chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction to the Pfizer booster; 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 female patient received BNT162b2 (BNT162B2), 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 , unknown manufacturer), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction to the Pfizer booster".  Patient characteristics   Sex: Female  Drug(s) Information: Characterization of Drug Role: Suspect Proprietary Medicinal Product Name: Comirnaty   Active Substance Information: Active Drug Substance Names: COVID 19 Vaccine, mRNA  Narrative case summary and further information: Originating AE Request:  Attachments: 1 Reporter Subtype: Patient PQC Present: No AE Present: Yes PQC Details:  Request Name:  Product: COMIRNATY Question: After hours page received on 11Apr2022 at 03:50 AM.  Voicemail verbatim:  "(states name but unable to hear clearly) (Phone number withheld) had an allergic reaction to the Pfizer booster. I'd like to talk about it, see if I could be compensated.  I reported it to the FDA and now I'm reporting it to you. (Phone number withheld) please give me a call back."   Agency: E-transmitting limited details from voicemail. Seems to be female consumer.  Placing in frontline queue for callback Monday. Please confirm Pfizer Covid 19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour
Clinical narrative: wearing lingeries, wants to have breasts implants; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 36-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 included: "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "wearing lingeries, wants to have breasts implants".  Additional information: It was reported that they have known him for 2 years now. He was a neuroscientist researcher and professor in (name) university. After his 3 pfizer shots he has been sending me pictures wearing lingeries. This he tells he wants to have breast implants. Is 5.8 feet tall 170 pounds with no medical conditions but has sister.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Body height, Investigation, Libido decreased
Clinical narrative: libido decreased; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 28-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 had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: LIBIDO DECREASED (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour
Clinical narrative: extremely flirtatious during her periods towards woman; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 29-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), 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: ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "extremely flirtatious during her periods towards woman".  Additional information: I have a friend who was 29 years old. She was vaccinated with Pfizer and Moderna was (race) woman. She has an autistic brother and her son was; her grandma had her menopause at 32 years old. She also becomes extremely flirtatious during her periods towards woman.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I got minor tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Lot number: FK9894), as dose 2, single (Lot number: FK9894) and as dose 3 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I got minor tired".  Additional information: The patient's weight is about 210 or 212 (pounds) somewhere around there. The patient had the other shots (Pfizer COVID-19 first dose, second dose and Booster dose) and did not get side effects whatsoever. The patient got tired but that was minor. The patient was on some kind of pills (unspecified medication) that interfere, he was on medication that puts his immune system down a little bit and he think that was what was causing some of this issue.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: I just got diagnosed with acute pericarditis and it's just like I got it from the vaccination the COVID vaccine; 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: PERICARDITIS (medically significant), outcome "unknown", described as "I just got diagnosed with acute pericarditis and it's just like I got it from the vaccination the COVID vaccine".  Additional information: Additional Context: Concern: Consumer stated, "I just wanted to report that I just got diagnosed with acute pericarditis and it's just like I got it from the vaccination the COVID vaccine. I just wanted to call and report that so, that I can be reported in VAERS." When requested to probe further: Consumer stated, "You know I'm actually at the Doctor's office right now 'in return' can you call me back in about hour is that okay." LOT#: Consumer stated, "Not with me right now but when I call back I will provide back to you guys." Consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I had my 4th COVID shot/I have arthritis and have been wheelchair bound. After the COVID booster, I was able to walk and climb upstairs for the first time; 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 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (not ongoing); "have been wheelchair bound" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 3, Manufacturer: unknown, Lot Number: Not Provided), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer: unknown, Lot Number: Not Provided), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Manufacturer: unknown, Lot Number: Not Provided), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I had my 4th COVID shot/I have arthritis and have been wheelchair bound. After the COVID booster, I was able to walk and climb upstairs for the first time".  