chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Grip strength decreased, Mobility decreased, Pain in extremity
Clinical narrative: Patient reports she had increasing pain in her arm over the course of the afternoon after the vaccine was administered and it became severe enough she did not want to use her arm that evening and she almost dropped a dish. The pain resolved by 3/22. No redness, swelling, bruising reported at the injection site. No generalized pain, fatigue or fever.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site rash, Injection site swelling
Clinical narrative: Tiredness; headache; swelling and rash near site of injection.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Tremor
Clinical narrative: Patient reported feeling under the weather, somewhat shaky and overall "icky" after getting vaccination for about 24 hours afterwards. Asked about fever and possibly chills and the patient reported unsure. The patient did not report seeking any medical treatment and appeared fine at time of reporting the event in person.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Ear swelling, Erythema, Rash, Rash erythematous, Swelling of eyelid
Clinical narrative: Patient states had facial redness when he work up the next morning and progressively got worse as the day went on. By Sunday symptoms were worse with Right Eye swelling shut, Right ear very swollen and rash and hives progressing down right side of body. Neck and Throat are red with rash. Hives progressed down the back side of  Right Leg--Hives behind Right Knee--Mother gave patient Benadryl OTC, Mother tried topical hydrocortisone and hydroxyzine 25 mg.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Patient states had facial redness when he work up the next morning and progressively got worse as the day went on. By Sunday symptoms were worse with Right Eye swelling shut, Right ear very swollen and rash and hives progressing down right side of body. Neck and Throat are red with rash. Hives progressed down the back side of  Right Leg--Hives behind Right Knee--Mother gave patient Benadryl OTC, Mother tried topical hydrocortisone and hydroxyzine 25 mg.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Patient had a fever of 103.7 F, drowsiness, and general achiness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Hypersomnia, Injection site erythema, Injection site inflammation, Myalgia
Clinical narrative: Patient received the SHINGRIX vaccine on 3/21/19, and a few hours later, she had to stop what she was doing and lie down. She said she felt weak and her muscles ached. She then slept until noon the following day. When she awoke the next day, she felt better, but the injection site was red and inflamed. Today, 3/23/19, I saw the injection site, and it is still inflamed and red.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood test, Injection site pain, Joint stiffness, Laboratory test
Clinical narrative: The day after the shot I felt pain in both upper arms, progressing to severe pain down the arms and into the hands. Hands and shoulders became very stiff and painful. Pain and stiffness eventually moved to many joints, bi-laterally. Loss of weight. Pain and swelling continue, primarily in the hands. Diagnosis - Parsonage Turner Syndrome, rheumatoid arthritis, small fiber neuropathy. Treatments, Prednisone, pain medications, Gabapentin, Leflunomide, REMICADE.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neuralgic amyotrophy, Pain in extremity, Peripheral swelling
Clinical narrative: The day after the shot I felt pain in both upper arms, progressing to severe pain down the arms and into the hands. Hands and shoulders became very stiff and painful. Pain and stiffness eventually moved to many joints, bi-laterally. Loss of weight. Pain and swelling continue, primarily in the hands. Diagnosis - Parsonage Turner Syndrome, rheumatoid arthritis, small fiber neuropathy. Treatments, Prednisone, pain medications, Gabapentin, Leflunomide, REMICADE.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rheumatoid arthritis, Small fibre neuropathy, Spinal X-ray, Swelling, Weight decreased
Clinical narrative: The day after the shot I felt pain in both upper arms, progressing to severe pain down the arms and into the hands. Hands and shoulders became very stiff and painful. Pain and stiffness eventually moved to many joints, bi-laterally. Loss of weight. Pain and swelling continue, primarily in the hands. Diagnosis - Parsonage Turner Syndrome, rheumatoid arthritis, small fiber neuropathy. Treatments, Prednisone, pain medications, Gabapentin, Leflunomide, REMICADE.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: X-ray limb
Clinical narrative: The day after the shot I felt pain in both upper arms, progressing to severe pain down the arms and into the hands. Hands and shoulders became very stiff and painful. Pain and stiffness eventually moved to many joints, bi-laterally. Loss of weight. Pain and swelling continue, primarily in the hands. Diagnosis - Parsonage Turner Syndrome, rheumatoid arthritis, small fiber neuropathy. Treatments, Prednisone, pain medications, Gabapentin, Leflunomide, REMICADE.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Autoimmune disorder, Injection site pain, Joint swelling, Laboratory test normal
