chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On 25-SEP-2016, the patient was vaccinated with improperly stored  VARIVAX subcutaneous injection (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-SEP-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provided contact details to contact other registered nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA009079: US-009507513-1610USA001984: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA009083: US-009507513-1610USA009084: US-009507513-1610USA009078: US-009507513-1610USA009081:, MERCK 1610USA009080:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX subcutaneous injection (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-SEP-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provided contact details to contact other registered nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA009079: US-009507513-1610USA009080: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA009083: US-009507513-1610USA009084: US-009507513-1610USA009078: US-009507513-1610USA001984:, MERCK 1610USA009081:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On 25-SEP-2016, the patient was vaccinated with improperly stored  VARIVAX subcutaneous injection (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-DEC-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provided contact details to contact other nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA009079: US-009507513-1610USA009080: US-009507513-1610USA009085: US-009507513-1610USA001984: US-009507513-1610USA009083: US-009507513-1610USA009084: US-009507513-1610USA009078: US-009507513-1610USA009081:, MERCK 1610USA009082:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored  VARIVAX subcutaneous injection (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-SEP-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provided contact details to contact other registered nurse nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA009079: US-009507513-1610USA009080: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA001984: US-009507513-1610USA009084: US-009507513-1610USA009078: US-009507513-1610USA009081:, MERCK 1610USA009083:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX subcutaneous injection (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-DEC-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provide contact details to contact other nurse who could provided additional information about the patient. This is one of several reports received from the same reporter.Additional information has been requested.; Sender's Comments: US-009507513-1610USA009079: US-009507513-1610USA009080: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA009083: US-009507513-1610USA001984: US-009507513-1610USA009078: US-009507513-1610USA009081:,MERCK 1610USA009084:Mfr number.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine administered. Child was mistakenly given Hepatitis A instead of Hepatitis B at 2 month visit.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Patient reported to pharmacy on 12/15/16 that she had a swollen bicep that was warm to the touch and itchy. This was not at the injection site. This resolved itself in a couple of days from injection date.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT CLAIM TO HAVE SWELLING, REDNESS, HEAT AND A RASH AT INJECTION SITE.
Age: 1.67
Sex: M
Vaccine: DTAP, PPV
Symptoms: Abnormal behaviour, Irritability, Listless, Mood altered
Clinical narrative: He became suddenly moody, sullen, clingy, was very cranky for no reason, and kind of listless, and very clingy, for about 2 weeks.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Local doctor diagnosed patient with cellulitis. Warm, red patches on left arm. Patient says that patches were on her deltoid a few days before. On presentation the deltoid was clear but the redness was on the tricep and sides of shoulder.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Chest pain, Chills, Cough, Headache, Hypoaesthesia
Clinical narrative: Awoke 1 day after vaccine administration with nausea, numbness in legs, chest pain, tactile fever and chills, cough, rhinorrhea, left fronto-parietal headache.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Influenza virus test negative, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Awoke 1 day after vaccine administration with nausea, numbness in legs, chest pain, tactile fever and chills, cough, rhinorrhea, left fronto-parietal headache.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's full arm is red and swollen on the forearm. He has been taking Ibuprofen, He states that he has completely movement in his arm.
Sex: F
Vaccine: UNK
Symptoms: Eczema
Clinical narrative: Severe eczema.
Age: 15.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Syncope
Clinical narrative: Patient fainted after the injection for a moment but regained consciousness soon after. Patient was put on the floor with legs on a chair for 10 to 15 minutes.
