chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site nodule, Liquid product physical issue, Product complaint, Product storage error
Clinical narrative: Incorrect storage of drug; Product Complaint; nodule at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site nodule in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H524, expiry date 22nd October 2021) for prophylaxis. This case was associated with a product complaint.   On 5th September 2019, the patient received Shingrix (intramuscular) .5 ml. On 5th September 2019, immediately after receiving Shingrix, the patient experienced injection site nodule. On an unknown date, the patient experienced incorrect storage of drug and pharmaceutical product complaint. On an unknown date, the outcome of the injection site nodule was recovering/resolving and the outcome of the incorrect storage of drug and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site nodule to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The pharmacist reported last 7 adjuvants of box appear to be thicker and difficult to withdraw. He noted the one he gave on the day before reporting was of this consistency, without particulate but the patient immediately developed a nodule at the site of injection. The reporter called today to report the difference with the remaining 7 adjuvants. He noted these have a clunkier flow and thick. They had been stored in a fridge that doesn't have a freezer attached, the temps have been at 41 and 42 degrees Fahrenheit, which led to incorrect storage of drug and pharmaceutical product complaint. The reporter also noted a "jelly like" consistency to the adjuvant. He would return the box and remaining vials of adjuvant and powder. The credit of 7 doses to direct GlaxoSmithKline account.  The patient nodule was reducing in size per the pharmacist. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: experienced neuropathy; experienced neuropathy (tingling and pain) in extremities; experienced neuropathy (tingling and pain) in extremities; Heat with extremities; This case was reported by a pharmacist via call center representative and described the occurrence of neuropathy in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included neuropathy (the patient had neuropathy due to B12 deficiency and was disappeared for 7 years) and vitamin b12 deficiency.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 21 days after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), pain in extremity, tingling of extremity and extremities hot feeling of. On an unknown date, the outcome of the neuropathy, pain in extremity, tingling of extremity and extremities hot feeling of were unknown.   It was unknown if the reporter considered the neuropathy, pain in extremity, tingling of extremity and extremities hot feeling of to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced neuropathy (tingling and pain) in extremities 3 weeks after 1st dose of Shingrix vaccine. The reporter reported that the patient had neuropathy before but was due to a B12 deficiency then disappeared for 7 years and now reappeared after shingrix vaccination. The reporter consented to follow up.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness and swelling in right arm from shoulder to elbow.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Severe muscle aches, headache, chills for @ 24 hours, then weakness, malaise for next 24 hours
Age: 36.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Chills, Headache, Insomnia, Muscle twitching, Pyrexia
Clinical narrative: Client stated she noticed a headache, chills, fever 100.2, sleepy, legs twitching,  restless and unable to sleep, Client stated she had 2 glasses of wine and had stopped taking antidepressants Sunday 9/15/19 and Monday 9/16/19.  Client stated fever is gone but is unable to sleep. after not sleeping the night before.
Age: 36.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Restlessness, Somnolence
Clinical narrative: Client stated she noticed a headache, chills, fever 100.2, sleepy, legs twitching,  restless and unable to sleep, Client stated she had 2 glasses of wine and had stopped taking antidepressants Sunday 9/15/19 and Monday 9/16/19.  Client stated fever is gone but is unable to sleep. after not sleeping the night before.
