chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Developed redness, swelling and slight discomfort at injection site of MMR vaccine 2 days after injection. Was seen in the office for follow up. Diagnosed with cellulitis of (L) upper arm. Placed on CEPHALEXIN 250 mg/5ml oral liquid.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a healthcare medical student refers to an approximately 60 year old female patient with lymphoma. No allergies reported. On approximately 04-APR-2014, reported as "about two weeks ago", the patient was vaccinated with ZOSTAVAX (dose and lot# were not reported). Concomitant therapy was not reported. In approximately April 2014, the patient experienced localized rash. It was unspecified where the rash was located. The reporter stated that the patient had lymphoma at the time of ZOSTAVAX vaccination but did not know it. No treatment was given for the localized rash. The patient sought medical attention. The outcome of localized rash was unknown. Causality was not reported. Additional information is not expected.
Age: 1.13
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Petechiae, Rhonchi
Clinical narrative: Orbital petechiae and rhonchi.
Age: 54.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 54 year old patient. Medical history and concurrent conditions were not reported. On 27-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer's son refers to his mother an 80 year old female patient with allergy (unspecified). The patient's medical history included multiple recurrences of shingles. On 10-APR-2014, the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not provided). Concomitant therapy included unspecified allergy medication. On 10-APR-2014, the patient experienced swelling at the injection site. No treatment was given for the adverse event. The patient did not seek medical attention. The patient's son stated that his mother could skip a year of shingles but they always returned, usually in the cranial area. The patient was given a prescription for ZOSTAVAX by physician and was told to wait until her last shingles symptoms cleared, then got the ZOSTAVAX vaccine. In approximately April 2014, after a few days, the swelling went away, reported as recovered. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX. Dose, route, lot number and dose number were not reported. On an unknown date the patients experienced injection site reactions after administration of ZOSTAVAX. The outcome of pharmacist had been seeing a lot of injection site reactions after administration of ZOSTAVAX was unknown. Reporter causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from C.M.A. nurse refers to a female patient of unknown age. ON 07-FEB-2014 the patient was vaccinated with GARDASIL dose 2, and patient was vaccinated with her first dose of GARDASIL on 27-FEB-2012. Patient was in office on 15-APR-2014, requesting administration of third dose. Patient did not experience any adverse effects due to dosing of GARDASIL outside of prescribing information. Patient did not seek medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Local reaction, Local swelling, Rash macular, Swelling face, Urticaria
Clinical narrative: Almost immediately after vaccines she got erythematous macular rash and then with 10-15 min hives on arms and legs large (6-8 cm) local reaction; also with some facial and foot swelling. BENADRYL and 30mg prednisone within 2 hours much better.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Tenderness
Clinical narrative: Patient called at 10:00 am on 4/24/14 complaining that arm was tender to the touch. With a circle around the area where the shot was given.
Age: 25.0
Sex: M
Vaccine: YF
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient received YF vaccine on 4/17/14. He reported redness at injection site starting on 4/22/14 and becoming more warm, tender, swollen and red over the past two days. He now reports rash is about 2 1/2 in. in diameter. He also reports low-grade fever and fatigue.
Age: 25.0
Sex: M
Vaccine: YF
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Patient received YF vaccine on 4/17/14. He reported redness at injection site starting on 4/22/14 and becoming more warm, tender, swollen and red over the past two days. He now reports rash is about 2 1/2 in. in diameter. He also reports low-grade fever and fatigue.
