chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Expired product administered, Off label use, Pain in extremity, Product use issue
Clinical narrative: arm sore; received an expired shot; Fluzone was given on same day as BNT162B2; Fluzone was given on same day as BNT162B2; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2022 at 18:00 as dose 1 (orange cap), single (Lot number: FL2757, Expiration Date: 11Oct2022) at the age of 11 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 20Oct2022 as dose number unknown, single (Lot number: UT77445A) intramuscular, in right deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 20Oct2022 at 18:00, outcome "unknown" and all described as "Fluzone was given on same day as BNT162B2"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 20Oct2022 at 18:00, outcome "unknown", described as "received an expired shot"; PAIN IN EXTREMITY (non-serious) with onset 21Oct2022, outcome "recovered", described as "arm sore". Therapeutic measures were not taken as a result of expired product administered, product use issue, off label use, pain in extremity.  Additional information: caller stated he is calling about the Pediatric Vaccine, verified Pfizer Pediatric Covid Monovalent Vaccine. Caller states he is calling from (name) because they gave an expired shot to someone last week, later clarified to two patients, and corporate told him he needed to reach out to Pfizer to get the stability information to fill out the VAERS form. Caller states he is wondering if there may be extended stability?. The patient provided information regarding the reported adverse event(s) with the use of the product. Pfizer product had no causal effect to the adverse event.  Follow-Up (27Oct2022): Follow-up attempts are completed. No further information is expected.  Follow-up (09Nov2022): This is a spontaneous follow-up report from the same contactable Pharmacist. This Pharmacist reported in response to HCP letter sent included that:  Updated Information Included: Reporter information updated, suspect product details (Dose start/stop time. Dose description. Anatomical Location, Vaccine Facility Information. Co-suspect product updated), event details (Event onset time. Event onset date. Event outcome. Treatment received updated) and additional information updated.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253324 same reporter/product/AE, different patient; Report 1 of 2;
Age: 5.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Expired product administered, Off label use, Pain in extremity, Product use issue
Clinical narrative: arm sore; they gave an expired shot to someone last week; fluzone/20Oct2022; fluzone/20Oct2022; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 5-year-old male patient received BNT162B2, on 20Oct2022 at 17:41 as dose 1, single (Lot number: FL2757, Expiration Date: 11Oct2022) at the age of 5 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 20Oct2022 as dose number unknown, single (Lot number: UT7744JA) intramuscular, in right deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 20Oct2022, outcome "unknown" and all described as "fluzone/20Oct2022"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 20Oct2022 at 17:41, outcome "unknown", described as "they gave an expired shot to someone last week"; PAIN IN EXTREMITY (non-serious) with onset 21Oct2022, outcome "recovered" (2022), described as "arm sore". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: caller stated he is calling about the Pediatric Vaccine, verified Pfizer Pediatric Covid Monovalent Vaccine. Caller states he is calling from (name) because they gave an expired shot to someone last week, later clarified to two patients, and corporate told him he needed to reach out to Pfizer to get the stability information to fill out the VAERS form. Caller states he is wondering if there may be extended stability? The seriousness of event arm sore was reported as non-serious.  Follow-up attempts are completed. No further information is expected.  Follow-up (09Nov2022): This is a spontaneous follow-up report received from a contactable Pharmacist reported in response to HCP letter sent which included that: Updated information included: Co-suspect, new event and additional information.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253323 same reporter/product/AE, different patient; Report 1 of 2;
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary mass, Axillary pain, Fear, Injection site pruritus
Clinical narrative: On 11/10/22 in the evening, I started to feel pain under my left and right armpits. Initially, I thought it was due to my bra, but the pain increased as time went on. I checked for lumps under both arms and researched side effects of the vaccine booster. It read that swollen lymph nodes are uncommon and could last for 10 days. I've had no reactions from the previous 3 Pfizer shots, but this one was itchy at the injection site hours later, and now I'm assuming my lymph nodes are swollen. It's either that or I'm scared I have cancer now (which does not run in my family). I also read that the effect is usually on the side where the injection was performed. In my case, it was both sides which prompted me to report this to you.   As of today, 11/11/22, my right armpit is slightly less painful than the left side (injection was left arm), but the left armpit pain is still the same as last night.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called pharmacy to report that she woke up in the early morning of 11/11 with the arm she got pneumovax in having swollen to twice its normal size and being red and warm to the touch.  She took acetaminophen for it, which had little effect.  She debated calling in sick to work but chose to go in anyway.  Patient called the pharmacy in the afternoon on 11/11 to report this reaction and say that while it hasn't yet gone down, it hasn't gotten any worse either.  Advised patient to try benadryl and topical hydrocortisone over the counter and monitor; if worsens to visit urgent care.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Moderna bivalent booster was administered even though patient had not received primary series with monovalent vaccine
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram thorax abnormal, Dyspnoea, Dyspnoea exertional, Pulmonary embolism
Clinical narrative: Pt with Moderna booster 10/5/22 (5th in series).  Approx 2 weeks later developed left-sided chest pressure (around 10/19/22).  Started having SOB and DOE approx 3 weeks from booster (~10/26/22).  Diagnosed with segmental and subsegmental RUL PE 11/11/22.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Magnetic resonance imaging, Seizure
Clinical narrative: seizures/They have worsened and have got more frequent; headaches; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent (mother).  A 32-year-old male patient received BNT162b2 on 09Dec2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "Atrial bigeminy" (unspecified if ongoing), notes: Atrial bigeminy diagnosed at three years old. Cardiologists and neurologist said his heart was fine and this was nothing contributing. He was always healthy when covid hit. Patient did not have family history relevant to adverse events. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EK9321 or EK4321, thinks it is EK9321 (populated lot number), Expiration: Apr 2021), administration date: 05Jan2021, when the patient was 31-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Lot: EJ1686, Expiration: Mar2021), administration date: 26Jan2021, when the patient was 31-year-old, for COVID-19 immunization, reaction(s): "seizures". Patient did not have prior vaccinations within 4 weeks aside from doses of COVID-19 vaccine.  The following information was reported: SEIZURE (medically significant), outcome "not recovered", described as "seizures/They have worsened and have got more frequent"; HEADACHE (non-serious), outcome "unknown", described as "headaches". Seizures was reported as worsened. He started having weekly seizures, lost his job and is unable to drive. The events "seizures/they have worsened and have got more frequent" and "headaches" required physician office visit and emergency room visit. Patient had numerous times to ER since having seizures at work and numerous times in ambulance. He was not admitted during these time. He went via ambulance when working. Confirms he was not admitted, he was released from ER and told to follow up with cardiologist and neurologist. He had been back and forth to neurologist. The patient underwent the following laboratory tests and procedures: Electrocardiogram: Fine; Magnetic resonance imaging: cannot find anything that would cause him to have weekly seizures. Therapeutic measures were taken as a result of seizure, headache. They put him on one medication for seizures called Lacosamide and then he was still having seizures so they added an additional medication, Lamotrigine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201291808 Same patient, similar event, different dose (dose 2);
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild arm soreness; 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 67-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (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), for COVID-19 immunization, reaction(s): "Mild arm soreness"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Mild arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Mild arm soreness".  Additional information included the patient states the other 3 Pfizer vaccines he previously received caused him "mild arm soreness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal stiffness, Nasal congestion, Off label use
Clinical narrative: Chills; Headache; Congestion nasal; Stiff neck; sore legs; generalized soreness; Off Label Use; Drug Use for Unapproved Combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 at 17:30 as dose number unknown (booster), single (Lot number: GJ6665) at the age of 47 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for influenza, on 06Nov2022 as unk unk, single. Vaccination history included: BNT162b2 (dose 1,, Lot: EL3247 , Expiry date: May2021, Site: Unknown), administration date: 24Feb2021, when the patient was 46-year-old, for Covid-19 vaccinations; BNT162b2 (dose 2, Lot: EN6203 , Expiry date: Jun2021 , Site: Unknown), administration date: 17Mar2021, when the patient was 46-year-old, for Covid-19 vaccinations; BNT162b2 (3rd dose:, Lot: FE3592 , Expiry date: Unknown), administration date: 01Oct2021, when the patient was 46-year-old, for Covid-19 vaccinations. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Nov2022, outcome "unknown", described as "Drug Use for Unapproved Combination"; OFF LABEL USE (non-serious) with onset 06Nov2022, outcome "unknown"; CHILLS (non-serious) with onset 07Nov2022, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 07Nov2022, outcome "not recovered", described as "Congestion nasal"; HEADACHE (non-serious) with onset 07Nov2022, outcome "not recovered"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 07Nov2022, outcome "not recovered", described as "Stiff neck"; PAIN (non-serious) with onset 07Nov2022, outcome "not recovered", described as "generalized soreness"; PAIN IN EXTREMITY (non-serious) with onset 07Nov2022, outcome "not recovered", described as "sore legs".  Additional information: Got the injection at about 17:30 and sometime at night the chills hit him with the headache along with everything else. This was in the early morning hours of 07Nov2022. Caller clarified that he had nasal congestion. Also reported that he had sore legs and generalized soreness. Chills are improved, he is still cold, but is not shivering anymore. He had no problems with the other 3 injections, but for some reason this one got him. He received the flu vaccine at the same time, but in the right deltoid.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Product use issue
Clinical narrative: Chills; Headache; Congestion nasal; Stiff neck; sore legs; generalized soreness; Off Label Use; Drug Use for Unapproved Combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 at 17:30 as dose number unknown (booster), single (Lot number: GJ6665) at the age of 47 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for influenza, on 06Nov2022 as unk unk, single. Vaccination history included: BNT162b2 (dose 1,, Lot: EL3247 , Expiry date: May2021, Site: Unknown), administration date: 24Feb2021, when the patient was 46-year-old, for Covid-19 vaccinations; BNT162b2 (dose 2, Lot: EN6203 , Expiry date: Jun2021 , Site: Unknown), administration date: 17Mar2021, when the patient was 46-year-old, for Covid-19 vaccinations; BNT162b2 (3rd dose:, Lot: FE3592 , Expiry date: Unknown), administration date: 01Oct2021, when the patient was 46-year-old, for Covid-19 vaccinations. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Nov2022, outcome "unknown", described as "Drug Use for Unapproved Combination"; OFF LABEL USE (non-serious) with onset 06Nov2022, outcome "unknown"; CHILLS (non-serious) with onset 07Nov2022, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 07Nov2022, outcome "not recovered", described as "Congestion nasal"; HEADACHE (non-serious) with onset 07Nov2022, outcome "not recovered"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 07Nov2022, outcome "not recovered", described as "Stiff neck"; PAIN (non-serious) with onset 07Nov2022, outcome "not recovered", described as "generalized soreness"; PAIN IN EXTREMITY (non-serious) with onset 07Nov2022, outcome "not recovered", described as "sore legs".  Additional information: Got the injection at about 17:30 and sometime at night the chills hit him with the headache along with everything else. This was in the early morning hours of 07Nov2022. Caller clarified that he had nasal congestion. Also reported that he had sore legs and generalized soreness. Chills are improved, he is still cold, but is not shivering anymore. He had no problems with the other 3 injections, but for some reason this one got him. He received the flu vaccine at the same time, but in the right deltoid.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: Within a few days of getting g the shot, my mouth developed sores; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 12:15 as dose 4 (booster), single (Lot number: 59267030402) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; SYNTHROID. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: STOMATITIS (non-serious) with onset 05Nov2022, outcome "not recovered", described as "Within a few days of getting g the shot, my mouth developed sores". It was unknown if therapeutic measures were taken as a result of stomatitis.  Additional information: No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: After I got my booster, I had lots of allergy that I was never allergic to; It's like, I am allergic to everything, I never had allergy before; 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), in Nov2021 as dose 3 (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. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "After I got my booster, I had lots of allergy that I was never allergic to; It's like, I am allergic to everything, I never had allergy before".  Additional information: Consumer stated had the two and my sister, my brother in law and myself, we all have the two Pfizer, you know that Covid vaccine and brother in law had two booster and my sister and myself had one booster (further clarification unknown). I just wanted to know, does anybody else report it. After the patient got booster had lots of allergy that was never allergic to. It's like, the patient was allergic to everything, never had allergy before.Consumer added after got first booster in last November, that's you know, my allergy started. Not the first two, the first booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Apr2022 at 01:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medications included: LISINOPRIL; OMEPRAZOLE; ATORVASTATIN; CETRIZINE. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Inappropriate schedule of product administration, Insomnia
Clinical narrative: he was given his 3rd dose in the primary series at 4 weeks instead of the intended 8 weeks.; he is not sleeping the same since that shot (Pfizer COVID-19 Vaccine); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 11-month-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "open heart surgery" (unspecified if ongoing), notes: He has a history of Open Heart surgery. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "he was given his 3rd dose in the primary series at 4 weeks instead of the intended 8 weeks."; INSOMNIA (non-serious), outcome "unknown", described as "he is not sleeping the same since that shot (Pfizer COVID-19 Vaccine)". Therapeutic measures were not taken as a result of insomnia. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: The reporter reported that her son got three doses of the vaccine and he was 11 months old. She stated that her son got the 3rd doses too early as primary series at 4 weeks instead of the intended 8 weeks by the pediatrician and wanted her son to be approved for the 3rd dose. The reporter reported that the patient has a history of open heart surgery and he has not been sleeping the same since the last shot. Prior to vaccination the patient received Flu Vaccine, 3 weeks before he got the third dose of Pfizer COVID-19 Vaccine.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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; 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201287006 same reporter/event/products, different patient;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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; 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: all four of them still got Covid.  Clinical Course: The caller wanted to know if there were any differences in the Pfizer BioNTech Covid-19 vaccines monovalent and bivalent for adults in terms of ingredients. No one can tell her what is different and if the new one will cause a problem. One HCP has told her not to get the Bivalent and another one is saying to get it. The caller stated her doctor was worried about her getting the Covid vaccine because she had seizures with vaccines as a child and was hospitalized and had loss of muscle control so she never gets pneumonia vaccines and flu vaccines. They don't know what shots she was given that caused such a severe reaction but just know that it was vaccines. When this one came out she was really afraid to get it. They had a doctor and ER tech to wait with her because they knew she could have complications, but she never did. She just had a little bit of a sore arm, very slightly. She had 3 of the original Pfizer covid shots, two primary and a booster. Her last booster dose was in January.They say that the original (Covid vaccine) is just as good as the new one at fighting. She has a lot of drug allergy issues to anything. They have to be cautious with whatever they give her. There is only one antibiotic she can take. Everyone she knows that has taken the Moderna (covid vaccine) has had issues but no one with Pfizer has. Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid, but they did not have long term problems with it or didn't get that sick with it. She declined providing their information.The caller stated there are still conspiracy theories people saying "don't get the shots they are killing us" (referring to covid vaccines)  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: Pain, Pruritus
Clinical narrative: 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), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing), notes: Have you seen this response with other patients with SLE/other autoimmune diseases; "other autoimmune diseases" (unspecified if ongoing), notes: Have you seen this response with other patients with SLE/other autoimmune diseases. Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE] taken for autoimmune disorder; BENLYSTA subcutaneous taken for autoimmune disorder. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "severe generalized burning type pain", "pruritis in my feet, hands, extremities, & occasionally in the abdomen & back". The following information was reported: PAIN (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "had minimal symptoms with the 2nd, 3rd and 4th doses". Therapeutic measures were taken as a result of pain, pruritus.    The information on the batch/lot number for BNT162b2 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: had covid and was hospitalized; had covid and was hospitalized; The initial case was missing the following minimum criteria: Medical Information. Upon receipt of follow-up information on 08Nov2022, 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)  A male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6202), on 21Mar2021 as dose 2, single (Lot number: EN6202), on 11Oct2021 as dose 3 (booster), single (Lot number: 30145BA) and on 19Apr2022 as dose 4 (booster), single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history included: "Had some heart problems before he got covid.", start date: 2007 (unspecified if ongoing), notes: Had some heart problems before he got covid since 2007. The patient's concomitant medications were not reported.    Conclusion of Previously Completed Investigation  The complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine lot EN6202 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6202, fill lot EN5334, and the formulated drug product lot EN5323. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   Follow-up (08Nov2022 & 09Nov2022): This is a spontaneous follow-up report received from a contactable consumer. This consumer reported for her husband in response to Non-HCP follow-up letter sent via telephonic follow-up activity in cross reference case that included: Updated information included: Primary reporter information; Other medical history start date added; hospitalization details;  investigation results (Batch and lot tested and found within specifications).
Sex: F
Vaccine: COVID19
Symptoms: ASIA syndrome, Anti-thyroid antibody, Autoantibody test, Basedow's disease, Blood thyroid stimulating hormone
Clinical narrative: Graves' disease; Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA); This is a literature report.  A 27-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BASEDOW'S DISEASE (medically significant), 2 months after the suspect product(s) administration, outcome "unknown", described as "Graves' disease"; ASIA SYNDROME (medically significant), outcome "unknown", described as "Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA)". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: greater than 40; Autoantibody test: positive; Blood thyroid stimulating hormone: below 0.001; Free thyroxine index: 4.3 ng/dL. Therapeutic measures were taken as a result of basedow's disease, asia syndrome. Additional information: The patient developed hyperthyroid symptoms and ophthalmopathy 2 months after first dose of Pfizer vaccine. Methimazole was started but she developed urticaria. The patient didn't had a personal or family history of thyroid disease. Our case series adds to the growing evidence for SARS-CoV-2 vaccine-induced Graves' disease (GD), suggesting the incidence may be higher than initially thought and may occur after the 1st, 2nd or booster doses. One potential mechanism is the Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA), which is likely triggered by the mRNA lipid nanoparticles present in the SARS-CoV-2 vaccine. Our patients all met criteria for ASIA with exposure to adjuvants, manifestations of autoimmune endocrine disorders, and positive autoantibodies. In our case series, patients had symptoms for weeks to months before their diagnosis of GD highlighting the importance of patient education regarding possible thyroid complications following vaccination to ensure prompt diagnosis and treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. 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. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200099853 Same article and different patient /drug.;
Sex: F
Vaccine: COVID19
Symptoms: Free thyroxine index
Clinical narrative: Graves' disease; Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA); This is a literature report.  A 27-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BASEDOW'S DISEASE (medically significant), 2 months after the suspect product(s) administration, outcome "unknown", described as "Graves' disease"; ASIA SYNDROME (medically significant), outcome "unknown", described as "Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA)". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: greater than 40; Autoantibody test: positive; Blood thyroid stimulating hormone: below 0.001; Free thyroxine index: 4.3 ng/dL. Therapeutic measures were taken as a result of basedow's disease, asia syndrome. Additional information: The patient developed hyperthyroid symptoms and ophthalmopathy 2 months after first dose of Pfizer vaccine. Methimazole was started but she developed urticaria. The patient didn't had a personal or family history of thyroid disease. Our case series adds to the growing evidence for SARS-CoV-2 vaccine-induced Graves' disease (GD), suggesting the incidence may be higher than initially thought and may occur after the 1st, 2nd or booster doses. One potential mechanism is the Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA), which is likely triggered by the mRNA lipid nanoparticles present in the SARS-CoV-2 vaccine. Our patients all met criteria for ASIA with exposure to adjuvants, manifestations of autoimmune endocrine disorders, and positive autoantibodies. In our case series, patients had symptoms for weeks to months before their diagnosis of GD highlighting the importance of patient education regarding possible thyroid complications following vaccination to ensure prompt diagnosis and treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. 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. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200099853 Same article and different patient /drug.;
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue
Clinical narrative: Can't focus Right; Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Headache" (ongoing); "Sleeping Pills" (ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for headache (ongoing); NATROL MELATONIN SLEEP taken for sleep disorder (ongoing). The following information was reported: FATIGUE (non-serious) with onset Sep2021, outcome "not recovered", described as "Tiredness"; DISTURBANCE IN ATTENTION (non-serious) with onset Oct2021, outcome "not recovered", described as "Can't focus Right".  Additional information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Family Medical History Relevant to Adverse Events (AEs) Father died of Cancer. Concomitant medications included vitamins.  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: Asthenia, Fatigue, Pain in extremity
Clinical narrative: weak; feel very tired; sore; 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), on 07Nov2022 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: FATIGUE (non-serious) with onset Nov2022, outcome "unknown", described as "feel very tired"; PAIN IN EXTREMITY (non-serious) with onset Nov2022, outcome "unknown", described as "sore"; ASTHENIA (non-serious) with onset Nov2022, outcome "unknown", described as "weak".  Additional information: It was also reported that patient got the vaccine shot day before reporting day and felt very tired and sore. Patient had been so good and have to go in 3 weeks to get another shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 5:Pfizer / Dose Number: 4:Pfizer / Dose Number: 3:Pfizer / Dose Number 2:Moderrna / Dose Number 1:Moderna; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Lot number: J6793) at the age of 36 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Lot number: 33030BD) and in Jul2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single (Lot number: 030A21A) and in Apr2021 as dose 2, single (Lot number: 018B21A) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESOMEPRAZOLE MAGNESIUM, start date: Jan2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2021, outcome "unknown", described as "Dose Number: 5:Pfizer / Dose Number: 4:Pfizer / Dose Number: 3:Pfizer / Dose Number 2:Moderrna / Dose Number 1:Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid on 08Nov2022 as treatment for COVID-19.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SARS-COV-2 test: Positive; SARS-COV-2 test: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 09:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 at 13:45 as dose 1, single (Batch/Lot number: unknown), in right arm, on 22Mar2021 at 14:30 as dose 2, single (Batch/Lot number: unknown), in right arm, on 12Oct2021 at 08:45 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN PLUS; LEVOTHYROXINE; DULOXETINE; AMLODIPINE; ADVIL [IBUPROFEN]; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "SARS-COV-2 test: Positive". 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 vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: an altered sense of taste and smell for many foods; an altered sense of taste and smell for many foods; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 03Jan2022 as dose number unknown (booster), 0.3 ml single (Lot number: 33036BD) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, 1st dose Pfizer COVID-19 Vaccine: , Route of Administration: Intramuscular , Batch/Lot number: ER8735), administration date: 30Mar2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, 2nd dose Pfizer COVID-19 Vaccine:, Route of Administration: Intramuscular , Lot number: ER8731), administration date: 20Apr2021, when the patient was 62-year-old, for COVID-19 Immunization; Flu shot (She got the flu shot but doesnt know if last year or year before but thinks 2021), administration date: 2021, when the patient was 62 years old, for immunization. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "an altered sense of taste and smell for many foods".  Additional information: Patient took Over the counter vitamin supplements as concomitant.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear pruritus, Erythema, Feeling hot, Pruritus
Clinical narrative: Red... face; warm ...face; itchy face; warm ...ears neck and chedt; itchy ears; itchy...neck and chedt; Red... neck; Red... chedt; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 4 (booster), single (Lot number: P59267-0304-02) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA taken for immunisation, on 13Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE), for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "Red... chedt"; ERYTHEMA (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "Red... face"; ERYTHEMA (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "Red... neck"; EAR PRURITUS (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "itchy ears"; PRURITUS (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "itchy face"; PRURITUS (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "itchy...neck and chedt"; FEELING HOT (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "warm ...ears neck and chedt"; FEELING HOT (non-serious) with onset 09Nov2022 at 13:00, outcome "recovering", described as "warm ...face". Therapeutic measures were not taken as a result of erythema, feeling hot, pruritus, feeling hot, ear pruritus, pruritus, erythema, erythema.