chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown. In May 2017 (reported as "within the past week (prior to 12-MAY-2017)"), the patient was vaccinated with a dose of VARIVAX injection, lot # M039318 with expiry date 20-SEP-2018, subcutaneously (exact dose was not reported) for prevention of varicella. The vaccine was administered together with sterile diluent (MERCK) injection, lot # M034911 with expiry date 05-MAY-2019 (exact dose was not reported). On an unknown date in May 2017, 3 to 4 days following the administration of VARIVAX and sterile diluent (MERCK), the patient experienced a severe injection site reaction consisting of redness, swelling, warmth and discomfort at the injection site. The patient sought medical attention by visiting the physician. The reaction was diagnosed as possible cellulitis and was treated with an unspecified antibiotic. The outcome of the events and causal relationship between the events and suspect therapies were not provided. The reporting nurse requested a lot check on the administered products. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA009116.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX 19400 plaque forming units (PFU) as prophylaxis (Dose, route, lot # and expiration date were not reported). On an unspecified date, 1 year later the patient inadvertently received a second dose of ZOSTAVAX 19400 plaque forming units (PFU) as prophylaxis (Dose, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown. In May 2017 (reported as "within the past week (prior to 12-MAY-2017)"), the patient was vaccinated with a dose of VARIVAX injection, lot # M039318 with expiry date 20-SEP-2018, subcutaneously (exact dose was not reported) for prevention of varicella. The vaccine was administered together with sterile diluent (DILUENT MERCK), lot # M034911 with expiry date 05-MAY-2019 (exact dose was not reported). On an unknown date in May 2017, 3 to 4 days following the administration of VARIVAX and sterile diluent (DILUENT MERCK), the patient experienced an injection site reaction consisting of redness, swelling, warmth and discomfort at the injection site. The patient sought medical attention by visiting the physician, however they did not require treatment. The outcome of the events and causal relationship between the events and suspect therapies were not provided. The reporting nurse requested a lot check on the administered products. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007174:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to unknown patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On unknown dates, the patients were vaccinated with 8 improperly stored doses of VARIVAX with lot # M045204 and expiration date 11-NOV-2018 (anatomical route of vaccination was not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. It was reported that, VARIVAX, was exposed to a temperature of -14 °C to -10 °C for a 12 hours time frame. Data logger was involved. Furthermore, it was reported that the vaccine was never involved on a previous temperature excursion. No adverse effects were reported and no product quality issue was involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abnormal behaviour, Cold sweat, Crying, Dyskinesia, Emotional distress
Clinical narrative: Fatigue but inability to sleep, clammy skin. She experienced unconsolable, uncontrollable, irrational screaming and crying for 30-45 minutes. Near the end of this bout, she stated through tears that she "couldn't stop crying" and said her head hurt and sounded like "swoosh swoosh" and motioned with her hands in a circular motion. My husband and I were both with her and we have never seen her act like that. It was very odd behavior for her. After 45 minutes we tried to get her down for a rest and she couldn't fall asleep and was just out-of-sorts for another hour or so. This was yesterday. She went to sleep last night as normal and appears to be behaving normally so far as of this morning (May 19, 2017). As of this time (9:21 AM) she seems to be back to "normal," but I have no idea if any long-term damage is present. I have therefore marked "unknown" in box 9.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Fatigue, Headache, Initial insomnia, Insomnia, Screaming
Clinical narrative: Fatigue but inability to sleep, clammy skin. She experienced unconsolable, uncontrollable, irrational screaming and crying for 30-45 minutes. Near the end of this bout, she stated through tears that she "couldn't stop crying" and said her head hurt and sounded like "swoosh swoosh" and motioned with her hands in a circular motion. My husband and I were both with her and we have never seen her act like that. It was very odd behavior for her. After 45 minutes we tried to get her down for a rest and she couldn't fall asleep and was just out-of-sorts for another hour or so. This was yesterday. She went to sleep last night as normal and appears to be behaving normally so far as of this morning (May 19, 2017). As of this time (9:21 AM) she seems to be back to "normal," but I have no idea if any long-term damage is present. I have therefore marked "unknown" in box 9.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient called stating she was having, pain redness and warm to the touch at the site of her injection, which was Tdap. That she was on Monday May 15, 2017. Provider was notified and patient was given a appointment at 3pm to come in. Patient then stated she couldn't come in due to work and she would just wait until tomorrow since she has an appointment already
