chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Right arm became painful swollen, red, and warm about 2 inches below were the vaccine  was administered. Reaction occurred a couple hours after administration and worsened over night. Patient went to local urgent care clinic 12/11/19 and received rx for cephalexin
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Employee noted swelling and slight warmer to touch at injection site a couple hours after administration.  No other symptoms. Site was observed by  myself and PA who instructed employee to apply ice and take Motrin if needed.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia
Clinical narrative: Patient's grand daughter states patient did not remember how she got home after the vaccination.  Grand daughter states patient concerning about  memory loss after the vaccine.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: patient reports fever greater than 101F, severe headache, flu-like symptoms for 24 hours. Aspirin provided some relief.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose increased, Diarrhoea, Heart rate increased, Injection site pain, Pruritus
Clinical narrative: High blood sugar, Fever, Sleepy, Very high resting pulse rate, vomiting, diarrhea, extreme soreness at injection site, intense itching or burning feeling under skin.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin burning sensation, Somnolence, Vomiting
Clinical narrative: High blood sugar, Fever, Sleepy, Very high resting pulse rate, vomiting, diarrhea, extreme soreness at injection site, intense itching or burning feeling under skin.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Large welt, itching at injection site. Appeared two days after injection administered
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Facial paralysis, Fibromyalgia, Laboratory test, Trigeminal neuralgia
Clinical narrative: bell's palsy, trigeminal neuralgia, fibromyalgia
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Shot reaction (redness, soreness, warm, inflammed) - about 6 inches in diameter around one of the vaccination sites (either Pneumovax or FluzoneHD)
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient had swelling down her arm accompanied with redness. She took tylenol for pain and I recommended benadryl for the reaction.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Red spots on her arm that spread and went underneath and towards her chest. Benadryl was recommended along with tylenol.
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient described pain down the front of her arm, not down the side where the injection was given, and she also has limited mobility to lift her arm. The symptoms started the day after the vaccines.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cough, Dysphonia, Erythema
Clinical narrative: After injection, the site was very red, warm to touch and very swollen.  On evening of injection (9/30), was out to dinner and began to feel ill; chills and weakness.  Flu-like symptoms continued once home.  Was very cold and began to hallucinate that someone was telling me to keep moving my legs and I would get warm.  Onset of sore throat (the 'worst ever'), followed by hoarseness.  No fever.  Next morning, 10/1, there was a deep red 'band' around my neck and felt hot to touch and also had dry cough.  No rash.  Texted symptoms to doctor. Had phone call discussion with Dr.  Chills stopped after about a day, but sore throat, hoarseness, and aches, continued until around 10/4, causing me to cancel normal activities.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Hallucination, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: After injection, the site was very red, warm to touch and very swollen.  On evening of injection (9/30), was out to dinner and began to feel ill; chills and weakness.  Flu-like symptoms continued once home.  Was very cold and began to hallucinate that someone was telling me to keep moving my legs and I would get warm.  Onset of sore throat (the 'worst ever'), followed by hoarseness.  No fever.  Next morning, 10/1, there was a deep red 'band' around my neck and felt hot to touch and also had dry cough.  No rash.  Texted symptoms to doctor. Had phone call discussion with Dr.  Chills stopped after about a day, but sore throat, hoarseness, and aches, continued until around 10/4, causing me to cancel normal activities.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Malaise, Oropharyngeal pain, Pain
Clinical narrative: After injection, the site was very red, warm to touch and very swollen.  On evening of injection (9/30), was out to dinner and began to feel ill; chills and weakness.  Flu-like symptoms continued once home.  Was very cold and began to hallucinate that someone was telling me to keep moving my legs and I would get warm.  Onset of sore throat (the 'worst ever'), followed by hoarseness.  No fever.  Next morning, 10/1, there was a deep red 'band' around my neck and felt hot to touch and also had dry cough.  No rash.  Texted symptoms to doctor. Had phone call discussion with Dr.  Chills stopped after about a day, but sore throat, hoarseness, and aches, continued until around 10/4, causing me to cancel normal activities.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: After injection, the site was very red, warm to touch and very swollen.  On evening of injection (9/30), was out to dinner and began to feel ill; chills and weakness.  Flu-like symptoms continued once home.  Was very cold and began to hallucinate that someone was telling me to keep moving my legs and I would get warm.  Onset of sore throat (the 'worst ever'), followed by hoarseness.  No fever.  Next morning, 10/1, there was a deep red 'band' around my neck and felt hot to touch and also had dry cough.  No rash.  Texted symptoms to doctor. Had phone call discussion with Dr.  Chills stopped after about a day, but sore throat, hoarseness, and aches, continued until around 10/4, causing me to cancel normal activities.
