chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine free
Clinical narrative: Graves' disease (GD); Autoimmune Inflammatory Syndrome Induced by Adjuvants; This is a literature report.  A 27-year-old female patient received BNT162b2 (BNT162B2), 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: BASEDOW'S DISEASE (medically significant), 14 days after the suspect product(s) administration, outcome "recovering", described as "Graves' disease (GD)"; ASIA SYNDROME (medically significant), outcome "recovering", described as "Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA)". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: 0.01 uiU/mL; Thyroid stimulating immunoglobulin: 4.5; Thyroxine free: 3.3 ng/dL; Autoantibody test: positive. Therapeutic measures were taken as a result of basedow's disease, ASIA syndrome. Additional information: The patient developed tachycardia 14 days after the Pfizer vaccination. She responded well to methimazole 20 mg daily. 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 limited information in the case a possible causal association between the reported event Graves' disease, Autoimmune/inflammatory syndrome induced by adjuvants and the suspect drug   BNT162B2 cannot be 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 RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-PV202200099853 Same article and different patient /drug.;
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Rhinorrhoea, Sjogren's syndrome, Systemic lupus erythematosus
Clinical narrative: Systemic Lupus erythematosus; Sjogren's syndrome which was ten times worse; triggered her Lupus and her Sjogren's syndrome which was ten times worse; sinuses had bloody mucus for 6 months that felt like it was in the chest; could not breathe correctly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003989.  A female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Systemic Lupus erythematosus" (unspecified if ongoing); "Sjogren's syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "Sickness", "very nauseous", "felt like she just had a fever".  The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown"; SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "Sjogren's syndrome which was ten times worse"; RHINORRHOEA (non-serious), outcome "unknown", described as "sinuses had bloody mucus for 6 months that felt like it was in the chest"; DYSPNOEA (non-serious), outcome "unknown", described as "could not breathe correctly"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "triggered her Lupus and her Sjogren's syndrome which was ten times worse".  Clinical information: On 25Oct2022, it was reported that a patient started treatment on Apr2021 with Pfizer BioNTech COVID-19 Vaccine at dose 2 for COVID-19 immunization and got very sick for 10 days. The patient was very nauseous and felt like she just had a fever. The patient also had a booster on Aug2021 which was really bad. It lasted for 6 months and felt like it just never really recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: Er8733), in left arm, on 17Apr2021 as dose 2, single (Lot number: Ew1062), in left arm and on 21Dec2021 as dose 4 (booster), single (Lot number: Fh8027) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Sulfa, reaction(s): "drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient did not received other medications in 2 weeks. Anti viral details, product=COVID 19 Treatment, brand=Pfizer. Treatment start date=31Oct2022 and treatment stop date=04Nov2022. Indication=Treatment of COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Haemoglobin, Haemoglobin decreased, Headache, Intestinal haemorrhage
Clinical narrative: bleeding from her intestines; hemoglobin level was very low/blood being low; could not breath, it took her a whole minute to catch her breath; couldn't raise her hand over her head; had a severe headache and other symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003916 (Novavax).  A 62-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EN6198) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: INTESTINAL HAEMORRHAGE (medically significant), outcome "unknown", described as "bleeding from her intestines"; HAEMOGLOBIN DECREASED (medically significant), outcome "unknown", described as "hemoglobin level was very low/blood being low"; DYSPNOEA (medically significant), outcome "unknown", described as "could not breath, it took her a whole minute to catch her breath"; JOINT RANGE OF MOTION DECREASED (medically significant), outcome "unknown", described as "couldn't raise her hand over her head"; HEADACHE (medically significant), outcome "unknown", described as "had a severe headache and other symptoms". The patient underwent the following laboratory tests and procedures: Haemoglobin: very low, notes: hemoglobin level was very low; SARS-CoV-2 test: Negative, notes: got tested 3 times, but it was negative; Negative, notes: got tested 3 times, but it was negative; Negative, notes: got tested 3 times, but it was negative. Therapeutic measures were taken as a result of intestinal haemorrhage, haemoglobin decreased, dyspnoea, joint range of motion decreased, headache.  Clinical course: It was reported that the patient stated treatment on 25Mar2021 with Pfizer-BioNTech COVID-19 Vaccine at second dose for an unspecified indication. It was reported that the patient could not breath, it took a whole minute to catch breath. Patient thought she had COVID and got tested 3 times, but it was negative. So, patient ran to the hospital, and they found out that patient hemoglobin level was very low. They gave patient two blood transfusions and then they said patient was bleeding from intestines. All the other symptoms that patient had were related to blood being low, patient couldn't raise hand over head, had a severe headache and other symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, SARS-CoV-2 test
