chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Vomiting
Clinical narrative: Sore throat; Feels really drained, tired; Severe vomiting; Body aches; Severe headache/headachy; she couldn't get out of bed; feeling crummy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021404659 (Pfizer).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 11:30 (Lot number: ER8730, Expiration Date: Jul2021) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto Thyroiditis" (unspecified if ongoing); "Rheumotoid arthritis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for autoimmune thyroiditis (ongoing); ZYRTEC ALLERGY; FLONASE ALLERGY RELIEF; ADVIL [IBUPROFEN] taken for arthritis (ongoing). The following information was reported: VOMITING (non-serious) with onset 10Apr2021 07:15, outcome "recovered" (Apr2021), described as "Severe vomiting"; PAIN (non-serious) with onset 10Apr2021 07:15, outcome "recovering", described as "Body aches"; HEADACHE (non-serious) with onset 10Apr2021 07:15, outcome "recovering", described as "Severe headache/headachy"; OROPHARYNGEAL PAIN (non-serious), outcome "recovering", described as "Sore throat"; FATIGUE (non-serious), outcome "recovering", described as "Feels really drained, tired"; MALAISE (non-serious) with onset 27Mar2021, outcome "unknown", described as "feeling crummy"; HYPOKINESIA (non-serious) with onset 10Apr2021, outcome "recovering", described as "she couldn't get out of bed". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, pain, headache.  Additional information: Patient had no known llergies. Patient had been taking Armour Thyroid for 5 years and Advil for about a year. Patient had no other vaccine in four weeks and no COVID prior vaccination. Patient had been tested for covid post vaccination. Patient got her 1st dose on 26Mar2021 and two weeks after she started to have side effects. She went and got tested for Covid but haven't gotten her results yet. Also, she took her allergy shot on Tuesday, 23Mar2021 and started feeling crummy that following Saturday (27Mar2021). 2 weeks out, this past Saturday (10Apr2021), she couldn't get out of bed, vomiting, terrible headache, body aches, no fever, sore throat, still recovering. She had stopped throwing up but still felt really drained, tired and headachy. Patient would like to know whether her allergy shot which she received prior to the covid vaccine could have interacted in some way. Patient receive 2nd dose on Friday 16Apr2021 (Lot: EW0161, EXP: Jul2021).  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: my left ear started ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 12:45 (Lot number: EW0158) at the age of 17 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 (Product=COVID 19, brand=Pfizer- Pfizer, lot number= ER2613, lot unknown = False, administration date= 19Mar2021, administration time= 04:00, vaccine location= Left arm, dose number=1), administration date: 19Mar2021, when the patient was 17 years old, for COVID-19 Immunisation, reaction(s): "After my first vaccine my right earstarted ringing".  The following information was reported: TINNITUS (non-serious) with onset 12Apr2021 16:00, outcome "not recovered", described as "my left ear started ringing". Therapeutic measures were not taken as a result of tinnitus.  Additional information: patient stated that after his second dose, his left ear started ringing on 12Apr at 4pm and gradually grew in intensity until holding steady. It did not ring as bad as it did after his first dose. Still ongoing as of now. Patient did not took any other vaccine in four weeks. Patient did not had Covid prior vaccination nor tested Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: when I was getting the shot it burn the whole time it was being injected. This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "periodically have a problem with lymph anyway because it gathers in my armpit" (unspecified if ongoing); "lymphatic drainage sometimes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Mar2021, outcome "unknown", described as "when I was getting the shot it burn the whole time it was being injected.". Additional information: Patient was asking if the event could have been because of the way it was injected or could it be the ingredients. She didn't have any issues at all after the shot. Patient was asking if going for lymphatic drainage would affect the efficacy of the vaccine if she did this between doses, since she read that sometimes the lymph gets clogged up as a side effect; asking if 4 hours shouldn't make a difference with her second shot. She was also asking if she should switch arms because of the lymphatic back up, and if there is primarily one side more than the other that people get lymphatic back up in. She was scheduled for the second shot on April 7th.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: eye started twitching and has been twitching since then/left eye is twitching; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 09:20 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "low thyroid" (unspecified if ongoing), notes: diagnosed a few years ago. The patient's concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious) with onset Apr2021, outcome "not recovered", described as "eye started twitching and has been twitching since then/left eye is twitching".  Additional Context: Reporter states her question is that she is not sure if she should get second vaccine, states she got the first dose of the Pfizer Covid vaccine on 2Apr2021, states she knows that knows bells palsy has been associated with some of the vaccines, does not specify. Caller states the lot number is EC9265 or EL9265, caller states it is handwritten on the card and hard to read. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Emergency Room and Physician Office visit. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No Family Medical History Relevant to AE.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Computerised tomogram, Crohn's disease, Gastrointestinal inflammation