Age: 1.22
Sex: F
Vaccine: MMR, PNC13
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Urticaria rash on the body. Temp 99.7. (Back, trunk, abd wall, all ext) No resp. distress.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes, Pain in jaw
Clinical narrative: Pt rec. vaccine on 4/5/13. Sat. The next Tuesday pt developed jaw pain and saw dentist. Shingles developed on face and in mouth.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Localized reaction at injection site - large area of erythema per MD note dated 4/23/14. Pt has recovered from most of it since then.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Local swelling, Pain in extremity
Clinical narrative: Swelling right anterior thigh. Painful (not bruised. not erythematous). Refusing to walk.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Immediately following vaccine which was administered high in my left shoulder, I started to feel pain.  I figured it was the shot but as the night went on it got worse.  Woke up the next morning and couldn't even move my arm.  I called my primary physician and was in to see him at 11:00 AM the next morning, 08/24/2011.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site reaction, Laceration
Clinical narrative: This case was received on 15 April 2014 via a third party query tool search on the VAERS database, under reference number 520018. A 26-year-old male patient, date of birth not reported, received the following vaccination on 11 December 2013: ACAM2000 (lot number VV04003A). Three weeks after vaccination on 01 January 2014, the patient experienced a break in his skin left upper arm. It was treated like smallpox and covered with a separate bandage. "Likely caused secondary smallpox site per doc". The patient's medical history and concomitant medications were reported as none. Laboratory tests were none. The patient recovery is unknown. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site reaction, Skin disorder
Clinical narrative: This case was received on 15 April 2014 via a third party query tool search on the VAERS database, under reference number 520018. A 26-year-old male patient, date of birth not reported, received the following vaccination on 11 December 2013: ACAM2000 (lot number VV04003A). Three weeks after vaccination on 01 January 2014, the patient experienced a break in his skin left upper arm. It was treated like smallpox and covered with a separate bandage. "Likely caused secondary smallpox site per doc". The patient's medical history and concomitant medications were reported as none. Laboratory tests were none. The patient recovery is unknown. Documents held by sender: None.
Age: 5.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Cellulitis, Cough, Ear pain, Injected limb mobility decreased, Injection site erythema
Clinical narrative: This spontaneous report was received from a health care worker via physician refers to a patient of unknown demographics. Approximately on 27-MAR-2014 (reported as about 2 weeks ago) the patient was vaccinated with VARIVAX (Merck) (dose, strength and dose number was not reported). No concomitant medication was reported. Approximately on 27-MAR-2014 (also reported as about 2 weeks ago) the patient experienced cellulitis. Patient had sought medical attention and contacted physician. There was no product quality complaint involved. The outcome of cellulitis was reported as recovered approximately on an unknown date in 2014. Causality assessment was not provided. Follow up information has been received from an unspecified type reporter. The 5 year old patient developed cellulitis after vaccinated with a dose of VARIVAX (Merck) (lot # J003711, expired date 27-MAR-2015). The patient was hospitalized from 02-APR-2014 to 04-APR-2014. The patient was treated with unspecified intravenous (IV) antibiotics and recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Injection site pain, Injection site scab, Injection site swelling, Myalgia, Nasopharyngitis
Clinical narrative: This spontaneous report was received from a health care worker via physician refers to a patient of unknown demographics. Approximately on 27-MAR-2014 (reported as about 2 weeks ago) the patient was vaccinated with VARIVAX (Merck) (dose, strength and dose number was not reported). No concomitant medication was reported. Approximately on 27-MAR-2014 (also reported as about 2 weeks ago) the patient experienced cellulitis. Patient had sought medical attention and contacted physician. There was no product quality complaint involved. The outcome of cellulitis was reported as recovered approximately on an unknown date in 2014. Causality assessment was not provided. Follow up information has been received from an unspecified type reporter. The 5 year old patient developed cellulitis after vaccinated with a dose of VARIVAX (Merck) (lot # J003711, expired date 27-MAR-2015). The patient was hospitalized from 02-APR-2014 to 04-APR-2014. The patient was treated with unspecified intravenous (IV) antibiotics and recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a health care worker via physician refers to a patient of unknown demographics. Approximately on 27-MAR-2014 (reported as about 2 weeks ago) the patient was vaccinated with VARIVAX (Merck) (dose, strength and dose number was not reported). No concomitant medication was reported. Approximately on 