chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 06-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002845 (expiration date: 23-JAN-2022) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter; Sender's Comments:  US-009507513-2008USA010124: US-009507513-2008USA010123: US-009507513-2008USA010126: US-009507513-2008USA010125: US-009507513-2008USA010121: US-009507513-2008USA010000: US-009507513-2008USA010127: US-009507513-2008USA010122: US-009507513-2008USA010128: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 07-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002845 (expiration date: 23-JAN-2022) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010124: US-009507513-2008USA010123: US-009507513-2008USA010126: US-009507513-2008USA010125: US-009507513-2008USA010122: US-009507513-2008USA010000: US-009507513-2008USA010134: US-009507513-2008USA010121: US-009507513-2008USA010127: US-009507513-2008USA010136: US-009507513-2008USA010137: US-009507513-2008USA010128:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 13-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002845 (expiration date: 23-JAN-2022) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010124: US-009507513-2008USA010123: US-009507513-2008USA010126: US-009507513-2008USA010125: US-009507513-2008USA010135: US-009507513-2008USA010000: US-009507513-2008USA010121: US-009507513-2008USA010122: US-009507513-2008USA010134: US-009507513-2008USA010127: US-009507513-2008USA010128: US-009507513-2008USA010137:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 14-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002845 (expiration date: 23-JAN-2022) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010124: US-009507513-2008USA010123: US-009507513-2008USA010126: US-009507513-2008USA010125: US-009507513-2008USA010127: US-009507513-2008USA010135: US-009507513-2008USA010121: US-009507513-2008USA010136: US-009507513-2008USA010134: US-009507513-2008USA010122: US-009507513-2008USA010000: US-009507513-2008USA010128:
Sex: M
Vaccine: FLUN3
Symptoms: Aphonia, Cough, Malaise
Clinical narrative: LOST HIS VOICE; COUGHING; EXTREMELY SICK; A spontaneous report has been received from a consumer concerning a male patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    On an unknown date, patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route.     It was reported that reporter's son got this one time ended up extremely sick (preferred term: Malaise),  coughing (preferred term: Cough) and lost his voice (preferred term: Aphonia) took him to the doctor they said it was a reaction to the mist. He gets the shot as they said the flumist has a live virus and thats likely what he reacted to. Shots don't bother him but he was terrified of the mist now.    The outcome of the events of lost his voice, extremely sick and coughing was unknown.     The event lost his voice was considered serious due to important medical event by the company physician. The events extremely sick and coughing were considered non-serious by the company physician.     The reporter considered the events coughing, lost his voice and extremely sick as related to treatment with Flumist.; Sender's Comments: Aphonia is not listed in the company core data sheet of Quadrivalent live attenuated influenza vaccine (Q/LAIV). Reported cough could be risk factor to the event. Due to limited information on relevant medical history ,concurrent conditions, event onset date and outcome, circumstance leading to the event, concomitant medications ,detailed etiological and diagnostic workup , it is not possible to make a conclusive assessment of the causal relationship of event with suspect drug.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: get a flu shot and he did get a terrible case of the flu / he did get a flu shot again and again he did get the flu; et a flu shot and he did get a terrible case of the flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional details were provided as follows: The case was reported by patient's daughter/ son. The age at vaccination was not reported. It was reported that the patient did get a flu shot and he did get a terrible case of the flu. The patient's family told him didn't get another flu shot.  The patient did not get any more flu shots and he never did get the flu again. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test was unknown. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR165248:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccine dates: 4/22/2019 and 7/3/2019 / shingles last week/suspected vaccination failure; shingles las week; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 3rd July 2019, the patient received the 2nd dose of Shingrix. In August 2020, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. Last week from the date of reporting, the patient experienced shingles. This was considered as a suspected vaccination failure since the details regarding laboratory test confirming singles were not provided.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Malaise, Nausea, Pyrexia, Underdose
