chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site swelling, Lacrimation increased, Sneezing
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 year old male patient. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with his first dose of M-M-R II for routine vaccination (dose, route of administration, lot number and expiration date were not reported) with no apparent side effects. Then, on an unknown date, in August 2018, reported as 3 weeks ago, the patient was vaccinated with his possible second injection in the series of M-M-R II for routine vaccination (dose, route of administration, lot number and expiration date were not reported). Immediately, the patient began sneezing repeatedly, his eyes started watering and a large swelling appeared around the injection site (sneezing, lacrimation increased and injection site swelling). A clinician gave the patient BENADRYL and sent the patient to an emergency hospital room. In the emergency room the patient received an unspecified dose of DECADRON. On the same day, in the evening, the physician called the patient's home and the patient's mother reported that the patient was doing fine and had fully recovered from the events. The causal relationship between M-M-R II and the aforementioned events were not reported.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling of eyelid
Clinical narrative: Painless swollen of Left eye lid, lower and upper eye without (angioedema), with erythrema developed about 24 hours after immunizations were given.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric dose administered when patient need an adult dose.
Age: 64.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Hypotension, Loss of consciousness, Vomiting
Clinical narrative: Hypotension,vomiting,loss of consciousness.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Diarrhoea, Influenza like illness, Muscle spasms, Pain
Clinical narrative: Patient complaining of flu like symptoms (diarrhea, cramps, body aches). States BP is 150/100s despite taking BP meds. States able to tolerate PO. States temperature over 100 but doesn't recall exact number. Doctor phones the patient and discussed the adverse reaction, and advised further evaluation at her PCP or UC, especially to evaluate for signs of dehydration since patient is having diarrhea every 10 minutes. Patient expressed understanding.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave Adult dose not a peds dose of Hep A.
Age: 72.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Body temperature increased, Decreased appetite, Feeling cold, Insomnia, Oxygen saturation decreased
Clinical narrative: Body temp - up 101.4. Body cold shake. No food. No sleep. Talking to self. Low oxy. in blood.
Age: 72.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Soliloquy, Tremor
Clinical narrative: Body temp - up 101.4. Body cold shake. No food. No sleep. Talking to self. Low oxy. in blood.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PATIENT COMPLAINED OF REDNESS ON AND AROUND INJECTION SITE, SLIGHT SENSATIONS OF HEAT ON SKIN, BEGINNING 8/23/18, TWO DAYS POST INJECTION. NO COMPLAINTS OF SWELLING NOR OF ITCHINESS OR OTHER IRRITATIONS. PATIENT CAME IN TO THE PHARMACY LATER IN THE AFTERNOON AND WE DETERMINED THAT THE REDNESS WAS TRAVELING SLIGHTLY DOWN THE ARM, BUT RESOLVING SLIGHTLY NEAR THE ORIGINAL INJECTION SITE. PATIENT HAD CONTACTED HER PRIMARY DOCTOR, AND WAS TOLD TO USE A HOT COMPRESS. WHEN I CALLED THE PATIENT ON 8/27/2018 TO FOLLOW UP ON HER SYMPTOMS, SHE SAID THEY HAD COMPLETELY RESOLVED BY 08/24/2018-08/25/2018, 4 DAYS AFTER THE INJECTION.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Muscle twitching, Slow response to stimuli
Clinical narrative: Become light- headed and faint feeling after administration of HPV. Slow to respond and twitching for approx. 15 seconds.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient had redness, swelling, and warmth at the injection site. She woke up in a sweat overnight on 8/23. On 8/24 she woke up, and injection site swelling was about 4 inches by 2 inches. She had a rash over entire upper body, which was warm and red, and was composed of large clusters. Temp was 99 degrees 1 hour after TYLENOL, 30 minutes after ibuprofen.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient had redness, swelling, and warmth at the injection site. She woke up in a sweat overnight on 8/23. On 8/24 she woke up, and injection site swelling was about 4 inches by 2 inches. She had a rash over entire upper body, which was warm and red, and was composed of large clusters. Temp was 99 degrees 1 hour after TYLENOL, 30 minutes after ibuprofen.
