chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Fatigue, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Expected fever where shot was given as well as muscle tenderness.. Joint pain, exhaustion but no fever. Was NOT expecting  swelling  with heated hives BELOW shot sight near elbow. As if serum traveled through muscle / tendon. Second day joint pain from wrist to shoulder with continued swelling, fever & hive. Fevered, swollen hive above elbow has continued to current date September 3 and reason for form being filed. Joint pain has subsided. Expect fevered hive will do the same in time. REGARDING ITEM 17 ABOVE: NO OTHER VACCINE WAS ADMINISTERED DURING THIS VISIT
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: on 9/3/2020 patient presented to the pharmacy with red swelling around the injection site that expanded to about the size of an orange and patient stated it hurt a little. patient got vaccine between 7-11am on 9/1/2020 and she got symptoms on the morning of 9/3/2020.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Myalgia, Nausea
Clinical narrative: I experienced nausea, muscle pain, feeling very weak, chills, and shivering for 10 days. There was no treatment; eventually it went away.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Right upper arm very swollen and aches
Age: 58.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: developed a fever of around 102 approximately 5 hours after vaccines administered.  had body aches and arm was sore.  went to emergency room at 8pm.  continued to have aches on 9-2, day following vaccine given.  left arm still red, slightly sore on 9-3
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect; a patient received improperly stored PROQUAD; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S027466, expiration date 02-MAR-2021 (dose and route of administration were not reported) for prophylaxis. The administered vaccines experienced temperature excursion of 47 degrees Fahrenheit (F) to 77 F (66 F) for 3 days. There was no adverse event reported. There was no previous temperature excursion. The digital data logger was involved.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 4 years old. On 17-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2008USA013494: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2003USA007542: US-009507513-2008USA013490:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 01-MAR-2010, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider for shingles (herpes zoster). On an unknown date, she was admitted to the hospital due to the event. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of herpes zoster was unknown. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion under case #01697141 for vaccines that were administered to patients after excursion occurred; This spontaneous report was received from a nursing assistant, referring to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 19-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported (lot number S038698, expiration date reported and validated as 01-DEC-2021) for prophylaxis.  On an unknown date, the temperature excursion was -10.2 degrees Celsius (C), for 1 hour and 53 minutes. There was no previous temperature excursion. The digital data logger was involved.   This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014798: US-009507513-2008USA014803:AE Case # 01697199 US-009507513-2008USA014705: US-009507513-2008USA014806: US-009507513-2008USA015018: US-009507513-2008USA015035: US-009507513-2009USA000117: US-009507513-2009USA000132: US-009507513-2008USA014937:
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Hemiparesis
Clinical narrative: cerebrovascular accident; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 06-NOV-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVA), the pt suffered acute left sided weakness and was diagnosed with cerebrovascular accident. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter regarded the event of cerebrovascular accident as related to zoster vaccine live (ZOSTAVAX).  The event of cerebrovascular accident was considered to be disabling. Upon internal review, the event of cerebrovascular accident was determined to be medically significant.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The patient did not express any abnormal signs of symptoms immediately after receiving the vaccine; inramuscular route instead of the indicated subcutaneous route; This spontaneous report was received from a pharmacist and refers to an adult male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 20-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) 0.5 ml, intramuscularly in the left arm, lot number S001338 was verified to be valid, expiration date reported and established as 14-JAN-2021 for prophylaxis.  The patient did not express any abnormal signs of symptoms immediately after receiving the vaccine. As the vaccine was administered intramuscularly instead of subcutaneously, the pharmacist wanted to know if the patient needed to visit the hospital.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: broke out into hives; Skin breakout; This case was reported by a other health professional via sales rep and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives and skin breakout. On an unknown date, the outcome of the hives and skin breakout were unknown.   It was unknown if the reporter considered the hives and skin breakout to be related to Shingrix.  Additional details were provided as follows: The patient broke out into hives after getting shingrix vaccination. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Malaise, Pain in extremity, Product preparation error
Clinical narrative: Patient was given lyophilize component of vaccine with sterile diluent.; Patient was given lyophilize component of vaccine with sterile diluent.; arm soreness; not feeling well; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adolescent female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA323A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced pain in arm, feeling unwell, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain in arm and feeling unwell were recovered/resolved and the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was given lyophilize component of vaccine with sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  The patient experienced generalized not feeling well, arm soreness for four days. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Malaise, Pain in extremity
