chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Within 2-3 hours, arm became painful and began to swell; spent evening with ice to sight and took acetaminophen; difficulty sleeping as arm hurting so much; by morning arm swollen to below elbow, unable to arm much at all due to pain; feeling ill....nauseated, chilling, light headed; returned to bed....unable to dress or eat much that day. By following day, arm swollen clear to wrist and still very painful; Taking BENADRYL to help, but didn't seem to do much. I was able to bathe and dress but still felt ill. Some improvement to swelling in upper arm but whole arm red, warm and still very swollen. Over the course of a week, symptoms abated and swelling slowly receded. I have not been so ill in a very very long time.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Limb discomfort
Clinical narrative: Patient had sore arm that turned into cellulitis. Patient had dr visit and was diagnosed with cellulitis and was prescribed cephalexin 500mg capsule four times daily for 10 days.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash macular, Rhinorrhoea
Clinical narrative: ERYTHEMATOUS MACULAR RASH STARTED ON FACE THEN PROGRESSED TO TRUNK AND EXTREMITIES. NON PRURITIC OR TENDER RASH. PT AFEBRILE, EYES CLEAR, PERSISTENT RUNNY NOSE (FROM PRIOR TO VACCINE)
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal chest pain
Clinical narrative: Patient complaints of soreness, tenderness/redness in injection site left arm, started 1 hour after vaccination and then next morning pain spread to muscles left chest.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Diarrhoea, Ear infection, Immediate post-injection reaction, Nasopharyngitis, Pyrexia
Clinical narrative: October 16th immediately after shots he cried for 4 hours straight then that same night at 10 pm he started projectile vomiting which lasted for 5 hours. October 17th he had diarrhea and a fever which lasted until October 20th. October 19th to November 3rd he had a severe cold. November 10th he got an ear infection and after 2 rounds of antibiotics still was not gone until November 29th which he still had fluid in his ears but was not considered to be a infection. December 10th he started having random and reoccurring fevers that's lasted 2-3 days anywhere from 99° F to 103° F. Fevers were once a month then every 2 weeks with the most recent being 3 days within each other. December 10th-12th Fever January 12-14th fever February 14-17th fever February 27-30th fever March 11-12th Fever March 15-17th Fever.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Vomiting projectile
Clinical narrative: October 16th immediately after shots he cried for 4 hours straight then that same night at 10 pm he started projectile vomiting which lasted for 5 hours. October 17th he had diarrhea and a fever which lasted until October 20th. October 19th to November 3rd he had a severe cold. November 10th he got an ear infection and after 2 rounds of antibiotics still was not gone until November 29th which he still had fluid in his ears but was not considered to be a infection. December 10th he started having random and reoccurring fevers that's lasted 2-3 days anywhere from 99° F to 103° F. Fevers were once a month then every 2 weeks with the most recent being 3 days within each other. December 10th-12th Fever January 12-14th fever February 14-17th fever February 27-30th fever March 11-12th Fever March 15-17th Fever.
