chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; patient was administered an improperly stored dose of PROQUAD; This spontaneous report has been received from a medical assistant, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drug reactions was not provided. The patient's concomitant medications included the sterile diluent (DILUENT MRK).  On 02-JUN-2020, the patient was vaccinated with an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Therapy type: rha), administered subcutaneously, lot number S031704 and expiration date 06-APR-2021 for prophylaxis (strength, dose, frequency and anatomical location were not provided). The diluent used for reconstitution was properly stored.  The vaccine was stored at a temperature of -13.3 celsius (C), for a timeframe of an hour and 15 minutes, with a previous temperature excursion of -1.8 (C), for 4 hours and 27 minutes, and -13.4 (C) for an hour. The call was due to the digital data logger.  No additional adverse events were reported.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Tiredness; Stomach ache; Nausea; Sore arm; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th June 2020, 1 days after receiving Shingrix, the patient experienced pain in arm and headache. On 27th June 2020, the patient experienced stomach pain and nausea. On 28th June 2020, the patient experienced tiredness. On 29th June 2020, the outcome of the pain in arm, headache, stomach pain and nausea were recovered/resolved and the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, stomach pain, nausea and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed sore arm, headache, stomach ache, nausea, and tiredness in the days following the vaccine. The patient had recovered from symptoms except the tiredness. The reporter did not consent to follow up.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Hyperhidrosis, Muscle contractions involuntary, Mydriasis
Clinical narrative: Also given Mantoux PPD skin test at same time, left forearm. Not quite 2 minutes later patient started having arms, legs somewhat contracting, relaxing, stared to the right with moderately dilated pupils. Lasted about 10 seconds. Laid her down on exam table as was sitting on end of table. She could hear during the episode, was oriented right afterwards but sweaty. Blood pressure low at first, then after sitting up, drank cool water felt much better, blood pressure back to normal. Kept in office awhile longer, then released to her mom who was informed.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Chest X-ray normal, Febrile convulsion, Full blood count normal, Metabolic function test normal, Rash
Clinical narrative: uncomplicated febrile seizure followed by rash
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Feeling hot, Headache, Pain
Clinical narrative: This was the second shot. First shot no adverse reaction. Around 2 PM extremely tired and then headache.   Went to bed around 8 had the following symptoms: chills, then hot, headache and teeth hurting, sharp pains in body that only lasted a short time. Next day slight headache and fatigue. Third day fatigue. Forth day feeling  like self.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Toothache
Clinical narrative: This was the second shot. First shot no adverse reaction. Around 2 PM extremely tired and then headache.   Went to bed around 8 had the following symptoms: chills, then hot, headache and teeth hurting, sharp pains in body that only lasted a short time. Next day slight headache and fatigue. Third day fatigue. Forth day feeling  like self.
