chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccinated twice and boosted twice with the BNT1682 vaccine and subsequently developed COVID-19; vaccinated twice and boosted twice with the BNT1682 vaccine and subsequently developed COVID-19. This is a literature report for the following literature source(s).  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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 FAILURE (medically significant), COVID-19 (medically significant, life threatening) all with onset 16Aug2022, outcome "recovered" (20Aug2022) and all described as "vaccinated twice and boosted twice with the BNT1682 vaccine and subsequently developed COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2022) Positive; (20Aug2022) Negative; (21Aug2022) Negative; (24Aug2022) Positive, notes: Asymptomatic Rebound; (29Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The 71-year-old was vaccinated twice and boosted twice with the BNT1682 vaccine and subsequently developed COVID-19. She was treated with 5 days of NM/R, rendering her COVID-19 negative. She experienced symptomless COVID-19. NM/R rebound diagnosed by a COVID-19 positive antigen test and subsequently, after testing COVID-19 antigen negative for two consecutive days, she quarantined for five additional days and was not retreated with NM/R throughout the rebound episode.  The reporter considered "vaccinated twice and boosted twice with the bnt1682 vaccine and subsequently developed covid-19" related to BNT162b2.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : PV202400129177 Same article/ drug/event and different patient;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Illness, Myalgia
Clinical narrative: On her first 2 days she's feeling fever, muscle pain, joint pain, etc.; On her first 2 days she's feeling fever, muscle pain, joint pain, etc.; On her first 2 days she's feeling fever, muscle pain, joint pain, etc.; Now the 7th day, she's still feeling very weak.; feeling very tired; feeling very sick; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Sep2024 as dose 1, single (Batch/Lot number: unknown, Expiration Date: 28Feb2025) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Discomfort"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Discomfort"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "Discomfort". The following information was reported: ILLNESS (non-serious) with onset 2024, outcome "unknown", described as "feeling very sick"; FATIGUE (non-serious) with onset Sep2024, outcome "not recovered", described as "feeling very tired"; ASTHENIA (non-serious) with onset 28Sep2024, outcome "not recovered", described as "Now the 7th day, she's still feeling very weak."; PYREXIA (non-serious) with onset 28Sep2024, outcome "recovered" (30Sep2024), MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 28Sep2024, outcome "unknown" and all described as "On her first 2 days she's feeling fever, muscle pain, joint pain, etc.".  Additional information: Reporter's wife had been experiencing side effects after Comirnaty 12 plus administration for about a week now. She was already on her 4th booster. Reporter was frustrated that he could not get an answer why does the side effects has been this long. Reporter's wife took covid vaccine last Saturday, was feeling very sick. On her first 2 days she was feeling fever, muscle pain, joint pain, etc. and for 1 week completely feeling very tired. After 2 days fever had gone, she was then also very tired. This was the 4th time that she took Pfizer COVID-19 vaccine. At reporting day that was 7th day, she was then also feeling very weak. Reporter was aware of all the vaccine side effects, but this was the first time it his wife experienced this for too long. Asking if why they did not have any treatment recommendations for the side effects.   Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: On her first 2 days she's feeling fever, muscle pain, joint pain, etc.; On her first 2 days she's feeling fever, muscle pain, joint pain, etc.; On her first 2 days she's feeling fever, muscle pain, joint pain, etc.; Now the 7th day, she's still feeling very weak.; feeling very tired; feeling very sick; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Sep2024 as dose 1, single (Batch/Lot number: unknown, Expiration Date: 28Feb2025) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Discomfort"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Discomfort"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "Discomfort". The following information was reported: ILLNESS (non-serious) with onset 2024, outcome "unknown", described as "feeling very sick"; FATIGUE (non-serious) with onset Sep2024, outcome "not recovered", described as "feeling very tired"; ASTHENIA (non-serious) with onset 28Sep2024, outcome "not recovered", described as "Now the 7th day, she's still feeling very weak."; PYREXIA (non-serious) with onset 28Sep2024, outcome "recovered" (30Sep2024), MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 28Sep2024, outcome "unknown" and all described as "On her first 2 days she's feeling fever, muscle pain, joint pain, etc.".  Additional information: Reporter's wife had been experiencing side effects after Comirnaty 12 plus administration for about a week now. She was already on her 4th booster. Reporter was frustrated that he could not get an answer why does the side effects has been this long. Reporter's wife took covid vaccine last Saturday, was feeling very sick. On her first 2 days she was feeling fever, muscle pain, joint pain, etc. and for 1 week completely feeling very tired. After 2 days fever had gone, she was then also very tired. This was the 4th time that she took Pfizer COVID-19 vaccine. At reporting day that was 7th day, she was then also feeling very weak. Reporter was aware of all the vaccine side effects, but this was the first time it his wife experienced this for too long. Asking if why they did not have any treatment recommendations for the side effects.   Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: HCP called to report an adult patient who received their first dose of GARDASIL 9 "about a year ago," and did not receive any subsequent doses of GARDASIL 9. Reason for missed doses unknown by reporter. Full patient demographics not provided by repor; No additional AE; This spontaneous report was received from a pharmacist referring an adult patient of unknown age or gender.  The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  In approximately 2023 (also reported as one year ago), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, exact dose, anatomical location, route of administration, lot number and expiration date were not reported) as prophylaxis. It was reported that the patient did not receive any subsequent doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)( Inappropriate schedule of vaccine administered).
