chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Joint stiffness, Pyrexia
Clinical narrative: mild fever only 100; wrist joint pain; stiffness in his joints; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 at 11:10 as dose 1, single (Lot number: HG4633) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease; LOSARTAN taken for hypertension; ASPIRIN COX [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose number unknown), administration date: Nov2022, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 31Oct2023, outcome "unknown", described as "mild fever only 100"; JOINT STIFFNESS (non-serious) with onset 31Oct2023, outcome "unknown", described as "stiffness in his joints"; ARTHRALGIA (non-serious) with onset 31Oct2023, outcome "unknown", described as "wrist joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient got his Pfizer COVID-19 booster the previous day and currently experiencing mild fever only 100 (unable to clarify with caller if in Fahrenheit or Celsius), stiffness in his joints, and wrist joint pain/pain in the wrist joint. The patient was asking if it was normal.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: she got numbness/numbness in her legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received bnt162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8732) at the age of 54 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "not recovered", described as "she got numbness/numbness in her legs". The event "she got numbness/numbness in her legs" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of hypoaesthesia. Additional information: Patient stated that she called about the Covid vaccination, a shot from Pfizer. She got three Pfizer vaccines. She had numbness in her legs sometimes. She clarified that she reported this previously. After the first vaccination she got numbness and it ran with the vaccinations. She was told that it was not from the vaccinations in the ER. She just kept going and she has got numbness in her legs. They emailed her all the time and asked how she was doing and they stopped doing it. She did a report on the phone previously. She later clarified that she reported this online with Pfizer previously. They were testing her for months and months and asked how she was feeling on a scale of 1-10 and then they stopped. She did not have anything medical she just went for the vaccination. She called because she went to a doctor because she was still having this numbness and was told that it was probably from the vaccinations because she has been having it since then. She went online and they sent something to ask how she was doing and how many days what was going on.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353366 same patient/suspect drug, different dose number/event;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation, Muscle spasms
Clinical narrative: got numbness in her legs; cramping in her legs sometimes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received bnt162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Lot number: F13209) at the age of 55 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (dose 1, Lot number: ER8732), administration date: 02Apr2021, for COVID-19 Immunization, reaction(s): "she got numbness/numbness in her legs"; bnt162b2 (dose 2, Lot number: EW0158), administration date: 23Apr2021, for COVID-19 Immunization, reaction(s): "she got numbness/numbness in her legs". The following information was reported: MUSCLE SPASMS (non-serious) with onset Jan2022, outcome "not recovered", described as "cramping in her legs sometimes"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "got numbness in her legs". The events "got numbness in her legs" and "cramping in her legs sometimes" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, muscle spasms. Additional information: Patient got three Pfizer vaccines. She had numbness in her legs sometimes. She clarified that she reported this previously. After the first vaccination she got numbness and it ran with the vaccinations. She was told that it was not from the vaccinations in the ER. She just kept going and she has got numbness in her legs. They emailed her all the time and asked how she was doing and they stopped doing it. She did a report on the phone previously. Later clarified that she reported this online with Pfizer previously. They were testing her for months and months and asked how she was feeling on a scale of 1-10 and then they stopped. She called because she went to a doctor because she was still having this numbness and was told that it is probably from the vaccinations because she has been having it since then. She went online and they sent something to ask how she was doing and how many days what was going on. She reported to a chiropractor because there was numbness and cramping with her legs sometimes. She did not have cramping at time of the previous report. When she got the third vaccination it was worst.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353354 same patient/suspect drug, different dose number/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got the Pfizer COVID-19 vaccine/taking Paxlovid; got the Pfizer COVID-19 vaccine/taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 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 included: "H. pylori" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) (DOSE 6 (BOOSTER), SINGLE, The last bivalent which caller had in 2022), administration date: 2022, for COVID-19 immunisation; Flu vaccine (Got all vaccines at doctors office, including flu shots.), for Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got the Pfizer COVID-19 vaccine/taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical Course: Patient had always took the Moderna COVID-19 vaccine, was wanted the Moderna COVID-19 vaccine this time but got the Pfizer COVID-19 vaccine, patinet was taking Paxlovid and wanted to knew if there was an issue with those shots interacting. Reporter had been took the Moderna COVID-19 vaccine for 4 boosters and the last bivalent which caller had in 2022, all were Moderna, never switched from one to another. Got all vaccines at doctors office, including flu shots.Then stated caller was taking Paxlovid, had H. pylori.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Needle issue, Poor quality product administered, Syringe issue
