chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 2-year-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 11-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage). On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes.There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 12-months-old male patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 27-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage). On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 20-months-old male patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 29-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage). On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. There was no previous temperature excursion. The call was due to digital data logger.  No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Sex: F
Vaccine: CHOL, FLUX, RAB, TYP
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Lip swelling; Tingling; Spontaneous report received on 17JAN2020.  A nurse reported that a 24-year-old female who developed "lip swelling" (PT: Lip swelling) and "tingling" (PT: Paraesthesia), while receiving oral Vivotif for immunisation. The consumer also had Vaxchora, Flu shot (influenza), and rabies vaccine before taking Vivotif. On 13JAN2019 (Monday), the consumer received Vaxchora (cholera vaccine), flu shot (influenza vaccine), and one dose of rabies. On an unknown date (Wednesday), the consumer took one dose of Vivotif at night and woke up in the middle of the night with lip swelling and tingling. Thus, she took Benadryl (diphenhydramine) for lip swelling and went to bed again. She awoke in the morning and still had swelling, and then she went to urgent care where the doctor told her it was possible it could be related to Vivotif. The consumer did not receive any treatment at the urgent care but was prescribed Epi Pen (epinephrine) as a precaution for future reactions. Moreover, the consumer was stopping oral typhoid and will attempt to take injectable vaccine. It was reported that the consumer did not have any allergic reactions.  Action taken with Vivotif with respect to reported events was vaccine withdrawn.  Action taken with Vaxchora and Flu shot with respect to reported events was not applicable.   Action taken with rabies vaccine with respect to reported events was unknown.  The patient was recovering from the event "lip swelling", while the clinical outcome of event "tingling" was unknown.  Company Comment: A consumer took one dose of Vivotif at night and woke in the middle of that night with lip swelling and tingling. The consumer also took Vaxchora, flu shot and one dose of rabies two days before taking the Vivotif dose. In response to the events, she took Benadryl and her lip swelling was resolving. The consumer stopped taking further doses of Vivotif. Considering the potential of Vivotif to cause allergic reactions, and the case information, the causality of both the events is assessed as possible with Vivotif. Considering the case information, the causality of both the events is assessed as unlikely with Vaxchora.; Sender's Comments: A consumer took one dose of Vivotif at night and woke in the middle of that night with lip swelling and tingling. The consumer also took Vaxchora, flu shot and one dose of rabies two days before taking the Vivotif dose. In response to the events, she took Benadryl and her lip swelling was resolving. The consumer stopped taking further doses of Vivotif. Considering the potential of Vivotif to cause allergic reactions, and the case information, the causality of both the events is assessed as possible with Vivotif. Considering the case information, the causality of both the events is assessed as unlikely with Vaxchora.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood glucose increased, Feeling abnormal
Clinical narrative: I hava an abnormally high blood sugar reading / my blood sugar went up; feeling a little blah; This case was reported by a consumer via call center representative and described the occurrence of blood sugar increased in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included steroid injections (abnormally high blood sugar reading with steroid injections).   On 14th May 2020, the patient received the 2nd dose of Shingrix. On 15th May 2020, 1 days after receiving Shingrix, the patient experienced blood sugar increased and feeling abnormal. On an unknown date, the outcome of the blood sugar increased and feeling abnormal were unknown.   It was unknown if the reporter considered the blood sugar increased and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and wondered if it contained steroids.  The patient had an abnormally high blood sugar reading this morning (on the day of reporting) and have had this occur with steroid injections. The patient felt abnormal and was curious to know if it contained steroid.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: the spot has a small white head; I had a red spot come up on my right arm; This case was reported by a consumer via call center representative and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2020, the patient received Shingrix. On 14th May 2020, 1 days after receiving Shingrix, the patient experienced red rash. On 15th May 2020, the patient experienced blistery rash. On an unknown date, the outcome of the red rash and blistery rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash and blistery rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix in right arm and had red spot come up on right forearm. At the time of reporting the spot has a small white head. The reporter asked was this the live vaccine showing.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Forgot to reconstitute the vaccine; Administered just the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number P2275, expiry date 25th September 2021) for prophylaxis.   On 15th May 2020, the patient received Shingrix. On 15th May 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The pharmacist reported that she accidentally administered just the adjuvant for Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist forgot to reconstitute the vaccine. The reporter consented to follow up. This case had been linked with US2020083389, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Influenza