Age: 0.58
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AE; a nurse who was in training and that nurse gave the MMRII vaccine to a 7 month old. This vaccine is not due until 12 months. She stated the mistake was discovered a few weeks afte; This spontaneous report was received from a consumer and refers to a 7-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered intramuscularly (IM) for prophylaxis (strength, scheme, dose, frequency, lot #, and expiry date were not provided).   On the same date (12-SEP-2024), it was reported that the nurse who was in training and that nurse gave the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine to a 7 month old (product administered to patient of inappropriate age). This vaccine is not due until 12 months. She stated the mistake was discovered a few weeks after. At the time of reporting, the outcome of the event was not provided. The patient did not experienced averse event (no adverse event).
Sex: F
Vaccine: COVID19
Symptoms: Product intolerance
Clinical narrative: Did not tolerate the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT INTOLERANCE (Did not tolerate the Moderna vaccine) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT INTOLERANCE (Did not tolerate the Moderna vaccine). At the time of the report, PRODUCT INTOLERANCE (Did not tolerate the Moderna vaccine) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not provided. Patient received the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) on the 24th and had strange reaction. She wanted to know if she was the only one that happened to around that morning. She got headache and after about 12, 13 hours later in the middle of the night woke up with an asthma attack and major asthma situation happened and that lasted for about three days which she was able to control with her inhalers. Patient stated that she switched to Pfizer right away from Moderna because she did not tolerate the Moderna vaccine. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature delivery, Preterm premature rupture of membranes
Clinical narrative: Prior history of prematurity. Last delivery was at 33 weeks; Water broke/Preterm premature rupture of the membranes (PPROM); Prior history of prematurity. Last delivery was at 33 weeks; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2712004-1 (VAERS ID).  A female patient in her 30's (pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing). The patient was 33 weeks pregnant at the time of exposure to BNT162b2. The patient was 33 weeks pregnant at the event onset. The patient is expected to deliver one baby(s). The patient's concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization) with onset 18Dec2020, outcome "unknown", PREMATURE DELIVERY (hospitalization) with onset, outcome "unknown" and all described as "Prior history of prematurity. Last delivery was at 33 weeks"; PRETERM PREMATURE RUPTURE OF MEMBRANES (hospitalization) with onset, outcome "unknown", described as "Water broke/Preterm premature rupture of the membranes (PPROM)". The baby was delivered premature, delivery date. The baby weighed 2778.25 grams. Clinical course: The patient reported a prior history of prematurity. Last delivery was at 33 weeks. The patient had received the COVID vaccine on 18Dec2020 at 32 weeks and 5 days of pregnancy and her water broke after receiving the COVID vaccine. Preterm premature rupture of the membranes (PPROM) was reported, and premature 33 week delivery of a newborn.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (23Sep2024): This is a spontaneous follow-up report received from the same Consumer from Regulatory Authority. Updated information: Reporter (Other Healthcare professional) added. Patient details updated.  Batch/lot number is not provided, and it cannot be obtained. Follow-up (09Oct2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400003517 baby case;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling of body temperature change, Malaise, Pain
Clinical narrative: Aches and pains; I am hot and then I am cold; feel terrible; Just not right in the head; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Oct2024 as dose 1, single (Lot number: 010030069243, Expiration Date: 10Mar2025) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "got stung in his eye by a yellow jacket wasp" (unspecified if ongoing), notes: No medication for stung in eye taken; "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN. The patient also took other concomitant therapy. The following information was reported: PAIN (non-serious) with onset 02Oct2024, outcome "unknown", described as "Aches and pains"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 02Oct2024, outcome "unknown", described as "I am hot and then I am cold"; FEELING ABNORMAL (non-serious) with onset 02Oct2024, outcome "unknown", described as "Just not right in the head"; MALAISE (non-serious) with onset 02Oct2024, outcome "unknown", described as "feel terrible". Therapeutic measures were taken as a result of pain, feeling of body temperature change, malaise, feeling abnormal.  Additional information: Patient stated, "he had new COVID Shot (Pfizer COVID-19 Shot) on Wednesday morning and Wednesday evening (02Oct2024), he just started to feel terrible, and he had been on his back ever since and he just was not right in the head and aches and pains, and he was hot and then he was cold then she was steady on his feet. Was asking if that had anything to do with the shot. Patient started experiencing them about eight hours after he got the shot. Dose stated, "0.3." The patient was taking some other medication (did not have all his medicines handy right now but could tell that he was taking one for blood pressure, cholesterol and some vitamins and acid reflux, that was about it). The patient was still experiencing the events and not improving. He had been on his back for two days. Regarding treatment, patient stated, yes, took Advil which seemed to help pretty good. There were no 4-week prior vaccination, and no other vaccines administered on the same date along with the Pfizer COVID shot but it was something interesting that had happened to him the day before that he got his shot. He got stung in his eye by a yellow jacket wasp which was like a wasp. He was just wondering if that would have anything to do with the COVID-19 shot. No medication for stung in eye taken. No investigations done.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested COVID19 positive; tested COVID19 positive; This is a spontaneous report received from a Physician.  A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Oct2024, outcome "unknown" and all described as "tested COVID19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2024) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: The association between the event lack of effect (COVID-19) with COMIRNATY (2024-2025 FORMULA can not be fully excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Dyspnoea
Clinical narrative: coughing; difficulty breathing; it felt like asthma; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Oct2024 at 15:15 as dose 5, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 05Oct2024), in left arm. The patient's relevant medical history included: "Bipolar disorder, asmtha" (unspecified if ongoing); "Mild asthma" (ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Dec2021; LAMICTAL, start date: 01Apr2023; KLONOPIN, start date: 01Dec2021; VITAMIN D [VITAMIN D NOS], start date: 01May2024; VITAMIN C + ZINC, start date: 01May2024; PSYLLIUM HUSKS, start date: 01May2024; UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE], start date: 01Apr2024. Past drug history included: Doxycycline, mango, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset 05Oct2024 at 20:15, outcome "not recovered", described as "coughing"; DYSPNOEA (non-serious) with onset 05Oct2024 at 20:15, outcome "not recovered", described as "difficulty breathing"; ASTHMA (non-serious) with onset 05Oct2024 at 20:15, outcome "not recovered", described as "it felt like asthma". Therapeutic measures were taken as a result of cough, dyspnoea, asthma.  Additional information: Patient reported that about 5 hrs after receiving the flu and covid vaccinations, she suddenly started coughing a lot and needing to clear her throat. Patient have mild asthma which typically only bothers her when she have a cold or during peak allergy season, but it felt like asthma. As such, she took her two inhalers. It helped but 3.5 hrs later, patient needed another puff of her rescue inhaler. It was unusual how quickly the difficulty breathing came on, and she thought it could have been related to the Covid vaccine. She did some research and found several papers reporting asthma exacerbation after Covid boosters, so she decided to report this as an adverse event. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which patient was reporting. Patient taking any other medications within 2 weeks of the event starting.   Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Neuropathy peripheral, Pain, Pyrexia
Clinical narrative: peripheral neuropathy; sick; Low fever under a hundred; body hurts like I had been hit by car; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) at the age of 61 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic pain/Pain" (ongoing); "Tremor" (unspecified if ongoing); "for sleep" (unspecified if ongoing). Concomitant medication(s) included: OXYCODONE taken for pain (ongoing); PROPRANOLOL taken for tremor; PROGESTERONE; TRAZODONE taken for sleep disorder; KETAMINE sublingual taken for pain; ESTROGEN; TESTOSTERONE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EH9899, Anatomical Location: Arm Left), administration date: 05Jan2021, when the patient was 61-year-old, for COVID-19 immunisation, reaction(s): "peripheral neuropathy", "mouth was red", "mouth was really sore inside and angry/ it hurt", "she could not eat", "jumped 10 pounds because she could not eat", "her mouth was red, really sore inside and angry, and she saw spots", "notice a rash on her left hand", "she got sick", "fever/I have a low fever under a hundred and my body hurts", "her body hurts like she had been hit by car". The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "peripheral neuropathy"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PYREXIA (non-serious), outcome "unknown", described as "Low fever under a hundred"; PAIN (non-serious), outcome "unknown", described as "body hurts like I had been hit by car". The patient underwent the following laboratory tests and procedures: Body temperature: under a hundred. Clinical course: Patient was having side-effects from the Covid vaccine that just came out; she actually had reactions to all; Every time she got sick. So, she had a low fever under a hundred and her body hurts like she had been hit by car. Every time, she got it, this was what happened. Additional Information for Other medicines Progesterone: Because her body never recovered after she had her children. She took bioidentical hormone estrogen, testosterone.  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-202400271156 same patient/product, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Neuropathy peripheral, Pain, Pyrexia
