chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Headache, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: Approximately 1.5 hours after receiving the flu shot on Thursday, 10/10/19, I developed severe migraine, nausea, vomiting, drenching sweats, confusion, dizziness, and fever of 101-102. I had to leave work early the next day due to continued nausea and migraine. The migraine and nausea continued, and I went to urgent care on Saturday morning. I was given a Toradol shot with no relief. the migraine lasted until Monday and was downgraded to a dull headache. I have gotten the flu shot for 4 consecutive years and have always gotten sick. This time was unbearable and resulted in lost wages, an urgent care bill and a terrible reaction making it very difficult to function.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Nausea, Pyrexia, Vomiting
Clinical narrative: Approximately 1.5 hours after receiving the flu shot on Thursday, 10/10/19, I developed severe migraine, nausea, vomiting, drenching sweats, confusion, dizziness, and fever of 101-102. I had to leave work early the next day due to continued nausea and migraine. The migraine and nausea continued, and I went to urgent care on Saturday morning. I was given a Toradol shot with no relief. the migraine lasted until Monday and was downgraded to a dull headache. I have gotten the flu shot for 4 consecutive years and have always gotten sick. This time was unbearable and resulted in lost wages, an urgent care bill and a terrible reaction making it very difficult to function.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Dizziness, Erythema, Nausea, Pain in extremity
Clinical narrative: A minute or two after receiving the injection I began to have a strong pain that radiated through arm into my core, I began to feel nauseous and lightheaded. My face became red and face felt like it was swelling. Floaters in my vision began and continued for about 20 -30 minutes.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Vitreous floaters
Clinical narrative: A minute or two after receiving the injection I began to have a strong pain that radiated through arm into my core, I began to feel nauseous and lightheaded. My face became red and face felt like it was swelling. Floaters in my vision began and continued for about 20 -30 minutes.
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Patient given MMR vaccine IM rather than SQ.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Flu shot given on Sat afternoon. Next morning (Sunday) noticed large red circle around shot site. It continued to feel hot, was swollen, raised, red, and sore - about 3 to 3.5 inches in diameter.  This continued all day Monday with it not being swollen on Tuesday but still red and hot.  On Wednesday the redness disappeared but left a purple/redish bruise instead and was itchy.  The bruise slightly remained on Thursday.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Flu shot given on Sat afternoon. Next morning (Sunday) noticed large red circle around shot site. It continued to feel hot, was swollen, raised, red, and sore - about 3 to 3.5 inches in diameter.  This continued all day Monday with it not being swollen on Tuesday but still red and hot.  On Wednesday the redness disappeared but left a purple/redish bruise instead and was itchy.  The bruise slightly remained on Thursday.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Asthenia, Fear, Myalgia, Pyrexia
Clinical narrative: Feverish, muscle aches , weakness,  severe anxiety  by  Saturday morning.  Repetitive  feeling of anxiety  throughout night and upon waking with a ringing to ears.  Unbearable of feeling of inescapable dread fixed on a specific experience . This was something that I have never experienced  in such a manner before.  Very concerning.  Diminishing effect over the  next two days as it subsided.  I have not had a flu shot before and would not attempt to be vaccinated for this again.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Tinnitus
Clinical narrative: Feverish, muscle aches , weakness,  severe anxiety  by  Saturday morning.  Repetitive  feeling of anxiety  throughout night and upon waking with a ringing to ears.  Unbearable of feeling of inescapable dread fixed on a specific experience . This was something that I have never experienced  in such a manner before.  Very concerning.  Diminishing effect over the  next two days as it subsided.  I have not had a flu shot before and would not attempt to be vaccinated for this again.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haematoma, Swelling, Venous injury
Clinical narrative: PATIENT DEVELOPED SWELLING AND BRUISING APPROXIMATELY 24 HOURS AFTER VACCINATION WAS GIVEN. PATIENT'S DAUGHTER REPORTED THAT SHE WAS TAKING HER TO HER PRIMARY CARE PHYSICIAN FOR FURTHER WORK UP
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain
Clinical narrative: Patient received vaccine in right deltoid in February 2018. He received his second dose in Oct 2018 at pharmacy (they will submit their own form). He states that after his first vaccine, he had residual pain in the right deltoid, but it went away after a few months. He then received his second dose in the same arm. On todays date, the patient came in for his annual flu vaccine. He stated he still has pain in that arm (a year after receiving vaccine). When he was asked to show where the pain was, he pointed to the area where vaccines are normally given on the deltoid. He stated he had the typical flu-like symptoms after each vaccine which lingered for about two days, but the dull pain has never went away.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Grip strength decreased, Headache, Malaise
