chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Possible dose of Boostrix administered to 7 year old; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Possible dose of Boostrix administered to 7 year old). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 14-SEP-2023. Possible adverse event submitted via sales representative on behalf of RN.  The vaccine administration facility was the same as primary reporter. Possible dose of Boostrix administered to 7 year old which lead to Inappropriate age at vaccine administration.  No additional adverse event information provided. Sales rep information emailed to safety team
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Amnesia, Confusional state
Clinical narrative: Experienced memory loss; Memory loss which continued into the next morning with confusion; This non-serious case was reported by a nurse via call center representative and described the occurrence of confusion in a 87-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9By32, expiry date 11-MAY-2024) for prophylaxis.   On 03-SEP-2023, the patient received Arexvy (left deltoid). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced confusion (Verbatim: Memory loss which continued into the next morning with confusion) and memory loss (Verbatim: Experienced memory loss).  In SEP-2023, the outcome of the memory loss was resolved. The outcome of the confusion was unknown.   It was unknown if the reporter considered the confusion and memory loss to be related to Arexvy.     It was unknown if the company considered the confusion and memory loss to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-SEP-2023. The reporter stated that the wife of the patient called the reporter on September 7, 2023.     After the patient received the vaccine, the patient experienced memory loss which continued into the next morning with confusion.   It took about 3 hours before the patient could remember everything. The reporter provide the lot number for Arevy, but this does match the product. The patient received the vaccine at a pharmacy. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: FLUX, RSV
Symptoms: Arthralgia, Condition aggravated, Musculoskeletal chest pain
Clinical narrative: sharp pain in the rib area; soreness in the shoulder area; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included rib pain (prior to the vaccination).   On 09-SEP-2023, the patient received Arexvy (left arm) and Flu vaccine (right arm). On 12-SEP-2023, 3 days after receiving Arexvy and Flu vaccine, the patient experienced rib pain (Verbatim: sharp pain in the rib area). In SEP-2023, the patient experienced shoulder soreness (Verbatim: soreness in the shoulder area).The outcome of the shoulder soreness and rib pain were unknown.   It was unknown if the reporter considered the shoulder soreness and rib pain to be related to Arexvy and Flu vaccine.   It was unknown if the company considered the shoulder soreness and rib pain to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter was the patient.  The patient received Arexvy and a Flu vaccine (unknown manufacturer).  The patient believed that the Arexvy was given in left arm and the Flu vaccine in the right. The patient experienced soreness in the shoulder area (right and left) after receiving the vaccines.  The patient also experienced a sharp pain in the rib area on Tuesday. The patient had experienced pain in the rib area in the past (prior to the vaccinations). Currently, the patient had a Chiropractor working near the area of the rib cage. The reporter/patient gave consent to follow up with healthcare professional (pharmacy). The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Headache, Hypoaesthesia
Clinical narrative: dead arm; debilitating; missed 1 and 1/2 days of work; dry Heaving; vomiting; sore arm on that same day; stomach Pain; nausea; fever; shivering; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of dry heaves in a 66-year-old female patient who received Herpes zoster (Shingrix) (expiry date 08-JUL-2024) for prophylaxis.   On 11-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 11-SEP-2023, less than a day after receiving Shingrix, the patient experienced dry heaves (Verbatim: dry Heaving), vomiting (Verbatim: vomiting), pain in arm (Verbatim: sore arm on that same day), stomach pain (Verbatim: stomach Pain), nausea (Verbatim: nausea), fever (Verbatim: fever), shivering (Verbatim: shivering) and headache (Verbatim: headache). On an unknown date, the patient experienced numbness of upper extremities (Verbatim: dead arm), weakness (Verbatim: debilitating) and inability to work (Verbatim: missed 1 and 1/2 days of work).  The patient was treated with acetylsalicylic acid (Aspirin). On 12-SEP-2023, the outcome of the nausea and headache were resolved (duration 1 day). The outcome of the dry heaves, vomiting, stomach pain, fever, shivering, numbness of upper extremities, weakness and inability to work were resolved and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the dry heaves, vomiting, pain in arm, stomach pain, nausea, fever, shivering, headache, numbness of upper extremities, weakness and inability to work to be related to Shingrix.     