27-MAR-2014 (also reported as about 2 weeks ago) the patient experienced cellulitis. Patient had sought medical attention and contacted physician. There was no product quality complaint involved. The outcome of cellulitis was reported as recovered approximately on an unknown date in 2014. Causality assessment was not provided. Follow up information has been received from an unspecified type reporter. The 5 year old patient developed cellulitis after vaccinated with a dose of VARIVAX (Merck) (lot # J003711, expired date 27-MAR-2015). The patient was hospitalized from 02-APR-2014 to 04-APR-2014. The patient was treated with unspecified intravenous (IV) antibiotics and recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a health care worker via physician refers to a patient of unknown demographics. Approximately on 27-MAR-2014 (reported as about 2 weeks ago) the patient was vaccinated with VARIVAX (Merck) (dose, strength and dose number was not reported). No concomitant medication was reported. Approximately on 27-MAR-2014 (also reported as about 2 weeks ago) the patient experienced cellulitis. Patient had sought medical attention and contacted physician. There was no product quality complaint involved. The outcome of cellulitis was reported as recovered approximately on an unknown date in 2014. Causality assessment was not provided. Follow up information has been received from an unspecified type reporter. The 5 year old patient developed cellulitis after vaccinated with a dose of VARIVAX (Merck) (lot # J003711, expired date 27-MAR-2015). The patient was hospitalized from 02-APR-2014 to 04-APR-2014. The patient was treated with unspecified intravenous (IV) antibiotics and recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site reaction, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 30-MAR-2014 the patient was vaccinated with ZOSTAVAX (dose 0.65 ml, one time vaccine, route described as injection, lot # J011341, expiry date 13-DEC-2014). On 31-MAR-2014 the patient experienced injection site swelling and injection site blister and was sick in bed for a week. No specific symptoms were reported for the sickness. The patient sought medical attention. She went to urgent care and primary doctor. On unknown date the patient recovered from the events. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin exfoliation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 30-MAR-2014 the patient was vaccinated with ZOSTAVAX (dose 0.65 ml, one time vaccine, route described as injection, lot # J011341, expiry date 13-DEC-2014). On 31-MAR-2014 the patient experienced injection site swelling and injection site blister and was sick in bed for a week. No specific symptoms were reported for the sickness. The patient sought medical attention. She went to urgent care and primary doctor. On unknown date the patient recovered from the events. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 30-MAR-2014 the patient was vaccinated with ZOSTAVAX (dose 0.65 ml, one time vaccine, route described as injection, lot # J011341, expiry date 13-DEC-2014). On 31-MAR-2014 the patient experienced injection site swelling and injection site blister and was sick in bed for a week. No specific symptoms were reported for the sickness. The patient sought medical attention. She went to urgent care and primary doctor. On unknown date the patient recovered from the events. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Muscle twitching, Pyrexia, Respiratory arrest, Somnolence, Vomiting
Clinical narrative: This is an initial spontaneous report by a contactable nurse, calling from a physician's office. A 2 month old male patient received PREVNAR 13 (Lot #: H00004, Exp date: Feb2015. NDC#: 0005197102) 0.5ml intramuscular injection unknown frequency on his left thigh at around 13:00 hrs on 11Apr2014. Relevant medical history was none. Relevant concomitant medications were none. Vaccines given on the same day included PENTACEL on right thigh, hepatitis B vaccine on left thigh for which one previous dose was already given and rotavirus vaccine by oral route. Vaccines taken within the last four weeks were none. On 12Apr2014 the patient experienced the following events: he felt extremely drowsy as it was hard to wake him, vomiting, stopped breathing, his one eye rolled back in head and one eye rolled to the side, his leg started to twitch, and he had mild fever of 100.5 degrees Fahrenheit and due to all these events he was sent to emergency room on 12Apr2014 at 05:00 hours. Relevant sibling information was none. Relevant lab was none. At the time of the report he had recovered from vomiting, stopped breathing, his one eye rolled back in head and one eye rolled to the side, his leg started to twitch and mild fever of 100.5 degrees Fahrenheit on 12Apr2014. At the time of report he was not recovered from extremely drowsy and it was hard to wake him.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Gaze palsy, Muscle twitching, Pyrexia, Respiratory arrest, Somnolence
