chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature excursion for vaccine that was administered after excursion occured; This spontaneous report has been received from a nursing assistant concerning a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.        On 07-AUG-2020,  the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX)  formulation not provided but defaulted to subcutaneous injection, Lot # T002846 and  expiration date 23-JAN-2022  for prophylaxis (dosage regimen was not provided). The storage temperature was reported to had been at  -10.2°C for 1 hour and 53 minutes.            There was digital data logger involved and  no previous temperature excursion was reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014798:AE case # 01697207 US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705:AE case # 01697215 US-009507513-2008USA014806:AE Case # 01697206 US-009507513-2008USA015018:AE Case # 01697159 US-009507513-2008USA015035:AE Case # 01697212 US-009507513-2009USA000117:AE Case # 01697209 US-009507513-2009USA000132:AE Case # 01697205 US-009507513-2008USA014937:AE Case # 01697191 US-009507513-2009USA000113:AE Case # 01697199
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent beginning 7/28/2020 involving PROQUAD states that there have been administered doses; This spontaneous report was received from a nurse, 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.  Since 28-JUL-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had intermittent temperature excursion between a temperature of minus 14 degrees Celsius to 10C (max -9.5C) for 38 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  On 13-AUG-2020, the patient was administered an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T009929, which has been verified to be valid, expiration date reported and validated as 16-SEP-2021) as prophylaxis (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014709: US-009507513-2008USA014853:
Age: 15.0
Sex: U
Vaccine: MENB, PPV
Symptoms: Cellulitis
Clinical narrative: The patient was admitted to hospital 2 days after vaccination with diagnosis of cellulitis.; This spontaneous report was received from a physician via company representative, referring to a 15 year old patient human immunodeficiency virus (HIV) positive. The patient's medical history, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) via intramuscular route (strength, dose, frequency, anatomical location,lot # and expiration date were unknown), and with  meningococcal b rfhbp rnada rnhba omv vaccine (e. coli)(BEXSERO) (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) at same time in same deltoid for vaccination.   On an unknown date (reported as "2 days after vaccination"), the patient seek for medical attention and was admitted to hospital with diagnosis of cellulitis, and received treatment for the event.  At the time of the report, it was reported that the vaccination was discontinued, and the outcome of cellulitis was reported as resolving. The patient was discharged and was doing fine at home.    Upon internal review, cellulitis was determined to be a medically significant event.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent beginning 7/28/2020 involving PROQUAD states that there have been administered doses; This spontaneous report was received from a nurse, 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.  Since 28-JUL-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had intermittent temperature excursion between a temperature of minus 14 degrees Celsius to -10C (max -9.5C) for 38 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  On 21-AUG-2020, the patient was administered an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T009929, which has been verified to be valid, expiration date reported and validated as 16-SEP-2021) as prophylaxis (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014709: US-009507513-2008USA014811:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: vaccines that were administered to patients after excursion occurred; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. Information regarding the patients' medical history, historical drugs and concomitant therapies was not provided.   On an unknown date,the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002846, expiration date 23-JAN-2022 for prophylaxis (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported).  The vaccine was stored in a temperature of -10.2 degrees Celsius (C) for 1 hour and 53 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014798: US-009507513-2008USA014951:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further adverse event was reported; expired vaccine used; This spontaneous report was received from a medical assistant calling on behalf of the health care professional, concerning a patient of unknown age and gender.    The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 30-JUL-2020, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA)  per intramuscular route, lot# S018419 expiration date 12-JUL-2020 (dose was not provided) for prophylaxis. No further adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown gender and age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported. Since 28-JUL-2020, improperly stored VARIVAX including lot number T002843, expiration date 23-JAN-2022; and lot number S032357, expiration date 14-OCT-2021, have been experienced an intermittent temperature excursion of -14 degree Celsius (°C) to -10 °C (maximum average temperature was -9.5 °C) for a period of 38 hours and 30 minutes, but it was not reported before. Then, on 31-JUL-2020, the patient was vaccinated with an improperly stored dose of VARIVAX 0.5 milliliter (dosage regimen and route of administration were not provided), lot number S032357; expiration date 14-OCT-2021, as prophylaxis. It was reported that the reported lot # did not have a previous temperature excursion. The call was because a digital data logger.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender.    Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 28-JUL-2020, the patient was vaccinated with an improperly stored dose  of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002843 (expiration date 23-JAN-2022) and lot # S032357 (expiration date 14-OCT-2021) 0.5 milliliters for prophylaxis (strength, frequency and route of administration were not reported).  Other suspect therapies included measles, mumps, rubella and varicella (oka-merck) virus vaccine live of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin)  (PROQUAD) lot # T009929 (expiration date 16-SEP-2021) and  lot # S031882 (expiration date  07-APR-2021) for prophylaxis (strength, dose, frequency, and route of administration were not reported). .  The improperly stored vaccines experienced all an intermitent temperature excursion between -14 degree Celsius (°C) to 10°C (max -9.5°C) for 38 hours and 30 minutes with no previous temperature excursion.  The call was made due to a digital data logger. No adverse symptoms were reported.  This is one of several cases from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion for vaccines that were administered to patient after excursion occurred; This spontaneous report was received from a registered nurse and refers to a patient of an unknown gender and age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen and route of administration were not provided), lot number lot number S038698; expiration date 01-DEC-2021, as prophylaxis.    The improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature excursion of -10.2 degree Celsius (°C) for a period of 1 hour and 53 minutes. It was reported that the vaccine did not had a previous temperature excursion. The call was because a digital data logger.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000117: US-009507513-2009USA000132: US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2008USA014803: US-009507513-2008USA014820: US-009507513-2008USA014936: US-009507513-2008USA014871: US-009507513-2008USA014869: US-009507513-2008USA014803:AE Case # 01697191
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  Since 28-JUL-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had intermittent temperature excursion to temperature of - 14 Celsius degrees to -10 Celsius degrees (maximus -9.5 Celsius degrees) for 38 hours and 30 minutes.  On 14-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (lot #T009929, expiration date 16-SEP-2021; route of administration not provided) for prophylaxis (it was also reported that the lot # S031882 expiration date 07-APR-2021 was involved, but no information of administration was provided) (product storage error). There were no previous excursions reported. The digital data logger was involved.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: The caller refused to give any additional information regarding the adverse experience; Was given VARIVAX while pregnant; This spontaneous prospective pregnancy report was received from a consumer concerning a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided) while pregnant (exposure during pregnancy). Additional information regarding the adverse experience was not reported (adverse event). The last menstrual period (LMP) and estimated date of delivery (EDD) were both not known; the pregnancy outcome was pending.   The outcome of adverse event and exposure during pregnancy was unknown.   The causality assessment between the suspect drug and the event occurrence was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Significant chills; Pain; This case was reported by a other health professional via sales rep and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and pain. On an unknown date, the outcome of the chills and pain were unknown.   It was unknown if the reporter considered the chills and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patients had been reporting significant chills with the 2nd dose of Shingrix.  The reporter wanted to know if this has been an observed pattern and if pre-medication with an NSAID or acetaminophen for pain relief was advised.  Upon additional inquiry, no further details were shared.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: swelling at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix. On 28th July 2020, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after the dose of Shingrix in the right arm experienced swelling at the injection site on the right arm that lasted 2 to 3 days, mentioned the size was about 100mm. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue
Clinical narrative: Fatigue; 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix and Shingrix (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue and extra dose administered. On an unknown date, the outcome of the fatigue and extra dose administered were unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient got a 3rd dose of Shingrix by mistake, which led to extra dose administered. The patient only had fatigue the following day. No other information was provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020172522:Same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu like symptoms; Redness in the injection area; Tender and redness in the injection area; Swelling, tender and redness in the injection area; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 97C2S, expiry date 14th May 2022) for prophylaxis.   On 22nd August 2020, the patient received Shingrix. On 22nd August 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness and injection site swelling. On 23rd August 2020, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, injection site tenderness and injection site swelling were not recovered/not resolved and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site swelling and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced flu like symptoms.  The patient also experienced swelling, tender and redness in the injection area, side effects she still had until the day of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness/adverse events such as a streak down the arm; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2020, the patient received the 1st dose of Shingrix. On 25th July 2020, 1 days after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that the patient was asking about the safety of a second dose of Shingrix after the first presented with adverse events such as a streak down the arm of the patient and redness.  This adverse event resolved after some days.  The reporter could not provide more information, such as for vaccine or vaccination information, since this was performed by the pharmacist. The reporter did not consent to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Mild to moderate pain at the injection site; limitation of arm movement; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose in the arm on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mild to moderate pain at the injection site, limitation of arm movement. The outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: full body hives; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves a 21-year-old female patient who experienced full body hives (urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On 24-Aug-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UJ432AB, expiry date not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On 24-Aug-2020, the patient developed a non-serious full body hives (urticaria) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Urticaria.  The event outcome was unknown for urticaria.
