chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria, Rash
Clinical narrative: Hives appearing next to injection site of MMR. No other symptoms. Given ibuprofen, BENADRYL 1 dose. Rash improved after 15 minutes.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Abnormal behaviour, Headache, Mobility decreased, Unresponsive to stimuli
Clinical narrative: Mom describes patient was "acting high" with headaches and she "couldn't get up". She was not responsive when spoken to. Mom recorded a video. No treatment.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Headache, Mobility decreased, Unresponsive to stimuli
Clinical narrative: Mom describes patient was "acting high" with headaches and she "couldn't get up". She was not responsive when spoken to. Mom recorded a video. No treatment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash, Rash erythematous, Type III immune complex mediated reaction
Clinical narrative: Within 12 hours of Tdap and MENACTRA vaccine patient developed red rash on both arms. The right (Tdap) measured 14cm by 10cm and the left (MENACTRA) measured 4cm by 3cm. The Arthus reaction is usually self limited. Antihistamines and steroid creams was given. A Tdap and MENACTRA booster will not be given again for at least 10 years.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Evening after vaccine she experienced soreness, by next AM: swelling, redness, soreness at site. No fever. Symptoms decreased but not gone by day 3.
Age: 2.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, itchy bump at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen 71/2 x 9cm given on (R) Delt - No pain or fever.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abscess, Pyrexia, Staphylococcus test positive
Clinical narrative: Patient presented to walk in clinic on 4/4/18 (6 days later) with 104.7 Fever and abscess near injection site. Patient was given TYLENOL and sent to Emergency Room.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a registered nurse and refers to a 20-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 06-DEC-2016, the patient was vaccinated with a dose of GARDASIL 9 injection (dose number, route of administration, lot number and expiration date were not provided) for immunisation, while she was five months pregnant (second trimester of exposure - exposure at 20 weeks). The patient had a live birth on an unknown date, she delivered a male infant. It was also reported that borned child was not growing like he should and the patient would be seeing a genetics. The patient last menstrual period (LMP) was calculated on 19-JUL-2016, estimated date of delivery (EDD) was calculated on 25-APR-2017, due date was calculated on 25-APR-2017. This case is linked with the MARRS # 1803USA007591 case due to parent-child link. Sender's Comments: US-009507513-1803USA007591: Original Case: 1803USA005894.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: This spontaneous retrospective pregnancy report was received from a registered nurse and refers to a 20-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 06-DEC-2016, the patient was vaccinated with a dose of GARDASIL 9 injection (dose number, route of administration, lot number and expiration date were not provided) for immunisation, while she was five months pregnant (second trimester of exposure - exposure at 20 weeks). The patient had a live birth on an unknown date, she delivered a male infant. It was also reported that borned child was not growing like he should and the patient would be seeing a genetics. The patient last menstrual period (LMP) was calculated on 19-JUL-2016, estimated date of delivery (EDD) was calculated on 25-APR-2017, due date was calculated on 25-APR-2017. This case is linked with the MARRS # 1803USA007591 case due to parent-child link. Sender's Comments: US-009507513-1803USA007591: Original Case: 1803USA005894.
