chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Respiratory rate increased
Clinical narrative: This spontaneous report has been received from a physician, referring to a 14 years old female patient. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medication was unknown by the physician. On an unspecified day in February 2018 (reported as "a year ago") the patient was vaccinated with one dosage form of GARDASIL 9 injection, as prevention of human papillomavirus (HPV) (dose number and frequency in vaccine series was not reported; route and anatomical location of vaccination, lot number and expiration date were unknown by the physician). The physician reported that, since an unspecified date after vaccination with GARDASIL 9 the patient began to experience panic attacks. The physician described the panic attacks as happening at random times during the unspecified days and stated that when they happened, the patient did not know where she was and seemed confused, like if she did not know what she should do. In addition, the physician mentioned that the panic attacks scared the patient, as she started to breathe fast and sometimes got dizzy. The patient was reported to be extremely tired after the panic attacks happened. According to the physician, the patient had had 2 to 3 episodes over the 2018 summer (reported as "past summer") which lasted from 30 minutes to several hours. On 04-JAN-2019 (reported as "6 weeks ago") the patient sought for medical attention and visited a neurologist who performed her a 24 hour electroencephalogram (EEG) and an unspecified bloodwork as diagnostic studies; however, both resulted normal. The patient was prescribed topiramate 25 milligrams (mg), once daily in the evening, as treatment. On an unspecified date, the patient also visited an endocrinologist, who informed her that her panic attacks were caused by GARDASIL 9. The physician reported that, since November 2018 (reported as "in the past 3 months") the patient had not had any panic attacks and, by reporting time, she had not needed to take topiramate anymore. However; on an unspecified date in February 2019 (reported as "over the past week") the panic attacks had gotten worse and more frequent as the physician described that, on 14-FEB-2019 (reported as "yesterday") the patient was sitting in class and she felt like someone "had pressed a slow-motion button" and she felt very weird. It was reported that she walked to her next class, where she felt like she and other people were moving slow and she felt like she should not be there. Finally, the physician also reported that since an unspecified date after administration of GARDASIL 9 the patient had constantly had a sore throat. By reporting time, the patient had not recovered from panic reaction, fatigue and oropharyngeal pain. The physician causality assessment between the occurred events and vaccination with GARDASIL 9 was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a pharmacy technician/student referring to an adult patient of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On approximately 08-FEB-2019 (reported as about a week ago) the patient was inadvertently vaccinated with a dose of pediatric VAQTA 25/0.5 (unit not provided) (dose, lot # and expiration date were unknown, intramuscular) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 51 year old non pregnant female patient. The patient was in the hospital for an unspecified reason, other currents conditions, medical history, concomitant medications, drug allergies or reactions were not reported. On 14-FEB-2019,  the patient was inadvertently vaccinated with PNEUMOVAX 23, by intravenous route (incorrect route of product administration  (strength, frequency, lot number and expiration date were not reported) for prophylaxis.The reporter stated that the patient remained hospitalized as of 16-FEB-2019, it was specified that she had not experienced any side effects from the intravenous administration and had not received any treatment but was remained under observation.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, at approximately 74 years of age, the patient was administered the ZOSTAVAX by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at an urgent care for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, at approximately 58 years of age, the patient was administered the ZOSTAVAX by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a hospital for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 22-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 29-SEP-2016, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving the ZOSTAVAX, the patient suffered herpes zoster. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Herpes zoster was considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, referring to a patient whose age and gender was not reported. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medication was not reported. On 22-FEB-2019, the patient was vaccinated with one expired dose of PNEUMOVAX 23 injection, by intramuscular route, for prophylaxis (dose number, frequency and anatomical location of vaccination were not reported; lot number N014188, expiration date 22-JAN-2019). No adverse reaction was reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 61 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-APR-2015, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. In May 2015, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself and economic losses. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) and refers to an adolescent (also reported as "over the age of 15 years old") female patient. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9 injection, intramuscularly in arm (exact dose, lot # and expiry date were not provided) for prophylaxis. Approximately on an unknown date in July 2018 (reported as 7 months ago), the patient missed her second dose of GARDASIL 9 of a three dose regiment. The patient did not experience any reaction.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse and refers to a 17 weeks and 5 days old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-FEB-2019, the patient was inadvertently vaccinated with ROTATEQ orally (dose was not reported, lot # R021650, expiration date 27-MAY-2020) for prophylaxis. The vaccine was administered to patient of inappropriate age. No adverse effects reported.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin (age 2 years, weight 29 lb). The patient's past and current medical history included asthma (ongoing). The following demography was reported for the patient's parent:   Sex: Female Concomitant medication included salbutamol and fluticasone propionate. The patient received FLUMIST QUADRIVALENT via nasal route, for immunization, on 24-Jan-2019 with unknown dose, frequency, and lot number. She reported the patient had the flu (preferred term: Influenza) on Friday, 25-Jan-2019, and was taken to the ER care on Saturday, 26-Jan-2019. The patient was prescribed generic Tamiflu 5 mL twice daily for five days and Cefdinir with both having started on Saturday, and she was also prescribed Prednisolone every morning, started on Sunday, no dates specified. The outcome of the event flu was unknown. The event flu was considered non-serious.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a female patient who received BEXERO for prophylaxis. On 30th January 2019, the patient received BEXERO. On an unknown date, less than a month after receiving BEXERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BEXERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXERO in the deltoid muscle and not in the shoulder. Till the time of reporting, the patient was experiencing soreness and aching of her arm, at the injection site. The reporter agrees to receive follow up from GlaxoSmithKline. Medical Science Liaison (MSL) has reached out reporter and would provide further details after they speak.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Drug interaction, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 78-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included escitalopram (LEXAPRO) for an unknown indication. On 12th February 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 13th February 2019, the patient started LEXAPRO at an unknown dose and frequency. On 15th February 2019, 3 days after receiving SHINGRIX, the patient experienced upset stomach, nausea and chills. In February 2019, the patient experienced drug interaction. LEXAPRO was interrupted. On an unknown date, the outcome of the upset stomach, nausea and chills were not recovered/not resolved and the outcome of the drug interaction was unknown. It was unknown if the reporter considered the upset stomach, nausea and chills to be related to SHINGRIX. Additional details were provided as follows: On Tuesday, the patient received SHINGRIX in the upper part of left arm. The patient was not sure if the vaccine was administered intramuscularly. The patient did not feel it when it was administered. By Friday, the patient experienced an upset stomach, nausea and chills. The patient had taken LEXAPRO on Wednesday, Thursday and Friday so he called his physician who told him to stop the Lexapro in the event of a potential drug interaction. The patient had not taken LEXAPRO since Friday but he still had the same symptoms. On Monday, the patient saw his physician for the first time, so he did not see the need to provide his information. The patient did not consent to follow-up.
Sex: M
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 70-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, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's neighbor. The age at vaccination was not reported, but the patient was 70 years old at the time of reporting. The patient received SHINGRIX on left arm. The patient experienced sore arm within 2 hours after receiving SHINGRIX. The soreness lasted 24 hours after receiving SHINGRIX. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 75-year-old female patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. On 12th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2019, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site rash were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The pharmacist reported that the patient experienced a red swollen spot that was approximately 3-4 inches in diameter at the injection site. The spot was raised and was on the patient's left deltoid. The symptoms are resolving but the patient came at the time of reporting and the area was still unresolved. Consent to follow up was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Skin disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site itching and skin breakdown. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching and skin breakdown were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching and skin breakdown to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About a week ago from the date of reporting, the patient received SHINGRIX on the left side of her body (did not indicated that it was given on arm). The patient experienced itchiness, redness and swelling at the site of the injection. The patient also experienced bursts or bumps on the right side of her neck. The patient would call her doctor if events did not resolve in a few days.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ice pick headache in a 56-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included migraine headache. On 16th February 2019, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th February 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and injection site erythema. On 18th February 2019, the patient experienced ice pick headache and shooting pain. On an unknown date, the outcome of the ice pick headache, influenza-like symptoms and injection site erythema were not recovered/not resolved and the outcome of the shooting pain was unknown. It was unknown if the reporter considered the ice pick headache and shooting pain to be related to SHINGRIX. The reporter considered the influenza-like symptoms and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated she had ice pick headaches where the pain was shooting through the same spot in her head and she described it as shooting pain. She wanted to know if the SHINGRIX could had triggered this headache. She said she had the normal flu like symptoms on Sunday and her arm is still was red at the site of the injection, till the reporting time. Due to the obvious pain the patient was having, additional questions were not asked.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Allergy test negative, Injection site papule, Injection site pruritus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site itching in a 65-year-old male patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 4ZY53, expiry date unknown) for prophylaxis. On 23rd October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 23rd October 2018, less than a day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site itching and injection site papule. The patient was treated with topical steroid NOS and antihistamine. On an unknown date, the outcome of the injection site itching and injection site papule were not recovered/not resolved.  It was unknown if the reporter considered the injection site itching and injection site papule to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the patient who himself was a physician. The patient has no allergies to report and has had allergy testing. The patient experiencing a local injection site reaction that was pruritic and papule-like in nature. Once the patient stops the local steroid cream and antihistamine treatment, the symptoms return. At the time of this report, the symptoms were ongoing. Lab Comments: Lab test performed on unknown date.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site itching in a 65-year-old male patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 4ZY53, expiry date unknown) for prophylaxis. On 23rd October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 23rd October 2018, less than a day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site itching and injection site papule. The patient was treated with topical steroid NOS and antihistamine. On an unknown date, the outcome of the injection site itching and injection site papule were not recovered/not resolved.  It was unknown if the reporter considered the injection site itching and injection site papule to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the patient who himself was a physician. The patient has no allergies to report and has had allergy testing. The patient experiencing a local injection site reaction that was pruritic and papule-like in nature. Once the patient stops the local steroid cream and antihistamine treatment, the symptoms return. At the time of this report, the symptoms were ongoing. Lab Comments: Lab test performed on unknown date.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a small red area at the site of injection after receiving SHINGRIX. No additional details were reported.
Sex: U
Vaccine: DT
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult patient who experienced allergy to vaccine, while he/she received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unspecified date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site. The patient developed a non-serious Allergies to Tetanus-Diphtheria toxoids Td (Unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS. (Other relevant tests included No lab data.) Final diagnosis was allergy to vaccine. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of document held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLU4, HEP, IPV, TD
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 20-Feb-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 17 years old female patient who was vaccinated with a 1.5 ml third dose of vaccine IPOL (lot P1A171M and Exp. Date 24-Apr-2020) via subcutaneous route in the left arm on 20 Feb 2019. The patient's medical history not reported and concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN); DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TD) and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) 0.5 ml on 20 Feb 2019 for Immunization. It was an actual medication error case due to overdose. There were no side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves 10 weeks old male patient who received 0.5 ml first dose of vaccine PENTACEL batch number UJ104AA (expiry date 13-Oct-2020) via unknown route in the left thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ and PREVNAR 13. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that child received the PENTACEL component DTap- IPV separate from the ACTHIB powder. It was unknown if any adverse event was occurred following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown demographic patient who was vaccinated with a dose of IPOL lot number not reported via unknown route in unknown administration site on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It is an actual medication error case due to incorrect product storage. It was reported that the patient injected with IPOL that was exposed to temperatures outside of recommended temperatures. At the time of report, the patient did not had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Fatigue, Feeling hot, Injected limb mobility decreased
Clinical narrative: Received the shot in upper left arm about 9:30 am. By 3:00 pm could hardly lift my arm it hurt so bad.  By 8:00 pm had fever, chills and overall very bad muscle aches. All my muscles hurt and could hardly get up from the couch. Took temperature at 10:30 pm and it was at 100.9 degrees. Teeth were chattering chills were so bad. Had a hard time laying down to sleep as everything hurt. Had chills first and had to put three blankets on the bed. Then was so hot could not have any covers on. Woke up at 7 a.m. feeling very tired and drained. Took temperature and fever was gone.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Received the shot in upper left arm about 9:30 am. By 3:00 pm could hardly lift my arm it hurt so bad.  By 8:00 pm had fever, chills and overall very bad muscle aches. All my muscles hurt and could hardly get up from the couch. Took temperature at 10:30 pm and it was at 100.9 degrees. Teeth were chattering chills were so bad. Had a hard time laying down to sleep as everything hurt. Had chills first and had to put three blankets on the bed. Then was so hot could not have any covers on. Woke up at 7 a.m. feeling very tired and drained. Took temperature and fever was gone.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Influenza like illness
Clinical narrative: Arthritis flare-up; flu-like symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Joint swelling, Musculoskeletal pain
Clinical narrative: Patient came into clinic 2 days later with left shoulder swelling, pain and decreased range of motion.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness swelling of left upper arm for 4 days. Treated with Kelfex 500mg BID for 7 days.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Patient had extreme pain in her arm that escalated to her chest for a day or 2. Patient went to urgent care where she was given some pain killer and got relief after 2 days. Now her arm is fine.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided. On 09-FEB-2019, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB intramuscularly from lot # R005114 with expiration date 26-NOV-2020, (strength and anatomical location were not reported) for prophylaxis. The vaccine was exposed to a temperature of 73 degrees Fahrenheit for a time frame of 74 hours and 45 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. The call was due to a data logger. This case was considered non-valid due to lack of patient identifiers. Upon receipt of follow-up information, it was determined that this case is now valid because patient identifier was received. Follow-up information was received from the physician on 25-FEB-2019. The physician has provided the patient's initials. The physician also stated that she was advised previously that it was ok to use the vaccine which was exposed to the temperature excursion. This is one of the two reports received from the same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 70 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2008, at approximately 63 years of age, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider. In February 2016, the patient was treated by a healthcare provider for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to himself and economic losses. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 8 year and 9 months old Child patient. There was no information regarding concomitant medication, historical medication and concurrent condition. On an unknown date the 8 year and 9 months old Child patient was vaccinated with GARDASIL 9 for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously, lot # N035941, expiry date: 18-DEC-2019 (dose and anatomical location were not provided) for prophylaxis. The dose of VARIVAX was stored out of recommended range (temperature: 12 Fahrenheit degrees) for 2 hours and 3 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-JAN-2018, the patient was inadvertently vaccinated with expired dose of GARDASIL 9 lot # L036301, expiry date: 20-DEC-2017 (dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided. On 09-FEB-2019, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB intramuscularly from lot # R005114 with expiration date 26-NOV-2020 for prophylaxis (Product storage error). The vaccine was exposed to a temperature of 73 degrees Fahrenheit for a time frame of 74 hours and 45 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. The call was due to a data logger. The physician also stated that she was advised that it was ok to use the vaccine which was exposed to the temperature excursion. This is one of the two reports received from the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 16th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th February 2019, 1 days after receiving SHINGRIX, the patient experienced fever, stomach discomfort and rash. On an unknown date, the outcome of the fever, stomach discomfort and rash were not recovered/not resolved. It was unknown if the reporter considered the fever, stomach discomfort and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The pharmacist reported that the patient's fever went as high as 101, and the rash was on her torso, front and back. On an unknown date , the patient's body temperature was recorded as 101 degree F. The pharmacist reported that the patient planned to continue follow up with her physician on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Device related infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of prosthesis related infection in a 77-year-old male patient who received SHINGRIX for prophylaxis.  The patient had a Family History of bacterial meningitis (bacterial meningitis type b  for his 55-year-old son in law). Concurrent medical conditions included shoulder replacement and exposure to communicable disease (bacterial meningitis type b). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced prosthesis related infection (serious criteria GSK medically significant). The patient was treated with sulphamethoxazole, trimethoprim (Bactrim). On an unknown date, the outcome of the prosthesis related infection was unknown. It was unknown if the reporter considered the prosthesis related infection to be related to SHINGRIX. Additional details were provided as follows: The patient called to ask questions about BEXSERO. The patient was concerned about being able to contract bacterial meningitis type B from his 55-year-old male son in law. The age at vaccination was not reported. The patient had received other vaccines, including SHINGRIX in the past and was particularly concerned because he was subject to infection. The patient at the time of reporting had an extremely bad infection on his artificial replacement in his shoulder and was being treated with Bactrim. The patient reported that if it did not clear up, he might need surgery. The patient was referred to healthcare professional. This was all the information that was captured. The patient did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Local reaction, Product administered at inappropriate site
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of local reaction in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 9th February 2019, the patient received SHINGRIX. On 9th February 2019, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In February 2019, the patient experienced local reaction, injection site pain and injection site swelling. In February 2019, the outcome of the local reaction was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site swelling and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the local reaction, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in lower back to upper hip area, due to patient's size, which led to vaccine administered at inappropriate site. The patient had horrible local reaction that lasted almost a week, really big area at the site of injection (size of a tennis ball or more), painful in the area. The patient received vaccine at a friend's house, friend was nurse practitioner.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a 97-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd 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. This case was reported for the patient's father. The patient received SHINGRIX and was in agony. No information available on lot or expiry date of receipt.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Pain in extremity
Clinical narrative: PATIENT WOKE UP MORNING AFTER VACCINATION WITH SORE ARM AND A RED, IRRITATED/ITCHY CIRCLE THE SIZE OF A NICKLE AT THE INJECTION SITE. IT DID GROW LARGER AS THE DAY WENT ON. PATIENT CALLED THE PHARMACY - WAS ADVISED BY PHARMACIST TO TRY A DAY OF BENADRYL AND KEEP TRACK IF THE MARK DECREASED IN SIZE AND IRRITATION. AFTER 2 DAYS ON BENADRYL THE PATIENT HAD RELIEF OF SYMPTOMS AND AFTER 4 DAYS ON BENADRYL, THE PATIENT HAD SAID THE MARK WAS GONE. PHYSICIAN NOT CONTACTED.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Decreased appetite, Malaise
Clinical narrative: Within 20 minutes I was very sick. Weak, no appetite. This was 3 weeks ago, and I am still not feeling well.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Feeling abnormal, Influenza like illness, Malaise, Muscle contractions involuntary
Clinical narrative: Patient complains of major pain after the vaccine and it subsided. The next morning she couldn't get up from sitting down and felt really "sick and fluish." Her friend stayed with her and he reported that her hand clenched up like a claw and she was shaking. She doesn't remember at this time what happened but said she was "spaced out." She couldn't get up from sitting and spent the rest of the day after she recovered laying down. She felt better after a 24 hour period.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: Patient complains of major pain after the vaccine and it subsided. The next morning she couldn't get up from sitting down and felt really "sick and fluish." Her friend stayed with her and he reported that her hand clenched up like a claw and she was shaking. She doesn't remember at this time what happened but said she was "spaced out." She couldn't get up from sitting and spent the rest of the day after she recovered laying down. She felt better after a 24 hour period.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Healthcare worker describes bruising at injection site on 2/26/2019 that then developed into localized redness with swelling. Healthcare worker states swelling in right arm has continued into 2/27/2019 - AM on 2/27/2019 she took Benadryl and used ice pack on area.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Reaction to second dose of SHINGRIX 50 mcg. Reaction not one listed as a side effect. Itching, redness, heat from various areas of the body. Itching etc. would appear in new area of the body, but on both sides. Started on the lower back and abdominal area, then the lower arms and palms of the hand, then to the arm pits and breast area, then to the backs of the legs and groin region. It was never itchy in more than one of these areas at the same time, and was not accompanied by any breathing problems, so did not warrant ER. It is day three after the shot and I still have symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: After receiving the Zoster vaccine, SHINGRIX, Feb. 21st, I developed fever 101, which lasted 8-10 hours, chills, headache, muscle aches, joint pain, and extreme fatigue. I had to call in sick Feb. 22 and I slept all day. I feel better today, Feb. 23.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: After receiving the Zoster vaccine, SHINGRIX, Feb. 21st, I developed fever 101, which lasted 8-10 hours, chills, headache, muscle aches, joint pain, and extreme fatigue. I had to call in sick Feb. 22 and I slept all day. I feel better today, Feb. 23.
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Influenza like illness, Injection site pain, Joint contracture, Musculoskeletal stiffness
Clinical narrative: Patient had received her second dose of SHINGRIX vaccine. She claims the vaccine process was routine and nothing out of ordinary. However, she said it was the most painful vaccine she had ever received. She said after her first dose of SHINGRIX she was fine. This time around she felt "flu-like'' symptoms. She phoned her friend to come over and help her. During the early morning she couldn't stand and had to sit. She doesn't remember what happened after that. Her friend stated that he saw the patient's hand in a claw like form and was stiff. He states she was shaking and had a blank stare. Patient mentioned her friend can over dramatize. She woke up at noon ate some cereal and fell back asleep until 6 pm.
Sex: F
Vaccine: VARZOS
Symptoms: Staring, Tremor
Clinical narrative: Patient had received her second dose of SHINGRIX vaccine. She claims the vaccine process was routine and nothing out of ordinary. However, she said it was the most painful vaccine she had ever received. She said after her first dose of SHINGRIX she was fine. This time around she felt "flu-like'' symptoms. She phoned her friend to come over and help her. During the early morning she couldn't stand and had to sit. She doesn't remember what happened after that. Her friend stated that he saw the patient's hand in a claw like form and was stiff. He states she was shaking and had a blank stare. Patient mentioned her friend can over dramatize. She woke up at noon ate some cereal and fell back asleep until 6 pm.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac function test, Cardiovascular examination, Disability, Electrocardiogram, Electroencephalogram
Clinical narrative: My daughter has cardiac syncope that she never had before. Now she's on disability and can't do anything by herself.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of personal independence in daily activities, Syncope, Tilt table test
Clinical narrative: My daughter has cardiac syncope that she never had before. Now she's on disability and can't do anything by herself.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Reporting side effects from Zoster Vaccine (Shingles). Soreness, headache, chills and slight fever.
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: See additional page(s) for complete text.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: See additional page(s) for complete text.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Lethargy
Clinical narrative: Flu like symptoms; headache; sore joints; fatigue; nasal congestion; lethargic.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasal congestion
Clinical narrative: Flu like symptoms; headache; sore joints; fatigue; nasal congestion; lethargic.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: PT HAD RASH REDNESS AND SWELLING ON RT THIGH WHERE KINRIX WAS GIVEN. DR PRESCRIBED BENADRYL AND IBUPROFEN, AND ASKED PARENTS TO  APPLY COLD COMPRESS ON RT THIGH.