chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Insomnia, Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: Pain was felt immediately when the flu shot was administered. It spread downward from the left shoulder to my hand, becoming painful to the touch making it impossible to sleep or perform functions like dressing  myself. It became very difficult to raise my arm or reach behind me without severe pain in the shoulder and upper arm. An MRI and X-rays were performed and physical therapy was recommended by an orthopedist. Therapy continues with some improvement. It is still difficult to perform routine functions like lifting, doing laundry, and cleaning.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Tenderness, X-ray
Clinical narrative: Pain was felt immediately when the flu shot was administered. It spread downward from the left shoulder to my hand, becoming painful to the touch making it impossible to sleep or perform functions like dressing  myself. It became very difficult to raise my arm or reach behind me without severe pain in the shoulder and upper arm. An MRI and X-rays were performed and physical therapy was recommended by an orthopedist. Therapy continues with some improvement. It is still difficult to perform routine functions like lifting, doing laundry, and cleaning.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Adverse event
Clinical narrative: Advrs effect of pertuss vaccine inc combin w pertuss, subs on 2018-03-16.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient received QUADRACEL instead of DAPTACEL.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Injection site erythema
Clinical narrative: "Site of administration was red, experienced headache and slept the entire next day".
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Acupuncture, Injected limb mobility decreased, Injection site pain, Middle insomnia, Musculoskeletal pain
Clinical narrative: I received a routine flu shot in my right shoulder. A few days after receiving the flu shot I contacted by healthcare provider to inform them my right shoulder was sore and that I was experiencing pain and had a lack of movement. Since receiving the vaccine and becoming aware of the problem I have underwent 2 cortisone injections (November 30th and February 14th), physical therapy (January 18, 23, 26 and 30th, February 1 and 13), acupuncture (March 22) and just recently an MRI (March 20) was completed. The MRI results show no physical or structural damage. I have essentially been told to deal with it. Currently, I have difficulty and pain associated with getting dressed, picking up anything over a few pounds, throwing, etc... I cannot sleep well and wake up at all hours of the night with shoulder pain. I have had a tremendous decline in the quality of my life. I stopped taking my anti-inflammatory after 4 months of continuous use because I am concerned about the potential for internal damage from the NSAID.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Pain, Poor quality sleep, Quality of life decreased
Clinical narrative: I received a routine flu shot in my right shoulder. A few days after receiving the flu shot I contacted by healthcare provider to inform them my right shoulder was sore and that I was experiencing pain and had a lack of movement. Since receiving the vaccine and becoming aware of the problem I have underwent 2 cortisone injections (November 30th and February 14th), physical therapy (January 18, 23, 26 and 30th, February 1 and 13), acupuncture (March 22) and just recently an MRI (March 20) was completed. The MRI results show no physical or structural damage. I have essentially been told to deal with it. Currently, I have difficulty and pain associated with getting dressed, picking up anything over a few pounds, throwing, etc... I cannot sleep well and wake up at all hours of the night with shoulder pain. I have had a tremendous decline in the quality of my life. I stopped taking my anti-inflammatory after 4 months of continuous use because I am concerned about the potential for internal damage from the NSAID.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Nodule
Clinical narrative: Patient developed a baseball sized knot at the injection site.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Approx 2 hours post injection, pt had 6cm x 6 cm area to inner left arm. Red and raised. Pt also reported reddened area to lower left leg in which dr did not observe. Was seen on 3-22-18 by dr in which pt was given Dexamethasone 10 mg IM in Right buttock. Pt also given rx for Clariten to be filled and taken daily.