Clinical narrative: Crohn's flare up (Pain, bloating); significant amount of inflammation in bowels however 6 weeks prior he had a colonoscopy and everything looked good then; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Mar2021 13:00 (Lot number: EP7534) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (ongoing), notes: Verbatim: Crohn's disease. The patient took concomitant medications.  The following information was reported: CROHN'S DISEASE (medically significant) with onset 16Mar2021, outcome "recovered" (18Mar2021), described as "Crohn's flare up (Pain, bloating)"; GASTROINTESTINAL INFLAMMATION (non-serious) with onset 16Mar2021, outcome "recovered" (18Mar2021), described as "significant amount of inflammation in bowels however 6 weeks prior he had a colonoscopy and everything looked good then".  The event "crohn's flare up (pain, bloating)" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: colonoscopy: everything looked good; computerised tomogram: significant amount of inflammation in bowels.  Clinical course: The patient stated he ended up hospitalized 48 hours after the initial vaccination dose. The patient clarified that he was not hospitalized but did go to the emergency room. The patient stated he does have a health background of Crohn's disease and about 48 hours after the vaccination he experienced symptoms of pain and bloating as if he was having a flare up. The patient stated that the pain got so severe that he went to the emergency room. The patient stated they were able to get his symptoms under control with pain management and intravenous steroid infusion and then he was released. The patient stated there was a CT scan performed and there had been a significant amount of inflammation in bowels however 6 weeks prior he had a colonoscopy and everything looked good then. The patient stated he woke up the morning of 17Mar2021 and was distended. Treatment: Dilaudid and intravenous steroid infusion. Concomitant Products: The patient stated nothing had changed he has been on the same medication regimen for a year and half now. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: sore throat; headache; colds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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: OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "sore throat"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache"; NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "colds".  Additional information: Reporter queried for if it's a side effect of the vaccine because she will be getting the 2nd dose on 17April 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Off label use, Product use issue
Clinical narrative: Light headedness; Headache; breast feeding; breast feeding; 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 25 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 25 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: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 06Apr2021, outcome "unknown" and all described as "breast feeding"; DIZZINESS (non-serious), outcome "unknown", described as "Light headedness"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: Received first shot of pfizer covid vaccine this am and reports intermittent dizziness and light headedness. Reports has become worse. Concerned as she is at home with a toddler. Also reports headaches but she was more concerned with the dizziness  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021376509 same reporter/ drug, different AE/ patient.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Nausea
Clinical narrative: feeling sick; nauseous; having colds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (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) with onset Apr2021, outcome "not recovered", described as "feeling sick"; NAUSEA (non-serious) with onset Apr2021, outcome "not recovered", described as "nauseous"; NASOPHARYNGITIS (non-serious) with onset Apr2021, outcome "not recovered", described as "having colds".  Additional Information: The patient wanted to know how long effects will last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hot flush, Vomiting
Clinical narrative: Hot flash; throwing up; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (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: HOT FLUSH (non-serious) with onset Apr2021, outcome "unknown", described as "Hot flash"; VOMITING (non-serious) with onset Apr2021, outcome "unknown", described as "throwing up"; DIARRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "diarrhea". Additional information: The patient was due to get her second dose on 24Apr2021 and would like to know what to do.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: soreness at injection site; extreme fatigue lasting 2 DAYS; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue lasting 2 DAYS"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at injection site". Additional information: No other vaccines had been administered except for dose 1 of COVID 19 vaccine in last 2 months.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, SARS-CoV-2 test negative
