chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male 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. In 2013, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Disability, Dysstasia, Gait disturbance, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of handicap in a 72-year-old male patient who received SHINGRIX (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse event (1st dose received on an unknown date, refer case US2019GSK043646) and prednisone. Concurrent medical conditions included multiple sclerosis. On 21st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, 7 days after receiving SHINGRIX, the patient experienced stomach cramps, general body pain and difficulty in standing. On 21st February 2019, the patient experienced influenza-like symptoms and walking difficulty. On an unknown date, the patient experienced handicap (serious criteria disability and GSK medically significant) and sickness. On an unknown date, the outcome of the handicap and sickness were unknown and the outcome of the influenza-like symptoms, stomach cramps, general body pain and difficulty in standing were recovered/resolved and the outcome of the walking difficulty was not recovered/not resolved. It was unknown if the reporter considered the handicap, influenza-like symptoms, walking difficulty, stomach cramps, general body pain, difficulty in standing and sickness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right arm. The same night of vaccination, the patient experienced flu like symptoms, and had trouble walking. This was lasted for 2 days and he started feeling better. About a week later, the patient experienced stomach cramps, stomach pain, flu like symptoms, body aches, trouble walking and trouble standing up. The patient had some prednisone lying around that he started taking that he uses for his multiple sclerosis. In 2019, less than a month after receiving SHINGRIX, the patient was sick and handicapped and no one was able to take care of him. The patient recovered from all the symptoms except he was still having trouble walking and standing up. The reporter consented to follow up. No further details were provided. This case has been linked with case US2019041402, reported by same reporter. (Patient's wife).
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of handicap in a 72-year-old male patient who received SHINGRIX (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse event (1st dose received on an unknown date, refer case US2019GSK043646) and prednisone. Concurrent medical conditions included multiple sclerosis. On 21st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, 7 days after receiving SHINGRIX, the patient experienced stomach cramps, general body pain and difficulty in standing. On 21st February 2019, the patient experienced influenza-like symptoms and walking difficulty. On an unknown date, the patient experienced handicap (serious criteria disability and GSK medically significant) and sickness. On an unknown date, the outcome of the handicap and sickness were unknown and the outcome of the influenza-like symptoms, stomach cramps, general body pain and difficulty in standing were recovered/resolved and the outcome of the walking difficulty was not recovered/not resolved. It was unknown if the reporter considered the handicap, influenza-like symptoms, walking difficulty, stomach cramps, general body pain, difficulty in standing and sickness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right arm. The same night of vaccination, the patient experienced flu like symptoms, and had trouble walking. This was lasted for 2 days and he started feeling better. About a week later, the patient experienced stomach cramps, stomach pain, flu like symptoms, body aches, trouble walking and trouble standing up. The patient had some prednisone lying around that he started taking that he uses for his multiple sclerosis. In 2019, less than a month after receiving SHINGRIX, the patient was sick and handicapped and no one was able to take care of him. The patient recovered from all the symptoms except he was still having trouble walking and standing up. The reporter consented to follow up. No further details were provided. This case has been linked with case US2019041402, reported by same reporter. (Patient's wife).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 63-year-old male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The patient experienced adverse reaction after receiving 1st dose of SHINGRIX. The patient was late for 2nd dose of SHINGRIX due to an ongoing adverse reaction from the 1st dose of SHINGRIX. The reporter did not consent to follow-up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of diarrhea in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 7th March 2019, 2 days after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not reported. It was unknown if the reporter considered the diarrhea to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's husband. The physician reported that his wife received the vaccine on the left arm, and 48 hours later experienced severe diarrhea. The reporter gave consent to follow up. This case has been linked to the case US2019042995 (husband's case) reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The event high grade fever and injection site pain occurred soon after second dose, where the specific time was unknown. The patient was on bed for one week. The events were resolved within one week following the second dose. The patient did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On 24th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not reported. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient felt very sick after the dose of SHINGRIX. The patient disconnected before providing any additional information. Call Notes: Caller only provided first name. She disconnected before providing any additional information.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Started 10-8-18 with large redness, warmth, and swelling. Continued to get larger the next day. Lasted 3 weeks.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Unknown, none noted.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Generalised erythema