Age: 5.0
Sex: M
Vaccine: FLUA3, MMR
Symptoms: Discomfort, Full blood count, Immune thrombocytopenic purpura
Clinical narrative: ITP Disorder, hospitalization, numerous blood draws, discomfort.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus
Clinical narrative: Pt states she got a rash from injection site to elbow and around back side of arm and down side. She states that is itches, does not hurt and is mildly relieved by benadryl gel and tablets. Office told pt to increase benadryl doses/day, if not better by tomorrow will send her a steroid.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Swelling
Clinical narrative: INJECTION SITE REACTION, RED SWOLLEN AREA.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Skin lesion
Clinical narrative: Janeway lesions on hands and feet. Patient sent to Emergency Department for evaluation, which has not been completed. Infectious Disease and cardiology consulted. Hand lesions appeared 24-48 hours after vaccine. Lesions on toes began 48-60 hours after vaccine. Patient is afebrile.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: I received SHINGRIX injection 1 of 2 Friday night, had soreness in that arm which wasn't unexpected. On Monday (3 days after the injection) I developed redness and swelling in a large patch near the injection area on my left arm. The redness was present from Monday until Thursday evening and is finally almost back to normal - almost an entire week after receiving the vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: PATIENT HAD RECEIVED THE VACCINE 16 DAYS AGO AND STILL HAS A LOT OF MUSCLE SORENESS AND SOME MINOR PAIN WHEN LIFTING HER ARM UP (E.G. PUTTING ON A SHIRT).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Soreness and red whelt on injection site (6) post injection.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: According to patient he received his second anthrax vaccine on the 19th of March 2019 and the next day 20th March said he had Baseball sized area of swelling that was red warm and itchy. He came to our clinic late on the 21st his arm from the L deltoid down to the Antecubital space was Red/Warm/Swollen/and Itchy.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: According to patient he received his second anthrax vaccine on the 19th of March 2019 and the next day 20th March said he had Baseball sized area of swelling that was red warm and itchy. He came to our clinic late on the 21st his arm from the L deltoid down to the Antecubital space was Red/Warm/Swollen/and Itchy.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Discomfort, Pain in extremity, Rash vesicular
Clinical narrative: Later in day of vax, developed lumbar pain and left thigh pain. Thigh pain a little better with ibuprofen. Discomfort persisted, not well described. Presented here for exam, expecting physical therapy rx, on 3.19.19, and rash typical of shingles (several days old, vesicles starting to crust) noted left paralumbar about L4.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Later in day of vax, developed lumbar pain and left thigh pain. Thigh pain a little better with ibuprofen. Discomfort persisted, not well described. Presented here for exam, expecting physical therapy rx, on 3.19.19, and rash typical of shingles (several days old, vesicles starting to crust) noted left paralumbar about L4.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: CSF protein increased, Demyelination, Electromyogram abnormal, Fatigue, Gait disturbance
Clinical narrative: Guillain-Barre syndrome (BLE numbness, fatigue, bilateral shoulder blade pain and muscle pain in both thighs. Numbness extended from mid-thigh down to both feet causing difficulty with his gait. 8 days of intravenous immunoglobulin. Also concern for transverse myelitis, started on steroids. Acute urinary retention, started on FLOMAX. Patient hospitalized and then transferred to rehab center. Patient has persistent/residual bilateral lower extremity weakness, gait abnormality, and urinary frequency plus urgency. He is continuing physical therapy and seeing neurology.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Micturition urgency, Muscular weakness
Clinical narrative: Guillain-Barre syndrome (BLE numbness, fatigue, bilateral shoulder blade pain and muscle pain in both thighs. Numbness extended from mid-thigh down to both feet causing difficulty with his gait. 8 days of intravenous immunoglobulin. Also concern for transverse myelitis, started on steroids. Acute urinary retention, started on FLOMAX. Patient hospitalized and then transferred to rehab center. Patient has persistent/residual bilateral lower extremity weakness, gait abnormality, and urinary frequency plus urgency. He is continuing physical therapy and seeing neurology.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Myalgia, Nuclear magnetic resonance imaging brain normal, Pollakiuria, Urinary retention
Clinical narrative: Guillain-Barre syndrome (BLE numbness, fatigue, bilateral shoulder blade pain and muscle pain in both thighs. Numbness extended from mid-thigh down to both feet causing difficulty with his gait. 8 days of intravenous immunoglobulin. Also concern for transverse myelitis, started on steroids. Acute urinary retention, started on FLOMAX. Patient hospitalized and then transferred to rehab center. Patient has persistent/residual bilateral lower extremity weakness, gait abnormality, and urinary frequency plus urgency. He is continuing physical therapy and seeing neurology.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Hot flush, Oropharyngeal pain, Pharyngeal swelling, Swelling
