chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaginal haemorrhage
Clinical narrative: Swollen lymph node in left armpit; Vaginal bleeding/spotting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2; Solution for injection), on 19Jun2022 at 09:15 as dose 3 (booster), single (Lot number: Fp7135) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: En6203, Location of injection: Arm Left), administration date: 25Feb2021, when the patient was 30-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: El9269, Location of injection: Arm Left), administration date: 04Feb2021, when the patient was 30-year-old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 20Jun2022, outcome "recovered", described as "Swollen lymph node in left armpit"; VAGINAL HAEMORRHAGE (non-serious) with onset 20Jun2022, outcome "recovered", described as "Vaginal bleeding/spotting". Therapeutic measures were not taken as a result of lymphadenopathy, vaginal haemorrhage.  Additional information: Swollen lymph node in left armpit for 5 days, vaginal bleeding/spotting for 5 days. I have never had spotting before in my life. Even when pregnant. This is what concerns me the most. If covid prior vaccination: No. If covid tested post vaccination: No. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: 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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 at 10:00 as dose 1, single (Lot number: EN6208), in left arm, on 31Mar2021 at 09:00 as dose 2, single (Lot number: EW0150), in left arm and on 07Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Jun2022 at 11:00 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. No known allergies. The patient's relevant medical history was not reported. There were no concomitant medications. No other medication in 2weeks. 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: (26Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: 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 52-year-old patient received BNT162b2 (BNT162B2), on 15Mar2021 at 18:00 as dose 1, single (Lot number: EN6107), in left arm, on 05Apr2021 at 18:00 as dose 2, single (Lot number: ER8734), in left arm, on 23Nov2021 as dose 3 (booster), single (Lot number: 3303080), in left arm and on 21May2022 as dose 4 (booster), single (Lot number: FMOR13), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). It was reported that patient had no known allergies. Concomitant medication(s) included: SULFASALAZINE, start date: 31Jan2020. Patient took Greenstone as other medication in 2weeks on 31Jan2020.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (25Jun2022) Positive, notes: Started getting symptoms back on Saturday 25Jun, still testing positive on Sunday 26Jun; (26Jun2022) Positive, notes: Started getting symptoms back on Saturday 25Jun, still testing positive on Sunday 26Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 64.0
Sex: M
Vaccine: 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 65-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 15Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 10Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jun2022 at 03:30, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: This is related to Paxlovid, not the vaccine. Exposed to Covid 14Jun. Symptoms presented 3:30 AM 17Jun. Began Paxlovid 17Jun late afternoon. Symptoms resolved except for being extremely tired 20Jun. Gradually felt better until 26Jun when I developed cold-like symptoms. Nasal congestion, coughing, sneezing but no fever. From everything I've read, this appears to be a rebound situation. I just wanted to report this so that you have data related to Paxlovid treatment.
Sex: F
Vaccine: 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) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 17Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Known allergies: Mangos" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: Post-traumatic stress disorder (PTSD). Concomitant medication(s) included: SERTRALINE, stop date: 23Jun2022; WEGOVY; METFORMIN; VYVANSE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Reported that For COVID 19 Treatment, Brand Paxlovid, Treatment start date 24Jun2022, Treatment stop date 26Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19/ After previously testing neg for COVID, tested positive again.; COVID-19/ After previously testing neg for COVID, tested positive again.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Treated hypertension" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "treated elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; LEVOTHYROXINE; METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19/ After previously testing neg for COVID, tested positive again.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment; Negative, notes: After previously testing neg for COVID, tested positive again; Positive, notes: After previously testing neg for COVID, tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter stated, Worsening of COVID symptoms, previously gone: cough, congestion, aches. After previously testing neg for COVID, tested positive again. The patient treated with anti-viral (Paxlovid) from 14Jun2022 to 19Jun2022.  No follow-up attempts are required. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Rebound case of Covid 19; Rebound case of Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown), on 02May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound case of Covid 19". The patient underwent the following laboratory tests and procedures: COVID-19: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were not taken as a result of covid-19.  Clinical course: The anti-viral details were product COVID 19 Treatment, with Paxlovid, treatment start date was16Jun2022 and treatment stop date: 21Jun2022. For the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: 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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 24Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EW0177) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", 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: (unspecified date) Positive, notes: COVID 19 Treatment; (27Jun2022) Positive, notes: Tested Positive again for rebound covid on 27Jun2022 5 days after stopping plaxovid. Therapeutic measures were taken as a result of covid-19. Clinical course: It was reported that patient did not take any other medication in weeks of vaccination. The treatment details for COVID-19 treatment were reported as patient was treated with plaxovid with treatment start date as 17Jun2022 and treatment stop date as 21Jun2022.