Age: 92.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Hallucination
Clinical narrative: & HALLUCINATIONS
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects; Nurse reported patient received an expired dose of M-M-R II; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concomitant therapies included sterile diluent. The patient's concurrent conditions, historical drugs and conditions were not provided.  On 25- JUN-2020,  the patient was vaccinated with an expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) (Expired product administered)  0,5 ml/once, Lot # R011221, expiration date 17-APR-2020, for prophylaxis(strength and patient route of administration were not provided).          No additional adverse effects were reported.  The nurse reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent used to reconstitute the vaccine were stored properly.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse affects reported; Medical assistant called reporting that an expired dose of VARlVAX was administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 25-JUN-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (vaccination scheme, anatomical location, route of administration were not reported; lot number R008394, which has been verified to be valid, expiration date reported and validated as 20-MAR-2020) as prophylaxis (expired product administered). No adverse effects reported. No product quality complaint (PQC) was reported.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: his wife is 44 years old and she received the first dose of GARDASIL; quarantine; This spontaneous report was received from a patient's husband and refers to a 44-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date in January 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, lot number and expiry date were not reported) for prophylaxis.   On an unknown date in 2020, the patient was on quarantine (the reason was not specified). Due to the event, the administration of second dose of the vaccine was delayed and the patient received the second dose on an unknown date in May 2020. The patient did not receive the third dose yet. The outcome of the event was not reported.  The relatedness between the event and the suspect vaccine was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; The patient was vaccinated with an improperly stored dose of GARDASIL 9; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered intramuscularly (dose and frequency were not reported) (lot number 9029515 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date was reported as 08-JUL-2020) for prophylaxis.  The improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature of 0.7 Celsius degrees for 3.048 hours (information captured by a data logger) without a previous temperature excursion. The patient did not experience symptoms.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; incorrect product storage; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided.    On 01-JUL-2020, the patient was vaccinated with dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, in the leg, lot #S021732 (verified to be valid), expiration date: 10-JAN-2021, albumin status has been verified as recombinant human albumin (rHA) for prophylaxis (strength, dose, frequency were not reported), which was reconstituted with properly stored sterile diluent, lot # R004036 (verified to be valid), expiration date: 08-OCT-2020. Administered dose of vaccine experienced the temperature excursion between -9 and 8 degrees Celsius (°C) (-8.77 °C) for 13 hours. Data logger was involved. There was previous excursion reported: between -9 and 8 degrees Celsius (-9.45 °C) for 6 hours and 30 minutes. No adverse event was reported.
Sex: M
Vaccine: MEN
Symptoms: Crohn's disease, Lethargy, Loss of personal independence in daily activities, Somnolence
Clinical narrative: has crohn's; falling asleep/ came home and slept/walking coma for three weeks; very letharhic; barely could function in school; This case was reported by a consumer via interactive digital media and described the occurrence of crohn's disease in a child male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than a day after receiving Meningococcal B vaccine, the patient experienced crohn's disease (serious criteria GSK medically significant), sleepiness, lethargy and activities of daily living impaired. On an unknown date, the outcome of the crohn's disease was unknown and the outcome of the sleepiness, lethargy and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the crohn's disease, sleepiness, lethargy and activities of daily living impaired to be related to Meningococcal B vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The day of patietnt's doctor visit, the patient was talking, walking, active mentally and physically. The patient was in a near walking coma for three weeks after vaccination. After the shot, by the time they hit the car, the patient was almost falling asleep, very lethargic, he was like that for three weeks, barely could function in school, came home and slept. But of course doctor said it could not be the vaccine and at the time of reporting, the patient had crohn's, an autoimmune disease. The reporter stated the vaccines were not what they were cracked up to be.