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # L008356 and expiration date of 11-SEP-2016 (route of administration, dose and anatomical location were unknown) prior to its expiration date but after the temperature excursion began, for prophylaxis, reconstituted with properly stored sterile water diluent (lot # and expiration date were not provided). No adverse effects were reported. There was previous temperature excursion. A "data logger" was involved. There was not product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In approximately May 2015 (reported as 2 years ago), the patient was vaccinated with ZOSTAVAX 1 dose (route of administration, lot # and expiration date were not reported) reconstituted with sterile diluent (MRK) injection (dose, route of administration, lot # and expiration date were not reported). On an unknown date (reported as recently), the patient had a negative antibody titer. No treatment was given for the adverse event. The patient sought medical attention by office visit. No product quality complaint was involved. The outcome of the event was not recovered. The relatedness between the event and suspect therapies was not reported. Additional information is not expected because there was no consent to contact the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date after the vaccination, the patient developed shingles of unknown severity. The patient visited a physician and was prescribed VALTREX (dose and frequency unknown) to treat the outbreak. The patient did not recover from the shingles outbreak (also reported as currently still recovering) at the time of this report. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient received an unspecified dose of pneumococcal vaccine injection (dose, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis (reported as "vaccination").   On an unknown date after the vaccination, the patient developed a Guillain-Barre syndrome. The patient had been receiving an unspecified treatment for the event. The patient sought medical attention and seeing hers physician. At the time of the report, the event of Guillain-Barre syndrome was still ongoing. The causality assessment was not reported. Upon internal review, the event of Guillain-Barre syndrome was determined to be medically significant. Additional information is not expected since the reporter did not wish further contact.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that on 17-MAY-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (Lot L009212, Exp 17-MAR-2017). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Atrial septal defect, Condition aggravated, Laryngeal papilloma, Surgery
Clinical narrative: This literature report as received from the authors of a published literature article, refers to 59-year-old male patient with a history of squamous cell carcinoma of the larynx and squamous papilloma of the right tonsillar pillar, both treated with laser resection, presented during routine follow-up with multiple nasopharyngeal papillomatous lesions on the posterior soft palate. His lesions were resected en bloc with CO2 laser via both transnasal endoscopic and transoral approaches. Final pathology revealed lesions consistent with squamous papilloma, and sequencing analysis showed the lesion to be positive for HPV 11. On a 3-month follow-up visit, the patient complained of mild nasal congestion. Endoscopic exam showed a recurrent papilloma of the nasopharyngeal surface of the soft palate. On an unknown date, the patient began vaccination with GARDASIL for recurring nasopharyngeal papilloma (dose and route were not reported). The patient's vaccination course was interrupted by the discovery of a symptomatic patent foramen ovale, which required surgery. The patient's nasopharyngeal lesion increased in size during that time, becoming visible by direct sight. After the patient resumed and completed the three-dose vaccination with GARDASIL, the lesion appeared subjectively smaller on exam. The patient underwent CO2 laser en bloc resection of this lesion. Surgical pathology confirmed the 1.7 x 1.2 x 0.6 cm lesion to be squamous papilloma. In the 6 years since the patient's second resection, the patient had no recurrences. This is one of the two cases from the same article (linked with MARRS # 1705USA000105). Additional information has been requested. Sender's Comments: US-009507513-1705USA000105.
Age: 20.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother) received via a Pfizer Sales representative. A 20 years old female patient received the 2nd dose of TRUMENBA in May2017, at 0.5 ml single, in right deltoid, for immunization. On the same day in May2017 the patient concomitantly received TDAP IMMUN in left arm, for immunization. Medical history was not reported. On an unspecified date in May2017 the patient experienced redness and a lump on her right deltoid. It was persistent for a week, then the events resolved on an unspecified date in May2017.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased
Clinical narrative: 104.0 Temp on 5/18/2017 approx 8 hours post vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema, Intussusception, Irritability, Poor feeding infant, Ultrasound abdomen abnormal
Clinical narrative: Intussusception of the bowel, vaccines received 5/11/17 as below. Parent called 5/16/17 in evening. Vomited x1, poor feeds, irritable, sent to urgent care, x-ray report possible intussusception. Diagnosis of intussusception made by ultrasound 5/17/17. Barium enema done, intussusception reduced, hospitalized overnight. No fever.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting, X-ray gastrointestinal tract
Clinical narrative: Intussusception of the bowel, vaccines received 5/11/17 as below. Parent called 5/16/17 in evening. Vomited x1, poor feeds, irritable, sent to urgent care, x-ray report possible intussusception. Diagnosis of intussusception made by ultrasound 5/17/17. Barium enema done, intussusception reduced, hospitalized overnight. No fever.