Clinical narrative: The day after the shot I felt pain in both upper arms, progressing to severe pain down the arms and into the hands. Hands and shoulders became very stiff and painful. Pain and stiffness eventually moved to many joints, bi-laterally. Loss of weight. Pain and swelling continue, primarily in the hands. Diagnosis - Parsonage Turner Syndrome, rheumatoid arthritis, small fiber neuropathy. Treatments, Prednisone, pain medications, Gabapentin, Leflunomide, REMICADE.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging spinal normal, Musculoskeletal pain, Pain in extremity, Rheumatoid arthritis, X-ray normal
Clinical narrative: The day after the shot I felt pain in both upper arms, progressing to severe pain down the arms and into the hands. Hands and shoulders became very stiff and painful. Pain and stiffness eventually moved to many joints, bi-laterally. Loss of weight. Pain and swelling continue, primarily in the hands. Diagnosis - Parsonage Turner Syndrome, rheumatoid arthritis, small fiber neuropathy. Treatments, Prednisone, pain medications, Gabapentin, Leflunomide, REMICADE.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Depression, Migraine, Musculoskeletal disorder, Vomiting
Clinical narrative: Throwing up, severe migraine, dead arm for 2 weeks, depressed.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Extreme pain in left arm from shoulder to hand for 18 hours seriously disturbing sleep, left arm sore for another 24 hours, upper arm sore for another 24 hours, currently only sore around injection site. The day following the injection I was feverish, achy, and sleepy and remained in bed all day. The second day the fever had subsided but I was still achy and dizzy and remained in bed. I took one (1) extra strength TYLENOL. The third day I experienced dizziness every time I moved my head, but was otherwise recovering and was able to be up and about part of the day. The fourth day all symptoms had disappeared except for soreness around the injection site and I was able to resume normal activities.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Somnolence
Clinical narrative: Extreme pain in left arm from shoulder to hand for 18 hours seriously disturbing sleep, left arm sore for another 24 hours, upper arm sore for another 24 hours, currently only sore around injection site. The day following the injection I was feverish, achy, and sleepy and remained in bed all day. The second day the fever had subsided but I was still achy and dizzy and remained in bed. I took one (1) extra strength TYLENOL. The third day I experienced dizziness every time I moved my head, but was otherwise recovering and was able to be up and about part of the day. The fourth day all symptoms had disappeared except for soreness around the injection site and I was able to resume normal activities.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Migraine
Clinical narrative: Right after I had the SHINGRIX vaccine I got Flu like symptoms. I had fever, chills, severe joint pain. Had horrible migraines. Then 2 weeks later I presented with post herpetic neuralgia which I still have now in March 23rd. I continue to have headaches on a daily basis. I got my second dose and had fever and some joint pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Pyrexia
Clinical narrative: Right after I had the SHINGRIX vaccine I got Flu like symptoms. I had fever, chills, severe joint pain. Had horrible migraines. Then 2 weeks later I presented with post herpetic neuralgia which I still have now in March 23rd. I continue to have headaches on a daily basis. I got my second dose and had fever and some joint pain.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient said her arm is swollen, hot and redness around her arm w/lots of soreness. Patient said she has a fever as well. Patient was directed to take ibuprofen, BENADRYL, and use cold pack and told see her PCP or go to ER.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Date of injection - fine. Next morning - shot area red - that afternoon, heavy breathing; 101.8 fever, weakness - (totally different reaction from shot #1 - where I got reappearance of shingles 3 more times in next 3 mo. In my left eye - 3 more times. Part I of SHINGRIX - given Oct. 2018 - same place - from Nov. thru Jan. I contracted shingles.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Date of injection - fine. Next morning - shot area red - that afternoon, heavy breathing; 101.8 fever, weakness - (totally different reaction from shot #1 - where I got reappearance of shingles 3 more times in next 3 mo. In my left eye - 3 more times. Part I of SHINGRIX - given Oct. 2018 - same place - from Nov. thru Jan. I contracted shingles.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient came in on 3-21-19 to report that in AM she broke with rash all over her neck. She was trying to find out if that is normal reaction to vacc. she received. She was advised to take BENADRYL and watch it. In case the condition was getting worse she was advised to go to the Urgent Care or ER.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Hypoaesthesia, Myalgia, Pyrexia