Clinical narrative: This is an initial spontaneous report by a contactable nurse, calling from a physician's office. A 2 month old male patient received PREVNAR 13 (Lot #: H00004, Exp date: Feb2015. NDC#: 0005197102) 0.5ml intramuscular injection unknown frequency on his left thigh at around 13:00 hrs on 11Apr2014. Relevant medical history was none. Relevant concomitant medications were none. Vaccines given on the same day included PENTACEL on right thigh, hepatitis B vaccine on left thigh for which one previous dose was already given and rotavirus vaccine by oral route. Vaccines taken within the last four weeks were none. On 12Apr2014 the patient experienced the following events: he felt extremely drowsy as it was hard to wake him, vomiting, stopped breathing, his one eye rolled back in head and one eye rolled to the side, his leg started to twitch, and he had mild fever of 100.5 degrees Fahrenheit and due to all these events he was sent to emergency room on 12Apr2014 at 05:00 hours. Relevant sibling information was none. Relevant lab was none. At the time of the report he had recovered from vomiting, stopped breathing, his one eye rolled back in head and one eye rolled to the side, his leg started to twitch and mild fever of 100.5 degrees Fahrenheit on 12Apr2014. At the time of report he was not recovered from extremely drowsy and it was hard to wake him.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: This is an initial spontaneous report by a contactable nurse, calling from a physician's office. A 2 month old male patient received PREVNAR 13 (Lot #: H00004, Exp date: Feb2015. NDC#: 0005197102) 0.5ml intramuscular injection unknown frequency on his left thigh at around 13:00 hrs on 11Apr2014. Relevant medical history was none. Relevant concomitant medications were none. Vaccines given on the same day included PENTACEL on right thigh, hepatitis B vaccine on left thigh for which one previous dose was already given and rotavirus vaccine by oral route. Vaccines taken within the last four weeks were none. On 12Apr2014 the patient experienced the following events: he felt extremely drowsy as it was hard to wake him, vomiting, stopped breathing, his one eye rolled back in head and one eye rolled to the side, his leg started to twitch, and he had mild fever of 100.5 degrees Fahrenheit and due to all these events he was sent to emergency room on 12Apr2014 at 05:00 hours. Relevant sibling information was none. Relevant lab was none. At the time of the report he had recovered from vomiting, stopped breathing, his one eye rolled back in head and one eye rolled to the side, his leg started to twitch and mild fever of 100.5 degrees Fahrenheit on 12Apr2014. At the time of report he was not recovered from extremely drowsy and it was hard to wake him.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Gaze palsy, Immunisation reaction, Muscle twitching, Respiratory arrest
Clinical narrative: This is an initial spontaneous report by a contactable nurse, calling from a physician's office. A 2 month old male patient received PREVNAR 13 (Lot #: H00004, Exp date: Feb2015. NDC#: 0005197102) 0.5ml intramuscular injection unknown frequency on his left thigh at around 13:00 hrs on 11Apr2014. Relevant medical history was none. Relevant concomitant medications were none. Vaccines given on the same day included PENTACEL on right thigh, hepatitis B vaccine on left thigh for which one previous dose was already given and rotavirus vaccine by oral route. Vaccines taken within the last four weeks were none. On 12Apr2014 the patient experienced the following events: he felt extremely drowsy as it was hard to wake him, vomiting, stopped breathing, his one eye rolled back in head and one eye rolled to the side, his leg started to twitch, and he had mild fever of 100.5 degrees Fahrenheit and due to all these events he was sent to emergency room on 12Apr2014 at 05:00 hours. Relevant sibling information was none. Relevant lab was none. At the time of the report he had recovered from vomiting, stopped breathing, his one eye rolled back in head and one eye rolled to the side, his leg started to twitch and mild fever of 100.5 degrees Fahrenheit on 12Apr2014. At the time of report he was not recovered from extremely drowsy and it was hard to wake him.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Somnolence, Vomiting
Clinical narrative: This is an initial spontaneous report by a contactable nurse, calling from a physician's office. A 2 month old male patient received PREVNAR 13 (Lot #: H00004, Exp date: Feb2015. NDC#: 0005197102) 0.5ml intramuscular injection unknown frequency on his left thigh at around 13:00 hrs on 11Apr2014. Relevant medical history was none. Relevant concomitant medications were none. Vaccines given on the same day included PENTACEL on right thigh, hepatitis B vaccine on left thigh for which one previous dose was already given and rotavirus vaccine by oral route. Vaccines taken within the last four weeks were none. On 12Apr2014 the patient experienced the following events: he felt extremely drowsy as it was hard to wake him, vomiting, stopped breathing, his one eye rolled back in head and one eye rolled to the side, his leg started to twitch, and he had mild fever of 100.5 degrees Fahrenheit and due to all these events he was sent to emergency room on 12Apr2014 at 05:00 hours. Relevant sibling information was none. Relevant lab was none. At the time of the report he had recovered from vomiting, stopped breathing, his one eye rolled back in head and one eye rolled to the side, his leg started to twitch and mild fever of 100.5 degrees Fahrenheit on 12Apr2014. At the time of report he was not recovered from extremely drowsy and it was hard to wake him.
