chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 07-AUG-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a medical facility for a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA256189 (same reporter). This case involves five patients (gender not reported), who were vaccinated with a dose of FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date that was in a shipping excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PENTACEL for Immunisation; ROTATEQ for Immunisation; HEPATITIS B VACCINE for Immunisation; and PREVNAR 13 for Immunisation on an unknown date. It was a case of actual medication error due to incorrect product storage. No known reported symptoms. 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: 1.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Diet refusal, Eye contusion, Fall, Gait disturbance
Clinical narrative: Her eyes were black like she was punched, she wouldn't play, eat, and she couldn't walk straight. Two days later, she fell and cut her head open needing 9 stitches. At the time, she had been walking for 4 months, so she could walk well. I told her doctor about the event at her 15 month visit and stated that I didn't want to vaccinate her anymore and was kicked out of their office.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Skin laceration, Suture insertion
Clinical narrative: Her eyes were black like she was punched, she wouldn't play, eat, and she couldn't walk straight. Two days later, she fell and cut her head open needing 9 stitches. At the time, she had been walking for 4 months, so she could walk well. I told her doctor about the event at her 15 month visit and stated that I didn't want to vaccinate her anymore and was kicked out of their office.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported possible fever following day but did not check temperature-no fever as of time reported. Patient developed soreness at site the evening received shot and reports increased pain and swelling as of two days later with the area feeling warm to the touch.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Patient reports experiencing a seizure the day after receiving the immunization.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: Left arm red and swollen at injection site. Pain on left side of neck, swollen painful lump on left side between clavicle and bottom of neck that lasted for at least 1 week, extreme shaking/ chills that lasted for 3 hours to the point it was difficult to walk, shaking started approximately 13 hours after the injection. Temp 101.8 when checked the following day, 24 hours after injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Neck pain, Pain, Swelling, Tremor
Clinical narrative: Left arm red and swollen at injection site. Pain on left side of neck, swollen painful lump on left side between clavicle and bottom of neck that lasted for at least 1 week, extreme shaking/ chills that lasted for 3 hours to the point it was difficult to walk, shaking started approximately 13 hours after the injection. Temp 101.8 when checked the following day, 24 hours after injection.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Pt developed rash about 2 days after vaccines were given. Described as red bumps, that did respond to BENADRYL. Parents also report low grade fever at time of rash. Also had new detergent.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chromaturia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient states his left arm became sore, swollen, red and hot, down to about the elbow. Saturday evening he had a fever. No fever Sunday or Monday. He states his urine is orange.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient states his left arm became sore, swollen, red and hot, down to about the elbow. Saturday evening he had a fever. No fever Sunday or Monday. He states his urine is orange.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient complained of right arm pain, counseled it was common and pain will pass.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right shoulder of deltoid area of injection site warm to touch, red, with lineated border from surrounding unaffected skin. Start Hydrocortisone Cream, 1 %, 1 application to affected area, Externally, Twice a day, 07 days. Notes: Suspicion is now cast on the KINRIX as the main culprit of this vaccine reaction. I'm using skin marker to delineate the area and will f/u in 2-3 days time. Mom has BENADRYL and will continue to dose appropriately.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Severe swelling, redness, heat and pain at the injection site which interfered with sleep. Swelling and redness migrated down the arm over the next week or so, with pain and heat diminishing each day. The day afterwards, achiness and malaise similar to the feeling with a bad cold.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Sleep disorder
Clinical narrative: Severe swelling, redness, heat and pain at the injection site which interfered with sleep. Swelling and redness migrated down the arm over the next week or so, with pain and heat diminishing each day. The day afterwards, achiness and malaise similar to the feeling with a bad cold.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Condition aggravated, Dysstasia, Gait disturbance, Herpes zoster, Sciatica
Clinical narrative: Broke out in shingles in 2 separate areas, different sides of the body. Never broke out 2 places at same time before. Areas of lesion: right buttocks and left labial. Severe pain from sciatica down both legs making walking or even standing very difficult.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Biopsy skin abnormal, Dermatitis psoriasiform, Immunology test, Papule, Pruritus