Age: 8.0
Sex: F
Vaccine: RV1
Symptoms: No adverse event, Product preparation error, Wrong product administered, Wrong technique in product usage process
Clinical narrative: Patient was ordered polio IM but given rotarix mixed with MMR diluent and given IM. No adverse effects seen yet
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: A few hours after vaccination, patient states she had extreme soreness in the upper arm and it  started to turn very red and hot. When she presented back to the Pharmacy 3 days later, the redness and edema was still present on her entire upper arm from the top of deltoid, down to the elbow and on the under side of the arm as well. She was counseled to take Benadryl and to seek medical attention if the swelling did not go down some in the morning or spread further. I asked her to mark the area so she could compare in the morning.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Headache, Myalgia, Pyrexia, Sensitive skin
Clinical narrative: patient claims symptoms started 12 hours after receiving the vaccine- she stated she had severe muscle aches, chills, skin hypersensitivity, headache, shaking, fever
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Tremor
Clinical narrative: patient claims symptoms started 12 hours after receiving the vaccine- she stated she had severe muscle aches, chills, skin hypersensitivity, headache, shaking, fever
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia, Nausea
Clinical narrative: Vaccine Saturday 12:30pm. Side effects: muscle ache, stomach ache, headache, nausea, fever, shivers. Began about 3am Sunday morning; Sunday, day after vaccine was height of side effects; 99.9 fever after Tylenol; fever did not return to normal until day 3 (Tuesday).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Vaccine Saturday 12:30pm. Side effects: muscle ache, stomach ache, headache, nausea, fever, shivers. Began about 3am Sunday morning; Sunday, day after vaccine was height of side effects; 99.9 fever after Tylenol; fever did not return to normal until day 3 (Tuesday).
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Lacrimation increased, Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: Patient claimed she felt tingling and swelling of throat and her eyes watered.  She was counseled to take a Benadryl and call her doctor, no visible signs, just her feeling.  She said she had to take another Benadryl later that day. She felt better the next day at lunch, about 24 hours after the immunization. Her doctor was notified.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no ADVERSE effect, vaccine administered in error, patient was due for MCV-4 at this office visit.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Pyrexia
Clinical narrative: About twelve hours after receiving vaccination I had. Chills and 100 degree fever. Even with a fever I felt very cold.i took two 500 mg acetaminophen gelcaps around one a.m.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Inflammation, Pruritus, Rash
Clinical narrative: patient reports that on 9/13/2019 after the office visit she began a rash, described as erythematous, inflamed and itchy. with associated symptoms of headache, painful rash, pruritus, dizziness and vision changes.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous, Rash pruritic, Visual impairment
Clinical narrative: patient reports that on 9/13/2019 after the office visit she began a rash, described as erythematous, inflamed and itchy. with associated symptoms of headache, painful rash, pruritus, dizziness and vision changes.
Age: 4.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient received an improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to an approximately 4-year-old patient of unknown gender. The patient's drug reactions or allergies, medical history and concomitant medications were not reported.       The vaccine underwent two temperature excursion of -14 degree Celsius to -10 degree Celsius (also reported as "-11.91 C, multiple") for 8 hours, one on 12-AUG-2019, and one on 13-AUG-2019. There was no previous temperature excursion. Data logger was involved. On 21-AUG-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (lot # R026722, expiration date 17-MAR-2020 or lot # R023499, expiration date 13-FEB-2020) (dose, route of administration were not reported) which was reconstituted with properly stored sterile diluent for prophylaxis. No adverse effect was reported. No product quality complains involved.
