chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; This spontaneous report was received from a nurse, referring to a child patient between 1 and 2-year-old of an unknown gender. The patient's pertinent medical history, previous drug reactions, allergies, or concomitant medications were unknown by the reporter.  On an unspecified date, the child was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dose administered subcutaneously, as "routine vaccination" (lot number S027459 which has been verified to be valid, expiration date reported and validated as 02-MAR-2021) (vaccination scheme and anatomical site of injection were not reported).  On an unspecified date (also reported as "within 1-10 days of administration"), the patient experienced fever (pyrexia) and rash. According to the nurse, it could be chickenpox (varicella). The patient sought medical attention, however, no treatment was given for the events and the patient did not have any laboratory diagnostics or studies performed.   The outcome of the events pyrexia, rash and varicella was reported as recovered. The causal relationship between the abovementioned events and therapy with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) was not reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001872: US-009507513-2006USA008951: US-009507513-2007USA001873:
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph glands; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. On 23rd June 2020 at 12:03:57 PM, the patient asked, are the swollen lymph glands was a side effect of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: flu like symptoms; painful injection; This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced painful injection and flu like symptoms after receiving vaccine. The reporter consented to follow up
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives around eyes with itching
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Explorative laparotomy, Intussusception, Ultrasound scan, X-ray
Clinical narrative: Intussusception, requiring surgery: exploratory laparotomy Intussusception reduction
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Gave client Adolescent dose instead of Adult dose
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Red area that is warm to the touch about 5 inches down from injection site.  Patient also had low-grade fever.
Age: 19.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient reported redness, swelling, inflammation and pain around injection site. She stated this also happened with her first Varivax injection as well. She had been given an antibiotic for cellulitus after her first Varivax injection because the correlation with the injection site reaction was not made at that time by another provider.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptoms; improperly stored dose; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-FEB-2020, the patient was vaccinated with a dose of improperly stored  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly lot # 9029515 with expiration date 08-JUL-2021 (dose number, frequency, formulation and anatomical location were not reported) for prophylaxis. Lot number 9029515 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  The digital data logger was involved in recording the temperature excursion details. The vaccine was stored in temperature of 0.7 degrees Celsius for 3.048 hours. There was no previous temperature excursion. The patient did not experience any symptoms.
Sex: M
Vaccine: FLU3
Symptoms: Myelitis transverse, Product administered to patient of inappropriate age
Clinical narrative: transverse myelitis that started in his left leg and moved to his right; 36 year old male patient received a FLUZONE HIGH DOSE; 36 year old male patient received a FLUZONE HIGH DOSE; Initial information received on 01-Jul-2020 regarding an unsolicited valid serious case from a nurse.  This case involves a 36 year old male patient who experienced transverse myelitis that started in his left leg and moved to his right (myelitis transverse), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination and family history were not provided.  In November 2018, the patient received a 0.5 ml dose (once) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI995AB and expiry date: 01-Apr-2019) via an unknown route in the left deltoid for prophylactic vaccination.  The patient did not receive any other vaccines or medications at that visit.   In January or February of 2019 the patient experienced what they thought were shingles but on 23-May-2029, the patient was hospitalized for serious transverse myelitis that started in his left leg and moved to his right (myelitis transverse) (few months latency) following vaccination. This event was also assessed as medically significant.   It was a case of actual medication error due to Product administered to patient of inappropriate age and overdose.  Details of laboratory data not reported.   Final diagnosis were myelitis transverse.  It was not reported if the patient received a corrective treatment.  At the time of report, outcome of events was not 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.; Sender's Comments: This case concerns a 36 year old male patient who presented with myelitis transverse after vaccination with FLUZONE HIGH DOSE. The time to onset is compatible. However, patient's medical condition at time of vaccination, lab data ruling other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Pentacel exposed to 27F for more than 3 hrs, due to temp was manually changed in the refrigerator, no adverse event; Initial information was received on 01-Jun-2020 regarding an unsolicited valid non-serious case from the other health professional.  