Age: 46.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Blood test, Burning sensation, Chest X-ray, Computerised tomogram thorax normal, Laboratory test normal
Clinical narrative: Swelling in both armpits, soreness and slight burning sensation. Has continued to get worse over past six months. Burning has spread to cover upper body, head, neck, and face. Have taken antibiotics started on 11/29/2016. Have seen PC Physician on 11/29/16, 1/11/17, and 5/16/17. Visited the ER on 1/7/17 due to increased pain and burning. Have seen a neurologist on 1/12/17, 1/25/17, 2/20/17, and 4/12/17. Seen an allergist on 3/7/17. Had a chest xray, chest CT, MRI, and numerous blood tests. Have been taking Gabapentin and Prednisone.
Age: 46.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Oedema peripheral, Pain
Clinical narrative: Swelling in both armpits, soreness and slight burning sensation. Has continued to get worse over past six months. Burning has spread to cover upper body, head, neck, and face. Have taken antibiotics started on 11/29/2016. Have seen PC Physician on 11/29/16, 1/11/17, and 5/16/17. Visited the ER on 1/7/17 due to increased pain and burning. Have seen a neurologist on 1/12/17, 1/25/17, 2/20/17, and 4/12/17. Seen an allergist on 3/7/17. Had a chest xray, chest CT, MRI, and numerous blood tests. Have been taking Gabapentin and Prednisone.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered
Clinical narrative: Patient received PEDIARIX (DTap, Hep B and IPOL combo) and IPV vaccine. Patient did not need the dose of Hepatitis B as he had 3rd dose on 3/14/2017 and received a dose of IPV in PEDIARIX as well as separate dose.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash
Clinical narrative: On and off fever over 101.5 lasting for 3 days. Fever broke on 05/18/2017, but general fussiness. Lost appetite, increased nursing. Rash on belly and back noticed morning on 05/19/2017.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 4.0
Sex: M
Vaccine: DTIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mom stated that when he woke up that he complained of it aching and itching at injection site. She looked and it was red, swollen, and warm to touch.
Age: 29.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Received a flu vaccine provided by my employer via Hospital mobile bus. Immediately after my shot was given, had a throbbing pain in my upper right arm where shot was given. Have had constant pain in my upper right arm since date of vaccination and am unable to move my arm straight above my shoulder without it hurting. Have taken OTC pain meds and prescribed muscle relaxers and still neither help.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (LPN) referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 17-MAY-2016, the patient was vaccinated with their first dose of RECOMBIVAX HB (dose, route, lot # and expiration date was not provided) for prophylaxis. On 17-JUN-2016, the patient was vaccinated with their second dose of RECOMBIVAX HB (dose, route, lot # and expiration date was not provided) for prophylaxis. On 27-APR-2017, the patient was seen in the office to receive their third dose of RECOMBIVAX HB (inappropriate schedule of drug administration as the third dose was due in DEC-2016). At the time of this report, the third dose of RECOMBIVAX HB has not yet been given. No adverse effect reported. No product quality compliant (PQC) involved. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received on 01-MAY-2017 from a pharmacist and refers to a 14 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, when the patient was 12 years old, they received the first dose of GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not reported). On an unknown date, when the patient was 14 years old, they were vaccinated with the second dose of GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not reported). No adverse effect reported. No additional information was provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Rash generalised
Clinical narrative: This initial spontaneous report was received from a 60 year old male patient referring to himself. Concurrent conditions included high blood pressure and pityriasis rosea. Medical history included measles and a fungal infection. He had no drug reactions/allergies. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) and hydrochlorothiazide (+) triamterene (DIAZIDE). On 06-JAN-2016, the patient received ZOSTAVAX subcutaneously for the prevention of shingles (lot # not reported). On 11-JAN-2016, the patient experienced a rash all over with the exception of the neck, face and genitals. He went to see a physician on 11-JAN-2016 who prescribed three courses of tapering dose of steroidal ointment clobetasol. The patient began noticing the rash clearing up by April 2016 but by November 2016, the rach returned. He was still experiencing discomfort from the rash and only felt some relief when using the ointment. The outcome of the event was not recovered. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from an unspecified source, concerning unknown patients from unmentioned ages (children), posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore it was reported, that on unspecified dates, the unspecified number of patients had severe reactions after the administration of GARDASIL. The outcome of the event was not known. The relatedness between events and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments: US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002408: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002414: US-009507513-1705USA002413: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1705USA002415.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of an unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On an unknown date, the patients were vaccinated with PNEUMOVAX23 (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patients experienced cellulitis. The outcome of cellulitis was unknown. The causality between PNEUMOVAX23 and cellulitis was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009127: US-009507513-1705USA009128:
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 75-year-old female patient. The patient was allergic to sulfa. No information regarding the patient's medical history was reported. On an unknown date in May 2017 (reported as "on 01-MAY-2017 or 09-MAY-2017"), the patient was vaccinated with PNEUMOVAX23 lot# N005096, expiration date: 22-OCT-2018 (dose, route of administration were not reported). Concomitant therapies included omeprazole, loratadine (manufacturer unknown) and probiotics (unspecified). On an unknown date in May 2017 (reported as "on 02-MAY-2017 or 10-MAY-2017" and "the day after"), the patient experienced cellulitis on the back of her left arm. The patient sought medical attention and was treated with unspecified antibiotics. There was no lab diagnostic studies performed. The outcome of cellulitis was reported as not recovered. The causality between PNEUMOVAX23 and cellulitis was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009128: US-009507513-1705USA007145:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # M037770, expiration date on 01-JUN-2019 (strength, dose, anatomical location and administration route were not provided) for prophylaxis. No adverse effects were reported. The vaccines had one temperature excursion of 31 Fahrenheit (F) during a time frame of 336 hours; it was confirmed that all the vaccines were administered, no previous excursions occurred and no digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA009727.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ lot # M038847, expiration date on 27-APR-2018; Lot # M034799, expiration date on 01-FEB-2018 or lot # M004726, expiration date on 19-OCT-2017 (strengths, doses, anatomical locations and administration routes were not provided) for prophylaxis. No adverse effects were reported. The vaccines had one temperature excursion of 31 Fahrenheit (F) during a time frame of 336 hours; it was confirmed that all the vaccines were administered, no previous excursions occurred and no digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA009135:
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Nuclear magnetic resonance imaging, Pain, Pain in extremity, Ultrasound scan
Clinical narrative: Pain and discomfort that evening, applied ice, everyday after the pain got worse to the point I couldn't lift my arm or use it in any way without pain.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Pain and discomfort that evening, applied ice, everyday after the pain got worse to the point I couldn't lift my arm or use it in any way without pain.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Vaccination site induration
Clinical narrative: Redness, heat and swelling at site. Hard in the center around vaccination entry. Redness continued to spread along with heat and hardness to 4 inches in circumference at this time.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Abasia, Guillain-Barre syndrome
Clinical narrative: Email received from patient on 05/10/17 stating: I am out on leave, I have Guillain Barre Syndrome (GBS). I have been out since 1/7/2017. I was not properly diagnosed until 1/25/2017, I had been in one hospital but they sent me home unable to walk. I was at Hospital from 1/25/2017 until 2-3-2017. Then I went to Rehabilitation Hospital also in. Discharged 3/2/2017 I have been going to outpatient rehab 3-times a week since then.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Soreness and ache in upper arm muscle and joints. Pain increases when I try to move my arm up and outward. Onset was within a day or two of when I received the vaccine.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose normal, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient fainted in waiting room was diaphoretic and pale. No injury occurred. Vitals at time of incident (10:35) are as follows blood sugar 75 Pulse 51 respirations 14 pulse ox 97% Blood pressure 102/80. Patient was given juice, color returned to her lips/face. Patient was monitored for 10 minutes by nurse and provider.