Sex: F
Vaccine: MMR
Symptoms: Viral titre increased
Clinical narrative: recently had a "titer test" and physician recommended that she have the MMR II administered as her " "titers were low"/ lack of efficacy; she have the MMR II administered as her " "titers were low"; This spontaneous report refers to a 55-year-old female patient reporting on herself. The patient's historical condition included allergic reaction to a unspecified tentnus vaccine. The patient's current condition included allergy to neomycin. There was no information about the patient's concomitant therapies. On an unknown date (reported as on a unspecified date in the late fifties or early sixties), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in the unspecified arm (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had a titer test and the physician recommended that the patient had the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered as her titers were low. The patient did not receive any treatment for the events. Due to response and lack of efficacy the adverse event was filed as a precaution. The patient didn't sought medical attention.  The outcome of the events and the causality assessment between the events and suspect therapy was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assislant confirmed route of administration was intramuscular.; No adverse effects reported.; Medical Assistant reports that one dose of an improperly stored vaccine, VARIVAX was administered to one patient.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 09-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter intramuscular route (Strength, dose, frequency, and anatomical location were unknown) with lot # S002877 and expiration date 29-JAN-2021 for prophylaxis reconstituted with sterile diluent(MERCK STERILE DILUENT) with possible Lot# S000130 and possible Expiration Date: 23-AUG-20219 that was stored in the correct storage temperature range.   The administered dose of vaccine experienced the temperature excursion of 8.1 °F degrees Fahrenheit for 20 minutes. There was a digital data logger invloved, and also a previous temperature excursion of 8.1 °F degrees Fahrenheit for 17 minutes and 9.5 °F degrees Fahrenheit 21 minutes . No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 09-SEP-2019, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, once, intramuscularly, lot # S002877, expiration date: 29-JAN-2021, for prophylaxis. Sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was stored in the correct storage temperature range. The vaccine underwent temperature excursion of 8.1 degrees Fahrenheit for 20 minutes. There were previous temperature excursions of 8.1 degrees Fahrenheit for 17 minutes and 9.5 degrees Fahrenheit for 21 minutes. The digital data logger was involved in recording excursion details. No adverse effects were reported.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain, Pyrexia
Clinical narrative: High Fever 102  lasting 3 days, body and  muscle aches 3 days,  painful joints 5 days
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Flushing, Influenza like illness, Injection site nodule, Lethargy
Clinical narrative: Large knot on spot of injection occurred with a hour.  The next day I had flu like symptoms that lasted all day.  Fever ranging from 99.9 to 100.8.  Tired all day and took three naps.  Face felt flush.  Both arms and legs ached.  Lethargic.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Large knot on spot of injection occurred with a hour.  The next day I had flu like symptoms that lasted all day.  Fever ranging from 99.9 to 100.8.  Tired all day and took three naps.  Face felt flush.  Both arms and legs ached.  Lethargic.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Feeling cold, Injection site pain, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: PATIENT REPORTED SHE HAD CHILLS, FEVER, AND VOMITING THE NIGHT IMMEDIATELY AFTER RECEIVING THE VACCINE AND FELT BETTER AGAIN AFTER 1 DAY. ALSO REPORTS INJECTION SITE WAS SWOLLEN AND PAINFUL.
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Rash, Swollen right neck gland.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Fatigue, Headache
Clinical narrative: Severe pain in shoulder at upper arm, radiating to neck and head. Began 2-3 hours following injection,  lasted three days before easing up. Rapid pulse first two days. Nausea and stomach discomfort, loss of appetite.   Tiredness and lack of strength in limbs. Considered ER visit but decided to wait it out. These are listed as normal reactions but I felt they were way too severe and disrupted my ability to do anything for three days. Today is day five and arm/shoulder pain is gone, pulse ok now, but still have fatigue, headache, low fever and hot flashes. I am reporting the incident to my healthcare provider and the pharmacy itself.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Hot flush, Loss of personal independence in daily activities, Musculoskeletal pain, Nausea
