chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Time Course:  1) Flu Shot - 11 am  2) Reaction/Hives - Noon (same day as the flu injection)  3) Reported to Health Clinic 2pm 4) Left Health Clinic 3pm   Signs:  1) Notice of Hives  2) Warmness  3) Tightness and Soreness in Arm Received Injection   Symptoms:  1) Severe Hives Both Front and Back of Arms Spread of Hives From Shoulders to Wrists  2) Area of Injection Swollen - Left Arm  3) Area Below Injection - Location of Start of Hives - Severe Redness and Warm - Left Arm  4) No Hives in Area of Injection  5) Hives On Leg Shins - After Returning From Health Clinic   Outcomes: 1) Recommended From Health Clinic Doctor - Report to Emergency Room to Receive Injection, etc. - Did Not Report to Emergency Room  2) Health Clinic Doctor - Provided a Benadryl for the Second Option - Oral Pill  3) Health Clinic Doctor - Provided Ice Pack for Swelling  4) Took 25 MG Benadryl with Water Departing From Clinic  5) Returned Directly Back to Work  6) Returned Home After Work  7) Reaction Gone Down Since Taking Medication 8) Tiredness - Bed Early From Benadryl
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Skin tightness, Skin warm, Urticaria
Clinical narrative: Time Course:  1) Flu Shot - 11 am  2) Reaction/Hives - Noon (same day as the flu injection)  3) Reported to Health Clinic 2pm 4) Left Health Clinic 3pm   Signs:  1) Notice of Hives  2) Warmness  3) Tightness and Soreness in Arm Received Injection   Symptoms:  1) Severe Hives Both Front and Back of Arms Spread of Hives From Shoulders to Wrists  2) Area of Injection Swollen - Left Arm  3) Area Below Injection - Location of Start of Hives - Severe Redness and Warm - Left Arm  4) No Hives in Area of Injection  5) Hives On Leg Shins - After Returning From Health Clinic   Outcomes: 1) Recommended From Health Clinic Doctor - Report to Emergency Room to Receive Injection, etc. - Did Not Report to Emergency Room  2) Health Clinic Doctor - Provided a Benadryl for the Second Option - Oral Pill  3) Health Clinic Doctor - Provided Ice Pack for Swelling  4) Took 25 MG Benadryl with Water Departing From Clinic  5) Returned Directly Back to Work  6) Returned Home After Work  7) Reaction Gone Down Since Taking Medication 8) Tiredness - Bed Early From Benadryl
Age: 1.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Rash, Sinusitis, Urticaria
Clinical narrative: Developed hives the next day.   Came and went intermittently over the next few months.   2 weeks later developed sinus infection and rash and chest and belly.    Over sensitive to light and sound.  Refused eye contact.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage, Pain in extremity
Clinical narrative: PATIENT CAME TO PHARMACY ON 09/11/19 TO GET FLUZONE HD ADMINISTERED. SHE CAME IN ON 09/18/19 CLAIMING SHE WAS BLEEDING AT THE INJECTION SITE THE EVENING OF 09/11/19 ONLY AND THAT HER ARM WAS HURTING  ALOT SINCE AND WAS LEFT WITH A BRUISE AROUND THE INJECTION SITE WHICH COULD STILL BE SEEN AS OF 09/18/19 WHEN SHE CAME TO THE PHARMACY.  I, PHARMACIST WHO SHE HAD CONTACTED ON 09/18/19 COULD SEE THE BRUISE AND ASKED IF SHE WAS TAKING ANY BLOOD THINNERS WHICH COULD POTENTIALLY LEAD TO BLEEDING AT THE INJECTION SITE BUT SHE REPLIED NO.  SHE CLAIMED SHE NEVER TOOK ANY MEDICATION SINCE APPLYING THE VACCINE AND THERE WAS NO ALLERGIC REACTION OR AT LEAST FROM WHAT I COULD SEE ON 09/18/19, BUT I DID SEE A BRUISE AROUND THE INJECTION SITE. IN MY OPINION I BELIEVE THIS IS NOT A TRUE ADVERSE EVENT BUT I AM FILLING THE FORM AS A LIABILITY PRECAUTION AND ALSO BECAUSE I WAS ADVISED BY MY MARKET HEALTH AND WELLNESS DIRECTOR TO DO SO, AGAIN, FOR LIABILITY PRECAUTION.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site rash
Clinical narrative: Pt reported on 9/18 big rash at site of injection and felt really painful in her back describing as like a really bad sunburn Says symptoms are worsening also I told her to try to take a Benadryl and if doesn't improve in 48 hours to go to doctor to get checked out
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: symptoms include pain at area of injection, loss of ability to move arm at injection. both injections, flu and pneumvox, were given on same arm as requested by the patient. one injection was given higher than the other. it is believed to be the flu shot but it is not certain that it is the flu shot that was given higher and may have caused pain and loss of mobility of arm at shoulder joint.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Pain, Rash pruritic, Skin warm
Clinical narrative: oN 9-17-2019 EVENING SHE STARTED FILLING CHILLS AND BODY ACHES ALL OVER. SHE DRESSED UP WARM CLOTHES AND WENT TO BED. IN MIDDLE OF NIGHT SHE WAKE UP WITH HEAVY SWEATING AND ALL HER CLOTHES WERE WET. SOMETIME IN NITE SHE DEVELOPED RASH WITH ITCHING. IT FEELS HOT AND BY TOUCHING IS ITS HOT. AT THIS TIME MEDICAL ATTENTION NOT NECESSARY. SHE CAME TO STORE ON 9-18-2019 AROUND 530PM TO TALK TO PHARMACIST. I SUGGESTED COLD COMPRESS WILL DO THE JOB. I HAVE TAKE A PICTURE OF RASH INCASE ANY ONE INTERESTED
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Decreased eye contact, Developmental delay, Ear infection, Food aversion
Clinical narrative: Swelling of face, crying screaming that night.  Loss of eye contact.  Will not eat solid foods. no responsiveness,  ear infection,  no progression in any milestones.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming, Swelling face, Unresponsive to stimuli