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: muscle ache; flu like symptoms; fever; headache; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 30th June 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th June 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, influenza-like symptoms, fever and headache. On an unknown date, the outcome of the muscle pain, influenza-like symptoms, fever and headache were unknown.   It was unknown if the reporter considered the muscle pain, influenza-like symptoms, fever and headache to be related to Shingrix.  Additional details were reported as follows: The patient reported that he had his second dose of Shingrix and experienced really bad side effects including, flu, muscle ache and fever with headache.  The reporter consented to follow up. The age group was reported as infant however it was captured as elder.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Temperature; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th June 2020, 8 hrs after receiving Shingrix, the patient experienced headache. On 1st July 2020, the patient experienced fever. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were reported as follows The patient  received Shingrix in the morning at her primary care physician's office and in the evening approximately 8 to 9 hours later had a headache. Next morning she had a temperature of 101 Fahrenheit. Headache and temperature were unresolved. The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 12 month old female patient received Pentacel vaccine /NO AE; Initial information received on 29-Jun-2020 regarding an unsolicited valid non-serious case from a other Health care professional (physician assistant).  This case involves a 12 months old female patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (inappropriate schedule of product administration).  Medical history, medical treatment, vaccination and family history were not provided. On an unknown date patient received concomitant medications which included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS A VACCINE (HEPATITIS A).  On 19-Jun-2020, the patient received a fourth series of 0.5 mL once dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ057AA, expiry date: 07-Nov-2020] via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was reported that, on 19-Jun-2020, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and should have only received HIB dose so consumer received 4th dose of IPV before 4 years of age and DTaP 3 months early (inappropriate schedule of product administration).  At the time of report, there were no adverse event symptoms.  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 and Module VI of the 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: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product storage error
Clinical narrative: a 4 years old female patient was administered Quadracel vaccine which had temperature excursion due to exposed at 27F for more than 3 hours,No AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a four year old female patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] which had a  temperature excursion due to exposed to 27f for more than 3 hours (lot number S025913 and expiry date: 20-Aug-2021) via an unknown route and administration site for prophylactic vaccination on 21-May-2020.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was a case of an actual medication error due to product storage error temperature too low.  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 holders compliance with the requirements set out in Directive and Module VI of the 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: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain, Chills, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: Patient developed fever of 102.7'F & chills within 2 hours of receiving vaccine. 6/3/20- Fatigue, slept all day, abdominal pain, poor appetite 6/4/20- Afebrile; pain at injection site improved activity & appetite
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient developed fever of 102.7'F & chills within 2 hours of receiving vaccine. 6/3/20- Fatigue, slept all day, abdominal pain, poor appetite 6/4/20- Afebrile; pain at injection site improved activity & appetite
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache
Clinical narrative: woke up with chills, and shaking  for 1 hour, headache for 4 hours. joint pain lasting 8 hours
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Biopsy skin normal, Blister, Pain, Rash
Clinical narrative: Blister  Left arm 6/3/2020,  Blister right arm 6/16/2020, Blister left arm 6/26 additionally general lack of energy, aches and pains more reactive to environment; sores, rash
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: Blister  Left arm 6/3/2020,  Blister right arm 6/16/2020, Blister left arm 6/26 additionally general lack of energy, aches and pains more reactive to environment; sores, rash
