chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Blister, Local swelling, Pain, Rash
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 65 years old female patient. The patient's pertinent medical history and drug reactions/allergies were not specified. On 27-MAY-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not provided). Concomitant therapies included PREVNAR 13. On an unknown date in May 2016, the patient developed a 4 inch red raised blistery rash on the back of her left arm. Her skin turned hard in the area near the injection site. It was reported as very painful. The reporter further stated that it might have also been infected but not for sure. The outcome of the events and the causality not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Injection site induration, Pain in extremity, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 65 years old female patient. The patient's pertinent medical history and drug reactions/allergies were not specified. On 27-MAY-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not provided). Concomitant therapies included PREVNAR 13. On an unknown date in May 2016, the patient developed a 4 inch red raised blistery rash on the back of her left arm. Her skin turned hard in the area near the injection site. It was reported as very painful. The reporter further stated that it might have also been infected but not for sure. The outcome of the events and the causality not reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Agitation, Crying, Emotional distress, Eyelid oedema, Injection site rash
Clinical narrative: Rash and hives all over her body, eyes red and puffy, rash and hives on face around neck, arms, thighs where shots were given and around, and head, crying for 2 days, agitated, could not be soothed, irritable, hurting and itchy all over. Gave TYLENOL and BENADRYL and a lot of extra love and affection.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site urticaria, Irritability, Ocular hyperaemia, Pain, Pruritus generalised
Clinical narrative: Rash and hives all over her body, eyes red and puffy, rash and hives on face around neck, arms, thighs where shots were given and around, and head, crying for 2 days, agitated, could not be soothed, irritable, hurting and itchy all over. Gave TYLENOL and BENADRYL and a lot of extra love and affection.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash and hives all over her body, eyes red and puffy, rash and hives on face around neck, arms, thighs where shots were given and around, and head, crying for 2 days, agitated, could not be soothed, irritable, hurting and itchy all over. Gave TYLENOL and BENADRYL and a lot of extra love and affection.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Erythematous rash on bilateral forearms. Rash still present on 17Jun2016 @ 2:30 PM with no progression.
Sex: M
Vaccine: DTP
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a non-health care professional via other company (Pfizer) (Manufacturer report number: 2016219273) on 21 April 2016. This case involves a male (age was not reported) patient who was vaccinated with a dose of DPT (batch number, expiration date, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had a reaction. Lab data and corrective treatment was not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional (medical assistant) on 05 May 2016. This case was linked to 2016SA060451 (same reporter and batch number). This case involves a 26-years-old male patient who was vaccinated with a 0.5 ml intradermal dose of ADACEL (batch number U4939AA, expiration date was not reported) in right forearm instead of TUBERCULIN PPD (PPD/TST) (batch number, expiration date, route and site of administration was not reported) on 21 March 2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not reported. On 23 March 2016, two days following vaccination, patient had redness around the injection site, one the size of a baseball and the other the size of a softball (erythema). Patient had a hard pea size nodule at the injection site. Patient stated the injection site felt itchy at first and then redness and swelling appeared. Patient had advised to see their primary care physician for evaluation. It was wrong vaccine administered, wrong route of administration and product use issue case. Patient required doctor visit. Lab data was reported as none. Corrective treatment was not reported. On 02 May 2016, patient was recovered from events. List of documents held by sender: none.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional (medical assistant) on 05 May 2016. This case was linked to 2016SA060451 (same reporter and batch number). This case involves a 26-years-old male patient who was vaccinated with a 0.5 ml intradermal dose of ADACEL (batch number U4939AA, expiration date was not reported) in right forearm instead of TUBERCULIN PPD (PPD/TST) (batch number, expiration date, route and site of administration was not reported) on 21 March 2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not reported. On 23 March 2016, two days following vaccination, patient had redness around the injection site, one the size of a baseball and the other the size of a softball (erythema). Patient had a hard pea size nodule at the injection site. Patient stated the injection site felt itchy at first and then redness and swelling appeared. Patient had advised to see their primary care physician for evaluation. It was wrong vaccine administered, wrong route of administration and product use issue case. Patient required doctor visit. Lab data was reported as none. Corrective treatment was not reported. On 02 May 2016, patient was recovered from events. List of documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Swollen arm from top to hands. Swollen and red. Started with swelling and moved down and got redder and redder.
