chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: shingles-like rash on right side of body/rash; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 4ZF42, expiry date 18th April 2021) for prophylaxis.   On 22nd March 2019, the patient received the 1st dose of Shingrix. On 24th March 2019, 2 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was recovered/resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were reported as follows: The patient developed a shingles like rash on the right side of his body that resolved after 2 weeks.  The patient did not seek medical treatment for the rash.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Muscle tightness
Clinical narrative: swollen glands; tightness in jaw; This case was reported by a nurse via call center representative and described the occurrence of swollen glands in a 70-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GA5Z5, expiry date unknown) for prophylaxis.   On 27th March 2019, the patient received Boostrix. On 30th March 2019, 3 days after receiving Boostrix, the patient experienced swollen glands and tightness of jaw muscles. On an unknown date, the outcome of the swollen glands and tightness of jaw muscles were not recovered/not resolved.   It was unknown if the reporter considered the swollen glands and tightness of jaw muscles to be related to Boostrix.  Additional details were reported as follows: The reporter was a nurse practitioner.  The patient developed tightness in the jaw and swollen glands.  The symptoms had improved, however, they had not resolved completely. Emergency room visit was required. The reported batch number GA525 for Boostrix did not exist and was updated to GA5Z5 as per the sales database.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Immediate post-injection reaction, Muscle twitching, Pain in extremity, Underdose
Clinical narrative: Sore arm; Underdose; exposure via skin contact; exposure via skin contact; the patient twitched severely; This case was reported by a pharmacist via call center representative and described the occurrence of twitching in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 9th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th May 2019, immediately after receiving Shingrix, the patient experienced twitching, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On 10th May 2019, the patient experienced pain in arm. On an unknown date, the outcome of the twitching, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the twitching and pain in arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that while he was administering the Shingrix to the patient into the right deltoid and after the needle was in, the patient twitched severely and most of the dose went down his arm, probably half of it. However, the pharmacist gave the remaining 0.1 ml that was in the syringe, which led to an underdose, exposure via skin contact and inadvertent exposure to vaccine. The patient complained of a very sore arm on the day of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: skin puffiness, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; skin red, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; sensitive skin, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; skin hot to touch, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in an elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included allergy (respiratory allergies).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site redness, injection site discomfort and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site redness, injection site discomfort and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site redness, injection site discomfort and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that an approximately 78-year-old patient developed an injection site reaction after receiving her 1st Shingrix vaccine 5 months before the date of reporting on an unknown date.  The patient received the Shingrix intramuscularly into the left deltoid. The following day after vaccination, the patient developed a 6 to 7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch.  The injection site reaction covered her deltoid and extended to the back side of her arm and covered her bicep. The patient was examined one month following her Shingrix injection by her health care professional and the injection site reaction had completely resolved without treatment or intervention. The patient had completely recovered. The pharmacist did not have patient's exact age as she was working from home when she called to report the event.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: skin puffiness, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; skin red, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; sensitive skin, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; skin hot to touch, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in an elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included allergy (respiratory allergies).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site redness, injection site discomfort and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site redness, injection site discomfort and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site redness, injection site discomfort and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that an approximately 78-year-old patient developed an injection site reaction after receiving her 1st Shingrix vaccine 5 months before the date of reporting on an unknown date.  The patient received the Shingrix intramuscularly into the left deltoid. The following day after vaccination, the patient developed a 6 to 7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch.  The injection site reaction covered her deltoid and extended to the back side of her arm and covered her bicep. The patient was examined one month following her Shingrix injection by her health care professional and the injection site reaction had completely resolved without treatment or intervention. The patient had completely recovered. The pharmacist did not have patient's exact age as she was working from home when she called to report the event.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Headache, Heart rate increased, Hypertension
