chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Inflammation, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Note - The above two shots were given in patients right arm. They are documented as given in RD, however patient points to location they were given as approx. 2-3 inches above her right olecranon.   Patient presented to clinic on 1/6/2020. Complained that symptoms began in the middle of the night (late night 1/3--early am 1/4). States her arm became swollen, red, hot and extremely painful. Reports being unable to use/move the right arm over the weekend. Reports using ice helped decrease swelling. At time of evaluation provider reports:  Skin - redness from 13cm proximal and 10.5cm distal to olecranon process. redness on dorsal surface, with sparing of the ventral surface including antecubital fossa. Area is mildly warm to touch, mild swelling in area - no joint swelling appreciated. Injection sites not visible.  Ortho - mildly decreased elbow flexion and shoulder abduction and IROM due to pain. No swelling in elbow joint." Assessment and Plan (per chart note): T50.Z95A Adverse effect of vaccine, initial encounter  (primary encounter diagnosis): suspect inflammatory reaction to vaccination- unclear which one as she received both in the same arm.  Less likely infectious, as her symptoms are improving with use of ice.  Advised her to continue ice 15-20 minutes TID, use naproxen BID x 1 week.  Needs to be seen asap for any worsening of sx- increased pain, redness, swelling, fever.   Plan : ? NAPROXEN 500 MG TABLET - Take 1 Tab by mouth            2 (two) times daily with a meal   M79.89 Swelling of arm Plan : ? NAPROXEN 500 MG TABLET - Take 1 Tab by mouth            2 (two) times daily with a meal
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Skin warm
Clinical narrative: Note - The above two shots were given in patients right arm. They are documented as given in RD, however patient points to location they were given as approx. 2-3 inches above her right olecranon.   Patient presented to clinic on 1/6/2020. Complained that symptoms began in the middle of the night (late night 1/3--early am 1/4). States her arm became swollen, red, hot and extremely painful. Reports being unable to use/move the right arm over the weekend. Reports using ice helped decrease swelling. At time of evaluation provider reports:  Skin - redness from 13cm proximal and 10.5cm distal to olecranon process. redness on dorsal surface, with sparing of the ventral surface including antecubital fossa. Area is mildly warm to touch, mild swelling in area - no joint swelling appreciated. Injection sites not visible.  Ortho - mildly decreased elbow flexion and shoulder abduction and IROM due to pain. No swelling in elbow joint." Assessment and Plan (per chart note): T50.Z95A Adverse effect of vaccine, initial encounter  (primary encounter diagnosis): suspect inflammatory reaction to vaccination- unclear which one as she received both in the same arm.  Less likely infectious, as her symptoms are improving with use of ice.  Advised her to continue ice 15-20 minutes TID, use naproxen BID x 1 week.  Needs to be seen asap for any worsening of sx- increased pain, redness, swelling, fever.   Plan : ? NAPROXEN 500 MG TABLET - Take 1 Tab by mouth            2 (two) times daily with a meal   M79.89 Swelling of arm Plan : ? NAPROXEN 500 MG TABLET - Take 1 Tab by mouth            2 (two) times daily with a meal
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: For 3 years in a row I have had the flu exactly 2 months after the vaccine. I have taken the regular flu shots for years and never had a problem. Only with the high-dose shots (3) have I had a problem.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Magnetic resonance imaging, Nerve conduction studies, Neuralgic amyotrophy
Clinical narrative: Parsonage TURNER Syndrome.  Unable to move left arm
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Middle insomnia, Swelling face, Swelling of eyelid
Clinical narrative: At 3AM woke with swelling of my forehead followed by nose, eye brow, eyelids, lower lip, Monday swelling of cheeks, upper lip.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient describes that the injection site is red, hot, swollen, and painful. The swollen and red spot is approximately 2 inches in diameter according  to a picture that the patient sent us via a message. Patient advised us that she had a fever on Tuesday, 1/7/2020. She had received the vaccine on 1/6/2020. Pt stated that her arm has been painful since receiving the vaccine. Patient had been given the pneumonia and flu vaccines in the same arm.  Pt was advised by Dr. to ice the injection site and take tylenol/ibuprofen to help with the pain. Also advised by PA to treat with compresses and anti-inflammatories, such as 800 mg ibuprofen 3 times daily and alternate with Tylenol between ibuprofen doses. Patient was informed to call us if no improvement or worsening in the next few days. Patient was offered to have a letter witten for her to have time off of work if she would like due to the reaction.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Give influenza vaccines in left deltoid on 11/4/19. Initially had localized achiness and pain but 1 week later developed redness, swelling and tenderness. The pain continued in the left deltoid area. Continues to have pain but does have decreased ROM including difficulty removing jacket. Determined to have post influenza vaccine subdeltoid bursitis. Will start Physical therapy 2-3 times per week, take Ibuprofen prn and continue to use warm packs.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Syncope, Tinnitus
Clinical narrative: Patient had syncope in the office 5 minutes after receiving vaccine. Lasted approximately 10 seconds.  Stated his "head hurt" and that he heard "ringing in my ears" immediately prior to the episode.  Patient was given juice and monitored in office until symptoms resolved.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Ear swelling, Hypoacusis, Lip swelling, Pyrexia, Swelling face