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: fever 100.4 degrees, chills,  aching joints lasting about 12 hours.  Treated with Ibuprofen.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse effects were reported in any patients; An unknown number of patients, received an unknown number of doses of VARIVAX following a temperature excursion; This spontaneous report has been received from a physician assistant concerning a female patient of  unknown age. The patient's concomitant therapies included sterile diluent. The patient's concurrent conditions and previous medical history were not reported.    From 30-MAR-2020 to 26-APR-2020, varicella virus vaccine live (oka/merck)(VARIVAX), was exposed to a range of temperature excursion between -4°C up to 0°C for 30 minutes.Information was extracted from data logger.     On 26-APR-2020, the  patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021321, expiration date 09-JUL-2021 for prophylaxis (dose, strength, formulation and patient route of  administration  were not reported) following a temperature excursion (product storage error).  A total of 12 hours of maximum temperature excursion was reported.  No other adverse effects were reported in any patients.   Due to the defrost cycle approximately once every 26 hours, there was  a 30-60 minute excursion above -15°C. On most of those days, the amount of time spent between 0°C and -9°C was 30 minutes. A cumulative time-frame for varicella virus vaccine live (oka/merck)(VARIVAX)temperature excursion of -9°C to 8°C (0°C) was 28 hours and 30 minutes  This is one of two  reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; A patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's concurrent conditions, concomitant drug, medical history and historical drug were not provided.  On 24-JUN-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot number S005875, expiration date 30-NOV-2020 administered orally for prophylaxis. Strength, dose and frequency were not provided.   The temperatures involved were: below 36 degrees farenheit (34.8 degrees F) for 25 minutes. A previous temperature excursion was reported, the temperatures involved then were: below 36 degrees farenheit (34.5 degrees F) for 1 hour and 24 minutes. A data logger was involved. No additional adverse effect was reported.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: MMR
Symptoms: Alopecia, Electroencephalogram, Growth retardation, Magnetic resonance imaging, Seizure
Clinical narrative: She would stare at something for a long time so I took her to the doctor and they told me she was having seizures; My daughter also grew very little after receiving the vaccination; she is losing lots of hair now; This spontaneous report was received from a consumer referring to his daughter, a 20-year-old female patient. Information regarding the patient's concurrent conditions was not provided. The patient had no relevant medical history. There were no concomitant medications.  On 28-JAN-2005, the patient was vaccinated with "one dose" of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (reported as "recommended by the doctor"), route of administration reported as "shot" (strength, frequency, lot number and expiration date were not reported).        In June 2005 (also reported as "about 6 months after the vaccination"), the patient started having seizures. She would stare at something for a long time so she was taken to the doctor and they told them she was having seizures. It was reported that she would have to take seizure medication (KEPPRA) for the rest of her life. The patient also grew very little after receiving the vaccination and she was losing lots of hair. According to the reporter, the patient was completely fine and healthy before receiving this vaccine.  The patient was hospitalized overnight on an unknown date in 2015 (reported as "5 years ago") for seizures.  On unknown dates (reported as every other year), the tests electroencephalogram (EEG) and magnetic resonance imaging (MRI) were performed (results not provided).   It was also reported that the patient sought medical attention with neurologists and neurosurgeons.   At the time of reporting, the patient had not recovered from the events.  The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and all the reported events was unknown.   Upon internal review the events seizures and growth retardation were considered to be medically significant.
Sex: F
Vaccine: MMR
Symptoms: Staring
Clinical narrative: She would stare at something for a long time so I took her to the doctor and they told me she was having seizures; My daughter also grew very little after receiving the vaccination; she is losing lots of hair now; This spontaneous report was received from a consumer referring to his daughter, a 20-year-old female patient. Information regarding the patient's concurrent conditions was not provided. The patient had no relevant medical history. There were no concomitant medications.  On 28-JAN-2005, the patient was vaccinated with "one dose" of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (reported as "recommended by the doctor"), route of administration reported as "shot" (strength, frequency, lot number and expiration date were not reported).        In June 2005 (also reported as "about 6 months after the vaccination"), the patient started having seizures. She would stare at something for a long time so she was taken to the doctor and they told them she was having seizures. It was reported that she would have to take seizure medication (KEPPRA) for the rest of her life. The patient also grew very little after receiving the vaccination and she was losing lots of hair. According to the reporter, the patient was completely fine and healthy before receiving this vaccine.  The patient was hospitalized overnight on an unknown date in 2015 (reported as "5 years ago") for seizures.  On unknown dates (reported as every other year), the tests electroencephalogram (EEG) and magnetic resonance imaging (MRI) were performed (results not provided).   It was also reported that the patient sought medical attention with neurologists and neurosurgeons.   At the time of reporting, the patient had not recovered from the events.  The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and all the reported events was unknown.   Upon internal review the events seizures and growth retardation were considered to be medically significant.