Clinical narrative: rapid heartbeat/high pulse; high blood pressure/worsening of high blood pressure; lightheaded; headache; This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On 9th May 2019 12:00, the patient received the 1st dose of Shingrix. On 9th May 2019 14:30, 2 hrs 30 min after receiving Shingrix, the patient experienced heartbeats increased, hypertension aggravated, light headedness and headache. On an unknown date, the outcome of the heartbeats increased, hypertension aggravated and light headedness were recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the heartbeats increased, hypertension aggravated, light headedness and headache to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix the day before reporting at noon. At 2:30 pm she started experiencing a rapid heartbeat. The patient started having very high blood pressure of about 188 by 96 and her pulse was high at 93.   The patient also felt lightheaded and had a massive headache.  The patient still had a massive headache the day of reporting.  All the other symptoms were gone.   The patient had a history of high blood pressure and takes medication for high blood pressure but after the vaccine her high blood pressure worsened. The reporter did not give consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Peripheral swelling
Clinical narrative: soreness at injection site; swelling on arm; redness on arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, swelling arm and erythema of extremities. On an unknown date, the outcome of the injection site pain, swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the injection site pain, swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient experienced soreness and pain at injection site. The patient was experiencing swelling and redness that was midway down her upper arm as well as just above the bend on her inner arm. The reporter did not consented to follow-up.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Myalgia, Peripheral swelling, Urticaria
Clinical narrative: Myalgias, chills, hives, and upper extremity swelling
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Balance disorder, Blood test, Dyskinesia, Gait disturbance, Nuclear magnetic resonance imaging
Clinical narrative: Loss of balance, stutter step, involuntary rocking when standing, occasional rocking when sitting
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Patient almost fainted right after receiving the vaccination. He also started sweating minutes later.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Status epilepticus
Clinical narrative: On 5/8 she had the vaccine. On 5/15 she had an episode of status epilepticus for which she is currently hospitalized. She is stable and recovering now. However, she had been stable with her seizure d/o, which for her is seizures about every 4 months. However, her last significant seizure was in Feb of 2018. The vaccine is one theory of what may have triggered her seizure.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: Patient's left arm is extremely painful, red, hot, and mobility is limited due to pain. Antibiotics were ordered educated to follow up as needed
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Cellulitis, Fatigue, Headache, Injection site erythema
Clinical narrative: Patient  reported that she had temp of 100.2, redness, swelling and pain at site. Body Aches, slight headache, nausea and fatigue.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Patient  reported that she had temp of 100.2, redness, swelling and pain at site. Body Aches, slight headache, nausea and fatigue.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: patient reported that the following evening the site began to itch.  the next day the site became red and swollen which gradually increased. The symptoms  itching, swelling, erythema with mild cellulitis.  She was treated with a Medrol Dose pack to be started 5/19/19 and if site not improved to begin Keflex 500mg bid for 7 days.  follow up call on 5/20 the patient reported she forgot to start the Medrol dose pack but the site had not gotten worse or increased in size beyond the marked area from the clinic visit the prior day.
Age: 0.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 7 month old patient was administered a VAQTA vaccine; No adverse effects; This spontaneous report as received from a medical assistant refers to a 7-month-old patient. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), (lot # R021233 has been verified to be a valid lot number, expiration date: 05-SEP-2019), (exact dose, route of administration, injection site were not provided) for prophylaxis (product administered to patient of inappropriate age). There was no adverse event.
Sex: F
Vaccine: HPVX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: This spontaneous social media report was received from a physician and refers to a female patient of unknown age. There was no information concerning the patient's pertinent medical history, concomitant medications drug reactions or allergies provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided) or with GARDASIL (dose, route of administration, lot# and expiration date were not provided) for prophylaxis.  On an unknown date, the patient experienced Guillain-Barre syndrome and paralysis. The outcome of the events was unknown. The causality assessment was not provided. Upon internal review, the events of Guillain-Barre syndrome and paralysis were concerned to be medically significant.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in right hand after administration of GARDASIL 9; Numbness and tingling in right hand after administration of GARDASIL 9; Information has been received from a pharmacist via a company representative referring to a 32 year old female patient. The patient's concurrent condition, historical drugs, medical history and concomitant therapies were not reported.   