chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Immunodeficiency, Madarosis, Malaise, Pain
Clinical narrative: 7 days following vaccination, patient lost eyelashes and had compromised immune system.  Was ill for 9 weeks following vaccine with severe cough, body aches, fever.  Was seen in the clinic on 12-20-19 and was prescribed steroids, antibiotics, inhaler, and cough syrup.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: 7 days following vaccination, patient lost eyelashes and had compromised immune system.  Was ill for 9 weeks following vaccine with severe cough, body aches, fever.  Was seen in the clinic on 12-20-19 and was prescribed steroids, antibiotics, inhaler, and cough syrup.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Haematoma, Injection site haematoma, Ultrasound Doppler normal
Clinical narrative: Hematoma involving the entire right arm from just above the elbow to the wrist.  Deep and not subcutaneous. Restricting blood flow but no blood clot present as verified by a dopler eco scan.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Rash, Rash erythematous
Clinical narrative: Redness and tenderness at injection site, diffuse red rash down R arm
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Bone pain, Erythema, Limb mass, Myalgia, Peripheral swelling
Clinical narrative: raised, red quarter sized lump on arm, extremely muscle and bone pain, throat tightness, ibuprofen, excedrin, benadryl, rest
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: raised, red quarter sized lump on arm, extremely muscle and bone pain, throat tightness, ibuprofen, excedrin, benadryl, rest
Age: 19.0
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Erythema, Full blood count, Influenza virus test, Rash, Swelling
Clinical narrative: Rash started 2/13/2020 on right arm got wose 2/14/20 - went to hospital was given on clindamycin - saw pt on 2/18/20 swelling subsided still red a little bit Called patient on 2/17/2020 @ 9AM as soon as I received the message & as soon as the pharmacy opened. She accused me that I didn't wear gloves. I explained to her that I did wear gloves & that is the protocol, & I cleaned her skin w/ 2 alcohol swaps. & I went to explain to her that pneumonia is related with redness & as I explained to her during the shot that of she received this redness to apply ice on it & sometimes it resolved 5 day. According to site of manufacture. PPSV23 is associated w/ injection site soreness/ tenderness/ swelling/ induration/ erythema contacted the manufacture to send info to pt as well on 2/17/20 w call 2/18/20 to follow up. Pt came in on 2/18/20 w/ her parents, the rash has subsided, area still a little red & 0 swolleness. I gave all the paper/documentation requested by pt VARS & VAERS form & explained to the pt the risk of pneumonia PPSV23 Rxn. Will speak w/manufacturer to send pt more info about vaccine  (rash swolleness Rxn.
Age: 19.0
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Rash started 2/13/2020 on right arm got wose 2/14/20 - went to hospital was given on clindamycin - saw pt on 2/18/20 swelling subsided still red a little bit Called patient on 2/17/2020 @ 9AM as soon as I received the message & as soon as the pharmacy opened. She accused me that I didn't wear gloves. I explained to her that I did wear gloves & that is the protocol, & I cleaned her skin w/ 2 alcohol swaps. & I went to explain to her that pneumonia is related with redness & as I explained to her during the shot that of she received this redness to apply ice on it & sometimes it resolved 5 day. According to site of manufacture. PPSV23 is associated w/ injection site soreness/ tenderness/ swelling/ induration/ erythema contacted the manufacture to send info to pt as well on 2/17/20 w call 2/18/20 to follow up. Pt came in on 2/18/20 w/ her parents, the rash has subsided, area still a little red & 0 swolleness. I gave all the paper/documentation requested by pt VARS & VAERS form & explained to the pt the risk of pneumonia PPSV23 Rxn. Will speak w/manufacturer to send pt more info about vaccine  (rash swolleness Rxn.
