chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever of 101 degree F and then 102 degree F on the same day of receiving 2nd dose of Shingrix. The fever resolved on the next day. The reporter did not consent to follow-up. The outcome of the event recovered reported and the age group reported in the database was different with that reported in the source document where it was resolved with sequele.      Lab Comments: On an unknown date, the patient's body temperature was recorded as 101 and 102 degree F.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pain at Injection site; swelling at Injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 2G2T7, expiry date 15th November 2021) for prophylaxis.   On 14th October 2019, the patient received Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient contacted the pharmacy over the weekend stating that she still had pain and swelling at the injection site.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: tenderness; redness; warmth; This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a 57-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 54T44, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 8th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site tenderness, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site erythema and injection site warmth to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received FluLaval in the left deltoid and within 12 hours experienced tenderness, redness and warmth at the injection site. The issues resolved within 24 hours. This case is 1 of 2 cases, reported by same reporter.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal behaviour, Aggression, Intentional self-injury, Irritability
Clinical narrative: Behavior changes started after receiving flu vaccine: aggressive, throwing things, running away very irritable, kicking, "fight or flight" appearance, harming self + others.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Mild cellulitis (L) thigh extending medially noted 3d after vaccine given. No fever, NT but 8x4 cm are of redness treated with 5d course of Keflex
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills
Clinical narrative: she had a chills and shivering  at night after she got flu shot
Age: 0.33
Sex: F
Vaccine: FLU4, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was mistaken for a 12 month old patient with similar name and address, mistakenly given a Influenza and Hep A vaccination. No reaction seen while under observation for 1 hour in public health clinic.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Influenza like illness
Clinical narrative: SEVERE FLU LIKE SYMPTOMS AND SHORTNESS OF BREATH
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Fatigue, Mental impairment, Pain, Pyrexia
Clinical narrative: high fever, angioedema, impaired thinking, body aches, fatigue
Age: 9.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient has significant swelling of the left elbow region, warmth, and redness. Patient is in pain and cannot extend elbow or raise her arm above the shoulder. Has increased over the last two days since receiving the influenza and pneumococcal 23 vaccines in the left deltoid. Patient received Cochlear implants. Patient was also experiencing loss of balance and photosensitivity prior to vaccines being given.  Patient received a dose of Prednisolone (ORAPRED) 15 mg/5 mL oral solution, given 15mL (2mg/kg). Patient instructed to ice area, take 5 day course of oral steroids, and Benadryl PRN. If in the next 24 hours, any symptoms worsen, patient was instructed to go to the Emergency Room.
Age: 9.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Neurological examination normal
Clinical narrative: Patient has significant swelling of the left elbow region, warmth, and redness. Patient is in pain and cannot extend elbow or raise her arm above the shoulder. Has increased over the last two days since receiving the influenza and pneumococcal 23 vaccines in the left deltoid. Patient received Cochlear implants. Patient was also experiencing loss of balance and photosensitivity prior to vaccines being given.  Patient received a dose of Prednisolone (ORAPRED) 15 mg/5 mL oral solution, given 15mL (2mg/kg). Patient instructed to ice area, take 5 day course of oral steroids, and Benadryl PRN. If in the next 24 hours, any symptoms worsen, patient was instructed to go to the Emergency Room.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Presyncope
Clinical narrative: Near Syncope Episode.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, headache, back pain, fatigue, chills.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Blood cholesterol, Blood count, Blood thyroid stimulating hormone, Erythema, Laboratory test