Age: 63.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Cold sweat, Loss of consciousness, Syncope
Clinical narrative: pt recieve shot at 1pm. At 1.02 pm pt had a syncopy episode with brief moment of unconciousness and went to the ground, people around to aid fall. Pt was quickly back responsive and alert but repirations in the 30-40s range and pt was cool and clammy. Pt aided to bench. bp reading was 88/50 and pulse ox was 96%. pt was having a conversation with me (pharmacist). ambulance arrived about 10-15 minutes later and took over
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeling abnormal, Injection site reaction, Pain
Clinical narrative: all joints the next morning after getting the 2nd shot were really hurting, aching feeling, low grade fever most of the day, chills generally felt really bad and couldn't do much.  The next day there was a red rash on my arm near the  injection area, It lasted about 3 days and arm was very sore.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: all joints the next morning after getting the 2nd shot were really hurting, aching feeling, low grade fever most of the day, chills generally felt really bad and couldn't do much.  The next day there was a red rash on my arm near the  injection area, It lasted about 3 days and arm was very sore.
Age: 27.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given outside of the recommended age range.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; Physician Assistant reported the patient received an expired dose ofZOSTAV AX (S016663, expiration 8/27/2020) on 8/28/2020; This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not provided. Concomitant medication included sterile diluent.  On 28-AUG-2020, the patient was vaccinated with an expired dose of zoster vaccine live (ZOSTAVAX) (lot # S016663, expiration date 27-AUG-2020; strength, dose, route were unknown) for prophylaxis (expired product administered). No adverse symptoms reported.
Sex: M
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: FEEL SICK FOR LIKE A WEEK AFTER; A spontaneous report has been received from a health professional. The report concerns a male patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced feel sick for like a week after (preferred term: Malaise).     The outcome of feel sick for like a week after was unknown.    The feel sick for like a week after was considered non-serious by reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site discomfort, Injection site erythema
Clinical narrative: that was "bothering him."; he had a red, pink injection site; pink injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site discomfort, injection site erythema and injection site discoloration. On an unknown date, the outcome of the injection site discomfort, injection site erythema and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the injection site discomfort, injection site erythema and injection site discoloration to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles vaccine sometime around the holidays, it was cold outside and had a red, pink injection site, that was bothering him. The reporter did not consent to follow up. No other information available about this AE.  The reporter declined all demographics and declined further details.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral
Clinical narrative: After Shingrix first dose (3 MONTHS AGO), patient was blind on one eye.; This case was reported by a physician via call center representative and described the occurrence of unilateral blindness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced unilateral blindness (serious criteria GSK medically significant). On an unknown date, the outcome of the unilateral blindness was unknown.   It was unknown if the reporter considered the unilateral blindness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination were not reported but adult has been selected as age group according to the vaccine. The patient received 1st dose of Shingrix 3 months ago from reporting date and was blind on one eye. According to reporter emergency room visit was required. The reporter consented to follow up.
Age: 68.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site urticaria, Rash erythematous
Clinical narrative: hives or small red rash on left arm below the injection site
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: incapacitating arthralgia and myalgia along with dizziness, headache, and nausea.
Age: 1.67
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: DTaP was ordered and documented, but Pediarix was given. Per Manufacturer and CDC recommendations, no patient action is needed. Although not recommended, CDC states that an accidental dose of Pediarix can count as a 4th dose of DTaP.  At this time, no known patient reaction to medication error.