Age: 20.0
Sex: M
Vaccine: FLUC4, HPV9
Symptoms: Dyspnoea, Loss of consciousness
Clinical narrative: Patient passed out, momentarily had trouble breathing. Pt recovered, no Epi or Benadryl needed.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Headache, Inadequate aseptic technique in use of product, Injection site reaction, Rash
Clinical narrative: Patient was given Flu and ZOSTAVAX vaccine on afternoon of 12/13/16. Pt waited for about 5 minutes or so at Pharmacy after given vaccine and then left because she did not experience any reactions at the time.  Patient came back to Pharmacy on the afternoon of 12/15/16 complaining of a red painful rash at the site of the ZOSTAVAX injection of the right arm. Patient also told RPh that she also have a headache which may or may not be related to the event. RPh on duty called patient's primary doctor for advice. Doctor advise patient  to go seek medical attention. Patient immediately went to an urgent care facility. Patient came back to Pharmacy about 30 minutes later with a prescription for an antibiotic. Patient said she was diagnosed with cellulitis. Patient said the RPh who administered the vaccine didn't inject her in the area that was swab by alcohol but instead it she injected to the side of the area that was swabbed by alcohol. Incident currently ended here. RPh to call patient at a later date to check up on her.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient was given Flu and ZOSTAVAX vaccine on afternoon of 12/13/16. Pt waited for about 5 minutes or so at Pharmacy after given vaccine and then left because she did not experience any reactions at the time.  Patient came back to Pharmacy on the afternoon of 12/15/16 complaining of a red painful rash at the site of the ZOSTAVAX injection of the right arm. Patient also told RPh that she also have a headache which may or may not be related to the event. RPh on duty called patient's primary doctor for advice. Doctor advise patient  to go seek medical attention. Patient immediately went to an urgent care facility. Patient came back to Pharmacy about 30 minutes later with a prescription for an antibiotic. Patient said she was diagnosed with cellulitis. Patient said the RPh who administered the vaccine didn't inject her in the area that was swab by alcohol but instead it she injected to the side of the area that was swabbed by alcohol. Incident currently ended here. RPh to call patient at a later date to check up on her.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Vomiting projectile
Clinical narrative: Baby started crying and was unconscionable and projectile vomiting.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site pruritus
Clinical narrative: 12/12/16 PCV-13 given in (R) deltoid - aspirated without blood - injected serum and upon removing needle-bleeding and bruising pressure applied. 12/16/16 Pt came into clinic with C/O (R) deltoid - itchy; redness, tender: muscle soreness, swelling. Pt has been treated with MEDROL Dose Pack-use as directed, BENADRYL 25mg 2 capsules every 6 hrs for 2 days, BACTRIM DS 800mg-160mg tablet one tablet every 12 hrs x10 days, KENALOG 40 mg given IM. Pt told to go to ER if no improvement within 24 hrs. Pt told to F/U by phone today.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site swelling
Clinical narrative: 12/12/16 PCV-13 given in (R) deltoid - aspirated without blood - injected serum and upon removing needle-bleeding and bruising pressure applied. 12/16/16 Pt came into clinic with C/O (R) deltoid - itchy; redness, tender: muscle soreness, swelling. Pt has been treated with MEDROL Dose Pack-use as directed, BENADRYL 25mg 2 capsules every 6 hrs for 2 days, BACTRIM DS 800mg-160mg tablet one tablet every 12 hrs x10 days, KENALOG 40 mg given IM. Pt told to go to ER if no improvement within 24 hrs. Pt told to F/U by phone today.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 4-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 29th November 2016, the patient received KINRIX (intramuscular) 0.5 ml. On an unknown date, less than a week after receiving KINRIX, the patient experienced injection site warmth, injection site swelling, injection site pain and injection site redness. On an unknown date, the outcome of the injection site warmth, injection site swelling, injection site pain and injection site redness were unknown. The reporter considered the injection site warmth, injection site swelling, injection site pain and injection site redness to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to health department. At 13.9 hours, the patient received a dose of KINRIX on her right arm. On the same day, the patient concomitantly received MMRV (non-GSK) vaccine on her left thigh. The batch number reported for MMRV was M026879 with expiry date as 27th November 2017. On 1st December 2016, reporter brought the patient back to see physician because her upper right arm was red, warm, swollen and was hurting. The redness was up to the size of the patient's