chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: The day after the vaccine(5-31-19) she complained of a fever of about 99 degrees and just general malaise and arm soreness. She said the fever went away the day after that(6-1-19) but the soreness stayed. Also on 6-1-19 her left arm where we gave the shot was inflammed, red and hot to the touch. The redness and a little bit swollen went down her arm about 8 inches. She said it was sore and hot to the touch. She is supposed to let me know if it gets any better or any worse today 6-2-19.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: The day after the vaccine(5-31-19) she complained of a fever of about 99 degrees and just general malaise and arm soreness. She said the fever went away the day after that(6-1-19) but the soreness stayed. Also on 6-1-19 her left arm where we gave the shot was inflammed, red and hot to the touch. The redness and a little bit swollen went down her arm about 8 inches. She said it was sore and hot to the touch. She is supposed to let me know if it gets any better or any worse today 6-2-19.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Severe Redness and bruising around injection site
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Allodynia, Fatigue, Haematocrit normal, Haemoglobin normal, Influenza like illness
Clinical narrative: flu-like symptoms (generalized myalgia, allodynia, arthralgia, chills) pain in shoulders especially left side, severe exhaustion, most severe in the first 10 days post administration but continue to today (12 days post vaccination)
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Mean cell volume normal, Musculoskeletal pain, Myalgia, Platelet count decreased, Red blood cell sedimentation rate normal
Clinical narrative: flu-like symptoms (generalized myalgia, allodynia, arthralgia, chills) pain in shoulders especially left side, severe exhaustion, most severe in the first 10 days post administration but continue to today (12 days post vaccination)
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: White blood cell count normal
Clinical narrative: flu-like symptoms (generalized myalgia, allodynia, arthralgia, chills) pain in shoulders especially left side, severe exhaustion, most severe in the first 10 days post administration but continue to today (12 days post vaccination)
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis approximately 3-4 inches below where the injection took place. Patient went to an urgent care and received a prescription for cephalexin 500mg, antibiotic and is currently taking it. Patient seems healthy otherwise at sign of contact and presentation of cellulitis. We are following up on Monday.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site discomfort, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Fever, chills, aches, soreness at injection site. Inability to perform daily activities for 48 hours.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Dizziness, Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: Patient stated she started feeling periodically lightheaded, warm, and nauseated shortly after leaving the center. Patient now has redness around the site, slightly hardened, and warm to touch. Temperature elevated at 99.8 F.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Nausea
Clinical narrative: Patient stated she started feeling periodically lightheaded, warm, and nauseated shortly after leaving the center. Patient now has redness around the site, slightly hardened, and warm to touch. Temperature elevated at 99.8 F.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Joint effusion, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: After two weeks of pain a doctor was contacted.  I ended up going to an orthopedic specialist who stated I have rotator cuff impingement syndrome (M75.42), post-injection adhesive capsulitis of left shoulder (M75.02) and frozen shoulder.  I have been in physical therapy since.  I also was not able to work normally and have been on light duty/work comp since October 30, 2018.  I am a mental health nurse and am unable to work with this patient population so I had to reluctantly find a new job.  I am continuing PT and still have lifting limits.  Rotation in my left shoulder is diminished and I struggle to lift over my head.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, Tendon disorder
Clinical narrative: After two weeks of pain a doctor was contacted.  I ended up going to an orthopedic specialist who stated I have rotator cuff impingement syndrome (M75.42), post-injection adhesive capsulitis of left shoulder (M75.02) and frozen shoulder.  I have been in physical therapy since.  I also was not able to work normally and have been on light duty/work comp since October 30, 2018.  I am a mental health nurse and am unable to work with this patient population so I had to reluctantly find a new job.  I am continuing PT and still have lifting limits.  Rotation in my left shoulder is diminished and I struggle to lift over my head.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Premature labour, Preterm premature rupture of membranes, Pyrexia
Clinical narrative: I received the shot during a prenatal check up and ultrasound that reported no abnormal findings.  Three days later at 21 week pregnant, my water broke and I was in preterm labor with a high grade fever. We went on to lose our son days after the shot( which we we pressured into after refusing it three separate times at the same appointment, and finally giving in). The FDA and CDC has since acknowledged this is a side effect of flu shots in pregnant women.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: I received the shot during a prenatal check up and ultrasound that reported no abnormal findings.  Three days later at 21 week pregnant, my water broke and I was in preterm labor with a high grade fever. We went on to lose our son days after the shot( which we we pressured into after refusing it three separate times at the same appointment, and finally giving in). The FDA and CDC has since acknowledged this is a side effect of flu shots in pregnant women.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Headache, body aches, chills, nausea
