chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Day of - chills, shakes, fever, sweats, body aches, headaches, difficulty breathing, insomnia Day 2 - same symptoms increased + cough, lost voice, lost appetite, nausea Day 3 - shakes, body aches, headaches, difficulty breathing, insomnia, lost appetite, nausea Day 4 - shakes, body aches, nausea, some difficulty breathing  Moving forward - randomized moments of pain, shaking, nausea, headaches. By Jan 2022 I began experiencing seizures and pain which worsened, went through a variety of testing  and hospitalization through Feb and was officially diagnosed with Epilepsy and fibromyalgia (no prior instances or genetic history) . I?m currently in pain management treatment, it?s unknown if anything COVID related like the vaccine directly caused or increased symptoms. I had a similar reaction to my first 2 as well.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Bedridden, COVID-19
Clinical narrative: DEVELOPED COVID 7-4-2022. SCRATCHY THROAT FEVER VARIABLE FOR 2 DAYS 100.3 DEGREES TO 103 DEGREES WEAKNESS, MALAISE BED-RIDDEN 2 DAYS OUT OF WORK FOR 8 DAYS ALSO LOSS OF SMELL & TASTE. SMELL & TASTE STILL  DIMINISHED AS OF 10-5-2022
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise, Pyrexia, SARS-CoV-2 test, Throat irritation
Clinical narrative: DEVELOPED COVID 7-4-2022. SCRATCHY THROAT FEVER VARIABLE FOR 2 DAYS 100.3 DEGREES TO 103 DEGREES WEAKNESS, MALAISE BED-RIDDEN 2 DAYS OUT OF WORK FOR 8 DAYS ALSO LOSS OF SMELL & TASTE. SMELL & TASTE STILL  DIMINISHED AS OF 10-5-2022
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Injection site pain, Mobility decreased, Urticaria
Clinical narrative: Reports Right shoulder pain Then pain in knees, ankles, hives Hip weakness Hard to get out of bed in AM
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke 4 days after shot
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Limb mass, Mammogram normal, Pain in extremity, Peripheral swelling
Clinical narrative: 13/09/21 First dose given (L) arm. 2 weeks later I noticed a lump under my (L) arm. Soft non painful. Doctor ordered Mamogram and ultrasound. (-) results. 2 weeks later same arm my hand swelled looked like a boxing glove. given steroids. Checked for gout with lab. (-) results. I still have the lump under my (L) arm. The swelling in the hand went down. Still have pain in (L) thumb. 2 mamogram (-)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan normal
Clinical narrative: 13/09/21 First dose given (L) arm. 2 weeks later I noticed a lump under my (L) arm. Soft non painful. Doctor ordered Mamogram and ultrasound. (-) results. 2 weeks later same arm my hand swelled looked like a boxing glove. given steroids. Checked for gout with lab. (-) results. I still have the lump under my (L) arm. The swelling in the hand went down. Still have pain in (L) thumb. 2 mamogram (-)
Sex: U
Vaccine: DTPPVHBHPB, PNC13, RV5, RV5
Symptoms: Unevaluable event
Clinical narrative: No additional AE reported.; an expired dose of ROTATEQ was administered to the patient on 6SEP2022; This spontaneous report was received from a registered nurse (R.N.), concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant medications were unknown.  On 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, lot #1741381, expiration date 04-SEP-2022, administered orally for prophylaxis (expired product administered). The patient did not experience any adverse event.  The reporter stated that the vaccine had not been involved in a temperature excursion through the date of administration. No additional information provided.
Sex: U
Vaccine: DTPPVHBHPB, PNC13, RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; an expired dose of ROTATEQ was administered to the patient on 6SEP2022; This spontaneous report was received from a registered nurse (R.N.), concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant medications were unknown.  On 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, lot #1741381, expiration date 04-SEP-2022, administered orally for prophylaxis (expired product administered). The patient did not experience any adverse event.  The reporter stated that the vaccine had not been involved in a temperature excursion through the date of administration. No additional information provided.
Sex: U
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, RV5
Symptoms: Expired product administered
Clinical narrative: No additional adverse event; an expired dose of ROTATEQ was administered to the patient; This spontaneous report was received from a registered nurse (R.N.), concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant medications were unknown.  On 16-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, lot #1741381, expiration date 04-SEP-2022, administered orally for prophylaxis (expired product administered). The patient did not experience any adverse event.  The reporter stated that the vaccine had not been involved in a temperature excursion through the date of administration. No additional information provided.
Sex: U
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; an expired dose of ROTATEQ was administered to the patient; This spontaneous report was received from a registered nurse (R.N.), concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant medications were unknown.  On 16-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, lot #1741381, expiration date 04-SEP-2022, administered orally for prophylaxis (expired product administered). The patient did not experience any adverse event.  The reporter stated that the vaccine had not been involved in a temperature excursion through the date of administration. No additional information provided.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: get a shooting pain on the outside of my lower left leg; It was very painful and on the same side I got my booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 19:15 as dose 4 (booster), single (Lot number: gh9694) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Known allergies: seasonal allergies to pollen and ragweed" (unspecified if ongoing); "Known allergies: seasonal allergies to pollen and ragweed" (unspecified if ongoing); "Known allergies: seasonal allergies to pollen and ragweed" (unspecified if ongoing); "Known allergies: allergic to cats, roaches and dustmites" (unspecified if ongoing); "Known allergies: allergic to cats, roaches and dustmites" (unspecified if ongoing); "Known allergies: allergic to cats, roaches and dustmites" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: had covid prior vaccination. Concomitant medication(s) included: JUNEL oral taken for oral contraception. Vaccination history included: Covid-19 vaccine (Dose: 3 (1st booster), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization Series Complete. Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Sep2022 at 22:00, outcome "recovered", described as "It was very painful and on the same side I got my booster shot"; PAIN IN EXTREMITY (non-serious) with onset 15Sep2022 at 22:00, outcome "recovered", described as "get a shooting pain on the outside of my lower left leg". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, vaccination site pain. Additional information: The patient had no other vaccine in four weeks. The last booster shot of the patient was on 15Sep2022 and caused her to get a shooting pain on the outside of her lower left leg that came and went. It was very painful and on the same side she got her booster shot, left side. It seemed to happen randomly and started the same night she got the booster but then started to happen more frequently the next day. At one point, she was having them every 2-3 minutes. It was terrible. She took pain killers for about 24 hours, and it finally went away.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: get a shooting pain on the outside of my lower left leg; It was very painful and on the same side I got my booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 19:15 as dose 4 (booster), single (Lot number: gh9694) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Known allergies: seasonal allergies to pollen and ragweed" (unspecified if ongoing); "Known allergies: seasonal allergies to pollen and ragweed" (unspecified if ongoing); "Known allergies: seasonal allergies to pollen and ragweed" (unspecified if ongoing); "Known allergies: allergic to cats, roaches and dustmites" (unspecified if ongoing); "Known allergies: allergic to cats, roaches and dustmites" (unspecified if ongoing); "Known allergies: allergic to cats, roaches and dustmites" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: had covid prior vaccination. Concomitant medication(s) included: JUNEL oral taken for oral contraception. Vaccination history included: Covid-19 vaccine (Dose: 3 (1st booster), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization Series Complete. Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Sep2022 at 22:00, outcome "recovered", described as "It was very painful and on the same side I got my booster shot"; PAIN IN EXTREMITY (non-serious) with onset 15Sep2022 at 22:00, outcome "recovered", described as "get a shooting pain on the outside of my lower left leg". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, vaccination site pain. Additional information: The patient had no other vaccine in four weeks. The last booster shot of the patient was on 15Sep2022 and caused her to get a shooting pain on the outside of her lower left leg that came and went. It was very painful and on the same side she got her booster shot, left side. It seemed to happen randomly and started the same night she got the booster but then started to happen more frequently the next day. At one point, she was having them every 2-3 minutes. It was terrible. She took pain killers for about 24 hours, and it finally went away.