Age: 95.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Patient has received Flu vaccine for last 8-9 years. During home visit, nurse administered vaccine and prescribed patient Clindamycin 300mg for tooth infection.  Patient stopped taking antibiotic after a few days because it made her sickthe product manufacturer was different. After vaccination, symptoms began immediately after; shoulder and neck started hurting.  Pain increased gradually and then it became excruciating. It was painful to move arm. Patient called insurance company the same day and nurse called the next day to provide vaccine information.   Excruciating pain lasted for about 1 week before it started to subside.   Patient called vaccine manufacturer who specified that it had not received a report like hers and given information about vaccine ingredients. Patient is awaiting date to see doctor. Patient has been taking 650mg Tylenol as needed for the pain, is using heat compresses, and using Two Old Goats ointment for pain.  Treatments have helped a little bit.  Patient still cannot move/raise arm even shoulder high or lift anything with left arm.  Pain in shoulder is has decreased a little bit but pain moving arm is not better at all.  The pain is worse with rain/cold weather.  Patient has no use of arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Next day, patient reports redness, swelling and itching on vaccination site. Patient did not take any medication, did not call pharmacist or doctor.   Patient experienced similar problems after the first dose.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Influenza like illness, Pain in extremity
Clinical narrative: chills, chatter teeth,flu like symptoms, joint pain, low grade fever, sorenes redness of arm
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: chills, chatter teeth,flu like symptoms, joint pain, low grade fever, sorenes redness of arm
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Influenza like illness, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Patient stated that his arm became swollen to twice the size and he could not lift it up.   He also complained of flu-like symptoms for about 1-2 days after the vaccine where he was weak, feverish and in extreme pain.  The swollen arm and arm pain continue to almost a week.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient stated that his arm became swollen to twice the size and he could not lift it up.   He also complained of flu-like symptoms for about 1-2 days after the vaccine where he was weak, feverish and in extreme pain.  The swollen arm and arm pain continue to almost a week.
Age: 48.0
Sex: M
Vaccine: HEPAB, IPV, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Nurse administered Polio vaccine that was expired on 11/14/19, NO symptoms noted
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: swollen nodule in Left deltoid. Reports was itching so patient was rubbing affected area. Reported swelling.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pain & swelling with redness started to Rt deltoid 2 hours after injection. 12/11/19 with mod-severe swelling, redness & tenderness to Rt deltoid. Pt has temp 99.86). Tylenol given, Benadryl 50mg one time oral given. Peptobismol for nausea given. Ibuprofen 400mg BID x 10 day, & Benadryl 25 mg BID x 7 days ordered. Daily vitals check.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Joint range of motion decreased, Pain in extremity, Periarthritis
Clinical narrative: Patient reports 1-3 days after the flu shot in the left upper extremity she noticed decreased range of motion and pain. Symptoms have persisted and she was seen in the office on 12/9/19. No erythema, edema or rashes. The pain is diffuse in the upper left extremity especially the bicep and triceps. No numbness or tingling. Physical exam showed 3/5 strength in upper left extremity with abduction and adduction against resistance. + spasm palpated over insertion of L triceps. After examining her I suspect that the patient has adhesive capsulitis and that it is just a coincidence that her left upper extremity symptoms started around the same time. She requested that I report her case just to be safe.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Aphthous ulcer, Nodule, Oral herpes, Pain
Clinical narrative: fever - shaking arm still bothers bothers me large (about 3" knot) & red & swollen & warm & throbbing sick to stomach  week later out break fever blisters & caucor sores lasted over a month
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin reaction, Skin warm, Tremor
Clinical narrative: fever - shaking arm still bothers bothers me large (about 3" knot) & red & swollen & warm & throbbing sick to stomach  week later out break fever blisters & caucor sores lasted over a month
Age: 60.0
Sex: M
Vaccine: FLUN4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient states no adverse events or effects. CMA.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Pruritus
Clinical narrative: One week post administration, patient noticed small bump and itchiness. 12/10/19, 22 days later, patient consulted pharmacist on duty, concerned area was still "bumpy" the size of an eraser, and itchy. Pharmacist suggested that Patient contact his physician. Patient did visit his doctor the same day.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site discomfort, Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: 3-4 in raised erythematous uncomfortable lesion at injection site of Dtap. Mom noted on 12/5/19.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: & redness, pain, swelling
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blister, Injection site pain, Pain in extremity, Rash
