chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified multiple patients of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified dates, the patients were vaccinated with a dose of improperly stored VARIVAX lot # L035124, expiration date of 14-SEP-2017 and lot #: L027287, expiration date of 21-JUL-2017  (strength, dose number, and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 63 hours: >5° Fahrenheit but < 14°Fahrenheit; the highest temperature was 6°Fahrenheit. Reportedly, there had been no previous temperature excursions. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA004735:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of ROTATEQ orally (strength, dose number, frequency, lot number and expiration date were not provided)  for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005965: US-009507513-1701USA005969: US-009507513-1701USA005967: US-009507513-1701USA005968: US-009507513-1701USA004881: US-009507513-1701USA005966:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of PNEUMOVAX 23 (strength, dose number, route, frequency, lot number and expiration date were not provided) for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004881: US-009507513-1701USA005969: US-009507513-1701USA005967: US-009507513-1701USA005968: US-009507513-1701USA005964: US-009507513-1701USA005966.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of RECOMBIVAX HB (strength, dose number, route, frequency, lot number and expiration date were not provided)  for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005965: US-009507513-1701USA005969: US-009507513-1701USA005967: US-009507513-1701USA005968: US-009507513-1701USA005964: US-009507513-1701USA004881:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of GARDASIL (strength, dose number, route, frequency, lot number and expiration date were not provided)  for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005965: US-009507513-1701USA005969: US-009507513-1701USA004881: US-009507513-1701USA005968: US-009507513-1701USA005964: US-009507513-1701USA005966.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (strength, dose number, route, frequency, lot number and expiration date were not provided) for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005965: US-009507513-1701USA005969: US-009507513-1701USA005967: US-009507513-1701USA004881: US-009507513-1701USA005964: US-009507513-1701USA005966.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of PEDVAXHIB (strength, dose number, route, frequency, lot number and expiration date were not provided) for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005965: US-009507513-1701USA004881: US-009507513-1701USA005967: US-009507513-1701USA005968: US-009507513-1701USA005964: US-009507513-1701USA005966.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not reported. On 08-MAR-2016, the patient was vaccinated with a dose of GARDASIL which had a lot # of K016966, an expiration date of 10-MAY-2017 (concentration, dose, dose number, route and anatomical place of vaccination were not provided), for prophylaxis. Subsequently on 11-NOV-2016, the patient was vaccinated with a dose of GARDASIL 9 which had a lot # of M023169, an expiration date of 13-JUN-2018 (concentration, dose, dose number, route and anatomical place of vaccination were not provided), for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot # M036459 exp date 18-JAN-2018) (route and dose not reported). The detail of the storage was a temperature excursion to 35 F for 24 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA006148: US-009507513-1701USA001796:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M016193 exp date 24-APR-2018) (route and dose not reported). The detail of the storage was a temperature excursion to 35 F for 24 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA001796: US-009507513-1701USA006147.
Age: 68.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site discomfort, Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: Pain/discomfort in right upper arm/shoulder (injection site), getting progressively worse over past 6 weeks and now going all the way down arm to hand.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain and swelling.  Pt states that she was anot able to use the arm d/t the pain.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 24 HRS AFTER TDAP INJECTION TO LEFT DELTOID, DONOR NOTICED WARMTH AND REDDNESS IN CIRCULAR AREA OF INJECTION WITH PAIN . NO TREATMENT DONE. 8 HR LATER REDDENED WAS LARGER WITHOUT TREATMENT PERFORMED. 5 DAYS LATER DONOR RETURNED TO CENTER WITH REDDNESS AND PAIN FROM UPPER ARM TO ELBOW WITH SWELLING NOTED IN INNER ELBOW AREA. DONOR STATES HE ONLY TOOK IBUPROFEN LAST EVENING.
