advised dad per MenB VIS headache is a side effect of vaccine to stay home rest and give TYLENOL for HA rest push fluids no fever no nausea if headaches becomes worse high fever to be seen dad agrees.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold
Clinical narrative: As per staff note, PT was speaking with staff member regarding her allergies and mentioned a past incident where she received "a shingles shot and when she woke up, the left side of her body was frozen". No further information was provided.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Pt reports knot at injection site. She also reports pain when lifting her arms or picking anything up. She states she will go to urgent care in the morning (12/6/18). Patient saw her doctor who thought it was probably fluid retention, with possible nerve or muscle damage, need further testing.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site nodule, Injection site pain, Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: Pt reports knot at injection site. She also reports pain when lifting her arms or picking anything up. She states she will go to urgent care in the morning (12/6/18). Patient saw her doctor who thought it was probably fluid retention, with possible nerve or muscle damage, need further testing.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Soft tissue swelling, X-ray abnormal
Clinical narrative: Pt reports knot at injection site. She also reports pain when lifting her arms or picking anything up. She states she will go to urgent care in the morning (12/6/18). Patient saw her doctor who thought it was probably fluid retention, with possible nerve or muscle damage, need further testing.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Dry skin, Injection site reaction, Wound
Clinical narrative: Patient developed dry rough area on injection site which developed into a dime-sized wound a week later. To date, wound had not healed and patient was advised to see MD.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site reaction, Urticaria
Clinical narrative: 11:30 am post vaccination, noted 2 small whelps to Rt thigh from PREVNAR 13 and to Lt thigh where Hep A was admin one whelp. There was a small one to Lt outer thigh where MMRV was given. Sent back to Dr for assessment.
Age: 19.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: HPV vaccine given in error. Client had 3 doses prior that were not noted. No adverse reactions noted.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pustular, Skin abrasion
Clinical narrative: After 1 wk of SHINGRIX vacc, pt noticed rash then pustules that spread from chest to forehead and cheek of (L) side. Pt couldn't get in to see primary doctor, but saw dermatologist who told pt to wait 1 mo before during skin abrasion. Pt has appt with primary MD next week to discuss about the pustules.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Entire body started to ache-got worse-Pain level 8/9, bursts of pain in both heels at level 10- in bed for two days. Headache-3 days. Nausea (mild). Shivering while in bed - 2 days. Upper right arm extremely sore, red, hot - still, on 11/6 (also swelling) finally, completely gone after 2 weeks. (The 1st SHINGREX caused only soreness, redness and warmth for appox. 31/2 days) (Also bad fatigue). Never had any prior adverse reactions to any vaccines: pneumonia, flu, and what seemed like "hundreds" - only short-term and mild soreness.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain, Pain in extremity
Clinical narrative: Entire body started to ache-got worse-Pain level 8/9, bursts of pain in both heels at level 10- in bed for two days. Headache-3 days. Nausea (mild). Shivering while in bed - 2 days. Upper right arm extremely sore, red, hot - still, on 11/6 (also swelling) finally, completely gone after 2 weeks. (The 1st SHINGREX caused only soreness, redness and warmth for appox. 31/2 days) (Also bad fatigue). Never had any prior adverse reactions to any vaccines: pneumonia, flu, and what seemed like "hundreds" - only short-term and mild soreness.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Erythema, Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: Patient arm was swollen around the injection site, it was all red, puffy and itchy. It resolved after 12 days using Triamcinolone and cold compression. Patient came today claiming she's still weak from the injection and asked to file a report for her.
Sex: F
Vaccine: PPV
Symptoms: Fluid retention, Swelling
Clinical narrative: This spontaneous report was received from a female patient of an unknown age, who reports on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly (dose, frequency, lot# and expiration date were not reported) for prophylaxis. On an unspecified date after vaccination, the patient swelled up and retained fluid. She sought medical attention and received a treatment for the swelling. No laboratory diagnostics were done. The outcome of the events was reported as recovered. The relatedness between the events and PNEUMOVAX 23 was not provided.