Clinical narrative: Fatigue; Headache; Shivering; Fever; gastro intestinal (GI) symptom; flu; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included irritable bowel syndrome (had irritable bowel syndrome) and reflux gastritis (had reflux).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fatigue, headache, shivering, fever, gastrointestinal disorder and influenza. On an unknown date, the outcome of the fatigue, headache, shivering and fever were recovered/resolved and the outcome of the gastrointestinal disorder and influenza were unknown.   It was unknown if the reporter considered the fatigue, headache, shivering and fever to be related to Shingrix. The reporter considered the gastrointestinal disorder and influenza to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 62 or 63 years. The patient had medical history of irritable bowel syndrome and reflux. The reporter stated that, about 3 months ago, the patient received dose of Shingrix. After receiving Shingrix, the patient experienced fatigue, headache, shivering and fever. The patient stated that, right after that she experienced GI (gastro intestinal) symptoms, caught the flu from one of the relatives. The patient reported that, currently, and for about a month, had GI ((gastro intestinal)) symptoms again, but believed it was due to everything that was happening with the pandemic and not the Shingrix shot. The patient has not had the second dose yet. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue; Headache; Shivering; Fever; gastro intestinal (GI) symptom; flu; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included irritable bowel syndrome (had irritable bowel syndrome) and reflux gastritis (had reflux).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fatigue, headache, shivering, fever, gastrointestinal disorder and influenza. On an unknown date, the outcome of the fatigue, headache, shivering and fever were recovered/resolved and the outcome of the gastrointestinal disorder and influenza were unknown.   It was unknown if the reporter considered the fatigue, headache, shivering and fever to be related to Shingrix. The reporter considered the gastrointestinal disorder and influenza to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 62 or 63 years. The patient had medical history of irritable bowel syndrome and reflux. The reporter stated that, about 3 months ago, the patient received dose of Shingrix. After receiving Shingrix, the patient experienced fatigue, headache, shivering and fever. The patient stated that, right after that she experienced GI (gastro intestinal) symptoms, caught the flu from one of the relatives. The patient reported that, currently, and for about a month, had GI ((gastro intestinal)) symptoms again, but believed it was due to everything that was happening with the pandemic and not the Shingrix shot. The patient has not had the second dose yet. The patient consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   The reporter considered the cancer to be unrelated to Shingrix.  Additional details were provided as follows: The patient received 1st dose Shingrix and then was diagnosed with cancer so the patient did not go for the second dose. The reporter stated that the cancer was not related to Shingrix. No further information was available regarding cancer. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date 15th November 2021) for prophylaxis.   On 2nd February 2020, the patient received the 1st dose of Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: All patient identifiers were reported as well as batch number and expiration date for Shingrix. The patient received Shingrix and after 2 months developed Shingles mild case. The reporter consent to Follow up was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Cataract nuclear, Rhegmatogenous retinal detachment, Vitreous disorder
Clinical narrative: Rhegmatogenous Retinal Detachment OD; nuclear sclerosis OU; Vitreous OU; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 04-JUL-2017, patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance an for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), patient experienced rhegmatogenous retinal detachment OD, nuclear sclerosis OU and vitreous OU. The patient continued to suffer and received treatments for her injuries As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient 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), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, 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. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of rhegmatogenous retinal detachment OD, nuclear sclerosis OU and vitreous OU was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling. Upon internal review, the events of rhegmatogenous retinal detachment OD, nuclear sclerosis OU were considered to be medically significant.