Clinical narrative: Severe pain in shoulder at upper arm, radiating to neck and head. Began 2-3 hours following injection,  lasted three days before easing up. Rapid pulse first two days. Nausea and stomach discomfort, loss of appetite.   Tiredness and lack of strength in limbs. Considered ER visit but decided to wait it out. These are listed as normal reactions but I felt they were way too severe and disrupted my ability to do anything for three days. Today is day five and arm/shoulder pain is gone, pulse ok now, but still have fatigue, headache, low fever and hot flashes. I am reporting the incident to my healthcare provider and the pharmacy itself.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: Severe pain in shoulder at upper arm, radiating to neck and head. Began 2-3 hours following injection,  lasted three days before easing up. Rapid pulse first two days. Nausea and stomach discomfort, loss of appetite.   Tiredness and lack of strength in limbs. Considered ER visit but decided to wait it out. These are listed as normal reactions but I felt they were way too severe and disrupted my ability to do anything for three days. Today is day five and arm/shoulder pain is gone, pulse ok now, but still have fatigue, headache, low fever and hot flashes. I am reporting the incident to my healthcare provider and the pharmacy itself.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: PATIENT HAD SEVERE BODY ACHES THROUGH THE NIGHT, THE NIGHT OF THE VACCINATION. LASTED APPROXIMATELY 12 HOURS. NO MEDICATIONS WERE TAKEN FOR THIS. PATIENT SAID THIS SUBSIDED IN THE MORNING
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: it started one hour after injections. painful, red and swallow. about 4x6 wide. warm and hard.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle twitching, Pain, Pain in extremity
Clinical narrative: PATIENT STATES HE HAS RANDOM TWITCH IN LEFT FOREARM WHICH STARTED A FEW DAYS AFTER VACCINE. NO PAIN OR DISCOMFORT HOWEVER CERTAIN WAYS HE MOVES HIS ARM IT WILL BE SORE BUT HE IS NOT SURE IF THAT IS DUE TO PAST ROTATER CUFF  INJURY. HE DOES LIFT WEIGHTS. STATES INJECTION SITE WAS NOT RED OR SWOLLEN OR ANY MORE SORE THEN NORMAL AFTER A VACCINE
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash pruritic, Rash vesicular
Clinical narrative: Patient developed a rash down both arms and on upper chest.  Rash itched and blistered.  Itching and blistering resolved, but redness is still clearly visible approx. 2 months later.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Erythema, Nausea, Ocular hyperaemia
Clinical narrative: patient started coughing/wheezing/nausea difficulty breathing- throat sore- face and eyes turned red. Pulse ox taken- Dr notified- breathing treatment albuterol given. o2 stat was 91 immediately upon symptoms  . After treatment o2 was 96-97.  patient observed for 2 hours after vaccine.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Wheezing
Clinical narrative: patient started coughing/wheezing/nausea difficulty breathing- throat sore- face and eyes turned red. Pulse ox taken- Dr notified- breathing treatment albuterol given. o2 stat was 91 immediately upon symptoms  . After treatment o2 was 96-97.  patient observed for 2 hours after vaccine.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Feeding disorder, Head injury, Loss of consciousness, Nausea
Clinical narrative: Due to the bee sting the previous day I took 50mg of Benadryl 9/14 in the afternoon. Began feeling nauseous,  at dinner time, could not eat, vomited, passed out and hit my head (laceration that did not need stitches).  Experienced the chills and went to bed and felt better the next morning.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Skin laceration, Vomiting
Clinical narrative: Due to the bee sting the previous day I took 50mg of Benadryl 9/14 in the afternoon. Began feeling nauseous,  at dinner time, could not eat, vomited, passed out and hit my head (laceration that did not need stitches).  Experienced the chills and went to bed and felt better the next morning.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; pediatric VAQTA were administered to a nineteen yera old patient; This spontaneous report was received from a Medical assistant regarding to a 19-year-old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 13-SEP-2019, (also reported as today) the patient was vaccinated with pediatric hepatitis a vaccine, inactivated (VAQTA) 2 doses of 0.5ml vials(route was not reported) lot # S002505 and expiry date 04-APR-2020, for prophylaxis (product administered to patient of inappropriate age). No product quality issue and no adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Ill; Body aches; Extreme fatigue; Headaches; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 2nd dose of Shingrix. On 6th September 2019, 1 days after receiving Shingrix, the patient experienced unwell. In September 2019, the patient experienced general body pain, fatigue, headache and low grade fever. On an unknown date, the outcome of the unwell, general body pain, fatigue, headache and low grade fever were recovering/resolving.   It was unknown if the reporter considered the unwell, general body pain, fatigue, headache and low grade fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was ill and less than a week after vaccination experienced body aches, extreme fatigue, headaches and low grade fever. The patient asked whether is this normal for the 2nd dose. This case has been linked with case US2019AMR163561, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Ill; Body aches; Extreme fatigue; Headaches; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 2nd dose of Shingrix. On 6th September 2019, 1 days after receiving Shingrix, the patient experienced unwell. In September 2019, the patient experienced general body pain, fatigue, headache and low grade fever. On an unknown date, the outcome of the unwell, general body pain, fatigue, headache and low grade fever were recovering/resolving.   