chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 at 16:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 50 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hereditary elevated cholesterol" (unspecified if ongoing), notes: Hereditary elevated cholesterol; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: SIMVASTATIN, start date: 01Jun2015, stop date: 14Sep2022. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Negative, notes: After Paxlovid treatment, felt fine and tested negative for two days; (Sep2022) Positive, notes: Then on the third day had mild sore throat and runny nose, tested and was positive again; (Sep2022) Negative, notes: After Paxlovid treatment, felt fine and tested negative for two days. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series of immunization was completed, Unknown manufacturer.), for Covid-19 immunization; Covid-19 vaccine (first booster dose, manufacturer unknown), for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 25Sep2022, outcome "unknown", described as "not feeling well". It was unknown if therapeutic measures were taken as a result of malaise. Additional Information: The patient received the booster vaccine 24Sep2022 and reported "not feeling well" the following day 25Sep2022. It was unknown if the patient received other vaccine in four weeks. It was also unknown if the patient had covid prior vaccinated and if the patient had tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: running a fever of 101.1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Sep2022, outcome "unknown", described as "running a fever of 101.1". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was calling on behalf of the husband (Name withheld). Caller just want to know, the Bivalent shot (Name for Bivalent shot was not clarified hence captured as Bivalent vaccine) was given yesterday to the husband (Name withheld) and he was running a fever of 101.1. Caller was querying how high the fever can go and how long it will last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 18Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 16Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hoshimotos" (unspecified if ongoing), notes: Other medical history: Hoshimotos. Concomitant medication(s) included: LISINOPRIL; SYNTHROID; MAGNESIUM; FISH OIL; D3. Past drug history included: Sulfa, reaction(s): "Known allergies: Sulfa", notes: Known allergies: Sulfa. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: my lymph system on the whole side was, on the side where I got my shot must have been inflamed or something and I just noticed that it is on the paper now that swollen lymph nodes; it was like the whole lymph system on my left side where I got my shot on the left and it was like I was sore on the whole side; 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 patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ5342) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 2022, outcome "unknown", described as "it was like the whole lymph system on my left side where I got my shot on the left and it was like I was sore on the whole side"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "my lymph system on the whole side was, on the side where I got my shot must have been inflamed or something and I just noticed that it is on the paper now that swollen lymph nodes".  Additional information: Consumer stated, Patient got the vaccine (Pfizer COVID 19 Vaccine) and patient don't know what one patient got. patient thought there was only one type but it sounds like there was two, was there like, patient wanted the new one and that's the Bivalent. Consumer further stated, Experiences with the Pfizer product. So you mean like if there was problem with the vaccine or something is what you handle ,any side effects you mean. Patient didn't have it this time. Patient do have one question if it was something you can answer. Patient think it was the last one (Unspecified vaccine) patient got or the one before that, patient think patient lymph system on the whole side was, on the side where patient got shot must have been inflamed or something and patient just noticed that it was on the paper now that swollen lymph nodes. patient don't know it wasn't like in patient neck, if you see a picture of your lymph node it was like the whole lymph system on my left side where patient got shot on the left and it was like patient was sore on the whole side and then it seemed to go to the right side a little bit but most of it was on the left. was that a normal reaction they have seen with the lymph nodes.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Positive, notes: On 18Sep I tested positive for COVID and started taking Paxlovid; (22Sep2022) Negative, notes: On 22Sep I tested negative for COVID with no symptoms; (26Sep2022) Positive, notes: This morning 26Sep I tested positive for COVID again with symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. No other medication in 2 weeks. Rebound covid. On 18Sep I tested positive for COVID and started taking Paxlovid. On 22Sep I tested negative for COVID with no symptoms. This morning 26Sep I tested positive for COVID again with symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: have blisters near the area where the injection was made; 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), on 22Sep2022 as dose number unknown (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE VESICLES (non-serious) with onset 23Sep2022, outcome "unknown", described as "have blisters near the area where the injection was made".  Additional information: Patient had the Pfizer booster (Further vaccine name could not be clarified over the call hence captured as Unspecified Vaccine) and that was yesterday and today patient had blisters near the area where the injection was made.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Blister, Burns second degree, Immunisation, Off label use, Product use issue