Clinical narrative: Nurse with Dr. office called the pharmacy on Thursday 3-14-2019 and asked what IMZ was the patient given. We faxed the Vaccine Administration Record and Informed Consent to them. Per Nurse, the patient was having a reaction and upon talking with the husband his wife's skin was red from the neck down and red all over. She was not in pain but knew she was having a reaction and she went to see the doctor for relief from the reaction.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Right arm with localized redness (2 3/4" X 2 1/2") , mild swelling and tender to touch.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Was vaccinated on 3-11-2019. Woke up the next morning with a temperature 101.3 and a sore throat.  Negative strep test. Unable to rule out fever being an adverse reaction of vaccine. Was told to take Tylenol and Motrin to control the fever.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Bone pain, Lethargy, Nuclear magnetic resonance imaging spinal, Pain of skin
Clinical narrative: Day after injection, all body bone pain and lethargy. Four days later full body rash. After a few weeks, began right sided thoracic level intermittent pain over right kidney area with a mild itchy rash. Had three different hospital clinic work ups: ultrasound for kidney stones, Xrays of spine, and MRI of spine. On fourth visit to see oncologist for possible MGUS progression, Dr. diagnosed the pain as =Dermatome pain. This had been suggested by PCP and Physical Therapist, but thought to be unlikely with no live virus in SHINGRIX vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic, Renal pain, Spinal X-ray, Ultrasound scan
Clinical narrative: Day after injection, all body bone pain and lethargy. Four days later full body rash. After a few weeks, began right sided thoracic level intermittent pain over right kidney area with a mild itchy rash. Had three different hospital clinic work ups: ultrasound for kidney stones, Xrays of spine, and MRI of spine. On fourth visit to see oncologist for possible MGUS progression, Dr. diagnosed the pain as =Dermatome pain. This had been suggested by PCP and Physical Therapist, but thought to be unlikely with no live virus in SHINGRIX vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Borrelia test, Headache, Injection site reaction, Injection site warmth, Lymphadenopathy
Clinical narrative: Evening of vaccine, developed high fever, uncontrollable shaking. Swollen glands, and severe headache only on left side. Next day, symptoms reappeared with a painful circular rash (3 inches across) on left arm well below injection site, rash was hot to touch and very painful. Fever, neck and head pain resolved on 3rd day but rash continued for a few days, then started to lighten but still has the sensation of discomfort when touched. Please note all symptoms, except fever, were all on the side that vaccine was given.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pyrexia, Rash, Tenderness, Tremor
Clinical narrative: Evening of vaccine, developed high fever, uncontrollable shaking. Swollen glands, and severe headache only on left side. Next day, symptoms reappeared with a painful circular rash (3 inches across) on left arm well below injection site, rash was hot to touch and very painful. Fever, neck and head pain resolved on 3rd day but rash continued for a few days, then started to lighten but still has the sensation of discomfort when touched. Please note all symptoms, except fever, were all on the side that vaccine was given.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Borrelia test negative, Chills, Headache, Immunology test, Injection site erythema
Clinical narrative: Evening of vaccine, developed high fever, uncontrollable shaking. Swollen glands, and severe headache only on left side. Next day, symptoms reappeared with a painful circular rash (3 inches across) on left arm well below injection site, rash was hot to touch and very painful. Fever, neck and head pain resolved on 3rd day but rash continued for a few days, then started to lighten but still has the sensation of discomfort when touched. Please note all symptoms, except fever, were all on the side that vaccine was given.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Evening of vaccine, developed high fever, uncontrollable shaking. Swollen glands, and severe headache only on left side. Next day, symptoms reappeared with a painful circular rash (3 inches across) on left arm well below injection site, rash was hot to touch and very painful. Fever, neck and head pain resolved on 3rd day but rash continued for a few days, then started to lighten but still has the sensation of discomfort when touched. Please note all symptoms, except fever, were all on the side that vaccine was given.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Miliaria, Pyrexia, Rash, Rash erythematous, Tremor
Clinical narrative: Evening of vaccine, developed high fever, uncontrollable shaking. Swollen glands, and severe headache only on left side. Next day, symptoms reappeared with a painful circular rash (3 inches across) on left arm well below injection site, rash was hot to touch and very painful. Fever, neck and head pain resolved on 3rd day but rash continued for a few days, then started to lighten but still has the sensation of discomfort when touched. Please note all symptoms, except fever, were all on the side that vaccine was given.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Vaccine administered on 3/12/19. Patient developed shingles rash on 3/16/19 on chest. Quickly spread across right side of chest around right side of neck and back and now appearing on right eye.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Diarrhoea, Dyspnoea, Fatigue, Full blood count
Clinical narrative: Had the shot on Monday, February 18. By Thursday, February 21, became totally exhausted, waves of fever and sweats, headache and muscle ache. On Friday, I had nausea and diarrhea, which continued for 4 days, coupled with vomiting and continuation of previous symptoms. On Sunday, red rash erupted on my chest. Developed chest congestion and severe coughing, difficulty breathing and sleeping. Spent Thursday through Tuesday in bed, exhausted. Finally went to emergency room on Tuesday evening when symptoms were not improving. At this time, one month after the shot, my stamina has not returned and the congestion and cough persist.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Influenza A virus test, Influenza B virus test, Insomnia