Age: 28.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Eyelid oedema, Fatigue, Pyrexia, Swelling face
Clinical narrative: Fever, tired, swollen left face, cheek and eyelid.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 87-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 31st March 2020). On 8th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th March 2018, 1 days after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of shivering was unchanged. The reporter considered the shivering to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on an unknown arm. On the morning of 9th March 2018, the patient reported shivering. She had shivered since the injection, and it occurred more in the morning, but it still comes and goes throughout the day.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Acne, Irritability, Pyrexia, Rash, Rash macular
Clinical narrative: Fever 103.0, shaky, fussy, red blotches over his torso up his neck pimple like spots.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Tremor
Clinical narrative: Fever 103.0, shaky, fussy, red blotches over his torso up his neck pimple like spots.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 15-MAR-2018, the patient was vaccinated with an expired VAQTA lot # M022924 with an expiration date 24-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Erythema, Headache, Herpes zoster, Herpes zoster oticus
Clinical narrative: This spontaneous report was received from a 71 year old female patient, who was reporting on herself. The patient's pertinent medical history included shingles (years ago). Her concurrent conditions included diabetes and drug reaction/allergy to penicillin and codeine. Concomitant therapies included unspecified medications. On 11-JAN-2018, the patient was vaccinated with ZOSTAVAX 1 dose, in the left arm, for prophylaxis (strength, route, lot # and expiration date were not reported) which was reconstituted with a sterile diluent (MERCK). Patient mentioned that, according to nurse, the vaccine had to be given in the muscle and "it went deep"; therefore, "it hurt" (also reported as: the needle hurt).    On an unknown date in 2018, reported as "soon after vaccination", the patient stated that she developed "a big place on her arm that got to looking terrible"; further explained  that she had a bad reaction (vaccination complication) and her left arm "broke out" and became red (erythema), hot (feeling hot) and swollen. Additionally, she stated that the arm swelled to as big as the palm of her hand (peripheral swelling). Then, after several weeks, the patient recovered from these adverse events (vaccination complication, erythema, feeling hot and peripheral swelling) on an unspecified date in 2018.  Then, on an unknown date in 2018, reported as "a few weeks after receiving the vaccine", the patient had a horrible ear pain and on 08-FEB-2018, when she saw an unspecified nurse practitioner, she was diagnosed with shingles which were in an unspecified ear (herpes zoster oticus).  As treatment, the patient was put on cefdinir 300 mg and ofloxacin drops. She was informed that ofloxacin drops were eye drops but she was instructed to apply 5 drops to her ear, twice a day.  After that, on an unspecified date in 2018, the patient recovered from herpes zoster oticus as the shingles were no longer inside her ear, but they were behind the ear and in her hair (herpes zoster). Additionally, the patient stated that she had a headache and believed that she had shingles in her head as she heard from the nurse.  No laboratory studies were performed and the patient was not hospitalized.  At the reporting time, the patient was not recovered from headache and herpes zoster; and the outcome of injection site pain was unknown. The causality assessment between the aforementioned adverse events and zoster vaccine live (ZOSTAVAX) was not provided.  Upon internal review, herpes zoster oticus was considered to be a medically significant event.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain, Peripheral swelling, Rash, Skin warm
Clinical narrative: This spontaneous report was received from a 71 year old female patient, who was reporting on herself. The patient's pertinent medical history included shingles (years ago). Her concurrent conditions included diabetes and drug reaction/allergy to penicillin and codeine. Concomitant therapies included unspecified medications. On 11-JAN-2018, the patient was vaccinated with ZOSTAVAX 1 dose, in the left arm, for prophylaxis (strength, route, lot # and expiration date were not reported) which was reconstituted with a sterile diluent (MERCK). Patient mentioned that, according to nurse, the vaccine had to be given in the muscle and "it went deep"; therefore, "it hurt" (also reported as: the needle hurt).    On an unknown date in 2018, reported as "soon after vaccination", the patient stated that she developed "a big place on her arm that got to looking terrible"; further explained  that she had a bad reaction (vaccination complication) and her left arm "broke out" and became red (erythema), hot (feeling hot) and swollen. Additionally, she stated that the arm swelled to as big as the palm of her hand (peripheral swelling). Then, after several weeks, the patient recovered from these adverse events (vaccination complication, erythema, feeling hot and peripheral swelling) on an unspecified date in 2018.  Then, on an unknown date in 2018, reported as "a few weeks after receiving the vaccine", the patient had a horrible ear pain and on 08-FEB-2018, when she saw an unspecified nurse practitioner, she was diagnosed with shingles which were in an unspecified ear (herpes zoster oticus).  As treatment, the patient was put on cefdinir 300 mg and ofloxacin drops. She was informed that ofloxacin drops were eye drops but she was instructed to apply 5 drops to her ear, twice a day.  After that, on an unspecified date in 2018, the patient recovered from herpes zoster oticus as the shingles were no longer inside her ear, but they were behind the ear and in her hair (herpes zoster). Additionally, the patient stated that she had a headache and believed that she had shingles in her head as she heard from the nurse.  No laboratory studies were performed and the patient was not hospitalized.  At the reporting time, the patient was not recovered from headache and herpes zoster; and the outcome of injection site pain was unknown. The causality assessment between the aforementioned adverse events and zoster vaccine live (ZOSTAVAX) was not provided.  