Clinical narrative: she "does not do well with vaccines"; left arm was so sore that she could not lift it for 3 days.; left arm was so sore that she could not lift it for 3 days.; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, mobility decreased and feeling unwell. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the pain in arm, mobility decreased and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix in her left arm was so sore that she could not lift it for 3 days.  The patient was advised to not get the 2nd dose. It was reported that the patient did not do well with vaccines in general including flu.  The reporter did not consented to follow up. The case has been linked with the case US2020AMR175151 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR175151:Same reporter, same patient
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: she "does not do well with vaccines"; This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a 53-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Influenza vaccine, the patient did not do well with vaccines. The patient also received Shingrix in March 2019. For the tolerance of dose, refer linked case US2020AMR175126.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR175126:Same reporter, same patient
Sex: U
Vaccine: FLUX
Symptoms: Immune system disorder
Clinical narrative: destroyed my immune system / near killed me; This case was reported by a consumer via interactive digital media and described the occurrence of immune system disorder in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced immune system disorder. On an unknown date, the outcome of the immune system disorder was unknown.   It was unknown if the reporter considered the immune system disorder to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Influenza vaccine, the patient experienced immune system disorder.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Decreased appetite, Dizziness, Fatigue
Clinical narrative: dizziness; fatigue; cough; pain from the injection site up to the shoulder; pain from the injection site up to the shoulder; lack of appetite; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles on face back in January 2020).   On 23rd August 2020, the patient received the 1st dose of Shingrix. In August 2020, 1 day after receiving Shingrix, the patient experienced dizziness, fatigue, cough, injection site pain, shoulder pain and appetite absent. On an unknown date, the outcome of the dizziness, fatigue, cough, injection site pain, shoulder pain and appetite absent were unknown.   It was unknown if the reporter considered the dizziness, fatigue, cough, injection site pain, shoulder pain and appetite absent to be related to Shingrix.  Additional details were provided as follows: In January 2020, the patient had  shingles.  The patient reported receiving the 1st dose of Shingrix and that she developed a cough, pain from the injection site up to the shoulder, fatigue and dizziness the day after injection. The patient also reported having a lack of appetite and is concerned about becoming sick if she decides to eat. The reporter consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: dizziness; fatigue; cough; pain from the injection site up to the shoulder; pain from the injection site up to the shoulder; lack of appetite; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles on face back in January 2020).   On 23rd August 2020, the patient received the 1st dose of Shingrix. In August 2020, 1 day after receiving Shingrix, the patient experienced dizziness, fatigue, cough, injection site pain, shoulder pain and appetite absent. On an unknown date, the outcome of the dizziness, fatigue, cough, injection site pain, shoulder pain and appetite absent were unknown.   It was unknown if the reporter considered the dizziness, fatigue, cough, injection site pain, shoulder pain and appetite absent to be related to Shingrix.  Additional details were provided as follows: In January 2020, the patient had  shingles.  The patient reported receiving the 1st dose of Shingrix and that she developed a cough, pain from the injection site up to the shoulder, fatigue and dizziness the day after injection. The patient also reported having a lack of appetite and is concerned about becoming sick if she decides to eat. The reporter consent to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysaesthesia, Herpes zoster
Clinical narrative: Zoster eruption; dysesthesia localized to the trunk area; This case was reported by a physician via call center representative and described the occurrence of herpes zoster in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 72 hrs after receiving Shingrix, the patient experienced dysesthesia. On 25th August 2020, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster and dysesthesia were unknown.   The reporter considered the herpes zoster and dysesthesia to be possibly related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and presented dysesthesia localized to the trunk area.  One week after the vaccination, patient had a zoster eruption.  The vaccine was administered at an unknown reported by physician so information about site of administration, lot and expiration was not available to physician.  It was reported as time to onset and the lack of immunocompromising conditions in the patient was suggestive of a causal relation between Shingrix and the onset of the zoster episode. The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was inadvertently administered a dose of expired IPOL vaccine, no AE; Initial information received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 16 years old male patient who was inadvertently administered with a 0.5 ml dose of expired POLIOMYELITIS VACCINE (INACTIVATED) IPV (VERO) [IPOL] (lot number P1A242M  and expiration date:26-Apr-2020) vaccine, via unknown route in unknown administration site as prophylactic vaccination on 25-Aug-2020.  The patient's medical history were not reported.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  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: F
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram head normal, Fall, Head injury, Syncope, Vomiting
Clinical narrative: PATIENT RECEIVED VACCINES, WITHIN TEN MINUTES PATIENT HAD A SYNCOPAL  EPISODE AND FELL AND HIT HER HEAD ON THE FLOOR. PATIENT WAS EVALUATED BY PCP, VITAL SIGNS STABLE, GIVEN A SNACK AND WATER, ICE PACK FOR HEAD, AND IBUPROFEN. PATIENT WAS SENT HOME, PARENTS NOTIFIED OF SIGNS AND SYMPTOMS TO WATCH FOR, FAMILY CALLED BACK TO NOTIFY THAT PATIENT WAS VOMITTING, THIS WAS ABOUT TWO HOURS AFTER THE EVENT OCCURRED. PATIENT SENT TO GET STAT CT SCAN OF HEAD.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Loss of consciousness
