chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Diarrhoea, Feeling abnormal, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: pain in hands; He feels blood rushes from waist to feet when he stands too fast; diarrhea worsened for 10 days following booster; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer (DOSE 1, DOSE 2)), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset Jan2022, outcome "recovering", described as "diarrhea worsened for 10 days following booster"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in hands"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "He feels blood rushes from waist to feet when he stands too fast". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient reported he had COVID booster Jan2022 and diarrhea worsened for 10 days following booster. symptoms have now improved to where they were prior to booster. He feels blood rushes from waist to feet when he stands too fast. this feeling passes in less than 30 seconds - new since start of therapy and has been happening less often lately. MD is not aware and he is advised to update. Patient reported lab work last week (no date) C - reactive protein 23.3/sedimentation rate 34, both elevated has not discussed with MD. Reported since covid booster Jan2022 experienced pain in hands which has gotten worse in last few weeks (no date). Unsure if md aware.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Pruritus, Swelling, Urticaria
Clinical narrative: Swelling, hives, itching. Still ongoing but in lesser places. I?m on antihistamines for about a week now. Diagnosis: Spontaneous Chronic Urticaria
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Influenza, Influenza like illness
Clinical narrative: insomnia which made her stay awake all night; heart was racing; light headed; body felt weak; really nauseous; which ended up to her vomiting; dry heaving for 10 mins; started seeing spots/ tried looking on phone but all the words were moving around; Flu like symptoms; she had a flu which she said was expected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administration date 06Feb2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset 07Feb2022, outcome "recovered", described as "she had a flu which she said was expected"; INSOMNIA (non-serious) with onset 09Feb2022, outcome "unknown", described as "insomnia which made her stay awake all night"; PALPITATIONS (non-serious) with onset 09Feb2022, outcome "unknown", described as "heart was racing"; DIZZINESS (non-serious) with onset 09Feb2022, outcome "not recovered", described as "light headed"; ASTHENIA (non-serious) with onset 09Feb2022, outcome "not recovered", described as "body felt weak"; NAUSEA (non-serious) with onset 09Feb2022, outcome "unknown", described as "really nauseous"; VOMITING (non-serious) with onset 09Feb2022, outcome "unknown", described as "which ended up to her vomiting"; RETCHING (non-serious) with onset 09Feb2022, outcome "recovered", described as "dry heaving for 10 mins"; VISUAL IMPAIRMENT (non-serious) with onset 09Feb2022, outcome "unknown", described as "started seeing spots/ tried looking on phone but all the words were moving around"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Feb2022, outcome "recovered", described as "Flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Palpitations, Retching, Visual impairment
Clinical narrative: insomnia which made her stay awake all night; heart was racing; light headed; body felt weak; really nauseous; which ended up to her vomiting; dry heaving for 10 mins; started seeing spots/ tried looking on phone but all the words were moving around; Flu like symptoms; she had a flu which she said was expected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administration date 06Feb2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset 07Feb2022, outcome "recovered", described as "she had a flu which she said was expected"; INSOMNIA (non-serious) with onset 09Feb2022, outcome "unknown", described as "insomnia which made her stay awake all night"; PALPITATIONS (non-serious) with onset 09Feb2022, outcome "unknown", described as "heart was racing"; DIZZINESS (non-serious) with onset 09Feb2022, outcome "not recovered", described as "light headed"; ASTHENIA (non-serious) with onset 09Feb2022, outcome "not recovered", described as "body felt weak"; NAUSEA (non-serious) with onset 09Feb2022, outcome "unknown", described as "really nauseous"; VOMITING (non-serious) with onset 09Feb2022, outcome "unknown", described as "which ended up to her vomiting"; RETCHING (non-serious) with onset 09Feb2022, outcome "recovered", described as "dry heaving for 10 mins"; VISUAL IMPAIRMENT (non-serious) with onset 09Feb2022, outcome "unknown", described as "started seeing spots/ tried looking on phone but all the words were moving around"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Feb2022, outcome "recovered", described as "Flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: insomnia which made her stay awake all night; heart was racing; light headed; body felt weak; really nauseous; which ended up to her vomiting; dry heaving for 10 mins; started seeing spots/ tried looking on phone but all the words were moving around; Flu like symptoms; she had a flu which she said was expected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administration date 06Feb2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset 07Feb2022, outcome "recovered", described as "she had a flu which she said was expected"; INSOMNIA (non-serious) with onset 09Feb2022, outcome "unknown", described as "insomnia which made her stay awake all night"; PALPITATIONS (non-serious) with onset 09Feb2022, outcome "unknown", described as "heart was racing"; DIZZINESS (non-serious) with onset 09Feb2022, outcome "not recovered", described as "light headed"; ASTHENIA (non-serious) with onset 09Feb2022, outcome "not recovered", described as "body felt weak"; NAUSEA (non-serious) with onset 09Feb2022, outcome "unknown", described as "really nauseous"; VOMITING (non-serious) with onset 09Feb2022, outcome "unknown", described as "which ended up to her vomiting"; RETCHING (non-serious) with onset 09Feb2022, outcome "recovered", described as "dry heaving for 10 mins"; VISUAL IMPAIRMENT (non-serious) with onset 09Feb2022, outcome "unknown", described as "started seeing spots/ tried looking on phone but all the words were moving around"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Feb2022, outcome "recovered", described as "Flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Acne, Folliculitis, Nasal congestion, Rhinorrhoea
Clinical narrative: folliculitis; follicular acne; sniffly/runny nose; sniffly/runny nose; slightly congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing), notes: individual has a heart condition that I believe is associated with Marfan's; "Marfan syndrome" (unspecified if ongoing), notes: individual has a heart condition that I believe is associated with Marfan's. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 Immunization. The following information was reported: FOLLICULITIS (non-serious), outcome "unknown", described as "folliculitis"; ACNE (non-serious), outcome "unknown", described as "follicular acne"; RHINORRHOEA (non-serious), RHINORRHOEA (non-serious) all with onset 04Feb2022, outcome "unknown" and all described as "sniffly/runny nose"; NASAL CONGESTION (non-serious) with onset 04Feb2022, outcome "recovered" (Feb2022), described as "slightly congestion".  Additional information: Patient developed a sniffly/runny nose in the afternoon. Patient had folliculitis or follicular acne or something like these previously.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Since 5-6 Year of Age; "Urticaria" (ongoing), notes: Since 5-6 Year of Age; "Raynaud's phenomenon" (ongoing), notes: Verbatim: Raynaud's disease. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "First Dose: dizzy". Therapeutic measures were taken as a result of dizziness. Additional information: Reporter stated the dates of the adverse events are unknown but they were like hers, dizzy with the first and then right after second one, it hit her like a ton of bricks with the side adverse effects are the exact same as she had. The patient had treatment with Motrin and Tylenol and stayed home. Stated her sister got her vaccine at her place of work. Follow-up attempts completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Retching
Clinical narrative: symptom milder-some dry heaves; loss of appetite. but not as bad as past shot; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 01Mar2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 10Aug2021 08:30 (Batch/Lot number: unknown) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6206, Doses: 0.3 mL, Route of administration: Intramuscular, Anatomical location: Upper arm muscle), administration date: 07Mar2021, when the patient was 82 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE , Lot number: NDC 59267-1000-02, Route of administration: Intramuscular, Anatomical location: Upper arm muscle), administration date: 28Mar2021, when the patient was 82 years old, for Covid-19 immunization. The following information was reported: RETCHING (non-serious), outcome "not recovered", described as "symptom milder-some dry heaves"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "loss of appetite. but not as bad as past shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "I didn't feel good for couple days and something like that but it was not anything you know major". The patient was a nurse many years ago and now she retired. The patient wanted to know why in the local location for the majority of healthcare providers when they give the Pfizer Covid19 vaccination, why do they not say any instructions to aspirate before injecting into the deltoid muscle. It was stated that people have had reactions to the vaccination (further clarifications unknown) and reporter think part of it was, it was pretty rare to hit a vessel in your deltoid muscle but it was possible. That was the gold standard and want to know there was no, don't think there was any negative reason for aspirating, it would not affect the vaccination at all because the person would still get the same amount of medication. The patient just wants to know why Pfizer just to prevent even a rare instance of a person getting that right in to their vein or their artery, that they wouldn't just say aspirate before injection. The patient had both vaccinations and booster all being Pfizer and never even questioned when healthcare provider was giving the vaccination because assumed that they were aspirating. So, that's question cause  think it was very important because even if it's very rare that they would hit a vessel and inject that vaccinations if even part of it, into a vessel which could cause some serious side effects including myocarditis and pericarditis which has happened to people (Further clarifications unknown. Hence, split case not made. The patient asking why they would not just put in the instructions, must aspirate before injection. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 16 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, got the last dose of the primary series (Pfizer-BioNTech COVID-19 Vaccine) on Jun2021), administration date: Jun2021, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "muscle and armpit pain after getting the booster dose". Therapeutic measures were taken as a result of myalgia, axillary pain. Additional information: Reporter stated that her daughter (16 years old) got the last dose of the primary series (Pfizer-BioNTech COVID-19 Vaccine) on Jun2021 and this Friday on 18Feb2022 got the booster dose. Reporter would like to know the difference between the primary series and the booster in terms of dosage and queried were they the same or was it just half the usual dose like Moderna. Reporter also stated that her daughter (16 years old) has experienced muscle and armpit pain after getting the booster dose and queried other than applying ice and taking Tylenol, what can we do, was it normal. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Petechiae
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (parent). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine,  batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient developed petechiae (experienced petechiae on her extremities that went away on its own), and lethargy (went away on its own), with outcome of recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Parosmia, Peripheral swelling, Swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), administration date: Mar2021, for Covid-19 Immunization, reaction(s): "the vaccine in Mar or Apr last year and then I got Covid pretty bad in Aug", "the vaccine in Mar or Apr last year and then I got Covid pretty bad in Aug"; Covid-19 vaccine (Dose 2, Manufacturer Unknown), administration date: Mar2021, for Covid-19 Immunization, reaction(s): "the vaccine in Mar or Apr last year and then I got Covid pretty bad in Aug"; Covid-19 vaccine (Dose 2, Manufacturer Unknown), administration date: Apr2021, for Covid-19 Immunization, reaction(s): "the vaccine in Mar or Apr last year and then I got Covid pretty bad in Aug". The following information was reported: PAROSMIA (non-serious), outcome "not recovered", described as "Smell burning all the time"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Under my arm started swelling up"; SWELLING (non-serious) with onset 25Feb2022, outcome "unknown", described as "Whole chest is swollen". Additional information: Patient had the shot, the vaccine in Mar or Apr last year and then got Covid pretty bad in Aug and then patient had the booster in Oct and now all of a sudden patient smell burning all the time, for like two months now patient had been smelling burning in house and patient searched everywhere and then all whatever 'the clothes patient wear' whatever under patient arm started swelling up and today patient's whole chest was swollen almost like it was like it's fluid'. Patient inquired was that a side effect from the Vaccine. Patient was on the way to the hospital (further not clarified) now because patient's whole chest was swelling up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Cough, Malaise, Pain, Pulmonary pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 26Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: PULMONARY PAIN (non-serious), outcome "unknown", described as "pain in lungs"; COUGH (non-serious), outcome "unknown", described as "Dry cough"; MALAISE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "not feeling well and is in pain"; ANXIETY (non-serious), outcome "unknown", described as "worry". Additional information: Took the third dose on Saturday, 26Feb2022, six days ago. Clarified product as Pfizer Covid vaccine. Has pain in lungs. The lungs are hurting for three days now. Reporter was kind of worried, Lungs feels like they hurt, dry cough and lungs hurt a lot. Reporter not feeling well and is in pain. Starting to worry. Didn't have this with second one but did with the third. Reporter was not sure what was in the shot because it doesn't specify on the papers. They need to know the chemicals inside the shot. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "She got a Booster Vaccine yesterday and she is having fever up to 103.9 and it is 103.5 right now after taking Tylenol". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter was Consumer or other non health professional. Dates for She got a Booster Vaccine yesterday and she is having fever up to 103.9 and it is 103.5 right now after taking Tylenol: (From: Unspecified To: Unspecified).The reporter had COVID-19 Vaccine a Pfizer product. The COVID-19 Vaccine and Tylenol a Pfizer product manufacturer , NDC , UPC number and Expiry date were unknown. The reporter was asked When probed for the concern, reporter stated, "So, my "cousin" (further not clarified), she (consumer) got a Booster (Pfizer, COVID-19 Vaccine) yesterday and she has been having fever of up to 103.9. When paraphrased to confirm the concern, reporter stated, "Yes, so she is having fever and the fever is up to 103.9 and it's 103.5 right now after taking Tylenol (Tylenol captured as suspect conservatively)". (Tylenol Manufacturer further not clarified hence left unchecked in the tab). The Reporter was informed about Pfizer Medical Information Department and provided contact. The Reporter stated, "Are they (MI Department) still open right now. The Reporter was provided with the number of Pfizer Medical Information and was requested to select option 3 and timings as 8 am to 9 pm from Monday to Friday as per (EST). In response to MI timing, reporter stated, "Then what can I do now and Reporter was informed to contact nearest Emergency care and did not meet only had Healthcare card. The reporter asked Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default. Follow-up (15Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Aphthous ulcer
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 14:00 (Lot number: ER8730) at the age of 71 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FINASTERIDE; ATORVASTATIN; METOPROLOL; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose 1, single Lot number: EL9266, arm left, Time: 14:00), administration date: 27Feb2021, for COVID-19 immunization. The following information was reported: APHTHOUS ULCER (non-serious), ACNE (non-serious) all with onset 01Oct2021 12:00, outcome "not recovered" and all described as "Canker sores continual since October 2021. Pimples on scalp Oct, Nov, Dec2021. Curious if these are related to vaccine". The event "canker sores continual since October 2021. pimples on scalp oct, Nov, Dec2021. Curious if these are related to vaccine" and "canker sores continual since October 2021. pimples on scalp Oct, Nov, Dec2021. Curious if these are related to vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of aphthous ulcer, acne. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The reporter considered the events as non-serious. Hospitalization prolonged was reported as no. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Received booster dose Pfizer Covid 19 Vaccine and had a rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown. Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "not recovered", described as "Received booster dose Pfizer Covid 19 Vaccine and had a rash". Therapeutic measures were taken as a result of rash.  Additional information: The patient was seen by a dermatologist, however the rash has not gone away. The dermatologist prescribed medication, but the rash was still there. Caller had a rash and was prescribed Unknown medication by dermatologist but the rash had not gone away. Medication name was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Head discomfort, Headache, Migraine, Vomiting
Clinical narrative: my migraines have returned almost daily; lost 20 pounds; couldn't eat; throwing up a lot; pressure; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 12Oct2021 (Lot number: FF2589) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Comirnaty (Dose:1, Lot: EN5318, Anatomical Location: Right arm), administration date: 05Feb2021, when the patient was 77 years old, for Covid-19 immunization; Comirnaty (Dose:2, Lot: EN6199, Anatomical Location: Right arm), administration date: 05Mar2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious), outcome "recovering", described as "my migraines have returned almost daily"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 20 pounds"; EATING DISORDER (non-serious), outcome "unknown", described as "couldn't eat"; VOMITING (non-serious), outcome "unknown", described as "throwing up a lot"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure"; HEADACHE (non-serious), outcome "unknown", described as "headache". The event "my migraines have returned almost daily" was evaluated at the physician office visit. Therapeutic measures were taken as a result of migraine.  Additional Information: Migraines that have returned almost daily: The caller was having almost no migraines for a long period of time and then after the caller received the booster dose Comirnaty, the migraines were daily. The caller has lost 20 pounds because couldn't eat and was throwing up a lot. Caller clarifies losing 20 pounds because couldn't eat and throwing up a lot occurred after receiving booster dose Comirnaty. Right now, at this moment the migraines seem a little better. The caller still has pressure and headache. Her doctor gave her a short term Prednisone and it did help while on, but now they are starting to come back again. Since it is heritary, she worries about her grandkids taking the vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: my migraines have returned almost daily; lost 20 pounds; couldn't eat; throwing up a lot; pressure; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 12Oct2021 (Lot number: FF2589) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Comirnaty (Dose:1, Lot: EN5318, Anatomical Location: Right arm), administration date: 05Feb2021, when the patient was 77 years old, for Covid-19 immunization; Comirnaty (Dose:2, Lot: EN6199, Anatomical Location: Right arm), administration date: 05Mar2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious), outcome "recovering", described as "my migraines have returned almost daily"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 20 pounds"; EATING DISORDER (non-serious), outcome "unknown", described as "couldn't eat"; VOMITING (non-serious), outcome "unknown", described as "throwing up a lot"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure"; HEADACHE (non-serious), outcome "unknown", described as "headache". The event "my migraines have returned almost daily" was evaluated at the physician office visit. Therapeutic measures were taken as a result of migraine.  Additional Information: Migraines that have returned almost daily: The caller was having almost no migraines for a long period of time and then after the caller received the booster dose Comirnaty, the migraines were daily. The caller has lost 20 pounds because couldn't eat and was throwing up a lot. Caller clarifies losing 20 pounds because couldn't eat and throwing up a lot occurred after receiving booster dose Comirnaty. Right now, at this moment the migraines seem a little better. The caller still has pressure and headache. Her doctor gave her a short term Prednisone and it did help while on, but now they are starting to come back again. Since it is heritary, she worries about her grandkids taking the vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the COVID-19 vaccine (primary immunization series complete; manufacturer unknown), for immunization. The patient experienced an adverse reaction (had an immune reaction/diagnosis after getting the booster), with outcome of unknown. Additional information: Adverse reaction after the COVID-19 vaccine booster. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: High fever; chills; tiredness; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): NUS2022US032691_NC.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "High fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, SARS-CoV-2 test
Clinical narrative: I got cold sores in my mouth after each vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2022 (Lot number: FM0698) at the age of 60 years as dose 3 (booster), single, administration date 27Aug2021 (Lot number: FC3180) as dose 2, single and administration date 06Aug2021 (Lot number: PC3180) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: ORAL HERPES (non-serious) with onset 07Aug2021, outcome "recovering", described as "I got cold sores in my mouth after each vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oral herpes.  additional information: the patient did not received other vaccine in four weeks and received Other medications in two weeks. no Covid prior vaccination, covid tested post vaccination and Known patient had no know allergies  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Rash
Clinical narrative: Expiration date booster: 26Sep2021; skin rash/ it also is less frequent and less invasive further I get from most recent vac. date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Sep2021 15:00 (Lot number: FE3592, Expiration Date: 26Sep2021) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "A Fib", start date: 15Apr2017 (unspecified if ongoing), notes: Ablation 15May2021; "Type 1 Diabetes", start date: 15Jan1986 (ongoing), notes: Diagnosed; "RA", start date: 15Sep2019 (ongoing), notes: Diagnosed; "Blood pressure" (ongoing). Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis, start date: Dec2019 (ongoing); HUMALOG taken for diabetes mellitus, start date: Jan1986 (ongoing); LANTUS taken for diabetes mellitus, start date: Jan1986 (ongoing); ATENOLOL taken for blood pressure measurement (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Time:10:00 PM, Intramuscular, Anatomical site: Left arm, Batch number: EL9262, Exp date: 31May2021), administration date: 21Jan2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Skin rash", "pressure on his skin", "a red rash normally on my arms, thighs, stomach, back", "sting"; Bnt162b2 (Dose 2, Time: 10:00 PM, Intramuscular, Left arm, Batch number: EL9267, Exp date: 31May2021), administration date: 10Feb2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Reports treatment first dose 24Jan2021 ;second dose 10Feb2021". The following information was reported: RASH (non-serious) with onset 2021, outcome "recovering", described as "skin rash/ it also is less frequent and less invasive further I get from most recent vac. date"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 26Sep2021, outcome "unknown", described as "Expiration date booster: 26Sep2021".  Additional information: Patient reported his rash is related to skin being pressurized is his skin up, sex, tagging shoes, blood pressure ups etc. It is a red rash normally on his arms, thighs, stomach, back. It stings but not badly. It goes away in 10 mins after the aggravating factor nor stopped. Exercise itself won't cause it i.e jogging won't cause it but yoga will. It also is less frequent and less invasive the further. he got from most recent vaccination date. Family medical history relevant to AE's and Relevant Test were None. Specific relevant test for thromboembolic events with thrombocytopenia: None  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug interaction
Clinical narrative: received four separate Restylane Kysse Injections. Her lips plump up nicely when injected, but then deflate back to normal after two weeks. Patient reported having had the Pfizer Covid-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-030122-5283.  A 27-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; hyaluronic acid (RESTYLANE) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "received four separate Restylane Kysse Injections. Her lips plump up nicely when injected, but then deflate back to normal after two weeks. Patient reported having had the Pfizer Covid-19 vaccine". The action taken for hyaluronic acid was unknown.  Additional information: Patient stated, over the past year, consumer received four separate Restylane Kysse Injections. Her lips plump up nicely when injected, but then deflate back to normal after two weeks. I've had Kysse injected four times, two months apart, and the same thing happens each time. It only lasts two weeks. Then I tried Juvederm xc that lasted a while, just got it retouched up a couple of days ago. Patient reported having had the Pfizer Covid-19 vaccine, but details were not provided  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joints hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joints hurt".  Additional information: The patient reported that his joints hurted now after activities and he felt 95 after receiving Covid vaccine. It was worse after part 2 also.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Product administered at inappropriate site
Clinical narrative: On day 19 after getting the Pfizer Covid vaccine started experiencing weakness in the right foot having difficulty walking, having a slapping gait; On day 19 after getting the Pfizer Covid vaccine started experiencing weakness in the right foot & having difficulty walking, having a slapping gait; vaccine_location=Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in leg left, administration date 09Feb2022 08:30 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 28Feb2022, outcome "not recovered", described as "On day 19 after getting the Pfizer Covid vaccine started experiencing weakness in the right foot having difficulty walking, having a slapping gait"; GAIT DISTURBANCE (non-serious) with onset 28Feb2022, outcome "not recovered", described as "On day 19 after getting the Pfizer Covid vaccine started experiencing weakness in the right foot & having difficulty walking, having a slapping gait"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 09Feb2022 08:30, outcome "unknown", described as "vaccine_location=Left leg". The event "on day 19 after getting the pfizer covid vaccine started experiencing weakness in the right foot having difficulty walking, having a slapping gait" was evaluated at the physician office visit. Therapeutic measures were taken as a result of asthenia. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She received orthopedic boot for the adverse event. Prior to vaccination, she was not diagnosed with COVID-19. Since the vaccination, she was not tested for COVID-19. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient received received Orthopedic boot for the adverse event.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: he no longer had depression; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "severe depression", "colds"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "severe depression", "colds". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "he no longer had depression".  Additional Information: Is The Reporter A Healthcare Professional (HCP)? No; Occupation/Specialty: Unknown, Is the reporter contact information available to you or a sub-contracted party? Unknown, Is The Reporter The Prescribing HCP? No, Name: Unknown, Address: Unknown, Occupation/Specialty: Unknown, Suspect Product(s): (provide Name/Indication/Dosage/Start and Stop date where possible):  Pfizer Covid-19 Vaccine, Start Date: Unknown, Stop Date: Unknown, Verbatim And Event Description: Patient Had Severe Depression And Only Had Colds After The First 2 Doses, When He Had The 3rd Dose Wanted To Inform And Thank Pfizer. This call was from sponsored program line Swap to Covid, Caller hangs up, Submitted AE form. Medical Information Were any medical questions addressed by this program forwarded/referred to Medical Information? (Live Operators Only): NO: Customer and/or medical inquiry was NOT forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: skin rash with itching only; skin rash with itching only; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2022 (Lot number: FL3209) at the age of 45 years as dose 3 (booster), single and intramuscular, administered in arm left, administration date 31Aug2021 (Lot number: FP8448) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st , Anatomical Site of Injection: Left Arm, Route of Administration: Intramuscular, Lot No: FA7485), administration date: 10Aug2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "Small rash on chest, upper back and right arm opposite arm from vaccination site", "Dry cough", "Flu like symptoms", "no appetite", "Feeling very tired", "some stuffiness", "runny nose", "Headache", "feverish", "Generalized pruritus with skin rash/Constant rash with itching". The following information was reported: RASH (non-serious), PRURITUS (non-serious) all with onset 01Sep2021, outcome "recovered" and all described as "skin rash with itching only". Therapeutic measures were taken as a result of rash, pruritus.  Additional information: Vaccination Facility Type: Pharmacy or Drug Store, Vaccine Administered at Military Facility: No, treatment received for events with Hydrocortisone cream over the counter.  Follow-up attempts are completed. No further information is expected.