chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site haemorrhage, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient called this morning at approximately 10am and stated she had pain in her left arm and upon taking off her Band-Aid, she saw a large amount of blood on the Band-Aid. I reassured her I didn't see much when I did give her the vaccine, but it could have occurred after she left. She stated she felt some tingling down her arm to her fingers and has pain up towards the clavicle bone (she stated more towards the muscle near the clavicle area). She stated she has no fever and there is no redness around the injection site. She described the pain around the clavicle as "tight" like a sprained ankle. I told patient she could call her primary care physician for any pain medication she needed and rehabilitation of the shoulder if needed.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Injection site erythema, Injection site paraesthesia, Injection site pruritus
Clinical narrative: Reported approximately 20-30 minutes after vaccine injection experienced facial flushing, upper extremity tingling feeling, itching and redness to injection site. Resolved by the next day. Denied shortness of breath.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: The nurse administered TDap instead of DTap.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Pain developed 3 days after injection in left upper arm. More severe than anticipated. Still experiencing significant pain near injection site. Painful just to lift arm off her lap.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; Patient received improperly stored VARIVAX; This spontaneous report was received from a certified medical assistant and refers to a 56 week old patient of unknown gender. The patient's medical history and concurrent conditions were not reported.   On 05-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # S002874, expiration date 29-JAN-2021, for prophylaxis (dose, dose number, and route were not provided). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect reported.   The temperature excursion was from 6°F to 14°F (10.2°F, multiple) for 50 minutes. There were no previous temperature excursions. Digital data logger involved.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231: US-009507513-1909USA005078: US-009507513-1909USA005119: US-009507513-1909USA005129: US-009507513-1909USA005134: US-009507513-1909USA005139: US-009507513-1909USA005220: US-009507513-1909USA005223: US-009507513-1909USA005365: US-009507513-1909USA005375: US-009507513-1909USA005424: US-009507513-1909USA005468: US-009507513-1909USA005525:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that the patient post vaccination developed shingles disease post vaccination. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The reporter agree to follow up from GlaxoSmithKline. This case has been linked with US2019AMR169849 reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Injection site pain, Tenderness
Clinical narrative: Painful lump in arm pit; Pain in her whole upper arm/ Pain at injection site; very painful to touch; This case was reported by a physician via call center representative and described the occurrence of axillary lump in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received Shingrix (intramuscular). In September 2019, 3 days after receiving Shingrix, the patient experienced axillary lump, injection site pain and tenderness. The patient was treated with levomenthol (Icy Hot Patch). On an unknown date, the outcome of the axillary lump, injection site pain and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the axillary lump, injection site pain and tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the Shingrix in right deltoid three days later physician noted the lump in the right arm pit, in the anterior aspect of her upper right arm. The lump was about one and a half to two inches in diameter. Physician states she also has injection site pain and pain in her whole upper arm. She notes the arm was still very painful to touch now.  The patient put Icy Hot pain patches on it for the last week and it helped. The whole upper arm was still sore to touch. The lump, the pain at the injection site, and upper arm pain are ongoing as of the time of this call.  The reporter consented to follow up. No further details were provided.  The physician consents to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia
Clinical narrative: Cardiac arrhythmia; This case was reported by a pharmacist via call center representative and described the occurrence of cardiac arrhythmia in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 9JG52, expiry date 27th September 2021) for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HD).   On 16th September 2019 09:26, the patient received the 1st dose of Shingrix .5 ml. On 17th September 2019, 1 days after receiving Shingrix, the patient experienced cardiac arrhythmia (serious criteria GSK medically significant). On an unknown date, the outcome of the cardiac arrhythmia was recovered/resolved.   It was unknown if the reporter considered the cardiac arrhythmia to be related to Shingrix.  Additional details were provided as follows: The patient also received Fluzone HD vaccine at the same time as Shingrix. The patient received Shingrix on left arm. The patient experienced cardiac arrhythmia.  The patient had experienced the event for 2 and half hours when the pharmacist called GSK.  The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles flare up; Rash and Shingles flare up; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received Shingrix. On 17th September 2019, 35 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   The reporter considered the vaccination failure, shingles and rash to be unrelated to Shingrix.  Additional case details were reported as follows: The patient had rash and shingles flare up after taking Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for herpes zoster were not provided.
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 3" diameter AREA of ERYTHEMA, WARMTH, & FULLNESS
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient experienced a rash/hives on the back of her neck roughly an hour or so after receiving the vaccination. She took diphenhydramine 25mg  to help with the itching, which helped to decrease the rash and itching.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient experienced a large red injection site reaction. Was warm to touch. Mildly itchy. Covered about a hand sized area of the upper arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: patient reports arm to be red, in pain, swollen. also, patient reports fever of 101
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Paraesthesia, Rash erythematous
Clinical narrative: Patient reported 9-24-19 for a flu shot and showed her left arm which had a dime sized rash on it, about 2.5 to 3 inches from top of arm. She said it tingles for alittle bit and then it hurts in that area in what she calls a nerve type pain. It lasts around thirty minutes and goes away. When the tingling comes, the rash shows up. The dime size of rash never goes away but it gets redder when the tingling happens which is followed by the pain. It happens maybe once a month.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Tinnitus
Clinical narrative: Tinnitus occurred at 0400 the day after administration. Tinnitus not accompanied by any other complaints or symptoms. No deafness. Tinnitus intermittent in nature.
Age: 43.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient presented with erythema, pain redness and rash on the area where the vaccine was administered. She has been on panadol so doesn't  know if she has been on fever. Medical evaluation was recommended as soon as possible.
Age: 67.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Injection site rash
Clinical narrative: 3-4 inch diameter rash on left arm around injection site. Not raised, itchy, or hot.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Mother called with concerns about side-effects from vaccines (nausea, dizziness).  She stated that she told her child to "sleep it off" and is checking on her periodically throughout the day.  I asked if child had high fever or unusual behavior, which mom denied. I told her that while it is not uncommon to have side effects to vaccines, that she should seek medical attention if they persist or become worse.  I asked her whether the child had a family doctor to seek attention.  Mom stated "she is fine.  Have a nice day."  That was the end of the call.  I will F/U with VAERS report.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Reported on 9-20-2019 that beginning 1-2 days after receiving flu vaccine on 9-13-2019, of gradual spread to overall torso and extremities pinhead to pinpoint sized raised reddened bumps, with slight itchiness. Stated was diagnosed by own dermatologist with "angry skin". Bumps remain 1 week after injection but diminishing.
Age: 54.0
Sex: F
Vaccine: FLUC4, HEP, PNC13, VARZOS
Symptoms: Urticaria
Clinical narrative: Severe hives reaction starting in left arm (shingrix, heplisav site) and then spreading to entire abdomen, torso, trunk.  Required visit to ED to receive prednisone, antihistamines and monitoring.  Pt did not report and other symptom and was discharged without any other incidents.  Will finish steroid course and antihistamines at home.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient is experiencing swelling and redness to the touch at and around the area of the injection site. Has been progressively getting worse since time of administration
Age: 86.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall
Clinical narrative: soon after receiving patient felt faint and fell
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: The nurse administered TDap instead of DTap
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Right after receiving the injection patient was sweaty and c/o feeling dizzy.