Age: 43.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in a 43-year-old female patient who received HAVRIX adult (batch number 4H37Y, expiry date 8th November 2020) for prophylaxis. On 26th November 2018, the patient received HAVRIX adult (intramuscular) 1 ml. On 26th November 2018, 1 sec after receiving HAVRIX adult, the patient experienced burning sensation, tingling, numbness and joint range of motion decreased. On 27th November 2018, the outcome of the tingling and numbness were recovered/resolved. On an unknown date, the outcome of the burning sensation was recovered/resolved and the outcome of the joint range of motion decreased was not recovered/not resolved. It was unknown if the reporter considered the burning sensation, tingling, numbness and joint range of motion decreased to be related to HAVRIX adult. Additional details were provided as follows: The patient received HAVRIX adult in right deltoid. The registered pharmacist planned to continue monitoring the patient. On 27th November 2018, the Health care professional stated they spoke to patient on the day of reporting and patient was feeling much better. The tingling and numbness resolved.
Age: 43.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Burning sensation, Hypoaesthesia, Joint range of motion decreased, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in a 43-year-old female patient who received HAVRIX adult (batch number 4H37Y, expiry date 8th November 2020) for prophylaxis. On 26th November 2018, the patient received HAVRIX adult (intramuscular) 1 ml. On 26th November 2018, 1 sec after receiving HAVRIX adult, the patient experienced burning sensation, tingling, numbness and joint range of motion decreased. On 27th November 2018, the outcome of the tingling and numbness were recovered/resolved. On an unknown date, the outcome of the burning sensation was recovered/resolved and the outcome of the joint range of motion decreased was not recovered/not resolved. It was unknown if the reporter considered the burning sensation, tingling, numbness and joint range of motion decreased to be related to HAVRIX adult. Additional details were provided as follows: The patient received HAVRIX adult in right deltoid. The registered pharmacist planned to continue monitoring the patient. On 27th November 2018, the Health care professional stated they spoke to patient on the day of reporting and patient was feeling much better. The tingling and numbness resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extremities hot feeling of in a 64-year-old female patient who received SHINGRIX (batch number 4ZF42, expiry date 4th April 2019) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 17th August 2018 with no reported events). On 14th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 14th November 2018, less than a day after receiving SHINGRIX, the patient experienced extremities hot feeling of, erythema of extremities and swelling arm. On 15th November 2018, the patient experienced mobility decreased. On an unknown date, the outcome of the extremities hot feeling of, erythema of extremities, swelling arm and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the extremities hot feeling of, erythema of extremities, swelling arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient reported to her pharmacist that she was experiencing a red, hot arm, which was swollen and about the size of a tennis ball. The symptoms began on the evening of the day dose was received and were becoming worse. On 15th November 2018, the patient could barely move her arm. The reporter consented to be followed up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Mobility decreased, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extremities hot feeling of in a 64-year-old female patient who received SHINGRIX (batch number 4ZF42, expiry date 4th April 2019) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 17th August 2018 with no reported events). On 14th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 14th November 2018, less than a day after receiving SHINGRIX, the patient experienced extremities hot feeling of, erythema of extremities and swelling arm. On 15th November 2018, the patient experienced mobility decreased. On an unknown date, the outcome of the extremities hot feeling of, erythema of extremities, swelling arm and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the extremities hot feeling of, erythema of extremities, swelling arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient reported to her pharmacist that she was experiencing a red, hot arm, which was swollen and about the size of a tennis ball. The symptoms began on the evening of the day dose was received and were becoming worse. On 15th November 2018, the patient could barely move her arm. The reporter consented to be followed up.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Extreme swollen leg with heat and redness turned into cellulitis requiring antibiotic therapy.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RVX
Symptoms: Crying, Pyrexia
Clinical narrative: DTaP/DTP ; Polio; HIB; Hepatitis B; PneumoConju; Rotavirus. The Dr. did not give additional information to properly list item 17. Infant began running a low fever about 10-12 hours after vaccination, we administered a dose of acetaminophen and fever subsided. About 0030-0100 infant woke up crying and running a fever about 102. Other parent took them to ER in response.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Nauseous and very achy muscles for about 4 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Parent of patient went to ER with c/o warmth with swelling and tenderness to touch to the left thigh.