Clinical narrative: Had the shot on Monday, February 18. By Thursday, February 21, became totally exhausted, waves of fever and sweats, headache and muscle ache. On Friday, I had nausea and diarrhea, which continued for 4 days, coupled with vomiting and continuation of previous symptoms. On Sunday, red rash erupted on my chest. Developed chest congestion and severe coughing, difficulty breathing and sleeping. Spent Thursday through Tuesday in bed, exhausted. Finally went to emergency room on Tuesday evening when symptoms were not improving. At this time, one month after the shot, my stamina has not returned and the congestion and cough persist.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Myalgia, Nausea, Pyrexia, Rash
Clinical narrative: Had the shot on Monday, February 18. By Thursday, February 21, became totally exhausted, waves of fever and sweats, headache and muscle ache. On Friday, I had nausea and diarrhea, which continued for 4 days, coupled with vomiting and continuation of previous symptoms. On Sunday, red rash erupted on my chest. Developed chest congestion and severe coughing, difficulty breathing and sleeping. Spent Thursday through Tuesday in bed, exhausted. Finally went to emergency room on Tuesday evening when symptoms were not improving. At this time, one month after the shot, my stamina has not returned and the congestion and cough persist.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Respiratory tract congestion, Vomiting
Clinical narrative: Had the shot on Monday, February 18. By Thursday, February 21, became totally exhausted, waves of fever and sweats, headache and muscle ache. On Friday, I had nausea and diarrhea, which continued for 4 days, coupled with vomiting and continuation of previous symptoms. On Sunday, red rash erupted on my chest. Developed chest congestion and severe coughing, difficulty breathing and sleeping. Spent Thursday through Tuesday in bed, exhausted. Finally went to emergency room on Tuesday evening when symptoms were not improving. At this time, one month after the shot, my stamina has not returned and the congestion and cough persist.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Insomnia, Pyrexia
Clinical narrative: The evening after I got the shot I started feeling so tired and then developed a splitting headache and low grade fever. I also had a very hard time sleeping and was up and down all night.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash in a right S1 dermatomal distribution starting 3 days after vaccine. Resolving as expected given the time frame.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Axillary pain, Injection site pain, Oedema peripheral
Clinical narrative: Intense pain where shot was given and extended around entire area of upper arm, including shoulder and under arm area. There is swelling and a lump under my armpit that is very painful. Shot was given Friday Mar 15, 2019 at approximately 2pm and it's now Monday Mar 18, 2019 at 12:19 and I still have the same pain in same areas, including the swelling and lump under my arm put.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Pain, Skin warm, Swelling
Clinical narrative: Imz given on 3-15-19. Pt stated on 3-18-19 that soreness was immediate and there was also some minor swelling. Pt also stated that redness about the size of the palm of her hand started on 3-17-19. Area was a little warm to the touch. Pt took advil and as of the time of this report, pt still has some redness. Pt stated she does not feel bad. She contacted dr who advised her to call pharmacy since that was where vax was given. Advised pt to continue with Advil for soreness and if redness still persisted on next day to see doctor.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), albumin status rHA, one dose, lot # R023500, expiry date 13-FEB-2020, subcutaneously, diluted in sterile diluent. The vaccine was kept in the range 15 degrees Fahrenheit to 46 degrees Fahrenheit (21.6 F) for 3 hours and 30 minutes. There was also previous temperature excursion reported for this vaccine: total time in the range 6 degrees Fahrenheit to 14 degrees Fahrenheit (6F) for 30 minutes maximum. Digital data logger was used to monitor temperature. No adverse event was reported.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a female patient of an unknown age (reported as "approximately 20 years"). The patient's medical history, drug reactions/allergies and concomitant therapies were not reported. On an unknown date in 2011, the patient was vaccinated with GARDASIL, one dose (dosage form) for prophylaxis (lot#, expiry date, and route of administration were not reported). On an unknown date, unspecified time after receiving vaccination with GARDASIL the patient fainted (syncope). The outcome of syncope was unknown. The causality assessment was not provided. Product quality complaint was not involved. Upon internal review, syncope was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concomitant medication included sterile diluent. The patient's pertinent medical history, drug reaction and drug allergies were unknown. On an unknown date, the patient was vaccinated with improperly stored PROQUAD via subcutaneous route, lot # R024015 and expiry date: 19-FEB-2020 for prophylaxis (product storage error). No adverse effect reported (no adverse event). The vaccine underwent temperature excursion of 5.6 degree Celsius for 72 hours. Previously no temperature excursion was reported. The call was due to digital data logger. Product quality complaint was not involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 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.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female 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. In 2010, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider 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.