Age: 0.3
Sex: M
Vaccine: HIBV, PPV
Symptoms: Allergy test positive, Asthma, Crying, Eczema, Food allergy
Clinical narrative: Fever of over 101 for three days, cried almost non-stop. Food allergies, eczema, and asthma started within one month.
Age: 0.3
Sex: M
Vaccine: HIBV, PPV
Symptoms: Pyrexia
Clinical narrative: Fever of over 101 for three days, cried almost non-stop. Food allergies, eczema, and asthma started within one month.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Red spots with rash in the areas - head itching - hives/ rash on ribs, head, shoulders- Benadryl on my regiment of medicines - prescribed triamcinolone acetonide cream apply 3 times daily for 7 days.
Age: 22.0
Sex: F
Vaccine: DT, HEP
Symptoms: Hypoaesthesia, Migraine, Muscular weakness, Neurological symptom
Clinical narrative: Numbness in feet, feeling in hands intermittent, migraine headaches, knee giving out, and other neurological issues.
Sex: U
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to 3 patients of unknown age. The pharmacist reported that 3 patients developed significant arm swelling after administration of PNEUMOVAX 23 (lot# was not reported) 8 months ago. On an unknown date the patient experienced arm swelling. The outcome of arm swelling was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 22 year old female patient. On 18-APR-2014 the patient was supposed to receive her first dose of VARIVAX, but was inadvertently vaccinated with ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Abnormal behaviour, Decreased appetite, Slow speech
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old male patient. The patient's pertinent medical history was not reported. On an unspecified date in October 2013 the patient was vaccinated with second dose of GARDASIL. The patient's mother brought the patient in for a follow up exam on an unspecified date in March 2014 and stated that after the second dose of GARDASIL, the patient experienced slow speech, loss of appetite and was not acting like himself on an unspecified date. The physician examined the patient and did not find anything outside of the "normal". The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Malaise, Pyrexia
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old patient of unknown gender. No information on medical history, concurrent conditions or concomitant medications was provided. On an unknown date the patient was vaccinated with MMR II dose, site and route of administration, lot#, expiration date not reported. On an unknown date the patient developed fever of 103.3 F, and was seen in the physician's office six days after vaccination. The patient was diagnosed with an "illness", but did not specify any diagnosis or treatment. No further information on the diagnosis or treatment provided. The outcome of illness and fever was reported as not recovered/not resolved. Relatedness between the adverse events and the use of the vaccine was not reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Muscle spasms, Neck pain, Pain in extremity
Clinical narrative: Injection site swollen, pain radiated up neck and down arm--had muscle spasms in affected side hand.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Eye irritation, Headache, Hyperhidrosis, Malaise
Clinical narrative: The pain awakened me approx 2 am (Tues) and sleep was very restless. Any mvt from my rt arm was very painful. Took an ASA. Didnt feel real well off/on throughout the day but didnt think it warrented me from not going to work that night. I work 12 hr shift at the Sleep Diagnostic Cntr this week Tues, Wed and Thrs. By 6:30 (I was at work) I was nauseous, Headache and then started running a fever (eyes started burning, chills and body aches). Fever broke approx 830pm and then sweat profusely. My fever came back approx 1am, chills, body aches, arm was/is feverish, headache) I had this the rest of the night. Left work at 7am, went straight to bed and slept 8.5 hrs that day (Wed) (I never sleep this long during the day). When i awakened, I felt better, arm felt a little better.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Middle insomnia, Nausea, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: The pain awakened me approx 2 am (Tues) and sleep was very restless. Any mvt from my rt arm was very painful. Took an ASA. Didnt feel real well off/on throughout the day but didnt think it warrented me from not going to work that night. I work 12 hr shift at the Sleep Diagnostic Cntr this week Tues, Wed and Thrs. By 6:30 (I was at work) I was nauseous, Headache and then started running a fever (eyes started burning, chills and body aches). Fever broke approx 830pm and then sweat profusely. My fever came back approx 1am, chills, body aches, arm was/is feverish, headache) I had this the rest of the night. Left work at 7am, went straight to bed and slept 8.5 hrs that day (Wed) (I never sleep this long during the day). When i awakened, I felt better, arm felt a little better.