Upon internal review, herpes zoster oticus was considered to be a medically significant event.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a 71 year old female patient, who was reporting on herself. The patient's pertinent medical history included shingles (years ago). Her concurrent conditions included diabetes and drug reaction/allergy to penicillin and codeine. Concomitant therapies included unspecified medications. On 11-JAN-2018, the patient was vaccinated with ZOSTAVAX 1 dose, in the left arm, for prophylaxis (strength, route, lot # and expiration date were not reported) which was reconstituted with a sterile diluent (MERCK). Patient mentioned that, according to nurse, the vaccine had to be given in the muscle and "it went deep"; therefore, "it hurt" (also reported as: the needle hurt).    On an unknown date in 2018, reported as "soon after vaccination", the patient stated that she developed "a big place on her arm that got to looking terrible"; further explained  that she had a bad reaction (vaccination complication) and her left arm "broke out" and became red (erythema), hot (feeling hot) and swollen. Additionally, she stated that the arm swelled to as big as the palm of her hand (peripheral swelling). Then, after several weeks, the patient recovered from these adverse events (vaccination complication, erythema, feeling hot and peripheral swelling) on an unspecified date in 2018.  Then, on an unknown date in 2018, reported as "a few weeks after receiving the vaccine", the patient had a horrible ear pain and on 08-FEB-2018, when she saw an unspecified nurse practitioner, she was diagnosed with shingles which were in an unspecified ear (herpes zoster oticus).  As treatment, the patient was put on cefdinir 300 mg and ofloxacin drops. She was informed that ofloxacin drops were eye drops but she was instructed to apply 5 drops to her ear, twice a day.  After that, on an unspecified date in 2018, the patient recovered from herpes zoster oticus as the shingles were no longer inside her ear, but they were behind the ear and in her hair (herpes zoster). Additionally, the patient stated that she had a headache and believed that she had shingles in her head as she heard from the nurse.  No laboratory studies were performed and the patient was not hospitalized.  At the reporting time, the patient was not recovered from headache and herpes zoster; and the outcome of injection site pain was unknown. The causality assessment between the aforementioned adverse events and zoster vaccine live (ZOSTAVAX) was not provided.  Upon internal review, herpes zoster oticus was considered to be a medically significant event.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from an Office Staff on 14-Mar-2018. This case involves a 68-year-old male patient, who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, route, dose not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient reported Guillian Barre syndrome. Lab test and corrective treatment was not reported. Outcome of the event was not reported. Upon internal review the case was considered as serious because of important medical event: Guillian Barre syndrome. Documents held by sender: none. Sender's Comments: Patient developed Guillain Barre syndrome after vaccination. Exact time to onset has not been mentioned. Further information regarding vaccination details, time to onset, symptoms and their evolution, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the given information the role of the vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Nausea
Clinical narrative: Nausea, chills, confusion 24 hours after vaccines went away.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Facial paresis, Hypotonia, Protrusion tongue
Clinical narrative: Protruding tongue, Mild facial weakness, (R), No seizure. Baby seen yesterday for WCC and immunizations. Mother ICU RN noticed protruding tongue,still good suck, a little flaccid cheeks. This morning better tongue tone. No seizures, no tongue fasciculations. Denies temp. Breast feeding well, good suck.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Dizziness, Fever and pain and swelling injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Quarter size swelling at injection sites. Ice pack to injection sites, and ibuprofen to help with any pain or swelling.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Patient who received MMRV (proquad) on 3/10/2018 with starting 3/22/18 rash on cheek that is now mostly on upper trunk and extremities. Maculopapular faintly erythematous. Pt is otherwise doing fine. No known prior immunization reaction.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: PATIENT STATES HE HAS RED AREAS ON BOTH ARMS (OPPOSITE OF ELBOWS). VERY RED, ERYTHEMA. AREA IS ROUGHLY 6 INCHES, IN AN OBLONG SHAPE. THIS IS BILATERAL TO BOTH ARMS AND SYMMETRICAL.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Scar
Clinical narrative: Developed scar 2 months after injection.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Gait disturbance, Hyperhidrosis, Limb discomfort
Clinical narrative: Chills no fever. Felt like legs were made out of lead and walking was like walking in quick sand. Then chills stopped and started sweating but again no fever. Symptoms started about 6hours after vaccination and continued for 12 hours. Following 2 days felt very fatigued.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed rash, shingles rash on right arm.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysuria, Headache, Insomnia, Joint range of motion decreased, Myalgia
Clinical narrative: Upper arm and shoulder had deep muscle pain for 4 days. Unable to sleep on left side and had restricted range of motion for 3 days. No redness or soreness at injection site. Headache for 2 days. Burning with urination for 1 day.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild erythema and swelling of (R) deltoid.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at the injection site. Dizziness lasting more than a week. Treated redness and pain with Ibuprofen 400 mg one to twice a day PRN. Outcome: no longer having any of these symptoms. Left arm appears normal, no redness and/or swelling at the injection site and no dizziness.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Death
Clinical narrative: Patient expired.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of right upper arm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: RAISED RED LUMP 4.3 CM BY 6 CM. AREA WAS WARM TO THE TOUCH AS WELL WHERE PROQUAD WAS ADMINISTERED.