Clinical narrative: bleeding from her intestines; hemoglobin level was very low/blood being low; could not breath, it took her a whole minute to catch her breath; couldn't raise her hand over her head; had a severe headache and other symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003916 (Novavax).  A 62-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EN6198) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: INTESTINAL HAEMORRHAGE (medically significant), outcome "unknown", described as "bleeding from her intestines"; HAEMOGLOBIN DECREASED (medically significant), outcome "unknown", described as "hemoglobin level was very low/blood being low"; DYSPNOEA (medically significant), outcome "unknown", described as "could not breath, it took her a whole minute to catch her breath"; JOINT RANGE OF MOTION DECREASED (medically significant), outcome "unknown", described as "couldn't raise her hand over her head"; HEADACHE (medically significant), outcome "unknown", described as "had a severe headache and other symptoms". The patient underwent the following laboratory tests and procedures: Haemoglobin: very low, notes: hemoglobin level was very low; SARS-CoV-2 test: Negative, notes: got tested 3 times, but it was negative; Negative, notes: got tested 3 times, but it was negative; Negative, notes: got tested 3 times, but it was negative. Therapeutic measures were taken as a result of intestinal haemorrhage, haemoglobin decreased, dyspnoea, joint range of motion decreased, headache.  Clinical course: It was reported that the patient stated treatment on 25Mar2021 with Pfizer-BioNTech COVID-19 Vaccine at second dose for an unspecified indication. It was reported that the patient could not breath, it took a whole minute to catch breath. Patient thought she had COVID and got tested 3 times, but it was negative. So, patient ran to the hospital, and they found out that patient hemoglobin level was very low. They gave patient two blood transfusions and then they said patient was bleeding from intestines. All the other symptoms that patient had were related to blood being low, patient couldn't raise hand over head, had a severe headache and other symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, COVID-19, Condition aggravated, Drug ineffective, Influenza like illness
Clinical narrative: Covid; Covid; back pain; flu like symptoms; Crohn's disease flare; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): .  A 42-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown), in 2020 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "unknown", described as "Crohn's disease flare"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; BACK PAIN (non-serious), outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid", "crohn's disease flare", "back pain" and "flu like symptoms" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Additional information: HUMIRA 40MG/0.4ML- COVID-19, Crohns disease aggravated, Back pain, Flu like symptoms, Not Reported. Pfizer BioNTech COVID-19 vaccine- Back pain, Crohns disease aggravated, Flu like symptoms, Possible.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the events drug ineffective, covid-19 and back pain are possibly related to the suspect BNT162b2 and events condition aggravated and flu like symptoms are not related.
Sex: M
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: compromised with severe respiratory problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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 reporter stated that he is calling on behalf of his son who took the Pfizer primary series and one booster shot. The caller said that his son was disabled, and he is compromised with severe respiratory problems. The caller is asking where his son can get the new variant vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Inflammatory marker test, Migraine, Myocarditis, Pyrexia
Clinical narrative: what seemed like myocarditis and kidney pain; what seemed like myocarditis and kidney pain; It was reported the patient experienced a migraine; The patient also had a fever and her inflammatory markers were high; The patient also had a fever and her inflammatory markers were high; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003937.  A female patient received BNT162b2 (BNT162B2), 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. It was reported that the patient experienced a migraine. The patient visited urgent care and her primary doctor for what seemed like myocarditis and kidney pain. The patient also had a fever, and her inflammatory markers were high. The patient's doctor stated that she had an inflammatory response, and the vaccine lipid delivery system may have caused it. No kidney infection was found, and the patient tested negative for COVID-19. The events "what seemed like myocarditis and kidney pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Inflammatory marker test: High; SARS-CoV-2 test: Negative. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, SARS-CoV-2 test
Clinical narrative: what seemed like myocarditis and kidney pain; what seemed like myocarditis and kidney pain; It was reported the patient experienced a migraine; The patient also had a fever and her inflammatory markers were high; The patient also had a fever and her inflammatory markers were high; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003937.  A female patient received BNT162b2 (BNT162B2), 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. It was reported that the patient experienced a migraine. The patient visited urgent care and her primary doctor for what seemed like myocarditis and kidney pain. The patient also had a fever, and her inflammatory markers were high. The patient's doctor stated that she had an inflammatory response, and the vaccine lipid delivery system may have caused it. No kidney infection was found, and the patient tested negative for COVID-19. The events "what seemed like myocarditis and kidney pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Inflammatory marker test: High; SARS-CoV-2 test: Negative. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got the new vaccine and felt a little sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient 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. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got the new vaccine and felt a little sick".  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: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Headache, Insomnia, Muscle spasms
Clinical narrative: Severe insomnia; muscle spasms in legs; chills; Headache; Arm pain for a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 at 10:00 as dose 1, single (Lot number: EW0153) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypogonadism", start date: 21Oct2017 (ongoing); "Seasonal depression", start date: Feb2021 (unspecified if ongoing), notes: winter and into spring. Well controlled by April; "depression", start date: 08May2009 (ongoing); "hypertension", start date: 27Oct2016 (ongoing); "GERD", start date: 21Dec2011 (ongoing). The patient's family history included: "GERD", start date: 21Dec2011 (ongoing), notes: Mother: GERD; "Hypertension", start date: 27Oct2016 (ongoing), notes: Father: Hypertension, Depression; "Depression", start date: 08May2009 (ongoing), notes: Father: Hypertension, Depression. Concomitant medication(s) included: BUPROPION oral taken for depression, start date: 08May2009 (ongoing); LISINOPRIL oral taken for hypertension, start date: 27Oct2016 (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease, start date: 21Dec2011 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "recovered" (Apr2021), described as "Arm pain for a few days"; HEADACHE (non-serious) with onset 06Apr2021, outcome "unknown"; INSOMNIA (non-serious) with onset 11Apr2021, outcome "recovered" (12Apr2021), described as "Severe insomnia"; CHILLS (non-serious) with onset 11Apr2021, outcome "recovered" (12Apr2021); MUSCLE SPASMS (non-serious) with onset 11Apr2021, outcome "recovered" (12Apr2021), described as "muscle spasms in legs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that before onset in Feb2021, physical wl primary care doctor, normal bloodwork, healthy for his age. Seasonal depression, winter and into spring. Well controlled by April. On 06Apr2021 first COVID vaccine left arm. Headache. Arm pain for a few days. On 11Apr2021 severe insomnia, muscle spasms in legs, chills. Resolved by next day.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe insomnia; muscle spasms in legs; chills; Headache; Arm pain for a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 at 10:00 as dose 1, single (Lot number: EW0153) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypogonadism", start date: 21Oct2017 (ongoing); "Seasonal depression", start date: Feb2021 (unspecified if ongoing), notes: winter and into spring. Well controlled by April; "depression", start date: 08May2009 (ongoing); "hypertension", start date: 27Oct2016 (ongoing); "GERD", start date: 21Dec2011 (ongoing). The patient's family history included: "GERD", start date: 21Dec2011 (ongoing), notes: Mother: GERD; "Hypertension", start date: 27Oct2016 (ongoing), notes: Father: Hypertension, Depression; "Depression", start date: 08May2009 (ongoing), notes: Father: Hypertension, Depression. Concomitant medication(s) included: BUPROPION oral taken for depression, start date: 08May2009 (ongoing); LISINOPRIL oral taken for hypertension, start date: 27Oct2016 (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease, start date: 21Dec2011 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "recovered" (Apr2021), described as "Arm pain for a few days"; HEADACHE (non-serious) with onset 06Apr2021, outcome "unknown"; INSOMNIA (non-serious) with onset 11Apr2021, outcome "recovered" (12Apr2021), described as "Severe insomnia"; CHILLS (non-serious) with onset 11Apr2021, outcome "recovered" (12Apr2021); MUSCLE SPASMS (non-serious) with onset 11Apr2021, outcome "recovered" (12Apr2021), described as "muscle spasms in legs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that before onset in Feb2021, physical wl primary care doctor, normal bloodwork, healthy for his age. Seasonal depression, winter and into spring. Well controlled by April. On 06Apr2021 first COVID vaccine left arm. Headache. Arm pain for a few days. On 11Apr2021 severe insomnia, muscle spasms in legs, chills. Resolved by next day.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had a tiny bit of sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to eggs" (unspecified if ongoing), notes: Also allergic to eggs. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a tiny bit of sore arm".  Additional information: The patient already took the primary series and two booster shots from Pfizer and scheduled for the fifth shot. The patient has been hearing reports that Pfizer and Moderna are planning on working with boosters that contain flu shots as well. She was suggesting that Pfizer's researchers might consider having the next booster without any egg based in it or other options because she is allergic to eggs, she also did not take her flu shot because of that. She had a tiny bit of sore arm after those four shots from Pfizer other than that she had no problem with the vaccines.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : 202201283736 same patient and event, different dose;202201283735 same patient and event, different dose;202201283734 same patient and event, different dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: he got the Pfizer booster shot, and after getting vaccinated, he got the COVID-19 virus again; he got the Pfizer booster shot, and after getting vaccinated, he got the COVID-19 virus again; he got the Pfizer booster shot, and after getting vaccinated, he got the COVID-19 virus again; 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 male patient 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "he got the Pfizer booster shot, and after getting vaccinated, he got the COVID-19 virus again". The patient mentioned that he bought Pfizer products like ibuprofen (ADVIL) and esomeprazole (NEXIUM) . The caller mentioned that he had his own personal policy. If the company where he bought the products did something political, he would stop buying them. He also stated that he posted his comment on social media six months ago. It was not that horrible and , and he wasn't being hateful; he was suspended from social media. The caller also mentioned that he got the Pfizer booster shot, and after getting vaccinated, he got the COVID-9 virus again. Since the patient mentioned that he had the Virus after getting the Pfizer Booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Subarachnoid haemorrhage
Clinical narrative: the patient experienced subarachnoid hemorrhag; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003933 (Novavax).  A male patient received BNT162b2 (BNT162B2), as dose  2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: SUBARACHNOID HAEMORRHAGE (medically significant), outcome "unknown", described as "the patient experienced subarachnoid hemorrhag". On 20Oct2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at second dose for COVID-19 immunisation. It was reported the patient experienced subarachnoid hemorrhage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: elevated heart rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient 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. 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: HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported that her husband had stated that he had had an elevated heart rate since receiving the Covid-19 booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: severe generalized burning type pain; pruritus in my feet, hands, extremities, & occasionally in the abdomen & back.; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 07Nov2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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 disease" (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. The following information was reported: PAIN (non-serious), outcome "unknown", described as "severe generalized burning type pain"; PRURITUS (non-serious), outcome "unknown", described as "pruritus in my feet, hands, extremities, & occasionally in the abdomen & back.". Therapeutic measures were taken as a result of pain, pruritus.  Additional information: The patient had autoimmune disease currently prescribed Cellcept and Benlysta. With the initial Pfizer vaccine and the 3rd booster dose (modified for defense against the omicron virus), the patient suffered from severe generalized burning type pain with occasional pruritus in feet, hands, extremities, and occasionally in the abdomen and back. These symptoms were unresponsive to over the counter (OTC) meds, partially responsive to oxycodone, and usually required short term use of prednisone. The patient reported symptoms occurred 6-7 days after the injection on both occasions. The patient asked if this response was seen with other patients with SLE/other autoimmune diseases or patients prescribed these immunosuppressants. The patient had minimal symptoms with the 2nd, 3rd and 4th doses; these symptoms only occurred with the 1st and the 5th doses. The patient asked was the fifth dose a totally modified vaccine. Patient also asked what would account for having such severe symptoms only with the 1st and 5th doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201287014 Same reporter/ patient/ event, different drug;
Sex: U
Vaccine: COVID19
Symptoms: Menopause, Palpitations
Clinical narrative: heart palpitations 3 days after receiving the Pfizer vaccine; menopause; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations 3 days after receiving the Pfizer vaccine"; MENOPAUSE (non-serious), outcome "unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Red rash at injection site; Red rash at injection site; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  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. 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: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Red rash at injection site". Additional Information: It was reported that red rash at injection site similar to that caused by the pneumonia vaccination. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Investigation, Polymers allergy, Reaction to excipient
Clinical narrative: allergic to PEG; allergic to PEG; GI tract episode; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000003978 (ProPharma Group on behalf of Novavax.).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccine (dose 1, single), for covid-19 immunisation. The following information was reported: REACTION TO EXCIPIENT (non-serious), POLYMERS ALLERGY (non-serious), outcome "unknown" and all described as "allergic to PEG"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "GI tract episode". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported the individual experienced GI tract episode but at that time it was not known it was related to the Pfizer vaccine. The individual then had to prep for colonoscopy and the individual was told that it was 100% due to Polyethylene Glycol (PEG). The individual had a super severe reaction and they had to abort the further testing. Then the pharmacy said the individual need to figure that out before getting the Pfizer booster. The individual went to an immunologist and got tested and it was reported that the individual was allergic to PEG. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Malaise
Clinical narrative: her glands were swollen; a little tired; malaise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN3505976.  A 37-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "uses a cane" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing); "allergies to antibiotics" (unspecified if ongoing), notes: allergies to antibiotics. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "her glands were swollen"; FATIGUE (non-serious), outcome "unknown", described as "a little tired"; MALAISE (non-serious), outcome "unknown".  Additional information: Patient's past medical history was not reported. On an unknown date, the patient said she received her first shot and did fine with it stating, she hardly had any reactions. She said her glands were swollen and maybe a little tired and malaise for a couple days but nothing awful.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a solicited report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 1, single (Batch/Lot number: unknown), on 28Dec2021 as dose 2, single (Batch/Lot number: unknown) and on 23Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160186), subcutaneous for crohn's disease. 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) all with onset Sep2022, outcome "recovering" and all described as "Covid". The action taken for adalimumab was unknown.  The reporter's causality for the event of Covid with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event of Covid with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility.   opinion was that the causality for the event of Covid with Adalimumab Solution for Injection was Not Provided. Opinion was that the causality for the event of Covid with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: boosted a month ago which helped her but had mild symptoms last Sunday; boosted a month ago which helped her but had mild symptoms last Sunday; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 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 included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "pneumonia" (unspecified if ongoing); "respiratory issues." (unspecified if ongoing), notes: respiratory issues. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Nov2022, outcome "unknown" and all described as "boosted a month ago which helped her but had mild symptoms last Sunday". The reporter wanted to know if she can start taking Paxlovid tonight, no intake yet. She mentioned that she had been boosted a month ago which helped her but had mild symptoms last Sunday, had slight chills and cough and head was congesting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Illness, Pain
Clinical narrative: hurting; still coughing; sick; Initial information received on 02-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who was hurting, still coughing and sick after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).   On an unknown date, on Sunday night the patient developed non-serious events of hurting (pain), still coughing (cough) and sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, got flu shot last Wednesday. Do I have the flue??? Or a really bad colds, who knows, pharmacy gave us cough medicine. It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (hurting, still coughing, sick).  At time of reporting, the outcome was Unknown for the event sick and Not Recovered/Not Resolved for other events.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant patient was administered Fluzone QIV; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was pregnant  and who got  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event.   The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left deltoid for Immunization.    On 27-OCT-2022 the patient developed a non-serious who was pregnant  was administered fluzone qiv (exposure during pregnancy) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE..  It was reported "The caller mentions that the pregnant patient received the Pfizer Covid-bivalent vaccine on 14Oct2022, A pregnant patient was administered Fluzone QIV from the multi-dose vial yesterday, 27Oct2022 in the left deltoid. The dose was administered by a medical assistant. No other vaccinations were given yesterday to the patient. The patient received the Pfizer bivalent Covid-19 booster vaccine on 14Oct2022.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (pregnant patient was administered Fluzone QIV).  At time of reporting, the outcome was Unknown for the event pregnant patient was administered fluzone qiv. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: they administered two ADACEL vaccines to the same patient two days in a row instead of another vaccine,with no reported adverse event; they administered two ADACEL vaccines to the same patient two days in a row instead of another vaccine,with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves adult male patient who administered two adacel vaccines to the same patient two days in a row instead of another vaccine,with no reported adverse event after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation, route, lot number not reported) in unknown administration site for immunisation.  On an unknown date, the patient reported a non serious event extra dose administered (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 25-OCT-2022 the patient reported a non-serious event they administered two adacel vaccines to the same patient two days in a row instead of another vaccine,with no reported adverse event (wrong product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event wrong product administered and extra dose administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: feeling a bit under the weather; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.   This case involves an unknown age/gender patient who experienced feeling a bit under the weather after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose 3 of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, dose, formulation, route,lot number not reported) in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event feeling a bit under the weather (malaise) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event (malaise).  At time of reporting, the outcome was Unknown for the event.