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, HEPAB, MNQ, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Monitored.
Age: 68.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Dizziness, Myelitis transverse, Pain, Paralysis
Clinical narrative: Weakness, dizzy, staph infection on face 1/4-1/12. Painful at wrist down 1/18 8:00 am. Paralyzed 12:00 ER admit. 9 days hosp disch 1/27 to rehab, discharged home in wheelchair. 2/18.
Age: 68.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Staphylococcal infection, Wheelchair user
Clinical narrative: Weakness, dizzy, staph infection on face 1/4-1/12. Painful at wrist down 1/18 8:00 am. Paralyzed 12:00 ER admit. 9 days hosp disch 1/27 to rehab, discharged home in wheelchair. 2/18.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20-year old (currently 22-year-old) female patient. The patient's medical history, concurrent conditions and concomitant drugs were not provided. The patient received 4 doses of M-M-R II (albumin status, strength, dose, route and site of administration, lot# and expiry date were not provided) for prophylaxis. The first dose was administered on an unspecified date in 1997, the second- in 2000, third (extra dose) in 2016, and fourth (extra dose)- in 2017. On an unknown date, the titers were drawn. The patient was still having negative titers. The outcome of negative titers was unknown. The reporter did not provide the causality assessment between the event and M-M-R II.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Varicella zoster pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-OCT-2011, the patient was inoculated at a hospital with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. 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 by a physician/MD for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, Severe varicella pneumonia was determined to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-OCT-2012, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided), for its intended purpose the prevention of shingles. On 16-OCT-2016, the patient suffered from a shingles outbreak; in addition to chronic pain, rash and lesions to various parts of his" (conflicting information states patient is a female) body as a direct result of the ZOSTAVAX. As a direct result of ZOSTAVAX vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient has sustained severe and permanent personal injuries, suffered serious, progressive, and incurable injuries, as well as conscious pain and suffering, mental and emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of ZOSTAVAX use. The outcome of the event was unknown. Causality assessment was related. The event of shingles outbreak was considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-MAY-2013, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 20-DEC-2014 and two more bouts of shingles on 23-FEB-2017 and 09-MAR-2018 respectively. The outcome of the events is unknown. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles outbreak, shingles, and shingles were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 22-AUG-2018, the patient were vaccinated with improperly stored doses of ZOSTAVAX lot # N026816, expiration date 25-DEC-2018, for prophylaxis (strength, dose, route and frequency were not reported). The vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) lot # N023306, expiration date 20-JAN-2020. The temperature excursion was of 15 Fahrenheit degrees (°F) to 46°F, during 6 days. However, a previous temperature excursion of 47°F to 77°F for 1 hour was also reported. A digital data logger was involved. No adverse effects were reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Infection, Injection site erythema, Injection site inflammation
Clinical narrative: Patient experienced pain in arm upon leaving pharmacy, the site then became red and inflamed. The next day she experienced shivering, fever, tiredness, and fever, she was then treated with antibiotics. Symptoms/infection has resolved and patients MD has recommended NOT getting second dose of vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient experienced pain in arm upon leaving pharmacy, the site then became red and inflamed. The next day she experienced shivering, fever, tiredness, and fever, she was then treated with antibiotics. Symptoms/infection has resolved and patients MD has recommended NOT getting second dose of vaccine.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, HEPAB, MNQ, TDAP
Symptoms: Throat irritation
Clinical narrative: Itchy throat.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Somnolence
Clinical narrative: Chills, aches, sleeplessness evening and day after (reporting this on 1st day after vaccination).