Age: 17.0
Sex: M
Vaccine: HPVX
Symptoms: Concussion, Loss of consciousness
Clinical narrative: This spontaneous report as received from an administrator via field representative refers to a 17 year old male patient. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were unknown by the reporter. On 10-JUN-2016, the patient was vaccinated with unidentified Merck HPV vaccine (GARDASIL or GARDASIL 9) lot # unspecified, via intramuscular route. The reporter stated that after receiving the vaccine, the patient passed out and suffered a concussion. The reporter did not know which shot in series was administered. The patient sought medical attention and was at the physician's office. Outcome of the events were unknown. Causality assessment was not provided. No further adverse event information was provided. Upon internal review, the event loss of consciousness was considered to be medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: On 6/3/2016, Patient noted a red rash to injection site and left deltoid (but not reported to clinic at that time).  Patient returned to clinic on 6/10/16 with redness to left deltoid, area sore to touch, arm to touch and redness expending up to left shoulder. MD prescribed clarithromycin 500mg PO 2 times daily.  Patient returned to clinic on 6/13/16 and improvement to site was noted, improved appearance of rash on left arm with decreased extention and significantly decreased erythema, no warmth and area nontender.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Headache, Injection site pain, Pollakiuria
Clinical narrative: Chills throughout the night, headache, weakness, frequent urination, soreness at the injection site.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Scab
Clinical narrative: Information has been received from a pharmacist via a field representative concerning a male patient of unknown age. No concurrent condition, medical history and concomitant therapies were reported. On an unspecified date in February 2015, the patient was administered ZOSTAVAX (Lot#, dosage and route not provided) and developed a pock mark at the injection site shortly after the administration. The patient's pock mark at the injection site continually oozed, crusts over, then eventually the scab fell off and it started oozing again. It never healed. The patient visited several unspecified physicians regarding this issues but none of them were able to assist him. The pock mark had never completely healed. The patient was not recovered from the events at time of the reporting. The relationship between the events and ZOSTAVAX was not reported. Follow up information has been received on 15-JUN-2016 from a physician in the form of medical records and a 553A specimen form. According to medical records: The patient, now 83 years old, was seen by physician on 15-JUN-2016 for a wellness visit. The patient was noted to be a nonsmoker with no alcohol use with a medical history of left knee replacement (December 2008). The patient's family history included atrial fibrillation (mother), hypertension (mother and father), leukemia (father), basal cell carcinoma (father) and breast cancer (sister). The patient's current assessments included osteoarthritis, plantar fasciitis, essential hypertension benign, sick sinus syndrome, hyperlipidemia, vitamin D deficiency, obesity, basal cell carcinoma treated with Mohs surgery on forehead and back, and prostate cancer status post radiation. The patient also reported a fall within the last 3 months. Upon physical examination, the patient was noted to have a skin lesion on his right deltoid with no subcutaneous nodules or induration. The patient reported the skin lesion was following shingles vaccination about 1 and 1/2 years ago. The physician took a swab of the area and sent for evaluation upon the patient's request. The physician advised the patient to follow up with his dermatologist and possibly undergo a skin biopsy. The patient agreed to recommendation. According to the 553A specimen form: On 15-JUN-2016, a sample of the vesicle on the right deltoid was taken and sent for evaluation (VZVIP case number 1-14215671106). On 11-FEB-2015, an 82 year old male with a history of chicken pox in childhood was vaccinated with ZOSTAVAX, lot # K015308 in the left deltoid (in conflict, skin lesion noted on right deltoid and previously reported at injection site). A few days later, the patient experienced 2 itchy pimples (location not provided). The outcome of 2 itchy pimples was reported as recovered (date not provided). Upon internal review, sick sinus syndrome, basal cell carcinoma treated with Mohs surgery on forehead and back and prostate cancer status post radiation were considered to be medically significant. All available medical records will be provided upon request. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Abnormal behaviour, Aphasia, Autism, Flat affect, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 12 month old male patient. The patient had no pertinent medical history, drug reactions or allergies. There were no concomitant medications. On 07-MAY-2015, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K022446, expiration date: 12-MAY-2016, subcutaneously (exact dose and anatomical location were not reported). On 07-MAY-2015, immediately following the vaccine for two weeks the patent ran high fevers. He also became lethargic. The patent was given ibuprofen and acetaminophen (manufacturer unknown) as a treatment for his fevers. In July 2015, two months after the vaccine, he stopped speaking, he had a flat affect and was not smiling anymore. He was taken to a specialist, who had diagnosed him with autism (considered as disability) and recommended that he started early intervention speech therapy, which the patient was still enrolled in at time of this report. The outcome of high fevers was reported as recovered/ resolved, on approximately 21-MAY-2015 (duration of high fevers was reported as "for two weeks"). The outcome of autism and lethargy was reported as not recovered/not resolved. Causality assessment was not provided. Upon internal review, the event of autism was considered to be medically significant. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Lethargy, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 12 month old male patient. The patient had no pertinent medical history, drug reactions or allergies. There were no concomitant medications. On 07-MAY-2015, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K022446, expiration date: 12-MAY-2016, subcutaneously (exact dose and anatomical location were not reported). On 07-MAY-2015, immediately following the vaccine for two weeks the patent ran high fevers. He also became lethargic. The patent was given ibuprofen and acetaminophen (manufacturer unknown) as a treatment for his fevers. In July 2015, two months after the vaccine, he stopped speaking, he had a flat affect and was not smiling anymore. He was taken to a specialist, who had diagnosed him with autism (considered as disability) and recommended that he started early intervention speech therapy, which the patient was still enrolled in at time of this report. The outcome of high fevers was reported as recovered/ resolved, on approximately 21-MAY-2015 (duration of high fevers was reported as "for two weeks"). The outcome of autism and lethargy was reported as not recovered/not resolved. Causality assessment was not provided. Upon internal review, the event of autism was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown demographics. The patient's medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosage information, lot number and expiry date were not reported). Concomitant medications were not reported. The pharmacist reported that, on an unknown date the patient developed rash at injection site. On an unknown date, after the vaccination with ZOSTAVAX, the patient went to hospital for an unspecified reason. Pharmacist also reported that the patient went hospital for another issues that was not related to ZOSTAVAX. The patient did seek the medical attention by visiting the pharmacist, on an unknown date. The reporter considered the adverse event serious due to hospitalization. The outcome of events was unknown. The reporter considered the adverse event not to be related with ZOSTAVAX. Causality of rash at injection site was not provided. No product quality complaint was reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Palpitations, Paraesthesia oral
Clinical narrative: Tongue and lips started tingling and went numb and heart raced for approximately two hours.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Injection site pain
Clinical narrative: Patient's arm from middle of deltoid to the top of elbow is red and inflammed.  It is only sore around the site of injections and otherwise no other symptoms.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Abasia, Cerebellar ataxia, Computerised tomogram head, Fall, Lumbar puncture
Clinical narrative: Patient was suddenly unable to walk without falling at 1:00 PM on 2/10. Was taken to emergency room. Was then admitted to hospital. Received CT of head and Xray of hips and legs in ER. Had MRI of head and Lumbar puncture, both under sedation. Also received physical therapy while in hospital. Was diagnosed with Acute Cerebella Ataxia. Symptoms improved in 48 hours, and resolved within 1 week.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Nuclear magnetic resonance imaging brain, X-ray limb, X-ray of pelvis and hip
Clinical narrative: Patient was suddenly unable to walk without falling at 1:00 PM on 2/10. Was taken to emergency room. Was then admitted to hospital. Received CT of head and Xray of hips and legs in ER. Had MRI of head and Lumbar puncture, both under sedation. Also received physical therapy while in hospital. Was diagnosed with Acute Cerebella Ataxia. Symptoms improved in 48 hours, and resolved within 1 week.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Erythema, Injection site erythema, Rash
Clinical narrative: Patient's leg started turning red at the injection site. The redness quickly spread from the injection site and covered her entire lower half of her body from her belly button to her knees. The redness looked like scalded burns.
Age: 0.32
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Kawasaki's disease
Clinical narrative: Kawasaki Disease.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: RASH ON FACE ET TRUNK.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Patient was given the Hep B vaccine the day she was born and shortly after her vaccination she broke out with a rash over her entire body.
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a nurse on 06 May 2016. This case involves a 19-year-old male patient who was vaccinated with a 0.1 ml dose of Meningococcal vaccine (frequency once) intradermally in right forearm on 06 May 2016 believing it to be TUBERSOL for a tuberculosis skin test. It was a wrong vaccine administered case. It was unknown whether the patient had some adverse event related to vaccination. Documents held by sender: none.
Sex: F
Vaccine: MENB
Symptoms: Blindness, Dizziness, Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient (the nurse's daughter) of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of TRUMENBA and experienced site reaction and fever. The patient experienced loss of vision, she felt like she passed out and experienced dizziness on an unspecified date. The outcome of the events was unknown.
Age: 0.44
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Condition aggravated, Rash
Clinical narrative: Patient's rash became more severe and a new rash developed on her face and scalp.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Inflammation, Injection site erythema, Injection site swelling
Clinical narrative: Local inflammatory reaction; swollen, red around site of injection, about 4 cm in diameter.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Peripheral swelling, Pyrexia
Clinical narrative: Pt. stated her left arm swelled up and she had fever and cellulitis in the arm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation
Clinical narrative: Non Painful inflammation at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain
Clinical narrative: Pt. said area was very red first, then changed to darker reddish bruise looking area with a small dark dot in center. She said it was not hot or feverish to her knowledge & is now slightly sore if you press it.
Age: 0.66
Sex: F
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX, DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX
Symptoms: Blister, Erythema, Rash, Skin disorder, Skin exfoliation
Clinical narrative: Severe rash and skin issues. Redness, blisters and peeling.
Age: 0.66
Sex: F
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX, DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX
Symptoms: Blister, Blood pressure decreased, Erythema, Rash, Skin exfoliation
Clinical narrative: Severe rash and skin issues. Redness, blisters and peeling.
Age: 0.66
Sex: F
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX, DTAP, FLUX, HEP, HIBV, IPV, PPV, RVX
Symptoms: Skin reaction
Clinical narrative: Severe rash and skin issues. Redness, blisters and peeling.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Mother of patient reported patient awoke with red, swollen itchy vaccine site and it was hot to the touch. Doctor notes: Patient had DTAP and Hep B (#2) in right arm. No pain to palpation. Child without fever or distress.
Age: 1.06
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Blister, Erythema, Rash, Skin exfoliation, Swelling
Clinical narrative: Severe rash, Severe redness, swelling, peeling, blisters on her body. Ointment therapy.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Blister, Erythema, Rash, Skin exfoliation, Swelling
Clinical narrative: Severe rash, Severe redness, swelling, blisters, peeling on her body. Ointment therapy.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, PPV
Symptoms: Pyrexia
Clinical narrative: Very high fever. 104.5. Cool cloth on forehead, cold water to drink, Tylenol given. Called doctor's office, advised to not seek emergency treatment.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Vaginal dysplasia
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 21 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2008, the patient completed series of GARDASIL injection (lot#, expiration date, dose, and anatomical location were not reported), intramuscularly. In December 2015, the patient experienced an abnormal papanicolaou (PAP) smear test with load grade dysplasia (not specified what kind of dysplasia). No treatment was given, but there would be a follow up with another PAP smear test in about one year. The outcome of the events was reported as not recovered. The patient sought medical attention and visited an unspecified doctor office on an unknown date. The relatedness between the events and GARDASIL was not reported. Upon internal review the event of vaginal dysplasia (reported as load grade dysplasia) was considered to be medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Anaphylactic shock, Chills, Hypersensitivity, Oropharyngeal pain, Pruritus
Clinical narrative: Anaphylaxis shock reaction w/biphasic allergic reaction 5 days reoccurring. Patient is a 13-year-old female with a history of tree nut and shrimp allergy and esophagitis, GERD, presented to Emergency Department with worsening of her hives. She started about 2 days ago having some itching. She then had appearance of her hives at 2:00 p.m. on June 4th where she was seen at an urgent care, where she was given 10 mg IM dexamethasone and BENADRYL, epinephrine IM at 0.1 mg. She was then transported to ER where she received a bolus of normal saline and famotidine and discharged to home at 7:00 p.m. the night prior to coming in here with anaphylaxis. She woke up just prior to coming in with a lot of hives and itching and sensation of her sore throat coming back. Mom brought her here. She is also having chills, but otherwise no other symptoms. She denies any new foods. No new exposures. Mom states that she thinks it may be from a mosquito bite, but they are really not sure.