chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Balance disorder, Chills, Genital herpes, Influenza like illness
Clinical narrative: Flu-like symptoms - fever, chills, nausea, body aches - for one week, Followed by itching scalp and back that flared up with small bumps on head, back of neck, middle back and groin that came and went for several weeks. Returned vigorously in January 2019 with raised patches of scaly skin on forehead, eyebrows and tops of ears. Small bumps alsoappeared in v-shape on upper chest. Bumps on back expanded to back of waist. Extreme itching. In January Dr. prescribed prednisone and topical cream. The prednisone diminished the symptoms, but as I tapered off it was apparent the cream was not having a noticeable effect and symptoms returned. During this time I have had 4 extreme genital herpes flareups. Since I was diagnosed over 30 years ago I have rarely had more than 1 or 2 flareups per year. Also in January the Dr. prescribed Valcyclovir to try to stave off the herpes flare ups. I am now on prednisone and Valcyclovir almost constantly. When I reduce or stop the prednisone or stop the Valcyclovir, the itching, bumpy skin and scaly patches return and I get the foreshadowing of a herpes outbreak. I have also experienced some persistent gastrointestinal upset, inner ear inflammation, and balance problems.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inner ear inflammation, Nausea, Pain, Pathology test, Pruritus
Clinical narrative: Flu-like symptoms - fever, chills, nausea, body aches - for one week, Followed by itching scalp and back that flared up with small bumps on head, back of neck, middle back and groin that came and went for several weeks. Returned vigorously in January 2019 with raised patches of scaly skin on forehead, eyebrows and tops of ears. Small bumps alsoappeared in v-shape on upper chest. Bumps on back expanded to back of waist. Extreme itching. In January Dr. prescribed prednisone and topical cream. The prednisone diminished the symptoms, but as I tapered off it was apparent the cream was not having a noticeable effect and symptoms returned. During this time I have had 4 extreme genital herpes flareups. Since I was diagnosed over 30 years ago I have rarely had more than 1 or 2 flareups per year. Also in January the Dr. prescribed Valcyclovir to try to stave off the herpes flare ups. I am now on prednisone and Valcyclovir almost constantly. When I reduce or stop the prednisone or stop the Valcyclovir, the itching, bumpy skin and scaly patches return and I get the foreshadowing of a herpes outbreak. I have also experienced some persistent gastrointestinal upset, inner ear inflammation, and balance problems.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Skin exfoliation
Clinical narrative: Flu-like symptoms - fever, chills, nausea, body aches - for one week, Followed by itching scalp and back that flared up with small bumps on head, back of neck, middle back and groin that came and went for several weeks. Returned vigorously in January 2019 with raised patches of scaly skin on forehead, eyebrows and tops of ears. Small bumps alsoappeared in v-shape on upper chest. Bumps on back expanded to back of waist. Extreme itching. In January Dr. prescribed prednisone and topical cream. The prednisone diminished the symptoms, but as I tapered off it was apparent the cream was not having a noticeable effect and symptoms returned. During this time I have had 4 extreme genital herpes flareups. Since I was diagnosed over 30 years ago I have rarely had more than 1 or 2 flareups per year. Also in January the Dr. prescribed Valcyclovir to try to stave off the herpes flare ups. I am now on prednisone and Valcyclovir almost constantly. When I reduce or stop the prednisone or stop the Valcyclovir, the itching, bumpy skin and scaly patches return and I get the foreshadowing of a herpes outbreak. I have also experienced some persistent gastrointestinal upset, inner ear inflammation, and balance problems.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hypersomnia, Influenza like illness, Pruritus
Clinical narrative: Beginning in the afternoon of receiving immunization, I started itching on my arms, chest and neck areas. Took 12.5mg of Benadryl and itching subsided. Later that evening, I started feeling symptoms similar to those of the flu. Chills, shivering, slight fever, felt tired and sleepy. Slept for about 12 hours, not my usual 8. Felt better next morning, back to usual routine about noon.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: Beginning in the afternoon of receiving immunization, I started itching on my arms, chest and neck areas. Took 12.5mg of Benadryl and itching subsided. Later that evening, I started feeling symptoms similar to those of the flu. Chills, shivering, slight fever, felt tired and sleepy. Slept for about 12 hours, not my usual 8. Felt better next morning, back to usual routine about noon.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient reports developing cellulitis requiring 4 different antibiotics