This case is linked to cases 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174941, 2020SA174940, 2020SA174932, 2020SA174906, 2020SA174911, 2020SA174910, 2020SA173110 and 2020SA172973 (same reporter).  This case involves a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ262AA and expiration date 14-May-2021) which was exposed to 27 F for more than 3 hours and vaccinated a dose of this vaccine to a four-month-old female patient via an unknown route at an unknown administration site on 11-May-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.   The patient's concomitant medication was not reported.  It was an actual medication error case due to product storage error temperature too low. This error occurred due to temp was manually changed in the refrigerator (human error).  No adverse event reported at the time of reporting.  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: 1.5
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: stability information for Adacel, exposed to 27Farenheit for more than 3 hours and the vaccines were also administered, no AE; adacel was given to patient of 18 months of age, no AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174941, 2020SA174940, 2020SA174906, 2020SA174932, 2020SA174911, 2020SA174910 and 2020SA173110(same reporter).  This case involves 18 months old male patient who was vaccinated with the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed.it   Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 14-May-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  (lot U6621BA and expiration date :22-Mar-2021) via unknown route in unknown administration site as prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low and inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  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: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Pentacel was exposed to 27Farenheit for more than 3 hours due to the temperature in the refrigeratorwas manually changed and also the vaccine was administered to 15 months old patient, no AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174885, 2020SA174942, 2020SA174941, 2020SA174940, 2020SA174906, 2020SA174932, 2020SA174911, 2020SA174910 and 2020SA173110(same reporter).  This case involves a 15 months old male patient who was vaccinated with the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 19-May-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6615AA and expiration: 20-Mar-2021) via unknown route in unknown administration site as prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low.  No adverse event reported at the time of reporting.  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: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine exposed to 27 F for more than 3 hours due to the temperature in the refrigerator was manually changed, given to 15 months old patient, no AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA172973, 2020SA172697 ,2020SA174880, 2020SA174942, 2020SA174941, 2020SA174940, 2020SA174906, 2020SA174932, 2020SA174911, 2020SA174910 and 2020SA173110(same reporter).  This case involves a 15 months old male patient who was vaccinated with the  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed.it   Medical history, medical treatment(s), vaccination(s) family history and concomitant medications were not provided.   On 18-May-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ196AB and expiration: 2-Mar-2021) via unknown route in unknown administration site as prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low.  No adverse event reported at the time of reporting.  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: 11.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion due to Adacel vaccine was exposed to 27F for more than 3 hrs/No AE; Initial information was received on 01-Jul-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174911, 2020SA174941, 2020SA174910, 2020SA174910, 2020SA174932, 2020SA174940 and 2020SA173110. (Same reporter)  This case involves a 11-year-old male patient who was received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed it (product storage error).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On 13-May-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6621BA, expiry date: 22-Mar-2021] via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case 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 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: 17.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion due to Adacel vaccine was exposed to 27F for more than 3 hours/No AE; Initial information was received on 01-Jul-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174941, 2020SA174906, 2020SA174940, 2020SA174932, 2020SA173110 and 2020SA174911. (same reporter)  This case involves a 17 years old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed it (product storage error).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On 15-May-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6621BA, expiry date: 21-Mar-2022] via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case 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 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: 11.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion due to Adacel vaccine was exposed to 27F for more than 3 hours/No AE; Initial information was received on 01-Jul-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174910, 2020SA174906, 2020SA174941, 2020SA174940, 2020SA174932 and 2020SA173110. (same reporter)  This case involves a 11-year-old male patient who was received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed it (product storage error).