Clinical narrative: third booster which was the Pfizer (COVID-19 Vaccine) booster/ dose 5 booster; third booster which was the Pfizer (COVID-19 Vaccine) booster/ dose 5 booster; got the flu shot and my third booster which was the Pfizer (COVID-19 Vaccine) booster; I noticed in the same arm that in my armpit ; I have white blisters, they almost look like burn blisters; I noticed in the same arm that in my armpit ; I have white blisters, they almost look like burn blisters; 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), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for 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 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, ), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN, (Booster 1)), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN, (Booster 2)), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "third booster which was the Pfizer (COVID-19 Vaccine) booster/ dose 5 booster"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "got the flu shot and my third booster which was the Pfizer (COVID-19 Vaccine) booster"; BURNS SECOND DEGREE (non-serious), BLISTER (non-serious), outcome "unknown" and all described as "I noticed in the same arm that in my armpit ; I have white blisters, they almost look like burn blisters".  Additional Information: It was reported that on Thursday at the pharmacy patient went in, got the flu shot and third booster which was the Pfizer (COVID-19 Vaccine) booster and patient noticed (yesterday) in the same arm that in the armpit now that patient had white blisters, they almost look like burn blisters. Patient called the pharmacist and he said, he had never heard of anything so, he gave the phone number and told me to call Pfizer if you heard of anything but he said, getting the Pfizer shot and flu shot, it would be hard to say if it was even one of them caused something, which one was that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Fatigue, Pain, Vaccination site pain
Clinical narrative: severe fatigue; Left arm pain at site of injection; anorexia; body aches; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 16:30 as dose 3 (booster), single (Lot number: Gh9703) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "Sjogren's syndrome" (unspecified if ongoing); "pulmonary scarring" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Known allergies: Many including chicken" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: anti-inflammatory meds" (unspecified if ongoing); "Known allergies: steroids" (unspecified if ongoing); "Known allergies: quinolones" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL. Vaccination history included: BNT162b2 (DOSE 2, (SINGLE), prev dose administration time:01:00 PM, prev dose lot number:Fj9943, prev dose vaccine location:Left arm), administration date: 28Mar2022, when the patient was 77-year-old, for COVID-19 immunization, reaction(s): "inappropriate schedule of vaccine administered"; BNT162b2 (DOSE 1, (SINGLE), prev dose administration time:02:00 PM, prev dose lot number: FC3180, prev dose vaccine location:Left arm), administration date: 18Aug2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Left arm pain at site of injection"; FATIGUE (non-serious), outcome "recovering", described as "severe fatigue"; DECREASED APPETITE (non-serious), outcome "recovering", described as "anorexia"; PAIN (non-serious), outcome "recovering", described as "body aches". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, decreased appetite, pain. Additional information: other medications in two weeks: Antidepressants; vitamins; lamictil 20mg. No treatment. No covid prior vaccination. No covid tested post vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 at 17:00 as dose 3 (booster), single (Lot number: FM7553) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hodgkin's Lymphoma 2017-2018", start date: 2017, stop date: 2018. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (24Sep2022) Positive, notes: Positive COVID test on 24Sep2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Sep2022 to 17Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Left arm weakness for a week; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 48 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EK570), administration date: 17Dec2020, when the patient was 47-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL3246), administration date: 06Jan2021, when the patient was 48-year-old, for Covid-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Left arm weakness for a week". Therapeutic measures were not taken as a result of muscular weakness.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 61 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: 001B21A), on 16Apr2021 as dose 2, single (Lot number: 020B21A) and on 09Jun2022 as dose 4 (booster), single (Lot number: 056A22A) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 18Jul2020; PEPCID AC, start date: 18Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has received Paxlovid from 14Sep2022 to 19Sep2022 for the treatment of COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Mouth ulceration, Oral pain, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: oral ulcers; roof of mouth pain; feeling of rawness; throat pain; I could not eat or drink anything for days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 15:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "migraines" (unspecified if ongoing); "anemia" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "COVID-19", start date: Aug2022 (unspecified if ongoing). Concomitant medication(s) included: ELDERBERRY [SAMBUCUS NIGRA]; PREVACID. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid". Vaccination history included: moderna (Dose Number: 3, Batch/Lot No: 010m20a, Location of injection: Arm Left), administration date: 10Jun2022, for COVID-19 immunization; moderna (Dose Number: 2, Batch/Lot No: 027b21a, Location of injection: Arm Left), administration date: 13May2022, for COVID-19 immunization; moderna (Dose Number: 1, Batch/Lot No: 013F21A, Location of injection: Arm Left), administration date: 09Dec2021, for COVID-19 immunization. The following information was reported: FEEDING DISORDER (non-serious) with onset 26Sep2022 at 02:00, outcome "not recovered", described as "I could not eat or drink anything for days"; STOMATITIS (non-serious) with onset 26Sep2022 at 02:00, outcome "not recovered", described as "feeling of rawness"; MOUTH ULCERATION (non-serious) with onset 26Sep2022 at 02:00, outcome "not recovered", described as "oral ulcers"; ORAL PAIN (non-serious) with onset 26Sep2022 at 02:00, outcome "not recovered", described as "roof of mouth pain"; OROPHARYNGEAL PAIN (non-serious) with onset 26Sep2022 at 02:00, outcome "not recovered", described as "throat pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of mouth ulceration, oral pain, stomatitis, oropharyngeal pain, feeding disorder. Additional information: With the newest Pfizer booster the patient had oral ulcers, roof of mouth pain (feeling of rawness) and throat pain. She most recently tested positive for Covid in Aug2022 with these same symptoms except much more extreme, she could not eat or drink anything for days because my mouth was so raw and painful inside. These felt like the exact same symptoms only much milder. There was no other vaccine in four weeks.  There were other medications in two weeks also included multivitamin.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: oral ulcers; roof of mouth pain; feeling of rawness; throat pain; I could not eat or drink anything for days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 15:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "migraines" (unspecified if ongoing); "anemia" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "COVID-19", start date: Aug2022 (unspecified if ongoing). Concomitant medication(s) included: ELDERBERRY [SAMBUCUS NIGRA]; PREVACID. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid". Vaccination history included: moderna (Dose Number: 3, Batch/Lot No: 010m20a, Location of injection: Arm Left), administration date: 10Jun2022, for COVID-19 immunization; moderna (Dose Number: 2, Batch/Lot No: 027b21a, Location of injection: Arm Left), administration date: 13May2022, for COVID-19 immunization; moderna (Dose Number: 1, Batch/Lot No: 013F21A, Location of injection: Arm Left), administration date: 09Dec2021, for COVID-19 immunization. The following information was reported: FEEDING DISORDER (non-serious) with onset 26Sep2022 at 02:00, outcome "not recovered", described as "I could not eat or drink anything for days"; STOMATITIS (non-serious) with onset 26Sep2022 at 02:00, outcome "not recovered", described as "feeling of rawness"; MOUTH ULCERATION (non-serious) with onset 26Sep2022 at 02:00, outcome "not recovered", described as "oral ulcers"; ORAL PAIN (non-serious) with onset 26Sep2022 at 02:00, outcome "not recovered", described as "roof of mouth pain"; OROPHARYNGEAL PAIN (non-serious) with onset 26Sep2022 at 02:00, outcome "not recovered", described as "throat pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of mouth ulceration, oral pain, stomatitis, oropharyngeal pain, feeding disorder. Additional information: With the newest Pfizer booster the patient had oral ulcers, roof of mouth pain (feeling of rawness) and throat pain. She most recently tested positive for Covid in Aug2022 with these same symptoms except much more extreme, she could not eat or drink anything for days because my mouth was so raw and painful inside. These felt like the exact same symptoms only much milder. There was no other vaccine in four weeks.  There were other medications in two weeks also included multivitamin.
Sex: M
Vaccine: COVID19
Symptoms: Aspiration, Muscular weakness, Pneumonia
Clinical narrative: Booster Loss of muscle strength including throat muscles which led to aspiration and pneumonia, 3 week hospital stay.; Booster Loss of muscle strength including throat muscles which led to aspiration and pneumonia, 3 week hospital stay.; Booster Loss of muscle strength including throat muscles which led to aspiration and pneumonia, 3 week hospital stay.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Aortic Valve replaced", start date: 2016 (unspecified if ongoing), notes: Aortic Valve replaced 2016. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Shot 2 Loss of muscle strength, from neck down), administration date: 20May2021, for Covid-19 immunization, reaction(s): "Shot 2 Loss of muscle strength from neck down"; Bnt162b2 (DOSE 1, SINGLE, Shot 1, No Issues), for Covid-19 immunization. The following information was reported: MUSCULAR WEAKNESS (hospitalization), ASPIRATION (hospitalization, medically significant), PNEUMONIA (hospitalization, medically significant) all with onset 20Oct2021, latency 5 months after the suspect product(s) administration, outcome "recovered" (11Nov2021) and all described as "Booster Loss of muscle strength including throat muscles which led to aspiration and pneumonia, 3 week hospital stay.". The patient was hospitalized for muscular weakness, aspiration, pneumonia (hospitalization duration: 21 day(s)). Therapeutic measures were taken as a result of pneumonia.  Clinical course: The patient did not received other medication in 2 weeks. The patient had no known allergies.   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-202201188395 Same patient, drug, and event separated in time;