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose abnormal, Chest X-ray normal, Chills, Culture throat, Full blood count normal
Clinical narrative: Patient received MenB2 at 9:13 am, at 5:30 pm parent took to ER. Per ER report back/neck/sore throat/headache, muscle aches, fever, chills. "Felt tingling in neck/back" pain score 7. Labs, x-ray completed, IV ketorolac and Ceftriaxone given. Patient discharged to home at 9:40pm. Symptoms improved. 8/28/18 call to patient - much better, "feels stiff" went to school today.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Glucose urine present, Headache, Human chorionic gonadotropin negative, Metabolic function test normal, Mononucleosis heterophile test negative
Clinical narrative: Patient received MenB2 at 9:13 am, at 5:30 pm parent took to ER. Per ER report back/neck/sore throat/headache, muscle aches, fever, chills. "Felt tingling in neck/back" pain score 7. Labs, x-ray completed, IV ketorolac and Ceftriaxone given. Patient discharged to home at 9:40pm. Symptoms improved. 8/28/18 call to patient - much better, "feels stiff" went to school today.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Myalgia, Oropharyngeal pain, Pain, Paraesthesia
Clinical narrative: Patient received MenB2 at 9:13 am, at 5:30 pm parent took to ER. Per ER report back/neck/sore throat/headache, muscle aches, fever, chills. "Felt tingling in neck/back" pain score 7. Labs, x-ray completed, IV ketorolac and Ceftriaxone given. Patient discharged to home at 9:40pm. Symptoms improved. 8/28/18 call to patient - much better, "feels stiff" went to school today.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Streptococcus test negative, Urine analysis normal
Clinical narrative: Patient received MenB2 at 9:13 am, at 5:30 pm parent took to ER. Per ER report back/neck/sore throat/headache, muscle aches, fever, chills. "Felt tingling in neck/back" pain score 7. Labs, x-ray completed, IV ketorolac and Ceftriaxone given. Patient discharged to home at 9:40pm. Symptoms improved. 8/28/18 call to patient - much better, "feels stiff" went to school today.
Age: 48.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Body temperature, Dizziness
Clinical narrative: "I was so dizzy" and 'I had a temperature" for two days starting on the day of vaccination. Denies any rash or vomiting. Symptoms resolved after four days.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left Arm became swollen and red on 08/27/18. Denied any pain.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Pallor, Pyrexia, Somnolence, Staring
Clinical narrative: My daughter begin running a fever that night of 103 and was very drowsy until the next day around 5pm. Her eyes are glazed and her skin appeared a pale gray for 2-3 days after vaccines.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives - face, arms, trunk developed a few hours after vaccination. Also developed a low-grade fever - 99.4 overnight. Seen next morning (this morning) and still a few residual hives - face, back of head and neck.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 21-JAN-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), as recommended for routine adult health maintenance for the prevention of shingles. 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 01-MAY-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as a severe herpetic rash. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 66-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration, single dose on Nov2017 for immunization. The patient medical history was not reported. The patient's concomitant medications includes unspecified other vaccinations. On an unspecified date, the patient experienced pain and swelling at the injection site and there was more pain than expected. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 39 years old male patient who was vaccinated with a first dose of IMOVAX RABIES lot M12962M via intramuscular route on 02-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included DAPTACEL for Immunisation; MENACTRA for Immunisation; and MMR for Immunisation on 02-Jun-2018. It was also case of actual medication error due to inappropriate schedule of vaccine administered. It was not reported whether the patient experienced any adverse events or not. 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: 1.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 17-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who experienced patient had been mistakenly given QUADRACEL and patient had been mistakenly given QUADRACEL, while she received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Aug-2018, the patient received a  dose of suspect QUADRACEL lot C5325BA via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered. It was unknown whether patient experienced 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 and Module VI of the 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: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Fatigue, Incorrect route of product administration, Induration
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old female patient who experienced discomfort, redness, induration of 4 cm, fatigue and inappropriate route of vaccination, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy taken. On 13-Aug-2018, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5872AA via subcutaneous route in the left arm. On an unknown date, the patient developed a non-serious discomfort following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious redness (erythema) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date The patient developed a non-serious induration of 4 cm (vaccination site induration) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date The patient developed a non-serious fatigue following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that Adacel was administered too low on the arm and it did not get into the deltoid. It seems to them that it was given SC. It was also a case of Inappropriate route of vaccination and Vaccine administered at inappropriate site. Final diagnosis was fatigue, induration of 4 cm, redness and discomfort. It was not reported if the patient received a corrective treatment. The patient was not recovered from events. 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 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: F
Vaccine: IPV
Symptoms: Injection site erythema, Injection site irritation, Wrong product administered
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 years old female patient who experienced redness of left forearm injection site, irritation of left forearm injection site while she received vaccine IPOL instead of TUBERSOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (VERO) lot N1A461M; expiry date: 09-Feb-2019. On an unknown date, the patient developed a non-serious redness of left forearm injection site following the administration of IPV (VERO). On an unknown date, the patient developed a non-serious irritation of left forearm injection site following the administration of IPV (VERO). Final diagnosis was irritation of left forearm injection site and redness of left forearm injection site. It was also a case of actual medication error due to wrong vaccine administered. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for redness of left forearm injection site, as Not Recovered / Not Resolved on an unknown date for irritation of left forearm injection site. 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.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Incorrect route of product administration
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA232895 (Sibling/ same reporter). This case involves an eight-year-old male patient who experienced discomfort, redness and inappropriate route of vaccination, while she received vaccine ADACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy taken. On 13-Aug-2018, the patient received a 0.5 ml once first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5872AA via subcutaneous route in the left arm. On an unknown date, the patient developed a non-serious little bit of redness (erythema) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious discomfort following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious it appears that it was a sc injection (incorrect route of drug administration) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious gave adacel to two patients at a site too low to be in the deltoid (product administered at inappropriate site) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was also a case of actual medication error due to inappropriate route of vaccination and vaccine administered at inappropriate site. No Lab data was reported. Final diagnosis was gave adacel to two patients at a site too low to be in the deltoid, it appears that it was a subcutaneous injection, discomfort and little bit of redness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for little bit of redness and as Unknown for discomfort. 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 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 the sender: None.
Age: 4.0
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Local reaction, Wrong product administered
Clinical narrative: Initial information received on 17-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a four-years old patient (gender not reported) who experienced localized reaction, while he/she received a dose of ADACEL instead of DAPTACEL on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot number not reported. On an unknown date, the patient developed non-serious localized reaction (Local reaction), following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. It was also a case of actual medication error due to wrong vaccine administered. Relevant tests were not reported. Final diagnosis was severe localized reaction. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. 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.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves elderly patient who received FLUZONE HIGH DOSE (lot details, expiry date were not reported). It was a case actual medication error due to Incorrect product storage as Shipment was too long in transit and one dose was given to patient before staff realized the mistake with the shipment. 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. Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from healthcare professional. This case involves six-year-old male patient who received an expired 0.5 ml dose FLUZONE QUADRIVALENT lot UT5897KA, expiry date 30 June 2018 on 21 Aug 2018 in right deltoid. It was a case of actual medication error due to Expired vaccine used. 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. Documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Expired product administered
Clinical narrative: Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 25 months old male patient who received a 0.25 mL expired dose of FLUZONE QUADRIVALENT lot UI889AA, expiry date: 30-Jun-2018, via intramuscular route in the left thigh on 20-Aug-2018 inadvertently. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. 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: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 15 years old male patient who was vaccinated with a 0.5 ml dose of MENACTRA (Batch number: U5180AA; expiry date: 22-Jan-2017 dose in series were not reported) via intramuscular route in the left arm on 01-Apr-2014. It was also reported that the patient was vaccinated with a primary dose of MENACTRA when he was 13 years old on 01-Apr-2014. The patient's concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation (Batch number, expiry date, dose, dose in series, route and site of administration were not reported). It was a case of actual medication error due to extra dose administered. It was reported that No know reported symptoms or need for treatment. 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 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: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves a 72 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HD (lot UI985AC and expiry date: 22-Mar-2019) (route of administration were not reported) in the right arm on 20-Aug-2018. The patient's 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 incorrect product storage because shipment of the product was 4 days late (transit for 4 days). 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 the sender: None.