Clinical narrative: From Derm Note: Dermatology- Within 3-4 days post-vaccine, patient developed discrete pruritic pink papules on his head/neck which gradually progressed to his upper trunk. He developed a low grade fever (approximately 100 degrees F) and was seen in the ED on 15 June. Patient was diagnosed with varicella secondary to VZV vaccine at that time, and also treated with 5-day course of PO KEFLEX for impetiginized wound on his left elbow. MOP states lesions continued to progress, although patient remained afebrile, alert, active, eating and drinking normally. Patient was then seen in ED last night, as lesions progressed to his lower trunk and legs. He was seen by Infectious Disease and started on PO Clindamycin at that time (1 dose so far). MOP states patient's only other medication is PO BENADRYL PRN for itching (approximately 2-3 times per day).  She states he has otherwise been health, no significant past medical history. No personal or family history of atopic dermatitis, psoriasis, or other skin condition per MOP. Derm T-con-.Called and spoke with mother of patient (MOP) regarding patient's biopsy result showing psoriasiform and spongiotic dermatitis.  Clinicopathologic correlation favors an eczematous process, which may be secondary to vaccine hypersensitivity reaction. Symptoms: RASH and OTH NONSPEC SKIN ERUPTION, FEVER, UNSPECIFIED.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Pyrexia, Rash pustular, Skin lesion, Staphylococcus test positive
Clinical narrative: From Derm Note: Dermatology- Within 3-4 days post-vaccine, patient developed discrete pruritic pink papules on his head/neck which gradually progressed to his upper trunk. He developed a low grade fever (approximately 100 degrees F) and was seen in the ED on 15 June. Patient was diagnosed with varicella secondary to VZV vaccine at that time, and also treated with 5-day course of PO KEFLEX for impetiginized wound on his left elbow. MOP states lesions continued to progress, although patient remained afebrile, alert, active, eating and drinking normally. Patient was then seen in ED last night, as lesions progressed to his lower trunk and legs. He was seen by Infectious Disease and started on PO Clindamycin at that time (1 dose so far). MOP states patient's only other medication is PO BENADRYL PRN for itching (approximately 2-3 times per day).  She states he has otherwise been health, no significant past medical history. No personal or family history of atopic dermatitis, psoriasis, or other skin condition per MOP. Derm T-con-.Called and spoke with mother of patient (MOP) regarding patient's biopsy result showing psoriasiform and spongiotic dermatitis.  Clinicopathologic correlation favors an eczematous process, which may be secondary to vaccine hypersensitivity reaction. Symptoms: RASH and OTH NONSPEC SKIN ERUPTION, FEVER, UNSPECIFIED.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Paraesthesia
Clinical narrative: Patient reported intramuscular pain at the injection site for 9 days. She also reported intermittent tingling down her arm and pain when she made a fist.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Between 11-JAN-2018 and 08-MAR-2018, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # N013276, expiration date on 21-JAN-2020; lot #N017686, expiration date on 02-FEB-2020; M-M-R II, lot #M044350, expiration date on 04-NOV-2018; lot #N010495, expiration date on 31-MAR-2019; which were concomitantly reconstituted with Merck sterile diluent; and LIQUID PEDVAXHIB, lot #N012921, expiration date on 28-FEB-2020. All vaccines were administered for prophylaxis (strengths, doses and routes of administration were not reported). Between 11-JAN-2018 and 16-MAR-2018, there were temperature excursions between 30.40 degrees F and 48.00 degrees F for 0.25-1 hour. No adverse effects were reported in any of the patients. The call was because of a data logger. This is a non-valid case due to lack of patient identifier. Follow-up information was received on 05-SEP-2018. It was confirmed that the patient was 3 month old infant. On 29-MAR-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot #N012921 (expiry date: 28-FEB-2020) for prophylaxis (strength, dose and route of administration were not reported). This case was previously considered non-valid, but per current process it was determined to be valid as patient identifiers were provided. This is one of several reports received from the same reporter. Follow-up call was placed to the Registered nurse on 05-SEP-2018 regarding patient(s) identifiers and dates of vaccination. The correspondence process was reviewed. Sender's Comments: US-009507513-1809USA002916; US-009507513-1809USA002917; US-009507513-1809USA002918; US-009507513-1809USA002919; US-009507513-1809USA002920; US-009507513-1809USA002921; US-009507513-1809USA002922; US-009507513-1809USA002923.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 12-SEP-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 11-JUN-2016, the patient was treated by a physician's assistant for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir for management of his painful symptoms and chronic pain. On or about 15-JUN-2016 the patient sought subsequent treatment from a physician assistant for a vesicular outbreak that was diagnosed as herpes zoster. He was prescribed gabapentin for management of his painful symptoms and chronic 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 has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 16-OCT-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 07-NOV-2014, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 20-MAR-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 22-JUL-2014, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