Age: 14.0
Sex: M
Vaccine: MEN
Symptoms: Death, Deep vein thrombosis, Meningitis, Thrombosis, Vaccination failure
Clinical narrative: deep vein thrombus; Suspected vaccination failure; Meningitis; This case was reported by a consumer via interactive digital media and described the occurrence of deep vein thrombosis in a 17-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, more than 2 years after receiving Meningococcal B vaccine, the patient experienced deep vein thrombosis (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria GSK medically significant). On an unknown date, the outcome of the deep vein thrombosis was fatal and the outcome of the vaccination failure was unknown and the outcome of the meningitis was recovered/resolved. The reported cause of death was deep vein thrombosis.   It was unknown if the reporter considered the deep vein thrombosis, vaccination failure and meningitis to be related to Meningococcal B vaccine.  Additional details were provided as follows: After receiving Meningococcal B vaccine, the patient got meningitis at the age of 17 years. The patient recovered however the doctors made mistakes in the process and a blood clot went into his heart and he passed away of that.  The cause of death was deep vein thrombus.  It was unknown which type of meningitis the patient had.  The patient was in his senior year of high school. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for Meningococcal B vaccine and type of meningitis and laboratory confirmation for meningitis were not provided.; Reported Cause(s) of Death: Deep vein thrombosis
Sex: M
Vaccine: MEN
Symptoms: Malaise
Clinical narrative: Deathly ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unwell (serious criteria life threatening). On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Meningococcal vaccine, the patient got deathly ill. For the tolerance of 2nd dose, refer linked case US2020AMR119686.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Interchange of vaccine products
Clinical narrative: 2nd dose of Meningococcal B  vaccine - first dose was Trumenba and second dose given was Bexsero
Age: 40.0
Sex: U
Vaccine: UNK
Symptoms: Diarrhoea, Fatigue, Headache, Hypoaesthesia, Muscle spasms
Clinical narrative: Box 17 - Gardisil 9 (first dose), Merck, Left Arm  Warned of arm soreness by vaccine administrator. Diarrhea since this morning, warm to the touch, sore throat, lower extremities sore/muscle cramping, overall fatigue, numbness in hands and feet, headache. Taking herbal tea and getting rest. Currently waiting for return phone call from OBGYN. CDC, please provide increased transparency in relation to vaccine ingredients.   Box 23 - Experienced vaccine adverse event when I received four vaccines in preparation for a trip.
Age: 40.0
Sex: U
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pain in extremity, Skin warm
Clinical narrative: Box 17 - Gardisil 9 (first dose), Merck, Left Arm  Warned of arm soreness by vaccine administrator. Diarrhea since this morning, warm to the touch, sore throat, lower extremities sore/muscle cramping, overall fatigue, numbness in hands and feet, headache. Taking herbal tea and getting rest. Currently waiting for return phone call from OBGYN. CDC, please provide increased transparency in relation to vaccine ingredients.   Box 23 - Experienced vaccine adverse event when I received four vaccines in preparation for a trip.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Injection site reaction, Pain, Rash erythematous
Clinical narrative: extreme pain in lower back to the extent that any movement was almost intolerable......occurred within an hour after injection and only had some lessening of pain on the 8th day ( today).   Also had a large  red rash below the injection site but this was not a problem.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: PROQUAD LOT# T007395 JUDGED TO BE TOO LONG IN TRANSIT TO BE RELIABLE PER VFC REGULATIONS. PATIENT SUFFERED NO ADVERSE REACTION TO ADMINISTRATION.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Nausea, Pyrexia, Vomiting
Clinical narrative: Donor reports of weakness about an hour after shot and felt Nausea, vomiting, and feverish for 24 hours. Donor  reports of taking Tylenol and Ibuprofen and a good night of rest and felt back to her normal self.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Fever began Friday, 7/3  ranging from 100.5 - 102 (at this point, currently 100.5 on 7/7) chills sweats extreme fatigue low appetite skin sensitivity
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: Fever began Friday, 7/3  ranging from 100.5 - 102 (at this point, currently 100.5 on 7/7) chills sweats extreme fatigue low appetite skin sensitivity
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: site sorness (lasting 48 hours) Headache (began 12 hours after injection and continues to present) body ache(began 12 hours after injection and continues to present) fever(began 12 hours after injection and continues to present) weakness(began 12 hours after injection and continues to present)
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: The evening of 7/6/2020 the patient developed patches of hives on both arms, both legs, chest and back.  The patient described them as raised red patches, ,more square than round in shape.  He stated that they were a little bit itchy, but not as itchy as bug bites.  The patient called his primary care provider's office before reporting to the pharmacy, and they advised him to take benadryl.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertently gave Influenza vaccine after expiration date. No symptoms, signs or concerns. Reviewed with patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: PT REPORTS 3 DAYS FOLLOWING 2ND SHINGLES VACCINE, SHE DEVELOPED SHINGLES, CONFIRMED BY DR UPON FOLLOWUP VISIT IN OUR OFFICE.  PT REPORTS RASH, PAIN AND ITCHING NEAR THE LEFT DELTOID AREA, NEAR WHERE THE INJECTION WAS GIVEN WHICH THEN SPREAD TO SURROUNDING AREAS.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient's wife called the next day after injection to report he was having injection site redness & swelling, and the area was warm to the touch. She noted that the swelling had extended to his elbow today (>24 hours post injection). He has been icing the site and taking ibuprofen for pain. I suggested to keep icing and alternating acetaminophen with ibuprofen and to monitor for improvement, and if no improvement or worsened symptoms within next 24-28 hours, to contact physician.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Developed  hives on the left arm , 5 days after the vaccine. Initially, he had redness, swelling and heat at the injection site for 72 hours, then disappeared , but today c/o arm itching and mom noticed hives present. Mother gave him Benadryl, he has a history of needing Benadryl  for hives from cold weather.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Rash erythematous
Clinical narrative: Mom called in at 3:41pm on 7/6/2020 and said pt was covered in a red, bumpy rash all over his body. The rash was not bothersome and there were no other symptoms. Advised mom to monitor patient and administer benadryl as directed. If symptoms worsened, patient would need to be taken to the ER for evaluation.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Mother called on 8/23/2017, the day after he received this vaccine, stating that there was a  3 inch area  of splotchy redness around injection site, as well as swelling on the outside of the arm, and is warm to the touch. He was seen in our pediatric clinic on that same day and the provider noted that  left upper arm had 1 large wheal just distal and medial to injection site; wheal is pink, raised, minimal tenderness, no drainage, no fever, no SOB or anaphylaxis. He was advised to take Benadryl and do cold/warm compresses to area.  On 8/25/17, this patient was seen again in our office for no improvement and the provider seeing him wrote" 11 yo male presents w/mom with increased redness/swelling of L deltoid region following a Tdap vaccine which was given 8/22 (3 days ago).  Was evaluated the day after injection and area was warm, red and tender.  Area now more red, spreading down arm, cont to be warm to touch, tender. Was using heat packs to area, which made it very itchy.  He does not tolerate benadryl well, so none use. Denies diff breathing, swelling in or around mouth, HA, tiredness, nausea/vomiting/diarrhea/abd pain, chills, swollen joints, body aches, swollen glands." She advised him to to cold treatment, elevation of limb, and to use caution with Tdap vaccines in the future. No other sx were reported after this
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Rash macular, Urticaria
Clinical narrative: Mother called on 8/23/2017, the day after he received this vaccine, stating that there was a  3 inch area  of splotchy redness around injection site, as well as swelling on the outside of the arm, and is warm to the touch. He was seen in our pediatric clinic on that same day and the provider noted that  left upper arm had 1 large wheal just distal and medial to injection site; wheal is pink, raised, minimal tenderness, no drainage, no fever, no SOB or anaphylaxis. He was advised to take Benadryl and do cold/warm compresses to area.  On 8/25/17, this patient was seen again in our office for no improvement and the provider seeing him wrote" 11 yo male presents w/mom with increased redness/swelling of L deltoid region following a Tdap vaccine which was given 8/22 (3 days ago).  Was evaluated the day after injection and area was warm, red and tender.  Area now more red, spreading down arm, cont to be warm to touch, tender. Was using heat packs to area, which made it very itchy.  He does not tolerate benadryl well, so none use. Denies diff breathing, swelling in or around mouth, HA, tiredness, nausea/vomiting/diarrhea/abd pain, chills, swollen joints, body aches, swollen glands." She advised him to to cold treatment, elevation of limb, and to use caution with Tdap vaccines in the future. No other sx were reported after this
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity, Periarthritis, X-ray limb normal
Clinical narrative: Arm was very painful & sore for two months. I did not have this reaction on the 1st injection in the left arm. This progressed to constant pain/stiffness/loss of range of motion in my right arm. This constant pain lasted until I received a Kenalog injection from my Orthopedic Specialist due to 'adhesive capsulitus'
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Arthralgia, Bladder pain, Dyspnoea, Headache
Clinical narrative: Pt went to a urgent care about 4 hours later with knee pain, bladder pain, terrible headache, and trouble breathing.  He said it was like having an asthma attack but worse.
Age: 22.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event has occurred to present time. I was expecting to receive Varivax to fulfill my second Varicella vaccination requirement for college. I should have received Varivax, however instead I was given Zostavax. Zostavax is intended for patients of at least 50 years of age, I was 22 years old at the time of administration. On the patient vaccination form, expiration date was concerning as well, not entirely sure if '7/26/17' or 7/26/19', looks more like a '7' making it out of date as well.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cough, Dyspnoea, Extremity contracture, Fatigue, Headache
Clinical narrative: Within 12 hours after injection, the patient developed the usual symptoms of fatigue, myalgia, headache. However, she also developed a dry cough, mild dyspnea and flexion of fingers in both hands, which eventually returned to normal. The fingers were flexed and could not be straightened up for several hours.  This is not reported in the PI
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: Within 12 hours after injection, the patient developed the usual symptoms of fatigue, myalgia, headache. However, she also developed a dry cough, mild dyspnea and flexion of fingers in both hands, which eventually returned to normal. The fingers were flexed and could not be straightened up for several hours.  This is not reported in the PI
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Migraine, Nausea, Pain, Pyrexia
Clinical narrative: I had a lot of pain in arm from first dose, but nothing else. With this dose I have had a bad migrane since last night, lasting all day today and came down with a fever around 2 pm today which started mild but got up to 102.5  I"m taking Tylenol which helps   I also have all over aches and am a little nauseous.  None of this happened with first dose. Under an abunence of caution I am quaranteening myself from my family, just in case it is covid related
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash pruritic, Rash vesicular
Clinical narrative: Around dinner time (6-7pm) he started to develop itchy bumps on the left side of  his forehead: rash like blister going down his forehead in lines. It leads towards his left eye and gives him an itchy and stinging sensation. This morning (7/7/20), he went to the local urgent care which confirmed he had shingles. He was prescribed Valtrex 1g as treatment.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye irritation, Injection site erythema, Injection site pain, Injection site swelling, Lacrimation increased
Clinical narrative: " A couple hours after you shot me, it felt like someone pepper sprayed my eyes.  They burned and were teary. I took a nap to see if that it go away, but it didn't help, the nap was good. At five o'clock I had to golf.  I think it helped my game to have blurred vision, I had to focus hard to see the ball, and slow my swing down so I could make good contact.  By the time we finished at 8 O'clock I was pretty much cured. This morning (Friday) my eyes are fine, but my arm hurts, not badly, but I know where you made the injection."   "Two days after the injection, I got my rash.  But this one is different from the first one, and it may not be a rash. My deltoid muscle is red and slightly swollen and sore to the touch, not painfully sore, just slightly sore. The red mark is about 4" long and 2 " wide. I'm not disappointed in the shots, I'm just reporting my observations.  If I had to do it again. I would.   The side effects are not insurmountable, they are just inconvenient. " Patient confirms that the rash was not from the bandaid as it was up and down and not side to side as the bandage was placed.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Vision blurred
Clinical narrative: " A couple hours after you shot me, it felt like someone pepper sprayed my eyes.  They burned and were teary. I took a nap to see if that it go away, but it didn't help, the nap was good. At five o'clock I had to golf.  I think it helped my game to have blurred vision, I had to focus hard to see the ball, and slow my swing down so I could make good contact.  By the time we finished at 8 O'clock I was pretty much cured. This morning (Friday) my eyes are fine, but my arm hurts, not badly, but I know where you made the injection."   "Two days after the injection, I got my rash.  But this one is different from the first one, and it may not be a rash. My deltoid muscle is red and slightly swollen and sore to the touch, not painfully sore, just slightly sore. The red mark is about 4" long and 2 " wide. I'm not disappointed in the shots, I'm just reporting my observations.  If I had to do it again. I would.   The side effects are not insurmountable, they are just inconvenient. " Patient confirms that the rash was not from the bandaid as it was up and down and not side to side as the bandage was placed.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: After the patient received the 2nd dose of Shingrix we came out of the immunization room.  The patient felt faint.  I had her sit down and place her head between her legs and I got her some water.  She sat there for a few minutes and felt better.  She then walked around the store for a little bit and stated that she felt fine and could go home.
