chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Abortion induced, Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report as received from a registered nurse refers to a 26 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient had no drug reactions/allergies. On 20-JUL-2018, the patient was vaccinated with GARDASIL 9 (Strength, dose and anatomical location were not reported) of lot # N022952 with an expiry date of 14-JUN-2020, intramuscularly for prophylaxis. It was mentioned that the pregnant patient was inadvertently administered with the vaccine. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not known. It was reported that it could not be further clarified if the patient terminated her pregnancy prior to or after the appointment. It was unknown if treatment was provided to the patient. It was unknown if lab diagnostics/studies were performed. The patient did not seek any medical attention. There was no product quality complaint involved. The outcome of the event of abortion was considered to be recovered on an unknown date in 2018. The causality assessment was not provided. Upon internal review, the event of abortion was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 18 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-AUG-2018, the patient inadvertently received adult dose (1 ml) of VAQTA instead of pediatric dose (0.5 ml) lot # N032753, expiration date 23-MAR-2019, intramuscularly for prophylaxis. No adverse effects were reported.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stool.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Bone pain, Chills, Feeling abnormal
Clinical narrative: Several hours after both the first and second vaccines, I started shivering and felt chills. Then symptoms included 102 + fever, muscle aches, bone and tooth aches, sick feeling and achy stomach, pounding headache, muscle weakness, feeling "foggy", similar to a hangover type of feeling. Most symptoms lasted for about a day and a half. Headaches, fogginess, and weakness lasted for an additional 2 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Several hours after both the first and second vaccines, I started shivering and felt chills. Then symptoms included 102 + fever, muscle aches, bone and tooth aches, sick feeling and achy stomach, pounding headache, muscle weakness, feeling "foggy", similar to a hangover type of feeling. Most symptoms lasted for about a day and a half. Headaches, fogginess, and weakness lasted for an additional 2 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Toothache
Clinical narrative: Several hours after both the first and second vaccines, I started shivering and felt chills. Then symptoms included 102 + fever, muscle aches, bone and tooth aches, sick feeling and achy stomach, pounding headache, muscle weakness, feeling "foggy", similar to a hangover type of feeling. Most symptoms lasted for about a day and a half. Headaches, fogginess, and weakness lasted for an additional 2 days.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Blood glucose normal, Dyskinesia, Eye movement disorder, Pallor, Unresponsive to stimuli
Clinical narrative: Around 4:45 PM, I administered PPd injection, IPV, Hep B, MMR, VZV, TDaP, Hep A, MENACTRA, vaccines as requested by physician. During the 7th vaccine (MENACTRA) patient eyes rolled back, he became pale, he was not able to verbalize, he lost control of his upper body, and began to have body jerking. I advised LPN to call the physician. I placed an alcohol pad underneath his nostrils and he quickly opened his eyes and began to become responsive. Patient was assisted to the exam bed and feet were elevated. Multiple doctors evaluated patient. Vital signs were taken; Temp 98.5, Pulse 62, Resp 22, Pulse oximeter 99%, B/P 100/60, glucose 118. Patient was monitored for 30 mins (until 5:30 PM).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Muscular weakness
Clinical narrative: Within 4 hours of the vaccine patient reported very painful arm to the point she could not lift shoulder. Throughout the evening she reported Headache, uncontrollable shivering, fatigue, muscle weakness, and nausea. She also has a fever of 100.0 2 hours after 400 mg of ibuprofen.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Within 4 hours of the vaccine patient reported very painful arm to the point she could not lift shoulder. Throughout the evening she reported Headache, uncontrollable shivering, fatigue, muscle weakness, and nausea. She also has a fever of 100.0 2 hours after 400 mg of ibuprofen.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 20 year old patient received the 0.5 mL Hep A dose and not the 1mL Hep A dose.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Tenderness
Clinical narrative: The patient states she has redness, swelling, itching, soreness, and tenderness from her shoulder down to her elbow. She says she feels like it is an allergic reaction. I called Merck and asked if this was a normal reaction. Merck said that it is rare but some people do get more than localized swelling near the injection site. I explained this to the patient and advised her to call her MD to get in to see him so that he can take a look at it. I also told her to ice the area while she was waiting for the MD to call her back. She said she would call her MD immediately.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site erythema