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On 18-May-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6378AA, expiry date: 04-Jul-2021] via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case 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 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: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Menactra was exposed to 27 Farenheit for more than 3 hours and was administered to 11 year old male patient, no AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174911, 2020SA174941, 2020SA174910, 2020SA174940, 2020SA174906 and 2020SA173110 (same reporter).  This case involves a 11 year old male patient who was vaccinated with the  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   On 14-May-2020, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6594AB and expiration: 21-May-2021) via an unknown route at an unknown administration site as prophylactic vaccination.  It was an actual medication error case 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 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: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Menactra exposed to 27F for more than 3 hours due to  temperature was manually changed in the refrigerator, no advesre event; Initial information was received on 01-Jun-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174911, 2020SA174940, 2020SA174932, 2020SA174906, 2020SA174910, 2020SA173110 and 2020SA174910 (same reporter).  This case involves MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6621BA and expiration date 21-Mar-2022) which was exposed to 27 F for more than 3 hours and a 16 year old male patient received this vaccine via an unknown route at an unknown administration site on 15-May-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  The patient's concomitant medication was not reported.  It was an actual medication error case due to product storage error temperature too low. This error occurred due to temp was manually changed in the refrigerator (human error).  No adverse event reported at the time of reporting.  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: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Menactra was exposed to 27 Farenheit for more than 3 hours due to the temperature in the refrigerator was manually changed and also the vaccine was administered to 11 year old male patient, no AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174941, 2020SA174940, 2020SA174906, 2020SA174932, 2020SA174911, 2020SA174910 and 2020SA173110 (same reporter).  This case involves a 11 year old male patient who was vaccinated with the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  On 18-May-2020, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6565AA and expiry date: 28-Mar-2021) via unknown route in unknown administration site as prophylactic vaccination.  It was an actual medication error case 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 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: 10.0
Sex: M
Vaccine: MENB, MMR, MNQ, PPV
Symptoms: Blood uric acid increased, C-reactive protein normal, Differential white blood cell count normal, Full blood count normal, Henoch-Schonlein purpura
Clinical narrative: 24 June 2020, 7 days after receipt of above 4 immunizations, patient developed bilateral lower extremity lesions consistent with Henoch Schonlein Purpura. No other clinical systemic symptoms and no preceding symptoms consistent with an infection. Laboratory assessment was within normal limits without systemic evidence of inflammation. Lesions continuing to appear and disappear every 5-7 days, decreasing in frequency, but not completely resolved.
Age: 10.0
Sex: M
Vaccine: MENB, MMR, MNQ, PPV
Symptoms: Metabolic function test normal, Red blood cell sedimentation rate normal, Skin lesion
Clinical narrative: 24 June 2020, 7 days after receipt of above 4 immunizations, patient developed bilateral lower extremity lesions consistent with Henoch Schonlein Purpura. No other clinical systemic symptoms and no preceding symptoms consistent with an infection. Laboratory assessment was within normal limits without systemic evidence of inflammation. Lesions continuing to appear and disappear every 5-7 days, decreasing in frequency, but not completely resolved.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Patient stated had pain, aches, and a rash that started on truck and expanded to extremities.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Injection site discomfort, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: On 62520 pt c/o discomfort at the site and by evening  he had a welt/redness down his arm 7" x 4".  Televisit done on 06-26-2020 per mom feels warm, mild tender w/palpation, no hematoma palpated - believed to be predominantly localized reaction but treated empirically with Augmentin 875-125 mg tablets, 1 tablet orally BID for 10 days.  Next day site was even larger and he had a headache
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site warmth, Local reaction, Urticaria
Clinical narrative: On 62520 pt c/o discomfort at the site and by evening  he had a welt/redness down his arm 7" x 4".  Televisit done on 06-26-2020 per mom feels warm, mild tender w/palpation, no hematoma palpated - believed to be predominantly localized reaction but treated empirically with Augmentin 875-125 mg tablets, 1 tablet orally BID for 10 days.  Next day site was even larger and he had a headache
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nodule
Clinical narrative: MUSCLE SORENESS RADIATING INTO SHOIULDER AND NECK AND KNOT ALMOST 1 MONTH POST INJECTION.