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Electrocardiogram normal, Epistaxis, Fatigue, Glycosylated haemoglobin increased
Clinical narrative: Day # 1. Wed 06/05/19 received vaccination, slight swelling upper left arm. 2. Thursday 06/06/2019 swelling increased to size of a fist increased pain and slight itching sensation, slight fatigue, restless nights sleep with periods of leg shaking. 3. Friday 06-07 increased fatigue resltessness nights sleep with periods of arm shaking(no leg shaking) slight soreness on left side of throat. 4. Saturday 06/08 continued fatigue daytime sleep, in bed by 8 pm sore throat worsens making it painful to swallow and sleep. Legs and arms calm at night. 5. Sunday 06/09 morning nosebleed, sore throat on left side continues difficult to swallow, tongue feels swollen making it hard to speak. Slight fatigue and drowsiness continues. Went to emergency room and was examined and tested for strep throat, results neg. O2 level 94. Given oxygen breathing treatment and zpack. ekg normal. started antibiotic that evening. 6. monday 06/10 arm swelling subsided slight soreness in throat and voice terurned to normal. Started steroids in am starting to feel normal. Noticed a small floater in left eye w/ ocasional flash. 7. Tue 06/11 feeling normal and slept well. Floater in left eye has gotten bigger with ocassional flash. 8. Wed 06/12 floaters have increased affecting 75% of the eye, center of eye ok. Called primary for course of action. Instructed to notify if condition worsens or go to ER if needed. 9- Thursday 06/13 minor change additional cloudiness left eye- not severe. Primary physician contacted. (pa, A1C 6.2, follow up eye exam, referred to otptometrist for examination and further evaluation.  10- Friday 06/14 Optometrist evaluation, no diabetes related changes, some hemorrhaging of concern, large detached vitreous. Reffered to retinal diagnostic centaer, for further deep examination and diagnosis.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Odynophagia, Oropharyngeal pain, Pain, Photopsia
Clinical narrative: Day # 1. Wed 06/05/19 received vaccination, slight swelling upper left arm. 2. Thursday 06/06/2019 swelling increased to size of a fist increased pain and slight itching sensation, slight fatigue, restless nights sleep with periods of leg shaking. 3. Friday 06-07 increased fatigue resltessness nights sleep with periods of arm shaking(no leg shaking) slight soreness on left side of throat. 4. Saturday 06/08 continued fatigue daytime sleep, in bed by 8 pm sore throat worsens making it painful to swallow and sleep. Legs and arms calm at night. 5. Sunday 06/09 morning nosebleed, sore throat on left side continues difficult to swallow, tongue feels swollen making it hard to speak. Slight fatigue and drowsiness continues. Went to emergency room and was examined and tested for strep throat, results neg. O2 level 94. Given oxygen breathing treatment and zpack. ekg normal. started antibiotic that evening. 6. monday 06/10 arm swelling subsided slight soreness in throat and voice terurned to normal. Started steroids in am starting to feel normal. Noticed a small floater in left eye w/ ocasional flash. 7. Tue 06/11 feeling normal and slept well. Floater in left eye has gotten bigger with ocassional flash. 8. Wed 06/12 floaters have increased affecting 75% of the eye, center of eye ok. Called primary for course of action. Instructed to notify if condition worsens or go to ER if needed. 9- Thursday 06/13 minor change additional cloudiness left eye- not severe. Primary physician contacted. (pa, A1C 6.2, follow up eye exam, referred to otptometrist for examination and further evaluation.  10- Friday 06/14 Optometrist evaluation, no diabetes related changes, some hemorrhaging of concern, large detached vitreous. Reffered to retinal diagnostic centaer, for further deep examination and diagnosis.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pruritus, Somnolence, Speech disorder, Streptococcus test negative