Clinical narrative: When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke; When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 31Oct2023 as dose number unknown, single (Lot number: HF1068, Expiration Date: Aug2024) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEEDLE ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 31Oct2023 and all described as "When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke".  Causality for "when they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  Additional information: Reporter (Nurse) stated, they had experienced an issue with the Prevnar 13 (Later clarified and confirm as Prevnar 20) and was not sure if it was here the LOT number or what the end of the prefilled syringe when they were activating the safety needle feature like after they administered the vaccine it was breaking off. With all three of these after the vaccine was administered when they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off. Right but it was the actual syringe that broke. Vaccine was administered to any of the patient. There was not an issue to the patient. After the needle on all three occasion, it was after it was administered to the patient and they pull the needle out and then went to activate the safety needle feature that was when it broke. Reporter did not know which Pharmacy we got it from they just place an order with they organization or Pharmacy and they just send it to the reporter. There is a product complaint to report. UPC#: maybe PAA201729.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353292 Same reporter/drug/event for different patients.;US-PFIZER INC-202300353440 Same reporter/drug/event for different patients.;
Sex: U
Vaccine: PNC20
Symptoms: Needle issue, Poor quality product administered, Syringe issue
Clinical narrative: When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke; When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 31Oct2023 as dose number unknown, single (Lot number: HF1068, Expiration Date: Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 31Oct2023, NEEDLE ISSUE (non-serious) and all described as "When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke". Additional information: they had experienced an issue with the Prevnar 20 and reporter was not sure if it is here the LOT number or what the end of the prefilled syringe when they were activating the safety needle feature like after they administered the vaccine it was breaking off. This was the three that they had. Reportability Determination: This complaint for Reported that after the vaccine was administered when they pull the needle out of the patient and when they went to activate the safety feature of the needle, the tip just breaks off. There was not an issue to the patient, for Prevnar 20, is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury.   Causality for "when they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353292 Same reporter/drug/event for different patients.;US-PFIZER INC-202300353439 Same reporter/drug/event for different patients.;
Sex: F
Vaccine: UNK
Symptoms: Vaccination site bruising, Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: Daughter's arm was bruised for weeks after and it looked yellow and it got kind of itchy.; Daughter's arm was bruised for weeks after and it looked yellow and it got kind of itchy.; Daughter's arm was bruised for weeks after and it looked yellow and it got kind of itchy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown" and all described as "Daughter's arm was bruised for weeks after and it looked yellow and it got kind of itchy.". Additional information: Caller reports her Daughter had bruising and it stayed yellow. Caller states she doesn't know if her Daughter has still gotten rid of it.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The individual test positive for Covid-19 today 01Nov2023; The individual test positive for Covid-19 today 01Nov2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, latency 20 days after the suspect product(s) administration, outcome "recovering" and all described as "The individual test positive for Covid-19 today 01Nov2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2023) Positive. Clinical course: It was unknown if patient received other Vaccine in Four weeks and other Medications in Two weeks. The Individual Test Positive for Covid-19 Today 01Nov2023 With Sinus Congestion, Sneezing, And Sore Throat. 20 Days After Vaccination. Patient did not have Covid Prior Vaccination and Covid Tested Post Vaccination. It was unknown if patient had any known Allergies and other Medical History.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353883 Same patient, different vaccine dose number, different AE;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: Nasal Swab: Positive (NOV2022); Nasal Swab: Positive (Nov2022); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN199gh), in left arm and on 02Nov2021 as dose 3, (booster) single (Lot number: FH8020) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve disease (stable and no issues until vaccine)" (unspecified if ongoing); "migraines; worse after vaccine" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing); "Mold allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Nov2022, outcome "unknown", described as "Nasal Swab: Positive (NOV2022)"; COVID-19 (medically significant) with onset Nov2022, outcome "unknown", described as "Nasal Swab: Positive (Nov2022)". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other vaccine in four weeks was reported as no. The patient received other medications in two weeks was reported as no. The patient received vaccine prior COVID was reported as no.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300354059 Same patient, same drug/different dose, different AEs.;US-PFIZER INC-202300354135 Same patient/drug/AE, event separated in time.;
