chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Pain in extremity
Clinical narrative: Sore arm and shoulder; Sore arm and shoulder; Swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 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: Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer: Unknown), for COVID-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset Oct2022, outcome "unknown" and all described as "Sore arm and shoulder"; LYMPHADENOPATHY (non-serious) with onset Oct2022, outcome "unknown", described as "Swollen lymph nodes". It was unknown if therapeutic measures were taken as a result of pain in extremity, arthralgia, lymphadenopathy.  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: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: Caught covid; Caught covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "recovering" and all described as "Caught covid". No covid prior vaccination. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (10Oct2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dyspnoea, Illness, Nausea
Clinical narrative: Shortness of breath; Nausea; Lightheaded; Blurry vision; Confusion; Bed sick for five weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2021 as dose 2, single (Lot number: EW0167) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast; "Known allergies: contrast" (unspecified if ongoing), notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast. The patient's concomitant medications were not reported. Past drug history included: Wellbutrin for drug use for unknown indication, reaction(s): "Known allergies: Wellbutrin", notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast; Ambien for drug use for unknown indication, reaction(s): "Known allergies: Ambien", notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast. Vaccination history included: BNT162b2 (Dose 1, (PURPLE CAP) SINGLE, Location of injection: Arm Left, Batch/Lot No: ER8731), administration date: 16Apr2021, when the patient was 59-year-old, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Bed sick for five weeks"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; NAUSEA (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "Lightheaded"; VISION BLURRED (non-serious), outcome "unknown", described as "Blurry vision"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confusion".  Additional information: Patient reported the second shot had her in bed sick for five weeks. She had shortness of breath, nausea, lightheaded, blurry vision and confusion. She understood they felt like the vaccine did not have adverse effects, but it does. Everyone's body/DNA isn't the same. What doesn't affect one person will effect another one. Unfortunately, she just happened to be one out of many that had got adverse side effects from the vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Shortness of breath; Nausea; Lightheaded; Blurry vision; Confusion; Bed sick for five weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2021 as dose 2, single (Lot number: EW0167) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast; "Known allergies: contrast" (unspecified if ongoing), notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast. The patient's concomitant medications were not reported. Past drug history included: Wellbutrin for drug use for unknown indication, reaction(s): "Known allergies: Wellbutrin", notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast; Ambien for drug use for unknown indication, reaction(s): "Known allergies: Ambien", notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast. Vaccination history included: BNT162b2 (Dose 1, (PURPLE CAP) SINGLE, Location of injection: Arm Left, Batch/Lot No: ER8731), administration date: 16Apr2021, when the patient was 59-year-old, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Bed sick for five weeks"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; NAUSEA (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "Lightheaded"; VISION BLURRED (non-serious), outcome "unknown", described as "Blurry vision"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confusion".  Additional information: Patient reported the second shot had her in bed sick for five weeks. She had shortness of breath, nausea, lightheaded, blurry vision and confusion. She understood they felt like the vaccine did not have adverse effects, but it does. Everyone's body/DNA isn't the same. What doesn't affect one person will effect another one. Unfortunately, she just happened to be one out of many that had got adverse side effects from the vaccine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She became COVID positive on 08Aug2022; She became COVID positive on 08Aug2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EM9810), on 11Mar2021 as dose 2, single (Lot number: EN6207) and on 25Mar2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "unknown" and all described as "She became COVID positive on 08Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive.  Clinical information: Patient recently had COVID and had asthma and she was fearful to get sick. She personally got vaccinated. She was treated with Albuterol for asthma. Her concomitant medication included birth control and vitamins. No other conditions reported. Patient received bivalent vaccine on 19Sep2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201233138 same patient/drug, different event/dose;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID Positive; COVID Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "COVID Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID Positive, reporter husband had 2 Pfizer doses and had it as well.  Clinical course: The reporter stated she had all 3 doses and she was that she had COVID positive, her husband had 2 Pfizer doses and has it as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: Pemphigus Vulgaris/blisters show up all over her body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Aug2022 as dose 3 (booster), single (Lot number: FP4554) at the age of 35 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (lot number=EW0161, dose number=2, vaccine location=Left arm), administration date: 15Apr2021, when the patient was 34-year-old, for COVID-19 immunization; BNT162b2 (lot number=EN6207, dose number=1, vaccine location=Left arm), administration date: 19Mar2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: PEMPHIGUS (hospitalization, disability, life threatening) with onset 07Aug2022, outcome "not recovered", described as "Pemphigus Vulgaris/blisters show up all over her body". The patient was hospitalized for pemphigus (hospitalization duration: 3 day(s)). The event "pemphigus vulgaris/blisters show up all over her body" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pemphigus. Clinical course: Patient started to have blisters show up all over her body just a couple of days after her 3rd shot. She ended up hospitalized and then was diagnosed with Pemphigus Vulgaris. Adverse event treatment: Steroids, Rituximab. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Hospitalization 3 days.
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Heavy menstrual bleeding, Hypoaesthesia, Peripheral coldness, Skin discolouration
Clinical narrative: period turned extremely heavy/now her period lasts 9 days; hands turn blue and feels like ice and cold and they feel numb; hands turn blue and feels like ice and cold; hands turned completely blue; circulatory issues; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "hands turned completely blue"; CARDIOVASCULAR DISORDER (non-serious) with onset Nov2021, outcome "not recovered", described as "circulatory issues"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "not recovered", described as "period turned extremely heavy/now her period lasts 9 days"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "hands turn blue and feels like ice and cold and they feel numb"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "hands turn blue and feels like ice and cold".  Additional information: She had her first dose on 10Nov2021, and she states 24 hours later her hands turned completely blue and she has continued to have circulatory issues since. Reports that her period turned extremely heavy, she used to have as a regular period, just moderate, and now her period lasts 9 days and was heavy the entire time. The caller's hands turn blue and feels like ice and cold and like neuropathy and they feel numb. This has all happened since her first vaccination. Caller did get the second dose but was forced to do that if she didn't get it she would be fired and her second dose was 16Apr2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID-19 in July2022; got COVID-19 in July2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got COVID-19 in July2022". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata, Clostridium difficile infection, Psoriatic arthropathy, Seasonal allergy, Vertigo
Clinical narrative: psoriatic arthritis; a C. diff infection; alopecia areatta; hay fever; vertigo; 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 63-year-old male patient received BNT162b2 (BNT162B2), on 20Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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: BNT162b2 (Dose: 2, Date: 08Sep2020), administration date: 08Sep2020, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "a C. diff infection", "psoriatic arthritis", "alopecia areatta", "hay fever", "vertigo"; BNT162b2 (Dose: 1, Date: 19Aug2020), administration date: 19Aug2020, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "a C. diff infection", "psoriatic arthritis", "alopecia areatta", "hay fever", "vertigo". The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "psoriatic arthritis"; CLOSTRIDIUM DIFFICILE INFECTION (medically significant), outcome "unknown", described as "a C. diff infection"; ALOPECIA AREATA (non-serious), outcome "unknown", described as "alopecia areatta"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "hay fever"; VERTIGO (non-serious), outcome "unknown". Therapeutic measures were taken as a result of psoriatic arthropathy.  Clinical information: Description of Event Outcome: Pfizer, I had two shots and a booster of your COVID vaccines as part of the clinical trial, starting in Aug2020 and booster in Jul2021. Since I began the shots I have been diagnosed with alopecia areatta, hay fever and, most recently, psoriatic arthritis. It's not been a good two years. I now need to see about getting a booster and, as you can imagine, I don't really want another Pfizer vaccine. Is there any problem to get a Moderna booster after 3 x Pfizer shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 at 17:30 as dose 3 (booster), single (Lot number: 30130BA) at the age of 45 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. Patient was not pregnant at the time of vaccination. The patient had no relevant medical history. There were no concomitant medications (Other medication in 2 weeks reported as no). Past drug history included: Metrogel, reaction(s): "Known allergies: Metrogel". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid (Lot number: GF3197) from 04Oct2022 to 09Oct2022.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: 05Oct2022 she self-tested and tested positive for COVID-19; 05Oct2022 she self-tested and tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9269), in arm, on 10Mar2021 as dose 2, single (Lot number: EL9269), in arm and on 05Aug2021 as dose 3 (booster), single (Lot number: EW0182) at the age of 89 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer", start date: 2013 (ongoing), notes: Skin cancer, Diagnosed 3or 4 years ago.  Still affected just a little in small areas.; "Waldenstrom's macroglobulinemia", start date: 2013 (ongoing), notes: Waldenstrom's macroglobulinemia; "blood cancer" (unspecified if ongoing), notes: She has blood cancer. The patient took concomitant medications. Past drug history included: Rosuvastatin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Oct2022, outcome "unknown" and all described as "05Oct2022 she self-tested and tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Oct2022) positive; Weight: (unspecified date) Used to weigh 125; (2013) Has lost a lot of weight from COVID-19; (Oct2022) lost 2, notes: lost 2 pounds since having COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested herself for COVID-19 on 05Oct2022 and her symptoms had started two days before that. She had a headache in the back and top of her head. Normally doesn't have headaches. Her chest hurt. Usually she gets a cold in the spring and the fall. Two days before she had the headache she felt like she was getting a cold and congestion. 05Oct2022 she self-tested and tested positive for COVID-19.; Sender's Comments: Based on available information in the case a possible causal association between the reported event Vaccination failure and COVID-19 and the suspect drug BNT162B2 cannot be excluded and also a contributory role of medical history.The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid 19; I tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Oct2022, outcome "not recovered" and all described as "I tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2022) Positive; (15Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 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: "Follicular lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no other medication in 2weeks. Past drug history included: Sulfur, reaction(s): "Known allergies: Sulfur". The following information was reported: DRUG INEFFECTIVE (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. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received the anti-viral treatment with Paxlovid, started on 08Oct2022 and stopped on 12Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 at 01:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Oct2022 at 06:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: I tested positive on 6am; (12Oct2022) Negative; (13Oct2022) Negative; (14Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid as treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Cerebral haemorrhage, Off label use, Product use issue
Clinical narrative: Massive brain bleed; Product use for unapproved combination; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Oct2022, outcome "unknown" and all described as "Product use for unapproved combination"; CEREBRAL HAEMORRHAGE (death, hospitalization) with onset 03Oct2022 at 20:00, outcome "fatal", described as "Massive brain bleed". The event "massive brain bleed" required emergency room visit. Therapeutic measures were taken as a result of cerebral haemorrhage and included various per 911 first responders and ER (emergency room). The patient date of death was 04Oct2022. Reported cause of death: "Brain bleed". It was not reported if an autopsy was performed. The clinical course was reported as follows: the patient received a Covid-19 booster and flu shot on Monday 03Oct2022. Later that evening, she began a seizure in my kitchen. 911 was called; first responders took action. She was taken by ambulance to a hospital where she passed away overnight due to apparent massive brain bleed. The patient was not Covid tested post vaccination. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Brain bleed
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Anxiety, Blood pressure measurement, Cardiac operation, Hypertension
Clinical narrative: interchange of vaccine products; open heart surgery; the right side of her head has less hair than the other/ thinning; the right side of her head has less hair than the other/ breaking off on one side; anxiety; high blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): CMOD22-04197 (Moderna).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, LOT: UNKNOWN), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, LOT: UNKNOWN), for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; CARDIAC OPERATION (medically significant), outcome "unknown", described as "open heart surgery"; ALOPECIA (non-serious), outcome "unknown", described as "the right side of her head has less hair than the other/ thinning"; TRICHORRHEXIS (non-serious), outcome "unknown", described as "the right side of her head has less hair than the other/ breaking off on one side"; ANXIETY (non-serious), outcome "unknown"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High, notes: high blood pressure. Therapeutic measures were taken as a result of anxiety, hypertension.  Clinical course: Reporter calls in to report that she had the first and second doses of the Moderna Covid-19vaccine and Pfizer for the 1st booster dose. She would like to know if these vaccines could cause her hair to come out. She states that the right side of her head has less hair than the other. It is thinning and breaking off on one side. She said she was not in too much trouble after the 1st 2 doses. She does not have any allergies. She had open heart surgery, anxiety and high blood pressure (not clear if these were present prior to getting the vaccine). She takes Xanax and unspecified medication for the high blood pressure. No other information was provided as she only wanted to know if her hair problem was caused by the vaccine, submitted AE with limited information. Seriousness criteria client data: Method of contact disc used: Yes. There was no product complaint associated with this case.  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: Interchange of vaccine products, Trichorrhexis
Clinical narrative: interchange of vaccine products; open heart surgery; the right side of her head has less hair than the other/ thinning; the right side of her head has less hair than the other/ breaking off on one side; anxiety; high blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): CMOD22-04197 (Moderna).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, LOT: UNKNOWN), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, LOT: UNKNOWN), for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; CARDIAC OPERATION (medically significant), outcome "unknown", described as "open heart surgery"; ALOPECIA (non-serious), outcome "unknown", described as "the right side of her head has less hair than the other/ thinning"; TRICHORRHEXIS (non-serious), outcome "unknown", described as "the right side of her head has less hair than the other/ breaking off on one side"; ANXIETY (non-serious), outcome "unknown"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High, notes: high blood pressure. Therapeutic measures were taken as a result of anxiety, hypertension.  Clinical course: Reporter calls in to report that she had the first and second doses of the Moderna Covid-19vaccine and Pfizer for the 1st booster dose. She would like to know if these vaccines could cause her hair to come out. She states that the right side of her head has less hair than the other. It is thinning and breaking off on one side. She said she was not in too much trouble after the 1st 2 doses. She does not have any allergies. She had open heart surgery, anxiety and high blood pressure (not clear if these were present prior to getting the vaccine). She takes Xanax and unspecified medication for the high blood pressure. No other information was provided as she only wanted to know if her hair problem was caused by the vaccine, submitted AE with limited information. Seriousness criteria client data: Method of contact disc used: Yes. There was no product complaint associated with this case.  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: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Fever; Body ache; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 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 completed, unknown manufacturer), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "Body ache"; CHILLS (non-serious) with onset 2022, outcome "unknown"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset 2022, outcome "unknown".  Additional information: patient wanted to report the following side effects that experienced after receiving the Pfizer Omicron booster shot for COVID 19: Chills, Fever, Body ache, Headache.  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: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: my left side is numb like its asleep especially my left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as unk unk, single. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE ), for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "my left side is numb like its asleep especially my left leg".  Additional information: The patient has received both the initial Pfizer vaccine the first booster and just recently the latest variant booster and my left side is numb like its asleep especially my left leg. I received the booster and flu shot in the left arm. The received the variant booster 12Oct2022 and have been experiencing numbness from my left shoulder where I received the shot to my left foot.  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: U
Vaccine: COVID19
Symptoms: Vasculitis
Clinical narrative: covid vaccine causing vasculitis in some patients; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 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: VASCULITIS (non-serious), outcome "unknown", described as "covid vaccine causing vasculitis in some patients".  Additional information: Reporter inquired if there was anything that could be done about the COVID vaccine causing vasculitis in some patients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: 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 (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (PFIZER COVID-19 VACCINE), as dose number unknown, single (Lot number: FH8030), as dose number unknown, single (Lot number: EW0171) and as dose number unknown, single (Lot number: EP6955) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Conclusion: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FH8030, fill lot FH4343, and the formulated drug product lot FA9187. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion: The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0171, fill lot EP8702, and formulated drug product lot EP8604. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature. Conclusion: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthma; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Covid-19"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Covid-19". The following information was reported: ASTHMA (non-serious), outcome "unknown".  Additional Information: It was reported that the patient received Pfizer primary series and first booster. Then got COVID-19 in Jul2022. Suspects to have developed asthma following the infection.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Investigation
Clinical narrative: Bipolar I Disorder Exacerbation Following COVID-19 Vaccination; This is a literature report.  A 60-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 included: "BD1" (unspecified if ongoing), notes: when she was 35 years old; "hospitalisation" (unspecified if ongoing), notes: for depression, mania, and paranoia; "depression" (unspecified if ongoing); "mania" (unspecified if ongoing); "paranoia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Risperidone for psychosis, notes: 2mg; Mirtazapine. The following information was reported: CONDITION AGGRAVATED (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "Bipolar I Disorder Exacerbation Following COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: Patient Health Questionnaire-9: 5, notes: (PHQ ) score of 5; 0, notes: assessed 17 days prior to vaccination. Therapeutic measures were taken as a result of condition aggravated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event CONDITION AGGRAVATED and the vaccine (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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate."
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She states that she had COVID in May2022; She states that she had COVID in May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-026672 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "She states that she had COVID in May2022".  Clinical course: Product Complaint: There is no product complaint associated with this case.  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: Feeling abnormal, Nausea
Clinical narrative: feels off; nauseaus; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A female patient in her 40's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 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: FEELING ABNORMAL (non-serious) with onset 15Oct2022, outcome "unknown", described as "feels off"; NAUSEA (non-serious) with onset 15Oct2022, outcome "unknown", described as "nauseaus".  Additional information: The patient's age was reported as mid 40's.   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: Arthralgia
Clinical narrative: After the 1st dose of the Pfizer COVID vaccine she had wrist pain; This is a spontaneous report received from a contactable reporter(s) (Physician). 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 and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "After the 1st dose of the Pfizer COVID vaccine she had wrist pain". Therapeutic measures were not taken as a result of arthralgia.  Additional information: It was reported that, After the 1st dose of the Pfizer COVID vaccine she had wrist pain, but it resolved on it's own.   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: Peripheral swelling
Clinical narrative: swelling of the arms; 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling of the arms".  Additional information: Reporter contacted us regarding the Covid-19 vaccine booster dose, he wanted to get more information about the side effects of the vaccine. They had a customer who experienced swelling of the arms after getting her booster dose.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-] has been requested and will be submitted if and when received.