Clinical narrative: Swelling of face, crying screaming that night.  Loss of eye contact.  Will not eat solid foods. no responsiveness,  ear infection,  no progression in any milestones.
Age: 83.0
Sex: M
Vaccine: FLUA3
Symptoms: Erythema, Muscle spasms, Palpitations, Tremor
Clinical narrative: A few moments after the vaccination was administered to the patient, the patient begin to turn red in the face and then his body was shaking and he said he was experiencing some kind of muscle spasms and finally his heart rate was palpitating. 10 minutes later, all the symptoms went away and patient returned back to normal state
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Feeling hot, Flushing
Clinical narrative: Fatigue, "flushed", warm feeling in face and body. No treatment
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Shot given 9/3/19, hives started 9/6/19 no fever and mild itching with hives over entire body but more pronounced on hands, mom went to clinic 9/14 and was told hives were from vaccines. Put on benadryl for 3 days, resolved. Saw patient today no hives or rash seen. No other complaints or adverse effects
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The next day after vaccination patient called to report extremely red and sore arm around injection site and extending around into armpit. Patient had taken some tylenol, It was recommended to apply ice and take some benadryl as well.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Eczema, Injection site rash
Clinical narrative: My son had an open wound and received stitches at Hospital on 3/10/19.  The emergency room doctor urged us to give my son his Dtap vaccine and the nurse administered the Dtap shot in my son's left thigh on 3/10/19 at hospital.  Two days later, I noticed a rash behind my son's left knee.  I took him to the pediatrician and he was diagnosed with Eczema. He did not have eczema prior to receiving the Dtap vaccine.   He still has an active eczema outbreak in the same location today. It never went away.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, arm soreness, muscle soreness, headache. Took ibuprofen p
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient stated that she had pain, numbness and tingling of right arm, due to flu shot. Possibly given too high in the deltoid. Denies any redness, fever, or chills.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Left upper arm swelling 4 x 4 cm. Reaction to Menveo vaccine
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Extreme (R) arm swelling post shingrix #1 given on 8-6-2019 that continued thru 8-13-19
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: As per mother, pt had fever, headaches, vomiting after HPV #2 vaccine was adminastered.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Full blood count normal, Heart rate increased
Clinical narrative: Dyspnea, SOB, increased heart rate, pale mottled skin Treated with: benadryl and 1 dose of steroid in ER.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Livedo reticularis, Pallor
Clinical narrative: Dyspnea, SOB, increased heart rate, pale mottled skin Treated with: benadryl and 1 dose of steroid in ER.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Blister, Burning sensation, Erythema, Herpes zoster
Clinical narrative: Patient received 2nd dose of shingles vaccine in March of 2019. On July 23, 2019 contacted provided with the following complaint. Patient believes that he has shingles. Has had shingles in the past, this seems worse. Pain started 1.5weeks. Rash developed over the weekend. Rash to left buttocks and spreading down his legs. +red patches, +fluid filled blisters, +drainage, +tender to touch, +burning sensation, +5-8/10 pain, +abdominal pain and +body aches. Denies fever, nausea, fatigue, weakness, or HA.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Secretion discharge, Tenderness
Clinical narrative: Patient received 2nd dose of shingles vaccine in March of 2019. On July 23, 2019 contacted provided with the following complaint. Patient believes that he has shingles. Has had shingles in the past, this seems worse. Pain started 1.5weeks. Rash developed over the weekend. Rash to left buttocks and spreading down his legs. +red patches, +fluid filled blisters, +drainage, +tender to touch, +burning sensation, +5-8/10 pain, +abdominal pain and +body aches. Denies fever, nausea, fatigue, weakness, or HA.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Pt with 3-4cm pale pink area on (L) deltoid. Symptoms started Monday night and pt improved compared to picture taken Thursday.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Rash, Rash macular
Clinical narrative: Rash on face & head about 15 minuts post vaccination. No urticaria or wheezing. Observed in clinic for 1 hour with fading of macular rash. Left in good condition
Age: 2.75
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Chest X-ray abnormal, Computerised tomogram head normal, Febrile convulsion, Full blood count normal, Postictal paralysis
Clinical narrative: Found in bed having a seizure & Vomiting EMT called Versed Administered, taken to ED. Dx Complete Febrile Seizure Todd's paralysis
Age: 2.75
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Seizure, Urine analysis normal, Vomiting
Clinical narrative: Found in bed having a seizure & Vomiting EMT called Versed Administered, taken to ED. Dx Complete Febrile Seizure Todd's paralysis