Age: 19.0
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Back pain, Cellulitis, Full blood count, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Rash started 2/13/2020 on right arm got wose 2/14/20 - went to hospital was given on clindamycin - saw pt on 2/18/20 swelling subsided still red a little bit Called patient on 2/17/2020 @ 9AM as soon as I received the message & as soon as the pharmacy opened. She accused me that I didn't wear gloves. I explained to her that I did wear gloves & that is the protocol, & I cleaned her skin w/ 2 alcohol swaps. & I went to explain to her that pneumonia is related with redness & as I explained to her during the shot that of she received this redness to apply ice on it & sometimes it resolved 5 day. According to site of manufacture. PPSV23 is associated w/ injection site soreness/ tenderness/ swelling/ induration/ erythema contacted the manufacture to send info to pt as well on 2/17/20 w call 2/18/20 to follow up. Pt came in on 2/18/20 w/ her parents, the rash has subsided, area still a little red & 0 swolleness. I gave all the paper/documentation requested by pt VARS & VAERS form & explained to the pt the risk of pneumonia PPSV23 Rxn. Will speak w/manufacturer to send pt more info about vaccine  (rash swolleness Rxn.
Age: 19.0
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Peripheral swelling, Pyrexia, Sensory loss, Ultrasound scan, X-ray
Clinical narrative: Rash started 2/13/2020 on right arm got wose 2/14/20 - went to hospital was given on clindamycin - saw pt on 2/18/20 swelling subsided still red a little bit Called patient on 2/17/2020 @ 9AM as soon as I received the message & as soon as the pharmacy opened. She accused me that I didn't wear gloves. I explained to her that I did wear gloves & that is the protocol, & I cleaned her skin w/ 2 alcohol swaps. & I went to explain to her that pneumonia is related with redness & as I explained to her during the shot that of she received this redness to apply ice on it & sometimes it resolved 5 day. According to site of manufacture. PPSV23 is associated w/ injection site soreness/ tenderness/ swelling/ induration/ erythema contacted the manufacture to send info to pt as well on 2/17/20 w call 2/18/20 to follow up. Pt came in on 2/18/20 w/ her parents, the rash has subsided, area still a little red & 0 swolleness. I gave all the paper/documentation requested by pt VARS & VAERS form & explained to the pt the risk of pneumonia PPSV23 Rxn. Will speak w/manufacturer to send pt more info about vaccine  (rash swolleness Rxn.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Ankle fracture, Asthenia, Guillain-Barre syndrome, Laboratory test, Lumbar puncture
Clinical narrative: 3wks after vaccine LE weakness 4-6 wks after: tingling in hands/feet w worsening weakness, dx of Gullian Barre
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Magnetic resonance imaging spinal, Muscular weakness, Paraesthesia
Clinical narrative: 3wks after vaccine LE weakness 4-6 wks after: tingling in hands/feet w worsening weakness, dx of Gullian Barre
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Infant was given Rotarix vaccine IM instead of Orally, afternoon of 02/11/2020. No adverse event in office, phone follow-up 02/17/2020 - no adverse event observed at home. No treatment required
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE information; administered both VARlVAX and PROQUAD on 2/4/2020; administered both VARlV AX and PROQUAD on 2/4/2020; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 04-FEB-2020, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S025610, expiration date 18-AUG-2021 (exact dose, route of administration were not reported) and 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # S027464, expiration date 02-MAR-2021 (exact dose, route of administration were not reported). It was reported that the vaccines were administered with sterile diluent (STERILE DILUENT). No additional adverse event information were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect; Received both doses of proquad and varivax; This spontaneous report was received from a Nurse referring to a 14-month-old patient of an unknown gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported. On 03-FEB-2020, the patient had subcutaneous administration of a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose/frequency were unknown, lot # S003866, expiration date reported as 08-AUG-2020, but upon internal validation established as 08-AUG-2024) and varicella virus vaccine live (oka/merck) (VARIVAX) (dose/frequency were unknown, lot# R033660, expiry date: 20-NOV-2020) for prophylaxis (inappropriate schedule of product administration). No adverse events were reported. The outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Fluid like ball at site of injection. surrounding area is red and itchy and patient said they were in pain at the time of injection but symptoms gotten red after.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Infant irritability, Muscle spasms, Pyrexia, Seizure
