chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over body; This is a spontaneous report from a non-contactable consumer (parent) or other non HCP via  Information Team. This consumer reported for a male patient (son)   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash all over body. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site rash
Clinical narrative: Fever; Patient got where patient got a shot is like a little red and it looks like a tiny rash but not itchy; Patient got where patient got a shot is like a little red and it looks like a tiny rash but not itchy; This is a spontaneous report from a contactable consumer (patient). A 32-year-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0185), via an unspecified route of administration on May2021 (age at vaccination: 32 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EW0162), dose 1 via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that I just had general question. So I got my second Pfizer vaccine (Further clarification was unknown hence captured as unspecified vaccine) shot last week which is fine I had you know like a normal side effect just having a fever and all that but today I got where I got a shot is like a little red and I know that a little common too, it looks like a tiny rash but not itchy or anything and I know a lot of people who got that too which must go away in few days but my real question is I am about to get a tattoo in two days in the spot that where I got a shot. So I gone an ask you I do not if something you know but I just take a call to Pfizer the number anyway, if the redness is went away on that day I can go ahead and get my tattoo or should I just wait a little bit longer or there is any guideline for anything like that mention. I had tattoo schedule in two days and I do not know how long this rash last but if it go it tomorrow but I just wanted to confirm that how long does redness go away to get a tattoo where I got a shot or should I been waiting longer? If I do that. It should be today but it could appeared yesterday I have no idea and its a very small not itchy its just overall red that you touch it I heard that a lot of people have it and it went away in couple of days. I would just say that its today. The patient reported that when last week i got and then there was no more content, the week later I have this red spot." The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Mania, Rash
Clinical narrative: Rash; Mania; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash and mania on an unspecified date. It was reported that the patient took the Pfizer Covid19 vaccine both shots and she said that she developed a rash. The patient wanted to know the side effect and that's all, hence she talked to the doctor, however doctor did not have the information. The patient clarify that she received Pfizer covid-19 vaccine and not the morphine. The patient had several hours of Mania now she trying to come out. The patient did not realize that was the sneaky thing about that disease. It just with her it's a rapid cycle and was do not hit the middle at all. The patient stated she was going down, but it was not always pleasant. The patient wanted to see if have any likable remarks on people. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Fear of injection, Pruritus, Rash
Clinical narrative: it's the bottom of the patient foot and little scared to take the second dose,; it gave me like rashness upon the bottom of my feet; I had like an itchy on the bottom of my feet; it became red and I am not very allergic person; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date it was reported that it's the bottom of the patient foot and little scared to take the second dose, it gave the patient like rashness upon the bottom of feet and had like an itchy on the bottom of the patient feet and it became red and the patient was not very allergic person. The outcome of the events was unknown.  Information on lot/ batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin disorder, Urticaria
Clinical narrative: Hives like rash; Hives like rash; Small bump; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: not reported), via an unspecified route of administration, administered in arm left on 06May2021 (age at vaccination was 28-year-old) as dose 1, single for COVID-19 immunization at urgent care. Medical history included polycystic ovarian syndrome from an unknown date and unknown if ongoing. Patient had no family history of rash. Concomitant medication included ethinylestradiol, norethisterone (NORTREL [ETHINYLESTRADIOL;NORETHISTERONE], Tablet); taken for polycystic ovarian syndrome from an unspecified start date and was ongoing. The patient reported that she never had a allergic reaction anything in the past but on 11May2021, the patient experienced hives like rash. The patient had been wearing tight pants around her waist so now there was a small bump. No investigation assessment was reported. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: Light-headed; Fever of 100.4 F; Nausea; Fatigue; This is a spontaneous report from a contactable consumer. A 14-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0187, Expiry date was not reported), via an unspecified route of administration on 08Jun2021 (Age at vaccination 14-year-old) as dose 2, single for covid-19 immunization. Medical history included allergic (rash) to penicillin and cephalosporin. The patients concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization, cephalosporin c and experienced dermatitis allergic. The patient experienced fever of 100.4 Fahrenheit (F), light-headed, nausea, fatigue onset about 12 hours post dose on an unspecified date 2021. The patient underwent lab tests and procedures which included body temperature: 100.4 Fahrenheit on an unspecified date 2021. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis, Oral mucosal eruption, Rash
Clinical narrative: he got a Herpes looking rash all around his mouth, lip, chin.; he got a Herpes looking rash all around his mouth, lip, chin.; he got a Herpes looking rash all around his mouth, lip, chin.; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), via unspecified route of administration, on an unspecified date as a dose 1, single for COVID-19 immunization (After the first shot patient felt sick with flu symptoms for several days). On an unspecified date the patient got a herpes looking rash all around his mouth, lip and chin. Patient stated that he has not felt the same since. The outcome for all the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Fatigue, Pyrexia
Clinical narrative: stomachache; fatigue; low grade fever; This is a spontaneous report from a contactable pharmacist. A 14-years-old male patient received second 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 an unspecified date, as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 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 an unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced stomachache, fatigue and low grade fever. On an unspecified date, the patient underwent lab test and procedure which included body temperature measurement which showed low grade fever. Outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: had pain in her lower legs and her knees hurts too and walking was difficult; had pain in her lower legs and her knees hurts too and walking was difficult; had pain in her lower legs and her knees hurts too and walking was difficult; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: -AMGEN-SP2021090895). This case was split from master case 2021754646 for a patient taking bnt162b2 and experienced leg pain, knee pain, walking difficulty.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Lot Number:unknown), via an unspecified route of administration, on 25May2021 as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. The patient had always had allergies to medications from the time allergies to penicillin, Biaxin, Z-pak, clarithromycin. The patient's concomitant medications included Enbrel (ETANERCEPT), Otezla (APREMILAST), Methotrexate (METHOTREXATE) and TILDRAKIZUMAB from an unspecified date for an unknown indication while AMLODIPINE from an unspecified date taken for blood pressure and ATORVASTATIN from an unspecified date taken for blood cholesterol, Taclonex (BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL) from an unspecified date taken for palmar-plantar psoriasis, PLAQUENIL (HYDROXYCHLOROQUINE PHOSPHATE) from an unspecified date taken for pain. The patient's co-suspect medications included Humira (ADALIMUMAB) from an unspecified date for an unknown indication. The patient received an unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Lot Number: unknown), via an unspecified route of administration, on an unspecified date  as single for COVID-19 immunization. On 28May2021 the patient experienced had pain in her lower legs and her knees hurts too and walking was difficult. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: FLU4
Symptoms: Decreased immune responsiveness, Illness
Clinical narrative: was sick every month for an entire year; my immune system tanked; Initial information received on 28-Oct-2021 regarding an unsolicited valid social media non-serious case from a consumer via.  This case involves Adult and unknown gender patient who experienced was sick every month for an entire year(illness) and my immune system tanked (Decreased immune responsiveness) while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatments, vaccinations,Concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. batch number, expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date the patient experienced a non-serious was sick every month for an entire year (illness) (latency unknown) and experienced a non-serious my immune system tanked (decreased immune responsiveness) (latency unknown) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  It was reported" I got the flu shot 20 years ago and my immune system tanked ... I was sick every month for an entire year. I've not taken the flu shot since and I have had the flu once in that time. Our immune system is powerful".  It is unknown if the patient experienced any additional symptoms/ events.   no Laboratory data was reported.   It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the reported event was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: been sick ever since; Initial information received on 28-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer/non-health care professional.  This case involves adult and unknown gender patient who experienced been sick ever since (Malaise) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease, or risk factor.  The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious been sick every since (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were laboratory data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4
Symptoms: Vaccination site pain
Clinical narrative: patient received a dose of annual Flublok vaccine and complained that it stung, at time of administration; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves adult female patient (unknown age) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. and complained that it stung, at time of administration (vaccination site pain),   The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 04-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. (batch number and expiry date not reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 04-Oct-2021, the patient experienced a non serious stung at time of administration(vaccination site pain) (latency same day) while receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   No laboratory data was reported.   0n an unknown date, the patient recovered from the event.   There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu: Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a female patient of unknown age who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "it was the same with my grandmother, as soon as she quit taking the shot she quit getting the flu."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: felt a bit achy; rotten; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional under reference number - US-SA-SAC20211103000091.  This case involves a patient of (unknown demographics) who experienced felt a bit achy (pain) and rotten (unevaluable event), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious felt a bit achy (pain) and rotten (unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Malaise
Clinical narrative: the patient had two episodes of chest tightness; felt poorly after receiving Flu vaccine; flushing; Initial information received on 28-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.    This case involves a 55-year-old male patient who experienced had two episodes of chest tightness (chest discomfort), felt poorly after receiving flu vaccine (malaise) and flushing after receiving vaccine INFLUENZA VACCINE.  The patient's medical history included Pulmonary arterial hypertension.  Medical treatment, vaccination and family history were not provided.   Concomitant medications included TREPROSTINIL SODIUM (TYVASO) Inhalation Gas, 0.6 mg/ml.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  In OCT-2021, the patient developed a non-serious had two episodes of chest tightness (chest discomfort), felt poorly after receiving flu vaccine (malaise) and flushing (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: get really sick; Initial information was received on 28-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional (under reference number: US-SA-SAC20211103000726).  This case involves an adult patient with an unknown gender who got really sick (illness) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious get really sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "And every time I get it, I get really sick. So, I'm going to keep me safe."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
Sex: U
Vaccine: DTAP, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: the products reached 30.9 Fahrenheit  for five hours with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (MI) (Reference number- 00833419) and transmitted to Sanofi on 28-Oct-2021.  This case involves an unknown age and unknown gender patient for whom it was reported the products reached 30.9 Fahrenheit for five hours while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for Prophylactic vaccination.  It was a of actual medication error due to product storage error [Latency: on the same day].   It was reported "Caller reporting a temperature excursion caused by human error; facility employee thought she was making the temperature warmer and turned the temperature down instead; the products reached 30.9 Fahrenheit for five hours".  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  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.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pruritus, Pyrexia
Clinical narrative: tiredness; generalized rash and itchiness all over body; high fever (103.0Fahrenheit); injection site redness and soreness; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (MI) (Reference number- 00835143) and transmitted to Sanofi on 29-Oct-2021.  This case is linked to case 2021SA366585 (same patient).  This case involves a 7 year old male patient who had high fever (103.0 fahrenheit) (pyrexia), injection site redness and soreness (vaccination site inflammation), generalized rash and itchiness all over body (rash pruritic) and tiredness (fatigue) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past vaccination(s) included Ipol on 09-AUG-2010 for prophylactic vaccination. The patient had pyrexia, vaccination site inflammation, rash pruritic and fatigue as a reaction to the vaccine.  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 30-Oct-2014, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C4644AA, expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 30-Oct-2014 the patient developed non-serious high fever (103.0fahrenheit) (pyrexia), injection site redness and soreness (vaccination site inflammation), generalized rash and itchiness all over body (rash pruritic) and tiredness (fatigue) on the same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  No other relevant test was reported.  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the events were resolved.  The reporter did not report the causality of events with suspect.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Rash, Vaccination site inflammation
Clinical narrative: tiredness; generalized rash and itchiness all over body; high fever (103.0Fahrenheit); injection site redness and soreness; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (MI) (Reference number- 00835143) and transmitted to Sanofi on 29-Oct-2021.  This case is linked to case 2021SA366585 (same patient).  This case involves a 7 year old male patient who had high fever (103.0 fahrenheit) (pyrexia), injection site redness and soreness (vaccination site inflammation), generalized rash and itchiness all over body (rash pruritic) and tiredness (fatigue) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past vaccination(s) included Ipol on 09-AUG-2010 for prophylactic vaccination. The patient had pyrexia, vaccination site inflammation, rash pruritic and fatigue as a reaction to the vaccine.  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 30-Oct-2014, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C4644AA, expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 30-Oct-2014 the patient developed non-serious high fever (103.0fahrenheit) (pyrexia), injection site redness and soreness (vaccination site inflammation), generalized rash and itchiness all over body (rash pruritic) and tiredness (fatigue) on the same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  No other relevant test was reported.  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the events were resolved.  The reporter did not report the causality of events with suspect.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: had an adverse reaction to the FLUZONE vaccine; had an adverse reaction to the FLUZONE vaccine and it got worse each year; Initial information received on 29-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Global Media Information (under the reference 00835362).    This case involves an unknown age female patient who experienced had an adverse reaction to the vaccine (adverse event) and it got worse each year (condition aggravated) after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical treatment, concomitant medication, vaccination and family history were not provided.   At the time of the event, the patient had ongoing Hypersensitivity.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious had an adverse reaction to the vaccine (adverse event) and it got worse each year (condition aggravated) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Injection site pain, Skin reaction, Swelling
Clinical narrative: Pain at vaccine site and  growing inflammation, spreading  to a red swollen circle roughly 6cm in diameter over the course of 60 hours (at time of writing) No  bodily fever, dizziness, or systemic hives.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block second degree, Cardiac pacemaker insertion, Catheterisation cardiac abnormal, Coronary arterial stent insertion, Dizziness
Clinical narrative: Fatigue day of injection. Day 2-4 Fatigue, lightheadedness, sweating. Day 5- Continuous dizziness, nausea developed. Went to ED, in 2nd degree type 2 heart block, transferred to Level 1 facility, Placed on vasopressors, TTVP placed in right IJ. Cardiac cath, blockage found and stent placed. Next day permanent pacemaker inserted. Hospitalized day 5-8 after injection.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Fatigue day of injection. Day 2-4 Fatigue, lightheadedness, sweating. Day 5- Continuous dizziness, nausea developed. Went to ED, in 2nd degree type 2 heart block, transferred to Level 1 facility, Placed on vasopressors, TTVP placed in right IJ. Cardiac cath, blockage found and stent placed. Next day permanent pacemaker inserted. Hospitalized day 5-8 after injection.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Muscle twitching, Pain
Clinical narrative: This afternoon, my left arm began to hurt around the site of my injection. The pain progressively began to increase and around seven PM it hurt to move my arm.  The muscles in my upper arm twitch occasionally. Pain is localized around the upper arm and radiates only until my elbow. Movement makes it worse. There is slight swelling around the area of injection.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUR4, PNC13
Symptoms: Hypoaesthesia, Inflammation, Injected limb mobility decreased, Paraesthesia, Ultrasound Doppler
Clinical narrative: At the time of the booster shot I informed the pharmacist that my arm was tingling and he stated it was because he just gave me the pneumonia shot in the same arm and it will go away and i did question him about giving me the covid shot on the inner part of my arm close to my shoulder as 4:00 pm that day neared my arm completely went numb and i lost use of my arm and with a history of pulmonary embolism my doctors ordered that i go to the outpatient department for an extremity venous study to rule out any blood clots caused by the injection(s) and put on a steroid to help with the inflammation  i am still having issues with tingling and numbness in my left arm and currently. under treatment by pain management.
Age: 7.0
Sex: M
Vaccine: UNK
Symptoms: Periorbital swelling, Swelling face
Clinical narrative: Pt received vaccination @ 1845 on 11/8.  Pt presented to ER @  2345 on 11/9 (practitioner filling out this report is  from ER).  Pt with diffuse facial swelling, primarily around BL  orbital regions @ 2230.  No signs of anaphylaxis.  Given 10ml children's Benadryl @ 2300 by parent.  Given PO dexamethasone, observation.  DC home with PMD follow up, strict return precautions.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: Lymphedema to right axila
Age: 51.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Lethargy, Pain
Clinical narrative: Not clear which of the two vaccines is giving me the side effects, though, my suspicion lies more with the Shingrix than with the Pneumo.   Side effects became more pronounced about six hours after administration. They have included fatigue. some lethargy, and body aches, that started in my arms, radiated to the remainder of my upper torso, then quickly spread throughout my entire body.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Itchy, rash, hurts  - still going on   haven't used anything yet to try to help   seems to be getting worse and rash is getting larger in area
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Dysuria, Genital ulceration, Herpes simplex test negative, Pain
Clinical narrative: A day after my vaccine I woke up and noticed that it bruned to pee a little. I saw a scratch on my right inner labia by the vaginal opening. It got worse and more painful and about three of four ulcers developed. Thelargest one was about a centimeter in diameter. All of them were on my right inner labia. I made an apointment with my gynecologist and I was perscribed 3% topical lidocaine for the pain. I was also perscibed a pill to take because the gynecologist did not know what it was so they treated me as if I had herpes. It took about a week for all of the ulcers to clear up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Genital ulceration
Clinical narrative: I woke up on 11/8/2021 with a slight burning sensation when I peed. I was able to see a very tiny cut on the inner right labia. On 11/9/2021 a small ulcer formed in a different and a second cut formed an ulcer as well.  This was a covid booster and I had this happen with my original vaccine too. Last time this happened I was perscribed 3% topical lidocaine cream which helps with the pain and that is what I have been using.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Headache, Loss of personal independence in daily activities, Ventricular extrasystoles
Clinical narrative: Severe headache (unable to perform daily activities). Increase in heart PVC and outer ear infection.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at injection site
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site haemorrhage, Pain, Pyrexia
Clinical narrative: About 1-2 hours after I received my third shot which was my booster shot of Pfizer I began quickly to feel body aches and developed a rather high fever. I had been previously feeling fine. My first shot I had no side effects other than sore Covid arm, my second shot I was bed ridden for a few days with similar side effects as expected (everyone says the second shot makes you feel sick) but this one the booster shot, I am still currently experiencing severe body aches and a rather high fever with chills over 24 hours later. I ended up having to be sent home from work because it was so bad. Others I know who had their third booster Shot by Pfizer had no side effects. Also at the time of my injection for my third booster shot I ended up bleeding pools of blood from the injection site for over an hour even with a bandaid on and some pressure from a tissue. I have no known bleeding problems and previously from shots I have never bled more or longer than the slight normal amount. I?m also extremely cautious during this entire pandemic even to this day, I don?t surround myself with people from other households without seeing a produced negative Covid test from them and I wear my mask and disposable gloves EVERYWHERE. I even sanitize after every small thing outside of my home so I am notoriously cautious. So this leads to some issue from my booster shot and not anything else.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Illness, Palpitations
Clinical narrative: First and second shot was very sick/felt like my head was going to explode for a few days after second shot along with extreme shacking and cold feeling that started app 12 hours after shot#2 and lasted a week. Tired all the time and extreme brain fog that is still here and has not stopped some days are better than others but some days are really bad. will start to feel better than without any cause I feel really bad. I try to work through it but many times it is debilitating and extreme frustration. Then in October admitted my self into emergency my heart felt like it was going to explode and was all over the place which the ekg recorded was given a shot of Protonin (if I remember properly) . they were going to give me a second shot and my heart went back to normal. I have not seen a cardiologist  as of  yet.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: First and second shot was very sick/felt like my head was going to explode for a few days after second shot along with extreme shacking and cold feeling that started app 12 hours after shot#2 and lasted a week. Tired all the time and extreme brain fog that is still here and has not stopped some days are better than others but some days are really bad. will start to feel better than without any cause I feel really bad. I try to work through it but many times it is debilitating and extreme frustration. Then in October admitted my self into emergency my heart felt like it was going to explode and was all over the place which the ekg recorded was given a shot of Protonin (if I remember properly) . they were going to give me a second shot and my heart went back to normal. I have not seen a cardiologist  as of  yet.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Cardiac disorder, Parosmia, Taste disorder
Clinical narrative: Doctor identified my symptoms to be called 1. Hyperosmia. And 2. Atypical heart syndrome  1. An extremely foul indescribable taste and smell  2. A pinch on the heart after taking a deep breath
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, COVID-19, Cough, Illness
Clinical narrative: I started to have a tickle in throat on September 8th, by September 10th I also had a cough. I went to the local urgent care to get a covid test. Got my positive result on September 11th around 7am. I was 12 weeks pregnant at that time. I was advised by my OB-GYN to only take my prenatal vitamin. However for my cough I took a natural kids cough medicine to help lessen the cough. I was sick for about 15 days. Over that time I had alot of mucus, cough, sneezing very hard where I lost control of my bladder sometimes and also had some bone pain mostly in my fore arms and neck/shoulder area. During my sickness my husband whom is also vaccinated, and 2 children who where not all got sick with positive covid-19 results.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, SARS-CoV-2 test positive, Secretion discharge, Sneezing
Clinical narrative: I started to have a tickle in throat on September 8th, by September 10th I also had a cough. I went to the local urgent care to get a covid test. Got my positive result on September 11th around 7am. I was 12 weeks pregnant at that time. I was advised by my OB-GYN to only take my prenatal vitamin. However for my cough I took a natural kids cough medicine to help lessen the cough. I was sick for about 15 days. Over that time I had alot of mucus, cough, sneezing very hard where I lost control of my bladder sometimes and also had some bone pain mostly in my fore arms and neck/shoulder area. During my sickness my husband whom is also vaccinated, and 2 children who where not all got sick with positive covid-19 results.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urinary incontinence
Clinical narrative: I started to have a tickle in throat on September 8th, by September 10th I also had a cough. I went to the local urgent care to get a covid test. Got my positive result on September 11th around 7am. I was 12 weeks pregnant at that time. I was advised by my OB-GYN to only take my prenatal vitamin. However for my cough I took a natural kids cough medicine to help lessen the cough. I was sick for about 15 days. Over that time I had alot of mucus, cough, sneezing very hard where I lost control of my bladder sometimes and also had some bone pain mostly in my fore arms and neck/shoulder area. During my sickness my husband whom is also vaccinated, and 2 children who where not all got sick with positive covid-19 results.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Asthenia, Dizziness, Ear discomfort, Ear pain
Clinical narrative: Body ache, slight fever, painful muscle ache, weakness, fatigue, headache, lower abdominal pain like cramping, feel like having a period, tiredness, vertigo attack, dizziness and vomitting, ear ache, left ear clicking loud,ear pressure on both ears, jaw tremor, head pressure, like flu symptoms. These symptoms were experienced for over two weeks  after the third booster vaccine on 09/30/2021. On 10/05/2021, I went to have the lower abdominal issue examined. Pelvic & Cervical exam and Urine test/culture was given and all results were normal. Up to now I still have ear and head pressure and left ear clicking.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gynaecological examination, Head discomfort, Headache, Influenza like illness
Clinical narrative: Body ache, slight fever, painful muscle ache, weakness, fatigue, headache, lower abdominal pain like cramping, feel like having a period, tiredness, vertigo attack, dizziness and vomitting, ear ache, left ear clicking loud,ear pressure on both ears, jaw tremor, head pressure, like flu symptoms. These symptoms were experienced for over two weeks  after the third booster vaccine on 09/30/2021. On 10/05/2021, I went to have the lower abdominal issue examined. Pelvic & Cervical exam and Urine test/culture was given and all results were normal. Up to now I still have ear and head pressure and left ear clicking.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Myalgia, Pain, Pyrexia, Tinnitus
Clinical narrative: Body ache, slight fever, painful muscle ache, weakness, fatigue, headache, lower abdominal pain like cramping, feel like having a period, tiredness, vertigo attack, dizziness and vomitting, ear ache, left ear clicking loud,ear pressure on both ears, jaw tremor, head pressure, like flu symptoms. These symptoms were experienced for over two weeks  after the third booster vaccine on 09/30/2021. On 10/05/2021, I went to have the lower abdominal issue examined. Pelvic & Cervical exam and Urine test/culture was given and all results were normal. Up to now I still have ear and head pressure and left ear clicking.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urine analysis normal, Vertigo, Vomiting
Clinical narrative: Body ache, slight fever, painful muscle ache, weakness, fatigue, headache, lower abdominal pain like cramping, feel like having a period, tiredness, vertigo attack, dizziness and vomitting, ear ache, left ear clicking loud,ear pressure on both ears, jaw tremor, head pressure, like flu symptoms. These symptoms were experienced for over two weeks  after the third booster vaccine on 09/30/2021. On 10/05/2021, I went to have the lower abdominal issue examined. Pelvic & Cervical exam and Urine test/culture was given and all results were normal. Up to now I still have ear and head pressure and left ear clicking.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, Palpitations
Clinical narrative: Feeling like my heart is beating out of my chest, pounding heart, fast heartbeat, uneasiness
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Nausea, Retching
Clinical narrative: Rapid heart beat, nausea, light headiness, dry heaves, with five minutes of vaccination. Zyrtec and water given Symptoms subsided with in half an hour
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Vaginal haemorrhage
Clinical narrative: vaginal bleeding believed to be menstrual cycle starting 10 days early.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Encephalitis, Myelitis transverse
Clinical narrative: transverse myelitis and encephalitis
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Blood test normal, Chest pain, Chills
Clinical narrative: Around 12:30 am on 10/24/21 I started to have very bad chills and pain in my entire left arm. Especially the joints. I started experiencing body aches as well. Around 1:30 am on 10/24/21, I started having severe chest pain. There was a stabbing sensation going in through my heart out to my shoulder blade. The pain radiated from my heart into my left collar bone, armpit, shoulder and jaw. There was a loss of grip strength in my left hand and I had a very bad headache. Around 5:30am I got very nauseous and started to vomit. Around 8:00 am I noticed swelling in my left armpit. The flu like symptoms only lasted 24 hours, but the chest pain continued. I went to ED on 10/26/21 and they said it was muscular. I went to Cardiologist on 11/1 and they said the vaccine most likely triggered my pericarditis.  I did also receive my flu vaccine on 10/23/21 (in right arm). I did not add it because I did not know which one it was.