Age: 66.0
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 vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 18-OCT-2016, at age 66, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a hospital for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2008, at approximately age 63, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 76.0
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 vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 11-DEC-2014, at age 76, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed 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.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, concomitant medications or medical history were reported. On 12-MAR-2019, the patient was inadvertently vaccinated with VARIVAX lot # R024022 with expiration date on 22-AUG-2020 and PROQUAD recombinant Human Albumin (rHA) with lot number R013575 with expiration date on 10-NOV-2019 (dose and route of administration was not reported) MERCK STERILE DILUENT. However, no adverse effects were reported.
Sex: U
Vaccine: FLU4
Symptoms: Allergy to vaccine, Drug hypersensitivity, Mental disorder
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of drug allergy in a patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis.  Co-suspect products included bupropion hydrochloride (Wellbutrin) unknown for product used for unknown indication. Concurrent medical conditions included drug allergy (Chantix (Varenicline), Ciprofloxacin, Flagyl (Metronidazole Hcl), Zithromax Z-pak (Azithromycin), Paper tape).  On an unknown date, the patient received Flu trivalent vaccine at an unknown dose and Wellbutrin at an unknown dose and frequency. On an unknown date, unknown after receiving Flu trivalent vaccine and Wellbutrin, the patient experienced drug allergy, drug intolerance and psychological disorder nos. The action taken with Wellbutrin was unknown. On an unknown date, the outcome of the drug allergy, drug intolerance and psychological disorder nos were unknown. It was unknown if the reporter considered the drug allergy and drug intolerance to be related to Flu trivalent vaccine. It was unknown if the reporter considered the drug allergy and psychological disorder nos to be related to Wellbutrin. Additional details were provided as follows: The age at vaccination was not reported. The patient was allergic and intolerant to trivalent influenza virus vaccine and experienced allergy and psychological reactions due to Wellbutrin. The patient was also allergic to Chantix (Varenicline) and experienced gastro-intestinal distress; Ciprofloxacin, Flagyl (Metronidazole Hcl) and Zithromax Z-pak (Azithromycin) and experienced hives and due to paper tape, the patient experienced intolerance.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on 1st December 2018, for tolerance, refer case number US2019043008). On 1st February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, injection site erythema, injection site pain and injection site swelling. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, injection site erythema, injection site pain and injection site swelling were not reported. It was unknown if the reporter considered the fever, injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received both injections (doses). The adverse events experienced after 1st dose of SHINGRIX were more intense compared to 2nd dose.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a elderly female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. Concurrent medical conditions included drug allergy (unspecified). On 1st March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced headache, chills, fever, diarrhea, pain, injection site redness, prickly heat, injection site warmth and reactogenicity event. On an unknown date, the outcome of the headache, chills, fever, diarrhea, pain, injection site redness, prickly heat, injection site warmth and reactogenicity event were unknown. It was unknown if the reporter considered the headache, chills, fever, diarrhea, pain, injection site redness, prickly heat, injection site warmth and reactogenicity event to be related to SHINGRIX. Additional details were provided as follows: The patient was very sensitive to medications and had high reactogenicity (unspecified).