Clinical narrative: Mother called 3-21-19 1230. She wanted Nsg and PCP aware son had HPV inj 3/19/19 went home no issue. Woke 3-20-19 AM "swollen Rt side neck outside sore and swollen throat inside". No temp. Received injection on Rt arm no redness. Pt c/o warm flashes. Mother had pt take IBU 800 mg tid; salt water gargles and ice to neck all day. Slept and became better. 3/21/19; improved still, no more swelling of neck. Mother stated prior immunization 1 month nasal congestion, no temp using OTC NYQUIL DAY AND NIGHT. 3-21-19 after mother's call received w/ MD listed. Pt will not receive #3/3 HPV, listed as allergy. Continue as mother was doing BENADRYL 25 mg 1-2 q 6 hr prn. Mother aware if any swelling or question throat swelling or s/s go to ER.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: On 03/19/19 patient with a red papule with a small induration in her right posterior arm. Mother denied fever, pain and tenderness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site reaction, Lymphadenopathy, Myalgia
Clinical narrative: Chills, fever, muscle pain, injection site reaction. Swollen lymph node in armpit, pain/tingling in joints in fingers, white patches on mucosal areas in mouth.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal discolouration, Paraesthesia, Pyrexia
Clinical narrative: Chills, fever, muscle pain, injection site reaction. Swollen lymph node in armpit, pain/tingling in joints in fingers, white patches on mucosal areas in mouth.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: After administering SHINGRIX, patient's (L) arm at injection site developed a bump from possibly striking a blood vessel. I put pressure w/ cotton ball and then put a Band-Aid. Pt waited 15 mins and said she felt fine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Local reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in a 5-year-old female patient who received KINRIX (batch number G9P35, expiry date 15th September 2020) for prophylaxis. This case was associated with product complaint. On 7th March 2019, the patient received KINRIX. On 8th March 2019, 1 days after receiving KINRIX, the patient experienced injection site reaction. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site reaction was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional details were provided as follows: This case was reported by a nurse from the physician's office. After vaccination with KINRIX the patient experienced reaction from the site of the injection down to her elbow. The nurse stated, the physician felt that something could be wrong with the lot of KINRIX. The nurse was requesting the lot be investigated and she would like to send back the six vials remaining in the box of ten. The nurse was requested to send a shipping label to the physician's office. The nurse was informed by the representative that GlaxoSmithKline (GSK) would not be able to provide any reimbursement or credit or replacement for this situation.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site reaction, Product complaint
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in a 5-year-old female patient who received KINRIX (batch number G9P35, expiry date 15th September 2020) for prophylaxis. This case was associated with product complaint. On 7th March 2019, the patient received KINRIX. On 8th March 2019, 1 days after receiving KINRIX, the patient experienced injection site reaction. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site reaction was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional details were provided as follows: This case was reported by a nurse from the physician's office. After vaccination with KINRIX the patient experienced reaction from the site of the injection down to her elbow. The nurse stated, the physician felt that something could be wrong with the lot of KINRIX. The nurse was requesting the lot be investigated and she would like to send back the six vials remaining in the box of ten. The nurse was requested to send a shipping label to the physician's office. The nurse was informed by the representative that GlaxoSmithKline (GSK) would not be able to provide any reimbursement or credit or replacement for this situation.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Neck pain, Pain in jaw
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 83-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hysterectomy, knee operation, wrist fracture and breast biopsy. Previously administered products included ZOSTAVAX. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, 2 hrs after receiving SHINGRIX, the patient experienced shoulder pain, neck pain and bone pain. On an unknown date, the patient experienced hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep. The patient was treated with TYLENOL, PERCOCET and Ice Pack (NOS). On an unknown date, the outcome of the shoulder pain, neck pain and bone pain were unknown and the outcome of the hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, neck pain, bone pain, hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep to be related to SHINGRIX. Additional details were provided as follows: The patient experienced excruciating pain in her left shoulder that radiated to the back of her neck and the left side of her clavicle 2 hours after receiving 1st dose of SHINGRIX. Less than a day due to pain, the patient finds difficult to sleep. Less than a week after 1st dose, the patient's left shoulder is swollen and patient is also feeling weak and dizzy. The patient's voice has also been affected.