chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Patient reported that after receiving vaccine her arm became red and hot. After a couple of days she saw her provider and was diagnosed with cellulitis. She was prescribed cephalexin and is currently taking the medication.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: chills, low grade fever- 99 degrees F,  some nausea I expect to be fine tomorrow. But effects of vaccine should be shared.
Age: 23.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Fall
Clinical narrative: PATIENT FELL AROUND 5 MINUTES AFTER GIVEN THE SHOTS
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: 8 days after flu shot (10/01/2020) came down with Shingles. Confirmed by doctor visit 4 days later (on 10/05/2020) and began medication for rash (Valacyclovir) and pain (Gabapenten)
Age: 52.0
Sex: F
Vaccine: FLUR4, TDAP, VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: red rash extend from site of injection to her forearm
Age: 66.0
Sex: M
Vaccine: FLUA4, PNC13, VARZOS
Symptoms: Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: Patient asked for 3 vaccinations (FLUAD, PREVNAR, SHINGRIX) at same time. I advised patient if he has a reaction, would not be able to determine which vaccination caused. He still preferred to get the 3 together. Patient's wife called the following morning and said patient's right arm (FLUAD AND PREVNAR) was extremely sore and difficult for him to lift it and he had a hard time sleeping. I explained soreness is common, but if he's unable to lift arm suggested he contact his MD. She also informed me he has Parkinson's Disease (not noted on consent form).  She will follow up with MD.
Age: 1.17
Sex: M
Vaccine: DTAP, FLU3, HIBV, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: 2 - 5sec generalized seizure Fever no treatment  Education regarding Febrile Seizure
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Cold sweat, Cough, Dry throat, Injection site pain
Clinical narrative: Patient received vaccine 9/16/20. Started having symptoms 9/28/20 evening - soreness/pain at site of injection, fever, body aches, generalized joint pain, dry cough, cold sweats, scratchy/dry throat. On 9/29/20 evening developed vesicular rash to BUE, BLE and trunk.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain, Pyrexia, Rash vesicular, Throat irritation
Clinical narrative: Patient received vaccine 9/16/20. Started having symptoms 9/28/20 evening - soreness/pain at site of injection, fever, body aches, generalized joint pain, dry cough, cold sweats, scratchy/dry throat. On 9/29/20 evening developed vesicular rash to BUE, BLE and trunk.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site movement impairment, Injection site pain, Pyrexia, X-ray abnormal
Clinical narrative: I was given the shot about 2 pm. It was very high on the left arm almost to the shoulder. It hurt more than usual going in. I went home. By .5 pm I could not move my left arm at all without severe pain. This continued for 3 days - no possible use of the arm at all. On day 4 I could move forward and backward a couple of inches still no movement to the side without severe pain.  Slowly I regained movement. At 2 weeks I could raise my arm forward strait out in front of me and sideways 1/2 way to a T position At 3 weeks I could raise my arm forward and straight up over my head and sideways to a T position.  It's now been 4 weeks and I can raise my arm over my head both forward and sideways, Going sideways hurts a little.  Also reaching behind me or doing a swimming motion hurts a little.  If I do a motion that hurts a little, my shoulder will ache deep inside for a few minutes afterwards. I also had the usual vaccine effects of low grade fever and not much energy for about 3 days after the shot.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Rash erythematous, Rash macular, Urticaria
Clinical narrative: Urticaria and blotchy erythematous rash; most notable on torso and groin; more mildly on extremities spares palms /soles and face no respiratory distress
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood thyroid stimulating hormone, Full blood count, Injected limb mobility decreased, Injection site pain, Metabolic function test
Clinical narrative: (R) ARM PAIN, PARESTHESIA, LIMITED  (R) SHLDR MOTION DUE TO PAIN x3d.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity, Paraesthesia, Spinal X-ray, Vitamin B12
Clinical narrative: (R) ARM PAIN, PARESTHESIA, LIMITED  (R) SHLDR MOTION DUE TO PAIN x3d.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Skin disorder
Clinical narrative: arm w/swelling, pain, parasthesia, decreased sensation to light touch & temperature, lasting weeks
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right arm @ injection - no rash. Above inj pain, swelling, warm to touch; pt could lift on right side - (couldn't tolerate pressure). Couldn't lift right arm above head for 1 week. Below inj was redness (3 inch or more diameter of redness & swelling. General fatigue. Overall, lasted 2 wks
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Right arm @ injection - no rash. Above inj pain, swelling, warm to touch; pt could lift on right side - (couldn't tolerate pressure). Couldn't lift right arm above head for 1 week. Below inj was redness (3 inch or more diameter of redness & swelling. General fatigue. Overall, lasted 2 wks
Age: 58.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray
Clinical narrative: Both Sore arms, unable to lift arms. Xray was done on 10/6/2020.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient came to the pharmacy a week later saying that she broke out in a rash on the trunk of her body a few days later. She went to her Dr and the Dr stated that he/she thought is was due to her taking prednisone while getting the flu shot. She stated Dr was going to have her now do allergy testing.
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: Rash developed 2 weeks after vaccine, raised, red, blister-like, worsening and spreading 3rd week after week vaccine. Not painful or itchy. Advised to contact Dr.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Rash, Rash papular, Rash pruritic, Seborrhoeic keratosis
Clinical narrative: received the first Shingrix vaccine on August 3, 2020 in her right hip; Inflamed Seborrhea Keratosis; Rash on her back itches/ Rash on her back, on her legs from the knees down, and on her arms; This case was reported by a consumer via call center representative and described the occurrence of inflamed seborrheic keratosis in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles. Concomitant products included vitamins nos (Vitamins) and hydrochlorothiazide.   On 3rd August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd August 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In August 2020, the patient experienced inflamed seborrheic keratosis and itchy rash. The patient was treated with triamcinolone and famotidine. On an unknown date, the outcome of the inflamed seborrheic keratosis and itchy rash were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the inflamed seborrheic keratosis and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient reported inflamed seborrhea keratosis. The patient received the first Shingrix vaccine on August 3, 2020 in her right hip, which led to vaccine administered at inappropriate site. The patient stated that three to four days later, she developed a rash on her back, on her legs from the knees down, and on her arms. The rash on her back itched. The patient had the rash biopsied and she was prescribed triamcinolone cream and famotidine. The patient's physician stopped her hydrochlorothiazide. The patient continued to have the rash. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy, Product administered at inappropriate site, Rash pruritic, Seborrhoeic keratosis
Clinical narrative: received the first Shingrix vaccine on August 3, 2020 in her right hip; Inflamed Seborrhea Keratosis; Rash on her back itches/ Rash on her back, on her legs from the knees down, and on her arms; This case was reported by a consumer via call center representative and described the occurrence of inflamed seborrheic keratosis in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles. Concomitant products included vitamins nos (Vitamins) and hydrochlorothiazide.   On 3rd August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd August 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In August 2020, the patient experienced inflamed seborrheic keratosis and itchy rash. The patient was treated with triamcinolone and famotidine. On an unknown date, the outcome of the inflamed seborrheic keratosis and itchy rash were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the inflamed seborrheic keratosis and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient reported inflamed seborrhea keratosis. The patient received the first Shingrix vaccine on August 3, 2020 in her right hip, which led to vaccine administered at inappropriate site. The patient stated that three to four days later, she developed a rash on her back, on her legs from the knees down, and on her arms. The rash on her back itched. The patient had the rash biopsied and she was prescribed triamcinolone cream and famotidine. The patient's physician stopped her hydrochlorothiazide. The patient continued to have the rash. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Back pain, Discomfort, Headache, Lethargy, Nausea
Clinical narrative: throbbing pain all over her entire body and seems to be localizing now; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 79 years old female patient who experienced throbbing pain all over her entire body and seems to be localizing now (pain), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  It was also reported that he had flu shots before and not allergic to eggs or anything.   On 30-Sep-2020, the patient received 0.7 mL of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ483AB and expiry date not reported) via intramuscular route in the right arm for prophylactic vaccination.  On 30-Sep-2020, the patient developed a non-serious throbbing pain all over her entire body (pain) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Age: 79.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Somnolence
Clinical narrative: throbbing pain all over her entire body and seems to be localizing now; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 79 years old female patient who experienced throbbing pain all over her entire body and seems to be localizing now (pain), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  It was also reported that he had flu shots before and not allergic to eggs or anything.   On 30-Sep-2020, the patient received 0.7 mL of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ483AB and expiry date not reported) via intramuscular route in the right arm for prophylactic vaccination.  On 30-Sep-2020, the patient developed a non-serious throbbing pain all over her entire body (pain) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Age: 79.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain
Clinical narrative: throbbing pain all over her entire body and seems to be localizing now; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 79 years old female patient who experienced throbbing pain all over her entire body and seems to be localizing now (pain), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  It was also reported that he had flu shots before and not allergic to eggs or anything.   On 30-Sep-2020, the patient received 0.7 mL of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ483AB and expiry date not reported) via intramuscular route in the right arm for prophylactic vaccination.  On 30-Sep-2020, the patient developed a non-serious throbbing pain all over her entire body (pain) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Age: 65.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Bedridden, Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: extreme exhaustion for 9 days and continuing. In bed or on couch.  I'm super energetic and in good shape and this has taken me to 0% energy level for 9 days thus far. Leg aches, and mild headache. Tested negative for COVID-19
Age: 65.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: extreme exhaustion for 9 days and continuing. In bed or on couch.  I'm super energetic and in good shape and this has taken me to 0% energy level for 9 days thus far. Leg aches, and mild headache. Tested negative for COVID-19
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site reaction, Injection site urticaria
Clinical narrative: pain at injection site; warmth at injection site,; shingles the next day after receiving Shingrix / shingles noted at the L3 dermatome on the Left leg; achiness; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 29th September 2020, the patient received the 1st dose of Shingrix. On 30th September 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site warmth, shingles and pain. On an unknown date, the outcome of the injection site pain and shingles were not recovered/not resolved and the outcome of the injection site warmth and pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, shingles and pain to be related to Shingrix.  Additional details were provided as follows: The HCP who was the patient's physician and who administered the injection of Shingrix to the patient, called to report adverse events of achiness, warmth at injection site, and pain at injection site, along with the patient developing shingles the next day after receiving Shingrix.   The patient stated the adverse events have subsided except achiness and the shingles noted at the L3 dermatome on the Left leg.   The physician wanted to know the incidence of developing Shingles after receiving the injection.   The reporter transferred the caller to the Medical Information department. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: pain at injection site; warmth at injection site,; shingles the next day after receiving Shingrix / shingles noted at the L3 dermatome on the Left leg; achiness; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 29th September 2020, the patient received the 1st dose of Shingrix. On 30th September 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site warmth, shingles and pain. On an unknown date, the outcome of the injection site pain and shingles were not recovered/not resolved and the outcome of the injection site warmth and pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, shingles and pain to be related to Shingrix.  Additional details were provided as follows: The HCP who was the patient's physician and who administered the injection of Shingrix to the patient, called to report adverse events of achiness, warmth at injection site, and pain at injection site, along with the patient developing shingles the next day after receiving Shingrix.   The patient stated the adverse events have subsided except achiness and the shingles noted at the L3 dermatome on the Left leg.   The physician wanted to know the incidence of developing Shingles after receiving the injection.   The reporter transferred the caller to the Medical Information department. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site warmth, Pain
Clinical narrative: pain at injection site; warmth at injection site,; shingles the next day after receiving Shingrix / shingles noted at the L3 dermatome on the Left leg; achiness; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 29th September 2020, the patient received the 1st dose of Shingrix. On 30th September 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site warmth, shingles and pain. On an unknown date, the outcome of the injection site pain and shingles were not recovered/not resolved and the outcome of the injection site warmth and pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, shingles and pain to be related to Shingrix.  Additional details were provided as follows: The HCP who was the patient's physician and who administered the injection of Shingrix to the patient, called to report adverse events of achiness, warmth at injection site, and pain at injection site, along with the patient developing shingles the next day after receiving Shingrix.   The patient stated the adverse events have subsided except achiness and the shingles noted at the L3 dermatome on the Left leg.   The physician wanted to know the incidence of developing Shingles after receiving the injection.   The reporter transferred the caller to the Medical Information department. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Rash, Urticaria
Clinical narrative: Hives, rash, chills, itching . Benadryl
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored administered PROQUAD; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's medical history and historical drugs was not provided.   On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD), lot #T013540 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 6 degree Fahrenheit (°F) to 14°F (11.7°F) for 25 minutes as recorded by a data logger. There was no previous temperature excursion reported.  Lot No. T013540 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD), expiration date reported and verified as 17-OCT-2021.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccination to patient with improperly stored vaccine; No additional adverse events reported; This spontaneous report was received from a nurse referring to a currently 2-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, and previous drug reaction or allergies were not reported.  