chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Musculoskeletal pain, Oral discomfort, Pain, Pain in extremity, Paraesthesia
Clinical narrative: right big toe hurt 02/10/2021, did cortison injection on big toe on 02/21/2021 then massive symptoms were started March 25th right buttock pain and right leg weakness, legs numbness, buttocks numbness, feet pins and needles, then 10 days later left buttocks and left legs are started then in May and June the pins and needles went upward to lower legs and thigh, like bug crawling, the middle June face numbness and arms and hands numbness then upper back pain and numbness then spread from upper back to front chest and trunk and abdominal, numbness head to toe, burning, pain almost everywhere, right big toe, legs pain, bottom feet pain, buttocks pain, upper back and upper arm pain, head, face all over body skin sensory loss some degrees, neck crunch sound, mouth tongue and gum burning, had UTI May 14th, ear ring in July, diaphragm and chest numbness more noticeable, fatigue and eye burning and eye corner shooting pain in Aug and shortness of breath, chest discomfort in Sep and high heat rate on Sep 29th, had fainting in restroom while in ER when they inject me medicine to push the lung fluid out, since then bought a BP tool AND BP are on lower side, like 95/55 - 110/74. Saw indigested salad and grapefruit 10/26/2022, still green leaves, went poo only couple of hours of eating it. Stomach gurling crazily since Sep, loose stool since beginning then constipation and diarrhea in turns since Sep.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sensory loss, Syncope, Thyroid function test, Tinnitus, Tongue discomfort
Clinical narrative: right big toe hurt 02/10/2021, did cortison injection on big toe on 02/21/2021 then massive symptoms were started March 25th right buttock pain and right leg weakness, legs numbness, buttocks numbness, feet pins and needles, then 10 days later left buttocks and left legs are started then in May and June the pins and needles went upward to lower legs and thigh, like bug crawling, the middle June face numbness and arms and hands numbness then upper back pain and numbness then spread from upper back to front chest and trunk and abdominal, numbness head to toe, burning, pain almost everywhere, right big toe, legs pain, bottom feet pain, buttocks pain, upper back and upper arm pain, head, face all over body skin sensory loss some degrees, neck crunch sound, mouth tongue and gum burning, had UTI May 14th, ear ring in July, diaphragm and chest numbness more noticeable, fatigue and eye burning and eye corner shooting pain in Aug and shortness of breath, chest discomfort in Sep and high heat rate on Sep 29th, had fainting in restroom while in ER when they inject me medicine to push the lung fluid out, since then bought a BP tool AND BP are on lower side, like 95/55 - 110/74. Saw indigested salad and grapefruit 10/26/2022, still green leaves, went poo only couple of hours of eating it. Stomach gurling crazily since Sep, loose stool since beginning then constipation and diarrhea in turns since Sep.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Urinary tract infection, Urine analysis, X-ray
Clinical narrative: right big toe hurt 02/10/2021, did cortison injection on big toe on 02/21/2021 then massive symptoms were started March 25th right buttock pain and right leg weakness, legs numbness, buttocks numbness, feet pins and needles, then 10 days later left buttocks and left legs are started then in May and June the pins and needles went upward to lower legs and thigh, like bug crawling, the middle June face numbness and arms and hands numbness then upper back pain and numbness then spread from upper back to front chest and trunk and abdominal, numbness head to toe, burning, pain almost everywhere, right big toe, legs pain, bottom feet pain, buttocks pain, upper back and upper arm pain, head, face all over body skin sensory loss some degrees, neck crunch sound, mouth tongue and gum burning, had UTI May 14th, ear ring in July, diaphragm and chest numbness more noticeable, fatigue and eye burning and eye corner shooting pain in Aug and shortness of breath, chest discomfort in Sep and high heat rate on Sep 29th, had fainting in restroom while in ER when they inject me medicine to push the lung fluid out, since then bought a BP tool AND BP are on lower side, like 95/55 - 110/74. Saw indigested salad and grapefruit 10/26/2022, still green leaves, went poo only couple of hours of eating it. Stomach gurling crazily since Sep, loose stool since beginning then constipation and diarrhea in turns since Sep.