It was unknown if the reporter considered the unwell, general body pain, fatigue, headache and low grade fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was ill and less than a week after vaccination experienced body aches, extreme fatigue, headaches and low grade fever. The patient asked whether is this normal for the 2nd dose. This case has been linked with case US2019AMR163558, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Within a couple of hours the area began to itch.  Pain at injection site in deltoid area of left arm started within 4-5 hours of the injection..  Became hot to touch.  Over next 12-24 hours redness progressed to entire upper left arm.  Area was swollen.  Area remained swollen and very painful through evening of September 16.  The Pharmacy suggested taking Advil and using ice to the area.  I only took the Advil.  I felt the ice would be too uncomfortable so did not use it.  As of today, September 17, the area remains red, less swollen and less painful.  It is itching again.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Asthma, Chest discomfort, Condition aggravated, Diarrhoea, Feeling abnormal
Clinical narrative: Both daughter 23 and my son 19 began have symptoms the next day starting to resemble a severe head cold and overall feeling bad, my son symptoms remain consistent with head cold. My daughter however, progressive got worse, with headache, severe head congestion, throat feels thick, heavy chest , asthma reaction, said feels like throat is closing up, diarrhea , vomiting. The vomiting and diarrhea started last night and worse today. We called several time to doctor his morning and then at 1130 I was finally able to reach someone and they called in Zovoran for her, but as of yet they have not and still waiting to for Doctor office to call this medicine , so we can pick it up. Due to making her asthmas worse she has taking two puffs of albuterol inhaler and 1 puff on Advair disk 30 mins ago. She also took Alkezelzer cold and flu medicine  30 min ago in hopes to help loosen up congestion and headache. . If Breathing gets worse and albuterol doesn't help we will take her to clinic or ER.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nasopharyngitis, Pharyngeal swelling, Sinus congestion, Throat tightness
Clinical narrative: Both daughter 23 and my son 19 began have symptoms the next day starting to resemble a severe head cold and overall feeling bad, my son symptoms remain consistent with head cold. My daughter however, progressive got worse, with headache, severe head congestion, throat feels thick, heavy chest , asthma reaction, said feels like throat is closing up, diarrhea , vomiting. The vomiting and diarrhea started last night and worse today. We called several time to doctor his morning and then at 1130 I was finally able to reach someone and they called in Zovoran for her, but as of yet they have not and still waiting to for Doctor office to call this medicine , so we can pick it up. Due to making her asthmas worse she has taking two puffs of albuterol inhaler and 1 puff on Advair disk 30 mins ago. She also took Alkezelzer cold and flu medicine  30 min ago in hopes to help loosen up congestion and headache. . If Breathing gets worse and albuterol doesn't help we will take her to clinic or ER.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Both daughter 23 and my son 19 began have symptoms the next day starting to resemble a severe head cold and overall feeling bad, my son symptoms remain consistent with head cold. My daughter however, progressive got worse, with headache, severe head congestion, throat feels thick, heavy chest , asthma reaction, said feels like throat is closing up, diarrhea , vomiting. The vomiting and diarrhea started last night and worse today. We called several time to doctor his morning and then at 1130 I was finally able to reach someone and they called in Zovoran for her, but as of yet they have not and still waiting to for Doctor office to call this medicine , so we can pick it up. Due to making her asthmas worse she has taking two puffs of albuterol inhaler and 1 puff on Advair disk 30 mins ago. She also took Alkezelzer cold and flu medicine  30 min ago in hopes to help loosen up congestion and headache. . If Breathing gets worse and albuterol doesn't help we will take her to clinic or ER.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored vaccine administered intramuscularly; confirmed route of administartation was intramuscular; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. Information on patient's pertinent medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002877, expiry date: 29-JAN-2021) (dose details, strength unknown) via intramuscular route for prophylaxis (incorrect route of product administration). The administered varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature of 8.1 degree fahrenheit within time frame of 20 minutes (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with sterile diluent (possible lot # S000130, expiry date: 23-AUG-2021) which was stored in correct temperature. The previous temperature excursions included were 8.1 degree fahrenheit for 17 minutes and 9.5 degree fahrenheit for 21 minutes. The digital data logger was involved. No adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Pain in extremity
Clinical narrative: Pain in arm; Redness around the injection site area; Felt bad for about 2 days; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling bad, pain in arm and injection site erythema. In September 2019, the outcome of the feeling bad was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad, pain in arm and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 58 or 57 years old at time of vaccination. The patient received 1st dose of Shingrix and she felt bad for about 2 days and that resolved. In September 2019, the patient experienced pain in arm that had improved but not totally resolved. In September 2019, the patient also experienced redness around the injection site area that had not cleared up yet. The reporter did not consent to follow-up. The reporter declined to provide demographics. This case has been linked with US2019164588, having same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Flu Like Symptoms; Chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, chills and fever. On an unknown date, the outcome of the influenza-like symptoms, chills and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, chills and fever that lasted for about 3 days after receiving Shingrix. No further details were provided.  The patient was reporting event for herself, her friend, and her friends husband.  This case was 1 of 3 cases, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received the first dose of Shingrix and then a few weeks later developed a case of shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age vaccination was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) reported that a patient had an outbreak of Shingles after receiving the 1st dose. The reporter did not consent to follow-up. The reporter asked that If i had patient who received the first dose of Shingrix and then a few weeks later developed a case of shingles, do I need to restart the entire vaccination series for her or can I just proceed with the second dose after confirming the appropriate amount of time has elapsed and the acute episode has resolved. The reporter disconnected without giving contact or patient information.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on torso; This case was reported by a consumer via call center representative and described the occurrence of rash in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 86 or 85 years old at time of vaccination. The reporter was daughter of patient who received first dose of Shingrix in Aug 2019. The reporter stated that patient experienced rash on his torso that had not resolved. The reporter did not consent to follow-up. The reporter declined to provide demographics or follow up. This case has been linked with US2019164591, having same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Nausea, Pain
Clinical narrative: Chills; Aching; Nausea; Fatigue; Weakness; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received Shingrix. On 10th September 2019, 1 days after receiving Shingrix, the patient experienced chills, pain, nausea, fatigue and weakness. On an unknown date, the outcome of the chills, pain, nausea, fatigue and weakness were not recovered/not resolved.   It was unknown if the reporter considered the chills, pain, nausea, fatigue and weakness to be related to Shingrix.  Additional details were provided as follows: Information obtained via webchat. The reporter was the wife of this patient.  The age at vaccination was not reported. The patient received Shingrix and was currently experiencing chills, aching, nausea, fatigue and weakness. The reporter did not consent to follow up. The reporter did not provide any demographic details and disconnected chat when asked for any demographic information to complete safety reporting.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on both Ankles; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number AS479, expiry date 25th September 2021) for prophylaxis.   On 9th September 2019, the patient received the 2nd dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist asked any information on this type of reaction after 2nd dose Shingrix. The healthcare professional (HCP) stated that patient experienced rash on both ankles within 5 hours after 2nd dose administration. The HCP stated that no fever, chills or pain.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Acute episode of shingles; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 10th September 2019, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy intern. The age at vaccination was not reported. After vaccination, the patient experienced an acute episode of shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Flu Like Symptoms; Chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, chills and fever. On an unknown date, the outcome of the influenza-like symptoms, chills and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, chills and fever that lasted for about 3 days after receiving dose of Shingrix. No further details were provided.  The patient was reporting event for herself, her friend, and her friends husband. This was 1 of the 3 cases, reported by same reporter.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt experienced pain in the evening after administration, with redness and puffiness about 4 inch area. Pt came into pharmacy a few days later and still showed redness which had extended to wider area but less puffiness with no pain. Pt stated she did not feel she needed to see her MD but would continue to monitor symptoms. Pt did not feel this needed attention but spouse recommeded she notify pharmacy.
Age: 13.0
Sex: F
Vaccine: HEPA, IPV, VARCEL
Symptoms: Headache, Nausea, Syncope
Clinical narrative: Child present for immunization clinic with her family.  Following administration of IPV and Hep A vaccinations, she experienced a syncopal episode.  Child was seated at the table and was caught by parent and RN as she fainted.  Child quickly began to rouse from syncopal episode, parent picked her up and then sat with her on a row of chairs so child?s head could be lowered and feet elevated above her heart.  VS taken while laying down-BP 110/70, HR 68 and RR 18.  After a few minutes, client reported feeling nauseous and requested to sit upright.  Once seated, she was able to take some sips of water.  Parent reported child had last eaten at lunch time.  Nausea subsided, and child continued to sip water and reported a slight headache.  Parents requested for child to receive Varicella vaccination after syncopal incident.  Following administration of final vaccination, client able to ambulate independently to the Public Health lobby space where family remained for an additional 10 minutes for parents and staff to observe child for any effect from additional vaccination.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Fungal test, Herpes virus test, Herpes zoster, Polymerase chain reaction
Clinical narrative: O V ZOSTER/HERPES VIRUS,  BENADRYL-MAALOX-XYLOCAINE,  KENALOG IN ORABASE
Age: 1.58
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Pt was given Varivax dose after being reconstituted in the fridge for greater than 30 minutes. No adverse reaction noted.
Age: 1.58
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product reconstitution quality issue
Clinical narrative: Pt was given Varivax dose after being reconstituted in the fridge for greater than 30 minutes. No adverse reaction noted.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: The patient right arm  which is Pneumovax shot was swelling and red.  She said she had fever.
Age: 82.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Peeling of both hands starting the day after vaccine was received.  He states the first layer of skin is coming off on both hands.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash, Streptococcus test negative, Vomiting
Clinical narrative: Started throwing up in the night on 9/11.  On 9/12, she started breaking out on her back and it quickly spread to different parts of the body.  By the 13th, it was all over her body including her face and scalp.  Took to a walk in clinic on the 12th and said to give Benadryl and come back if got worse.  As of today, Sept 17th, it is mostly gone and she has returned to school.
Age: 4.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; one patient received an improperly stored V ARlV AX; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 28-AUG-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R006221, expiration date: 29-FEB-2020 (or lot # R029517, expiration date: 14-OCT-2020)(dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The nurse reported that the varicella virus vaccine live (oka/merck)(VARIVAX) experienced two temperature excursions: one on 12-AUG-2019 and one on 13-AUG-2019. Neither were reported to the nurse until 06-SEP-2019. The nurse did not have the specific lot or expiration administered to the patient but it was one of the two reported. The vaccine underwent temperature excursion of minus 14 Celsius degrees to minus 10 Celsius degrees (-11.91 Celsius degrees, multiple) for 8 hours. There were no previous temperature excursions. The digital data logger was involved in recording excursion details. No adverse effect was reported.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: pt here for routine f/u; Pt received pneumovax 23 IM in lt deltoid. After administration had erythema noted to lt shoulder with itching reported. Pt denies SOB, throat swelling sensation or diffuse body itching. No edema or hives noted to body. Lungs sound clear equal B/L anteriorly and posteriorly. Pt given prophylitically IM of Solu-medrol 125mg, and Benadryl 25 mg PO TID. Benadryl to be taken at home due to sedative effects
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Gait disturbance, Injection site erythema, Injection site movement impairment, Injection site pain, Injection site warmth
Clinical narrative: Patient complained of soreness at injection site about 7 hours after shot.  Injection site was slightly red and warm to touch.  By evening patient would not move her right leg and dragged it was she walked because of extreme pain when bending leg. Slight fever of 100 or so the day after shot.  Limping continued for 3 days (Friday - Sunday).