On an unknown date of 2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 0.5 milliliter, for prophylaxis (route of administration, vaccination scheme frequency, anatomical location, were not reported; the lot number and expiration date were unknown by the reporter). The administered dose of the vaccine experienced a temperature excursion which went from 28 degrees Fahrenheit (F) to 33.9 (F), and then to 50.2 F in a timeframe of 7 hours and 10 minutes. There was not previous temperature excursions and the data logger was not involved. There was no adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA009426: US-009507513-2009USA009550:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Freezer door was left open. Products are back under recommended storage range/confirmed that vaccines were administered after previous excursion; This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age, gender and ethnicity. The patients concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On an unspecified date, the patients were vaccinated with improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Lot # S022914 with expiration date 19-JAN-2021; Lot # T013541 with expiration date 17-OCT-2021; and lot # T009932 with expiration date 16-SEP-2021) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot # S024366 with expiration date 06-AUG-2021; Lot # T002846 with expiration date 23-JAN-2022; and lot # T010308 with expiration date 24-MAR-2022)  (dose, route of administration and anatomical location not provided) for prophylaxis. The reporter stated that a freezer door was left opened, and in consequence, the vaccines were exposed to a temperature excursion of -11.1 degree celsius (C) during a time frame of 1 hour and 4 minutes. The vaccines had previous temperature excursions (unspecified) reported. The excursion was called by a data logger.  This case in non-valid due to lack of patient identifiers.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 30-APR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by a healthcare provider for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster. The patient claimed the damages as a result of injury to themselves, loss of consortium, loss of service and economic losses. The outcome of the event herpes zoster was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 17-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reports the patient had no adverse sign and symptoms./No other AE reported.; Caller is a HCP calling to report that MMR II was given 10/02/2020 and it expired 01/01/2020.; This spontaneous report was received from a nurse practitioner (also reported as "nurse prescriber"), referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 02-OCT-2020, the patient was vaccinated with and expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), administered at a dose of 0.5 milliliters (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number R028004, which has been verified to be valid, expiration date reported and validated as 01-OCT-2020). The caller stated that the patient did not have adverse sing and symptoms; no additional adverse events were reported.  As of 05-OCT-2020, all telephone attempts trying to obtain additional information has been unsuccessful.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported.; A medical assistant states that on 09/30/2020 an expired dose of VARIVAX (lot R026715. expiration 09/18/2020) was administered on 09/30/2020.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.    On 30-SEP-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number R026715, which has been verified to be valid, expiration date reported and validated as 18-SEP-2020) as prophylaxis. The vaccine administered did not experienced any temperature excursions. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; One dose of improperly stored PROQUAD was administered after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 23-SEP-2020, the patient was vaccinated with one dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # T005400, expiration date 12-AUG-2021, for prophylaxis (route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of -9 degree Celsius (°C) to 8°C (-2.5 C) for 3 hours and 45 minutes as recorded by a data logger. There was a previous temperature excursion of -9°C to 8°C (0.1 C) for 2 hours and 7 minutes. There was no additional adverse event reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE noted.; She administered an expired PNEUMOV AX 23 PFS today; This spontaneous report was received from a Medical assistant referring to a 66 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.      On 02-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were not reported), with lot # S026366, and expiration date 17-SEP-2020 for prophylaxis. No other adverse event was noted. The Medical assistant wanted to know if the vaccination was still viable or did she needed to revaccinate the patient. No prior temperature excursions on the product. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Shingles; Spot that still itches not marks or sot; Spot-like rash; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th April 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles, localized itching and spot-like rash. On an unknown date, the outcome of the shingles, localized itching and spot-like rash were unknown.   It was unknown if the reporter considered the shingles, localized itching and spot-like rash to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Patient reported that after receiving Shingrix experienced shingles and asked about when its to get the shot again. Patient reported about still experiencing spot that still itches not marks or sot. The reporter did not consent to follow up. There was a discrepancy regarding capturing event shingles. Query had been raised to HUB, it was unknown whether the patient experienced shingles after the dose. In addition, it was unknown whether the patient had 1st dose but as per notes, it seems that this was the patient's 1st dose and yet to receive 2nd one
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Never been so sick after I had to take the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient been so sick after taken the Flu vaccine.  The patient refused before and refusing again. No contact details were provided.
Sex: U
Vaccine: FLUX
Symptoms: Alopecia
Clinical narrative: Hair fall out; This case was reported by a consumer via interactive digital media and described the occurrence of hair loss 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 hair loss. On an unknown date, the outcome of the hair loss was unknown.   The reporter considered the hair loss to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that the flu vaccine made hair fall out and no way anymore.