Age: 13.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given bivalent booster instead of the monovalent to start her COVID series
Age: 13.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given bivalent booster instead of the monovalent to start her COVID series
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42-year-old male patient received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "monkey pox" (unspecified if ongoing), notes: Got in this Jun and had monkey pox and felt like getting better after 3 weeks; "COVID", start date: Jan2020 (unspecified if ongoing), notes: tested positive once and the first time was Jan2020; "COVID", start date: Apr2020 (unspecified if ongoing), notes: They got delta in late Apr2020 and not yet vaccinated.; "Hydrocele like a build of lymphatic fluid in the scrotum" (unspecified if ongoing), notes: Hydrocele like a build of lymphatic fluid in the scrotum; "Covid-19" (unspecified if ongoing), notes: They had covid several times; "Long covid" (unspecified if ongoing), notes: she had long Covid and lost sense of smell and all the symptoms with the first round of Covid. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; MELATONIN; PEPCID [FAMOTIDINE]; REISHI MUSHROOM; TURKEY TAIL MUSHROOM; VITAMIN C [ASCORBIC ACID]; MAGNESIUM. Vaccination history included: BNT162b2 (Lot: EW0175), administration date: 27Apr2021, when the patient was 40-year-old, for COVID-19 Immunization; BNT162b2 (Lot: EW0183), administration date: 19May2021, when the patient was 41-year-old, for COVID-19 Immunization.  The following information was reported: INFLAMMATION (non-serious), outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201204867 similar report from same reporter.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Inflammation, SARS-CoV-2 test
Clinical narrative: inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42-year-old male patient received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "monkey pox" (unspecified if ongoing), notes: Got in this Jun and had monkey pox and felt like getting better after 3 weeks; "COVID", start date: Jan2020 (unspecified if ongoing), notes: tested positive once and the first time was Jan2020; "COVID", start date: Apr2020 (unspecified if ongoing), notes: They got delta in late Apr2020 and not yet vaccinated.; "Hydrocele like a build of lymphatic fluid in the scrotum" (unspecified if ongoing), notes: Hydrocele like a build of lymphatic fluid in the scrotum; "Covid-19" (unspecified if ongoing), notes: They had covid several times; "Long covid" (unspecified if ongoing), notes: she had long Covid and lost sense of smell and all the symptoms with the first round of Covid. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; MELATONIN; PEPCID [FAMOTIDINE]; REISHI MUSHROOM; TURKEY TAIL MUSHROOM; VITAMIN C [ASCORBIC ACID]; MAGNESIUM. Vaccination history included: BNT162b2 (Lot: EW0175), administration date: 27Apr2021, when the patient was 40-year-old, for COVID-19 Immunization; BNT162b2 (Lot: EW0183), administration date: 19May2021, when the patient was 41-year-old, for COVID-19 Immunization.  The following information was reported: INFLAMMATION (non-serious), outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201204867 similar report from same reporter.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight
Clinical narrative: She had some Eczema breakout before the COVID 30Sep2021 vaccine/she broke out again; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: EN0176) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sinus problems" (unspecified if ongoing), notes: She had sinus problems and was negative at home; "seasonal allergies" (unspecified if ongoing), notes: She can be susceptible to seasonal allergies.; "allergy" (unspecified if ongoing), notes: First 10 yrs in (city name withheld) had weekly allergy shot and finally got immune built up to it.; "pituitary cyst" (unspecified if ongoing), notes: She has pituitary cyst found accidentally, discovered contrast dye to do MRI is bad on her kidney.; "kidney problems" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "contrast dye MRI is bad on her kidney" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (2nd dose  Lot EN6205, expiration is unknown. Injected in left arm.), administration date: 06Mar2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "Eczema break out"; BNT162b2 (1st dose Lot EN6201, expiration is unk. Injected in Unk arm. She thinks it was right arm because she is left handed.), administration date: 13Feb2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "sore arm", "felt tired"; Shingles (She did the Shingles and the Flu.), for Immunization; Flu (She did the Shingles and the Flu.), for Immunization; Shingles (She did the Shingles and the Flu. Last fall Sep2021, did one flu shot after that Pfizer COVID 19 vaccine.), administration date: Sep2021, when the patient was 71 years old, for Immunization. The following information was reported: ECZEMA (medically significant) with onset 2021, outcome "unknown", described as "She had some Eczema breakout before the COVID 30Sep2021 vaccine/she broke out again". She had some Eczema breakout before the COVID 30Sep2021 vaccine. She got a shot of steroids for that and again 6 weeks later because she broke out again (2021) and did a patch test 31Jan2022, where she went on Monday, Wednesday and Friday. The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) Little less than 5'2"; Physical: (unspecified date) 100, notes: Sudden increase of Vitamin D. It was a little over 100 and usually they are trying to work on it; Magnetic resonance imaging: (unspecified date) bad on her kidney, notes: MRI is bad on her kidney; Skin test: (31Jan2022) Unknwon results, notes: did a patch test 31Jan2022; Weight: (unspecified date) 118-119 lbs. Therapeutic measures were taken as a result of eczema.