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 83-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hysterectomy, knee operation, wrist fracture and breast biopsy. Previously administered products included ZOSTAVAX. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, 2 hrs after receiving SHINGRIX, the patient experienced shoulder pain, neck pain and bone pain. On an unknown date, the patient experienced hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep. The patient was treated with TYLENOL, PERCOCET and Ice Pack (NOS). On an unknown date, the outcome of the shoulder pain, neck pain and bone pain were unknown and the outcome of the hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, neck pain, bone pain, hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep to be related to SHINGRIX. Additional details were provided as follows: The patient experienced excruciating pain in her left shoulder that radiated to the back of her neck and the left side of her clavicle 2 hours after receiving 1st dose of SHINGRIX. Less than a day due to pain, the patient finds difficult to sleep. Less than a week after 1st dose, the patient's left shoulder is swollen and patient is also feeling weak and dizzy. The patient's voice has also been affected.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Bone pain, Dizziness, Dysphonia, Initial insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 83-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hysterectomy, knee operation, wrist fracture and breast biopsy. Previously administered products included ZOSTAVAX. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, 2 hrs after receiving SHINGRIX, the patient experienced shoulder pain, neck pain and bone pain. On an unknown date, the patient experienced hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep. The patient was treated with TYLENOL, PERCOCET and Ice Pack (NOS). On an unknown date, the outcome of the shoulder pain, neck pain and bone pain were unknown and the outcome of the hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, neck pain, bone pain, hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep to be related to SHINGRIX. Additional details were provided as follows: The patient experienced excruciating pain in her left shoulder that radiated to the back of her neck and the left side of her clavicle 2 hours after receiving 1st dose of SHINGRIX. Less than a day due to pain, the patient finds difficult to sleep. Less than a week after 1st dose, the patient's left shoulder is swollen and patient is also feeling weak and dizzy. The patient's voice has also been affected.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint swelling, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 83-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hysterectomy, knee operation, wrist fracture and breast biopsy. Previously administered products included ZOSTAVAX. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, 2 hrs after receiving SHINGRIX, the patient experienced shoulder pain, neck pain and bone pain. On an unknown date, the patient experienced hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep. The patient was treated with TYLENOL, PERCOCET and Ice Pack (NOS). On an unknown date, the outcome of the shoulder pain, neck pain and bone pain were unknown and the outcome of the hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, neck pain, bone pain, hoarse voice, dizziness, weakness, swollen joints and trouble falling asleep to be related to SHINGRIX. Additional details were provided as follows: The patient experienced excruciating pain in her left shoulder that radiated to the back of her neck and the left side of her clavicle 2 hours after receiving 1st dose of SHINGRIX. Less than a day due to pain, the patient finds difficult to sleep. Less than a week after 1st dose, the patient's left shoulder is swollen and patient is also feeling weak and dizzy. The patient's voice has also been affected.
Age: 64.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Dyspnoea, Headache
Clinical narrative: Developed a high fever (104.2) 4 hours after receiving injection. Then 8 hours later developed severe headache and shortness of breath. Used albuterol nebs throughout the night, but it became increasingly difficult to breath.
Age: 64.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea, Headache, Intensive care, Mechanical ventilation
Clinical narrative: Developed a high fever (104.2) 4 hours after receiving injection. Then 8 hours later developed severe headache and shortness of breath. Used albuterol nebs throughout the night, but it became increasingly difficult to breath.
Age: 64.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Respiratory failure
Clinical narrative: Developed a high fever (104.2) 4 hours after receiving injection. Then 8 hours later developed severe headache and shortness of breath. Used albuterol nebs throughout the night, but it became increasingly difficult to breath.