Clinical narrative: peripheral neuropathy; sick; have a low fever under a hundred; body hurts like I had been hit by car; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), 0.3 ml single (Lot number: FF2500) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic pain/pain" (ongoing); "Tremor" (unspecified if ongoing); "for sleep" (unspecified if ongoing). Concomitant medication(s) included: OXYCODONE taken for pain (ongoing); PROPRANOLOL taken for tremor; PROGESTERONE; TRAZODONE taken for sleep disorder; ESTROGEN; TESTOSTERONE; KETAMINE sublingual taken for pain. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 05Jan2021, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "mouth was red", "mouth was really sore inside and angry/ it hurt", "she could not eat", "jumped 10 pounds because she could not eat", "her mouth was red, really sore inside and angry, and she saw spots", "notice a rash on her left hand", "she got sick", "fever/I have a low fever under a hundred and my body hurts", "her body hurts like she had been hit by car", "peripheral neuropathy"; BNT162b2 (DOSE 2, 0.3 ML SINGLE, Route of Administration: Intramuscular, Anatomical Location: Left arm), administration date: 26Jan2021, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "peripheral neuropathy", "sick", "Low fever under a hundred", "body hurts like I had been hit by car". The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "peripheral neuropathy"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PYREXIA (non-serious), outcome "unknown", described as "have a low fever under a hundred"; PAIN (non-serious), outcome "unknown", described as "body hurts like I had been hit by car". The patient underwent the following laboratory tests and procedures: Body temperature: Under a hundred, notes: low fever. Clinical course: Consumer stated she called to report that she was having side-effects from the Covid vaccine that just came out. She have actually had reactions to all, every. Patient had her fifth vaccine and every time she got sick. She does not know, if she ever reported it before. So, she had a low fever under a hundred and her body hurts like she had been hit by car. Every time, she got it, this was what happened. She had peripheral neuropathy which was usually well managed but on the same day, it was not after she got a shot. She believed that one of her vaccine was Moderna but the same thing happened with that. Five, most of them have been Pfizer, four out of five have been Pfizer. It was not showing the Moderna, the Moderna must have been her fourth one and she do not have anything for that.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400271156 same patient/product, different dose/formulation/events;
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue
Clinical narrative: there was a black spike inside the vial; This is a spontaneous report received from an Other HCP from product quality group, Program ID.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5 ml single (Lot number: HE6175, Expiration Date: 31Mar2025) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "there was a black spike inside the vial".  Causality for "there was a black spike inside the vial" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).  Additional Information: It was reported that when the pharmacist tried to mix it, there was a black spike inside the vial. The particle was floating, it was black and tiny, it was very small.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: After injection a very large bruise appeared about the size of a softball; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 01Oct2024 as right arm). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 04Oct2024, outcome "recovering", described as "After injection a very large bruise appeared about the size of a softball". Therapeutic measures were not taken as a result of vaccination site bruising. Additional information: Patient was allergy to sulpha. The patient has not received any other vaccines within 4 weeks prior to the vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Erythema nodosum
Clinical narrative: erythema nodosum; This is a spontaneous report received from a Physician from a sales representative.  A patient (age and gender not provided) 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: ERYTHEMA NODOSUM (non-serious), outcome "unknown". Additional information: Patient experienced erythema nodosum after night of or day after Abrysvo administration. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Mucosal disorder, Product use issue