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: (L) arm deltoid red + swollen - spreading down arm - itchy
Age: 64.0
Sex: F
Vaccine: PPV, FLU4, PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Inflammation to upper right arm from injection site to elbow, pt reporting inflammation began around injection site and has increased in size overnight. No other symptoms. Noted in records pt received PPV23 4 months prior, injected IM right deltoid on 5/14/19
Age: 64.0
Sex: F
Vaccine: PPV, FLU4, PPV, VARZOS
Symptoms: Injection site inflammation
Clinical narrative: Inflammation to upper right arm from injection site to elbow, pt reporting inflammation began around injection site and has increased in size overnight. No other symptoms. Noted in records pt received PPV23 4 months prior, injected IM right deltoid on 5/14/19
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: Intermittent dizziness that has lasted 7 days thus far. She is being treated with increased hydration and a trial of antihistamine. She is avoiding driving for now.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray, Computerised tomogram head, Decreased appetite, Electrocardiogram, Headache
Clinical narrative: Patient went to his PCP on 8/10 complaining of a swollen arm that went up his arm and into his neck on the side where the injection was given. He was told by his PCP to keep  monitoring it and if it got any worse to go to ER. On 8/11 he went to ER and was admitted to the hospital with fever, sensitive skin, migraine, no appetite, dehydration, confusion and sore legs. He was unable to coordinate his thoughts and told me multiple times that he was unable to tell his fingers what strings to play when he was playing his guitar he played for many years. He was in the hospital for 2 days and states they ran all kinds of tests and gave him IV antibiotics.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Impaired driving ability, Laboratory test, Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: Patient went to his PCP on 8/10 complaining of a swollen arm that went up his arm and into his neck on the side where the injection was given. He was told by his PCP to keep  monitoring it and if it got any worse to go to ER. On 8/11 he went to ER and was admitted to the hospital with fever, sensitive skin, migraine, no appetite, dehydration, confusion and sore legs. He was unable to coordinate his thoughts and told me multiple times that he was unable to tell his fingers what strings to play when he was playing his guitar he played for many years. He was in the hospital for 2 days and states they ran all kinds of tests and gave him IV antibiotics.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pyrexia, Temperature regulation disorder
Clinical narrative: Patient went to his PCP on 8/10 complaining of a swollen arm that went up his arm and into his neck on the side where the injection was given. He was told by his PCP to keep  monitoring it and if it got any worse to go to ER. On 8/11 he went to ER and was admitted to the hospital with fever, sensitive skin, migraine, no appetite, dehydration, confusion and sore legs. He was unable to coordinate his thoughts and told me multiple times that he was unable to tell his fingers what strings to play when he was playing his guitar he played for many years. He was in the hospital for 2 days and states they ran all kinds of tests and gave him IV antibiotics.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Decreased appetite, Dehydration, Injection site swelling, Laboratory test
Clinical narrative: Patient went to his PCP on 8/10 complaining of a swollen arm that went up his arm and into his neck on the side where the injection was given. He was told by his PCP to keep  monitoring it and if it got any worse to go to ER. On 8/11 he went to ER and was admitted to the hospital with fever, sensitive skin, migraine, no appetite, dehydration, confusion and sore legs. He was unable to coordinate his thoughts and told me multiple times that he was unable to tell his fingers what strings to play when he was playing his guitar he played for many years. He was in the hospital for 2 days and states they ran all kinds of tests and gave him IV antibiotics.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Migraine, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient went to his PCP on 8/10 complaining of a swollen arm that went up his arm and into his neck on the side where the injection was given. He was told by his PCP to keep  monitoring it and if it got any worse to go to ER. On 8/11 he went to ER and was admitted to the hospital with fever, sensitive skin, migraine, no appetite, dehydration, confusion and sore legs. He was unable to coordinate his thoughts and told me multiple times that he was unable to tell his fingers what strings to play when he was playing his guitar he played for many years. He was in the hospital for 2 days and states they ran all kinds of tests and gave him IV antibiotics.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Sensitive skin, Swelling, Thinking abnormal
Clinical narrative: Patient went to his PCP on 8/10 complaining of a swollen arm that went up his arm and into his neck on the side where the injection was given. He was told by his PCP to keep  monitoring it and if it got any worse to go to ER. On 8/11 he went to ER and was admitted to the hospital with fever, sensitive skin, migraine, no appetite, dehydration, confusion and sore legs. He was unable to coordinate his thoughts and told me multiple times that he was unable to tell his fingers what strings to play when he was playing his guitar he played for many years. He was in the hospital for 2 days and states they ran all kinds of tests and gave him IV antibiotics.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Fall, Head injury, Loss of consciousness
