chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; A patient was administered an improperly stored dose of Varivax; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies and pertinent medical history were not reported.  On 14-APR-2020, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # S028926, expiration date 16-SEP-2021(dose was not reported) for prophylaxis.  The diluent used for administration was properly stored. The vaccine was stored at 10.4 grades Fahrenheit for 1 hour and 32 minutes. There was no previous temperature excursion. The call was made due to "data logger". The patient experienced no symptoms.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: I had a horrible case of flu-like symptoms / the worst most intense case of flu-like symptoms I've ever had; intense shivering / chills; fever but only lasted 12-14 hours; sweating; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms, shivering, fever and sweating. On an unknown date, the outcome of the influenza-like symptoms, shivering, fever and sweating were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, shivering, fever and sweating to be related to Shingrix.  Additional details were provided as follows: The patient had a horrible severe reaction- flu-like symptoms, intense shivering, chills, fever, sweating but only lasted about 12-14 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Paraesthesia, Sensitive skin
Clinical narrative: possible Shingles; burning; pins and needles feeling; very sensitive skin; This case was reported by a consumer via call center representative and described the occurrence of possible shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles, burning sensation, pins and needles and sensitive skin. On an unknown date, the outcome of the shingles, burning sensation, pins and needles and sensitive skin were unknown.   It was unknown if the reporter considered the shingles, burning sensation, pins and needles and sensitive skin 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 was selected as adult as per vaccine indication. The patient received 1st dose of Shingrix in mid December 2019 and experienced burning, pins and needles feeling, very sensitive skin. The patient ask question can you get shingles even if you've had the 1st dose 4 months ago? The patient was experiencing symptoms of Shingles after first dose of the Shingrix vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the 2nd dose of shingrix last October. I just got back from my primary doctor. I have shingles; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis, systemic lupus erythematosus and raynauds.   On an unknown date, the patient received the 1st dose of Shingrix. In October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and less than 6 months after receiving 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 provide as follows: The age at vaccination was not reported. The patient just got back from his primary physician and the patient had shingles. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported. The age group adult selected as per vaccine specification.  The reporter asked, Shingle shot side effects how long do they last.
Sex: U
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: I had a skin reaction after both the first and second injection; This case was reported by a consumer and described the occurrence of skin reaction in a 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 skin reaction. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had skin reaction after 1st dose. For tolerance to 2nd dose, refer case US2020AMR065889.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Skin reaction
Clinical narrative: I had a skin reaction after both the first and second injection; Has the vaccine had a reported side effect of long-lasting abdominal pain? / starting at the time of the second injection, stomach pain; This case was reported by a consumer and described the occurrence of skin reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of skin reaction (received 1 st dose on an unknown date, and experienced skin reaction, refer case US2020AMR065886).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin reaction and stomach pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the skin reaction and stomach pain were unknown.   It was unknown if the reporter considered the skin reaction and stomach pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had reported side effect of long-lasting abdominal pain and skin reaction.
Sex: M
Vaccine: RAB
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: Flu; This case was reported by a consumer via call center representative and described the occurrence of influenza in a male patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received RabAvert at an unknown dose. On an unknown date, 4 days after receiving RabAvert, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to RabAvert.  Additional details were reported as follows: The age at vaccination was not reported.  It was unknown if RabAvert was pre or post exposure. The patient stated he developed and tested positive for flu 4 days after getting the last shot of Rabavert.       Lab Comments: Lab test on an unknown date
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for an unknown indication.   On 12th October 2019, the patient received the 1st dose of Shingrix. On 12th October 2019, less than a day after receiving Shingrix, the patient experienced chills. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced sore arm. She states he also had chills a couple hours after the injection and that they lasted a couple days.  No other information was provided. The reporter did not consented to follow up.  This case was linked with case US2020051451 (wife's case), reported  by the same reporter.
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of shortness of breath in a 70-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Anoro with an associated reaction of dyspnoea (using since March 26, 2020 and was still having trouble breathing, defined as shortness of breath, refer case US2020AMR064641) and albuterol  with an associated reaction of dyspnoea (albuterol an unknown manufacturer's, refer case US2020AMR064641).   In November 2017, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced shortness of breath. On an unknown date, the outcome of the shortness of breath was unknown.   It was unknown if the reporter considered the shortness of breath to be related to Boostrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient also mentioned that she had a shot of Boostrix in November 2017 and experienced shortness of breath. Did not consent to follow-up. The patient was having a hard time breathing during this call.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: Cancer / maybe it was Multiple Myeloma; Multiple Myeloma; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced cancer (serious criteria GSK medically significant) and multiple myeloma (serious criteria GSK medically significant). The patient was treated with acyclovir, lenalidomide and dexamethasone. On an unknown date, the outcome of the cancer and multiple myeloma were unknown.   It was unknown if the reporter considered the cancer and multiple myeloma to be related to Shingrix.  Additional details were provide as follows: After vaccination, the patient started taking medications for Cancer. The pharmacist did not provide lot number and expiration date of the first dose because it was administer in another pharmacy. The pharmacist was not sure of the type of cancer, she thought that might be it was Multiple Myeloma.  She mentioned that the medications were Lenalidomide, Dexamethasone, Acyclovir and another one which name was not clear. The pharmacist wanted to administer the second dose before the patient started with chemotherapy. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dyspnoea, Lethargy, Pain
Clinical narrative: Covid-19 like symptoms/possible Coronavirus infection; cough; shortness of breath; lethargy; achiness; This case was reported by a consumer via call center representative and described the occurrence of possible coronavirus infection in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced coronavirus infection, cough, shortness of breath, lethargy and pain. The patient was treated with steroids nos (Steroids) and azithromycin (Z Pak). On an unknown date, the outcome of the coronavirus infection, cough, shortness of breath, lethargy and pain were unknown.   It was unknown if the reporter considered the coronavirus infection, cough, shortness of breath, lethargy and pain to be related to Shingrix.  Additional details were provided as follows: Customer stating around January 2020 and February 2020 she had Covid-19 like symptoms of cough, shortness of breath, lethargy, achiness, all symptoms of Covid-19 except no temperature. She was not tested so she does not know if it was Covid-19. She was put on steroids and ZPAK. She would like to get her second dose of Shingrix as soon as possible.. Did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Impaired work ability, Pain
Clinical narrative: felt achy; could not get to their yardwork; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain and impaired work ability. On an unknown date, the outcome of the pain and impaired work ability were unknown.   It was unknown if the reporter considered the pain and impaired work ability 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 was selected as adult as per vaccine indication. Consumer mentioned that his neighbor had a more severe reaction to the second Shingrix injection. He stated that the neighbor reported that they felt achy and could not get to their yardwork. Caller did not wish to provide any additional details (initials DOB, etc.) Did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; headaches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than a day after receiving Shingrix, the patient experienced fever, chills, general body pain and headache. On an unknown date, the outcome of the fever, chills, general body pain and headache were recovered/resolved.   It was unknown if the reporter considered the fever, chills, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: Caller was a patient. The patient received the 1st dose of Shingrix during the last week of December 2019. Patient states that on the same evening that she received the vaccine, she developed fever, chills, body aches and headaches. Patient states that these symptoms lasted for approximately 3 days before resolving. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Severe side effects; This case was reported by a physician via call center representative and described the occurrence of adverse event in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. Shingrix was discontinued. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were received as follows: This case received via chat.  The age at vaccination was not reported. The reporter reported that reports a male patient with immunodeficiency had severe reaction to the first dose of Shingrix and wants to avoid the second dose if first dose efficacy was reasonable. He later adds this patient had no adverse reaction just severe, known and reported side effects. The reporter consented to follow up. No further details provided via chat.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: she developed a "sore arm"; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 8th November 2019, 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 received as follows: On the same day of vaccination, the patient developed a sore arm and that resolved two days later. The reporter did not consented to follow up.  The reporter did not have any additional details for this case.  The reporter did not consented to follow up.  This case was linked with case US2020065625, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 6 months ago from the date of reporting). Concurrent medical conditions included tooth abscess (started on 8th April 20, for which she was taking an antibiotic and that antibiotic was making her nauseous and was also making her feel tired).   On 15th April 2020, the patient received the 2nd dose of Shingrix. On 15th April 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were received as follows: The patient received second dose of the Shingrix in her left arm (second dose received within six months of the first dose of the Shingrix vaccine). The reporter did not specified, the date of the first Shingrix vaccine. Before receiving the second dose of the Shingrix vaccine, the customer was being treated with antibiotics for a tooth abscess, after experiencing events from antibiotics, at the day of reporting, she went to the pharmacy to get another medication filled, at which time she received the second dose of the Shingrix vaccine.  The reporter stated she started to experience fever a few hours after receiving the vaccine. The reporter did not consented to follow up.  The reporter did not want to provide her address, the doctor's information or the pharmacy information.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: a 57 year old female who received the high dose vaccination/ no AE; a 57 year old female who received the high dose vaccination/ no AE; Initial information received on 13-Apr-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 57 years old female patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination on an unknown date.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  It is an actual case of medication error due to inappropriate age at vaccine administration and overdose. It was reported that a 57 year old female who received the high dose vaccination.  At the time of this report, no adverse event was reported.  There will be no information available on the batch number for this case.   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 Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Appetite disorder, Cough, Defaecation urgency, Diarrhoea
Clinical narrative: Within 24 hours the left arm swelled up. About 10 times the size of his arm. An intense cough started on the second day after the injection and lasted for 3 weeks. Poor sleeping started almost immediately as well as changes in appetite. Diarrhea started one week post vaccination and lasted for 8 weeks. Bowels are still not what they used to be. Still loose and urgency is increased. Behavioral changes occurred a couple of weeks after the vaccination and are still continuing.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Immediate post-injection reaction, Injection site swelling, Poor quality sleep
Clinical narrative: Within 24 hours the left arm swelled up. About 10 times the size of his arm. An intense cough started on the second day after the injection and lasted for 3 weeks. Poor sleeping started almost immediately as well as changes in appetite. Diarrhea started one week post vaccination and lasted for 8 weeks. Bowels are still not what they used to be. Still loose and urgency is increased. Behavioral changes occurred a couple of weeks after the vaccination and are still continuing.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Prostate cancer
Clinical narrative: Diagnosed with prostate cancer; This case was reported by a pharmacist via call center representative and described the occurrence of prostate cancer in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number TJ35Z, expiry date 1st December 2021) for prophylaxis.   On 28th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced prostate cancer (serious criteria GSK medically significant). The patient was treated with leuprorelin acetate (Eligard). On an unknown date, the outcome of the prostate cancer was unknown.   It was unknown if the reporter considered the prostate cancer to be related to Shingrix.  Additional details were provided as follows: The patient was diagnosed with prostate cancer.  Now the patient was taking Eligard, so the health care provider called asking if the patient could receive the second dose of Shingrix.  Also ask for information in the case that the patient did not want to receive a second dose or receive a late second dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pyrexia
Clinical narrative: Fever; Redness in the arm; Malaise; This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 15th April 2020, less than a day after receiving Shingrix, the patient experienced fever, erythema of extremities and malaise. On an unknown date, the outcome of the fever, erythema of extremities and malaise were unknown.   It was unknown if the reporter considered the fever, erythema of extremities and malaise to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix and experienced fever, redness in the arm and malaise. Nurse practitioner did not provide any detail for the adverse event report, she said she was in a hurry. She talked in regards to the patient as a female.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site reaction, Urticaria
Clinical narrative: Patient states after receiving vaccine she experienced a large circular welt at the injection site.  She was advised by MD to not received second dose of vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication, Vertigo
Clinical narrative: Woke up with severe vertigo 2 days after being vaccinated. Called pharmacist and he said it was a side effect from the vaccination. Advised me to take motion sickness medicine. It got a little better each day and was gone after 3 days.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling
Clinical narrative: Intermittent swelling and discomfort/pain at injection site. Still occurring today,  7 months later.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptoms; a patient was administered improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 13-APR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously (lot# S028926, expiration date 16-SEP-2021) (exact dose and site of administration were not reported) reconstituted with properly stored diluent for prophylaxis. The administered vaccine was stored in temperature of 10.4 Fahrenheit degrees for 1 hour and 32 minutes. There was no previous temperature excursion. Digital data logger was involved. The patient experienced no symptoms.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Rash
Clinical narrative: felt bad; Experienced flare up of the arm; late second dose of Shingrix over 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced feeling bad, rash over arms and incomplete course of vaccination. On an unknown date, the outcome of the feeling bad, rash over arms and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the feeling bad and rash over arms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient the patient experienced flare up of the arm and felt bad after first dose and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  The pharmacist unable to provide full patient details. The reporter did not consented to follow up.  This case was 1 of 8 cases, reported by same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Malaise
Clinical narrative: Experienced sickness after first dose; late second dose of Shingrix over 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that the patient experienced sickness after first dose and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  The pharmacist unable to provide full patient details. The reporter did not consented to follow up.  This case was 1 of 8 cases, reported by same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Leukaemia
Clinical narrative: was diagnosed with leukemia in January of 2020; This case was reported by a consumer via call center representative and described the occurrence of leukemia in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In January 2020, between 1 and 3 months after receiving Shingrix, the patient experienced leukemia (serious criteria GSK medically significant). On an unknown date, the outcome of the leukemia was unknown.   It was unknown if the reporter considered the leukemia to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left deltoid. The patient was diagnosed with leukemia. The reporter did not consent to follow-up. This case has been linked with case US2020065624, reported by the same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Arthralgia
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states only had soreness for a few days with the first administration of shingrix...upon receiving the second shot she states her arm has been sore for 58 days ..."at first radiating down to her elbow and then up into her neck"  does not report any range of motion issue     She has not sought medical services for this issue    She states it is now gradually feeling better, but wanted us to report her experience
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Patient had a fever of 104 degrees at 5:30 in the evening.  He was sore, nauseated, vomiting.  He felt bad all over.  He took Tylenol and his fever started going down about 3 AM.  He was feeling alright the next morning.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Patient complains that he received a shot in the left deltoid on December 10, 2019 and noticed that his left deltoid area began to be sore a couple of days later.  The pain has persisted somewhat since then and most noticeable when reaching upwards and/or backwards, behind him.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: experienced fever and body aches after the 2nd dose of Shingrix; experienced fever  after the 2nd dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of general body pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were unknown.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. A couple of people who experienced fever and body aches after the 2nd dose of Shingrix. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Nausea and vomiting with myalgia
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: & Urticaria
Age: 58.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Blister
Clinical narrative: Pt reported small fluid filled blisters on left arm after first zoster vaccine(shingrex) and 2nd dose was held.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vomiting
Clinical narrative: mild diarrhea and vomiting/stool swan was done and positive for rotavirus; This spontaneous report has been received from field representative on behalf of nurse practitioner and nurse concerning a 15-month-old patient of unknown gender. Patient's concurrent conditions and medical history was not reported. The patient's concomitant therapies included diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (PEDIARIX), hib conj vaccine (ompc)(PEDVAXHIB) and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). At 2 months of age (approximately on an unknown date in February 2019, also reported as December 2018), the patient was vaccinated with first dose of rotavirus vaccine, live, pentavalent (ROTATEQ) (dose not reported) orally (lot number: R016790, expiry date: 20-APR-2020) for prophylaxis. At 4 months of age (approximately on an unknown date in April 2019), the patient was vaccinated with second dose of rotavirus vaccine, live, pentavalent (ROTATEQ), (dose not reported) orally (lot number: R022223, expiry date: 24-MAY-2020). At 6 months of age (approximately on an unknown date in June 2019), the patient was vaccinated with third dose of rotavirus vaccine, live, pentavalent (ROTATEQ) (dose not reported) orally (lot number: R029815, expiry date: 18-JUN-2020). On 27-MAR-2020, the patient experienced mild diarrhea and vomiting. On the same day, stool swab was taken and came back as positive for rotavirus(gastroenteritis rotavirus) on 31-MAR-2020. The patient has sought medical attention and was treated with oral hydration and paracetamol(TYLENOL). On 31-MAR-2020, the patient recovered from the event. Casual relationship between the suspect therapy and the event was not reported.  Upon internal review, the event of gastroenteritis rotavirus was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid ptosis, Myasthenia gravis
Clinical narrative: Myasthenia gravis; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. In or around 05-JUN-2012, plaintiff was inoculated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for it's intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the zoster vaccine live (ZOSTAVAX), plaintiff suffered a severe droop to his eye. Plaintiff was diagnosed with autoimmune injury myasthenia gravis. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, plaintiff symptoms had resulted in physical limitations not present prior to using the vaccine. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.As a direct and proximate result of Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not reported.  The reporter considered myasthenia gravis to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, myasthenia gravis was determined to be medically significant. The reporter considered the event to be disabling.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event; a patient was inadverently administered a dose of MMR II, that had been improperly stored; This spontaneous report was received from a nurse and refers to a 12-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was provided. On 15-APR-2020, the patient was inadvertently vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot # S013415 with expiry date: 01-MAY-2021 ; dose, dose number, route of administration were not provided). Albumin status for lot # S013415 has been verified as recombinant human albumin (rHA). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (dose, lot number, expiry date were not provided). No adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 10 degrees Celsius for 4 hours and 30 minutes. There were no previous excursions related. Data logger was involved.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: About 3 weeks after shot I developed an area of parasthesia, 3-5 inches in diameter w/o rash on upper right back approximately midline to  mid-scapula, T4 to T8. not painful but distracting and constant which improved over months but did not resolve. I had my 2nd shot in early March of 2020, and at 4 weeks tingling sensation has returned with equal intensity in the same area. I am hoping it continues to diminish over time.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Condition aggravated, Gastrooesophageal reflux disease, Laboratory test, Major depression, Meningitis aseptic
Clinical narrative: This represents a re-challenge reaction, similar cascade of neurologic and neuropsychiatric difficulties following Td and Hepatitis B-2 injections in childhood. 1. GERD, significant, requiring treatment with gaba-nergic Baclofen, within days. 2. Major Depression symptoms over next two weeks - medication initiated. 3. Obsessive Compulsive symptoms marked especially by morbid indecision. 4. Aseptic Meningitis, possibly Drug-Induced, requiring hospitalization, onset about 4.5 months post-injection, hospitalization. 5. Worsening of neuropsychiatric symptoms ultimately resulted in suicidal ideation and first-ever psychiatric hospitalization for same
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Neurological symptom, Neuropsychiatric symptoms, Obsessive-compulsive disorder, Suicidal ideation
Clinical narrative: This represents a re-challenge reaction, similar cascade of neurologic and neuropsychiatric difficulties following Td and Hepatitis B-2 injections in childhood. 1. GERD, significant, requiring treatment with gaba-nergic Baclofen, within days. 2. Major Depression symptoms over next two weeks - medication initiated. 3. Obsessive Compulsive symptoms marked especially by morbid indecision. 4. Aseptic Meningitis, possibly Drug-Induced, requiring hospitalization, onset about 4.5 months post-injection, hospitalization. 5. Worsening of neuropsychiatric symptoms ultimately resulted in suicidal ideation and first-ever psychiatric hospitalization for same
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm very swollen, red and warm to touch.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills
Clinical narrative: Shaking chills, arthralgias.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: vertigo that started day after vaccine
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Condition aggravated, Neuropathy peripheral, Tinnitus
Clinical narrative: Tinnitus bilateral began within 25 minutes of administration and has been ongoing since the time of administration. Peripheral neuropathy worsened within one hour of administration and has not resolved or subsided since administration.
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Seizure
Clinical narrative: FEVER WITH SEIZURE  WITH IN  24 HRS
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Erythema, Injection site rash, Swelling face
Clinical narrative: Patient had a rash on L leg approximately 3-4 inches in length, approximately 1 inch below injection site. Rash look like little white heads that combined into a large area. Patient also had a 102 temperature and his face was very red and puffy
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Irritability
Clinical narrative: Left thigh redness, increased fussiness - RN tx interventions: Tylenol q4' for pain, fussiness: monitor for increasing redness/swelling; call back if not better in 3-7 -RN
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: -Swelling, redness right thigh -RN -increased fussiness -RN -tx interventions: administer Tylenol q4'; recommended in-office evaluation, RN
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Injection site erythema
Clinical narrative: -49.8' temp after vaccines - RN -bilateral redness to thighs - RN tx interventions - Tylenol q4' pain/fever/fussiness; monitor for increasing redness/swelling; call back if not better in 3-7d - RN
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Insomnia, Pain
Clinical narrative: Due to similar reaction with first injection in Nov, I took qty 1 Advil every 6 hrs At 8:00pm I felt tired At 10:00pm, I had chills and felt increasing body aches Fever with Advil 101.7  Body aches so bad that I couldn?t sleep - awakened 5-6 times between 1130and 0830 Fever at 0830 approx 101 With Advil next day, body aches continued, unable to work full day. Fever until 11:00pm in 99.7 prior to Advil  Similar symptoms with first does, except I was sick to stomach.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Due to similar reaction with first injection in Nov, I took qty 1 Advil every 6 hrs At 8:00pm I felt tired At 10:00pm, I had chills and felt increasing body aches Fever with Advil 101.7  Body aches so bad that I couldn?t sleep - awakened 5-6 times between 1130and 0830 Fever at 0830 approx 101 With Advil next day, body aches continued, unable to work full day. Fever until 11:00pm in 99.7 prior to Advil  Similar symptoms with first does, except I was sick to stomach.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pain
Clinical narrative: The patient reported feeling severe achiness about 1pm  on 4/8/2020 the day following the administration(4/7/20 @7:31am).  She contacted her obstetrician(pt is pregnant due date 6/7/20) and had a phone consultation.  The dr questioned the patient about Covid19, and expressed to the patient that Tylenol and monitoring were all that was needed at that time.  Pt felt better upon awakening the following day on 4/9/2020, and required no further follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: event began within hours of injection;  ongoing event as of today - upper arm sore, red area - 3" diameter, advil for pain
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives one hour after receiving the above listed vaccines. No shortness of breath, no wheezing, no increased work of breathing. Examined in office on 4/15/2020
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Fever 103.2, Severe Redness, Severe Soreness, Swelling, Severe Itching and Severe Heat at the site of the injection and Severe leg pain.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 103.2, Severe Redness, Severe Soreness, Swelling, Severe Itching and Severe Heat at the site of the injection and Severe leg pain.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Chills, Electrocardiogram, Feeling hot, Full blood count
Clinical narrative: Patient reported to medical department approximately 36 hours after Anthrax vaccination. He complained of 6/10 right arm pain and aches around vaccination site and noticed firmness and redness on upper right arm upon waking in AM of 4/12/2020. He took acetaminophen for pain and felt chills and felt warmer despite taking medication. No discharge from the arm and no other complaints. Patient denied any symptoms of chest pain/discomfort, difficulty breathing, cough, nausea/vomiting/diarrhea. Denies GI, MSK, and neurological symptoms. He was alert and oriented x3. Admitted to ICU for treatment and observation. IV placed and infused 2 Liters NS. Given Ceftriaxone 1 gram IV and started on Doxycycline 100mg TAB, given twice a day with meals on Day 1 and 2 with no significant improvement. Started Clindamycin IV in PM of 4/13/2020 and showed good results. 4/14/2020, Day 3, patient improved with resolution of cellulitis. Diagnosis: Cellulitis. Discharged with Clindamycin 150mg capsule, to be taken as 2 capsule every 6 hours, x12 days.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Intensive care, Metabolic function test, Neutrophil count increased
Clinical narrative: Patient reported to medical department approximately 36 hours after Anthrax vaccination. He complained of 6/10 right arm pain and aches around vaccination site and noticed firmness and redness on upper right arm upon waking in AM of 4/12/2020. He took acetaminophen for pain and felt chills and felt warmer despite taking medication. No discharge from the arm and no other complaints. Patient denied any symptoms of chest pain/discomfort, difficulty breathing, cough, nausea/vomiting/diarrhea. Denies GI, MSK, and neurological symptoms. He was alert and oriented x3. Admitted to ICU for treatment and observation. IV placed and infused 2 Liters NS. Given Ceftriaxone 1 gram IV and started on Doxycycline 100mg TAB, given twice a day with meals on Day 1 and 2 with no significant improvement. Started Clindamycin IV in PM of 4/13/2020 and showed good results. 4/14/2020, Day 3, patient improved with resolution of cellulitis. Diagnosis: Cellulitis. Discharged with Clindamycin 150mg capsule, to be taken as 2 capsule every 6 hours, x12 days.