Clinical narrative: Staff reported individual face and nose were swollen.  Assessed by nurse swollen lips, nose, ears, and hard of hearing to voice.  Respiratory rate is even and regular non-labored.  Low grade fever 100.04 F (37.8 C)noted.  Referred to medical clinic.  In no distress assessment noted mild reaction to influenza immunization, use acetaminophen PO if needed for pain or fever. Progress note makes no comment on swelling unclear if still present at time of assessment.  APAP 650 mg administered 11/15/19 11:24AM, 11/16/19 8:15AM, 11/17/19 915PM.  Resolved.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Middle insomnia, Nausea, Vomiting
Clinical narrative: clt stated at 1:30am on 1/7/20 she awoke with a headache.  she took a Tylenol and returned to bed.  she awoke again at 5:30 am and had nausea.  stated she vomited x 2.  came to Health department on 1/8/20 and clt was interviewed and vaers completed. encouraged clt to contact pmd and notify him of above and completion of report.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: red, swollen, itchy, spreading and worsening over 36 hrs. Treatment to include Clindamycin and to apply ice to area
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Pt received extra dose of vaccine
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt states that left arm is still  extremely sore and hurts to lift and sleep on (almost 6 months after receiving shot)
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Fainted in lobby about 5 minutes after receiving vaccine and PPD placement.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody positive, Arthralgia, Blood iron normal, Blood lactate dehydrogenase normal, Blood phosphorus normal
Clinical narrative: I have been experiencing extreme joint pain since 3 days after receiving the shot. The pain is 24/7. I have been to my PCP, a rheumatologist, and a holistic doctor to find a solution to the inflammation and pain. I've had extensive blood work done as well. I have another  appointment on 1/10/2020 with the rheumatologist to see if she can recommend something to get the pain and stiffness under control. This has affected every day of my life since the symptoms began. Most nights, it is difficult to sleep. When I first get up in the morning, the pain and stiffness are unbearable. I try to move around as much as possible so I do not stay stiff. I take daily naps due to the loss of sleep. Before the Shingrix vaccine, I was a healthy, very active, and energetic woman who exercised 5-6 days a week.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: C-reactive protein normal, Full blood count normal, Glycosylated haemoglobin normal, Inflammation, Insomnia
Clinical narrative: I have been experiencing extreme joint pain since 3 days after receiving the shot. The pain is 24/7. I have been to my PCP, a rheumatologist, and a holistic doctor to find a solution to the inflammation and pain. I've had extensive blood work done as well. I have another  appointment on 1/10/2020 with the rheumatologist to see if she can recommend something to get the pain and stiffness under control. This has affected every day of my life since the symptoms began. Most nights, it is difficult to sleep. When I first get up in the morning, the pain and stiffness are unbearable. I try to move around as much as possible so I do not stay stiff. I take daily naps due to the loss of sleep. Before the Shingrix vaccine, I was a healthy, very active, and energetic woman who exercised 5-6 days a week.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test normal, Lipids normal, Metabolic function test normal, Musculoskeletal stiffness, Red blood cell sedimentation rate normal
Clinical narrative: I have been experiencing extreme joint pain since 3 days after receiving the shot. The pain is 24/7. I have been to my PCP, a rheumatologist, and a holistic doctor to find a solution to the inflammation and pain. I've had extensive blood work done as well. I have another  appointment on 1/10/2020 with the rheumatologist to see if she can recommend something to get the pain and stiffness under control. This has affected every day of my life since the symptoms began. Most nights, it is difficult to sleep. When I first get up in the morning, the pain and stiffness are unbearable. I try to move around as much as possible so I do not stay stiff. I take daily naps due to the loss of sleep. Before the Shingrix vaccine, I was a healthy, very active, and energetic woman who exercised 5-6 days a week.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rheumatoid factor negative, Serum ferritin normal
Clinical narrative: I have been experiencing extreme joint pain since 3 days after receiving the shot. The pain is 24/7. I have been to my PCP, a rheumatologist, and a holistic doctor to find a solution to the inflammation and pain. I've had extensive blood work done as well. I have another  appointment on 1/10/2020 with the rheumatologist to see if she can recommend something to get the pain and stiffness under control. This has affected every day of my life since the symptoms began. Most nights, it is difficult to sleep. When I first get up in the morning, the pain and stiffness are unbearable. I try to move around as much as possible so I do not stay stiff. I take daily naps due to the loss of sleep. Before the Shingrix vaccine, I was a healthy, very active, and energetic woman who exercised 5-6 days a week.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aldolase, Antinuclear antibody, Arthralgia, Bacterial test, Blood creatine phosphokinase
Clinical narrative: I have been experiencing extreme joint pain since 3 days after receiving the shot. The pain is 24/7. I have been to my PCP, a rheumatologist, and a holistic doctor to find a solution to the inflammation and pain. I've had extensive blood work done as well. I have another  appointment on 1/10/2020 with the rheumatologist to see if she can recommend something to get the pain and stiffness under control. This has affected every day of my life since the symptoms began. Most nights, it is difficult to sleep. When I first get up in the morning, the pain and stiffness are unbearable. I try to move around as much as possible so I do not stay stiff. I take daily naps due to the loss of sleep. Before the Shingrix vaccine, I was a healthy, very active, and energetic woman who exercised 5-6 days a week.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood iron, Blood lactate dehydrogenase, Blood magnesium, Blood phosphorus, Blood thyroid stimulating hormone
Clinical narrative: I have been experiencing extreme joint pain since 3 days after receiving the shot. The pain is 24/7. I have been to my PCP, a rheumatologist, and a holistic doctor to find a solution to the inflammation and pain. I've had extensive blood work done as well. I have another  appointment on 1/10/2020 with the rheumatologist to see if she can recommend something to get the pain and stiffness under control. This has affected every day of my life since the symptoms began. Most nights, it is difficult to sleep. When I first get up in the morning, the pain and stiffness are unbearable. I try to move around as much as possible so I do not stay stiff. I take daily naps due to the loss of sleep. Before the Shingrix vaccine, I was a healthy, very active, and energetic woman who exercised 5-6 days a week.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood uric acid, Borrelia test, C-reactive protein, Full blood count, Glycosylated haemoglobin
Clinical narrative: I have been experiencing extreme joint pain since 3 days after receiving the shot. The pain is 24/7. I have been to my PCP, a rheumatologist, and a holistic doctor to find a solution to the inflammation and pain. I've had extensive blood work done as well. I have another  appointment on 1/10/2020 with the rheumatologist to see if she can recommend something to get the pain and stiffness under control. This has affected every day of my life since the symptoms began. Most nights, it is difficult to sleep. When I first get up in the morning, the pain and stiffness are unbearable. I try to move around as much as possible so I do not stay stiff. I take daily naps due to the loss of sleep. Before the Shingrix vaccine, I was a healthy, very active, and energetic woman who exercised 5-6 days a week.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lipids, Liver function test, Metabolic function test, Parasite blood test, Red blood cell sedimentation rate
Clinical narrative: I have been experiencing extreme joint pain since 3 days after receiving the shot. The pain is 24/7. I have been to my PCP, a rheumatologist, and a holistic doctor to find a solution to the inflammation and pain. I've had extensive blood work done as well. I have another  appointment on 1/10/2020 with the rheumatologist to see if she can recommend something to get the pain and stiffness under control. This has affected every day of my life since the symptoms began. Most nights, it is difficult to sleep. When I first get up in the morning, the pain and stiffness are unbearable. I try to move around as much as possible so I do not stay stiff. I take daily naps due to the loss of sleep. Before the Shingrix vaccine, I was a healthy, very active, and energetic woman who exercised 5-6 days a week.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rheumatoid factor, Serum ferritin, Vitamin D
Clinical narrative: I have been experiencing extreme joint pain since 3 days after receiving the shot. The pain is 24/7. I have been to my PCP, a rheumatologist, and a holistic doctor to find a solution to the inflammation and pain. I've had extensive blood work done as well. I have another  appointment on 1/10/2020 with the rheumatologist to see if she can recommend something to get the pain and stiffness under control. This has affected every day of my life since the symptoms began. Most nights, it is difficult to sleep. When I first get up in the morning, the pain and stiffness are unbearable. I try to move around as much as possible so I do not stay stiff. I take daily naps due to the loss of sleep. Before the Shingrix vaccine, I was a healthy, very active, and energetic woman who exercised 5-6 days a week.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Dizziness, Pallor, Vomiting
Clinical narrative: Pt was administered flucelvax on the left arm. She was fine during and a few minutes after receiving the vaccination. When she stood up and left the immunization room, she felt dizzy and sat down on the bench. She did not fall or hurt herself.  She threw up after having some water, along with cold sweat and pale color skin. After getting some rest on the bench, around 15 minutes, she felt fine and left with her father. Her father declined to for us to call for any help.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Muscle spasms, Myalgia, Nausea
Clinical narrative: Muscle pain, headache, shivering, nausea, muscle cramps/spasms in lower hanstrings on both legs
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Entire arm was red, hot, swollen, tender. No systemic
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: A well defined erythematous area appeared after injection. Area is located below the injection site, about halfway down arm. Area is not painful and only slightly itchy. As of 5 days after injection, area is still prominently erythematous. Told to consult doctor
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: PATIENT C/O BUMPS AND ITCHING ON FACE THAT LATER RESOLVED THE SAME DAY
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe redness, swelling, pain at site of injection radiating to axilla.  body wide muscle aches/pains.  Started within 12 hours of vaccine.  Treated with naproxen/loratadine as patient declined prednisone burst.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Oedema peripheral
