chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in jaw, Sleep disorder
Clinical narrative: Began to ache from my jawline down to my feet.  Aching increasing became worse until I could barely turn over in bed or sleep properly - almost shooting pain primarily in the neck, back and hips. Also got the chills during the night and had to wrap up in a blanket for several hours until I could get warm.  The next morning (today), aching continues although I am able to function.  Also had diarrhea today.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Neck pain, Pain in extremity
Clinical narrative: site is swollen and painful.had pain radiating to neck and other arm
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Oral mucosal eruption, Rash generalised, Rash pruritic
Clinical narrative: Patient reported to me on 9/14/19 that within 2-3 hours he devoloped an itching rash on body, in both axilla, and in mouth. The itching was unbearable. I recommended that he go to an urgent care clinic or the ER. He reported back to after the physician visit that he received a shot of steroid and the doctor told him to also take Zyrtec. I was unable to reach him on 9/15/19 to determine his status today.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site erythema, Injection site pruritus, Injection site reaction, Paraesthesia
Clinical narrative: Upper arm pink to deep pink, hot, pimply, itchy,  Ice packs, benadryl tablet, benadryl liquid spray to site, lasted about 5 days,   two weeks later, electric shocks from trigeminal  nerve radiating from lower left jaw upward to eyetooth are
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray dental normal
Clinical narrative: Upper arm pink to deep pink, hot, pimply, itchy,  Ice packs, benadryl tablet, benadryl liquid spray to site, lasted about 5 days,   two weeks later, electric shocks from trigeminal  nerve radiating from lower left jaw upward to eyetooth are
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received the vaccines around 11L30am on 9/13/2019. She had soreness, swelling, heat and delineated redness in area around injection site of left arm by that evening. States the symptoms were worse on day 2 including redness and swelling of the upper arm spreading to bicep area, hardness of the upper arm.  She came to pharmacy on day 3 to report her symptoms and said her left upper arm isn't as swollen but redness has spread. Still feels soreness/pain as well as heat on the upper arm. Patients is directed to follow-up with her PCP or go to urgent care/ED if new symptoms present. Otherwise, no tightness of the chest or difficulty with breathing per patient.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: cellulitis.  redness swelling.  hot.  pt went to urgent care
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: swelling, redness on the upper half of the left arm
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: PATIENT SAID SHE WOKE UP AT 3 AM ITCHING ALL OVER HER BODY, HAD SPOTS EVERY WHERE AND BURNING PAIN ON BOTH LEGS AND FEET. I TOLD HER TO TAKE A BENADRYL AND GO TO URGENT CARE OR SEE HER PCP AS SOON AS POSSIBLE. SHE SAID ONE LEG STARTED TO GET BETTER BUT THE OTHER LEG STILL HAS SPOTS. SHE WILL CALL HER DR ON MONDAY WHEN THE OFFICE IS OPEN.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Pt described injection site reaction.  Says tolerated  first shot well with minimal reaction.  This was 2nd shot & pt reported redness & swelling at injection site (approx 1.5 inches diameter) & feeling like had "flu".  Pt called pharmacy the day after having 2nd shot to report adverse reaction.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Paraesthesia oral, Periorbital swelling, Pruritus, Pyrexia
Clinical narrative: Patient states about  1 hour to 1.5 hours after receiving vaccine she started feeling tingling around the mouth, face itching. Thought eyes felt puffy but checked in mirror and no facial swelling. Took one dose of benadryl then in one hour took another dose. No problems with tingling/itching after 2nd dose. She did feel sluggish, tired and had low grade fever the next three days.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Sluggishness
Clinical narrative: Patient states about  1 hour to 1.5 hours after receiving vaccine she started feeling tingling around the mouth, face itching. Thought eyes felt puffy but checked in mirror and no facial swelling. Took one dose of benadryl then in one hour took another dose. No problems with tingling/itching after 2nd dose. She did feel sluggish, tired and had low grade fever the next three days.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Oral pruritus, Paraesthesia, Pyrexia, Sluggishness
Clinical narrative: Patient states about  1 hour to 1.5 hours after receiving vaccine she started feeling tingling around the mouth, face itching. Thought eyes felt puffy but checked in mirror and no facial swelling. Took one dose of benadryl then in one hour took another dose. No problems with tingling/itching after 2nd dose. She did feel sluggish, tired and had low grade fever the next three days.
Age: 11.0
Sex: F
Vaccine: HEP, MMR, MNQ, TDAP, VARCEL
Symptoms: Fatigue, Feeling cold, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right arm sore, swollen and hot around shot area (tricep area where varicela shot was given) Fever, face itching, tiredness and arm pain.  Next day she woke up with no fever, no face itching  but around 6pm (sep 15th) she felt tired and cold. Arm still swollen but less pain.