Clinical narrative: Blood pressure dropped significantly.  Patient passed out 3 times. Taken to hospital.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Daughter called in today mother got recent shot on Sunday (aug. 30th) Noticed a raised, swollen, and red area where the shot was given and she had itching around the area. Patient had no changes to medications or any other detergents or anything else pATIENT would be reaching out to doctor for further follow-up was advised to take 1 benadryl to help control and avetiate the reaction
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Patients wife reported on 09/03/20 that her husband experienced severe aching in both legs to the point where he could hardy walk staring one day post vaccine on 09/02/20.  Reported NO fever only extreme leg pain.  Patient reported to MD who encourage patient to call pharmacy.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called pharmacy at approximately 9:30 am on the day following administration of vaccine and states that she has developed redness and swelling at the injection site approximately the size of a quarter. Patient was advised to take ibuprofen 200mg and apply ice/cold compress to the area. Patient states there is no other rash, no blisters or open skin at injection site.  Pharmacist called patient at 2:15pm to check on her status and patient states that it has resolved for the most part and she is unconcerned at this time.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Feeling abnormal, SARS-CoV-2 test, Syncope
Clinical narrative: Mother reported child fell out while playing basketball,  she thought he had fever, and he felt bad. She took him to the ER  late that night after immunization given earlier in the day. Mother contacted clinic on 09/02/20 and reported that she thought he may have had a reaction and took him to the ER where he was tested for COVID.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Patient had headache, body aches, fever, starting about 8-10 hours after injection.  Effects are subsiding at this time, 11 AM, 9/3/20 (21 hours after injection)
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: upper left arm swollen, painful and warm
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: Painful outbreak of pruritus and shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On an unspecified date, shortly after to patient's dose zoster vaccine live (ZOSTAVAX) vaccine, the patient presented a painful outbreak of pruritus and shingles. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. The patient's symptoms had resulted in physical limitations not presented prior vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 0.5
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: 6 month old daughter, was accidentally administered the GARDASIL vaccine instead of his 12 year old daughter; 6 month old daughter, was accidentally administered the GARDASIL vaccine instead of his 12 year old daughter; No additional adverse effects to report; This spontaneous report was received from a consumer and refers to his 6-month-old daughter. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  The reporter stated that on 24-AUG-2020, the patient was accidentally administered with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) first dose (dose, lot#, expiration date were not provided) intramuscularly, instead of his 12-year-old daughter (product administered to patient of inappropriate age,  wrong patient received product). No additional adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 4 years old. On 17-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2003USA007542: US-009507513-2008USA013494: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2008USA013488: US-009507513-2008USA013490:
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 5 years old. On 16-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2008USA013494: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2008USA013488: US-009507513-2003USA007542:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 1 year old. On 13-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2008USA013494: US-009507513-2003USA007542: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2008USA013488: US-009507513-2008USA013490:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; temperature excursion that was intermittent, involving PROQUAD states thatthere have been administered doses; This spontaneous report was received from a registered nurse and refers to patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    Beginning 28-JUL-2020, the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature excursion of -14 degree Celsius (C) to -10 C (average temperature was -9.5 C) degree Celsius (C) for a period of 38 hours and 30 minutes. It was reported that the vaccine did not had any previous temperature excursion. The excursion was called by a digital data logger.  On an unspecified date in 2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter (dosage regimen and route of administration were not provided), lot number T009929; expiration date 16-SEP-2021, as prophylaxis. The patient did not experience any adverse event. On 13-AUG-2020, the temperature excursion was noticed.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving VARIVAX states that there have been administered doses; This spontaneous report has been received from a registered nurse (RN) concerning to a patient of an unknown age, gender and ethnicity. Information concerning patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.   It was reported that since 28-JUL-2020, the following lot # T002843, expiration date 23-JAN-2022; and lot# S032357, expiration date 14-OCT-2021 of varicella virus vaccine live (oka/merck) (VARIVAX) had a intermittent temperature excursion, but was not previously reported. Then, on 11-AUG-2020, the patient was vaccinated with a improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (dosage regimen and route of administration were not provided), lot # T002843, expiration date 23-JAN-2022, as prophylaxis.  The improperly stored doses experienced a temperature of -14 degrees Celsius (°C) to -10 °C (maximum average temperature was -9.5 °C), for 38 hours and 30 minutes. The call was due to a digital data logger. There was not previous temperature excursions. No additional information was provided.
Age: 24.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: showed low titers for varicella; Patient received a dose of VARIVAX today via intamuscular route instead of subcutaneously; This spontaneous report has been received from a nurse referring to a 24 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not provided. Concomitant therapies included sterile diluent.  On an unknown date, an unspecified antibody test was performed which showed low titers for varicella, therefore, on 28-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), intramuscularly instead of subcutaneously (incorrect route of product administration) (strength, indication, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis.  On the same date, the patient also was vaccinated with an unspecified hepatitis a vaccine, inactivated (manufacturer unknown).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Epistaxis, Lethargy
Clinical narrative: Lethargic, nose bleeds, inconsolably crying
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Palpitations
Clinical narrative: PT CALLED TODAY 9/3/20 AT 245PM THAT SHE RECEIVED VACCINATION AT 1030 AM, BUT HAD PALPITATIONS AND ELEVATED BP AND PULSE AT 1030PM 165/90 AND PULSE 78. SHE HAS LEFT A MESSAGE AT MD OFFICE
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: the patient is having muscle pain and joint pain around his knee area.  He also has redness at the injection site and swelling.   Patient will follow up with doctor next week in person if not getting better.  Patient has contacted his physician.
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Back pain, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Sore arm shortly after injection on 09/02/2020. On night of 09/02/2020 experienced:  Patient states she had Fever,  (did not take temperature) headache, body aches, Nausea, pain to back and legs. Fever of 101.1 on morning of 09/03/2020.  Patient took 200mg Ibuprofen on 09/03/2020 and symptoms improved. Offered appointment, she declined. Advised if symptoms return or worsen to seek medical attention.
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Sore arm shortly after injection on 09/02/2020. On night of 09/02/2020 experienced:  Patient states she had Fever,  (did not take temperature) headache, body aches, Nausea, pain to back and legs. Fever of 101.1 on morning of 09/03/2020.  Patient took 200mg Ibuprofen on 09/03/2020 and symptoms improved. Offered appointment, she declined. Advised if symptoms return or worsen to seek medical attention.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling hot, Injection site erythema
Clinical narrative: Sore arm where shot was given.  Swollen location of shot.  Redness at shot location.  Warmth at shot location.  Feeling tired.  Body ache.  Muscle pain.   Switch from heat to chills and vice versa.  Foggy headed.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Myalgia, Pain
Clinical narrative: Sore arm where shot was given.  Swollen location of shot.  Redness at shot location.  Warmth at shot location.  Feeling tired.  Body ache.  Muscle pain.   Switch from heat to chills and vice versa.  Foggy headed.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Skin warm
Clinical narrative: large patch of Redness and warmth to arm
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy skin, Rash
Clinical narrative: RASH. PT CURRENTLY SEEING DERMATOLOGIST AND WAITING FOR RESULTS FROM BIOPSY.