Clinical narrative: Severe redness, swelling, pain at site of injection radiating to axilla.  body wide muscle aches/pains.  Started within 12 hours of vaccine.  Treated with naproxen/loratadine as patient declined prednisone burst.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Patient stated he had blurred vision day after vaccine, symptoms were starting to clear up but patient was unsure if they were related to the vaccine, however they did start 1-2 days after the vaccine
Age: 69.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pts right arm had redness swelling and pain at injection site. It is improving but is not yet 100%better
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram normal, Electroencephalogram, Lumbar puncture normal
Clinical narrative: On Friday December 11th, my son was given the DTap vaccine. He then had seizures on Friday December 20th. I called 911 and later that night were transferred to the hospital. He had 4 seizures total with in a 5 hour period. We got transferred to a different hospital where they did more tests and what not. After 3 days the discharged us and now have my son on medication. He is on Keppra and Phenytoin.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Magnetic resonance imaging normal, Seizure
Clinical narrative: On Friday December 11th, my son was given the DTap vaccine. He then had seizures on Friday December 20th. I called 911 and later that night were transferred to the hospital. He had 4 seizures total with in a 5 hour period. We got transferred to a different hospital where they did more tests and what not. After 3 days the discharged us and now have my son on medication. He is on Keppra and Phenytoin.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, CSF protein increased, Chest X-ray normal, Computerised tomogram normal, Dysstasia
Clinical narrative: Days after the flu shot I started feeling very tired. On 11/12/19 i noticed my hands and feet numb and tingling . On 11/14/19 I started getting a pounding headache. The week of 11/17/19 to 11/23/19 I started getting weaker by the day to the point where i needed help to get in and out of bed, standing and walking and going to the bathroom i was only able to take baby steps i couldn?t even stand to brush my teeth. I fell twice trying to walk on my own. I was breastfeeding and my milk supply completely dried up.  On 11/25/19 I was diagnosed with Guillain Barre Syndrome and was treated on 11/27/19 - 12/1/19 with Immune Globulin Intravenous
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Fatigue, Gait disturbance, Guillain-Barre syndrome, Headache
Clinical narrative: Days after the flu shot I started feeling very tired. On 11/12/19 i noticed my hands and feet numb and tingling . On 11/14/19 I started getting a pounding headache. The week of 11/17/19 to 11/23/19 I started getting weaker by the day to the point where i needed help to get in and out of bed, standing and walking and going to the bathroom i was only able to take baby steps i couldn?t even stand to brush my teeth. I fell twice trying to walk on my own. I was breastfeeding and my milk supply completely dried up.  On 11/25/19 I was diagnosed with Guillain Barre Syndrome and was treated on 11/27/19 - 12/1/19 with Immune Globulin Intravenous
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Lactation disorder, Loss of personal independence in daily activities, Lumbar puncture abnormal
Clinical narrative: Days after the flu shot I started feeling very tired. On 11/12/19 i noticed my hands and feet numb and tingling . On 11/14/19 I started getting a pounding headache. The week of 11/17/19 to 11/23/19 I started getting weaker by the day to the point where i needed help to get in and out of bed, standing and walking and going to the bathroom i was only able to take baby steps i couldn?t even stand to brush my teeth. I fell twice trying to walk on my own. I was breastfeeding and my milk supply completely dried up.  On 11/25/19 I was diagnosed with Guillain Barre Syndrome and was treated on 11/27/19 - 12/1/19 with Immune Globulin Intravenous
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging normal, Maternal exposure during breast feeding, Paraesthesia
Clinical narrative: Days after the flu shot I started feeling very tired. On 11/12/19 i noticed my hands and feet numb and tingling . On 11/14/19 I started getting a pounding headache. The week of 11/17/19 to 11/23/19 I started getting weaker by the day to the point where i needed help to get in and out of bed, standing and walking and going to the bathroom i was only able to take baby steps i couldn?t even stand to brush my teeth. I fell twice trying to walk on my own. I was breastfeeding and my milk supply completely dried up.  On 11/25/19 I was diagnosed with Guillain Barre Syndrome and was treated on 11/27/19 - 12/1/19 with Immune Globulin Intravenous
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm  very swollen for 3 days
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Patient complaining of face swelling on same side as injection arm that began the day after received vaccination. No other symptoms present. Patient denies pain or trouble breathing.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema
Clinical narrative: Pt noticed red spots on upper half of thigh bilaterally on 1/1/20. The spots worsened until 1/8/20. The spots cause a burning sensation with touch of clothes or skin.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initially I did not think that patient had a Havrix dose previously. I searched in records and did not find her profile. She also could not remember if she had it before. Afterwards, I looked again and found out she had a dose in August.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Emotional distress