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Anaphylaxis shock reaction w/biphasic allergic reaction 5 days reoccurring. Patient is a 13-year-old female with a history of tree nut and shrimp allergy and esophagitis, GERD, presented to Emergency Department with worsening of her hives. She started about 2 days ago having some itching. She then had appearance of her hives at 2:00 p.m. on June 4th where she was seen at an urgent care, where she was given 10 mg IM dexamethasone and BENADRYL, epinephrine IM at 0.1 mg. She was then transported to ER where she received a bolus of normal saline and famotidine and discharged to home at 7:00 p.m. the night prior to coming in here with anaphylaxis. She woke up just prior to coming in with a lot of hives and itching and sensation of her sore throat coming back. Mom brought her here. She is also having chills, but otherwise no other symptoms. She denies any new foods. No new exposures. Mom states that she thinks it may be from a mosquito bite, but they are really not sure.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a nurse on 04 Mar 2011: This patient was vaccinated with only MenCWY liquid conjugate component of MENVEO (batch number not reported) intramuscularly without being reconstitutes with the MenA conjugate component on an unspecified date. No adverse events were noted following this administration error. The reporter stated that no addition details including batch number, date of vaccine administration and patient identifying information would be available.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial health care professional (medical assistant) report received on 10 Feb 2011: These 3 patients were vaccinated with MENVEO (batch number: M10030) intramuscularly. The patient were inadvertently administered with only the MenA lyophilized conjugate component of MENVEO reconstituted with a sterile diluent; the patients did not originally receive the MenCYW-135 liquid conjugate component of MENVEO. The patients were revaccinated with another dose of MENVEO.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage
Clinical narrative: Initial health care professional (medical assistant) report received on 10 Feb 2011: These patients (unspecified number) were vaccinated with MENVEO (batch number: 100001) intramuscularly, which was stored at 0 C for nearly 10,284 hours.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial report received from a health care professional in 04 Mar 2011: This patient was vaccinated with MENVEO (batch number M10030) on 28 Feb 2011. The patient was administered only the MenA lyophilized conjugate component of MENVEO, which was reconstituted with sterile solvent. The patient did not receive MenCYW-135 liquid conjugate component of MENVEO. No adverse event had occurred.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial report received from a nurse on 10 Mar 2011: This patient was vaccinated with MENVEO (batch number X10030) on 04 Mar 2011. The patient was inadvertently administered 0.5 ml IM dose of only the MenCWY liquid conjugate component of 04 Mar 2011. No adverse event was reported since administration.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Underdose
Clinical narrative: Initial report received from a medical assistant on 11 Mar 2011: This patient was vaccinated with MENVEO (batch number unknown) 0.5 ml intramuscularly on 04 Mar 2011. While administering vaccine, some of the dose leaked out and ran down the patient's arm. No adverse event occurred following this administration.
Age: 13.0
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial health care professional (nurse) report received on 14 Mar 2011: This patient with an unknown medical history was vaccinated with MENVEO (batch number: X10029) intramuscularly in the right deltoid on 14 Mar 2011: This patient with an unknown medical history was vaccinated with MENVEO (batch number: X10029) intramuscularly in the right deltoid on 14 Mar 2011. The patient received only the liquid CYW-135 component of MENVEO without the lyophilized A component. No adverse event was reported following this drug administration error.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 18 Mar 2011: This patient with an unknown medical history was vaccinated with MENVEO (batch number: M10030) 0.5 ml dose intramuscularly on 17 Mar 2011. The patient received only the Men CWY liquid conjugate without reconstituting with Men A component. No adverse events were noted following this medication error. Follow up report received on 01 Apr 2011. This patient received 0.5 ml of varicella vaccine (batch number 1470Z) on left arm on 17 Mar 2011. The batch numbers for Men A Lyophilized conjugate component of Men CYW-135 liquid conjugate were reported as A10030 and X10030 respectively. The patient received Men CYW-135 liquid conjugate component only. The patient did not experience any adverse reaction.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 18 Mar 2011: This patient with an unknown medical history was vaccinated with MENVEO (batch number: M100031) 0.5 ml dose intramuscularly on 18Mar 2011. The patient received only the Men conjugate component of MENVEO that was reconstituted with another diluent. No adverse events were noted following this medication error.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a nurse on 18 Mar 2011: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number: X10030) intramuscularly without being reconstituted with the MenA lyophilized conjugate component on 15 Mar 2011. No adverse events were noted following this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Heart rate increased
Clinical narrative: Case number PHHY2011US25104 is an initial, spontaneous report received from a registered nurse on 24 Mar 2011. This report refers to a female patient of unknown age group. This patient was vaccinated with MENVEO vaccine (batch number unknown) on an unspecified date. The patient experienced rapid heartbeat after 36 hours of being vaccinated. The outcome of the event was not reported.