Age: 11.0
Sex: F
Vaccine: HEP, MMR, MNQ, TDAP, VARCEL
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Right arm sore, swollen and hot around shot area (tricep area where varicela shot was given) Fever, face itching, tiredness and arm pain.  Next day she woke up with no fever, no face itching  but around 6pm (sep 15th) she felt tired and cold. Arm still swollen but less pain.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pain
Clinical narrative: Providing report while still recuperating so final outcome TBD.  Some arm soreness at site of injection but normal activity and diet until 4 am with onset of chills, body aches, and other flu like symptoms. Temperature not measured but may have been feverish. In bed until about 1 pm, still on couch at 4 pm.
Age: 61.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Donor reported approx. three hours after vaccine that his face was numb on the left side from his eye to mid way down his cheek, He also reported numbness on the left side of his tongue and left neck. No swelling, pain, speech or swallowing difficulties. When donor called the symptoms had been present for approx. 45min not increasing or decreasing. Donor had eaten and drank well. Donor felt otherwise normal. Donor stated he has had this happen once or twice before when he has been active all day and not eaten.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness at and around injection site that has extended to a larger area over the last 24 hours. Entire arm sore, muscles soreness, fatigue, upset stomach and headache,
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Swelling, redness at and around injection site that has extended to a larger area over the last 24 hours. Entire arm sore, muscles soreness, fatigue, upset stomach and headache,
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Respiratory distress, Throat irritation
Clinical narrative: Patient usually receives the flu shot every year with no problems - Pharmacist decides to administer the shingles vaccine first (shingrix) within a minute patient starts to have itchy throat, by the time the flu shot is administered it's become apparent to the patient that she is experiencing symptoms- she reports chest tightness, difficulty breathing and reaches for her inhaler, pharmacist reaches for the epipen as symptoms progress and shows obvious distress... pt adamantly refuses the injection, pharmacist insists she says NO, pharmacist then offers to administer diphenhydramine 50mg as an alternative and pt accepts... symptoms seem to stop getting worse after treatment with diphenhydramine... pharmacist recommends that patient goes to the hospital, pt refuses, she starts feeling better and wants to go home. pharmacist again recommends the hospital for follow up as symptoms may return patient says No, pharmacist then trains husband on how to use the Epipen and recommends a second dose of diphenhydramine in about 6 hours ...
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Fatigue, Headache, Middle insomnia
Clinical narrative: Received vaccination around 9:20AM. At 7:30PM started feeling fatigued, chilled, headache, generalized muscle and joint pain. By 8:30PM was having severe chills and fatigue.  Went to bed, fitful night with waking every hour. Awoke at 7:20AM still fatigued and sore. No injection site redness or swelling, but minor soreness.  Have received flu vaccine every year since 1973 without incident.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain, Poor quality sleep
Clinical narrative: Received vaccination around 9:20AM. At 7:30PM started feeling fatigued, chilled, headache, generalized muscle and joint pain. By 8:30PM was having severe chills and fatigue.  Went to bed, fitful night with waking every hour. Awoke at 7:20AM still fatigued and sore. No injection site redness or swelling, but minor soreness.  Have received flu vaccine every year since 1973 without incident.
Age: 66.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: 48 hours of rash. 36 hours of 102 fever and chills
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Ear infection, Ear pain, Influenza like illness, Myalgia
Clinical narrative: Started  later in the evening  with achy muscles, fever, and cold or flu like symptoms.  Middle of the night stomach cramps and feeling of nausea.  Lasted about 3 days and then progressed to an earache in the left ear.  Ear became badly infected and had to go back to the doctor for tests and Rx antibiotic oral medication and ear drops.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: Started  later in the evening  with achy muscles, fever, and cold or flu like symptoms.  Middle of the night stomach cramps and feeling of nausea.  Lasted about 3 days and then progressed to an earache in the left ear.  Ear became badly infected and had to go back to the doctor for tests and Rx antibiotic oral medication and ear drops.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain, Pain in extremity
Clinical narrative: Extreme burning sensation during injection and significant pain in upper arm for 3 days and minor pain for additional 3 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site became red, swollen, hard, and quite painful. Swelling Lasted  more than 2 days. Became itchy on second day. Took ibuprofen for pain.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Decreased appetite, Disturbance in attention, Fatigue, Headache
Clinical narrative: Woke up last night with bad chills and fever (103.1 F); also stabbing pains in upper thighs, cramping around shins and worse headache. Once up in the morning, mild nausea and lack of appetite, very tired (slept at least 4-5 more hours during the day), impaired concentration and ability to function, e.g. too tired to watch a movie or even part of one. Vision may have been off - or just too tired for sustained focus of eyes (could read some but had convergence difficulties). Fever reduced by ibuprofen but returning if more not taken.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Muscle spasms, Nausea, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Woke up last night with bad chills and fever (103.1 F); also stabbing pains in upper thighs, cramping around shins and worse headache. Once up in the morning, mild nausea and lack of appetite, very tired (slept at least 4-5 more hours during the day), impaired concentration and ability to function, e.g. too tired to watch a movie or even part of one. Vision may have been off - or just too tired for sustained focus of eyes (could read some but had convergence difficulties). Fever reduced by ibuprofen but returning if more not taken.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Strabismus
Clinical narrative: Woke up last night with bad chills and fever (103.1 F); also stabbing pains in upper thighs, cramping around shins and worse headache. Once up in the morning, mild nausea and lack of appetite, very tired (slept at least 4-5 more hours during the day), impaired concentration and ability to function, e.g. too tired to watch a movie or even part of one. Vision may have been off - or just too tired for sustained focus of eyes (could read some but had convergence difficulties). Fever reduced by ibuprofen but returning if more not taken.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site urticaria
Clinical narrative: Patient received influenza vaccine in (L) deltoid on 9/12/19. On 9/13/19 pt developed headache & redness in area of injection. Since then, developed hive like reaction at injection site. No other rash. No respiratory symptoms. Rash measures 8 cm x 8 cm on (L) deltoid.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Loss of consciousness, Neurological examination normal, Pallor, Syncope
Clinical narrative: Syncope vasovagal; Loss of consciousness; Neurological examination normal; Pallor; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  This spontaneous report was received from the Agency and refers to a 15-year-old female patient. The patient's medical history included anxiety and attention deficit disorder (ADD). Other medications included sertraline and dexmethylphenidate.   On 10-JAN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly in the left arm (lot number R008164, expiration date: 12-NOV-2020, dose was not provided) and influenza virus split virion 4v vaccine inactivated (FLUZONE QUADRIVALENT), intramuscularly in the right arm (lot number UI982AC, dose and expiration date were not provided); both for prophylaxis. On the same date, patient gradually fainted from one chair to other chair and head down first after injection of immunization. Patient regained consciousness about 1 to 2 minutes after doctor went to patient's room. Facial color went from pale to pink in about 1 to 2 minutes. Patient had normal conversation with doctor and family after regaining consciousness. Blood pressure (BP) was 110/70 and heart rate (HR) was 88 (units not provided for both). Neurological exam was normal.   The outcome of the events was reported as recovered on the same date. The causality assessment was not provided.  Follow up information has been received from a health care professional on 03-JUL-2019, on request by the Company from the FDA under the Freedom of Information Act. The patient was a non pregnant female without allergies to medications, food or other product. There were not illness at the time of vaccination and up to one month prior. The patient was vaccinated on 10-JAN-2019 at 14:40 and the aforementioned adverse events occurred at 14:45.  Follow up information has been received from a health care professional on 10-SEP-2019 via questionnaire: At the moment of this follow-up report the patient was 16 years and 6 moths old. The trade name of concomitant therapies was confirmed as sertraline hydrochloride (ZOLOFT) for Anxiety and dexmethylphenidate hydrochloride (FOCALIN XR) for ADD. The reporter confirmed that the patient received the second dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the first dose of influenza virus split virion 4v vaccine inactivated (FLUZONE QUADRIVALENT).    On 23-JAN-2019, the patient was sent to pediatric cardiology consultation, the consultation was performed on 11-FEB-2019 and a diagnosis of vasovagal syncope was made. Additionally, it was confirmed that no treatment was required for the event.  Upon internal review, the event vasovagal syncope was determined to be medically significant. No additional information was received for the event of loss of consciousness previously reported by the agency.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Head injury, Loss of consciousness, Neurological examination normal, Pallor, Syncope
Clinical narrative: Syncope vasovagal; Loss of consciousness; Neurological examination normal; Pallor; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  This spontaneous report was received from the Agency and refers to a 15-year-old female patient. The patient's medical history included anxiety and attention deficit disorder (ADD). Other medications included sertraline and dexmethylphenidate.   On 10-JAN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly in the left arm (lot number R008164, expiration date: 12-NOV-2020, dose was not provided) and influenza virus split virion 4v vaccine inactivated (FLUZONE QUADRIVALENT), intramuscularly in the right arm (lot number UI982AC, dose and expiration date were not provided); both for prophylaxis. On the same date, patient gradually fainted from one chair to other chair and head down first after injection of immunization. Patient regained consciousness about 1 to 2 minutes after doctor went to patient's room. Facial color went from pale to pink in about 1 to 2 minutes. Patient had normal conversation with doctor and family after regaining consciousness. Blood pressure (BP) was 110/70 and heart rate (HR) was 88 (units not provided for both). Neurological exam was normal.   The outcome of the events was reported as recovered on the same date. The causality assessment was not provided.  Follow up information has been received from a health care professional on 03-JUL-2019, on request by the Company from the FDA under the Freedom of Information Act. The patient was a non pregnant female without allergies to medications, food or other product. There were not illness at the time of vaccination and up to one month prior. The patient was vaccinated on 10-JAN-2019 at 14:40 and the aforementioned adverse events occurred at 14:45.  Follow up information has been received from a health care professional on 10-SEP-2019 via questionnaire: At the moment of this follow-up report the patient was 16 years and 6 moths old. The trade name of concomitant therapies was confirmed as sertraline hydrochloride (ZOLOFT) for Anxiety and dexmethylphenidate hydrochloride (FOCALIN XR) for ADD. The reporter confirmed that the patient received the second dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the first dose of influenza virus split virion 4v vaccine inactivated (FLUZONE QUADRIVALENT).    On 23-JAN-2019, the patient was sent to pediatric cardiology consultation, the consultation was performed on 11-FEB-2019 and a diagnosis of vasovagal syncope was made. Additionally, it was confirmed that no treatment was required for the event.  Upon internal review, the event vasovagal syncope was determined to be medically significant. No additional information was received for the event of loss of consciousness previously reported by the agency.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Chills, Headache, Heart rate increased, Injection site pain