Clinical narrative: Fussy baby all day. Come night time he developed a high fever started having spasms while sleeping.  Ended up having a seizure.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, RV1
Symptoms: Infantile apnoea, Oxygen saturation decreased, Respiratory arrest
Clinical narrative: Patient stopped breathing during next feed. He required stimulation to resume breathing rhythm. He continued to struggle with saturation levels every hour for the next day. His seats would drop during every feed for the next 2 weeks. He had regular spells while sleeping. He had to be given suck therapy to relearn how to coordinate breathing and eating.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site erythema, Injection site mass, Pain in extremity
Clinical narrative: Sore arm, upset stomach and headache. Redness/lump at site of injection the size of a fist.  According to patient measuring 5 inches x 6.5 inches.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Salmon colored rash that began on head and worked down entire body. Rash began 11 days after vaccine was given
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient is a pleasant 60-year-old male who comes into the urgent care this morning with chief complaint of left shoulder pain.  He states that his shoulder began hurting last night after he received his third hepatitis B vaccine.  He states that he did not receive any other vaccines yesterday.  He denies having any fevers nor erythema over the skin, however states he has had pain when he moves his left shoulder.  He states that the pain is so bad that he has limited range of motion and has even had some zingers go down his left arm.  He denies having any numbness or tingling at this time however.  He states he has not taken any medications for the pain and discomfort nor has he used any ice.  He states he is simply been resting the shoulder.  He states that he began traveling internationally recently and has had many vaccines and this is the first time he is ever had such significant pain.  He states that he still needs to get a yellow fever vaccine as well as a meningitis vaccine.  Patient states he is never had an allergic reaction to a vaccine either.  He denies having any edema of the oropharynx, tongue or lips and denies having any shortness of breath.  Patient also denies having any trauma to the left shoulder in the last couple of days.  He states that he was playing with his dog and he was pulling on a rope, however he states that he really did not feel any pain at that time.  He also denies having any recent falls.  Patient denies having any other concerns at this time.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Magnetic resonance imaging
Clinical narrative: Chronic severe L shoulder pain lasting through present.Seen by ortho specialty. . Rehab therapy and steroid  and nsaid treatment initiated and continued.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: rash started at head and worked down body.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Impaired work ability, Nausea, Vomiting
Clinical narrative: I was awakened at 1:00 am Sunday, February 9th.  I was throwing up, chilled, and had a terrible headache.  The rest of that day I had a terrible headache (a 9-10), nauseous, and consequently couldn't take any pain reliever.  I was finally able to take some in the mid afternoon. I could not work on Monday and finally found relief around 1 pm.  If this had been my first shot I would not be getting my second dose.  I only had some chills and body aches with the first dose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Vomiting
Clinical narrative: Weakness, dizziness, vomiting all night, headache
Sex: F
Vaccine: PPV
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: patient had a baby and was breast feeding; This spontaneous report as received from a registered nurse refers to a 15 year old female patient with no pertinent medical history or drug reactions or allergies. On 11-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S021740 exp date 25-MAR-2021) intramuscularly for a scheduled spleen surgery that she would have on an unspecified date. Her surgeon wanted her to receive the vaccine. Concomitant therapies included influenza virus vaccine (unspecified).  The nurse reported that the patient had a baby in December 2019 "2 months ago" and was now breastfeeding. The patient's current status was "fine".