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 12-AUG-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-SEP-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2006 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles in a medical office. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-SEP-2014 the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2009 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a health center pharmacy. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-NOV-2014 the patient was treated at urgent care for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 22-APR-2013 the patient sought additional (conflicting info) treatment at urgent care for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2008 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a physician's network. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016 the patient was treated at an urgent care for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-07-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Within 4 hrs arm began to ache, sore. Redness appeared 2 inches around injection within 6 hrs. 10 hrs - after shot had chills and fever. Took ALEVE and that took care of fever, soreness and redness lasted 3 cays. Very painful to lay on the arm where injection was.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient come to clinic to report that on 9/17/18 at 1:00 am his left arm where the pneumonia vaccine was given was painful and red. On 9/18/18 he went to urgent care where they gave him a steroid shot and KEFLEX antibiotics. They drew with a pen around the redness on arm.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Angioedema, Cough, Flushing, Malaise
Clinical narrative: Patient (11 year old male) had anaphylaxis. Symptoms of flushing and "not feeling well" began about 10-15 minutes after receiving the vaccine. He then developed hives to his thighs and trunk just moments later. He self-administered his Epinephrine auto-injector in the car while mother drove to nearby Emergency Room (ER). They arrived to ER within 5 minutes of symptom onset/Epi administration, and he was noted to have generalized hives, facial puffiness (eyelids and lip angioedema, mild-moderate), and was developing a dry, hacky cough. He was given another dose of Epinephrine (0.3mg IM) in the ER, as well as H1-antihistamine, Prednisone and IV fluids, and was monitored closely for about 3 hours before being discharged home in improved/stable condition.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling face, Urticaria
Clinical narrative: Patient (11 year old male) had anaphylaxis. Symptoms of flushing and "not feeling well" began about 10-15 minutes after receiving the vaccine. He then developed hives to his thighs and trunk just moments later. He self-administered his Epinephrine auto-injector in the car while mother drove to nearby Emergency Room (ER). They arrived to ER within 5 minutes of symptom onset/Epi administration, and he was noted to have generalized hives, facial puffiness (eyelids and lip angioedema, mild-moderate), and was developing a dry, hacky cough. He was given another dose of Epinephrine (0.3mg IM) in the ER, as well as H1-antihistamine, Prednisone and IV fluids, and was monitored closely for about 3 hours before being discharged home in improved/stable condition.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Throat tightness, Vomiting
Clinical narrative: Patient called the pharmacy after talking to her physician's office and stated that he told her to go to the emergency room after complaining of vomiting, swollen tongue and throat closing. She states that she believes it is from the flu shot as she had a similar reaction last year but did not report it to anyone. She stated she took BENADRYL but did not relieve the symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Bone pain, Injection site pain, Injection site rash, Pain, Skin warm
Clinical narrative: Sunday night started feeling the effects of the intramuscular shot. Skin only felt a little warm to the touch. Pain across the shoulder radiating toward the collarbone. Using the arm exacerbated the shoulder/collarbone pain. Pt did not notice any rash until Monday 9/17 in the evening. Pt has a six inch rash that is radiating from the deltoid toward the inside of the elbow. Marked the area the rash has appeared and advised the pt to keep an eye on the area if it goes outside the marking lines to contact her pcp.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pyrexia
Clinical narrative: Fever and local reaction with redness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inflammation, Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: This was the second dose rec'd after initial shot on June 6th when I also had adverse effects the following morning. Felt nauseous throughout the early part of day and threw up once. The second shot gave me a severe headache when I awoke, also felt a little nauseous, and inflamed left arm for two days.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Foetal death, Stillbirth
Clinical narrative: 2 days after receiving the flu shot, I was told my daughter (35 weeks gestation) was dead. I delivered her a day later (October 18)- the OB guessed she had died 3 days earlier, the day I had gotten the flu shot.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Patient went home and vacuumed shortly after receiving the vaccines. During this time she felt a stiffness in the left side of her neck. Felt worse than a kink, it hurt to move until she called on 9/17/18. She had a chiropractor appt on 9/17/18 as well and stated that her neck felt better, but was still sore.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red, raised area about 4 or 5 cm at injection site. Itchy and painful for a week.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Wheal 18 x 20cm.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Red, sore injection site. Erythema area: 4 1/2 inches x 6 inches. Headache, stomach ache, fatigue.  Unable to perform normal activities. Took Tylenol and went to bed. So far this is within 24 hours of injection.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin irritation
Clinical narrative: Patient stated that 5 days after shot she had about and 8 X 8 area that felt like sandpaper on back and it itched. However, it was not red. The symptoms lasted for about 10-14 days and then disappeared.
