chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-OCT-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # R002344 and expiration date on 16-NOV-2020, for prophylaxis (route of administration and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion above 47 degrees Fahrenheit (°F) (52°F) for 1440 hours. The call was not because of a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age (currently 1 year old). Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PROQUAD (therapy type: rHA, lot # R008206, expiration date: 16-SEP-2019; 1 dosage form, subcutaneous for prophylaxis) following two temperature excursions. No adverse effects were reported in the patient. Temperature/Time frame 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) (15.2F) for 2 hours 30 minutes. Previous temperature excursion 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C) (13.2F) for 9 hours 5 minutes.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAY-2017, the patient was inoculated with the ZOSTAVAX vaccine, at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, and on an unknown date, the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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 considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2018, the patient was inoculated with the ZOSTAVAX vaccine, at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, and on an unknown date, the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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 considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a consumer regarding her daughter of unknown age. The patient's pertinent medical conditions and concomitant medications were not reported. On unknown dates, the patient was vaccinated two doses with GARDASIL 9 or GARDASIL for prophylaxis (dosing details were not reported). The patient missed her last dose of vaccine. Reporter enquired whether the patient could still take her last dose. No product quality complaint was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Myelofibrosis, Splenomegaly
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of splenomegaly in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included ruxolitinib phosphate (Jakafi) for myelofibrosis. On an unknown date, the patient received SHINGRIX at an unknown dose and Jakafi (oral) 5 mg twice daily (10 mg daily). On an unknown date, unknown after receiving SHINGRIX, the patient experienced splenomegaly. The action taken with Jakafi was unknown. On an unknown date, the outcome of the splenomegaly was unknown. It was unknown if the reporter considered the splenomegaly to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination were not provided; however captured as Adult as per vaccine indication. The patients' medical history and concomitant details were not available. The patient was vaccinated with SHINGRIX and experienced (Speen grew) Splenomegaly. It was reported that the patient initiated the use of oral Jakafi (ruxolitinib) 5 mg tablet twice a day from the unknown date for Myelofibrosis for 1 month (batch number and expiration details were not provided). It was unknown if the reporter considered the splenomegaly to be related to Jakafi. No other information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 24th December 2018, the patient received the 1st dose of SHINGRIX. On 24th December 2018, 2 hrs after receiving SHINGRIX, the patient experienced pain in arm, chills, nausea, headache and fatigue. On 25th December 2018, the outcome of the pain in arm, chills, nausea, headache and fatigue were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, nausea, headache and fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a sore arm about 2 hours afterwards. Later that evening of vaccination, after about 7 hours after the dose, the patient experienced chills, nausea, fatigue and headache. The reporter did not give consent to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 83-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 6th March 2019, the patient received SHINGRIX (intramuscular). On an unknown date, 7 days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX vaccine on left arm. The dose of SHINGRIX was given to a patient and almost 1 week later, she was experiencing ongoing redness at the injection site. The site was reportedly 2.5 to 3 inches in diameter and had gradually decreased in size since the redness first appeared. The patient denied any pain or swelling. The reporting pharmacist was not the immunizing pharmacist, however the vaccine was administered at the same facility.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre Syndrome in a patient who received Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced Guillain Barre Syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre Syndrome was unknown. It was unknown if the reporter considered the Guillain Barre Syndrome to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient told to the pharmacist, they had a Guillain Barre Syndrome after an unknown influenza immunization in the past. The reporter inquired about that, if there would be a problem after receiving SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site reaction, Local reaction, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of sickness in a 81-year-old 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 sickness, injection site cellulitis and nonspecific reaction. On an unknown date, the outcome of the sickness, injection site cellulitis and nonspecific reaction were unknown. It was unknown if the reporter considered the sickness, injection site cellulitis and nonspecific reaction to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the reporter on behalf of the patient. The age at vaccination was not reported, but the patient was 81 years old at the time of reporting. The patient experienced a localized reaction at the injection site (suspected cellulitis) and also experienced a systemic reaction to the vaccine as well. It was reported that the vaccine made the patient very sick. The reporter stated that the patient called her to report the event but she had not physically seen the patient. No additional details were available. This is one of the three cases reported by the same reporter.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Neck pain, Rash pruritic
Clinical narrative: Developed pruritic rash bilateral arms, headache, lightheaded and neck pain. Rash started 4 hours after injection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue
Clinical narrative: Please not pharmacy administered the vaccine. I provided my PCP info. Extreme fatigue, lack of appetite, chills began 12 hours after vaccination and lasted approximately 12 hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Headache, aches, fatigue, nausea.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Localized erythema and edema to upper left arm. Associated with local pruritis. Prescribed diphenhydramine 25mg PRN.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: Development of erythematous, indurated area at (L) deltoid approximately 1 day after administration of MMRV. Reaction site-approx. 8x10 cm induration and erythema with central vesicular eruption. Tx'd with PO antibiotic and BENADRYL.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Abnormal behaviour, Feeling abnormal, Seizure, Skin warm
Clinical narrative: Mom reports child was running and playing at time of vaccine, but went to sleep a while after got home. When he woke up he acted like he didn't feel good so she put him back in bed. Around 7pm a cousin went to get him up and he was hot, didn't act normal, and then had a seizure. They called 911 and he is in hosp.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Pruritus, Pyrexia, Rash erythematous
Clinical narrative: MOP brought patient in on 3/14/19 stating noticed the reddened rash and bumps the evening before when giving patient a bath. Itchy and low grade temp at that time. Mother stated that the rash not as red in the office at that time as the evening before. No longer itchy or fevered.
Age: 94.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood glucose, Blood pressure normal, Dysstasia, Fall
Clinical narrative: Patient woke up the morning after the immunization and felt very weak. He tried to walk his dog and could not stand and ended up falling, even while using a walker. Patient lives in assisted living. Nurse came and did BP and glucose and all labs were within normal limits.
Age: 94.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Walking aid user
Clinical narrative: Patient woke up the morning after the immunization and felt very weak. He tried to walk his dog and could not stand and ended up falling, even while using a walker. Patient lives in assisted living. Nurse came and did BP and glucose and all labs were within normal limits.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site pruritus, Limb discomfort, Pain, Swelling
Clinical narrative: Patient had a large amount of swelling and pain, felt like she couldn't move her arm. She also broke out into hives. The injection site became very itchy and painful.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Patient had a large amount of swelling and pain, felt like she couldn't move her arm. She also broke out into hives. The injection site became very itchy and painful.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood pressure increased, Chills, Fatigue, Headache
Clinical narrative: Elevated BP: 182/89 (144/74 night before), pain in arm, feeling tired/weak, slight headache, shivering during sleep, slight fever, redness at injection sight 3-4 days following injection. Normal on day five (5).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Elevated BP: 182/89 (144/74 night before), pain in arm, feeling tired/weak, slight headache, shivering during sleep, slight fever, redness at injection sight 3-4 days following injection. Normal on day five (5).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle aches and pains, fever, nausea lasting approximately 8 hrs.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache
Clinical narrative: Patient reports severe headache that lasted all day as well as temperatue of 100 degrees F. Next day (03/16/2019) back to normal/she was fine.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Nothing reported at this time. Found incorrect dose given during balancing vaccine inventory. Provider is calling parent to discuss extra dose of Varicella.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous, non-valid report was received from an immunization official and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX one dose each, lot # N020016, expiration date 17-JUL-2019 (exact dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -3.05 degrees Celsius for 4 hours 25 minutes. Digital Data Logger was involved. There was a previous excursion of -11.52 degrees Celsius for 1 hour reported. This report is considered non-valid due to lack of patients identifiers.
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. On or about 17-DEC-2014, 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 physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
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 01-JAN-2013, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a healthcare provider. 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.
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 11-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 from 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-009507513-1903USA006946: 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 12-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 from 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-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006949: US-009507513-1903USA006950.
Sex: U
Vaccine: HPV9
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 12-FEB-2019, the patient was vaccinated with improperly stored GARDASIL 9 (1 injection, via intramuscular, lot # reported as: N025428, expiration date: 19-JUN-2020; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The GARDASIL 9 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 from 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-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: 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 15-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 from 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-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from a physician via Pfizer regarding a female patient of an unknown age. The patient's relevant medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiry date were not reported) for an unknown indication. It was reported that the patient was allergic to PNEUMOVAX 23. The outcome of the event was unknown. The reporter considered drug hypersensitivity to be related to PNEUMOVAX 23. This is one of the several reports received from the same reporter. Sender's Comments: US-PFIZER INC-2013341054: WWID#. US-009507513-1903USA007749: US-009507513-1903USA008450.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Emotional distress, Impaired work ability, Ovarian cyst ruptured, Pain, Ultrasound scan
Clinical narrative: I have been having issues for years and it took a lot of money and doctors to find out what was going on. Finally after cysts rupturing I went to the ER. After speaking with other people my age who also have been diagnosed I found the common denominator of GARDASIL. It is a painful and ongoing struggle that has cost me thousands of dollars, time from work, and emotional trauma.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: Rather pronounced ear ringing - noticed after breakfast 8am approx.  I did take an ADVIL at that time because i was feeling badly. Its only been 2 1/2 hours so possibly it is premature.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Decreased appetite, Enema administration, Fluid intake reduced, Haematochezia, Intussusception
Clinical narrative: Symptoms: not eating/drinking, lethargic, vomiting, blood in stool. Infant was evaluated in ER & admitted (3/20/19).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Symptoms: not eating/drinking, lethargic, vomiting, blood in stool. Infant was evaluated in ER & admitted (3/20/19).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Heart rate increased, Injection site pain, Pyrexia
Clinical narrative: Extreme soreness in injection site. Extreme chills, fever, elevated heart rate.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Hypertension, Rash erythematous, Rash pruritic, Tremor
Clinical narrative: Patient reports that within the hour after receiving the vaccine and leaving the health department he developed a red itchy rash. He works at a local NP office and was given BENADRYL and dexamethasone. He then began to have trouble breathing and was taken to ER where he was given Epinephrine, BENADRYL, and another medication that he didn't know the name of. He stated that today 3/21/19 he is feeling better but his blood pressure is still high and he has some tremors.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy
Clinical narrative: LOCALIZED PAIN AT INJECTION SITE, GENERALIZED LETHARGY.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: With the first injection exactly 6 months prior and this injection, I feel like I have the flu for a day. My normal temp runs a bit low and both times after the injection I have a temp of 99^.  My arm is sore which is understandable but I wanted to report feeling so sluggish with a low grade fever, especially since it has happened both times.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Fall, Head injury, Syncope
Clinical narrative: After receiving the vaccines in the clinic room by student nurse supervised by nurse, Patient was asked "Are you feeling OK?" and replying "Yes." Patient was then escorted to the hallway to receive a copy of his immunization record. Nurse followed Patient out asking some insurance questions. Patient proceeded to text his mother and had a syncopal episode next to the visitors bathroom. He proceeded to fall backwards hitting his head on the door of the bathroom and slide to the floor. Ammonia stimulate was used and Patient aroused immediately. He sat up and was given a glass of water, nurse inspected the back of his head and neck, assessing no S&S of injury. Patient denied concerns. Patient was instructed to stay in the office for at least 15 min following the syncopal episode, but refused. Patient was accompanied by an uncle and was taken home. Patient denied dizziness, lightheadedness or injury to head or neck.
Age: 48.0
Sex: M
Vaccine: FLU4, HEP, TD
Symptoms: Underdose
Clinical narrative: A hepatitis B PEDS dose of 0.5 ml was accidentally pulled and given instead of the Hepatitis B ADULT dose of 1 ml. The health department was called and it was advised to give the patient the proper 1 ml dose of the ADULT Hepatitis B vaccine. Patient and physician was notified of the event. Patient was okay with receiving the correct dosage.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Chills and shivering, fever and sweating, headache, extreme fatigue (in bed from 10pm Monday night to 9am Thursday morning), nausea, pain at injection site, red dot and small rash on hand.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Rash, Rash erythematous
Clinical narrative: Chills and shivering, fever and sweating, headache, extreme fatigue (in bed from 10pm Monday night to 9am Thursday morning), nausea, pain at injection site, red dot and small rash on hand.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Localized swelling to Right deltoid approx. 10cm. tender to touch.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient came next day after receiving SHINGRIX in right deltoid. Complaining of severe muscle soreness; trouble lifting her arm.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Tremor
Clinical narrative: Patient was completing second dose of SHINGRIX series. She only experienced a sore arm with the first dose but the second dose gave her severe uncontrollable shakes, headache, and nausea.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dehydration, Headache
Clinical narrative: Patient was completing second dose of SHINGRIX series. She only experienced a sore arm with the first dose but the second dose gave her severe uncontrollable shakes, headache, and nausea.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lethargy, Nausea, Pain, Retching, Tremor
Clinical narrative: Patient was completing second dose of SHINGRIX series. She only experienced a sore arm with the first dose but the second dose gave her severe uncontrollable shakes, headache, and nausea.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site rash, Musculoskeletal stiffness, Pain, Pain in extremity, Pruritus
Clinical narrative: ITCHING, MILD UPPER EXTREMITY PAIN, SKIN RASH AT INOCULATION SITE 3 DAYS AFTER VACCINATION. 3/17/19 - PT C/O OF BODY ACHES, STIFF NECK AND LEFT SHOULDER.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: 03/20/19 Soreness at injection site a few hours after 4pm. 03/21/19 2am muscle stiffness and soreness. Woke at 5am with joint and muscles aches, headache, tiredness, not hungry but no nausea. 11am still feel the same.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: 03/20/19 Soreness at injection site a few hours after 4pm. 03/21/19 2am muscle stiffness and soreness. Woke at 5am with joint and muscles aches, headache, tiredness, not hungry but no nausea. 11am still feel the same.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dehydration, Disorientation, Dizziness, Feeling abnormal
Clinical narrative: About 6 hours after vaccination woke up and had to go to urinate, felt heart racing, aching as if it was going to get the flu. Also felt like someone hit him in the shoulder with a sledge hammer and couldn't put weight on the left shoulder. In the next couple of hours had to go urinate multiple times--8 times; felt incontinent, also achy and weaklike flu-like symptoms. Patient did not have fever and did not take any medicine. Next day, went to work, ate something light and drank water because felt dehydrated. Patient worked a full day, during the day felt nauseous, weak, thirsty, and spaced out/disoriented. Patient almost had to stop working because he felt so nauseous but symptoms subsided by the end of the day. Left shoulder and arm was sore and uncomfortable. Patient took 3 Advil but did not seem to help that much. Patient's vision was a bit blurry because noticed glasses were not enough. Patient did not feel worse than in the morning so was hesitant to call doctor on Friday. On Friday ate light, drank more water because felt dehydrated, felt better but still queasy/lightheaded, and had soreness on shoulder; went to sleep early--around 5:15pm. Patient slept until next morning on and off until 8:30am. On Saturday ate and went about the day but still felt off; took 3 Advil and no improvement. Saturday went to bed early again since had to work on Sunday. On Sunday, felt a little better, arm was sore, felt queasy/unsettled but felt better; patient did not take Advil that day. By Monday there was improvement but still felt soreness on left shoulder but mostly back to normal.    Today, almost 2 weeks later patient is feeling back to normal. After first dose of SHINGRIX, had soreness on shoulder but nothing that stands out as unusual.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site discomfort, Injection site pain, Limb discomfort, Musculoskeletal pain