Additional information: Forwarded as an Adverse Event by the team. The patient had 4th COVID shot, had no negative side affects only was amazing good one. The patient had arthritis and had been wheelchair bound. After the COVID booster, the patient was able to walk and climb upstairs for the first time to see son_(withheld) bedroom. Painkillers never produced the results the vaccine did.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: Arm was little bit sore but now its kind of little bit swollen and it's very sensitive to touch; Arm was little bit sore but now its kind of little bit swollen and it's very sensitive to touch; Arm was little bit sore but now its kind of little bit swollen and it's very sensitive to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 09Apr2022 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 (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), HYPERAESTHESIA (non-serious), outcome "unknown" and all described as "Arm was little bit sore but now its kind of little bit swollen and it's very sensitive to touch".  Additional information: System Reference: No transfer required. No the report is not related to a study or programme. Yes, the patient also the reporter. Reason for no lot number: of Covid-19 Vaccine: Complainant hung up abruptly/transfer incomplete. Expiry Date of Covid-19 Vaccine: Unknown. Consumer stated, pt received 4th Pfizer vaccination on Saturday and pt was fine, pt arm was little bit sore but now it was kind of little bit swollen and it was very sensitive to touch. Should pt just take some Tylenol or Advil or was there something pt should take to try to help with the reaction. Pt took the 4th shot for the Pfizer COVID vaccine (Clarified as Pfizer Covid-19 vaccine). Consumer was informed about the role of Pfizer Drug Safety.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Burning feet syndrome, Paraesthesia, Sciatica
Clinical narrative: feet developed burning and tingling; feet developed burning and tingling; two days after the shot I developed severe back pain sciatica; two days after the shot I developed severe back pain sciatica; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Jan2022 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, SINGLE, Lot number: Unknown), administration date: Dec2021, for Covid-19 immunization, reaction(s): "did not have a reaction to the first one that patient was aware of in Dec2021 ". The following information was reported: BACK PAIN (non-serious), SCIATICA (non-serious) all with onset 15Jan2022, outcome "not recovered" and all described as "two days after the shot I developed severe back pain sciatica"; BURNING FEET SYNDROME (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "feet developed burning and tingling". The events "two days after the shot i developed severe back pain sciatica" and "feet developed burning and tingling" required physician office visit. Additional information: Two days after the shot, patient developed severe back pain sciatica since that time patient have had seen his primary care a chiropractor orthopedic podiatrist as his feet developed burning and tingling. His back is not getting better and was feeling like no one cares, no one was helping. Patient thought that this needs to be investigated and needed help.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200554784 same product/events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning feet syndrome, Paraesthesia
Clinical narrative: two days after the shot I developed severe back pain sciatica; my feet developed burning and tingling my back; my feet developed burning and tingling my back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (P183645). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), on 13Jan2022 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 (1st dose), administration date: Dec2021, for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset 15Jan2022, outcome "unknown", described as "two days after the shot I developed severe back pain sciatica"; BURNING FEET SYNDROME (non-serious), PARAESTHESIA (non-serious) all with onset 2022, outcome "not recovered" and all described as "my feet developed burning and tingling my back". The events "two days after the shot i developed severe back pain sciatica" and "my feet developed burning and tingling my back" required physician office visit.  Additional information: She had her second Pfizer vaccine on 13Jan2022 she did not have a reaction to the first one that she was aware of in Dec2021 two days after the shot she developed severe back pain sciatica since that time she had seen her primary care a chiropractor orthopedic podiatrist as her feet developed burning and tingling her back was not getting better she felt like no one cares no one was helping her sister had the same reaction to your vaccine she thought this needs to be investigated we need help please.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200554783 same patient , different drug and event
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash all over my body with intense itching; rash all over my body with intense itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) 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; Bnt162b2 (dose 2, Single), for Covid-19 immunization. The following information was reported: RASH (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "rash all over my body with intense itching". Additional Information: Customer Verbatim reported as: I have received 3 Pfizer Covid-19 vaccines. One week after the booster shot I began breaking out in rash all over my body with intense itching. I now know that I am predisposed to eczema and should never have had the booster shot which pushed my body over the edge, so to speak. The vaccine was too much for my immune system. It is still a very bad situation and rash.  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: Dehydration, Dysuria, Somnolence