Clinical narrative: Pt received 1st dose Shingrix on 10/30/19.  Pt reports soreness/inj site rxn x 3 days, then pain began to spread from inj site, down the arm and to his back around day 6 (~11/4/19). Currently, still has rash and blisters present as of 11/18/19.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Mobility decreased, Pain
Clinical narrative: Pt experienced excrutiating pain around 11 am on 12/9/19, couldn't move arm/shoulder. Did not have this reaction on the first shot.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pt developed painful, swollen, itchy, rash @ injection site
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Eye irritation, Gastrointestinal pain, Pyrexia
Clinical narrative: FOR ABOUT 24 HOURS I hAd FEVER, JOINT pAin, Burning EYes, DIGESTIVE PAIN. EVER SINCE, I CONTINUE TO HAVE mildLy BURnIng EYES ThaT REQUIRE USING EYE DROPS
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Impaired work ability, Joint swelling, Pain, Renal pain
Clinical narrative: Extreme reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  .Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The reporter stated that his medical doctor told him that someone else had an extreme reaction to the Shingrix vaccine. The follow up consent was not granted. This case has been linked with case US2019218858, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Feeling abnormal, Gait inability, Impaired work ability, Joint swelling
Clinical narrative: Extreme reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  .Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The reporter stated that his medical doctor told him that someone else had an extreme reaction to the Shingrix vaccine. The follow up consent was not granted. This case has been linked with case US2019218858, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test normal
Clinical narrative: Extreme reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  .Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The reporter stated that his medical doctor told him that someone else had an extreme reaction to the Shingrix vaccine. The follow up consent was not granted. This case has been linked with case US2019218858, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Extreme reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  .Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The reporter stated that his medical doctor told him that someone else had an extreme reaction to the Shingrix vaccine. The follow up consent was not granted. This case has been linked with case US2019218858, reported by same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram abnormal, Chest pain, Dyspnoea, Fibrin D dimer increased, Insomnia
Clinical narrative: Within about 6 hours of the administration of the vaccine, I was not able to sleep.  I had chest pain and could not lay flat.  I had trouble taking in a breath.  In the following 4 days I slept only a short periods of time sitting upright.  I ended up in the emergency room early Saturday morning.  Blood work did not suggest MI, but CT showed bilateral pleural effusions and pericardial effusion.  The EKG showed some abnormalities.  I seen in cardiology on 7/24 where I was diagnosed pericarditis.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pericardial effusion, Pleural effusion
Clinical narrative: Within about 6 hours of the administration of the vaccine, I was not able to sleep.  I had chest pain and could not lay flat.  I had trouble taking in a breath.  In the following 4 days I slept only a short periods of time sitting upright.  I ended up in the emergency room early Saturday morning.  Blood work did not suggest MI, but CT showed bilateral pleural effusions and pericardial effusion.  The EKG showed some abnormalities.  I seen in cardiology on 7/24 where I was diagnosed pericarditis.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: Within about 6 hours of the administration of the vaccine, I was not able to sleep.  I had chest pain and could not lay flat.  I had trouble taking in a breath.  In the following 4 days I slept only a short periods of time sitting upright.  I ended up in the emergency room early Saturday morning.  Blood work did not suggest MI, but CT showed bilateral pleural effusions and pericardial effusion.  The EKG showed some abnormalities.  I seen in cardiology on 7/24 where I was diagnosed pericarditis.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pericardial effusion, Pericarditis, Pleural effusion
Clinical narrative: Within about 6 hours of the administration of the vaccine, I was not able to sleep.  I had chest pain and could not lay flat.  I had trouble taking in a breath.  In the following 4 days I slept only a short periods of time sitting upright.  I ended up in the emergency room early Saturday morning.  Blood work did not suggest MI, but CT showed bilateral pleural effusions and pericardial effusion.  The EKG showed some abnormalities.  I seen in cardiology on 7/24 where I was diagnosed pericarditis.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal distension, Abdominal pain upper, Blood pressure decreased, Cold sweat, Diarrhoea
Clinical narrative: Pt. had syncopal reaction < 1 minute after receiving Gardasil injection. Pt. stated she was feeling lightheaded, as I was offering Pt. to get on exam table, she appeared to lose consciousness. Pt. was upright in chair, diaphoretic and started to show signs of mild seizure like activity. Pt. was incontinent while sitting in the chair. We were unable to safely lower her to floor, Pt. remained sitting in chair as we attempted to bring her around, using ammonia inhalants. BP and pulse monitored. Oxygen applied. Pt. sent out to ER by ambulance, for evaluation.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Feeling cold, Hyperhidrosis, Loss of consciousness, Nausea, Seizure