Age: 64.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction, Life support
Clinical narrative: Developed a high fever (104.2) 4 hours after receiving injection. Then 8 hours later developed severe headache and shortness of breath. Used albuterol nebs throughout the night, but it became increasingly difficult to breath.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever, fatigue for 36 hours.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, X-ray limb normal
Clinical narrative: AFTER RECEIVING THE FLU SHOT, I HAVE HAD PAIN AT THE INJECTION SITE FOR OVER 5 MONTHS. IT HURTS THE MOST WHEN I LIE ON MY LEFT SIDE. I HAVE BEEN UNABLE TO SLEEP ON THAT SIDE.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Fever 101, muscle and joint pain beginning at 11pm and continuing overnight until morning.  Responding to Acetaminophen.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, swollen area at injection site. Onset within 6 hours of vaccine. Progressively spreading to cover the entire thigh within 45 hrs.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, warm 3" area at site of injection - about 2 wks after immunization.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent. On 21-FEB-2019, the patient was vaccinated with improperly stored VARIVAX (lot# R021098, expiration date was 23-JUL-2010; lot# R023502, expiration date: 16-AUG-2020; dose, route and frequency were unknown) for prophylaxis. The administered VARIVAX was stored under the temperature ranging from 6 Fahrenheit degrees to 14 Fahrenheit degrees (5.53 Fahrenheit degrees) for 15 minutes. The temperature excursion occurred as a result of a reading from a digital data logger. Moreover, there was no occurrence of previous temperature excursion. The sterile diluent used to reconstitute VARIVAX was stored appropriately. No adverse effects reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA009810.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 26 years old patient of unknown gender. The concomitant medication, medical history and drug allergies/reactions regarding the patient were not reported. The reporter reported that the patient was vaccinated with dose one of GARDASIL 9 (route, dose detail, lot# and expiration date were unknown) on 17-JAN-2019 and dose two (route, dose detail, lot# and expiration date were unknown) on 21-FEB-2019 for prophylaxis. This time interval was shorter than recommended (inappropriate schedule of vaccine administered). No adverse effect was provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 11-MAR-2019, the patient was inadvertently vaccinated with an expired dose of VARIVAX, subcutaneously, lot # N001527, expiration date 13-JAN-2017 (dose was not reported) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 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. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-SEP-2007, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a physician. On an unspecified date, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 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 was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2017, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a pharmacist. On an unspecified date the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 04-FEB-2019, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis (product storage error). No adverse effect was reported. The LIQUID PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 08-FEB-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, Injection site pain, Injection site paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 52-year-old female patient. The patient's concurrent conditions and concomitant medications were not provided. Her medical history included allergy to "sulfa" (sulfonamide). On 16-JAN-2019, the patient was vaccinated with a dose of M-M-R II, lot # R019391 and expiration date 05-JUL-2019, for prophylaxis (frequency and anatomical location were unknown). This dose of the vaccine was administered intramuscularly (incorrect route of product administration). Other suspect therapies included sterile diluent (MERCK), used with the vaccine and administered intramuscularly as well. On an unspecified date in 2019, after been vaccinated, the patient experienced soreness and a tingling sensation at the injection site. The outcome of injection site pain and injection site paraesthesia was reported as not recovered. The causality assessment between M-M-R II and the aforementioned events was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a 9 year old patient of unknown gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 2 for prevent varicella (dosage schedule, route, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient experienced shingles after having previously received 2 doses of VARIVAX. The outcome of herpes zoster was unknown.
Sex: M
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from the mother of a patient via an online article dated 14-MAR-2019 regarding a case for GARDASIL (# 1903USA007559) concerning a male patient (age unknown). On an unspecified date the patient was administered GARDASIL (lot #, indication for use, and route of administration were not provided). The mother of the patient reported "He received the HPV vaccine and had a bad reaction to it". The onset date and outcome of the event were not provided. Additional information is not expected. Sender's Comments: US-009507513-1903USA007559.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Incomplete course of vaccination, Syncope
Clinical narrative: This spontaneous report was received from a pharmacist concerning her daughter who might have been between 9 and 11 years old. It was reported that the patient was not receiving any concomitant therapies and did not receive concomitant vaccinations at the time of vaccination. The patient's relevant medical history and concurrent conditions were unknown by reporter. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 1 dosage form, for human papilloma virus (HPV) prevention (strength, route of administration, frequency, lot# and expiration date were not reported). On an unknown date, after the first dose, the patient experienced syncope, and in the week that followed, experienced bad dizziness and headaches lasting 2 to 3 weeks. It was reported that the pharmacist was contacted and that no treatment was given for the adverse events but the patient was currently taking an unspecified medication for headaches. It was reported that the patient refused completing series. The outcome of syncope, headache and dizziness was reported as recovered on its own on an unknown date. Causal relationship between GARDASIL 9 and the events syncope, headache and dizziness was not reported. Upon internal review, the event syncope was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a 16-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (dose, units, frequency, lot # and expiration date unknown). On an unknown date, the patient experienced shingles (herpes zoster) after a dose VARIVAX. The outcome of herpes zoster was unknown. Causality assessment of the event was not provided by the reporter. Product quality issue was not present.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. The patient's concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patient was inadvertently vaccinated with (recombinant Human albumin (rHA)) M-M-R II (lot # R028224, expiration date 02-OCT-2020, dose was unknown) intramuscularly for prophylaxis. No adverse effects. The outcome of the events was unknown. No product quality complaint (PQC) presented.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On 15-MAR-2019 the patient was vaccinated with RECOMBIVAX HB therapy type: Thimerosal free; lot # L044917, expiration date: 05-OCT-2018, 1 dosage form for prophylaxis (expired vaccine used). No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were not known. On 26-FEB-2019 the patient was vaccinated with an improperly stored dose of VARIVAX lot # R002509 and expiration date 25-JAN-2020, for prophylaxis (strength, dose, frequency and route of administration were unknown). Sterile diluent used was properly stored. The patient experienced no adverse events. It was reported that the vaccine used had been at 6°F to 14°F (12.9 F) for 30 minutes. No previous excursions were reported. Data logger was involved. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1903USA009466: US-009507513-1903USA009465.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were not known. On 26-FEB-2019 the patient was vaccinated with an improperly stored dose of VARIVAX lot # R002509 and expiration date 25-JAN-2020, for prophylaxis (strength, dose, frequency and route of administration were unknown). Sterile diluent used was properly stored. The patient experienced no adverse events. It was reported that the vaccine used had been at 6°F to 14°F (12.9 F) for 30 minutes. No previous excursions were reported. Data logger was involved. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1903USA009416: US-009507513-1903USA009466.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were not known. On 28-FEB-2019 the patient was vaccinated with an improperly stored dose of VARIVAX lot # R002509 and expiration date 25-JAN-2020, for prophylaxis (strength, dose, frequency and route of administration were unknown). Sterile diluent used was properly stored. The patient experienced no adverse events. It was reported that the vaccine used had been at 6°F to 14°F (12.9 F) for 30 minutes. No previous excursions were reported. Data logger was involved. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1903USA009416: US-009507513-1903USA009465.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent. On 21-FEB-2019, the patient was vaccinated with improperly stored VARIVAX (lot # R021098, expiration date was 23-JUL-2010; lot # R023502, expiration date: 16-AUG-2020; dose, route and frequency were unknown) for prophylaxis. The administered VARIVAX was stored under the temperature ranging from 6 Fahrenheit degrees to 14 Fahrenheit degrees (5.53 Fahrenheit degrees) for 15 minutes. The temperature excursion occurred as a result of a reading from a digital data logger. Moreover, there was no occurrence of previous temperature excursion. The sterile diluent used to reconstitute VARIVAX was stored appropriately. No adverse effects reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA009575.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: Off label use, Product administered to patient of inappropriate age, Rash macular, Rash papular, Rash pustular