Age: 27.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pain in extremity
Clinical narrative: Continued arm soreness 1 year later.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling cold, Palpitations
Clinical narrative: Four hours after the shot my heart raced, I was terribly cold, and I grew very, very weak. The racing heart and severe cold lasted 12 hours; the severe weakness, 3 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Muscle spasms, Pyrexia
Clinical narrative: I had severe joint pains throughout my body, fever, chills, muscle spasms in my shoulders, and a headache. I went to work, but had to leave early to go home and sleep. Today, 12/7/2018, I am back at work -- feeling better, but still have symptoms. They are at least manageable today, though.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Rash, Rash generalised
Clinical narrative: Information has been received from a physician referring to a male patient of unknown age. The patient had no concomitant medication. The patient had unspecified food allergies and aspirin allergies. In approximately 2012 (reported as about 6 years ago), the patient was vaccinated with a second dose of VARIVAX 1 dosage form (subcutaneous; strength, lot# and expiration date were not reported) for prophylaxis. Suspect therapy also included sterile diluent (lot# and expiration date were not reported). After receiving the VARIVAX, a rash developed on his arms (rash) on an unspecified date a couple days later. The rash spread to his legs (rash) and then to the rest of his body (rash generalised). There was no reaction to the first dose of VARIVAX administered on unspecified date several years ago. The patient's recent titer drawn was negative for varicella antibodies (antibody test negative). Treatment was given for the events. The outcome of the rash and rash generalised was reported as recovered. The outcome of antibody test negative was unknown. The causality between the events and VARIVAX was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not provided. In 2018 (reported as in the last week), the patient was vaccinated with improperly stored VARIVAX lot # N029628, expiration date 23-OCT-2019 for prophylaxis (strength, dose number, anatomical location and route of administration were not reported) with properly stored sterile diluent. No adverse effects were reported. The vaccines were exposed to multiple temperature excursions between 6 degree Fahrenheit (F) and 14 F for a time frame of cumulative 155 hours without previous temperature excursion. Data logger was involved.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 69 year old female patient with hypothyroidism. Concomitant medication included FLUZONE. The patient had no drug reactions/allergies. On 12-MAR-2014 and 05-NOV-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # R018741, expiration date 06-APR-2020 for prophylaxis (strength and anatomical location were not reported) separately (inappropriate schedule of vaccine administration). On 06-NOV-2018, the patient developed redness and swelling at the site of PNEUMOVAX 23 injection. The patient called pharmacist to seek medical attention. There was no treatment given for the events. At the time of the report, the outcome of redness and swelling at the site of PNEUMOVAX 23 injection was reported as not recovered. No causality assessment was provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's concomitant therapies, pertinent medical history, drug reactions and allergies were not reported. On 16-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # N028258 with an expiration date 30-MAY-2019), orally for prophylaxis (dose was not reported). Administered dose of ROTATEQ, was stored in the temperature of 47.8 degrees Fahrenheit for 23 hours and 8 minutes. Previous excursions were not reported. Temperature excursion was detected by digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA003002: US-009507513-1812USA003003.
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a physician, referring to a female patient of unknown age. The patient had no pertinent medical history or concomitant medications. The patient had no drug reactions or allergies. On an unknown date, the patient was vaccinated with VARIVAX (dose, strength, route, frequency, lot# and expiration date were unknown), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(TDaP) (dose, strength, route, frequency, lot# and expiration date were unknown) and M-M-R II (dose, strength, route, frequency, lot# and expiration date were unknown) for prophylaxis. Other suspect therapies included sterile diluent (reported as DILUENT). It was later discovered the patient was 3 weeks pregnant during the administration of the vaccines (maternal exposure during pregnancy, first trimester). The patient was planning to continue with the pregnancy and was scheduled for her first obstetric appointment later this week. There was no treatment given to the patient. No lab diagnostics/studies were performed. The last menstrual period (LMP), estimated date of delivery (EDD) and date of conception were unknown. The pregnancy outcome was pending.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 23 year old female patient. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported. On an unspecified date in May 2017, the patient was vaccinated with the first dose of VARIVAX injection, and then, on an unspecified date in June 2017, the patient received the second dose of the vaccine, both doses for prophylaxis (dose, route of administration, anatomical location, lot/batch # and expiration date were not reported). On an unknown date (reported as recently), the patient had unspecified titers drawn for nursing school, and the titers came back negative (antibody test negative). At the reporting time, the event was ongoing. The reporter did not provide a causal relationship between VARIVAX and the event.