Clinical narrative: Pt. had syncopal reaction < 1 minute after receiving Gardasil injection. Pt. stated she was feeling lightheaded, as I was offering Pt. to get on exam table, she appeared to lose consciousness. Pt. was upright in chair, diaphoretic and started to show signs of mild seizure like activity. Pt. was incontinent while sitting in the chair. We were unable to safely lower her to floor, Pt. remained sitting in chair as we attempted to bring her around, using ammonia inhalants. BP and pulse monitored. Oxygen applied. Pt. sent out to ER by ambulance, for evaluation.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Sensory loss, Tremor, Urinary incontinence, Visual impairment, Vomiting
Clinical narrative: Pt. had syncopal reaction < 1 minute after receiving Gardasil injection. Pt. stated she was feeling lightheaded, as I was offering Pt. to get on exam table, she appeared to lose consciousness. Pt. was upright in chair, diaphoretic and started to show signs of mild seizure like activity. Pt. was incontinent while sitting in the chair. We were unable to safely lower her to floor, Pt. remained sitting in chair as we attempted to bring her around, using ammonia inhalants. BP and pulse monitored. Oxygen applied. Pt. sent out to ER by ambulance, for evaluation.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Hyperhidrosis, Incontinence, Loss of consciousness, Seizure like phenomena
Clinical narrative: Pt. had syncopal reaction < 1 minute after receiving Gardasil injection. Pt. stated she was feeling lightheaded, as I was offering Pt. to get on exam table, she appeared to lose consciousness. Pt. was upright in chair, diaphoretic and started to show signs of mild seizure like activity. Pt. was incontinent while sitting in the chair. We were unable to safely lower her to floor, Pt. remained sitting in chair as we attempted to bring her around, using ammonia inhalants. BP and pulse monitored. Oxygen applied. Pt. sent out to ER by ambulance, for evaluation.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Pt. had syncopal reaction < 1 minute after receiving Gardasil injection. Pt. stated she was feeling lightheaded, as I was offering Pt. to get on exam table, she appeared to lose consciousness. Pt. was upright in chair, diaphoretic and started to show signs of mild seizure like activity. Pt. was incontinent while sitting in the chair. We were unable to safely lower her to floor, Pt. remained sitting in chair as we attempted to bring her around, using ammonia inhalants. BP and pulse monitored. Oxygen applied. Pt. sent out to ER by ambulance, for evaluation.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: A few hours after immunization, patient had swelling, Reddness, hot and pain. She went to see an urgent care Dr. They gave her Benadryl and Tylenol. She stopped taking Benadryl it made her too sleepy. She is still taking claritin. She still have pain, stiff arm, week arm, can't lift arm as of 12-12-19
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ultrasound scan normal
Clinical narrative: A few hours after immunization, patient had swelling, Reddness, hot and pain. She went to see an urgent care Dr. They gave her Benadryl and Tylenol. She stopped taking Benadryl it made her too sleepy. She is still taking claritin. She still have pain, stiff arm, week arm, can't lift arm as of 12-12-19
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Mobility decreased, Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: A few hours after immunization, patient had swelling, Reddness, hot and pain. She went to see an urgent care Dr. They gave her Benadryl and Tylenol. She stopped taking Benadryl it made her too sleepy. She is still taking claritin. She still have pain, stiff arm, week arm, can't lift arm as of 12-12-19
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: A few hours after immunization, patient had swelling, Reddness, hot and pain. She went to see an urgent care Dr. They gave her Benadryl and Tylenol. She stopped taking Benadryl it made her too sleepy. She is still taking claritin. She still have pain, stiff arm, week arm, can't lift arm as of 12-12-19
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Bone marrow oedema, Magnetic resonance imaging abnormal, Musculoskeletal pain, Oedema
Clinical narrative: Shoulder pain when my arm is raised above shoulder level and/or across my body
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Hot flush, Injection site pain, Nausea, Syncope
Clinical narrative: Dec 11th 2pm - Mild pain at the injection site 4:45pm - Stood up, experienced dizziness & spots in vision, fainted (Was caught and put on couch) , injection site pain increased to severe pain (patient said it feels like her muscle is torn), Nausea, hot flashes.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Visual impairment
Clinical narrative: Dec 11th 2pm - Mild pain at the injection site 4:45pm - Stood up, experienced dizziness & spots in vision, fainted (Was caught and put on couch) , injection site pain increased to severe pain (patient said it feels like her muscle is torn), Nausea, hot flashes.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Headache, Hypersomnia, Influenza like illness
Clinical narrative: Flu-like weakness and headache. Aching joints. Random stinging pain in extremities. Sore shoulder where shot was received.  Unable to function normally, having slept most of the two days following the second shot. Just as bad with the first round, months earlier.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Flu-like weakness and headache. Aching joints. Random stinging pain in extremities. Sore shoulder where shot was received.  Unable to function normally, having slept most of the two days following the second shot. Just as bad with the first round, months earlier.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising
Clinical narrative: the second dose of VARIVAX intramuscularly; black bruise that spread from the injection site within a day or so; black bruise that spread from the injection site within a day or so; This spontaneous report was received from a pharmacist and refers to a 25-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-OCT-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously lot # R017636, expiration date 20-JUN-2020 (anatomical location not reported), for prophylaxis needed for internship. On unspecified date in October 2019, within a day or so after being vaccinated, the patient developed a black bruise that spread from the injection site within a day or so. The patient did not seek a medical attention and the bruise lasted about a week or two, and the patient recovered on unspecified date in October 2019. On an unknown date in 2019, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly lot # R017636, expiration date 20-JUN-2020 (anatomical location not reported), for prophylaxis needed for internship. There were no adverse symptoms after the second dose of varicella virus vaccine live (oka/merck) (VARIVAX).  The causality assessment was not provided.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Bacterial test negative, Fungal test, Granulomatous dermatitis, Immunohistochemistry, Rubivirus test positive
Clinical narrative: Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; This literature marketed report has been received from authors of a published article, referring to an unknown age patient with Nijmegen breakage syndrome (NBS) (primary immunodeficiency diseases (PID)). Information about concomitant medication and medical history was not provided.  On an unknown date, at about one year old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient developed cutaneous granulomatous lesions in different body sites, e.g. face, chest, arms or legs, at various times after vaccination. No pathogenic organisms were identified by the histochemical staining or bacterial, fungal and mycobacterial cultures. Rubella viruses (RV) antigen was detected in the available tissue sections of cutaneous granulomas by fluorescent immunohistochemical staining for measles and rubella antigens. Live vaccines, including rubella vaccine, were contraindicated for individuals with severe antibody deficiency, T-cell deficiencies or innate immune defects because they may cause severe or chronic disease.   The outcome of the events was unknown. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-1911USA008596:
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash papular, Rash vesicular
Clinical narrative: he had a full blown vesicular rash/ papular rash; the patient experienced "injection site pain and itching"; the patient experienced "injection site pain and itching"; vesicular rash to his left upper extremity/he had a full blown vesicular rash; Indication: "patient has HIV"; This spontaneous report was received from a physician referring to a 50 years old male patient. The patient's medical histories included human immunodeficiency virus (HIV) and hepatitis C. The patient's drug reactions/allergies included sulfa. The patient had no concomitant medications.  On 19-NOV-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S004548, expiration date 12-AUG-2020; strength and dose details were not reported) intramuscularly for prophylaxis (reported as HIV) (product use in unapproved indication). On 23-NOV-2019, the patient experienced injection site pain and itching, vesicular rash to his left upper extremity. By 24-NOV-2019, the patient had a full blown vesicular rash/papular rash. By 01-DEC-2019, the rash was crusted over and he was healing. There was no lab diagnostics/studies were performed. The patient did not seek medical attention. The outcome of the events was reported as still recovering. The causality assessment was not reported.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Scab
Clinical narrative: he had a full blown vesicular rash/ papular rash; the patient experienced "injection site pain and itching"; the patient experienced "injection site pain and itching"; vesicular rash to his left upper extremity/he had a full blown vesicular rash; Indication: "patient has HIV"; This spontaneous report was received from a physician referring to a 50 years old male patient. The patient's medical histories included human immunodeficiency virus (HIV) and hepatitis C. The patient's drug reactions/allergies included sulfa. The patient had no concomitant medications.  On 19-NOV-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S004548, expiration date 12-AUG-2020; strength and dose details were not reported) intramuscularly for prophylaxis (reported as HIV) (product use in unapproved indication). On 23-NOV-2019, the patient experienced injection site pain and itching, vesicular rash to his left upper extremity. By 24-NOV-2019, the patient had a full blown vesicular rash/papular rash. By 01-DEC-2019, the rash was crusted over and he was healing. There was no lab diagnostics/studies were performed. The patient did not seek medical attention. The outcome of the events was reported as still recovering. The causality assessment was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: painful blistering rash on face and torso; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On unknwon date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly after receiving zoster vaccine live(ZOSTAVAX)"), the patient suffered a painful blistering rash on her face and torso. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experiences 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 zoster vaccine live(ZOSTAVAX), 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 zoster vaccine live(ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event to be disability.