Clinical narrative: The booster knocked me out; increased urination; woke up dehydrated; 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 female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization.   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): "sore arm"; Bnt162b2 (dose 2, single), for COVID-19 immunization.  The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "The booster knocked me out"; DYSURIA (non-serious), outcome "unknown", described  as "increased urination"; DEHYDRATION (non-serious), outcome "unknown", described as "woke up dehydrated". The events "increased urination" and "woke up dehydrated" required physician office visit.  Additional information: The patient was not taking medications or anything like that. The booster knocked the patient out. After the first dose patient had a lot of the typical symptoms such as a sore arm, etc. After the booster all night long, every 45 minutes, patient had to go to the bathroom. It was not a big stream, but it was constant. She woke up dehydrated, it was such an excessive urination. Her doctor told that she had heard about similar cases and recommended patient to stay hydrated. The patient was anxious about getting a fourth shot of 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: Linked Report(s) : US-PFIZER INC-202200557881 Same pt/drug, diff event sep in time
Sex: U
Vaccine: COVID19
Symptoms: Near death experience, Neoplasm malignant
Clinical narrative: I will die within 6 months.; ampillary cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional), Program ID. 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 relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "I will die within 6 months.", NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "ampillary cancer".  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Within 4 weeks developed a severe DVT in right leg and multiple pulmonary emboli bilaterally in both lungs; Within 4 weeks developed a severe DVT in right leg and multiple pulmonary emboli bilaterally in both lungs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (Prev dose product=COVID 19, Prev dose brand=Moderna, Prev dose brand unknown=False, Prev dose lot number=019B21A, Prev dose lot unknown=False, Prev dose administration date=09Apr2021, Prev dose number=2), administration date: 09Apr2021, when the patient was 53-year-old, for COVID-19 Immunization; moderna (Prev dose product=COVID 19, Prev dose brand=Moderna, Prev dose brand unknown=False, Prev dose lot number=03021A, Prev dose lot unknown=False, Prev dose administration date=12Mar2021, Prev dose number=1), administration date: 12Mar2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, disability, medically significant, life threatening), DEEP VEIN THROMBOSIS (hospitalization, disability, medically significant, life threatening) all with onset 26Jan2022, outcome "not recovered" and all described as "Within 4 weeks developed a severe DVT in right leg and multiple pulmonary emboli bilaterally in both lungs". The patient was hospitalized for pulmonary embolism, deep vein thrombosis (hospitalization duration: 7 day(s)). The events "within 4 weeks developed a severe dvt in right leg and multiple pulmonary emboli bilaterally in both lungs" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Feb2022) Negative. Therapeutic measures were taken as a result of pulmonary embolism, deep vein thrombosis.   Clinical course: Treated with Heparin by IV and Eliquest for up to 1 year. No covid prior vaccination. No known allergies.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Emotional distress, Vomiting
Clinical narrative: threw up a number of times too; her stomach or belly is hugely distended and that she was also in distress; her stomach or belly is hugely distended and that she was also in distress; very bad diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years 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: ABDOMINAL DISTENSION (non-serious), EMOTIONAL DISTRESS (non-serious) all with onset Sep2021, outcome "unknown" and all described as "her stomach or belly is hugely distended and that she was also in distress"; VOMITING (non-serious) with onset Sep2021, outcome "unknown", described as "threw up a number of times too"; DIARRHOEA (non-serious) with onset Sep2021, outcome "unknown", described as "very bad diarrhea".  Additional information: Patient received her booster dose on Sep2021 (at the age of 80 years old) and reported that the night she got the shot, her stomach or belly is hugely distended and that she was also in distress. patient added that she had a very bad diarrhea and that she threw up a number of times too. patient is asking if anyone has reported this experience since she is contemplating on getting her 2nd booster dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for Covid; positive for 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 68-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 included: "he does have a history of sensitivity with side effects" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive.  Clinical course: Caller was a scientist stating that he currently was positive for Covid, He was 68-year-old and was triple vaccinated so he had some immunity to covid. His friend that was a pulmonologist had encouraged him to start Paxlovid. He would like to know the statistics of the side effects with Paxlovid because he does had a history of sensitivity with side effects.  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: Tremor