Clinical narrative: SEVERE MUSCLE ACHES, CHILLS, SHAKES, NAUSEA, HEADACHE-ALL  WHICH WERE LISTED ITS POSSIBLE SIDE EFFECTS BUT I DID NOT  EXPECT TO HAVE THEM ALL SIMUTANEOUSLY!  THE REASON I AM REPORTING THESE REACTIONS IS THAT THEY WERE  ALSO ACCOMPANIED BY HEART PALPITATIONS & ELEVATED HEARTBEAT. I RECEIVED THE FIRST DOSE OF THIS VACCINE IN JUNE, 2019 & EXPERIENCED ONLY SORENESS IN ARM NEAR INJECTION  SITE. HOWEVER, WITHIN 8 HRS. OF THIS 2ND DOSE, ALL ADVERSE SYMPTOMS WERE PRESENTING. IN 2005 AND 2008 I HAD EPISODES OF ATRIAL FIBRILLATION BUT TAKE FLECAINIDE AND HAVE NOT HAD AN EPISODE IN 11 YEARS. HOWEVER WITH THE PALPITATIONS I WAS CONCERNED ENOUGH TO BEGIN TAKING BOOD PRESSURE & PULSE WHICH WERE BOTH ELEVATED. MY PULSE IS USUALLY IN MID 70 - MID 0 RANGE BUT I WAS REGISTERING UP TO 111 PULSE AND BLOOD PRESSURE WHICH USUALLY RUNS LOW WAS ALSO QUITE A BIT HIGHER.  THE NAUSEA & POUNDING HEADACHE WERE STILL WITH ME APPROX. 30 HRS. AFTER INJECTION AS THE OTHER SYMPTOMS BEGAN TO LESSEN.  I AM FILING THIS REPORT BECAUSE I FEEL PROSPECTIVE PATIENTS SHOULD BE MADE AWARE OF THE INVOLVEMENT OF HEARTBEAT & PULSE IRREGULARITIES AS A POSSIBLITY AFTER RECEIVING THIS VACCINE.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Nausea, Pain, Palpitations
Clinical narrative: SEVERE MUSCLE ACHES, CHILLS, SHAKES, NAUSEA, HEADACHE-ALL  WHICH WERE LISTED ITS POSSIBLE SIDE EFFECTS BUT I DID NOT  EXPECT TO HAVE THEM ALL SIMUTANEOUSLY!  THE REASON I AM REPORTING THESE REACTIONS IS THAT THEY WERE  ALSO ACCOMPANIED BY HEART PALPITATIONS & ELEVATED HEARTBEAT. I RECEIVED THE FIRST DOSE OF THIS VACCINE IN JUNE, 2019 & EXPERIENCED ONLY SORENESS IN ARM NEAR INJECTION  SITE. HOWEVER, WITHIN 8 HRS. OF THIS 2ND DOSE, ALL ADVERSE SYMPTOMS WERE PRESENTING. IN 2005 AND 2008 I HAD EPISODES OF ATRIAL FIBRILLATION BUT TAKE FLECAINIDE AND HAVE NOT HAD AN EPISODE IN 11 YEARS. HOWEVER WITH THE PALPITATIONS I WAS CONCERNED ENOUGH TO BEGIN TAKING BOOD PRESSURE & PULSE WHICH WERE BOTH ELEVATED. MY PULSE IS USUALLY IN MID 70 - MID 0 RANGE BUT I WAS REGISTERING UP TO 111 PULSE AND BLOOD PRESSURE WHICH USUALLY RUNS LOW WAS ALSO QUITE A BIT HIGHER.  THE NAUSEA & POUNDING HEADACHE WERE STILL WITH ME APPROX. 30 HRS. AFTER INJECTION AS THE OTHER SYMPTOMS BEGAN TO LESSEN.  I AM FILING THIS REPORT BECAUSE I FEEL PROSPECTIVE PATIENTS SHOULD BE MADE AWARE OF THE INVOLVEMENT OF HEARTBEAT & PULSE IRREGULARITIES AS A POSSIBLITY AFTER RECEIVING THIS VACCINE.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: SEVERE MUSCLE ACHES, CHILLS, SHAKES, NAUSEA, HEADACHE-ALL  WHICH WERE LISTED ITS POSSIBLE SIDE EFFECTS BUT I DID NOT  EXPECT TO HAVE THEM ALL SIMUTANEOUSLY!  THE REASON I AM REPORTING THESE REACTIONS IS THAT THEY WERE  ALSO ACCOMPANIED BY HEART PALPITATIONS & ELEVATED HEARTBEAT. I RECEIVED THE FIRST DOSE OF THIS VACCINE IN JUNE, 2019 & EXPERIENCED ONLY SORENESS IN ARM NEAR INJECTION  SITE. HOWEVER, WITHIN 8 HRS. OF THIS 2ND DOSE, ALL ADVERSE SYMPTOMS WERE PRESENTING. IN 2005 AND 2008 I HAD EPISODES OF ATRIAL FIBRILLATION BUT TAKE FLECAINIDE AND HAVE NOT HAD AN EPISODE IN 11 YEARS. HOWEVER WITH THE PALPITATIONS I WAS CONCERNED ENOUGH TO BEGIN TAKING BOOD PRESSURE & PULSE WHICH WERE BOTH ELEVATED. MY PULSE IS USUALLY IN MID 70 - MID 0 RANGE BUT I WAS REGISTERING UP TO 111 PULSE AND BLOOD PRESSURE WHICH USUALLY RUNS LOW WAS ALSO QUITE A BIT HIGHER.  THE NAUSEA & POUNDING HEADACHE WERE STILL WITH ME APPROX. 30 HRS. AFTER INJECTION AS THE OTHER SYMPTOMS BEGAN TO LESSEN.  I AM FILING THIS REPORT BECAUSE I FEEL PROSPECTIVE PATIENTS SHOULD BE MADE AWARE OF THE INVOLVEMENT OF HEARTBEAT & PULSE IRREGULARITIES AS A POSSIBLITY AFTER RECEIVING THIS VACCINE.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Palpitations, Tremor
Clinical narrative: SEVERE MUSCLE ACHES, CHILLS, SHAKES, NAUSEA, HEADACHE-ALL  WHICH WERE LISTED ITS POSSIBLE SIDE EFFECTS BUT I DID NOT  EXPECT TO HAVE THEM ALL SIMUTANEOUSLY!  THE REASON I AM REPORTING THESE REACTIONS IS THAT THEY WERE  ALSO ACCOMPANIED BY HEART PALPITATIONS & ELEVATED HEARTBEAT. I RECEIVED THE FIRST DOSE OF THIS VACCINE IN JUNE, 2019 & EXPERIENCED ONLY SORENESS IN ARM NEAR INJECTION  SITE. HOWEVER, WITHIN 8 HRS. OF THIS 2ND DOSE, ALL ADVERSE SYMPTOMS WERE PRESENTING. IN 2005 AND 2008 I HAD EPISODES OF ATRIAL FIBRILLATION BUT TAKE FLECAINIDE AND HAVE NOT HAD AN EPISODE IN 11 YEARS. HOWEVER WITH THE PALPITATIONS I WAS CONCERNED ENOUGH TO BEGIN TAKING BOOD PRESSURE & PULSE WHICH WERE BOTH ELEVATED. MY PULSE IS USUALLY IN MID 70 - MID 0 RANGE BUT I WAS REGISTERING UP TO 111 PULSE AND BLOOD PRESSURE WHICH USUALLY RUNS LOW WAS ALSO QUITE A BIT HIGHER.  THE NAUSEA & POUNDING HEADACHE WERE STILL WITH ME APPROX. 30 HRS. AFTER INJECTION AS THE OTHER SYMPTOMS BEGAN TO LESSEN.  I AM FILING THIS REPORT BECAUSE I FEEL PROSPECTIVE PATIENTS SHOULD BE MADE AWARE OF THE INVOLVEMENT OF HEARTBEAT & PULSE IRREGULARITIES AS A POSSIBLITY AFTER RECEIVING THIS VACCINE.