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: Initial unsolicited case received from a consumer (patient herself)  on 09 Jan 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (Batch number, expiry date, dose and site of administration was not reported) administered intramuscularly on an unspecified date in Oct 2016. The patient illness at the time of vaccination , Pre-existing physician diagnosed allergies, birth defects, medical conditions was not provided and Any other vaccinations within 4 weeks of vaccinations was not reported. The patient concomitant medications were unknown. On an unknown date in Oct 2016, after the vaccination the patient had 3 or 4 colds, runny nose, sneezing and feeling tired. The patient lab tests and corrective treatment was unknown. The outcome of the events were unknown. List of documents held by sender: none.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: 6 non-pruritic, scattered, fluid-filled vesicles on skin of arms bilaterally.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient had syncope & collapse after receiving TDAP & MENACTRA.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Patient was given a vaccine that was expired for 2 days.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Broke out with hives and swelling of right arm and hives on Back.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Contusion, Fatigue, Immediate post-injection reaction
Clinical narrative: Right after the injection, patient states she had bruising and a rash around the injection site (fatty area above her right tricep). About a week and a half later, she noticed bruising appear on her other arm and on her lower abdomen. Multiple dark brown, circular bruises with uneven margins, roughly the size of a dime, were observed on the upper left arm in the tricep area. She reports having the same bruises on her lower abdomen; however, when she briefly showed us, it looked more like petechiae. Patient also has a diffuse, red, itchy rash on the top of her lower arms and on her upper right chest. She denies taking any regular immunosuppressants for lupus; her flares are typically internal related to joint pain and cardiac issues. She also reported having a fever blister roughly one week after the injection; she hasn't had a fever blister in years. She came to the pharmacy today to check her blood pressure because she was feeling very tired and weak with increased pain in her knee joints, more than normal.  Her blood pressure was 126/73mmHg. She reports starting a new diet and losing 7 pounds in the last week.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash, Oral herpes, Petechiae, Rash
Clinical narrative: Right after the injection, patient states she had bruising and a rash around the injection site (fatty area above her right tricep). About a week and a half later, she noticed bruising appear on her other arm and on her lower abdomen. Multiple dark brown, circular bruises with uneven margins, roughly the size of a dime, were observed on the upper left arm in the tricep area. She reports having the same bruises on her lower abdomen; however, when she briefly showed us, it looked more like petechiae. Patient also has a diffuse, red, itchy rash on the top of her lower arms and on her upper right chest. She denies taking any regular immunosuppressants for lupus; her flares are typically internal related to joint pain and cardiac issues. She also reported having a fever blister roughly one week after the injection; she hasn't had a fever blister in years. She came to the pharmacy today to check her blood pressure because she was feeling very tired and weak with increased pain in her knee joints, more than normal.  Her blood pressure was 126/73mmHg. She reports starting a new diet and losing 7 pounds in the last week.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Weight decreased
Clinical narrative: Right after the injection, patient states she had bruising and a rash around the injection site (fatty area above her right tricep). About a week and a half later, she noticed bruising appear on her other arm and on her lower abdomen. Multiple dark brown, circular bruises with uneven margins, roughly the size of a dime, were observed on the upper left arm in the tricep area. She reports having the same bruises on her lower abdomen; however, when she briefly showed us, it looked more like petechiae. Patient also has a diffuse, red, itchy rash on the top of her lower arms and on her upper right chest. She denies taking any regular immunosuppressants for lupus; her flares are typically internal related to joint pain and cardiac issues. She also reported having a fever blister roughly one week after the injection; she hasn't had a fever blister in years. She came to the pharmacy today to check her blood pressure because she was feeling very tired and weak with increased pain in her knee joints, more than normal.  Her blood pressure was 126/73mmHg. She reports starting a new diet and losing 7 pounds in the last week.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The patient stated she felt soreness at injection site on Monday, 01/16/2017, morning and noticed a little redness as well. She went to her prescriber, and he instructed her to take some Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Erythema, Erythema of eyelid, Eyelid oedema, Swelling face
Clinical narrative: Patient had crying for an "extended" period of time on 01/06/17, (unable to get amount from parent); Redness and puffiness of eye lids and face following admin. On 01/06/17 at 3:45pm through Saturday 01/07/17. Resolved 01/08/17. No fever or reaction at injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain
Clinical narrative: Injection in deltoid-initially had soreness and tenderness in deltoid-currently pain is supraspinatus and insertion on same side. Was sent for PT for ROM to prevent frozen shoulder.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Tonic clonic movements
Clinical narrative: On 1/11/17 patient had several seconds of tonic-clonic movements of all extremities which self resolved. It was followed by sleeping for 30 minutes and return to baseline.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reported redness from the injection site and travelling down her arm 2 days after receiving the ZOSTAVAX vaccine. She came into the pharmacy and showed me the area. To me it looked blush pink and a little swollen. The area was about 6 in. in length and 2-3 in. in width.