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (bosster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Early stage glaucoma" (unspecified if ongoing). Concomitant medication(s) included: LATANOPROST. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Negative, notes: Re bound of  symptoms after course of Paxlovid. Antigen negative 3 days after end of Paxlovid course; (25Jun2022) Positive, notes: antigen positive test 6 days after end of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  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: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a literature report for the following literature source:  A 40-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 included: "food and drug allergies" (unspecified if ongoing); "food and drug allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis".  The initial vaccination with COVID-2019 vaccines with emergency use authorization began in December 2020, less than a year after the SARS-CoV-2 RNA sequence was known. anaphylaxis suffered by two female healthcare workers aged 40 and 49 years after receiving the Pfizer- BioNTech mRNA vaccine, 24 hours after the start of mass vaccination. Both patients had a history of food and drug allergies and carried epinephrine auto-injectors.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a literature report.  A 49-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 included: "food and drug allergies" (ongoing); "food and drug allergies" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis ".  The initial vaccination with COVID-2019 vaccines with emergency use authorization began in December 2020, less than a year after the SARS-CoV-2 RNA sequence was known. Global alarm is raised with the first two cases of anaphylaxis suffered by two female healthcare workers aged 40 and 49 years after receiving the Pfizer- BioNTech mRNA vaccine, 24 hours after the start of mass vaccination. Both patients had a history of food and drug allergies and carried epinephrine auto-injectors.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded. The case will be reassessed after Full Publication will be received.,Linked Report(s) : US-PFIZER INC-202200902646 Same article/drug/event; different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: she is diagnosed with covid; she is diagnosed with covid; 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 58-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she is diagnosed with covid". The patient underwent the following laboratory tests and procedures: she was diagnosed with granuloma anular: granuloma anular, notes: she was diagnosed with granuloma anular; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional Information:  Patient was diagnosed with covid and is taking Paxlovid; stated that she had three booster doses of the Pfizer BioNTech covid19 vaccine and when the transferring agent probed the caller's doses of vaccine, the caller stated she wants to get her 3rd booster of the vaccine. Patient stated that every time she gets a dose of vaccine she gets mouth blisters and ulcers and bleeding gums and this happens every time within 7 days of the dose of vaccine; stated she went to a dermatologist and they told her that was an autoimmune response to the vaccine and she was diagnosed with granuloma anular. Stated this doctor advised her not to take another dose of the vaccine; states the caller's question was in regards to these oral side effects and also wanted some recommendation as to whether to take the 3rd booster of the vaccine or not. Patient wanted to get some information on the Pfizer COVID-19 vaccine. Patient  took three boosters and was looking at oral side effects. Patient currently have COVID which is absolutely nasty. Patient wanted to find out is the incidence of oral reactions like blisters and stuff in your mouth.  Every time I´ve got a COVID vaccine Patient broken out with mouth blisters and bleeding gums. Patient still want and got them all but didn't get my last her booster and patient had three. Physician advised not to get another vaccine. Patient got hit with full force COVID. Patient was on Paxlovid right now, its been seven days and Patient was still testing positive but she don't feel like I'm going to die at least. Patient's concern is this something that has come up before. Apparently this is something other people has experienced." She wants to know this information in order to decide if she should get another booster or not.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received treatment with Paxlovid from 19Jun2022 to 24Jun2022. The patient did not received any other medication in two weeks. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 15Mar2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild intermittent asthma" (unspecified if ongoing), notes: Mild intermittent asthma; "history of stage 1 ovarian cancer (in remission)" (unspecified if ongoing), notes: history of stage 1 ovarian cancer (in remission); "obesity (BMI 35)" (unspecified if ongoing), notes: obesity (BMI 35),; "ADHD" (unspecified if ongoing), notes: ADHD. Concomitant medication(s) included: ESTRADIOL oral; HYDROXYZINE; VENTOLIN HFA.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 35, notes: Obesity(BMI 35); SARS-CoV-2 test: (07Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 07Jun2022 the oral Paxlovid was taken as Treatment medication for COVID-19 upto 11Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment/ first positive test; COVID-19 Treatment/ first positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8732), on 16Apr2021 as dose 2, single (Lot number: EW0158), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 07May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebral palsy" (unspecified if ongoing), notes: Cerebral palsy - mild; "Hemiplegic" (unspecified if ongoing), notes: hemiplegic, right side. There were no concomitant medications. Past drug history included: None, notes: Known allergies: None. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment/ first positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: New positive test/ first positive test; Positive, notes: Before re-testing positive; Negative, notes: Had 3 negative tests; Negative, notes: Had 3 negative tests; Negative, notes: Had 3 negative tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Rebound -New positive test and modified version of symptoms resurfaced, less severe 10 days after first positive test and starting Paxlovid. Had 3 negative tests over the course of a week before re-testing positive. COVID 19 was treated with Paxlovid on start date 13Jun2022 and treatment stop date was 17Jun2022 and the indication was treatment of COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FJ5682) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Yeast infection treatment" (unspecified if ongoing). Concomitant medication(s) included: MONISTAT 3 taken for fungal infection, start date: 12Jun2022, stop date: 14Jun2022. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline", notes: Known allergies: tetracycline. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Full rebound of covid symptoms. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical information: She had other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: 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 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL8982), in right arm, on 18Feb2021 as dose 2, single (Lot number: EN6198), in right arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in right arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 79 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of covid-19.  Clinical course: Rebound symptoms were sore throat, nasal congestion which was started on 24Jun2022. The patient received Paxlovid from 14Jun2022 to 19Jun2022 with Lot number Fy4445 for indication of treatment of COVID-19. The patient had non known allergies. The patient did not received  other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "primary sclerosing cholangitis" (unspecified if ongoing), notes: Other medical history: primary sclerosing cholangitis. Concomitant medication(s) included: PREDNISONE; STELARA, stop date: 22May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Jun2022 at 08:00, outcome "unknown", COVID-19 (medically significant) with onset 25Jun2022 at 08:00, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound of COVID-19 symptoms 5 days after completion of paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no allergies. Patient received treatment of Paxlovid for covid-19, treatment start date: 16Jun2022, treatment stop date: 20Jun2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test
Clinical narrative: felt something itchy on the left underside of her arm/ itching/ had the same feeling on the right side from armpit to wrist; 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 71-year-old 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: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "felt something itchy on the left underside of her arm/ itching/ had the same feeling on the right side from armpit to wrist". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did have some side effects after the Pfizer BioNTech Covid 19 vaccines, she received the first two initial doses as well as both boosters, and all shots were Pfizer. When she got the first vaccination she was fine. After the second vaccination, within 15 minutes or so she felt something itchy on the left underside of her arm. It was about a year and half ago in the winter and she was wearing a wool sweater and she's allergic to wool. She changed to a cotton sweater but the itching continued. It was a weird sensation from armpit to wrist on the underside.  It was an unusual sensation, it felt like something under the skin like heebee geebees, creepy crawly sensations, like a mosquito bite but keeps spreading.  Within two weeks she had the same feeling on the right side from armpit to wrist.  It was always there but now its subsided. Now with Covid, it has reactivated and flared up again a little bit, now can deal with it.  She has a lot of allergies, she used to get allergy shots a long time ago. With the two boosters from Pfizer, she had the same tingly arm sensations but they were more mild but not as bad as the second shot. She became more accustomed to it and knew how to deal with it.  She doesn't remember if vaccine was given on left or right side.  While waiting after the injection she was fine but after she got in car, she felt weird little mosquito bite, and then started to grow. Sensation never went away 100% but subsided and got tolerable.  When she got Covid, all of a sudden it came back, a twingy feeling under both arms. She takes no medications and is very healthy. She wanted to know when can she see if she is negative to Covid  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2022 at 10:00 as dose 4 (booster), single (Lot number: Fm0698) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Limited Wegeners Granulomatosis" (unspecified if ongoing), notes: Limited Wegeners Granulomatosis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (unspecified date) Positive, notes: I tested positive for another full week; (06Jun2022) Negative, notes: I tested negative on day 7; (11Jun2022) Positive, notes: On day 12, I tested positive for Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. After taking Paxlovid for the prescribed 5 days from 31May2022 to 05Jun2022 for Treatment of COVID-19 and having a major reduction in symptoms of Covid, Patient tested negative on day 7. On day 11, Patient developed a runny nose and sore throat. On day 12, Patient tested positive for Covid again. Patient tested positive for another full week and during that time, exposed my family members. We didn't realize the likelihood of a Covid rebound.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Renal transplant
Clinical narrative: immunocompromised; kidney transplant; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID.  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown), on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 19Feb2022 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: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised"; RENAL TRANSPLANT (medically significant), outcome "unknown", described as "kidney transplant". Clinical course: patient was a female and had a kidney transplant. Patient is immunocompromised. Patient received dose 1 and dose 2 of the Pfizer COVID-19 vaccine, and instead of getting dose 3 at the recommended time frame, the patient received the 3rd dose on 19Aug2021, which was 6 months after the 2nd dose. And then the patient received the 4th dose on 19Feb2022, which 6 months to the day after the 3rd dose. Caller clarified that the patient did get the doses within the recommended time frame, but caller knows someone that is immunocompromised and a transplant recipient, should receive the 3rd dose in the primary series, so caller is asking if the patient can get a 5th dose of the vaccine. Had a kidney transplant: Unable to confirm if this occurred prior to the patient receiving the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported serious events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Tremor, Vomiting
Clinical narrative: vomiting; bad chills; shaking; and had a temperature of 99.2 degrees Fahrenheit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5-year-old male patient received BNT162b2 (BNT162B2), on 27Jun2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; measles vaccine, mumps vaccine, rubella vaccine (MMR), on 27Jun2022 (Batch/Lot number: unknown) for immunisation; polio vaccine (POLIO), on 27Jun2022 (Batch/Lot number: unknown) for immunisation; varicella zoster vaccine (VARICELLA VACCINE), on 27Jun2022 (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 27Jun2022 (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), on 27Jun2022 (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 27Jun2022, outcome "unknown", described as "and had a temperature of 99.2 degrees Fahrenheit"; CHILLS (non-serious) with onset 27Jun2022, outcome "unknown", described as "bad chills"; TREMOR (non-serious) with onset 27Jun2022, outcome "unknown", described as "shaking"; VOMITING (non-serious) with onset 27Jun2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was calling about her 5-year-old son who got his first Pfizer BioNTech Covid-19 vaccine today. 4 hours later he was vomiting, had bad chills, was shaking, and had a temperature of 99.2F. He also got all of his kindergarten shots today too- MMR, polio, varicella (with the MMR), and Tdap. She wanted to know if other kids had this experienced this and how long will it last. Caller was calling about the Pfizer COVID-19 vaccine. The patient, who is 5-years-old, got his first Pfizer COVID-19 vaccine today and was doing okay, the Pfizer COVID-19 vaccine was in patients system for about 4 hours, then patient started vomiting, had bad chills, was shaking, and had a temperature of 99.2 degrees Fahrenheit. Patient also got his kindergarten shots today too, which was MMR, varicella, which they put the varicella with MMR, polio, and the patient also got DTaP. Declined to provide additional reporter details or complete a report, requested to get transferred to hospital.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: extreme sensitivity to light and particularly electronic items; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient in his 70's 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: PHOTOPHOBIA (non-serious) with onset 24Jun2022, outcome "unknown", described as "extreme sensitivity to light and particularly electronic items".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: 101 fever; injection site pain; muscle pain; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A female patient received BNT162b2 (BNT162B2), on 24Jun2022 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. Vaccination history included: Bnt162b2 (Dose:3), administration date: Oct2021, for COVID-19 Immunization; Bnt162b2 (Dose:2), for COVID-19 Immunization; Bnt162b2 (Dose:1), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 25Jun2022, outcome "not recovered", described as "101 fever"; VACCINATION SITE PAIN (non-serious) with onset 25Jun2022, outcome "unknown", described as "injection site pain"; MYALGIA (non-serious) with onset 25Jun2022, outcome "unknown", described as "muscle pain"; FATIGUE (non-serious) with onset 25Jun2022, outcome "unknown", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  QR Comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default.  Additional information: Reporter stated that the first Pfizer shot they have taken it was last year in Feb and after that they received two more boosters the second booster was taken on last Oct again all of them are Pfizer. Now, yesterday they got the third booster, and until now never had any problem but now reporter's wife is showing other than regular things which are all listed in documentation like injection site pain, muscle pain and tiredness but now she was running 101 fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Musculoskeletal stiffness
Clinical narrative: after the 2nd Pfizer Covid19 vaccine, she experienced stiffness in her joints and muscles from her hips on down; after the 2nd Pfizer Covid19 vaccine, she experienced stiffness in her joints and muscles from her hips on down; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old 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: Bnt162b2 (Dose: 01, had no side effects from either), for covid-19 immunization; Flu shot (had no side effects from either), for immunization. The following information was reported: JOINT STIFFNESS (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovered" and all described as "after the 2nd Pfizer Covid19 vaccine, she experienced stiffness in her joints and muscles from her hips on down".  Additional information: after the 2nd Pfizer COVID-19 vaccine, she experienced stiffness in her joints and muscles from her hips on down which lasted for 4 months and then resolved. Caller states that after she received the Pfizer COVID-19 booster she also experienced stiffness and soreness from hips on down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 79-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Allergy".  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID infection". Therapeutic measures were taken as a result of covid-19, drug ineffective.  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 in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown), on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive, notes: covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.   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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.