On an unknown date, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose detail, strength, lot#, and expiration date were not reported) via unknown route for prevention of human papillomavirus (HPV).  An unspecified amount of time later, the patient developed numbness and tingling in right hand for about a week. The patient had sought medical attention. The outcome of the events was not reported.   Causality assessment was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: she received her first dose of GARDASIL 9 three years ago and she never received her next two doses" .; no adverse effect; This spontaneous report was received from a female consumer of unknown age regarding herself. The patient's pertinent medical history, concurrent condition, concomitant therapy, drug reactions or allergies were not reported. On an unknown date (reported as three years ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 shot (route of administration, lot number and expiration date were not reported) for prophylaxis. The patient never received the next two doses (inappropriate schedule of product administration). No adverse effect reported. There was no product quality complaint associated with this report.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal stiffness, Swelling
Clinical narrative: Soreness; Stiffness; Red area; Knot on upper left arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, stiffness, injection site erythema and local swelling. On an unknown date, the outcome of the injection site pain, stiffness, injection site erythema and local swelling were unknown.   It was unknown if the reporter considered the injection site pain, stiffness, injection site erythema and local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness, stiffness, red area of injection site, knot on upper left arm, after the 1st dose. The patient information was gathered.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Myalgia, Nipple pain, Paraesthesia
Clinical narrative: muscle pain; electrical impulses coming out of the left nipple; nipple is highly sensitive to something; sharp stabs; This case was reported by a consumer via call center representative and described the occurrence of nipple hyperesthesia in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th May 2019, the patient received the 1st dose of Shingrix. On 9th May 2019, 1 days after receiving Shingrix, the patient experienced myalgia of lower extremities. In May 2019, the patient experienced nipple hyperesthesia, nipple pain and electric shock sensation. On an unknown date, the outcome of the nipple hyperesthesia, nipple pain, myalgia of lower extremities and electric shock sensation were not recovered/not resolved.   It was unknown if the reporter considered the nipple hyperesthesia, nipple pain, myalgia of lower extremities and electric shock sensation to be related to Shingrix.  Additional details were reported as follows: The patient reported that she had called the physician and her pharmacist and was told to callus directly.   The patient received Shingrix vaccine on left arm on wednesday night.  The patient woke up on Thursday morning with electrical impulses coming out of the left nipple, like her nipple is highly sensitive to something, there was nothing palpable. It was only on the left nipple. It comes and goes. It was still happening the day of reporting less frequently.  The patient also described it as having sharp stabs.  During the conversation the patient mentioned that she felt some strange muscle pains here and there for example, she was experiencing one on her leg at the time of the call. The reporter did not agree to follow up with GlaxoSmithKline. The reporter did not want to provide any demographic information. The outcome reported for all AES in the structured field of database was RECOVERING/RESOLVING instead of not recovered/not resolved  (outcome uploaded in database)
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: flu like symptoms; injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 9th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced flu like symptoms and injection site pain after receiving her second dose of Shingrix.
Age: 56.0
Sex: M
Vaccine: MMR
Symptoms: Injection site mass, Injection site rash, Rash
Clinical narrative: Approximately 3 days after receiving the MMR vaccine, pt developed a rash on both upper arms and a lump in her L antecubital area. She report that she hasn't changed anything else (ie detergents, etc,).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Intussusception
Clinical narrative: ER for incontrollable crying DX: intussusception - suspected. Self-resolved
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Headache, Injection site pain, Lethargy, Pyrexia
Clinical narrative: High fever, lethargy, stomach pain, pain at injection site, headache
Age: 57.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Peripheral swelling, Urticaria
Clinical narrative: Received phone call on 05/17/19 from patients wife explaining that they day after the vaccination the patient reported significant joint pain. She also stated that as of 05/16/09 the patient had been experiencing a "welt like rash" on his face and that his hands had been swelling. I advised her to take her husband to see a provider and that given that it had been three weeks since vaccination it may be difficult to know if this current reaction is due to a vaccine reaction.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient was administered 1st known dose of Hepatitis A vaccine as part of an outreach project at a recovery center. Vaccine given at approx. 3:55 in left deltoid. At approx. 4:25, patient returned to the vaccination area to report she had a rash. Localized area of erythema noted on outer aspect of left forearm below the thumb, approx. 4 inches in length and 2 inches in width at widest point. Reported some mild itching. Injection site clear, no erythema or edema noted. Patient denied any difficulty breathing or shortness of breath. No other complaints. Administered Diphenhydramine 25mg po at approx. 