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Brain fog, Dyspnoea, Fatigue
Clinical narrative: soreness; feeling extremely weak; blurry vision; headache; arms and legs put on weight; cannot walk properly; difficulty in breathing; low grade fever (around 100.8F); brain fog; tinnitus; extreme fatigue; feeling very unwell; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "soreness"; ASTHENIA (non-serious), outcome "unknown", described as "feeling extremely weak"; VISION BLURRED (non-serious), outcome "unknown", described as "blurry vision"; HEADACHE (non-serious), outcome "unknown"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "arms and legs put on weight"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "cannot walk properly"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty in breathing"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever (around 100.8F)"; BRAIN FOG (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; MALAISE (non-serious), outcome "unknown", described as "feeling very unwell". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that she received the most recent Pfizer covid19 vaccine along with her flu vaccine 3 weeks ago. She said that after receiving the vaccine, she has experienced the following symptoms, soreness, feeling extremely weak, blurry vision, headache, arms and legs put on weight, cannot walk properly, difficulty in breathing, low grade fever (around 100.8F), brain fog, and tinnitus. Her main concerns were the, extreme fatigue and tinnitus. She wanted to check if there are other people who reported these SEs. She said that she was an active person and this was not typical of her. She mentioned during the call that she did not have any pre-existing conditions. She said that she was feeling very unwell but contacted Pfizer to see if other people have experienced this too. She mentioned that she went to have an assessment and had a PCR test which came out negative. She will be coming back on Friday of the reporting week for additional lab work.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Limb discomfort, Malaise, Pain
Clinical narrative: soreness; feeling extremely weak; blurry vision; headache; arms and legs put on weight; cannot walk properly; difficulty in breathing; low grade fever (around 100.8F); brain fog; tinnitus; extreme fatigue; feeling very unwell; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "soreness"; ASTHENIA (non-serious), outcome "unknown", described as "feeling extremely weak"; VISION BLURRED (non-serious), outcome "unknown", described as "blurry vision"; HEADACHE (non-serious), outcome "unknown"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "arms and legs put on weight"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "cannot walk properly"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty in breathing"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever (around 100.8F)"; BRAIN FOG (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; MALAISE (non-serious), outcome "unknown", described as "feeling very unwell". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that she received the most recent Pfizer covid19 vaccine along with her flu vaccine 3 weeks ago. She said that after receiving the vaccine, she has experienced the following symptoms, soreness, feeling extremely weak, blurry vision, headache, arms and legs put on weight, cannot walk properly, difficulty in breathing, low grade fever (around 100.8F), brain fog, and tinnitus. Her main concerns were the, extreme fatigue and tinnitus. She wanted to check if there are other people who reported these SEs. She said that she was an active person and this was not typical of her. She mentioned during the call that she did not have any pre-existing conditions. She said that she was feeling very unwell but contacted Pfizer to see if other people have experienced this too. She mentioned that she went to have an assessment and had a PCR test which came out negative. She will be coming back on Friday of the reporting week for additional lab work.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tinnitus, Vision blurred
Clinical narrative: soreness; feeling extremely weak; blurry vision; headache; arms and legs put on weight; cannot walk properly; difficulty in breathing; low grade fever (around 100.8F); brain fog; tinnitus; extreme fatigue; feeling very unwell; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "soreness"; ASTHENIA (non-serious), outcome "unknown", described as "feeling extremely weak"; VISION BLURRED (non-serious), outcome "unknown", described as "blurry vision"; HEADACHE (non-serious), outcome "unknown"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "arms and legs put on weight"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "cannot walk properly"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty in breathing"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever (around 100.8F)"; BRAIN FOG (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; MALAISE (non-serious), outcome "unknown", described as "feeling very unwell". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that she received the most recent Pfizer covid19 vaccine along with her flu vaccine 3 weeks ago. She said that after receiving the vaccine, she has experienced the following symptoms, soreness, feeling extremely weak, blurry vision, headache, arms and legs put on weight, cannot walk properly, difficulty in breathing, low grade fever (around 100.8F), brain fog, and tinnitus. Her main concerns were the, extreme fatigue and tinnitus. She wanted to check if there are other people who reported these SEs. She said that she was an active person and this was not typical of her. She mentioned during the call that she did not have any pre-existing conditions. She said that she was feeling very unwell but contacted Pfizer to see if other people have experienced this too. She mentioned that she went to have an assessment and had a PCR test which came out negative. She will be coming back on Friday of the reporting week for additional lab work.