Age: 13.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Rash
Clinical narrative: RASH ON FACE; RASH ON BODY/ BUMPS ON ARMS/ BUMPS ON FACE/ BUMPS ON LEGS; SORENESS AT INJECTION SITE; Rash is pimply; This case was reported by a nurse via call center representative and described the occurrence of rash in a 13-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA60BA, expiry date 30th September 2021) for prophylaxis.   On 4th September 2019, the patient received Bexsero. In September 2019, less than a week after receiving Bexsero, the patient experienced rash, generalized rash, injection site pain and papular rash. On an unknown date, the outcome of the rash, generalized rash, injection site pain and papular rash were unknown.   It was unknown if the reporter considered the rash, generalized rash, injection site pain and papular rash to be related to Bexsero.  Additional case details were reported as follows: The patient received vaccine on unknown arm. The reporter stated that a teenage girl received Bexsero on wednesday of this week and developed a rash on her face and body that was not itchy.  The patient reported the rash appearing within 2 days of vaccination.  The rash was pimply in appearance on face, arms, and neck. The patient broke out in bumps on her arms, face and legs and experienced soreness at the injection site. It was unknown how long the rashes lasted and if they were treated because they only called in to report the adverse event. No additional details were available but reporter agreed to follow up. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by the same reporter.
Age: 13.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Rash, Rash papular
Clinical narrative: RASH ON FACE; RASH ON BODY/ BUMPS ON ARMS/ BUMPS ON FACE/ BUMPS ON LEGS; SORENESS AT INJECTION SITE; Rash is pimply; This case was reported by a nurse via call center representative and described the occurrence of rash in a 13-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA60BA, expiry date 30th September 2021) for prophylaxis.   On 4th September 2019, the patient received Bexsero. In September 2019, less than a week after receiving Bexsero, the patient experienced rash, generalized rash, injection site pain and papular rash. On an unknown date, the outcome of the rash, generalized rash, injection site pain and papular rash were unknown.   It was unknown if the reporter considered the rash, generalized rash, injection site pain and papular rash to be related to Bexsero.  Additional case details were reported as follows: The patient received vaccine on unknown arm. The reporter stated that a teenage girl received Bexsero on wednesday of this week and developed a rash on her face and body that was not itchy.  The patient reported the rash appearing within 2 days of vaccination.  The rash was pimply in appearance on face, arms, and neck. The patient broke out in bumps on her arms, face and legs and experienced soreness at the injection site. It was unknown how long the rashes lasted and if they were treated because they only called in to report the adverse event. No additional details were available but reporter agreed to follow up. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: When I woke up the morning after the injection I experienced dizziness  on that one day.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Acute lymphocytic leukaemia, Alopecia, Aspiration bone marrow abnormal, Blood test abnormal, Condition aggravated
Clinical narrative: First symptom of ALL Leukemia (thinning hair and paleness) was noted 9/13/2016. First low grade fever was noted 10/1/2016. Low grade fevers were noted throughout October 2016, always resolving themselves after a day. She continued to become more and more pale, loose more hair and get more tired. On 11/9/2016 she had sudden pain on her shin and went to the ER for multiple tests. Leukemia suspected on 11/10/2016 and diagnosed on 11/11/2016. Her oncologist stated that based on the number of blasts in her blood and marrow, they estimate her leukemia started about a week after her vaccination. It was the first vaccination she had had for varicella and she had had over a year in between her previous vaccinations.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Pain in extremity, Pallor, Pyrexia
Clinical narrative: First symptom of ALL Leukemia (thinning hair and paleness) was noted 9/13/2016. First low grade fever was noted 10/1/2016. Low grade fevers were noted throughout October 2016, always resolving themselves after a day. She continued to become more and more pale, loose more hair and get more tired. On 11/9/2016 she had sudden pain on her shin and went to the ER for multiple tests. Leukemia suspected on 11/10/2016 and diagnosed on 11/11/2016. Her oncologist stated that based on the number of blasts in her blood and marrow, they estimate her leukemia started about a week after her vaccination. It was the first vaccination she had had for varicella and she had had over a year in between her previous vaccinations.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Tachycardia
Clinical narrative: Pt had chills, body aches, severe nausea & tachycardia beginning 5:30pm on day of 2nd vaccine (9-13-19) that lasted until sunday 9-15-19 4pm EST
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patients received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Their concomitant therapies included properly stored sterile diluent.  On unknown dates in 2019 (reported as between 01-JUL-2019 and 02-AUG-2019), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R030612, expiration date 23-OCT-2020 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, lot # S002490, expiration 23-JUL-2020 (doses, routes, vaccination sites and concentration were not reported) for prophylaxis. The temperature was from -14°C to -10°C (-14.2 C) for 6 hours. Previous temperature excursion was from -14°C to -10°C (-14.2 C) for 30 minutes. Digital data logger was involved. No adverse events were reported.   This case was considered to be non-valid due to lack of patients' identifiers.  Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.  Follow-up information was received from the nurse on 27-AUG-2019 and refers to three 1-year-old patients. On an unknown dates in 2019 (reported as between 01-JUL-2019 and 12-AUG-2019), the patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot # S002490, expiration 23-JUL-2020. There was no reactions or problems with the patients. The freezer was defrosted on 08-AUG-2019 (reported as last Thursday). On 12-AUG-2019, the temperature was -14.9°C for 30 minutes. The clinic manager was checking into getting a lab grade/ vaccine grade freezer. Total hours of excursions was 6 hours and 30 minutes at -14°C.  