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: The pain awakened me approx 2 am (Tues) and sleep was very restless. Any mvt from my rt arm was very painful. Took an ASA. Didnt feel real well off/on throughout the day but didnt think it warrented me from not going to work that night. I work 12 hr shift at the Sleep Diagnostic Cntr this week Tues, Wed and Thrs. By 6:30 (I was at work) I was nauseous, Headache and then started running a fever (eyes started burning, chills and body aches). Fever broke approx 830pm and then sweat profusely. My fever came back approx 1am, chills, body aches, arm was/is feverish, headache) I had this the rest of the night. Left work at 7am, went straight to bed and slept 8.5 hrs that day (Wed) (I never sleep this long during the day). When i awakened, I felt better, arm felt a little better.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Exposure to body fluid, HIV test, Injury associated with device, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who was also a female patient. The pharmacist stated that on 12-APR-2014, after administering a dose of ZOSTAVAX (lot number unknown) to a patient, she had a 'needle stick' with that same needle that was used to immunize an unspecified patient. The pharmacist was evaluated at an unspecified emergency room as per the 'needle stick' protocol at her pharmacy. Human immunodeficiency virus (HIV) blood test and other unspecified blood tests were collected in the emergency room. The pharmacist (age unknown) had a chicken pox in the past. No adverse effect reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 20 year old female patient. Patients pertinent medical history, drug reactions and allergies were reported as none. On 16-APR-2014, the patient accidentally received PNEUMOVAX 23 injection, (lot number J009827 expiry date 10-AUG-2014), 0.5 ml, subdermal instead of Purified Protein Derivative (PPD) test. Concomitant therapy was reported as none. The healthcare worker states that the patient was seen in the office on 18-APR-2014 to have her PPD read and it was realized then that PNEUMOVAX 23 was accidentally administered on 16-APR-2014 instead. On 18-APR-2014, swelling was noted at the injection site. The patient reported that the physician prescribed the patient ZYRTEC on 18-APR-2014. No lab diagnostics studies were performed. No product quality complaint was involved. The outcome of event swelling was noted at the injection site was reported as recovering. The outcome of a patient accidentally received PNEUMOVAX 23 instead of a PPD test and PNEUMOVAX 23 administered subdermally was unknown. The reporters causality assessment for the event swelling was noted at the injection site with the therapy of PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her 6 months old son with no pertinent medical history, drug reactions or allergies. On 07-APR-2014 the patient was vaccinated with a dose of MMR II (route, dose, lot# and expiry date not reported). Concomitant therapy included reflux medication (unspecified). The reporter stated that her son was administered vaccinations intended for a twelve-month-old, instead of a six-month-old children. The consumer reported that the physician stated that the patient would need to be re-vaccinated at the appropriate age for the twelve-month-old vaccines. The consumer stated that three vaccines were administered, but could only identify one as MMR II. The consumer was concerned about any potential problems with additional vaccinations. No adverse symptoms were reported. The patient did not take any medication for treatment. Lab diagnostic studies were not performed. The patient did not seek medical attention. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Respiratory disorder
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date in August 2013 (also reported as 8 months ago)the patient was vaccinated with first dose of GARDASIL (0.5 ml) intramuscular. The physician called the patient's mother to remind for the second dose of GARDASIL. The physician stated that the patient was out of the country at the time of second dose was due. On an unknown date, the patient experienced unspecified respiratory illness. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to case 1404USA013210 (same reporter link). Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 17 year old male patient. No pertinent medical history of the patient was reported. On 16-APR-2014 the patient was vaccinated with GARDASIL, (dose number, dose, lot number and expiration dates were not reported) intramuscular. No concomitant medications were reported. On 16-APR-2014, the patient was inadvertently administered two doses of GARDASIL. There were no adverse effects reported. It was unspecified whether the patient had sought medical attention. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a physician refers to unknown number of patients. On an unknown date, unspecified number of patients were vaccinated with first dose of GARDASIL (dose, route and frequency were not reported). On an unkown date, the unspecified number of patients experienced pain. The physician also reported that there was no adverse effects on the second and third dose of GARDASIL. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1404USA013021 (same reporter link). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Diarrhoea, Full blood count, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative and refers to a 19 year old non-pregnant female patient. The patient was vaccinated with the first dose of GARDASIL (lot # H021346, expiry date: 01-OCT-2015) on 07-MAY-2013, with second dose of 17-JUL-2013 and third dose of GARDASIL (route and administration not specified). Concomitant therapies included doxycycline (manufacturer unknown) and an unspecified topical acne medication. Patient's medical history included acne. No known allergies were reported. The healthcare worker reported that the patient on 15-APR-2014 after receiving third dose of GARDASIL the patient developed vomiting (vomited twice), diarrhoea, a stomach ache and nausea and was still having a stomach ache during an office visit on 16-APR-2014 (reported as yesterday). There was no adverse events reported with the first two doses of GARDASIL. The treatment was given for the adverse events: fluids and ZOFRAN (manufacturer unknown). Laboratory test: complete blood count was performed on 16-APR-2014 in the office. The outcome of the events was recovering/resolving. The relationship between the GARDASIL and the events was unknown. This is one of several reports received from the same reporter (case # 1404USA012598). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: Information was received from a registered nurse regarding an adult female patient, age unknown, who recently had her antibody levels checked and was found to have a negative measles titer. The nurse was not sure if the patient had received MMR II (albumin status unknown) in the past because she did not have the patient's chart available at the time of the report. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Developed a mild fever that changed over to a moderate fever after 24 hours (04/04/2014 07:00pm) and then subsided about 36 hours after that.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a consumer (patient mother) refers to a male patient of unknown age. On an unknown date at 12 months of age, the patient was vaccinated with VARIVAX (Merck) 1350 U (dose, route and frequency were not reported). Other suspect therapies included M-M-R II (dose, route and frequency were not reported). On an unknown date at 24 months of age, the patient experienced autism. The consumer also stated that the patient also received other vaccines (brand names and manufactures unknown) on an unknown date. The consumer also reported that on an unknown date, inadvertently received 2 doses of polio vaccine (brand name and manufacturer unknown). The consumer called and stated that what was the duration of immunity after one dose of VARIVAX (Merck) and M-M-R II and also stated that can titers be drawn as evidence of immunity for VARIVAX (Merck) and M-M-R II. AE filed. No PQC. Preemie 7 weeks early titers. The outcome of the event autism was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 15-APR-2014 the patient was vaccinated subcutaneously with an improperly stored (that was exposed to 8F for 14 minutes) 0.5 ml dose of VARIVAX (Merck) (lot number: J005427 and expiration date: 02-MAY-2015). No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Local swelling
Clinical narrative: Patient's Right arm was swollen.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: C-reactive protein increased, Groin pain, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: Unexplained pain right groin and thigh. Continuous. Self administered Advil.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Groin pain, Muscle tightness, Polymyalgia rheumatica
Clinical narrative: Unexplained pain right groin and thigh. Continuous. Self administered Advil.