Clinical narrative: Pt experienced extensive bruising in the deltoid region, pt also had a flare up (visible redness) at sites of previous shingles outbreak along the left arm and the right side just below the waist. No signs of blisters....pt taking acetaminophen for pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Muscle swelling
Clinical narrative: Patient reports ongoing joint pain, and muscle swelling.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Immune system disorder, Myalgia, Pain
Clinical narrative: Redness and swelling; Muscle pain; Body Ache; Immune system responses; Headache; Fever.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Redness and swelling; Muscle pain; Body Ache; Immune system responses; Headache; Fever.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Headache, Pain, Pain in extremity
Clinical narrative: The following day very early I wake up with lots of fever 102 and 103 I felt terrible lots of aching in my whole body, headache, redness on my arm and pain. The fever last 24h but the pain on my arm more than a week it was terrible believe me I am thinking on the second doses, also swelling on my arm.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: The following day very early I wake up with lots of fever 102 and 103 I felt terrible lots of aching in my whole body, headache, redness on my arm and pain. The fever last 24h but the pain on my arm more than a week it was terrible believe me I am thinking on the second doses, also swelling on my arm.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Patient says she had a small cold sore in the corner of her mouth. It does not cause any pain but appeared a few days after getting the vaccine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Hemiparesis, Hypoaesthesia
Clinical narrative: Left sided weakness, facial numbness and facial droop.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Dyspnoea, Paraesthesia oral, Visual field defect
Clinical narrative: Almost immediately after vaccination, patient reported dizziness ("seeing stars"), so I (pharmacist) grabbed water and had her remain seated. Upon return with water, patient reported tingling in the lips and trouble breathing so I called 911. While on the phone with the dispatcher, I grabbed an epinephrine auto-injector but I did not use it as the patient reported feeling better (tingling in lips had stopped and breathing was not as difficult), although she did mention severe sharp back pain. When EMTs arrived she reported feeling OK but before they left she seemed to decline and was having trouble breathing again and felt faint.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Severe shaking, headache, fever, nausea, exhaustion lasted for 3 days and still felt ill, but improved, on the 4th day.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Severe shaking, headache, fever, nausea, exhaustion lasted for 3 days and still felt ill, but improved, on the 4th day.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Dermatitis allergic, Pruritus, Rash
Clinical narrative: The patients arms developed raised rashes above and below both elbows. He experienced itching and blisters. It presents like allergic dermatitis. Upon visiting his physician, he was told it could be related to the vaccine. His symptoms presented the same day he received the vaccine.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Limb discomfort, Rash pruritic, Rash vesicular
Clinical narrative: The patients arms developed raised rashes above and below both elbows. He experienced itching and blisters. It presents like allergic dermatitis. Upon visiting his physician, he was told it could be related to the vaccine. His symptoms presented the same day he received the vaccine.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Pt was given an pneumonia 23 08/07/18. He last pneumonia vaccine was in 2016. She accumulated a localized reaction around 5 PM.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: For both vaccinations of SHINGRIX, patient reported fever and chills within 6 hours of vaccination and lasting about 24 hours with full recovery thereafter.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Deafness
Clinical narrative: Patient came in about a week after injections and stated that since the event, she was have intermittent hearing loss in one or both of the ears. She said it was just essentially stuffy but it would come and go. She did decide to try some OTC products due to not being able to see her doctor until the following week.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Drooling, Mental status changes, Seizure, Trismus, Unresponsive to stimuli
Clinical narrative: Patient developed mental status changes within 5 minutes of vaccine administration. Unable to verbally respond to questions and unusual jaw movements progressing to complete unresponsiveness, drooling and eventual convulsions. Epi-pen was administered 15 mins after symptoms developed to right thigh.  From time of immunization to EMS transport to hospital approx 20 mins.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Delirium, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Very sore arm the morning following injection. Two hours after awakening mild flu like symptoms (headache, lethargy). Normal routine interrupted by intermittent sleep. Headache remained through the day. Later the evening following injection major flu like symptoms appeared including significant headache. Delirium interrupted sleep for 12 hours. Hot and cold sweats. Awakened next morning somewhat improved, still have minor headache with sharp pain when I cough. Injection site pain substantially improved, no external signs present (rash, etc.).