It was unknown if the company considered the dry heaves, vomiting, pain in arm, stomach pain, nausea, fever, shivering, headache, numbness of upper extremities, weakness and inability to work to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-SEP-2023 The case was reported by the patient. The reporter reported that she received Shingrix from her pharmacist in her left arm on Monday at 1 PM and by 11PM- 12AM that evening she was pretty sick experiencing vomiting, dry heaving, headache, shivering, fever, nausea, stomach pain and a sore arm on that same day. The patient reported that her arm hurt so much it felt like a dead arm and she put her arm in a sling until yesterday, 13th September 2023.  The patient reported that the headache was very severe and the headache and the stomach pain were debilitating.  The patient reported that the nausea and the headache lasted until 3 PM on Tuesday, 12-SEP-2023. The patient reported that it took 2 days, until yesterday, 13-SEP-2023 to start feeling better and she took 1 Aspirin (no product information or date provided) to help her tolerate everything.  The patient reported that she missed 1 and 1/2 days of work.  The patient reported that she was over all the adverse reactions at the time of reporting, except her arm was still a little sore if she lifts it above the shoulder.  The patient did not have the lot for the vaccine. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: dead arm; debilitating; missed 1 and 1/2 days of work; dry Heaving; vomiting; sore arm on that same day; stomach Pain; nausea; fever; shivering; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of dry heaves in a 66-year-old female patient who received Herpes zoster (Shingrix) (expiry date 08-JUL-2024) for prophylaxis.   On 11-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 11-SEP-2023, less than a day after receiving Shingrix, the patient experienced dry heaves (Verbatim: dry Heaving), vomiting (Verbatim: vomiting), pain in arm (Verbatim: sore arm on that same day), stomach pain (Verbatim: stomach Pain), nausea (Verbatim: nausea), fever (Verbatim: fever), shivering (Verbatim: shivering) and headache (Verbatim: headache). On an unknown date, the patient experienced numbness of upper extremities (Verbatim: dead arm), weakness (Verbatim: debilitating) and inability to work (Verbatim: missed 1 and 1/2 days of work).  The patient was treated with acetylsalicylic acid (Aspirin). On 12-SEP-2023, the outcome of the nausea and headache were resolved (duration 1 day). The outcome of the dry heaves, vomiting, stomach pain, fever, shivering, numbness of upper extremities, weakness and inability to work were resolved and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the dry heaves, vomiting, pain in arm, stomach pain, nausea, fever, shivering, headache, numbness of upper extremities, weakness and inability to work to be related to Shingrix.     It was unknown if the company considered the dry heaves, vomiting, pain in arm, stomach pain, nausea, fever, shivering, headache, numbness of upper extremities, weakness and inability to work to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-SEP-2023 The case was reported by the patient. The reporter reported that she received Shingrix from her pharmacist in her left arm on Monday at 1 PM and by 11PM- 12AM that evening she was pretty sick experiencing vomiting, dry heaving, headache, shivering, fever, nausea, stomach pain and a sore arm on that same day. The patient reported that her arm hurt so much it felt like a dead arm and she put her arm in a sling until yesterday, 13th September 2023.  The patient reported that the headache was very severe and the headache and the stomach pain were debilitating.  The patient reported that the nausea and the headache lasted until 3 PM on Tuesday, 12-SEP-2023. The patient reported that it took 2 days, until yesterday, 13-SEP-2023 to start feeling better and she took 1 Aspirin (no product information or date provided) to help her tolerate everything.  The patient reported that she missed 1 and 1/2 days of work.  The patient reported that she was over all the adverse reactions at the time of reporting, except her arm was still a little sore if she lifts it above the shoulder.  The patient did not have the lot for the vaccine. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching, Vomiting
Clinical narrative: dead arm; debilitating; missed 1 and 1/2 days of work; dry Heaving; vomiting; sore arm on that same day; stomach Pain; nausea; fever; shivering; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of dry heaves in a 66-year-old female patient who received Herpes zoster (Shingrix) (expiry date 08-JUL-2024) for prophylaxis.   On 11-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 11-SEP-2023, less than a day after receiving Shingrix, the patient experienced dry heaves (Verbatim: dry Heaving), vomiting (Verbatim: vomiting), pain in arm (Verbatim: sore arm on that same day), stomach pain (Verbatim: stomach Pain), nausea (Verbatim: nausea), fever (Verbatim: fever), shivering (Verbatim: shivering) and headache (Verbatim: headache). On an unknown date, the patient experienced numbness of upper extremities (Verbatim: dead arm), weakness (Verbatim: debilitating) and inability to work (Verbatim: missed 1 and 1/2 days of work).  The patient was treated with acetylsalicylic acid (Aspirin). On 12-SEP-2023, the outcome of the nausea and headache were resolved (duration 1 day). The outcome of the dry heaves, vomiting, stomach pain, fever, shivering, numbness of upper extremities, weakness and inability to work were resolved and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the dry heaves, vomiting, pain in arm, stomach pain, nausea, fever, shivering, headache, numbness of upper extremities, weakness and inability to work to be related to Shingrix.     It was unknown if the company considered the dry heaves, vomiting, pain in arm, stomach pain, nausea, fever, shivering, headache, numbness of upper extremities, weakness and inability to work to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-SEP-2023 The case was reported by the patient. The reporter reported that she received Shingrix from her pharmacist in her left arm on Monday at 1 PM and by 11PM- 12AM that evening she was pretty sick experiencing vomiting, dry heaving, headache, shivering, fever, nausea, stomach pain and a sore arm on that same day. The patient reported that her arm hurt so much it felt like a dead arm and she put her arm in a sling until yesterday, 13th September 2023.  The patient reported that the headache was very severe and the headache and the stomach pain were debilitating.  The patient reported that the nausea and the headache lasted until 3 PM on Tuesday, 12-SEP-2023. The patient reported that it took 2 days, until yesterday, 13-SEP-2023 to start feeling better and she took 1 Aspirin (no product information or date provided) to help her tolerate everything.  The patient reported that she missed 1 and 1/2 days of work.  The patient reported that she was over all the adverse reactions at the time of reporting, except her arm was still a little sore if she lifts it above the shoulder.  The patient did not have the lot for the vaccine. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received Shingrix shot #1 but failed get shot #2 within the 6 month window; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received Shingrix shot #1 but failed get shot #2 within the 6 month window).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-SEP-2023 The reporter reported that she was unaware that she should report asymptomatic event of a patient failing to get the Shingrix 2nd shot within the six month window.  She stated different doctors have informed her numerous times that a patient has received Shingrix shot1 but failed get shot 2 within the 6 month window (or at all). GSK field representative did not recall specific dates when she learned of these events but it was over 24 hours ago therefore I am putting yesterday's date. Till the date of reporting the patient did not received2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The case is linked with US2023127597, US2023127596, by same reporter.; Sender's Comments:  US-GSK-US2023127597:Same reporter US-GSK-US2023127596:Same reporter
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Injection site urticaria
Clinical narrative: mild hives at injection site; fatigue; headache; Pain; received her AREXVY and SHINGRIX vaccines on the same day and in the same arm; pain in the injected arm; pain in the injected shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hives in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-SEP-2023, the patient received Shingrix (intramuscular, unknown arm) and Arexvy (unknown arm). On 12-SEP-2023, less than a day after receiving Shingrix and Arexvy, the patient experienced headache (Verbatim: headache), pain (Verbatim: Pain) and wrong technique in drug usage process (Verbatim: received her AREXVY and SHINGRIX vaccines on the same day and in the same arm). On 13-SEP-2023, the patient experienced injection site hives (Verbatim: mild hives at injection site) and fatigue (Verbatim: fatigue). In SEP-2023, the patient experienced pain in arm (Verbatim: pain in the injected arm) and shoulder pain (Verbatim: pain in the injected shoulder).The outcome of the injection site hives was resolved and the outcome of the headache, pain in arm and pain were not resolved and the outcome of the fatigue was resolving and the outcome of the shoulder pain was not reported and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the injection site hives, headache, fatigue, pain in arm, shoulder pain and pain to be related to Shingrix and Arexvy.  It was unknown if the company considered the injection site hives, headache, fatigue, pain in arm, shoulder pain and pain to be related to Shingrix and Arexvy.   Additional Information: GSK Receipt Date:15-SEP-2023 The patient called with questions about Arexvy and mentioned that she experienced some side effects. She received her Arexvy and Shingrix vaccines on the same day and in the same arm.  She mentioned that she experienced pain in the injected arm/shoulder, mild hives at the injection site, fatigue and headache.  The hives had resolved and the fatigue was lessening.  The headache and arm pain were still bothersome. The reporter did not consent to follow-up.
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pain, Pain in extremity, Wrong technique in product usage process
Clinical narrative: mild hives at injection site; fatigue; headache; Pain; received her AREXVY and SHINGRIX vaccines on the same day and in the same arm; pain in the injected arm; pain in the injected shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hives in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-SEP-2023, the patient received Shingrix (intramuscular, unknown arm) and Arexvy (unknown arm). On 12-SEP-2023, less than a day after receiving Shingrix and Arexvy, the patient experienced headache (Verbatim: headache), pain (Verbatim: Pain) and wrong technique in drug usage process (Verbatim: received her AREXVY and SHINGRIX vaccines on the same day and in the same arm). On 13-SEP-2023, the patient experienced injection site hives (Verbatim: mild hives at injection site) and fatigue (Verbatim: fatigue). In SEP-2023, the patient experienced pain in arm (Verbatim: pain in the injected arm) and shoulder pain (Verbatim: pain in the injected shoulder).The outcome of the injection site hives was resolved and the outcome of the headache, pain in arm and pain were not resolved and the outcome of the fatigue was resolving and the outcome of the shoulder pain was not reported and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the injection site hives, headache, fatigue, pain in arm, shoulder pain and pain to be related to Shingrix and Arexvy.  It was unknown if the company considered the injection site hives, headache, fatigue, pain in arm, shoulder pain and pain to be related to Shingrix and Arexvy.   Additional Information: GSK Receipt Date:15-SEP-2023 The patient called with questions about Arexvy and mentioned that she experienced some side effects. She received her Arexvy and Shingrix vaccines on the same day and in the same arm.  She mentioned that she experienced pain in the injected arm/shoulder, mild hives at the injection site, fatigue and headache.  The hives had resolved and the fatigue was lessening.  The headache and arm pain were still bothersome. The reporter did not consent to follow-up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site muscle weakness, Vaccination site pain
Clinical narrative: muscle weakness around the injection site (mild); Arm pain at injection site (mild); This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE MUSCLE WEAKNESS (muscle weakness around the injection site (mild)) and VACCINATION SITE PAIN (Arm pain at injection site (mild)) in a 41-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced INJECTION SITE MUSCLE WEAKNESS (muscle weakness around the injection site (mild)) and VACCINATION SITE PAIN (Arm pain at injection site (mild)). At the time of the report, INJECTION SITE MUSCLE WEAKNESS (muscle weakness around the injection site (mild)) and VACCINATION SITE PAIN (Arm pain at injection site (mild)) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication not reported.   Treatment medication not reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart palpitations" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Mangos" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid received).  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: FLUX
Symptoms: Immunisation reaction
Clinical narrative: gets bad side effects from the flu shot; Initial information received on 18-Sep-2023 regarding an unsolicited valid social media non-serious case received from consumer/non-hcp.  This case involves an unknown age female patient who gets bad side effects from the flu shot after receiving influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had got bad side effects from the flu shot (immunisation reaction) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (gets bad side effects from the flu shot).  At time of reporting, the outcome was Unknown for the event gets bad side effects from the flu shot.
Age: 67.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Lichen planus
Clinical narrative: lichen planus rash which covered her entire body; Initial information received on 18-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 67-years-old female patient who had lichen planus rash which covered her entire body after receiving covid-19 vaccine and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Allergy to chemicals.  On an unknown date in 2021, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer and COVID-19 vaccine not produced by Sanofi Pasteur (formulation, batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date in 2021 the patient had lichen planus rash which covered her entire body (lichen planus) (unknown latency) following the administration of influenza vaccine and covid-19 vaccine.  Action taken: not applicable.  It was reported the patient received a corrective treatment with oral steroids, topical steroids, and light therapy for the event (lichen planus rash which covered her entire body).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event lichen planus rash which covered her entire body.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: missed the second dose due to not showing up on the scheduled date with no adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 19-years-old female patient who had missed the second dose of rabies (HDC) vaccine [Imovax Rabies] due to not showing up on the scheduled date with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Sep-2023, the patient missed Dose 2 of suspect rabies (HDC) vaccine, powder and solvent for suspension for injection (batch number, expiry date unknown) via unknown route in unknown administration site for immunization due to not showing up on the scheduled date with no adverse event (product dose omission issue) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Myocarditis, Pain
Clinical narrative: Myocarditis. Discomfit and pain have continued intermittently since first Covid vaccination. Often the associated discomfort/pain will also directly precede and then accompany symptomatic expression of any similar illness (minor cold for example) suffered since vaccination.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Pain
Clinical narrative: I got shot on 9/13 approx an hour later my shoulder was sore but I thought it was just normal soreness from the flu shot, over the next couple of days it progressed into my shoulder joint.  Now I can't lift my arm above 30 degrees without having pain in my shoulder joint. Today is the first day I've noted a slight amount of improvement but still painful when lifting my arm without support or pushing/pulling objects.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Headache, Insomnia, Nausea, Pain
Clinical narrative: overall body aches to the point of nausea with pain particularly bad around joints, headache and difficulty sleeping.
Age: 53.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Abdominal discomfort, Anxiety, Arthralgia, Blood test, Chest X-ray
Clinical narrative: Swollen tongue. tickling on the tongue. little difficulty breathing. dry cough with a  "strange sound". headache and joint pain. Little desire to eat due to stomach discomfort. insomnia and a lot of anxiety; It has improved after 24 days.
Age: 53.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Cough, Decreased appetite, Dyspnoea, Headache, Insomnia
Clinical narrative: Swollen tongue. tickling on the tongue. little difficulty breathing. dry cough with a  "strange sound". headache and joint pain. Little desire to eat due to stomach discomfort. insomnia and a lot of anxiety; It has improved after 24 days.
Age: 53.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Paraesthesia oral, Swollen tongue, Urine analysis
Clinical narrative: Swollen tongue. tickling on the tongue. little difficulty breathing. dry cough with a  "strange sound". headache and joint pain. Little desire to eat due to stomach discomfort. insomnia and a lot of anxiety; It has improved after 24 days.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Abdominal discomfort, Burning sensation, Headache, Stress
Clinical narrative: At about 7 p.m., roughly seven hours after the shot, I started feeling a burning sensation in my right arm that I figured was probably a normal reaction so I didn't think much of it. By 9 p.m. the same burning sensation was occurring in my left arm. I took an Advil PM and went to bed but the burning continued to spread. By midnight, both arms, my thighs, feet, hands and abdomen were all on fire. I had a splitting headache as well, but that may have been from the stress of not being able to stop the burning all over my body. This continued throughout the night. My plan was to go to the emergency room if it continued to the morning. But sometime between 5 and 7 a.m. it stopped. Thank God!!
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Induration, Pain, Pruritus, Skin discolouration
Clinical narrative: swelling, harness in center, hot to touch, swelling,  redness grew, black and blue one right side of shot and skin discoloration to right of black and blue hour glass shape.  shot on 20. itching started on the 25 hardess and heat less but redness spreading. Area involved is about 3 inches in diameter of a circle. sore less on day 5, swelling slightly less.  I have never had a reaction to a shot before. I was not given batch number nor list of ingredients just info sheet from cdc so I am to sure which RSV shot I got. I showed the reaction to the pharmacist on 9/22. He filled out a report.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Skin warm, Swelling
Clinical narrative: swelling, harness in center, hot to touch, swelling,  redness grew, black and blue one right side of shot and skin discoloration to right of black and blue hour glass shape.  shot on 20. itching started on the 25 hardess and heat less but redness spreading. Area involved is about 3 inches in diameter of a circle. sore less on day 5, swelling slightly less.  I have never had a reaction to a shot before. I was not given batch number nor list of ingredients just info sheet from cdc so I am to sure which RSV shot I got. I showed the reaction to the pharmacist on 9/22. He filled out a report.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: I?ve had Covid arm for Pfizer COVID shots 3-6. (The very first two- dose did not give it to me). Covid arm appear anywhere from 12-24 hours after injection. Just thought I would report it since I seem to get it every time now.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: reported that they have administered an expired FLUZONE QIV-NP vaccine with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 14-year-old female patient and the reporter reported that they have administered an expired influenza quadrival A-B vaccine [Fluzone QIV] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 12-Sep-2023, the patient received  0.5 ml total dose of suspect influenza quadrival A-B vaccine Suspension for injection (strength: unknown) (lot: UT7759KA, expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for Immunization and reporter reported that they have administered an expired fluzone qiv-np vaccine with no reported adverse event (expired product administered) (latency: same day).  Action taken with quadrivalent influenza vaccine (Fluzone QIV) was not applicable.  Outcome: Unknown    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 the 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: 1.33
Sex: M
Vaccine: TDAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: staff was attempting to administer the boostrix to a 15-month old patient, but gave the adacel instead with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old male patient and reporter reported that the staff was attempting to administer the Boostrix to a patient, but gave the Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hib Vaccine Conj (Tet Tox) (Acthib) for Prophylactic vaccination.  On 14-Sep-2023, the patient received a dose of 0.5 ml of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (Strength: standard, Frequency: once, expiry date: 03-Oct-2025 and lot U7905AA) instead of Boostrix (lot number unknown) (strength: not reported) via intramuscular route in the left thigh as immunization (wrong product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles a couple months later/suspected vaccination failure; got shingles a couple months later; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles a couple months later/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles a couple months later). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-SEP-2023 The case was received from the consumer interactive digital media. The reporter stated that two people (patient) in the neighborhood got the shingles vaccine and they were also the only two people in the neighborhood who got shingles a couple months later. The reporter stated that people were starting to wake up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2023AMR128169, reported by same reporter. The follow-up would not required per process.; Sender's Comments:  US-GSK-US2023AMR128169:Original Case : US2023AMR128156
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-740880 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740880:Same reporter
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, hard to the touch, and hot starting 09/23/2023 through the present. Additionally, site became itchy 09/24/2023. Swollen area around injection site about 3" width and 1" height.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, COVID-19 pneumonia, Dyspnoea, Productive cough
Clinical narrative: Presented with weakness, fever, SOB, productive cough; + Covid ED; Admitted  to medical with Covid PNA; tx with maxipime, steroids, remdesivir, zithromax, rocephin, singulair, zinc, minimal O2 supplement;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Presented with weakness, fever, SOB, productive cough; + Covid ED; Admitted  to medical with Covid PNA; tx with maxipime, steroids, remdesivir, zithromax, rocephin, singulair, zinc, minimal O2 supplement;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cough, Decreased appetite, Dyspnoea
Clinical narrative: sick x9 days. C/O cough, decreased appetite, cough sob. sat 84%, fever 102.5. Acute resp failure hypoxia, COVID Pneumonia. Dexamethasone, ABX, and 3L O2. Overnight placed on AirVO 40L/50%. CPAP at night. remdisivir given. Wean AirVO to 30L35%. prior to discharge pt weaned to 3L NC. Walk study done, pt discharged with O2. Discharged with 4 more days of steroids.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Positive airway pressure therapy, Pyrexia, Walking distance test
Clinical narrative: sick x9 days. C/O cough, decreased appetite, cough sob. sat 84%, fever 102.5. Acute resp failure hypoxia, COVID Pneumonia. Dexamethasone, ABX, and 3L O2. Overnight placed on AirVO 40L/50%. CPAP at night. remdisivir given. Wean AirVO to 30L35%. prior to discharge pt weaned to 3L NC. Walk study done, pt discharged with O2. Discharged with 4 more days of steroids.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, C-reactive protein, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Presented with SOB/cough/fever x 2days; +covid in ED; CXR - multifocal PNA type pattern, dx: Covid PNA; Labs: D dimer 0.42; CRP 4.1; Ferritin 250.; Tx: Zithromax, remdesivir, Rocephin, Decadron, Singulair, Xarelto, Zinc; Initially on 3-4 LPM supplement O2; down to room air by d/c
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fibrin D dimer, Pneumonia, Pyrexia
Clinical narrative: Presented with SOB/cough/fever x 2days; +covid in ED; CXR - multifocal PNA type pattern, dx: Covid PNA; Labs: D dimer 0.42; CRP 4.1; Ferritin 250.; Tx: Zithromax, remdesivir, Rocephin, Decadron, Singulair, Xarelto, Zinc; Initially on 3-4 LPM supplement O2; down to room air by d/c
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Serum ferritin normal
Clinical narrative: Presented with SOB/cough/fever x 2days; +covid in ED; CXR - multifocal PNA type pattern, dx: Covid PNA; Labs: D dimer 0.42; CRP 4.1; Ferritin 250.; Tx: Zithromax, remdesivir, Rocephin, Decadron, Singulair, Xarelto, Zinc; Initially on 3-4 LPM supplement O2; down to room air by d/c
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, COVID-19, Cough, Dyspnoea
Clinical narrative: Presneted with cough, lethargy, weakness, SOB x2 weeks; + Hypoxia on arrival; + Covid 12-14 days prior; No acute disease; most likely post covid syndrome and viral PNA; no remdesivir (out of tx window); Tx: Decadron, pulmicort, heparin, Singulair; supplemental O2 via NC; pt improved and home on O2
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Lethargy, Pneumonia viral, Post-acute COVID-19 syndrome, SARS-CoV-2 test positive
Clinical narrative: Presneted with cough, lethargy, weakness, SOB x2 weeks; + Hypoxia on arrival; + Covid 12-14 days prior; No acute disease; most likely post covid syndrome and viral PNA; no remdesivir (out of tx window); Tx: Decadron, pulmicort, heparin, Singulair; supplemental O2 via NC; pt improved and home on O2
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Lung opacity
Clinical narrative: presents to the ED c/o sOB x1 week; 88% RA but went up to 96% on 3 liters; CT chest negative for any PE;  shows bilateral ground-glass opacity suggestive possible pneumonia; Dx Covid PNA; Continued  oxygen supplementation and respiratory treatments.Empirically started  Merrem, Decadron ,Zinc and vitamin-D supplementation.Put on Lovenox for DVT prophylaxis; 02/05/2022 Patient is feeling better.  No further chest pain, palpitation or any increased shortness of breath.  States that family member can pick her up today.  Will switch antibiotic to p.o. doxycycline for 7 days also to complete Decadron for total 10 days.  Arrangement for home oxygen completed.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: presents to the ED c/o sOB x1 week; 88% RA but went up to 96% on 3 liters; CT chest negative for any PE;  shows bilateral ground-glass opacity suggestive possible pneumonia; Dx Covid PNA; Continued  oxygen supplementation and respiratory treatments.Empirically started  Merrem, Decadron ,Zinc and vitamin-D supplementation.Put on Lovenox for DVT prophylaxis; 02/05/2022 Patient is feeling better.  No further chest pain, palpitation or any increased shortness of breath.  States that family member can pick her up today.  Will switch antibiotic to p.o. doxycycline for 7 days also to complete Decadron for total 10 days.  Arrangement for home oxygen completed.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Decreased appetite, Lethargy, Pharyngeal enanthema, Pyrexia, Rash
Clinical narrative: Approx 4hr. after recieving varicella vaccine the infant developed a fever of 102.6, lethargy & decreased appetite. On 9/20/2023 he developed red, itchy rash on arms/legs. As of 9/21/2023 rash spreading & now in throat. Benadryl ineffective - advised to use OTC Calamine lotion.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash erythematous, Rash pruritic, Varicella
Clinical narrative: Approx 4hr. after recieving varicella vaccine the infant developed a fever of 102.6, lethargy & decreased appetite. On 9/20/2023 he developed red, itchy rash on arms/legs. As of 9/21/2023 rash spreading & now in throat. Benadryl ineffective - advised to use OTC Calamine lotion.
Age: 29.0
Sex: F
Vaccine: FLUR4
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Seasonal flu vaccine was being administered to patient from a pre-filled syringe. Product was Flublok. After administering vaccine, noticed that some of the vaccine serum had leaked from the connection point of the needle to PFS. Therefore patient did not receive the complete dose of the vaccine. Patient was notified of event.
Age: 27.0
Sex: F
Vaccine: FLUN4
Symptoms: Dyspnoea
Clinical narrative: I noticed difficulty taking a full breath or breathing a day after receiving the flumist quad and this side effect is continuing for many days. It feels like I am not getting enough oxygen to my lungs and am breathing at 50% capacity. I have never had side effects related to it when I have had it the past four times. There is some wheezing associated, and I was not aware this was a possible side effect until I researched further into the flu mist, but it states is a rate side effect and only occurs in those 2 years old and below.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachicardia 18 hrs after Spikevax dose.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: I reported this to my doctor but he said I was a hysterical patient who bought into conspiracy theories. I do not. I am not anti vaccine. I was trying to share what happened. Within days of receiving my first covid vaccine I developed shingles. After the second I developed neuropathy. After the third the neuropathy became worse. I am young and healthy and this should not have happened. The neuropathy was improved because I resorted to natural remedies because my doctor again insisted I was being overly reactive. I wasn't. I needed help. I have used tumeric with success. I refuse to get any further covid vaccines as there was a direct correlation for me. I didn't say anything to any other doctor or person because that doctor made me feel ashamed. My friend in the drug industry encouraged me to submit this to the FDA as she said this is only how things get better for others.