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, warm to the touch, swollen, painful.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received on 28-APR-2017 from a registered nurse who reported that improperly stored doses of VARIVAX (lot# M025865, expiration 24-MAY-2018) (lot# M039316, expiration 20-SEP-2018) and PROQUAD (lot# M034692, expiration 24-JAN-2018) (lot# M038861, expiration 13-MAR-2018) were administered to unspecified patients from "06-MAR-2017 - 27-APR-2017". Temperature was 6 degrees F to 14 degrees F for a time frame of 32 minutes. There was no previous temperature excursion. Call was because of a "data logger". Nurse confirmed that the sterile diluent used to reconstitute the VARIVAX and PROQUAD was not improperly stored. No adverse effects. No further information to report. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant. On an unknown date, the medical assistant reported that PROQUAD lot # M042499, expiration date: 17-APR-2018 was mistaken for M-M-R II, and it was stored improperly in the refrigerator for 14 days due to this confusion. No patients received any of the improperly stored doses of PROQUAD. No additional information was provided. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 05-MAY-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M036296, expiration date 14-NOV-2017) for prophylaxis (dose and route of administration were not reported). It was verified that ZOSTAVAX was reconstituted with a sterile diluent (manufacturer unknown), which did not undergo an excursion. The storage temperature was in the range 15 Fahrenheit (°F) to 46°F (32°F) and the excursion lasted for 7 hours and 15 minutes. Information was obtained from a digital data logger. There were no previous temperature excursions and no adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Bipolar disorder, Pruritus generalised, Quality of life decreased, Rash, Schizophrenia
Clinical narrative: This initial spontaneous report was received on 18-MAY-2017 from a pharmacist and a 61 year old female patient. Medical history and concomitant medications were not provided. On approximately 30-MAR-2017 (reported as seven weeks ago), the pt received ZOSTAVAX) for prevention of shingles (lot # M037015; expiration 22-NOV-2017).  The pharmacist reported that the patient experienced itching on an unspecified place on her body for the last seven weeks. She was treated by an unspecified number or doctors with unspecified oral steroids, antihistamines and steroid creams with no relief. The patient reported that she has experienced itching since the ZOSTAVAX vaccine. She itches from her head to her feet. She reported that the itch has "destroyed her life" and she cannot have a normal day anymore because of the constant itching. On an unspecified date, she developed a huge rash on both shins from her ankles to her knees. The patient's physician sent her to a dermatologist. The dermatologist referred her to a psychiatrist. The psychiatrist prescribed an unspecified medication for schizophrenia and bipolar disorder. The patient was also referred to a hematologist. She stated she was prescribed may unspecified medications. The patient feels the company should pay for all of her doctor bills and medications that she has been taking. She also wanted something for her "pain and suffering". The patient stated that the product is "bad" and that she was not at all happy and that she is in agony. She will be telling people not to get the shot. The outcome of the events were not recovered. The pharmacist did not rate causality. Upon internal review, schizophrenia and bipolar disorder were considered medically significant. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 2 month old patient of unknown gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 18-MAY-2017, the patient was inadvertently vaccinated with PNEUMOVAX23 lot # M027552 (strength, dose, route were unknown) instead PREVNAR 13 for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited case received from a nurse via other company Pfizer under the Manufacturer Report Number: 2017183876 on 11 May 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS) (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed allergy to tetanus. The patient relevant lab tests and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Dermatitis, Rash erythematous, Rash generalised
Clinical narrative: Red raised rash on entire body. Saw Dr. on 05/19/2017 and diagnosed as dermatitis. RX for steroid cream. No fever, no loss of appetite.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Pain
Clinical narrative: Patient is having elbow pain and pain with full extension which they feel started at the time of the vaccine.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting (once).
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had a large reddened swollen area on the back of the right upper arm. Size 3" x 4".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm (Deltoid area) red and swollen. 4 1/2" long and 2 1/2" wide.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Blood and mucous in stool, confirmed with stool guaiac test.