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Pain, Pain in extremity
Clinical narrative: Very sore arm the morning following injection. Two hours after awakening mild flu like symptoms (headache, lethargy). Normal routine interrupted by intermittent sleep. Headache remained through the day. Later the evening following injection major flu like symptoms appeared including significant headache. Delirium interrupted sleep for 12 hours. Hot and cold sweats. Awakened next morning somewhat improved, still have minor headache with sharp pain when I cough. Injection site pain substantially improved, no external signs present (rash, etc.).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Injection site pain, Nausea, Pyrexia
Clinical narrative: About 24 hours later, had high fever and nausea. For fever used ice packs on head and chewing ice; fever reduced. Nausea continued until 11pm; had some pretzels to settle stomach. Contacted pharmacist who reviewed literature and confirmed symptoms were common. Symptoms resolved completely. There were no problems after 1st dose; just expected pain at site.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom returned from the parking lot of our office to show me his right leg, 5 minutes after receiving vaccinations. Right lateral thigh found to be red, hot, firm for approximately a 4-inch circular area surrounding the site of Varicella. Child did not appear to be in discomfort and was not crying, agitated or favoring his right leg. Mom asked if this could be a hive. It did not seem to be a hive as evidenced by lack of a distinct area in the middle; it was a consistent large swollen, erythemic area. Instructed mom to administer Children's dose of Tylenol (by weight) and apply a cold compress to the area when they get home. She was to monitor him for signs of worsening of the leg and for fever or issues with breathing. If these occur she will call 911 or take him to the nearest ER or UCC. Mom acknowledged understanding and left about 1 minute later. I have left follow-up voicemail messages for mom on Monday, 8/6, and today, 8/8, with no return call. The child is scheduled to return to our clinic for a 4th dose Pentacel on 8/24/18.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Myoclonus, Seizure, Urinary incontinence
Clinical narrative: Within 1-2 minutes of receiving vaccine teen became unconscious, had myoclonic jerking of supper extremities and was incontinent to urine. Lasted about 30s and then recovered quickly.
Age: 22.0
Sex: M
Vaccine: HEPA, HPV9, TDAP
Symptoms: Feeling abnormal, Hyperhidrosis, Immediate post-injection reaction, Laboratory test, Pallor
Clinical narrative: Pt was given three vaccines. As I pulling needle out of arm on third vaccine, he instantly started to look pallor and stated "I feel weird" and his head started to tilt downward. He started to become diaphoretic and would not talk back to me. Cracked ammonia and pt came back to. Pt layed down and was given juice and crackers. BP was 100/50. After monitoring, pt stated he feels much better. BP rechecked upon leaving and was 110/68. Patient advised that he will need to lay down for further injections. He understands.
Age: 22.0
Sex: M
Vaccine: HEPA, HPV9, TDAP
Symptoms: Posture abnormal, Unresponsive to stimuli
Clinical narrative: Pt was given three vaccines. As I pulling needle out of arm on third vaccine, he instantly started to look pallor and stated "I feel weird" and his head started to tilt downward. He started to become diaphoretic and would not talk back to me. Cracked ammonia and pt came back to. Pt layed down and was given juice and crackers. BP was 100/50. After monitoring, pt stated he feels much better. BP rechecked upon leaving and was 110/68. Patient advised that he will need to lay down for further injections. He understands.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Dizziness, Dysstasia, Loss of personal independence in daily activities, Nausea
Clinical narrative: This was my second new shingles shot. I had the old one a year ago. I spiked a fever of 101 for 7 hours. I was so dizzy I could not stand. Bedridden. Nauseous. One second day still not good. Third day better. Arm very sore but i expected that. This totally prevented me from doing regular activities.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This was my second new shingles shot. I had the old one a year ago. I spiked a fever of 101 for 7 hours. I was so dizzy I could not stand. Bedridden. Nauseous. One second day still not good. Third day better. Arm very sore but i expected that. This totally prevented me from doing regular activities.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Injection site pain, Pain
Clinical narrative: Severe pain at injection site. YOUR information reads to give in large muscle. MY DELTOID is not large. I weigh less than 110lbs. YOU should define "LARGE" so pharmacist administering shot know NOT to give in arm if deltoid is small. Pain felt like muscle being ripped. Pain radiated around arm DOWN laterally to abdomen. NEVER felt such pain before - even more severe than the immunoglobulin serum given in buttocks.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING, REDNESS ON THE RIGHT SIDE OF THIGH.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Loss of consciousness, Pallor
Clinical narrative: Pt became pale and complained of a headache and passed out for approx. 10 seconds during vaccine administration.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site urticaria
Clinical narrative: Left leg hives from top to bottom of leg, right leg hives from thigh to knee. Patient went to urgent care.  Started on 3 day course of prednisone.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Swelling, soreness, hardness, redness and heat at injection site and 3 inches all around, increasing until very severe at 24 hours after injection, and diminishing slowly. At 5 days after injection the skin is still red and slightly sore to touch, but the underlying tissue is no longer hard, and the injection site no longer feels hot. In addition to the injection site reaction, I had a severe headache requiring alternating ibuprofen and acetaminophen for 3 days. Also, fatigue and muscle languor lasting 3 days. These side effects took me by surprise because I has no reactions all to initial dose, not even skin redness.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Muscle fatigue
Clinical narrative: Swelling, soreness, hardness, redness and heat at injection site and 3 inches all around, increasing until very severe at 24 hours after injection, and diminishing slowly. At 5 days after injection the skin is still red and slightly sore to touch, but the underlying tissue is no longer hard, and the injection site no longer feels hot. In addition to the injection site reaction, I had a severe headache requiring alternating ibuprofen and acetaminophen for 3 days. Also, fatigue and muscle languor lasting 3 days. These side effects took me by surprise because I has no reactions all to initial dose, not even skin redness.