Clinical narrative: Feel sick; Severe nausea; Fever; Recieved half a dose; This case was reported by a other health professional via call center representative and described the occurrence of sickness in a 10-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, immediately after receiving Boostrix, the patient experienced sickness, nausea, fever and underdose. On an unknown date, the outcome of the sickness, nausea, fever and underdose were unknown.   It was unknown if the reporter considered the sickness, nausea and fever to be related to Boostrix.  Additional information was provided as follows: The patient was about 10 years old. The patient received Boostrix but she received half a dose at the time because it made her feel sick with severe nausea and fever. The patient received hald dose, which led to underdose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: flu like symptoms; really sick; This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (for tolerance of 1st dose refer case US2020161250) and Influenza vaccine.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and sickness. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and she was really sick with flu like symptoms that lasted 2 to 3 days. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020161250:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: outbreak on her right ankle; This case was reported by a consumer via interactive digital media and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix. On 16th August 2020, 2 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were reported as follows: The case was reported by the husband of the patient. The age at vaccination was not reported. The patient received dose on Shingrix and on the day of reporting patient experienced a small outbreak on her right ankle of what looks like shingles. The patient asked could the vaccine had cause that.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Terrible illness; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced malaise (serious criteria other: as per reporter). On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by patient's daughter/ son. The age at vaccination was not reported. It was reported that the patient did get a flu shot  again for the 3rd year the patient got deathly ill. The patient's family told him din't get another flu shot.  The patient did not get any more flu shots and he never did get the flu again. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR157706:same reporter US-GLAXOSMITHKLINE-US2020AMR165253:same reporter US-GLAXOSMITHKLINE-US2020AMR165254:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: did get a terrible case of the flu; did get a terrible case of the flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that several people that get the flu shot regularly and they get the flu every year. The people purposely knowing that they would more than likely get the flu right after getting the flu shot every year, year after year. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test was unknown. This is 1 of 4 cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR157706:same reporter US-GLAXOSMITHKLINE-US2020AMR165254:same reporter US-GLAXOSMITHKLINE-US2020AMR165248:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: several people that get the flu shot regularly and they get the flu every year; several people that get the flu shot regularly and they get the flu every year; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of influenza (patient received influenza vaccine on an unknown date, refer case US2020AMR157706).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the vaccination failure and influenza were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient's daughter/ son. The age at vaccination was not reported. It was reported that the patient did get a flu shot and he did get a terrible case of the flu. The patient's family told him didn't get another flu shot.  The patient did not get any more flu shots and he never did get the flu again. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test was unknown. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR157706:same reporter US-GLAXOSMITHKLINE-US2020AMR165253:same reporter US-GLAXOSMITHKLINE-US2020AMR165248:same reporter
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Skin swelling
Clinical narrative: puffy rash across the bridge of my nose and arching up to my right eyebrow; it is itchy; puffy rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2020, the patient received the 1st dose of Shingrix. On 18th August 2020, 5 days after receiving Shingrix, the patient experienced rash, itchy rash and puffy skin. On an unknown date, the outcome of the rash, itchy rash and puffy skin were unknown.   It was unknown if the reporter considered the rash, itchy rash and puffy skin to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix about 5 days ago and at the date of reporting getting a puffy rash across the bridge of my nose and arching up to my right eyebrow and it was itchy.  The reporter asked was it possible for the vaccine to trigger a Shingles episode.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: fever; pain in his left arm at injection site; headache; body aches; tiredness; could not sleep that night; could not raise his arm up or move his arm back / not able to get his clothes on; not able to get his clothes; This case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd July 2019, the patient received the 1st dose of Shingrix. In July 2019, 24 hrs after receiving Shingrix, the patient experienced fever, injection site pain, headache, general body pain, tiredness, insomnia, injected limb mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the fever, injection site pain, headache, general body pain, tiredness, insomnia, injected limb mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fever, injection site pain, headache, general body pain, tiredness, insomnia, injected limb mobility decreased and activities of daily living impaired to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the 1st Shingrix vaccine and twenty-four hours later he developed a fever, pain in his left arm at injection site, headache, body aches, tiredness and could not sleep that night.  Two days later he started having problems with his left arm, he could not raise his arm up or move his arm back.  He also was not able to get his clothes on.  The issue with his left arm continued for a month with out any improvement, he then decided to see his primary physician. His physician did not see anything broken and suggested that he exercise his arm. Caller reported that he exercised his arm for three months with no improvements.  The reporter decided to see an orthopedic doctor who x-rayed his left arm and the results came back negative. Orthopedic doctor recommended rehab. The reporter had six sessions at rehab and afterwards continued the daily exercises at home for the past several months.  The reporter went back to his orthopedic physician recently and was told that he may not fully recover the mobility of his arm and to continue with the exercises.  The reporter reported that he feels he had recovered 98 present use of his left arm and is exercising his left arm every other day.  The reporter reported that he had not received his second Shingrix vaccine yet due to his experience with loss of function of his left arm. The reporter did not consent to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain, Pyrexia, X-ray normal
Clinical narrative: fever; pain in his left arm at injection site; headache; body aches; tiredness; could not sleep that night; could not raise his arm up or move his arm back / not able to get his clothes on; not able to get his clothes; This case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd July 2019, the patient received the 1st dose of Shingrix. In July 2019, 24 hrs after receiving Shingrix, the patient experienced fever, injection site pain, headache, general body pain, tiredness, insomnia, injected limb mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the fever, injection site pain, headache, general body pain, tiredness, insomnia, injected limb mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fever, injection site pain, headache, general body pain, tiredness, insomnia, injected limb mobility decreased and activities of daily living impaired to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the 1st Shingrix vaccine and twenty-four hours later he developed a fever, pain in his left arm at injection site, headache, body aches, tiredness and could not sleep that night.  Two days later he started having problems with his left arm, he could not raise his arm up or move his arm back.  He also was not able to get his clothes on.  The issue with his left arm continued for a month with out any improvement, he then decided to see his primary physician. His physician did not see anything broken and suggested that he exercise his arm. Caller reported that he exercised his arm for three months with no improvements.  The reporter decided to see an orthopedic doctor who x-rayed his left arm and the results came back negative. Orthopedic doctor recommended rehab. The reporter had six sessions at rehab and afterwards continued the daily exercises at home for the past several months.  The reporter went back to his orthopedic physician recently and was told that he may not fully recover the mobility of his arm and to continue with the exercises.  The reporter reported that he feels he had recovered 98 present use of his left arm and is exercising his left arm every other day.  The reporter reported that he had not received his second Shingrix vaccine yet due to his experience with loss of function of his left arm. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site swelling
Clinical narrative: swelling at the injection site; 1st dose of Shingrix on 19Sep2019 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site swelling and incomplete course of vaccination. On an unknown date, the outcome of the injection site swelling and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported for 1st dose. The experienced swelling at the injection site after receiving 1st dose of Shingrix. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site mass, Injection site swelling
Clinical narrative: swelling lump on the injection side; received a dose of Shingrix subcutaneously; swelling lump on the injection side; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2020, the patient received Shingrix (subcutaneous). On 15th August 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling and intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site lump. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the injection site lump and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling and injection site lump to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix subcutaneously on her left arm, which led to intramuscular formulation administered by other route and then developed a swelling lump on the injection side, it was administered. The reporter consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash pruritic, Urticaria
Clinical narrative: Hives that are itchy; Hives that are itchy; Red spot the size of a 50 cent piece on the area where the vaccine was administered; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 2B3P2, expiry date 10th May 2022) for prophylaxis.   On 12th August 2020, the patient received the 1st dose of Shingrix .5 ml. In August 2020, less than a week after receiving Shingrix, the patient experienced hives, itchy rash and injection site erythema. On an unknown date, the outcome of the hives, itchy rash and injection site erythema were unknown.   It was unknown if the reporter considered the hives, itchy rash and injection site erythema to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in left arm and experienced hives that were itchy and a red spot the size of a 50 cent piece on the area where the vaccine was administered. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Injection site pain
Clinical narrative: Pain at the injection side; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Menveo.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Menveo with lots of local reaction (pain) injection site pain.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: Dose of Boostrix on Aug 14th / Already received Boostrix vaccination on February; pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 67-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 374LB, expiry date 20th June 2022) for prophylaxis.   Previously administered products included Boostrix (received 1st dose in February 2020).   On 14th August 2020, the patient received the 2nd dose of Boostrix. On 14th August 2020, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. In August 2020, the patient experienced pain. On an unknown date, the outcome of the pain and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pain to be related to Boostrix.  Additional details were reported as follows: The patient received a dose of boostrix on 14th August 2020 but after they administered they realized patient already received boostrix vaccination on February 2020 as well. The patient received 2nd dose of boostix, before than the recommended interval, which led to shortening of vaccination schedule. The patient experienced pain and reporter wondered if it was related to receiving the vaccine (Boostrix) at such a short interval. The reporter consented to follow up. No further details provided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: left arm has pain and tenderness/ sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (SEASONAL INFLUENZA VACCINE)).   On 17th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient himself. The patient got his first Shingrix dose a day before reporting in the left deltoid and was experiencing a sore arm. He did not see the size of the needle but he believed it was given intramuscularly. He reported that his left arm has pain and tenderness. He looked at the paperwork given to him by the pharmacy who administered the injection but was unable to find a lot number or expiration date for Shingrix. The patient had an appointment to return for Shingrix dose number 2 on October 16, 2020. The patient did receive Fluzone shot also but that was given in his right arm and he stated his right arm did not hurt. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling, Urticaria
Clinical narrative: Hives; pain at the injection site; swelling of the arm/ swelling, pain and redness at the injection site.; redness at the injection site; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in left arm on an unspecified date at single dose for start the vaccination series for the product. Medical history included GI Issues but is not immuno-compromised from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient experienced pain at the injection site, swelling of the arm, hives, redness at the injection site on an unspecified date. The reporter stated the customer told her that they had a patient who came in today for their second meningococcal group b rlp2086 injection, and mentioned that they had a reaction after their first injection of pain at the injection site and swelling of the arm, but the patient never called and told the doctor about it. Caller stated that the customer said the patient reported that she also had hives after that first injection and had gone to urgent care and it went away, but the doctor's office just found out about the patient's reaction today, even though it happened a year ago. The reporter went into the Package Insert to read the common side effects to the customer and it was all the same side effects that the patient had. Caller reported the patient was 16 at the time of her first injection with the side effects and the injection was placed into the patient's left arm. Caller states that the customer indicated that the patient is fine today, but the reaction the patient had a year ago to the meningococcal group b rlp2086 injection was swelling, pain and redness at the injection site. Caller stated that the customer told her that the patient has GI Issues but is not immuno-compromised. Caller stated that all she knows was that the patient is female, she was 16 at the time of the first injection and reaction, which occurred one year ago, and that injection was administered into the patient's left arm. She does not know if the patient received any other vaccines at the time of the adverse event. The outcome of event was resolved on an unspecified date. Therapeutic measures were taken as a result of hives.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Fatigue, Influenza like illness, Injection site erythema, Oropharyngeal pain
Clinical narrative: Shot caused pain, fever, and redness around injection site the size of a baseball. I developed flu-like symptoms about 10 hours after the shot. I have sore throat,fatigue, horrible body aches even in my eyes like I have the flu.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Shot caused pain, fever, and redness around injection site the size of a baseball. I developed flu-like symptoms about 10 hours after the shot. I have sore throat,fatigue, horrible body aches even in my eyes like I have the flu.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Reports a deep red bumpy rash over scapula with itching and burning sensation
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eye swelling, Lip swelling, Rash
Clinical narrative: RASH ALL OVER, SWELLING OF EYES AND LIPS
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received vaccine in the L deltoid on 08/18/20 in office. Patient states that she reported redness, swelling, and pain below injection site (x1 inch below) about x1 hour after receiving injection. Pt. return to the office and was seen by provider on 08/20/20 reporting the incident. Patient denies having any reactions to immunizations before. Provider (FNP) diagnosed pt. with a allergic reaction to the immunization and prescribed a Prednisone 20MG for x5 days, pt. received a steroid injection at time of OV on 08/20/20 and was prescribed a antibiotic (Cephalexin) if symptoms worsen  or not improved after x2 day for pt. to take to prevent possible cellulitis.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Lethargy, Pain
Clinical narrative: Fever, now up to 100.4 at 8:15 am, achy, sore, lethargic , pain touching or raising arm. headache, shivers,  stomach pain.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, now up to 100.4 at 8:15 am, achy, sore, lethargic , pain touching or raising arm. headache, shivers,  stomach pain.
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; expired VARIVAX was administered to a patient; This spontaneous report was received from a nurse and refers to a 19-year-old male patient. His pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 22-JUL-2020, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R017365 was found be not a valid number with a reported expiration date of 06-JUN-2020 (exact dose and route of administration were not reported) for prophylaxis. There were no adverse events reported. The outcome was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Painful for a week and a half at injection site; Inflammation of about 5 inches around / at injection site; Red / at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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, unknown after receiving Shingrix, the patient experienced injection site pain, injection site inflammation and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site inflammation and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site inflammation and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had painful, inflammation of about 5 inches around, red, painful for a week and a half at injection site.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Injection site urticaria, Pruritus, Skin warm
Clinical narrative: Around 9:00 pm my upper arm began to itch and was warm to the touch. A hive formed at the injection site with a clear raised line approximately 1.5" around. By the time I called the nurse line at Hospital told me to take a pen and mark around it and go to the ER if it continued to get larger. It was about 2.5" diameter by the next morning. I called the pharmacy the next day to report and he thought it was a common reaction and call my doctor. I was told to take benadryl and to watch it. The benadryl has helped and redness has subsided greatly. I still have an itch and the swelling is subsiding.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Pt received a HPV to left deltoid at approx. 10:30am  mother reported they went to store after and pt started itching and noticed raised red areas to his back.  No further treatment needed or administered.  Mother stated the hives were gone after about 1 hour or less
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Upper right arm swelling, redness and pain 7 days after vaccine given. No fever.  Ice and Motrin relieves pain.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13
Symptoms: Blood count normal, Metabolic function test normal, Resuscitation, Seizure
Clinical narrative: My child had the Vaccinations for her 1 year old check up. In the night at about 11:30pm, She started having a seizure. I had to do CPR on her. We called the ambulance and she was taken to the hospital.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chest pain, Pain of skin, X-ray
Clinical narrative: horrible pain in upper chest and back, skin sensitivity to touch. Today is the fifth day on a row that I have been enduring this.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Myalgia, Sensitive skin
Clinical narrative: horrible pain in upper chest and back, skin sensitivity to touch. Today is the fifth day on a row that I have been enduring this.
Age: 65.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Night following vaccinations patient states 50-cent piece sized red/itchy/slightly raised bump formed. They have had a similar reaction with the flu shot last year but it was only a small red/itchy area but with no swelling.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Skin warm, Swelling, Urticaria
Clinical narrative: CLIENT CALLED THIS MORNING AND REPORTED THAT SHE HAD HIVES ON HER RIGHT ARM THE DAY AFTER RABIES VACCINE WAS GIVEN ON TUEDAY 8/19/2020, IT WAS OVER HER TATOO AREA,RAISED, ITCHY AND HOT TO TOUCH AND LASTED FOR 2 DAYS. SHE TOOK BENADRYL AND IT WENT AWAY.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Abdominal pain upper, Headache, Injection site bruising, Injection site swelling, Injection site urticaria
Clinical narrative: Noticed hives at injection site of dtap, left thigh. Area swelling and hot to touch. Given 25 mg of benadryl and notification clinic of reactio, 1:15 pm. Hives subsided with benadryl but 2 hours later they reappeared. complained of her head hurting a lot and stomach pain. RN from clinic called and I gave her further information, no treatment advice given. Area marked with pen to watch for spreading, given another 25 mg dose of benadryl and added 10 mg claritin before bed, 8 pm. Also given 4 mg zofran for nausea as she complained she felt very sick.  This morning she complains of stomach pains and the hives have spread past the pen markings. Swelling still present and bruising at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site warmth, Nausea
Clinical narrative: Noticed hives at injection site of dtap, left thigh. Area swelling and hot to touch. Given 25 mg of benadryl and notification clinic of reactio, 1:15 pm. Hives subsided with benadryl but 2 hours later they reappeared. complained of her head hurting a lot and stomach pain. RN from clinic called and I gave her further information, no treatment advice given. Area marked with pen to watch for spreading, given another 25 mg dose of benadryl and added 10 mg claritin before bed, 8 pm. Also given 4 mg zofran for nausea as she complained she felt very sick.  This morning she complains of stomach pains and the hives have spread past the pen markings. Swelling still present and bruising at injection site.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Rash, Skin warm, Swelling
Clinical narrative: REDNESS AT SITE, HOT TO THE TOUCH, 4" X 3" RASH AREA, SWELLING. VACCINE ADMINISTERED 8/14/20, SYMPTOMS STARTED 8/20/20.
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Pain, Swelling, Vomiting
Clinical narrative: Swelling "the size of grapefruit" in left arm, sore to touch and vomiting on 08/20/20. RPh on duty advised to use ice and OTC pain reliever and monitor for improvement or more severe symptoms. Followed up on 08/21:patient used ice to bring down swelling and after vomiting stopped in the evening of 08/20 was able to use a pain reliever.  Swelling is down, "still a little swollen" and some pain upon touch, no redness reported.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Full blood count normal, Headache, Injection site pain, Malaise, Metabolic function test normal
Clinical narrative: had shingrix vax 7/20/20  woke up that night w nausea, vomit, body aches, muscle aches, ha. came in next day w severe sx. L arm sore at inj site wo redness. no nasal congestion or cough. does have lupus and is on plaquenil. This was her first of shingrix series. she denies any ill contacts. she did have a mild cold earlier this month.  we gave her toradol and promethazine in clinic and tramadol.  symptoms lasted for about 5 days and pt was so ill was unable to leave her house
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Pain, SARS-CoV-2 test negative, Vomiting
Clinical narrative: had shingrix vax 7/20/20  woke up that night w nausea, vomit, body aches, muscle aches, ha. came in next day w severe sx. L arm sore at inj site wo redness. no nasal congestion or cough. does have lupus and is on plaquenil. This was her first of shingrix series. she denies any ill contacts. she did have a mild cold earlier this month.  we gave her toradol and promethazine in clinic and tramadol.  symptoms lasted for about 5 days and pt was so ill was unable to leave her house
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Mobility decreased
Clinical narrative: had shingrix vax 7/20/20  woke up that night w nausea, vomit, body aches, muscle aches, ha. came in next day w severe sx. L arm sore at inj site wo redness. no nasal congestion or cough. does have lupus and is on plaquenil. This was her first of shingrix series. she denies any ill contacts. she did have a mild cold earlier this month.  we gave her toradol and promethazine in clinic and tramadol.  symptoms lasted for about 5 days and pt was so ill was unable to leave her house
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cold sweat, Diarrhoea haemorrhagic
Clinical narrative: Patient had cold sweats and chills 8 hours after vaccine, and then 10 hours after vaccine developed bloody diarrhea
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Conjunctival oedema, Erythema, Swelling face, Urticaria, Vomiting
Clinical narrative: Family returned at 11:30 am.  Infant's face was swollen and appears urticarial.  She has bulbar conjunctival swelling.  On exam, there were no wheezes or respiratory distress.  No tongue swelling or vomiting.  She was given Benadryl 3.75 p.o. in office and within 15 minutes she is sleepy and swelling is markedly improved.  She had no prior issues with her 2 month and 4 month vaccines.  Of note, mom fed the infant a small piece of egg for the 1st time, but mom says her face was already starting to turn red at theat point.  2:00 p., the father called stating she woke up and vomited x1.  Advised not to give egg again.  No other issues noted.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic, Vomiting
Clinical narrative: Mom states in the evening after receiving vaccines that morning, that the patient had vomiting and diarrhea with blood x 3 days.
Age: 39.0
Sex: M
Vaccine: FLUR4
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient passed out approximately 10 minutes after received vaccination. Was also very pale.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of vaccine and should have been given an adult dose.
Age: 22.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Chest pain, Dyspnoea, Headache
Clinical narrative: near "end of July" dev one day of chest pain, SOB, HA.  Then 1 AUG dev severe chest pain, diagnosed with STEMI/trop 15, clean cath, ultimately diagnosed with myocarditis
Age: 22.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Laboratory test, Myocarditis, Troponin increased
Clinical narrative: near "end of July" dev one day of chest pain, SOB, HA.  Then 1 AUG dev severe chest pain, diagnosed with STEMI/trop 15, clean cath, ultimately diagnosed with myocarditis