Age: 39.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash
Clinical narrative: Rash on arms trunk.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Cough, Erythema, Gait disturbance
Clinical narrative: Increasing soreness and swelling in upper right arm, chills. The pain was acute and I could not sleep for hours. I awoke at 5 in pain and all of my other joints hurt-- it was hard to walk and my thumb joints were enlarged and swollen and painful. Excruciating pain in shoulder which had become hot and red and swollen, I couldn't move my arm without intense pain. My eyes were watering, nose running and coughing-- I did already have a cold, but it felt like an allergic attack on top of the cold. I called Dr office at 5:30 a.m., who works at the same practice, was on call and said I was having a reaction and to take NSAID and that I could take VICODIN which I have for ongoing shoulder pain and migraines. It is now day 2 and shoulder pain is persisting and intense.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Joint swelling, Lacrimation increased, Musculoskeletal pain, Pain
Clinical narrative: Increasing soreness and swelling in upper right arm, chills. The pain was acute and I could not sleep for hours. I awoke at 5 in pain and all of my other joints hurt-- it was hard to walk and my thumb joints were enlarged and swollen and painful. Excruciating pain in shoulder which had become hot and red and swollen, I couldn't move my arm without intense pain. My eyes were watering, nose running and coughing-- I did already have a cold, but it felt like an allergic attack on top of the cold. I called Dr office at 5:30 a.m., who works at the same practice, was on call and said I was having a reaction and to take NSAID and that I could take VICODIN which I have for ongoing shoulder pain and migraines. It is now day 2 and shoulder pain is persisting and intense.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Rhinorrhoea, Skin warm
Clinical narrative: Increasing soreness and swelling in upper right arm, chills. The pain was acute and I could not sleep for hours. I awoke at 5 in pain and all of my other joints hurt-- it was hard to walk and my thumb joints were enlarged and swollen and painful. Excruciating pain in shoulder which had become hot and red and swollen, I couldn't move my arm without intense pain. My eyes were watering, nose running and coughing-- I did already have a cold, but it felt like an allergic attack on top of the cold. I called Dr office at 5:30 a.m., who works at the same practice, was on call and said I was having a reaction and to take NSAID and that I could take VICODIN which I have for ongoing shoulder pain and migraines. It is now day 2 and shoulder pain is persisting and intense.
Sex: U
Vaccine: HPV4
Symptoms: Suicidal ideation
Clinical narrative: Information has been received from a consumer referring to an unknown number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with doses of GARDASIL (lot#, dose, dose# and route unknown) for prophylaxis. It was reported that the vaccine destroyed health in turn happiness, educations, athleticism, mental health, happiness, bodies and families. This vaccine was deadly and it inflicted a suffering so sever children were becoming suicidal because they could not live with the everyday pain and suffering. The outcome of the events was unknown. Upon internal review, the event becoming suicidal was considered to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected since there was no contact details provided.; Sender's Comments: US-009507513-1604USA014045:
Sex: U
Vaccine: HPVX
Symptoms: Cervix carcinoma, Skin lesion
Clinical narrative: This spontaneous report as received from 25 year old patient of unknown gender via facebook concerning herself/himself. On an unknown date the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacture unknown) (strength, dose and route unknown) for prophylaxis. The patient was waiting to be diagnosed with cervical cancer when the doctor found suspicious lesions on her/him. At the time of reporting, the outcome of adverse event was unknown. The causality was not provided. Upon internal review, cervical cancer was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This non-valid, social media, spontaneous report as received from a patient's mother refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiry date, dose, and route of administration were not reported). The reporter stated that the patient suffered terrible effects from the GARDASIL (date not reported). It was also reported that the patient was not healthier and she was in the hospital again, at the time of the report. Action taken with suspect therapy was not provided. The outcome of the event was not reported. The relatedness between the event and therapy with GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information is not expected, as no contact details were provided. Sender's Comments: US-009507513-1605USA011378.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: This spontaneous non-valid, social media report as received from a parent refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the patient got very ill from GARDASIL and did not finish the series. The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. Additional information is not expected, as there were no contact details provided.
Sex: U
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This non-valid, social media, spontaneous report as received from a consumer refers to many unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, the patients were vaccinated with GARDASIL (lot #, expiry date, dose, and route of administration were not reported). The reporter stated that the patients suffered terrible effects from the GARDASIL (dates not reported). Action taken with suspect therapy was not provided. The outcomes of the events were not reported. The relatedness between the events and therapy with GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information is not expected, as no contact details were provided. Sender's Comments: US-009507513-1605USA010456.