Clinical narrative: the freezing of hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: had history of anxiety and gets to panic immediately. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "the freezing of hands". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported also that her sister who was a nurse in Boston experienced the same effect as to the freezing of hands.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Headache
Clinical narrative: Caller reported that his "equilibrium" was affected and is "still off"; have a headache on left side; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 74 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BALANCE DISORDER (non-serious), outcome "not recovered", described as "Caller reported that his "equilibrium" was affected and is "still off""; HEADACHE (non-serious), outcome "not recovered", described as "have a headache on left side". Therapeutic measures were taken as a result of headache.  Additional information: Caller was scheduled to receive the second dose of the Pfizer-BioNTech COVID-19 Vaccine this coming Monday, 12APR2021. On his first dose, Caller reported that his "equilibrium" was affected and was "still off". He also mentioned to have a headache on left side which is still there even after taking medications (aspirin etc.) Caller was seeking guidance if he should get his second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block, Hepatic failure, Myalgia
Clinical narrative: severe muscle pain leg and neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 02:00 (Lot number: EN6205) as dose 2, single and intramuscular, administered in arm left, administration date 08Feb2021 09:00 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. Relevant medical history included: "liver transplant", start date: Jan2003 (ongoing), notes: The caller (Name) said that he already received the 1st dose, he underwent a liver transplant 18 years ago and he's taking Prograf everyday.; "Heart attack", start date: Jun2019 (unspecified if ongoing), notes: quadruple by pass. Concomitant medication(s) included: PROGRAF taken for liver transplant. The following information was reported: MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "severe muscle pain leg and neck". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia.  Additional information: The caller (Name) said that he already received the 1st dose, he underwent a liver transplant 18 years ago, and he is taking Prograf everyday. No prior vaccination was reported within the 4 weeks and adverse event started 10-12 days after second dose.  No follow-up attempts are possible. No further information is expected.  Follow-up (12Apr2021): New follow-up report received from same contactable consumer. Updated information included: Additional information and event added.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: experiencing severe restriction of range of motion in the neck area; 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 73 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ER8727) at the age of 73 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: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "experiencing severe restriction of range of motion in the neck area".  Additional Information: Reporter stated that patient previously spoke with a nurse from our safety department. Patient mentioned that she had her first shot of the PFIZER-BIONTECH COVID-19 VACCINE last March 30 and said that for the last 5 days that patient was experiencing severe restriction of range of motion in the neck area, patient wanted to know if this was a possible side effect of the vaccine. Patient phoned her doctor; patient was told she can get lymph node swelling and that has been reported from the vaccine. PQC Present: No.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Pain, X-ray
Clinical narrative: dull ache; burning sensation; Her arm never stopped hurting.; 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 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 14:22 (Lot number: ER8733) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bilateral mastectomies " (unspecified if ongoing), notes: 22 years ago she had bilateral mastectomies.; "prophylactic surgery", start date: 1999 (unspecified if ongoing), notes: It was a prophylactic surgery done in 1999. For reconstruction she had latissimus dorsi muscles from her back moved forward to form her breast. Concomitant medication(s) included: TYLENOL.  The following information was reported: PAIN (non-serious) with onset 27Mar2021, outcome "not recovered", described as "dull ache"; BURNING SENSATION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "burning sensation"; LIMB DISCOMFORT (non-serious) with onset 27Mar2021, outcome "unknown", described as "Her arm never stopped hurting.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She's nervous to get the second vaccine. She doesn't want to have this happen with the other arm. Everyone she talked to had pain that went away after a week, but she's at two weeks and a half. She's nervous and is asking have you heard this from other people? Ironically she had yearly physical on 5Apr2021 and her doctor saw her arm. There is no swelling, no rash there's nothing to see, it's not warm to the touch, no restriction in range of motion, and she had normal blood work. It was a week and a half into it. Now it's another week and a half later and she's getting nervous. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): no  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Positron emission tomogram, T-lymphocyte count increased