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pain, Rash
Clinical narrative: Spreading rash on lower left chest, pain in left back, noticeable beginning 05/25/2019.   Diagnosed 05/29/2019 by M.D. as shingles.  Treated with acyclovir 400mg 5 times per day for 7 days, beginning 05/29/2019.  Rash and pain persisting as of today (06/02/2019), with back pain making it hard to sleep.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Rash
Clinical narrative: Patient reporting rash developing along neck and up into hairline. Also reports that face feels like it is a little sunburned
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Symptoms appear approx. 1 day after vaccination.  Presented as a patchy red rash approx.  2 to 3 inches in width around the circumference of upper arm about 2 inches below injection site.  Worsened on the 2nd day, but began to improve on the 3rd day post vaccination.  Patient took fexofenadine to minimize symptoms
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: First shot on June 12, 2018 was fine. Second shot on August 20, 2018 has had continual  low level pain at the site 24/7. Shot was given at pharmacy. I have contacted the pharmacy and my doctor.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of left arm around area of injection with warmth to touch and soreness for a few days. At site of injection there is still persisting pea sized red rash. For first week of rash at area of injection there were also white bumps. While rash area persists there is no current pain or itchiness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Swelling of left arm around area of injection with warmth to touch and soreness for a few days. At site of injection there is still persisting pea sized red rash. For first week of rash at area of injection there were also white bumps. While rash area persists there is no current pain or itchiness.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Herpes zoster, Injection site erythema, Pain in extremity, Rash
Clinical narrative: Dose 1: Patient had redness at the injection site and soreness of arm. (not reported to pharmacy) Dose 2: Patient had a spot show up on body about a week after Immunization dose 2. The spot is still visible and also has leg/back pain. She stated that the MD believes this is a case of shingles. She was just prescribed Valtrex 500mg on 5/31/19 at a different pharmacy location.  -Patient reported on 6/1/19
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Broke out in hives all over body a week after shots were given.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 27 hours after the vaccine, patient's left thigh from where the injection was down to her knee only on the front side turned extremely swollen, red, warm, painful, sore, itchy with a rash. Her anus and vulva were also red.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth, Perianal erythema, Vulvovaginal erythema
Clinical narrative: 27 hours after the vaccine, patient's left thigh from where the injection was down to her knee only on the front side turned extremely swollen, red, warm, painful, sore, itchy with a rash. Her anus and vulva were also red.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient has continued pain and weakness in the right arm after receiving the vaccine several months ago (01/21/2019)
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: pain in right arm more than normal shot;  arm was not swollen, but hand on the same arm gets hot to the touch and very itchy and swollen;
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Patient stated fever and soreness around injection site that has go towards arm/hand.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: large rash UNDER injection site ( about 3 inches below injection site).  Diameter of rash at least 4 inches at that time. Reports hot to touch, not as painful as day before. Recommended ice, acetaminophen, diphenhydramine. Mark borders to see if rash increases in size over next 24 hours. Seek medical attention if condition worsens
Age: 86.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus generalised
Clinical narrative: after receiving the vaccine the patient started itching over his body.  it lasted 4 or 5 days
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dizziness, Feeling cold
Clinical narrative: Patient Presented to Pharmacy with mom to receive vaccines. After carefully evaluating patient's vaccine history, recommendations' were made for patient to receive the above vaccine. patient seemed very nervous but tried to put her mind at ease by discussing the weather, and her summer plans. The first vaccine was given. Waited for about 5 minutes to make sure patient was okay before proceeding to the next one. Patient said she was ok, so decision was made to give the second vaccine. A couple of minutes after the second vaccine, patient reported of feeling dizzy and cold.  Since this was a typical sign of syncope, I asked mom to help me lay patient on the ground. Patient did not show any signs of difficulty breathing or a true allergic reaction. However proper action plan was put in place should this happen. After 10  minutes patient said she felt fine, mom and I helped her sit back up in a chair and they were asked to wait in the pharmacy for about 20minutes while constantly checking on her. After 20minutes they decided to go ahead and leave. Patient was encouraged to seek medical help and contact us should and anything else result. Follow up call was made to patient and mom on 05/31/2019, Patient mom said patient was ok and was doing better after she ate. Another follow up call was made on 06/02/2019  and again patient said she was well.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Feeling hot, Pyrexia