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient came to pharmacy 9/18/18 and stated her arm was sore on 9/15/18 after receiving shot. She said on 9/16/18 in the afternoon her arm started bruising. She said it is not painful but going to follow up with doctor.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: She called the pharmacy the evening following the vaccine. She said her arm became swollen after 1-2 hours of receiving the 2 vaccines and that is was painful throughout the night. She said the swelling was worsening and was now from her elbow to shoulder.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-JUN-2015, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with improperly stored dose of ARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-AUG-; 2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 64 year old woman was inadvertently given the high dose of FLUZONE at an off-site clinic; no problems noted, patient will call pharmacy if anything happens.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: On 9/2/2018 I gave a Hep A vaccine to the pt. then when I was charting realized vaccine expired 09/02/2018.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site rash, Injection site reaction
Clinical narrative: Vaccine was given on 9/14/18 and 9/15/18 patient felt flu like symptoms mounting a response to the vaccine. Later on 9/15/18 the patient had local injection site reaction about the size of a quarter where injection was given. In addition, a rash started to develop on the patient's arm below the injection site and had undefined edges. On 9/16/18 the rash appeared to get worse. Patient reported to the pharmacy on 9/18/18 to have us look at the rash but said after 9/16/18 the rash did not progressively get worse. The rash on 9/18/18 was about the size of an orange starting an inch below the injection site with undefined edges. Patient reports no warmth on rash or fever. Recommended patient follow up with physician (he states will make an appointment). Patient instructed to visit ER if develops fever or if rash becomes warm.
Age: 66.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Patient reported pain, fever, swelling, redness, "cellulitis." Patient claims to have seen physician the day after the vaccination was given.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site erythema, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Body aches, chills, sore arm, redness and heat at injection site started day of injection. By 9-18-18 body aches and chills are gone, but sore arm and heat and redness are still present.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Injection site pain, Pain, Pyrexia
Clinical narrative: Two hours after the injection I became ill for the next 30 hours. I had a very high fever (103), chills, diarrhea, really bad overall body aches and pains and an extremely sore and painful arm at the site of the injection. This was worse than having the flu. It was so bad that I do not intend to get the second dosage.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Feeling cold, Headache
Clinical narrative: Arm pain at first, tiredness, fever, belly pain, fast heartbeat, dizziness, headache symptoms started approximately 14 hours after the vaccination, except the arm stiffness/pain which started within 2-3 hours. I ate and took 800mg of Ibuprofen. The next morning I was very tired. By the time I started my job at school I was getting colder and the nausea had started which turned to belly pain. I also felt woozy off and on. I visited the school nurse. She took my temp and I was sent home with a fever. I ate and took another 800mg of Ibuprofen. I went to bed. An hour later I checked my pulse which seemed to be pounding. It was 100 per minute laying in bed, not moving for an hour. A slight headache started in the late afternoon. I'm really wondering if I should take the 2nd dose in a couple of months.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Musculoskeletal stiffness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm pain at first, tiredness, fever, belly pain, fast heartbeat, dizziness, headache symptoms started approximately 14 hours after the vaccination, except the arm stiffness/pain which started within 2-3 hours. I ate and took 800mg of Ibuprofen. The next morning I was very tired. By the time I started my job at school I was getting colder and the nausea had started which turned to belly pain. I also felt woozy off and on. I visited the school nurse. She took my temp and I was sent home with a fever. I ate and took another 800mg of Ibuprofen. I went to bed. An hour later I checked my pulse which seemed to be pounding. It was 100 per minute laying in bed, not moving for an hour. A slight headache started in the late afternoon. I'm really wondering if I should take the 2nd dose in a couple of months.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Nausea, Pain, Pyrexia