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Had a severe reaction getting a Prevnar, Pneumonia vaccine 6 years ago; had high fever for 4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Had a severe reaction getting a Prevnar, Pneumonia vaccine 6 years ago; had high fever for 4 days".  Additional information: Consumer (patient) stated: "I am 65 and I would like to get the Prevnar pneumonia vaccine. However, I had a severe reaction getting a Prevnar, Pneumonia vaccine, 6 years ago (don't know which Prevnar). I had high fever for 4 days and I am a little concerned. I don't want to be setting myself up. My concern is, is this going to be safe? If I get that vaccine or am I likely going to get ill as I was before? ".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein), pneumococcal 13-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Depressed mood, Nausea, Pain
Clinical narrative: she hadn't had much of an appetite; was queasy; achy; a little down in the dumps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 34-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEPRESSED MOOD (non-serious) with onset 01Nov2023, outcome "unknown", described as "a little down in the dumps"; PAIN (non-serious) with onset 01Nov2023, outcome "unknown", described as "achy"; DECREASED APPETITE (non-serious) with onset 01Nov2023, outcome "unknown", described as "she hadn't had much of an appetite"; NAUSEA (non-serious) with onset 01Nov2023, outcome "unknown", described as "was queasy".  Additional information: Reporter's daughter had the vaccine yesterday (01Nov2023) and she hadn't had much of an appetite, was queasy, achy, a little down in the dumps.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on 01Nov2023. Sore throat, runny nose, cough; Tested positive for COVID on 01Nov2023. Sore throat, runny nose, cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 15-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 14 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. Patient received bivalent Pfizer COVID-19 vaccine in Pharmacy or Drug Store. The patient's relevant medical history included: "Lactose intolerance" (unspecified if ongoing). No covid prior vaccination. Patient had no allergies. There were no concomitant medications. No other vaccine in four weeks, no other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Oct2023, outcome "recovering" and all described as "Tested positive for COVID on 01Nov2023. Sore throat, runny nose, cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2023) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Adverse event start date was 28Oct2023.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I am positive for Covid after receiving 3 Pfizer Covid Vaccines; I am positive for Covid after receiving 3 Pfizer Covid Vaccines; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Lot number: EW0153), as dose 2, single (Lot number: EW0171) and in 2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN B12 [CYANOCOBALAMIN].  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "I am positive for Covid after receiving 3 Pfizer Covid Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Nov2023) Positive, notes: I am positive for Covid after receiving 3 Pfizer Covid Vac-cines. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Malaise
Clinical narrative: sweating; dizzy; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 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: Covid-19 vaccine (got a Covid shot, booster , Dose number unknown; manufacturer unknown), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious) with onset 31Oct2023, outcome "unknown", described as "not feeling well"; DIZZINESS (non-serious) with onset 03Nov2023, outcome "unknown", described as "dizzy"; HYPERHIDROSIS (non-serious) with onset 03Nov2023, outcome "unknown", described as "sweating".  Additional information: the patient reported that he always got a Covid shot, booster and everything and then he now got the new Covid shot that came out on Tuesday, Pfizer shot and he was not feeling well he had enough of this Covid shots, you felt a little down, sit on the couch a few days, didn't have your energy but, he got it on Tuesday today is Friday he was feeling worse than last Tuesday it's been 3 days he had enough of the Covid shot to know the routine, today I'm sweating, dizzy, this was not the reaction he got from the other Covid shots.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5], has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder
Clinical narrative: he constant had salty taste and that his lips also had salty taste; change in taste; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 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: DYSGEUSIA (non-serious), outcome "unknown", described as "he constant had salty taste and that his lips also had salty taste"; TASTE DISORDER (non-serious), outcome "unknown", described as "change in taste".  Additional information: Patient reported that he experienced a change in the ability to taste where he constant had salty taste and that his lips also had salty taste so he was unable to drink. Patient already went to the doctor to find a solution, however, was unable to receive any. Patient wanted to know how to get rid of the salty taste. He received the Comirnaty vaccine last 06Oct2023. Patient said he can drink and eat but everything is affected by the taste. Patient mentioned that the only difference before and after he experienced the change in taste was the Comirnaty vaccine so "it has to be related to that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Vital capacity
Clinical narrative: fatigue; headache; body aches; mild nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 73-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 5 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset Oct2023, outcome "unknown"; HEADACHE (non-serious) with onset Oct2023, outcome "unknown"; NAUSEA (non-serious) with onset Oct2023, outcome "unknown", described as "mild nausea". The events "fatigue", "headache", "body aches" and "mild nausea" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, headache, pain, nausea. Additional information: Visited doctor on 24Oct2023. Doctor told to treat the symptoms. Patient was taking aspirin.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Food allergy
Clinical narrative: have a very bad allergic reaction to eggwhite; her lungs lock up and can't breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 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: FOOD ALLERGY (non-serious), outcome "unknown", described as "have a very bad allergic reaction to eggwhite"; DYSPNOEA (non-serious), outcome "unknown", described as "her lungs lock up and can't breathe". Additional information: It was reported that the patient got all her COVID-19 shot because she have health issues and stuff.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anaemia, Illness
Clinical narrative: sick; Anemia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; ANAEMIA (non-serious), outcome "unknown", described as "Anemia".  Additional Information: Patent had been sick since he/she received our vaccine and developed Anemia from it.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: dropping platelets; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 30Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "dropping platelets". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of platelet count decreased.  Additional information: She further added, with every shot with every vaccine, she have had a dropping platelets. In both cases, being on 20 mg of Prednisone has reversed the incident. Then comes out, the duration is short, the incident is minor. With that information in tow, she took the 3rd shot. And then she developed severe thrombocytopenia. Her platelet level went down to 2. She was on every medication known to the pharmaceutical industry to get her platelets back to normal. And the doctors seem to believe that it was the vaccines because even though you have a mild reactions in the past does not preclude having a severe reaction and that's what should've been stressed by Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352575 Same patient/vaccine/event, different dose;US-PFIZER INC-202300352577 Same patient/vaccine, different dose/event;US-PFIZER INC-202300352576 Same patient/vaccine/event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: I'm allergic to the Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I'm allergic to the Pfizer". Additional information: Patient called regarding the availability of the vaccines and why there is not enough. Asked if doctors office has the vaccine and the caller stated, "They only give out the Pfizer they can't get the Moderna...I can't take that. I'm allergic to it." Asked name of the vaccine and caller stated, "well I haven't got it in a year there's only two of them here its either Pfizer or Moderna and I get the Moderna shot because I'm allergic to the Pfizer I don't know what you're talking about other than that that's what we call it here. the corona virus shot. Note: The reporters/patients name was not provided on the phone call The following information was not confirmed during the call, but retrieved from the system: Reporter phone No.,The following information was not provided during the call: Patient gender  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Magnetic resonance imaging, X-ray
Clinical narrative: could not lift the arm for months; still have some pain in the shoulder of the left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in 2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (dose 2, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (dose 3 (booster), Lot number: unknown), for COVID-19 immunization. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "could not lift the arm for months"; ARTHRALGIA (non-serious), outcome "not recovered", described as "still have some pain in the shoulder of the left arm". The events "could not lift the arm for months" and "still have some pain in the shoulder of the left arm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of joint range of motion decreased, arthralgia. Additional information: In Fall 2022, patient received the fourth Pfizer shot and a flu shot. They said taking both simultaneously and in the same arm was fine. That was exactly what the patient did. As a result, the patient could not lift the arm for months. The patient ended up getting an X-ray as well as an MRI. The best the doctor could recommend was physical therapy, which ultimately helped, but occasionally, patient still had some pain in the shoulder of the left arm. Patient was convinced, as was patient's physician, that the patient should not have gotten both the same day and in the same arm. They did not feel there was any problem with the particular batch of Pfizer booster that patient received that day.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Renal transplant
Clinical narrative: kidney transplant; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL TRANSPLANT (medically significant), outcome "unknown", described as "kidney transplant"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". Clinical course: Caller was calling in mentioned that after they take the Pfizer vaccine and her husband experienced a flu like symptoms. Asking if it was normal. Created manual AE form because the caller's husband developed a flu like symptoms after getting a vaccine shot and caller mentioned that her husband had a kidney transplant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.