Age: 25.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Chills, Decreased appetite, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Reaction to pneumo vaccine. Swelling of injection site on right deltoid. Injection site very painful, entire arm hurting. Fever (up to 101.5 degrees), muscle weakness, chills, fatigue, loss of appetite.
Age: 25.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Reaction to pneumo vaccine. Swelling of injection site on right deltoid. Injection site very painful, entire arm hurting. Fever (up to 101.5 degrees), muscle weakness, chills, fatigue, loss of appetite.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid swelling, redness, erythema and warm to touch - 20 cm red area underside of (L) arm and 10 cm red area inside of (L) arm.
Age: 78.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 78 year old patient. Medical history and concurrent conditions were not reported. On 13-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J009689; expiration date: 29-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm ) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Nurse reported about other patients who were vaccinated with improperly stored ROTATEQ (captured into MARRS #1403USA014557). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Aggression
Clinical narrative: Mom called office stating pt had severe behavioral changes with some aggression since injection.
Age: 1.39
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Erythema, Injection site abscess, Nodule, Pain
Clinical narrative: Patient developed abscess on (R) thigh at injection site about 6 days after vaccine administration. Afebrile in office on 4/22/14 4 x 5 cm erythematous, fluctuant painful nodule noted.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness
Clinical narrative: After receiving a Hep A inj. pt passed out. He did recover quickly.
Age: 18.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea after taking 1st capsule.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Rash, Respiration abnormal, Respiratory rate increased
Clinical narrative: 1050 AM - Pt called in states had felt warm when leaving after vaccine given - presently feeling dizzy, breathing fast and funny. BP 140/95- states previous vaccine she noted a rash on arms. Husband is Dr. - advised to seek medical care per nurse.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza B virus test positive
Clinical narrative: Initial case received from a Health Care professional on 15 April 2014. A 46-year-old male patient, with a reported medical history of seasonal allergies and no reported concomitant therapies, had received an intradermal dose of FLUZONE on 30 October 2013 (batch number UT4722BA, site of administration not reported). The reporter denied any illness at time of vaccination in the patient. On 01 April 2014, the patient was tested positive for influenza B with a Rapid Test. He received a corrective treatment with TAMIFLU. The outcome was reported as unknown. The reporter also reported another adverse event which is captured in case number 2014SA049810 (same product and same reporter). Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Influenza A virus test positive
Clinical narrative: Initial case received from a literature article on 11 April 2014. This case is linked to the case nos.2014SA052439, 2014SA052440, 2014SA052441 (same reporter). Out of the 23 patients who received Influenza vaccine on an unspecified date, 10 patients were tested positive for influenza A (subtype pending). The patient's demographic details, medical history and concomitant medications were not reported. The batch number, route and site of administration of Influenza vaccine were not reported. Laboratory data and corrective treatment details were not reported. At the time of this report, the outcome was unknown. List of documents held by sender were none.
Age: 1.07
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Rash
Clinical narrative: Child received chicken pox shot on 04/22/2014 and child had small rash 04/23/2014.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: 4/24/14 Morning began w/ rash in groin area and down upper legs. One larger red spot on abd. (+) itching (-) fever.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Fever and lethargy, not feeling normally. Local area of redness/swelling at injection site.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Contusion, Immediate post-injection reaction, Local swelling
Clinical narrative: Immediately after given vaccine (IM), pt's (L) arm began to bruise and swell very quickly. I asked pt if he had any other sx and he reported no other sx. I had pt stay seated and hold an ice pack over the area for 20 minutes. I continued to talk to him to assess his status during those 20 min. After 20 min. swelling decreased significantly and pt went home.