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no serious adverse event; expired dose of vaqta was inadvertently administered to patient; This spontaneous report as received from a pharmacist refers to a 7 years old patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 20-MAY-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) pre-filled syringe of strength 25 units/0.5 milliliter, (lot # S021092, expiry date : 18-MAY-2020, anatomical location was not reported) for prophylaxis (expired product administered). The patient had no adverse event. No product quality complaint (PQC) was involved. The outcome of expired product administered and no adverse event was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S021092; expirationdate: 18-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; improperly stored VARIVAX was administered to patient; This spontaneous report was received from a 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.  On 07-MAY-2020 the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S012036, expiration date 17-APR-2020; dose, frequency and route were not reported) for prophylaxis (product storage error).        The administered dose of the vaccine experienced a temperature 48.2 for 2 hours. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.5
Sex: M
Vaccine: FLU4, HIBV, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 1.58
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13month old patient given adult dose Hep A
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects; Patient received an expired vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 16-MAY-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 25U/0.5 ml, 0.5 milliliter, once, lot # S002459, expiration date on 15-MAY-2020 (route and anatomical location were not provided) for prophylaxis. No adverse events were reported. Medical assistant reported pre-filled syringe of hepatitis a vaccine, inactivated (VAQTA) had been discarded and was not available for retrieval. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S002459; expirationdate: 15-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; improperly stored VARIVAX was administered to patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No additional information regarding patient's medical history, concomitant medication and concurrent condition was provided.  On 07-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S012036, expiration date 17-APR-2021 (exact dose and route of administration were not reported) for prophylaxis.   Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 48.2 (unit not provided), the time frame as 4 hours. There was no previous temperature excursion reported.  No adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; Nurse called reporting improperly stored VARIVAX was administered to patient on 18-MAY-2020; This spontaneous report was received from a nurse who refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not provided. On 18-MAY-2020, the patient was administered improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis, lot # S012036, expiry date 17-APR-2021 (formulation, strength, dose, route of administration and frequency were not reported). Digital data logger was involved. The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at temperature of 48.2 (units not provided) for 4 hours. There was no previous temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site on my upper arm is still extremely painful. / still have such pain; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingles vaccine. In May 2020, less than a month after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix o an unknown deltoid. After receiving Shingrix, four months later, the injection site on the patient's upper site was still extremely painful. The patient asked was this considered normal, also asked should he/she get the 2nd shot when still had such pain from the first injection.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: I am very dizzy; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included depression (take lot of medications), blood pressure high and cholesterol.   On 18th May 2020, the patient received Shingrix. On 19th May 2020, 1 days after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and felt dizzy. The reporter wanted to know does dizziness was related to Shingrix. The reporter just drove to get gas and was got scared because of the dizziness.  The reporter wanted to know how long this would last.
Age: 95.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 95-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 30th January 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and experienced pain at the injection site that lasted for one week. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Injection site pain, Injection site rash, Myalgia
Clinical narrative: diagnosed a bacterial infection; rash at injection site/The rash is just below the injection site and measures about 2 inches by 3 inches; muscle aches; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of bacterial infection in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2019210389).   On 15th May 2020, the patient received the 2nd dose of Shingrix. On 15th May 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th May 2020, the patient experienced bacterial infection, rash and muscle pain. The patient was treated with doxycycline. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bacterial infection was unknown and the outcome of the injection site pain and muscle pain were recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the bacterial infection, injection site pain, rash and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced injection site pain that had resolved.   The patient experienced muscle aches the next day, which had resolved.   The patient reported that a rash at the injection site began the next day, and had progressed further and larger.   The rash was just below the injection site and measured about 2 inches by 3 inches and was rectangular.  This event has not resolved. The patient called again and reported that the rash was below the injection site.  The patient took photos and sent them to her dermatologist who diagnosed a bacterial infection and prescribed doxycycline.  The rash was still present. The reporter did not consent to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date 21st November 2021) for prophylaxis.   On 24th March 2020, the patient received the 1st dose of Shingrix. On 5th May 2020, 42 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Nurse reported that a patient developed shingles after receipt of his first dose of Shingrix.
Age: 0.58
Sex: M
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.