Age: 20.0
Sex: F
Vaccine: MENB, MMR, VARCEL
Symptoms: Measles, Pyrexia, Rash
Clinical narrative: Fever 12 days after vaccine followed by rash and oral Koplik spot 1/11 (13 days after vaccine).
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt. appears with small bump on (L) arm at injection site. C/O pain to site. No S/S of redness, or drainage or edema.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant (on behalf of a physician) via other company notification from Pfizer (manufacturer report number 2016558822), and refers to unspecified patients of unknown demographics. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On an unknown dates, the patients received an improperly stored (reported as "affected") doses of ROTATEQ expiration dates were not reported). The reporter stated that their daily use refrigerator was affected on an unknown date, so only 10 doses of ROTATEQ were placed in the fridge. Therefore, 10 doses of ROTATEQ were affected by temperature excursion. The reporter provided that the excursion reached the highest temperature of 49 degrees Fahrenheit for almost 2 hours on 22-NOV-2016 and 28-NOV-2016. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Disability, Drug administered at inappropriate site, Impaired driving ability, Impaired work ability
Clinical narrative: Initial unsolicited misuse report received from a nurse on 05-Jan-2017. This case involves a 42-year-old female patient, who was inadvertently vaccinated with 1 ml of FLUZONE QIV MDV via intradermal route (batch number: UI673AB, expiry date: 30-Jun-2017,) in right forearm instead of first dose of APPLISOL (manufacturer: PAR) (batch number: 772984; expiry date, route not reported) in left forearm on 12-Dec-2016. Patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies were reported as no known allergy and birth defects, medical conditions were reported as depression anxiety disorder. Patient's concomitant medication was not reported, any other vaccination within four weeks of suspect vaccination was reported as none. On 12-Dec-2016, same day following the vaccination, the patient developed redness at the site of the injection. On 19 December 2016 one week after the vaccination, patient had pain in right elbow that was difficult to move at all and patient was referred to ortho where she was diagnosed with a possible bursitis. On an unknown date, after the vaccination, patient reported that she was disabled due to the medication error and cannot drive or work. It was a case of wrong vaccine administration and inappropriate route of vaccination. Patient required emergency room/doctor visit on 19-Dec-2016. Patient had a right elbow X-ray negative. The patient received corrective treatment with Claritin and Medrol for vaccination site erythema. The outcome of the events was reported as not recovered. List of the documents held by sender none. Sender's Comments: Patient was wrongly vaccinated with influenza instead of PPD due to which patient had erythema at vaccinated site which was treated. A week later she had pain over right elbow which was diagnosed as bursitis due to which she was unable to work which lead to disability. Time to onset is compatible, additional information regarding patient medical history, disability whether temporary or permanent, and history of trauma over elbow or any positional problem like working with pressure on the elbow are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Injection site erythema, Mobility decreased, Wrong drug administered, X-ray limb normal
Clinical narrative: Initial unsolicited misuse report received from a nurse on 05-Jan-2017. This case involves a 42-year-old female patient, who was inadvertently vaccinated with 1 ml of FLUZONE QIV MDV via intradermal route (batch number: UI673AB, expiry date: 30-Jun-2017,) in right forearm instead of first dose of APPLISOL (manufacturer: PAR) (batch number: 772984; expiry date, route not reported) in left forearm on 12-Dec-2016. Patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies were reported as no known allergy and birth defects, medical conditions were reported as depression anxiety disorder. Patient's concomitant medication was not reported, any other vaccination within four weeks of suspect vaccination was reported as none. On 12-Dec-2016, same day following the vaccination, the patient developed redness at the site of the injection. On 19 December 2016 one week after the vaccination, patient had pain in right elbow that was difficult to move at all and patient was referred to ortho where she was diagnosed with a possible bursitis. On an unknown date, after the vaccination, patient reported that she was disabled due to the medication error and cannot drive or work. It was a case of wrong vaccine administration and inappropriate route of vaccination. Patient required emergency room/doctor