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: Patient complained of soreness at injection site about 7 hours after shot.  Injection site was slightly red and warm to touch.  By evening patient would not move her right leg and dragged it was she walked because of extreme pain when bending leg. Slight fever of 100 or so the day after shot.  Limping continued for 3 days (Friday - Sunday).
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain, Swelling, Ultrasound Doppler normal
Clinical narrative: 1am day after vaccination pt awoke and could not move her L arm.  Around 5am went to parents and entire L upper arm spreading to axilla, shoulder and upper back with significant swelling.  Due to swelling and pain went to ER, had eval to r/o DVT which was negative, felt swelling 2/2 vaccine reaction.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: Vaccination complication
Clinical narrative: 1am day after vaccination pt awoke and could not move her L arm.  Around 5am went to parents and entire L upper arm spreading to axilla, shoulder and upper back with significant swelling.  Due to swelling and pain went to ER, had eval to r/o DVT which was negative, felt swelling 2/2 vaccine reaction.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Pain, Pyrexia
Clinical narrative: high fever, severe body aches (9 on the scale of 1-10) and crying.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Malaise, Oropharyngeal pain
Clinical narrative: Site redness, edema, induration, reported fever, malaise, body aches.  Reported started with malaise on 8/19 by 8/21 felt body aches , fever and sore throat.  Seen my MD on 8/23 the day she reported symptoms.  Dr Prescribed prednisone. Follow up on 9/5/2019 symptoms resolved.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: Site redness, edema, induration, reported fever, malaise, body aches.  Reported started with malaise on 8/19 by 8/21 felt body aches , fever and sore throat.  Seen my MD on 8/23 the day she reported symptoms.  Dr Prescribed prednisone. Follow up on 9/5/2019 symptoms resolved.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pt's husband explained that her arm swelled up, and is warm to the touch. She does not have a fever. Explained to husband to let us and dr know of any changes, if pain/warmness increases, she develops a fever, or if it is still warm/painful after 24 hours.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMR, MNQ
Symptoms: Arthralgia, Burning sensation, Pain, Pyrexia, Rash erythematous
Clinical narrative: Patient called on 9/17/19 to report possible adverse event to vaccines. She said on 09/13/19, about 9 days after receiving her first dose of 6 different vaccines, she started to get body aches and fevers. Fevers were between 102-104' F for 4 days. She also had significant joint pain. She was in bed the whole 4 days. Then the fever broke this morning , 09/17/19, and she started to get a rash. She described the rash as bumpy, red, itchy, and almost burning sensation. The rash is on her face, neck, shoulders, and chest. She thought it might be hives.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMR, MNQ
Symptoms: Rash pruritic
Clinical narrative: Patient called on 9/17/19 to report possible adverse event to vaccines. She said on 09/13/19, about 9 days after receiving her first dose of 6 different vaccines, she started to get body aches and fevers. Fevers were between 102-104' F for 4 days. She also had significant joint pain. She was in bed the whole 4 days. Then the fever broke this morning , 09/17/19, and she started to get a rash. She described the rash as bumpy, red, itchy, and almost burning sensation. The rash is on her face, neck, shoulders, and chest. She thought it might be hives.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Localized red, swollen, warm reaction
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Pt received shingrix shot on 9/14/19.  This is second shot, was sore for about 4 days.  Received 2nd shot.  Within 24 hours got red, about 3 inch diameter red spot.  Warm to the touch.  The redness is bright red and the red part is swollen.  Pt has taken ibuprofen and Tylenol to relieve discomfort.