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No addittional AE; Customer called for a temperature excursion in case 02261220. Caller reported that VARIVAX that had undergone temperature; was administered to a patient on 08-SEP-2022; This spontaneous report was received from a registered nurse, referring to a 6-day-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 08-SEP-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number U039726, expiration date was reported and validated as 15-DEC-2023) as prophylaxis (product administered to patient of inappropriate age), that undergone a temperature excursion (product storage error). No additional adverse event reported.  The vaccine experienced a temperature excursion of minus (-) 11.8 degrees Celsius (C) for 1 hour and 45 minutes. There was a previous temperature excursion.; Sender's Comments:  US-009507513-2210USA001062: US-009507513-2210USA000872:MSD
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No addittional AE; Customer called for a temperature excursion in case 02261220. Caller reported that VARIVAX that had undergone temperature; was administered to a patient on 08-SEP-2022; This spontaneous report was received from a registered nurse, referring to a 6-day-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 08-SEP-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number U039726, expiration date was reported and validated as 15-DEC-2023) as prophylaxis (product administered to patient of inappropriate age), that undergone a temperature excursion (product storage error). No additional adverse event reported.  The vaccine experienced a temperature excursion of minus (-) 11.8 degrees Celsius (C) for 1 hour and 45 minutes. There was a previous temperature excursion.; Sender's Comments:  US-009507513-2210USA001062: US-009507513-2210USA000872:MSD
Age: 1.0
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer called for a temperature excursion in case 02261220. Caller reported that VARIVAX that had undergone temperature; Inappropriate age at vaccine administration; This spontaneous report was received from a registered nurse, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 16-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number U039726, expiration date was reported and validated as 15-DEC-2023) as prophylaxis, that undergone a temperature excursion (product storage error and product administered to patient of inappropriate age). No additional adverse event reported.  The vaccine experienced a temperature excursion of minus (-) 11.8 degrees Celsius (C) for 1 hour and 45 minutes. There was a previous temperature excursion.; Sender's Comments:  US-009507513-2210USA001062: US-009507513-2210USA000872:
Age: 1.0
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE; Customer called for a temperature excursion in case 02261220. Caller reported that VARIVAX that had undergone temperature; Inappropriate age at vaccine administration; This spontaneous report was received from a registered nurse, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 16-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number U039726, expiration date was reported and validated as 15-DEC-2023) as prophylaxis, that undergone a temperature excursion (product storage error and product administered to patient of inappropriate age). No additional adverse event reported.  The vaccine experienced a temperature excursion of minus (-) 11.8 degrees Celsius (C) for 1 hour and 45 minutes. There was a previous temperature excursion.; Sender's Comments:  US-009507513-2210USA001062: US-009507513-2210USA000872:
Age: 9.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Fatigue, Injection site pain, Injection site swelling, Irritability, Product preparation issue
Clinical narrative: pfizer pediatric Dose was administered without first adding diluent to vaccine - resulting in a higher dose than advised
Age: 9.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: pfizer pediatric Dose was administered without first adding diluent to vaccine - resulting in a higher dose than advised
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired dose of PNEUMOVAX 23 was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number T040202 with expiration date 11-SEP-2022 (dosage, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse events (AEs) reported.  Follow up information has been received from pharmacist office concerning to a 74-yearl-old female patient with no known drug allergies. Patient's concurrent conditions included heart disease and hyperlipidemia.  On 19-SEP-2022, the patient was vaccinated with an expired first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscularly, 0.5 milliliter, in the left deltoid. This error occurred during product storage in clinical practice. Concomitant therapies included acetylsalicylic acid (ASPIRINE) and atorvastatin.  The patient was notified of the expired vaccine that she received. The patient decided no to return for revaccination.  This case was previously considered non- valid due to lack of patient's identifiers but per current process it was determined to be valid.
