chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment, Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment, Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma, insulin resistant; "Insulin resistant" (unspecified if ongoing), notes: other medical history: Asthma, insulin resistant. Concomitant medication(s) included: METFORMIN, start date: 01May2022, stop date: 15May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment, Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Remains antigen test negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details: The COVID 19 Treatment (Paxlovid). Treatment received on 07May2022 and stop date: 11may2022. Indication is used for treatment of COVID-19. Other medication in 2 weeks product Metformin on 01May2022 and stop date 15May2022. The patent experienced adverse event Recurrence of symptoms 4 days after completion of treatment. Remains antigen test negative on 15May2022 at 03:00 AM. If the patient is Recovering. If the patent did not receive treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2021 as dose number unknown, single (Lot number: 33025BD) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: other medical history: Multiple Sclerosis; "Crawfish" (unspecified if ongoing), notes: known allergies: Crawfish. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; IBUPROFEN; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13May2022) Positive, notes: COVID came back. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 03May2022 to 08May2022.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 03Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm, on 24Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in left arm and on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "NAFLD" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: LISINOPRIL, start date: 01Jul2016; HYDROCHLOROTHIAZIDE, start date: 01Jul2016; ROSUVASTATIN; SERTRALINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID-19 is treated with Paxlovis, treatment start date=12May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and COVID-19 cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Batch/Lot number: unknown), on 10May2021 as dose 2, single (Batch/Lot number: unknown) and on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROGESTERONE taken for contraception, start date: 04Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested Positive for covid again and also had new symptoms; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Other medication in 2weeks product included Progesterone only birth control with start date 04Jan2021. Adverse event reported was tested positive for covid again and also had new symptoms with start date May2022 , Treatment start date for COVID-19 was from 02May2022 till 06May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8782), in left arm, on 13Sep2021 as dose 3 (booster), single (Lot number: EW0169), in left arm and on 14Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: high blood pressure; "Breast cancer Survivor" (unspecified if ongoing), notes: breast cancer survivor in last to years; "Known allergies: dust mites" (unspecified if ongoing), notes: dust mites. The patient's concomitant medications were not reported. Past drug history included: Thiomersal, reaction(s): "known allergies thimerosol", notes: known allergies thimerosol.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. It was reported that the patient received treatment of Paxlovid for COVID-19 from 03May2022.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Prostatic specific antigen, Swelling
Clinical narrative: I got it on left arm and it is little swollen under the armpit; I knew it was not before; Body ache; Tiredness; 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 patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FK9729) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psychosis" (unspecified if ongoing); "Hodgkin's lymphoma", start date: 2015 (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer, Prior vaccinations (within 4 weeks): Consumer stated, "No, nothing. My last vaccine was first dose was 202 days."), for COVID-19 immunization, reaction(s): "first shot do not have reaction"; Covid-19 vaccine (Dose :2 , Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 3, First booster), for Covid-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "I got it on left arm and it is little swollen under the armpit; I knew it was not before"; PAIN (non-serious), outcome "unknown", described as "Body ache"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got his second booster on Thursday in now the first shot do not have reaction it was not anything like swelling. Now second one patient get this Thursday patient noticed today, patient got it on left arm and it is little swollen under the armpit. patient knew it was not before. That reaction to the shot?" Product Pfizer, Covid-19 Vaccine. When paraphrased the concern patient stated, Yes. It was fine before, it was okay on Thursday and nothing yesterday but today but it looks like little swollen under the armpit but patient feel nothing has swollen ever.Prior vaccinations within 4 weeks: Patient stated, No, nothing. Patient last vaccine was first dose was 202 days.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: joint pains; Constant headaches; tired; low energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 at 13:00 as dose 2, single (Lot number: ER8731) at the age of 48 years, in left arm for covid-19 immunisation at Pharmacy or Drug Store. The patient's relevant medical history included: "cilantro" (unspecified if ongoing), notes: known allergies: Cilantro. The patient's concomitant medications were not reported. Past drug history included: Ddoxycycline, reaction(s): "known allergies doxycycline", notes: known allergies: Doxycycline. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left at 01:00 PM), administration date: 17Mar2021, when the patient was 47-year-old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 15Apr2021 at 07:00, outcome "recovering", described as "Constant headaches"; ARTHRALGIA (non-serious) with onset 15Apr2021 at 07:00, outcome "recovering", described as "joint pains"; ASTHENIA (non-serious) with onset 15Apr2021 at 07:00, outcome "recovering", described as "low energy"; FATIGUE (non-serious) with onset 15Apr2021 at 07:00, outcome "recovering", described as "tired". The events "joint pains", "constant headaches", "tired" and "low energy" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of arthralgia, headache, fatigue, asthenia.  Additional information: If other vaccine in four weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: Yes.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia, Inappropriate schedule of product administration, Off label use
Clinical narrative: I just want to know if I got this shot too soon because I did have COVID last month; I just want to know if I got this shot too soon because I did have COVID last month; Feeling numb; too tired; My body is aching; I don't feel good; 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 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: I just want to know if I got this shot too soon because I did have COVID last month. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: Unknown), for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot number: Unknown), for COVID-19 immunization.  The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "I just want to know if I got this shot too soon because I did have COVID last month"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Feeling numb"; FATIGUE (non-serious), outcome "unknown", described as "too tired"; PAIN (non-serious), outcome "unknown", described as "My body is aching"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I don't feel good".  Additional Information: Consumer stated, "I got your number on the paper from when I got the Pfizer booster shot and I was just calling to confirm some side effects. "I just want to know if I got this shot too soon because I did have COVID last month but, and I did have (incomplete sentence). I took the Pfizer both shots like a year ago like in April and then I got both shot (COVID-19 vaccine) and then I got booster now but I did have COVID last month, I was down for like a week." Consumer was informed about the role of Pfizer Drug Safety Department. Consumer further stated, "Okay. You know, I don't know how many days should I wait to be like, feeling numb, too tired and my body is aching. It was Friday after the shot and now Sunday morning you know, I didn't go to work yesterday and then today I woke up and it was not as bad but it is still, I don't feel good. So, I am wondering how many days should I expect to not to feel down and tired you know after this shot?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I just want to know if I got this shot too soon because I did have COVID last month; I just want to know if I got this shot too soon because I did have COVID last month; Feeling numb; too tired; My body is aching; I don't feel good; 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 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: I just want to know if I got this shot too soon because I did have COVID last month. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: Unknown), for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot number: Unknown), for COVID-19 immunization.  The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "I just want to know if I got this shot too soon because I did have COVID last month"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Feeling numb"; FATIGUE (non-serious), outcome "unknown", described as "too tired"; PAIN (non-serious), outcome "unknown", described as "My body is aching"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I don't feel good".  Additional Information: Consumer stated, "I got your number on the paper from when I got the Pfizer booster shot and I was just calling to confirm some side effects. "I just want to know if I got this shot too soon because I did have COVID last month but, and I did have (incomplete sentence). I took the Pfizer both shots like a year ago like in April and then I got both shot (COVID-19 vaccine) and then I got booster now but I did have COVID last month, I was down for like a week." Consumer was informed about the role of Pfizer Drug Safety Department. Consumer further stated, "Okay. You know, I don't know how many days should I wait to be like, feeling numb, too tired and my body is aching. It was Friday after the shot and now Sunday morning you know, I didn't go to work yesterday and then today I woke up and it was not as bad but it is still, I don't feel good. So, I am wondering how many days should I expect to not to feel down and tired you know after this shot?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain
Clinical narrative: upper back pain/ my upper back is really hurting me bad; She stated she is in pain and could not continue the phone call. 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 52-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (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: Covid-19 vaccine (Primary Immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Third dose (1st booster), MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "upper back pain/ my upper back is really hurting me bad"; PAIN (non-serious), outcome "unknown", described as "She stated she is in pain and could not continue the phone call."  Additional Information: Consumer stated, "I am just wondering, I had the COVID booster shot, my 2nd booster and my upper back is really hurting me bad. Is that a common side effect from that or uncommon side effect?" Consumer was provided Pfizer Medical Information department. Limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I came down with Covid, I started Covid on Tuesday and in other words in the night of Wednesday or Tuesday; I came down with Covid, I started Covid on Tuesday and in other words in the night of Wednesday or Tuesday; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19), 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 included: "Hypertension" (unspecified if ongoing), notes: Hypertension. Concomitant medication(s) included: LEXAPRO; SINGULAIR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "I came down with Covid, I started Covid on Tuesday and in other words in the night of Wednesday or Tuesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: I started Covid on Tuesday and in other words in the night of Wednesday or Tuesday. Therapeutic measures were taken as a result of covid-19. COVID is treated with Paxlovid. Report is not related to a study or programme.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, SARS-CoV-2 test
Clinical narrative: Persistent muscle twitching mostly in legs (calf/thigh) and arms (bicep/tricep/shoulders), but can appear all over (abdomen, back to lesser extent) except for face/neck area; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40-year-old male patient received bnt162b2 (BNT162B2) on 18May2021 as dose 2, single (Lot number: EW0187), at the age of 39 years, in left arm 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: EW0167; Anatomical site: Right arm), administration date: 17Apr2021, when the patient was 39 years old, for COVID-19 immunisation.  The following information was reported: MUSCLE TWITCHING (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Persistent muscle twitching mostly in legs (calf/thigh) and arms (bicep/tricep/shoulders), but can appear all over (abdomen, back to lesser extent) except for face/neck area". The event " Persistent muscle twitching mostly in legs (calf/thigh) and arms (bicep/tricep/shoulders), but can appear all over (abdomen, back to lesser extent) except for face/neck area" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle twitching.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of right underarm lymph nodes started approximately 2-3 hours after injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FG3527) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "heart surgery to remove tumor" (unspecified if ongoing); "heart surgery to remove tumor" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ATORVASTATIN. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin". Vaccination history included: BNT162b2 (previous dose details , prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EN6204,, prev dose lot unknown=False,, prev dose administration date=21Apr2021,, prev dose administration time=12:00 PM, prev dose dose number=2,, prev dose vaccine location=Right arm,), administration date: 21Apr2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (prev  dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EN6203,, prev dose lot unknown=False,, prev dose administration date=31Mar2021,, prev dose administration time=12:00 PM, prev dose dose number=1,, prev dose vaccine location=Right arm), administration date: 31Mar2021, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Nov2021 at 14:00, outcome "not recovered", described as "Swelling of right underarm lymph nodes started approximately 2-3 hours after injection". The event "swelling of right underarm lymph nodes started approximately 2-3 hours after injection" required physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Adverse event: Swelling of right underarm lymph nodes started approximately 2-3 hours after injection. Left-arm lymph nodes also swelled roughly 2 months later, but have reduced. Right arm is still swollen today, but not as much as before.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I have severe chronic pain in my left bicep where I had the injection; 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I have severe chronic pain in my left bicep where I had the injection".  Additional information:  Consumer stated, "I couldn't understand reactions before I got to do Pfizer since I have been having adverse effect to my COVID injection for a year now. I am having adverse effect to my COVID injection for a year now. I was left in (voice distorted) yesterday they told me that there is another complaint similar to what I am having (voice distorted). I am having adverse effect to my COVID injection." Name of Vaccine: Pfizer COVID-19 Vaccine. When paraphrased to clarify the concern: Consumer stated, "Yes, for 12 months by now." When probed to clarify if consumer had any medical queries: Consumer stated, "I have severe chronic pain in my left bicep where I had the injection and the facility of administration recommended that I notify Pfizer. "When probed to clarify if consumer wanted to report the adverse event or had any medical queries: Product details, Pharmacy details and other details could not be probed. Hence further probing could not be done. Limited information available over the call. QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Neuralgia