Clinical narrative: Day # 1. Wed 06/05/19 received vaccination, slight swelling upper left arm. 2. Thursday 06/06/2019 swelling increased to size of a fist increased pain and slight itching sensation, slight fatigue, restless nights sleep with periods of leg shaking. 3. Friday 06-07 increased fatigue resltessness nights sleep with periods of arm shaking(no leg shaking) slight soreness on left side of throat. 4. Saturday 06/08 continued fatigue daytime sleep, in bed by 8 pm sore throat worsens making it painful to swallow and sleep. Legs and arms calm at night. 5. Sunday 06/09 morning nosebleed, sore throat on left side continues difficult to swallow, tongue feels swollen making it hard to speak. Slight fatigue and drowsiness continues. Went to emergency room and was examined and tested for strep throat, results neg. O2 level 94. Given oxygen breathing treatment and zpack. ekg normal. started antibiotic that evening. 6. monday 06/10 arm swelling subsided slight soreness in throat and voice terurned to normal. Started steroids in am starting to feel normal. Noticed a small floater in left eye w/ ocasional flash. 7. Tue 06/11 feeling normal and slept well. Floater in left eye has gotten bigger with ocassional flash. 8. Wed 06/12 floaters have increased affecting 75% of the eye, center of eye ok. Called primary for course of action. Instructed to notify if condition worsens or go to ER if needed. 9- Thursday 06/13 minor change additional cloudiness left eye- not severe. Primary physician contacted. (pa, A1C 6.2, follow up eye exam, referred to otptometrist for examination and further evaluation.  10- Friday 06/14 Optometrist evaluation, no diabetes related changes, some hemorrhaging of concern, large detached vitreous. Reffered to retinal diagnostic centaer, for further deep examination and diagnosis.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Swollen tongue, Tremor, Vision blurred, Vitreous detachment, Vitreous floaters
Clinical narrative: Day # 1. Wed 06/05/19 received vaccination, slight swelling upper left arm. 2. Thursday 06/06/2019 swelling increased to size of a fist increased pain and slight itching sensation, slight fatigue, restless nights sleep with periods of leg shaking. 3. Friday 06-07 increased fatigue resltessness nights sleep with periods of arm shaking(no leg shaking) slight soreness on left side of throat. 4. Saturday 06/08 continued fatigue daytime sleep, in bed by 8 pm sore throat worsens making it painful to swallow and sleep. Legs and arms calm at night. 5. Sunday 06/09 morning nosebleed, sore throat on left side continues difficult to swallow, tongue feels swollen making it hard to speak. Slight fatigue and drowsiness continues. Went to emergency room and was examined and tested for strep throat, results neg. O2 level 94. Given oxygen breathing treatment and zpack. ekg normal. started antibiotic that evening. 6. monday 06/10 arm swelling subsided slight soreness in throat and voice terurned to normal. Started steroids in am starting to feel normal. Noticed a small floater in left eye w/ ocasional flash. 7. Tue 06/11 feeling normal and slept well. Floater in left eye has gotten bigger with ocassional flash. 8. Wed 06/12 floaters have increased affecting 75% of the eye, center of eye ok. Called primary for course of action. Instructed to notify if condition worsens or go to ER if needed. 9- Thursday 06/13 minor change additional cloudiness left eye- not severe. Primary physician contacted. (pa, A1C 6.2, follow up eye exam, referred to otptometrist for examination and further evaluation.  10- Friday 06/14 Optometrist evaluation, no diabetes related changes, some hemorrhaging of concern, large detached vitreous. Reffered to retinal diagnostic centaer, for further deep examination and diagnosis.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: REDNESS AT INJECTION SITE, PATIENT ALSO COMPLAINED OF SORENESS
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal dreams, Asthenia, Chills, Feeling hot, Injection site erythema
Clinical narrative: Around 9 pm on the day of the injection, I started to alternate between chills and being hot. This continued over night with profuse sweating during the night. My wife says I was running a fever. My sleep was not restful and I had strange dreams during the night. The next morning my body ached all over and I had a very red spot about 2 inches in diameter where I had the injection the day before. The spot was very sensitive and slightly swollen. I had no energy the following day and still had the body aches. The following night I felt overheated during the night with profuse seating again. I was not able to lay on the arm with the injection as it was very sore and sensitive. I started to feel better on the second day and the swelling was slowly going down with the injection site and the redness was disappearing. I did not have any reaction when I had the first shot in April in the series of 2. As of today's date I am back to normal and my arm is not longer feeling any signs of the shot.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Night sweats, Pain, Poor quality sleep