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of macular rash in a 39-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included systemic lupus erythematosus (patient with mixed connective disease or lupus who also has autoantibodies to single stranded DNA), immunocompromised (immunocompromised state) and mixed connective tissue disease. On 18th March 2019, the patient received SHINGRIX. In March 2019, 1 day after receiving SHINGRIX, the patient experienced macular rash, papular rash and pustular rash. On an unknown date, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the macular rash, papular rash and pustular rash were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and off label use were unknown. It was unknown if the reporter considered the macular rash, papular rash and pustular rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a macular, papular, pustular rash 1 day after vaccination and it is still present 5 days post vaccination. The reporter understands that they vaccinated off label at an inappropriate age, but her rheumatologist wanted her vaccinated due to her immunocompromised state. The reporter stated that he would be seeing this patient in about 19 minutes when he spoke to GlaxoSmithKline and reported that they would be filing a VAERS report so the reporter did not feel the need to provide any additional details.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 4th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, 2 days after receiving SHINGRIX, the patient experienced stomach pain, fever, shivering, headache, fatigue, injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the stomach pain was not recovered/not resolved and the outcome of the fever, shivering, headache, fatigue, injection site pain, injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the stomach pain, fever, shivering, headache, fatigue, injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient received a dose of SHINGRIX into the left arm and developed shivering, fever, headache, fatigue, stomach pain as well as soreness, redness, and swelling around the injection site. In March 2019, all the events had resolved except the stomach pain. The patient asked if there was any research which showed stomach pain lasted longer than the median duration. The patient did not know if it was intramuscular injection as she said her pharmacist gave it to her and she did not know the lot number or expiration date. The patient did not give the permission to contact her physician. Instead, she referred to her health care professional for additional information and follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 4th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, 2 days after receiving SHINGRIX, the patient experienced stomach pain, fever, shivering, headache, fatigue, injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the stomach pain was not recovered/not resolved and the outcome of the fever, shivering, headache, fatigue, injection site pain, injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the stomach pain, fever, shivering, headache, fatigue, injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient received a dose of SHINGRIX into the left arm and developed shivering, fever, headache, fatigue, stomach pain as well as soreness, redness, and swelling around the injection site. In March 2019, all the events had resolved except the stomach pain. The patient asked if there was any research which showed stomach pain lasted longer than the median duration. The patient did not know if it was intramuscular injection as she said her pharmacist gave it to her and she did not know the lot number or expiration date. The patient did not give the permission to contact her physician. Instead, she referred to her health care professional for additional information and follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 74 or 75 years old. The patient received SHINGRIX and has no adverse reaction other than soreness. The reporter heard that many people get a bad reaction from 2nd dose. The reporter wanted to know was that likely.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site stinging in a female patient who received SHINGRIX for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX (subcutaneous). On 11th March 2019, immediately after receiving SHINGRIX, the patient experienced injection site stinging and intramuscular formulation administered by other route. In March 2019, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site stinging, injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site stinging, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself who stated that she got her 1st Shingrix dose at doctor's office but had a reaction to it. The patient had redness and swelling at the injection site, the area was red and swollen and it was stinging and it stung when the vaccine was administered. The patient stated that her pharmacist said they gave her the shot in the wrong spot because they gave it to her behind her arm and not in the muscle (subcutaneously), which led to and intramuscular formulation administered by other route. The patient asked if she was supposed to repeat the dose and she was advice to speak with her healthcare provider as they will determine right treatment plan for her. The patient inquired whether the shot would not be effective since it was given at the wrong site. The patient was less concerned with the side effects and more concerned with the shot effectiveness and she asked to refer her to someone at a company who could help her. The patient insisted to talk with medical information department.