Sex: U
Vaccine: PNC13
Symptoms: Condition aggravated, Pneumonia
Clinical narrative: This is a spontaneous report from Pfizer sponsored program, reported from a contactable consumer reporting for him/herself. A patient of unspecified age ethnicity and gender to receive PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) via an unspecified route of administration at single dose in 2013 for immunization, because he/she have chronic conditions. Medical history included pneumonia. The patient's concomitant medications were not reported. The patient experienced pneumonia in left lung the year before. This year he/she had it again in the same lung. No follow up attempts are needed. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Conjunctivitis allergic
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient) through a Pfizer sales representative. A male patient of an unspecified age received PREVENAR 13 intramuscularly, in the arm, on an unknown date, in 2017, at 0.5 ml, single dose, for immunization. Relevant medical history included acid reflux (esophageal) and the patient had no spleen (splenectomy). Concomitant medications included unspecified drugs for acid reflux. On an unspecified date, in 2017, the patient experienced allergic conjunctivitis. Clinical outcome of the event was recovering at time of this report.
Age: 46.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Salivary gland enlargement
Clinical narrative: States the gland under her chin is swollen. She feels it when she swallows but no trouble swallowing or breathing. No rash, hives, fever, nausea, HA or any other symptoms.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Malaise, Nausea, Vomiting
Clinical narrative: SHE REPORTED FEELING SICK AFTER LUNCH TIME WITH NAUSEA, SOME SWEATING AND VOMITED ALL HER LUNCH.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Diffuse raised red/pink rash to chest and arms. Very itchy. Sweating, low grade fever. TYLENOL for fever. Antihistamines for itching, CALMOSEPTINE for rash.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Burning sensation, Cerebral disorder, Death, Decompressive craniectomy
Clinical narrative: As soon as received GARDASIL vaccine, had burning thru entire body. Felt different after that. Balance issues, concentration issues. Said her brain felt different. Soon after that, had a virus that was thought to be flu. Treated with antibiotics. Had a headache that would not go away for 45 days. Went from being a 115 lb athlete, to a 155 lbs and could not eat. Hospitalized at two hospitals. Also hospitalized other times and other places afterwards. She never got better--had terrible pain. Had multiple tests and saw many doctors and all tests were normal. They could never find the cause of the headaches, but she did have 2 surgeries to improve the headaches-decompression surgery in 2015 and removal of nerves in forehead in 2016. She was diagnosed with POTS and with polycystic ovarian syndrome after vaccination. Had possible seizures-saw over 200 doctors. Died in the bathtub due to drowning.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Disturbance in attention, Drowning, Feeding disorder, Feeling abnormal, Headache
Clinical narrative: As soon as received GARDASIL vaccine, had burning thru entire body. Felt different after that. Balance issues, concentration issues. Said her brain felt different. Soon after that, had a virus that was thought to be flu. Treated with antibiotics. Had a headache that would not go away for 45 days. Went from being a 115 lb athlete, to a 155 lbs and could not eat. Hospitalized at two hospitals. Also hospitalized other times and other places afterwards. She never got better--had terrible pain. Had multiple tests and saw many doctors and all tests were normal. They could never find the cause of the headaches, but she did have 2 surgeries to improve the headaches-decompression surgery in 2015 and removal of nerves in forehead in 2016. She was diagnosed with POTS and with polycystic ovarian syndrome after vaccination. Had possible seizures-saw over 200 doctors. Died in the bathtub due to drowning.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Influenza, Laboratory test normal, Pain, Peripheral nerve operation
Clinical narrative: As soon as received GARDASIL vaccine, had burning thru entire body. Felt different after that. Balance issues, concentration issues. Said her brain felt different. Soon after that, had a virus that was thought to be flu. Treated with antibiotics. Had a headache that would not go away for 45 days. Went from being a 115 lb athlete, to a 155 lbs and could not eat. Hospitalized at two hospitals. Also hospitalized other times and other places afterwards. She never got better--had terrible pain. Had multiple tests and saw many doctors and all tests were normal. They could never find the cause of the headaches, but she did have 2 surgeries to improve the headaches-decompression surgery in 2015 and removal of nerves in forehead in 2016. She was diagnosed with POTS and with polycystic ovarian syndrome after vaccination. Had possible seizures-saw over 200 doctors. Died in the bathtub due to drowning.