Clinical narrative: hand trembling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). 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: TREMOR (non-serious), outcome "unknown", described as "hand trembling". 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: Pain in extremity
Clinical narrative: After the first dose I had a lot of the typical symptoms such as a sore arm, etc; 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 female patient (unknown if pregnant) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "After the first dose I had a lot of the typical symptoms such as a sore arm, etc".  Additional information: The patient later received second dose and booster dose of BNT162b2 for covid-19 immunisation. She received the booster dose of the Pfizer-BioNTech COVID-19 Vaccine on an unknown date in Dec2021 and it knocked her out, she experienced increased urination ever since. After the vaccine all night long, every 45 minutes, she had to go to the bathroom. It was not a big stream, but it was constant. She woke up dehydrated, it was such an excessive urination. She was not taking meds or anything like that.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200555679 Same pt/drug, diff event sep in time
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 3 months in the hospital with COVID and 2 more months in a rehab after that facility; 3 months in the hospital with COVID and 2 more months in a rehab after that facility; 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 1, single (Lot number: 30145BA, Expiration Date: 15Sep2021) and as dose 2, single (Lot number: 30145BA, Expiration Date: 06Oct2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "3 months in the hospital with COVID and 2 more months in a rehab after that facility". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Additional information: I was in a hospital last year since Jul till 03Dec months in the hospital with COVID and 2 more months in a rehab after that facility (further clarifications unknown). So, I had COVID bad case last year. I don't know what to do, do I need to go in emergency or should I wait? Because, I have been (voice not clear) test was, I just checked it right now and it was negative." When confirmed the name of the vaccine as Pfizer COVID Vaccine booster shot, Consumer stated, "Yes, third one, third vaccine after 6 months, after my 2 doses last year in Oct2021 Expiration date: Consumer stated, "So date is 15Sep21, 15Sep2021 the first dose, second one you need second one? It's the same 30145BA Pfizer, 06Oct2021 (further not clarified hence not captured in tab)."   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Vertigo, Vomiting
Clinical narrative: Caller states that she was in hospital for 3 days and "couldn't walk"; Also had episodes of "throwing up."; Caller states that she is "off balance" on a daily basis since receiving the vaccine; after the 2nd Pfizer Covid19 vaccine her vertigo worsened; 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 70-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, SINGLE), administration date: Feb2021, for COVID-19 Immunization, reaction(s): "Affected her balance and vision", "Vertigo", "Affected her balance and vision". The following information was reported: GAIT DISTURBANCE (hospitalization), outcome "unknown", described as "Caller states that she was in hospital for 3 days and "couldn't walk""; VOMITING (non-serious), outcome "unknown", described as "Also had episodes of "throwing up.""; BALANCE DISORDER (non-serious), outcome "not recovered", described as "Caller states that she is "off balance" on a daily basis since receiving the vaccine"; VERTIGO (non-serious), outcome "not recovered", described as "after the 2nd Pfizer Covid19 vaccine her vertigo worsened". The patient was hospitalized for gait disturbance (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of gait disturbance. Clinical course: Patient got the Pfizer COVID-19 vaccine in Feb2021 and has had side effects from it for over a year now. Caller states she has been experiencing vertigo which has affected her balance and vision since having the 1st dose of the vaccine and after the 2nd Pfizer COVID-19 Vaccine her vertigo worsened. Caller states that she was in hospital for 3 days and "couldn't walk" and had to go through Physical Therapy and also had episodes of throwing up. Patient states that she was off balance on a daily basis since receiving the vaccine. Patient was asking are there any other reports of vertigo after getting the Pfizer COVID-19 Vaccine.  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: Asthenia, Blood pressure measurement, Dizziness, Fatigue, Heart rate increased