Sex: U
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Customer reports the administration of 2 doses of PNEUMOVAX 23 to a Patient/ Nurse confirms both doses were 0.5mL. The first dose was administered 9/13/2022 and the second was administered 9/29/2022.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies, drug reactions or allergies were not reported.  On 13-SEP-2022, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter (lot number U032086 had been verified to be a valid number; expiration date reported and established as: 29-AUG-2023). In addition, on 29-SEP-2022 (also reported as between a 2-week period), the patient received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with the same lot number, both administered as prophylaxis (strengths, vaccination schemes, route of administration and anatomical location were not provided) (inappropriate schedule of product administration). No additional adverse event (AE) was reported.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller did not report any side effects or adverse reactions; her daughter received expired GARDASIL 9 on 14OCT2022; This spontaneous report was received from the patient's mother and refers to a 13-year-old female patient. The patient's medical history, concurrent conditions, or concomitant therapies were not reported.  On 14-OCT-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, which had already expired (lot #T008101, expiration date: 01-MAY-2022,) as prophylaxis (strength, and route of administration were not provided). The patient did not experience any side effects or adverse reactions.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid on 15Oct2022 and started Paxlovid treatment; tested positive for Covid on 15Oct2022 and started Paxlovid treatment; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Oct2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6200), on 19Mar2021 as dose 2, single (Lot number: ER2613), on 13Oct2021 as dose 3 (booster), single (Lot number: 30155BA) and on 21Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "unknown" and all described as "tested positive for Covid on 15Oct2022 and started Paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Phone answered by the reporter who confirmed he has had a total of 4 Pfizer Covid-19 vaccine doses. Reporter also confirmed he did not experience any adverse events with any of the 4 Pfizer Covid-19 vaccine doses. Reporter stated he tested positive for Covid on 15Oct2022 and started Paxlovid treatment on 16Oct2022 and completed Paxlovid treatment on 20Oct2022.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: pretty bad high fever; chills; really not well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, (the other three shot she got pretty bad high fever, chills, really not well.)), for Covid-19 immunization, reaction(s): "Chills", "really not well", "pretty bad high fever"; Bnt162b2 (DOSE 1, SINGLE, (the first one she was semi-okay with it)), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "pretty bad high fever"; CHILLS (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "really not well".  Additional information: The patient had 4 shots, the first one she was semi-okay with it but the other three shot she got pretty bad high fever, chills, really not well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201252978 same product, patient, different AEs, different dose;
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Magnetic resonance imaging, Pain in extremity, SARS-CoV-2 test, Tissue injury
Clinical narrative: I had extreme pain in my left arm/ very hard time lifting her arm up; He said that I had inflammation from the vaccine; it caused the tissue to rub on bone spurs.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: Ew0164) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; DHA; LUTEIN. The following information was reported: INFLAMMATION (non-serious) with onset 15Apr2021, outcome "recovered with sequelae", described as "He said that I had inflammation from the vaccine"; PAIN IN EXTREMITY (non-serious) with onset 15Apr2021, outcome "recovered with sequelae", described as "I had extreme pain in my left arm/ very hard time lifting her arm up"; TISSUE INJURY (non-serious) with onset 15Apr2021, outcome "recovered with sequelae", described as "it caused the tissue to rub on bone spurs.". The events "i had extreme pain in my left arm/ very hard time lifting her arm up", "he said that i had inflammation from the vaccine" and "it caused the tissue to rub on bone spurs." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, inflammation, tissue injury.  Additional information: Patient had extreme pain in her left arm from first shot. she had a very hard time lifting her arm up. After waiting for 4 months she went to go see an orthopedist who did X-rays and a MRI. He said that she had inflammation from the vaccine and it caused the tissue to rub on bone spurs. He did a cortisone injection. That helped her a lot. patient still have pain in her left arm though. No other vaccine in four weeks, Other medications in two weeks was Birth control, multi-vitamin, Calcium, DHA, luetin, no covid prior vaccination, post vaccination tested for covid (Nasal Swab). Patient administered dose 2 of Pfizer on 30Aug2021, Lot number Fc3182, dose 3 of Pfizer on 16Dec2021, Lot number Fe3594.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: I had extreme pain in my left arm/ very hard time lifting her arm up; He said that I had inflammation from the vaccine; it caused the tissue to rub on bone spurs.