Clinical narrative: Ten hours after receiving the vaccine I experienced terrible chills that caused my teeth to chatter, fever, body pain and nausea like I thought I would vomit. This lasted for a full 24 hours after receiving the vaccine, and took a full 48 hours for all flu-like symptoms to subside.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Influenza like illness, Nausea, Pain
Clinical narrative: About 10 hours after receiving the injection I experienced flu-like symptoms of fever, headache, nausea and severe body aches and pains. The symptoms were so bad that I was confined to bed the next day, sleeping all day. The symptoms improved after 40 hours and were pretty much gone by 48 hours after onset.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: About 10 hours after receiving the injection I experienced flu-like symptoms of fever, headache, nausea and severe body aches and pains. The symptoms were so bad that I was confined to bed the next day, sleeping all day. The symptoms improved after 40 hours and were pretty much gone by 48 hours after onset.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis  to upper arm.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: HIGH FEVER. MALAISE. NAUSEA.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Dizziness, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: 3 mile, easy, mostly-flat hike began with deep fatigue from beginning, developing profuse sweating and dizziness, then chills, rapid increase in BP, ending with Grand Mal Seizure and arrested breathing.  Given CPR which resumed breathing. Taken by ambulance to emergency room. Subsequently saw heart doctor and two neurologists. Had MRI, EEG, EKG. All tests negative. Only treatment was from 2nd neurologist who diagnosed epilepsy and prescribed Roweepra. No treatment.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Epilepsy, Fatigue, Feeling cold, Generalised tonic-clonic seizure, Hyperhidrosis
Clinical narrative: 3 mile, easy, mostly-flat hike began with deep fatigue from beginning, developing profuse sweating and dizziness, then chills, rapid increase in BP, ending with Grand Mal Seizure and arrested breathing.  Given CPR which resumed breathing. Taken by ambulance to emergency room. Subsequently saw heart doctor and two neurologists. Had MRI, EEG, EKG. All tests negative. Only treatment was from 2nd neurologist who diagnosed epilepsy and prescribed Roweepra. No treatment.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Neurological examination abnormal, Nuclear magnetic resonance imaging normal, Respiratory arrest, Resuscitation
Clinical narrative: 3 mile, easy, mostly-flat hike began with deep fatigue from beginning, developing profuse sweating and dizziness, then chills, rapid increase in BP, ending with Grand Mal Seizure and arrested breathing.  Given CPR which resumed breathing. Taken by ambulance to emergency room. Subsequently saw heart doctor and two neurologists. Had MRI, EEG, EKG. All tests negative. Only treatment was from 2nd neurologist who diagnosed epilepsy and prescribed Roweepra. No treatment.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Bed rest, Fatigue, Feeling cold, Headache, Injection site erythema
Clinical narrative: Sore left arm. Swelling and redness at injection site. Muscle pain. Headache. Chills. Fever. Tiredness. Symptoms lasted 3 days. Treated with acetaminophen and bed rest.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore left arm. Swelling and redness at injection site. Muscle pain. Headache. Chills. Fever. Tiredness. Symptoms lasted 3 days. Treated with acetaminophen and bed rest.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Patient received vaccine 09/10/2018 and then developed a hive appearing rash per mom 6 days later on 09/16/2018. Rash had a raised appearance however improved within 24 hours. According to mom, patient is guarding area however patient is non-verbal so unsure if there is pain present.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm was swollen, red and hot from injection site to the elbow.
Age: 68.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Patient received PNEUMOVAX-23 vaccine in left arm on 9/12/18. (He received FLUAD in his right arm on this day, but that arm showed adverse reaction). Next day in the evening his left arm became warm, red, sore and had a low grade fever. Patient went to the doctor Friday afternoon and was diagnosed with cellulitis. He was given IV antibiotics Friday afternoon (9/14/18) and went back for a second course of IV antibiotics the following day.