Clinical narrative: I've noticed a mucosal response having had every combo; Product use for unapproved combination; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00589 (Novavax).  This non serious initial spontaneous report was reported by a Consumer via social media monitoring and concerns an individual of unspecified age and sex who experienced I'VE NOTICED A MUCOSAL RESPONSE HAVING HAD EVERY COMBO on an unknown day after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on an unknown date.At the time of the report, the  outcome of the Mucosal disorder was Unknown. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect.  Company Remarks (Sender's Comments): This individual of an unspecified age and sex experienced Mucosal disorder after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula). The event Mucosal disorder was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Mucosal disorder is considered Possible.  Causality as per reporter and per Mfr was possible for the event and Novavax COVID-19 Vaccine, while unknown for PFIZER BIONTECH COVID-19 VACCINE.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick/"only med I've used was poison to me"; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 74-year-old female patient 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 "sick/"only med I've used was poison to me"". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Obsessive-compulsive disorder, Vaccination site paraesthesia
Clinical narrative: severe hit-and-run OCD; concentration issues; fatigue; pins and needles in his left arm, at the injection site; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 10000099760.  A 31-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OBSESSIVE-COMPULSIVE DISORDER (non-serious), outcome "unknown", described as "severe hit-and-run OCD"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "concentration issues"; FATIGUE (non-serious), outcome "unknown"; VACCINATION SITE PARAESTHESIA (non-serious), outcome "unknown", described as "pins and needles in his left arm, at the injection site". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101540464 same patient/reporter,different doses/AE;US-PFIZER INC-202101542628 same patient/reporter,different doses/AE;
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: vertigo; dizziness; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00525 (Novavax).  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: VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: MENQUADFI was administered post excursion with reported adverse event; Initial information received on 06-Sep-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case was linked to 2024SA269367, 2024SA269596, 2024SA269314, 2024SA269307 (cluster).  This case involves 31 patients of 11-17 years of age, who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   From 24-Aug-2024 to 05-Sep-2024, the 31 patients received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine, Solution for injection, that was involved in a temperature excursion resulting in below 0 temperature exposure with no adverse event (poor quality product administered) (latency same day) (lot U7996BB, expiry 31-AUG-2026 and Lot: U8124AA, with unknown expiry) (dose, strength and route: unknown) in unknown administration site for immunization.  Reportedly, Reason: Refrigerator issue Max/low temperature reached: Negative 1.1C, Duration out of labelled range: Less than 5 minutes, Human error: No, Does extended stability data cover the excursion: No, all of the unopened vaccines are not covered by the extended stability data. If negative advice, was the product administered to a patient: Yes, all affected products were administered to patients. Per guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.   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.  Additional information was received on 24-Sep-2024 from Nurse: Case was upgraded from non-valid to valid. Number of patients and their age range was added. Additional batch number added for suspect. Suspect and event start and stop information added. Clinical course updated. Text amended.; Sender's Comments:  US-SA-2024SA269314: US-SA-2024SA269596: US-SA-2024SA269367: US-SA-2024SA269307:
Sex: F
Vaccine: UNK
Symptoms: Chest pain, Dyspnoea, Muscle spasms
Clinical narrative: Chest pain; Shortness of breath; Leg cramping; This spontaneous case initially received on 30-Sep-2024, was reported by a non health professional and concerns an unknown age group female patient.  Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for Indication flu immunization, Dose Regimen: not reported, Lot number: Lot number: Not reported and would be requested upon follow up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Chest pain (Hospitalized, outcome: Unknown), Shortness of breath (Hospitalized, outcome: Unknown), Leg cramping (Hospitalized, outcome: Unknown).  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the events as serious (Hospitalization) and did not provide the causality assessment.; Reporter's Comments: Causality: Unassessable for chest pain, shortness of breath and leg cramp. The information provided is insufficient to perform a more in-depth analysis. (event onset date, product start date and relevant medical history)
Sex: M
Vaccine: UNK, UNK
Symptoms: Dysphagia, Ear pain, Headache, Neck pain, Oropharyngeal pain
Clinical narrative: Sore throat; Headaches off and on; Sharp pain behind the ear, all the way down the left hand side of the neck'.; Feel groggy; trouble swallowing; This spontaneous case, initially received on 03-Oct-2024, with additional information (04-OCt-2024) was reported by a non-health professional and concerns an elderly male patient.  Past medical history included swollen left knee, measles, rotator cuff tear.  Administration of company suspect drugs: On an unknown date, the patient received Flucelvax Quadrivalent for Prevention of seasonal influenza., Lot number: 946609, dosage and route of administration: not reported.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 2024, the patient experienced Sore throat (outcome: Not recovered / Not resolved), Headaches off and on (outcome: Not Reported), Sharp pain behind the ear, all the way down the left hand side of the neck'. (outcome: Not recovered / Not resolved), Feel groggy (outcome: Not Reported), trouble swallowing (outcome: Not Reported).  Events were started, two weeks ago, going on to the third week.  The patient experienced an adverse event following the administration of a Seqirus vaccine as he has sore throat, headaches off and on, sharp pain behind the ear, all the way down the left-hand side of the neck'. Moreover, consumer stated he has had a sore throat for over two weeks now and trouble swallowing. Consumer stated not feeling 100% after the flu shot, feel groggy and sore throat is not improving continue to feel sore throat and pain behind the ear.  Non-drug treatment/Other action taken:  Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event:  Eat smart, take vitamins and minerals, exercise, drink celery juice in the morning  Reporter assessment: The reporter did not provide the seriousness and causality assessment of all events.; Reporter's Comments: Company causality for events as related
Sex: M
Vaccine: UNK, UNK
Symptoms: Somnolence
Clinical narrative: Sore throat; Headaches off and on; Sharp pain behind the ear, all the way down the left hand side of the neck'.; Feel groggy; trouble swallowing; This spontaneous case, initially received on 03-Oct-2024, with additional information (04-OCt-2024) was reported by a non-health professional and concerns an elderly male patient.  Past medical history included swollen left knee, measles, rotator cuff tear.  Administration of company suspect drugs: On an unknown date, the patient received Flucelvax Quadrivalent for Prevention of seasonal influenza., Lot number: 946609, dosage and route of administration: not reported.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 2024, the patient experienced Sore throat (outcome: Not recovered / Not resolved), Headaches off and on (outcome: Not Reported), Sharp pain behind the ear, all the way down the left hand side of the neck'. (outcome: Not recovered / Not resolved), Feel groggy (outcome: Not Reported), trouble swallowing (outcome: Not Reported).  Events were started, two weeks ago, going on to the third week.  The patient experienced an adverse event following the administration of a Seqirus vaccine as he has sore throat, headaches off and on, sharp pain behind the ear, all the way down the left-hand side of the neck'. Moreover, consumer stated he has had a sore throat for over two weeks now and trouble swallowing. Consumer stated not feeling 100% after the flu shot, feel groggy and sore throat is not improving continue to feel sore throat and pain behind the ear.  Non-drug treatment/Other action taken:  Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event:  Eat smart, take vitamins and minerals, exercise, drink celery juice in the morning  Reporter assessment: The reporter did not provide the seriousness and causality assessment of all events.; Reporter's Comments: Company causality for events as related
Sex: M
Vaccine: UNK, UNK
Symptoms: Migraine, Oropharyngeal pain
Clinical narrative: Sore throat; Headaches off and on; Sharp pain behind the ear, all the way down the left hand side of the neck'.; Feel groggy; trouble swallowing; This spontaneous case, initially received on 03-Oct-2024, with additional information (04-OCt-2024) was reported by a non-health professional and concerns an elderly male patient.  Past medical history included swollen left knee, measles, rotator cuff tear.  Administration of company suspect drugs: On an unknown date, the patient received Flucelvax Quadrivalent for Prevention of seasonal influenza., Lot number: 946609, dosage and route of administration: not reported.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 2024, the patient experienced Sore throat (outcome: Not recovered / Not resolved), Headaches off and on (outcome: Not Reported), Sharp pain behind the ear, all the way down the left hand side of the neck'. (outcome: Not recovered / Not resolved), Feel groggy (outcome: Not Reported), trouble swallowing (outcome: Not Reported).  Events were started, two weeks ago, going on to the third week.  The patient experienced an adverse event following the administration of a Seqirus vaccine as he has sore throat, headaches off and on, sharp pain behind the ear, all the way down the left-hand side of the neck'. Moreover, consumer stated he has had a sore throat for over two weeks now and trouble swallowing. Consumer stated not feeling 100% after the flu shot, feel groggy and sore throat is not improving continue to feel sore throat and pain behind the ear.  Non-drug treatment/Other action taken:  Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event:  Eat smart, take vitamins and minerals, exercise, drink celery juice in the morning  Reporter assessment: The reporter did not provide the seriousness and causality assessment of all events.; Reporter's Comments: Company causality for events as related
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Evening after receiving immunization, patient experienced swelling at site of injection. The next day, the area around the injection site was red and itchy.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a dose of Prevnar 20, after administration pharmacy verified System and found the patient had already had Prevnar 20 in August 2023.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Bell's palsy
Clinical narrative: Symptoms started on Monday (10/7), went to hospital and possibly diagnosed with bells parsley
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: PATIENT PREVIOUSLY RECIEVED PREVNAR20 ON 04/24/2024, THEN RECIEVED AGAIN ON 10/03/2024
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Cellulitis
Clinical narrative: Day 5 - cellulitis to right shoulder area
Age: 79.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received Prevnar20 on 04/24/2024, then received it again on 10/03/2024
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Pt was given full, undiluted amount of COVID vial for 6 m - 4 yrs instead of diluted and given 1/3 the total amount.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received Prevnar20 on 04/24/2024, then received the same vaccine on 10/03/2024
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site discolouration, Injection site haemorrhage, Injection site reaction, Injection site vesicles
Clinical narrative: The site was bleeding.  About 2 days after removing the bandaid, site began to blister similar to a Keloid.  After approx. 1 week, the blister began to discharge a liquid.  The day following the discharge, the skin broke and something black was in the middle.  Approx. another week later, the skin is peeling.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Skin exfoliation
Clinical narrative: The site was bleeding.  About 2 days after removing the bandaid, site began to blister similar to a Keloid.  After approx. 1 week, the blister began to discharge a liquid.  The day following the discharge, the skin broke and something black was in the middle.  Approx. another week later, the skin is peeling.
Age: 90.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received Prevnar20 on 04/24/2024, then received it again on 10/03/2024.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Pt was given full, undiluted vial of COVID vaccine for 6 m- 4 yrs instead of diluted and given 1/3 the diluted dose
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Back pain, Chest pain
Clinical narrative: PATIENT CALLED ME AND TOLD ME THAT SHE HAD SEVERE CHEST AND BACK PAIN AFTER 4 HOURS OF GETTING THE PNUEMONIA VACCINE. SHE TALKED TO  ONE OF THE DOCTOR ABOUT IT WHERE SHE WORKS AND THE DOCTOR TOLD HER THAT IT WILL GO AWAY IN FEW MORE DAYS.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside "Best By" date. Patient notified. No reaction stated.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Myelitis transverse
Clinical narrative: Patient husband came to pharmacy on 10/9/24 and told RPH thay her wife was admitted in hospital for transverse myelitis T4 and T5 spinal cord day after getting flu vaccine at Pharmacy on 9/27/24. Husband said that injury caused her to be in hopsital for 8 days afterwards where she could not move around and currently now doing physical therphy. He told me that doctor told him this is rare adverse reaction that can happen in individual after getting a vaccine.
Age: 83.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: Insurance states that the patient has previously received Prevnar20, however initial vaccination is not reported on form. Patient received the vaccine again on 10/03/24.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC20, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flulaval was given at the incorrect age, patient did not have an adverse reaction. Consulted with Dr, parents were notified and verbalized understanding.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "best by" date. Patient notified. No reaction stated.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Dysgeusia
Clinical narrative: Patient states that after his vaccine he has experienced loss of taste and everything tastes blanc and terrible. Patient has not tested for COVID. Patient wants to wait it out and see what happens before seeking treatment.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 81.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient previously received Prevnar20 on 04/24/2024, then received it again on 10/03/24