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: Ew0164) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; DHA; LUTEIN. The following information was reported: INFLAMMATION (non-serious) with onset 15Apr2021, outcome "recovered with sequelae", described as "He said that I had inflammation from the vaccine"; PAIN IN EXTREMITY (non-serious) with onset 15Apr2021, outcome "recovered with sequelae", described as "I had extreme pain in my left arm/ very hard time lifting her arm up"; TISSUE INJURY (non-serious) with onset 15Apr2021, outcome "recovered with sequelae", described as "it caused the tissue to rub on bone spurs.". The events "i had extreme pain in my left arm/ very hard time lifting her arm up", "he said that i had inflammation from the vaccine" and "it caused the tissue to rub on bone spurs." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, inflammation, tissue injury.  Additional information: Patient had extreme pain in her left arm from first shot. she had a very hard time lifting her arm up. After waiting for 4 months she went to go see an orthopedist who did X-rays and a MRI. He said that she had inflammation from the vaccine and it caused the tissue to rub on bone spurs. He did a cortisone injection. That helped her a lot. patient still have pain in her left arm though. No other vaccine in four weeks, Other medications in two weeks was Birth control, multi-vitamin, Calcium, DHA, luetin, no covid prior vaccination, post vaccination tested for covid (Nasal Swab). Patient administered dose 2 of Pfizer on 30Aug2021, Lot number Fc3182, dose 3 of Pfizer on 16Dec2021, Lot number Fe3594.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Lymph node pain, Lymphadenopathy, Menstruation irregular
Clinical narrative: Two large swollen glands at left clavicle, one very sore; Two large swollen glands at left clavicle, one very sore; Breakthrough bleeding 7 days before period; Then very heavy period 5 days earlier than predicted period start; Then very heavy period 5 days earlier than predicted period start; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 15:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Jan2022 (unspecified if ongoing), notes: Had Covid in Jan. 2022. Concomitant medication(s) included: SERTRALINE; KRILL OIL; VIT D [VITAMIN D NOS]. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 18Oct2022 at 17:00, outcome "recovering", described as "Breakthrough bleeding 7 days before period"; MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 18Oct2022 at 17:00, outcome "recovering" and all described as "Then very heavy period 5 days earlier than predicted period start"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 18Oct2022 at 17:00, outcome "recovering" and all described as "Two large swollen glands at left clavicle, one very sore". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, intermenstrual bleeding, menstruation irregular, heavy menstrual bleeding.  Additional information: Two large swollen glands at left clavicle. One very sore. Breakthrough bleeding 7 days before period Then very heavy period 5 days earlier than predicted period start. The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Heart rate, Heart rate increased
Clinical narrative: HR to 104; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset Oct2022, outcome "recovered"; HEART RATE INCREASED (non-serious) with onset Oct2022, outcome "recovered", described as "HR to 104". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, chills.  Additional information: The patient had no other vaccine in four weeks; no other medication in two weeks. The patient had no COVID prior vaccination. COVID was not tested post vaccination. Adverse events did not result in physician office visit or emergency room visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Amaurosis fugax, Transient ischaemic attack
Clinical narrative: Patient experienced a Transient Ischemic Attack approximately 4 weeks after the second shot; Lost sight in 1 eye for about 5 minutes during the attact; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 57-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Lot number: ER8734) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Ehlers Danlos Syndrome" (unspecified if ongoing); "Leidens Factor V" (unspecified if ongoing).  Patient had no known allergies. The patient took concomitant medications. Patient did not receive other vaccine in four weeks but had other unspecified medciations (concomitant drug) in two weeks. Vaccination history included: BNT162b2 (Dose 1, Pfizer, lot number ER8734, vaccine location Right arm), administration date: 23Mar2021, when the patient was 56-year-old, for COVID-19 Immunization. The following information was reported: AMAUROSIS FUGAX (medically significant) with onset 13May2021 at 14:30, outcome "recovered", described as "Lost sight in 1 eye for about 5 minutes during the attact"; TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 13May2021 at 14:30, outcome "recovered", described as "Patient experienced a Transient Ischemic Attack approximately 4 weeks after the second shot". The events "patient experienced a transient ischemic attack approximately 4 weeks after the second shot" and "lost sight in 1 eye for about 5 minutes during the attact" required physician office visit. First patient was visit to Optometrist. Then patient was seen by primary care, neurologist, and cardiologist. Therapeutic measures were taken as a result of transient ischaemic attack, amaurosis fugax.