chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix was diluted with sterile water and administered to a patient; Shingrix was diluted with sterile water and administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a elderly female patient who received Herpes zoster (Shingrix) (batch number Y5YH2, expiry date 11-APR-2026) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix was diluted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: Shingrix was diluted with sterile water and administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-MAY-2024 The charge nurse reported that the Shingrix was diluted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fungal infection, Headache, Herpes zoster, Malaise
Clinical narrative: joint pain; felt unwell; headache; rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of joint pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) film-coated tablet for product used for unknown indication.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On 08-MAY-2024, the patient started Valtrex. On 08-MAY-2024, more than 2 years after receiving Shingrix and less than a day after starting Valtrex, the patient experienced headache (Verbatim: headache). On 09-MAY-2024, the patient experienced feeling unwell (Verbatim: felt unwell). On 10-MAY-2024, the patient experienced joint pain (Verbatim: joint pain). In MAY-2024, the patient experienced rash (Verbatim: rash). Valtrex was discontinued on 11-MAY-2024 (Dechallenge was negative). The outcome of the joint pain, feeling unwell, headache and rash were not resolved.   It was unknown if the reporter considered the joint pain, feeling unwell, headache and rash to be related to Shingrix and Valtrex.     It was unknown if the company considered the joint pain, feeling unwell, headache and rash to be related to Shingrix and Valtrex.   Additional Information: GSK receipt date: 16-MAY-2024 Reporter is the patient who started taking Valtrex last Wednesday. The patient had a rash that her provider suspected was either shingles or a fungal infection so she was prescribed both Valtrex and an fungal cream (unknown name) 1 percent. She also mentioned that she already had 2 dose of the Shingrix in 2017. She started both the cream and Valtrex on the same day. The first day after starting Valtrex, she had a headache. The second day, her headache became worse and she felt unwell. On the third day, her headache remained and she experienced joint pain the middle of the night. She discontinued Valtrex on Saturday. Symptoms still remained.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: joint pain; felt unwell; headache; rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of joint pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) film-coated tablet for product used for unknown indication.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On 08-MAY-2024, the patient started Valtrex. On 08-MAY-2024, more than 2 years after receiving Shingrix and less than a day after starting Valtrex, the patient experienced headache (Verbatim: headache). On 09-MAY-2024, the patient experienced feeling unwell (Verbatim: felt unwell). On 10-MAY-2024, the patient experienced joint pain (Verbatim: joint pain). In MAY-2024, the patient experienced rash (Verbatim: rash). Valtrex was discontinued on 11-MAY-2024 (Dechallenge was negative). The outcome of the joint pain, feeling unwell, headache and rash were not resolved.   It was unknown if the reporter considered the joint pain, feeling unwell, headache and rash to be related to Shingrix and Valtrex.     It was unknown if the company considered the joint pain, feeling unwell, headache and rash to be related to Shingrix and Valtrex.   Additional Information: GSK receipt date: 16-MAY-2024 Reporter is the patient who started taking Valtrex last Wednesday. The patient had a rash that her provider suspected was either shingles or a fungal infection so she was prescribed both Valtrex and an fungal cream (unknown name) 1 percent. She also mentioned that she already had 2 dose of the Shingrix in 2017. She started both the cream and Valtrex on the same day. The first day after starting Valtrex, she had a headache. The second day, her headache became worse and she felt unwell. On the third day, her headache remained and she experienced joint pain the middle of the night. She discontinued Valtrex on Saturday. Symptoms still remained.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late dose/received their first dose of shingrix on 05/15/2023 and the second dose on 03/15/2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15th May 2023).   On 15-MAR-2024, the patient received the 2nd dose of Shingrix. On 15-MAR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late dose/received their first dose of shingrix on 05/15/2023 and the second dose on 03/15/2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2024 The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 43-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received in 2019, batch number 53AT5).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-MAY-2024 The healthcare professional reported that a patient had the 1st dose of Engerix-B on 2019, they were planning to provide the 2nd dose today or in this week. The healthcare professional only mentioned that the 1st dose was on 2019, not specifying day or month. The reporter also asked healthcare professional the expiration date, but they did not had this info. The original call was to know when they should give the 3rd dose. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Third dose administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 2SK93, expiry date 16-MAY-2026) for prophylaxis.   Concurrent medical conditions included hiv infection and immunocompromised.   On 20-MAY-2024, the patient received Shingrix. On 20-MAY-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Third dose administered.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 20-MAY-2024 and 21-MAY-2024 On 20th May 2024, a pharmacist called to inform that they administered the vaccine and afterwards found out that the patient already had two doses. The patient had received a third dose which led to extra dose administered. The patient who received the third dose of Shingrix was immunocompromised, the patient had HIV.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Fabry's disease, Immunisation reaction
Clinical narrative: each vaccines I had a reaction which was like having Covid again.; I have Alpha Gal in January of this year; reaction was so bad that I couldn't get Out Of bed for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (each vaccines I had a reaction which was like having Covid again.), FABRY'S DISEASE (I have Alpha Gal in January of this year) and BEDRIDDEN (reaction was so bad that I couldn't get Out Of bed for 24 hours) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Had covid in the fall of 2020) in 2020. Previously administered products included for Vaccination adverse reaction: Covid-19 vaccine (Patient had all of the covid vaccine except 2023). Past adverse reactions to the above products included No adverse effect with Covid-19 vaccine. Concurrent medical conditions included Alpha galactosidase A deficiency (Patient had Alpha Gal but was misdiagnosed with IBS-D) since 2012.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In January 2024, the patient experienced FABRY'S DISEASE (I have Alpha Gal in January of this year). On an unknown date, the patient experienced IMMUNISATION REACTION (each vaccines I had a reaction which was like having Covid again.) and BEDRIDDEN (reaction was so bad that I couldn't get Out Of bed for 24 hours). At the time of the report, IMMUNISATION REACTION (each vaccines I had a reaction which was like having Covid again.) and FABRY'S DISEASE (I have Alpha Gal in January of this year) outcome was unknown and BEDRIDDEN (reaction was so bad that I couldn't get Out Of bed for 24 hours) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported. With each vaccine patient had a reaction which was like covid again. Treatment medications were not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for a day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm for a day) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for a day). At the time of the report, PAIN IN EXTREMITY (sore arm for a day) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient received total of 8 Moderna vaccines beginning in January of 2021. No issues with previous 7 vaccines; just a sore arm for a day. All the 7 vaccines were with moderna only. Patient is a healthy individual, no chronic disease of any kind and stated patient was not a disease-oriented person.   No treatment medications were reported.   This case was linked to MOD-2024-767811 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2024: Live non-significant follow up received: reference ids were added. On 17-May-2024: Live non-significant follow-up received: reference numbers were added
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032712) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2024, the patient received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 04-May-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (covid 19). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) at a dose of 20 gram every four hours. At the time of the report, COVID-19 (covid 19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2024, SARS-CoV-2 test: (Positive) On day 2 and (Positive) On day 11, still testing positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient was healthy individual and no chronic disease of any kind. Reporter stated that she was not a disease-oriented person.    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received total 8 doses of Moderna vaccines beginning in January of 2021. No issues with previous 7 vaccines just had a sore arm for a day.   The reporter had a concern about the Moderna 2024 spring vaccine. Reporter stated that she never had COVID until after this last spring vaccine. Reporter stated that she received the vaccine on 13-APR-2024 and on 05-MAY-2024 came down with COVID, 3 weeks later when the vaccine should've been its most effective. Patient stated that she was so sick and was asking her HCP for a Z pack or some antibiotic, but the HCP insisted that it was viral, and that the Z pack wouldn't make any difference, so the reporter continued with aspirin and fluids.   Reporter stated that she started with a slight sore throat, very minimal, on 04-MAY-2024. On 05-MAY-2024, the Sunday, the reporter stated that she had an enormous amount of pressure in her head, a throbbing headache and a low-grade fever and she was down for 10 days with no alleviation in these symptoms at all. Reporter stated that she was taking 20 grams of aspirin every 4 hours with no change. She stated that her headache stopped 2 days ago, she was currently recovering while no longer taking aspirin, continuing with fluids but still expectorating and blowing a lot of gunk out of her head. No other details were provided.   This case was linked to MOD-2024-767877 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2024: Live non-significant follow-up received, and references were added. On 17-May-2024: Live significant follow up received: Lab data and event outcome were updated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Dysgeusia, Headache
Clinical narrative: metallic taste in mouth; mild headache/ brain fog feeling; mild headache/ brain fog feeling; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in mouth), BRAIN FOG (mild headache/ brain fog feeling) and HEADACHE (mild headache/ brain fog feeling) in a 38-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-May-2024, the patient experienced DYSGEUSIA (metallic taste in mouth), BRAIN FOG (mild headache/ brain fog feeling) and HEADACHE (mild headache/ brain fog feeling). At the time of the report, DYSGEUSIA (metallic taste in mouth), BRAIN FOG (mild headache/ brain fog feeling) and HEADACHE (mild headache/ brain fog feeling) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  Patient experienced events almost immediately after the dose, within a couple of minutes of receiving the vaccine, and had persisted for more than 8 hours (since the shot). The patient did not experience any additional symptoms/events.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Stargardt's disease
Clinical narrative: elevated symptoms of Guards disease; elevated symptoms of Guards disease; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Guards disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: STARGARDT'S DISEASE (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 22Jun2022, outcome "unknown" and all described as "elevated symptoms of Guards disease". Therapeutic measures were not taken as a result of stargardt's disease, condition aggravated. Additional information: Patient noticed vaccine elevated symptoms of Guards disease for up to four months (vaccine booster for COVID administration is once every 6 months).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine interchange; Covid infection; Covid infection; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 30Dec2022 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Lot number: 057A22A), in left arm and on 22Dec2023 as dose 4 (booster), single (Lot number: 8058876), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: AZELASTINE, start date: 15Jun2022, stop date: 03May2024; RHINOCORT [BUDESONIDE], start date: 15Jun2022, stop date: 03May2024. The reporter also reported that the 3rd dose of Moderna covid-19 vaccination date on 22Aug2022. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "recovering" and all described as "Covid infection"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine interchange". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 04May2024 and 08May2024.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Muscular weakness, Peripheral swelling
Clinical narrative: Weakness in my left arm; I have not been able to strengthen my left arm; The arm looks very swollen/left arm appears to be larger; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 81-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Feb2024 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis", start date: 2023 (unspecified if ongoing), notes: come in the last six months. Concomitant medication(s) included: NAPROXEN taken for pain. The patient also took other concomitant therapy. Vaccination history included: BNT162b2 (DOSE 1; left arm), administration date: 30Dec2020, when the patient was 78-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2; left arm), administration date: 20Jan2021, when the patient was 78-year-old, for COVID-19 immunisation; Bnt162b2 (DOSE 3; left arm), for COVID-19 immunisation; Bnt162b2 (DOSE 4; left arm), for COVID-19 immunisation; Bnt162b2 (DOSE 5; left arm), for COVID-19 immunisation; Bnt162b2 (DOSE 6; left arm), for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 06Feb2024, outcome "not recovered", described as "The arm looks very swollen/left arm appears to be larger"; MUSCULAR WEAKNESS (non-serious) with onset 06Feb2024, outcome "not recovered", described as "Weakness in my left arm; I have not been able to strengthen my left arm". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Therapeutic measures were not taken as a result of muscular weakness, peripheral swelling. Additional information: The patient calling because she was having a weakness in left arm since the last booster that she had in 06Feb2024. She felt that the weakness had been progressing from that period of time till now and she was not able to strengthen it even though she did try to work out with weights and other exercises. It was just not getting strong. The patient left arm had been getting weaker and weaker since the booster. When probed if the product is Pfizer Covid-19 Booster shot, consumer stated, "Yes, I had all the, from the first vaccination for COVID, I have had all of the original vaccination as well as all of the boosters." They are seven shots and different throughout since 2020. The patient took a blood pressure pill and thyroid medication. The patient said she did not received treatment, and the only treatment that she had done was some physical therapy and she took exercise classes and water aerobics. There was a blood draw done by a cardiologist that the patient has an appointment to see.     The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Hay fever" (unspecified if ongoing); "Mild cholesterol" (unspecified if ongoing), notes: Mild cholesterol. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 10May2024 till 14May2024  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Negative test day after taking paxlovid; Positive, notes: Then 2 days later positive and symptoms reappeared. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Shoulder injury related to vaccine administration, Weight
Clinical narrative: I have a Sirva form a vaccine shot; I am still hurting from it all these years later and it comes in waves the pain; It comes and goes in waves; sometimes it last for days; Left arm it just really swell; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2021 at 12:19 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (ongoing), notes: I always have Fibromyalgia, I have that for years; "Heel spurs" (ongoing), notes: I have heels spurs in my foot and I had that for a couple of years now. Concomitant medication(s) included: IBUPROFEN taken for fibromyalgia, plantar fasciitis (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for fibromyalgia, plantar fasciitis (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (non-serious), outcome "unknown", described as "I have a Sirva form a vaccine shot"; PAIN (non-serious), outcome "recovered with sequelae", described as "I am still hurting from it all these years later and it comes in waves the pain; It comes and goes in waves; sometimes it last for days"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Left arm it just really swell". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of shoulder injury related to vaccine administration, pain, peripheral swelling.  Additional information: Consumer stated, "Well as soon as the lady shot me and this is back in 2021. As soon as she gave me the shot. I had many shots in my life. I am 60 years old. I have never had so much pain, I screamed and I knew right away she just did something wrong, but I did not know what and I am still hurting from it all these years later and it comes in waves the pain. It comes and goes in waves, but sometimes it last for days and my left arm it just really swell." When probed consumer taking Ibuprofen or Aspirin for fibromyalgia and heels spurs: Consumer stated, "No, there nothing. I mean let me think. I am doing exercises on my foot, I am trying different thing with my foot. I am wearing a special boot. Fibromyalgia is just Aspirin and Ibuprofen once in while.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomited". Additional information: Reporter stated that she and her son have had many Pfizer Covid vaccines with no problem. Yesterday, after getting a Covid booster, they both vomited.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400173511 same reporter, same vaccine/event, different patient.;
Age: 16.0
Sex: U
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a 16-year-old came in to get vaccine, but this could possible been her third dose with no reported adverse event; Initial information received on 17-May-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 year old patient of unknown gender and is reported patient came in to get vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi], but this could possible been her third dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, a 16-year-old came in to get dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site as immunization, but this could possible been her third dose with no reported adverse event (extra dose administered) (latency on same day).  Information on the batch number was requested.  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: 54.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: patient was given Tenivac that expired with no reported adverse event; Initial information received on 20-May-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 54 years old female patient who was given Diphtheria-2/Tetanus-5 Adsorbed Toxoids NO Preservative Adult [Tenivac] that expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-May-2024, the patient received unknown dose of expired suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids NO Preservative Adult (Suspension for injection) with no reported adverse event (expired product administered) (latency: same day) (lot C5965AA) (expiry date: 02-Mar-2024) (strength not reported) via intramuscular route in the left deltoid for Immunization.  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: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Constipation, Dizziness, Ear discomfort, Eye pain
Clinical narrative: Started with fever, body ache. Took tylenol 500mg, consumed more amounts of fluid.  Then started: Head: Headache, heaviness of head, dizziness Ear: Ear discomfort with pressure feeling, hearing sensitivity. Eye: Red, pain, unable to open completely, change in vision constipation Tiredness: Unable to do even personal care Blood Pressure (BP): Raised to 202/115 & fluctuated in high levels. Was normal before vaccination. Ear discomfort became more severe with collection  of fluid in ears.Attended urgent care , followed by frequent visit to PCP as the issues were not relieved.Started Amlodipine, Losartan Potassium and Nasal spray Ryaltris. Many days of absence from work due to the issue
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid function disorder, Fatigue, Head discomfort, Headache, Hyperacusis
Clinical narrative: Started with fever, body ache. Took tylenol 500mg, consumed more amounts of fluid.  Then started: Head: Headache, heaviness of head, dizziness Ear: Ear discomfort with pressure feeling, hearing sensitivity. Eye: Red, pain, unable to open completely, change in vision constipation Tiredness: Unable to do even personal care Blood Pressure (BP): Raised to 202/115 & fluctuated in high levels. Was normal before vaccination. Ear discomfort became more severe with collection  of fluid in ears.Attended urgent care , followed by frequent visit to PCP as the issues were not relieved.Started Amlodipine, Losartan Potassium and Nasal spray Ryaltris. Many days of absence from work due to the issue
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Middle ear effusion, Ocular hyperaemia, Pain
Clinical narrative: Started with fever, body ache. Took tylenol 500mg, consumed more amounts of fluid.  Then started: Head: Headache, heaviness of head, dizziness Ear: Ear discomfort with pressure feeling, hearing sensitivity. Eye: Red, pain, unable to open completely, change in vision constipation Tiredness: Unable to do even personal care Blood Pressure (BP): Raised to 202/115 & fluctuated in high levels. Was normal before vaccination. Ear discomfort became more severe with collection  of fluid in ears.Attended urgent care , followed by frequent visit to PCP as the issues were not relieved.Started Amlodipine, Losartan Potassium and Nasal spray Ryaltris. Many days of absence from work due to the issue
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Visual impairment
Clinical narrative: Started with fever, body ache. Took tylenol 500mg, consumed more amounts of fluid.  Then started: Head: Headache, heaviness of head, dizziness Ear: Ear discomfort with pressure feeling, hearing sensitivity. Eye: Red, pain, unable to open completely, change in vision constipation Tiredness: Unable to do even personal care Blood Pressure (BP): Raised to 202/115 & fluctuated in high levels. Was normal before vaccination. Ear discomfort became more severe with collection  of fluid in ears.Attended urgent care , followed by frequent visit to PCP as the issues were not relieved.Started Amlodipine, Losartan Potassium and Nasal spray Ryaltris. Many days of absence from work due to the issue
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: Patient had no adverse events or outcomes, even during the vaccine was fine. Asked if any possible side effects, informed some typical symptoms include arm soreness or fever, but may take tylenol if really need to . Patient specifically claimed that this was her second dose with the technician who used a double check system that the company provides, called Agency. Agency did not pick up that she got had gotten her two doses (one in Novmber, and one in January), and the patient  confirmed with me as well that this was her second dose. After she left and with the extreme short staff issue, once the wave of patients went down, I double checked and found it to be her third when we manually checked her central profile. They system did not put a DUR on it and neither did her insurance reject it as picking up her third dose. All parties of corporate informed and patient  did not pick up phone. She made her appointment herself and changed it several times throughout the week per my pharmacy manager. However, when she came here, she was certain it was her second shot and we took her word for it.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLUA4, RSV
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Pain in Rt. arm above elbow to Rt. shoulder & to Rt. side of neck. "Frozen" Shoulder for about 2 weeks. Still experiencing constant pain in upper Rt. arm,, Rt. shoulder & RT. side of neck. Unable to raise Rt. arm above rt. shoulder or move Rt. arm behind my back. Makes it painful to put a shirt on over my head or put my Rt. arm in the sleeve of a button down shirt, sweater or jacket. Using topical pain relievers like BioFreeze and Salonpas patches. Taking asprin & Tylonal. Unknown if condition will be permanant.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLUA4, RSV
Symptoms: Periarthritis
Clinical narrative: Pain in Rt. arm above elbow to Rt. shoulder & to Rt. side of neck. "Frozen" Shoulder for about 2 weeks. Still experiencing constant pain in upper Rt. arm,, Rt. shoulder & RT. side of neck. Unable to raise Rt. arm above rt. shoulder or move Rt. arm behind my back. Makes it painful to put a shirt on over my head or put my Rt. arm in the sleeve of a button down shirt, sweater or jacket. Using topical pain relievers like BioFreeze and Salonpas patches. Taking asprin & Tylonal. Unknown if condition will be permanant.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong technique in product usage process
Clinical narrative: Vaccine was administered using a 5/8" needle instead of the recommended 1" needle
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administrative error, vaccine was out date as of 04/06/24.  The individual waited in the waiting area for 15 minutes after receiving the vaccine with no complaints or signs and symptoms of an adverse reaction.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Anxiety, Crying, Electroencephalogram normal, Exposure to fungus, Fear
Clinical narrative: He developed a copule of times a day episodes where if laid down on his back he would look terrified and his hands would go up to his face like a startle reflex and he would cry like he was really scared until he was comforted. In the subsequent days it would happen more and more frequently, every time he was laid down on his back. If he was being held or touched, holding his hands or legs, he would be okay. If they let go, he would do the same thing startle, cry and act scared until picked up and comforted again. neurologist reviewed videos of events and determined need for EEG to r/o seizure/infantile spasms. Seen in ED. Normal EEG. Continued to have events for several days. Resolved when they were staying at another home. Started again when returned home. Found mold in the home near where he was sleeping. Symptoms resolved within a couple of weeks. Family didn't return to living space with mold - moved out.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Reflexes abnormal
Clinical narrative: He developed a copule of times a day episodes where if laid down on his back he would look terrified and his hands would go up to his face like a startle reflex and he would cry like he was really scared until he was comforted. In the subsequent days it would happen more and more frequently, every time he was laid down on his back. If he was being held or touched, holding his hands or legs, he would be okay. If they let go, he would do the same thing startle, cry and act scared until picked up and comforted again. neurologist reviewed videos of events and determined need for EEG to r/o seizure/infantile spasms. Seen in ED. Normal EEG. Continued to have events for several days. Resolved when they were staying at another home. Started again when returned home. Found mold in the home near where he was sleeping. Symptoms resolved within a couple of weeks. Family didn't return to living space with mold - moved out.
Age: 46.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient  was due for Hep B and Tdap MA administer the wrong vaccine for Tdap MA accidentally  administered Dtap. Pt was not advice because pt left. Per pt was in a hurry, Per pt had another appt. MA informed another MA and was advice to call Pt to schedule appt for correct vaccine to be given. MA called Pt an was informed about being administered the wrong vaccine pt stated she was feeling ok. MA offer to schedule on float to get Tdap pt agreed. MA apologized for error.  MA repot to Facility and try getting a hold of manager. MA let provider about incident.
Age: 55.0
Sex: F
Vaccine: MNQ
Symptoms: Axillary pain, Dyspnoea, Oedema peripheral
Clinical narrative: one day after injection of right deltoid, patient report right axilla swelling with intense pain.  SOB but resolved with albuterol inhaler.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMIN POST bud
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED BEYOND bud
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED BEYOND BUD
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered beyond bud
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered beyond BUD
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: Audiogram, Deafness unilateral, Sudden hearing loss
Clinical narrative: Asymmetric sudden hearing loss left ear, diagnosed 4/15/24. 40 dB sensitivity difference for > 2 kHz
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth, Wrong technique in product usage process
Clinical narrative: Although it's her 4th dose, this is the first time she received Pentacel. We noticed a reaction the next day (Saturday 5/18): the injection site was red, hot and inflamed. There was also a small bump. No signs of discomfort or fever. The following day (Sunday 5/19), the injection site reaction grew larger to about a 5 inch circle and still felt warm to the touch. It was very splotchy and at first we thought it was cellulitis but know that is rare. On Monday 5/20, the reaction center looked to be fading, but the outer edge of the 5 inch circle became even more red, inflamed and the texture became bumpy. We took her back to the pediatrician on Tuesday 5/21. The doctor called another more experienced doctor to look at it as well to get her opinion. They believe the nurse administered the vaccine incorrectly and did not inject into her muscle. The injection was on the top of her thigh vs the outer side of the thigh. One strange thing to note is that she did not cry during the vaccine injection. Today, Wednesday 5/22, it looks the same as yesterday, no change. She does point to it and say "boo boo". We have concerns of any long term implications of being injected incorrectly. We have photos documenting each day to show the progress.
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Headache, Injection site pain, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Pain at site, sore throat, fever to 102.3, headache
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Streptococcus test negative
Clinical narrative: Pain at site, sore throat, fever to 102.3, headache
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Developed cellulitis infection to site of injection. Developed erythema, edema, warmth to site of injection which spread to entire left thigh. Required antibiotic therapy to treat infection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Sleep disorder
Clinical narrative: Night of vaccine woke up continuously feeling like my knees and arms were breaking.  Arms ok but still having problems with both knees.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Contusion, Rash, Swollen tongue
Clinical narrative: rcvd vaccines early on 5/17 by that night rash started. by next day even worse, tongue swelling rash to lower extremities black & blue, steroids & benadryl helping.
Age: 78.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Injection site swelling, Peripheral swelling, Vaccination site haematoma
Clinical narrative: Swelling of upper & lower arm at site of injection and underside of arm progressed to forearm/elbow area. Hematoma per ER visit on patient's left arm where Comirnaty vaccine was given.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10046735:URTICARIA; Narrative: Patient received her second Zoster vaccine on 1/19/24. She called on 2/5/24 stating that she developed a rash following her vaccination that began on her left arm and then began to spread to her right arm and legs. A prescription for oral prednisone was prescribed on 2/6/24. There are no further mentions of the rash following the steroid prescription. Other Relevant HX: Other: URTICARIA; RASH; PRURITUS
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Pain, Sleep disorder
Clinical narrative: Reported Symptoms: 10016256:FATIGUE; 10019211:HEADACHE; 10033371:PAIN; Narrative: Patient is a 61 y/o male who presented to primary care clinic on 2/12/24 for follow up and COVID-19 vaccination. Patient has previously had 3 COVID vaccines, no reported side effects, last one was in 6/22/2022. Patient received PFIZER COVID-19 vaccination IM in left deltoid, reportedly administered without complications and went home. On 2/13/24, patient called nursing and reported that he had the worst night ever. Reported his pain scale was more than a 10, with pain in every part of his body. "It was up and down my body, I wasn't able to sleep until 3am." Denied hives or SOB. Patient reported that he was feeling better after but not "yet 100%" and wanted this documented in his chart. He was instructed to continue monitoring symptoms and if they persist or worsen, go to the nearest ED. No further information. Other Relevant HX: Prior COVID-19 Immunization history Immunization: COVID-19 (PFIZER), MRNA, LNP-S, PF, 30 MCG/0.3 ML DOSE, TRIS-SUCROSE (AGES 12+ YEARS) 06/22/2022@9:20 - SERIES 3 Comments: PFR; FM7553; 08/10/2022 Immunization: COVID-19 (PFIZER), MRNA, LNP-S, PF, 30 MCG/0.3 ML DOSE 11/17/2021@13:30 series - SERIES 2 Comments: PFR; FG3527; 12/10/2021 Immunization: COVID-19 (JANSSEN), VECTOR-NR, R5-AD26, PF, 0.5 ML 06/09/2021@10:00 series - SERIES 1 Comments: JSN; 204A21A; 06/23/2021 Other: GENERALIZED ACHES AND PAINS; FATIGUE; HEADACHE
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pyrexia
Clinical narrative: Reported Symptoms: 10013573:DIZZINESS; 10013963:DYSPNEA; 10016558:FEVER; Narrative: Patient received covid vaccine on 1/12/23. He stayed 15 minutes after and had no side effects. No other information was provided. On 2/21, patient said that his last covid vaccine gave him fever, SOB and dizziness. No other information provided. No record in database of him going to ED for this vaccine related side effect. Other Relevant HX: Other: DYSPNEA; DIZZINESS; FEVER