palm. The physician was also notified about this situation. Further details were unable to obtain. The reporter's call was transferred to Medical Information (MI). The reporter also reported similar adverse events for 4 other children (see cases US2016180181, US2016180183, US2016180270 and US2016180187) that received the same lot of KINRIX vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via call representative and described the occurrence of redness in a 4-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 2nd December 2016, the patient received KINRIX (intramuscular) 0.5 ml. In December 2016, less than a week after receiving KINRIX, the patient experienced redness and swelling arm. On an unknown date, the outcome of the redness and swelling arm were unknown. The reporter considered the redness and swelling arm to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to health department. At 11.45 hours, the patient received a dose of KINRIX on her right arm. On the same day, the patient concomitantly received MMRV (non-GSK) vaccine on her left arm. The batch number reported for MMRV was M026879 with expiry date as 27th November 2017. The patient's parent had called the physician's office over the weekend before reporting date to report that the patient had a red and swollen right arm. The physician was also notified about this situation. Further details were unable to obtain. The reporter's call was transferred to Medical Information (MI). The reporter also reported similar adverse events for 4 other children (see cases US2016180181, US2016180183, US2016180270 and US2016180271) that received the same lot of KINRIX vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 4-year-old male patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 29th November 2016, the patient received KINRIX (intramuscular) 0.5 ml. On 30th November 2016, 1 days after receiving KINRIX, the patient experienced injection site swelling and injection site redness. On an unknown date, the outcome of the injection site swelling and injection site redness were unknown. The reporter considered the injection site swelling and injection site redness to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to health department. At 8:47 hours, the patient received a dose of KINRIX on her left arm. On the same day, the patient concomitantly received MMRV (non-GSK) vaccine on her right arm. The batch number reported for MMRV was M026879 with expiry date as 27th November 2017. On 1st December 2016, two days after receiving the vaccination, the mother brought the patient back to the physician's office because the upper part of his left arm was swollen and red. These symptoms started the day after the vaccination and were unchanged at the time of the appointment. The physician was also notified about this situation. Further details were unable to obtain. The reporter's call was transferred to Medical Information (MI). The reporter also reported similar adverse events for 4 other children (see cases US2016180181, US2016180183, US2016180271 and US2016180187) that received the same lot of KINRIX vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 26th October 2016, the patient received KINRIX (intramuscular) 0.5 ml. In October 2016, less than a week after receiving KINRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site itching, injection site warmth and injection site induration. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site itching, injection site warmth and injection site induration were unknown. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site itching, injection site warmth and injection site induration to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to health department. At 11.33 hours, the patient received a dose of KINRIX on her left arm. On the same day, the patient concomitantly received MMRV (non-GSK) vaccine on her right arm. The batch number reported for MMRV was M015700 with expiry date as 26th September 2017. On 28th October 2016, two days after receiving the vaccination, the patient was brought back to the physician's office because her left upper arm was red, swollen and itchy. The swelling extended two inches from the elbow up to the shoulder and the area was hard, red and warm. The physician was also notified about this situation. Further details were unable to obtain. The reporter's call was transferred to Medical Information (MI). The reporter also reported similar adverse events for 4 other children (see cases US2016180181, US2016180270, US2016180271 and US2016180187) that received the same lot of KINRIX vaccine.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Headache, Wheezing
Clinical narrative: Cough onset 30" after vaccine positive chest tightness, wheezing, h/a . Essentially resolved by 11/15/16.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Pt received vaccines-went to check out area and passed out. Examined by provided-did not hit head, vasovagal response. Did not eat breakfast today.
Age: 64.0
Sex: U
Vaccine: FLU4, PNC13
Symptoms: Inflammation, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Bump, raised muscle on left deltoid, pain, swelling and inflammation, limited arm mobility. Dull pain more in the AM and at bedtime.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness over the pubic bone. Seen that night in the Urgent Care Clinic. The swelling decreased and was gone by the next day.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Clumsiness, Decreased appetite, Grip strength decreased, Poor quality sleep, Pyrexia
Clinical narrative: Fever began 12-11 per mother highest 102 decreased appetite and not sleeping well began 12-11 as well. Mother stated could move clumsy than normal. He could not grasp a cracker she handed him.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain in extremity
Clinical narrative: Pain/decreased range of motion that has persisted after flu vaccine given in (L) arm. Pain/discomfort has continued in (L) shoulder since vaccine given 4-5 weeks ago.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site induration, Injection site swelling
Clinical narrative: Swelling at injection site - waited with patient. Swelling subsided quickly - bruised the next day (felt hard). Hard at the injection site.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Patient mentioned that at the injection site on the arm had strong pain. Went to the doctor who examined it and prescribed Cataflam 50.  More tests will be done because the pain recurs sometimes. The patient said that he lifts weights in the gym.   Pt was offered for the report to be completed but he refused
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary mass, Axillary pain, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat, swelling at injection site and upper left arm. Reports pain, swelling and lump in left axilla.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema peripheral
Clinical narrative: Redness, heat, swelling at injection site and upper left arm. Reports pain, swelling and lump in left axilla.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Malaise, Pain
Clinical narrative: Redness, irritation, swelling around injection site. Patient also felt generally not well, some fever. Onset was not immediate but within 12 hours of receiving immunization. Patient was treated with triamcinolone cream and lidocaine gel for the itching/irritation/pain.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia
Clinical narrative: Redness, irritation, swelling around injection site. Patient also felt generally not well, some fever. Onset was not immediate but within 12 hours of receiving immunization. Patient was treated with triamcinolone cream and lidocaine gel for the itching/irritation/pain.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: (L) arm 5 x 6 area pinkness with warmth and tenderness.
Age: 65.0
Sex: U
Vaccine: FLUC4, PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: (1) Vaccine give 11/30/16 in right arm. (2) Pt. presents today with swelling and firmness to upper right arm.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching and hot in left arm the day after receiving flu vaccine (11/17/2016). BENADRYL OTC not helping.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Rash on chest shoulders - itching - all over body swelling under arm on side of vaccine shot. Swelling moved to breast on same side.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 20 hours after administration swelling/bulge at injection site; red and warm to the touch.
Age: 11.0
Sex: M
Vaccine: HPV9, MMRV, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth, redness; 9 x 6 cm induration in left deltoid.
Age: 73.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site irritation, Injection site pain, Pain, Pruritus, Swelling
Clinical narrative: Site very painful and irritated several days after vaccine administered. Called MD and reported 12/16/16 they want Pt to come in. (Pt out of town-will call MD).
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parents report redness and swelling from left upper thigh to knee. Resolved within 24 hours.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Pyrexia, Urticaria
Clinical narrative: Blistering, hives, mild fever.
Age: 40.0
Sex: U
Vaccine: FLU3
Symptoms: Oedema, Skin lesion
Clinical narrative: Multiple marked raised edematous lesions spread over entire body after flu vaccination given. BENADRYL 25 mg PO BID x 3 days. CALAMINE Lotion PRN itching. 125 mg SOLU-MEDROL IM given with follow up ordered 5 days.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient has pain in arm where injection was administered. Pain has not resolved has only gotten worse.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEP, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given KINRIX before the age of 4. Patient did not have any adverse event.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Pain in the muscle in my arm.
Age: 36.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Pt complained of fever 102.5 approximately 8 hours after immunizations, with swelling and redness.
Age: 78.0
Sex: F
Vaccine: PNC
Symptoms: Cellulitis, Injection site erythema, Pyrexia
Clinical narrative: Patient said that redness started at the injection site and spread to the lower arm. Patient had mild fever and was diagnosed with cellulitis.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Diarrhoea, Nausea
Clinical narrative: Nausea, diarrhea, tightness in lower abdomen.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Erythema, Rash, Rash macular, Restlessness, Swelling face
Clinical narrative: Cheeks swelled up, skin became splotchy red, little bumps formed on her cheeks, became extremely restless.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Rash
Clinical narrative: Pt had a severe rash at injection site which spread to his underarm area.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Oropharyngeal pain, Pain, Productive cough, Secretion discharge
Clinical narrative: Sore throat symptoms appeared about 8 hours after injection. Over 24 hours later at the time of this submission (4:12 PM on 12/17/2016) symptoms persist and are stronger. No other flu-like symptoms are present. The pain/soreness feels more like a physical injury than from a flu infection. Phlegm/mucus of some sort also appeared a day after injection but is subsiding fast. No treatment administered.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: She developed a significantly sore shoulder, worried that it may become a frozen shoulder.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash, Skin warm
Clinical narrative: PATIENT STATES SHE HAS A RASH AND SKIN IS WARM TO TOUCH. ASKED HER TO USE BENADRYL TABLETS/CAPSULES.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Impaired work ability, Pain, Pyrexia
Clinical narrative: Approximately one hour after receiving the vaccine, patient became light headed and dizzy. The following morning (11/29/16) patient experienced severe body aches, exhaustion, and a fever of 102 degrees. As a result, patient missed a day of work. By the third day (11/30/16) patient was no longer experiencing a fever.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Headache, Wheezing
Clinical narrative: Intense coughing and wheezing, followed by headache. No treatment, medical facility closed.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Severe Shoulder and arm pain. Very limited range of motion. Could not lift my hand to my face. Fever reaching 101. 4 days later and still facing limited range of motion and major pain in shoulder.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching, hives all over body.  Started on arms and within 24 hours covered 1/2 of his body in patches of hives.
Age: 1.0
Sex: F
Vaccine: DPP, HEPA
Symptoms: Heart rate increased, Laboratory test normal, Pyrexia
Clinical narrative: At first she was just having fevers since Thursday night but on Saturday night her heartbeat was really fast so I went straight to the ER she was beating 178 beats which is highly fast and her fever was 103.4 the Dr said that that's a high fever just for shots and that the heartbeat was high too. They did some tests and everything came back ok so they linked it to the vaccines.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site swelling, Peripheral swelling
Clinical narrative: PT SAID HER WHOLE LEFT ARM WAS SWOLLEN, RED PATCHES, ROUND CIRCLES, AND KNOTS AROUND THE INJECTION SITE..PT SAID SHE COULD NOT LIFT HER ARM BECAUSE TOO PAINFUL.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid arthritis
Clinical narrative: Gradual onset of what has been diagnosed as atypical rheumatoid arthritis.
Age: 75.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: PT EXPERIENCED A LOW-GRADE FEVER ACCOMPANIED WITH SORE ARM. THE PAIN RADIATED FROM THE SHOULDER TO THE ELBOW AND THE ERYTHEMA AND SWELLING MOVED FROM THE SITE OF INJECTION DOWN AND AROUND THE ARM. THE PATIENT SELF TREATED WITH ASPIRIN AND REST.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Confusional state, Fatigue, Headache, Lacrimation increased
Clinical narrative: Vertigo, unsteadiness when rising from sleep, awakened from sleep by sensation of room spinning, sensation of brain shaking, confusion, fatigue, headache, runny nose, runny eyes. Doctor advised to take Tylenol, stay hydrated and rest.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Sensory disturbance, Vertigo
Clinical narrative: Vertigo, unsteadiness when rising from sleep, awakened from sleep by sensation of room spinning, sensation of brain shaking, confusion, fatigue, headache, runny nose, runny eyes. Doctor advised to take Tylenol, stay hydrated and rest.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Red local reaction, slightly warm. Does not hurt or itch but did get bigger since Friday.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Choking, Dysphagia, Dyspnoea
Clinical narrative: Choking due to a restriction in the throat not from food or drink. Husband did Heimlich Maneuver twice before airway opened up enough for me to catch my breath. Next day, difficulty swallowing food unless it was soft or cut up finely.
Age: 85.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Eyelid oedema, Malaise, Pruritus generalised
Clinical narrative: Puffy eyes, no rash but skin red and felt itchy all over. Pt said "doesn't feel well". No fever. No irritation at injection site. No difficulty breathing, swelling of lips, tongue or throat. Took BENADRYL at 8:30 am on 12/17/20016. That helped. Called back 12/17/2016 and 5pm on 12/18/2016. Pt stated feeling better and not itching as much. Has not taken any more BENADRYL.
Age: 85.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dry eye, Eye swelling, Malaise, Pruritus generalised
Clinical narrative: Puffy eyes, no rash but skin red and felt itchy all over. Pt said "doesn't feel well". No fever. No irritation at injection site. No difficulty breathing, swelling of lips, tongue or throat. Took BENADRYL at 8:30 am on 12/17/20016. That helped. Called back 12/17/2016 and 5pm on 12/18/2016. Pt stated feeling better and not itching as much. Has not taken any more BENADRYL.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Diarrhoea, Dizziness, Feeling cold, Headache
Clinical narrative: Lightheaded, nausea, headache, diarrhea, tingling sensation in legs, feet, and fingers. Flushing hot and cold chills. Low grade fever.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Hot flush, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Lightheaded, nausea, headache, diarrhea, tingling sensation in legs, feet, and fingers. Flushing hot and cold chills. Low grade fever.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: INJECTION SITE IS RED AND HOT THE THE TOUCH.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy prostate, Blood test, Chills, Dysuria, Hypoaesthesia
Clinical narrative: Body aches, chills, severe leg pain, pain during urination, numbness in rectum, genitals, bottom of feet and abdomen.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Neurological examination, Nuclear magnetic resonance imaging, Pain, Pain in extremity, Urine analysis
Clinical narrative: Body aches, chills, severe leg pain, pain during urination, numbness in rectum, genitals, bottom of feet and abdomen.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Palpitations, Tremor
Clinical narrative: PATIENT REPORTED TREMBLING AND RACING HEART.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Cough, Eye irritation, Fatigue, Headache
Clinical narrative: Headache, cough, burning lungs, aching all over, tired, burning eyes. Taking TYLENOL, DAYQUIL, NYQUIL and Cough Suppressant.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Headache, cough, burning lungs, aching all over, tired, burning eyes. Taking TYLENOL, DAYQUIL, NYQUIL and Cough Suppressant.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Ultrasound scan normal, Weight bearing difficulty, X-ray limb normal
Clinical narrative: Pt reported 11/8/16 to have painful arm, unable to lift baggage. Pain continued until pt saw a APRN 11/13/16. Xray and sonogram was done to see if any soft tissue damage - none was found. Pt was prescribed Diclofenac 100mg. 1/day. Pt took 1 tab daily x 2 days but made him dizzy, fell from bike and continued to have arm pain. He is still seeing a MD in regards.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Pain
Clinical narrative: Patient recd FLUZONE High-Dose 2016-17 0.5 ml on 10/6/2016 around 1pm. Pt states by about 430pm she could not raise her arm. This was reported 12/17/2016. Pt. states she has not sought medical attention but will do so because pain has not resolved and she can't put her arm behind her back or put a shirt on or have normal range of motion.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Nausea, Tenderness
Clinical narrative: Patient experienced headache, nausea, redness at injection site, and left arm tenderness for 24 hours after receiving this vaccination.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Extreme pain in entire arm of administration. Pt finally got some movement back in it on 12/15. Still no usage of arm. Pt never had persistent but debilitating pain over every aspect of arm that rendered it useless.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Skin Rash. Diphenhydramine 25 mg TID.
Age: 67.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Received shot in right arm. Pain from shot has gone all the way down to hands and fingers and shoulder blade.
Age: 67.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: Received shot in right arm. Pain from shot has gone all the way down to hands and fingers and shoulder blade.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Cervical radiculopathy, Electromyogram abnormal, Muscular weakness, Musculoskeletal pain, Neuralgic amyotrophy
Clinical narrative: Initial unsolicited report received from a physician on 08 Dec 2016. This case involves a 36 years old male patient who was vaccinated with a dose of Fluzone QIV (batch number- UI443AC; expiry date, dose- unknown) intramuscularly in deltoid region on 12 Jan 2015. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Any other vaccinations within 4 weeks of vaccination was reported as unknown. The patient concomitant medications were not reported. On an unspecified date, six weeks following the vaccination, the patient experienced temporary weakness of his hands, diagnosed as Parsonage Turner syndrome, brachial plexis neuropathy. The patient required emergency room/ doctor visit. Laboratory investigations were reported as: EMG and MRI of the cervical spineto r/o possible small herniation or lesion at brachial plexis or nerve root. On an unknown date, after six months patient recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical event: Parsonage Turner syndrome. List of documents held by sender: none. Sender's Comments: This case concerns 36 year old male patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and developed temporary weakness of his hands. Patient was diagnosed of having Parsonage Turner syndrome/brachial plexis neuropathy. Time to onset is not compatible with the role of vaccine. However further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, reaction to previous vaccination to rule out the alternative cause are needed for complete assessment of the case.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Pain in extremity, Radiculopathy
Clinical narrative: Initial unsolicited report received from a physician on 08 Dec 2016. This case involves a 36 years old male patient who was vaccinated with a dose of Fluzone QIV (batch number- UI443AC; expiry date, dose- unknown) intramuscularly in deltoid region on 12 Jan 2015. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Any other vaccinations within 4 weeks of vaccination was reported as unknown. The patient concomitant medications were not reported. On an unspecified date, six weeks following the vaccination, the patient experienced temporary weakness of his hands, diagnosed as Parsonage Turner syndrome, brachial plexis neuropathy. The patient required emergency room/ doctor visit. Laboratory investigations were reported as: EMG and MRI of the cervical spineto r/o possible small herniation or lesion at brachial plexis or nerve root. On an unknown date, after six months patient recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical event: Parsonage Turner syndrome. List of documents held by sender: none. Sender's Comments: This case concerns 36 year old male patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and developed temporary weakness of his hands. Patient was diagnosed of having Parsonage Turner syndrome/brachial plexis neuropathy. Time to onset is not compatible with the role of vaccine. However further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, reaction to previous vaccination to rule out the alternative cause are needed for complete assessment of the case.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Electromyogram, Muscular weakness, Neuralgic amyotrophy, Neuropathy peripheral, Nuclear magnetic resonance imaging spinal
Clinical narrative: Initial unsolicited report received from a physician on 08 Dec 2016. This case involves a 36 years old male patient who was vaccinated with a dose of Fluzone QIV (batch number- UI443AC; expiry date, dose- unknown) intramuscularly in deltoid region on 12 Jan 2015. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Any other vaccinations within 4 weeks of vaccination was reported as unknown. The patient concomitant medications were not reported. On an unspecified date, six weeks following the vaccination, the patient experienced temporary weakness of his hands, diagnosed as Parsonage Turner syndrome, brachial plexis neuropathy. The patient required emergency room/ doctor visit. Laboratory investigations were reported as: EMG and MRI of the cervical spineto r/o possible small herniation or lesion at brachial plexis or nerve root. On an unknown date, after six months patient recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical event: Parsonage Turner syndrome. List of documents held by sender: none. Sender's Comments: This case concerns 36 year old male patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and developed temporary weakness of his hands. Patient was diagnosed of having Parsonage Turner syndrome/brachial plexis neuropathy. Time to onset is not compatible with the role of vaccine. However further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, reaction to previous vaccination to rule out the alternative cause are needed for complete assessment of the case.
Age: 80.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Dizziness, Hyperhidrosis, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 80-year-old male patient received PREVNAR 13 (NDC# 00005197102, UPC# 300051971022, Lot# N34935, Exp date 01Oct2017), intramuscular, on 31Oct2016, at 0.5 ml single, for immunisation. The patient was vaccinated at the pharmacy. The patient's medical history and concomitant medications were not reported. The patient felt ill and was hospitalized three days after immunisation for pneumonia like symptoms and he was being treated for pneumonia in the hospital for at least a period of two weeks. Outcome was unknown. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Age: 80.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Malaise, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 80-year-old male patient received PREVNAR 13 (NDC# 00005197102, UPC# 300051971022, Lot# N34935, Exp date 01Oct2017), intramuscular, on 31Oct2016, at 0.5 ml single, for immunisation. The patient was vaccinated at the pharmacy. The patient's medical history and concomitant medications were not reported. The patient felt ill and was hospitalized three days after immunisation for pneumonia like symptoms and he was being treated for pneumonia in the hospital for at least a period of two weeks. Outcome was unknown. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLU4, PPV
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: This spontaneous case, initially received on 05-Dec-2016, was reported by a health professional and concerns a(n) 72-year-old female patient. Weight: not provided; Height: not provided. Drug history included PREVNAR 13 (Reaction: No adverse effect). Concomitant medication: losartan, omeprazole, liothyronine sodium, levothyroxine sodium. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for Indication not reported from 07-NOV-2016 to 07-NOV-2016. Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. Non-company suspect drugs: PNEUMOVAX 23, Indication: Prevention of pneumococcal disease, from 07-NOV-2016 to 07-NOV-2016, in the opposite arm. Adverse reactions/events and outcomes: On 07-Nov-2016, the patient's arm that received Pneumovax 23 developed swelling and redness in the whole arm from shoulder to an inch above the elbow (Medically Significant, outcome: Unknown) and the injection site was swollen outcome: Unknown) and red "the size of baseball" (outcome: Unknown). On 09-Nov-2016, the patient experienced Vomiting (outcome: Unknown) and Felt weak (outcome: Unknown). Treatment: The patient was treated with unspecified "topical steroids" on an unknown date. Sender's Comments: Company comments: Listedness: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, extensive swelling of vaccinated arm and asthenia are unlisted. Injection site swelling, Injection site erythema and vomiting are listed. Causality: Not Related for events relating to extensive swelling of vaccinated arm and injection site reactions as they occurred at site/arm which received Pneumovax. Systemic events of vomiting and asthenia can be attributable to Influenza vaccine due to plausible temporal association of 3 days following vaccination.
Age: 84.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Intensive care, Monoplegia, Oxygen saturation, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (Husband) via Pfizer-sponsored program. A 84-year-old female patient received the first single dose of PREVNAR 13 on 10Oct2016 in the right arm around noon to avoid pneumonia. Concomitant medication included influenza vaccine (FLU) given on 10Oct2016 in the right arm and other unspecified medications. Medical history included atrial fibrillation (AFib) from Oct2016 and ongoing and pneumonitis from 06Oct2016 to 10Oct2016, due to which was hospitalized: she went to emergency room on 06Oct2016 and was discharged from the hospital's ICU on 10Oct2016. She was discharged within a half an hour of getting pneumococcal 13-val conj vaccine and influenza vaccine. Patient has never had the pneumonia shot before. On 10Oct2016 around midday, the patient's right arm was paralyzed, she had zero range of motion and was getting therapy and she also had pain (right arm pain). On 11Oct2016 her oxygen level was really low below 90. The patient who was discharged on 10Oct2016, went back to the hospital on 11Oct2016 due to oxygen level low and stayed until 22Oct2016. Lab tests included right shoulder X-ray on 10Oct2016 that did not show anything, the doctor thought they severed a nerve when they gave her the shot; right shoulder X-ray on 07Dec2016 was negative and was to check rotator cuff. Outcome of oxygen saturation decreased was unknown, while right arm pain and right arm paralyzed not recovered.