Age: 17.0
Sex: F
Vaccine: ANTH
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE SYMPTOMS REPORTED.  LITERATURE STATES VACCINE IS FOR 18YRS AND OLDER.  PT IS 17 AND 11MONTHS.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Fatigue, Injection site pain, Pyrexia, Rash
Clinical narrative: Night after the shots he got rashes on his arms and chest. The next day he woke up with a fever that got up to 104+ and he was tired, complained about his leg hurting, and had a distinct loss of appetite/ water had to be forced.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: deep joint pain, facial rash, sore throat, fever
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt is here for Shingrix #2 only.   Redness, swelling on left arm below injection; about 5" by 1" red patch; warm to the touch.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Generalized muscle aches, soreness at vaccine site (right arm), low grade fever of 99.3F,
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Dyspepsia, Gastrointestinal pain, Irritable bowel syndrome, Muscle spasms
Clinical narrative: Note: I took this same vaccine 6 years ago with no reaction at all. This is the second time I have had this vaccine in my life.  With the initial pill Wednesday, just irritable bowel,   Second pill on Friday, waves of nausea and GI pain, cramping and heartburn like pain Third dose, Sunday, continued nausea in waves and cramping, epi-gastric "ulcer" like pain, some generalized itching,  Hives on the morning of the last dose that I didn't notice until I had already take the last dose.  So they must have developed on back between the last two doses. Hives from buttocks up to mid back and some appearing on back of thighs. Day after last dose some itching and nausea still and doesn't seem to be resolving.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Pruritus, Urticaria
Clinical narrative: Note: I took this same vaccine 6 years ago with no reaction at all. This is the second time I have had this vaccine in my life.  With the initial pill Wednesday, just irritable bowel,   Second pill on Friday, waves of nausea and GI pain, cramping and heartburn like pain Third dose, Sunday, continued nausea in waves and cramping, epi-gastric "ulcer" like pain, some generalized itching,  Hives on the morning of the last dose that I didn't notice until I had already take the last dose.  So they must have developed on back between the last two doses. Hives from buttocks up to mid back and some appearing on back of thighs. Day after last dose some itching and nausea still and doesn't seem to be resolving.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Burning sensation, Dermatitis acneiform, Dizziness, Fatigue
Clinical narrative: Within 5 days of my son being vaccinated, he began to exhibit welts upon his torso and upper leg/groin region. Initially, these welts varied in size ranging approximately 6-12 inches in length & diameter. Twelve hours after these welts initially appeared, they began to grow in number and in extreme size, ultimately covering his entire body. The welts would also consistently disappear and reappear in different locations on his entire body. Per his explanation, these welts burned and itched immensely. He also experienced light-headedness, weakness and moderate fatigue. In addition to this, he experienced numbness & tingling in his lower extremities and they were cold to the touch.  He was seen at an urgent care the same day as the reaction and then ultimately the emergency 16 hours later when his body was covered in welts. He received a diagnosis of both urticaria and rash. I was given the instruction for him to take antihistamines and he was prescribed hydrocortisone cream to apply topically. We implemented the prescribed regimen, and followed up with his pediatrician?s office the next day. 24 hours since the reaction, the welts have diminished moderately. They are still somewhat visible, but per his demeanor, he seems to be feeling somewhat better.  To our surprise, no further medical tests and or labs were performed to determine a proper diagnosis by the urgent care, emergency room or the pediatrician?s office. Additionally, no further medical investigation was ordered to determine if this reaction could be due to any other condition or reaction to any environmental source.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness, Pruritus, Urticaria
Clinical narrative: Within 5 days of my son being vaccinated, he began to exhibit welts upon his torso and upper leg/groin region. Initially, these welts varied in size ranging approximately 6-12 inches in length & diameter. Twelve hours after these welts initially appeared, they began to grow in number and in extreme size, ultimately covering his entire body. The welts would also consistently disappear and reappear in different locations on his entire body. Per his explanation, these welts burned and itched immensely. He also experienced light-headedness, weakness and moderate fatigue. In addition to this, he experienced numbness & tingling in his lower extremities and they were cold to the touch.  He was seen at an urgent care the same day as the reaction and then ultimately the emergency 16 hours later when his body was covered in welts. He received a diagnosis of both urticaria and rash. I was given the instruction for him to take antihistamines and he was prescribed hydrocortisone cream to apply topically. We implemented the prescribed regimen, and followed up with his pediatrician?s office the next day. 24 hours since the reaction, the welts have diminished moderately. They are still somewhat visible, but per his demeanor, he seems to be feeling somewhat better.  