Clinical narrative: Around 9 pm on the day of the injection, I started to alternate between chills and being hot. This continued over night with profuse sweating during the night. My wife says I was running a fever. My sleep was not restful and I had strange dreams during the night. The next morning my body ached all over and I had a very red spot about 2 inches in diameter where I had the injection the day before. The spot was very sensitive and slightly swollen. I had no energy the following day and still had the body aches. The following night I felt overheated during the night with profuse seating again. I was not able to lay on the arm with the injection as it was very sore and sensitive. I started to feel better on the second day and the swelling was slowly going down with the injection site and the redness was disappearing. I did not have any reaction when I had the first shot in April in the series of 2. As of today's date I am back to normal and my arm is not longer feeling any signs of the shot.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Around 9 pm on the day of the injection, I started to alternate between chills and being hot. This continued over night with profuse sweating during the night. My wife says I was running a fever. My sleep was not restful and I had strange dreams during the night. The next morning my body ached all over and I had a very red spot about 2 inches in diameter where I had the injection the day before. The spot was very sensitive and slightly swollen. I had no energy the following day and still had the body aches. The following night I felt overheated during the night with profuse seating again. I was not able to lay on the arm with the injection as it was very sore and sensitive. I started to feel better on the second day and the swelling was slowly going down with the injection site and the redness was disappearing. I did not have any reaction when I had the first shot in April in the series of 2. As of today's date I am back to normal and my arm is not longer feeling any signs of the shot.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Erythema, Headache, Pain
Clinical narrative: REDNESS AND SWELLING, ITCHING, FEVER, GENERAEL ACHES/PAIN, JOINT PAIN, HEADACHE, DIZZINESS
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: REDNESS AND SWELLING, ITCHING, FEVER, GENERAEL ACHES/PAIN, JOINT PAIN, HEADACHE, DIZZINESS
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Differential white blood cell count, Full blood count, HIV test, Metabolic function test
Clinical narrative: Patient stated that day after receiving vaccine, he started having some swelling with tenderness of the neck, jawline, axilla and pain of lower back. Injection site has no redness, warmth or swelling at this time.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Mononucleosis heterophile test, Oedema peripheral, Swelling, Swelling face, Tenderness
Clinical narrative: Patient stated that day after receiving vaccine, he started having some swelling with tenderness of the neck, jawline, axilla and pain of lower back. Injection site has no redness, warmth or swelling at this time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: Mom stated tongue was swelling and baby could not breathe. 911 called and baby was fine upon arrival. States breast milk and tylenol were only things ingested.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Hypoaesthesia, Mobility decreased, Pain, Pre-eclampsia
Clinical narrative: Patient received boostrix immunization on 5/28/19. She states that she started experiencing pain and soreness that evening of the shot, but that it has progressed and she now had numbness in her hand at times. It feels like it is sleeping. She states that she can still use her arm and hand, but there are times when she cannot lift her arm. She is pregnant and is due on 7/25/19; however, she also has preeclampsia and may have her baby before her due date. She spoke with her OB on 6/13/19 and was advised to take tylenol and to apply cold compress. Her OB stated that she could not apply a topical pain relieving gel, such as biofreeze. I advised patient that looking at the literature, there was 1.6% of patients aged
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Pallor, Pulse abnormal, Respiratory rate decreased
Clinical narrative: -Shaking, trouble breathing, weak pulse, Low respiratory rate, pale skin, dizziness, syncope -Epipen & call 911
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope, Tremor
Clinical narrative: -Shaking, trouble breathing, weak pulse, Low respiratory rate, pale skin, dizziness, syncope -Epipen & call 911
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient called 6/17/19 complaining that she was still experiencing a very sore arm at the injection site. Recommended heating pad and icing the area and following up with Dr. for further evaluation.