Clinical narrative: Patient complained of muscle aches, joint pains, severe headache and fever after the vaccination. She started to have numbness on forehead, eyelid and eye on 3/19/2019. She also complained about blurred vision.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Patient complained of muscle aches, joint pains, severe headache and fever after the vaccination. She started to have numbness on forehead, eyelid and eye on 3/19/2019. She also complained about blurred vision.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue, lasting about 21 hours; slight headache. Resolved by itself with no treatment.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Nausea
Clinical narrative: Pain in arms and legs with extreme pain and tingling in arm vaccine administered within 4 hours. Chills, headache, joint pain, nausea, 100F fever, sensation of not getting enough air all started at about 24 hours post vaccine and ended within 24 hours after onset. Severe soreness in shot arm persisted for a total of 4 days. Hives and itchiness on shot arm began 5 days after vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Pyrexia, Urticaria
Clinical narrative: Pain in arms and legs with extreme pain and tingling in arm vaccine administered within 4 hours. Chills, headache, joint pain, nausea, 100F fever, sensation of not getting enough air all started at about 24 hours post vaccine and ended within 24 hours after onset. Severe soreness in shot arm persisted for a total of 4 days. Hives and itchiness on shot arm began 5 days after vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Nausea, Pain
Clinical narrative: Fever 101.2, shivering, headache, nausea, weak, total body aching.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 101.2, shivering, headache, nausea, weak, total body aching.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Continuous positive airway pressure, Heart rate decreased, Infantile apnoea
Clinical narrative: Baby had increased oxygen needs 30 min following shots, continued to have labile oxygen needs during the day. Began having apneic spells and heart rate drops at 1800 that evening, which persisted into the following day. Increased respiratory support (CPAP) and increased caffeine dose for apnea.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash
Clinical narrative: Significant rash on bilateral arms and legs. Significant swelling of the right arm. Immune response. Rash at the time of the event- I suspect she will improve every day.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Tired, chills, body aches, and headache. Only lasted for one day.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Chills, shivering, headache, feverish (low), tiredness, muscle aches. The chills and shivering came on very suddenly about 12 hours after getting the vaccine. I also have arm soreness where the vaccine was administered.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, shivering, headache, feverish (low), tiredness, muscle aches. The chills and shivering came on very suddenly about 12 hours after getting the vaccine. I also have arm soreness where the vaccine was administered.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: 100.5 degree fever, muscle/body aches at the site and all over the body due to fever.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Headache, dizziness, vomit liquid.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site rash, Pain
Clinical narrative: Patient complained of flu like symptoms (low grade fever, sore all over but mostly in joints, very bad headache) and rash at injection site. She states that it was worse than getting the flu and left her wiped out all day.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient complained of flu like symptoms (low grade fever, sore all over but mostly in joints, very bad headache) and rash at injection site. She states that it was worse than getting the flu and left her wiped out all day.
Age: 20.0
Sex: M
Vaccine: FLUA3
Symptoms: Hypoaesthesia
Clinical narrative: In the patient's medical chart, the reaction noted by a nurse on 1/17/2019 was, "numbness". The patient's last documented influenza immunization was 12/12/2017 and for this reason this was the date that was entered for this report. The patient was unable to be interviewed as there were patient care activities performed when attempted for an interview. This report is filed solely based on the information included in the chart as influenza virus vaccines were documented in his chart as an allergy with the reaction, "numbness" on the noted date as described above.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Cough, Ear pain, Headache
Clinical narrative: General body ache, head ache, scratchy throat, sore jaw left side, sore inner ear left side, chills, elevated temperature, cough.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in jaw, Throat irritation
Clinical narrative: General body ache, head ache, scratchy throat, sore jaw left side, sore inner ear left side, chills, elevated temperature, cough.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Back pain, Erythema, Feeling hot, Oral mucosal erythema