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE; and PREVNAR. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route. It was a case of actual medication error due to Inappropriate reconstitution technique. PENTACEL injection was given and mixed with Saline but not the Diluent that came with the vaccine. It was unknown if adverse event occurred or not. 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: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Injection site erythema, Injection site swelling, Pain, Paraesthesia
Clinical narrative: Red, swollen at site of injection, body aches, elevated blood pressure, some facial tingling.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Migraine
Clinical narrative: Headache the night of the administration. Migraine the following morning.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, warmth. Antihistamines, AUGMENTIN. Not yet resolved.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cardiac monitoring, Computerised tomogram head normal, Electroencephalogram normal, Full blood count, Generalised tonic-clonic seizure
Clinical narrative: Mom phoned for ambulance around 5:30pm due to sudden onset of seizure like activity while in store. No recent fever or illness reported but had immunizations on 08/23/2018. Infant was transported to hospital. CT without contrast was done with Impression being Normal CT head. Placed on cardiac monitor, IV started and ATIVAN given. Option given to admit or transfer to MC. Transferred to MC via non-emergent ambulance. Admitted on 08/24/2018 to MC, EEG and MRI of the brain done. The etiology of the seizure like activity was unclear. He was referred to see Neurology in 4-6 weeks and PCP in about 1 week. Discharged from MC on 08/25/2018.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Metabolic function test, Monocyte percentage increased, Nuclear magnetic resonance imaging brain normal, Platelet count increased, Rash
Clinical narrative: Mom phoned for ambulance around 5:30pm due to sudden onset of seizure like activity while in store. No recent fever or illness reported but had immunizations on 08/23/2018. Infant was transported to hospital. CT without contrast was done with Impression being Normal CT head. Placed on cardiac monitor, IV started and ATIVAN given. Option given to admit or transfer to MC. Transferred to MC via non-emergent ambulance. Admitted on 08/24/2018 to MC, EEG and MRI of the brain done. The etiology of the seizure like activity was unclear. He was referred to see Neurology in 4-6 weeks and PCP in about 1 week. Discharged from MC on 08/25/2018.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Seizure like phenomena, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: Mom phoned for ambulance around 5:30pm due to sudden onset of seizure like activity while in store. No recent fever or illness reported but had immunizations on 08/23/2018. Infant was transported to hospital. CT without contrast was done with Impression being Normal CT head. Placed on cardiac monitor, IV started and ATIVAN given. Option given to admit or transfer to MC. Transferred to MC via non-emergent ambulance. Admitted on 08/24/2018 to MC, EEG and MRI of the brain done. The etiology of the seizure like activity was unclear. He was referred to see Neurology in 4-6 weeks and PCP in about 1 week. Discharged from MC on 08/25/2018.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Blister, Irritability, Rash, Skin warm, Varicella post vaccine
Clinical narrative: Mom called the health department on 08/16/2018 c/o rash/bumps/blisters all over the legs-whiny and feels warm-not around somewhere to check his temperature-going to monitor at this time. Mom called back on 08/17/2018, mom took patient to the doctor and was diagnosed as having the Chickenpox disease-temp. at the doctor was 99.4.