Age: 61.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Condition aggravated, Multiple sclerosis relapse
Clinical narrative: The patient's mother contacted pharmacy on 9/23/19 at 1:30pm to report after receiving immunizations on 9/13/19 the patient arrived home about 1 pm and was fine but at about 5pm later the same day the patient began experiencing exasperated symptoms of his M.S. According to mother, patient's neurologist was contacted on Saturday 9/14 and recommended patient proceed to hospital. The patient refused to go to the hospital until Sunday 9/15 when he was transported and hospitalized. The patient was discharged "Wednesday or Thursday" per mother.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Mother called??patient started with hives-like rash on 9/21 on the upper and lower back. No fever, no other symptoms. No changes in soaps, detergents, fabric softeners. Concerned about association with vaccine??Menactra given. No local injection site symptoms. With Benadryl, hives are dissipating.   Recommended Zyrtec 10 mg daily until rash is gone.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Magnetic resonance imaging abnormal, Tendonitis, X-ray normal
Clinical narrative: Patient received vaccination on 11/12/2018. She contacted the office on 11/19/2019 stating she was having shoulder pain in the same arm she received the vaccination. Patient was seen for follow up in the clinic. X-rays were negative. She was treated with steroids and advised if not better would consider MRI. Patient completed steroids and continued to have pain. She was sent for MRI Left Shoulder on 11/29/2018 which revealed tendonitis. Patient was given the options of Physical therapy, Orthopedic referral or treatment with oral NSAIDs. Patient requested to think it over and call back with decision. On 12/3/18 patient called back stating that she would like to see an orthopedist and a referral was started.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Mobility decreased, Myalgia
Clinical narrative: Weakness and fatigue, muscle and joint aches so bad she couldn't get up.
Age: 23.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Chest pain, Injection site rash, Peripheral swelling
Clinical narrative: left arm in which the vaccine was administered began to swell and experienced pain in her chest. Also, a rash began to develop around the injection site. Patient instructed to take Benadryl and Motrin. Instructed to go to urgent care as she later stated she has a pork allergy (gelatin in vaccine is of porcine derivate)
Age: 23.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypoaesthesia, Peripheral swelling
Clinical narrative: left arm in which the vaccine was administered began to swell and experienced pain in her chest. Also, a rash began to develop around the injection site. Patient instructed to take Benadryl and Motrin. Instructed to go to urgent care as she later stated she has a pork allergy (gelatin in vaccine is of porcine derivate)
Age: 23.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: left arm in which the vaccine was administered began to swell and experienced pain in her chest. Also, a rash began to develop around the injection site. Patient instructed to take Benadryl and Motrin. Instructed to go to urgent care as she later stated she has a pork allergy (gelatin in vaccine is of porcine derivate)
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Sleep disorder
Clinical narrative: Patient came in and showed us her arm. She had a huge bruise going 4 inches below the injection site saying that she had more pain than usual after the injection. She also stated it was hard for her to sleep on that side for a day or two after.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Burning sensation
Clinical narrative: Patient reports severe burning in mid section after 2nd Shingrix vaccination.  Patient stated it started at least 2 weeks ago (~9-1-19).  Patients primary care physician treated patient (unknown treatment) and sent him to us (pharmacy) to report to VAERS.
Age: 60.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site erythema, Injection site inflammation
Clinical narrative: On Friday 9/20/19 pt and RN discussed if pt should get varicella vaccine because pt reported having disease as a child and also having shingles as an adult so it was decided to not give and just give mmr and tdap and get blood drawn for varicella antibodies for pre-employment. When nurse went to ddraw up vaccines she grabbed the varicella instead of the mmr and worote the varicella lot # under the mmr on the inventory tracking list. Later when inventory was being counted it was found that there was 1 extra dose of mmr and short a dose of varicella and the nurse checked the lot she wrote and found it was for varicella. Pt was then contacted and she came in to get the mmr she needed. Called pt on Tues 9/24/19 and she reports she had been very ill over weekend reporting severe flu like symptoms including malaise, fatigue, nausea, body aches severe joint pain, warm, red swollen left arm at site of Varicella injection. Pt reports she took ibuprofen multiple times throughout the weekend but helped very little but does not think she ran a fever. She reports now she is feeling fine and inflammation improved at site. of injection
Age: 60.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Malaise, Nausea, Pain
Clinical narrative: On Friday 9/20/19 pt and RN discussed if pt should get varicella vaccine because pt reported having disease as a child and also having shingles as an adult so it was decided to not give and just give mmr and tdap and get blood drawn for varicella antibodies for pre-employment. When nurse went to ddraw up vaccines she grabbed the varicella instead of the mmr and worote the varicella lot # under the mmr on the inventory tracking list. Later when inventory was being counted it was found that there was 1 extra dose of mmr and short a dose of varicella and the nurse checked the lot she wrote and found it was for varicella. Pt was then contacted and she came in to get the mmr she needed. Called pt on Tues 9/24/19 and she reports she had been very ill over weekend reporting severe flu like symptoms including malaise, fatigue, nausea, body aches severe joint pain, warm, red swollen left arm at site of Varicella injection. Pt reports she took ibuprofen multiple times throughout the weekend but helped very little but does not think she ran a fever. She reports now she is feeling fine and inflammation improved at site. of injection
Age: 60.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Wrong product administered
Clinical narrative: On Friday 9/20/19 pt and RN discussed if pt should get varicella vaccine because pt reported having disease as a child and also having shingles as an adult so it was decided to not give and just give mmr and tdap and get blood drawn for varicella antibodies for pre-employment. When nurse went to ddraw up vaccines she grabbed the varicella instead of the mmr and worote the varicella lot # under the mmr on the inventory tracking list. Later when inventory was being counted it was found that there was 1 extra dose of mmr and short a dose of varicella and the nurse checked the lot she wrote and found it was for varicella. Pt was then contacted and she came in to get the mmr she needed. Called pt on Tues 9/24/19 and she reports she had been very ill over weekend reporting severe flu like symptoms including malaise, fatigue, nausea, body aches severe joint pain, warm, red swollen left arm at site of Varicella injection. Pt reports she took ibuprofen multiple times throughout the weekend but helped very little but does not think she ran a fever. She reports now she is feeling fine and inflammation improved at site. of injection
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Formication, Pruritus
Clinical narrative: Pt. vaccinated  with the Flu vaccine on 9/23/2019 at 1515, noted itching and "skin crawling" in all her extremities and stomach at approximately 2230 symptoms continued through the night and until the next morning.  Denies any visible rash.  Reported to Occupational Heath the next morning 9/24/2019.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: After receiving vaccines patient fainted for approx. 5-10 seconds. Client was assisted to lying position. Client quickly started talking and following at commands. Vital sign: B/P=112/71, HR=53, pulse ox 99%. Client given water and snack. Client stated he was nervous and was holding his breath. 2nd set of Vital signs taken 10 minutes after 1st set: B/P=10/68, HR=50, pulse ox=99%.  Mother present and child left with mother.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Diarrhoea, Laboratory test, Pain in extremity, Pyrexia
Clinical narrative: Deep pain in right arm, Diarrhea, up set stomach, vomiting, fever.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Deep pain in right arm, Diarrhea, up set stomach, vomiting, fever.
Age: 81.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Contusion, Hyperaesthesia, Pruritus, Rash, Skin irritation
Clinical narrative: Large rash developed with bruising in the center. Patient reports sensitivity on skin as well as slightly irritation and itchiness.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Loss of consciousness, Syncope, Tension, Tremor
Clinical narrative: Patient said about a minute after receiving vaccine that she felt like she was going to faint. She put her head down and then fainted. I caught her and lowered her to ground. She tensed up and shook a little and was unconscious. I called 911 and she became conscious in less than a minute. Paramedics arrived and took over.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient reported redness, swelling, and itching below the injection site that developed 3 days after the vaccination.  She stated that she took Benadryl for the symptoms.  2 days later, the redness and swelling subsided, but some itching remained if she did not take the Benadryl.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: Patient reported redness, swelling, and itching below the injection site that developed 3 days after the vaccination.  She stated that she took Benadryl for the symptoms.  2 days later, the redness and swelling subsided, but some itching remained if she did not take the Benadryl.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pruritus, Rash, Skin warm
Clinical narrative: Patient reported redness, swelling, and itching below the injection site that developed 3 days after the vaccination.  She stated that she took Benadryl for the symptoms.  2 days later, the redness and swelling subsided, but some itching remained if she did not take the Benadryl.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Patient reported redness, swelling, and itching below the injection site that developed 3 days after the vaccination.  She stated that she took Benadryl for the symptoms.  2 days later, the redness and swelling subsided, but some itching remained if she did not take the Benadryl.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Paraesthesia
Clinical narrative: Tingling in all limbs and both hands and feet. Parenthesis in both hands and feet
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: no initial reaction.  24 hours post vaccination bruising present at injection site spreading to swelling which spread from the shoulder to the elbow.  patient stated the entire surface of the arm was raised, red and swollen.  1 week after there is no residual swelling and minor bruising left.  no bursitis, no tingling, no pain currently.  injection site based on bruised area was correct.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Feeling of despair, Nausea
Clinical narrative: PATIENT stated she experienced nausea, vomiting, dizziness, joint ache, tachycardia, blurred vision, chills, she stated she wanted to die
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Vision blurred, Vomiting
Clinical narrative: PATIENT stated she experienced nausea, vomiting, dizziness, joint ache, tachycardia, blurred vision, chills, she stated she wanted to die
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose normal, Dry mouth, Exposure during pregnancy, Feeling abnormal, Headache
Clinical narrative: I was given the shot at approximately 8:30 am. I left the clinic and was driving home. At approximately 8:45 am, I had to pull over because I felt very drowsy. As soon as I pulled over, I got very tingly and blacked out. I?m unsure how long I was unconscious. I woke up and I decided to try to make it home. I parked in the parking lot at my apartment building where I blacked out again, this time having severe shakes. I managed to take a Zofran as I felt like I was going to vomit. I called 911 because I kept falling in and out of unconsciousness. I managed to tell the dispatcher where I was at and what car I was in, but again, I fell unconscious. I woke up to paramedics banging on my car windows because my car door was locked. I unlocked it before starting to pass out again. My blood sugar and blood pressure was taken. My blood sugar was 96, and I cannot remember my blood pressure. I had a weak pulse so they had to use a stethoscope to take my pulse. I do not remember what my pulse was either. I cannot afford a hospital visit so I asked the paramedics to just take my to my bedroom, and help me lie down. I have been in bed since. During these black out events, I was tingling all over my body, I could hear - but it sounded like I was underwater, I had very dry mouth and I was very sick to my stomach. As of right now, it?s been 7 hours since receiving the vaccine and I have a strong headache, and feel generally unwell and lethargic. I am 26 weeks pregnant with an expected due date of December 26th, 2019. I have not noticed any issues with my baby. He is moving around normally.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Loss of consciousness, Malaise, Nausea, Paraesthesia
Clinical narrative: I was given the shot at approximately 8:30 am. I left the clinic and was driving home. At approximately 8:45 am, I had to pull over because I felt very drowsy. As soon as I pulled over, I got very tingly and blacked out. I?m unsure how long I was unconscious. I woke up and I decided to try to make it home. I parked in the parking lot at my apartment building where I blacked out again, this time having severe shakes. I managed to take a Zofran as I felt like I was going to vomit. I called 911 because I kept falling in and out of unconsciousness. I managed to tell the dispatcher where I was at and what car I was in, but again, I fell unconscious. I woke up to paramedics banging on my car windows because my car door was locked. I unlocked it before starting to pass out again. My blood sugar and blood pressure was taken. My blood sugar was 96, and I cannot remember my blood pressure. I had a weak pulse so they had to use a stethoscope to take my pulse. I do not remember what my pulse was either. I cannot afford a hospital visit so I asked the paramedics to just take my to my bedroom, and help me lie down. I have been in bed since. During these black out events, I was tingling all over my body, I could hear - but it sounded like I was underwater, I had very dry mouth and I was very sick to my stomach. As of right now, it?s been 7 hours since receiving the vaccine and I have a strong headache, and feel generally unwell and lethargic. I am 26 weeks pregnant with an expected due date of December 26th, 2019. I have not noticed any issues with my baby. He is moving around normally.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Pulse abnormal, Somnolence, Tremor
Clinical narrative: I was given the shot at approximately 8:30 am. I left the clinic and was driving home. At approximately 8:45 am, I had to pull over because I felt very drowsy. As soon as I pulled over, I got very tingly and blacked out. I?m unsure how long I was unconscious. I woke up and I decided to try to make it home. I parked in the parking lot at my apartment building where I blacked out again, this time having severe shakes. I managed to take a Zofran as I felt like I was going to vomit. I called 911 because I kept falling in and out of unconsciousness. I managed to tell the dispatcher where I was at and what car I was in, but again, I fell unconscious. I woke up to paramedics banging on my car windows because my car door was locked. I unlocked it before starting to pass out again. My blood sugar and blood pressure was taken. My blood sugar was 96, and I cannot remember my blood pressure. I had a weak pulse so they had to use a stethoscope to take my pulse. I do not remember what my pulse was either. I cannot afford a hospital visit so I asked the paramedics to just take my to my bedroom, and help me lie down. I have been in bed since. During these black out events, I was tingling all over my body, I could hear - but it sounded like I was underwater, I had very dry mouth and I was very sick to my stomach. As of right now, it?s been 7 hours since receiving the vaccine and I have a strong headache, and feel generally unwell and lethargic. I am 26 weeks pregnant with an expected due date of December 26th, 2019. I have not noticed any issues with my baby. He is moving around normally.
Sex: M
Vaccine: MMR, UNK
Symptoms: Expired product administered
Clinical narrative: This pharmacist reports giving the patient the MMR II vaccine which was reconstituted with expired diluent; Route: Subdermic; This spontaneous report was received from a pharmacist and refers to a 59 year old male patient. The patient's past medical history, concurrent conditions and concomitant medications were unknown. On 30-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot # M044952 (expiration date not reported), subdermally for prophylaxis. The vaccine was reconstituted with an expired sterile diluent.  Lot numberM044952 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation, referring to a male pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In 2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a physician office for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was considered as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In or about 2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a physician at a medical center for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a physician office for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was considered as not recovered. The lawyer considered herpes zoster be related to zoster vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: MMR, UNK
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: pregnant when she received a dose of MMR Il; This spontaneous retrospective pregnancy report was received from a nurse regarding a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, when the patient was pregnant, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route of administration, lot number and expiration date were not reported) for prophylaxis (exposure during pregnancy). The vaccine was reconstituted with a sterile diluent. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was unknown. On an unknown date, the patient delivered a child (live birth). The child had unspecified developmental delays. The outcome of exposure during pregnancy was recovered.  This case is cross referenced with 1909USA008792 (child case).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The patient received a dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.     On 19-SEP-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), via subcutaneous for vaccination lot number S013715 and expiration date 01-NOV-2020 (strength, dose and frequency) (product storage error). The vaccine was reconstituted with Merck sterile diluent that did not experience a temperature excursion (lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion range of 6°F to 14°F(14F) for 3 hours and a range of range of 15°F to 46°F (27F) for 11 hours. The vaccine experienced a previous temperature excursion of 15°F to 46°F (38F) for 51 hours.  There was no adverse effect reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: Developmental delay, Foetal exposure during pregnancy
Clinical narrative: the child has unspecified developmental delays; patient was pregnant when she received a dose of MMR Il. Patient gave birth to a child; This spontaneous report was received from a nurse regarding a child patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The mother of the patient was pregnant. Her last menstrual period (LMP) and Estimated date of delivery (EDD) was not reported. On an unknown date, when the mother of the patient was pregnant, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, lot number and expiration date unknown) and the patient was exposed to the vaccine via transplacental route (foetal exposure during pregnancy). The vaccine was reconstituted with a sterile diluent. On an unknown date, the child was born and had some unspecified developmental delays. The outcome of developmental delay was unknown. The outcome of foetal exposure during pregnancy was recovered.   This case is cross referenced with 1909USA006681 (mother case).
Sex: F
Vaccine: RAB, UNK
Symptoms: Extra dose administered, Product administered at inappropriate site
Clinical narrative: was given HRIG in one gluteal muscle, rabies vaccine is not recommended to be administered in the gluteal muscle; On 22 Jul 2019, the patient was given HRIG and in one gluteal muscle and rabies vaccine; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient of unknown age who was vaccinated with a dose of HUMAN RABIES IMMUNOGLOBULIN [HUMAN ANTIRABIES IMMUNOGLOBULIN] and RABIES VACCINE (lot number and exp. Date not reported) in the gluteal muscle on 22-Jul-2019  for animal bite as patient's rabies exposure consists of saliva exposure to mucus membrane (no wound).  The patient's medical history not reported.  It was an actual medication error case due to vaccine administered at inappropriate site and Extra dose administered.  It was reported that, the hospital then decided that the first dose of HRIG that was administered to the patient was invalid, for a reason that was not clear. It might have been that since rabies vaccine is not recommended to be administered in the gluteal muscle they thought that HRIG should not be administered in the gluteal muscle either, or since HRIG and rabies vaccine should be administered distant to one another that the two gluteal muscles were not distant enough. Hence as corrective on the same evening (22 Jul 2019) they administered a second dose of HRIG in the patient's left and right thighs.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: one patient received expired ActHIB/ No AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA242256 same reporter.  This case involves a 15 months old female patient who received 0.5 mL dose of expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] Lot UI859AAA via intramuscular route in the right thigh on 26-Jan-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysarthria, Feeling abnormal, Hypoaesthesia
Clinical narrative: side of her face went numb; she woke up and felt funny; wanted to say but the words would not come out right; feel dizzy and faint; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 25 years old female patient who experienced side of her face went numb (hypoaesthesia), feel dizzy and faint (dizziness), she woke up and felt funny (feeling abnormal) and wanted to say but the words would not come out right (dysarthria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant therapies were reported.  In January 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious side of her face went numb (hypoaesthesia), feel dizzy and faint (dizziness), she woke up and felt funny (feeling abnormal) and wanted to say but the words would not come out right (dysarthria), unknown latency, following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was wanted to say but the words would not come out right, she woke up and felt funny, feel dizzy and faint and side of her face went numb.   It was not reported if the patient received a corrective treatment. The patient sat with her head between her legs for a couple of minutes and she felt better  The patient outcome is reported as Unknown for side of her face went numb, she woke up and felt funny and for wanted to say but the words would not come out right and as recovering for feel dizzy and faint.  List of document held: none; Sender's Comments: This case involves a 25 years old female patient who experienced syncope, numbness in face and dizziness after vaccination. Exact time to onset was unknown. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Daptacel was inadvertently administered to a patient, no adverse event; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who was vaccinated with a dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5202AA and Exp. Date May-2019) on an unknown date.   The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was not reported at the time of reporting whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Fluzone Quadrivalent pre-filled 0.5mL syringes were administered that was delayed in transit, no AE; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked with 2019SA265062 (18 month old patient administered with another dose).  This case involves a 2 years old female patient who received 0.5 ml dose vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6645LA, expiry date:30-Jun-2020) via intramuscular route in the left thigh), on 13-Sep-2019 which was delayed in transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Incorrect product storage.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: receiving an expired dose of Fluzone Quadrivalent; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 63 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that receiving an expired dose of Fluzone Quadrivalent (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-Sep-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UI996AB and expiry date: 30-Jun-2019 via intramuscular route in the right deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none