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Swollen lymph glands in both armpits; Pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2022 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 (non-serious) with onset Sep2022, outcome "not recovered"; LYMPHADENOPATHY (non-serious) with onset Sep2022, outcome "not recovered", described as "Swollen lymph glands in both armpits". The events "swollen lymph glands in both armpits" and "pain" required physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, pain. Additional information: It now has been over 6 weeks an the pain was still intense, got worse in the morning. Patient did not have COVID-19 or COVID-19 test positive prior vaccination. Patient did not have any known allergies.  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: Feeling abnormal, Headache
Clinical narrative: (My symptoms the same for that episode and current one.) Still had mild intermittent headache; (My symptoms the same for that episode and current one.) Still had mild intermittent headache, brain fog from first episode; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "allergic rhinitis" (unspecified if ongoing); "GERD (with h/o gastric ulcer)" (unspecified if ongoing); "GERD (with h/o gastric ulcer)" (unspecified if ongoing); "remote h/o asthma" (unspecified if ongoing); "remote h/o alopecia" (unspecified if ongoing); "h/o depression" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE, start date: Jan1990, stop date: 25Oct2022; MONTELUKAST, start date: Jan2000, stop date: 25Oct2022; PANTOPRAZOLE, start date: Apr2019, stop date: 25Oct2022; FISH OIL, start date: Jan2010, stop date: 25Oct2022; PROBIOTICS, start date: Jan2015, stop date: 25Oct2022; LEXAPRO, stop date: 06Oct2022. Past drug history included: Wellbutrin, reaction(s): "drug allergy". Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF2588), administration date: 03Oct2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9261), administration date: 08Feb2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE; Lot number: FL3249), administration date: 18Jan2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "(My symptoms the same for that episode and current one.) Still had mild intermittent headache"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "(My symptoms the same for that episode and current one.) Still had mild intermittent headache, brain fog from first episode". Therapeutic measures were taken as a result of headache, feeling abnormal.  Additional information: the patient was on Lexapro for 25 years.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Red mark, size of a quarter, on her arm; for over a year; Itchy; drives her insane; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), on 03Jan2021 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: ERYTHEMA (non-serious), outcome "not recovered", described as "Red mark, size of a quarter, on her arm; for over a year"; PRURITUS (non-serious), outcome "not recovered", described as "Itchy; drives her insane".  Additional information: Received her first Pfizer Covid 19 vaccine on 03Jan2021. Caller states since then, she has had a red mark, size of a quarter, on her arm later states, as itchy. Caller states it is now 2022 and it is still on her arm, it is itchy, and drives her insane. Specifically still itchy and red for over a year?  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, COVID-19, Drug ineffective, Investigation, Liver function test
Clinical narrative: feeling ill; Positive 2 days later; Positive 2 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Lyme disease" (unspecified if ongoing); "stones" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing), notes: her husband is immunocompromised (Intent: history). Concomitant medication(s) included: METFORMIN; METOPROLOL; GLIPIZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Sep2022, outcome "unknown" and all described as "Positive 2 days later"; MALAISE (non-serious), outcome "unknown", described as "feeling ill". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: (unspecified date) antibodies were raised; Lab work: (unspecified date) all great, notes: He had Liver function, Metabolic panel, CVP stuff like that. His antibodies were raised for his ANA that was the only thing and his liver enzymes were raised but they are all great (As the results of Lab test was not available over the call hence, tab left unchecked); Liver function test: (unspecified date) raised but they are all great; Metabolic function test: (unspecified date) all great; SARS-CoV-2 test: (12Sep2022) Positive, notes: He received the vaccine on 10Sep then he tested positive on 12Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19.For Covid patient took Paxlovid.  Product Quality Group provided investigational results on 26Oct2022 for BNT162b2, BNT162b2 omi ba.4-5 included Conclusion of Previously Completed Investigation: The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Company (Name) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The company process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Metabolic function test, SARS-CoV-2 test