Age: 35.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Lymphadenopathy, Oedema, Tenderness
Clinical narrative: Pt with significant erythema and edema involving right upper extremity chest and neck with subclavicular, axillary and anterior right cervical lymphadenopathy and tenderness.
Age: 35.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site rash, Injection site swelling, Lymph node pain, Rash, Swelling
Clinical narrative: Pt with significant erythema and edema involving right upper extremity chest and neck with subclavicular, axillary and anterior right cervical lymphadenopathy and tenderness.
Age: 35.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Lymphadenopathy, Oedema, Tenderness
Clinical narrative: Rt arm swollen and heavy rash that carried into the rt clavical to mid-sternum. Pain in the lymph nodes on the affected areas.
Age: 35.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site rash, Injection site swelling, Lymph node pain, Rash, Swelling
Clinical narrative: Rt arm swollen and heavy rash that carried into the rt clavical to mid-sternum. Pain in the lymph nodes on the affected areas.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms- Day 1 was the worst with fever and flu-like symptoms, symptomsare improving but have not resolved completely as of AM of 8/8/18 (no fever but still feeling run down, etc).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-JUL-2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On or about 17-MAY-2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed acyclovir and tramadol for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse supervisor and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 02-AUG-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M034857 and expiration date 27-JUL-2018, for prophylaxis (dose, strength, and route of administration were unknown). The patient experienced no adverse events. The doses were supported per post expiry memo. This is one of 2 cases from the same reporter. Sender's Comments: US-009507513-1808USA003414.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse supervisor and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 02-AUG-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M034857 and expiration date 27-JUL-2018, for prophylaxis (dose, strength, and route of administration were unknown). The patient experienced no adverse events. The doses were supported per post expiry memo. This is one of 2 cases from the same reporter. Sender's Comments: US-009507513-1808USA002314.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a Four-years old female patient who was administered vaccine subcutaneously instead of IM, no AE. She received Quadracel. This was the case of actual medication error due to inappropriate route of vaccination. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccination was given. On 24-Jul-2018, the patient received a dose of 0.5 ml of suspect Quadracel lot C5248AA, exp date not reported, via subcutaneous route in unknown administration site. The patient did not experience any event. Lab data and corrective treatment: not applicable. Event outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a four-years old male patient who was administered QUADRACEL twice. This was the case of actual medication error due to extra dose administered. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccination was given. On 25-Jul-2018, the patient received a fifth dose of 0.5 ml of suspect QUADRACEL lot C5248AA, exp date: 21-Aug-2019, via unknown route in unknown administration site. On 27-Jul-2018 the patient again received a dose of QUADRACEL lot C5248AA, exp date: 21-Aug-2019, via unknown route in unknown administration site. It was not reported if the patient experienced any adverse event. This was medication error case. Lab data and corrective treatment: not applicable. Event outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited non-serious case received from a consumer/non-healthcare professional (market research). This case involves a patient (age in between 50-64 and gender was not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number, expiry date, route and site of administration were unknown) on an unknown date. The patients medical history and concomitant medication were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration since FLUZONE HIGH DOSE is indicated only for patients aged 65 plus. It was unknown if patient experienced any adverse events following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a nurse on 31-Jul-2018. This case is linked to 2018SA212665, 2018SA212627, 2018SA212638 and 2018SA212648 (Same reporter). This case involves a 15-month old male patient who was vaccinated with fourth dose of PENTACEL (Batch number: C5529AA, expiration date: 04-Oct-2019) via unknown route in unknown administration site on 24-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a lyophilized powder portion of ACT-HIB that was not given from a box of 5 single doses of PENTACEL and the reporter was unsure which one of the 5 patients who received doses from this lot didn't get the ACTHIB portion. It was reported that the patient had no reaction. 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: U