Sex: F
Vaccine: FLUR4
Symptoms: Dyspnoea, Heart rate increased, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Initial unsolicited report received from health authority (Under reference number: 724344) on 03-Apr-2018. This case involves 41 years old female patient who was vaccinated with second dose of FLUBLOK QIV (batch number: QFAA1701, expiry date was not reported) intramuscularly in right arm on 19 Oct 2017. The patient's had medical history of galactorrhea, sensitive to medications and did not have current Illnesses. Patient previously received INFLUENZA VACCINE (INFLUENZA) and had shortness of breath local reaction. Concomitant medication includes Bromocriptine. On 19 Oct 2017 same day post vaccination patient had started local reaction to injection site with redness and swelling elevated pulse and shortness of breath. Nurse administered EPI (EPINEPHRINE) and employee was transferred to Emergency room. Laboratory investigation and other corrective treatment were not reported. On an unspecified date, patient was recovered from events. Upon internal review the case was considered as serious because of important medical events: dyspnoea, heart rate increased, injection site erythema, injection site swelling and local reaction. List of documents held by sender: none.; Sender's Comments: The patient experienced dyspnoea, heart rate increased, injection site swelling and erythema post vaccination with Flublok QIV. Time to onset was compatible. Patient had history of Galactorrhea, sensitive to medications. The events are suggestive of a possible allergic response. Patient's medical history for any allergic reactions or testing should be requested. The patient had experienced shortness of breath post vaccination with influenza vaccine in past. Based upon reported information an allergic reaction appears more likely and the role of the vaccine cannot be denied.
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder, Pain
Clinical narrative: Received flu shot upper left arm. Initially experienced soreness then by day two the pain at flu site began. Pain was so severe I could not move arm and then over two weeks it subsided. Went to doctor completed form to CDC. Pain at site randomly occurs still - no use of arm. I continue to have random pain at flu site which prevents me form lifting left arm.
Age: 43.0
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Antinuclear antibody negative, Blood creatinine increased, Blood urea increased, Condition aggravated, Glomerular filtration rate decreased
Clinical narrative: Initial unsolicited report received from health authority (under reference number: 731771) on 03-Apr-2018. This case involves a 43-year-old female patient who was vaccinated with a dose of FLUBLOK QIV (batch number: QFAA1702, expiry date, dose and dose in series not reported) intramuscularly in right arm on 07-Nov-2017. It was also reported that patient had no medical history prior to starting FLUBLOK vaccines; fall of 2015, prior to any FLUBLOK vaccines, perfectly healthy with normal renal function, as well as a sharply declining renal function after this year's vaccine, was assured no correlation but lab work show it had a profound effect. Concomitant medications and current illness were reported as none. On 20-Nov-2017, 13 days following the vaccination, the patient experienced IgA nephropathy, renal impairment, tubulointerstitial nephritis, blood creatinine increased, blood urea increased and glomerular filtration rate decreased and patient also performed HIV test negative, Hepatitis viral test negative and Antinuclear antibody test negative. It was reported that after three doses of FLUBLOK - IgA neuropathy and tubulointerstitial nephritis. Viral infections such as Hepatitis and HIV has been ruled out. Lupus ruled out. ANA titer negative. All other typical causes of her disorder have been ruled out. Normal renal function prior to first dose of FLUBLOK; Fall of 2015, had first vaccine fall of 2015 and second fall of 2016. Decreased renal function was noted in Oct. of 2017. I was assured not related to FLUBLOK. Patient's Lab data included: After this dose BUN went from 25 to a BUN of 28, CR 1.5 to 1.75 and GFR of 36 to 31. Fall of 2015 all renal function was perfectly normal (on low side of normal). Corrective treatment was not reported. The patient was not yet recovered/resolved from all the events. Upon internal review the case was considered as serious because of important medical event: IgA nephropathy, renal impairment and tubulointerstitial nephritis. It was reported that reporter assured no correlation but lab work show it had a profound effect. List of documents held by the sender: None; Sender's Comments: This adult developed renal disorders following vaccination with FLUBLOK QIV vaccine. Time to onset is compatible. All reported events are unlisted events. Based on the data provided regarding laboratory investigations and medical history the role of vaccine cannot be ruled out. Further lab work would be needed to confirm the cause of infection.
Age: 43.0
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: HIV test negative, Hepatitis viral test negative, IgA nephropathy, Renal impairment, Tubulointerstitial nephritis
Clinical narrative: Initial unsolicited report received from health authority (under reference number: 731771) on 03-Apr-2018. This case involves a 43-year-old female patient who was vaccinated with a dose of FLUBLOK QIV (batch number: QFAA1702, expiry date, dose and dose in series not reported) intramuscularly in right arm on 07-Nov-2017. It was also reported that patient had no medical history prior to starting FLUBLOK vaccines; fall of 2015, prior to any FLUBLOK vaccines, perfectly healthy with normal renal function, as well as a sharply declining renal function after this year's vaccine, was assured no correlation but lab work show it had a profound effect. Concomitant medications and current illness were reported as none. On 20-Nov-2017, 13 days following the vaccination, the patient experienced IgA nephropathy, renal impairment, tubulointerstitial nephritis, blood creatinine increased, blood urea increased and glomerular filtration rate decreased and patient also performed HIV test negative, Hepatitis viral test negative and Antinuclear antibody test negative. It was reported that after three doses of FLUBLOK - IgA neuropathy and tubulointerstitial nephritis. Viral infections such as Hepatitis and HIV has been ruled out. Lupus ruled out. ANA titer negative. All other typical causes of her disorder have been ruled out. Normal renal function prior to first dose of FLUBLOK; Fall of 2015, had first vaccine fall of 2015 and second fall of 2016. Decreased renal function was noted in Oct. of 2017. I was assured not related to FLUBLOK. Patient's Lab data included: After this dose BUN went from 25 to a BUN of 28, CR 1.5 to 1.75 and GFR of 36 to 31. Fall of 2015 all renal function was perfectly normal (on low side of normal). Corrective treatment was not reported. The patient was not yet recovered/resolved from all the events. Upon internal review the case was considered as serious because of important medical event: IgA nephropathy, renal impairment and tubulointerstitial nephritis. It was reported that reporter assured no correlation but lab work show it had a profound effect. List of documents held by the sender: None; Sender's Comments: This adult developed renal disorders following vaccination with FLUBLOK QIV vaccine. Time to onset is compatible. All reported events are unlisted events. Based on the data provided regarding laboratory investigations and medical history the role of vaccine cannot be ruled out. Further lab work would be needed to confirm the cause of infection.
Age: 43.0
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Anaemia, Biopsy kidney, Blood urine present, Haemoglobin decreased, Renal function test
Clinical narrative: Initial unsolicited report received from health authority (under reference number: 731771) on 03-Apr-2018. This case involves a 43-year-old female patient who was vaccinated with a dose of FLUBLOK QIV (batch number: QFAA1702, expiry date, dose and dose in series not reported) intramuscularly in right arm on 07-Nov-2017. It was also reported that patient had no medical history prior to starting FLUBLOK vaccines; fall of 2015, prior to any FLUBLOK vaccines, perfectly healthy with normal renal function, as well as a sharply declining renal function after this year's vaccine, was assured no correlation but lab work show it had a profound effect. Concomitant medications and current illness were reported as none. On 20-Nov-2017, 13 days following the vaccination, the patient experienced IgA nephropathy, renal impairment, tubulointerstitial nephritis, blood creatinine increased, blood urea increased and glomerular filtration rate decreased and patient also performed HIV test negative, Hepatitis viral test negative and Antinuclear antibody test negative. It was reported that after three doses of FLUBLOK - IgA neuropathy and tubulointerstitial nephritis. Viral infections such as Hepatitis and HIV has been ruled out. Lupus ruled out. ANA titer negative. All other typical causes of her disorder have been ruled out. Normal renal function prior to first dose of FLUBLOK; Fall of 2015, had first vaccine fall of 2015 and second fall of 2016. Decreased renal function was noted in Oct. of 2017. I was assured not related to FLUBLOK. Patient's Lab data included: After this dose BUN went from 25 to a BUN of 28, CR 1.5 to 1.75 and GFR of 36 to 31. Fall of 2015 all renal function was perfectly normal (on low side of normal). Corrective treatment was not reported. The patient was not yet recovered/resolved from all the events. Upon internal review the case was considered as serious because of important medical event: IgA nephropathy, renal impairment and tubulointerstitial nephritis. It was reported that reporter assured no correlation but lab work show it had a profound effect. List of documents held by the sender: None; Sender's Comments: This adult developed renal disorders following vaccination with FLUBLOK QIV vaccine. Time to onset is compatible. All reported events are unlisted events. Based on the data provided regarding laboratory investigations and medical history the role of vaccine cannot be ruled out. Further lab work would be needed to confirm the cause of infection.
Age: 43.0
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Renal impairment, Scar
Clinical narrative: Initial unsolicited report received from health authority (under reference number: 731771) on 03-Apr-2018. This case involves a 43-year-old female patient who was vaccinated with a dose of FLUBLOK QIV (batch number: QFAA1702, expiry date, dose and dose in series not reported) intramuscularly in right arm on 07-Nov-2017. It was also reported that patient had no medical history prior to starting FLUBLOK vaccines; fall of 2015, prior to any FLUBLOK vaccines, perfectly healthy with normal renal function, as well as a sharply declining renal function after this year's vaccine, was assured no correlation but lab work show it had a profound effect. Concomitant medications and current illness were reported as none. On 20-Nov-2017, 13 days following the vaccination, the patient experienced IgA nephropathy, renal impairment, tubulointerstitial nephritis, blood creatinine increased, blood urea increased and glomerular filtration rate decreased and patient also performed HIV test negative, Hepatitis viral test negative and Antinuclear antibody test negative. It was reported that after three doses of FLUBLOK - IgA neuropathy and tubulointerstitial nephritis. Viral infections such as Hepatitis and HIV has been ruled out. Lupus ruled out. ANA titer negative. All other typical causes of her disorder have been ruled out. Normal renal function prior to first dose of FLUBLOK; Fall of 2015, had first vaccine fall of 2015 and second fall of 2016. Decreased renal function was noted in Oct. of 2017. I was assured not related to FLUBLOK. Patient's Lab data included: After this dose BUN went from 25 to a BUN of 28, CR 1.5 to 1.75 and GFR of 36 to 31. Fall of 2015 all renal function was perfectly normal (on low side of normal). Corrective treatment was not reported. The patient was not yet recovered/resolved from all the events. Upon internal review the case was considered as serious because of important medical event: IgA nephropathy, renal impairment and tubulointerstitial nephritis. It was reported that reporter assured no correlation but lab work show it had a profound effect. List of documents held by the sender: None; Sender's Comments: This adult developed renal disorders following vaccination with FLUBLOK QIV vaccine. Time to onset is compatible. All reported events are unlisted events. Based on the data provided regarding laboratory investigations and medical history the role of vaccine cannot be ruled out. Further lab work would be needed to confirm the cause of infection.
Age: 43.0
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Cardiac function test, Chest X-ray, Dyspnoea, Renal function test, Renal impairment
Clinical narrative: Initial unsolicited report received from health authority (under reference number: 731771) on 03-Apr-2018. This case involves a 43-year-old female patient who was vaccinated with a dose of FLUBLOK QIV (batch number: QFAA1702, expiry date, dose and dose in series not reported) intramuscularly in right arm on 07-Nov-2017. It was also reported that patient had no medical history prior to starting FLUBLOK vaccines; fall of 2015, prior to any FLUBLOK vaccines, perfectly healthy with normal renal function, as well as a sharply declining renal function after this year's vaccine, was assured no correlation but lab work show it had a profound effect. Concomitant medications and current illness were reported as none. On 20-Nov-2017, 13 days following the vaccination, the patient experienced IgA nephropathy, renal impairment, tubulointerstitial nephritis, blood creatinine increased, blood urea increased and glomerular filtration rate decreased and patient also performed HIV test negative, Hepatitis viral test negative and Antinuclear antibody test negative. It was reported that after three doses of FLUBLOK - IgA neuropathy and tubulointerstitial nephritis. Viral infections such as Hepatitis and HIV has been ruled out. Lupus ruled out. ANA titer negative. All other typical causes of her disorder have been ruled out. Normal renal function prior to first dose of FLUBLOK; Fall of 2015, had first vaccine fall of 2015 and second fall of 2016. Decreased renal function was noted in Oct. of 2017. I was assured not related to FLUBLOK. Patient's Lab data included: After this dose BUN went from 25 to a BUN of 28, CR 1.5 to 1.75 and GFR of 36 to 31. Fall of 2015 all renal function was perfectly normal (on low side of normal). Corrective treatment was not reported. The patient was not yet recovered/resolved from all the events. Upon internal review the case was considered as serious because of important medical event: IgA nephropathy, renal impairment and tubulointerstitial nephritis. It was reported that reporter assured no correlation but lab work show it had a profound effect. List of documents held by the sender: None; Sender's Comments: This adult developed renal disorders following vaccination with FLUBLOK QIV vaccine. Time to onset is compatible. All reported events are unlisted events. Based on the data provided regarding laboratory investigations and medical history the role of vaccine cannot be ruled out. Further lab work would be needed to confirm the cause of infection.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia, Vaccination complication
Clinical narrative: Fever 6 hours after flu shot and "violent" shaking with chills.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Fever 6 hours after flu shot and "violent" shaking with chills.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Flushing, Injection site erythema, Injection site warmth
Clinical narrative: Patient received SHINGRIX vaccine on March 20, 2018 and developed cellulitis of same arm 4 days after vaccine administration. Patient required antibiotics to treat infection.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Patient received SHINGRIX vaccine on March 20, 2018 and developed cellulitis of same arm 4 days after vaccine administration. Patient required antibiotics to treat infection.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient received SHINGRIX vaccine on March 20, 2018 and developed cellulitis of same arm 4 days after vaccine administration. Patient required antibiotics to treat infection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Electrocardiogram normal, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: On 4/11/2018 around 2:27pm patient named was given her first dose of SHINGRIX shot. She was given the shot on her left arm (IM). Before giving her the shot I verified her vaccine history with ALERT, and confirmed name, DOB, if she had never gotten this shot before, if she was allergic to anything, had any reactions to any vaccines in the past, and if she was allergic to anything other than PCN. She confirmed her name and answered no to all the questions I asked her. I advised her about SHINGRIX, and told her she needed to sit down at least 15 minutes after getting the vaccine. She said she would wait. I gave her the shot in the left deltoid (with both of us seated), and asked her how she was feeling. She said she was fine, and she also did not display any stress from the injection. She wanted to wait in the waiting room, and so I waited for her to remain seated. I returned to the pharmacy to get a copy of the VIS information, so walked it over to her in the waiting room. I asked her again if she was alright and she said yes. I was working and my tech and I saw her lying down on the floor of the waiting room through the TV monitor. I rushed over to her to see if she was ok. I asked her what was wrong, and she said was feeling dizzy/lightheaded, and nauseous. She said she was feeling hot and sweaty. I asked staff to bring me the emergency kit, and also BP cuff so I could take her BP - her hands were cold to the touch. I asked her if I could check for any hives, and there was none. I asked if she had trouble breathing but she said no, she was fine with breathing. I asked her if she knew where she was, she said pharmacy, and she also knew what day it was. She also told me she had to use the bathroom. I told her, we want her to stay lying down. In the meantime, staff was told to call 911. As I was trying to get her BP - the paramedics came, and I moved aside to let them do their assessment. I provided all the information to the EMTs. Due to her age, and previous history of heart condition, the EMTs decided to take to the hospital for tests. I called the patient around 8 o'clock tonight (4/11/18) at home, and she was at home. She said she was doing much better, and they did all the tests on her. She said the MD thinks it is not an allergic reaction but a vaso-syncope from the immunization. I told her we will call her in a day or so to check on her again.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Syncope
Clinical narrative: On 4/11/2018 around 2:27pm patient named was given her first dose of SHINGRIX shot. She was given the shot on her left arm (IM). Before giving her the shot I verified her vaccine history with ALERT, and confirmed name, DOB, if she had never gotten this shot before, if she was allergic to anything, had any reactions to any vaccines in the past, and if she was allergic to anything other than PCN. She confirmed her name and answered no to all the questions I asked her. I advised her about SHINGRIX, and told her she needed to sit down at least 15 minutes after getting the vaccine. She said she would wait. I gave her the shot in the left deltoid (with both of us seated), and asked her how she was feeling. She said she was fine, and she also did not display any stress from the injection. She wanted to wait in the waiting room, and so I waited for her to remain seated. I returned to the pharmacy to get a copy of the VIS information, so walked it over to her in the waiting room. I asked her again if she was alright and she said yes. I was working and my tech and I saw her lying down on the floor of the waiting room through the TV monitor. I rushed over to her to see if she was ok. I asked her what was wrong, and she said was feeling dizzy/lightheaded, and nauseous. She said she was feeling hot and sweaty. I asked staff to bring me the emergency kit, and also BP cuff so I could take her BP - her hands were cold to the touch. I asked her if I could check for any hives, and there was none. I asked if she had trouble breathing but she said no, she was fine with breathing. I asked her if she knew where she was, she said pharmacy, and she also knew what day it was. She also told me she had to use the bathroom. I told her, we want her to stay lying down. In the meantime, staff was told to call 911. As I was trying to get her BP - the paramedics came, and I moved aside to let them do their assessment. I provided all the information to the EMTs. Due to her age, and previous history of heart condition, the EMTs decided to take to the hospital for tests. I called the patient around 8 o'clock tonight (4/11/18) at home, and she was at home. She said she was doing much better, and they did all the tests on her. She said the MD thinks it is not an allergic reaction but a vaso-syncope from the immunization. I told her we will call her in a day or so to check on her again.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, body aches: started around 9pm after getting the vaccine at about 10:45am.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain
Clinical narrative: Muscle aches, sharp pains, shivering.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Muscular weakness, Vaccination site induration
Clinical narrative: Patient said after vaccine was given that night, "My arm was swollen, hard, red, hot, and itchy at the vaccination site. I could not move my arm for 4 days and my arm felt very weak."
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient said after vaccine was given that night, "My arm was swollen, hard, red, hot, and itchy at the vaccination site. I could not move my arm for 4 days and my arm felt very weak."
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non-valid report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On or after 27-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # N017394, expiration date (exp.dt.) 07-JUN-2019, or lot # M037008 exp. dt. 25-AUG-2018; and/or with M-M-R II lot # M045393 exp. dt. 14-NOV-2018, or lot # reported as N039914 exp. dt. 26-SEP-2018 (strength, dose and route of administration were not provided for the vaccines). The sterile diluent (MERCK STERILE DILUENT) (lot # M041812, exp. dt. 17-MAY-2019) used for reconstitution of any of the doses did not undergo a temperature excursion. The vaccines were exposed to a temperature excursion of 50 degrees Celsius during a time frame of 2 hours, this was not detected by the data logger. There was no prior temperature excursion and no adverse events were reported. Lot number N039914 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Albumin status for lot number M045393 is rHA.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of Oka/Merck VARIVAX with one of these lot #'s reported N026070, expiration date on 20-SEP-2019; lot # N021722, expiration date on 10-AUG-2019; lot # N020686 27-JUL-2019;  lot # N01739 07-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) and an improperly stored dose of Oka-Merck (rHA) PROQUAD with one of these lot #'s reported N02592, expiration date on 18-MAR-2019; N019251, expiration date on 20-DEC-2018  (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F (8.4F ) degrees Fahrenheit for 102 min. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects reported. Lot number N01739 is an invalid lot number for varicella virus vaccine live. Lot number N02592 is an invalid lot number for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live. Follow-up Information has been received on 04-APR-2018, from the nurse, with new lot and expiration dates for Oka/Merck VARIVAX for prophylaxis, lot number: N017395, expiration date: 07-JUN-2019, and Oka-Merck PROQUAD lot number: N014948 and expiration date: 11-NOV-2018. The reporter was unsure specifically as to the number of patients who received the vaccinations, identification information was provided for one of the patients; patient who had received a dose of Oka-Merck PROQUAD was a 4 year old (MARRS # 1804USA004248). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA004248.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 18-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was provided. On 28-APR-2017, the patient was vaccinated with a first dose of GARDASIL 9 injection, 1 dose (route, lot #, expiration date were not reported) for prophylaxis of human papilloma virus (HPV). On 21-AUG-2017, the patient was vaccinated with a second dose of GARDASIL 9 injection, 1 dose (route, lot #, expiration date were not reported) for prophylaxis of human papilloma virus (HPV). On 28-OCT-2017, the patient was vaccinated with a third dose of GARDASIL 9 injection, 1 dose (route, lot #, expiration date were not reported) for prophylaxis of human papilloma virus (HPV). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 9 year old patient of an unknown gender, who had no history of wild type Varicella zoster virus. No information regarding the patient's concurrent conditions and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of Oka/Merck VARIVAX injection, subcutaneous (lot #, expiration date were not reported) for prophylaxis. On an unknown date, the patient was diagnosed with herpes zoster on the left upper extremity. The outcome of herpes zoster was unknown. Causality assessment was not reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with (wistar ra 27-3) M-M-R II (lot#, expiration date, dose and frequency unknown) intramuscularly (inappropriate route of vaccination) for prophylaxis. No adverse symptoms reported.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Abnormal faeces, Occult blood negative
Clinical narrative: This spontaneous report was received from a nurse prescriber (NP) regarding a 4 month old female patient. The patient's pertinent medical history, drug allergies/reactions, concurrent condition and concomitant medication were not reported. On 19-MAR-2018, the patient was vaccinated with ROTATEQ, oral solution for vaccination (dose, lot#, expiry date were unknown). On 23-MAR-2018, after administration of ROTATEQ, the patient had black specks in the unspecified patient's stool (abnormal faeces). Patient was seen by NP on 25-MAR-2018. NP reported that black specks were a size of black pepper and it were hard. On the same day, a stool test was performed and the NP confirmed that there was no blood in the stool. NP reported that number of black specks decreased from the time which was initially reported on 23-MAR-2018, but it was still present in the stool. The outcome of the event was recovering. The reporter causality was not reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. On 28-MAR-2018, he was inadvertently vaccinated with two doses of PNEUMOVAX 23, less than 6 hours apart. One dose of PNEUMOVAX 23 (specific dose, site and route of administration, lot number and expiration date were not reported) was administered in an unspecified physician's office earlier in the day and an additional dose of PNEUMOVAX 23 one dosage form (DF), intramuscularly, lot number: N030111, expiration date: 21-APR-2019 (specific dose and site of administration were not reported) was administered in a pharmacy later in the day. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.  On 28-MAR-2018, the patient was vaccinated with an expired dose of VAQTA (1 DF, lot # M036459, expiration date 18-JAN-2018; route was not reported) for prophylaxis. No adverse effects was reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Mass, Pain
Clinical narrative: This spontaneous report was received from field representative on behalf of patient's mother refers to a 13 year old female patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. Approximately in 2017 (reported as when patient was 12 years old), the patient was vaccinated with first dose of GARDASIL 9 in the thigh (lot#, expiry date and dose not reported), intramuscularly as human papillomavirus (HPV) vaccination. Approximately in December-2017 (reported as "over Christmas break"), the patient was vaccinated with second dose of GARDASIL 9 in the thigh. It was unspecified if patient received both doses in the same thigh. On an unknown date, a few days after vaccination with the 2nd dose of GARDASIL 9, the patient developed a baseball sized lump, which was extremely painful. The patient sought medical attention, she returned to physician, who informed patient that she had a bad response to the GARDASIL 9, and informed patient to take an unspecified dose of unspecified analgesics (also reported as no treatment was given for events). None lab diagnostics/ studies were performed. No product quality complaint (PQC) was involved. It was reported that patient continued to feel an unspecified amount of pain in the injection site. The outcome of the events was reported as not recovered. The reporter did not provide any causality assessment.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a male patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 04-APR-2018, the patient was vaccinated with an expired and improperly stored dose of VAQTA lot # M031806 with expiration date of 30-MAR-2018 (strength, route, dose, and anatomical location were not provided) for prophylaxis. No adverse events were reported. The vaccine was exposed to a temperature range between 9°C to 25°C, during a time frame of 1.25 hours, which was called by a data logger. No previous temperature excursions were reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a 4 year old male patient. 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  PROQUAD lot # N014948, with expiration date 11-NOV-2018 for prophylaxis (Strength, route, dose, frequency, and anatomical location were were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F (8.4F ) degrees Fahrenheit for 102 min. There was a digital data logger invloved, but there was no previous temperature excursion. No adverse effects reported. There was no adverse event reported. This is one of several reports received from the same reporte; Sender's Comments: US-009507513-1803USA001061:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 20-FEB-2018 at 20:59, Oka/Merck VARIVAX was shipped from a wholesaler. On 23-FEB-2018 at 11:00, the vaccine arrived to the reporter's office. On 26-FEB-2018, the patient was subsequently vaccinated with Oka/Merck VARIVAX (dose and route of administration were not reported) lot # N030406 with expiration date 30-OCT-2019, for prophylaxis, "that was in transit to the office too long". No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2016, the patient was inoculated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. Later in 2016, she was treated at physician's office for a vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 11-SEP-2011, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. The female patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 09-MAY-2016, she was treated by a physician at an unspecified facility for a vesicular outbreak on her face with ocular interference, which was diagnosed as herpes zoster eye disease. The patient has been prescribed acyclovir, oxycodone, and gabapentin for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, vesicular outbreak on her face with ocular interference, which was diagnosed as herpes zoster eye disease was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-JUN-2014, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 07-MAR-2016, she was treated by nurse practitioner a for a vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a identifiable patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 09-APR-2018, the patient was vaccinated with Oka-Merck) PROQUAD from lot M041082 that expired on 04-APR-2018 (expired product administered) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 30-MAR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB)(dose, frequency and route were not reported) (lot # N034005, expiry date: 31-JAN-2020) for prophylaxis. No adverse effect reported. No product quality complaint involved. The LIQUID PEDVAXHIB was stored in temperature of 32 degree Fahrenheit (F) to 35 F (32 F) for 8 minutes. No previous temperature excursion was reported. A digital data logger was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 06-APR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency and route were not reported) (lot # N034005, expiry date: 31-JAN-2020) for prophylaxis. No adverse effect reported. No product quality complaint involved. The LIQUID PEDVAXHIB) was stored in temperature of 32 degree Fahrenheit (F) to 35 F (32 F) for 8 minutes. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 02-APR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency and route were not reported) (lot # N034005, expiry date: 31-JAN-2020) for prophylaxis. No adverse effect reported. No product quality complaint involved. The LIQUID PEDVAXHIB was stored in temperature of 32 degree Fahrenheit (F) to 35 F (32 F) for 8 minutes. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 03-APR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency and route were not reported) (lot # N034005, expiry date: 31-JAN-2020) for prophylaxis. No adverse effect reported. No product quality complaint involved. The LIQUID PEDVAXHIB was stored in temperature of 32 degree Fahrenheit (F) to 35 F (32 F) for 8 minutes. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.