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Miliaria, Pain, Pyrexia, Reactogenicity event
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a elderly female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. Concurrent medical conditions included drug allergy (unspecified). On 1st March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced headache, chills, fever, diarrhea, pain, injection site redness, prickly heat, injection site warmth and reactogenicity event. On an unknown date, the outcome of the headache, chills, fever, diarrhea, pain, injection site redness, prickly heat, injection site warmth and reactogenicity event were unknown. It was unknown if the reporter considered the headache, chills, fever, diarrhea, pain, injection site redness, prickly heat, injection site warmth and reactogenicity event to be related to SHINGRIX. Additional details were provided as follows: The patient was very sensitive to medications and had high reactogenicity (unspecified).
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 84-year-old male patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injected limb mobility decreased and limbs stiffness. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the limbs stiffness was unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and limbs stiffness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the lower part of his left deltoid. In 2019, the patients left arm hurts at the injection site and it limits movement. The reporter reported that it hurts a little less than it did initially but has stayed like this for a while. The reporter gave consent to follow up. Reporter was transferred to MI for additional information and indicated that he had not reported this to his physician so he wanted to be sent the letter personally. The healthcare professional also mentioned that, stiffness limiting movement in the affected arm.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Depressed mood, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 63-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included tinnitus. On 4th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, 1 days after receiving SHINGRIX, the patient experienced fatigue, injection site pain, injection site erythema and injection site itching. On an unknown date, the patient experienced anxiety and feeling blue. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the injection site pain, injection site erythema and injection site itching were recovering/resolving and the outcome of the anxiety was not recovered/not resolved and the outcome of the feeling blue was unknown. It was unknown if the reporter considered the fatigue, injection site pain, injection site erythema, injection site itching, anxiety and feeling blue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The next day after vaccination patient felt tired and lasted for 24 hours. He also had pain, redness and itching at the injection site the day after receiving SHINGRIX. The patient experienced tinnitus prior to receiving the vaccine and it seemed to be present at the time of reporting and said it occurred when he would be anxious. He also said he sort of had the blues as in feeling down. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 63-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included tinnitus. On 4th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, 1 days after receiving SHINGRIX, the patient experienced fatigue, injection site pain, injection site erythema and injection site itching. On an unknown date, the patient experienced anxiety and feeling blue. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the injection site pain, injection site erythema and injection site itching were recovering/resolving and the outcome of the anxiety was not recovered/not resolved and the outcome of the feeling blue was unknown. It was unknown if the reporter considered the fatigue, injection site pain, injection site erythema, injection site itching, anxiety and feeling blue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The next day after vaccination patient felt tired and lasted for 24 hours. He also had pain, redness and itching at the injection site the day after receiving SHINGRIX. The patient experienced tinnitus prior to receiving the vaccine and it seemed to be present at the time of reporting and said it occurred when he would be anxious. He also said he sort of had the blues as in feeling down. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Decreased appetite, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 1st February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st February 2019, 12 hrs after receiving SHINGRIX, the patient experienced headache, joint pain, chills, sweating, upset stomach, insomnia, appetite absent and muscle pain. On an unknown date, the outcome of the headache, joint pain, chills, sweating, upset stomach, insomnia, appetite absent and muscle pain were recovered/resolved. It was unknown if the reporter considered the headache, joint pain, chills, sweating, upset stomach, insomnia, appetite absent and muscle pain to be related to SHINGRIX. Additional details were provided as follows: It was reported that within 12 hours of the injection, the patient experienced headache, joint pain, chills, sweating, stomach upset, could not sleep, could not eat and muscle aches. All the symptoms were lasted about 2 days and resolved. The reporter declined consent for follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Insomnia, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 1st February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st February 2019, 12 hrs after receiving SHINGRIX, the patient experienced headache, joint pain, chills, sweating, upset stomach, insomnia, appetite absent and muscle pain. On an unknown date, the outcome of the headache, joint pain, chills, sweating, upset stomach, insomnia, appetite absent and muscle pain were recovered/resolved. It was unknown if the reporter considered the headache, joint pain, chills, sweating, upset stomach, insomnia, appetite absent and muscle pain to be related to SHINGRIX. Additional details were provided as follows: It was reported that within 12 hours of the injection, the patient experienced headache, joint pain, chills, sweating, stomach upset, could not sleep, could not eat and muscle aches. All the symptoms were lasted about 2 days and resolved. The reporter declined consent for follow up.