Clinical narrative: "arm hurt bad" it was hot to the touch compared to the rest of her skin; "arm hurt bad" it was hot to the touch compared to the rest of her skin; pain while trying to sleep; arm was red and swollen; arm was red and swollen/swelling that is now located on the inner part of her elbow that faces her body; This spontaneous report was received from a 64-year-old female registered nurse who was referring to herself. The patient's pertinent medical history included high blood pressure and allergy to esomeprazole magnesium (NEXIUM), metoclopramide hydrochloride (REGLAN) and cyclobenzaprine hydrochloride (FLEXERIL). The patient's concomitant therapies included carvedilol, omeprazole, amlodipine, olmesartan medoxomil (BENICAR) and levothyroxine sodium.  On 04-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, once in the left arm for prevent pneumonia (dose, lot# and expiration date were not reported).  On 04-OCT-2019, the patient experienced pain while she was trying to sleep. Since the night of the vaccination, her arm hurt bad and it was hot to touch compared to the rest of her skin, her arm was red and swollen. At the reporting time, swelling was located on the inner part of her elbow that faces her body. The patient did not seek medical attention. However, it was reported that following lab diagnostics were performed: blood count, chemistry, cholesterol, lipid profile and thyroid stimulating hormone (TSH) (results not provided).  At the reporting, the patient did not recover from the events. The reporter considered pain to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The relatedness between the other events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Lipids, Pain, Pain in extremity, Skin warm
Clinical narrative: "arm hurt bad" it was hot to the touch compared to the rest of her skin; "arm hurt bad" it was hot to the touch compared to the rest of her skin; pain while trying to sleep; arm was red and swollen; arm was red and swollen/swelling that is now located on the inner part of her elbow that faces her body; This spontaneous report was received from a 64-year-old female registered nurse who was referring to herself. The patient's pertinent medical history included high blood pressure and allergy to esomeprazole magnesium (NEXIUM), metoclopramide hydrochloride (REGLAN) and cyclobenzaprine hydrochloride (FLEXERIL). The patient's concomitant therapies included carvedilol, omeprazole, amlodipine, olmesartan medoxomil (BENICAR) and levothyroxine sodium.  On 04-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, once in the left arm for prevent pneumonia (dose, lot# and expiration date were not reported).  On 04-OCT-2019, the patient experienced pain while she was trying to sleep. Since the night of the vaccination, her arm hurt bad and it was hot to touch compared to the rest of her skin, her arm was red and swollen. At the reporting time, swelling was located on the inner part of her elbow that faces her body. The patient did not seek medical attention. However, it was reported that following lab diagnostics were performed: blood count, chemistry, cholesterol, lipid profile and thyroid stimulating hormone (TSH) (results not provided).  At the reporting, the patient did not recover from the events. The reporter considered pain to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The relatedness between the other events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: the patient had equivocal titer results for varicella in 2015, 2017, and 2018; This spontaneous report was received from a physician and refers to a 23-year-old male patient. The patient's concurrent conditions and concomitant medications were not reported. Medical history included history of drug reaction/allergy for azithromycin.  On an unknown date, reported as at age 12 months, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (dose, site, route of administration, lot number and expiration date were not reported) as routine vaccine series.  On an unknown date in 2015, 2017 and 2018, the patient had equivocal titer results for varicella. No treatment was given for the event.   The outcome of the event was unknown (also reported as "Present status: healthy"). The causality between the event and the suspect vaccine was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site induration, Injection site mass, Injection site nodule
Clinical narrative: Redness of the area around the vaccine injection; Itching of the area around the vaccine injection; Swelling of the area around the vaccine injection; Heat of the area around the vaccine injection; Hurts; Hard knot at injection site; Hard knot at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (twice).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site itching, injection site swelling, injection site warmth, injection site pain, injection site induration and injection site mass. The patient was treated with benadryl (nos) (Benadryl), naproxen (Aleve) and ibuprofen (Advil). On an unknown date, the outcome of the injection site erythema, injection site itching, injection site swelling, injection site warmth, injection site pain, injection site induration and injection site mass were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site swelling, injection site warmth, injection site pain, injection site induration and injection site mass to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and the area was fine the day after receiving the vaccine. The patient experienced redness, hard knot, and heat appeared the 2nd day after the shot and was really miserable that day. The patient rested the 3rd day and continued taking Benadryl and Aleve. The reporter was asking if rest would help to reduce the redness, itching, swelling, hard knot and heat of area around the injection site. That area was bright red and both hurts and itched much like when she had shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness of the area around the vaccine injection; Itching of the area around the vaccine injection; Swelling of the area around the vaccine injection; Heat of the area around the vaccine injection; Hurts; Hard knot at injection site; Hard knot at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (twice).