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Feeling hot, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: FLU-TYPE SYMPTOMS; BODY ACHES & PAINS, EXTREMELY COLD - EVENTUALLY TURNING TO EXCESSIVELY HOT/SWEATS - REPEAT, SEVERE HEADACHE, NAUSEA, FAINT,  IT LASTED UNTIL AROUND 1:00 P.M. THE FOLLOWING DAY, TUESDAY, FEBRUARY 18, 2020
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Syncope
Clinical narrative: FLU-TYPE SYMPTOMS; BODY ACHES & PAINS, EXTREMELY COLD - EVENTUALLY TURNING TO EXCESSIVELY HOT/SWEATS - REPEAT, SEVERE HEADACHE, NAUSEA, FAINT,  IT LASTED UNTIL AROUND 1:00 P.M. THE FOLLOWING DAY, TUESDAY, FEBRUARY 18, 2020
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: 1. Fever the next morning, Tylenol relieved the symptom. Fever came back later that evening, took Tylenol again, fever did not return.  2. Persistent redness/soreness: a large area remains red and sore 4 days after vaccine was administered. Red area is about 3.5 inches in diameter.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Disorientation, Injection site pain, Injection site swelling, Insomnia, Mania
Clinical narrative: insomnia, disorientation, feeling "manic", pain and swelling at injection site, perioral pain and erythema, painful oral lesions (possible lupus flare). Present x 6 days
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Oral disorder, Oral mucosal erythema, Oral pain
Clinical narrative: insomnia, disorientation, feeling "manic", pain and swelling at injection site, perioral pain and erythema, painful oral lesions (possible lupus flare). Present x 6 days
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Differential white blood cell count, Fatigue, Full blood count, Injection site erythema, Injection site pain
Clinical narrative: Patient was unable to provide specific timeline on the onset of symptoms on 2/11 but reported adverse event to our office (PCP) approximately 15 hours after receiving injection.   Per ER provider note 2/11/20: "Pt was given the pneumovax vaccine shot yesterday. Since then it was very swollen and painful. She has felt tired all day and has minimal sleep. Pt's daughter was concerned about her and has been afraid to let her sleep. Daughter noticed some redness to the area today. Her pain is on the lateral aspect of the deltoid and has radiation of the pain to the posterior aspect of the shoulder. She tried 1000mg of Tylenol today with minimal relief. On further questioning, pt remembers that the person who gave her the vaccine yesterday couldn't find alcohol wipes. She remembers that she was runnign around looking for them, but couldn't find them. Pt is unsure if the area was cleansed prior to the vaccine. "  After ED evaluation on 2/11/20, patient given prescription for Keflex 500 mg qid x 10 days. While in ED received IV fluids and ketoralac 15 mg.  Patient then returned to ED on 2/13 with this assessment by ED MD:  "Patient was seen by her primary care physician on 2/10 and had an inoculation performed at that time.  Shortly thereafter patient began developing swelling and erythema of her left upper extremity where she got the injection.  She seen in the emergency room on 2/11 and started on antibiotics with Keflex.  She did fatigue since that time but afebrile.  Her symptoms seem to improve, however this evening it began to worsen with increased erythema and worsening swelling of the left upper extremity.  No weakness or numbness.  Has been taking her antibiotics as prescribed.  No fevers at this time.  Reports that the pain is been improved since being on the initial antibiotics."   Patient was prescribed Bactrim DS bid x 10 days for treatment to expand coverage for MRSA.   Patient followed up with PCP Dr. on 2/14/20 for follow up.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Insomnia, Metabolic function test, Pain, Vascular imaging
Clinical narrative: Patient was unable to provide specific timeline on the onset of symptoms on 2/11 but reported adverse event to our office (PCP) approximately 15 hours after receiving injection.   Per ER provider note 2/11/20: "Pt was given the pneumovax vaccine shot yesterday. Since then it was very swollen and painful. She has felt tired all day and has minimal sleep. Pt's daughter was concerned about her and has been afraid to let her sleep. Daughter noticed some redness to the area today. Her pain is on the lateral aspect of the deltoid and has radiation of the pain to the posterior aspect of the shoulder. She tried 1000mg of Tylenol today with minimal relief. On further questioning, pt remembers that the person who gave her the vaccine yesterday couldn't find alcohol wipes. She remembers that she was runnign around looking for them, but couldn't find them. Pt is unsure if the area was cleansed prior to the vaccine. "  After ED evaluation on 2/11/20, patient given prescription for Keflex 500 mg qid x 10 days. While in ED received IV fluids and ketoralac 15 mg.  Patient then returned to ED on 2/13 with this assessment by ED MD:  "Patient was seen by her primary care physician on 2/10 and had an inoculation performed at that time.  Shortly thereafter patient began developing swelling and erythema of her left upper extremity where she got the injection.  She seen in the emergency room on 2/11 and started on antibiotics with Keflex.  She did fatigue since that time but afebrile.  Her symptoms seem to improve, however this evening it began to worsen with increased erythema and worsening swelling of the left upper extremity.  No weakness or numbness.  Has been taking her antibiotics as prescribed.  No fevers at this time.  Reports that the pain is been improved since being on the initial antibiotics."   Patient was prescribed Bactrim DS bid x 10 days for treatment to expand coverage for MRSA.   Patient followed up with PCP Dr. on 2/14/20 for follow up.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Tenderness
Clinical narrative: Tenderness left upper arm. Ibuprofen  600 mg every 8 hours PRN x 5 days.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Groin pain, Muscle spasms
Clinical narrative: muscle cramping, (Charlie horse), inside both thighs, hamstrings Charlie horse, buttocks cramp, groin very sore, duration about 2 months. as of Feb 1 no more cramping.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Seizure
Clinical narrative: seizure
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Pt reported a blotchy rash on her chest area and left arm that started about a week after her 1st Shingrix, which was given on 10/18/19. She said it took about a month to go away. Patient said that she did go out of town and she said she wonders if it could have been just her being in the sun or the new sunscreen that she used but with the proximity of the symptoms being so close to the time that the Shingrix was given she is thinking it is from Shingrix.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Cough, Feeling abnormal, Injection site erythema, Injection site swelling
Clinical narrative: By that night, patient started feeling very achy.  Injection site was very swollen, red, and warm.  Patient had muscle and joint aches.  That night, patient felt a bit nauseous and woke up around 3am to read vaccine information.   Patient took Advil, which helped through the night.  Next day, patient still felt bad, face swollen and eyes were puffy.   Patient contacted the pharmacy for follow-up and directed to doctor. Doctor saw patient on Tuesday but no guidance/treatment given; told not to get the second dose.  Patient was flat out in bed and could not function.  Patient had fever of 99.   Body aches and arm symptoms show a bit improvement but then cough started.   Patient continues to take the Advil and now Mucinex for cough.   Patient is at 30% recovery.  Per patient, patient's vaccine information should specify how bad adverse events could be; only soreness and fever was mentioned--there needs to be more education.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Myalgia, Nausea, Pain
Clinical narrative: By that night, patient started feeling very achy.  Injection site was very swollen, red, and warm.  Patient had muscle and joint aches.  That night, patient felt a bit nauseous and woke up around 3am to read vaccine information.   Patient took Advil, which helped through the night.  Next day, patient still felt bad, face swollen and eyes were puffy.   Patient contacted the pharmacy for follow-up and directed to doctor. Doctor saw patient on Tuesday but no guidance/treatment given; told not to get the second dose.  Patient was flat out in bed and could not function.  Patient had fever of 99.   Body aches and arm symptoms show a bit improvement but then cough started.   Patient continues to take the Advil and now Mucinex for cough.   Patient is at 30% recovery.  Per patient, patient's vaccine information should specify how bad adverse events could be; only soreness and fever was mentioned--there needs to be more education.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Periorbital swelling, Pyrexia, Swelling face
Clinical narrative: By that night, patient started feeling very achy.  Injection site was very swollen, red, and warm.  Patient had muscle and joint aches.  That night, patient felt a bit nauseous and woke up around 3am to read vaccine information.   Patient took Advil, which helped through the night.  Next day, patient still felt bad, face swollen and eyes were puffy.   Patient contacted the pharmacy for follow-up and directed to doctor. Doctor saw patient on Tuesday but no guidance/treatment given; told not to get the second dose.  Patient was flat out in bed and could not function.  Patient had fever of 99.   Body aches and arm symptoms show a bit improvement but then cough started.   Patient continues to take the Advil and now Mucinex for cough.   Patient is at 30% recovery.  Per patient, patient's vaccine information should specify how bad adverse events could be; only soreness and fever was mentioned--there needs to be more education.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Headache, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: By that night, patient started feeling very achy.  Injection site was very swollen, red, and warm.  Patient had muscle and joint aches.  That night, patient felt a bit nauseous and woke up around 3am to read vaccine information.   Patient took Advil, which helped through the night.  Next day, patient still felt bad, face swollen and eyes were puffy.   Patient contacted the pharmacy for follow-up and directed to doctor. Doctor saw patient on Tuesday but no guidance/treatment given; told not to get the second dose.  Patient was flat out in bed and could not function.  Patient had fever of 99.   Body aches and arm symptoms show a bit improvement but then cough started.   Patient continues to take the Advil and now Mucinex for cough.   Patient is at 30% recovery.  Per patient, patient's vaccine information should specify how bad adverse events could be; only soreness and fever was mentioned--there needs to be more education.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Swelling face, Tenderness
Clinical narrative: By that night, patient started feeling very achy.  Injection site was very swollen, red, and warm.  Patient had muscle and joint aches.  That night, patient felt a bit nauseous and woke up around 3am to read vaccine information.   Patient took Advil, which helped through the night.  Next day, patient still felt bad, face swollen and eyes were puffy.   Patient contacted the pharmacy for follow-up and directed to doctor. Doctor saw patient on Tuesday but no guidance/treatment given; told not to get the second dose.  Patient was flat out in bed and could not function.  Patient had fever of 99.   Body aches and arm symptoms show a bit improvement but then cough started.   Patient continues to take the Advil and now Mucinex for cough.   Patient is at 30% recovery.  Per patient, patient's vaccine information should specify how bad adverse events could be; only soreness and fever was mentioned--there needs to be more education.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity, Pruritus
Clinical narrative: Patient was given 2nd dose in series of Shingrix approximately 5 to 6 weeks after experiencing  a very mild case of shingles (4 dots on abdomen). Patien wanted to complete her 2nd dose in the 2 to 6 month window.  The first dose was 7/26/2019.  After her second dose a week later the patient began to experience severe itching over her body. Patient went to her physician where she was given a course of prednisone which helped her.  When she stopped Prednisone the itching came back and was given a 2nd course of Prednisone.  Dr. told patient she believes that the patien had an "acute allergic  reaction to the Shingrix vaccine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: headache, shivering, nausea, fatigue
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Kinesitherapy, Pyrexia, Tic
Clinical narrative: Severe head pain day 10, 11, 12 after vaccine with  low grade fever.   no treatment. Facial tics, contortions started 6 weeks later around Nov 12, 2020.  increasing in severity  and continue to present day.   Tics Observed by therapist Dr. and reported to both parents via phone conference call on Jan 14, 2020.   treating with chiropractic, applied kinesiology.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: About 2 hours after receiving the vaccine, the patient returned to the pharmacy while shopping in the store because she believed to be having an adverse effect to the vaccine. She had a mildly swollen, itchy, red, bumpy patch about 3 inches in diameter on the entire back of her left hand. The rash was localized to the back of her hand and did not extend up her arm and was not present near the injection site. She denied contact with irritants throughout the store. The patient had no other reaction to the first dose other than a sore arm. To treat the reaction, the patient purchased and took a diphenhydramine 25 mg tablet.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Patient called stating she had a little larger than a quarter size hard lump where the shingrix immunization was administered along with some redness and swelling. no fever
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: Six hours after injection I started to have chills, fever, headache, nausea, joint pain and skin had a stinging sensation.  I could not sleep all night because of the pain in my joints and headache.  Next day I had low grade fever but chills had stopped. I was very tired and was unable to stay up sleeping much of the time.  Nausea persisted.  Next day I was a lot better and was able to do my regular routine altho was tired.  I did not get any medical attention. I thought It would disappear by itself which it did.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: Six hours after injection I started to have chills, fever, headache, nausea, joint pain and skin had a stinging sensation.  I could not sleep all night because of the pain in my joints and headache.  Next day I had low grade fever but chills had stopped. I was very tired and was unable to stay up sleeping much of the time.  Nausea persisted.  Next day I was a lot better and was able to do my regular routine altho was tired.  I did not get any medical attention. I thought It would disappear by itself which it did.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache Muscle pain Chills
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: patient reports arm and shoulder pain since time of vaccination in the right arm. she has not seen her doctor yet, but has plans to see her physcian in the future
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gingival swelling, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: After getting Shringrix vaccine on 2/14/20. She noticed palpitation & dizziness that evening. She grabbed a towel holder in bathroom to get steady or break her fall. She did not fall. (Unsure if episode since she has dizziness anyways or secondary to vaccine), but also had localized redness & tenderness on injection site that is gradually getting better, but still red, painful & warm today. She also noticed gum swelling & sore throat (unsure if related to vaccine)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Palpitations
Clinical narrative: After getting Shringrix vaccine on 2/14/20. She noticed palpitation & dizziness that evening. She grabbed a towel holder in bathroom to get steady or break her fall. She did not fall. (Unsure if episode since she has dizziness anyways or secondary to vaccine), but also had localized redness & tenderness on injection site that is gradually getting better, but still red, painful & warm today. She also noticed gum swelling & sore throat (unsure if related to vaccine)
Age: 19.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Erythema, Injection site erythema, Injection site papule, Injection site vesicles
Clinical narrative: he developed, 102 fever the following day from the shots then followed by red red papules & vesicular lesions on his forearms, thighs, legs & trunk itching & 2 on face treated him with Benadryl/PO Calamine lotion & oatmeal Baths. getting better when I called today Feb/18/2020
Age: 19.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Papule, Pruritus, Pyrexia
Clinical narrative: he developed, 102 fever the following day from the shots then followed by red red papules & vesicular lesions on his forearms, thighs, legs & trunk itching & 2 on face treated him with Benadryl/PO Calamine lotion & oatmeal Baths. getting better when I called today Feb/18/2020
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Mouth swelling
Clinical narrative: Patient experienced upper lip swelling 7 hours after receiving the flu shot. No other swelling or difficulty breathing documented. & ORAL SWELLING
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: chills
Age: 90.0
Sex: M
Vaccine: TTOX
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Pain
Clinical narrative: Patient's wife reported that patient had experienced nausea, diarrhea, chills, and aches since the vaccine was administered (2 days). They entered to follow up with primary care provider
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: High-pitched crying, Screaming
Clinical narrative: Within 2 hrs of getting vaccination, child woke up screaming at top of her lungs. lasted x1hr. Calmed down within 10 minutes cried with high pitch x 30 minutes; waves of crying; ok in between. Took 2-3 to be ok.
Age: 74.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient stated he did feel some pain at time of injection, but pain has increased over the course of the week and he is having difficulty reaching and lifting his arm past his shoulder. Recommended follow-up with PCP at this time to further determine what is going on.
Age: 23.0
Sex: M
Vaccine: JEV1, SMALL, SMALL
Symptoms: Chest pain, Pericarditis, Troponin increased
Clinical narrative: ~10 days after receiving the smallpox vaccine, the patient presented to the ED with ~1 day history of persistent left-sided chest pain which was worse with respiration and lying down.  Patient was admitted and ACS was ruled out.  Patient diagnosed with myo-pericarditis secondary to smallpox vaccine
Age: 23.0
Sex: M
Vaccine: JEV1, SMALL, SMALL
Symptoms: Blood creatinine normal, Brain natriuretic peptide normal, C-reactive protein increased, Chest pain, Myocarditis
Clinical narrative: ~10 days after receiving the smallpox vaccine, the patient presented to the ED with ~1 day history of persistent left-sided chest pain which was worse with respiration and lying down.  Patient was admitted and ACS was ruled out.  Patient diagnosed with myo-pericarditis secondary to smallpox vaccine
Age: 23.0
Sex: M
Vaccine: JEV1, SMALL, SMALL
Symptoms: Painful respiration, Red blood cell sedimentation rate increased, Troponin increased, Vaccination complication
Clinical narrative: ~10 days after receiving the smallpox vaccine, the patient presented to the ED with ~1 day history of persistent left-sided chest pain which was worse with respiration and lying down.  Patient was admitted and ACS was ruled out.  Patient diagnosed with myo-pericarditis secondary to smallpox vaccine
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: muscle aches joint pain headache chills tiredness
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: the "29 week pregnant patient was inadvertently administered a dose of VARIVAX; This spontaneous prospective pregnant report was received from a registered nurse referring to a pregnant female patient of unknown age. The patient had no pertinent medical history and drug reactions/ allergies. Concomitant medication was not reported.      On 27-JAN-2020, the patient who was at 29 weeks of pregnancy was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S002736 with expiration date 28-JAN-2021, subcutaneous; dose was not reported) for negative titers for varicella(exposure during pregnancy).  The patient's last menstrual period (LMP) was on 08-JUL-2019 and estimated date of delivery (EDD) was on 13-APR-2020. The pregnancy outcome was pending. The outcome of the event was unknown.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Butterfly rash, Histone antibody positive, Immunology test normal, Loss of personal independence in daily activities, Swelling face
