chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. A Nurse Practitioner (NP) at a family practice recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of prevention and protection against shingles and zoster-related conditions. In or about October 2016, a healthcare provider at the family practice (unclear if was the NP) administered ZOSTAVAX to the patient (dose, route, and lot # not provided). In or about February 2017, the patient was treated by the NP for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a elderly female patient who received 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 fever, pain localized, chills, erythema and skin warm. On an unknown date, the outcome of the fever, pain localized, chills, erythema and skin warm were unknown. It was unknown if the reporter considered the fever, pain localized, chills, erythema and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient's age was in 70's. The patient experienced local pain, chills, fever and body temperature was recorded as 100 to 101 degree F, redness from shoulder almost to elbow and warm to touch. The doctor advised not to take second shot due to severity of reaction. The reporters did not consent to receive follow up. Lab Comments: Lab test was performed on an unknown date.
Sex: F
Vaccine: FLUX, TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml, dTpa vaccine and Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a month after receiving SHINGRIX and less than a year after receiving dTpa vaccine and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be related to SHINGRIX, dTpa vaccine and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: This case was reported by the other healthcare professional (HCP) for herself. The age at vaccination was not reported. In 2018, the patient received dose 1 of SHINGRIX in the left arm, approximately one month before the reporting date. The patient also received Tdap in the right arm prior week as well as flu shot in the left arm prior week. The patient's arm hurt significantly for a couple of weeks. The patient reported that her arm hurts almost one month later although she was unsure if it was related. The patient was not sure if the sore arm or arm hurt was full resolved or unrelated issue in arm. The patient did feel the sore arm or arm hurt was related to vaccines. No other obvious symptoms according to patient were reported. The patient did not agree to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist for the practice. The age at the vaccination was not reported. The patient experienced flu like symptoms for 1 to 2 days. The reporter agreed to receive follow up from GlaxoSmithKline. This case was linked with the cases US2018GSK205481 and US2018GSK204598, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included 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 injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The consumer reported that with a two to six month lead time, she had spent hours calling local pharmacies that were listed on website, but none of them had any shots. The patient was running out of time in her six month window and reported how painful the first shot was. She did not want to have to start over.
Sex: F
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa 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 DTPa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The reporter mentioned that the patient nearly lost to the DTPa shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blood pressure decreased, Diarrhoea, Flushing, Generalised erythema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 61-year-old female patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included irritable bowel syndrome and multiple allergies. On 5th November 2018, the patient received SHINGRIX. On 5th November 2018, less than a day after receiving SHINGRIX, the patient experienced diarrhea, stomach cramps, rash, swelling, low blood pressure, flushing, generalized erythema, lip swelling and hand swelling. On 6th November 2018, the patient experienced sickness. The patient was treated with prednisone, methylprednisolone sodium succinate (Solu-Medrol) and decadron (nos) (Decadron). On an unknown date, the outcome of the diarrhea, stomach cramps, rash, swelling, low blood pressure, flushing, sickness, generalized erythema, lip swelling and hand swelling were unknown. It was unknown if the reporter considered the diarrhea, stomach cramps, rash, swelling, low blood pressure, flushing, sickness, generalized erythema, lip swelling and hand swelling to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the other health professional (HCP) her herself. On 5th November 2018, in the middle of the night, the patient began to experience diarrhea all night, severe stomach cramps, a rash, swelling, and low blood pressure (90 over 60 something). This was further described as, flushed and red all over the body, lips, hands and feet were swollen, and related to the patient's irritable bowel syndrome. On 6th November 2018, the patient was seen in the emergency room (ER), and was given 40 mg Prednisone, intravenous (IV) Solu-Medrol and 8 mg Decadron, and discharged after 3 hours. On 6th November 2018, 1 day after receiving SHINGRIX the patient was really sick.The patient stated that the some of the reported symptoms began 2 to 3 weeks prior to receiving the SHINGRIX and were on and off due to her diet. The patient related the symptoms to accidentally eat rice and black beans, and a history of allergies, and Irritable bowel syndrome. The patient also stated that the ER physician related the symptoms to a histamine release since the symptoms began 24 hours after receiving the vaccine and not immediately following administration. No additional information or clarification could be obtained. The representative was unable to clarify specific allergies.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Lip swelling, Malaise, Peripheral swelling, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 61-year-old female patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included irritable bowel syndrome and multiple allergies. On 5th November 2018, the patient received SHINGRIX. On 5th November 2018, less than a day after receiving SHINGRIX, the patient experienced diarrhea, stomach cramps, rash, swelling, low blood pressure, flushing, generalized erythema, lip swelling and hand swelling. On 6th November 2018, the patient experienced sickness. The patient was treated with prednisone, methylprednisolone sodium succinate (Solu-Medrol) and decadron (nos) (Decadron). On an unknown date, the outcome of the diarrhea, stomach cramps, rash, swelling, low blood pressure, flushing, sickness, generalized erythema, lip swelling and hand swelling were unknown. It was unknown if the reporter considered the diarrhea, stomach cramps, rash, swelling, low blood pressure, flushing, sickness, generalized erythema, lip swelling and hand swelling to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the other health professional (HCP) her herself. On 5th November 2018, in the middle of the night, the patient began to experience diarrhea all night, severe stomach cramps, a rash, swelling, and low blood pressure (90 over 60 something). This was further described as, flushed and red all over the body, lips, hands and feet were swollen, and related to the patient's irritable bowel syndrome. On 6th November 2018, the patient was seen in the emergency room (ER), and was given 40 mg Prednisone, intravenous (IV) Solu-Medrol and 8 mg Decadron, and discharged after 3 hours. On 6th November 2018, 1 day after receiving SHINGRIX the patient was really sick.The patient stated that the some of the reported symptoms began 2 to 3 weeks prior to receiving the SHINGRIX and were on and off due to her diet. The patient related the symptoms to accidentally eat rice and black beans, and a history of allergies, and Irritable bowel syndrome. The patient also stated that the ER physician related the symptoms to a histamine release since the symptoms began 24 hours after receiving the vaccine and not immediately following administration. No additional information or clarification could be obtained. The representative was unable to clarify specific allergies.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 61-year-old female patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included irritable bowel syndrome and multiple allergies. On 5th November 2018, the patient received SHINGRIX. On 5th November 2018, less than a day after receiving SHINGRIX, the patient experienced diarrhea, stomach cramps, rash, swelling, low blood pressure, flushing, generalized erythema, lip swelling and hand swelling. On 6th November 2018, the patient experienced sickness. The patient was treated with prednisone, methylprednisolone sodium succinate (Solu-Medrol) and decadron (nos) (Decadron). On an unknown date, the outcome of the diarrhea, stomach cramps, rash, swelling, low blood pressure, flushing, sickness, generalized erythema, lip swelling and hand swelling were unknown. It was unknown if the reporter considered the diarrhea, stomach cramps, rash, swelling, low blood pressure, flushing, sickness, generalized erythema, lip swelling and hand swelling to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the other health professional (HCP) her herself. On 5th November 2018, in the middle of the night, the patient began to experience diarrhea all night, severe stomach cramps, a rash, swelling, and low blood pressure (90 over 60 something). This was further described as, flushed and red all over the body, lips, hands and feet were swollen, and related to the patient's irritable bowel syndrome. On 6th November 2018, the patient was seen in the emergency room (ER), and was given 40 mg Prednisone, intravenous (IV) Solu-Medrol and 8 mg Decadron, and discharged after 3 hours. On 6th November 2018, 1 day after receiving SHINGRIX the patient was really sick.The patient stated that the some of the reported symptoms began 2 to 3 weeks prior to receiving the SHINGRIX and were on and off due to her diet. The patient related the symptoms to accidentally eat rice and black beans, and a history of allergies, and Irritable bowel syndrome. The patient also stated that the ER physician related the symptoms to a histamine release since the symptoms began 24 hours after receiving the vaccine and not immediately following administration. No additional information or clarification could be obtained. The representative was unable to clarify specific allergies.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tingling in a 55-year-old female patient who received 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 tingling. On an unknown date, the outcome of the tingling was recovered/resolved. It was unknown if the reporter considered the tingling to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The physician reported that the patient experienced tingling in her face following SHINGRIX. The patient drove to the emergency room but felt better on arrival and did not go in. No further details were available to the reporter. The reporter gave consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Product supply issue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 27th April 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and fever. On an unknown date, the patient experienced product supply issue. On 30th April 2018, the outcome of the influenza-like symptoms, general body pain and fever were recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the influenza-like symptoms, general body pain and fever to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine in left arm. In the evening the patient developed flu like symptoms, including body aches and fever. The reporter reported that the patient was late to receive second dose of the SHINGRIX vaccine, as the last day for her to have received it in order to be within the six month time frame was 27th October 2018. The patient was already about 10 days past for six month mark. The patient was trying for weeks now to find the second vaccine. The reporter gave permission for her physician to be contacted.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain
Clinical narrative: felt horrific; aches; flu-like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of feeling abnormal in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number J4D5J, expiry date 8th February 2021) for prophylaxis.   On 1st November 2018, the patient received the 1st dose of Shingrix. On 2nd November 2018, 1 days after receiving Shingrix, the patient experienced feeling abnormal, pain and influenza-like symptoms. On 6th November 2018, the outcome of the feeling abnormal, pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the feeling abnormal, pain and influenza-like symptoms to be related to Shingrix.  Additional information received as follows: The case was reported by the pharmacy technician. The patient felt horrific, felt like she had the flu with aches. The reporter did not have further qualitative details about the flu-like symptoms or the felt horrific events. The reporter gave consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received BEXSERO for prophylaxis. On 24th August 2018, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site erythema, injection site swelling, injection site bruising, injection site induration and skin discoloration. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site bruising and skin discoloration were unknown and the outcome of the injection site induration was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site bruising, injection site induration and skin discoloration to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. Lot number was unavailable at time of reporting. The reported that the patient experienced an injection site reaction after vaccination with BEXSERO. The injection site was red, swollen, bruised, and brownish in color, and at the time of reporting the site was hard after 1 week.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult female patient who received 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 wheal. On an unknown date, the outcome of the injection site wheal was unknown. It was unknown if the reporter considered the injection site wheal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the experienced a welt at the injection site. The reporter did not wish to provide demographics or participate in a safety report.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacist for herself. The age at the vaccination was not reported. The patient experienced soreness for a couple of hours after receiving SHINGRIX. The patient did not provide vaccine information.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in an unspecified number of adult patients who received 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 and fever. On an unknown date, the outcome of the injection site pain and fever were unknown. It was unknown if the reporter considered the injection site pain and fever 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 adult as per vaccine indication. The pharmacist reported that multiple physicians have reported that patients complain of pain at injection and fever and do not want to get the 2nd dose. The pharmacist reported that some of the physicians said they reported it and others said they did not. The pharmacist consented to follow up. No patient identifiers were reported. This was all the information provided. This case has been linked with the case US2018GSK217223, reported by same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Injection site erythema, Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX. On 8th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell and headache. On 9th November 2018, the patient experienced fever, feeling cold, injection site erythema, sleep disturbance and injection site pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the feeling unwell, headache, fever, feeling cold, injection site erythema and injection site pain were recovered/resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the pain in arm, feeling unwell, headache, fever, feeling cold, injection site erythema, sleep disturbance and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX last Thursday on left arm and later that evening she had a sore arm, general unwell feeling, and headache. Early in the AM on Friday 1 day after vaccination, the patient kept waking up freezing, stated she had a fever probably and she had a 4 inch long by 2 inch wide red area at the site of the injection and more painful. On Saturday the area was now 2 inches lower on her arm. All issues resolved except the area was still tender to touch. The patient noted she also had allergy shots in her left arm in the same area as the SHINGRIX shot on Thursday as well. The patient noted she gets the shots every 7 weeks and the two she received that day were for mold and dust which were major allergens for her. Consented to follow up. The healthcare professional info not asked. The product received at pharmacy.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Sleep disorder, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX. On 8th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell and headache. On 9th November 2018, the patient experienced fever, feeling cold, injection site erythema, sleep disturbance and injection site pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the feeling unwell, headache, fever, feeling cold, injection site erythema and injection site pain were recovered/resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the pain in arm, feeling unwell, headache, fever, feeling cold, injection site erythema, sleep disturbance and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX last Thursday on left arm and later that evening she had a sore arm, general unwell feeling, and headache. Early in the AM on Friday 1 day after vaccination, the patient kept waking up freezing, stated she had a fever probably and she had a 4 inch long by 2 inch wide red area at the site of the injection and more painful. On Saturday the area was now 2 inches lower on her arm. All issues resolved except the area was still tender to touch. The patient noted she also had allergy shots in her left arm in the same area as the SHINGRIX shot on Thursday as well. The patient noted she gets the shots every 7 weeks and the two she received that day were for mold and dust which were major allergens for her. Consented to follow up. The healthcare professional info not asked. The product received at pharmacy.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 19-year-old female patient who received BEXSERO for prophylaxis. Concurrent medical conditions included drug hypersensitivity. On 31st October 2018, the patient received BEXSERO. On an unknown date, 3 days after receiving BEXSERO, the patient experienced fatigue, general body pain, nausea, headache, neck pain, pain in hand, muscle pain and joint pain. On an unknown date, the outcome of the fatigue, general body pain, nausea, headache, neck pain, pain in hand, muscle pain and joint pain were not recovered/not resolved. It was unknown if the reporter considered the fatigue, general body pain, nausea, headache, neck pain, pain in hand, muscle pain and joint pain to be related to BEXSERO. Additional details were reported as follows: This case was reported by the patient's mother. The patient received BEXSERO on right arm. Three days following the vaccination, the patient experienced symptoms of fatigue, body aches, nausea, pain at injection site, headache and neck pain. The fatigue was so severe that, she stayed in bed all day. The injection pain went down to her hand where there was a spot which was very tender. The body aches were throughout her muscles and joints. The reporter gave consent to follow up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 19-year-old female patient who received BEXSERO for prophylaxis. Concurrent medical conditions included drug hypersensitivity. On 31st October 2018, the patient received BEXSERO. On an unknown date, 3 days after receiving BEXSERO, the patient experienced fatigue, general body pain, nausea, headache, neck pain, pain in hand, muscle pain and joint pain. On an unknown date, the outcome of the fatigue, general body pain, nausea, headache, neck pain, pain in hand, muscle pain and joint pain were not recovered/not resolved. It was unknown if the reporter considered the fatigue, general body pain, nausea, headache, neck pain, pain in hand, muscle pain and joint pain to be related to BEXSERO. Additional details were reported as follows: This case was reported by the patient's mother. The patient received BEXSERO on right arm. Three days following the vaccination, the patient experienced symptoms of fatigue, body aches, nausea, pain at injection site, headache and neck pain. The fatigue was so severe that, she stayed in bed all day. The injection pain went down to her hand where there was a spot which was very tender. The body aches were throughout her muscles and joints. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Inappropriate schedule of product administration, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included 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, 1 day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced tiredness, pain, cold, pain in arm and drug dose administration interval too long. On an unknown date, the outcome of the tiredness, pain, cold and pain in arm were recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the tiredness, pain, cold and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient was late to receive the second dose in the series, which led to which led to lengthening of the vaccination schedule. The patient reported that she experienced feeling super tired, achy, and cold starting the next day after receiving the vaccination. These symptoms resolved within one day of starting. The patient also reported that her arm was sore for a couple of days after receiving the vaccination. The reporter gave consent to follow up. The reporter gave permission for her physician to be contacted.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 5th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th October 2018, 1 days 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 details were reported as follows: The next day of vaccination the patients left arm was sore. The patient stated that the soreness had diminished some, however, her arm was still a little sore. The reporter did not give consent to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received PREVNAR 13 (Lot number and expiration date were not reported), with route of administration and therapy dates unspecified at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had flu-like symptoms and severe arm pain/soreness. The outcome of the events, 'flu-like symptoms' and 'severe arm pain/soreness', was unknown. No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Computerised tomogram abdomen, Computerised tomogram head, Concussion, Postictal state, Seizure like phenomena
Clinical narrative: Collapsed from standing. Seizure-like activity. Concussion. Prolonged post-ictal period.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Collapsed from standing. Seizure-like activity. Concussion. Prolonged post-ictal period.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Pain, Skin warm, Swelling
Clinical narrative: Swelling, bruising, hot to touch and painful.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin warm, Urticaria
Clinical narrative: 2nd SHINGRIX shot on 11/29 at 10a. By evening, body aches, big as my fist, hot to touch. 12/1: very sore with same welt hot to touch, aching.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Chest discomfort, Echocardiogram normal, Electrocardiogram normal, Muscle tightness
Clinical narrative: I'm a 70 year old ovarian cancer patient, had total hysterectomy on Oct 23 and received my first chemo treatment Nov 7 and my second treatment of TAXOL/Carboplatin on Nov 28. At that appointment my oncologist said I should get a flu shot, which I did on Nov 29 about 12:30 PM. About 9 PM that evening I experienced tightness in the center of my chest and tightness in my neck. We went to the ER and they ran EKG, echocardiogram, vascular ultrasound and blood work and found no heart problem. I was admitted and monitored overnight. I've never had a flu shot before, so I don't know how I'd respond if not getting chemo. I read the info sheet on the possible flu shot side effects and saw that even though rare, the chest and throat tightness are listed as possible side effects and felt I should report it.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound Doppler normal
Clinical narrative: I'm a 70 year old ovarian cancer patient, had total hysterectomy on Oct 23 and received my first chemo treatment Nov 7 and my second treatment of TAXOL/Carboplatin on Nov 28. At that appointment my oncologist said I should get a flu shot, which I did on Nov 29 about 12:30 PM. About 9 PM that evening I experienced tightness in the center of my chest and tightness in my neck. We went to the ER and they ran EKG, echocardiogram, vascular ultrasound and blood work and found no heart problem. I was admitted and monitored overnight. I've never had a flu shot before, so I don't know how I'd respond if not getting chemo. I read the info sheet on the possible flu shot side effects and saw that even though rare, the chest and throat tightness are listed as possible side effects and felt I should report it.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Erythema, Induration, Malaise, Myalgia
Clinical narrative: I am 69 years old and just had my second dose of PNEUMOVAX 23. My arm became red, hard and extremely sore with swelling all the way to my elbow. My deltoid muscle has never been so sore. I have felt sick and no appetite. Two days later the soreness is still there but the swelling is beginning to dissipate. This is the worse vaccine I have ever had.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: I am 69 years old and just had my second dose of PNEUMOVAX 23. My arm became red, hard and extremely sore with swelling all the way to my elbow. My deltoid muscle has never been so sore. I have felt sick and no appetite. Two days later the soreness is still there but the swelling is beginning to dissipate. This is the worse vaccine I have ever had.
Sex: F
Vaccine: HPV4
Symptoms: Emotional distress, Impaired work ability, Ovarian cyst ruptured, Pain, Ultrasound scan
Clinical narrative: I have been having issues for years and it took a lot of money and after cysts rupturing I went to the ER. After speaking with other people my age who diagnosis I found the common denominator of GARDASIL. It is a painful and ongoing struggle that has cost thousands of dollars, time from work, and emotional trauma.
Age: 43.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Burning sensation, Limb injury, Pain in extremity, Tendonitis
Clinical narrative: I was given the flu shot on Oct 29 2018 and a Tdap booster in the left arm at my Doc office. The first shot I received felt like burning in my arm almost like somebody threw acid on my skin. I told the Nurse that burned she replied that was the flu shot it usually hurts. The Tdap was given next I didn't feel anything. Afterwards I knew I had to use the arm even if it's sore. I work as a Nurse in a Nursing home. I continued my daily duties at home and work but my arm stayed in pain. I went to work and questioned it maybe 4 days in. The Nurses thought maybe since I had two shots I was in more pain. I went with that until it was hard to take my shirt off and sleep on my left side. I contacted my Doc office that administered the shot. Dr. said TYLENOL, heating pad and if not better in 1 week return. That didn't work, I returned to the office and was diagnosed with bicep tendinitis. I have to do physical therapy starting Tuesday. That Doc also stated I had some type of injury in my shoulder. I cried as he assessed my upper arm/shoulder. I've never had history of any tendinitis anywhere in my body. I don't have any history of any injuries to any arms either. None of this occurred until after I received the flu shot on 10/29. Daily activities are now painful for me. What am I to do next?
Sex: F
Vaccine: HPV4
Symptoms: Amyotrophic lateral sclerosis, Autopsy, Death, Disease progression, Spinal cord disorder
Clinical narrative: This spontaneous report was received from a physician via an online article and refers to a 20-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, reported as within four months after her first GARDASIL shot, the patient developed symptoms of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The reporter stated that disease progressed very fast(the disease progressed more quickly than typical for young ALS patients). She died on an unknown date in August 2008 (reported as last August), reported as 28 months later (also reported as 13 months later), at the age of 22 years old. The cause of death was reported as amyotrophic lateral sclerosis (ALS). An autopsy was performed. The autopsy results showed that the patient's spinal cord was so inflammatory(also reported as distinct immunological features), very different that normally seen in ALS (as reported). The reporter considered amyotrophic lateral sclerosis to be related to GARDASIL. The physician reported that both the timing of the symptoms and autopsy results "suggest a link between" the vaccine and the fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. She also stated that with only two confirmed cases, they did not know for sure if it was coincidence or if they were connected to the vaccine. The pathology features all supported a temporal association between the illness and vaccination. The relatedness between the spinal cord inflammatory and GARDASIL was not provided. Upon internal review, the amyotrophic lateral sclerosis and spinal cord inflammatory (disorder) were considered to be medically significant. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA000380: US-009507513-1811USA012613: Reported Cause(s) of Death: amyotrophic lateral sclerosis; Autopsy-determined Cause(s) of Death: spinal cord was so inflammatory. That is very different from what we normally see in ALS.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: This case was reported by a other health professional via patient support programs and described the occurrence of inappropriate route of vaccination in a 9-week-old female patient who received ROTARIX lyophilized formulation (batch number G5JL7, expiry date 19th October 2019) for prophylaxis. On 14th September 2018, the patient received ROTARIX lyophilized formulation (intramuscular). On 14th September 2018, unknown after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown. Additional details were reported as follows: The age at vaccination was not reported. The caller reported misadministration, vaccine was given intramuscularly instead of orally, which led to inappropriate route of vaccination. The caller was not aware of any adverse symptoms or reactions. The reason for faxing form was GlaxoSmithKline response center was closed. Follow up information received from other health professional (clinic administrator) on 26th November 2018: The patient's demographic details and reporter's contact details were updated. The patient had no adverse reaction, other than redness at the injection site. Less than a year after vaccination the patient experienced redness at the injection site. The GlaxoSmithKline was called and no forms were fixed. The VAERS details were updated. This was medication error without harm. It was unknown if the reporter considered redness at the injection site to be related to Rotarix lyophilized formulation.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 72-year-old female patient who received 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 fever, pain and feeling miserable. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the pain and feeling miserable were unknown. It was unknown if the reporter considered the fever, pain and feeling miserable to be related to SHINGRIX. Additional details were received as follows; The age at vaccination was not reported. After receiving SHINGRIX vaccine the patient had a fever for two days, ached, and was miserable. For tolerance refer US2018GSK215265 for 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nervousness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose). On 14th November 2018, the patient received the 2nd dose of SHINGRIX. On 15th November 2018, 1 days after receiving SHINGRIX, the patient experienced headache, chills and general body pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, chills and general body pain were unknown. It was unknown if the reporter considered the headache, chills and general body pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with the second dose of SHINGRIX one day before the date of reporting. On the date of reporting, the patient woke up with headache, chills and body aches. The patient stated that this did not happen with the first dose. The patient saw these side effects were common. The patient enquired that how long would the events last, the patient was nervous because she had to travel on the next day of reporting and hoped she would feel better. The patient stated that Advil seemed to helped out somewhat.
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of nausea in a female patient who received BOOSTRIX for prophylaxis. On 16th November 2018, the patient received BOOSTRIX. In November 2018, less than a week after receiving BOOSTRIX, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were unknown. It was unknown if the reporter considered the nausea and vomiting to be related to BOOSTRIX. Additional details were received as follows: The age at vaccination was not reported. The patient had nausea and vomited twice after vaccination with SHINGRIX. The reporter agreed to follow up from GlaxoSmithKline.
Sex: F
Vaccine: DTAP
Symptoms: Movement disorder, Paralysis
Clinical narrative: This case was reported by a consumer via Interactive Digital Media and described the occurrence of paralysis in a child female patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced paralysis (serious criteria GSK medically significant) and movement disorder. On an unknown date, the outcome of the paralysis and movement disorder were unknown. It was unknown if the reporter considered the paralysis and movement disorder to be related to DTPa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that her daughter was paralyzed by the pertussis vaccine as a child. The reporter reported build your immune system instead of taking a chance. The reporter reported that the patient could move was her eyes only. The reporter reported that she was an anti Vac and tell everyone not to get GARDASIL shot for their kids too. Case correction was done on 03 December 2018: The first time the reporter mentioned the DPT vaccine was from the follow-up comments that were received by GSK on 26 November 2018. This is the time when the case was considered as valid.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills and injection site pain. On an unknown date, the outcome of the fever, chills and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, chills and injection site pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The case was reported by the registered nurse for herself. The patient had fever, chills and the site was painful when pressed. Lot and expiration date was not available. The patient informed that the 2nd dose of SHINGRIX had her a worst reaction that the 1st dose that was fever, chills and painful when pressed. For tolerance refer case US2018211886.