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site itching, injection site swelling, injection site warmth, injection site pain, injection site induration and injection site mass. The patient was treated with benadryl (nos) (Benadryl), naproxen (Aleve) and ibuprofen (Advil). On an unknown date, the outcome of the injection site erythema, injection site itching, injection site swelling, injection site warmth, injection site pain, injection site induration and injection site mass were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site swelling, injection site warmth, injection site pain, injection site induration and injection site mass to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and the area was fine the day after receiving the vaccine. The patient experienced redness, hard knot, and heat appeared the 2nd day after the shot and was really miserable that day. The patient rested the 3rd day and continued taking Benadryl and Aleve. The reporter was asking if rest would help to reduce the redness, itching, swelling, hard knot and heat of area around the injection site. That area was bright red and both hurts and itched much like when she had shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site pain, Middle insomnia, Paraesthesia
Clinical narrative: Hurt during administration; Her arm bothered her when she rolled over on the injection site; Felt a tingling down her arm  for one second during administration; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, injection site discomfort and tingling of extremity. On an unknown date, the outcome of the injection site pain, injection site discomfort and tingling of extremity were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site discomfort and tingling of extremity to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in right arm. The Shingrix vaccine was hurt during administration and she felt a tingling down her arm for one second during administration.  That night her arm bothered her when she rolled over on the injection site. It was sore and would cause her to wake up. This lasted for one day and then resolved. Unable to obtain additional details. The reporter did not consent to follow-up. This is 1 of the 3 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles breakout on her neck, where she usually has shingles breakouts; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received dose one of Shingrix and then had a shingles breakout on her neck, where she usually had shingles breakouts. The reporter was busy and did not provide further details during this call. The reporter consent to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in hand up to elbow; This case was reported by a consumer via call center representative and described the occurrence of pain in hand in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in hand. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in hand was unknown.   It was unknown if the reporter considered the pain in hand to be related to Shingrix.  Additional case details were reported as follows: The reporter did not provide lot number and expiration date. The patient received vaccine in unknwon arm. The patient had pain in hand up to elbow, after receiving first dose of Shingrix. The patient taking Tylenol, and was intermittent. The patient was in another city until November. The reporter consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test negative, Fatigue, Injection site erythema, Injection site macule, Injection site pain
Clinical narrative: Pain at injection site; Fatigue; Aches from head to toe; Could not sleep; Fever; Blotchy at injection site; Itchiness at injection site; Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included chicken pox vaccine.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, fatigue, general body pain, insomnia, fever, injection site macule, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, fatigue, general body pain, insomnia, fever, injection site macule, injection site itching and injection site erythema were recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the fatigue, general body pain, insomnia, fever, injection site macule, injection site itching and injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient stated that she never had chickenpox, however her doctor recommended that she should get the Shingrix vaccine anyway. The patient stated that she had blood work done and it showed that she was not immune to chickenpox. Approximately 2 months before the reporting date, the patient received Shingrix on the left arm. The patient stated that after receiving the vaccine, she developed pain at the injection site, fatigue, fever, achiness from head to toe and she could not sleep. The patient stated that she also developed a 3 inch by 3 inch area at the injection site that was blotchy, itchy and red. The patient stated that the symptoms lasted for approximately 4 days before resolving. The reporter consented to follow up. This case has been linked with US2019190822, reported by the same reporter. The outcome of the events reported in database was recovered while in the source document it was recovered with sequele.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Insomnia, Pain, Pyrexia