Age: 9.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Chest X-ray normal, Chest pain, Fall, Head injury, Syncope
Clinical narrative: Unobserved fall in room 15 minutes after vaccine given. Mom states hit head on fall. Doctor checked patient, observed, sent home. On call doctor sent patient to Emergency room for repeated fainting evening 6-5-19. (possible seizure??) 6-6-19 still fainting, doctor sent back to Emergency room emergency room said test normal - referring to cardiologist
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Hx of Infantile atopic dermatitis, Rash large patches started am of 6/14/19 3 days after vaccination not sure if just dermatitis urticaria secondary to vaccines.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Fairly severe pain in left upper arm  + shoulder. Hard to dress or raise  arm. Severe pain 3 days - less for 4 for more days.  took Aleve for 3 days
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Musculoskeletal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: I had chills & Fever started at 4P-3-6-19 chills & Fever lasted until I had surg. to Rt arm-I had shooting pain from my fingers to my shoulder I had clindamycin 300mg cap- before or-after OR-back
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Surgery, X-ray limb
Clinical narrative: I had chills & Fever started at 4P-3-6-19 chills & Fever lasted until I had surg. to Rt arm-I had shooting pain from my fingers to my shoulder I had clindamycin 300mg cap- before or-after OR-back
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: redness, warmth, and swelling below her L should injection site of Shingrix given 3 days ago. Symptoms started 2 days ago. Was already on Motrin-600mg TID for another issue. Redness, swelling, and warmth has already started to improve. No difficulty swallowing or breathing. No fevers.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Injection site swelling
Clinical narrative: Swelling on Lt upper arm
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Rash (red papular exanthem over entire body)
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient with swelling and moderate pain in the area of vaccine administration; Patient with swelling and moderate pain in the area of vaccine administration; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 696548) on 13-DEC-2017.  This spontaneous report was received from a Regulatory Authority and refers to a 12-year-old female patient. The patient had no current illnesses. The patient's pertinent medical history was unknown. There was no information about the patient's concomitant therapies.  On 16-MAY-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # M041212 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 21-JUN-2019, intramuscularly in the left arm (exact dose was not reported) for prophylaxis.  On the same day, the patient experienced swelling (vaccination site swelling) and moderate pain (vaccination site pain) in area of vaccine administration, presented on exam 2 weeks later. The outcome of the events was unknown. The causality assessment was not provided.  Follow-up report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 696548) information was received from licensed practical nurse on 16-APR-2019. On 16-MAY-2017 17:04, the patient was vaccinated with first dose (previously reported as second) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left deltoid. On 16-MAY-2017 17:15, the patient experienced swelling and moderate pain in the area of vaccine administration. None relevant diagnostics tests were performed. The outcome of the event was unknown but also reported as "at this time still having a symptoms".   Follow-up information was received from licensed practical nurse on 20-MAY-2019. The patient's information was updated. She had not received any additional vaccinations. She had had no medical problems.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA006739:
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID: 739142), referring to a 30 (units not provided) old female patient. The patient had no medical history, current illnesses, other medication and lab test provided.   On 13-FEB-2018, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N023952, expiration date 12-JUL-2020, intramuscular in the right arm, for prophylaxis (exact dose was not provided).   On 15-FEB-2018, two days after vaccination the patient experienced injection site pain reported as pain at right arm biceps and shoulder. The patient was treated with RICE and naproxen sodium 550 mg, one tab orally every 12 hours as needed. The outcome of injection site pain was reported as not recovered.   The causality between the event and suspect vaccine was not reported.  Follow-up information has been received from a healthcare professional via Agency refers to a 30 year old female patient. The patient's previous vaccinations included influenza virus split virion 3v vaccine inactivated (FLUZONE). On 13-FEB-2018 at 10:30, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis.  Follow-up information has been received from a nurse on 17-JUN-2019. The reporter stated that the patient had recovered (date unspecified) and went on to receive the rest of the vaccination series of the above product without any further adverse reaction.  Moreover, she stated that she had provided the information and did not wish to fill out the correspondence letter received from the company. As of 17-JUN-2019, additional information was not expected. All scheduled correspondence was canceled.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: erythema; oedema peripheral; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 741275).  