Clinical narrative: face swelling and a butterfly rash; face swelling and a butterfly rash; anti-histone antibody test was positive; This spontaneous report was received from a nurse practitioner via a company representative and refers to a 14-year-old female patient. The patient had family history of unspecified autoimmune disease. The patient did not have any concomitant medications, drug reactions or allergies. Additionally, the reporter informed that on an unknown dates (reported as in the past), the patient received unspecified flu vaccines without any issues.  On 18-JAN-2020, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) first dose in the series, intramuscularly (exact dose, anatomical location, lot # and expiration date were not reported) for prophylaxis (reported as vaccination). On the same date, during the same office visit the patient also received one dose of an unspecified influenza virus vaccine (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported).  On 20-JAN-2020, the patient developed face swelling and butterfly rash and was sent home form school. The patient sought medical attention and on an unknown date in 2020, she was seen in the office by an unknown physician. As a treatment, the patient received diphenhydramine hydrochloride (BENADRYL) and lab tests were ordered. On an unknown date in 2020, the anti-histone antibody test was positive and the autoimmune workup (details not provided) was negative. The outcome of the event was reported as not recovered (also reported as condition improving, details not provided).  The causality assessment between the event and the suspect therapies was not provided.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: currently had a pap with positive HPV; currently had a pap with positive HPV; This spontaneous report was received from a registered nurse referring to a female patient of unknown age.  Information about medical history, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose details, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient currently had a pap with positive human papilloma virus (HPV). The outcome of the events was unknown. The causality assessment was not reported.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Loop electrosurgical excision procedure
Clinical narrative: the daughter underwent a loop electrosurgical excision procedure (LEEP) for cervical dysplasia despite completing the 3 dose GARDASIL series and having limited unvaccinated partners; the daughter underwent a loop electrosurgical excision procedure (LEEP) for cervical dysplasia despite completing the 3 dose GARDASIL series and having limited unvaccinated partners; daughter was administered 3 doses of GARDASIL (4 valent) on 6/19/2009, 11/17/2009 and 7/2/2010; This spontaneous report was received from a physician via a company representative, regarding her daughter - a 22-year-old female patient. No information on the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-JUN-2009, the patient was vaccinated instramuscularly with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (exact dose, anatomical location, lot # and expiration date were not reported) as a normal childhood vaccination. On 17-NOV-2009, she was given the second and on 02-JUL-2010, the third dose of the vaccine.   On an unspecified date in September 2019 (reported as in the fall of 2019), the patient developed cervical dysplasia despite completing the 3-dosage regimen of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and having limited unvaccinated partners. At that time, she underwent a loop electrosurgical excision procedure (LEEP) for cervical dysplasia. The outcome of the events was unknown.  The causality assessment between cervical dysplasia and vaccination failure was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; received an expired dose of VAQTA; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On 13-FEB-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R024008, expiration date 15-NOV-2019 (dose, route of administration and anatomical location of administration were not reported) for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness bilateral, Deafness neurosensory, Sudden hearing loss
Clinical narrative: sudden hearing loss in his left ear. He went totally deaf and was diagnosed with bilateral sensorineural deafness; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 21-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (the dosage regimen information was not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden hearing loss in his left ear, then, he went totally deaf and was diagnosed with bilateral sensorineural deafness. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using this vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. The patient sustained severe and permanent personal injuries, serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of vaccination, the patient had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic losses.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: full blown shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2019, the patient received Shingrix. On 6th January 2020, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient received shingrix and experienced a full blown shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: symptoms of an allergic reaction to the shot; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided but it could be 66 or 67 years. The pateint had symptoms of an allergic reaction after taking shot of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills overnight; fever over night; This case was reported by a other health professional via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever 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 received Shingrix shot and had chills and fever overnight. The reporter enquired that if he/she was contagious.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles in her eye; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was diagnosed after the injection by an eye doctor that she had shingles in her eye. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided. The reporter did not consent to follow-up.