To our surprise, no further medical tests and or labs were performed to determine a proper diagnosis by the urgent care, emergency room or the pediatrician?s office. Additionally, no further medical investigation was ordered to determine if this reaction could be due to any other condition or reaction to any environmental source.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Injection site bruising, Injection site discolouration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling from shoulder to elbow, hot to touch and painful. Also black bruising at 1 of the injection entry sites.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache, low fever, nausea
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness & itchness at injection site. Referred pt to take Benadryl & cortisone cream.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eye movement disorder, Head injury, Syncope, Trismus
Clinical narrative: child fainted and hit head on  table a minute after vaccine was  given and then his eyes rolled  back and forth and his jaw  started opening/closing.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Following injection pt reported feeling dizzy, sweating and appeared pale. No Syncope. Pt was put in a comfortable position. Provided juice, water & crackers and remained in office under close supervision for 20 minutes. Pt reported improvement in symptoms after 20 minutes and father of PT and clinical staff felt PT was safe to leave office. PT walked out of office on her own accord with mo
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Muscle rigidity, Pallor, Posturing, Seizure like phenomena
Clinical narrative: patient given vaccines about 5 minutes earlier, and was waiting in office for 15 minutes Heard dad holler for help. fount pt. unresponsive and rigid in siting position. helped to floor. unresponsive for about 15 seconds. grey in pallor. some posturing and seizure like movement in upper extremities. 30 seconds after waking up - alert and oriented x 3. Hot to touch. BP 100/50; HR 84; Pulse ox 100% RA. transported to ER
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Skin warm, Unresponsive to stimuli
Clinical narrative: patient given vaccines about 5 minutes earlier, and was waiting in office for 15 minutes Heard dad holler for help. fount pt. unresponsive and rigid in siting position. helped to floor. unresponsive for about 15 seconds. grey in pallor. some posturing and seizure like movement in upper extremities. 30 seconds after waking up - alert and oriented x 3. Hot to touch. BP 100/50; HR 84; Pulse ox 100% RA. transported to ER
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red itchy patch on LT with  no pain. provider prescribed  Benadryl 12.5mgl/5ml 2.5 ml  PO Q4-6hrs prn.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: SkinRash & RASH
Age: 70.0
Sex: M
Vaccine: FLUC4
Symptoms: Diarrhoea, Dry mouth, Pruritus, Rash, Urticaria
Clinical narrative: UrticariaPruritus & DRY MOUTH; WHEEZING; RASH; DIARRHEA; URTICARIA INFLUENZA 0.5 ML ONCE
Age: 70.0
Sex: M
Vaccine: FLUC4
Symptoms: Wheezing
Clinical narrative: UrticariaPruritus & DRY MOUTH; WHEEZING; RASH; DIARRHEA; URTICARIA INFLUENZA 0.5 ML ONCE
Age: 84.0
Sex: M
Vaccine: BCG
Symptoms: Chills, Pyrexia
Clinical narrative: & FEVER; CHILL
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Pt states after vaccination develop soreness and pain at site of injection. Notice when rotating or lifting arm is painful. Develop slight fever. Recommends cold compress to site and take apap/ motrin for pain relief.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Erythema, Limb discomfort, Pain, Skin warm
Clinical narrative: Pt received her 2nd dose of Shingrix on Monday, 6/29/20. On Wednesday, 7/1/20 in the AM, pt stopped in to report she was having an adverse reaction. Her arm was red across a large area, probably at least 6 inches long and 3 inches wide. She said it was warm, tender, and was throbbing and very uncomfortable. She was due to see her provider on Thursday so she was going to address it with them. Called on 7/8/20 to f/u with patient. She said it had just resolved, but it had taken a full week. Her provider had not prescribed anything for her. It resolved on its own over the 7 day time frame.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Pt received her 2nd dose of Shingrix on Monday, 6/29/20. On Wednesday, 7/1/20 in the AM, pt stopped in to report she was having an adverse reaction. Her arm was red across a large area, probably at least 6 inches long and 3 inches wide. She said it was warm, tender, and was throbbing and very uncomfortable. She was due to see her provider on Thursday so she was going to address it with them. Called on 7/8/20 to f/u with patient. She said it had just resolved, but it had taken a full week. Her provider had not prescribed anything for her. It resolved on its own over the 7 day time frame.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster disseminated, Varicella
