chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness on injection site; swelling on injection site; pain at injection site; feels hot again after 6 days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site warmth. On an unknown date, the patient experienced injection site erythema, injection site swelling and injection site pain. In September 2020, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient had reported the events for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received vaccine 7 days ago from the reporting date and experienced redness, swelling and pain on injection site, which was wane away on the 4th day, but it was red, swollen and felt hot again after 6 days.  The reporter asked what should he/she do. The follow-up was not required.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dehydration, Fatigue, Hyperhidrosis
Clinical narrative: chills; fatigue; stomach pain; dehydration; nausea; muscle pain; sweating; This case was reported by a consumer and described the occurrence of chills in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th September 2020 17:30, the patient received the 1st dose of Shingles vaccine. On 4th September 2020, 12 hrs after receiving Shingles vaccine, the patient experienced chills, fatigue, stomach pain, dehydration, nausea, muscle pain and sweating. On an unknown date, the outcome of the chills, fatigue, stomach pain, dehydration, nausea, muscle pain and sweating were recovered/resolved.   It was unknown if the reporter considered the chills, fatigue, stomach pain, dehydration, nausea, muscle pain and sweating to be related to Shingles vaccine.  Additional details were reported as follows: The patient received 1st dose of Shingrix on 4th September 2020 5:30 pm and she experienced chills, fatigue, stomach pain, nausea, a lot of muscle pain, sweating, and dehydration these adverse events occurred after 12 hours  She was not taking any other medications at time of vaccination.  All adverse events subsided within a couple of hours she thinks the adverse events may have been due to dehydration. The patient asked should expect the same with the second dose  The reporter did not consent to follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: chills; fatigue; stomach pain; dehydration; nausea; muscle pain; sweating; This case was reported by a consumer and described the occurrence of chills in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th September 2020 17:30, the patient received the 1st dose of Shingles vaccine. On 4th September 2020, 12 hrs after receiving Shingles vaccine, the patient experienced chills, fatigue, stomach pain, dehydration, nausea, muscle pain and sweating. On an unknown date, the outcome of the chills, fatigue, stomach pain, dehydration, nausea, muscle pain and sweating were recovered/resolved.   It was unknown if the reporter considered the chills, fatigue, stomach pain, dehydration, nausea, muscle pain and sweating to be related to Shingles vaccine.  Additional details were reported as follows: The patient received 1st dose of Shingrix on 4th September 2020 5:30 pm and she experienced chills, fatigue, stomach pain, nausea, a lot of muscle pain, sweating, and dehydration these adverse events occurred after 12 hours  She was not taking any other medications at time of vaccination.  All adverse events subsided within a couple of hours she thinks the adverse events may have been due to dehydration. The patient asked should expect the same with the second dose  The reporter did not consent to follow-up.
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Loss of personal independence in daily activities
Clinical narrative: dizziness; This case was reported by a nurse via sales rep and described the occurrence of dizziness in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Bexsero .5 ml. On an unknown date, unknown after receiving Bexsero, 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 Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported dizziness that prompted her to miss work after receiving both doses of Bexsero. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Hypotonia, Inappropriate schedule of product administration, Insomnia, Loss of personal independence in daily activities
Clinical narrative: extreme pain in her arm /  still in pain; lost all the muscle in her left arm; no strength in that arm; does not sleep at night; she has trouble putting on bra and clothes.; was unable to get the second shot within the 6 month window; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In April 2019, the patient received the 2nd dose of Shingrix. In April 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced pain in arm, decreased muscle tone, strength loss of, sleeplessness and activities of daily living impaired. The patient was treated with non-medicated dressings nos (Bandage). On an unknown date, the outcome of the pain in arm, decreased muscle tone, strength loss of, sleeplessness and activities of daily living impaired were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, decreased muscle tone, strength loss of, sleeplessness and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was unable to get the second shot within the 6 month window and received it delayed than the recommended schedule, which led to lengthening of the vaccination schedule. The patient received vaccine in left arm and experienced extreme pain in her arm. The patient was told to wait one month so she did but her arm got no better. Till the time of reporting patient had lost all the muscle in her left arm and she had no strength in that arm. The doctor said that the patient needed an magnetic resonance imaging (MRI) but she was unable to undergo that procedure.  