chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I am 15 years old, no side effects on the day of vaccination. Woke up in the middle of the night with fever and chills. Typical side effects occurred the following day (fever, fatigue, chills, headach; I am 15 years old, no side effects on the day of vaccination. Woke up in the middle of the night with fever and chills. Typical side effects occurred the following day (fever, fatigue, chills, headach; I am 15 years old, no side effects on the day of vaccination. Woke up in the middle of the night with fever and chills. Typical side effects occurred the following day (fever, fatigue, chills, headach; I am 15 years old, no side effects on the day of vaccination. Woke up in the middle of the night with fever and chills. Typical side effects occurred the following day (fever, fatigue, chills, headach; Throughout the day I experienced severe chest pain; At first I thought it may have been heartburn; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 15-years-old male patient received second dose of bnt162b2 (BNT162B2), Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 13Jun2021 at 15:00 (at the age of 15-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Facility type of vaccine was pharmacy or Drug Store. No, other vaccine in four weeks. None of other medications in two weeks. No, covid prior vaccination, no, covid tested post vaccination. No, known allergies. No, other medical history. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 23May2021 for COVID-19 immunisation. It was reported that on 14Jun2021 at 04:00, the patient experienced i am 15 years old, no side effects on the day of vaccination. woke up in the middle of the night with fever and chills. typical side effects occurred the following day (fever, fatigue, chills, headache, throughout the day patient experienced severe chest pain, at first patient thought it may have been heartburn. Therapeutic measures were taken as a result of, at first patient thought it may have been heartburn. Patient was 15 years old, no side effects on the day of vaccination. Woke up in the middle of the night with fever and chills. Typical side effects occurred the following day (fever, fatigue, chills, headache, etc) however throughout the day patient experienced severe chest pain. At first patient thought it may have been heartburn but after taking tums (antacid) the chest pain was not reduced in the slightest leading me to believe it could not have been heartburn. The pain was severe and could be described as the sensation of swallowing something too large however with a more painful and long lasting feeling. No, treatment for AE. The outcome of event was recovered.  Information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain aggravated in both instances; This is a spontaneous report from a contactable consumer. This 50-year-old male consumer reported himself who received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via intramuscular route to left arm on Mar2021 at 13:00 and on 05Apr2021 at 13:00 as SINGLE dose for covid-19 immunization respectively and was administered at Health Clinic/Administration facility. Medical history included degenerated disc between L4/L5, episode of serious pain happened in mid-2016, post the treatment, he was ok and known allergies included IV dye and Ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included Amlodipine besylate 2.5mg, given for unknown indication and start date and stop date was not provided. The patient reported that post the vaccination in Mar2021 and then second dose in 05Apr2021, his pain aggravated in both instances, and he was not back to normal even as of 11Jun2021. He has been put on a regime of oral Prednisone for a week since 12Jun2021 and getting some relief in pain. Event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was recovering.  The lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Lethargy, Somnolence
Clinical narrative: Lethargy; I can barely get through a day without feeling like I am going to fall asleep at some point; Low energy levels; This is a spontaneous report from a contactable other hcp. A 47-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in left arm on 04Mar2021 10:00 (Batch/Lot Number: EN6203) as Dose 1, single (at the age of 50 year) for covid-19 immunisation, dose 2 intramuscular, administered in Arm Left on 25Mar2021 03:00 (Batch/Lot Number: EL3248) as Dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient did not have covid prior vaccination, was not tested for covid post vaccination and no other vaccine in four weeks. The patient experienced lethargy, he can barely get through a day without feeling like he was going to fall asleep at some point, low energy levels (asthenia) on Mar2021. The patient did not received treatment for the events. Outcome of the events was not recovered.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Confusional state, Dizziness, Feeling abnormal
Clinical narrative: series of emotions; headache; nausea; muscle pain; weakness; fever; confusion; chest pain; light headed; This is a spontaneous report from a non-contactable other hcp (patient). A 21-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Right on 15Jun2021 14:00 as DOSE 1, SINGLE for COVID-19 immunisation. Facility type for vaccination was hospital.The patient medical history and concomitant medications were not reported. Patient did not receive other medications in four weeks. No Other medications in two weeks. No covid prior vaccination.The patient previously took ceclor and experienced known allergies: Ceclor. On 15Jun2021 14:00, the patient experienced series of emotions, headache, nausea, muscle pain, weakness, fever, confusion, chest pain, light headed. Patient was not received treatment. No covid tested post vaccination. The outcome of events were not recovered.  No follow-up attempts are possible; Information on lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: series of emotions; headache; nausea; muscle pain; weakness; fever; confusion; chest pain; light headed; This is a spontaneous report from a non-contactable other hcp (patient). A 21-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Right on 15Jun2021 14:00 as DOSE 1, SINGLE for COVID-19 immunisation. Facility type for vaccination was hospital.The patient medical history and concomitant medications were not reported. Patient did not receive other medications in four weeks. No Other medications in two weeks. No covid prior vaccination.The patient previously took ceclor and experienced known allergies: Ceclor. On 15Jun2021 14:00, the patient experienced series of emotions, headache, nausea, muscle pain, weakness, fever, confusion, chest pain, light headed. Patient was not received treatment. No covid tested post vaccination. The outcome of events were not recovered.  No follow-up attempts are possible; Information on lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Immunisation reaction, Inflammation, Lymph node pain
Clinical narrative: Body aches; fatigue; joint pain; pain in lymph nodes around breasts; High ANA test result; overactive autoimmune/inflammatory response; overactive autoimmune/inflammatory response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0158), via an unspecified route of administration in left arm on 09Apr2021 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation at other facility. The patient medical history was not reported. Concomitant medications included sertraline taken for an unspecified indication, start and stop date were not reported; trazodone taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if COVID-19 was diagnosed prior to vaccination. The patient had tested for COVID-19 since the vaccination. On 10Apr2021, The patient experienced body aches, fatigue, joint pain, pain in lymph nodes around breasts. High ANA test result, with an overactive autoimmune/inflammatory response that was still lasting with daily pain. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included high antinuclear antibody test result on an unknown date in Apr2021, Vault saliva test (COVID-19) was negative on an unknown date in Feb2021, negative on 05Apr2021 and negative on 14Apr2021. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; fatigue; joint pain; pain in lymph nodes around breasts; High ANA test result; overactive autoimmune/inflammatory response; overactive autoimmune/inflammatory response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0158), via an unspecified route of administration in left arm on 09Apr2021 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation at other facility. The patient medical history was not reported. Concomitant medications included sertraline taken for an unspecified indication, start and stop date were not reported; trazodone taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if COVID-19 was diagnosed prior to vaccination. The patient had tested for COVID-19 since the vaccination. On 10Apr2021, The patient experienced body aches, fatigue, joint pain, pain in lymph nodes around breasts. High ANA test result, with an overactive autoimmune/inflammatory response that was still lasting with daily pain. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included high antinuclear antibody test result on an unknown date in Apr2021, Vault saliva test (COVID-19) was negative on an unknown date in Feb2021, negative on 05Apr2021 and negative on 14Apr2021. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Feeling abnormal, Flushing, Headache
Clinical narrative: painful band on left of chest (bra line); warm flush; dizzy; numbness with heavy feeling in left arm and hand.; vaccine the numbness; needles (tingly); hyper sensitivity (feels like sunburn or really cold) also affects my left body, left arm & leg and left face.; Bad headache; After 2 weeks affect my joints, jaws, teeth and muscles on left side.; Painful with cramps at times.; This is a spontaneous report from a non-contactable consumer. This 51-year-old female consumer reports that: A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8736 and expiry date were not reported, Solution for injection), via an unspecified route of administration, administered in left arm, on 23May2021 (at the age of 51-year-old) as an unknown, single dose for COVID-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccine in four weeks. The patient was not tested COVID prior and post vaccination. The concomitant medications included Irbesartan. On 23May2021 (same day of vaccination), within first 10 minutes of vaccine experienced painful band on left of chest (bra line), warm flush and dizzy, pins & needles, numbness with heavy feeling in left arm and hand. By 11th day after vaccine the numbness, pins and needles (tingly) and hypersensitivity (feels like sunburn or really cold) also affects her left body, left arm & leg and left face. Bad headache that lasts for a couple days has happened 4 times in a month. After 2 weeks affect her joints, jaws, teeth, and muscles on left side. Painful with cramps at times. As of 4 weeks post 1st vaccine it was still noticeable. It was unknown that patient received any treatment for events. Due to events patient needs to visit doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Muscle spasms, Paraesthesia, Vaccination site hypoaesthesia
Clinical narrative: painful band on left of chest (bra line); warm flush; dizzy; numbness with heavy feeling in left arm and hand.; vaccine the numbness; needles (tingly); hyper sensitivity (feels like sunburn or really cold) also affects my left body, left arm & leg and left face.; Bad headache; After 2 weeks affect my joints, jaws, teeth and muscles on left side.; Painful with cramps at times.; This is a spontaneous report from a non-contactable consumer. This 51-year-old female consumer reports that: A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8736 and expiry date were not reported, Solution for injection), via an unspecified route of administration, administered in left arm, on 23May2021 (at the age of 51-year-old) as an unknown, single dose for COVID-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccine in four weeks. The patient was not tested COVID prior and post vaccination. The concomitant medications included Irbesartan. On 23May2021 (same day of vaccination), within first 10 minutes of vaccine experienced painful band on left of chest (bra line), warm flush and dizzy, pins & needles, numbness with heavy feeling in left arm and hand. By 11th day after vaccine the numbness, pins and needles (tingly) and hypersensitivity (feels like sunburn or really cold) also affects her left body, left arm & leg and left face. Bad headache that lasts for a couple days has happened 4 times in a month. After 2 weeks affect her joints, jaws, teeth, and muscles on left side. Painful with cramps at times. As of 4 weeks post 1st vaccine it was still noticeable. It was unknown that patient received any treatment for events. Due to events patient needs to visit doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Hives; rash; swelling of right side of face by the cheek; This is a spontaneous report from a contactable consumer(patient) reported that. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 17Jun2021 10:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 68 years). The patient past Medical history included Hashimoto's disease from an unknown date and unknown if ongoing, Allergies: Penicillin from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, Algae no's, cyanocobalamin, nicotinamide, pantothenic acid, pyridoxine, riboflavin, selenium, thiamine, tyrosine (THYROID COMPLEX) taken for an unspecified indication, vitamin C [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 18Jun2021 14:00, the patient experienced hives, rash and swelling of right side of face by the cheek. No treatment was received. The event outcome was recovering.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, SARS-CoV-2 test
Clinical narrative: Chest pain, started 2+ months after last dose.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: Ew0150) via an unspecified route of administration, administrated in left arm on 08Apr2021 at 03:30 PM as dose 2, single for COVID-19 immunization. The patient medical history included Fibromyalgia, chronic Epstein Bar Virus. The patient previously received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: En6208) via an unspecified route of administration, administrated in left arm, on 18Mar2021 at 03:30 PM, as dose 1, single for COVID-19 immunization and also received amoxicillin and experienced drug hypersensitivity. The patient concomitant medications were not reported. On 01Jun2021 the patient experienced with chest pain, started 2+ months after last dose. On 28May2021 the patient underwent lab tests and procedures which included sars-cov-2 test was negative and Covid test type post vaccination with nasal Swab Covid test result was negative. The event was reported as non-serious. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Acute chest pain adverse reaction to COVID-19 vaccine.; This is a spontaneous report from a contactable consumer. This 14-year-old non pregnant female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 29Jun2021 09:30 (Batch/Lot Number: EW0162) as dose 1, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced acute chest pain adverse reaction to COVID-19 vaccine on an unspecified date. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Hyperhidrosis, Insomnia, Vaginal haemorrhage
Clinical narrative: Vaginal Spotting at 18 days into my cycle; Menstrual cramps; Sweating; Insomnia; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0183), dose 1 via an unspecified route of administration, administered in arm right on 11Jul2021 18:15 as (at the age of 48-years) dose 1, single for covid-19 immunisation. Facility type of vaccine was other. Medical history included known allergies: penicillin, shellfish, and pineapple. Concomitant medication included zinc taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10) taken for an unspecified indication, start and stop date were not reported and prenatal vitamin. No other vaccine in four weeks. No covid prior vaccination. The patient was not covid tested post vaccination. It was reported that it was unknown if patient was pregnant at the time of vaccination. The patient experienced vaginal spotting at 18 days into her cycle, had menstrual cramps, sweating, and insomnia on 12Jul2021 20:00. Patient did not receive any treatment for the events. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: c/o pain in her arm and also a magnet was sticking to her arm.; c/o pain in her arm and also a magnet was sticking to her arm./there's the magnet that get stuck into my arm where the injection site is.; This is a spontaneous report from a contactable consumer (patient).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 14Jul2021 as dose 1, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. The patient received her 1st Pfizer vaccine dose today (details unspecified) and she had pain in her arm and also a magnet was sticking to her arm. Her arm just happened to be like getting scanned and arm got scanned on the scanner and there was the magnet that got stuck into her arm where the injection site was (Dates was unspecified to unspecified). Today she got her first dose of Pfizer vaccine and she came back home and she went to (name-withheld) and bought some stuff. When she was at (name-withheld) she was checking price some stuff at the little scanner thing and moved her arm where the injection site was she did not mean to and it scan her arm, all the other stuff was in her cart, there was nothing in her hand. She moved to go get one of her item and her arm just happened to be like getting scanned and her arm got scanned on the scanner. The outcome of events was unknown.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Overdose
Clinical narrative: arm is sore; drew up 0.3mL of vaccine without diluent; This is a spontaneous report from a contactable pharmacist (patient's mother). This pharmacist reported for a 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 14Jul2021 at 10:00 AM, as a single dose, 0.3 ML, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller was a pharmacist calling on behalf of her daughter and reported that she took her daughter to receive her first dose of the Pfizer Covid-19 vaccine yesterday on 14Jul2021. Caller reported that she administered the vaccine because her daughter was scared. She drew up 0.3 mL of vaccine without diluent. Caller reported this happened yesterday at 10 am. Caller asked what we should look for in an over dosage and for how long. Caller stated "she had no fever yesterday but an overdose big time. she wanted to get her on board before she was aware of what's going on but after she knew what happened she got scared. There was really no issue except arm was sore which was common with most but if it becomes more than you can handle let me know". Caller stated "She has had no other side effects, just worried about that (myocarditis) now. She will leave it at that. As far as the over dosage and asked how many cases have you had". Outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hypoaesthesia, Nausea, Oropharyngeal pain
Clinical narrative: Numbness in her arm; nauseas; She felt faint like she was going to fall over; she felt swelling in that area; she got pain so bad in her arm it hurt any which way she moved it/ Pain in arm; sore throat; a lot of saliva; she felt light headed; Feeling of hotness; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient)   A 28-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), on 11Jul2021 at 11:00 via an unspecified route of administration, administered in Arm Left (as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications.  The patient received received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0181) on 20Jun2021 on arm left. The patient received Flu vaccine on an unspecified date and experienced site swelling. On 11Jul2021 immediately after vaccination patient felt swelling in that area. Patient also had swelling and numbness in her arm that continued throughout that day and in the middle of the night she was awakened by the pain in her arm that hurt any which way she moved it, extending or reaching for anything hurt. About 15 hours later that night patient got pain so bad in her arm it hurt any which way she moved it. Patient woke up the next morning and that pain was gone but then she was nauseated. Patient also informed she was walking with her dog that morning and had to sit on the sidewalk as she felt faint like she was going to fall over, she felt light headed and spitting helped her feel better. She spitted a few times in a bag and the nausea went away and she was able to get up and walk back home (as reported). Patient also had a feeling of hotness but no fever on the thermometer, she felt very hot but didn't register a fever and that started on the 2nd day with the nausea. She also informed the hotness was more the full day and the nausea was a little less but worse in the morning for some reason on the 2nd day. On days 3 and 4 patient had no nausea but had a sore throat. She had no fever or fatigue just an isolated sore throat and a lot of saliva. AT the time of the reporting outcome for She felt faint like she was going to fall over, she felt swelling in that area', she felt light headed', Feeling of hotness' was unknown. The patient recovered from Numbness in her arm, nauseas' on an unspecified date in Jul2021, while had not yet recovered from other reported events.  The information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Salivary hypersecretion, Vaccination site swelling, Weight
Clinical narrative: Numbness in her arm; nauseas; She felt faint like she was going to fall over; she felt swelling in that area; she got pain so bad in her arm it hurt any which way she moved it/ Pain in arm; sore throat; a lot of saliva; she felt light headed; Feeling of hotness; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient)   A 28-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), on 11Jul2021 at 11:00 via an unspecified route of administration, administered in Arm Left (as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications.  The patient received received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0181) on 20Jun2021 on arm left. The patient received Flu vaccine on an unspecified date and experienced site swelling. On 11Jul2021 immediately after vaccination patient felt swelling in that area. Patient also had swelling and numbness in her arm that continued throughout that day and in the middle of the night she was awakened by the pain in her arm that hurt any which way she moved it, extending or reaching for anything hurt. About 15 hours later that night patient got pain so bad in her arm it hurt any which way she moved it. Patient woke up the next morning and that pain was gone but then she was nauseated. Patient also informed she was walking with her dog that morning and had to sit on the sidewalk as she felt faint like she was going to fall over, she felt light headed and spitting helped her feel better. She spitted a few times in a bag and the nausea went away and she was able to get up and walk back home (as reported). Patient also had a feeling of hotness but no fever on the thermometer, she felt very hot but didn't register a fever and that started on the 2nd day with the nausea. She also informed the hotness was more the full day and the nausea was a little less but worse in the morning for some reason on the 2nd day. On days 3 and 4 patient had no nausea but had a sore throat. She had no fever or fatigue just an isolated sore throat and a lot of saliva. AT the time of the reporting outcome for She felt faint like she was going to fall over, she felt swelling in that area', she felt light headed', Feeling of hotness' was unknown. The patient recovered from Numbness in her arm, nauseas' on an unspecified date in Jul2021, while had not yet recovered from other reported events.  The information on the lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Inappropriate schedule of product administration, Off label use
Clinical narrative: Hard to breathe; Heart Palpitations; Dose number: 1 Administration date: 26Jun2021/ Dose number: 2 Administration date: 11Jul2021; Dose number: 1 Administration date: 26Jun2021/ Dose number: 2 Administration date: 11Jul2021; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 11Jul2021 13:00 (age at vaccination 16-years-old) as dose 2, single for covid-19 immunisation. Medical history included Leg-calve perches' disease, food allergy and milk allergy. The patient's concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 26Jun2021 13:00 (age at vaccination 16-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested COVID-19 post vaccination. On 14Jul2021 22:30 the patient experienced heart palpitations and hard to breathe. The adverse events were resulted in a visit to Emergency room/department or urgent care. The patient was received treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, x-ray: unknown results on unknown date. The outcome of the events was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, X-ray
Clinical narrative: Hard to breathe; Heart Palpitations; Dose number: 1 Administration date: 26Jun2021/ Dose number: 2 Administration date: 11Jul2021; Dose number: 1 Administration date: 26Jun2021/ Dose number: 2 Administration date: 11Jul2021; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 11Jul2021 13:00 (age at vaccination 16-years-old) as dose 2, single for covid-19 immunisation. Medical history included Leg-calve perches' disease, food allergy and milk allergy. The patient's concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 26Jun2021 13:00 (age at vaccination 16-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested COVID-19 post vaccination. On 14Jul2021 22:30 the patient experienced heart palpitations and hard to breathe. The adverse events were resulted in a visit to Emergency room/department or urgent care. The patient was received treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, x-ray: unknown results on unknown date. The outcome of the events was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was administered with an expired Menactra vaccine, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via consumer/non-health care professional via Medical Information (MI) (Reference number- 00751957) and transmitted to Sanofi on 01-Sep-2021.  This case involves a 12-year-old female patient who was administered with an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [Expired product administered].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 31-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (batch number not reported and expiry: 23-Aug-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  No adverse event was reported.  It was reported, "Hello, I am seeking guidance regarding a Menactra vaccine administered to a 12-year-old female. The vaccine expired 23-Aug-2021 and was administered 31-Aug-2021. Do you have any data to support that the dose is valid or should the dose be repeated?"   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Body temperature, Chills, Headache, Hypersomnia
Clinical narrative: slept for 2 days; stomach pain; felt lethargic for 3 days; low grade fever 100.1; chills; headache; Initial information was received on 03-Sep-2021 regarding an unsolicited valid non-serious case received from a Patient via Global Medical Information (GMI) (Reference number- 00754167) and transmitted to Sanofi on 03-Sep-2021 in the United States.  This case involves a 72-year-old female patient who experienced slept for 2 days (Hypersomnia), stomach pain (Abdominal pain upper), felt lethargic for 3 days (Lethargy), low grade fever 100.1 (Pyrexia), chills and headache while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient slept for 2 days (Hypersomnia), stomach pain (Abdominal pain upper), felt lethargic for 3 days (Lethargy), low grade fever 100.1 (Pyrexia), chills and headache (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, "Caller states she is 72 years old with a body like a 62 year old; she states last year flu rates were down because of people wearing masks but she got the flu on Christmas day; she states she got it from being in the doctors office for cataract surgery and that she was there for 4 hours, afterwards, she reports that she felt lethargic for 3 days and slept for 2 and her symptoms included a low grade fever 100.1 (which she states is unusual for her as her normal temperature runs around 97 or 98 degrees), stomach pain, chills, and headache, she states that she had no nausea or vomiting, she states that at that time she was tested for Covid and had a negative test result, so she states for certain it was the flu, even though she was vaccinated, she states that she has a terrible reaction to "mega doses" and when she even takes a 300 mg Tylenol pill it puts her to sleep, she states she does not know if she should take the Fluzone HD or the Fluzone regular dose, she states she does not want to have a reaction with the Fluzone HD and wants to know the antigen used, her primary HCP is out of the office until 10Aug2021 but she really wants the Flu vaccine on the earlier side this year as compared when she received the vaccine in October last year, she states she wants a middle dose of the antigen and does want the vaccine to be egg based, she is requesting information on the antigen used in the formulation of the vaccines."  Relevant laboratory test results included: Body temperature - On an unknown date: 100.1 UNK [low grade fever 100.1] SARS-CoV-2 test - On an unknown date: Negative  The patient was treated with PARACETAMOL (TYLENOL).  At the time of report, the outcome of events was unknown.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Lethargy, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: slept for 2 days; stomach pain; felt lethargic for 3 days; low grade fever 100.1; chills; headache; Initial information was received on 03-Sep-2021 regarding an unsolicited valid non-serious case received from a Patient via Global Medical Information (GMI) (Reference number- 00754167) and transmitted to Sanofi on 03-Sep-2021 in the United States.  This case involves a 72-year-old female patient who experienced slept for 2 days (Hypersomnia), stomach pain (Abdominal pain upper), felt lethargic for 3 days (Lethargy), low grade fever 100.1 (Pyrexia), chills and headache while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient slept for 2 days (Hypersomnia), stomach pain (Abdominal pain upper), felt lethargic for 3 days (Lethargy), low grade fever 100.1 (Pyrexia), chills and headache (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, "Caller states she is 72 years old with a body like a 62 year old; she states last year flu rates were down because of people wearing masks but she got the flu on Christmas day; she states she got it from being in the doctors office for cataract surgery and that she was there for 4 hours, afterwards, she reports that she felt lethargic for 3 days and slept for 2 and her symptoms included a low grade fever 100.1 (which she states is unusual for her as her normal temperature runs around 97 or 98 degrees), stomach pain, chills, and headache, she states that she had no nausea or vomiting, she states that at that time she was tested for Covid and had a negative test result, so she states for certain it was the flu, even though she was vaccinated, she states that she has a terrible reaction to "mega doses" and when she even takes a 300 mg Tylenol pill it puts her to sleep, she states she does not know if she should take the Fluzone HD or the Fluzone regular dose, she states she does not want to have a reaction with the Fluzone HD and wants to know the antigen used, her primary HCP is out of the office until 10Aug2021 but she really wants the Flu vaccine on the earlier side this year as compared when she received the vaccine in October last year, she states she wants a middle dose of the antigen and does want the vaccine to be egg based, she is requesting information on the antigen used in the formulation of the vaccines."  Relevant laboratory test results included: Body temperature - On an unknown date: 100.1 UNK [low grade fever 100.1] SARS-CoV-2 test - On an unknown date: Negative  The patient was treated with PARACETAMOL (TYLENOL).  At the time of report, the outcome of events was unknown.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was received on 27-Aug-2021 via Med Communications (reference number: SEQW21-01771) from pharmacist and concerned a 19-year-old, female patient.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine), after which the patient developed flu like symptoms, reported as, this also happened (case 202102928).   On an unknown date in 2019, reported as two years ago, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; route of administration: intramuscular, dose: 0.5 ml and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.  On an unknown date in 2019, unknown amount of time after receiving Afluria Quadrivalent, the patient experienced flu like symptoms for a week.   On an unknown date in 2019, a week later, the patient recovered from the event.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  The case is linked to case 202102928 due to the same reporter and patient.  Company comment: The event of flu like symptoms was assessed as related to Afluria Quad.; Sender's Comments: The event of flu like symptoms was assessed as related to Afluria Quad.
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: This also happened; This spontaneous case was received on 27-Aug-2021 via Med Communications (reference number: SEQW21-01771) from pharmacist and concerned an unknown age, female patient.   The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; route of administration, dose, indication and anatomical location: not reported). The batch number was not reported.  On an unknown date, unknown amount of time after receiving Fluvirin, the patient experienced flu like symptoms, reported as this also happened (case 202102927).  The outcome of the event was not reported.   The reporter did not provide causality assessment.  The case was assessed as non-serious.   The case is linked to case 202102927 (the same reporter and patient).  Company comment: A patient of an unknown age was administered Fluvirin. On an unknown date, an unknown amount of time after receiving Fluvirin, the patient experienced flu like symptoms. The patient's medical history and concomitant medications were not reported. Due to unclear information regarding temporal relationship, causal role of the suspect vaccine is assessed as unassessable.; Sender's Comments: A patient of an unknown age was administered Fluvirin. On an unknown date, an unknown amount of time after receiving Fluvirin, the patient experienced flu like symptoms. The patient's medical history and concomitant medications were not reported. Due to unclear information regarding temporal relationship, causal role of the suspect vaccine is assessed as unassessable.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: Covid arm.  Large itchy rash over much of the body, arms, belly, groin, legs.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Extra dose administered, Intensive care, SARS-CoV-2 test positive
Clinical narrative: COVID-19 infection - tested positive 9/8.  He was admitted to the hospital 9/8, currently in the ICU on maximal high flow nasal cannula settings with very tenuous respiratory status on the verge of being intubated
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Limb discomfort, Muscle twitching, Sleep disorder
Clinical narrative: Lingering muscle twitch in the arm. Causing interference with sleep and discomfort
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Extra dose administered, Interchange of vaccine products
Clinical narrative: Within 30-45 minutes of the booster I began having abdominal cramps and felt the onset of diarrhea. Within an hour, I had to rush home from work because of intense diarrhea. After it passed from my system, I took an Imodium and did not have further problems.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Injection site swelling, Nodule
Clinical narrative: 3 days after vaccine I started noticing a swollen arm at the site injection, hot to the touch, redness, and a knot under the skin
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Back pain, Blister, Diarrhoea, Eczema herpeticum
Clinical narrative: 1st Vaccine shot - following day major skin reaction. Itchy patches on hands and legs, turned into large patches of fluid-filled blisters/boils. Horrible pain and itchiness, not able to work, lasted 2 weeks. Went to dermatologist, discovered  a severe case of "eczema herpticum". Strongly suggested no second dose of vaccine following severe allergic reaction. Other reactions on a large scale include: body aches, fatigue, headache, diarrhea, swollen throat and voice loss, low back aches, changes in menstrual cycle.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Furuncle, Headache, Impaired work ability, Menstrual disorder
Clinical narrative: 1st Vaccine shot - following day major skin reaction. Itchy patches on hands and legs, turned into large patches of fluid-filled blisters/boils. Horrible pain and itchiness, not able to work, lasted 2 weeks. Went to dermatologist, discovered  a severe case of "eczema herpticum". Strongly suggested no second dose of vaccine following severe allergic reaction. Other reactions on a large scale include: body aches, fatigue, headache, diarrhea, swollen throat and voice loss, low back aches, changes in menstrual cycle.