Sex: F
Vaccine: MNQ
Symptoms: Lip swelling, Muscular weakness, Pyrexia
Clinical narrative: Case number PHHY2011US25821 is an initial spontaneous report received from a registered nurse on 25 Mar 2011. This report refers to a female of unknown age group. This patient was vaccinated with MENVEO vaccine (batch number 02301/090601A) on 14 Mar 2011. The patient experienced puffy lips, fever and weakness in limbs on the same day. The patient was treated with BENADYL. The outcome of the event was complete recovery.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US26134 is an initial spontaneous report received from a nurse on 29 Mar 2011. This report refers to 11 years old female patient. She was vaccinated with MENVEO vaccine (batch number 100022) on 20 Mar 2011. The vaccine was given intramuscularly. She did not receive the MenA lyophilized conjugate component of MENVEO vaccine. No other adverse reaction was reported. The final outcome of the event was not reported. Follow-up report received from a nurse on 12 Apr 2011: The patient did not present any adverse event.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US26136 is an initial spontaneous report received from a healthcare professional on 29 Mar 2011. This report refers to a patient of unknown age group and gender. This patient was not given the MenCYW-135 liquid conjugate component of MENVEO vaccine (batch number 024011) on 21 Mar 2011. The vaccine was administered intramuscularly. No other adverse reaction was reported.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US26719 is an initial spontaneous report received from a health care professional on 29 Mar 2011. This report refers to a 16 years old male patient. He was given on the CYW-135 liquid component MENVEO vaccine (batch number M10030) intramuscularly on 26 Mar 2011. No adverse reaction was reported.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US27085 is an initial spontaneous report received from a health care professional on 29 Mar 2011 with combine follow-up from a nurse on 28 Apr 2011. This report refers to a 17-year-old male patient. he was vaccinated with MenA lyophilized conjugate component of MENVEO (batch number 024011, expiry date: Apr 2012) reconstituted with sterile diluent instead of Men CWY liquid conjugate component intramuscularly on 12 Mar 2011. This was found during an inventory on 29 Mar 2011. No other adverse reaction was reported. The patient was advised for re-vaccination. Follow-up received on 28 Apr 2011: Updated reporter information.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US27181 is an initial spontaneous case received from a medical assistant on 30 Mar 2011 with combine follow-up from a physician on 28 Apr 2011. This report concerns a 13-year-old male patient. He was vaccinated with MENVEO (batch number: 024011 and expiry date: Apr 2012) 0.5 ml intramuscularly on 21 Mar 2011. Later it was found that the Men A powder conjugate was inadvertently reconstituted with sterile diluent instead of Men CWY liquid conjugate. No adverse event was reported following this drug administration error. The patient was contacted for re-vaccination. Follow-up received on 28 Apr 2011: Updates reporter information.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US28383 is an initial report from a health care professional received on 05 Apr 2011 with a follow up from a health care professional received on 21 Apr 2011: This report refers to an adolescent female patient. The patient received vaccination with MENVEO (batch number M10030) on 28 Mar 2011. The patient received the MenA lyophilized conjugate component of MENVEO reconstituted with a sterile diluent; patient did not receive the MenCYW-135 liquid conjugate component of MENVEO. The powder component of the vaccine was mixed with another diluent instead of the one that came with it. No adverse event had occurred. The outcome of the event was reported as patient completely recovered. Follow up received on 21 Apr 2011: The patient's demographic, event description and outcome of the event was updated. Follow internal review on 05 May 2011, it was noted that the significant follow up tick box was not ticked for the previous dates. Hence, the check box was ticked now and the reports for the previous dates were generated.