The patient was still in pain, she did not sleep at night. The patient did not want to wear a sling all the time, she wraps an ace bandage around her arm to sleep.  The patient was in perfect health before this and now she had trouble putting on bra and clothes. The reporter gave permission to contact pharmacy. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: extreme pain in her arm /  still in pain; lost all the muscle in her left arm; no strength in that arm; does not sleep at night; she has trouble putting on bra and clothes.; was unable to get the second shot within the 6 month window; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In April 2019, the patient received the 2nd dose of Shingrix. In April 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced pain in arm, decreased muscle tone, strength loss of, sleeplessness and activities of daily living impaired. The patient was treated with non-medicated dressings nos (Bandage). On an unknown date, the outcome of the pain in arm, decreased muscle tone, strength loss of, sleeplessness and activities of daily living impaired were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, decreased muscle tone, strength loss of, sleeplessness and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was unable to get the second shot within the 6 month window and received it delayed than the recommended schedule, which led to lengthening of the vaccination schedule. The patient received vaccine in left arm and experienced extreme pain in her arm. The patient was told to wait one month so she did but her arm got no better. Till the time of reporting patient had lost all the muscle in her left arm and she had no strength in that arm. The doctor said that the patient needed an magnetic resonance imaging (MRI) but she was unable to undergo that procedure.  The patient was still in pain, she did not sleep at night. The patient did not want to wear a sling all the time, she wraps an ace bandage around her arm to sleep.  The patient was in perfect health before this and now she had trouble putting on bra and clothes. The reporter gave permission to contact pharmacy. The reporter consented to follow-up.
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: arm was more sore; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves male patient of an unknown age who experienced arm was more sore (pain in extremity), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Past vaccination included FLUZONE QUADRIVALENT.  Medical history, medical treatment and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm was more sore (pain in extremity), (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event pain in extremity was reported as unknown.   There will be no information available on the batch number for this case.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Condition aggravated, Headache, Mobility decreased
Clinical narrative: Fever Severe joint and muscle pain Worsening of arthritis pain Chills, Headache Inability to get out of bed Rash on second after after shot on both arms, legs and leg side of torso
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Fever Severe joint and muscle pain Worsening of arthritis pain Chills, Headache Inability to get out of bed Rash on second after after shot on both arms, legs and leg side of torso
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Heart rate increased
Clinical narrative: Elevated H, Heart Rate 130 Plus, Severe Dizziness, General Weakness, Headache, Nausea, Shivering.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Elevated H, Heart Rate 130 Plus, Severe Dizziness, General Weakness, Headache, Nausea, Shivering.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Patient reported redness in the arm that she received the vaccine, 2 days after receiving the vaccine. The red patch started 2-3 inches below the injection site and spanned 5 inches long and 3 inches wide. Patient was referred to a medical facility for further evaluation, but instead decided to come to the pharmacy to present the red patch (financial limitations). She was recommended an ice pack to the area and was told to seek further medical treatment if the patch worsens with redness or swelling. The patient was contacted a few days later to assess progress/improvement, but the patient did not answer. A voicemail was left for the patient to return our call.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis, Laboratory test abnormal
Clinical narrative: Cellulitis at the site of injection. Patient was treated with antibiotics and is doing better now.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: pain in left shoulder & left upper arm with decreased range of motion
Age: 19.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Loss of consciousness
Clinical narrative: PATIENT PASSED OUT AFTER VACCINATION
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blister, Headache, Impaired work ability, Pain
Clinical narrative: Severe shoulder and elbow pain, headache.  By Friday 9/11 blisters were starting to form on left hand.  More blisters and worsening pain on Saturday.  Went to urgent care.  Prescribed Prednisone 20mg and cyclobenzaprine 5mg for 5 days. Went to work Monday, was told to leave at the end of the day and not return until it clears up.  have appt with primary doctor today 9/15/20
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash, Swelling