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given HPV vaccine at 4 months of age. No adverse effects at present time. Pt's Mother and provider were notified. Will monitor and research info on possible side effects.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nasopharyngitis, Retching
Clinical narrative: PATIENT EXPERIENCED EXCESSIVE COLD, CHILLS, AND DRY HEAVING
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Eye swelling, Hypersensitivity, Ocular hyperaemia, Sinus disorder
Clinical narrative: 08/31/20 @ 1620 employee received flu vaccine. Approximately 2 hours later, employee had c/o red/swollen eyes bilaterally, sinus' that felt like "concrete", and some difficulties breathing. Went to clinic 09/01/20. Symptoms were starting to resolve. MD confirmed diagnosis of allergic reaction and prescribed prednisone. Employee did not take prednisone as his symptoms were improving. Employee Health followed up with the employee on 09/02/20. At this time all symptoms had resolved with no sequela.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Mobility decreased, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: around 1600 , pt reports starting to feel ill. fever, severe arm pain. was advised by pharmacist to take ibuprofen and rest arm so painful, unable to sleep last night or lift arm above head advised by this RN to apply ice and diclofenac cream and rest
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Vitamin D
Clinical narrative: around 1600 , pt reports starting to feel ill. fever, severe arm pain. was advised by pharmacist to take ibuprofen and rest arm so painful, unable to sleep last night or lift arm above head advised by this RN to apply ice and diclofenac cream and rest
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Mother called into the office two days after vaccine was administered and stated that the child's right thigh is red and that he is complaining of pain.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Blood gases, Blood lactic acid, Blood magnesium, Blood phosphorus, Cardio-respiratory arrest
Clinical narrative: Time line of events: ? 08-18-20  Routine protocol cranial MRI without contrast under sedation. Dx: Macrocephaly/Gorlin Sydrome ? 08-24-20 at 3:00 PM  Patient here at Clinic for 9 mo WCC appt and received vaccines at 3:30 PM (Pediarix and PCV13).  Normal WCC for age  ? 08-25-20 at 1:48 PM  EMS called by parent for cyanosis and apnea. EMS arrived on scene at 1:54 PM (per EMS: approx. 30 min downtime prior to EMS arrival), found patient to be apneic and with very faint pulse.  Per EMS, patient was fine earlier in the morning.  Transported to Hosp Emergency Department arriving at 2:14 PM  presenting in full cardiopulmonary arrest.  From there transferred to Hosp. ? 08-26-20  Discharged from Hosp with Dx Level 1 ? Medical treatment with full resuscitation and transferred to the Cardiac Critical Care Uni. ? 08-27-20  Decease at 10:57 AM  (an autopsy is planned)
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Chest X-ray, Coagulation test, Computerised tomogram head, Cyanosis, Death
Clinical narrative: Time line of events: ? 08-18-20  Routine protocol cranial MRI without contrast under sedation. Dx: Macrocephaly/Gorlin Sydrome ? 08-24-20 at 3:00 PM  Patient here at Clinic for 9 mo WCC appt and received vaccines at 3:30 PM (Pediarix and PCV13).  Normal WCC for age  ? 08-25-20 at 1:48 PM  EMS called by parent for cyanosis and apnea. EMS arrived on scene at 1:54 PM (per EMS: approx. 30 min downtime prior to EMS arrival), found patient to be apneic and with very faint pulse.  Per EMS, patient was fine earlier in the morning.  Transported to Hosp Emergency Department arriving at 2:14 PM  presenting in full cardiopulmonary arrest.  From there transferred to Hosp. ? 08-26-20  Discharged from Hosp with Dx Level 1 ? Medical treatment with full resuscitation and transferred to the Cardiac Critical Care Uni. ? 08-27-20  Decease at 10:57 AM  (an autopsy is planned)
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Differential white blood cell count, Electrocardiogram, Electroencephalogram, Full blood count, Infantile apnoea
Clinical narrative: Time line of events: ? 08-18-20  Routine protocol cranial MRI without contrast under sedation. Dx: Macrocephaly/Gorlin Sydrome ? 08-24-20 at 3:00 PM  Patient here at Clinic for 9 mo WCC appt and received vaccines at 3:30 PM (Pediarix and PCV13).  Normal WCC for age  ? 08-25-20 at 1:48 PM  EMS called by parent for cyanosis and apnea. EMS arrived on scene at 1:54 PM (per EMS: approx. 30 min downtime prior to EMS arrival), found patient to be apneic and with very faint pulse.  Per EMS, patient was fine earlier in the morning.  Transported to Hosp Emergency Department arriving at 2:14 PM  presenting in full cardiopulmonary arrest.  From there transferred to Hosp. ? 08-26-20  Discharged from Hosp with Dx Level 1 ? Medical treatment with full resuscitation and transferred to the Cardiac Critical Care Uni. ? 08-27-20  Decease at 10:57 AM  (an autopsy is planned)
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Intensive care, Laboratory test, Metabolic function test, Pulse abnormal, Resuscitation