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY20111US28921, is an initial report from a nurse received on o1 Apr 2011: This report refer to a 17-year-old male patient. The patient was vaccinated with MENVEO (batch number X100028) intramuscularly on 18 Mar 2011. The patient only received the Men-CYW-135 liquid component on 18 Mar 2011. No adverse event had been reported. Following an internal review on 27 Apr 2011: The event drug administration error was captured incorrectly as listed, hence corrected to unlisted.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Case number PHHY2011US29432, is an initial spontaneous report from a health care professional received on 04 Apr 2011: This patient was vaccinated with MENVEO (batch number M10028) on an unspecified date. The nurse administered diluent only, without reconstitution. No other information reported.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial report received from a health care professional on 05 Aug 2010: This patient received only the conjugate component (without the vaccine) of MENVEO (batch number: not reported), (dose: unknown) intramuscularly on an unspecified date.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial report received from the health care professional on 10 Aug 2010: The health care professional suspects that this patient might have received only a partial dose of MENVEO because the patient received only the MenA lyophilized component of MENVEO (batch number: 100005), dose: unknown) intramuscularly on an unspecified date.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial report received from a health care professional (medical assistant) on 11 Aug 2010: On 10 Aug 2010, this patient was vaccinated with 0.5 ml intramuscular dose of MenA conjugate component of MENVEO (batch number: 028011) that was diluted with a diluent for MMR vaccine. No adverse events were reported following this administration. Follow up report received from a health care professional (medical assistant) on 27 Aug 2010: Added patient information. This patient with medical history of asthma was previously vaccinated with DTAP vaccine on 24 Aug 1997, 28 Oct 1997, 29 Dec 1997, 19 Oct 1998 and on 02 Aug 2011. The patient also vaccinated with polio vaccine on 24 Aug1997, 23 Oct 1997, 29 Dec 1997 and on 02 Aug 2001. The patient had MMR vaccine on 30 Jun 1998 and on 02 Aug 2001. The patient received vaccination with Hib vaccine on 24 Aug1997, 27 Oct 1997, 29 Dec 1997 and on 19 Oct 1998. The patient received hepatitis B vaccine on 26  Jun 1997, 24 Aug 1997 and on 29 Dec 1997. The patient vaccinated with varicella vaccine on 05 Jul 1999 and second dose (batch number: 0847U, subcutaneously) in right arm on 07 Aug 2007. On 18 Dec 2003, patient was vaccinated with influenza vaccine. The patient received concomitant therapy with GARDASIL and BOOSTRIX on 10 Aug 2010. The outcome of event was reported as completely recovered.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse practitioner) on 10 Aug 2010: This patient was vaccinated with only the MenCWY liquid conjugate component instead of being reconstituted with the MenA lyophilized powder component of MENVEO (batch number of liquid: 091001), (dose: 0.5 ml) intramuscularly on 10 Aug 2010. No adverse events were noted following this administration.
Age: 0.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Central nervous system infection, Malaise, Peripheral coldness, Pneumonia
Clinical narrative: We had no sign at all of anything being wrong with patient. Until the night of Oct 4th. When she just didn't seem to feel well. We put her to bed around 130 a.m. and woke up just a few hours later to find her not breathing and cold in her bed. Upon completion of her autopsy it was found that she had pneumonia and infection of the brain and spine.