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Anal incontinence, Diarrhoea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of diarrhea in a 87-year-old male patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 8th March 2019, 3 days after receiving SHINGRIX, the patient experienced diarrhea and fecal incontinence. On an unknown date, the outcome of the diarrhea and fecal incontinence were unknown. It was unknown if the reporter considered the diarrhea and fecal incontinence to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he received the vaccine on the left arm, and 72 hours later experienced severe diarrhea. The patient was driving on the reporting date and lost control of his bowels. The reporter gave consent to follow up. This case has been linked to the case US2019042996 reported by same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain and muscle pain. On an unknown date, the outcome of the injection site pain and muscle pain were recovering/resolving. It was unknown if the reporter considered the injection site pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The reporter was the husband. The patient received SHINGRIX on right arm. The patient experienced pain at the injections site and muscle aches the day after receiving the injection. The reporter consented to follow up. The reporter was in a hurry to get off the phone to call his registered Pharmacist. The reporter was not able to get address and phone number because he was too busy giving details and asking me questions and then had to go.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 71-year-old male patient who received SHINGRIX (batch number P57AA, expiry date 20th March 2020) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, less than a week after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The patient was vaccinated with SHINGRIX and experienced redness on his arm, swelling the size of a grapefruit, and pain. The exact start date were not provided, the patient stated yesterday it was kind of small and then today it got bigger, the size of a grapefruit. The pain was a little worse, but then got better on the day of reporting. The patient had not provided the further specifics information to the reporter.
Age: 54.0
Sex: U
Vaccine: PNC13
Symptoms: Blister, Swelling
Clinical narrative: This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A 54-years-old patient of an unspecified gender received PREVNAR 13, via an unspecified route of administration on 27Feb2019 on right arm at single dose for immunisation. The patient medical history was not reported. Concomitant medication included prednisone, anastrozole, calcium and cholecalciferol. The patient experienced blistered arms, swollen and spreading on an unspecified date. Patient was given BENADRYL 25 mg, cephalexin 500 mg to treat. The outcome of the events was unknown.   No follow-up attempts are possible; information on the batch number cannot be requested.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 16-year-old female patient received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient medical history was not reported. There were no concomitant medications. The patient had a very high fever after administration of first dose of meningococcal group b rlp2086 with temperature of 103 Fahrenheit. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Allergy to vaccine, Contrast media allergy, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable nurse. A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (lot number and expiration date unknown) at a single dose for immunization; dopamine hcl at an unspecified dose and frequency for an unspecified indication; influenza vaccine at a single dose for immunization; and levofloxacin (LEVAQUIN) at an unspecified dose and frequency for an unspecified indication; all via an unspecified route of administration from an unspecified date. The patient's medical history and concomitant medications were not reported. The patient experienced allergies: contrast medium (i.v dye); penicillins; dopamine; influenza vaccines; levaquin; and pneumococcal 13-val conj vacc on an unspecified date. The action taken in response to the events for pneumococcal 13-val conj vac (dipht crm197 protein) and influenza vaccine was not applicable, for dopamine hcl and levofloxacin was unknown. The outcome of the event was unknown. Pfizer is a marketing authorization holder of [Dopamine HCl and pneumococcal 13-valent conjugate Vaccine (diphtheria CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Dopamine HCl and pneumococcal 13-valent conjugate Vaccine (diphtheria CRM197 Protein)] has submitted the same report to the regulatory authorities. Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Diaarhea nonstop 36 hours, Headache - 4 days, Chills, Arm pain radiating to wrist, rash on arm (still 3 x 5" in size), fatigue (still).
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: Diaarhea nonstop 36 hours, Headache - 4 days, Chills, Arm pain radiating to wrist, rash on arm (still 3 x 5" in size), fatigue (still).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Tenderness
Clinical narrative: 6 inch red patch, warm to the touch, tender and sore.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever 100.5-101.2.
Age: 51.0
Sex: F
Vaccine: CHOL, FLUC4, HEP, HEPA, MMR, PPV, TDAP, TYP
Symptoms: Arthralgia, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: 03/15/2019 Nausea and Muscle Aches. 03/16/2019 Chills, Muscle aches, Generalized Joint pain.  Left arm pain and limitation of range of motion. Pain of left arm 8/10. Headache, Tiredness and Lightheadedness. 03/17/2019 Redness on left deltoid injection site described by patient as 3-4 inches in diameter and redness on left upper chest. Can move her arm. Tender to touch. Describes pain as 5/10.