Clinical narrative: Time line of events: ? 08-18-20  Routine protocol cranial MRI without contrast under sedation. Dx: Macrocephaly/Gorlin Sydrome ? 08-24-20 at 3:00 PM  Patient here at Clinic for 9 mo WCC appt and received vaccines at 3:30 PM (Pediarix and PCV13).  Normal WCC for age  ? 08-25-20 at 1:48 PM  EMS called by parent for cyanosis and apnea. EMS arrived on scene at 1:54 PM (per EMS: approx. 30 min downtime prior to EMS arrival), found patient to be apneic and with very faint pulse.  Per EMS, patient was fine earlier in the morning.  Transported to Hosp Emergency Department arriving at 2:14 PM  presenting in full cardiopulmonary arrest.  From there transferred to Hosp. ? 08-26-20  Discharged from Hosp with Dx Level 1 ? Medical treatment with full resuscitation and transferred to the Cardiac Critical Care Uni. ? 08-27-20  Decease at 10:57 AM  (an autopsy is planned)
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Skin lesion
Clinical narrative: Mom states child broke out in a rash that looked ling ringworm.  Patient has round lesions and a lot of pin print lesions all over trunk, back, arms, neck, legs.  Has large lesions on the L leg.  Some of the lesions look like they are drying.  Mom states she  is using lamosil powder and magnesium in the PM.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient experienced pain and swelling in her arm as well as fever starting the day following vaccination. She has been alternating Tylenol and Advil
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event. Documenting because child received after age 15 weeks.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Autism spectrum disorder, Disturbance in attention
Clinical narrative: DECLINE IN ATTENTION DECLINE OF MILESTONES BEING MET
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Condition aggravated, Seizure
Clinical narrative: seizure activity occurred after patient left the office.  When vaccines were administered, patient did stay in the office for 15 minutes to monitor.  Parents call the office to notify provider of seizure.  Patient has seizure disorder.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; a patient was inadvertently administered an expired MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On 12-AUG-2020, the patient was inadvertently administered an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (strength, dose and route were not reported; lot # R014690 and expiration date 23-MAY-2020) for prophylaxis (expired product administered). The sterile diluent (MERCK STERILE DILUENT) that was used to reconstitute the vaccine was not expired. No additional adverse event. The outcome of expired product administered was unknown.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored administered.; This spontaneous report was received from a certified medical assistant and refers to a 4-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 19-AUG-2020, the patient was vaccinated with improperly sored dosed of varicella virus vaccine live (Oka/Merck) lot # T002848 was confirmed to be valid, expiration date 23-JAN-2022 (exact dose, route and site of administration were not provided), for prophylaxis, which was reconstituted with properly stored sterile diluent (STERILE DILUENT) lot # S008566 was confirmed to be valid, expiration date was reported as but upon internal validation was established as 23-JAN-2022.  Administered doses of vaccine was multiple exposed to the temperature between -14 to 8 degrees Celsius (C) (-12.1 C) for 3 hours, from -9C to 8C (-7.5C) for 8 hours and 30 minutes. There was no previous temperature excursion. The call was because of a digital data logger
Age: 5.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effect reported; Physician called to report a 5 year old patient received GARDASIL 9 inadvertently.; This spontaneous report was received from a physician and refers to a 5-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 27-AUG-2020, the patient was inadvertently vaccinated with the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number reported as 5023475 but upon internal validation was confirmed to be valid as S023475, expiration date 26-MAR-2022 (exact dose, route and site of administration were not provided) for prophylaxis. No additional adverse effect was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent/involving PROQUAD states that there have been administered doses; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not reported.   On 21-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (0.5ml, route of administration and anatomical location were not reported, lot # S031882 with an expiry date of 07-APR-2021 or lot# T009929 with an expiry date of 16-AEP-2021), for prophylaxis. Beginning from 28-JUL-2020, the temperature excursion of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) was between -14 Celsius degrees and -10 Celsius degrees (max -9.5 Celsius degrees) for a total of 38 hours and 30 minutes and was assessed as intermittent. There had not been previous temperature excursion. Digital data logger was used.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain
Clinical narrative: a lot of pain at injection site; This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received flu and shingrix and had a lot of pain at injection site. Event took place after use of product.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site rash, Pain, Pruritus, Rash
Clinical narrative: rash as itchy; Rash; Pain; rash as itchy at times and swollen and red; rash as itchy at times and swollen and red; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced swelling and erythema. On 21st August 2020, the patient experienced pain. On 22nd August 2020, the patient experienced rash. On 24th August 2020, the patient experienced pruritus. On an unknown date, the outcome of the pruritus, rash and pain were not recovered/not resolved and the outcome of the swelling and erythema were unknown.   It was unknown if the reporter considered the pruritus, rash, pain, swelling and erythema to be related to Shingrix.  Additional information was provided as follows: The patient would be 62 in September 2020. The patient noticed pain on the same day of injection. The patient stated she had a rash that she noticed 1 day after the injection and each day it got larger up to 4 inches wide but below the injection site. She described the rash as itchy at times and swollen and red. The reporter did not consent to follow up. No DOB, LOT, or EXP provided. Caller did want to provide her demographics but did state her Birthday was in September and she was born in 1958.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Swelling
Clinical narrative: rash as itchy; Rash; Pain; rash as itchy at times and swollen and red; rash as itchy at times and swollen and red; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced swelling and erythema. On 21st August 2020, the patient experienced pain. On 22nd August 2020, the patient experienced rash. On 24th August 2020, the patient experienced pruritus. On an unknown date, the outcome of the pruritus, rash and pain were not recovered/not resolved and the outcome of the swelling and erythema were unknown.   It was unknown if the reporter considered the pruritus, rash, pain, swelling and erythema to be related to Shingrix.  Additional information was provided as follows: The patient would be 62 in September 2020. The patient noticed pain on the same day of injection. The patient stated she had a rash that she noticed 1 day after the injection and each day it got larger up to 4 inches wide but below the injection site. She described the rash as itchy at times and swollen and red. The reporter did not consent to follow up. No DOB, LOT, or EXP provided. Caller did want to provide her demographics but did state her Birthday was in September and she was born in 1958.
Sex: U
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: swelling down to the elbow from the injection site.; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: Pharmacist left after hours voicemail message. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and experienced swelling down to the elbow from the injection site. It was improving. The reporter consented to follow up. No further details were provided in the voicemail message and pharmacist was not available when specialist attempted callback.  The message was left with the pharmacy staff requesting pharmacist return call to Medical Information and submitting limited available details as provided via voicemail message.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019129045:Same reporter
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: received Boostrix vaccine two years ago and developed hives.; This case was reported by a consumer via call center representative and described the occurrence of hives in a adult female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 2 years after receiving Boostrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Boostrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Boostrix vaccine two years ago and developed hives. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Pain and warm on the injection area; Warm on the injection area; Redness 5 inch; Dermatitis; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2020, the patient received the 2nd dose of Shingrix. On 24th August 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, erythema and dermatitis. On an unknown date, the outcome of the injection site pain, injection site warmth, erythema and dermatitis were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, erythema and dermatitis to be related to Shingrix.  Additional information was provided as follows: The patient expereinced local reaction, redness 5 inch, pain and warm on the injection area and dermatitis after second dose of shingrix. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: LIGHTHEADEDNESS, NAUSSEA
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Angiogram, Central nervous system vasculitis, Cerebrovascular accident, Computerised tomogram, Headache
Clinical narrative: Extreme headaches over 2 1/2 week period, 2 ER visits,  blurred vision, bilateral,  numbness and tingling in right hand,  CNS Vasculitis, Stroke
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Hypoaesthesia, Laboratory test, Magnetic resonance imaging, Paraesthesia, Venogram
Clinical narrative: Extreme headaches over 2 1/2 week period, 2 ER visits,  blurred vision, bilateral,  numbness and tingling in right hand,  CNS Vasculitis, Stroke
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Vision blurred
Clinical narrative: Extreme headaches over 2 1/2 week period, 2 ER visits,  blurred vision, bilateral,  numbness and tingling in right hand,  CNS Vasculitis, Stroke
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: pt threw up after administration of vaccine and continued for 1 day
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at the injection site and then large red area below it, extending from below the vax site to just above her elbow. Her granddaughter says she has fever as well, but that she is not uncomfortable.