Rec'd. routine imaging on 13-MAR-2018. Patient was seen on 14-MAR-2018, for sign and symptoms - on left (LT) arm with erythema and edema; non-painful. The were decreased at time of visit, afebrile. Treatment with diphenhydramine hydrochloride (BENADRYL) at hospital; Ibuprofen every 6 hours per needed (prn). Return if sign and symptoms worsen.  Lab data On exam.  Other Medications None  Current Illnesses None  History PCN allergy  hives  Prior Vaccinations  Follow up information was received from a physician on 11-JUN-2019.   The patient concurrent conditions included gastrooesophageal reflux disease (GERD).  At the reporting time, the outcome of the vents of erythema and edema peripheral (oedema peripheral) was unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Allergy to metals, Furuncle, Infection, Pruritus, Rash vesicular
Clinical narrative: chicken pox; oozing and open sores; oozing and open sores; contact dermatitis; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chickenpox, skin ulcer, secretion discharge and contact dermatitis. On an unknown date, the outcome of the chickenpox, skin ulcer, secretion discharge and contact dermatitis were unknown.   It was unknown if the reporter considered the chickenpox, skin ulcer, secretion discharge and contact dermatitis 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 patient experienced chicken pox and 6 months after at the time of reporting, still have oozing open sores that are spread all over the body and also experienced contact dermatitis. The vaccine administrator blame the bed bug or contact dermatis for oozing open sores.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Scratch, Skin exfoliation, Skin mass, Skin test positive
Clinical narrative: chicken pox; oozing and open sores; oozing and open sores; contact dermatitis; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chickenpox, skin ulcer, secretion discharge and contact dermatitis. On an unknown date, the outcome of the chickenpox, skin ulcer, secretion discharge and contact dermatitis were unknown.   It was unknown if the reporter considered the chickenpox, skin ulcer, secretion discharge and contact dermatitis 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 patient experienced chicken pox and 6 months after at the time of reporting, still have oozing open sores that are spread all over the body and also experienced contact dermatitis. The vaccine administrator blame the bed bug or contact dermatis for oozing open sores.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis contact, Secretion discharge, Skin ulcer, Varicella
Clinical narrative: chicken pox; oozing and open sores; oozing and open sores; contact dermatitis; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chickenpox, skin ulcer, secretion discharge and contact dermatitis. On an unknown date, the outcome of the chickenpox, skin ulcer, secretion discharge and contact dermatitis were unknown.   It was unknown if the reporter considered the chickenpox, skin ulcer, secretion discharge and contact dermatitis 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 patient experienced chicken pox and 6 months after at the time of reporting, still have oozing open sores that are spread all over the body and also experienced contact dermatitis. The vaccine administrator blame the bed bug or contact dermatis for oozing open sores.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Influenza virus test negative, Laboratory test normal, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: No symptoms after the mmr shot. After 6 days my son started a fever. We gave him Tylenol at 7 pm and he went to sleep. At 2 am he woke up screaming. His face was red and he was extremely hot to touch. I took him to the ER right away. We were there from 2 am - 5 am. His temp was 103.2 they gave him Motrin and his fever went down and we were discharged after 3 hours. While there they tested patient for RSV, influenza, and an ear infection which all came back negative. Less than 24 hours later he has a fever of 104.8 and hot to touch. We are not happy about this mmr vaccine.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Screaming, Skin warm
Clinical narrative: No symptoms after the mmr shot. After 6 days my son started a fever. We gave him Tylenol at 7 pm and he went to sleep. At 2 am he woke up screaming. His face was red and he was extremely hot to touch. I took him to the ER right away. We were there from 2 am - 5 am. His temp was 103.2 they gave him Motrin and his fever went down and we were discharged after 3 hours. While there they tested patient for RSV, influenza, and an ear infection which all came back negative. Less than 24 hours later he has a fever of 104.8 and hot to touch. We are not happy about this mmr vaccine.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Electromyogram, Hypoaesthesia, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: Within 3 weeks of vaccine pt developed a tremor in her right hand and numbness began in both heels.  Pain and numbness began to creep up both legs over the course of time , month or so.  Both feet became numb.  By October , Shooting pains up to knees and painful to the touch.  Pain increases with walking or trying to engage in any activity. Pt was unable to participate in usual activities.  She was very athletic and active prior.  Could not complete a swim practice because pain was debilitating.  She still is unable to run any distance or take long walks with out pain and weakness flaring up.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Tenderness, Tremor
Clinical narrative: Within 3 weeks of vaccine pt developed a tremor in her right hand and numbness began in both heels.  Pain and numbness began to creep up both legs over the course of time , month or so.  Both feet became numb.  By October , Shooting pains up to knees and painful to the touch.  Pain increases with walking or trying to engage in any activity. Pt was unable to participate in usual activities.  She was very athletic and active prior.  Could not complete a swim practice because pain was debilitating.  She still is unable to run any distance or take long walks with out pain and weakness flaring up.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received improperly stored doses of VARIVAX and M-M-R II; Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and current conditions was not provided.   On 28-MAY-2019, the patient received improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R018142 and expiration date 28-NOV-2019 defaulted as 25-JUN-2020; frequency, route of administration and anatomical location were unknown) for prophylaxis and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number R000552 and expiration date 08-JAN-2020; frequency, route of administration and anatomical location were unknown) for prophylaxis (product storage error). It was unknown the sterile diluent (DILUENT MRK INJ) (lot number R001254 and expiration date 20-SEP-2020) was improperly stored. No adverse effects were reported.  The time frame was varicella virus vaccine live (Oka/Merck) (VARIVAX) 15 Fahrenheit scale to 46 Fahrenheit scale (26.7 Fahrenheit scale) for 3 hours and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) highest temperature above 47 Fahrenheit scale (59.3 Fahrenheit scale) for 3 hours. There was no previous temperature excursion. Data logger was not involved.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Malaise
Clinical narrative: Since then the daughter has frequently been sick; This spontaneous report was received from a consumer via a company representative and refers to a female patient of unknown age, a daughter of a reporter's friend. There was no information concerning the patient's pertinent medical history, concomitant medications, concurrent conditions, drug reactions or allergies provided. It was reported that on 08-JUN-2019, reporter's friend told her that on an unknown date, a friend of hers, whom the reporter did not know, had gotten the unidentified Merck hpv vaccine administered (name and lot number not provided)(dose, route of administration, expiration date and indication were not provided) shot for her daughter (the reporter was not sure if she meant the original quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)).  Since an unknown date, reported as since then, the patient has frequently been sick, whereas before the shot she was generally healthy.  The reporter's friend was hesitating to vaccinate her own son with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) because of her friend's experience at the time of the reporting. The outcome of the event was unknown. The causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: lump at unspecified injection site; This spontaneous report was received from a nurse practitioner via company representative regarding a 12-year-old female patient. The patient had no pertinent medical history, drug reactions or allergies. The patient did not receive any concomitant medications. On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot # and expiry date) for prevention of human papillomavirus/ prophylaxis. On an unknown date 48 hours after receiving therapy, the patient developed an unspecified "lump" at the unspecified injection site (injection site mass). The patient did not seek medial attention and also did not receive any treatment drugs. There was no cancer or overdose associated. There was no product quality complaint. The outcome of injection site mass was unknown. Causality assessment was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; Expired vaccine used; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 13-JUN-2019 the patient was vaccinated with a properly stored, expired dose of hepatitis a vaccine, inactivated (VAQTA) lot number R006342 and expiration date of 21-APR-2019, at a dose of 1 ml./once, intramuscularly for prophylaxis (anatomical location was not reported). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No known adverse effects; received a dose of VARIVAX via the intramuscular route in error.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 13-JUN-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number R018780 and expiration date of 01-JUL-2020, via intramuscular route in error for prophylaxis (dose and anatomical location  were not reported). No known adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; A patient was administered an expired PROQUAD.; This spontaneous report was received from a nurse and refers to a 4 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 10-JUN-2019, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot # N035176, expiration date 09-JUN-2019 for prophylaxis (dose and route of administration were not reported) (expired product administered). No adverse effects. The outcome of expired product administered was not reported.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received first dose of improperly stored PNEUMOVAX 23; This spontaneous report was received from a medical assistant referring to a 66 year old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 30-MAY-2019, the patient was vaccinated with a first dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vial lot # R031812 with expiration date on 26-SEP-2020, by intramuscular route (strength, dose, and anatomical location were not reported) indicated for prophylaxis.         