Clinical narrative: Patient called around 6pm on 01/08/2020 to report pain in her back "similar to what [she] felt when [she] had the shingles" which started the day prior to the report.  Patient was making noises of distress.  Patient was advise to seek medical attention if she is in substantial pain.  Patient stated she would try over the counter pain medication prior to being seen by a physician.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Received flu shot 10/19/19 and symptoms of CIDP started November 6th 2019.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Patients daughter came in today 1/8/2018 after concern that her mom almost dropped her newborn baby. She stated she was a nurse and thought that when her mom received the vaccine back in November the placement was high on the arm. Her mom complained of pain as to be expected for a few days, but then a week later it continued to increase. She noticed no bruising or swelling just that it continued to worsen to the point were her mom can not lift her arm to a normal level and when she almost dropped her baby today she decided it was time to come in and let us know and as our advice. I advised her that she should have her mom seen by a doctor and she informed she did not have insurance. I tried to follow up this evening and left a voice mail with the daughter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Fear
Clinical narrative: So sick I thought I was going to die.  Heavy dizziness, so much so it was actually like a couldn't see.  Throw-up violently for 7 hrs.  The first one came on so stronge I couldn't even get 1 foot away before throwing up like the exorcist.  From then on it was every15 minutes. But if I was able to stay completely still it would stretch it out for 20-25 minutes.  Heavy sweating as well.  Major, major migraine and I'm use to migraines.  Very weak and tired, so much so my had to almost drag me up the stairs. Shivering but hot.  I got so scared with all the throwing up, I almost called 911 but I figured they just say I had a bug.  I'm also pretty stoic. At the 6hr point I did call my sister to come over. It never occurred to me it was from the shot because others I knew had no adverse affect, but apparently the paper included had the problems that could happen, I was told only about 1% get sick like this, so I didn't think it would happen to me because I never have adverse affects from meds. It got half better everyday till after 3rd day it was gone. I did tell my Dr. later when I saw her about it and she said she had been hearing this from a lot of patients.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Hyperhidrosis, Malaise, Migraine, Visual impairment
Clinical narrative: So sick I thought I was going to die.  Heavy dizziness, so much so it was actually like a couldn't see.  Throw-up violently for 7 hrs.  The first one came on so stronge I couldn't even get 1 foot away before throwing up like the exorcist.  From then on it was every15 minutes. But if I was able to stay completely still it would stretch it out for 20-25 minutes.  Heavy sweating as well.  Major, major migraine and I'm use to migraines.  Very weak and tired, so much so my had to almost drag me up the stairs. Shivering but hot.  I got so scared with all the throwing up, I almost called 911 but I figured they just say I had a bug.  I'm also pretty stoic. At the 6hr point I did call my sister to come over. It never occurred to me it was from the shot because others I knew had no adverse affect, but apparently the paper included had the problems that could happen, I was told only about 1% get sick like this, so I didn't think it would happen to me because I never have adverse affects from meds. It got half better everyday till after 3rd day it was gone. I did tell my Dr. later when I saw her about it and she said she had been hearing this from a lot of patients.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: So sick I thought I was going to die.  Heavy dizziness, so much so it was actually like a couldn't see.  Throw-up violently for 7 hrs.  The first one came on so stronge I couldn't even get 1 foot away before throwing up like the exorcist.  From then on it was every15 minutes. But if I was able to stay completely still it would stretch it out for 20-25 minutes.  Heavy sweating as well.  Major, major migraine and I'm use to migraines.  Very weak and tired, so much so my had to almost drag me up the stairs. Shivering but hot.  I got so scared with all the throwing up, I almost called 911 but I figured they just say I had a bug.  I'm also pretty stoic. At the 6hr point I did call my sister to come over. It never occurred to me it was from the shot because others I knew had no adverse affect, but apparently the paper included had the problems that could happen, I was told only about 1% get sick like this, so I didn't think it would happen to me because I never have adverse affects from meds. It got half better everyday till after 3rd day it was gone. I did tell my Dr. later when I saw her about it and she said she had been hearing this from a lot of patients.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: pt has pain in left arm at injection site and pain while lifting arm as well
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Status epilepticus
Clinical narrative: Brought by EMS with status epilepticus/fever
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported redness and lumpy swelling at the site of injection including occasional itching. Patient was advised to apply ice pack to the site and report to ER if symptoms get worse. Patient reported decrease in swelling and redness the following day.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pt. C/O pain Next day From vaccine. State excruciating pain for 20+ days. Pt. complained of excruciating pain in (L) Deltoid after receiving her flu vaccine. Pt C/O pain for 15-20 days - which has improved throughout that time. Pt now states she has some slight pain at injection site.