Clinical narrative: Woke up to uncontrollable shivering.  Lasted about 30 minutes. Felt warm,  but no fever then.  Also upset stomach and dizzy. Took Tylenol and went back to sleep.  Woke up again a couple hours later and was very hot.  Low grade fever of 99.8.  Stomach more irritated.  Chewed Gaviscon, drank water, sat up for awhile and went back to sleep.  Morning felt better, although very groggy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Woke up to uncontrollable shivering.  Lasted about 30 minutes. Felt warm,  but no fever then.  Also upset stomach and dizzy. Took Tylenol and went back to sleep.  Woke up again a couple hours later and was very hot.  Low grade fever of 99.8.  Stomach more irritated.  Chewed Gaviscon, drank water, sat up for awhile and went back to sleep.  Morning felt better, although very groggy.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Following 2nd dose of Shingrix, pt has been experiencing shooting pain where he previously had shingles rash. He has had shingles twice before. I advised him to use topical numbing agent to treat pain.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Swollen in supraclavicular lymph nodes, soreness, muscle aches, fever,  nausea, skin rash
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Swollen in supraclavicular lymph nodes, soreness, muscle aches, fever,  nausea, skin rash
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Ear pain, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Severe pain immediately at site of injection, redness at injection site, developed 2 pink red spots one inch below and half inch to right of  injection site, pain for 2 and 1/2 days. Monday afternoon developed stinging pain of left upper ear, then developed large amount of swelling and blisters with fluid filled pus. Also developed severe itching of ear and crusty drainage for several days. Over the next two days from Tuesday through Wednesday developed various areas of shooting pain.  Developed intermittent pain to top of right foot Developed itching and pain in left scalp that later developed a scabbed over area. Developed painful blisters to right forearm and left lower leg that later developed scabbed area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Otorrhoea, Pain, Pain in extremity, Pain of skin, Pruritus
Clinical narrative: Severe pain immediately at site of injection, redness at injection site, developed 2 pink red spots one inch below and half inch to right of  injection site, pain for 2 and 1/2 days. Monday afternoon developed stinging pain of left upper ear, then developed large amount of swelling and blisters with fluid filled pus. Also developed severe itching of ear and crusty drainage for several days. Over the next two days from Tuesday through Wednesday developed various areas of shooting pain.  Developed intermittent pain to top of right foot Developed itching and pain in left scalp that later developed a scabbed over area. Developed painful blisters to right forearm and left lower leg that later developed scabbed area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Swelling
Clinical narrative: Severe pain immediately at site of injection, redness at injection site, developed 2 pink red spots one inch below and half inch to right of  injection site, pain for 2 and 1/2 days. Monday afternoon developed stinging pain of left upper ear, then developed large amount of swelling and blisters with fluid filled pus. Also developed severe itching of ear and crusty drainage for several days. Over the next two days from Tuesday through Wednesday developed various areas of shooting pain.  Developed intermittent pain to top of right foot Developed itching and pain in left scalp that later developed a scabbed over area. Developed painful blisters to right forearm and left lower leg that later developed scabbed area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Influenza like illness, Malaise, Paraesthesia
Clinical narrative: 4/16/19:@ 7pm night of Shingrix immunization, pt developed "flu-like" symptoms with fever and so she went to bed.  4/17/19:Patient stated she did not "feel well" 4/18/19: Patient felt better 4/19/19: Patient developed blisters on left side of face from nose down around mouth. tingling and prickly on left side of face and mouth. She called pharmacy and we told her to go to urgent care. She was seen and physician diagnosed her with shingles. Patient was prescribed Medrol, gabapentin, and valtrex. Over the next few days, the blisters dried up and she felt better. No signs of anything by the following Friday 4/26/19 when she saw her PCP.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Pyrexia
Clinical narrative: 4/16/19:@ 7pm night of Shingrix immunization, pt developed "flu-like" symptoms with fever and so she went to bed.  4/17/19:Patient stated she did not "feel well" 4/18/19: Patient felt better 4/19/19: Patient developed blisters on left side of face from nose down around mouth. tingling and prickly on left side of face and mouth. She called pharmacy and we told her to go to urgent care. She was seen and physician diagnosed her with shingles. Patient was prescribed Medrol, gabapentin, and valtrex. Over the next few days, the blisters dried up and she felt better. No signs of anything by the following Friday 4/26/19 when she saw her PCP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient reported severe pain at injection site lasting until next morning. Treated with steroids
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Cough, Malaise
Clinical narrative: As per staff member, no side effects were reported to the office following vaccination. As per staff member, mother called on Monday, 11/12/2007 and stated that the child was feeling sick and had cough. Mother was urged to come to the office but failed to do so.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nuclear magnetic resonance imaging brain normal, Photophobia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the Food and Drug Administration (FDA) (HA #707172) under the Freedom of Information Act. This spontaneous report as received from an Agency refers to a 12-year-old female patient. The patient had no concomitant medications, pertinent medical history or current illness. On 23-SEP-2016, the patient was vaccinated with second dose of GARDASIL 9 injection intramuscular in the left arm for prophylaxis (lot # reported as M011840). On 23-SEP-2016, the patient experienced headache and photophobia. It was reported that there was daily headaches since second dose of GARDASIL 9 vaccine. It happened at various times of the day for various amounts of time (described as being the whole head, sometimes throbbing). The patient had also some light sensitivity, there was no nausea and no blurry vision. Some improvement occurred after giving Ibuprofen(manufacturer unknown) as a treatment. The patient reported that she had 48 hours of headaches after first dose of GARDASIL 9. No laboratory diagnostic studies were performed. The outcome of headache and photophobia was reported as unknown. The reporter did not assess the relatedness between the events and GARDASIL 9. Lot number M011840 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow-up information was received from a healthcare professional via the Agency (HA #707172). The patient's race was White, ethnicity: Not Hispanic or Latino. The patient was not pregnant at the time of vaccination. The patient had no known drug allergies.  The patient has not ever had an adverse event following any previous vaccine. On 23-SEP-2016 at 10:00, the patient was vaccinated with second dose of GARDASIL 9 in left deltoid arm and at 12:00, she experienced headache and photophobia. The patient did not recover from the events. Follow-up information was received on 30-MAY-2019 from an unknown source (reported as vaccine provider). The patient experienced headaches within days of getting vaccine. The patient did not receive any vaccine 4 weeks prior to the suspect therapy. It was reported that patient underwent magnetic resonance imaging (MRI) of brain without(w/o) contrast (reported as unremarkable brain MRI) and the patient returned to neuro. The patient did not recovered from the event of headache. The reporter considered the event of headache to be serious due to disability.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Erythema, Grunting, Hyperhidrosis
Clinical narrative: MOP advised she and her husband took this 9yo to pharmacy for routine annual flu vaccine (Fluarix, no lot # available) on 9/29/2017.  Mom advised he tolerated the vaccine administration well and when a bandaid was applied to vaccine site, he jumped out of dads lap and immediately began coughing.  This was <1-2 min post vaccination.  He would not stop coughing and would not talk. He was looking up to the sky with eyes appearing blood shot. His ears, face were red and he was sweating profusely.  She noted his lips appeared to be swelling with red blotches also seen on his face, arms, neck, and was grunting having issues breathing.  His eyes were wide and he would shake his head no when asked if he was okay.  He looked exhausted.  Nurse administer epipen to left leg a few minutes after vaccination where quickly afterwards he took in a deep breath, sighed and was able to stop coughing and sit down.  911 was activated and he was transported to nearby hospital with lips still swollen and c/o funny feeling in his heart.  On arrive to ER at CHKD in Norfolk, he c/o skin itching all over with fine red rash noted.  Mom advised ER treated with dexamethasone, benadryl and Ranitidine. He was monitored in ER overnight and released next AM.  Mom advised he has a latex allergy and the bandaid was reported to be latex free, but it was removed and his s/s seemed to begin before it was applied (coughing).  Mom advised he eats scrambled eggs with sausage or a boiled egg every other day w/o issue.  He has received flu vaccines and all childhood vaccines w/o issues since birth.  At this time (10/11/2017) he is well and has no further issues.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Ocular hyperaemia, Radioallergosorbent test positive, Rash macular
Clinical narrative: MOP advised she and her husband took this 9yo to pharmacy for routine annual flu vaccine (Fluarix, no lot # available) on 9/29/2017.  Mom advised he tolerated the vaccine administration well and when a bandaid was applied to vaccine site, he jumped out of dads lap and immediately began coughing.  This was <1-2 min post vaccination.  He would not stop coughing and would not talk. He was looking up to the sky with eyes appearing blood shot. His ears, face were red and he was sweating profusely.  She noted his lips appeared to be swelling with red blotches also seen on his face, arms, neck, and was grunting having issues breathing.  His eyes were wide and he would shake his head no when asked if he was okay.  He looked exhausted.  Nurse administer epipen to left leg a few minutes after vaccination where quickly afterwards he took in a deep breath, sighed and was able to stop coughing and sit down.  911 was activated and he was transported to nearby hospital with lips still swollen and c/o funny feeling in his heart.  On arrive to ER at CHKD in Norfolk, he c/o skin itching all over with fine red rash noted.  Mom advised ER treated with dexamethasone, benadryl and Ranitidine. He was monitored in ER overnight and released next AM.  Mom advised he has a latex allergy and the bandaid was reported to be latex free, but it was removed and his s/s seemed to begin before it was applied (coughing).  Mom advised he eats scrambled eggs with sausage or a boiled egg every other day w/o issue.  He has received flu vaccines and all childhood vaccines w/o issues since birth.  At this time (10/11/2017) he is well and has no further issues.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: With the first shot, my left arm below shoulder hurt very badly for 2 weeks. 2nd shot- 2 1/2 months later-I had a fever for 4-5 days, felt nauseated and sick - and had a headache for over 5 days
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: With the first shot, my left arm below shoulder hurt very badly for 2 weeks. 2nd shot- 2 1/2 months later-I had a fever for 4-5 days, felt nauseated and sick - and had a headache for over 5 days
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: continued soreness, pain and heaviness in arm
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 77 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about 2011, the pt was vaccinated by a healthcare provider with a dose of zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unknown date, the pt developed shingles, therefore was treated by a healthcare provider. The outcome of shingles was unknown and the reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 77 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about 15-SEP-2016, the pt was vaccinated by a healthcare provider with a dose of zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unknown date, the pt developed shingles, therefore was treated by physician. The outcome of shingles was unknown and the reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: painful rash accompained by headaches, neck pain, weakness in her right arm and pain throughout her ride side/ herpes zoster; painful rash accompained by headaches, neck pain, weakness in her right arm and pain throughout her ride side/ post herpetic neuralgia; This initial 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 concomitant medications, concurrent conditions or medical history.  On an unknown date, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for routine health maintenance and for prevention of shingles (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unknown date, the pt developed painful rash accompanied by headaches, neck pain, weakness in her right arm and pain throughout her ride side. Then, the pt was presented to a medical provider and was diagnosed with herpes zoster and Postherpetic Neuralgia. The outcome of herpes zoster and Postherpetic Neuralgia was not resolved and the reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash
Clinical narrative: painful rash accompained by headaches, neck pain, weakness in her right arm and pain throughout her ride side/ herpes zoster; painful rash accompained by headaches, neck pain, weakness in her right arm and pain throughout her ride side/ post herpetic neuralgia; This initial 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 concomitant medications, concurrent conditions or medical history.  On an unknown date, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for routine health maintenance and for prevention of shingles (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unknown date, the pt developed painful rash accompanied by headaches, neck pain, weakness in her right arm and pain throughout her ride side. Then, the pt was presented to a medical provider and was diagnosed with herpes zoster and Postherpetic Neuralgia. The outcome of herpes zoster and Postherpetic Neuralgia was not resolved and the reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Chronic shingles outbreak; Information has been received regarding a case in litigation from a lawyer referring a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 01-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for prophylaxis.         On 01-AUG-2012, (reported as "since she received the vaccination"), she had experienced chronic shingles outbreaks.  The outcome of the shingles was unknown.     The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; two patient were administered one dose of PEDVAXHIB before 2 month of age; This spontaneous report has been received from a physician concerning  an approximately 7 week old patient of unknown gender and ethnicity.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 25-MAR-2019, the patient was vaccinated with 2 doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), (frequency and anatomical location were not reported) (lot # R021083 and expiration date 13-JUN-2021) for prophylaxis.  At the vaccination time, the patient had approximately 7 weeks old (product administered to patient of inappropriate age). No adverse event reported.; Sender's Comments:  US-009507513-1905USA014123:
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; two patient were administered one dose of PEDVAXHIB before 2 month of age; This spontaneous report has been received from a physician concerning  an approximately 7 week old patient of unknown gender and ethnicity.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 25-MAR-2019, the patient was vaccinated with 2 doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB),  (frequency and anatomical location were not reported) (lot # R021083 and expiration date 13-JUN-2021) for prophylaxis.  At the vaccination time, the patient had approximately 7 weeks old (product administered to patient of inappropriate age). No adverse event reported.; Sender's Comments:  US-009507513-1905USA013730:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: the patient experienced "red, swollen, painful injection site"; the patient experienced "red, swollen, painful injection site"; the patient experienced "red, swollen, painful injection site"; This spontaneous report was received from two nurses via company representative, referring to a 75-year-old female patient.  The patient's concurrent conditions and medical history were not reported. Concomitant medications included many unspecified medications and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid injection.  On 28-MAY-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot# R017900, expiration date 26-MAR-2020) 0.5 mL, one shot intramuscularly in the deltoid of the left arm due to center for disease control (CDC) recommendation based on age.  On an unknown day in May 2019, after receiving Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), the patient's injection site became red, swollen and painful (injection site erythema, injection site swelling, injection site pain). The patient reported the events on 30-MAY-2019. The patient called the clinic and received an unspecified treatment for the event. At the time of the report, the patient was recovering from the events.  The causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events was not reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No known adverse effects; A patient received a dose of M-M-R II via the intramuscular route in error; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant therapy included sterile diluent. No information was provided regarding pertinent medical history and drugs reactions or allergies.   On 28-MAY-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) by intramuscular route (Incorrect route of product administration), lot #R015163, expiration date of 29-MAY-2020 (strength, dose and anatomical site of injection were not reported).   No adverse effects was known.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: the patient had an unspecified "reaction" on an unspecified date; This spontaneous report was received from a medical assistant referring to a female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an unspecified number of doses of Zoster Vaccine Live (ZOSTAVAX) vial 19400 plaque forming units (PFU) (dose, frequency, route, lot# and expiration date not reported) for prophylaxis.  On an unknown date, the patient experienced an unspecified adverse event. The reporter did not know the details of the event. It was unknown if the patient had received any treatment for the event. At the time of the report, the patient had recovered from the adverse event.  The causal relationship between Zoster Vaccine Live (ZOSTAVAX) and the unspecified adverse event was not reported.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Fatigue, Pruritus, Rash
Clinical narrative: the patient experienced tiredness, itching and little rashes after receiving ZOSTAVAX; the patient experienced tiredness, itching and little rashes after receiving ZOSTAVAX; the patient experienced tiredness, itching and little rashes after receiving ZOSTAVAX; This spontaneous report has been received from a consumer referring to herself, a female patient of unknown age and ethnicity.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On an unknown date (also reported as "9 days ago"), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, anatomical location, lot and expiration date were not provided) for prophylaxis.  Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (dose, frequency, indication, anatomical location, lot and expiration date were not provided)  On an unknown date, the patient experienced tiredness (fatigue), itching (pruritus) and little rashes (rash) after receiving zoster vaccine live (ZOSTAVAX). The outcome of fatigue, rash and pruritus was unknown. In addition, the patient refused to provided any additional information.   The causal relationship between fatigue, rash and pruritus and both suspect therapies was not reported.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: pain in the left arm; This spontaneous report was received from a registered nurse, via company representative and refers to a 69 year old female patient.  No information was provided regarding the patient's concomitant medications, medical history or concurrent conditions.   On 03-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R033080 with expiration date on 06-JUN-2020, one shot of 0.5 milliliter, intramuscular in the deltoid of the left arm as Centers for Disease Control and Prevention (CDC) recommendation based on age. On 04-MAY-2019, the patient called the practice's office and reported that on an unknown date, after vaccination, experienced pain in the left arm (vaccination site pain).      The outcome of vaccination site pain was reported as resolved. The causal relationship between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the event was not reported.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Interchange of vaccine products; inappropriate schedule of vaccine administration; No adverse effects reported; This spontaneous report was received from the patient's mother and refers to a 18 year old male patient. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.     On an unknown date, when he was 16 years old, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis. Then, when he was 18 years old, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and another dose when he was 20 years old for prophylaxis (route of administration, lots numbers and expirations dates were not reported for both vaccines)( interchange of vaccine products and inappropriate schedule of product administration). However, no adverse effects were reported.
Age: 41.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Axillary pain, Chills, Influenza like illness, Malaise, Musculoskeletal discomfort
Clinical narrative: Flu like symptoms, fever, chills, right armpit soreness, neck aches. Started day after receiving immunizations, still not feeling well on 6/3/19.
Age: 41.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms, fever, chills, right armpit soreness, neck aches. Started day after receiving immunizations, still not feeling well on 6/3/19.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: SWOLLEN, HARDENED, REDDENED. ITCHY.  ALL SYMPTOMS STARTED THE NEXT DAY.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Pain in extremity, Peripheral swelling
Clinical narrative: Pt with SEVERE RT arm pain/swelling for over 3 weeks.  Pt states she was up for several nights with the pain and could not use her hand due to swelling.  No f/c/s.  Continues to have aching in arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm pt took Motrin but pain still exists 3 weeks latet
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: SEVERE SORENESS AND PAIN IN THE LEFT ARM, CHILLS, LOW GRADE TEMPERATURE.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: fever 101.1, chills, sensitive skin, muscle aches, headache, fatigue
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: fever 101.1, chills, sensitive skin, muscle aches, headache, fatigue
Age: 1.08
Sex: M
Vaccine: MMR, PPV
Symptoms: Injection site erythema, Injection site swelling, Rash, Vomiting
Clinical narrative: Rash (mainly on torso), vomit, swelling/redness at injection site
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Patient diagnosed with Chicken pox in office today 6/3/19.
Age: 11.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Hyperhidrosis, Loss of consciousness, Pain, Rash, Rash generalised
Clinical narrative: Pre-teen presented for routine camp physical (Camp in July). Cleared with NKDA, Zyrtec prn for spring seasonal allergies, Liquid motrin prn musculoskeletal growth pain (89lb and 65in), no PMH.  Can eat eggs just doesn't like, can drink milk, eat beef, etc.....no food allergies.  He received routine Tdap and first MEN vaccine about 0954am.  They went home and mom gave him oral motrin for body aches (first time using pill form Motrin).  Mom advised no PE that day (missed as getting vaccines), had normal food/lunch, no change in detergents, soaps, etc.... He reports about 3:15pm his chest began to itch.  Home at 3:30, mom noted chest and back with multiple red and blotchy welts as if bitten by a bug. He took a shower and condition worsened - now on face, neck, back, chest, abdomen, groin area.  Teen had no other systemic symptoms, SOB, difficulty swallowing, breathing, etc. Mom called HCP and teen taken to ER where given oral benadryl....mom reports it was not effective after 30 min so ER MD prescribed prednisolone.  Again no response or easing of reaction (but not worse) so MD sent home to continue use of Benadryl and Steroids.  On way home, mom stopped for meds, picked up some food, but teen was sleeping and once home difficult to arouse.  Mom said he "blacked out", was hot and sweaty but had awakened by time ambulance arrived.  She transported to hospital by POV where MD again gave 2nd dose of Benadryl as due, an IV and monitored. Welts were easing but now visible on legs.  Mom said took a couple of days <2 to fully resolve. Mom said 2nd MD at hospital advised reaction most likely due to the vaccines and his "blackout" could have been a hypoglycemic event.
Age: 11.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Rash pruritic, Skin warm, Urticaria
Clinical narrative: Pre-teen presented for routine camp physical (Camp in July). Cleared with NKDA, Zyrtec prn for spring seasonal allergies, Liquid motrin prn musculoskeletal growth pain (89lb and 65in), no PMH.  Can eat eggs just doesn't like, can drink milk, eat beef, etc.....no food allergies.  He received routine Tdap and first MEN vaccine about 0954am.  They went home and mom gave him oral motrin for body aches (first time using pill form Motrin).  Mom advised no PE that day (missed as getting vaccines), had normal food/lunch, no change in detergents, soaps, etc.... He reports about 3:15pm his chest began to itch.  Home at 3:30, mom noted chest and back with multiple red and blotchy welts as if bitten by a bug. He took a shower and condition worsened - now on face, neck, back, chest, abdomen, groin area.  Teen had no other systemic symptoms, SOB, difficulty swallowing, breathing, etc. Mom called HCP and teen taken to ER where given oral benadryl....mom reports it was not effective after 30 min so ER MD prescribed prednisolone.  Again no response or easing of reaction (but not worse) so MD sent home to continue use of Benadryl and Steroids.  On way home, mom stopped for meds, picked up some food, but teen was sleeping and once home difficult to arouse.  Mom said he "blacked out", was hot and sweaty but had awakened by time ambulance arrived.  She transported to hospital by POV where MD again gave 2nd dose of Benadryl as due, an IV and monitored. Welts were easing but now visible on legs.  Mom said took a couple of days <2 to fully resolve. Mom said 2nd MD at hospital advised reaction most likely due to the vaccines and his "blackout" could have been a hypoglycemic event.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Activated partial thromboplastin time, Differential white blood cell count, Full blood count, Injection site reaction, International normalised ratio
Clinical narrative: Petechial rash on full left upper extremity in patches which then appeared on left upper extremity in patches the following morning.  It then spread down her arm. She was seen in the office on 5/30 for this and followed up on 5/31. On 5/31 she presented with similar rash to right arm.  She has a history of epistaxis and severe menstrual bleeding. Spoke with hematology and infectious disease, no treatment advised at this time.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Petechiae, Prothrombin time, Rash
Clinical narrative: Petechial rash on full left upper extremity in patches which then appeared on left upper extremity in patches the following morning.  It then spread down her arm. She was seen in the office on 5/30 for this and followed up on 5/31. On 5/31 she presented with similar rash to right arm.  She has a history of epistaxis and severe menstrual bleeding. Spoke with hematology and infectious disease, no treatment advised at this time.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Swelling
Clinical narrative: The patient phoned the pharmacy on Sunday May 12,2019  saying she started having tingling in lips and swelling. I told her to go to the ER. Patinet received shot the previous Friday 5/10/10  at 12:32pm.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Patient receieved the HPV vaccine and MCV 4 vaccine. Patient reported feeling lightheaded and dizzy afterwards. Patient was layed down on a couch with feet elevated for a few minutes. Patient also received graham crackers and apple juice. Patient reported feeling better after a few minutes. Provider assessed patient and determined patient was okay to leave the facility.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: patient reports redness at site of injection  patient reports that injection was done subcutaneously
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site vesicles
Clinical narrative: Patient developed a cluster of vesicles at injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy, Lip blister, Oral mucosal blistering
Clinical narrative: Headaches, fever, chills, lethargy,  body aches for 10 days and STILL COUNTING.   I also got blisters on the insides of my lips in my mouth. And the sad part is that after ten days I am STILL dealing with these relentless reactions.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Headaches, fever, chills, lethargy,  body aches for 10 days and STILL COUNTING.   I also got blisters on the insides of my lips in my mouth. And the sad part is that after ten days I am STILL dealing with these relentless reactions.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Starting the day following the injection (3/8/19) headache, muscle aches, general malaise, tiredness, shivering.  Resolved by the following day (3/9/19).
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse reaction, vaccine given 7 days past expiration