Age: 30.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Mobility decreased
Clinical narrative: limb immobility - 6 days past, cannot yet abduct or flex beyond 90 degrees
Age: 30.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: limb immobility - 6 days past, cannot yet abduct or flex beyond 90 degrees
Age: 30.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Mobility decreased
Clinical narrative: Shoulder pain + decrease in range of motion in left arm. orthopedic referral
Age: 30.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Shoulder pain + decrease in range of motion in left arm. orthopedic referral
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vaccination site reaction
Clinical narrative: RD-RCV'd 2 vaccines - RXN to vaccine area. Saw Dr & started on Keflex BIDx7days Follow up as needed.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Menveo given on 7-1-20, went to ER on 7-2-20 due to swollen & red L.D. ER Rx'd Medrol dosepak & Keflex 250mg QIDx7 days. Followed up in office on 7-6-20 RNX improving--complete abx & steroid
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Shingles recurred sev days after vaccine admin. Hx varicella infection Sev-yrs ago Vaccine 6/24/2020. visit with vesicular rash 6/29/2020
Age: 1.33
Sex: M
Vaccine: PNC13
Symptoms: Lethargy
Clinical narrative: LETHARGY
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster disseminated, Rash
Clinical narrative: Disseminated zoster; Rash on legs, different rash to face; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2014US119788).  This spontaneous report was received from a health professional concerning a 79-year-old male patient. The patient's medical history, concomitant medications, historical drugs, and allergies were not reported. His concurrent conditions included chronic lymphocytic leukemia (CLL).  On 07-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), lot number J002869 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 14-JUN-2014, at a dose of 1 dosage form (DF) (anatomical location, formulation and strength were not reported; route of administration was reported as unknown), and with influenza virus vaccine, at a dose of 1 DF (anatomical location, formulation, expiration date and strength were not reported; lot number and route of administration were reported as unknown) both administered as immunization.  On 28-OCT-2013, the patient experienced rash on legs, with different rash to face (rash). On 30-OCT-2013, the patient experienced disseminated zoster (herpes zoster disseminated). Due to the events, the patient was hospitalized on an unknown date.   On an unknown date, the patient recovered from herpes zoster disseminated and rash.  The causal relationship between zoster vaccine live (ZOSTAVAX) and influenza virus vaccine and the aforementioned events was not provided.  Herpes zoster disseminated and rash were reported to be life-threatening.; Sender's Comments:  537688:
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been downloaded from Regulatory Authority (US-CHIRONMA-PHHY2015US109738).  This spontaneous report was received from a healthcare professional concerning to a 63-year-old female patient. The patient's concurrent conditions, concomitant medications, medical history, previous drugs reactions and allergies were not reported.   On 06-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), 1 dosage form,by subcutaneous route, lot #K007990 expiration date not reported, but upon internal validation established as 03-SEP-2015, for immunization (strength, dose schedule and anatomical site of injection were not reported) and influenza virus sag 3v vaccine inactivated (FLUVIRIN 2014/2015), injection, 1 dosage form, by intramuscular route, lot # 1411001, for immunization (strength, dose schedule, anatomical site of injection and expiration date were not reported).   On 24-OCT-2014, the patient experienced shingles (herpes zoster).  The outcome of herpes zoster was reported as not resolved.   The causality assessment between zoster vaccine live (ZOSTAVAX) and the event was not reported; regarding the therapy with influenza virus sag 3v vaccine inactivated (FLUVIRIN 2014/2015) and the event of herpes zoster was considered suspected.   The event of herpes zoster was considered to be medically significant.; Sender's Comments:  553223: