chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: fever; Injection site has a ring; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On 12th May 2020, the patient received Bexsero. In May 2020, less than a week after receiving Bexsero, the patient experienced fever and injection site reaction. On an unknown date, the outcome of the fever and injection site reaction were unknown.   It was unknown if the reporter considered the fever and injection site reaction to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient received vaccine and developed fever and the injection site had a ring around it. No other information was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: Like had the flu; Felt sick; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about one year before the date of reporting, did not have any symptoms).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and malaise. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the malaise was unknown.   It was unknown if the reporter considered the influenza-like symptoms and malaise to be related to Shingrix.  Additional details were provided as follows: The patient might be 74 or 75 year of age at the time of vaccination. The patient felt sick like he had the flu after the 2nd dose. It was unknown if the reporter consented to follow-up. This case was linked to case US2019205793 and US2019205795 reported by same reporter.  Following a correction performed, 'Drug Not Administered' was unchecked.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Eye irritation, Occupational exposure to product, Vision blurred
Clinical narrative: eyes irritated /burning; blurred vision; Accidental Exposure; Exposure via eye contact; This case was reported by a pharmacist via call center representative and described the occurrence of eye irritation in a 35-year-old female patient who was administering Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021)  to the patient for prophylaxis.   On 17th December 2019, the patient received Shingrix. On 17th December 2019, unknown after receiving Shingrix, the patient experienced occupational exposure while administering product and exposure via eye contact. On 18th December 2019, the patient experienced eye irritation and blurred vision. On an unknown date, the outcome of the eye irritation, blurred vision, occupational exposure while administering product and exposure via eye contact were unknown.   It was unknown if the reporter considered the eye irritation and blurred vision to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, while injecting the patient, vaccine slashed into eyes, which led to occupational exposure while administering product, exposure via eye contact. On the day of reporting, the eyes were irritated and burning  and had some blurred vision. The reporter consented to follow up.   Following a correction performed, 'Drug Not Administered' was unchecked.
Age: 59.0
Sex: M
Vaccine: PPV, PPV, VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: feels hot; tingling; his arm was inflammed, red and swollen; his arm was inflammed, red and swollen; his arm was inflammed, red and swollen; itching around his bicep area; headache; tired; flu like symptoms; chills; fever; body aches; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   On 25th February 2020 05:30, the patient received the 2nd dose of Shingrix. On 25th February 2020, the patient received PNEUMOVAX. On an unknown date, the dose was an unknown dose. In February 2020, 7 hrs 30 min after receiving Shingrix, the patient experienced influenza-like symptoms, chills, fever, general body pain and feeling unwell. On 26th February 2020, the patient experienced headache and tiredness. On 28th February 2020, the patient experienced erythema of extremities, inflammation, swelling arm and pruritus. On an unknown date, the patient experienced feeling hot and tingling. The patient was treated with naproxen (Aleve) and paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, chills, fever, general body pain, feeling unwell, headache, tiredness, erythema of extremities, inflammation, swelling arm, pruritus, feeling hot and tingling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, fever, general body pain, feeling unwell, headache, tiredness, erythema of extremities, inflammation, swelling arm, pruritus, feeling hot and tingling to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at 5:30pm on 25th February 2020 on left arm. The patient stated that received PneumoVax vaccine in the same arm and on the same day. The patient stated that, after vaccination went to bed and woke up about 1am with flu like symptoms, chills, fever, body aches and not feeling well. On wednesday 26th February 2020, the patient went to work but when got home, was very tired and slept. On friday 28th February 2020, the patient's arm was inflammed, red and swollen adnd was itching around his bicep area. One day after vaccination, the patient experienced headache, 2 days after vaccination experienced tiredness, 3 days after vaccination experienced erythema of extremities, inflammation localised, swelling aem and pruritus. Less than a week, after vaccination, the patient experienced feeling hot and tingling. The patient received Aleve and Tylenol but within 6 hours, the events returned. The patient stated that, the adverse events lasted through saturday. The patient was referred to his physician.   Following a correction performed, 'Drug Not Administered' was unchecked.
Age: 59.0
Sex: M
Vaccine: PPV, PPV, VARZOS
Symptoms: Inflammation, Influenza like illness, Malaise, Pain, Paraesthesia
Clinical narrative: feels hot; tingling; his arm was inflammed, red and swollen; his arm was inflammed, red and swollen; his arm was inflammed, red and swollen; itching around his bicep area; headache; tired; flu like symptoms; chills; fever; body aches; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   On 25th February 2020 05:30, the patient received the 2nd dose of Shingrix. On 25th February 2020, the patient received PNEUMOVAX. On an unknown date, the dose was an unknown dose. In February 2020, 7 hrs 30 min after receiving Shingrix, the patient experienced influenza-like symptoms, chills, fever, general body pain and feeling unwell. On 26th February 2020, the patient experienced headache and tiredness. On 28th February 2020, the patient experienced erythema of extremities, inflammation, swelling arm and pruritus. On an unknown date, the patient experienced feeling hot and tingling. The patient was treated with naproxen (Aleve) and paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, chills, fever, general body pain, feeling unwell, headache, tiredness, erythema of extremities, inflammation, swelling arm, pruritus, feeling hot and tingling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, fever, general body pain, feeling unwell, headache, tiredness, erythema of extremities, inflammation, swelling arm, pruritus, feeling hot and tingling to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at 5:30pm on 25th February 2020 on left arm. The patient stated that received PneumoVax vaccine in the same arm and on the same day. The patient stated that, after vaccination went to bed and woke up about 1am with flu like symptoms, chills, fever, body aches and not feeling well. On wednesday 26th February 2020, the patient went to work but when got home, was very tired and slept. On friday 28th February 2020, the patient's arm was inflammed, red and swollen adnd was itching around his bicep area. One day after vaccination, the patient experienced headache, 2 days after vaccination experienced tiredness, 3 days after vaccination experienced erythema of extremities, inflammation localised, swelling aem and pruritus. Less than a week, after vaccination, the patient experienced feeling hot and tingling. The patient received Aleve and Tylenol but within 6 hours, the events returned. The patient stated that, the adverse events lasted through saturday. The patient was referred to his physician.   Following a correction performed, 'Drug Not Administered' was unchecked.
Age: 59.0
Sex: M
Vaccine: PPV, PPV, VARZOS
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: feels hot; tingling; his arm was inflammed, red and swollen; his arm was inflammed, red and swollen; his arm was inflammed, red and swollen; itching around his bicep area; headache; tired; flu like symptoms; chills; fever; body aches; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   On 25th February 2020 05:30, the patient received the 2nd dose of Shingrix. On 25th February 2020, the patient received PNEUMOVAX. On an unknown date, the dose was an unknown dose. In February 2020, 7 hrs 30 min after receiving Shingrix, the patient experienced influenza-like symptoms, chills, fever, general body pain and feeling unwell. On 26th February 2020, the patient experienced headache and tiredness. On 28th February 2020, the patient experienced erythema of extremities, inflammation, swelling arm and pruritus. On an unknown date, the patient experienced feeling hot and tingling. The patient was treated with naproxen (Aleve) and paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, chills, fever, general body pain, feeling unwell, headache, tiredness, erythema of extremities, inflammation, swelling arm, pruritus, feeling hot and tingling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, fever, general body pain, feeling unwell, headache, tiredness, erythema of extremities, inflammation, swelling arm, pruritus, feeling hot and tingling to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at 5:30pm on 25th February 2020 on left arm. The patient stated that received PneumoVax vaccine in the same arm and on the same day. The patient stated that, after vaccination went to bed and woke up about 1am with flu like symptoms, chills, fever, body aches and not feeling well. On wednesday 26th February 2020, the patient went to work but when got home, was very tired and slept. On friday 28th February 2020, the patient's arm was inflammed, red and swollen adnd was itching around his bicep area. One day after vaccination, the patient experienced headache, 2 days after vaccination experienced tiredness, 3 days after vaccination experienced erythema of extremities, inflammation localised, swelling aem and pruritus. Less than a week, after vaccination, the patient experienced feeling hot and tingling. The patient received Aleve and Tylenol but within 6 hours, the events returned. The patient stated that, the adverse events lasted through saturday. The patient was referred to his physician.   Following a correction performed, 'Drug Not Administered' was unchecked.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Malaise
Clinical narrative: soreness at the injection site; malaise / She felt sick for about 4 days; experienced fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix. On 17th January 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, malaise and fatigue. On 21st January 2020, the outcome of the malaise was recovered/resolved. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, malaise and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine nad next day experienced fatigue, malaise and soreness at the injection site. She felt sick for about 4 days and one day she did not get out of bed. The reporter consented to follow up. This case has been linked with US2020081799, reported by same reporter. The outcome for events was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: his arm really hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain in arm after getting Shingrix vaccine. No other information was reported. This case has been linked with US2020081798, reported by same reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pain in extremity, Skin warm, Swelling face, Urticaria
Clinical narrative: Slight swelling of cheeks, body hot but doing oral temp was only 99 degrees,  slight hives , pain in arms, legs and feet.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Pt broke out in wide spread hives
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse effects were reported.; a patient received a dose of PROQUAD following a temperature excursion.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.  On 03-MAR-2020, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot# S006830, expiration date 02-SEP-2020, strength, dose and route were not provided) for prophylaxis following a temperature excursion with Merck sterile diluent 5 ml (lot # and expiration date were unknown).  The improperly stored of vaccine experienced a temperature of 6 degrees Fahrenheit (F) to 14 F (-14 degree Celsius to -10 degree Celsius) (-9.9 degree Celsius) for 2 hours. The previous temperature excursion included 15 F to 46 F (-9 degree Celsius to 8 degree Celsius) (-1.9 degree Celsius) for 2 hours 30 minutes. The digital data logger was involved. No other adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; the patient received a dose of improperly stored PEDVAXHIB.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was provided.   On 14-MAY-2020, the patient received a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 dose, lot# S023218 with expiration date: 04-MAR-2022; route and strength were unknown) for prophylaxis (incorrect product storage). No additional adverse event (AE) information.  Administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 47 degrees fahrenheit (F) (63.3F) for 4 hours. There was no previous temperature excursion. The digital data logger was involved to capture the temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: An expired dose of VARIVAX (R011809 4/23/2020) was reconstituted with expired STERILE DILUENT (N029293 4/25/2020) and administered to the patient on 5/14/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On 14-MAY-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R011809 and expiration date: 23-APR-2020; strength and route not reported) for prophylaxis, which was reconstituted with an expired sterile diluent (lot # N029293 and expiration date: 25-APR-2020) (expired product administered). There was no temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent. No product quality complaint (PQC) involved.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Flu shot made me very ill; This case was reported by a consumer via call center representative and described the occurrence of malaise in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concomitant products included fluticasone propionate (Flonase).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and an unknown time after starting Flonase, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received flu shot and was very ill after vaccination. The patient was currently on Flonase drug which kept patient breathing healthily. No other inforamtion was repoted. This case has been linked with US2020078871, reported by same reporter.
Age: 1.58
Sex: F
Vaccine: MMR
Symptoms: Irritability, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Patient presented with enlarged right inguinal lymph nodes 72 hours after vaccine administration. Patient's mother spoke with nurse at the pediatrician's office and was instructed to call to have patient seen patient exhibited fever, increased irritability, increase in size of lymph nodes, or pain at lymph nodes. Patient had fever of 103 on Saturday, May 16th and increased lymph node size was noted by patient's mother. Patient's mother scheduled follow-up with pediatrician on Monday, May 18th. Pediatrician stated that lymph node size was not "clinically significant," but prescribed augmentin and requested that patient's mother follow-up via phone call in about 48 hours.
Age: 1.0
Sex: M
Vaccine: HIBV, MENB, MMR, PNC13
Symptoms: Aphasia, Autism spectrum disorder, Decreased eye contact, Developmental delay, Gastrooesophageal reflux disease
Clinical narrative: Fever, blank stare, lost speech, lost interaction
Age: 1.0
Sex: M
Vaccine: HIBV, MENB, MMR, PNC13
Symptoms: Hypersensitivity, Pyrexia, Staring
Clinical narrative: Fever, blank stare, lost speech, lost interaction
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Middle insomnia, Muscle swelling, Pain, Skin warm
Clinical narrative: Deltoid muscle swollen, mildly warm and painful 12 - 24 hours post vaccination.  Pain severe enough to wake him and require a phone call to on call MD
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; Nurse reported the patient received an improperly stored dose of VARIVAX on 5/4/2020; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.  On 04-MAY-2020, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#S030223 with expiration date: 26-SEP-2021; route, dose and strength were unknown) with sterile diluent for prophylaxis (incorrect product storage). No adverse symptoms reported.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion under -14 degrees Celsius (C) to -10 degrees Celsius (-12.9C) for 1 hour and 8 minutes. There was no previous temperature excursion. The digital data logger was involved to capture the temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received Shinrix last year and this year I had singles on my face/ Suspected Vaccination failure; shingles on my face; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shinrix a year before time of reporting and this year experienced singles on face. This case was considered as suspected vaccination failure as details regarding vaccination schedule and time to onset for target disease were unknown at the time of reporting.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: she began experiencing herpes zoster outbreaks again; Herpes zoster; she got really sick after the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included liver transplant (had in 2002) and herpes zoster (Chronic outbreaks).   On an unknown date, the patient received the 1st dose of Shingrix. In September 2018, the patient received the 2nd dose of Shingrix. In February 2020, unknown after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the patient experienced malaise. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure and herpes zoster were unknown and the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix. It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received both doses of Shingrix and she got really sick but it passed within 48 hours. The patient also had outbreak of herpes zoster. The reporter consented for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: developed shingles on unspecified date after receiving the vaccine; shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The physician received Shingrix in October 2019, and developed shingles on unspecified date after receiving the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: experienced pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   On 27th February 2020, the patient received Havrix. In February 2020, immediately after receiving Havrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Havrix.  Additional details were provided as follows: The patient received Havrix and experienced pain at the injection site since receiving the vaccine. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel had been inadvertently given to a patient/No AE; Initial information was received on 13-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a two-year-old male patient who inadvertently received an expired dose (0.5 mL) of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (4th dose in series, lot C5367AA, expiry date: 30-Jan-2020) via an intramuscular route at the left thigh for prophylactic vaccination on 12-May-2020 (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site induration, Injection site pustule, Injection site rash
Clinical narrative: Child developed secondary cellulitis at the Kinrix injection site in her left thigh. MMRV injection site in the right thigh did not demonstrate any adverse event. The left thigh rash began with a pustule within the first 24 hours following Kinrix immunization and then progressed to surrounding induration over a 2 day period. She was diagnosed with cellulitis on a follow-up visit on 05/19/2020 and prescribed empiric cephalexin for treatment.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient received Bexsero vaccine on 05/14/2020. On  05/15/2020 morning arm felt sore. On 05/16, 05/17  arm painful ,swollen and warm. 05/18/2020 Patient had virtual appointment with DR, was prescribed hydrocortisone 2.5% twice daily.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Diarrhoea, Pain
Clinical narrative: Vaccine taken 5pm 4/21/2020 - woke up about 7am 4/22/2020 with bad shivers and increasing temperature with lots of body ache.  This lasted for 3 days, and the following 2 days with upset stomach and diarrhea.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: UrticariaPruritus & PRURITUS; URTICARIA (2/19/20@14:42); ERYTHEMA; PERIPHERAL EDEMA
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint effusion, Leukocytosis, Myalgia, Ultrasound joint
Clinical narrative: Myalgia, Arthralgia & Leukocytosis and shoulder joint effusion
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound scan abnormal, White blood cell count increased
Clinical narrative: Myalgia, Arthralgia & Leukocytosis and shoulder joint effusion
Age: 26.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: 4/29 - Vaccine administered (Tdap) during pre-employment physical. Developed pain & decrease ROM afterwards 5/4 - spoke with PCP - conservative treatment. 5/11 - spoke with PCP again, was prescribed Nabumetone for pain. 5/15 - Seen at clinic and referred to ortho specialist for possible steroid injection & PT.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse effects were reported.; a patient received a dose of PROQUAD following a temperature excursion.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.  On 10-DEC-2019, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot# S006830, expiration date 02-SEP-2020, strength, dose and route were not provided) for prophylaxis following a temperature excursion with Merck sterile diluent 5 ml (lot # and expiration date were unknown).  The improperly stored of vaccine experienced a temperature of 6 degrees Fahrenheit (F) to 14 F (-14 degree Celsius to -10 degree Celsius) (-9.9 degree Celsius) for 2 hours. The previous temperature excursion included 15 F to 46 F (-9 degree Celsius to 8 degree Celsius) (-1.9 degree Celsius) for 2 hours 30 minutes. The digital data logger was involved. No other adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection
Clinical narrative: herpes flare up; This case was reported by a other health professional and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included herpes virus infection (herpes had been dormant for over 30 years.).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   The reporter considered the herpes virus infection to be unrelated to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and herpes got a flare up. The reporter consulted with Doctor who told there was no connection and had only had one sex partner it the last 30 years.  The patient had not a major change to lifestyle or diet, the biggest change had been the shingles vaccine.  This did not appear to be a coincidence.  For tolerances of 2nd dose, refer case US2020AMR079275, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection, Vaccine positive rechallenge
Clinical narrative: and after the second dosage its even worse; condition aggravated; This case was reported by a other health professional and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes virus infection (received 1st dose on unknown date,refer case US2020AMR079265.). Concurrent medical conditions included herpes virus infection (herpes had been dormant for over 30 years.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced herpes virus infection and condition aggravated. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved and the outcome of the condition aggravated was unknown.   The reporter considered the herpes virus infection and condition aggravated to be unrelated to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and herpes got worse after 2nd dose. The reporter consulted with Doctor who told there was no connection and had only had one sex partner it the last 30 years.  The patient had not a major change to my lifestyle or diet, the biggest change has been the shingles vaccine.  This did not appear to be a coincidence.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: pain throughout most of my joints; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th May 2020, the patient received the 1st dose of Shingrix. On 13th May 2020, 1 days after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix yesterday day before reporting and woke up at 3 am with aching pain throughout most of his/her joints. The reporter asked was this side effect, if so then how long did it last.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Pain in extremity
Clinical narrative: Flu; Arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd November 2019, the patient received the 1st dose of Shingrix. On 23rd November 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. In January 2020, the patient experienced influenza. On an unknown date, the outcome of the pain in arm and influenza were recovered/resolved.   It was unknown if the reporter considered the pain in arm and influenza to be related to Shingrix.  Additional details were reported as follows: The patient did not remember which arm was injected but the arm was sore the following day and the soreness lasted approximately 5 days. The patient had flu in January 2020. The reporter did not consent to follow up. The outcome for events was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Swelling
Clinical narrative: Bumps/ felt like bumps on buttocks and she saw more on her foot.; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of sciatica (for 1st dose refer case US2020AMR082346). Concurrent medical conditions included sciatic neuralgia.   On 30th April 2020, the patient received the 2nd dose of Shingrix. On 5th May 2020, 5 days after receiving Shingrix, the patient experienced shingles. On 8th May 2020, the patient experienced swelling. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the swelling was unknown.   It was unknown if the reporter considered the shingles and swelling to be related to Shingrix.  Additional details were reported as follows: On 26th April 2020, patient was working outside and strained her sciatica. On 30th April 2020, she got the 2nd dose of Shingrix. On 4th May 2020, she was in a pain still from straining her sciatica and and she went to her chiropractor. On the night of 4th May 2020, she could not laid down on bed from the pain and slept on the floor. She woke up the next morning with what she thought were spider bites in ankle.  On 5th May 2020, she slept on the floor again, and she woke up with what she thought it was spider bites on her right knee. It was kind of following the sciatic nerve.  On 8th May 2020, patient noticed what felt like bumps on buttocks and she saw more on her foot. Patient told it was following the path of the sciatic nerve. The patient visited her physician and was diagnosed with shingles. Patient confirmed she did not have spider bites. It was shingles. She was being put on medication, but she was still not recovered from shingles. The patient did not have previous history of shingles. The reporter consented to follow up. This case has been linked with US2020AMR082346, reported by same reporter.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Syncope, Tonic clonic movements, Vertigo
Clinical narrative: Pt w LOC and 2 episodes of tonic  clonic movement immediately following injection of HPV and Boostrix.  LOC x 45 sec.  Immediately following gaining consciousness patient was appropriate w questions. Patient notes prior to syncope room began spinning.  Vision darkened.  Diaphoretic following episode.  Minutes later as per patient feeling fine.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Visual impairment
Clinical narrative: Pt w LOC and 2 episodes of tonic  clonic movement immediately following injection of HPV and Boostrix.  LOC x 45 sec.  Immediately following gaining consciousness patient was appropriate w questions. Patient notes prior to syncope room began spinning.  Vision darkened.  Diaphoretic following episode.  Minutes later as per patient feeling fine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was provided regarding medical history, concurrent condition, or concomitant medication. In 2016 the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 4-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 5-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004992: US-009507513-2005USA004993: