chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Racing/pounding heart; short of breath; nasuea; fever; diarehea; dizziness; headache; chills; body aches; weakess; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Sep2021 12:00 (Lot number: fd8448) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had Covid Nov 2020", start date: Nov2020 (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LEVOTHYROXINE and multi vitamin. The following information was reported: PALPITATIONS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "Racing/pounding heart"; DYSPNOEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "short of breath"; NAUSEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "nasuea"; PYREXIA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "fever"; DIARRHOEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "diarehea"; DIZZINESS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "dizziness"; HEADACHE (non-serious) with onset 05Sep2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 05Sep2021, outcome "not recovered", described as "body aches"; ASTHENIA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "weakess". The events "racing/pounding heart", "short of breath", "nasuea", "fever", "diarehea", "dizziness", "headache", "chills", "body aches" and "weakess" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, dyspnoea, nausea, pyrexia, diarrhoea, dizziness, headache, chills, pain, asthenia.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal discomfort, Rash, Tinnitus
Clinical narrative: Constant ringing in ears; Hips and legs feel very heavy; Hips and legs feel very heavy; Minor rash on wrists; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Sep2021 10:00 (Lot number: EW0187) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: known allergies: Sulfa antibiotics; "Asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Demerol, reaction(s): "known allergies", notes: known allergies: demerol; Dilaudid, reaction(s): "known allergies", notes: known allergies: dilaudid. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EW0187, lot unknown=False, administration date=30Aug2021, administration time=10:00 AM, dose number=1, vaccine location=Right arm), administration date: 30Aug2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: TINNITUS (non-serious) with onset 21Sep2021 08:00, outcome "not recovered", described as "Constant ringing in ears"; MUSCULOSKELETAL DISCOMFORT (non-serious), LIMB DISCOMFORT (non-serious) all with onset 21Sep2021 08:00, outcome "not recovered" and all described as "Hips and legs feel very heavy"; RASH (non-serious) with onset 21Sep2021 08:00, outcome "not recovered", described as "Minor rash on wrists". Therapeutic measures were not taken as a result of tinnitus, musculoskeletal discomfort, limb discomfort, rash.  Follow-up (24Sep2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia
Clinical narrative: When given the injection I got a burning sensation in my chest and stomach that lasted 1 hour; When given the injection I got a burning sensation in my chest and stomach that lasted 1 hour; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 16:30 (Lot number: FC3184) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Brain injury" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Food and drug allergies" (unspecified if ongoing), notes: known allergies: Food and drug allergies; "Food and drug allergies" (unspecified if ongoing), notes: known allergies: Food and drug allergies. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious), DYSPEPSIA (non-serious) all with onset 18Sep2021, outcome "recovered" (Sep2021) and all described as "When given the injection I got a burning sensation in my chest and stomach that lasted 1 hour". Therapeutic measures were not taken as a result of chest pain, dyspepsia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Hospitalization prolonged. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Oedema peripheral
Clinical narrative: joint pain on the insides of my knees; Adema in both of my legs from the knee down that lasted for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 10:00 (Lot number: FC3183) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DUPIXENT. The following information was reported: OEDEMA PERIPHERAL (non-serious) with onset 24Aug2021 09:00, outcome "not recovered", described as "Adema in both of my legs from the knee down that lasted for 24 hours"; ARTHRALGIA (non-serious) with onset Sep2021, outcome "not recovered", described as "joint pain on the insides of my knees". The events "adema in both of my legs from the knee down that lasted for 24 hours" and "joint pain on the insides of my knees" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of oedema peripheral, arthralgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Dupixent. The seriousness criteria reported as NO included: results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect. After the first Pfizer vaccine the next morning I had Adema in both of my legs from the knee down that lasted for 24 hours. About two weeks later I started having joint pain on the insides of my knees that have not gone away. AE resulted in: Doctor or other healthcare professional office/clinic visit. Hospitalization Prolonged: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Known allergies: No. Other medical history: No. The seriousness of adverse events was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: Persistent cough; Fever; Chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: COUGH (non-serious), outcome "unknown", described as "Persistent cough"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional information: Fever chills persistent cough-first shot, Nauseous and uncomfortable with second shot, Event took place after use of product. Reporter does not wish to be contacted for follow-up.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart alternation, Heart rate increased
Clinical narrative: last night she was feeling a small wheeze in her chest; heart beating fast; loud thump when it beats in her chest; This is a spontaneous report received from contactable consumers (one was patient). A 48 year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FF2588), via an unspecified route of administration on 16Sep2021 as DOSE 1, SINGLE on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Sep2021 she began to experience her heart beating fast and she could hear a loud thump when it beats in her chest. She was treated in the Emergency room. Patient states she has a question, as a secondary side effect, was the heart beating fast or louder thumps, is this a side effect of the vaccine. Patient clarifies that she experienced this after her dose of the vaccine. Patient stated last night she was feeling a small wheeze in her chest, states it was just staying the same. Patient states she did go to the emergency room. The outcome of heartbeats increased was not recovered while outcome for other events was unknown.  Follow-Up (19Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Shortness of breath/difficulty breathing; Rapid heart beat; 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 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 17:15 (Lot number: FE3592) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset Sep2021, outcome "unknown", described as "Shortness of breath/difficulty breathing"; HEART RATE INCREASED (non-serious) with onset Sep2021, outcome "unknown", described as "Rapid heart beat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states is it a common thing, her 15 year old daughter got her 1st dose on Monday and she is complaining of shortness of breath and now is complaining that it is difficult to breathe so she is not sure if it's a side effect from the vaccine. Caller is asking had anyone else experienced this. Caller states she looked up side effects and didn't see shortness of breath listed. Caller states she was having allergy like symptoms but the breathing is new. When queried caller states she does not need emergent care, she is eating right now and she is ok. Prescribing Healthcare Professional Info: Caller does not have information to provide, that even prior to Covid they did doctor on demand and don't have a specific provider. Caller states she got her 1st dose on 20Sep2021 and the shortness of breath started Tuesday in the afternoon. States she was sent home from school yesterday because she was having difficulty breathing in the mid afternoon. Caller states she thinks she is going through different periods of it, that she remembers when she, the caller, got Covid she had to do steam showers and she has been making her daughter do that and that helps, she can go a couple of hours and then go back and do it again. Caller states they were in the car and she started freaking out and she told her not to hyperventilate and create a serious issue for herself.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Urticaria, Vulval ulceration
Clinical narrative: a red welt on my left arm that got to be 4cm round; sore; itchy; developed a painful labial ulcer on left side; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 11:00 (Lot number: FD8448) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Right side Frozen shoulder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "avacado allergy" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; ZOLOFT. Past drug history included: Codiene, reaction(s): "known allergies: codiene", notes: known allergies: codiene. The following information was reported: URTICARIA (non-serious) with onset 03Sep2021 14:00, outcome "recovering", described as "a red welt on my left arm that got to be 4cm round"; PAIN (non-serious) with onset 03Sep2021 14:00, outcome "recovering", described as "sore"; PRURITUS (non-serious) with onset 03Sep2021 14:00, outcome "recovering", described as "itchy"; VULVAL ULCERATION (non-serious) with onset 03Sep2021 14:00, outcome "recovering", described as "developed a painful labial ulcer on left side". The events "a red welt on my left arm that got to be 4cm round", "sore", "itchy" and "developed a painful labial ulcer on left side" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, pain, pruritus, vulval ulceration.  Additional information: Had a red welt on my left arm that got to be 4cm round hot sore itchy then developed a painful labial ulcer on left side. AE treatment: hSV cultire  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye irritation, Feeling abnormal, Headache, Pyrexia
Clinical narrative: I have a temperature 100.2 right now; I have little weird feeling this morning like heavy headache; I have little weird feeling this morning like heavy headache; burning over my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 21Sep2021 (Lot number: EW0191) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had COVID" (unspecified if ongoing), notes: I had COVID (further clarification unknown) in March I know I have the antibodies. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "I have a temperature 100.2 right now"; FEELING ABNORMAL (non-serious), HEADACHE (non-serious) all with onset 22Sep2021, outcome "unknown" and all described as "I have little weird feeling this morning like heavy headache"; EYE IRRITATION (non-serious) with onset Sep2021, outcome "unknown", described as "burning over my eyes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, feeling abnormal, headache, eye irritation. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: injection site pain; headache; fever; chills; worsened joint pain; on and off fast heart beat; dizziness on and off/lightheaded; rash all over her body; her back and stomach are itchy; Fatigue; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Lot number: FC3183) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "COPD" (ongoing); "type 2 diabetic" (ongoing), notes: She started to become diabetic around age 36 to 37; "bronchitis" (unspecified if ongoing); "million allergies" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "injection site pain"; HEADACHE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "headache"; PYREXIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "fever"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "chills"; ARTHRALGIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "worsened joint pain"; HEART RATE IRREGULAR (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "on and off fast heart beat"; DIZZINESS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "dizziness on and off/lightheaded"; RASH (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "rash all over her body"; PRURITUS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "her back and stomach are itchy"; FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "sore arm".  Additional information: She was diagnosed with COPD maybe within a year or two ago. She was at the hospital for bronchitis and they claimed that she had COPD. She has a million allergies to who knows what. She has had her allergies since she was a kid so now she is allergic to who knows what. Maybe her side effects are from whatever. She is the type that if the doctor gives her a typical medicine for anything then she will have a bad reaction. Her doctors don't know what to do with her. She will have reactions, rash or a rapid heart beat or whatever to anything.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Pain in extremity, Pruritus, Pyrexia, Rash
Clinical narrative: injection site pain; headache; fever; chills; worsened joint pain; on and off fast heart beat; dizziness on and off/lightheaded; rash all over her body; her back and stomach are itchy; Fatigue; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Lot number: FC3183) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "COPD" (ongoing); "type 2 diabetic" (ongoing), notes: She started to become diabetic around age 36 to 37; "bronchitis" (unspecified if ongoing); "million allergies" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "injection site pain"; HEADACHE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "headache"; PYREXIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "fever"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "chills"; ARTHRALGIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "worsened joint pain"; HEART RATE IRREGULAR (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "on and off fast heart beat"; DIZZINESS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "dizziness on and off/lightheaded"; RASH (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "rash all over her body"; PRURITUS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "her back and stomach are itchy"; FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "sore arm".  Additional information: She was diagnosed with COPD maybe within a year or two ago. She was at the hospital for bronchitis and they claimed that she had COPD. She has a million allergies to who knows what. She has had her allergies since she was a kid so now she is allergic to who knows what. Maybe her side effects are from whatever. She is the type that if the doctor gives her a typical medicine for anything then she will have a bad reaction. Her doctors don't know what to do with her. She will have reactions, rash or a rapid heart beat or whatever to anything.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; headache; fever; chills; worsened joint pain; on and off fast heart beat; dizziness on and off/lightheaded; rash all over her body; her back and stomach are itchy; Fatigue; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Lot number: FC3183) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "COPD" (ongoing); "type 2 diabetic" (ongoing), notes: She started to become diabetic around age 36 to 37; "bronchitis" (unspecified if ongoing); "million allergies" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "injection site pain"; HEADACHE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "headache"; PYREXIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "fever"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "chills"; ARTHRALGIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "worsened joint pain"; HEART RATE IRREGULAR (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "on and off fast heart beat"; DIZZINESS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "dizziness on and off/lightheaded"; RASH (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "rash all over her body"; PRURITUS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "her back and stomach are itchy"; FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "sore arm".  Additional information: She was diagnosed with COPD maybe within a year or two ago. She was at the hospital for bronchitis and they claimed that she had COPD. She has a million allergies to who knows what. She has had her allergies since she was a kid so now she is allergic to who knows what. Maybe her side effects are from whatever. She is the type that if the doctor gives her a typical medicine for anything then she will have a bad reaction. Her doctors don't know what to do with her. She will have reactions, rash or a rapid heart beat or whatever to anything.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: bad allergic reaction; This is a spontaneous report received from a contactable Physician for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "bad allergic reaction". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Muscular weakness, Myalgia
Clinical narrative: Lightheadedness/dizziness; Weak leg; Muscle pain in legs; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Aug2021 (Lot number: EW0175) at the age of 59 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE; ATORVASTATIN; GABAPENTIN; SERTRALINE; TRELEGY; VENTOLINE [SALBUTAMOL]; LISINOPRIL; FUROSEMIDE; ALBUTEROL [SALBUTAMOL]; ASPIRIN [ACETYLSALICYLIC ACID]; JANUMET; FARXIGA; NOVOLOG. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: BioNTech, Lot number: EW0175, Dose number: 1, Vaccine location: Right arm), administration date: 05Aug2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 09Sep2021, outcome "not recovered", described as "Lightheadedness/dizziness"; MUSCULAR WEAKNESS (non-serious) with onset 09Sep2021, outcome "not recovered", described as "Weak leg"; MYALGIA (non-serious) with onset 09Sep2021, outcome "not recovered", described as "Muscle pain in legs"; DYSPNOEA (non-serious) with onset 09Sep2021, outcome "not recovered", described as "Shortness of breath". It was unknown if therapeutic measures were taken as a result of dizziness, muscular weakness, myalgia, Dyspnoea.  Additional information: It was unknown if the received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether patient was diagnosed with COVID-19 Prior to vaccination. The patient was not tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Iritis, SARS-CoV-2 test
Clinical narrative: Inflammation throughout body; Iritis in left eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 12:00 (Lot number: FD0809) at the age of 19 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: INFLAMMATION (non-serious) with onset 19Sep2021 16:00, outcome "not recovered", described as "Inflammation throughout body"; IRITIS (non-serious) with onset 19Sep2021 16:00, outcome "not recovered", described as "Iritis in left eye". The events "inflammation throughout body" and "iritis in left eye" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation, iritis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. The treatment received for the adverse event was eye drops. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chest discomfort, Decreased appetite, Diarrhoea
Clinical narrative: sonic issues and feels like burning; sonic issues and feels like burning; chest does not feel right in which she stated "her heart does not feel right".; diarrhea; lost of appetite; her joints hurt; her face is swollen around her chin.; arm hurts; chest and stomach does not feel right; Experiencing stomach issues, it feels like it is burning; the nurse did not dilute the vial and was given multiple doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101275650 (Pfizer).  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunization.  The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "the nurse did not dilute the vial and was given multiple doses"; HYPOACUSIS (non-serious), EAR DISCOMFORT (non-serious), outcome "unknown" and all described as "sonic issues and feels like burning"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest does not feel right in which she stated "her heart does not feel right"."; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; DECREASED APPETITE (non-serious), outcome "unknown", described as "lost of appetite"; ARTHRALGIA (non-serious), outcome "unknown", described as "her joints hurt"; SWELLING FACE (non-serious), outcome "unknown", described as "her face is swollen around her chin."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurts"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "chest and stomach does not feel right"; DYSPEPSIA (non-serious), outcome "unknown", described as "Experiencing stomach issues, it feels like it is burning".  Additional information- Reporter asks, if this could be damaging to her daughter, since she received too much vaccine and asks what is the recommendation in this situation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Ear discomfort, Hypoacusis, Overdose, Pain in extremity
Clinical narrative: sonic issues and feels like burning; sonic issues and feels like burning; chest does not feel right in which she stated "her heart does not feel right".; diarrhea; lost of appetite; her joints hurt; her face is swollen around her chin.; arm hurts; chest and stomach does not feel right; Experiencing stomach issues, it feels like it is burning; the nurse did not dilute the vial and was given multiple doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101275650 (Pfizer).  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunization.  The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "the nurse did not dilute the vial and was given multiple doses"; HYPOACUSIS (non-serious), EAR DISCOMFORT (non-serious), outcome "unknown" and all described as "sonic issues and feels like burning"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest does not feel right in which she stated "her heart does not feel right"."; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; DECREASED APPETITE (non-serious), outcome "unknown", described as "lost of appetite"; ARTHRALGIA (non-serious), outcome "unknown", described as "her joints hurt"; SWELLING FACE (non-serious), outcome "unknown", described as "her face is swollen around her chin."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurts"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "chest and stomach does not feel right"; DYSPEPSIA (non-serious), outcome "unknown", described as "Experiencing stomach issues, it feels like it is burning".  Additional information- Reporter asks, if this could be damaging to her daughter, since she received too much vaccine and asks what is the recommendation in this situation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: sonic issues and feels like burning; sonic issues and feels like burning; chest does not feel right in which she stated "her heart does not feel right".; diarrhea; lost of appetite; her joints hurt; her face is swollen around her chin.; arm hurts; chest and stomach does not feel right; Experiencing stomach issues, it feels like it is burning; the nurse did not dilute the vial and was given multiple doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101275650 (Pfizer).  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunization.  The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "the nurse did not dilute the vial and was given multiple doses"; HYPOACUSIS (non-serious), EAR DISCOMFORT (non-serious), outcome "unknown" and all described as "sonic issues and feels like burning"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest does not feel right in which she stated "her heart does not feel right"."; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; DECREASED APPETITE (non-serious), outcome "unknown", described as "lost of appetite"; ARTHRALGIA (non-serious), outcome "unknown", described as "her joints hurt"; SWELLING FACE (non-serious), outcome "unknown", described as "her face is swollen around her chin."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurts"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "chest and stomach does not feel right"; DYSPEPSIA (non-serious), outcome "unknown", described as "Experiencing stomach issues, it feels like it is burning".  Additional information- Reporter asks, if this could be damaging to her daughter, since she received too much vaccine and asks what is the recommendation in this situation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Malaise, Peripheral swelling
Clinical narrative: she had arthritis on her leg; swelling on her feet; she hasn't been well at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (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: ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "she had arthritis on her leg"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swelling on her feet"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "she hasn't been well at all".  Additional Information: It was reported that, the patient and her daughter received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 11Aug2021. They were originally scheduled to receive the 2nd dose on 01Sep2021, but they were not able to go. The patient said she had arthritis on her leg and swelling on her feet. She said she had not been well at all. She wanted to know how long she could still get the 2nd dose after missing her schedule.  Follow-up attempts completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Grip strength decreased, Muscular weakness, Pain in extremity
Clinical narrative: My right arm is weak; no strength; hurts badly to bend move laying on it.; The joints are what hurts the most; I can no longer grip anything.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Sep2021 11:00 (Lot number: 301308A) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 21Sep2021 01:30, outcome "not recovered", described as "My right arm is weak"; ASTHENIA (non-serious) with onset 21Sep2021 01:30, outcome "not recovered", described as "no strength"; PAIN IN EXTREMITY (non-serious) with onset 21Sep2021 01:30, outcome "not recovered", described as "hurts badly to bend move laying on it."; ARTHRALGIA (non-serious) with onset 21Sep2021 01:30, outcome "not recovered", described as "The joints are what hurts the most"; GRIP STRENGTH DECREASED (non-serious) with onset 21Sep2021 01:30, outcome "not recovered", described as "I can no longer grip anything.". Therapeutic measures were not taken as a result of muscular weakness, asthenia, pain in extremity, arthralgia, grip strength decreased.  Additional information: Prior to vaccination, patient was diagnosed with COVID, Since the vaccination, patient has not been tested for COVID-19  Follow-up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: lump appeared saturday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 10:30 (Lot number: Unknown) at the age of 67 years 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: MASS (non-serious) with onset 25Sep2021, outcome "unknown", described as "lump appeared saturday". Therapeutic measures were not taken as a result of mass.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Patient received other medications within 2 weeks of vaccination. Patient was not diagnosed with covid-19 prior to vaccination. Patient has not been tested for covid-19 since the vaccination. The patient had no known allergies. The vaccine was administered in a pharmacy. The event occurred on 25Sep2021 (reported as Saturday). Device date reported was 27Sep2021.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Pruritus, Rash macular, Swelling, Weight
Clinical narrative: itchy; her arm was a little puffy, there was a red blotch and it was sort of swollen; red blotches; 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 72 year-old female patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Batch/Lot number: unknown) at the age of 71 years 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 1, SINGLE, Lot Number: ER8730), administration date: 21Mar2021, for COVID-19 Immunization. The following information was reported: RASH MACULAR (non-serious) with onset 21Apr2021, outcome "not recovered", described as "red blotches"; PRURITUS (non-serious), outcome "not recovered", described as "itchy"; SWELLING (non-serious), outcome "recovered", described as "her arm was a little puffy, there was a red blotch and it was sort of swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  Additional information: They had put a band aid over where she had her shot and a few days afterwards she decided to take the band aid off, because it had started to peel, and it was a little puffy, there was a red blotch, and it was sort of swollen. But that had went down then it was itchy. Since then, she had been experiencing red blotches even on that same arm and now she experienced some in other parts of her body as well. Since she had been using skin soap it takes away the itching and stuff like that and the blotch fades away in certain areas but then it would pop up somewhere else. Inquired for outcome and she said that there were a lot more now than there were in the beginning. When she had taken the band aid off, she didn't give it a second thought because when you have a shot you may have a little swelling and redness. Then a few days after she had started itching so she had looked at her arm and there was the red blotch below the area where she had her shot at. She didn't think anything about it, but she had rubbed it and it had itched and then she had to go use her skin soap to stop the itching. After that every now and then there will be another red blotch that will pop up and a lot have started popping up on the same arm, but she does have some on her other arm, the right arm, and she has had some on her chest and her stomach and her leg but they sort of stated to fade away since she had been using her skin soap, but she still had some pop up. She also had one on her shoulder and it was quite a few there. It looks like it was almost like measles. She would like to know if this had been reported before, she was not sure if it was a side effect but when it showed up after the vaccine, she thought that maybe it could be one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: left breast and nipple were itching on; 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 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single and administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PRURITUS (non-serious) with onset 01May2021, outcome "unknown", described as "left breast and nipple were itching on".  Additional information: she got both Pfizer Covid shots and they both took effect 01 May. Does not know, but her left breast is very itchy and her left nipple is very itchy in the same arm she got her shot, the left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: her Vitamin D has been low; arm being red and sore; arm being red and sore; arm is swollen and red; started to itch; 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 65-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 11:15 (Lot number: FE3592) at the age of 65 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diagnosed 15 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot FC3182), administration date: 02Sep2021, for COVID-19 Immunization. The following information was reported: ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Sep2021, outcome "not recovered" and all described as "arm being red and sore"; PERIPHERAL SWELLING (non-serious) with onset 26Sep2021, outcome "not recovered", described as "arm is swollen and red"; PRURITUS (non-serious) with onset 26Sep2021, outcome "not recovered", described as "started to itch"; VITAMIN D DECREASED (non-serious), outcome "not recovered", described as "her Vitamin D has been low". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any Prior Vaccinations (within 4 weeks) of suspect vaccine. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.