4:28 and advised client that she would be monitored for at least the next hour. Advised to notify a health department. employee immediately for any shortness of breath, difficulty breathing, or if any additional signs and symptoms were noted or if rash/itching worsened. Patient verbalized understanding. Patient continued to work without difficulty. Checked on patient frequently as able as she had to walk several area within the building to complete her work. At 4:35 patient stated "I feel fine. I think it's better now". Rash was still present, but not spreading. Stated itching had improved. At 4:55 patient reported continued improvement in itching, rash present, but not spreading. At 5:15 patient reported no longer itching. Rash not spreading. Advised patient to seek medical attention if rash spreads or does not resolve in 24 hours, seek immediate medical attention for any shortness of breath, difficulty breathing, dizziness or lightheadedness, or if any signs and symptoms of anaphylaxis occur. Patient verbalized understanding. Alert and oriented, ambulatory, and continuing her work without difficulty. Unable to contact patient again before end of outreach due to she had to leave the area for her work. Call to patient on 3/13/19 at 11:26 to check status. No answer, left voicemail to contact this nurse for update.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Diarrhoea, Lethargy, Pyrexia, Rash, Vomiting
Clinical narrative: Patient's mother states child started having mild fever on the night of 04/26/2019. Child woke up on 04/27/209 with uncontrollable vomiting, high fever, diarrhea, and was lethargic. Child also had a rash on right arm that was 3 inches long and 1 inch wide. Child had mild fever on 04/28/2018. Child was seen by pediatrician. As of 05/01/2019 the symptoms have resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Patient is a 4 y.o. male. He presents with his family to the office today with complaints of rendess, swelling in thighs that have been ongoing since his vaccinations.  There is mild itch in both thighs, some pain in Lt thigh.  No fevers.  He was "tired" for a few days, mother denies fevers.  Pt with hyperemic rash on both thighs, Lt > Rt; Pt with indurated, red and tender area on Lt thigh within the hives rash.  Both thighs were ink-marked and dated. Vaccine reaction, initial encounter Vaccine reaction, initial encounter [T50.Z95A] Comment: Pt has notable history of vaccine reaction as an infant, and again now as a toddler; will only vaccinate ONE AT A TIME with predosing of Claritin
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Patient is a 4 y.o. male. He presents with his family to the office today with complaints of rendess, swelling in thighs that have been ongoing since his vaccinations.  There is mild itch in both thighs, some pain in Lt thigh.  No fevers.  He was "tired" for a few days, mother denies fevers.  Pt with hyperemic rash on both thighs, Lt > Rt; Pt with indurated, red and tender area on Lt thigh within the hives rash.  Both thighs were ink-marked and dated. Vaccine reaction, initial encounter Vaccine reaction, initial encounter [T50.Z95A] Comment: Pt has notable history of vaccine reaction as an infant, and again now as a toddler; will only vaccinate ONE AT A TIME with predosing of Claritin
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Differential white blood cell count, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: At approximately 9:30 p.m. on May 9, 2019, sudden onset SVT with heartbeat reaching 233 bpm and attendant shivers. EMTs registered heart rate via ECG. After two doses of adenosine to slow heart rate to 117 bpm, transport to ER at 10:30 p.m. Released at 1:30 a.m. with normal labs.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Supraventricular tachycardia, Troponin I
Clinical narrative: At approximately 9:30 p.m. on May 9, 2019, sudden onset SVT with heartbeat reaching 233 bpm and attendant shivers. EMTs registered heart rate via ECG. After two doses of adenosine to slow heart rate to 117 bpm, transport to ER at 10:30 p.m. Released at 1:30 a.m. with normal labs.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: A few days after shot got shingles all over my back.   Vaccine = SHINGRIX     ( GlaxoSmithKline )
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Malaise
Clinical narrative: Patient had malaise and discomfort. Today he developed shingle like spots on his belly and under his arm. He called saying he now has shingles.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Back pain, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: I got the shot early in the AM but didn't start feeling poorly until around 4:00 pm.  I first noticed I was feeling flu'ish with a very bad headache, felt like I was getting a fever (but did not), all over body aches but worse in my neck, shoulders and back.  However I didn't get alarmed until I had trouble breathing.  That's when I looked at the "reaction page" and realized it was one of the "sever allergic reactions" listed.  I took Benadryl and was able to breath more comfortably.  Saturday the symptoms lessened but were still bad enough to keep me in bed and taking more Benedryl.  By Sunday, I was feeling 80% better.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Influenza like illness, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: I got the shot early in the AM but didn't start feeling poorly until around 4:00 pm.  I first noticed I was feeling flu'ish with a very bad headache, felt like I was getting a fever (but did not), all over body aches but worse in my neck, shoulders and back.  However I didn't get alarmed until I had trouble breathing.  That's when I looked at the "reaction page" and realized it was one of the "sever allergic reactions" listed.  I took Benadryl and was able to breath more comfortably.  Saturday the symptoms lessened but were still bad enough to keep me in bed and taking more Benedryl.  By Sunday, I was feeling 80% better.