Vaccine: DTAP, DTAPIPVHIB, HIBV, IPV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 01-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 15 months old patient who received vaccines POLIO VACCINE, ACT-HIB, PENTACEL and DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 01-Aug-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route. On 01-Aug-2018, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route. On 01-Aug-2018, the patient received a dose of suspect POLIO VACCINE not produced by Sanofi Pasteur lot number not reported. On 01-Aug-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. It was a case of actual medication error due to extra dose administered. It was unknown whether 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.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (Office staff). This case involves a 4 months old male patient who experienced expired PENTACEL is given, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE for Immunisation; and PREVNAR for Immunisation. On an unknown date, the patient received 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5389AA (expiry date: 17-JUL-2018) via unknown route in left leg. It was a case of actual medication error due to expired vaccine used. It was unknown whether 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.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 6 years old female patient who received an expired dose of vaccine DAPTACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 02-Aug-2018, the patient inadvertently received a 0.5 ml single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5014BA as fifth dose in series. It was a case of actual medication error due to Expired vaccine used. It was unknown whether 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 holders 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Child patient (age and gender not reported), who was vaccinated with an expired dose of ACT-HIB (expiry date: 28-Jun-2018, batch number, dose, dose in series, route and site of administration were not reported) 02 Aug 2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Age: 10.0
Sex: U
Vaccine: TD
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 10 years old patient who was vaccinated with a 0.5 ml dose of Diphtheria and Tetanus Toxoids, Pediatric (DT) (Diphtheria Tetanus Toxoids Adsorbed) (batch number, expiry date, dose in series, route and site of administration were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the 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. Documents held by sender: none   .
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Product preparation error
Clinical narrative: Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old male patient who was vaccinated with 0.5 ml  ACTHIB (lot number: UI904AA) in intramuscular route in left thigh on 01 Aug 2018. The patients past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included VARIVAX II for Immunisation. It was an actual medication error due to wrong solution used in drug reconstitution (product preparation error) as box of diluent confused and mixed the hib with sterile water instead of the diluent. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient was seen for her annual exam 2 days ago. She was given PNEUMOVAX at that visit. The following day she developed redness, warmth, and swelling of her left upper arm. She also had a low grade fever yesterday morning. She has been taking acetaminophen.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Lethargy, Neck pain, Pyrexia
Clinical narrative: First arm pain at site, then the next early AM fever and as the day progressed, headache, neck ache, lethargy, fever 100-101.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal
Clinical narrative: Patient reports received PNEUMOVAX 3 days ago on 7/31. He felt very "wiped out." About 48 hours after the vaccine, he developed redness of upper arm. He denies fever. He outlined the area of redness. Today, it has significantly improved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Muscle ache, warm, red and puffy at injection site. Patient also felt clammy and cold.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: 102 F fever and rash developed around mid arm. Also a rash new vaccine injection site.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis
Clinical narrative: Awoke in the night with very heavy sweating, soaked pajamas and bedding. Only one episode. Gone the next day. No abiding fever or other symptoms.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: One week after administration of Tdap, right arm became red, swollen, raised, warm and sore. Treatment was sought at a walk in clinic and KEFLEX was prescribed with a diagnosis of cellulitis.