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Expired vaccine used; Incorrect product storage; This spontaneous report has been received from a medical assistant, concerning a 14-year-old female patient. The patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 18-NOV-2019, the patient was vaccinated with an improperly stored (product storage error) dose of Hepatitis A Vaccine, Inactivated (VAQTA), Lot No. S009562 has been verified to be a valid lot number for (Hepatitis A Vaccine, Inactivated), expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019 (strength, dose, route of administration and anatomical location of vaccination were not reported)  for prophylaxis. Upon internal lot validation, the vaccine was administered after the expiration date (expired product administered).  The vaccine was stored at a temperature range above 47 Fahrenheit degrees (52.09 F) for the time frame of 1.39 hours. the previous temperature excursion was above 47 Fahrenheit degrees (64.83 F) for 13.35 hours and, the call was because of a data logger. No additional adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported.   On or about 23-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions.   Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a male  patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a rehabilitation center and clinics  for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving defendants' zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a stroke. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not presented prior to using the vaccine. The 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), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the 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 zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of stroke was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event of stroke to be disability. Upon internal review, the event of stroke was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Visual impairment
Clinical narrative: impacted her vions and balance.; impacted her vions; multiple outbreaks of shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).Shortly after receiving Defendants'  zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered multiple outbreaks of shingles, which have impacted her vision and balance. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences 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), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the 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 zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of suffered multiple outbreaks of shingles, which have impacted her vision and balance were considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events of suffered multiple outbreaks of shingles, which have impacted her vision and balance to be disability.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose of V AQTA; No adverse effects reported.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions and allergies were not provided.  On 04-DEC-2019, the patient received an expired dose (expired product administered) of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis; lot number R030120 and expiration date 15-NOV-2019. Information about strength, dose, frequency and route of administration was not provided. No additional adverse effects were reported.
Sex: F
Vaccine: HEPA
Symptoms: Circumstance or information capable of leading to medication error, Injury associated with device, Limb injury, Occupational exposure to product, Product container issue
Clinical narrative: The nurse stated that while attempting to attach the needle, she cut her finger; The nurse stated that while attempting to attach the needle, she cut her finger; The nurse stated that while attempting to attach the needle, she cut her finger; The nurse stated that while attempting to attach the needle, she cut her finger; VAQTA pre-frill syringed that is missing the finger flange; This spontaneous report was received from a nurse of 51-year-old reporting on herself. The patient's pertinent medical history, concomitant medications, concurrent conditions and drug allergies or reactions were not reported.  On an unspecified date in December 2019 (reported as "a few days ago"), while attempting to attach the needle to hepatitis a vaccine, inactivated (VAQTA)( lot number S019435, and expiration date 23-AUG-2020) for prophylaxis, the nurse cut her finger (limb injury and injury associated with device), and then noticed the finger flange was broken off of the barrel of the syringe. Also, she noticed that the hepatitis a vaccine, inactivated (VAQTA) pre-frill syringed that is missing the finger flange (product container issue). The medication was still in the syringe with no leaking of liquid (occupational exposure to product and circumstance or information capable of leading to medication error). No patient received this dose, no missed doses. The patient did not received medication for the event, and don't sought for medical attention.  It was reported, that there was no crack on the syringe, but it was broken into two or more pieces, near the purple plunger. Also, the entire finger flange was missing all the way around the vial leaving a jagged edge.   The outcome of limb injury was reported as recovering/resolving. The outcome of injury associated with device, circumstance or information capable of leading to medication error, occupational exposure to product and product container issue was unknown.  The causality between the aforementioned events and hepatitis a vaccine, inactivated (VAQTA) was not provided.