Age: 1.0
Sex: M
Vaccine: FLU4, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, required alternating tylenol and motrin. One epidose of vomiting.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: patient received two doses of the HIB vaccine on the same day
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Employee Health nurse gave Varicella vaccine, dose #2, per CDC recommendations for healthcare personnel.  Healthcare worker, patient, developed raised, red, swollen, very painful area, max measurement was approximately 7x15cm.  PA-C, prescribed 5 day course of Keflex for possible cellulitis.  Reaction improved tremendously after 2nd dose of Keflex.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles 2 days later.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: fever of 101.5 same day vaccine was given
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; M-M-R II was administered by the intramuscular rather than subcutaneous route to a 1 year; This spontaneous report was received from a Licensed Practical Nurse refers to a 1 year old female patient. The patient's pertinent medical history, drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent. On 16-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (M-M-R II) (lot #: N034002, expiration date: 04-DEC-2019), intramuscularly for prophylaxis instead of subcutaneous route (incorrect route of product administration). No adverse effects reported. Both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (M-M-R II) and sterile diluent were properly stored. No adverse effects reported.   Product quality complaint not involved.
Age: 11.0
Sex: M
Vaccine: MMR, UNK
Symptoms: Chills, Immunoglobulins, Measles antibody positive, Pain, Polymerase chain reaction
Clinical narrative: chills; body aches; skin rash; fever; This spontaneous report was received from a other health professional via company representative regarding to a 11 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 08-FEB-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot # N014482 and expiry date 10-MAY-2019, (strength, dose, frequency, route was not reported) for prophylaxis. Other suspect therapies included sterile diluent. The reporter described that, on 08-FEB-2019, (also reported possibly two days after vaccine was administered), the patient was developed skin rash (rash), fever (pyrexia), body aches (pain), chills. The reporter stated that on an unspecified date, the patient was performed blood test which was showed results antibodies, measles, polymerase chain reaction, rubella, and immunoglobulins. The patient had sought medical attention. The outcome of chills, pyrexia, rash and pain was unknown. The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent and events were not provided.
Age: 11.0
Sex: M
Vaccine: MMR, UNK
Symptoms: Pyrexia, Rash, Rubella antibody positive
Clinical narrative: chills; body aches; skin rash; fever; This spontaneous report was received from a other health professional via company representative regarding to a 11 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 08-FEB-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot # N014482 and expiry date 10-MAY-2019, (strength, dose, frequency, route was not reported) for prophylaxis. Other suspect therapies included sterile diluent. The reporter described that, on 08-FEB-2019, (also reported possibly two days after vaccine was administered), the patient was developed skin rash (rash), fever (pyrexia), body aches (pain), chills. The reporter stated that on an unspecified date, the patient was performed blood test which was showed results antibodies, measles, polymerase chain reaction, rubella, and immunoglobulins. The patient had sought medical attention. The outcome of chills, pyrexia, rash and pain was unknown. The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent and events were not provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling cold, Feeling hot, Headache, Injection site pain
Clinical narrative: Face hot; Arm feels heavy; injection site pain/feel sore at the injection site; feeling cold; Headache; Light-headed; Nauseous; This case was reported by a consumer via call center representative and described the occurrence of headache in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced headache, light headedness, nausea, heaviness in arm, injection site pain and feeling cold. On 10th May 2019, the patient experienced feeling of warmth facial. On an unknown date, the outcome of the headache, light headedness, nausea, feeling of warmth facial and heaviness in arm were not recovered/not resolved and the outcome of the injection site pain and feeling cold were unknown.   It was unknown if the reporter considered the headache, light headedness, nausea, feeling of warmth facial, heaviness in arm, injection site pain and feeling cold to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine on right arm the day before reporting.  Within 1.5 to 2 hours she started to feel sore at the injection site.   By 5:00 pm she started to feel cold, and light headed.   By 7:00pm that same day she started to feel nauseous, and developed a headache.   The day of reporting, the patient had the same symptoms and 1 day after vaccination, her face was hot.   She also said her arm was sorer than the day before reporting. The reporter did not give consent to follow up. The reporter unable to obtain additional information. The outcome reported for all AES in the structured field of XML is recovering instead of not resolved (outcome uploaded in Argus)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Nausea