Clinical narrative: Gave the patient a flu shot and she did really well. As I was giving the mother her flu shot, she said, "mom that wasn't bad" and then when the mother bled a little and the daughter saw and passed out. She passed out, fell and hit her head. She regained conscience right away, and the mother started asking her questions to make sure she didn't have a concussion. She was able to recall everything. I offered to call 911 but the mother said that wasn't necessary. Ice was provided and she sat for a bit while the mother and I talked. The daughter had never gone through this before but the mother has experienced this where she faints at the sight of blood. We asked patient if it was because it was the sight of blood that caused her to faint and she said yes. The mother carried her and she felt better. I reached out later in the day to see how patient was doing and the mother said she was resting and was going to give Tylenol for the bruise on her head. Expressed that her family consists of multiple healthcare professionals and they had everything under control.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Body temperature increased, Fatigue, Headache, Influenza like illness
Clinical narrative: Pain at shot site on day 1. Following day pain was worse, body temp elevated 2 degrees, fasting blood sugar was 170 (it has NEVER been that high before), headache, body aches, nausea, fatigue. The flu-like symptoms lasted more than 2 weeks.  My fasting blood sugar continues to be about  20 points higher than it was prior to the Shingrix  -- after 2 1/2 months. Body aches continue to be bad enough to make it difficult to sleep.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Nausea, Pain
Clinical narrative: Pain at shot site on day 1. Following day pain was worse, body temp elevated 2 degrees, fasting blood sugar was 170 (it has NEVER been that high before), headache, body aches, nausea, fatigue. The flu-like symptoms lasted more than 2 weeks.  My fasting blood sugar continues to be about  20 points higher than it was prior to the Shingrix  -- after 2 1/2 months. Body aches continue to be bad enough to make it difficult to sleep.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: 1.  Fatigue, general weakness, headache noticed on waking approx. 15 hours after vaccine. Milder at day 2 (40 hours) but still tired. 2.  Arm muscle soreness accompanied by 2" diameter circular red mark at site of injection. Tender to touch. Slightly swollen. Noticed on second day after vaccination at approx. 40-42 hours. Was not there at 15 hours.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: 1.  Fatigue, general weakness, headache noticed on waking approx. 15 hours after vaccine. Milder at day 2 (40 hours) but still tired. 2.  Arm muscle soreness accompanied by 2" diameter circular red mark at site of injection. Tender to touch. Slightly swollen. Noticed on second day after vaccination at approx. 40-42 hours. Was not there at 15 hours.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Injection site started to get red with a small area around it red as well. Red area continued to grow in diameter and was warm to the touch, hard, and sensitive. This all was noticed Saturday morning and continued through the day. Sunday night at bath time, dad noticed the area had grown to a red area around his right groin area, which promoted a visit to urgent care.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects; a 19 year old patient received a pediatric/adolescent dose of VAQTA; This spontaneous report has been received from a physician via field representative referring to a 19-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.             On 21-AUG-2019, the patient was vaccinated with a pediatric/adolescent dose of hepatitis a vaccine, inactivated (VAQTA) (strength: 25/0.5 (unit not provided); dose, route, lot number and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age). No adverse effects were reported in the patient. No product quality complaint (PQC). No other information was available.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects.; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 22-AUG-2019, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (batch/lot# S010702 with expiration date 16-JAN-2021; dose, frequency, route of administration were not reported) for prophylaxis (Product storage error). The temperature and time frame were unknown (late shipment). Information of previous temperature excursion was not provided. No adverse effects were reported. Data logger was not involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 22-AUG-2019, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (batch/lot# S010702 with expiration date 16-JAN-2021; dose, frequency, route of administration were not reported) for prophylaxis (Product storage error). The temperature and time frame were unknown (late shipment). Information of previous temperature excursion was not provided. No adverse effects were reported. Data logger was not involved.
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: pneumonia; the vaccine did not prevent shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-APR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles.         On an unknown date, "few months" of receiving zoster vaccine live (ZOSTAVAX), the patient developed and was diagnosed with pneumonia. The vaccine did not prevent shingles, but rather caused the patient to contract pneumonia. As a direct and proximate result of the defective Zoster Vaccine Live (ZOSTAVAX), the patient suffered painful injuries and damages, and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. The outcome of the event was considered to be not recovered.  Pneumonia was considered to be disabling.  Upon internal review pneumonia was considered to be medically significant.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Chemotherapy, Leukaemia, Polymerase chain reaction positive, Rash, Rash vesicular
Clinical narrative: confirmed VZV infection by PCR of skin lesions on 8/30; patient was diagnosed with leukemia; vesicular lesions; This spontaneous report was received from a physician via former company representative refers to a 18 year old patient. The patient's concurrent condition included leukaemia. Information on medical history, concomitant mediactions were not reported.  On 30-JUL-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, anatomical location, route, lot # and expiry date not reported) for prophylaxis. On 02-AUG-2019, the patient experienced leukaemia. The patient started chemo including a 28-day course of prednisone. Subsequently, on an unknown date in August 2019, the patient experienced rash vesicular, which started out on the neck and was initially considered as a possible case of acne (vesicular lesions). On 30-AUG-2019, the patient experienced varicella infection (VZV infection) and it was confirmed by polymerase chain reaction (PCR) of skin lesions. It was also reported that it would be helpful to confirm that this was vaccine strain. The former company representative suggested the physician, if he would test the sample or would suggest another hospital physician. The reporter also stated that the patient was doing well after the course of prednisone. The rash had resided and there were no longer any lesions from which to obtain a sample. The only available sample was the one used for PCR testing. The outcome of rash vesicular was considered as not recovered. The outcome of leukaemia was considered to be recovering and the outcome of varicella was unknown. Causality assessment was not provided.  Upon internal review, the event leukaemia was determined to be medically significant.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: confirmed VZV infection by PCR of skin lesions on 8/30; patient was diagnosed with leukemia; vesicular lesions; This spontaneous report was received from a physician via former company representative refers to a 18 year old patient. The patient's concurrent condition included leukaemia. Information on medical history, concomitant mediactions were not reported.  On 30-JUL-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, anatomical location, route, lot # and expiry date not reported) for prophylaxis. On 02-AUG-2019, the patient experienced leukaemia. The patient started chemo including a 28-day course of prednisone. Subsequently, on an unknown date in August 2019, the patient experienced rash vesicular, which started out on the neck and was initially considered as a possible case of acne (vesicular lesions). On 30-AUG-2019, the patient experienced varicella infection (VZV infection) and it was confirmed by polymerase chain reaction (PCR) of skin lesions. It was also reported that it would be helpful to confirm that this was vaccine strain. The former company representative suggested the physician, if he would test the sample or would suggest another hospital physician. The reporter also stated that the patient was doing well after the course of prednisone. The rash had resided and there were no longer any lesions from which to obtain a sample. The only available sample was the one used for PCR testing. The outcome of rash vesicular was considered as not recovered. The outcome of leukaemia was considered to be recovering and the outcome of varicella was unknown. Causality assessment was not provided.  Upon internal review, the event leukaemia was determined to be medically significant.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: The patient developed unspecified swelling at the injection site; This spontaneous report was received from a nurse referring to a 42-year-old female patient. Her pertinent medical history included hypertension (considered concurrent condition). On an unspecified time in the past, the patient received lisinopril (LISlNOPRlL) (considered an historical drug), to which she developed an unspecified drug reaction (also considered a concurrent conditions) (captured on MARRS # 1909USA005728). The patient had no concomitant medications.  On 10-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular route for prophylaxis (strength and dose were not provided; lot number S021740 has been verified to be a valid number; expiration date 25-MAR-2021, and upon internal validation established as the same date).         On 12-SEP-2019, the patient developed unspecified swelling at the injection site (injection site swelling). The outcome of injection site swelling was reported as not recovered. The patient stated that she sought for medical attention and was treated by the physician with diphenhydramine (BENADRYL) 25 milligram (mg) tablet and Acetaminophen (TYLENOL) (unspecified dose). Laboratory diagnostics or studies were not performed.   The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the injection site swelling was not reported.  This is one of two same patient cases.; Sender's Comments:  US-009507513-1909USA005728:
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; expired dose administered; This spontaneous report was received from a licensed practical nurse and refers to a 15-year-old female patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 13-SEP-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) one dose via intramuscular route, lot # R027431, expiration date 08-SEP-2019 (injection site was not reported) for prophylaxis. There was no adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: bell's palsy; Information has been received from a lawyer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In 2017, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions.  On an unknown date, the patient experienced bell's palsy. The outcome of the event was unknown. As per the reporter, the patient has suffered and will continue to 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 pre-existing conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The event of bell's palsy was determined to be disabling and medically significant. The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
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. On or about 23-DEC-2008, 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 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: 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. In 2012, 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 physician office 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: 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 2008, 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 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: HPV9
Symptoms: Blood test, Lymphadenopathy, Tumour marker test
Clinical narrative: supraclavicular lymphadenopathy; This spontaneous report was received from a nurse practitioner regarding a 12-year-old female patient. The patient did not have any medical history, concurrent conditions, drug reactions/allergies and concomitant medications. The patient was not pregnant.  On an unknown date, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and on 05-SEP-2019, the patient finished hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series (strength, dose, lot number and expiry date were not provided) which were given via intramuscular route in the left deltoid region for prophylaxis (reported as for prevention). On an unknown date in September 2019, also reported as shortly after last dose administration, the patient experienced supraclavicular lymphadenopathy. The patient sought medical attention and treatment was given for adverse event. On an unknown date in September 2019, blood work cancer markers were performed and showed negative result. The outcome of lymphadenopathy was reported as not recovered. The reporter's causality assessment was not reported. No product quality complaints (PQC) were involved.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt bad for about a day; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her pharmacist told her that she herself had the Shingrix shot and felt bad for about a day afterwards and then it resolved. No further details were provided. The reporter did not consent to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Headache; Aching muscle at injection site; This case was reported by a consumer and described the occurrence of headache in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced headache and injection site muscle pain. On an unknown date, the outcome of the headache and injection site muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination with dose of Shingrix, experienced headache and muscle pain at the injection site. The reporter wanted to know how long does side effects would last.
Sex: M
Vaccine: VARZOS
Symptoms: Stress
Clinical narrative: Stress is Mild; This case was reported by a consumer and described the occurrence of stress in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced stress. On an unknown date, the outcome of the stress was recovered/resolved.   It was unknown if the reporter considered the stress to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, after vaccination with dose of Shingrix, experienced stress. The patient reported that, the stress was mild, and it was comes and goes.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: Pain in her legs; Feeling Tired; nausea; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix. In April 2019, couple of days after receiving Shingrix, the patient experienced tiredness and nausea. In July 2019, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was recovering/resolving and the outcome of the tiredness and nausea were resolved with sequelae.   It was unknown if the reporter considered the leg pain, tiredness and nausea to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in her legs but mostly her left leg. The pain was on the back of her legs and was worse at night. The patient also experienced feeling tired and had nausea. The patient consented to follow up.
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure systolic increased, Ocular hyperaemia
Clinical narrative: blood pressure over 200 systolic; eyes turned red; Initial information received on 12-Sep-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 39 years old female patient who experienced blood pressure over 200 systolic (blood pressure systolic increased) and red eyes (ocular hyperaemia), while she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, in 2013, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE lot UH906AE expiry date: 30-Jun-2014.  On an unknown date, in 2013, the patient had blood pressure over 200 systolic (blood pressure systolic increased) and red eyes (ocular hyperaemia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. The patient was admitted in a hospital at an emergency clinic. She was declining immunization on adverse events.  Relevant laboratory test results included: On an unknown date, the blood pressure systolic was over 200.   Final diagnosis was increased systolic blood pressure and ocular hyperaemia.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for increased systolic blood pressure and ocular hyperaemia.  List of document held by sender: none.; Sender's Comments: This case concerns a 39 years old female patient who had increased systolic blood pressure and ocular hyperaemia following the vaccination with FLUZONE. Exact time to onset was unknown. The patient's past medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient started receiving severe pain in left arm after vaccine and cannot lift arm.  He has arm in sling and slight movement today.  He took hydrcodone/apap for the pain.  Contacted Dr. and waiting for call back.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Dysphonia, Eye discharge, Headache
Clinical narrative: Headache, trouble swallowing, hoarseness, Redness in both eyes and muscus, muscle aches, chills, drank plenty of fluids and stayed in bed.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Ocular hyperaemia
Clinical narrative: Headache, trouble swallowing, hoarseness, Redness in both eyes and muscus, muscle aches, chills, drank plenty of fluids and stayed in bed.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Dyskinesia, Head injury, Loss of consciousness
Clinical narrative: Patient was given the hepatitis A vaccine by RN in the left deltoid.  After given the vaccine and sitting for approximatly 5 minutes aferwards she indicated she felt fine and stood against a wall and was talking with a coworker.  Patient lost consciousness about two minutes later and slid down the wall and employee heard and observed her bumping her head lightly.  Patient lay on her right side while tended to by employee and nurse.  She had some jerking body movements which lasted a few seconds.  Regained consciousness in about 5 seconds.  Employee asked her where she was, her name and what the last thing she remembered was.   fully alert.  Nurse took vital signs while patient sat against the wall; pulse 56, blood pressure 102/66, temp 98.6 F, O2 sats 98%.  patient sat under observation for 30 minutes, drank some water, reported feeling fine and was escorted out of the programs room. Follow up done by health services per their protocol.Patient answered all of these questions appropriately and was
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: The day after patient received his vaccines I noticed bumps on his body, mainly his thighs and arms. The next day, two days after the vaccines the bumps started to spread pretty bad. By three days after the vaccines his body was covered in red bumps all over his body. His face, armpits, back, stomach, legs, feet and his butt.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Electrocardiogram abnormal, Painful respiration, Pericarditis
Clinical narrative: 19yo M presents to clinic c/o chest pain since 0330 this morning. Member states that he woke up with an ''intense pressure and a sharp pain upon inhalation.'' Member denies any SOB or wheezing. He denies any trauma. Patient denies chest being induced by physical activity. Member notes that he had a small pox vaccine last Friday.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Swollen glands left super clavicle starting 48 hours after injection, pain at injection site (2 hours)
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient had previously received Fluzone 0.25 in previous seasons without reaction. He was given Fluzone 0.5 IM on 9/5/19 and was initially noted to have some pain with refusal to bear weight on the left leg about 4 hours after the immunization was given. The following evening 9/6/19 about 29 hours after the immunization was given he was noted to have significant circumferential swelling of the left leg. There was no notable warmth or erythema concerning for cellulitis or type I sensitivity reaction, only extensive limb swelling in the same leg as the injection was given. He was able to move move and use leg well, and swelling was notably improved the following day.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Tension
Clinical narrative: Gardasil and menactra given in the right arm, and tolerated well.  Tdap given in the left arm and promptly after vaccine delivered, patient leans forward and his body tenses.  I am able to prevent him from falling and help him up onto the examination table, where he arouses with some mild confusion.  The incident lasted about 5-10 seconds.  He states he was really nervous about getting the vaccines today.  I examine him and find everything WNL.  Provide him with some water and graham crackers (from the school nurse), and he starts to feel better.  Mother states that has never happened before.  After some more rest, he feels well and mother opts to take him home.