Clinical narrative: feeling ill; Positive 2 days later; Positive 2 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Lyme disease" (unspecified if ongoing); "stones" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing), notes: her husband is immunocompromised (Intent: history). Concomitant medication(s) included: METFORMIN; METOPROLOL; GLIPIZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Sep2022, outcome "unknown" and all described as "Positive 2 days later"; MALAISE (non-serious), outcome "unknown", described as "feeling ill". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: (unspecified date) antibodies were raised; Lab work: (unspecified date) all great, notes: He had Liver function, Metabolic panel, CVP stuff like that. His antibodies were raised for his ANA that was the only thing and his liver enzymes were raised but they are all great (As the results of Lab test was not available over the call hence, tab left unchecked); Liver function test: (unspecified date) raised but they are all great; Metabolic function test: (unspecified date) all great; SARS-CoV-2 test: (12Sep2022) Positive, notes: He received the vaccine on 10Sep then he tested positive on 12Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19.For Covid patient took Paxlovid.  Product Quality Group provided investigational results on 26Oct2022 for BNT162b2, BNT162b2 omi ba.4-5 included Conclusion of Previously Completed Investigation: The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Company (Name) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The company process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Glycosylated haemoglobin
Clinical narrative: blood sugar was averaging 200 or even up to 300 after a vaccine or booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 09Jul2021 as dose 1, single (Lot number: EW0191) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Severe Osteoporosis", start date: 2020 (unspecified if ongoing), notes: Onset Date: Severe Osteoporosis 2020-2021; "She is type 2 diabetic", start date:  (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. Vaccination history included: Flu shot. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset Jul2021, outcome "unknown", described as "blood sugar was averaging 200 or even up to 300 after a vaccine or booster". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that each time patient had a Pfizer COVID 19 vaccine or booster, she always had high blood sugars. Patient stated her blood sugar was averaging 200 or even up to 300 after a vaccine or booster. She did not have a lack of appetite and was on a low card diet to control her diabetes noting that she does not use insulin. Patient stated prior to any vaccine, her A1C went from 9 to 6.6 to 6.4 and she was doing so well her HCP cut her glipizide dose in half. After the vaccine she had to go back to her regular dose. Stated it took a while for her blood sugar to go where it usually is. Patient provided the information that she had 2 vaccines that first came out and 1 booster shortly after. Even though she took her normal dose of Glipizide 10mg twice a day, she was on 5mg, she did not tell her doctor she upped it, and it really is not helping. It is not making it come down. She is type 2 diabetic. It would go to 60 before. Further reported that when she would get each vaccine and her blood sugar would take a good 3 months before it came down, and then she would get the next one. It was bad and would get better in between. Final outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hand dermatitis
Clinical narrative: massive explosion of eczema on my hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 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: HAND DERMATITIS (non-serious), outcome "unknown", described as "massive explosion of eczema on my hand".  Additional information: The patient got massive explosion of eczema on hand from the Pfizer vaccine (Covid 19 vaccine) and Pfizer has admitted that this is the side effect of the vaccine and hands are just exploding.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 10Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "a-fib" (unspecified if ongoing); "Known allergies: water pills" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2022) Negative, notes: testing negative; (24Oct2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: eh9989), on 06Jan2021 as dose 2, single (Lot number: el3246) and on 14Aug2021 as dose 3 (booster), single (Lot number: 088D21A) at the age of 43 years for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), from 08Mar2022 (Batch/Lot number: unknown) to 08Mar2022 at single (unk, single). The patient's relevant medical history included: "Common Variable Immune Deficiency (CVID)" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive with slight sore throat/runny nose. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 16Oct2022 to 20Oct2022.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Vaccination failure and Covid-19  cannot be completely excluded.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: Positive COVID infection; Positive COVID infection; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 17:00 as dose 5 (booster), single (Lot number: Gh9693) at the age of 59 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 20Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 18Oct2022, outcome "not recovered", described as "Positive COVID infection"; DRUG INEFFECTIVE (medically significant) with onset 18Oct2022, outcome "not recovered", described as "Positive COVID infection ". The events "positive covid infection " and "positive covid infection" required physician office visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (18Oct2022) Positive, notes: Nasal Swab covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.