Age: 31.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site scab, Injection site vesicles, Injection site warmth
Clinical narrative: Small blisters with scab on top at right medial upper arm. Small blisters without scab on left medial arm. Itchy, painful, and feels warm. denies having fever, recent illness.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient said,"about 5 hours after injection her arm began to swell, turn red, and became warm to the touch. She also said she felt as if she was getting another shot as far a pain goes. She did not have a fever. She came into our pharmacy 8/28/18 to show me her arm. I told her to call her primary care physician. Her arm was quite swollen and very red. No fever, nausea, or vomiting.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came into store on 08/28/18 around 9:30am with a red swollen upper arm. She complained of pain and swelling in arm. Advised patient to take antihistamine and acetaminophen as well as using ice to help with allergic reaction. Patient stated that she felt well enough to return to work.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Axillary mass, Pain in extremity
Clinical narrative: Pain in the upper arm which it continued to increase after 24 hours then on Monday morning I found a large lump under the left armpit. The size is approximately the size of a ping pong ball.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Gait disturbance, Hypoaesthesia, Injection site pain, Musculoskeletal pain
Clinical narrative: I must note that on my vaccination card it reads ID Biomedical as the manufacturer. Not sure if they are a subset of GlaxoSmithKline? On 4 Dec 2017, I received my annual flu shot from my employer. Two hours after the shot, my arm was numb with pins and needles in it. I also had shooting pains in my hands. A few hours later, the pain was going through my whole arm, up past my collar bone up to my neck. I was also having pins and needle sensations on top of my head from ear to ear. All this lasted until the next morning. The next morning I only had left some pain on top of my shoulders, and tenderness at the injection site. But it felt like the reaction was going away, or so I thought. On 10 Dec 2017, I woke up with shooting pains in my right leg hip joint/hip flexor area. It hurt to walk. On 11 Dec 2017, the pain increased. It went just below my hip joint/hip flexor area to the top of my hip bone. Again it hurt to walk and I was noticeably limping. Fast forward to 14 Dec 2017, and the pain has decreased, but the pain has spread down to my knee. I am also getting tingling in my toes. I am still having to limp from the pain and tingling in my right hip/leg. When I press on my leg it feels tender and feels like I have been bruised. As of 10 Jan 2018, I am still having pain, and pins and needles feeling in my right hip/leg. Pain, pins and needles, and the ability to walk without pain finally healed end of Feb 2018.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: I must note that on my vaccination card it reads ID Biomedical as the manufacturer. Not sure if they are a subset of GlaxoSmithKline? On 4 Dec 2017, I received my annual flu shot from my employer. Two hours after the shot, my arm was numb with pins and needles in it. I also had shooting pains in my hands. A few hours later, the pain was going through my whole arm, up past my collar bone up to my neck. I was also having pins and needle sensations on top of my head from ear to ear. All this lasted until the next morning. The next morning I only had left some pain on top of my shoulders, and tenderness at the injection site. But it felt like the reaction was going away, or so I thought. On 10 Dec 2017, I woke up with shooting pains in my right leg hip joint/hip flexor area. It hurt to walk. On 11 Dec 2017, the pain increased. It went just below my hip joint/hip flexor area to the top of my hip bone. Again it hurt to walk and I was noticeably limping. Fast forward to 14 Dec 2017, and the pain has decreased, but the pain has spread down to my knee. I am also getting tingling in my toes. I am still having to limp from the pain and tingling in my right hip/leg. When I press on my leg it feels tender and feels like I have been bruised. As of 10 Jan 2018, I am still having pain, and pins and needles feeling in my right hip/leg. Pain, pins and needles, and the ability to walk without pain finally healed end of Feb 2018.
Age: 21.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Hepatitis A vaccine given too early. Due on 9/13/18, given on 8/28/18. No negative outcomes known at this time. Patient does not report any problems immediately after administration.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Hypersensitivity, Pain, Pruritus, Rash
Clinical narrative: Allergic reaction, rash, streaking, itching, bumps, pain at site over 15 areas of my body. Took antihistamines, prescribed prednisone and Triamcinolone Acetonide Ointment. Lasting 8 days.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site induration, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: On 8/24/18 pt noted 3 inch hot, firm, welts at both injection sites. These have been resolving with warm packs. On 8/26/18 at 4 am pt was noted to have fever of 102.7 and moderate headache. Mom administered ibuprofen for fever and headache. Fever reduced to about 100 and headache improved after second dose of ibuprofen. Yesterday, 8/26/18, fevers persisted around 100 and reduced to 99.8 with ibuprofen. 8/27/18 Today, fever is 100.8 and reduces to 99.8 with ibuprofen.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: On 8/24/18 pt noted 3 inch hot, firm, welts at both injection sites. These have been resolving with warm packs. On 8/26/18 at 4 am pt was noted to have fever of 102.7 and moderate headache. Mom administered ibuprofen for fever and headache. Fever reduced to about 100 and headache improved after second dose of ibuprofen. Yesterday, 8/26/18, fevers persisted around 100 and reduced to 99.8 with ibuprofen. 8/27/18 Today, fever is 100.8 and reduces to 99.8 with ibuprofen.