Age: 20.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness & swelling of Arm. Full itching, redness developed of Arm as well as upper shoulder and nape of neck. Treated with Benadryl and ICE compress. Monitored for 30 minutes prior to discharge. Checked on pt 4hrs later and all sx resolved.
Age: 58.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Dizziness, Dyspnoea, Nausea, Wheezing
Clinical narrative: Patient became dizzy & nauseous shortly after receiving a flu & shingrix shot. She took a generic Zofran she had, but minutes later she was having trouble breathing & started to wheeze. After I administered Epinephrine, pt. was able to breath & speak within a minute or so. 911 was called as soon as breathing problems started, & evaluated pt. when they arrived.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Presumed possible reaction to imm given in Right arm. Persistent arm pain that started the day after the imm. that hasn't gone away and has variable locations in the right shoulder
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Fontanelle bulging, Rash
Clinical narrative: Rash all over body and soft spot swollen
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Hypotension
Clinical narrative: Patient called primary care physician, Dr. and reported generalized weakness and hypotension BP @ 112/60 mmHg (normally 124/80) 4 hours after receiving 2nd Shingrix shot. No syncope reported by office
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Severe pain throughout left arm
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: redness on spot; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and feeling abnormal. On an unknown date, the outcome of the influenza-like symptoms and feeling abnormal were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patients received Shingrix and had flu like symptoms and feeling out of it. This case linked with US2019AMR211850 and US2019AMR229253, reported by same reporter.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Haematoma, Injection site discolouration, Injection site pain, Injection site swelling, Skin discolouration
Clinical narrative: AFTER A FEW DAYS, RIGHT ARM WAS QUITE SORE AND DIFFICULT TO RAISE. SUBSEQUENTLY. FROM THE SHOULDER TO THE ELBOW, ARM BROKE OUT IN A RASH AND WAS STILL DIFFICULT TO RAISE. ALSO SWELLING I RETURNED TO PHARMACIST, AND SHE WAS SHOCKED TO SEE MY ARM. WENT TO EMERGENCY ROOM AND WAS TREATED FOR HEMATOMA IN THE ARM. I AM VERY APPREHENSIVE ABOUT GETTING SECOND INJECTION FOR SHINGLES.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Haematoma, Injected limb mobility decreased, Injection site rash, Pain in extremity, Peripheral swelling
Clinical narrative: AFTER A FEW DAYS, RIGHT ARM WAS QUITE SORE AND DIFFICULT TO RAISE. SUBSEQUENTLY. FROM THE SHOULDER TO THE ELBOW, ARM BROKE OUT IN A RASH AND WAS STILL DIFFICULT TO RAISE. ALSO SWELLING I RETURNED TO PHARMACIST, AND SHE WAS SHOCKED TO SEE MY ARM. WENT TO EMERGENCY ROOM AND WAS TREATED FOR HEMATOMA IN THE ARM. I AM VERY APPREHENSIVE ABOUT GETTING SECOND INJECTION FOR SHINGLES.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Diarrhoea, Eczema, Electroencephalogram, Haematochezia
Clinical narrative: Dipped fontanelle, crying/screaming 4 hours straight within 2 hours of shots, eczema head to toe within 3 days of vaccines, diarrhea within 48 hours.  Eczema and diarrhea lasted until 4 month vaccines. At this point he had the same vaccinations. Eczema flared back up in larger patches, blood in stool, seizure within 30 days of 4 month immunizations.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Screaming, Seizure
Clinical narrative: Dipped fontanelle, crying/screaming 4 hours straight within 2 hours of shots, eczema head to toe within 3 days of vaccines, diarrhea within 48 hours.  Eczema and diarrhea lasted until 4 month vaccines. At this point he had the same vaccinations. Eczema flared back up in larger patches, blood in stool, seizure within 30 days of 4 month immunizations.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Crying, Hyperacusis, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: On morning of 12/24/19, patient received an intramuscular injection of PC vaccine. On evening of day 1 (12/24/19), patient began crying and screaming at the slightest of noises. She became increasingly hyper-sensitive to sounds. Being bothered by sounds and the extreme fussiness (extreme for her) lasted until 12/28. Also occurring on evening of 12/24/19, patient developed a quarter sized welt on her left thigh, consistent with that of what was described on our pediatrician?s website as a ?common reaction ? to the PC vaccine. However, on the mornings and evenings that followed, the welt and an associated rash grew significantly larger than the 3? size where, according to the pediatrician office website a phone call should be made within 24 hours. The welt was hard as a rock, bright red, hot to the touch, and quite painful for patient. Documentation pictures were taken during this time. An email was sent on the evening of 12/25/19 followed by a phone call on morning of 12/26/19 to the pediatrician office. The receptionist stated she?s received the email and would review the concern with the pediatrician who was filling in for Dr. He informed her to tell me this reaction was still considered ?normal? despite my protest of it being MUCH larger than what was considered ?normal? on their website. I asked if I could send him the pictures to prove to him this wasn?t ?normal? and she said it wasn?t necessary, that he believed what I was describing to be ?normal?. I asked if we needed to be seen (their website suggests that with a 3? or larger reaction site, a phone call should be made within 24 hours), and they simply brushed it off saying, ?only if she begins to have trouble breathing.? They basically refused to admit this was a reaction!!  On 12/25, 12/26, 12/27, and 12/28, I applied a thick paste of bentonite clay directly to the reaction site twice per day, covered it with a cool wet washcloth and encouraged patient to allow it to stay on the site for 20 minutes each time. I never received a follow up call about if the injection site healed up. There still remains a small knot on her thigh where the injection site was, and as of 1/8/20 there is the faintest hint of a rash where the welt had been. With one more treatment of bentonite clay, the rash seems to be going away.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Injection site warmth, Irritability
Clinical narrative: On morning of 12/24/19, patient received an intramuscular injection of PC vaccine. On evening of day 1 (12/24/19), patient began crying and screaming at the slightest of noises. She became increasingly hyper-sensitive to sounds. Being bothered by sounds and the extreme fussiness (extreme for her) lasted until 12/28. Also occurring on evening of 12/24/19, patient developed a quarter sized welt on her left thigh, consistent with that of what was described on our pediatrician?s website as a ?common reaction ? to the PC vaccine. However, on the mornings and evenings that followed, the welt and an associated rash grew significantly larger than the 3? size where, according to the pediatrician office website a phone call should be made within 24 hours. The welt was hard as a rock, bright red, hot to the touch, and quite painful for patient. Documentation pictures were taken during this time. An email was sent on the evening of 12/25/19 followed by a phone call on morning of 12/26/19 to the pediatrician office. The receptionist stated she?s received the email and would review the concern with the pediatrician who was filling in for Dr. He informed her to tell me this reaction was still considered ?normal? despite my protest of it being MUCH larger than what was considered ?normal? on their website. I asked if I could send him the pictures to prove to him this wasn?t ?normal? and she said it wasn?t necessary, that he believed what I was describing to be ?normal?. I asked if we needed to be seen (their website suggests that with a 3? or larger reaction site, a phone call should be made within 24 hours), and they simply brushed it off saying, ?only if she begins to have trouble breathing.? They basically refused to admit this was a reaction!!  On 12/25, 12/26, 12/27, and 12/28, I applied a thick paste of bentonite clay directly to the reaction site twice per day, covered it with a cool wet washcloth and encouraged patient to allow it to stay on the site for 20 minutes each time. I never received a follow up call about if the injection site healed up. There still remains a small knot on her thigh where the injection site was, and as of 1/8/20 there is the faintest hint of a rash where the welt had been. With one more treatment of bentonite clay, the rash seems to be going away.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Screaming, Urticaria
Clinical narrative: On morning of 12/24/19, patient received an intramuscular injection of PC vaccine. On evening of day 1 (12/24/19), patient began crying and screaming at the slightest of noises. She became increasingly hyper-sensitive to sounds. Being bothered by sounds and the extreme fussiness (extreme for her) lasted until 12/28. Also occurring on evening of 12/24/19, patient developed a quarter sized welt on her left thigh, consistent with that of what was described on our pediatrician?s website as a ?common reaction ? to the PC vaccine. However, on the mornings and evenings that followed, the welt and an associated rash grew significantly larger than the 3? size where, according to the pediatrician office website a phone call should be made within 24 hours. The welt was hard as a rock, bright red, hot to the touch, and quite painful for patient. Documentation pictures were taken during this time. An email was sent on the evening of 12/25/19 followed by a phone call on morning of 12/26/19 to the pediatrician office. The receptionist stated she?s received the email and would review the concern with the pediatrician who was filling in for Dr. He informed her to tell me this reaction was still considered ?normal? despite my protest of it being MUCH larger than what was considered ?normal? on their website. I asked if I could send him the pictures to prove to him this wasn?t ?normal? and she said it wasn?t necessary, that he believed what I was describing to be ?normal?. I asked if we needed to be seen (their website suggests that with a 3? or larger reaction site, a phone call should be made within 24 hours), and they simply brushed it off saying, ?only if she begins to have trouble breathing.? They basically refused to admit this was a reaction!!  On 12/25, 12/26, 12/27, and 12/28, I applied a thick paste of bentonite clay directly to the reaction site twice per day, covered it with a cool wet washcloth and encouraged patient to allow it to stay on the site for 20 minutes each time. I never received a follow up call about if the injection site healed up. There still remains a small knot on her thigh where the injection site was, and as of 1/8/20 there is the faintest hint of a rash where the welt had been. With one more treatment of bentonite clay, the rash seems to be going away.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Neck pain, Screaming, Urticaria