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200078665 same patient/drug different dose;US-PFIZER INC-PV202200078664 same patient/drug different dose;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Overdose, Parosmia, Product use issue
Clinical narrative: 14 hours after receiving the vaccine I had the chills and an extreme head ache; an extreme head ache; Bad enough I was unable to sleep.; When I woke up the coffee I was making smelled different.; Other vaccine same date details: dose number=1, lot number ER8727; dose number=2, lot number EW0158; dose number=3, lot number FF2587; Other vaccine same date details: dose number=1, lot number ER8727; dose number=2, lot number EW0158; dose number=3, lot number FF2587; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 10:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Oct2022, outcome "unknown" and all described as "Other vaccine same date details: dose number=1, lot number ER8727; dose number=2, lot number EW0158; dose number=3, lot number FF2587"; CHILLS (non-serious) with onset 11Oct2022 at 01:00, outcome "recovering", described as "14 hours after receiving the vaccine I had the chills and an extreme head ache"; SLEEP DISORDER (non-serious) with onset 11Oct2022 at 01:00, outcome "recovering", described as "Bad enough I was unable to sleep."; PAROSMIA (non-serious) with onset 11Oct2022 at 01:00, outcome "recovering", described as "When I woke up the coffee I was making smelled different."; HEADACHE (non-serious) with onset 11Oct2022 at 01:00, outcome "recovering", described as "an extreme head ache". Therapeutic measures were not taken as a result of chills, headache, sleep disorder, parosmia.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: 14 hours after receiving the vaccine I had the chills and an extreme head ache; an extreme head ache; Bad enough I was unable to sleep.; When I woke up the coffee I was making smelled different.; Other vaccine same date details: dose number=1, lot number ER8727; dose number=2, lot number EW0158; dose number=3, lot number FF2587; Other vaccine same date details: dose number=1, lot number ER8727; dose number=2, lot number EW0158; dose number=3, lot number FF2587; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 10:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Oct2022, outcome "unknown" and all described as "Other vaccine same date details: dose number=1, lot number ER8727; dose number=2, lot number EW0158; dose number=3, lot number FF2587"; CHILLS (non-serious) with onset 11Oct2022 at 01:00, outcome "recovering", described as "14 hours after receiving the vaccine I had the chills and an extreme head ache"; SLEEP DISORDER (non-serious) with onset 11Oct2022 at 01:00, outcome "recovering", described as "Bad enough I was unable to sleep."; PAROSMIA (non-serious) with onset 11Oct2022 at 01:00, outcome "recovering", described as "When I woke up the coffee I was making smelled different."; HEADACHE (non-serious) with onset 11Oct2022 at 01:00, outcome "recovering", described as "an extreme head ache". Therapeutic measures were not taken as a result of chills, headache, sleep disorder, parosmia.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Computerised tomogram, Magnetic resonance imaging, Neck pain, Stenosis
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 (around 11 am) as dose 1, single (Lot number: 9L3302), in left arm, on 04Apr2021 (around noon) as dose 2, single (Lot number: EN6201), in right arm, on 09Sep2021 as dose 3 (booster), single (Lot number: EW0191), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: He takes a small blood pressure pill every am called amlodipine 10 mg by mouth every morning.; "nonsmoker" (unspecified if ongoing), notes: he is very healthily and nonsmoker and runs 2 to 3 miles a day,No diabetes. Concomitant medication(s) included: AMLODIPINE oral taken for blood pressure measurement. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Positive, notes: He tested positive for Covid on the 10th.  Clinical course: No vaccines administered on same date with the Pfizer vaccine considered as suspect reported. Emergency Room visit and Physician Office visit reported as No. No prior Vaccinations (within 4 weeks). Adverse events following prior vaccinations reported as None. Nothing and he is very healthily and nonsmoker and nondrinker and ran 2 to 3 miles a day and he takes a small blood pressure pill every am called amlodipine 10 mg by mouth every morning. No diabetes and no nothing and he was blessed to be healthy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225557 SAME PATIENT / DRUG AND DIFFERENT EVENT;