This is one of 4 cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA010528: US-009507513-1908USA010527: US-009507513-1908USA010526:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the administration of one dose of an improperly stored vaccine, PROQUAD; PROQUAD was administered to a 58 year old male patient; This spontaneous report as received from a registered nurse refers to a 58 year old male patient. No pertinent medical history, concurrent conditions, drug reactions or allergies were provided.  On 20-AUG-2019,  the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) (lot # S009756 expiration date 27-SEP-2020) 0.5 milligram/once time, first dose for prophylaxis (route and anatomical location were not reported). The sterile diluent used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored in the correct temperature storage range. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 46 degrees Fahrenheit for 336 hours. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patients received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Their concomitant therapies included properly stored sterile diluent.  On unknown dates in 2019 (reported as between 01-JUL-2019 and 02-AUG-2019), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R030612, expiration date 23-OCT-2020 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # S002490, expiration 23-JUL-2020 (doses, routes, vaccination sites and concentration were not reported) for prophylaxis. The temperature was from -14°C to -10°C (-14.2 C) for 6 hours. Previous temperature excursion was from -14°C to -10°C (-14.2 C) for 30 minutes. Digital data logger was involved. No adverse events were reported.   This case was considered to be non-valid due to lack of patients' identifiers.  Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.  Follow-up information was received from the nurse on 27-AUG-2019 and refers to ten children patients at the age between 3 and 5 years old. On an unknown dates in 2019 (reported as between 01-JUL-2019 and 12-AUG-2019), the patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot # S002490, expiration 23-JUL-2020. There was no reactions or problems with the patients. The freezer was defrosted on 08-AUG-2019 (reported as last Thursday). On 12-AUG-2019, the temperature was -14.9°C for 30 minutes. The clinic manager was checking into getting a lab grade/ vaccine grade freezer. Total hours of excursions was 6 hours and 30 minutes at -14°C.  This is one of 4 cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA004659: US-009507513-1908USA010527: US-009507513-1908USA010528:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects; accidental administration of PROQUAD in place of MMR II concomitantly with VARIVAX in patient; accidental administration of PROQUAD in place of MMR II concomitantly with VARIVAX in patient resulting in an extra dose ofVARIVAX; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On 27-AUG-2019, the patient was accidental vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003176, expiration date: 30-JUL-2020 (dose, unit, and route of administration were not reported) in place of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Wrong product administered) concomitantly with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, unit, lot#, expiration date and route of administration were not reported) for prophylaxis. This resulting in an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Extra dose administered). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient was administered improperly stored V ARlV AX (reconstituted with properly stored Merck STERILE DILUENT); This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.       On 26-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S006017, expiration date was reported as 27-FEB-2021; dose and route were not reported) for prophylaxis; reconstituted with properly stored Merck sterile diluent (lot # R034106, expiration date reported as 22-JUN-2021; dose and route were not reported). No adverse effects were reported. No additional information was provided.    The administrated vaccine experienced the following temperature excursion: temperature -4.5 Celsius (C) (-9 degree Celsius to 8 degree Celsius) for 3 hours 20 minutes. There were no previous temperature excursions. The digital data logger was involved.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; administered properly stored M-M-R II on 1/31/2019 two weeks after administration of properly stored V ARIV AX; This spontaneous report as received from a physician refers to a 16 year old patient of unknown gender. No information on patient's pertinent medical history, concomitant medications and drug reaction or allergies was provided.     On 15-JAN-2019, the patient was vaccinated with properly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # reported as M023963 that is an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX) , expiration date reported as 01-SEP-2019, dose and route of administration were not provided) for prophylaxis. On 31-JAN-2019 (also reported as two weeks after vaccination with  varicella virus vaccine live (oka/merck)(VARIVAX)) , the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # reported as M025898 that is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 19-SEP-2019, dose and route of administration were not provided) for prophylaxis. Both vaccines were reconstituted with properly stored sterile diluent. No adverse effects reported.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse events; a patient who was administered the first dose of ROTATEQ on 6/18/2019 and the second dose of ROTATEQ on 9/4/2019; This spontaneous report was received from a registered nurse referring to a 4 month old patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 18-JUN-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dose, lot number and expiration date were not reported) for prophylaxis. On 04-SEP-2019, the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient orally, with lot number S010046 and expiration date on 08-NOV-2020 (dose was not reported) for prophylaxis (inappropriate schedule of product administration). No adverse events.
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: The patient experienced "excruciating pain and can't move his arm."; The patient experienced "excruciating pain and can't move his arm."; This spontaneous report was received from a pharmacist concerning a 70 year old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies. On 03-SEP-2019, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscular, lot # S004548, expiration date 12-AUG-2020 for vaccination (strength, dose and frequency were not reported). On the same date, he experienced excruciating pain and couldn't move his arm (movement disorder).  The outcome of pain and movement disorder was reported as not recovered. The causal relationship between the events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; The patient was administered improperly stored Varivax; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 30-JUL-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R002506, expiration date reported as 25-JAN-2020 for prophylaxis.  (strength, dosage schedule, route and anatomical location were not reported) which was reconstituted with sterile diluent (DILUENT MRK).  The varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature range of 6°F to 14°F (7.7 °F) for the time frame of 3 hours and 55 minutes. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; The primary reporter states an expired dose of VAQTA was given on 9/9/2019; This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.   On 09-SEP-2019, an expired dose of Hepatitis A Vaccine, inactivated (VAQTA) (expired product administered) lot number R027987, expiration date 09-AUG-2019, was administered per intramuscular route, to the patient (strength, dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The outcome of the event was not reported.
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Incorrect route of product administration, Injection site pain
Clinical narrative: When the needle went in, the patient said, "ow"; patient had received MMR II several years ago but there was no record of her receiving it so she got another one on 07Sep2019; The pharmacist inadvertently gave it ( content of one vial) intramuscularly instead of subcutaneously; This spontaneous report was received from a pharmacist, concerning a 21 year female patient. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On an unspecified date, several years ago, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis, (strength, dose, frequency, route of administration, lot number and expiration date were not reported), however there was no registry of this vaccination, then on 07-SEP-2019, the patient had a new vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) (extra dose administered) which was inadvertently administrated intramuscularly instead of subcutaneously (incorrect route of product administration) for prophylaxis, expiration date reported as 09-DEC-2020 (strength, dose, frequency and lot number were not reported).   On the same date, upon administration of vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II), when the needle went in, the patient said "ow" (injection site pain).   At the time of reporting, the outcome of injection site pain was unknown.   The causal relationship between the vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II)  and injection site pain was not provided by the reporting pharmacist.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic product effect decreased
Clinical narrative: ZOSTAVAX is not effective beyond 3 to 5 years and only 50% effective originally; ZOSTAVAX is not effective beyond 3 to 5 years and only 50% effective originally; This spontaneous report was received from a female patient of unknown age regarding herself. Patient's medical history, concomitant medication and drug allergies/reactions were not reported. On an unknown date in 2009, (mentioned as 10 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route, strength, lot/batch and expiry: unknown) for prophylaxis. The patient called to verify the availability status of zoster rgE vaccine (mammalian) (SHINGRIX). The patient reported that her physician recommended zoster rgE vaccine (mammalian) (SHINGRIX), because the physician stated to her that the zoster vaccine live (ZOSTAVAX) was not effective (drug ineffective) beyond 3 to 5 years, and only 50% effective originally whereas zoster rgE vaccine (mammalian) (SHINGRIX) was 90% (therapeutic product effect decreased). Outcome and causality of the events were not reported.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes zoster
Clinical narrative: stroke; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a 65 years old male patient (pt). There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. On an unknown day in February 2017, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at military clinic as prescribed and/or administered by a healthcare provider, for prevention of shingles and herpes Zoster related conditions. On 09-SEP-2019, the pt experienced shingles and a stroke (cerebrovascular accident), including any and all of its sequalae. It was reported that the pt would continue to suffer ongoing personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. The outcome of the events of shingles and cerebrovascular accident was not reported.   The reporter considered shingles and cerebrovascular accident to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of cerebrovascular accident was determined to be medically significant.