Clinical narrative: Pain at injection site; Fatigue; Aches from head to toe; Could not sleep; Fever; Blotchy at injection site; Itchiness at injection site; Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included chicken pox vaccine.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, fatigue, general body pain, insomnia, fever, injection site macule, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, fatigue, general body pain, insomnia, fever, injection site macule, injection site itching and injection site erythema were recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the fatigue, general body pain, insomnia, fever, injection site macule, injection site itching and injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient stated that she never had chickenpox, however her doctor recommended that she should get the Shingrix vaccine anyway. The patient stated that she had blood work done and it showed that she was not immune to chickenpox. Approximately 2 months before the reporting date, the patient received Shingrix on the left arm. The patient stated that after receiving the vaccine, she developed pain at the injection site, fatigue, fever, achiness from head to toe and she could not sleep. The patient stated that she also developed a 3 inch by 3 inch area at the injection site that was blotchy, itchy and red. The patient stated that the symptoms lasted for approximately 4 days before resolving. The reporter consented to follow up. This case has been linked with US2019190822, reported by the same reporter. The outcome of the events reported in database was recovered while in the source document it was recovered with sequele.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness bilateral, Sudden hearing loss
Clinical narrative: Sudden Bilateral Hearing Lost; This case was reported by a nurse via call center representative and described the occurrence of hearing loss bilateral in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced hearing loss bilateral (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss bilateral was unknown.   It was unknown if the reporter considered the hearing loss bilateral to be related to Shingrix.  Additional details were provided as follows: This case was reported by the license practice nurse. The patient experienced sudden bilateral hearing lost. The reporter was unable to provide full details.  The reporter would like follow up at earliest convenience and gave consent
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Nausea, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine; Headache; Nausea; Low grade fever; This case was reported by a other health professional via call center representative and described the occurrence of headache in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced headache, nausea and low grade fever. On 22nd October 2019, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the headache, nausea, low grade fever and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the headache, nausea and low grade fever to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the medical assistant. On 10th Se0tember 2019, the patient received 1st dose of Shingrix. The patient was inadvertently received a 2nd dose of Shingrix at public health department, which was earlier than recommended schedule, which led to shortening of the vaccination schedule. The reporter consented to follow up. This case has been linked with case US2019193749, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm sore for a couple of days, then pain began increasing and spreading from upper arm down to elbow.  Arm is still sore more than  2 weeks after the shot.  Provider recommended she see her doctor since the pain is persistent.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Immediate post-injection reaction, Posture abnormal
Clinical narrative: 10/30/19 1:20 PM Shots prepared and administered in the following order (Left Deltoid) 1) Tdap, 2) Flu (Right Deltoid) 3) MCV4 and 4) HPV9. Immediately after last shot is administered, client slowly begins to lean forward towards his lap. Client?s mother got up from her chair and assisted this RN in providing client with head support; both client?s mother and this RN slowly began to ease client in an upright and back position towards the wall his chair is sitting against. Client?s eyes closed and his body jerked oppositely from mother and this RN, towards the adjoining chair that mom was previously sitting and he hit the back of his head on the seat of that chair. Client is assisted to the floor and is helped to prop up his legs. 911 called and EMS dispatched. Vitals stable BP 110/70, HR 64, RR 15. Client is conscious and A & Ox3. Cold compress applied to neck and cool cloth to forehead. Cool drink provided. Mom does report that client has not eaten since breakfast. This RN, another RN, the Site Supervisor and the lead APRN wait with client until EMS arrive. After assessment by EMS, mom and client decide to transport to ER for further evaluation.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pain in arm immediately after injection. more than anticipated. Pain continuing and shooting down patient's arm with movement. Difficulty lifting arm and moving over head.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Insomnia, Muscle spasms, Myalgia, Rash macular
Clinical narrative: rash, red, blister type, started with one or two spots then spread in patches oi arms, neck, buttocks, Fatigue, muscle aches one or two days- not bad per pt, 09/29 could nt sleep , like restless leg syndrome, with cramping per patient, no fever, no nausea/ vomiting or diarrhea,
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash vesicular, Restless legs syndrome
Clinical narrative: rash, red, blister type, started with one or two spots then spread in patches oi arms, neck, buttocks, Fatigue, muscle aches one or two days- not bad per pt, 09/29 could nt sleep , like restless leg syndrome, with cramping per patient, no fever, no nausea/ vomiting or diarrhea,
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: I am a registered nurse. I have been getting the flu shot yearly and never had this happen. Since the day I received the flu shot my hips and legs are hurting terribly everyday. I have to work 12.5 hour shifts and I?m crying in pain through every shift. I know it?s the shot because around 8pm that evening my left hip started aching. Then the ache moved down my leg, then I started aching a couple days later in my right hip. Now the pain is in bilateral hips and legs. I am having trouble working. I?ve done so many things to help this pain but there is nothing. I can?t believe that I take care of patients everyday as a healthy strong nurse only to become a patient with severe pain after a shot. I can?t ever take this shot again. I am so disheartened. I need someone to help me.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: Patient has redness and swelling of the upper left arm and the redness extends to the chest area. Warmth and pain.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: Patient presented convulsions after vaccine administration
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effect; 2 month old patient inadvertently received a dose of GARDASIL 9; This spontaneous report was received from a nurse practitioner referring to a 2-month-old infant patient. His concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On 29-OCT-2019, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (batch/lot # R025729 and expiration date: 18-JUN-2021) for prophylaxis (strength, dose, unit, route and anatomical location were not reported) (wrong vaccine administered). No adverse effects were reported. The outcome of wrong product administered was unknown.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient reports that 1 day after vaccination she developed a large rash on the same arm as the injection that extended from the injection site (left deltoid) down to almost the patient's elbow, about 3 inches wide
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Dermatitis allergic, Full blood count, Hypersensitivity, Urine analysis
Clinical narrative: R hand contact dermatitis nearly healed (dermatologist Dr.) on 10/3/19. Day after flu shot, 2 allergic spots showed up on lower L leg, and R hand began worsening with allergic spots becoming more and more pronounced daily. Internist (diabetic) physician seen 10/11/19 - physical. By 10/26/19 ER visit for pronounced allergic spots up to thigh. By 10/28/19 follow-up dermatology visit for spots now on hips, buttocks, and breasts. Hypersensitivity immune response skin reaction probable.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anxiety, Burning sensation, Feeling abnormal, Limb discomfort, Muscular weakness
Clinical narrative: 24/7 Head burning sensation with intermittent tightening sensation; brain fog;  leg weakness and heaviness ;  nervousness;  high anxiety  Similar report -Adverse event VAERS ID#- 761392-1 ending in Suicide(7/10/18).    Similar reported symptoms.   [Sep 2019   LOT: NDC 49281-405-65 Sanofi Pasteur]My double Senior Dose.  Husband injected just before me, using same lot, same nurse.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nervousness, Tension headache
Clinical narrative: 24/7 Head burning sensation with intermittent tightening sensation; brain fog;  leg weakness and heaviness ;  nervousness;  high anxiety  Similar report -Adverse event VAERS ID#- 761392-1 ending in Suicide(7/10/18).    Similar reported symptoms.   [Sep 2019   LOT: NDC 49281-405-65 Sanofi Pasteur]My double Senior Dose.  Husband injected just before me, using same lot, same nurse.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Abdominal discomfort, Anxiety, Burning sensation, Dissociation, Feeling abnormal
Clinical narrative: 24/7 Head burning sensation with intermittent tightening sensation; brain fog;  leg weakness and heaviness ;  nervousness;  high anxiety  Similar report -Adverse event VAERS ID#- 761392-1 ending in Suicide(7/10/18).    Similar reported symptoms.   [Sep 2019   LOT: NDC 49281-405-65 Sanofi Pasteur]My double Senior Dose.  Husband injected just before me, using same lot, same nurse.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Headache, Influenza like illness, Limb discomfort, Memory impairment, Muscular weakness
Clinical narrative: 24/7 Head burning sensation with intermittent tightening sensation; brain fog;  leg weakness and heaviness ;  nervousness;  high anxiety  Similar report -Adverse event VAERS ID#- 761392-1 ending in Suicide(7/10/18).    Similar reported symptoms.   [Sep 2019   LOT: NDC 49281-405-65 Sanofi Pasteur]My double Senior Dose.  Husband injected just before me, using same lot, same nurse.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nasal congestion, Nervousness, Sleep disorder, Suicidal behaviour, Tension headache
Clinical narrative: 24/7 Head burning sensation with intermittent tightening sensation; brain fog;  leg weakness and heaviness ;  nervousness;  high anxiety  Similar report -Adverse event VAERS ID#- 761392-1 ending in Suicide(7/10/18).    Similar reported symptoms.   [Sep 2019   LOT: NDC 49281-405-65 Sanofi Pasteur]My double Senior Dose.  Husband injected just before me, using same lot, same nurse.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tremor
Clinical narrative: 24/7 Head burning sensation with intermittent tightening sensation; brain fog;  leg weakness and heaviness ;  nervousness;  high anxiety  Similar report -Adverse event VAERS ID#- 761392-1 ending in Suicide(7/10/18).    Similar reported symptoms.   [Sep 2019   LOT: NDC 49281-405-65 Sanofi Pasteur]My double Senior Dose.  Husband injected just before me, using same lot, same nurse.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthritis, Cerebral disorder, Feeling abnormal, Headache, Muscular weakness
Clinical narrative: 24/7 Head burning sensation with intermittent tightening sensation; brain fog;  leg weakness and heaviness ;  nervousness;  high anxiety  Similar report -Adverse event VAERS ID#- 761392-1 ending in Suicide(7/10/18).    Similar reported symptoms.   [Sep 2019   LOT: NDC 49281-405-65 Sanofi Pasteur]My double Senior Dose.  Husband injected just before me, using same lot, same nurse.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Speech disorder
Clinical narrative: 24/7 Head burning sensation with intermittent tightening sensation; brain fog;  leg weakness and heaviness ;  nervousness;  high anxiety  Similar report -Adverse event VAERS ID#- 761392-1 ending in Suicide(7/10/18).    Similar reported symptoms.   [Sep 2019   LOT: NDC 49281-405-65 Sanofi Pasteur]My double Senior Dose.  Husband injected just before me, using same lot, same nurse.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: pain, swelling, heat at injection site starting within 48 hours of injection
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Visual impairment
Clinical narrative: Patient shingles in her left eye. Patient went to emergency room and the she was refered to an eye doctor who diagnosed with her shingles. Patient is under treatment and can't see clearly with left eye.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Hypoaesthesia, Musculoskeletal stiffness, Nausea
Clinical narrative: Right arm pain, right neck stiffness, right fingertip numbness and tingling, right toe numbness and tingling, chills, sweating, waves of nausea. Started15 minutes after the injection, overall improvement but continued distal numbness and tingling of fingertips and toes on right side at 24 hours.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Right arm pain, right neck stiffness, right fingertip numbness and tingling, right toe numbness and tingling, chills, sweating, waves of nausea. Started15 minutes after the injection, overall improvement but continued distal numbness and tingling of fingertips and toes on right side at 24 hours.
Age: 78.0
Sex: F
Vaccine: FLUR4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complains of being unable to raise left arm, complains of pain from elbow to shoulder region, denies any redness or swelling at injection site. Instructed to use warm compresses or heating pad and take Ibuprofen for inflammation
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Chromaturia, Injection site pain, Pyrexia, Tremor
Clinical narrative: 5-6 hours after injection fever began.  During the night the fever reached as high as 102.9 with uncontrollable chills/shaking. vomiting began  approx 10 hours after injection.  (4x) Some time in the early morning hours fever broke and was normal (98.6) by  10 AM  Also, normal/typical soreness at injection site, slightly darkened urine(?)
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: 5-6 hours after injection fever began.  During the night the fever reached as high as 102.9 with uncontrollable chills/shaking. vomiting began  approx 10 hours after injection.  (4x) Some time in the early morning hours fever broke and was normal (98.6) by  10 AM  Also, normal/typical soreness at injection site, slightly darkened urine(?)
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: On 10/30/2019 at 06:30 the patient woke up with site reaction. Noted to be approximately 3-4cm in size with warmth and tenderness, itchiness noted. By the evening of 10/30/2019 the reaction site was 6-7cm in size circular in shape and surrounding the injection site. On 10/31/2019 the reaction site is reported to be 10-15cm in size and continues to be irritated, warm, tender, and itchy. Ibuprofen and Benadryl taken to treat. Appointment to be scheduled with PCP later today.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest pain, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Fever, shortness of breath, chest pain, body pain, dizziness,  fatigue, diarrhea, upset stomach. The patient made a visit to the physician but did not mention the treatment or  the outcome
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever, shortness of breath, chest pain, body pain, dizziness,  fatigue, diarrhea, upset stomach. The patient made a visit to the physician but did not mention the treatment or  the outcome
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Feeling hot, Headache, Influenza
Clinical narrative: Injection site pain, achy, massive headache, stomach pain, nauseous, chills, fever, hot, face swelling, eyelid swelling. Flu symptoms. Four days. 2 Alleve every eight hours did not help.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain, Pyrexia, Swelling face
Clinical narrative: Injection site pain, achy, massive headache, stomach pain, nauseous, chills, fever, hot, face swelling, eyelid swelling. Flu symptoms. Four days. 2 Alleve every eight hours did not help.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: Injection site pain, achy, massive headache, stomach pain, nauseous, chills, fever, hot, face swelling, eyelid swelling. Flu symptoms. Four days. 2 Alleve every eight hours did not help.
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Intensive care, Laboratory test, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received 1st dose of Shingrix and Flucelvax intramuscularly on each arm on October 22,2019 during a clinic at her work.  It is not known which shot was given on which arm.  Patient's right arm was really sore right after the administration.  The next day October 23, patient had to stay at home because she did not feel well and experienced a very significant seizure that evening.  She was fever free and had no prior history of seizures.  On Thursday October 24, she was admitted to hospital and was an ICU.  Her husband called on Saturday October 26 to inquire which vaccination was given on the right arm since that was the arm that was still swollen.  Pharmacist on duty inquired about patient's health.  Husband indicated that Saturday was the first day patient has become alert.  Pharmacist asked to call husband back in a couple of days to check up on patient.  Pharmacist called husband on 10/29 (Tuesday) to follow up.  Husband stated that she is a little better but right arm is still swollen.  Patient is alert and able to communicated.  She was still in the hospital and all test coming back have been normal.  The facility still do  not know what the root cause of her seizure.  I informed husband I would open up a VAERS and may be contacted for further information.  Pharmacist asked husband to reach out to the pharmacy if there was anything else we could assist with.
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Seizure
Clinical narrative: Patient received 1st dose of Shingrix and Flucelvax intramuscularly on each arm on October 22,2019 during a clinic at her work.  It is not known which shot was given on which arm.  Patient's right arm was really sore right after the administration.  The next day October 23, patient had to stay at home because she did not feel well and experienced a very significant seizure that evening.  She was fever free and had no prior history of seizures.  On Thursday October 24, she was admitted to hospital and was an ICU.  Her husband called on Saturday October 26 to inquire which vaccination was given on the right arm since that was the arm that was still swollen.  Pharmacist on duty inquired about patient's health.  Husband indicated that Saturday was the first day patient has become alert.  Pharmacist asked to call husband back in a couple of days to check up on patient.  Pharmacist called husband on 10/29 (Tuesday) to follow up.  Husband stated that she is a little better but right arm is still swollen.  Patient is alert and able to communicated.  She was still in the hospital and all test coming back have been normal.  The facility still do  not know what the root cause of her seizure.  I informed husband I would open up a VAERS and may be contacted for further information.  Pharmacist asked husband to reach out to the pharmacy if there was anything else we could assist with.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient received an influeza (FLUAD) vaccine instead of Shingrix vaccine due to pharmacist error. Patient thought she was receiving Shingrix, but when pharmacist was done giving injection, patient realized that FLUAD was given instead of Shingrix. The patient had already received her influenza vaccine at her doctor's office within the last month so this is second influenza vaccine within one month. Patient reported no adverse reaction at time of injection or to the pharmacy since the event.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: swollen arm from elbow to neck on side of injection and fever and chills for 3 days after vaccination.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Head discomfort, Headache, Injection site erythema, Injection site swelling, Muscle spasms
Clinical narrative: Headache, head pressure, aches, muscle cramps, night sweats , redness and swelling at and surrounding injection site.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Night sweats, Pain
Clinical narrative: Headache, head pressure, aches, muscle cramps, night sweats , redness and swelling at and surrounding injection site.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms, achy, chills, headache.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Biopsy skin abnormal, Lymphocytic infiltration, Oedema, Pruritus, Rash
Clinical narrative: rash with 2 lesions on left arm, one near wrist, and other near elbow. Lesion on rt forearm with 2 small bumps on rt index finger. Also has one lesion just right of umbilicus and 2 lesions on rt hip. First lesion appeared yesterday, and has gotten bigger with new lesions appearing. Reports itching, no other sx.    Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Skin lesion
Clinical narrative: rash with 2 lesions on left arm, one near wrist, and other near elbow. Lesion on rt forearm with 2 small bumps on rt index finger. Also has one lesion just right of umbilicus and 2 lesions on rt hip. First lesion appeared yesterday, and has gotten bigger with new lesions appearing. Reports itching, no other sx.    Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Nurse reported the patient received 3 doses of "HPV vaccine" on an altered dosing schedule; no adverse effects; This spontaneous report as received from a nurse refers to a 14-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 09-AUG-2010, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis(lot number, expiration date, strength, dose, frequency, route of administration were not reported). The patient received additional doses of the suspect vaccine on 01-FEB-2011 and 07-APR-2011 (also reported as the patient received 3 doses of "HPV vaccine" on an altered dosing schedule). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 27-SEP-2019, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S012246, expiration date 10-FEB-2021 (exact dose, injection site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 68 degrees Fahrenheit for 8 hours. The digital data logger was involved in recording the temperature excursion details. Administered dose of vaccine experienced the previous temperature excursion of 57 degrees Fahrenheit for 2 hours. There was no adverse effects reported.