visit on 19-Dec-2016. Patient had a right elbow X-ray negative. The patient received corrective treatment with Claritin and Medrol for vaccination site erythema. The outcome of the events was reported as not recovered. List of the documents held by sender none. Sender's Comments: Patient was wrongly vaccinated with influenza instead of PPD due to which patient had erythema at vaccinated site which was treated. A week later she had pain over right elbow which was diagnosed as bursitis due to which she was unable to work which lead to disability. Time to onset is compatible, additional information regarding patient medical history, disability whether temporary or permanent, and history of trauma over elbow or any positional problem like working with pressure on the elbow are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Computerised tomogram head normal, Decreased vibratory sense, Dysarthria, Electroencephalogram normal
Clinical narrative: Parasthesia in bilateral hands and feet, weakness in extremities, slurred speech parasthesia of lips/mouth, vision changes, back pain, pain in bilateral arms, mood changes.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Mood altered, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Parasthesia in bilateral hands and feet, weakness in extremities, slurred speech parasthesia of lips/mouth, vision changes, back pain, pain in bilateral arms, mood changes.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Paraesthesia oral, Visual impairment
Clinical narrative: Parasthesia in bilateral hands and feet, weakness in extremities, slurred speech parasthesia of lips/mouth, vision changes, back pain, pain in bilateral arms, mood changes.
Age: 13.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Blood pressure abnormal, Cold sweat, Dizziness, Malaise, Pallor
Clinical narrative: Pt was administered HAVRIX in left deltoid, then YF-VAX SQ in the right arm. Very shortly after administration of the second vaccine the patient said he did not feel well and described it as lightheadedness. His arm was clammy to the touch and he laid his head in his hands. We checked his blood pressure and it was 79/44. 911 was called. He remained responsive but clammy, lightheaded, and pale. Repeat BP was 68/54. He was given water to drink and 1 glucose tablet. He reported no nausea and was still responsive. Repeat BP was now to 100 systolic. EMS arrived and verified his BP was on upward trend. They instructed him to walk around with them. After about 15 minutes, EMTs cleared him to go and did not recommend taking him to the hospital. They took him to his car with his mother. His mother chose to take him to his pediatrician for follow-up today.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Pruritic rash starting in extremities and spreading to trunk/total body.  50mg diphenhydramine was taken and patient noted resolution upon waking the following morning.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swelling in arm at injection site with a bump like sore that is hot to touch.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain
Clinical narrative: REDNESS AND SORE.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: Lump on upper left deltoid/bicep region; at site of Tdap injection. Patient treated with Keflex TIDx 7 Days also to use Warm moist compresses on site.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Respiratory tract congestion
Clinical narrative: Pt asked for preservative free flu vaccine w/o thimerosal.  She said she has had anaphylactic rxn in past, & has had PF flu shot last 2 yrs and ok.  She was given AFLURIA (PF) but said she was experiencing shortness of breath and some chest/throat congestion.  We gave her 50mg benadryl and watched her for 25 min.  She was ok when she left the store.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 29-DEC-2016, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, route of administration was not provided (lot number K001500, expiration date 06-NOV-2016) (expired vaccine used) for prophylaxis. No adverse effects reported.   Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Death
Clinical narrative: This spontaneous report was received from a consumer via social media, referring to an unspecified number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with a dose of an unidentified HPV vaccine (name and lot number not provided) for prophylaxis. The reporter stated that "did research and found out a leading scientist for the drug came out and said it's killing kids". The reporter considered the event was related the unidentified Merck HPV vaccine. Upon internal review, the event "death" was considered to be medically significant. This is one of several reports received from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004856: US-009507513-1701USA005334: Interaction number.
Sex: M
Vaccine: HPVX
Symptoms: Paralysis
Clinical narrative: This spontaneous report was received from a consumer via social media, referring to an adolescent male patient of unknown age.  Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On an unknown date, the patient was vaccinated with a dose of vaccinated with a dose of an unidentified hpv vaccine (name and lot number not provided) for prophylaxis. The reporter stated that "the drug it's bad and it's paralyzed a teen boy". Upon internal review, the event "Paralysis" was considered to be medically significant. This is one of several reports received from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004850: US-009507513-1701USA005334.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report received from a nurse and refers to a 19 year old female patient. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported.    On an unknown date (reported as "in childhood"), the patient was vaccinated with routine doses of properly stored M-M-R II (route, dosage schedule, lot # and expiration date were not reported) and with VARIVAX (route, dosage schedule, lot # and expiration date were not reported) both therapies for prophylaxis. On an unknown date, the patient did not show any evidence of unspecified antibody titers (antibody test negative). At the reporting time, the outcome of antibody test negative was unknown. The reporter did not assess causality between the antibody test negative and the vaccination with M-M-R II and VARIVAX. There was no Product Quality Complaint (PQC) involved.  Additional information is not expected as there is not consent to follow-up.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions, drug allergies and concomitant therapies was not reported. On 07-NOV-2016, the patient was vaccinated with a second dose of GARDASIL, intramuscularly, (strength, lot# and expiration date  were not provided) for prophylaxis, and then on 04-JAN-2017 the patient was vaccinated with a third dose of GARDASIL, intramuscularly, (strength, lot# and expiration date were not provided) for prophylaxis. No adverse events were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected because the reporter details were not provided. Sender's Comments:  US-009507513-1701USA006657.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a female patient of unknown age. Information regarding medical history, concurrent conditions, drug allergies and concomitant therapies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis, and then on an unknown date outside of the recommended intervals the patient was vaccinated with another dose of GARDASIL, (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis. This is one of two reports received from the same reporter. Additional information is not expected because the reporter details were not provided. Sender's Comments: US-009507513-1701USA005467.
Age: 52.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Activities of daily living impaired, Back pain, Computerised tomogram abnormal, Lymphadenopathy, Lymphoma
Clinical narrative: Severe back pain.  To the point of not being able to perform daily activities.  Kept getting worse. Then waves of nausea and vomiting. CT scans show swollen lymph nodes.
Age: 52.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Severe back pain.  To the point of not being able to perform daily activities.  Kept getting worse. Then waves of nausea and vomiting. CT scans show swollen lymph nodes.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Hypertension
Clinical narrative: Patient became hypertensive and had to visit the ER. It isn't conclusive that vaccine caused symptoms, but patient came in to tell us considering he had just had the vaccine the previous day.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Pyrexia, Seizure
Clinical narrative: Per parent, the day after vaccines, patient developed high fever and seizures.  Taken to ER where she was informed it was due to the flu.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Hypersomnia, Incoherent, Injection site swelling, Thinking abnormal
Clinical narrative: I was extremely tired, incoherently so.  I had to go to bed at 6:30 p.m. (that is extremely unusual).  After sleeping all night with one interruption, I ran errands Saturday morning and by noon had to go back to bed.  I could barely think.  I had to sleep all day.  At some point, I realized the injection site was raised - a walnut in the middle and about 3 inches in diameter.  Ten days later, the injection site is reduced to a marble and finally going down.  It was like I lost 36 hours.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Basophil count decreased, Basophil percentage, Blood creatinine normal, Blood electrolytes increased
Clinical narrative: He started to complain that his legs hurt. He received the vaccine in his arms He was very fatigued and laid down at home. Mom was concerned that he was more tired than normal. He started shaking and mom stated he had a temp of 100.4F. He then continued to be very fatigued. According to mom he seemed to be very limp. His heart started racing and he started breathing very fast. Mom became concerned and started to take him to the Emergency Room. On the way to the Emergency Room, mom called 911 because she was concerned that he was starting to lose consciousness. On arrival to the ED, EMS reported that he was tachycardic and complaining of abdominal pain and headache. It is noted in the ED note that he had been taking FLOVENT for a cough he had for 3 weeks. Parents told the ED doctors that he had a cough and congestion for the past 1 week prior to the vaccine. His vitals in the ED were Temp 100.9F, HR 150, RR 20 BP 110/61. He was given a NS bolus, albuterol nebulizer and acetaminophen. He was well appearing to the ED physicians and was dx with a viral URI. He did have lab work done at the parental request: Hematology LATEST RESULTS HISTORICAL RESULTS: WBC 01/14/17 14:38  12.2 12/27/16  10.4 RBC  01/14/17 14:38 5.17 High 12/27/16 5.12  High HGB  01/14/17 14:38  12.8   12/27/16  12.6 HCT 01/14/17 14:38  39.1 12/27/16  38.7 MCV  01/14/17 14:38 76 12/27/16 76 MCH  01/14/17 14:38  24.8  12/27/16  24.6 MCHC  01/14/17 14:38 32.7 12/27/16  32.6 Platelet  01/14/17 14:38  275  12/27/16  301 MPV  01/14/17 14:38  8.6 Low  12/27/16  9.2 RDW-SD  01/14/17 14:38 38.3  12/27/16 37.0 RDW-CV  01/14/17 14:38  13.7   12/27/16  13.4 Abs Neut Ct  01/14/17 14:38   9.55  High   12/27/16  5.10 Abs Immature Gran Ct  01/14/17 14:38  0.03   12/27/16  0.02 Abs Lymph Ct  01/14/17 14:38   1.43  Low   12/27/16  3.98 Abs Mono Ct  01/14/17 14:38  1.11 High 12/27/16  1.04  High Abs Eos  01/14/17 14:38  0.03 12/27/16  0.23 Abs Baso Ct  01/14/17 14:38  0.02 12/27/16  0.05 Mature Neutrophils  01/14/17 14:38  78   12/27/16  49 Immature Gran  01/14/17 14:38  0.2 12/27/16  0.2 Lymphocytes - Normal  01/14/17 14:38  12 12/27/16  38 Monocyte  01/14/17 14:38  9  12/27/16 10 Eosinophil  01/14/17 14:38  0  12/27/16  2 Basophils  01/14/17 14:38 0 12/27/16  0 Sed Rate  01/14/17 14:38  11  High Electrolytes  LATEST RESULTS BUN  01/14/17 14:38 12 Creatinine  01/14/17 14:38 0.30 Low Sodium  01/14/17 14:38  135  Low  Potassium  01/14/17 14 He was discharged to home. He followed up in our office 2 days later and was doing well. He continued to have cough.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Blood potassium increased, Blood sodium decreased, Blood urea normal, Body temperature increased, Cough
Clinical narrative: He started to complain that his legs hurt. He received the vaccine in his arms He was very fatigued and laid down at home. Mom was concerned that he was more tired than normal. He started shaking and mom stated he had a temp of 100.4F. He then continued to be very fatigued. According to mom he seemed to be very limp. His heart started racing and he started breathing very fast. Mom became concerned and started to take him to the Emergency Room. On the way to the Emergency Room, mom called 911 because she was concerned that he was starting to lose consciousness. On arrival to the ED, EMS reported that he was tachycardic and complaining of abdominal pain and headache. It is noted in the ED note that he had been taking FLOVENT for a cough he had for 3 weeks. Parents told the ED doctors that he had a cough and congestion for the past 1 week prior to the vaccine. His vitals in the ED were Temp 100.9F, HR 150, RR 20 BP 110/61. He was given a NS bolus, albuterol nebulizer and acetaminophen. He was well appearing to the ED physicians and was dx with a viral URI. He did have lab work done at the parental request: Hematology LATEST RESULTS HISTORICAL RESULTS: WBC 01/14/17 14:38  12.2 12/27/16  10.4 RBC  01/14/17 14:38 5.17 High 12/27/16 5.12  High HGB  01/14/17 14:38  12.8   12/27/16  12.6 HCT 01/14/17 14:38  39.1 12/27/16  38.7 MCV  01/14/17 14:38 76 12/27/16 76 MCH  01/14/17 14:38  24.8  12/27/16  24.6 MCHC  01/14/17 14:38 32.7 12/27/16  32.6 Platelet  01/14/17 14:38  275  12/27/16  301 MPV  01/14/17 14:38  8.6 Low  12/27/16  9.2 RDW-SD  01/14/17 14:38 38.3  12/27/16 37.0 RDW-CV  01/14/17 14:38  13.7   12/27/16  13.4 Abs Neut Ct  01/14/17 14:38   9.55  High   12/27/16  5.10 Abs Immature Gran Ct  01/14/17 14:38  0.03   12/27/16  0.02 Abs Lymph Ct  01/14/17 14:38   1.43  Low   12/27/16  3.98 Abs Mono Ct  01/14/17 14:38  1.11 High 12/27/16  1.04  High Abs Eos  01/14/17 14:38  0.03 12/27/16  0.23 Abs Baso Ct  01/14/17 14:38  0.02 12/27/16  0.05 Mature Neutrophils  01/14/17 14:38  78   12/27/16  49 Immature Gran  01/14/17 14:38  0.2 12/27/16  0.2 Lymphocytes - Normal  01/14/17 14:38  12 12/27/16  38 Monocyte  01/14/17 14:38  9  12/27/16 10 Eosinophil  01/14/17 14:38  0  12/27/16  2 Basophils  01/14/17 14:38 0 12/27/16  0 Sed Rate  01/14/17 14:38  11  High Electrolytes  LATEST RESULTS BUN  01/14/17 14:38 12 Creatinine  01/14/17 14:38 0.30 Low Sodium  01/14/17 14:38  135  Low  Potassium  01/14/17 14 He was discharged to home. He followed up in our office 2 days later and was doing well. He continued to have cough.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Depressed level of consciousness, Eosinophil count decreased, Eosinophil percentage decreased, Fatigue, Granulocyte count increased
Clinical narrative: He started to complain that his legs hurt. He received the vaccine in his arms He was very fatigued and laid down at home. Mom was concerned that he was more tired than normal. He started shaking and mom stated he had a temp of 100.4F. He then continued to be very fatigued. According to mom he seemed to be very limp. His heart started racing and he started breathing very fast. Mom became concerned and started to take him to the Emergency Room. On the way to the Emergency Room, mom called 911 because she was concerned that he was starting to lose consciousness. On arrival to the ED, EMS reported that he was tachycardic and complaining of abdominal pain and headache. It is noted in the ED note that he had been taking FLOVENT for a cough he had for 3 weeks. Parents told the ED doctors that he had a cough and congestion for the past 1 week prior to the vaccine. His vitals in the ED were Temp 100.9F, HR 150, RR 20 BP 110/61. He was given a NS bolus, albuterol nebulizer and acetaminophen. He was well appearing to the ED physicians and was dx with a viral URI. He did have lab work done at the parental request: Hematology LATEST RESULTS HISTORICAL RESULTS: WBC 01/14/17 14:38  12.2 12/27/16  10.4 RBC  01/14/17 14:38 5.17 High 12/27/16 5.12  High HGB  01/14/17 14:38  12.8   12/27/16  12.6 HCT 01/14/17 14:38  39.1 12/27/16  38.7 MCV  01/14/17 14:38 76 12/27/16 76 MCH  01/14/17 14:38  24.8  12/27/16  24.6 MCHC  01/14/17 14:38 32.7 12/27/16  32.6 Platelet  01/14/17 14:38  275  12/27/16  301 MPV  01/14/17 14:38  8.6 Low  12/27/16  9.2 RDW-SD  01/14/17 14:38 38.3  12/27/16 37.0 RDW-CV  01/14/17 14:38  13.7   12/27/16  13.4 Abs Neut Ct  01/14/17 14:38   9.55  High   12/27/16  5.10 Abs Immature Gran Ct  01/14/17 14:38  0.03   12/27/16  0.02 Abs Lymph Ct  01/14/17 14:38   1.43  Low   12/27/16  3.98 Abs Mono Ct  01/14/17 14:38  1.11 High 12/27/16  1.04  High Abs Eos  01/14/17 14:38  0.03 12/27/16  0.23 Abs Baso Ct  01/14/17 14:38  0.02 12/27/16  0.05 Mature Neutrophils  01/14/17 14:38  78   12/27/16  49 Immature Gran  01/14/17 14:38  0.2 12/27/16  0.2 Lymphocytes - Normal  01/14/17 14:38  12 12/27/16  38 Monocyte  01/14/17 14:38  9  12/27/16 10 Eosinophil  01/14/17 14:38  0  12/27/16  2 Basophils  01/14/17 14:38 0 12/27/16  0 Sed Rate  01/14/17 14:38  11  High Electrolytes  LATEST RESULTS BUN  01/14/17 14:38 12 Creatinine  01/14/17 14:38 0.30 Low Sodium  01/14/17 14:38  135  Low  Potassium  01/14/17 14 He was discharged to home. He followed up in our office 2 days later and was doing well. He continued to have cough.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Haematocrit normal, Haemoglobin normal, Headache, Hypotonia, Lymphocyte count normal
Clinical narrative: He started to complain that his legs hurt. He received the vaccine in his arms He was very fatigued and laid down at home. Mom was concerned that he was more tired than normal. He started shaking and mom stated he had a temp of 100.4F. He then continued to be very fatigued. According to mom he seemed to be very limp. His heart started racing and he started breathing very fast. Mom became concerned and started to take him to the Emergency Room. On the way to the Emergency Room, mom called 911 because she was concerned that he was starting to lose consciousness. On arrival to the ED, EMS reported that he was tachycardic and complaining of abdominal pain and headache. It is noted in the ED note that he had been taking FLOVENT for a cough he had for 3 weeks. Parents told the ED doctors that he had a cough and congestion for the past 1 week prior to the vaccine. His vitals in the ED were Temp 100.9F, HR 150, RR 20 BP 110/61. He was given a NS bolus, albuterol nebulizer and acetaminophen. He was well appearing to the ED physicians and was dx with a viral URI. He did have lab work done at the parental request: Hematology LATEST RESULTS HISTORICAL RESULTS: WBC 01/14/17 14:38  12.2 12/27/16  10.4 RBC  01/14/17 14:38 5.17 High 12/27/16 5.12  High HGB  01/14/17 14:38  12.8   12/27/16  12.6 HCT 01/14/17 14:38  39.1 12/27/16  38.7 MCV  01/14/17 14:38 76 12/27/16 76 MCH  01/14/17 14:38  24.8  12/27/16  24.6 MCHC  01/14/17 14:38 32.7 12/27/16  32.6 Platelet  01/14/17 14:38  275  12/27/16  301 MPV  01/14/17 14:38  8.6 Low  12/27/16  9.2 RDW-SD  01/14/17 14:38 38.3  12/27/16 37.0 RDW-CV  01/14/17 14:38  13.7   12/27/16  13.4 Abs Neut Ct  01/14/17 14:38   9.55  High   12/27/16  5.10 Abs Immature Gran Ct  01/14/17 14:38  0.03   12/27/16  0.02 Abs Lymph Ct  01/14/17 14:38   1.43  Low   12/27/16  3.98 Abs Mono Ct  01/14/17 14:38  1.11 High 12/27/16  1.04  High Abs Eos  01/14/17 14:38  0.03 12/27/16  0.23 Abs Baso Ct  01/14/17 14:38  0.02 12/27/16  0.05 Mature Neutrophils  01/14/17 14:38  78   12/27/16  49 Immature Gran  01/14/17 14:38  0.2 12/27/16  0.2 Lymphocytes - Normal  01/14/17 14:38  12 12/27/16  38 Monocyte  01/14/17 14:38  9  12/27/16 10 Eosinophil  01/14/17 14:38  0  12/27/16  2 Basophils  01/14/17 14:38 0 12/27/16  0 Sed Rate  01/14/17 14:38  11  High Electrolytes  LATEST RESULTS BUN  01/14/17 14:38 12 Creatinine  01/14/17 14:38 0.30 Low Sodium  01/14/17 14:38  135  Low  Potassium  01/14/17 14 He was discharged to home. He followed up in our office 2 days later and was doing well. He continued to have cough.