Sex: F
Vaccine: PPV
Symptoms: Alpha 1 foetoprotein abnormal, Ataxia, Balance disorder, Cytogenetic analysis abnormal, Dizziness
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a female child with ataxia telangiectasia and lymphopenia. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. The previously healthy patient was initially evaluated at the age of 15 months for recurrent dizziness and poor balance. Between the ages of 15 and 22 months, her neurologic symptoms worsened. Extensive imaging revealed no abnormalities. An ear, nose, and throat (ENT) evaluation was undertaken secondary to persistent middle ear effusions. Around the age of 22 months a Pediatric Neurologist finally determined that her symptoms represented ataxia and not developmental delay. Evaluation at that point included measurement of alfa fetoprotein levels which were markedly abnormal. After referral to our center, an immunologic evaluation revealed abnormal quantitative immunoglobulins, marked lymphopenia and absent response to polysaccharide antigens when challenged with the pneumococcal polysaccharide vaccine (no therapeutic response). Genetic testing confirmed the suspected diagnosis of Ataxia Telangiectasia and revealed the presence of two novel mutations in the Ataxia-Telangiesctasia mutated (ATM) gene that had not been previously reported. The outcome of the event was unknown. The authors considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: PPV
Symptoms: Gene mutation identification test positive, Imaging procedure, Immunoglobulins abnormal, Middle ear effusion, Neurological symptom
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a female child with ataxia telangiectasia and lymphopenia. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. The previously healthy patient was initially evaluated at the age of 15 months for recurrent dizziness and poor balance. Between the ages of 15 and 22 months, her neurologic symptoms worsened. Extensive imaging revealed no abnormalities. An ear, nose, and throat (ENT) evaluation was undertaken secondary to persistent middle ear effusions. Around the age of 22 months a Pediatric Neurologist finally determined that her symptoms represented ataxia and not developmental delay. Evaluation at that point included measurement of alfa fetoprotein levels which were markedly abnormal. After referral to our center, an immunologic evaluation revealed abnormal quantitative immunoglobulins, marked lymphopenia and absent response to polysaccharide antigens when challenged with the pneumococcal polysaccharide vaccine (no therapeutic response). Genetic testing confirmed the suspected diagnosis of Ataxia Telangiectasia and revealed the presence of two novel mutations in the Ataxia-Telangiesctasia mutated (ATM) gene that had not been previously reported. The outcome of the event was unknown. The authors considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: PPV
Symptoms: Therapy non-responder
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a female child with ataxia telangiectasia and lymphopenia. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. The previously healthy patient was initially evaluated at the age of 15 months for recurrent dizziness and poor balance. Between the ages of 15 and 22 months, her neurologic symptoms worsened. Extensive imaging revealed no abnormalities. An ear, nose, and throat (ENT) evaluation was undertaken secondary to persistent middle ear effusions. Around the age of 22 months a Pediatric Neurologist finally determined that her symptoms represented ataxia and not developmental delay. Evaluation at that point included measurement of alfa fetoprotein levels which were markedly abnormal. After referral to our center, an immunologic evaluation revealed abnormal quantitative immunoglobulins, marked lymphopenia and absent response to polysaccharide antigens when challenged with the pneumococcal polysaccharide vaccine (no therapeutic response). Genetic testing confirmed the suspected diagnosis of Ataxia Telangiectasia and revealed the presence of two novel mutations in the Ataxia-Telangiesctasia mutated (ATM) gene that had not been previously reported. The outcome of the event was unknown. The authors considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-AUG-2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (lot#, expiration date, dose and route were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 28-OCT-2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. The patient continued to suffer ongoing injuries with mental and physical pain and suffering. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The causality assessment of events was reported to be related.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-OCT-2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. The patient continued to suffer ongoing injuries with mental and physical pain  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events (shingles, vaccination failure, injury, pain and emotional distress) was unknown. Causality assessment for the events was related with respect to the ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2012 (reported as on or about 2012), the patient was inoculated with ZOSTAVAX by a pharmacist to obtain permanent prevention and protection against shingles and zoster-related conditions (dose, route, lot # and expiry date not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 03-DEC-2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, injuries, pain and suffering (emotional distress) and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On an unknown date in 2012, the patient was treated by a physician for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2014, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 2014, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-JUN-2008, the patient's healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 13-MAR-2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 12-MAR-2018, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 14-APR-2018, the patient was treated by a physician at a walk-in facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX, (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries (prophylaxis). No other suspect or concomitant therapies were reported. On an unknown date, the patient was diagnosed with shingles (herpes zoster) and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure), and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life (Quality of life decreased); increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions (condition aggravated), lost wages, loss of earning capacity and other losses and damages. On an unknown date in 2012, the patient was treated for shingles. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter determined adverse events as medically significant, disabling and life-threatening events.