Age: 79.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt report fever the next morning of 99.9, then later 98 then later 100.0.  Instructed pt to continue to monitor and f/u with primary care
Age: 16.0
Sex: F
Vaccine: HEPA, IPV, MNQ, VARCEL
Symptoms: Hypotonia, Loss of consciousness, Urinary incontinence
Clinical narrative: I called patient back for vaccinations. In exam room, patient stated she "faints when getting vaccines." Upon learning this, I called back an LVN to assist in case of syncope episode. Began administration of vaccines with Hep A, MCV4, and varicella into left deltoid (intramuscular) and left subcutaneous, respectively. Proceeded to administer intramuscular IPV to patient in right deltoid. Just as vaccine was administered, patient went limp, head forward, cutting off airway. LVN helped move patient to floor and reposition airway, while I elevated legs and she regained consciousness.  Upon assessment, patient voided bladder and was alert and oriented. Vitals signs were taken and after allowing her to rest for 10-15 minutes, she stated she felt fine. Reassessed vitals and was discharged ambulatory with guardian. Episode occurred at 2:22 pm and was over by 2:25 pm. Discharged ambulatory at 2:40 pm.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood glucose normal, Hypotonia, Unresponsive to stimuli
Clinical narrative: Episode of becoming limp and unresponsive lasting approximately 25 minutes. Occurred after feed. No jerking or posturing. Normal O2 sat and blood glucose. Taken to Hospital by ambulance and was responsive there on arrival.  Infant had no fever and was otherwise well. Normal exam. Has referral to neurology.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Patient states the vaccine was administered too high, above the deltoid. She states she does not have any symptoms of nerve damage, but is worried of long term effects. She reports extreme] soreness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Mother reported to nurse that patient broke out in full body hives 30 minutes after administration of vaccines, after having left clinic. No other new exposures in time frame. Denies breathing difficulties or swelling. Resolved in 3 hours w/o intervention. No reinsurance of symptoms.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Urticaria
Clinical narrative: Hives all over body with vesicle
Age: 85.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: pain, swollen, redness
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Limb injury, Mobility decreased
Clinical narrative: patient experienced a shoulder injury, she could not move her arm shortly after leaving the pharmacy and had to go to the emergency room
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Diarrhoea, Injection site rash, Rash
Clinical narrative: DIARRHEA, RASH (ARMS, CHEST, ABDOMEN, AND BACK), RASH TO LEFT THIGH AROUND INJECTION SITE, LOSS OF APPETITE
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Patient states that the evening of the vaccine she developed a bad  headache which lasted about 2 days. The vaccine was given on a Thursday. She states that her right side went numb on the following Tuesday. The numbness didn't linger but returned the next day (Wednesday) at 3am, she then went to the ER. They found nothing wrong or substantial. She returned to the ER on that Friday because the numbness returned, but was not quite as bad this time. They admitted her and she stayed 2 nights. They did an MRI and several other tests. All came back clear. The following Monday, after returning home from the hospital, she had 3 spells with a slight headache and tingling on her right side.. which only lasted seconds. Since that day (Monday, 8/24/20) she has not had any  more symptoms.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chills, Dizziness
Clinical narrative: Done at Pharmacy. NOT life threatening. Exacerbation of most current chronic problems.: Increase gut aches, muscle aches, joint aches. Dizzy, weak, nausea, chills, headache. If I were not recently retired, there would have been absolutely no way I could go to work.   Improved with acetaminophen 500 mg q6h , tea with cloves for nausea. I do not usually have this reaction to the flu vaccine that I have taken almost every year as repiratory therapy staff of Regional Medical Center
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Done at Pharmacy. NOT life threatening. Exacerbation of most current chronic problems.: Increase gut aches, muscle aches, joint aches. Dizzy, weak, nausea, chills, headache. If I were not recently retired, there would have been absolutely no way I could go to work.   Improved with acetaminophen 500 mg q6h , tea with cloves for nausea. I do not usually have this reaction to the flu vaccine that I have taken almost every year as repiratory therapy staff of Regional Medical Center
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: red rash from injection site to elbow
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Abdominal discomfort, Vomiting
Clinical narrative: Received vaccines and had 3 episodes of vomiting on the car ride home(around 12:01PM 9/3/2020). Stomach now feeling better.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal pain, Back pain, Burning sensation, Headache, Injected limb mobility decreased
Clinical narrative: Severe headache, vomiting, pain so severe in arms that they could not be raised above waist level.  Lower back pain.  Feeling of body being on fire.  Did not affect legs at all.  Day 2 took Aleve and headache began to subside.  Used ice packs on head and Right arm.  Day 3 and the right arm is still very sore.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Severe headache, vomiting, pain so severe in arms that they could not be raised above waist level.  Lower back pain.  Feeling of body being on fire.  Did not affect legs at all.  Day 2 took Aleve and headache began to subside.  Used ice packs on head and Right arm.  Day 3 and the right arm is still very sore.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Rash
Clinical narrative: rash and pain in arm extending to shoulder lasting > 6 weeks
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Patient developed mild rash to right leg near the site of the varicella vaccine and also 2 small raised spots noted to posterior thigh.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Fever 100.4, chills, soreness at site of Shingrix vaccine,  flu like symptoms
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, pain and swelling (>4 inches) at injection site, fever > 102 F for more than 48 hours
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Syncope
Clinical narrative: About 3 minutes after receiving the vaccination, patient fainted. She was very warm to the touch. Said she had nothing to eat or drink that day
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Tendon injury
Clinical narrative: Patient came to the pharmacy on 9/3 to pick up prescriptions after seeking treatment for ongoing arm pain following her flu shot on 8/21. Her provider thought that when she received the flu shot, the immunizer hit a tendon which is causing the patient ongoing pain.