Clinical narrative: Patient has been previously diagnosed with ASD and global developmental delay. Patient is considered by dr?s and the school district IEP Team as being non-verbal, as most of the words he is able to say are incomprehensible to most family and non-family members. On morning of 12/24/19, patient  received an intramuscular injection of PC vaccine. On evening of day 1 (12/24/19), patient  began crying and screaming at the slightest of noises. He became increasingly agitated at the littlest changes or annoyances. This lasted night and day until 12/28. Also occurring on evening of 12/24/19,  patient developed a quarter sized welt on his left thigh, consistent with that of what was described on our pediatrician?s website as a ?common reaction ? to the PC vaccine. However, on the mornings and evenings that followed, the welt and an associated rash grew significantly larger than the 3? size where, according to the pediatrician office website a phone call should be made within 24 hours. The welt was hard as a rock, bright red, hot to the touch, and quite painful for patient, and spread beyond the 3? in diameter around the injection site and began to spread to his inside thigh, near his diaper area. Documentation pictures were taken during this time. An email was sent on the evening of 12/25/19 followed by a phone call on morning of 12/26/19 to the pediatrician office. The receptionist stated she?s received the email and would review the concern with the pediatrician who was filling in for Dr. He informed her to tell me this reaction was still considered ?normal? despite my protest of it being MUCH larger than what was considered ?normal? on their website. I asked if I could send him the pictures to prove to him this wasn?t ?normal? and she said it wasn?t necessary, that he believed what I was describing to be ?normal?. I asked if we needed to be seen (their website suggests that with a 3? or larger reaction site, a phone call should be made within 24 hours), and they simply brushed it off saying, ?only if he begins to have trouble breathing.? They basically refused to admit this was a reaction!!  On 12/25, 12/26, 12/27, and 12/28, I applied a thick paste of bentonite clay directly to the reaction site twice per day, covered it with a cool wet washcloth and had to help patient in order to keep the paste and cloth on the site for 20 minutes each time. He repeatedly attempted to claw at the washcloth as well as the injection site saying ?ow? and ?bad? and ?hurt.? This occurred with and without the bentonite treatment. I never received a follow up call about if the injection site healed up. The welt/rash appeared to be raised almost 1/4-1/2? in thickness (eye-measurement). It covered  approximately 5.5-7? of his thigh and inside of his thigh depending on where measured. It stopped about 1.5? above his knee. Since 12/25 patient has complained daily of a ?tummy hurt? (stomach ache) and of his neck hurting. We have given 2 doses (1/day) of children?s acetaminophen on 12/29 and 12/30 for his neck and stomach issues, but appear to not be helping much.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: muscle pain, weak, tired, headache, stomach ache, diarrhea and nausea
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: muscle pain, weak, tired, headache, stomach ache, diarrhea and nausea
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Burning sensation, Deafness unilateral, Herpes zoster, Otitis media
Clinical narrative: right ear hearing loss; serous otitis media; tinnitus.; posterior capsule opacification; posterior vitreous detachment; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 04-AUG-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Defendants' zoster vaccine live (ZOSTAVAX) vaccine, patient suffered right ear hearing loss, serous otitis media and tinnitus. Additionally, patient suffered vision loss and was diagnosed with posterior capsule opacification and posterior vitreous detachment. Later, patient began to experience an itching and burning rash on the back of her left shoulder and was diagnosed with herpes zoster.   As a direct and proximate result of zoster vaccine live (ZOSTAVAX)  vaccine, patient symptoms have resulted in physical limitations not present prior to using this product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries, further, as a tragic consequence of this wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, deafness, vitreous detachment and posterior capsule opacification were determined to be medically significant.