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Later that night, vaccination area was hurting and red. The next day vaccine area hot and getting a fever. By night fever was 101; took 2 TYLENOLS. On Saturday, fever continued went to ER. At ER, examined by NP first then doctor marked the vaccination spot (3x5) to see if it extended. Given KEFLEX (500mg 3 x day) for possible cellulitis. Fever went down and spot never grew bigger. Two days later the symptoms (pain/heat) at vaccination site resolved. Patient will complete antibiotic dose although symptoms have resolved already. Patient did not contact doctor yet. Patient reports no problems after first dose of SHINGRIX vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Later that night, vaccination area was hurting and red. The next day vaccine area hot and getting a fever. By night fever was 101; took 2 TYLENOLS. On Saturday, fever continued went to ER. At ER, examined by NP first then doctor marked the vaccination spot (3x5) to see if it extended. Given KEFLEX (500mg 3 x day) for possible cellulitis. Fever went down and spot never grew bigger. Two days later the symptoms (pain/heat) at vaccination site resolved. Patient will complete antibiotic dose although symptoms have resolved already. Patient did not contact doctor yet. Patient reports no problems after first dose of SHINGRIX vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Later that night, vaccination area was hurting and red. The next day vaccine area hot and getting a fever. By night fever was 101; took 2 TYLENOLS. On Saturday, fever continued went to ER. At ER, examined by NP first then doctor marked the vaccination spot (3x5) to see if it extended. Given KEFLEX (500mg 3 x day) for possible cellulitis. Fever went down and spot never grew bigger. Two days later the symptoms (pain/heat) at vaccination site resolved. Patient will complete antibiotic dose although symptoms have resolved already. Patient did not contact doctor yet. Patient reports no problems after first dose of SHINGRIX vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient had cellulitis. She went to hospital and was given KEFLEX.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient had cellulitis. She went to hospital and was given KEFLEX.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient had cellulitis. She went to hospital and was given KEFLEX.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: The patient states he is still having joint pain at the arm and shoulder. He explained it as pain the joint and not the muscle.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Epistaxis, Gingival bleeding, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Patient had notable bruising and nose/gum bleeding the week of December 11, 2017 (2 weeks prior to a scheduled tonsillectomy). Patient CBC w/ Diff noted below. Treatments have been WinRho et IVIG.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Muscle rigidity
Clinical narrative: About 4 minutes after the patient received the vaccination, they began to show signs of unconsciousness and rigid body motions. This lasted about 1 minute and the patient regained consciousness. Her vitals were checked and her BP was 96/51.We placed a cold pack on her head and elevated her feet for approximately 30 minutes. Patient was stable, BP was stable and she was able to leave on her own.
Age: 17.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Eye pruritus, Eye swelling, Lip swelling, Pruritus, Throat tightness
Clinical narrative: Patient after 4pm appointment, went to gym to lift weights, then returned home and drank a protein drink and cherries then went to soccer practice. While at practice about 30 min patient developed itching swollen eyes, lip. Returned home where patient was given BENADRYL and taken to ER. On route throat was closing up.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms or reactions.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Paraesthesia, Pruritus
Clinical narrative: Blister (R) buttocks tingling 1st symptoms offset itching.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Skin warm, Swelling
Clinical narrative: Minimal redness, immediately following vaccine then increased swelling size erythema and warmth starting 7/3/18. Seen in ER on 7/4/18 prescribed Abx for ?cellulitis. Seen in office at PCP on 7/5/18 with cont. Sx and prescribed prednisone.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Asthma, Urticaria
Clinical narrative: Patient received BOOSTRIX around 1pm 8/6/18. Mom reports child broke out in hives and "asthma attack" after going to be around 10pm 8/6/18. Mom gave 2 BENADRYL and an albuterol breathing treatment and hives resolved and breathing was better.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Injection site pain, Malaise, Pyrexia
Clinical narrative: On 8/1/18, patient experienced fever of 100 degrees F, upper arm pain at site of injection, fatigue, and malaise. Took ibuprofen with some relief.
Age: 1.33
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site calcification
Clinical narrative: Calcification at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Malaise, Vomiting
Clinical narrative: Vaccine given around 10:30 am on 08/07/18. Pt was feeling well. Around 3:00 am on 08/08/18 mom noticed pt. feeling unwell, temp 102.5 degrees F vomiting. Went to sleep around 5:30 am after keeping MOTRIN down. As of 8:30 am pt. still asleep and appears well to mom.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Blindness, Laboratory test, Multiple sclerosis
Clinical narrative: Lost eyesight. Later dx of MS. WHO causality assessment "B1. Indeterminate. A temporal relationship is consistent but there is insufficient definitive evidence for vaccine-causing event."
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 02-AUG-2018, the patient was inadvertently vaccinated with an adult dose of VAQTA (lot # N032753, expiration date 23-MAR-2019) 1 ml, intramuscularly as a second dose in immunization. The medical assistant stated that vaccinator (unspecified) inadvertently selected wrong strength of vaccine. No adverse effects reported.