Age: 52.0
Sex: M
Vaccine: PNC20
Symptoms: Asthenia, Hypokinesia, Pain, Pyrexia
Clinical narrative: Fever; Couldn't move his body at all: hurt to move body; Couldn't move his body at all: hurt to move body; Barely had any energy to do anything; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician).  A 52-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15Sep2022 as dose number unknown, single (Lot number: FX6073, Expiration Date: 31Aug2023) at the age of 52 years, in right deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 15Sep2022, outcome "recovered" (17Sep2022), described as "Barely had any energy to do anything"; HYPOKINESIA (non-serious), PAIN (non-serious) all with onset 15Sep2022, outcome "recovered" (17Sep2022) and all described as "Couldn't move his body at all: hurt to move body"; PYREXIA (non-serious) with onset 15Sep2022, outcome "recovered" (17Sep2022), described as "Fever".  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19 after Covid Vaccines; Covid 19 after Covid Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "just has always had a weak stomach" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 after Covid Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller States that she started taking the medication on Thursday when she found out she had Covid 19. Caller mentions that she has had the shots, she got them, she thinks, in April or May. States that she has received 2 doses of the vaccine The patient received Paxlovid (Batch/lot number: 1918538A; Expiry Date: Mar2023) ongoing since 22Sep2022, twice a day for 5 days; three tablets in morning, three tablets at night for COVID-19. Caller denies any other medications, medical conditions, labs, testing, or treatments relevant to these events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications (Other medication in 2 weeks reported as no). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 20Sep2022 to 25Sep2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2
Symptoms: Interchange of vaccine products, Malaise, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 4 (booster), single (Lot number: GJ5342) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (Dose: 03), for Covid-19 immunization; Moderna vaccine (Dose:02), for Covid-19 immunization; Moderna vaccine (Dose: 01), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "it doesn't make me feel comfortable"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller mentions that she has a sore arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown".
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2021 at 14:00 as dose 2, single (Lot number: ER8731), in right arm and on 14Dec2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient started Paxlovid as treatment for covid-19 from 25Sep2022 to 26Sep2022 (lot: GE4518).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pemphigoid
Clinical narrative: I developed an auto immune disease called bullous pemphigoid a week after receiving my fourth dose of the Pfizer Covid vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: 30145BA, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 14Sep2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 07Mar2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9266, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 14Feb2021, when the patient was 65-year-old, for Covid-19 Immunization. The following information was reported: PEMPHIGOID (medically significant) with onset Apr2022, outcome "not recovered", described as "I developed an auto immune disease called bullous pemphigoid a week after receiving my fourth dose of the Pfizer Covid vaccine.". The event "i developed an auto immune disease called bullous pemphigoid a week after receiving my fourth dose of the pfizer covid vaccine." required physician office visit. Therapeutic measures were taken as a result of pemphigoid.  Clinical summary: The patient had pemphigoid on an unspecified date in Apr2022 at 12:00. The patient was treated with prednisone and antibiotics for the event pemphigoid. The patient did not receive any other vaccine in four weeks prior to COVID-19 immunisation. The patient did not receive other medication in two weeks prior to COVID-19 immunisation. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not have any known allergies. Other medical history was none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: finding out positive for covid right after booster receipt; finding out positive for covid right after booster receipt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFEC TIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "finding out positive for covid right after booster receipt". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Shot 2 Loss of muscle strength from neck down; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Aortic Valve replaced 2016", start date: 2016 (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no other medication in 2 weeks. Vaccination history included: Bnt162b2 (Dose 1, Shot 1, No Issues), for COVID-19 immunization.  The following information was reported: MUSCULAR WEAKNESS (medically significant), outcome "recovered", described as "Shot 2 Loss of muscle strength from neck down".  Clinical course: It was reported that after shot 2 patient experienced loss of muscle strength from neck down.  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-202201188088 Same patient, drug, and event separated in time;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, Hypotension, SARS-CoV-2 test
