chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Chest discomfort, Discomfort, Fatigue, Headache
Clinical narrative: Flu like symptoms; Headache; Fatigue; Fever; Joint pain; Muscle pain; Heaviness in chest; Heavy feeling; This case was reported by a physician via licensee and described the occurrence of influenza-like symptoms in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 1st October 2020, the patient received the 2nd dose of RabAvert. On 1st October 2020, less than a day after receiving RabAvert, the patient experienced influenza-like symptoms, headache, fatigue, fever, joint pain, muscle pain, chest heaviness and sensation of heaviness. On an unknown date, the outcome of the influenza-like symptoms, headache, fatigue, fever, joint pain, muscle pain, chest heaviness and sensation of heaviness were recovered/resolved.   The reporter considered the influenza-like symptoms, headache, fatigue, fever, joint pain, muscle pain, chest heaviness and sensation of heaviness to be possibly related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The patient received pre-exposure vaccine series. The patient received 1st dose of RabAvert on 24th September 2020 and was fine. The patient received 2nd dose of vaccine and about 6-8 hours later she had flu like symptoms, headache, fatigue, fever, joint and muscle pain, heaviness in chest but later it was more like a heavy feeling all over. The patient had no chest pain, rashes, shortness of breath, cough, wheezes, upper respiratory symptoms (runny nose, congestion), abdominal pain, vomiting diarrhea, hives, closing throat/ airway. It sounded like side effects and not having a true anaphylactic reaction. The patient went to bed on the same evening and felt fine the next morning. The patient was also concerned enough to get a COVID test, but it came back negative. This case has been linked with US2020AMR208129 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR208129:same reporter
Sex: F
Vaccine: RAB
Symptoms: Influenza like illness, Myalgia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Flu like symptoms; Headache; Fatigue; Fever; Joint pain; Muscle pain; Heaviness in chest; Heavy feeling; This case was reported by a physician via licensee and described the occurrence of influenza-like symptoms in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 1st October 2020, the patient received the 2nd dose of RabAvert. On 1st October 2020, less than a day after receiving RabAvert, the patient experienced influenza-like symptoms, headache, fatigue, fever, joint pain, muscle pain, chest heaviness and sensation of heaviness. On an unknown date, the outcome of the influenza-like symptoms, headache, fatigue, fever, joint pain, muscle pain, chest heaviness and sensation of heaviness were recovered/resolved.   The reporter considered the influenza-like symptoms, headache, fatigue, fever, joint pain, muscle pain, chest heaviness and sensation of heaviness to be possibly related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The patient received pre-exposure vaccine series. The patient received 1st dose of RabAvert on 24th September 2020 and was fine. The patient received 2nd dose of vaccine and about 6-8 hours later she had flu like symptoms, headache, fatigue, fever, joint and muscle pain, heaviness in chest but later it was more like a heavy feeling all over. The patient had no chest pain, rashes, shortness of breath, cough, wheezes, upper respiratory symptoms (runny nose, congestion), abdominal pain, vomiting diarrhea, hives, closing throat/ airway. It sounded like side effects and not having a true anaphylactic reaction. The patient went to bed on the same evening and felt fine the next morning. The patient was also concerned enough to get a COVID test, but it came back negative. This case has been linked with US2020AMR208129 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR208129:same reporter
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Inappropriate schedule of product administration, Product administered at inappropriate site
Clinical narrative: Sick; Missed the 6 month window; Administered it intramuscularly into her left thigh; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number H4H34, expiry date 27th November 2021) and (batch number J3M5J, expiry date 6th February 2022) for prophylaxis. This case was associated with a product complaint.   Previously administered products included Zostavax (live shingles) injection and Shingrix with an associated reaction of product administered at inappropriate site (1st dose received on 29th February 2020 with batch number H4H34 and expiry date 27th November 2021 refer case US2020AMR206531).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced sickness, drug dose administration interval too long and vaccine administered at inappropriate site. On an unknown date, the outcome of the sickness, drug dose administration interval too long and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.   Additional information was provided as follows: The case was reported by patient herself who was a nurse. She said that she was very experienced.  She had been a nurse for 45 years and had given thousands of shots.  She bought the dose of Shingrix from the pharmacy and they allowed her to reconstitute and administer the injections at their home.  She stored the un-reconstituted vials in the refrigerator.  The pharmacy dispensed her two of the one dose combo packs and both had the same lot number and same expiration date.  She administered the Shingrix shot to herself about 2 weeks ago.  She did not remember the exact date because she said that both she had both been "sick" recently. Prior to reconstitution, when she was pulling the liquid adjuvant out of the vial into the syringe she said it leaked/sprayed all over the place.  She said that at the time you could see the hole where the needle had pierced the rubber stopper but you cannot see it anymore thus she will not be sending any pictures.  Because the first adjuvant vial leaked she used the second adjuvant vial instead and was able to draw it up with no problem and reconstitute it and administer it to herself.  She administered it intramuscularly into her left thigh which led to vaccine administered at inappropriate site The patient had missed the 6 month window which led to drug dose administration interval too long. The case also linked with US2020204764 same reporter. It was unknown if the reporter considered the sickness to be related to Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020204764:Husband's case
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Influenza, Respiratory disorder, Suspected COVID-19
Clinical narrative: received the first dose / on 31-Dec-2019 but have not received the 2nd dose; it may have beed COVID-19 or influenza; respiratory tract symptoms / respiratory tract symptoms in february 2020; it may have beed COVID-19 or influenza/ suspected Influenza; This case was reported by a nurse via call center representative and described the occurrence of suspected covid-19 in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. In February 2020, between 1 and 2 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced suspected covid-19, respiratory tract disorder and influenza. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the suspected covid-19, respiratory tract disorder and influenza were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the suspected covid-19, respiratory tract disorder and influenza to be related to Shingrix.  Additional details were provided as follows: The reporter was a consumer but who was also a nurse. The patient experienced upper respiratory tract symptoms in february 2020 after the first dose of Shingrix (the patient did not have the lot numbers). The reporter thought it might be COVID-19 or influenza. Outcome was reported as fully recovered. The age at vaccination was not applicable for the 2nd dose of Shingrix.  The patient had not received the 2nd dose till the time of reporting, this led to incomplete course of vaccination. The reporter consented to follow up. The case has been linked with the case US2020206902 reported for husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206902:same reporter
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: painful red bump 0.8 cm in diameter erupted in her right arm; Itchy, painful red bump 0.8 cm in diameter erupted in her right arm; Itchy, painful red bump 0.8 cm in diameter erupted in her right arm; Itchy, painful red bump 0.8 cm in diameter erupted in her right arm; This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 73-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2KK23, expiry date unknown) for prophylaxis.   On 23rd September 2020, the patient received Boostrix. On 23rd September 2020, less than a day after receiving Boostrix, the patient experienced local swelling, pruritus, pain in arm and erythema. On an unknown date, the outcome of the local swelling, pruritus and pain in arm were unknown and the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the local swelling, pruritus, pain in arm and erythema to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix and experienced itchy, painful red bump 0.8 cm in diameter erupted on her arm (unknown if bump is at exact site of injection, it is the right arm, same as injected arm) which was not recovered till the time of reporting. When palpitated it doesn't feel like there's water or liquid inside. The reporter did not consented to follow up. No further information was available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Arm is still tender; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received the dose of Shingrix and experienced arm tender which did not resolved till the time of reporting. The reporter did not consented to follow up. No further information was available.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: administration of a booster dose or a complete dosing schedule of the Engerix-B vaccine if a patient tested negative for HepB antibodies; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a child patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received engerix B vaccine nad tested negative for Hepatitis B anibody which led to therapy non-responder.  The reporter called to request information about the administration of a booster dose or a complete dosing schedule of the Engerix-B vaccine if a patient tested negative for Hepatitis B antibodies but was vaccinated during childhood. The reporter did not consent to follow-up.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Based on information previously received, the case assessed as non-case was reassessed as valid.  Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves male patient (demographics unknown) who had flu (influenza), while he received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  The patient had taken 1st and last flu shot, which was 30 years ago. He got the worst case of the flu he ever had before or after. He had the flu twice since he took the shot.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
Sex: M
Vaccine: FLUX
Symptoms: Gait inability, Guillain-Barre syndrome, Neuralgia, Paralysis
Clinical narrative: Guillain Barre Syndrome; body began paralyzing itself; lost his ability to walk; So much suffering and severe nerve pain; Initial information received on 14-Oct-2020 regarding an unsolicited valid serious case from a non-health care professional (patient's wife) via social media .  This case involves a male patient of an unknown age who developed Guillain-Barre syndrome, his body began paralyzing itself (paralysis), lost his ability to walk (gait inability) and severe nerve pain/ so much suffering (neuralgia), while he received vaccine INFLUENZA VACCINE.  At the time of the event, the patient was a compromised sick guy with ongoing dialysis (Crazy blood cleaning treatment) and was suffering so much.  Concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date were not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date , the patient developed serious events of Guillain-Barre syndrome, 3 years ago, his body began paralyzing itself (paralysis) ,lost his ability to walk (gait inability) and severe nerve pain/ so much suffering (neuralgia) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  A patient was seeing  specialists and they started the transplant process over at a better hospital.  No laboratory data reported.  Diagnosis was reported as Guillain-Barre syndrome.  The patient recovered from the event of gait inability on an unknown date, while did not recovered from Guillain Barre syndrome.  The outcome was unknown for the events paralysis and neuralgia.  Information on the batch number to be requested for this case.; Sender's Comments: This case involves male patient of unknown age who presented with Guillain-Barre syndrome, paralysis, gait inability and neuralgia, after vaccination with INFLUENZA VACCINE from unknown manufacturer. Time to onset is unknown. Patient was already on dialysis. Other relevant information regarding patient's condition and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: the patient died from the flu shot; Initial information received on 19-Oct-2020 regarding an unsolicited valid serious case received from a consumer via social media.  This case involves a male patient (unknown age) who died (death) after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  Date of death was not reported. It was unknown at the time of reporting if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: A case was reported from social media, which involved a male patient of an unknown age who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset was unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination, concomitant medication and Laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS
Age: 13.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13 year-old female patient received FLUBLOK, no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 year old female patient who received 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Patient no other vaccines administered to the patient.   On 13-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2035 and expiry date: 30-Jun-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on same day).  At the time of report no adverse event was reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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: 41.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Peripheral swelling
Clinical narrative: swelling and redness of left thumb starting a few minutes after vaccination. There was no swelling or redness at the injection site.
Age: 86.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Balance disorder, Loss of consciousness, Vomiting
Clinical narrative: 6 hours after receiving the vaccine patient's family reported patient became unsteady on her feet and lost consciousness for 30 seconds. after she regained consciousness she reportedly vomited
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Pain, Pyrexia, Rash
Clinical narrative: Light headedness, body aches, fever, nausea, rash on arm from 10/20/2020 until afternoon of 10/22/2020.  Rash persists.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Dizziness, Faeces soft, Nausea
Clinical narrative: Started feeling very nausea and woozy around dinner time the day of receiving the vaccine (vaccine was administered around 10:20AM on 10/20/20). Threw up twice, and had soft stools. Had some ginger ale to calm stomach. Went to sleep, woke up weak and dizzy the next morning (10/21/20). Almost fell down twice due to dizziness. Felt nauseous and dizzy on and off all day and didn't eat much. Slept well that night, and felt better the morning of 10/22/20.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Started feeling very nausea and woozy around dinner time the day of receiving the vaccine (vaccine was administered around 10:20AM on 10/20/20). Threw up twice, and had soft stools. Had some ginger ale to calm stomach. Went to sleep, woke up weak and dizzy the next morning (10/21/20). Almost fell down twice due to dizziness. Felt nauseous and dizzy on and off all day and didn't eat much. Slept well that night, and felt better the morning of 10/22/20.
Age: 91.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Malaise, Mobility decreased, Myalgia
Clinical narrative: Severe muscle aches, headache, unable to get out of bed - aches started a few hours after injection.  By the next morning the patient could not even get out of bed even while on tylenol.  Very sick.  Couldn't eat or sit up. 21 hours later - on Tylenol and Advil - can sit up for a few minutes
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dysarthria, Hypoaesthesia, Limb discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: 2 hours later tingling in both shoulders radiating down both arms and hands, eventually heaviness and numbness in both hands. Took 2 hour nap and had difficulty speaking, slurred speech, heavy tongue.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder
Clinical narrative: 2 hours later tingling in both shoulders radiating down both arms and hands, eventually heaviness and numbness in both hands. Took 2 hour nap and had difficulty speaking, slurred speech, heavy tongue.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: MMRV was given instead of Varicella vaccine, in addition to another MMR vaccine. Continuing to monitor for outcomes, but this increases the risk of febrile seizures.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Chills, shivers, body aches
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Patient is here to follow-up on injection site reaction she had to Pneumovax 23.  She was given the immunization on October 13 in her left deltoid.  Patient states the area became red and swollen and tender within a few hours after getting the shot.  He states the following day she felt more tired and dizzy as well as a little lethargic.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lethargy
Clinical narrative: Patient is here to follow-up on injection site reaction she had to Pneumovax 23.  She was given the immunization on October 13 in her left deltoid.  Patient states the area became red and swollen and tender within a few hours after getting the shot.  He states the following day she felt more tired and dizzy as well as a little lethargic.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Immediately after administration it was very painful, unlike any she's had before, felt like an electric shock or a deep burn.  Over 2 weeks the pain has shifted to a dull ache that is deep steady and worse with use of the shoulder. Hurts to sleep on it, hurts to lift and reach behind/above her head. No history of shoulder problems before.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Immediately after administration it was very painful, unlike any she's had before, felt like an electric shock or a deep burn.  Over 2 weeks the pain has shifted to a dull ache that is deep steady and worse with use of the shoulder. Hurts to sleep on it, hurts to lift and reach behind/above her head. No history of shoulder problems before.
Age: 76.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Mobility decreased, Nodule, Pain in extremity
Clinical narrative: Patient and husband had the same vaccines. Felt fine afterwards. By the third, she had some soreness, progressively got worse to the point where she couldn't lift her arm. Very uncomfortable. Pain went down arm to the fingertips. Thought that it could have hit a nerve. The spot at the injection is sore into the left breast. She has had a double mastectomy. Feeling kind of lumpy in the arm.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: rash on left arm and chest redness and some swelling on left arm at injection site
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Dysphagia, Dyspnoea
Clinical narrative: at 2000 developed nausea, stomach upset, and diarrhea. then chills, diaphoresis. around 2200 developed shortness of breath, wheezing, pharyngeal edema. presented to PCP clinic this AM for walk in visit. I sent her to the emergency room for IV steroids as she was unable to swallow pills due to the pharyngeal edema.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Nausea, Pharyngeal oedema, Wheezing
Clinical narrative: at 2000 developed nausea, stomach upset, and diarrhea. then chills, diaphoresis. around 2200 developed shortness of breath, wheezing, pharyngeal edema. presented to PCP clinic this AM for walk in visit. I sent her to the emergency room for IV steroids as she was unable to swallow pills due to the pharyngeal edema.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, aches, nausea. I had them for approximately 24-48 hours.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, chills, aches, nausea. I had them for approximately 24-48 hours.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Peripheral swelling, Rash
Clinical narrative: The day after the immunization, Bicep swelled up with a rash.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Neuralgia
Clinical narrative: Patient states she is experiencing nerve pain,still from the shot given on 9/11/2020 over 30 days ago. I recommended patient contact prescriber to be since
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: pain in his shoulders, arms and legs; pain in his shoulders, arms and legs; soreness at injection site; full body myalgia; This spontaneous report was received from a physician and refers to a 72-year-old male patient. His concurrent conditions included hypercholesterolaemia. His medical history included microcytic anaemia. The patient had no known drug allergies. His concomitant medications were not reported.  On 20-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 injection, intramuscularly (IM)  (lot # T017385 and expiry date 01-SEP-2021 verified to be valid) for prophylaxis against pneumococcal disease.  On the same day, the patient experienced soreness at injection site and full body myalgia. Additionally, after 5 minutes of post-administration observation, the patient walked to his car and experienced pain in his shoulders, arms and legs, requiring him to return to the clinic. He was given intravenous (IV) acetaminophen (dose undisclosed) and recovered after 30-40 minutes. The physician reported he felt comfortable letting the patient leave. No lab diagnostics/studies were performed.  The relatedness between the events and the suspect vaccine was not reported.