Clinical narrative: Disseminated shingles/chicken pox; Disseminated shingles/chicken pox; Information has been downloaded from Agency (US-CHIRONMA-PHHY2012US110947).  This spontaneous report was received from a health care professional concerning to a 79-year-old female patient. The patient's concurrent conditions, concomitant medications, medical history, previous drugs reactions and allergies were not reported.   On 07-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), 1 dosage form, by intramuscular route, lot # 0242AE expiration date not reported, but upon internal validation established as 01-APR-2013 (strength, formulation, anatomical site of injection and indication were not reported) and influenza virus sag 3v vaccine inactivated (FLUVIRIN 2012/2013), injection, 1 dosage form, by intramuscular route, lot # 1203901, for immunization (strength, dose schedule, anatomical site of injection and expiration date were not reported).  On 28-SEP-2012, the patient experienced disseminated shingles/chicken pox (varicella and herpes zoster). The outcome of  varicella and herpes zoster was reported as not resolved.  The causality assessment between zoster vaccine live (ZOSTAVAX) and the events of varicella and herpes zoster was not reported; regarding the therapy of influenza virus sag 3v vaccine inactivated (FLUVIRIN 2012/2013) and the events was reported as suspected (related).   The events of varicella and herpes zoster were considered to be life threatening.; Sender's Comments:  466114:
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Emotional distress, Herpes zoster, Rash
Clinical narrative: Minor distress; Rash on her abdomen and chest; Weak version of the shingles; Information has been downloaded from Agency (US-CHIRONMA-PHHY2015US015784).  This spontaneous report was received from a health care professional concerning a 67 years old female patient. Her concurrent condition, medical history and concomitant therapy were not reported.   On 07-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (at the dose of 1 dosage form, subcutaneous; lot# K008880, expiration date 09-SEP-2015) for immunization and influenza virus sag 3v vaccine inactivated (FLUVIRIN) (at the dose of 1 dosage form, intramuscular; batch/lot # 1411001) for immunisation.   On 09-OCT-2014, the patient experienced minor distress, weak version of the shingles and rash on her abdomen and chest. The outcome of all the events was resolved. Action taken with zoster vaccine live (ZOSTAVAX) and influenza virus sag 3v vaccine inactivated (FLUVIRIN) was not applicable.   The causality between minor distress and influenza virus sag 3v vaccine inactivated (FLUVIRIN) was reported as not assessable. The causality between events of weak version of the shingles and rash on her abdomen and chest and influenza virus sag 3v vaccine inactivated (FLUVIRIN) was reported as suspected. The causality between all the events and zoster vaccine live (ZOSTAVAX) was not reported. All the events were considered to be medically significant by agency.; Sender's Comments:  550915:
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, PPV, VARCEL
Symptoms: Polymerase chain reaction positive, Product administered to patient of inappropriate age, Rash, Rash macular, Rash papular
Clinical narrative: Less than 50 lesions; Diagnosed with Varicella; Macular, papular, vesicular, itchy generalized rash; Macular, papular, vesicular, itchy generalized rash; Macular, papular, vesicular, itchy generalized rash; Macular, papular, vesicular, itchy generalized rash; Macular, papular, vesicular, itchy generalized rash; Vaccine administered to a 1 year patient; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2016US088664).  This spontaneous report was received from an other health professional and refers to a 1-year-old male patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided.  On 10-MAR-2016, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form, lot number L025205, expiration date was not reported, but upon internal verification was established as 07-JUL-2017 (injection site and route of administration were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) 1 dosage form (therapy type, injection site, route of administration, lot # and expiration date were not provided), pneumococcal vaccine, polyvalent (manufacturer unknown) 1 dosage form (injection site, route of administration, lot # and expiration date were not provided), hepatitis a vaccine (manufacturer unknown) 1 dosage form (injection site, route of administration, lot # and expiration date were not provided) and influenza virus vacc seasonal inn, 1 dosage form (injection site, route of administration, lot # and expiration date were not provided) all for immunisation. On 01-APR-2016, he experienced macular, papular, vesicular, itchy generalized rash. On 04-APR-2016, varicella virus test and polymerase chain reaction (PCR) were performed with positive results and the patient was diagnosed with varicella. On an unknown date, he developed less than 50 lesions. The outcome of rash pruritic, varicella post vaccine, skin lesion, rash papular, generalised rash, rash macular and rash vesicular was reported as recovered/resolved on unknown dates.   The relatedness between the events and varicella virus vaccine live (oka/merck) (VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), pneumococcal vaccine, polyvalent (manufacturer unknown) and hepatitis a vaccine (manufacturer unknown) was not reported. The relatedness between the events and influenza virus vacc seasonal inn was reported as suspected.  The reporter considered the events of rash pruritic, varicella post vaccine, skin lesion, rash papular, generalised rash, rash macular, rash vesicular and inappropriate age at vaccine administration to be medically significant.; Sender's Comments:  633515: