chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: only liquid portion administered to patient/didn't reconstitute with powder; only liquid portion administered to patient/didn't reconstitute with powder; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number amvb030A, expiry date 30-APR-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only liquid portion administered to patient/didn't reconstitute with powder) and inappropriate dose of vaccine administered (Verbatim: only liquid portion administered to patient/didn't reconstitute with powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-SEP-2024 The pharmacist reported that a couple weeks ago (from the reporting date) someone (patient) got only the 2nd vial of Menveo (liquid vial only) which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist did not have any patient details at the time of reporting as she was just informed of the situation.
Age: 1.33
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration in patient under 10 years of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old male patient who received Men B NVS (Bexsero) (batch number 2G3S9, expiry date 30-SEP-2027) for prophylaxis.   On 10-SEP-2024, the patient received Bexsero. On 10-SEP-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration in patient under 10 years of age). The outcome of the inappropriate age at vaccine administration 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: 11-SEP-2024 A registered nurse contacted GSK to report that a patient accidentally received a dose of Bexsero and wanted to know if there was any safety data available for this specific scenario. The patient received Bexsero below than the recommended age limit, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received pediatric dose; underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 24-year-old male patient who received HBV (Engerix B pediatric) (batch number 95D74, expiry date 28-MAR-2025) for prophylaxis.   On 11-SEP-2024, the patient received Engerix B pediatric. On 11-SEP-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult patient received pediatric dose) and underdose (Verbatim: underdose). The outcome of the adult use of a child product and underdose were 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: 11-SEP-2024 The reporter reported that the adult patient received pediatric dose at the time of reporting, which led to, adult use of a child product and underdose. The reporter consented to the follow up.
Age: 1.33
Sex: U
Vaccine: RVX
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 16 month old patient inadvertently received a third dose of Rotarix; 16 month old patient inadvertently received a third dose of Rotarix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 16-month-old patient who received Rotavirus vaccine for prophylaxis.   Previously administered products included Rotarix (1st dose received on an unknown date) and Rotarix (2nd dose received on an unknown date).   In SEP-2024, the patient received the 3rd dose of Rotavirus vaccine. In SEP-2024, an unknown time after receiving Rotavirus vaccine, the patient experienced extra dose administered (Verbatim: 16 month old patient inadvertently received a third dose of Rotarix) and inappropriate age at vaccine administration (Verbatim: 16 month old patient inadvertently received a third dose of Rotarix). The outcome of the extra dose administered and inappropriate age at vaccine administration were 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: 11-SEP-2024 The pharmacist explained that a 16 month old patient inadvertently received a third dose of Rotarix a week ago (from the reporting date, no specific date), which led to extra dose administered and inappropriate age at vaccine administration.  The patient got 2 prior Rotarix doses at the corresponding age, but reporter  did not know specific dates either.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Neck mass, Sjogren's syndrome, Tenderness
Clinical narrative: lump near her collar bone; she claims is a swollen lymph node; first dose of SHINGRIX January 2023, and the second dose on September 9, 2024; tender but not painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of mass in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of sjogren's syndrome (received first dose of Shingrix in January 2023).   On 09-SEP-2024, the patient received the 2nd dose of Shingrix. On 09-SEP-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of SHINGRIX January 2023, and the second dose on September 9, 2024). On 11-SEP-2024, the patient experienced mass (Verbatim: lump near her collar bone) and swollen lymph nodes (Verbatim: she claims is a swollen lymph node). In SEP-2024, the patient experienced tenderness (Verbatim: tender but not painful). The outcome of the mass, swollen lymph nodes and tenderness were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the mass, swollen lymph nodes and tenderness to be related to Shingrix.     It was unknown if the company considered the mass, swollen lymph nodes and tenderness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR115851   Additional Information: GSK Receipt Date: 12-SEP-2024 The patient self reported this case for herself.  The patient received the first dose and second dose of Shingrix. The patient felt a lump near her collar bone which she claims was a swollen lymph node.  The patient reported that this lump can be moved, and was tender but not painful.  The lump was on the same side that she received the 2nd Shingrix vaccine.  The patient reported that a couple of weeks ago, she was diagnosed with Sjogren's disease.; Sender's Comments:  US-GSK-US2024AMR115851:Same patient/Diff event
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 36 year old adult male accidentally given Pediatric dose of Engerix-B.; 36 year old adult male accidentally given Pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 36-year-old male patient who received HBV (Engerix B pediatric) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 36 year old adult male accidentally given Pediatric dose of Engerix-B.) and accidental underdose (Verbatim: 36 year old adult male accidentally given Pediatric dose of Engerix-B). The outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK Receipt date: 11-SEP-2024 The nurse reported that a 36 years old adult patient was accidently injected with a pediatric dose of Engerix-B to the left deltoid, which led to adult use of a child product and accidental underdose.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Limb discomfort, Pain in extremity
Clinical narrative: arm pain and discomfort; rotator cuff became inflamed or something; arm pain and discomfort; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (arm pain and discomfort), INFLAMMATION (rotator cuff became inflamed or something) and PAIN IN EXTREMITY (arm pain and discomfort) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In September 2024, the patient experienced LIMB DISCOMFORT (arm pain and discomfort), INFLAMMATION (rotator cuff became inflamed or something) and PAIN IN EXTREMITY (arm pain and discomfort). At the time of the report, LIMB DISCOMFORT (arm pain and discomfort), INFLAMMATION (rotator cuff became inflamed or something) and PAIN IN EXTREMITY (arm pain and discomfort) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  It was reported that the patient recently had a problem after the latest Moderna Covid vaccination, not the vaccine itself but rather the way it was administered. He mentioned that he had all of the COVID vaccinations so far and usually have arm pain for about 24 hours. However, this time he had arm pain and discomfort for the past 7 days. It feels as though his rotator cuff became inflamed or something.  Patient thinks that the problem was that the vaccination was given very high up on his arm, almost at the top of his arm. He mentioned that he never had an injection that high on his arm before. He stated that the problem seems to be gradually resolving, although it still hurts to raise his arm.   This case was linked to US-MODERNATX, INC.-MOD-2024-774002 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774002:Same patient with Different dose
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Hyperglycaemia
Clinical narrative: Patient was supposed to be around or below 180 but his insulin numbers were up in the 400's or 500's; This spontaneous case was reported by a patient and describes the occurrence of HYPERGLYCAEMIA (Patient was supposed to be around or below 180 but his insulin numbers were up in the 400's or 500's) in a 76-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Coronary stent placement. Concurrent medical conditions included Diabetic, Blood pressure high, Eye disorder, Heart disorder and Sulfonamide allergy (diagnosed when he was a kid).    On 12-Sep-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 12-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced HYPERGLYCAEMIA (Patient was supposed to be around or below 180 but his insulin numbers were up in the 400's or 500's). At the time of the report, HYPERGLYCAEMIA (Patient was supposed to be around or below 180 but his insulin numbers were up in the 400's or 500's) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2024, Blood glucose: Increased (400-500).         No concomitant medication was reported. Patient could not get his insulin numbers before 400-500. He was supposed to be around or below 180 but his numbers were up in the 400's or 500's. He stated that he was using the pump properly, he changed the insulin in the pump and changed the infusion sets. He stated that he took additional insulin and doubled the dose. He stated that when he finally reached somebody, they told him to just continue doing that because those symptoms started on the 12th after he got the shot. He states that his doctor was extremely smart and cautioned him after the fact, not to take it because she said there were too many negatives with diabetics and people with heart trouble. He said that at least she told him how to get his numbers down. He stated, as of this morning (Sept 16, 2024), he was still doubling the dose of the insulin he would normally take just to get it down so that he was not in a danger level. He did not want anybody else that's on a pump to go through the same thing. He stated that he had trouble with his eyes and if his insulin levels stay high, his eye would hemorrhage. So, he was trying to keep his numbers low. Patient stated he has an alarm on his phone that will go off if his levels go down too quick. He stated, as an example: He had breakfast that morning and it told him to take 4 units of insulin, so he took 4 units of insulin through the pump. Then, 15-2-30 minutes later, the number was still going up, so he had to take extra insulin out of a vial and inject it into his arm. He stated that he was still trying to get it down now and that situation happened around 11 this morning. His doctor told him to keep watching his levels.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Patient's arm had a ring around the area that was a "bright yellow color"; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCOLOURATION (Patient's arm had a ring around the area that was a "bright yellow color") in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2024, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 07-Sep-2024,  after starting , the patient experienced VACCINATION SITE DISCOLOURATION (Patient's arm had a ring around the area that was a "bright yellow color"). At the time of the report, VACCINATION SITE DISCOLOURATION (Patient's arm had a ring around the area that was a "bright yellow color") had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  HCP stated she thought patient had caught some bruising, but patient told her that it had been yellow the whole 10 days since vaccination (it has not gone down or gotten larger). She stated patient was possibly in his mid 20's No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-774159 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774159:Patient's case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Somnolence
Clinical narrative: Feeling sleepy; aches and pain; fever; very tired feeling; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Feeling sleepy), PAIN (aches and pain), PYREXIA (fever) and FATIGUE (very tired feeling) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. HJ5892) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Nov-2023, the patient experienced SOMNOLENCE (Feeling sleepy), PAIN (aches and pain), PYREXIA (fever) and FATIGUE (very tired feeling). In November 2023, SOMNOLENCE (Feeling sleepy), PAIN (aches and pain), PYREXIA (fever) and FATIGUE (very tired feeling) had resolved.            No concomitant medication was reported.  Patient was satisfied, she didn't get covid and felt the vaccines were efficient, the side effects were not as bad in the last vaccination compared to the first ones. No treatment information was reported.   This case was linked to MOD-2024-774186, MOD-2024-774188, MOD-2024-774207 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Positron emission tomogram, Vomiting
Clinical narrative: swelling of lymph nodes; fatigue; vomiting; large diffuse B-cell lymphoma; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthmatic" (unspecified if ongoing); "Chronic lymphocytic leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (2023-2024 formula) (DOSE 6 (BOOSTER), SINGLE), administration date: 08Jun2024, for COVID-19 immunization, reaction(s): "large diffuse B-cell lymphoma", "swelling of lymph nodes", "fatigue", "vomiting"; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The patient had booster doses of Pfizer COVID-19 Vaccines on 08Jun2024 and 05Sep2024 the new formulation 2024-2025 reported that after the booster shot her husband experienced swelling of lymph nodes, fatigue and vomiting (Sep2024). The patient who is 66 years old and is asthmatic with CLL (Medical history), as he has been taking the boosters (Pfizer COVID-19 Vaccine), including one that he took on 08Jun2024 and another one on 05Sep2024, the new one just came out, as he is taking these, his lymph nodes are swelling. The reported called to find out. The patient was having such strong reactions to the booster that he will need to be in bed and can be vomiting, too fatigued to function for about 36 hours or so at a time. Patient has recently been to a doctor, and they had him do a booster that just came out and they are concerned that his CLL (Chronic lymphocytic leukemia) maybe transforming into diffused B-cell lymphoma but his tests keep coming back as inconclusive including a biopsy of one of his very swollen lymph nodes but it turned out were three matted lymph nodes upon the biopsy. Even a PET scan came back is inconclusive for a true lymphoma diagnosis. The patient had multiple diagnostic tests these tests were inconclusive to confirm diagnosis and wanted to confirm if her husband's response to covid-19 vaccine may be a factor. Husband was recommended for chemotherapy.  The patient got Pfizer COVID-19 Vaccines ever since and it was his 7th booster, patient is an immunocompromised patient. Reporter would like to know if the vaccine maybe contributing to patient symptoms because it has been transforming. The outcome for the events large diffuse B-cell lymphoma, swelling of lymph nodes, fatigue and vomiting was unknown.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400256707 same patient/reporter/drug/events, different dose number;
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Illness, Pain
Clinical narrative: body aches; ill; fatigue; joint pain; This is a spontaneous report received from a Pharmacist.  An adult male patient received BNT162b2 multivalent nos (COMIRNATY MULTIVALENT NOS), as dose number unknown, 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: PAIN (non-serious), outcome "recovered", described as "body aches"; ILLNESS (non-serious), outcome "recovered", described as "ill"; FATIGUE (non-serious), outcome "recovered"; ARTHRALGIA (non-serious), outcome "recovered", described as "joint pain". Therapeutic measures were not taken as a result of pain, illness, fatigue, arthralgia. Additional information: Person reported after getting the bivalent Covid vaccine (years ago) he felt so ill it made him not want to get last years formula (2023-2024 formula). Side effects were fatigue, joint pain, body aches.  Patient called into work the following day. Symptoms resolved within 24 hrs per.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: PPV
Symptoms: Feeling abnormal, Incorrect route of product administration
Clinical narrative: I am not feeling too good; The Pneumococcal Pneumonia Vaccine (Pneumococcal Vaccine); I drink a lot of it; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) oral for immunisation; glimepiride (GLOW), (Lot number: Unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am not feeling too good"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "The Pneumococcal Pneumonia Vaccine (Pneumococcal Vaccine); I drink a lot of it". The action taken for glimepiride was unknown.  Additional information: Consumer stated, "So, few of my friends were like joking around and then we (Later clarified only one patient drank the glow drug) drank the liquid that is inside the glowsticks. We will be okay right?" Medication name, consumer stated, "Glowstick (Later clarified as Glow)." When paraphrased the concern, consumer stated, "No, we drank the glowsticks." When probed to clarify if consumer took the glowsticks or Glow drug, consumer stated, "Glow drug." (Suspect clarified and captured as suspect as Glow). When probed to clarify if it is a Pfizer medication, consumer stated, "Yes." (Further manufacturer name was not appropriately clarified hence, 'Is this a Pfizer product tab' left unchecked). Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information department and provided with the number and requested to select Option  and the timings as 9 AM to 5 PM, Monday to Friday.  Consumer was suggested to contact ambulance or nearest Healthcare professional in case of emergency. Consumer was again informed about the timings of Pfizer Medical Information department as 9 AM to 5 PM, Monday to Friday. When probed to clarify the number of patients who took the glow drug, consumer stated, "It was just me." Consumer stated, "I took the Pneumococcal Pneumonia Vaccine (Hence, suspect captured as Pneumococcal Vaccine)." When paraphrased the concern, consumer stated, "No, just the pneumococcal pneumonia vaccine I drank it, I drink a lot of it (Further it was not clarified if the consumer has taken the Glow drug or the pneumococcal vaccine, hence both captured as suspect)." When probed to clarify the concern regarding the pneumococcal pneumonia vaccine, consumer stated, " I am not feeling too good." When requested to place the call on hold, consumer hung up the call. Limited information was available over the call as consumer hung up the call abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Investigation
Clinical narrative: have received the Pfizer Covid 19 vaccine in the past and am allergic to some components in the Pfizer Covid 19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 67-year-old female patient received BNT162b2 (BNT162B2), in 2021 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: ALLERGY TO VACCINE (medically significant), outcome "unknown", described as "have received the Pfizer Covid 19 vaccine in the past and am allergic to some components in the Pfizer Covid 19 vaccine". Clinical course: The patient have received the Pfizer Covid 19 vaccine in the past and was allergic to some components in the Pfizer Covid 19 vaccine. The first allergic reaction was the very first vaccine in ~2021 and it happened when she was in another state.  She didn't have any case numbers but she know that it was recorded because she was not allowed to get the booster until she went to Allergy and Asthma and got completely tested.  The state documented it previously and the patient was red flagged and she had to take the paperwork from Allergy and Asthma with her to get the booster, noting there needed to be an Epipen available. She was trying to find a location to get the most recent version of the Pfizer Covid 19 vaccine at a hospital setting in PRIVACY.  She usually go to PRIVACY but they don't have it.  She can't get it at a pharmacy.  She was slightly allergic so she have to get it in a medical setting and with appropriate pretreatment and at a facility equipped with an Epipen for management of possible allergic reactions.  This was advised by her Allergy and Asthma team.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: severe arm and neck pain; severe arm and neck pain; vaccine accidentally being given into the shoulder capsule; This is a spontaneous report received from a Physician.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "severe arm and neck pain"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "vaccine accidentally being given into the shoulder capsule".  Additional information: A colleague of reporter had a Pfizer COVID vaccine on Sept 1.- 48 hours later she had severe arm and neck pain and when it persisted, she went to the ED due to pain on day 7. They did a CT but did not find anything. She asked if reporter had heard of anything similar. The only thing reporter recalled was a participant had similar symptoms and was thought to be due to the vaccine accidentally being given into the shoulder capsule.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: felt "woozy"; extremely tired; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An elderly female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Unknown, reaction(s): "Hypersensitivity". The following information was reported: FATIGUE (non-serious) with onset 17Sep2024, outcome "recovering", described as "extremely tired"; DIZZINESS (non-serious) with onset 17Sep2024, outcome "recovering", described as "felt "woozy"". It was unknown if therapeutic measures were taken as a result of dizziness, fatigue.  Additional information: It was unknown if the patient receives other vaccines on the same date as the vaccine and it was unknown if patient received any other vaccines within 4 weeks PRIOR to the vaccine. The patient was taking other medications within 2 weeks of the event starting?: Patient  stated that 2 hrs after vaccination she felt "woozy" and extremely tired. She had some PVCs (which she has a history of and is on medication for) and those went away but she still felt "weird"   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Drug ineffective, Myalgia, Nausea, Pneumonia, Vomiting
Clinical narrative: Patient diagnosed with pneumonia; Patient diagnosed with pneumonia; patient initially had myalgias, nausea and vomiting; patient initially had myalgias, nausea and vomiting; patient initially had myalgias, nausea and vomiting; This is a spontaneous report received from an Other HCP from a sales representative.  An elderly female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), DRUG INEFFECTIVE (medically significant), all with latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "Patient diagnosed with pneumonia"; MYALGIA (non-serious), VOMITING (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "patient initially had myalgias, nausea and vomiting". It was unknown if therapeutic measures were taken as a result of pneumonia, drug ineffective, myalgia, vomiting, nausea. Clinical course: Patient diagnosed with pneumonia approximately 2 weeks after being administered Abrysvo- patient initially had myalgias, nausea and vomiting. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (pneumonia) with the suspect product RSV VACCINE PROT.SUBUNIT PREF 2V cannot be fully excluded.
Age: 33.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Erythema, Lymph node pain
Clinical narrative: Left underarm painful lymph node; red skin at site of pain without skin feeling irritated; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Sep2024 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 09Sep2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "Allergy: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 10Sep2024 at 08:00, outcome "not recovered", described as "Left underarm painful lymph node"; ERYTHEMA (non-serious) with onset 10Sep2024 at 08:00, outcome "not recovered", described as "red skin at site of pain without skin feeling irritated". Therapeutic measures were not taken as a result of lymph node pain, erythema.  Additional information: The patient had Left underarm painful lymph node. Started a day or so after and persisting until 18Sep2024 10 days later. Red skin at site of pain without skin feeling irritated. Patient did not receive any other vaccines within 4 weeks prior to the suspect vaccine(s).  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site erythema
Clinical narrative: injection site is really red; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Sep2024 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: VACCINATION SITE ERYTHEMA (non-serious) with onset Sep2024, outcome "unknown", described as "injection site is really red".  Additional information: Reporter stated that patient got it yesterday and right now she has no fever, no itching, none of that but her injection site was really red. When clarified the concern, reporter stated, "Yes, it was really red. It was kind of like a, it was just red."  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Body temperature increased, Headache, Somnolence
Clinical narrative: Sore at vaccine sight; Temperature; Joint pain in leg; Balance; Sleepy most of the time; Headache; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old male patient received BNT162b2 (BNT162B2 NOS), on 18Sep2024 at 11:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Amyloidosis" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "AFIB" (unspecified if ongoing); "attr wild type" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 03Sep2024. Past drug history included: Bactrim, reaction(s): "Hypersensitivity"; Aspirin, reaction(s): "Hypersensitivity". The following information was reported: BALANCE DISORDER (non-serious) with onset 18Sep2024, outcome "unknown", described as "Balance"; HEADACHE (non-serious) with onset 18Sep2024, outcome "unknown"; ARTHRALGIA (non-serious) with onset 18Sep2024, outcome "unknown", described as "Joint pain in leg"; SOMNOLENCE (non-serious) with onset 18Sep2024, outcome "unknown", described as "Sleepy most of the time"; VACCINATION SITE PAIN (non-serious) with onset 18Sep2024, outcome "unknown", described as "Sore at vaccine sight"; BODY TEMPERATURE INCREASED (non-serious) with onset 18Sep2024, outcome "unknown", described as "Temperature". Therapeutic measures were not taken as a result of vaccination site pain, body temperature increased, arthralgia, balance disorder, somnolence, headache.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at vaccine sight; Temperature; Joint pain in leg; Balance; Sleepy most of the time; Headache; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old male patient received BNT162b2 (BNT162B2 NOS), on 18Sep2024 at 11:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Amyloidosis" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "AFIB" (unspecified if ongoing); "attr wild type" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 03Sep2024. Past drug history included: Bactrim, reaction(s): "Hypersensitivity"; Aspirin, reaction(s): "Hypersensitivity". The following information was reported: BALANCE DISORDER (non-serious) with onset 18Sep2024, outcome "unknown", described as "Balance"; HEADACHE (non-serious) with onset 18Sep2024, outcome "unknown"; ARTHRALGIA (non-serious) with onset 18Sep2024, outcome "unknown", described as "Joint pain in leg"; SOMNOLENCE (non-serious) with onset 18Sep2024, outcome "unknown", described as "Sleepy most of the time"; VACCINATION SITE PAIN (non-serious) with onset 18Sep2024, outcome "unknown", described as "Sore at vaccine sight"; BODY TEMPERATURE INCREASED (non-serious) with onset 18Sep2024, outcome "unknown", described as "Temperature". Therapeutic measures were not taken as a result of vaccination site pain, body temperature increased, arthralgia, balance disorder, somnolence, headache.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vaccination site erythema, Vaccination site mass
Clinical narrative: Nausea; pain and swelling at the injection site; pain and swelling at the injection site; Reddened hard lump approximately radiating approximately 1.25in from injection site; Reddened hard lump approximately radiating approximately 1.25in from injection site; fever of 101; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 16Sep2024 at 14:45 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "adhesives allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "cephalosporins allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 16Sep2024 at 18:00, outcome "recovering"; VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 16Sep2024 at 18:00, outcome "recovering" and all described as "Reddened hard lump approximately radiating approximately 1.25in from injection site"; PYREXIA (non-serious) with onset 16Sep2024 at 18:00, outcome "recovering", described as "fever of 101"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 16Sep2024 at 18:00, outcome "recovering" and all described as "pain and swelling at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, vaccination site swelling, vaccination site pain, vaccination site mass, vaccination site erythema, pyrexia.  Additional information: Comirnaty administered at Left upper arm.The patient did not receive any other vaccines on the same date as the vaccine, The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. The patient was not taking any other medications within 2 weeks of the event starting. Treatment received includes: Ice packs, Ibuprofen and acetaminophen  . The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Nausea; pain and swelling at the injection site; pain and swelling at the injection site; Reddened hard lump approximately radiating approximately 1.25in from injection site; Reddened hard lump approximately radiating approximately 1.25in from injection site; fever of 101; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 16Sep2024 at 14:45 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "adhesives allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "cephalosporins allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 16Sep2024 at 18:00, outcome "recovering"; VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 16Sep2024 at 18:00, outcome "recovering" and all described as "Reddened hard lump approximately radiating approximately 1.25in from injection site"; PYREXIA (non-serious) with onset 16Sep2024 at 18:00, outcome "recovering", described as "fever of 101"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 16Sep2024 at 18:00, outcome "recovering" and all described as "pain and swelling at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, vaccination site swelling, vaccination site pain, vaccination site mass, vaccination site erythema, pyrexia.  Additional information: Comirnaty administered at Left upper arm.The patient did not receive any other vaccines on the same date as the vaccine, The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. The patient was not taking any other medications within 2 weeks of the event starting. Treatment received includes: Ice packs, Ibuprofen and acetaminophen  . The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of taste + smell; Loss of taste + smell; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pain" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Loss of taste + smell".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400104062 same patient, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: allergic to the booster/broke out in rash/blotchy rash from chest and trunk; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00291 (Novavax).  A female patient received BNT162b2 (COMIRNATY NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown", described as "allergic to the booster/broke out in rash/blotchy rash from chest and trunk". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: sick with colds; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20240916000004 (Moderna).  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. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunisation; Comirnaty (DOSE 2, SINGLE), for COVID-19 immunisation; Flu vaccine, for Immunisation. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "sick with colds". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that she and her husband were sick with colds. Patient stated that she was sick with a cold right now, slowly improving, up and down with feeling better. She stated that they were travelling out of country in two weeks and planned to get the Moderna Spikevax (2024-2025) and she didn't want to take antibiotics or steroids because that could mess with the vaccine. Patient stated that she would not take acetaminophen before she got the vaccine. Patient stated that she had not had COVID and had received 3 or 4 Pfizer COVID vaccines and the flu vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: covid vaccine made patient very sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: ILLNESS (non serious) outcome "unknown", described as "covid vaccine made patient very sick". The patient wanted to know why it almost killed her/him.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: my sense of smell was being affected / smell of burning; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Sep2024 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: PAROSMIA (non-serious) with onset 18Sep2024, outcome "not recovered", described as "my sense of smell was being affected / smell of burning".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.