Clinical narrative: Severe shoulder and elbow pain, headache.  By Friday 9/11 blisters were starting to form on left hand.  More blisters and worsening pain on Saturday.  Went to urgent care.  Prescribed Prednisone 20mg and cyclobenzaprine 5mg for 5 days. Went to work Monday, was told to leave at the end of the day and not return until it clears up.  have appt with primary doctor today 9/15/20
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Syncope
Clinical narrative: Shot received approx 4 pm. Same day@ 9 pm rash started on face and neck. Took Benadryl. At 5:30 am next morning while standing - fainted. Rash returned early evening and took another Benadryl.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: unusual tiredness, nasal congestion, nausea , diarrhea , extreme chills, joint pain in whole body, headache,  like actual illness
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Malaise, Nasal congestion, Nausea
Clinical narrative: unusual tiredness, nasal congestion, nausea , diarrhea , extreme chills, joint pain in whole body, headache,  like actual illness
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella virus test
Clinical narrative: had shingles outbreak 9/2020 despite shingles vaccination 2 doses back in 2018
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Mobility decreased
Clinical narrative: SHE GOT SHINGLES A WEEK AFTER THE IMZ AFTER SHE GOT THE VACCINE, SHE WAS VERY ILL, HAD TO LAY IN BED FOR TWO DAYS AND COULDN'T MOVE.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever and  fatigue
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: Left supraclavicular lymphadenopathy
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Blindness transient, Dysstasia, Hyporesponsive to stimuli, Loss of consciousness, Pallor
Clinical narrative: Employee had a change in LOC minutes after administration of HBV . She had minimal response to verbal command and tactile stimuli. She reported loss of vision, not being able to read vaccination card  and inability to stand. She was pale and was not breathing. Rapid response team called. Respiratory  therapy arrived first. Ammonia inhalant administered Ee began to breathe and was alert to self. VS remained stable . Ee declined to go to ER. She recovered in Clinic for a hours oral hydration given . After about a hours he felt well and was discharged home. She does recall having a similar symptoms in the past. Advised her to F/u with her PCP Dr. FNP.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Respiratory arrest
Clinical narrative: Employee had a change in LOC minutes after administration of HBV . She had minimal response to verbal command and tactile stimuli. She reported loss of vision, not being able to read vaccination card  and inability to stand. She was pale and was not breathing. Rapid response team called. Respiratory  therapy arrived first. Ammonia inhalant administered Ee began to breathe and was alert to self. VS remained stable . Ee declined to go to ER. She recovered in Clinic for a hours oral hydration given . After about a hours he felt well and was discharged home. She does recall having a similar symptoms in the past. Advised her to F/u with her PCP Dr. FNP.
Age: 79.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: 1 week after vaccination developed shingles. Pt had flu vaccination at the same time. I do not have the information about which flu vaccination he had.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Patient said the evening after she received the vaccine she lost bladder control and urinated about 7 times without her control. She said she had extreme muscle weakness/paralysis in her extremities and needed to be helped in and out of bed. She got a major headache. All of the previous symptoms lasted for about 24 to 48 hours. She also had a large amount of injection site pain which is still ongoing and started about 1 hour after receiving the shot. She states she had chills for about 24 hours after the shot, but no fever.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Paralysis, Urinary incontinence
Clinical narrative: Patient said the evening after she received the vaccine she lost bladder control and urinated about 7 times without her control. She said she had extreme muscle weakness/paralysis in her extremities and needed to be helped in and out of bed. She got a major headache. All of the previous symptoms lasted for about 24 to 48 hours. She also had a large amount of injection site pain which is still ongoing and started about 1 hour after receiving the shot. She states she had chills for about 24 hours after the shot, but no fever.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Skin warm, Swelling
Clinical narrative: SWELLING AND WARM TO TOUCH
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Over the course of the evening, my arm wasswollen, red and painful. I developed a fever of , 102?, and had chills-my teeth chattered. At about 2 AM I still had a fever but was very hot. The fever was down by morning but was still hovering around 99-100  for another day.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Over the course of the evening, my arm wasswollen, red and painful. I developed a fever of , 102?, and had chills-my teeth chattered. At about 2 AM I still had a fever but was very hot. The fever was down by morning but was still hovering around 99-100  for another day.
Age: 30.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Diarrhoea, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Diarrhea, low grade fever, sore throat, cough, and body rash  which lasted a couple of days.
Age: 73.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood culture positive, Chills, Escherichia test positive, Fatigue, Influenza like illness
Clinical narrative: Vaccine administered on 08/24/2020. Symptoms appeared on 09/10 with "acute onset massive onset trembling and chills." Wife called 911 at that time (due to low oxygenation via pulse oximeter). Fever of 101.2 F upon evaluation with EMTs. EMTs evaluated and offered transportation to local hospital. EMTs were okay with patient staying home at that time. Patient declined due to COVID-19 concerns. A few hours later, patient's fever up to 103.5. PCP was contacted; if patient's condition changed or worsened, patient was advised to go to urgent care or hospital. Patient declined. After a nap and observation for a few hours, patient's fever was down to around 101 without fever reducing medications. On 09/11 in the morning, no symptoms observed except fatigue. On 09/12 in the evening, fever went up to 101.8 and patient described flu-like symptoms. Went to hospital on 09/12 in evening. Patient was tested for COVID, had labs drawn, blood culture then discharged home. Approximately 24 hours later, hospital physician called and informed patient and wife that blood culture came back positive for gram negative rods. Physician elaborated with "probably E. coli." Patient was instructed to return to hospital for admission and IV antibiotics (unknown duration of treatment at this time). RN at hospital confirmed that E. coli was grown in blood culture.
Age: 73.0
Sex: M
Vaccine: FLUC4
Symptoms: Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: Vaccine administered on 08/24/2020. Symptoms appeared on 09/10 with "acute onset massive onset trembling and chills." Wife called 911 at that time (due to low oxygenation via pulse oximeter). Fever of 101.2 F upon evaluation with EMTs. EMTs evaluated and offered transportation to local hospital. EMTs were okay with patient staying home at that time. Patient declined due to COVID-19 concerns. A few hours later, patient's fever up to 103.5. PCP was contacted; if patient's condition changed or worsened, patient was advised to go to urgent care or hospital. Patient declined. After a nap and observation for a few hours, patient's fever was down to around 101 without fever reducing medications. On 09/11 in the morning, no symptoms observed except fatigue. On 09/12 in the evening, fever went up to 101.8 and patient described flu-like symptoms. Went to hospital on 09/12 in evening. Patient was tested for COVID, had labs drawn, blood culture then discharged home. Approximately 24 hours later, hospital physician called and informed patient and wife that blood culture came back positive for gram negative rods. Physician elaborated with "probably E. coli." Patient was instructed to return to hospital for admission and IV antibiotics (unknown duration of treatment at this time). RN at hospital confirmed that E. coli was grown in blood culture.
Age: 52.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Axillary pain, Injection site rash, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: Reaction was to the Shingrix shot I got on Friday morning. Noticed the reactions when I woke up the next morning. Right arm was very swollen, both at the injection site and the entire armpit area and below it. A lot of pain from neck to waist on right side of body. Rash appeared above injection site. Ran a fever with body aching all over the entire day (saturday). Sunday fever and rash was gone, still had a lot of pain, especially armpit area.  Today (tues) pain is mild and swelling has subsided a lot, still not back to normal.
Age: 52.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Pyrexia
Clinical narrative: Reaction was to the Shingrix shot I got on Friday morning. Noticed the reactions when I woke up the next morning. Right arm was very swollen, both at the injection site and the entire armpit area and below it. A lot of pain from neck to waist on right side of body. Rash appeared above injection site. Ran a fever with body aching all over the entire day (saturday). Sunday fever and rash was gone, still had a lot of pain, especially armpit area.  Today (tues) pain is mild and swelling has subsided a lot, still not back to normal.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Per pt., started to experience arm pain not discomfort a couple of hours after injection, temperature variations (94-98), and a feeling of fuzziness. No other changes to diet or routine besides Influenza vaccine and TB test administered a couple of hours prior. Informed pt. that employee health nurse would be making a VAERS report in which she verbalized understanding. Pt. states that she has had some minor reactions to other vaccines before. Informed pt. to consult PCP in regards to reaction to Influenza vaccine in which she verbalized understanding.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; administered an improperly stored dose ofROTATEQ; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-SEP-2020, the patient was administered a dose of inappropriately stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (orally, lot # S038691, expiration date 12-MAY-2021 (also reported as 20-MAY-2021) (dose number not reported.) No additional adverse effects reported.  The reported temperature excursion was below "36 degree of Fahrenheit: 35 degree of Fahrenheit" through 20 minutes. There was no previous temperature excursion. The temperature excursions were detected by a Data Logger.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 27-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot #  T002845 was verified to be valid, expiration date reported and establised as 23-JAN-2022 (strength, dose, frequency and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent.  The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. There was also a previous temperature excursion of 6 to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. Digital Data Logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 27-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002845 was verified to be valid, expiration date reported and establised as 23-JAN-2022 (strength, dose, frequency and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent.  The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. There was also a previous temperature excursion of 6 to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. Digital Data Logger was involved.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747:
Age: 1.67
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: There was no other AE reported; she inadvertently gave an expired PROQUAD; This spontaneous report was received from a nurse and refers to a 20-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 01-SEP-2020, the patient was inadvertently vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) therapy type: rha, lot # S005879, expiration date 25-AUG-2020 (dose and route of administration were not provided) for prophylaxis. It was reported, that the vaccine had never had a temperature excursion. There was no other adverse event reported. The reporter wanted to know if the vaccination was good and what should she do.  The outcome of medication error was unknown.
Age: 42.0
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored vaccine administered to patient; This spontaneous report as received from a licensed practical nurse refers to a 42-year-old patient. The patient's medical history and concurrent condition were not reported.   On 20-AUG-2020,  the patient was vaccinated with incorrectly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (product formulation pre-filed syringe, lot # T009744, expiry date: 28-JAN-2022, dose: 0.5 milliliter, route of administration not reported). The vaccine was stored under the temperature excursion of 48.39 degrees of Fahrenheit through 1 hour and 45 minutes. Temperature excursion was detected by Data Logger. There was no previous temperature excursion. No adverse event was reported.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Headache, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: reaction to pneumovax; pain from her arm to her chest after getting vaccine, having serious pain and swollen arm and headaches pain traveled up to her neck; pain from her arm to her chest after getting vaccine, having serious pain and swollen arm and headaches pain traveled up to her neck; pain from her arm to her chest after getting vaccine, having serious pain and swollen arm and headaches pain traveled up to her neck; pain from her arm to her chest after getting vaccine, having serious pain and swollen arm and headaches pain traveled up to her neck; pain from her arm to her chest after getting vaccine, having serious pain and swollen arm and headaches pain traveled up to her neck; This spontaneous report as received from a physician via a company representative refers to a 65-year-old female patient. The patient's medical history and concurrent conditions were not reported. However, it was reported that the patient experienced reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on an unknown date.  On 09-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose number, route of administration and dose volume were not reported) for pneumonia prophylaxis.        On 10-SEP-2020, after getting the vaccine, the patient experienced pain from her arm to her chest, having serious pain and swollen arm and headaches pain traveled up to her neck. The patient's outcome was not reported. Causality between the event of arm pain, chest pain, swollen arm, headache and neck pain was not reported. Causality between unspecified reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the vaccination with reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was assessed as related.  The reporting physician considered pain from her arm to her chest, having serious pain and swollen arm and headaches pain traveled up to her neck to be serious (medically significant).
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: reaction to pneumovax; pain from her arm to her chest after getting vaccine, having serious pain and swollen arm and headaches pain traveled up to her neck; pain from her arm to her chest after getting vaccine, having serious pain and swollen arm and headaches pain traveled up to her neck; pain from her arm to her chest after getting vaccine, having serious pain and swollen arm and headaches pain traveled up to her neck; pain from her arm to her chest after getting vaccine, having serious pain and swollen arm and headaches pain traveled up to her neck; pain from her arm to her chest after getting vaccine, having serious pain and swollen arm and headaches pain traveled up to her neck; This spontaneous report as received from a physician via a company representative refers to a 65-year-old female patient. The patient's medical history and concurrent conditions were not reported. However, it was reported that the patient experienced reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on an unknown date.  On 09-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose number, route of administration and dose volume were not reported) for pneumonia prophylaxis.        On 10-SEP-2020, after getting the vaccine, the patient experienced pain from her arm to her chest, having serious pain and swollen arm and headaches pain traveled up to her neck. The patient's outcome was not reported. Causality between the event of arm pain, chest pain, swollen arm, headache and neck pain was not reported. Causality between unspecified reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the vaccination with reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was assessed as related.  The reporting physician considered pain from her arm to her chest, having serious pain and swollen arm and headaches pain traveled up to her neck to be serious (medically significant).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: mild arm soreness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and shingles.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was a retired nurse. The patient received Shingrix and had mild arm soreness. It resolved quickly. The reporter consented to follow up. This case linked with US2020180914 and US2020AMR181528, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020180914:same reporter US-GLAXOSMITHKLINE-US2020AMR181528:same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Influenza like illness, Injection site pain, Injection site pruritus
Clinical narrative: itchiness at injection site; warm to touch at injection site; swelling at injection site; pain at the injection site; flu like symptoms; fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2020, immediately after receiving Shingrix, the patient experienced injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue. In September 2020, the outcome of the injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received dose 1 of Shingrix in left arm. Almost immediately, the patient reported pain at the injection site, swelling at injection site, warm to touch at injection site, flu like symptoms described as fatigue, and itchiness at injection site.  The patient reported as events lasted about 3 days and then resolved. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: itchiness at injection site; warm to touch at injection site; swelling at injection site; pain at the injection site; flu like symptoms; fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2020, immediately after receiving Shingrix, the patient experienced injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue. In September 2020, the outcome of the injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received dose 1 of Shingrix in left arm. Almost immediately, the patient reported pain at the injection site, swelling at injection site, warm to touch at injection site, flu like symptoms described as fatigue, and itchiness at injection site.  The patient reported as events lasted about 3 days and then resolved. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: itchiness at injection site; warm to touch at injection site; swelling at injection site; pain at the injection site; flu like symptoms; fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2020, immediately after receiving Shingrix, the patient experienced injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue. In September 2020, the outcome of the injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received dose 1 of Shingrix in left arm. Almost immediately, the patient reported pain at the injection site, swelling at injection site, warm to touch at injection site, flu like symptoms described as fatigue, and itchiness at injection site.  The patient reported as events lasted about 3 days and then resolved. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: itchiness at injection site; warm to touch at injection site; swelling at injection site; pain at the injection site; flu like symptoms; fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2020, immediately after receiving Shingrix, the patient experienced injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue. In September 2020, the outcome of the injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site warmth, injection site swelling, injection site pain, influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received dose 1 of Shingrix in left arm. Almost immediately, the patient reported pain at the injection site, swelling at injection site, warm to touch at injection site, flu like symptoms described as fatigue, and itchiness at injection site.  The patient reported as events lasted about 3 days and then resolved. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: swollen neck lymph nodes; sore arm; This case was reported by a consumer via call center representative and described the occurrence of lymphadenopathy cervical in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced lymphadenopathy cervical and pain in arm. On an unknown date, the outcome of the lymphadenopathy cervical and pain in arm were recovered/resolved.   It was unknown if the reporter considered the lymphadenopathy cervical and pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that it had almost been 2 months since she received dose 1 of Shingrix.  She stated that after she received dose 1 of the vaccine she experienced swollen neck lymph nodes and a sore arm. It took a few days but these symptoms were resolved. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the 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 an adult as per the vaccine indication. The patient experienced rash after receiving Shingrix the following day. The reporter did not consent to follow up. The HCP was in a hurry and provided a few details of the case. This case linked with US2020182652, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020182652:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) (batch number NB9D3, expiry date 16th April 2022) for prophylaxis.   On 1st September 2020, the patient received Shingrix. On 2nd September 2020, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the 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 an adult as per the vaccine indication. The batc number was updated from NB903 to NB9D3, as per sales data sheet. The patient experienced rash after receiving Shingrix the following day. The reporter did not consent to follow up. The HCP was in a hurry and provided a few details of the case. This case linked with US2020182653, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020182653:same reporter
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 61 years old was administered FLUZONE HIGH-DOSE QUADRIVALENT , no AE; 61 years old was administered FLUZONE HIGH-DOSE QUADRIVALENT , no AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 61 years old patient (gender unknown) who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  (lot number and expiration date not reported) (PTs: Product administered to patient of inappropriate age and overdose) via unknown route in unknown administration site as prophylactic vaccination on an unspecified date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to Inappropriate age at vaccine administration (same day latency).  It was also a case of overdose (same day latency) .  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Eating disorder, Pain, Pain in jaw, Swelling face
Clinical narrative: experienced a bad reaction,jaw pain to the point of not being able to eat; jaw pain to the point of not being able to eat; left ear pain; facial swelling; lots of pain; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 70 years old female patient who experienced bad reactions such as jaw pain to the point of not being able to eat (pain in jaw) (feeding disorder),left ear pain (ear pain),facial swelling (swelling face) and lots of pain (pain), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 26-Aug-2020, the patient received a dose  of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ444AA and expiration date:30-Jun-2021) via unknown route in unknown administration site as prophylactic vaccination.  On an unspecified date, the patient developed non-serious bad reactions such as jaw pain to the point of not being able to eat (pain in jaw) (feeding disorder),left ear pain (ear pain),facial swelling (swelling face), 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unspecified date , the patient developed a non-serious event such as lots of pain (pain) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was reported as unknown for all the events.  There will be no information on the batch number for this case.