chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Hyperhidrosis, Tremor
Clinical narrative: I was covered in sweat when I got up and shaking; I was covered in sweat when I got up and shaking; Cold all over; Terrible headache; I have got 'chill bumps'; 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 22Oct2021 03:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), TREMOR (non-serious) all with onset Oct2021, outcome "unknown" and all described as "I was covered in sweat when I got up and shaking"; FEELING COLD (non-serious) with onset Oct2021, outcome "unknown", described as "Cold all over"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Terrible headache"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "I have got 'chill bumps'".  Additional information: event onset dates was unspecified, Consumer stated, patient have a couple questions and got the Pfizer vaccine today probably about 03:00 O' Clock and I have done just fine no problems at all and I went in and lay down and took a nap at 06:00 O'clock and just got up. I am covered in sweat and while I was covered in sweat when I got up and shaking and now I have got 'chill bumps'(word not clear) and cold all over, terrible headache and I got my paperwork out and read it and it says something about like you should not have it if you are on blood thinners (Intent: Medical query). Is that true?" Consumer was informed about role of Pfizer drug safety and informed that Pfizer Medical Information is the concerned department to answer the question. Consumer was informed that Medical Information department is closed on Saturday and Sunday. Consumer was again informed about role of Pfizer Drug Safety Department and also informed that Pfizer Medical Information can answer the Medical query. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: fatigue; nausea; vomiting; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Oct2021 12:15 (Lot number: 30155BA) at the age of 51 years as dose 3(booster),single for covid-19 immunisation. Relevant medical history included: "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes. Concomitant medication(s) included: FLU, administration date 12Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5318), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1284), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 21Oct2021, outcome "recovered" (Oct2021), described as "fatigue"; NAUSEA (non-serious) with onset 21Oct2021, outcome "recovered" (Oct2021), described as "nausea"; VOMITING (non-serious) with onset 21Oct2021, outcome "recovered" (Oct2021), described as "vomiting"; DIARRHOEA (non-serious) with onset 21Oct2021, outcome "recovered" (Oct2021), described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, nausea, vomiting, diarrhoea.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination: yes. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Device Date: 25Oct2021. Outcome of reaction/event at the time of last observation: Recovered/ Resolved. Hospitalization Prolonged: No. Treatment Received: No.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Fatigue; headache; muscle pain; injection site pain; feeling unwell; swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 (Lot number: 32030BD) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ESCITALOPRAM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of vaccine: Arm Left), administration date: 06Jan2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3302, Location of Vaccine: Arm Left), administration date: 27Jan2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 22Oct2021, outcome "recovering", described as "Fatigue"; HEADACHE (non-serious) with onset 22Oct2021, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "muscle pain"; VACCINATION SITE PAIN (non-serious) with onset 22Oct2021, outcome "recovering", described as "injection site pain"; MALAISE (non-serious) with onset 22Oct2021, outcome "recovering", described as "feeling unwell"; LYMPHADENOPATHY (non-serious) with onset 22Oct2021, outcome "recovering", described as "swollen lymph nodes". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, vaccination site pain, malaise, lymphadenopathy.  Additional Information: The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fatigue; headache; muscle pain; injection site pain; feeling unwell; swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 (Lot number: 32030BD) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ESCITALOPRAM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of vaccine: Arm Left), administration date: 06Jan2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3302, Location of Vaccine: Arm Left), administration date: 27Jan2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 22Oct2021, outcome "recovering", described as "Fatigue"; HEADACHE (non-serious) with onset 22Oct2021, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "muscle pain"; VACCINATION SITE PAIN (non-serious) with onset 22Oct2021, outcome "recovering", described as "injection site pain"; MALAISE (non-serious) with onset 22Oct2021, outcome "recovering", described as "feeling unwell"; LYMPHADENOPATHY (non-serious) with onset 22Oct2021, outcome "recovering", described as "swollen lymph nodes". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, vaccination site pain, malaise, lymphadenopathy.  Additional Information: The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Lymphadenopathy, Mobility decreased, Pain in extremity
Clinical narrative: Swelling under the armpit; very hot; couldn't put an arm down for days; very hot couldn't put an arm down for days still swollen to this day with pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 (Lot number: 30155BA) at the age of 37 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: LYMPHADENOPATHY (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Swelling under the armpit"; FEELING HOT (non-serious) with onset 02Oct2021, outcome "not recovered", described as "very hot"; MOBILITY DECREASED (non-serious) with onset 02Oct2021, outcome "not recovered", described as "couldn't put an arm down for days"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2021, outcome "not recovered", described as "very hot couldn't put an arm down for days still swollen to this day with pain.". Therapeutic measures were not taken as a result of lymphadenopathy, feeling hot, mobility decreased, pain in extremity.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was No. List of any other medications the patient received within 2 weeks of vaccination was No. Reported Event Swelling under the armpit after A hour getting vaccinated ,very hot couldn't put an arm down for days still swollen to this day with pain. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, has the patient been tested for COVID-19 was No. No Known allergies.  Follow-up attempts are completed. No further information is expected. .
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Pain in extremity, Somnolence
Clinical narrative: I really did not feel this way, I feel terrible; my body is so heavy like I have to lay down; I feel like somebody has run me over with the truck; Diarrhea; Arm is hurting so bad and I can''t move it; I am more concerned; I can''t stay awake, I have to lay down; 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) (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 (first dose), for Covid-19 immunization; Bnt162b2 (second dose), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I really did not feel this way, I feel terrible; my body is so heavy like I have to lay down; I feel like somebody has run me over with the truck"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is hurting so bad and I can''t move it; I am more concerned"; SOMNOLENCE (non-serious), outcome "unknown", described as "I can''t stay awake, I have to lay down".  Additional information: Patient really did not feel this way, patient felt terrible; patient's body was so heavy like patient had to lay down, patient felt like somebody had run patient over with the truck. Patient really did not feel this way when patient got the first two (first dose and second dose), so patient was just more concerned.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: nausea; vomiting; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non- HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 (Lot number: 3203080) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "kidney failure stage 3" (unspecified if ongoing), notes: Stage 3; "Colitis" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 23Oct2021 16:00, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 23Oct2021 16:00, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 23Oct2021 16:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of nausea, vomiting, headache.  Additional Information: Relevant past drug history includes Allergy. Facility where the most recent COVID-19 vaccine was administered is Other. 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: yes. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The shot was administered to patient on Saturday 23Oct2021. She experienced the adverse effects later that same day.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). An 18-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 301308A), at the age of 18, on Sep 1, 2021, single dose, for COVID-19 immunisation.  Medical history and concomitant medications not reported. The patient experienced dizziness, onset 2021, with outcome of unknown. Additional information: Patient received his first dose of the vaccine on Sep 1, 2021. He hasn't had the second dose of the vaccine because he experienced dizziness since the first dose. No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Eye irritation
Clinical narrative: mild reactions; eyes burn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid 19", start date: 2020 (unspecified if ongoing), notes: developed covid 19 infection at age 17 in jan or feb2020. There were no concomitant medications. The following information was reported: ADVERSE DRUG REACTION (non-serious) with onset 2021, outcome "recovered" (2021), described as "mild reactions"; EYE IRRITATION (non-serious) with onset 2021, outcome "recovered" (2021), described as "eyes burn". The patient was fine after the first dose of steroids. Therapeutic measures were taken as a result of adverse drug reaction, eye irritation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: I am constipated; it is kind of bad constipation for two days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 19Oct2021 (Lot number: FF2590, Expiration Date: 31Dec2021) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: METFORMIN; LISINOPRIL. Vaccination history included: Bnt162b2 (First dose covid-19 vaccine, Lot no.: EN6201 , Expiry date: 30Jun2021), for Covid-19 immunization; Bnt162b2 (Second dose covid-19 vaccine, Lot no.: EN6201 , Expiry date: 30Jun2021), for Covid-19 immunization. The following information was reported: CONSTIPATION (non-serious) with onset Oct2021, outcome "unknown", described as "I am constipated; it is kind of bad constipation for two days.". Therapeutic measures were not taken as a result of constipation.  Additional information: Consumer stated, "I had my booster shot last Tuesday and I don't know if it is from that but I am constipated like for two days. I don't know if this from that or not". When Paraphrased: Consumer stated, "Yes, I think so because I am never constipated but it is kind of bad constipation for two days, today and yesterday. Patient did not receive any treatment, consumer stated, "No, I just ate ice cream and that is it." Prior to 4 weeks of COVID Vaccine, patient did not receive any other vaccine.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I started feeling sick with a bunch of symptoms; 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 11Oct2021 (Lot number: 30155DA) 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) with onset 20Oct2021, outcome "unknown", described as "I started feeling sick with a bunch of symptoms".  Additional Information: Dates for I started feeling sick with a bunch of symptoms was unspecified. Reporter seriousness for I started feeling sick with a bunch of symptoms was Unspecified. Consumer stated, "I don't know what that is 30155DA." When probed for the concern, consumer stated, I got the first shot on the Monday 11Oct I felt fine until 19Oct and then I started feeling sick with a bunch of symptoms or whatever. I didn't know if it was just from the shot or maybe it should be from the Covid vaccine shot or not. I received the Pfizer first vaccination and since then seen some symptoms.consumer stated, I just want to ensure that if it is like side effect of this shot (vaccine) or not, or actually some other thing.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: after taking vaccine has headaches; muscle ache legs arms; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "after taking vaccine has headaches"; MYALGIA (non-serious), outcome "unknown", described as "muscle ache legs arms".  Additional information: Event took place after use of product. Patient claimed after taking vaccine has headaches and muscle ache legs arms. She recently lost both parents to Covid and not sure if this is afresh or the vaccine side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, SARS-CoV-2 test, Skin disorder, Somnolence
Clinical narrative: Sleepy; Red bump the next day; Chills; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 10:30 (Lot number: FF2593) at the age of 52 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: Bnt162b2 (Dose 1, administration time: 08:00 AM, Lot number: ERS739, Vaccine location: Right arm), administration date: 25Mar2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, administration time: 08:00 AM, Lot number: EW0158, Vaccine location: Right arm), administration date: 15Apr2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 24Oct2021 07:00, outcome "recovering", described as "Sleepy"; SKIN DISORDER (non-serious) with onset 24Oct2021 07:00, outcome "recovering", described as "Red bump the next day"; CHILLS (non-serious) with onset 24Oct2021 07:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 24Oct2021 07:00, outcome "recovering", described as "Body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence, skin disorder, chills, pain.  Additional Information: The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had been tested post the vaccination. The patient underwent a unknown lab test for Covid-19 (Nasal Swab) resulted in Negative. No other medication in two weeks. No other medical history.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Every time it gets hot, he is itching/itching spells anytime he gets hot or is out in the heat; 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 48 year-old male patient received bnt162b2 (COMIRNATY) (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: PRURITUS (non-serious), outcome "not recovered", described as "Every time it gets hot, he is itching/itching spells anytime he gets hot or is out in the heat".  Additional information: Every time it was getting hot, he was itching. The patient was asking what he should do or if this would be related to the vaccine. He had been having itching spells the last 3 to 4 weeks, anytime he was getting out, or was out in the heat, or when the sun hit him.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue
Clinical narrative: Caller relays she didn't have an side effects with the first 2, just a little tiredness for a few days.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 24Feb2021 (Lot number: EL9266) as dose 1, single and administered in deltoid left, administration date 19Mar2021 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. Relevant medical history included: "breast cancer lymphoma", start date: 2014 (unspecified if ongoing), notes: it's been 7 years, she is not supposed to do anything that that right arm; "Sleep apnoea syndrome" (unspecified if ongoing), notes: Verbatim: Sleep apnea; "irregular heart beat" (unspecified if ongoing), notes: Verbatim: irregular heart beat; "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Arthritis" (unspecified if ongoing), notes: In her hips bad, it's hard to walk up and down stairs; "doesn't have her thyroid" (unspecified if ongoing), notes: doesn't have her thyroid. There were no concomitant medications. Vaccination history included: Flu shot (stating it's for 1 day and it's nothing), administration date: Aug2020, reaction(s): "Tenderness in that arm". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Caller relays she didn't have an side effects with the first 2, just a little tiredness for a few days.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccination Facility Type was pharmacy. Patient did not receive additional vaccines on same date of the. Patient did not go to emergency room or physician office. Relevant tests: none. Additional Information for other conditions: too fast. In her hips bad, it's hard to walk up and down stairs and took medication for that. She has had the shingles shot and they went to withheld 2-3 years ago and she had no side effects from any of those. She had bloodwork done before at the hospital, in a week she sees her endocrinologist. It was reported that she was taking Aspirin or Tylenol and she thinks it will correct itself and if it didn't she will call her doctor.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Condition aggravated, Pain in extremity
Clinical narrative: Her arm is still sore/Soreness in Arm/Sore arm; Soreness in Arm was reported as worsened; 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 53 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 13Oct2021 (Lot number: FF8841) at the age of 53 years as dose 3 (booster), single, administered in arm left, administration date 02Apr2021 (Lot number: ER8733) as dose 2, single and administered in arm left, administration date 12Mar2021 (Lot number: EN6206) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu shot (No. of Previous Doses: 1, End of September like 29Oct2021 ), administration date: 2021, for immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Her arm is still sore/Soreness in Arm/Sore arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "Soreness in Arm was reported as worsened". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, condition aggravated.  Additional information: No additional Vaccines were administered on Same Date of the Pfizer Suspect. Family history included none. Patient took the booster dose of the Pfizer Covid-19 vaccine on 13Oct2021 and her arm was still sore. Patient states that it went over 2 weeks. Patient wants to know what to do and if this is a normal side effect. Patient states her arm was sore after her first two doses but that only lasted a couple of days, probably 3-4 days. Soreness in Arm after booster dose started on 14Oct2021. AE(s) did not require a visit to: Emergency Room or Physician Office.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non- HCP). Other Case identifier(s): 2021SA337125. A 58-old female patient received bnt162b2 (BNT162B2), administration date 01Sep2021 (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 "unknown", described as "Felt sick".  Additional Information: This consumer reported for a (Age-58, Unit-unknown) female patient (Reporter sister). Brother (name-withheld) age 65 got the JNJ vaccination and then felt sick. 1.One on 01Sep2021 then felt sick. 2.One on 05Oct2021 then felt sick and developed 102 degrees fever. While driving in the car 10Oct2021 Son girlfriend (name-withheld) age 27 mentioned she received a vaccination and sight of injection very painful for 3days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain
Clinical narrative: moderately sore at test site; site was reddish for a couple days; Entire arm sore after shot; Stiff; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Oct2021 (Lot number: FF8841) at the age of 86 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic UTI", start date: 1970 (unspecified if ongoing), notes: Now under control; "Marrow degenration disease", start date: 2012 (ongoing). Concomitant medication(s) included: FOSAMAX taken for osteoporosis; BROVANA taken for lung disorder; AZITHROMYCIN taken for lung disorder; PULMICORT taken for lung disorder; CARDIZEM CD taken for heart rate; ESTRADIOL taken for bladder disorder; FLONASE ALLERGY RELIEF; LIDOCAINE taken for skin disorder; COZAAR taken for cardiac disorder; SINGULAIR taken for lung disorder; NYSTATIN taken for lip dry; PREDNISONE taken for lung disorder; PREVIDENT taken for teething; RESTASIS taken for eye disorder; SODIUM CHLORIDE taken for lung disorder; SPIRIVA taken for lung disorder; CALCIUM taken for bone disorder; ZYRTEC ALLERGY taken for antiallergic therapy; BENADRYL taken for pruritus; BENADRYL taken for pruritus; IBUPROFEN taken for pain, inflammation; KY taken for nasal dryness; LOPERAMIDE taken for diarrhoea; RETAINE CMC taken for eye disorder; LUTEIN ZEAXANTHIN taken for eye disorder; VIT C taken for bladder disorder. Vaccination history included: Bnt162b2 (dose 1, Anatomical location: L upper arm, Route of administration: Intramuscular, Time: about 15:00, Lot number: EL3249), administration date: 15Jan2021, when the patient was 85 years old, for Covid-19 Immunisation; Bnt162b2 (dose 2, Anatomical location: L upper arm, Route of administration: Intramuscular, Time: about 15:00, Lot number: GN5318), administration date: 05Mar2021, when the patient was 85 years old, for Covid-19 Immunisation, reaction(s): "Entire arm sore".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "moderately sore at test site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "site was reddish for a couple days"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "Entire arm sore after shot"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "recovered", described as "Stiff". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema, pain in extremity, musculoskeletal stiffness.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site; Headache; Fatigue; Fever with associated chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old patient received bnt162b2 (BNT162B2), administration date 20Oct2021 (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 Number:01), for Covid-19 Immunization; Bnt162b2 (Dose Number:02), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Oct2021, outcome "recovered" (22Oct2021), described as "Soreness at injection site"; HEADACHE (non-serious) with onset 21Oct2021, outcome "recovered" (22Oct2021), described as "Headache"; FATIGUE (non-serious) with onset 21Oct2021, outcome "recovered" (22Oct2021), described as "Fatigue"; PYREXIA (non-serious) with onset 21Oct2021, outcome "recovered" (22Oct2021), described as "Fever with associated chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (26Nov2021): 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharitis, Dermatitis atopic, Inappropriate schedule of product administration
Clinical narrative: Atopic dermatitis on face started with eyes and has progressed to entire face with periodic outbreaks over last 4 months; Atopic dermatitis on face started with eyes and has progressed to entire face with periodic outbreaks over last 4 months; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Feb2021 15:00 (Lot number: EN6200) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma 3 yrs ago; "Breast cancer" (unspecified if ongoing), notes: breast cancer 21 years ago. There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". Vaccination history included: Bnt162b2 (Dose 1, single; Batch/Lot No: EL9265; via Intramuscular route in right upper arm; at 03:00 PM), administration date: 01Jan2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: DERMATITIS ATOPIC (non-serious), BLEPHARITIS (non-serious) all with onset 03Jul2021 03:00, outcome "not recovered" and all described as "Atopic dermatitis on face started with eyes and has progressed to entire face with periodic outbreaks over last 4 months"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Feb2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The event "atopic dermatitis on face started with eyes and has progressed to entire face with periodic outbreaks over last 4 months" and "atopic dermatitis on face started with eyes and has progressed to entire face with periodic outbreaks over last 4 months" was evaluated at the physician office visit. Therapeutic measures were taken as a result of dermatitis atopic, blepharitis. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other medications within two weeks of vaccination. Relevant tests reported as none. Specific relevant tests for thromboembolic events with thrombocytopenia reported as none. Atopic Dermatitis starting 4 months after 2nd dose of vaccine- started with eyes and has moved to all over face with varying lengths of duration. Have seen a dermatologist who has only given creams to use to diminish length of outbreak, lot no. long term effects- one cream had a steroid bot not recommended for long term use. Eye ointment with a steroid and antibiotic. She previously never had any skin rashes. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain in extremity
Clinical narrative: Nausea; arm pain; general malaise; 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) (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 number:2), for COVID-19 Immunization; Bnt162b2 (Dose number:1), for COVID-19 Immunization.The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; MALAISE (non-serious), outcome "unknown", described as "general malaise".  Additional information:Description of Event: Nausea, arm pain and general malaise after Covid vaccine booster 12 hours after administration.Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: he was experiencing headaches that wouldn't go away since 1 month ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (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: HEADACHE (non-serious) with onset Sep2021, outcome "not recovered", described as "he was experiencing headaches that wouldn't go away since 1 month ago".  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: Alopecia
Clinical narrative: Experiencing significant hairloss; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 09:00 (Lot number: FF2590) at the age of 65 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "Osteopenia" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin". Vaccination history included: Bnt162b2 (dose 2, single, Batch/Lot No: EP8737, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 12Apr2021, for Covid-19 Immunization; Bnt162b2 (dose 1, single, Batch/Lot No: 6204, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 17Mar2021, for Covid-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset 25Oct2021 06:00, outcome "not recovered", described as "Experiencing significant hairloss". Therapeutic measures were not taken as a result of alopecia.  Additional information: No if other vaccine in four weeks. Adverse event: Experiencing significant hair loss. Large clump of hair found about 3" wide after waking this morning on 25Oct21. Have been experiencing hair loss after washing hair for a couple of months now. This recent event was the most significant event. No if covid prior vaccination. No if covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Insomnia, Palpitations, Panic attack, Thinking abnormal
Clinical narrative: Heart racing; Anxiety; Trouble sleeping; Panic attacks; Thought process is not clear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Oct2021 11:00 (Lot number: FD0809) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), intramuscular, administered in deltoid right, administration date 21Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,single, Lot number:EP6955, Dose administration time:12:00, Vaccine location:Left arm (Left deltoid), Route of administration: Intramuscular), administration date: 24Mar2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Dose 2,single, Lot number:EW015D, Dose administration time:10:00, Vaccine location:Right arm (Right deltoid), Route of administration: Intramuscular), administration date: 14Apr2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Heart racing"; ANXIETY (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Anxiety"; INSOMNIA (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Trouble sleeping"; PANIC ATTACK (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Panic attacks"; THINKING ABNORMAL (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Thought process is not clear". Therapeutic measures were not taken as a result of palpitations, anxiety, insomnia, panic attack, thinking abnormal.  Additional Information: If covid prior vaccination was reported as no. if covid tested post vaccination was reported as no. Concomitant drugs was reported as none. Patient's Medical History (including any illness at time of vaccination) was reported none. Relevant Tests was reported was none. Specific Relevant Test For Thromboembolic Events With Thrombocytopenia was reported as None.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Nausea, Pain
Clinical narrative: nausea; moderate body aches; hard to walk; This is a spontaneous report received from contactable reporter(s) (Other HCP and Pharmacist). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 19Oct2021 16:20 (Lot number: FH8020) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Viral infection" (ongoing). Concomitant medication(s) included: FLUZONE QUADRIVALENT taken for immunisation, administration date 04Oct2021; SHINGRIX taken for immunisation, administration date 04Oct2021; LEVOTHYROXINE taken for thyroid disorder, start date: Jul2021 (ongoing); VALACYCLOVIR [VALACICLOVIR] taken for viral infection, start date: Jul2021 (ongoing). Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Demerol, reaction(s): "Known allergies: Demerol"; Phenergan, reaction(s): "Known allergies: phenergan"; Mobix, reaction(s): "Known allergies: Mobix". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK9231), administration date: 07Jan2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730), administration date: 07Dec2020, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 21Oct2021, outcome "not recovered", described as "nausea"; PAIN (non-serious) with onset 21Oct2021, outcome "not recovered", described as "moderate body aches"; GAIT DISTURBANCE (non-serious) with onset 21Oct2021, outcome "not recovered", described as "hard to walk". Therapeutic measures were not taken as a result of nausea, gait disturbance. Therapeutic measures were taken as a result of pain.  Additional information: Patient did not had covid prior vaccination and was not covid tested post vaccination. Reportedly, with the booster patient had nausea and moderate body aches. Had intense body aches that make it hard to walk. Patient was away from home and have taken Alieve but it doesnt really touch the pain.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Paraesthesia
Clinical narrative: face was tingly; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 15:00 (Lot number: EW0151) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hearing loss" (unspecified if ongoing); "PNC" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication included: TYLENOL. Past drug history included: Aspirin, reaction: "Allergy Aspirin". The following information was reported: PARAESTHESIA (non-serious) with onset 31Mar2021, outcome "not recovered", described as "face was tingly". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of paraesthesia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event: 30 minutes after first shot, face was tingly for 24 hours. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with 4 Claritin a day. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vac-cination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.