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 (around 11 am) as dose 1, single (Lot number: 9L3302), in left arm, on 04Apr2021 (around noon) as dose 2, single (Lot number: EN6201), in right arm, on 09Sep2021 as dose 3 (booster), single (Lot number: EW0191), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: He takes a small blood pressure pill every am called amlodipine 10 mg by mouth every morning.; "nonsmoker" (unspecified if ongoing), notes: he is very healthily and nonsmoker and runs 2 to 3 miles a day,No diabetes. Concomitant medication(s) included: AMLODIPINE oral taken for blood pressure measurement. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Positive, notes: He tested positive for Covid on the 10th.  Clinical course: No vaccines administered on same date with the Pfizer vaccine considered as suspect reported. Emergency Room visit and Physician Office visit reported as No. No prior Vaccinations (within 4 weeks). Adverse events following prior vaccinations reported as None. Nothing and he is very healthily and nonsmoker and nondrinker and ran 2 to 3 miles a day and he takes a small blood pressure pill every am called amlodipine 10 mg by mouth every morning. No diabetes and no nothing and he was blessed to be healthy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225557 SAME PATIENT / DRUG AND DIFFERENT EVENT;
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 (around 11 am) as dose 1, single (Lot number: 9L3302), in left arm, on 04Apr2021 (around noon) as dose 2, single (Lot number: EN6201), in right arm, on 09Sep2021 as dose 3 (booster), single (Lot number: EW0191), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: He takes a small blood pressure pill every am called amlodipine 10 mg by mouth every morning.; "nonsmoker" (unspecified if ongoing), notes: he is very healthily and nonsmoker and runs 2 to 3 miles a day,No diabetes. Concomitant medication(s) included: AMLODIPINE oral taken for blood pressure measurement. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Positive, notes: He tested positive for Covid on the 10th.  Clinical course: No vaccines administered on same date with the Pfizer vaccine considered as suspect reported. Emergency Room visit and Physician Office visit reported as No. No prior Vaccinations (within 4 weeks). Adverse events following prior vaccinations reported as None. Nothing and he is very healthily and nonsmoker and nondrinker and ran 2 to 3 miles a day and he takes a small blood pressure pill every am called amlodipine 10 mg by mouth every morning. No diabetes and no nothing and he was blessed to be healthy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225557 SAME PATIENT / DRUG AND DIFFERENT EVENT;
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Moderna on 12Feb2021/Pfizer / BioNTech on 03Dec2021; Moderna on 12Feb2021/Pfizer / BioNTech on 03Dec2021; 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 male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 2 (initial pfizer dose), single (Lot number: FJ8762) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE; Lot Number: 030M20A; Anatomical Location : Arm Left), administration date: 12Feb2021, when the patient was 45-year-old, for Covid-19 Immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), OFF LABEL USE (non-serious) all with onset 03Dec2021, outcome "unknown" and all described as "Moderna on 12Feb2021/Pfizer / BioNTech on 03Dec2021". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: Moderna on 12Feb2021/Pfizer / BioNTech on 03Dec2021; Moderna on 12Feb2021/Pfizer / BioNTech on 03Dec2021; 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 male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 2 (initial pfizer dose), single (Lot number: FJ8762) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE; Lot Number: 030M20A; Anatomical Location : Arm Left), administration date: 12Feb2021, when the patient was 45-year-old, for Covid-19 Immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), OFF LABEL USE (non-serious) all with onset 03Dec2021, outcome "unknown" and all described as "Moderna on 12Feb2021/Pfizer / BioNTech on 03Dec2021". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: very bad allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID The reporter is the patient.  A 46-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "shellfish allergy" (unspecified if ongoing); "had 114 brain surgeries" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "very bad allergic reaction".  Additional information: Patient had a very bad allergic reaction to the Covid shot and was asking as she was told there will be a shot coming out that for them that have a shellfish allergy could have but all she have seen was booster shots. She asked if it meant it was bad for them. She have had 114 brain surgeries and now Covid twice and have been hospitalized. She was due to have another brain bolt in the next week.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: very bad allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID The reporter is the patient.  