It was unknow if there was a previous temperature excursion. A data logger was not involved.  No adverse effect was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; the patient received first dose of improperly stored VAQTA; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported.  On 23-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # R025518 (expiration date: 15-NOV-2019) first dose, intramuscularly for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: non oncological HPV; This spontaneous report was received from another health professional referring to her daughter, a female patient of unknown age. The patient's pertinent medical history, previous drug reactions, allergies and concomitant medication were not provided.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. The reporter stated that the patient completed the vaccination scheme with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) on an unspecified date (reported as "years ago").   On an unknown date (reported as "recently"), the patient was diagnosed with a non-oncological type of human papilloma virus (HPV). It was unknown if the patient sought for medical attention, was treated for the event or had laboratory test performed. The outcome of papilloma viral infection was reported as resolved on an unspecified date. No additional information was provided.  The causal relationship assessment between the event and the suspect vaccine therapy was not provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain; Injection site redness; Injection site swelling; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number X3M27, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On 20th April 2019, 1 day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. The patient was treated with benadryl (nos) (Benadryl) and medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient experienced of pain, redness and swelling at injection site 1 days after. The patient had 2 inch red band extended around inner arm from injection site. The patient came into clinic 3 days later as it had not improved. The patient was given Benadryl and ice pack. The event resolved on it own. The reporter was agreed to follow up from GlaxoSmithKline.
Sex: M
Vaccine: HEP
Symptoms: Death, Rash, Thrombocytopenia
Clinical narrative: rash; thrombocytopenia; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a 5-day-old male patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, less than a day after receiving Hepatitis B vaccine, the patient experienced rash (serious criteria death and hospitalization) and thrombocytopenia (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the rash and thrombocytopenia were fatal. The reported cause of death was rash and thrombocytopenia.   It was unknown if the reporter considered the rash and thrombocytopenia to be related to Hepatitis B vaccine.  Additional details were provided as follows: Within 12 hours after vaccination, the patient had a rash and within 24 hours severe thrombocytopenia set in and he was in fatal state from then on. The patient suffered nearly his entire life. His parent's literally lived at the hospital and never left his side. The patient lived for 47 days after receiving the vaccine. No doctors, nurses, staff would even consider the vaccination as the source.; Reported Cause(s) of Death: Rash; Thrombocytopenia
Sex: M
Vaccine: MENB, MNQ
Symptoms: Altered state of consciousness, Dizziness
Clinical narrative: Patient was going to pass out when receive the Trumenba and also given Menactra at the same time; Patient got very dizzy; This is a spontaneous report from a contactable physician via Pfizer sales representative.  An 18-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose, and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration at unknown dose, both on an unspecified date for immunisation.  The two vaccines were administered at the same time. The patient medical history and concomitant medications were not reported.  The patient was going to pass out when received the two vaccines at the same time and the patient got very dizzy on an unspecified date. The outcome of the events was unknown.  The information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 (TRUMENBA) contributed to the development of the reported events passing out and dizzy.
Age: 50.0
Sex: F
Vaccine: RAB, VARZOS
Symptoms: Blister, Dysphonia, Fatigue, Headache, Hypersomnia
Clinical narrative: 50 y/o female here today with c/o itchy rash, blisters on her body since Friday. She received her final rabies vaccine and a shingles vaccine on the same day. Patient states she felt very fatigued after immunizations. She immediately fell asleep on hammock and slept for 8 hours. She first noticed rash on her arms when she woke up. She says her voice has been raspy, but she denies difficulty breathing. She said that since then she started having jaw pain and a headache. Rash has continued to spread since Friday, now she has it on her torso as well. She reports her husband has a similar rash. She has been taking OTC meds to try to help. She is not sure if maybe she got into poison ivy on her farm or not. She said she has not changed any soaps, lotions, detergents, etc. Vesicles were seen Lesions noted to bilateral arms, thighs, lower extremities, stomach, and chest. ranging in patient described progression from flat red rash to chest and between breasts to small (less than 1/4cm) vesicles to flat rash with scabbing.