Clinical narrative: Caller states she now has Covid-19/except she is positive for the virus; Caller states she now has Covid-19/except she is positive for the virus; her blood pressure is low: 127, 56, 70 SBP; 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.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Local anesthetic in the teeth, reaction(s): "some adverse reactions ". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Caller states she now has Covid-19/except she is positive for the virus"; HYPOTENSION (non-serious) with onset Sep2022, outcome "unknown", described as "her blood pressure is low: 127, 56, 70 SBP". The patient had COVID-19. She went to urgent care Friday and saw doctor, doctor told her that her COVID was mild and her lungs were fine. The patient had gotten 2 of the Pfizer COVID-19 vaccine shots for primary series and 1 booster dose of the Pfizer COVID-19 vaccine, and a shingles vaccine. No problems with any of those vaccines. The patient had no breathing problems with COVID and no fever. She was prescribed Paxlovid on 23Sep2022. Doctor said she didn't need the Paxlovid because everything else was okay. The patient also took lisinopril and exercised a lot, did breathing exercises in the nursing home. The patient had not yet taken any of the Paxlovid. She explained that her lungs, body, blood pressure and other parameters were fine, except she was positive for the virus.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller tested positive for COVID on Tuesday of last week; Caller tested positive for COVID on Tuesday of last week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9269), on 05Mar2021 as dose 2, single (Lot number: EN6198, Expiration Date: May2021), on 17Dec2021 as dose 3 (booster), single (Lot number: 320308D) and on 20May2022 as dose 4 (booster), 0.3 ml single (Lot number: FM9992, Expiration Date: 30Sep2022) at the age of 72 years, in arm 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 20Sep2022, outcome "recovered" (Sep2022) and all described as "Caller tested positive for COVID on Tuesday of last week". The patient underwent the following laboratory tests and procedures: Tests: (unspecified date) Unknown results, notes: They had done a couple tests the week before; SARS-CoV-2 test: (Sep2022) Negative, notes: She almost very quickly tested negative for COVID; (20Sep2022) Positive, notes: Caller tested positive for COVID on Tuesday of last week; (20Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was 5 foot 6 and a half, she could not say 5 foot 7 anymore. Weight was 200-205 pounds. The patient had "four Pfizer COVID vaccines". The patient was diagnosed with COVID-19 on 20Sep2022 by home test and on 21Sep2022, she started an antiviral Paxlovid. She would like to know how taking Paxlovid may affect COVID vaccination and how long she could wait to get the next vaccine. She wanted to know protocol for getting another vaccine and how does the medicine affect past coverage. In her understanding, it did great and knocked down viral load tested negative on day 5 (almost very quickly tested negative) for COVID-19. As she got COVID-19 after years, hence she was trying to be careful. She got the answer that one could get some resistance when you get COVID and having an antiviral. It affects it in some way where it was not so much an effective deterrent to additional COVID infection.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, SARS-CoV-2 test
Clinical narrative: I started burning so bad, it burns so bad that It was ring in my hands, It was like my whole body was all burn, my blood stream was something even down my feet was burning so bad I couldn't stand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), on 22Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure. Concomitant medication(s) included: ADVIL [IBUPROFEN]; ZOLOFT. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious) with onset 23Sep2022, outcome "unknown", described as "I started burning so bad, it burns so bad that It was ring in my hands, It was like my whole body was all burn, my blood stream was something even down my feet was burning so bad I couldn't stand". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of burning sensation.  Additional information: Patient took the Pfizer shot, the booster (Clarified as Pfizer COVID-19 Vaccine) and took it on Thursday at 8 O' clock, Thursday night and came home, patient had done real good and then at 1 O' clock the next day, I started burning so bad. Patient was 75 years old and was strong, patient worked outside, and it burns so bad that It was ring in my hands walk on the floor. It lasted about 7 or 8 hours. It was like whole body was all burn, my blood stream was something even down my feet was burning so bad patient couldn't stand it.  When paraphrased the concern: Consumer stated, "Yes, it was bad, somebody is not healthy as patient. Patient did not knew what they would have done but would never take another one. Patient did not had, the expiration date. Its the top the first one patient took was the expiration date on it but did not have the expiration date that on the other three. It says Pfizer 37J25W and other one says WAGF659. W is what look likes or 2, it got it scribbled on it there. Other medications: Consumer stated, "Sugar Pills (Name not clarified hence, not captured in tab) and then Blood pressure." Lab test: Consumer stated, "I had COVID two months ago (Further clarifications unknown if consumer took the Pfizer COVID-19 Vaccine as his previous shot hence, PC not filed) and it was nearest bad is what I experienced, Nothing is wrong with me, No, I don't know what you are saying." (Further clarifications unknown hence, tab left unchecked)." Treatment: Consumer stated, "I took extra Tylenol  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.