A 46-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "shellfish allergy" (unspecified if ongoing); "had 114 brain surgeries" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "very bad allergic reaction".  Additional information: Patient had a very bad allergic reaction to the Covid shot and was asking as she was told there will be a shot coming out that for them that have a shellfish allergy could have but all she have seen was booster shots. She asked if it meant it was bad for them. She have had 114 brain surgeries and now Covid twice and have been hospitalized. She was due to have another brain bolt in the next week.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; The patient thinks that she may have received a full dose instead of a half dose.; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (The patient thinks that she may have received a full dose instead of a half dose.) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (The patient thinks that she may have received a full dose instead of a half dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (The patient thinks that she may have received a full dose instead of a half dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided. The patient received her first Moderna Covid-19 vaccine on 11FEB2021 lot number 043L20A expiration date is not known. The patient received her second vaccine on 11MAR2022 lot number 012M20A Patient does not remember which arm she received the vaccine in. The patient received her first Moderna vaccine booster dose on 27OCT2021 lot number 039D21A expiration date is not known. Patient does not remember which arm she received the vaccine in.   This case was linked to MOD-2022-658743, MOD-2022-658750 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; The patient thinks that she may have received a full dose instead of a half dose.; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (The patient thinks that she may have received a full dose instead of a half dose.) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (The patient thinks that she may have received a full dose instead of a half dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (The patient thinks that she may have received a full dose instead of a half dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided. The patient received her first Moderna Covid-19 vaccine on 11FEB2021 lot number 043L20A expiration date is not known. The patient received her second vaccine on 11MAR2022 lot number 012M20A Patient does not remember which arm she received the vaccine in. The patient received her first Moderna vaccine booster dose on 27OCT2021 lot number 039D21A expiration date is not known. Patient does not remember which arm she received the vaccine in.   This case was linked to MOD-2022-658743, MOD-2022-658750 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: No adverse event; The patient thinks that she may have received a full dose instead of a half dose.; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (The patient thinks that she may have received a full dose instead of a half dose.) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (The patient thinks that she may have received a full dose instead of a half dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (The patient thinks that she may have received a full dose instead of a half dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided. The patient received her first Moderna Covid-19 vaccine on 11FEB2021 lot number 043L20A expiration date is not known. The patient received her second vaccine on 11MAR2022 lot number 012M20A Patient does not remember which arm she received the vaccine in. The patient received her first Moderna vaccine booster dose on 27OCT2021 lot number 039D21A expiration date is not known. Patient does not remember which arm she received the vaccine in.   This case was linked to MOD-2022-658743, MOD-2022-658750 (Patient Link).
Age: 64.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Chills, Dyspnoea, Dyspnoea exertional, Headache
Clinical narrative: pt states that later that day she started to have flu like symptoms....fever, chills, weakness, sniffles, rapid heartbeat that is being controlled by a pacemaker. Her arm also was extremely red and swollen and hot to the touch.  The pt presented to the pharmacy on 10/17/22 and spoke to myself the pharmacist and related all her symptoms and the fact that the most concerning adverse event is her rapid heart rate at which i was able to witness on her watch monitor raise from 110 to 128.  It has been 4 days and looking at her arm it is no longer as red or swollen as a few days ago but is still noticeably red and raised.  She also does not feel as weak or feverish but she did still have the sniffles.  Pt. at the time of talking to me had reached out to her internist and was heading home to contact her cardiologist to notify him and see what he thought she should do next.  I told her that I would report this reaction to the vaccine and asked her to do so as well and let me know how else we can help and gave her the lot number on her vaccine form.  She stated that she wanted to document that it was alright to give all her information and that she would like to be contacted.