Clinical narrative: Patient reports a "sore shoulder, nerve pain in my hands and arms" after taking Pfizer COVID; Patient reports a "sore shoulder, nerve pain in my hands and arms" after taking Pfizer COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Broken back vertebrae C8" (unspecified if ongoing), notes: Broken back vertebrae C8; "Shot by 8 nails through hand" (unspecified if ongoing), notes: Shot by 8, nail through hand; "Almost cut fingers off" (unspecified if ongoing), notes: Almost cut fingers off; "astigmatism" (unspecified if ongoing); "blacked out" (unspecified if ongoing); "COPD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "spinal slippage in L5 & S1" (unspecified if ongoing), notes: spinal slippage in L5 & S1; "allergic to marijuana" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "aortic stenosis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Wet Age Related Macular Degeneration" (unspecified if ongoing), notes: Wet Age Related Macular Degeneration. Concomitant medication(s) included: OMEPRAZOLE; SIMVASTATIN; ALBUTEROL [SALBUTAMOL]; ASPIRIN [ACETYLSALICYLIC ACID]; NOVOCAINE [PROCAINE]; LUCENTIS; EYLEA; AVASTIN [BEVACIZUMAB]. The following information was reported: ARTHRALGIA (non-serious), NEURALGIA (non-serious), outcome "unknown" and all described as "Patient reports a "sore shoulder, nerve pain in my hands and arms" after taking Pfizer COVID". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Anti viral details: product: COVID 19 Treatment, Brand: Pfizer,; Anti viral details: product: COVID 19 Treatment, Brand: Pfizer,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 at 08:30 as dose 1, single (Lot number: EP6955), in left arm and on 28Apr2021 at 08:30 as dose 2, single (Lot number: EW0162) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Nov2021 at 16:30 as dose 3 (booster), single (Lot number: 058F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Anti viral details: product: COVID 19 Treatment, Brand: Pfizer,". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid Treatment start date: 04May2022, Treatment stop date: 08May2022, As treatment of COVID-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: overwhelming fatigue; pain in my legs; I continue to feel extremely tired; unable to do things throughout the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "I continue to feel extremely tired"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "overwhelming fatigue"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "pain in my legs"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "not recovered", described as "unable to do things throughout the day".  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: Decreased appetite, Illness, Somnolence
Clinical narrative: She states she felt like sleeping and didn't want to eat and really made her sick; She states she felt like sleeping and didn't want to eat and really made her sick; She states she felt like sleeping and didn't want to eat and really made her sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 14May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 3), administration date: 01Oct2021, for COVID-19 immunization, reaction(s): "real sick"; Covid-19 vaccine (dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset May2022, outcome "recovered" (May2022), SOMNOLENCE (non-serious), DECREASED APPETITE (non-serious) all with onset May2022, outcome "unknown" and all described as "She states she felt like sleeping and didn't want to eat and really made her sick".  Additional information: She states she had her 3rd dose of the Pfizer COVID-19 vaccine on 01Oct2021 and wants to mention that she is almost 88 years old. She states number 3 made her real sick but nothing like this. Caller states the information was probably in the report as she did report this after her 3rd dose of the COVID-19 Vaccine in Oct. She states only one day and then this was 2 days. She states 2 days ago she got the 4th dose of the Pfizer COVID-19 vaccine. She states she felt like sleeping and didn't want to eat and really made her sick. She states yesterday she was very sick and today she is fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9266), on 04Mar2021 as dose 2, single (Lot number: EN6205) and on 01Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 80 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL; ASPIRIN 81; ZETIA. The following information was reported: HEADACHE (non-serious), outcome "recovered"; FATIGUE (non-serious), outcome "recovered".  Additional Information: Caller states he had a severe reaction to the fourth vaccine. Caller states he had a headache and fatigue which he had with the first 3 too but this one he was up all night long with dry heaves, dizziness, achiness and just not feeling well at all. Caller states he had Covid before any of the vaccines were available so he knows it is not a good thing to have.  Treatment included Stay in bed a lot. Fourth Dose or Second Booster Dose taken on 11May2022 with Lot FP7557 or FP4554. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations was None. Patient's does not have any medical History (including any illness at time of vaccination). And no family Medical History Relevant to AE(s). AE(s) does not required visit to Emergency room or physician room. Generic zetia and statin are reported; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200720046 Same patient, same event, different dose
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), in right arm and on 23Mar2021 as dose 2, single (Lot number: ED6955), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3 (booster), single (Lot number: 030H218), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: positive home covid test. Therapeutic measures were taken as a result of covid-19. Clinical course: No other medication in 2weeks. COVID 19 Treatment: Paxlovid. Treatment start date: 05May2022 and stop date: 10May2022. On 15May2022, rebound of symptoms on the 5th day after final dose of Paxlovod. Positive home Covid test. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8735), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Former breast cancer patient" (unspecified if ongoing), notes: Former breast cancer patient. Concomitant medication(s) included: METOPROLOL SUCCINATE, stop date: 03May2022; CELLTRION FAMOTIDINE, stop date: 03May2022; TARO ENALAPRIL, stop date: 03May2022; MYLAN ATORVASTATIN, stop date: 03May2022.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient began Paxlovid on 03May2022 for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team.  An 85-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "auto immune disease" (unspecified if ongoing), notes: Caller stated that there were persons with auto immune disease and still took the shot. The patient's concomitant medications were not reported.  The following information was reported: ISCHAEMIC STROKE (medically significant), outcome "unknown", described as "received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke".  Clinical course: Reporter Subtype: Caregiver. Caller stated that she read that the second dose of the Pfizer covid 19 vaccine was stronger, and this could be why the patient had the stroke. Caller stated that she heard that Pfizer and Moderna stopped doing trials on persons in their seventies. Caller asked if there were any specific trials for persons in their eighties. Caller stated she called a year ago. Caller would not provide any demographics. Caller wanted to speak with someone in the lab. Caller wanted to know the data regarding a person in their early eighties that received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke and then got the booster. Caller wanted to know if there was any data on a person that had an ischemic stroke and got the booster and got sick, asking what the adverse reaction was. Caller wanted to know if the vaccine was contraindicated in this person. Caller refused to be sent to RA because she said it would not help and she was not here to help the company. Caller stated the patient would only agree to report to RA if the patient got the information about persons having an ischemic stroke and then getting the booster. Caller stated that it is too bad that Pfizer does not have information about persons that are 65,75 or 85 because they are the ones in danger noting it is too bad that the trials were not done on the age group 80 and older. Caller stated this age group was the age group that needs the vaccine the most. Caller stated that there were persons with auto immune disease and still took the shot. Caller stated she was at ground zero because Pfizer did not have any specific information. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: eye pain; 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), in Jan2021 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), administration date: Dec2020, for Covid-19 immunization. The following information was reported: EYE PAIN (non-serious) with onset Sep2021, outcome "unknown". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Received positive covid test. Symptoms were mild - headache, 102 fever, sore throat; Received positive covid test. Symptoms were mild - headache, 102 fever, sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 15:10 as dose 1, single (Lot number: EJ1685) intramuscular, in left arm, on 25Mar2021 at 13:45 as dose 2, single (Lot number: EK5730) intramuscular, in left arm and on 27Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Ciprofloxin, reaction(s): "ciprofloxin: Drug Allergy", notes: known allergies: ciprofloxin; Tessalon perles, reaction(s): "tessalon perles: Drug allergy", notes: known allergies: tessalon perles; Gluten, reaction(s): "Gluten: Drug allergy", notes: known allergies: gluten; Differin, reaction(s): "differin: Drug allergy", notes: known allergies: differin; Yellow, reaction(s): "yellow: Drug allergy", notes: known allergies: yellow. The following information was reported: VACCINATION FAILURE (medically significant) with onset 13May2022, outcome "unknown", COVID-19 (medically significant) with onset 13May2022, outcome "recovering" and all described as "Received positive covid test. Symptoms were mild - headache, 102 fever, sore throat". The patient underwent the following laboratory tests and procedures: Body temperature: (13May2022) 102; SARS-CoV-2 test: (14May2022) Positive. Therapeutic measures were not taken as a result of covid-19.Clinical Course: Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no.
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Joint swelling, Vaccination site erythema
Clinical narrative: redness at the injection site and redness and swelling all the way down to the elbow.; redness at the injection site and redness and swelling all the way down to the elbow.; redness at the injection site and redness and swelling all the way down to the elbow.; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), ERYTHEMA (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "redness at the injection site and redness and swelling all the way down to the elbow.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Reaction from injection site down to elbow redness and swelling; Reaction from injection site down to elbow redness and swelling; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative.  A 62-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Reaction from injection site down to elbow redness and swelling". Additional information: Reaction from injection site down to elbow redness and swelling. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.