Clinical narrative: About 6 hours after vaccination woke up and had to go to urinate, felt heart racing, aching as if it was going to get the flu. Also felt like someone hit him in the shoulder with a sledge hammer and couldn't put weight on the left shoulder. In the next couple of hours had to go urinate multiple times--8 times; felt incontinent, also achy and weaklike flu-like symptoms. Patient did not have fever and did not take any medicine. Next day, went to work, ate something light and drank water because felt dehydrated. Patient worked a full day, during the day felt nauseous, weak, thirsty, and spaced out/disoriented. Patient almost had to stop working because he felt so nauseous but symptoms subsided by the end of the day. Left shoulder and arm was sore and uncomfortable. Patient took 3 Advil but did not seem to help that much. Patient's vision was a bit blurry because noticed glasses were not enough. Patient did not feel worse than in the morning so was hesitant to call doctor on Friday. On Friday ate light, drank more water because felt dehydrated, felt better but still queasy/lightheaded, and had soreness on shoulder; went to sleep early--around 5:15pm. Patient slept until next morning on and off until 8:30am. On Saturday ate and went about the day but still felt off; took 3 Advil and no improvement. Saturday went to bed early again since had to work on Sunday. On Sunday, felt a little better, arm was sore, felt queasy/unsettled but felt better; patient did not take Advil that day. By Monday there was improvement but still felt soreness on left shoulder but mostly back to normal.    Today, almost 2 weeks later patient is feeling back to normal. After first dose of SHINGRIX, had soreness on shoulder but nothing that stands out as unusual.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Palpitations, Pollakiuria, Thirst
Clinical narrative: About 6 hours after vaccination woke up and had to go to urinate, felt heart racing, aching as if it was going to get the flu. Also felt like someone hit him in the shoulder with a sledge hammer and couldn't put weight on the left shoulder. In the next couple of hours had to go urinate multiple times--8 times; felt incontinent, also achy and weaklike flu-like symptoms. Patient did not have fever and did not take any medicine. Next day, went to work, ate something light and drank water because felt dehydrated. Patient worked a full day, during the day felt nauseous, weak, thirsty, and spaced out/disoriented. Patient almost had to stop working because he felt so nauseous but symptoms subsided by the end of the day. Left shoulder and arm was sore and uncomfortable. Patient took 3 Advil but did not seem to help that much. Patient's vision was a bit blurry because noticed glasses were not enough. Patient did not feel worse than in the morning so was hesitant to call doctor on Friday. On Friday ate light, drank more water because felt dehydrated, felt better but still queasy/lightheaded, and had soreness on shoulder; went to sleep early--around 5:15pm. Patient slept until next morning on and off until 8:30am. On Saturday ate and went about the day but still felt off; took 3 Advil and no improvement. Saturday went to bed early again since had to work on Sunday. On Sunday, felt a little better, arm was sore, felt queasy/unsettled but felt better; patient did not take Advil that day. By Monday there was improvement but still felt soreness on left shoulder but mostly back to normal.    Today, almost 2 weeks later patient is feeling back to normal. After first dose of SHINGRIX, had soreness on shoulder but nothing that stands out as unusual.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: About 6 hours after vaccination woke up and had to go to urinate, felt heart racing, aching as if it was going to get the flu. Also felt like someone hit him in the shoulder with a sledge hammer and couldn't put weight on the left shoulder. In the next couple of hours had to go urinate multiple times--8 times; felt incontinent, also achy and weaklike flu-like symptoms. Patient did not have fever and did not take any medicine. Next day, went to work, ate something light and drank water because felt dehydrated. Patient worked a full day, during the day felt nauseous, weak, thirsty, and spaced out/disoriented. Patient almost had to stop working because he felt so nauseous but symptoms subsided by the end of the day. Left shoulder and arm was sore and uncomfortable. Patient took 3 Advil but did not seem to help that much. Patient's vision was a bit blurry because noticed glasses were not enough. Patient did not feel worse than in the morning so was hesitant to call doctor on Friday. On Friday ate light, drank more water because felt dehydrated, felt better but still queasy/lightheaded, and had soreness on shoulder; went to sleep early--around 5:15pm. Patient slept until next morning on and off until 8:30am. On Saturday ate and went about the day but still felt off; took 3 Advil and no improvement. Saturday went to bed early again since had to work on Sunday. On Sunday, felt a little better, arm was sore, felt queasy/unsettled but felt better; patient did not take Advil that day. By Monday there was improvement but still felt soreness on left shoulder but mostly back to normal.    Today, almost 2 weeks later patient is feeling back to normal. After first dose of SHINGRIX, had soreness on shoulder but nothing that stands out as unusual.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Dyspnoea, Fatigue, Hypotension, Passive smoking
Clinical narrative: Within a day after receiving the initial vaccine, I began feeling somewhat fatigued. I chalked it up to old age and kept going but it didn't get better. A couple of weeks later my trainer noticed I was having difficulty breathing during our sessions. I told her I had had a lot of pneumonia as a child and my lungs were probably just getting worn out. I bought some oxygen supplementation and went on about my business. But I kept getting more and more fatigued. I was about to go see the doctor thinking I might have chronic fatigue syndrome when I caught a virus (or so I thought) in October and so I chalked up the excess tiredness to my body fighting that. But the 'virus' never went away. Usually I can kick a cold or flu in a matter of days. Whatever this was, it laid me out throughout the holidays and I was developing other symptoms inconsistent with a cold or flu such as tachycardia (my resting heart rate was 135 as opposed to my normal 78) and hypo-tension (my BP would drop to 90/60 and sometimes lower if I stood for any length of time but was a little higher 130/85 than my normal 118/75 when resting). I got the booster shot late in December and within hours, I was flat on my back and could barely walk to the bathroom without passing out. So in January I went to see the doctor.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Within a day after receiving the initial vaccine, I began feeling somewhat fatigued. I chalked it up to old age and kept going but it didn't get better. A couple of weeks later my trainer noticed I was having difficulty breathing during our sessions. I told her I had had a lot of pneumonia as a child and my lungs were probably just getting worn out. I bought some oxygen supplementation and went on about my business. But I kept getting more and more fatigued. I was about to go see the doctor thinking I might have chronic fatigue syndrome when I caught a virus (or so I thought) in October and so I chalked up the excess tiredness to my body fighting that. But the 'virus' never went away. Usually I can kick a cold or flu in a matter of days. Whatever this was, it laid me out throughout the holidays and I was developing other symptoms inconsistent with a cold or flu such as tachycardia (my resting heart rate was 135 as opposed to my normal 78) and hypo-tension (my BP would drop to 90/60 and sometimes lower if I stood for any length of time but was a little higher 130/85 than my normal 118/75 when resting). I got the booster shot late in December and within hours, I was flat on my back and could barely walk to the bathroom without passing out. So in January I went to see the doctor.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare professional (Nurse practitioner) via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL 9 injection, via intramuscular route for prophylaxis (strength, dose, frequency, lot number, expiry date unspecified). On an unknown date, the patient left her GARDASIL 9 at home in room temperature for about 2 weeks before having the vaccine injected. The office staff were not aware of improper storage of vaccine at the time of injection. No adverse effect reported. No product quality complaint (PQC) was involved. No additional adverse event (AE) information provided. The patient did not discontinue the therapy. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 16-JAN-2019, the patient was vaccinated with VARIVAX (strength, dose, frequency, route, lot # and expiry were not reported) for prophylaxis, reconstituted with expired sterile diluent (strength, dose, frequency were not reported) lot # M019891 and expiry date reported 11-OCT-2018 and no adverse effects were reported. This is one of the 3 reports concerning same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (on 11th January 2019, the patient received 1st dose, for tolerance refer case number US2019045270). On 11th March 2019, the patient received the 2nd dose of SHINGRIX. On 12th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the following day (12th March 2019), she had a sore arm but no other side effects.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult male patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) and (batch number TZ2578, expiry date 6th July 2021) for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced rash. The patient was treated with prednisone. On an unknown date, the outcome of the rash was recovering/resolving.  It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however it could be 69 or 70 years. The reported batch number TZ2578 seems to be adjuvant's batch number was not available in sales data base, however it was captured as TZ2578 ? The patient developed a rash on his back. The patient was given a course of prednisone and rash was resolving. No additional details were provided at the time of the call.
Sex: U
Vaccine: PNC13
Symptoms: Bacterial infection, Laboratory test, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 2 patients. This is first of two reports. A patient of unspecified age and gender received PREVNAR 13 (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as 3 to 4 years ago), the patient got pneumonia after receiving pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The patient was tested and showed that the pneumonia strains were not covered or protected by pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein).   The following information on the batch number has been requested.; Sender's Comments: Reported event pneumonia (pneumonia strains not covered by PREVNAR 13) more likely represents coincidental bacterial infection, which considered not related to PREVENAR 13.,Linked Report(s) : US-PFIZER INC-2019114411 same reporter/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Laboratory test, Laboratory test abnormal, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for 2 patients. This is second of two reports. A patient of unspecified age and gender received PREVNAR 13 (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as 3 to 4 years ago), the patient got pneumonia after receiving pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The patient was tested and showed that the pneumonia strains were not covered or protected by pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The outcome of the event was unknown. The following information on the batch number has been requested.; Sender's Comments: Reported event pneumonia (pneumonia strains not covered by PREVNAR 13) more likely represents coincidental bacterial infection, which considered not related to PREVENAR 13.,Linked Report(s) : US-PFIZER INC-2019114309 same reporter, product, events; different patient.