Clinical narrative: The same night I experienced malaise, headache, myalgia. The following morning I had a fever and chills. These symptoms continued for approx 5 days.    The myalgia continued for approx 1 month and is ongoing now.  The hands are mostly affected - unable to form a grip, swelling and joint pain - also trigger finger is noted in left baby finger.  I take meloxicam for the pain and swelling - with effect.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Peripheral swelling, Pyrexia, Trigger finger
Clinical narrative: The same night I experienced malaise, headache, myalgia. The following morning I had a fever and chills. These symptoms continued for approx 5 days.    The myalgia continued for approx 1 month and is ongoing now.  The hands are mostly affected - unable to form a grip, swelling and joint pain - also trigger finger is noted in left baby finger.  I take meloxicam for the pain and swelling - with effect.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Hard swollen tissue at injection site, hot to the touch with a mild rash present. Numbness and tingling down the right arm to the fingers and up into the right side of the neck. Grip strength in right hand reduced. Itching on right arm within an hour of injection and spread to neck and torso within 24 hours.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site warmth, Paraesthesia, Pruritus
Clinical narrative: Hard swollen tissue at injection site, hot to the touch with a mild rash present. Numbness and tingling down the right arm to the fingers and up into the right side of the neck. Grip strength in right hand reduced. Itching on right arm within an hour of injection and spread to neck and torso within 24 hours.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Patient reports fatigue, body ache, nausea
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dizziness, Dyspnoea, Swelling, Throat irritation
Clinical narrative: Two hours after receiving Sanofi P influenza vaccine Lot # UJ210AA, I developed cough with tightness and scratchiness in throat. Then developed hives and swelling to neck with worsening cough. Remained alert, however experienced dizziness and vision changes (haziness). Symptoms progressed to having difficulty breathing, which required injection of EpiPen. Was transported to the ER via ambulance and remained inpatient for 24 hour observation.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Urticaria, Vision blurred
Clinical narrative: Two hours after receiving Sanofi P influenza vaccine Lot # UJ210AA, I developed cough with tightness and scratchiness in throat. Then developed hives and swelling to neck with worsening cough. Remained alert, however experienced dizziness and vision changes (haziness). Symptoms progressed to having difficulty breathing, which required injection of EpiPen. Was transported to the ER via ambulance and remained inpatient for 24 hour observation.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Deafness unilateral, Hypoacusis, Pyrexia
Clinical narrative: I received the Shingrex vaccination (2nd vaccination in the two-part series) on Friday (10/11/19), and had some feverish symptoms afterwards, which I also had with the first vaccination, but I noticed on 10/12/19 that my hearing seemed impaired (I already had some hearing loss in my right ear, but it was markedly worse now), on Monday, 10/14/19, I went to Urgent Care and received a prescription for Methylprednisolone tablets 4 mg dosepak + Acyclovir 800 mg, which I have been taking as prescribed, but my hearing isn't improving. I fear I have loss a significant amount of hearing in my right ear as a result of the vaccination on 10/11/19  I wish I had known that this could happen, I would have been more vigilant and would have received medical care sooner - which could have prevented what I am now afraid is permanent hearing loss.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: I received the first Shingrix vaccine dose on the date noted above. One day post-injection, a fever of 101 degrees developed, as did aching in both knees. These symptoms disappeared within a day or two, however, joint pain returned several weeks later. The pain was in knees, hips and shoulders with both left and right sides of the body being involved with each of those joints. Aleve was helpful in reducing the pain, but after several weeks of ongoing symptoms, I scheduled an appointment with my physician. I am awaiting the MD's advice on anti-inflammatory treatment for which blood pressure considerations must be taken into account.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Had SHINGRIX vaccine yesterday and experienced chills, fever, muscle aches, nausea, headache, shivering and general malaise starting 6 hrs after the injection. Symptoms got worse and I took 800mg of Ibuprophen and slept. Still not 100% this morning.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Had SHINGRIX vaccine yesterday and experienced chills, fever, muscle aches, nausea, headache, shivering and general malaise starting 6 hrs after the injection. Symptoms got worse and I took 800mg of Ibuprophen and slept. Still not 100% this morning.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Malaise, Pyrexia
Clinical narrative: Received a flu shot on Monday afternoon 10/14/19 and became very ill the next day with a fever, stomach cramps, headache and diarrhea. Fever subsided the next day but diarrhea persist and is severe. Flu shot was Fluarix Quad PFS 2019-20 #0.5.
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Hyperhidrosis, Tremor
Clinical narrative: Patient reports that about 11 hours after receiving a Afluria Quadrivalent Flu Vaccine IM he experienced shaking chills that latest for several hours which culminated with diaphoresis. Additionally noted he had a headache.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Eye pruritus, Headache, Injection site bruising
Clinical narrative: - Scratchy throat - deep in Throat - Not oN toNsils - Itchy eyes - wanted to dig itching badly  - PaiN Neck behind both ears - Threw up - Chills for about 4 hours  No Fever - At approximately All symptoms disappeared  - Eyes (lids) swollen For 2 days  - Slight brusing At injection site - arm red and warm to the touch.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Skin warm, Swelling of eyelid, Throat irritation, Vomiting
Clinical narrative: - Scratchy throat - deep in Throat - Not oN toNsils - Itchy eyes - wanted to dig itching badly  - PaiN Neck behind both ears - Threw up - Chills for about 4 hours  No Fever - At approximately All symptoms disappeared  - Eyes (lids) swollen For 2 days  - Slight brusing At injection site - arm red and warm to the touch.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Hypoaesthesia, Injected limb mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Vaccine given at 7:25am and at 8:15am patient reported throbbing pain to left arm. Pain goes down entire arm. Numbness and tingling to left arm comes and goes. Reports can't move arm.  Dx-Bursitis  possible injection to high  Dx Bursitis
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Chills, Headache, Hyperventilation, Hypoaesthesia, Nausea
Clinical narrative: Per ER report: pt presented to ER with headache at 1848 onset was 2 hours prior. He also had nausea and chills that began at the same time as the headache. He then started to have symptoms of periorbital numbness and tingling as well as numbness and tingling in his hands. Mild tachypnea was noted. Felt to be related to hyperventilation reaction. IV Phenergan 12.5mg and IV Benadryl 50mg were given. Pt. reported improvement and was discharged, pt and mom agreeable to discharge.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Paraesthesia, Tachypnoea
Clinical narrative: Per ER report: pt presented to ER with headache at 1848 onset was 2 hours prior. He also had nausea and chills that began at the same time as the headache. He then started to have symptoms of periorbital numbness and tingling as well as numbness and tingling in his hands. Mild tachypnea was noted. Felt to be related to hyperventilation reaction. IV Phenergan 12.5mg and IV Benadryl 50mg were given. Pt. reported improvement and was discharged, pt and mom agreeable to discharge.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Hypoaesthesia, Localised infection, Monoplegia, Pulse absent, Thrombosis
Clinical narrative: Patient reported that some time after receiving the vaccines they experienced paralysis and numbness in their right arm. Patient went to doctor and was found to have no pulse in right arm. Patient was transported to ED then hospitalized 3 days. Patient reported a blood clot and blood infection in right arm. Infection was treated with antibiotics for 3 days.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Human chorionic gonadotropin positive, Maternal exposure before pregnancy
Clinical narrative: Patient had dose #1 of Varivax on 9/13/19. She returned for dose #2 of varivax but when questioned before administration she told RN she took a pregnancy test that morning and it was positive. Confirmed (+) urine HCG while in office on 10/11/2019. Varivax #2 was not given. Told to followup with OB. Denied pregnancy before #1 on 9/13/19
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Myalgia
Clinical narrative: Muscle soarness. Dizziness. Diarrhea.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient REPORTED to Employee Health Dept 24 Hours After injection, LEFT upper ARM HAS large area swollen, RED, & HOT to toucH. Reported Burning & pain to SITE of injection.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Condition aggravated, Encephalomalacia, Magnetic resonance imaging brain abnormal, Seizure
Clinical narrative: Increased Seizure Activity
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Eye haemorrhage, Feeding disorder, Mastication disorder, Pain, Pain in jaw
Clinical narrative: Vaccinated on 9/26/19 @ 10:30 @ 13:00 developed Pain and swelling under (R) jaw and in front of (R) ear; pain->headache. unable to eat/chew as pain & swelling worsened. Went to physician Rx'd: Benadryl, Zanax, ibuprofen. Condition remained present x 3 days. Also had bld vessel break in (R) eye.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Vaccinated on 9/26/19 @ 10:30 @ 13:00 developed Pain and swelling under (R) jaw and in front of (R) ear; pain->headache. unable to eat/chew as pain & swelling worsened. Went to physician Rx'd: Benadryl, Zanax, ibuprofen. Condition remained present x 3 days. Also had bld vessel break in (R) eye.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest pain, Dysarthria, Dyspnoea, Fatigue
Clinical narrative: Patient presents for a emergent visit. She sent me a message yesterday through the portal explaining that she had the Shingrix vaccine on Wednesday and had concerning neurological symptoms later that day. She and her daughter were talking on the phone and her daughter explained to her that her speech was a little slurred. Patient felt very tired and weak which she attributed to the vaccine. She did not have specific extremity weakness, just overall felt weak. When she got home her daughter called her again and thought that she sounded better. Her husband was home and did not think she had any facial droop or change in mental status. She also complains of intermittent chest pain. It is not exertional. It occurs when she is sitting watching TV or doing nothing at all. Feels little short of breath with it. Denies diaphoresis or nausea. Denies radiating pain. She had a nuclear stress test done a little over 2 years ago for bilateral knee surgery. She is been having the chest pain off and on for 1 month. She tells me that she experiences shortness of breath with cleaning but can exercise and do speed walking without shortness of breath. She has been stressed lately. Her brother was diagnosed with testicular cancer. She herself had breast cancer last year and has ongoing issues with fatigue
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Neurological symptom
Clinical narrative: Patient presents for a emergent visit. She sent me a message yesterday through the portal explaining that she had the Shingrix vaccine on Wednesday and had concerning neurological symptoms later that day. She and her daughter were talking on the phone and her daughter explained to her that her speech was a little slurred. Patient felt very tired and weak which she attributed to the vaccine. She did not have specific extremity weakness, just overall felt weak. When she got home her daughter called her again and thought that she sounded better. Her husband was home and did not think she had any facial droop or change in mental status. She also complains of intermittent chest pain. It is not exertional. It occurs when she is sitting watching TV or doing nothing at all. Feels little short of breath with it. Denies diaphoresis or nausea. Denies radiating pain. She had a nuclear stress test done a little over 2 years ago for bilateral knee surgery. She is been having the chest pain off and on for 1 month. She tells me that she experiences shortness of breath with cleaning but can exercise and do speed walking without shortness of breath. She has been stressed lately. Her brother was diagnosed with testicular cancer. She herself had breast cancer last year and has ongoing issues with fatigue
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient got vaccine on 10/14 and noticed her arm where vaccine was given was breaking out on 10/15. On 10/16 it looked like the break out got bigger. Does not hurt
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: L deltoid red @ injection spreading down + around arm measuring 15 x 16 1/2 cm. Parent stated fever previous night up to 101.
Age: 1.4
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, warm, rt upper leg. Observed by Dr.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Pyrexia
Clinical narrative: Pt. completed Keflex 500 Q 12hr x 7 days @ 10/14/2019 for UTI. temp./fever checked prior to flu shot & temp 97.0 & felt cold 10/16/2019 even fever @ 101.7 & today 10/17 99.4
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: patient developed rash/itchiness all over body
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain in extremity
Clinical narrative: Patient developed bright red bruising and soreness underneath the arm. (Not in the area the shot was given.) It is not a local reaction, no warmth. Appears like bruising in the initial stages.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Chills, Headache, Incoherent, Pallor, Speech disorder
Clinical narrative: 5 hours after vaccination began to have chills, shaking, pale "out of it" appearance, headache worse. ? unusual vocalizations, incoherent. Taken to local ED. Observation only. - sent home. Seen in PCP office this morning. Symptoms resolved.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Tremor
Clinical narrative: 5 hours after vaccination began to have chills, shaking, pale "out of it" appearance, headache worse. ? unusual vocalizations, incoherent. Taken to local ED. Observation only. - sent home. Seen in PCP office this morning. Symptoms resolved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient called the pharmacy and reported that she was diagnosed with cellulitis at the injection site after receiving her vaccine. She was prescribed Bactrim DS 1 tablet twice daily for 10 days to treat the infection.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: left arm pain, left arm swelling, fever
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Patient complaint of redness, puritis & edema of injection-site. patient currently at work, and we have not seen or assessed site yet. LVN
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Fatigue, Feeling abnormal, Magnetic resonance imaging abnormal, Malaise
Clinical narrative: Feeling fatigue; Not Feeling Well; Brain Fog; Nausea; Dizziness; Vestibular dysfunction; This case was reported by a physician via sales rep and described the occurrence of fatigue in a 29-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number K5F5R, expiry date unknown) for prophylaxis.   On 4th April 2019, the patient received Boostrix (intramuscular). On an unknown date, less than 6 months after receiving Boostrix, the patient experienced fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder. On an unknown date, the outcome of the fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder were not recovered/not resolved.   The reporter considered the fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder to be possibly related to Boostrix.  Additional information received were as follows: The patient called other healthcare professional to report that since receiving Tdap vaccine on left deltoid, the patient had not been feeling well, fatigue, brain fog, nausea, dizziness and vestibular dysfunction. The reports were under care of private MD who suggested he should report Tdap possible reactions. The patient had magnetic resonance imaging and viral cultures which were all negative.
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Viral test negative
Clinical narrative: Feeling fatigue; Not Feeling Well; Brain Fog; Nausea; Dizziness; Vestibular dysfunction; This case was reported by a physician via sales rep and described the occurrence of fatigue in a 29-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number K5F5R, expiry date unknown) for prophylaxis.   On 4th April 2019, the patient received Boostrix (intramuscular). On an unknown date, less than 6 months after receiving Boostrix, the patient experienced fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder. On an unknown date, the outcome of the fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder were not recovered/not resolved.   The reporter considered the fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder to be possibly related to Boostrix.  Additional information received were as follows: The patient called other healthcare professional to report that since receiving Tdap vaccine on left deltoid, the patient had not been feeling well, fatigue, brain fog, nausea, dizziness and vestibular dysfunction. The reports were under care of private MD who suggested he should report Tdap possible reactions. The patient had magnetic resonance imaging and viral cultures which were all negative.
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Fatigue, Feeling abnormal, Magnetic resonance imaging normal, Malaise
Clinical narrative: Feeling fatigue; Not Feeling Well; Brain Fog; Nausea; Dizziness; Vestibular dysfunction; This case was reported by a physician via sales rep and described the occurrence of fatigue in a 29-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number K5F5R, expiry date unknown) for prophylaxis.   On 4th April 2019, the patient received Boostrix (intramuscular). On an unknown date, less than 6 months after receiving Boostrix, the patient experienced fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder. On an unknown date, the outcome of the fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder were not recovered/not resolved.   The reporter considered the fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder to be possibly related to Boostrix.  Additional information received were as follows: The patient called other healthcare professional to report that since receiving Tdap vaccine on left deltoid, the patient had not been feeling well, fatigue, brain fog, nausea, dizziness and vestibular dysfunction. The reports were under care of private MD who suggested he should report Tdap possible reactions. The patient had magnetic resonance imaging and viral cultures which were all negative.
Age: 29.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Vestibular disorder, Viral test negative
Clinical narrative: Feeling fatigue; Not Feeling Well; Brain Fog; Nausea; Dizziness; Vestibular dysfunction; This case was reported by a physician via sales rep and described the occurrence of fatigue in a 29-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number K5F5R, expiry date unknown) for prophylaxis.   On 4th April 2019, the patient received Boostrix (intramuscular). On an unknown date, less than 6 months after receiving Boostrix, the patient experienced fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder. On an unknown date, the outcome of the fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder were not recovered/not resolved.   The reporter considered the fatigue, feeling unwell, foggy feeling in head, nausea, dizziness and vestibular disorder to be possibly related to Boostrix.  Additional information received were as follows: The patient called other healthcare professional to report that since receiving Tdap vaccine on left deltoid, the patient had not been feeling well, fatigue, brain fog, nausea, dizziness and vestibular dysfunction. The reports were under care of private MD who suggested he should report Tdap possible reactions. The patient had magnetic resonance imaging and viral cultures which were all negative.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Dysphagia, Ear pain, Headache, Neck pain
Clinical narrative: pt called 10/6/19 stating she had headaches, pain in the neck. Soreness, pustule blister on neck starting several days after Shingrix vaccine. Was advised to contact Dr. Pt went to urgent care and was given valtrex and Gabapentin prescription. No fever reported, no injection site reactions. reported
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal pain, Skin ulcer
Clinical narrative: pt called 10/6/19 stating she had headaches, pain in the neck. Soreness, pustule blister on neck starting several days after Shingrix vaccine. Was advised to contact Dr. Pt went to urgent care and was given valtrex and Gabapentin prescription. No fever reported, no injection site reactions. reported
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Headache, Neck pain, Pain, Pustule
Clinical narrative: pt called 10/6/19 stating she had headaches, pain in the neck. Soreness, pustule blister on neck starting several days after Shingrix vaccine. Was advised to contact Dr. Pt went to urgent care and was given valtrex and Gabapentin prescription. No fever reported, no injection site reactions. reported
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Urticaria
Clinical narrative: hives; chills; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) for prophylaxis.   On 8th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 9th October 2019, 1 days after receiving Shingrix, the patient experienced hives and chills. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the hives and chills to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that the patient experienced hives and chills The chills had resolved, but the patient still had hives at the reporting date.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Fatigue, Body Ache, Nausea
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Feeling abnormal, Swelling, Urticaria
Clinical narrative: Hives, swelling, hard to breathe, breathing has gotten easier , hives and swelling are still bad, feel like crap
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Right upper arm muscle soreness has been  increasing severeness and become very painful about 4 hours after the injection. Feeling chill and fever 100.1F by the evening at 9 p.m. (10/17/2019)
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient had onset of nausea, vomiting, and diarrhea approximately 4 hours after immunization.  He reports having multiple episodes (>10) diarrhea with yellow-brown, loose stool without melena or hematochezia and multiple (>10) episodes emesis that was nonbloody and nonbillious.  Denied fevers, chills, body aches, or other symptoms.  He was treated symptomatically with antiemetics and oral rehydration solution.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Joint range of motion decreased, Musculoskeletal disorder, Pain in extremity, Sleep disorder
Clinical narrative: Within 2 hours of receiving the vaccination I was unable to use my left arm.  The pain was excruciating.  I had to lie down and stay immobile for more then 24 hours.  When I did have to get up, for bio breaks, I became light headed.   The pain continued for three days after the vaccination, disrupting my sleep.  Each day it was a little less, however one week later I am still not able to use my arm to it's fullest extent, my shoulder joint not having full motion. I do feel the shot was administered high on my shoulder rather than in the usual site.  That being lower than the shoulder in the upper arm muscles.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: muscle soreness, redness of skin at injection site and skin around site ~6sq in in size I do have photographs of the redness
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia, Upper-airway cough syndrome
Clinical narrative: Big post nasal drip, followed by soreness at and around injection site. Light fever about 6 hours after shot; fever continued through the night and next morning.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Headache, Insomnia, Myalgia, Pain in extremity
Clinical narrative: 30 hours of fever, headache, left arm pain, inability to sleep, Muscle aches, mild mental confusion- improved with time and Motrin
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 30 hours of fever, headache, left arm pain, inability to sleep, Muscle aches, mild mental confusion- improved with time and Motrin
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Loss of personal independence in daily activities, Pain
Clinical narrative: Day after, 10/16/19 - fever - 101.  Flu-like symptoms - body ache and headache.  Stayed in recliner chair all day. Could not perform normal activities.  Treatment: Tylenol every four hours - didn't help. 10/17/19 - feeling better, still fatigued.  10/19/19 (today); feeling ok.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Day after, 10/16/19 - fever - 101.  Flu-like symptoms - body ache and headache.  Stayed in recliner chair all day. Could not perform normal activities.  Treatment: Tylenol every four hours - didn't help. 10/17/19 - feeling better, still fatigued.  10/19/19 (today); feeling ok.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect were reported; improperly stored administered vacine; This spontaneous report was received from a office manager regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not provided. On 01-OCT-2019, the patient was vaccinated with a dose of inappropriate stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S009758, expiration date: 27-SEP-2020 (strength, dose number and anatomical location were not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 Fahrenheit to 46 Fahrenheit (-9 degree Celsius to 8 degree Celsius) (36 Fahrenheit) with unknown time frame. There was no previous temperature excursion involved. A digital data logger was involved. No adverse effects were reported. No product quality complaints (PQC) were involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The patient received improperly stored vaccine at an unspecified date; This spontaneous information has been received from a physician regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin(PROQUAD) injection for prophylaxis, (lot number S003865 with expiration date in 08-AUG-2020) (route of administration, strength and anatomical location were not reported).  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored at a temperature of 32.5 degrees Fahrenheit (°F) for the time frame of 8 hours. There was no previous temperature excursion and the call was because of a data logger.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; a patient was administered improperly stored PROQUAD; This spontaneous report as received from a medical assistant regarding a 2-year-old patient with unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not provided. On 19-SEP-2019, the patient was administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live,rHA (recombinant Human albumin)(PROQUAD) vaccine injection (Lot# S013715, Expiration date: 01-NOV-2020) (dose, dose number and anatomical location were not provided) which was reconstituted with properly stored sterile diluent for prophylaxis use. No adverse event reported. The temperature and time frame were reported as 5 degree Fahrenheit to 46 degree Fahrenheit (17.6 degree Fahrenheit) for 6 hours and 15 minutes. There was no previous temperature excursion. No data logger was involved. No product quality complaints (PQC) were involved.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects noted; a patient received improperly stored PROQUAD; Information has been received from a medical assistant referring to a female patient of unknown age. Information about concurrent condition and medical history was not provided. Concomitant therapies included properly stored sterile diluent.  On 04-OCT-2019, the patient was vaccinated with improperly stored (temperature: -12.3 degree Celsius. Time frame: 6.05 hours) measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot#S017237, expiration date: 01-DEC-2020; strength, dose, frequency, route were not reported) for prophylaxis. No adverse effects were noted. There was no previous temperature excursion.  This one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1910USA006992: US-009507513-1910USA007211: US-009507513-1910USA007203: US-009507513-1910USA007189: US-009507513-1910USA007200: US-009507513-1910USA007348:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; A patient was administered VAQTA that expired on 09/05/2019; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 28-SEP-2019, the patient was vaccinated with an expired hepatitis a vaccine, inactivated(VAQTA) lot # R021233 with expiration date of 05-SEP-2019, (strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored VARlVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information on pertinent medical history, concomitant medication and drug allergies/reactions was not reported.  On 12-SEP-2019 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (Lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020; dose, frequency and route were not provided) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent.  The administered dose of the vaccine experienced a temperature excursion -14 degree Celsius to -10 degree Celsius (-9.74 C) for an unknown time frame. There was no previous temperature excursion. The digital data logger was involved.  There was no adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pyrexia, Skin warm
Clinical narrative: rash; Warm to touch; fever; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2019, the patient received Shingrix. On 5th October 2019, 1 days after receiving Shingrix, the patient experienced injection site rash and skin warm. In October 2019, the patient experienced fever. On an unknown date, the outcome of the injection site rash, skin warm and fever were unknown.   It was unknown if the reporter considered the injection site rash, skin warm and fever 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. Right after receiving the Shingrix, the patient experienced rash on the vaccinated arm, the day after. Warm to touch appeared quickly a day after vaccination. Less than 2 weeks after vaccination, the patient experienced fever of 105 Fahrenheit. The rash was worst on the first day, and had gotten smaller by the time the patient went to the pharmacy on the 2nd or 3rd day. The reporter was unable to provide full details. The reporter did not consent to follow up. Time to onset for rash had been considered precisely in this case instead of immediately as it seems a general statement and there was a discrepancy in 2 source documents. This case is for 1 of the 3 patients, reported by the same reporter.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen Injection Site; Red at site of injection; Hot to the touch at site of injection; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 4-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 425T2, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 2 months after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that the 4 years old patient experienced red, hot to touch, swollen at site of injection after vaccination. The batch number reported for Fluarix Quadrivalent 2019-2020 season(42512) did not exist and was updated to 425T2, as per sales database. The reporter did not agree to the follow up. This case has been linked with case US2019AMR185042, reported by the same reporter.
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Felt like hroat was closing; Couldn't breathe; This case was reported by a nurse via sales rep and described the occurrence of throat constriction in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season .5 ml. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced throat constriction and difficulty breathing. On an unknown date, the outcome of the throat constriction and difficulty breathing were unknown.   It was unknown if the reporter considered the throat constriction and difficulty breathing to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported but could be between 36 or 37 years. The reporter stated that the patient felt like her throat was closing and she could not breathe after vaccination. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Hard injection site; Sore injection site; fever; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 30th September 2019, the patient received Boostrix. On an unknown date, less than 2 weeks after receiving Boostrix, the patient experienced injection site pain, fever and injection site induration. On an unknown date, the outcome of the injection site pain and fever were recovered/resolved and the outcome of the injection site induration was unknown.   It was unknown if the reporter considered the injection site pain, fever and injection site induration to be related to Boostrix.  Additional details were provided as follows: The age at the vaccination was not reported. The healthcare professional stated that a patient received a dose of Boostrix last Monday and developed a hard, sore injection site and a fever that lasted for four days. The reporter did not consent to follow-up. The reporter declined to follow up, refused to provide any further information. The case has been linked to the case US2019183215, reported by same reporter.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Vaccine Administered at Inappropriate Site; Erythema about 1.5 inches in diameter at the injection site; Injection site indurated; Injection site swollen; Injection site warm; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 41-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number J75AH, expiry date 30th June 2020) for prophylaxis.   On 7th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 7th October 2019, unknown after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced vaccine administered at inappropriate site. In October 2019, the patient experienced injection site erythema, injection site induration, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site swelling, injection site warmth and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site erythema, injection site induration, injection site swelling and injection site warmth to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were received as follows: The patient received Fluarix not in the deltoid muscle but about 4 inches below the deltoid muscle on the lateral side of the left arm, which led to vaccine administered at inappropriate site. In addition, the patient also had erythema about 1.5 inches in diameter at the injection site which is warm to touch with induration and it was swollen. The reporter consented to follow up.
Sex: U
Vaccine: HEP, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Inappropriate Schedule of Vaccine; Incomplete course of vaccination; This case was reported by a physician via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 2nd dose of Twinrix and Hepatitis B vaccine at an unknown dose. On an unknown date, not applicable after receiving Twinrix and unknown after receiving Hepatitis B vaccine, the patient experienced inappropriate schedule of vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and incomplete course of vaccination were unknown.  Additional details were received as follows: Twinrix started then switched to Hepatitis B monovalent vaccine, which led to inappropriate schedule of vaccine administered and incomplete course for hepatitis A vaccine. The reporter did not consented to follow up.  Website had no additional information on the patient or the vaccines as they were chatting in for another provider.