Clinical narrative: Within 60 seconds of immunization, patient complained of feeling hot all over, then became profoundly weak and complained of severe low back pain. On exam, she was tachycardic, then developed redness and swelling of both ocular and oral mucosa as well as diffuse red rash. She was administered diphenhydramine 50mg orally, acetaminophen 1000mg orally, and epinephrine 1mg IM with complete resolution of her symptoms over the next 5-10 minutes.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Tachycardia
Clinical narrative: Within 60 seconds of immunization, patient complained of feeling hot all over, then became profoundly weak and complained of severe low back pain. On exam, she was tachycardic, then developed redness and swelling of both ocular and oral mucosa as well as diffuse red rash. She was administered diphenhydramine 50mg orally, acetaminophen 1000mg orally, and epinephrine 1mg IM with complete resolution of her symptoms over the next 5-10 minutes.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Cough, Crying, Decreased eye contact, Eating disorder, Gaze palsy
Clinical narrative: Vaccine was administered approx. 9am 12/15/2017 my child had not been sick at all when brought to the doctors for the 18 month old well visit. By 2pm that day my child had over 102 f temperature and was sick. Not eating well, cranky, coughing and just overall sick. 12/16/2017 saturday child is still sick and running fever of approx. 100-101, she is coughing, congested, and overall sick. Child is still drinking and eating small amounts and is talking and responsive. Saturday night into sunday early morning child woke up twice that night crying and took an hour each time to console and put back to sleep. Approx 7am 12/17/2017 sunday am child wakes up and grandmother gets child from crib, grandmother states child is still sleepy/lethargic and falls asleep in grandmothers arms alomost immediatly. After 30 minutes of sleep child wakes up but is very lethargic temperature is over 102 degrees f . Mother now wakes up and goes to her child, grandmother states child does not look well.  Child does not respond to her mother, mother is calling her name with no response, child is not blinking, no eye contact, no talking, child becomes limp with no muscle tone, eyes roll back in head, unable to keep child awake. 911 called chuild taken to emergency room in hospital.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Hypotonia, Irritability, Lethargy, Malaise, Pyrexia
Clinical narrative: Vaccine was administered approx. 9am 12/15/2017 my child had not been sick at all when brought to the doctors for the 18 month old well visit. By 2pm that day my child had over 102 f temperature and was sick. Not eating well, cranky, coughing and just overall sick. 12/16/2017 saturday child is still sick and running fever of approx. 100-101, she is coughing, congested, and overall sick. Child is still drinking and eating small amounts and is talking and responsive. Saturday night into sunday early morning child woke up twice that night crying and took an hour each time to console and put back to sleep. Approx 7am 12/17/2017 sunday am child wakes up and grandmother gets child from crib, grandmother states child is still sleepy/lethargic and falls asleep in grandmothers arms alomost immediatly. After 30 minutes of sleep child wakes up but is very lethargic temperature is over 102 degrees f . Mother now wakes up and goes to her child, grandmother states child does not look well.  Child does not respond to her mother, mother is calling her name with no response, child is not blinking, no eye contact, no talking, child becomes limp with no muscle tone, eyes roll back in head, unable to keep child awake. 911 called chuild taken to emergency room in hospital.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Respiratory tract congestion, Somnolence, Unresponsive to stimuli
Clinical narrative: Vaccine was administered approx. 9am 12/15/2017 my child had not been sick at all when brought to the doctors for the 18 month old well visit. By 2pm that day my child had over 102 f temperature and was sick. Not eating well, cranky, coughing and just overall sick. 12/16/2017 saturday child is still sick and running fever of approx. 100-101, she is coughing, congested, and overall sick. Child is still drinking and eating small amounts and is talking and responsive. Saturday night into sunday early morning child woke up twice that night crying and took an hour each time to console and put back to sleep. Approx 7am 12/17/2017 sunday am child wakes up and grandmother gets child from crib, grandmother states child is still sleepy/lethargic and falls asleep in grandmothers arms alomost immediatly. After 30 minutes of sleep child wakes up but is very lethargic temperature is over 102 degrees f . Mother now wakes up and goes to her child, grandmother states child does not look well.  Child does not respond to her mother, mother is calling her name with no response, child is not blinking, no eye contact, no talking, child becomes limp with no muscle tone, eyes roll back in head, unable to keep child awake. 911 called chuild taken to emergency room in hospital.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: Patient developed Guillain-Barre syndrome 2 weeks after influenza vaccination. Required incubation, prolonged hospital course. Discharged to rehabilitation facility.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Abnormal Pap smear 1/31/2018 with mild dysplasia and with HPV 18/45 positive on this date.
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Donor states she began to fell numbness in bilateral fingers of hands and dull pain after shot, but pain went away within a minute. Staff had Donor sit, relax and elevate hands on table for about 30 minutes, but no changes in numbness. Donor was sent out to Emergency Department per Med-Ops Dr. if signs did not subside.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Shivering (probably due to a fever??), severe headache, nausea, vomiting, pain as well as redness and swelling of the injection site, muscle soreness, tiredness. In trying to figure out what was going on with me, I looked up possible side effects as I woke to serious shivering in the early morning hours while sleeping under my electric blanket (this was almost exactly 12 hours after the SHINGRIX shot).  I knew that was completely unusual. At that same time my headache resembled migraine headaches that I used to have years ago. The headache faded after about 24 hours as did the shivering. My injection site was red, sore, and swollen which actually seemed to worsen before it improved over the next 5 to 7 days. The nausea hit me by morning after the afternoon SHINGRIX shot, and the only vomiting I experienced was about 24 hours after receiving the SHINGRIX vaccine. However, my appetite did not return until 5 days, almost to the hour of having the SHINGRIX shot. Please know that I had these side effects only with the second of the two SHINGRIX shots. Having only a sore arm and slight redness with the first injection almost 6 months prior, I was totally blindsided by the side effects I experienced as I thought I would have just the same type of reaction (very minimal) as I did to the first of the two SHINGRIX shots! I did not seek medical help for the side effects once I realized that the things I was experiencing were things other people had experienced with the SHINGRIX vaccine, however, it would have been helpful to know what I might experience before getting the second shot!  I have warned others about it after my experience.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Vomiting
Clinical narrative: Shivering (probably due to a fever??), severe headache, nausea, vomiting, pain as well as redness and swelling of the injection site, muscle soreness, tiredness. In trying to figure out what was going on with me, I looked up possible side effects as I woke to serious shivering in the early morning hours while sleeping under my electric blanket (this was almost exactly 12 hours after the SHINGRIX shot).  I knew that was completely unusual. At that same time my headache resembled migraine headaches that I used to have years ago. The headache faded after about 24 hours as did the shivering. My injection site was red, sore, and swollen which actually seemed to worsen before it improved over the next 5 to 7 days. The nausea hit me by morning after the afternoon SHINGRIX shot, and the only vomiting I experienced was about 24 hours after receiving the SHINGRIX vaccine. However, my appetite did not return until 5 days, almost to the hour of having the SHINGRIX shot. Please know that I had these side effects only with the second of the two SHINGRIX shots. Having only a sore arm and slight redness with the first injection almost 6 months prior, I was totally blindsided by the side effects I experienced as I thought I would have just the same type of reaction (very minimal) as I did to the first of the two SHINGRIX shots! I did not seek medical help for the side effects once I realized that the things I was experiencing were things other people had experienced with the SHINGRIX vaccine, however, it would have been helpful to know what I might experience before getting the second shot!  I have warned others about it after my experience.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Pruritus, Pyrexia
Clinical narrative: Symptoms began the night of the vaccination 03/22/19: Rash (arms, neck), itchiness, fever, headache, fatigue, feeling cold.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Symptoms began the night of the vaccination 03/22/19: Rash (arms, neck), itchiness, fever, headache, fatigue, feeling cold.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Discomfort, Erythema, Feeling cold, Feeling hot
Clinical narrative: Symptoms began the night of the vaccination 03/22/19: Rash (arms, neck), itchiness, fever, headache, fatigue, feeling cold.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Insomnia, Myalgia, Pain, Pruritus
Clinical narrative: Symptoms began the night of the vaccination 03/22/19: Rash (arms, neck), itchiness, fever, headache, fatigue, feeling cold.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Scar, Secretion discharge, Tenosynovitis stenosans, Tremor
Clinical narrative: Symptoms began the night of the vaccination 03/22/19: Rash (arms, neck), itchiness, fever, headache, fatigue, feeling cold.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Headache, Nausea
Clinical narrative: 03/21/19 at 7 am: arm pain and nausea, 03/21/19 11 am: achy all over, headache and nausea, 03/21/19 3 pm: slept until 6:30 pm, restless, achy, 03/21/19 7:30 back to bed same symptoms, 03/22/19 8:00 to 6:00 all the same symptoms, 03/22/19 7:00 pm: showered and noticed a red circle on her left arm that was not near the injection site, it hurt to touch. 03/23/19: Morning: felt nauseous, tired, no energy, 03/23/19 03:30 pm nausea is gone, red circle is still present on arm but the pain is almost gone. The red circle only hurts when she presses on it. 03/23/19: 6pm more energy, able to make supper. 03/24/19: 9:13 am not sore, all symptoms are gone except red circle is still there but not painful unless it is pressed on (2 to 3 pain scale).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Restlessness
Clinical narrative: 03/21/19 at 7 am: arm pain and nausea, 03/21/19 11 am: achy all over, headache and nausea, 03/21/19 3 pm: slept until 6:30 pm, restless, achy, 03/21/19 7:30 back to bed same symptoms, 03/22/19 8:00 to 6:00 all the same symptoms, 03/22/19 7:00 pm: showered and noticed a red circle on her left arm that was not near the injection site, it hurt to touch. 03/23/19: Morning: felt nauseous, tired, no energy, 03/23/19 03:30 pm nausea is gone, red circle is still present on arm but the pain is almost gone. The red circle only hurts when she presses on it. 03/23/19: 6pm more energy, able to make supper. 03/24/19: 9:13 am not sore, all symptoms are gone except red circle is still there but not painful unless it is pressed on (2 to 3 pain scale).
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Swelling in right knee on 3/21/19 and swelling in right middle finger on 3/23/19. No history of joint swelling.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling cold, Hallucination, Headache
Clinical narrative: Patient describes feeling cold from the inside out and could not get warmed, this lasted for 4 to 5 days. He said that he was not running a fever, had aching joints, and head ache, these symptoms also lasted 4 to 5 days. The last thing that he described was hallucination that only occurred for a couple of hours on the day after the vaccination.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Somnolence
Clinical narrative: Patient called pharmacy complaining of adverse effect from vaccine given the previous day SHINGRIX patient having whole body weakness and felt sleepy the whole day. Instructed patient to seek medical treatment right away. She said she will.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Induration, Pyrexia, Staphylococcal infection, Swelling
Clinical narrative: Red, swollen, feverish, hard to touch, fever, Dr. stated it had turned into a staph infection.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: PATIENTS' HUSBAND REPORTED THAT PATIENT DEVELOPED A RED RAISED RASH THE DAY AFTER INJECTION. STARTED OUT THE EVENING OF 3-18-19 AT THE INJECTION SITE THE SIZE OF A QUARTER AND GREW TO A RED RAISED RASH 3" BY 5" BY THE FOLLOWING DAY. PATIENT ALSO REPORTED PAIN AT THE INJECTION SITE. BY 3-24-19 THE RASH WAS SUBSIDING AND GETTING BETTER. THE PATIENT SAW AN URGENT CARE PHYSICIAN FOR AN UNRELATED MATTER AND HAD THE URGENT CARE PHYSICIAN LOOK AT RASH. THE URGENT CARE PHYSICIAN DID NOT PRESCRIBE ANY TREATMENT FOR THE RASH ACCORDING TO THE PATIENT.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: Patient reported to Pharmacy 6 days after the shot was given: She has a big round rash under her armpit that is about 4 inches by 6 inches round. The rash is red, and warm to touch. She started the rash after 5 day from receiving the shot. She is reporting mild pain. Ice did not help the rash. I informed her to go see the doctor asap.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: 4 hours post vaccination developed 103 fever, vomiting, and diarrhea. Child was hospitalized for IV fluids, symptoms improved over 2 days.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt called and stated she has redness and pain at the injection site.
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: It is believed by the on call doctor that the DTaP (unsure of which DTaP was received) was the vaccine given in the right thigh which is where the reaction site is. Vaccine given Friday morning, but Saturday evening, right thigh was red, raised, and warm to the touch, as well as itchy. A circle was drawn around the site. By Sunday evening, the site had gotten bigger and more itchy. Does not seem to cause any pain and no other adverse reactions to report. Doctor said to give MOTRIN and call if anything else changes.
Age: 42.0
Sex: M
Vaccine: JEV1
Symptoms: Injected limb mobility decreased, Injection site pain, Periarthritis
Clinical narrative: 42 y/o AD M RTC with L shoulder Px. Pt states his L Shoulder is completely frozen. Pt was given his JEV shot on 29JAN19, pt states the staff may have gone too deep with shot. Pt states when he woke up the next day he couldn't move his L arm at all. Pt states this is the worst PX of his life. Pt would like his L shoulder evaluated for damage done.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Area of vaccine administration turned red, swollen, hot and itching the day after of vaccine was administered. Patient come to pharmacy to indicated what was happening 7 days after vaccine was administered. I recommended patient to visit the doctor office. Doctor prescribed Cefadroxil 500 mg twice a day and DERMAGESIC lotion. Today 03/24/2019 patient indicated me that the area is as yesterday and she don't see any improvement. Doctor said that the follow appointment will be two days after the first dose of antibiotics.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Influenza like illness
Clinical narrative: At dinner approx. 5 hours after administration of SHINGRIX, pt became lightheaded and experienced severe chills. The next and pt reported flu like symptoms with chills and no fever.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hyperaesthesia, Influenza like illness, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for cold sores. Previously administered products included Shingles vaccine with an associated reaction of oral herpes (the patient received 2 part singles vaccine on unknown date) and Shingles vaccine with an associated reaction of erythema (the patient received shingles vaccine 6 years ago, with event as soreness). On 10th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient started Valacyclovir at an unknown dose and frequency. On 10th March 2019, less than a day after receiving SHINGRIX and unknown after starting Valacyclovir, the patient experienced erythema of extremities, swelling, feeling unwell and pain in arm. The action taken with Valacyclovir was unknown. On 14th March 2019, the outcome of the erythema of extremities, swelling, feeling unwell and pain in arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, swelling, feeling unwell and pain in arm to be related to SHINGRIX and Valacyclovir. Additional case details were provided as follows: The age at vaccination was not provided, however captured as adult as per vaccine indication. The patient medical history of shingles vaccine with associated reactions redness and soreness. The patient received single dose of Valacyclovir to stop a 6 week run of cold sores. The patient had received SHINGRIX vaccine and experienced severe red mark on upper left arm and swelling, arm sore and overall did not feel well. The arm soreness and redness was 10 time as bad from the previous one. The arm continued to be sore, when it was finally touchable and was able to raise arm without pain. All the events, continued for 4 days. The patient enquired regarding the 2nd shot of shingrix whether to take or not and the also enquiry about valacyclovir could be cause of the extreme reaction. The patient did saw on one site that, patient should not take, if patient was on Valacyclovir. On another site it was not listed that this was an interaction drug. The patient was sure that the nurse looked this up and did not see an interaction with this vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Malaise, Pain in extremity, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for cold sores. Previously administered products included Shingles vaccine with an associated reaction of oral herpes (the patient received 2 part singles vaccine on unknown date) and Shingles vaccine with an associated reaction of erythema (the patient received shingles vaccine 6 years ago, with event as soreness). On 10th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient started Valacyclovir at an unknown dose and frequency. On 10th March 2019, less than a day after receiving SHINGRIX and unknown after starting Valacyclovir, the patient experienced erythema of extremities, swelling, feeling unwell and pain in arm. The action taken with Valacyclovir was unknown. On 14th March 2019, the outcome of the erythema of extremities, swelling, feeling unwell and pain in arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, swelling, feeling unwell and pain in arm to be related to SHINGRIX and Valacyclovir. Additional case details were provided as follows: The age at vaccination was not provided, however captured as adult as per vaccine indication. The patient medical history of shingles vaccine with associated reactions redness and soreness. The patient received single dose of Valacyclovir to stop a 6 week run of cold sores. The patient had received SHINGRIX vaccine and experienced severe red mark on upper left arm and swelling, arm sore and overall did not feel well. The arm soreness and redness was 10 time as bad from the previous one. The arm continued to be sore, when it was finally touchable and was able to raise arm without pain. All the events, continued for 4 days. The patient enquired regarding the 2nd shot of shingrix whether to take or not and the also enquiry about valacyclovir could be cause of the extreme reaction. The patient did saw on one site that, patient should not take, if patient was on Valacyclovir. On another site it was not listed that this was an interaction drug. The patient was sure that the nurse looked this up and did not see an interaction with this vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Cough, Hyperhidrosis, Screaming
Clinical narrative: She began sweating within about 5 minutes, this lasted about 2 hours. She had a minor cough which lasted 3 days. She screamed for 3 days, only wanted to be held while standing up.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to multiple patients of unknown age and genders. The patients historical condition, concomitant medications and drug reactions or allergies were not reported. On unspecified date, the patients were vaccinated with an improperly stored dose of  LIQUID PEDVAXHIB lot # N003698  and expiration date 31-OCT-2019, and lot number R013573 and expiration date 22-MAR-2021 for prophylaxis (dosage schedule, route, anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit  for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Follow up information has been received from the nurse via telephonic call on 21-MAR-2019. The nurse clarified that, only one improperly stored lot (# N003698  and expiration date 31-OCT-2019) was administered to 9 separate patients between July 2018 to March 2019. Patient ID number was provided for each individual patient. This case refers to a patient of unknown age and gender, who was vaccinated with improperly stored lot on 17-SEP-2018.  This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1903USA010363: Original Case : 1903USA004795 US-009507513-1903USA010364: Original Case : 1903USA004795  US-009507513-1903USA010365: Original Case : 1903USA004795 US-009507513-1903USA010362: Original Case : 1903USA004795 US-009507513-1903USA010359: Original Case : 1903USA004795 US-009507513-1903USA010358: Original Case : 1903USA004795 US-009507513-1903USA010361: Original Case : 1903USA004795 US-009507513-1903USA010360.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-JAN-2019 the patient was vaccinated with LIQUID PEDVAXHIB, 1 dosage form, intramuscular for prophylaxis. On 29-JAN-2019, 1 day after onset of therapy the patient experienced product storage error. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site swelling, Pain in extremity, Vomiting
Clinical narrative: This spontaneous report was received from an other health professional referring to a 61-year-old female patient. Her concurrent conditions included hypertension, migraine, gastritis, insomnia, nephropathy, rheumatoid arthritis, osteoporosis, gastrooesophageal reflux disease, asthma, sjogren's syndrome, raynaud's phenomenon, sensorineural hearing loss, depression, hypersensitivity, drug hypersensitivity and immunisation. The patient's medical history included pneumonia, colon polyps, constipation, varicose vein, spinal fracture and haemorrhoids. Concomitant therapies included zolpidem, omeprazole, sumatriptan, fluticasone furoate (+) vilanterol trifenatate (BREO ELLIPTA), citalopram, epinephrine, methotrexate, cyclosporine (RESTASIS), montelukast sodium (SINGULAIR), albuterol (VENTOLIN INHALER), cetirizine hydrochloride (ZYRTEC), valacyclovir hydrochloride (VALTREX), fluorometholone (FLUCASON), naproxen, promethazine, albuterol sulfate inhaler, linaclotide (LINZESS), prednisone, ondansetron, aclidinium bromide (TUDORZA PRESSAIR), omalizumab (XOLAIR), calcium supplements, magnesium oxide supplements, multi vitamin supplements, cholecalciferol (VITAMIN D3) supplements and omega-3 marine triglycerides (FISH OIL) supplements. On 13-MAR-2019, the patient was vaccinated with PNEUMOVAX 23, lot # R011632 and expiry date: 02-FEB-2020, intramuscularly for immunization (dose, unit, dose number, anatomical location was not reported). On 15-MAR-2019, the patient experienced left arm pain (pain in extremity), swelling from the injection site to the elbow (injection site swelling and peripheral swelling), lightheadedness (dizziness) and vomiting. The patient sought medical attention and was treated for the events. No lab diagnostics/ studies were performed. The outcome of pain in extremity, vomiting, injection site swelling, peripheral swelling and dizziness was reported as recovering/resolving. Causality assessment of the events was not reported. No product quality complaint (PQC) was involved.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Needle issue, Underdose
Clinical narrative: This spontaneous report was received from an other health professional referring to a 1-year-old infant patient of unspecified gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies was not reported. Approximately on 26-FEB-2019 (also reported as three weeks ago), the patient was vaccinated with M-M-R II (strength, dose, unit, dose number, anatomical location, lot # and expiry date were not reported) subcutaneously for prophylaxis. On the same day, it was reported that while vaccinating the patient some of the vaccine came out. The outcome of needle issue and incorrect dose administered was unknown. Causality assessment of the event was not reported. No product quality complaint (PQC) was involved.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report was received form a physician concerning to a 16 years old female patient. Information regarding the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications was not reported. On 23-JAN-2019, the patient was vaccinated with the second dose of GARDASIL 9, (strength, dosage schedule, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On unspecified date in 2019, the patient experienced rash on their abdomen and arm (rash). It was also reporter that the patient had been seen by a dermatologist numerous times. It was unknown if laboratory test were performed.  At the time of this report, the outcome of rash was unknown. The reporter did not provide the causal relationship between GARDASIL 9 and rash.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 21-FEB-2019 the patient was vaccinated with one dose of improperly stored VARIVAX injection (dose and frequency was not reported) (lot # R023502, expiry date: 16-AUG-2020) via subcutaneous route for prophylaxis. The sterile diluent (MRK) injection that was used to reconstitute the VARIVAX was stored properly. No adverse effect was reported. No product quality complaint was involved. The VARIVAX vaccine underwent a temperature excursion: 6 degree Fahrenheit (°F) to 14°F (7.2F) for a time frame of 4 hours. No previous temperature excursion was reported. Digital data logger was involved.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Henoch-Schonlein purpura
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 10 years old male patient. Information on patient's pertinent medical history, concurrent condition and drug allergies/reactions were unknown by reporter. On an unknown date in 2013, the patient was vaccinated with RECOMBIVAX HB of strength 5/0.5 microgram per milliliter, intramuscularly (dose, frequency, lot# and expiration date were unknown) for vaccination. Concomitant therapies included ZYRTEC and NASACORT. The nurse reported that the patient developed Henoch-Schonlein purpura after receiving a dose of a RECOMBIVAX HB (also reported as Hepatitis B Vaccine(manufacturer unknown). The involvement of Merck products could not be ruled out). No further adverse event(no adverse event) was reported. The outcome of Henoch-Schonlein purpura was reported as recovered. The outcome of no adverse event was unknown. Causality assessment for the event Henoch-Schonlein purpura was not reported.