Clinical narrative: Face hot; Arm feels heavy; injection site pain/feel sore at the injection site; feeling cold; Headache; Light-headed; Nauseous; This case was reported by a consumer via call center representative and described the occurrence of headache in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced headache, light headedness, nausea, heaviness in arm, injection site pain and feeling cold. On 10th May 2019, the patient experienced feeling of warmth facial. On an unknown date, the outcome of the headache, light headedness, nausea, feeling of warmth facial and heaviness in arm were not recovered/not resolved and the outcome of the injection site pain and feeling cold were unknown.   It was unknown if the reporter considered the headache, light headedness, nausea, feeling of warmth facial, heaviness in arm, injection site pain and feeling cold to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine on right arm the day before reporting.  Within 1.5 to 2 hours she started to feel sore at the injection site.   By 5:00 pm she started to feel cold, and light headed.   By 7:00pm that same day she started to feel nauseous, and developed a headache.   The day of reporting, the patient had the same symptoms and 1 day after vaccination, her face was hot.   She also said her arm was sorer than the day before reporting. The reporter did not give consent to follow up. The reporter unable to obtain additional information. The outcome reported for all AES in the structured field of XML is recovering instead of not resolved (outcome uploaded in Argus)
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: 3 inch red mark that is warm; 3 inch red mark that is warm; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of the two reports.  A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number and expiration date were not reported), with route of administration and therapy dates unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a 3-inch red mark that was warm. The outcome of the event, '3-inch red mark that was warm', was unknown.  Information on lot number, batch number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019208282 same reporter/drug/events, different patient
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 3 inch red mark that is warm; 3 inch red mark that is warm; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of the two reports.  A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number and expiration date were not reported), with route of administration and therapy dates unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a 3-inch red mark that was warm. The outcome of the event, '3-inch red mark that was warm', was unknown.  Information on lot number, batch number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019208282 same reporter/drug/events, different patient
Age: 29.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: 3 inch red mark on the left deltoid that is warm and tender; 3 inch red mark on the left deltoid that is warm and tender; 3 inch red mark on the left deltoid that is warm and tender; This is a spontaneous report from a contactable nurse. This Nurse reported similar events for two patients. This is 1st of two reports.   A 29-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, suspension for injection, NDC: 0005197101), via an unspecified route of administration in the left deltoid on 01May2019 at 0.5 ml, single for immunosuppresion. Medical history was reported as none. There were no concomitant medications. The patient developed 3 inch red mark on the left deltoid that was warm and tender on 03May2019 72 hours after injection. The events were considered as non-serious. Outcome of the events was unknown.   Information on lot number, batch number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019207323 same reporter/drug/events different patient
Age: 29.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 3 inch red mark on the left deltoid that is warm and tender; 3 inch red mark on the left deltoid that is warm and tender; 3 inch red mark on the left deltoid that is warm and tender; This is a spontaneous report from a contactable nurse. This Nurse reported similar events for two patients. This is 1st of two reports.   A 29-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, suspension for injection, NDC: 0005197101), via an unspecified route of administration in the left deltoid on 01May2019 at 0.5 ml, single for immunosuppresion. Medical history was reported as none. There were no concomitant medications. The patient developed 3 inch red mark on the left deltoid that was warm and tender on 03May2019 72 hours after injection. The events were considered as non-serious. Outcome of the events was unknown.   Information on lot number, batch number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019207323 same reporter/drug/events different patient
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Hypertension, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itchy; Had a rash and it was red; Swollen at the injection site; This is a spontaneous report from a contactable pharmacist.  A 77-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: X13847, expiration date:Jul2020), intramuscular on  03May2019 at 0.5 ml, intramuscular in the right deltoid muscle for immunisation .  Medical history included glaucoma, High blood pressure, hypertension, Anxiety, Fluid retention, Anticoagulation, all ongoing. Concomitant medication included latanoprost for glaucoma,  labetalol  for Blood pressure high,alprazolam for Anxiety, hydrochlorothiazide for hypertension and fluid retention and clopidogrel for anticoagulation. Pharmacist stated to report an adverse event associated with the Prevnar 13 vaccine on 10May2019. She just had a rash and it was red and swollen at the injection site but it did not occur until one week after the injection. Reporter was not 100% certain but it occurred at exactly where she received the injection but it did not populate until about a week later. She received the injection on May the 3rd but she said the rash did not come up until May the 10th that she noticed because it was itchy.  Patient did not receive any treatments for the adverse event. Outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Pt got vaccine (2nd dose). First Shingrix Jan 29 pt got sore arm couple days & fine. This vaccine received the workout hard at pounding truck tires. (R) shoulder sore yet 5/17/19.
Age: 54.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Asthenia, Head discomfort, Influenza like illness, Injection site pain, Insomnia
Clinical narrative: Shingrix arm was the sore arm first few hours, body aches like flu for first full day with increased heaviness of head on neck. Second day patient was in outdoor sun and literally wore out of energy and felt extremely weak quickly. Had other s get patient out of sun and drank fluid along with Coke for sugar for energy. Spent rest of day asleep with continued body aches and weakness mimicking flu-like body ache symptoms. Third day awoke after spotty minimal sleep with body aches and heavy head on neck feeling. Almost precisely at 3 days the effects began to wear off from aching. Arm still sore after day 4 at injection site. (Patients significant other (same address, same dates) also received same shot at same time and she experienced body aches for 2 full days which mimicked flu symptoms. Both patients spent two days laying around semi-laughing at how pathetic this was and should not have been hurting this bad.
Age: 54.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Pain
Clinical narrative: Shingrix arm was the sore arm first few hours, body aches like flu for first full day with increased heaviness of head on neck. Second day patient was in outdoor sun and literally wore out of energy and felt extremely weak quickly. Had other s get patient out of sun and drank fluid along with Coke for sugar for energy. Spent rest of day asleep with continued body aches and weakness mimicking flu-like body ache symptoms. Third day awoke after spotty minimal sleep with body aches and heavy head on neck feeling. Almost precisely at 3 days the effects began to wear off from aching. Arm still sore after day 4 at injection site. (Patients significant other (same address, same dates) also received same shot at same time and she experienced body aches for 2 full days which mimicked flu symptoms. Both patients spent two days laying around semi-laughing at how pathetic this was and should not have been hurting this bad.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site papule, Injection site reaction
Clinical narrative: - had anthrax vaccine on 29 April 2019 in medical clinic, administered to R deltoid; a day or two later noticed small red blotches distal to the deltoid insertion on his upper arm, that coalesced 1 day later into an erythematous, TTP, warm patch; no redness overlying the deltoid; no fever; no previous reaction to this vaccine (has had multiple doses over the years) - did notice a possible insect bite or bump inside the area of redness yesterday (mid upper arm) - on exam: R lateral upper arm: 12x7cm warm and TTP region of erythema and edema. Distal to deltoid insertion, with small 2mm papule within the circular skin lesion (anteroinferior aspect of the erythema, mid upper arm, not at typical deltoid injection site for vaccine). Skin at injection site well healed with no surounding erythema or TTP. No purulence/fluctance/drainage noted. -exam seemed consistent with mild cellulitis; however, was unclear if related to his recent Anthrax vaccine as erythema/edema distal to deltoid with no erythema or TTP tracking from this site. Had possible insect bite in the affected region of the upper arm, which may have been a more likely contributing factor. treated with Kelfex 500mg PO qid for 5 days  - on follow-up 48hrs later, reports redness has faded and receded from previous borders marked (with exception that it initially extended slightly beyond the inferior border (but has since been fading); pain improved - instructed to complete the 5 day course and Allergy consultation via teleconsult service - per Allergy, given the patient?s prior doses of Anthrax vaccine and the timing of onset as well as the appearance of the area of erythema, they suspected a local, robust inflammatory reaction (not IgE mediated) and the movement down the arm was likely related to dependent effects