Age: 0.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory arrest, Spinal cord infection
Clinical narrative: We had no sign at all of anything being wrong with patient. Until the night of Oct 4th. When she just didn't seem to feel well. We put her to bed around 130 a.m. and woke up just a few hours later to find her not breathing and cold in her bed. Upon completion of her autopsy it was found that she had pneumonia and infection of the brain and spine.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Allergy test negative, Blister, Erythema, Rash, Skin exfoliation
Clinical narrative: Severe rash, severe redness and swelling, blisters, peeling on her body. Ointment therapy. I have always suspected her ongoing severe skin issues were directly related to the vaccines. The skin issues never completely healed between each series of vaccinations but only gotten worse right after receiving her vaccinations. Each episode would take weeks to months before starting to subside, only to be triggered again by another round of vaccinations. I would discuss these medical issues with . Doctors at each visit and voice my concern that her medical issues were related to her vaccinations. However each doctor suggested a different possible cause and either provide a prescription or an ointment therapy to administer at home. I switch diaper brands. Tried different milk products and even removed all possible food allergens that her doctors would suggest. I switched soaps also. Nothing worked. To my astonishment and aggression no doctor did nor suggested allergy testing. I held off on filing any VAERS reports until we were able to get a doctor to agree to allergy testing to rule out an allergy.  Once she had the allergy testing and the results revealed no link to food allergies, we knew the only other possible cause were the vaccines.  This is why I'm reporting now.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Swelling
Clinical narrative: Severe rash, severe redness and swelling, blisters, peeling on her body. Ointment therapy. I have always suspected her ongoing severe skin issues were directly related to the vaccines. The skin issues never completely healed between each series of vaccinations but only gotten worse right after receiving her vaccinations. Each episode would take weeks to months before starting to subside, only to be triggered again by another round of vaccinations. I would discuss these medical issues with . Doctors at each visit and voice my concern that her medical issues were related to her vaccinations. However each doctor suggested a different possible cause and either provide a prescription or an ointment therapy to administer at home. I switch diaper brands. Tried different milk products and even removed all possible food allergens that her doctors would suggest. I switched soaps also. Nothing worked. To my astonishment and aggression no doctor did nor suggested allergy testing. I held off on filing any VAERS reports until we were able to get a doctor to agree to allergy testing to rule out an allergy.  Once she had the allergy testing and the results revealed no link to food allergies, we knew the only other possible cause were the vaccines.  This is why I'm reporting now.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Crying, Dissociation, Emotional disorder, Pain
Clinical narrative: Severe emotional outbursts and disconnected. He cried and said he hurt and begged us to take his pain away. His issues have at times been very difficult. We have worked with him at home by practicing behavior control and patience. In 2015 doctor suggested possible Asperger.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Paleness, sweating, dizziness, light-headedeness, fainting.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hypoaesthesia, Muscle twitching
Clinical narrative: Hand going numb, fingers twitching, dizzy, -pt states had gone for a long walk prior to receiving vaccine - after resting and eating something symptoms resolved.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial physician report received on 13 Aug 2010: This patient was vaccinated with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml) intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial physician report received on 13 Aug 2010: This patient was vaccinated with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml) intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error. Follow up received from physician on 24 Aug 2010: It was reported that the patient received MENVEO vaccine on 16 Jul 2010. The date of medication error was reported as 16 Jul 2010.
Age: 43.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report from a health care professional on 09 Aug 2010: This patient was vaccinated with MENVEO (batch number 100005), 0.5ml intramuscularly, on 13 Jul 2010. The reporter stated that patient was administered with partial dose of MENVEO (only MenCYW-135 liquid conjugate component). No adverse events were reported. Follow up report received health care professional on 27 Aug 2010: The patient potentially received a partial dose of MENVEO. It was reported that, they would send titers and based on results of titers they would determine full dose of patient.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial physician report received on 13 Aug 2010: This patient was vaccinated with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial physician report received on 13 Aug 2010: This patient was vaccinated with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml) intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error. Follow-up report received from a physician on 24 Aug 2010: The date of vaccination was reported as 16 Jul 2010 (previously reported as 13 Aug 2010). The reporter stated that no adverse events were reported and the patient was in healthy condition.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial physician report received on 13 Aug 2010: This patient was vaccination with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml) intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error.
Age: 49.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 17 Aug 2010: On 15 Aug 2010, this patient was vaccinated with only the MenCYW liquid conjugate of MENVEO (batch number: 091101), (dose: 0.5 ml) intramuscularly without being reconstituted with the MenA conjugate component. No adverse events were noted following this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional on 16 Aug 2010: On 13 Aug 2010, this patient inadvertently received a intramuscular dose of MenA lyophilized conjugate component of MENVEO (batch number not reported) that was reconstituted with a sterile diluent. The patient had not received the MenCWY-135 liquid conjugate component of MENVEO. No adverse reaction had occurred following this administration.