Age: 72.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Flank pain, Herpes zoster, Laboratory test, Rash
Clinical narrative: Dose given at pharmacy 3/13/2018. Prev. ZOSTAVAX 9/14/10. Shingles left flank  - pain 3/19/2018, rash 3/21/2018.
Age: 72.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Flank pain, Herpes zoster, Rash
Clinical narrative: Dose given at pharmacy 3/13/2018. Prev. ZOSTAVAX 9/14/10. Shingles left flank  - pain 3/19/2018, rash 3/21/2018.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Approx. 24 hrs after, right arm below where vaccine was given turned red, very sore, started swelling and kept spreading till it completely covered my right upper bicep and large portion of right upper arm.
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding an unspecified 18 and 1/2 year old female patient. The patient's medical history, concomitant medications and drug reactions/allergies were not provided. On an unspecified date, the patient was vaccinated with a adult dose of VAQTA for prophylaxis (route, anatomical location, lot # and expiration date were not provided), instead of a pediatric dose. No adverse effects were reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referred to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Therapy Type: rHA) (strength, dose, frequency and route of administration were not reported) (lot # N020620, expiration date: 22-JAN-2019) for prophylaxis (product storage error). The vaccine was stored in between -14 degrees Celsius (C) to -10 degree C (-10 degree C) for 2 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This case is linked to case 1803USA007893 (same reporter link).; Sender's Comments: US-009507513-1803USA007893:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referred to a 4 year old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Therapy Type: rHA) (strength, dose, frequency and route of administration were not reported) (lot # N020620, expiration date: 22-JAN-2019) for prophylaxis (product storage error). The vaccine was stored in between -14 degrees Celsius (C) to -10 degree C (-10 degree C) for 2 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This case is linked to the case 1803USA007736 (same reporter link).; Sender's Comments: US-009507513-1803USA007736:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a currently one year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N030406 with expiration date on 30-OCT-2019 (strength , dose, route of administration and anatomical location were not reported) for prophylaxis. It was stated that the sterile diluent (manufacturer unknown) (lot number and expiration date were not reported) used for reconstitution was properly stored. The administered dose of the vaccine experienced a temperature excursion in the range between 6°F to 14°F (10°F) for 53 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Lot number N030406 has been verified to be a valid lot number for VARIVAX.; Sender's Comments: US-009507513-1803USA008853:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a currently one year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N030406 with expiration date on 30-OCT-2019 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. It was stated that the sterile diluent (manufacturer unknown) (lot number and expiration date were not reported) used for reconstitution was properly stored. The administered dose of the vaccine experienced a temperature excursion in the range between 6°F to 14°F (10°F) for 53 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1803USA008837:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a other nurse, concerning a 12 month old patient.  There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 21-MAR-2018, the patient was vaccinated with VARIVAX lot # M012990 and expiration date of 14-MAR-2018, (route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reocnstituted with properly stored sterile diluent(MERCK STERILE DILUENT). Expired VARIVAX had no temperature excursions prior to being administered. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in 2010, the patient was vaccinated with an unspecified PREVENAR 13, however, after checking the vaccination records, it was determined the patient received a dose of PENUMOVAX 23 for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). Then, on 22-MAR-2018, the patient inadvertently received a second dose of PNEUMOVAX 23, lot # N025656 and expiration date on 19-APR-2019, for the same indication (route of administration and anatomical location were not reported). No adverse events were reported for the patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Spoke with mother 3/23/18 - was informed of reaction. Please see attached physician note. Patient is a 4 YO male who complains of heat and redness to R thigh. Pt. received vaccines at health department Tuesday. Had preschool shot. We think DPT, IPV and varicella and MMR. Go red mostly the next morning and today. No fever systemically. Acting ok overall. No Hx of RXN in past. Denies - headaches, blurred vision, double vision, earache, decreased hearing, nasal congestion, nose bleeds, runny nose, sore throat. Diagnoses: Cellulitis of right lower limb. Plan: Rx Cephalexin 50 mg/ml, oral suspension 1 tsp. TID. Return to office if any persistent problems.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Rales
Clinical narrative: Date entered in date administered field is the date the allergy was documented by employee health. Actual date of administration is not known. Lip swelling; respiratory crackles.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever of 102.5-103.5 for 24+ hrs. Fever began 7 am 3/1/2018 (day after vaccination) and continued until 9 am 3/2/2018 the following morning. Patient was awake for a combined total of a maximum of 3 hrs during this time.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Loss of consciousness, Skin haemorrhage, Suture insertion, Syncope
Clinical narrative: After pt received her vaccine she was initially OK, she sat down in a chair while her brother received his Immunization. Upon standing up to leave the exam room she had a syncope event in which she hit her head on the handle of the door. The MA witnessed the event and immediately call for assistance. 911 was activated and Multiple staff responded. Pt slowly regained consciousness. Pt was wearing glasses at the time of the event and the glasses were broken with the earpiece embedded in the skin at the  lateral aspect of the right eyebrow. Bleeding was controlled with pressure. Once the EMT's arrived the wound and the  embedded glass earpiece were covered and wrapped to maintain control. Pt was alert at time she left on the squad, pt was taken to clinic for treatment of the wound and head injury.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Wound
Clinical narrative: After pt received her vaccine she was initially OK, she sat down in a chair while her brother received his Immunization. Upon standing up to leave the exam room she had a syncope event in which she hit her head on the handle of the door. The MA witnessed the event and immediately call for assistance. 911 was activated and Multiple staff responded. Pt slowly regained consciousness. Pt was wearing glasses at the time of the event and the glasses were broken with the earpiece embedded in the skin at the  lateral aspect of the right eyebrow. Bleeding was controlled with pressure. Once the EMT's arrived the wound and the  embedded glass earpiece were covered and wrapped to maintain control. Pt was alert at time she left on the squad, pt was taken to clinic for treatment of the wound and head injury.
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Amnesia, Mental status changes, Seizure
Clinical narrative: Pt called and reported being hospitalized. He reported he had a seizure, alter mental status and short-term memory loss.
Age: 1.92
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Urticaria (hives) appeared on upper body (no localized injection site hives).
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Vaccination site swelling
Clinical narrative: Patient c/o swelling and itching to vaccination site. Pt was seen by provider on 03/22/18 - oral histamine and cool compress to site.
Age: 1.83
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Pyrexia
Clinical narrative: Back Pain. Patient received TRUMENBA and within 4 to 6 hours after vaccine. Patient complained of feeling feverish and back pain. Back pain is still persistent and nothing is helping with the pain. Plan Ice to back, Ibuprofen 3 tabs q 6 hr X 2 today and X 3 tomorrow, then 2 tabs 2x on Sunday. Wean as tolerated. Rest over weekend. Out of gym x 3 days. Call if needs excuse for rest of week. Call if pain persisting another week.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: Severe Headache and Body Ache, mild Nausea.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a 23 year old patient of an unspecified gender. The patient's medical history, drug reactions, allergies or concomitant therapies were not provided. It was reported that on 27-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dosage, route, lot# and expiration date were not provided). Subsequently, on 04-JAN-2018 the patient received the second dose of GARDASIL 9 and finally on 04-JAN-2018, the patient received the third dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: The patient's arm is red at the administration site and dark red and purple around the site. It is get progressively better every day patient's wife stated.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Infection
Clinical narrative: The doctor reported that the patient experienced an infection and was prescribed an antibiotic. The area appeared to be rather in a circular pattern.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Customer came to pharmacy at  2:50 pm on 3/23/18 and showed me an itching red and swollen left arm. She stated it was from a vaccination on 3/17/18. She stated the arm starting swelling on Monday 3/19/18. She was given equate brand diphenhydramine 2% and zinc 0.1% cream. She stated she would go see a doctor.
Age: 73.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Antiphospholipid antibodies positive, Blood iron decreased, Blood potassium decreased, C-reactive protein increased, Loss of personal independence in daily activities
Clinical narrative: Painful hands--couldn't make fist, cut vegetables, open jars. Used a ball to exercise hands. Kept getting worse. Difficulty moving--getting out of bed, getting up and down from sitting position, getting dressed, bathing. Steroids helped but couldn't be on too long.
Age: 73.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Painful hands--couldn't make fist, cut vegetables, open jars. Used a ball to exercise hands. Kept getting worse. Difficulty moving--getting out of bed, getting up and down from sitting position, getting dressed, bathing. Steroids helped but couldn't be on too long.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient received SHINGRIX vaccine on 03/20/18. it was administered via subcutaneous route instead of intramuscular route. Patient reported injection site reaction to her Dr's office on 3/22/18. Described reaction as warm, hard, redness, pain at site of injection. Pharmacist who administered the vaccine, gave it by the wrong route, subQ instead of IM. He followed up with the manufacuter's and was informed that patient does not need revacination but will experience more localized reaction when SHINGRIX is given subQ.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Incorrect route of drug administration, Pain, Rash, Swelling
Clinical narrative: Patient received SHINGRIX vaccine on 03/20/18. it was administered via subcutaneous route instead of intramuscular route. Patient reported injection site reaction to her Dr's office on 3/22/18. Described reaction as warm, hard, redness, pain at site of injection. Pharmacist who administered the vaccine, gave it by the wrong route, subQ instead of IM. He followed up with the manufacuter's and was informed that patient does not need revacination but will experience more localized reaction when SHINGRIX is given subQ.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: Shivering, chills, sweating, headache, body ache. Lasted about 16 hours. Took ibuprofen.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Rash, Rash vesicular
Clinical narrative: Received first dose of SHINGRIX at a clinic on Sunday 3/18/18. On Monday 3/20/18 she developed right shoulder pain and a vesicular rash in right axilla and right arm. Pt came into clinic today 3/23/18 for these symptoms. Pt was diagnosed with herpes zoster without complications. Pt received prescription for Valtrex and Tylenol #3 today.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Pain in extremity, Paraesthesia
Clinical narrative: I am experiencing what I am going to call brain or head zaps or electric shocks when I get up to do anything. I have no symptoms while I am sitting still. But anytime I get up I get a series of these electric head shocks. Last night I also had upper stomach abdominal pain but that has cleared up and so has most of the soreness in my left arm. I want to know if it's really advisable for me to take the 2nd shot in 3 months time considering this reaction.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Back pain, Confusional state, Dizziness, Gait inability, Headache
Clinical narrative: Confusion, dizziness and lethargy. Extremely difficult to properly wake up after a long sleep, nighttime incontinence. Nausea, vomiting, headache and neckache, backache.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Incontinence, Lethargy, Nausea, Neck pain, Poor quality sleep
Clinical narrative: Confusion, dizziness and lethargy. Extremely difficult to properly wake up after a long sleep, nighttime incontinence. Nausea, vomiting, headache and neckache, backache.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: Confusion, dizziness and lethargy. Extremely difficult to properly wake up after a long sleep, nighttime incontinence. Nausea, vomiting, headache and neckache, backache.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site mass, Musculoskeletal pain, Pain in extremity, Periarthritis
Clinical narrative: My left arm and shoulder have been painful ever since I received the vaccine. I am unable to do simple tasks with my left arm. Sometimes the pain is excruciating. I have been communicating with my doctor. He was giving me advice and then he said I should come in. He noted that there is a lump in the area of the arm where the shot was administered. My Doctor believes that I am developing adhesive capsulitis. I may need to see an orthopedic doctor to get a cortisone shot and physical therapy. I am unable to do much activity with my left arm. My arm am shoulder pain wake me up throughout the night.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: My left arm and shoulder have been painful ever since I received the vaccine. I am unable to do simple tasks with my left arm. Sometimes the pain is excruciating. I have been communicating with my doctor. He was giving me advice and then he said I should come in. He noted that there is a lump in the area of the arm where the shot was administered. My Doctor believes that I am developing adhesive capsulitis. I may need to see an orthopedic doctor to get a cortisone shot and physical therapy. I am unable to do much activity with my left arm. My arm am shoulder pain wake me up throughout the night.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: FEVER, CHILLS, FLU-LIKE SYMPTOMS.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Influenza like illness
Clinical narrative: FEVER, CHILLS, FLU-LIKE SYMPTOMS.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt claims that his arms was swollen and painful... pain never went away even after several weeks. Pt claims shot was given correctly (since he is also a pharmacist) and I verifed with vaccinator and it was done correctly in the correct location.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 64-year-old male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGIRX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. No further information was provided by the caller, as caller refused to provide the further information. This case was linked to case US2018GSK042362 and case US2018GSK042391, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Muscle spasms
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, cramp and chills. On an unknown date, the outcome of the fatigue, cramp and chills were unknown. It was unknown if the reporter considered the fatigue, cramp and chills to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. No further information was provided by the caller, as caller refused to provide the further information and the identity of the patient. This case was linked to case US2018038368 and case US2018GSK042391, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain localized in a adult female patient who received SHINGRIX. On 8th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain localized, insomnia and chills. On an unknown date, the outcome of the pain localized, insomnia and chills were unknown. The reporter considered the pain localized, insomnia and chills to be related to SHINGRIX. Additional details were reported as follows: An internal employee reported this case on behalf of another employee (patient). The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The patient experienced significant local pain, and she could not sleep. The patient did not expect to experienced chills after receiving SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Gait inability, Hyperhidrosis, Malaise, Muscular weakness
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a male patient who received Shingles vaccine. Previously administered products included shingles vaccine (received couple of years ago and it was about 50 percent effective). On 9th March 2018, the patient received Shingles vaccine. On 10th March, 1 days after receiving Shingles vaccine, the patient experienced unable to walk. On an unknown date, the patient experienced fever, chills, lower extremities weakness of, sickness and sweating. On an unknown date, the patient experienced fever, chills, lower extremities weakness of, sickness and sweating. On an unknown date, the outcome of the fever, chills, lower extremities weakness of, sickness, sweating and unable to walk were unknown. The reporter considered the fever, chills, lower extremities weakness of, sickness, sweating and unable to walk to be related to Shingles vaccine. Additional details were provided as follows: This report was taken from the radio conversation. The age at vaccination was not reported. On 9th March 2018 at 15:00, a healthy patient received Shingles vaccine. Less than a week after vaccination, the patient experienced high fever, chills, legs were weak like rubber, sweating and sick. The body temperature was not measured. On whole weekend, the patient was so sick. Whole weekend the patient was lying on bed. The patient stated that he needed to go to bed. That was what he did and it was disgusting. The patient was discussing about the possible treatment drug (Aspirin), but patient did not take it. The patient stated it was like you sweat through about 20 t-shirts.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a male patient who received Shingles vaccine. Previously administered products included shingles vaccine (received couple of years ago and it was about 50 percent effective). On 9th March 2018, the patient received Shingles vaccine. On 10th March, 1 days after receiving Shingles vaccine, the patient experienced unable to walk. On an unknown date, the patient experienced fever, chills, lower extremities weakness of, sickness and sweating. On an unknown date, the patient experienced fever, chills, lower extremities weakness of, sickness and sweating. On an unknown date, the outcome of the fever, chills, lower extremities weakness of, sickness, sweating and unable to walk were unknown. The reporter considered the fever, chills, lower extremities weakness of, sickness, sweating and unable to walk to be related to Shingles vaccine. Additional details were provided as follows: This report was taken from the radio conversation. The age at vaccination was not reported. On 9th March 2018 at 15:00, a healthy patient received Shingles vaccine. Less than a week after vaccination, the patient experienced high fever, chills, legs were weak like rubber, sweating and sick. The body temperature was not measured. On whole weekend, the patient was so sick. Whole weekend the patient was lying on bed. The patient stated that he needed to go to bed. That was what he did and it was disgusting. The patient was discussing about the possible treatment drug (Aspirin), but patient did not take it. The patient stated it was like you sweat through about 20 t-shirts.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 84-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 30th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st February 2018, 2 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be probably related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. On 15th March 2018, the patient returned to the pharmacy complaining that he had a persistent dull pain at the injection site, which began approximately 2 days after he receiving the vaccine. The reporter reported that the patient did not have concomitant vaccines and known significant medical history.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Muscle spasms
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, cramp and chills. On an unknown date, the outcome of the fatigue, cramp and chills were unknown. It was unknown if the reporter considered the fatigue, cramp and chills to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. No further information was provided by the caller, as caller refused to provide the further information and the identity of the patient. This case was linked to case US2018038368 and case US2018GSK042362, reported by the same reporter.