Clinical narrative: BP was really high; dizzy; weak; tired; woke up with a rash all over her body; has a fast heart rate; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 22Mar2022 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: HYPERTENSION (non-serious) with onset 11Apr2022, outcome "unknown", described as "BP was really high"; DIZZINESS (non-serious) with onset 2022, outcome "not recovered", described as "dizzy"; HEART RATE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "has a fast heart rate"; FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "tired"; ASTHENIA (non-serious) with onset 2022, outcome "not recovered", described as "weak"; RASH (non-serious) with onset 2022, outcome "recovering", described as "woke up with a rash all over her body". The events "dizzy", "weak", "tired", "woke up with a rash all over her body", "has a fast heart rate" and "bp was really high" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: she got her Pfizer Covid-19 vaccine adult dose on 22Mar2022 and have been having symptoms since she got her vaccine. States she feels dizzy, weak, tired, woke up with a rash all over her body and has a fast heart rate. States she already went to the doctor and got her steroid shot for the allergic reaction. She is scared to get the second dose and wants to know if she can get something. She didn't clarify but is seeking guidance on what to do. States she has been feeling like this since she got the vaccine. The rash is going away because of her steroid shot but she still feels weak, dizzy like she's gonna passed out. States sometimes it comes and goes away. Today when she went to urgent care her BP was really high and she doesn't have High BP. It was always normal.  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: Hypertension, Rash
Clinical narrative: BP was really high; dizzy; weak; tired; woke up with a rash all over her body; has a fast heart rate; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 22Mar2022 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: HYPERTENSION (non-serious) with onset 11Apr2022, outcome "unknown", described as "BP was really high"; DIZZINESS (non-serious) with onset 2022, outcome "not recovered", described as "dizzy"; HEART RATE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "has a fast heart rate"; FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "tired"; ASTHENIA (non-serious) with onset 2022, outcome "not recovered", described as "weak"; RASH (non-serious) with onset 2022, outcome "recovering", described as "woke up with a rash all over her body". The events "dizzy", "weak", "tired", "woke up with a rash all over her body", "has a fast heart rate" and "bp was really high" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: she got her Pfizer Covid-19 vaccine adult dose on 22Mar2022 and have been having symptoms since she got her vaccine. States she feels dizzy, weak, tired, woke up with a rash all over her body and has a fast heart rate. States she already went to the doctor and got her steroid shot for the allergic reaction. She is scared to get the second dose and wants to know if she can get something. She didn't clarify but is seeking guidance on what to do. States she has been feeling like this since she got the vaccine. The rash is going away because of her steroid shot but she still feels weak, dizzy like she's gonna passed out. States sometimes it comes and goes away. Today when she went to urgent care her BP was really high and she doesn't have High BP. It was always normal.  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: Blood test, HIV test false positive, Lactation disorder, Retching
Clinical narrative: she experienced dry heaves or as she explained as the feeling of wanting to throw up but not being able to; affect her lactation in any sort of way; She also shares that when she took a blood test after taking the Covid 19 vaccine it showed as if she had HIV, which she does not have; 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 73-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she last lactated", start date: 1972 (unspecified if ongoing), notes: she last lactated on 1972. The patient's concomitant medications were not reported. The following information was reported: HIV TEST FALSE POSITIVE (non-serious) with onset 2022, outcome "unknown", described as "She also shares that when she took a blood test after taking the Covid 19 vaccine it showed as if she had HIV, which she does not have"; Lactation disorder(non-serious) with onset 2022, outcome "unknown", described as "affect her lactation in any sort of way"; Retching(non-serious) with onset 2022, outcome "unknown", described as "she experienced dry heaves or as she explained as the feeling of wanting to throw up but not being able to". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information:Question: Caller states she was born on (withheld). Caller states that she is about to take her booster shot of the Pfizer Covid 19 vaccine on 18Apr2022. Caller states that 3 days after she received her last shot which was 4 weeks ago, she experienced dry heaves or as she explained as the feeling of wanting to throw up but not being able to. She is asking if the Pfizer Covid 19 vaccine may have cause her dry heaves. Caller also states that she last lactated on 1972 but would like to know if the Pfizer Covid 19 vaccine may affect her lactation in any sort of way. She also shares that when she took a blood test after taking the Covid 19 vaccine it showed as if she had HIV, which she does not have.Caller dropped the phone while she was on hold. Successful call back attempt was made (Mon, 11Apr2022 5:41 PM)E-transmitting to agent for possible AE. Not able to offer warm transfer to agent, forgot to offer to caller.Request Name:  -#Question: Caller states that she would like a list of the ingredients in the Pfizer Covid 19 vaccine, since she would like to be prepared for the dose that she will be taking on 18Apr2022. She is also trying to identify what ingredient caused her to experience dry heaves.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Inflammation, Joint swelling, Knee arthroplasty
Clinical narrative: severe pain and swelling in my right knee; severe pain and swelling in my right knee; The fluid was inflammatory; I have mild arthritis in that knee at baseline; TKR in my other knee; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EW0167) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CALCIUM taken for supplementation therapy. Vaccination history included: BNT162b2 (Dose Number: 2, Brand: Pfizer, Batch/Lot No: EK9231, Location of injection: Arm Left), administration date: 11Jan2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Brand: Pfizer, Batch/Lot No: EJ1685, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 54-year-old, for Covid-19 immunization. The following information was reported: ARTHRITIS (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "I have mild arthritis in that knee at baseline"; KNEE ARTHROPLASTY (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "TKR in my other knee"; INFLAMMATION (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "The fluid was inflammatory"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset 02Oct2021, outcome "recovered" (Oct2021) and all described as "severe pain and swelling in my right knee". The events "severe pain and swelling in my right knee", "the fluid was inflammatory", "i have mild arthritis in that knee at baseline" and "tkr in my other knee" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint swelling, inflammation, arthritis, knee arthroplasty.  Additional information: Adverse event: 3 days after vaccine I developed severe pain and swelling in my right knee. Pain was acute onset and required fluid being removed from my knee. The fluid was inflammatory. I have mild arthritis in that knee at baseline. TKR in my other knee. Within a week to 10 days all symptoms were resolved. Ae treatment: Fluid drained from knee. Anti inflammatory prescr.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: severe pain and swelling in my right knee; severe pain and swelling in my right knee; The fluid was inflammatory; I have mild arthritis in that knee at baseline; TKR in my other knee; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EW0167) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CALCIUM taken for supplementation therapy. Vaccination history included: BNT162b2 (Dose Number: 2, Brand: Pfizer, Batch/Lot No: EK9231, Location of injection: Arm Left), administration date: 11Jan2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Brand: Pfizer, Batch/Lot No: EJ1685, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 54-year-old, for Covid-19 immunization. The following information was reported: ARTHRITIS (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "I have mild arthritis in that knee at baseline"; KNEE ARTHROPLASTY (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "TKR in my other knee"; INFLAMMATION (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "The fluid was inflammatory"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset 02Oct2021, outcome "recovered" (Oct2021) and all described as "severe pain and swelling in my right knee". The events "severe pain and swelling in my right knee", "the fluid was inflammatory", "i have mild arthritis in that knee at baseline" and "tkr in my other knee" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint swelling, inflammation, arthritis, knee arthroplasty.  Additional information: Adverse event: 3 days after vaccine I developed severe pain and swelling in my right knee. Pain was acute onset and required fluid being removed from my knee. The fluid was inflammatory. I have mild arthritis in that knee at baseline. TKR in my other knee. Within a week to 10 days all symptoms were resolved. Ae treatment: Fluid drained from knee. Anti inflammatory prescr.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Inflammation, Joint fluid drainage, Joint swelling, SARS-CoV-2 test
Clinical narrative: severe pain and swelling in my right knee; severe pain and swelling in my right knee; The fluid was inflammatory; I have mild arthritis in that knee at baseline; TKR in my other knee; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EW0167) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CALCIUM taken for supplementation therapy. Vaccination history included: BNT162b2 (Dose Number: 2, Brand: Pfizer, Batch/Lot No: EK9231, Location of injection: Arm Left), administration date: 11Jan2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Brand: Pfizer, Batch/Lot No: EJ1685, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 54-year-old, for Covid-19 immunization. The following information was reported: ARTHRITIS (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "I have mild arthritis in that knee at baseline"; KNEE ARTHROPLASTY (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "TKR in my other knee"; INFLAMMATION (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "The fluid was inflammatory"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset 02Oct2021, outcome "recovered" (Oct2021) and all described as "severe pain and swelling in my right knee". The events "severe pain and swelling in my right knee", "the fluid was inflammatory", "i have mild arthritis in that knee at baseline" and "tkr in my other knee" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint swelling, inflammation, arthritis, knee arthroplasty.  Additional information: Adverse event: 3 days after vaccine I developed severe pain and swelling in my right knee. Pain was acute onset and required fluid being removed from my knee. The fluid was inflammatory. I have mild arthritis in that knee at baseline. TKR in my other knee. Within a week to 10 days all symptoms were resolved. Ae treatment: Fluid drained from knee. Anti inflammatory prescr.  No follow-up attempts are needed. No further information is expected.