Age: 64.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Heart rate increased, Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: pt states that later that day she started to have flu like symptoms....fever, chills, weakness, sniffles, rapid heartbeat that is being controlled by a pacemaker. Her arm also was extremely red and swollen and hot to the touch.  The pt presented to the pharmacy on 10/17/22 and spoke to myself the pharmacist and related all her symptoms and the fact that the most concerning adverse event is her rapid heart rate at which i was able to witness on her watch monitor raise from 110 to 128.  It has been 4 days and looking at her arm it is no longer as red or swollen as a few days ago but is still noticeably red and raised.  She also does not feel as weak or feverish but she did still have the sniffles.  Pt. at the time of talking to me had reached out to her internist and was heading home to contact her cardiologist to notify him and see what he thought she should do next.  I told her that I would report this reaction to the vaccine and asked her to do so as well and let me know how else we can help and gave her the lot number on her vaccine form.  She stated that she wanted to document that it was alright to give all her information and that she would like to be contacted.
Age: 64.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Chills, Erythema, Heart rate increased, Influenza like illness
Clinical narrative: pt states that later that day she started to have flu like symptoms....fever, chills, weakness, sniffles, rapid heartbeat that is being controlled by a pacemaker. Her arm also was extremely red and swollen and hot to the touch.  The pt presented to the pharmacy on 10/17/22 and spoke to myself the pharmacist and related all her symptoms and the fact that the most concerning adverse event is her rapid heart rate at which i was able to witness on her watch monitor raise from 110 to 128.  It has been 4 days and looking at her arm it is no longer as red or swollen as a few days ago but is still noticeably red and raised.  She also does not feel as weak or feverish but she did still have the sniffles.  Pt. at the time of talking to me had reached out to her internist and was heading home to contact her cardiologist to notify him and see what he thought she should do next.  I told her that I would report this reaction to the vaccine and asked her to do so as well and let me know how else we can help and gave her the lot number on her vaccine form.  She stated that she wanted to document that it was alright to give all her information and that she would like to be contacted.
Age: 64.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Peripheral swelling, Pyrexia, Rhinorrhoea, Skin warm
Clinical narrative: pt states that later that day she started to have flu like symptoms....fever, chills, weakness, sniffles, rapid heartbeat that is being controlled by a pacemaker. Her arm also was extremely red and swollen and hot to the touch.  The pt presented to the pharmacy on 10/17/22 and spoke to myself the pharmacist and related all her symptoms and the fact that the most concerning adverse event is her rapid heart rate at which i was able to witness on her watch monitor raise from 110 to 128.  It has been 4 days and looking at her arm it is no longer as red or swollen as a few days ago but is still noticeably red and raised.  She also does not feel as weak or feverish but she did still have the sniffles.  Pt. at the time of talking to me had reached out to her internist and was heading home to contact her cardiologist to notify him and see what he thought she should do next.  I told her that I would report this reaction to the vaccine and asked her to do so as well and let me know how else we can help and gave her the lot number on her vaccine form.  She stated that she wanted to document that it was alright to give all her information and that she would like to be contacted.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported ROTATEQ was administered to a patient after a temperature excursion. No further information provided. No additional AE reported. No PQC reported.  Name of vaccine involved (including lot/exp): ROTATEQ (W000381, Apr 13, 2023; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.  On 19-SEP-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered once, lot #W000381, expiration date: 13-APR-2023, (strength, dose and dose number were not provided) for prophylaxis (product storage error). The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion of 48.4 Fahrenheit (F) degrees for 2 hours. It was reported that previous temperature excursion for the suspect vaccine did not occurred. No additional adverse event (AE) was reported (no adverse event).