Clinical narrative: cluster of T cells; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 (Lot number: EN6204, Expiration Date: 30Jun2021) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple myeloma", start date: 13Apr2016 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (Lot No: EN6200; Expiry date: reported as 31Jun2021) in left arm), administration date: 19Feb2021, when the patient was 78 years old, for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: T-LYMPHOCYTE COUNT INCREASED (non-serious) with onset 02Apr2021, outcome "unknown", described as "cluster of T cells". Relevant laboratory tests and procedures are available in the appropriate section.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: sinus headaches; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 30Mar2021 (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: SINUS HEADACHE (non-serious), outcome "unknown", described as "sinus headaches". Additional Information: Patient wants to know if she can proceed with the 2nd dose on 30Apr2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Cold sweat, Headache, Malaise, Nasopharyngitis
Clinical narrative: sore arm; I had the second dose 3 weeks ago and still have a headache and nausea every day and a clammy feeling that comes and goes; I had the second dose 3 weeks ago and still have a headache and nausea every day and a clammy feeling that comes and goes; clammy feeling; sore throat; cold symptom; occasional runny nose; she had not been feeling well; balance was a bit off; 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 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 70 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, administration date: 13Feb2021, for covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "I had the second dose 3 weeks ago and still have a headache and nausea every day and a clammy feeling that comes and goes"; COLD SWEAT (non-serious), outcome "unknown", described as "clammy feeling"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptom"; RHINORRHOEA (non-serious), outcome "unknown", described as "occasional runny nose"; MALAISE (non-serious), outcome "unknown", described as "she had not been feeling well"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance was a bit off".  Additional information: Patient had no underlying health issues. Patient did not take any pharmaceuticals. Arm was very sore and very tender - close to be in sick - headaches on and off - balance was a bit off  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: sore arm; I had the second dose 3 weeks ago and still have a headache and nausea every day and a clammy feeling that comes and goes; I had the second dose 3 weeks ago and still have a headache and nausea every day and a clammy feeling that comes and goes; clammy feeling; sore throat; cold symptom; occasional runny nose; she had not been feeling well; balance was a bit off; 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 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 70 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, administration date: 13Feb2021, for covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "I had the second dose 3 weeks ago and still have a headache and nausea every day and a clammy feeling that comes and goes"; COLD SWEAT (non-serious), outcome "unknown", described as "clammy feeling"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptom"; RHINORRHOEA (non-serious), outcome "unknown", described as "occasional runny nose"; MALAISE (non-serious), outcome "unknown", described as "she had not been feeling well"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance was a bit off".  Additional information: Patient had no underlying health issues. Patient did not take any pharmaceuticals. Arm was very sore and very tender - close to be in sick - headaches on and off - balance was a bit off  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, COVID19
Symptoms: Alopecia, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives on head and stomach; Hair loss on head; This is a spontaneous report from a 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 right, administration date 19Nov2021 (Lot number: FJ8757) at the age of 65 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6199, Anatomical site: right arm), administration date: 08Mar2021, when the patient was 64 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8734, Anatomical site: right arm), administration date: 31Mar2021, when the patient was 64 years old, for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "Hives on head and stomach"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss on head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID -19. Since the vaccination, the patient had been tested for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dysphagia, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Throat tightness
Clinical narrative: Hives on head and stomach; Hair loss on head; This is a spontaneous report from a 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 right, administration date 19Nov2021 (Lot number: FJ8757) at the age of 65 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6199, Anatomical site: right arm), administration date: 08Mar2021, when the patient was 64 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8734, Anatomical site: right arm), administration date: 31Mar2021, when the patient was 64 years old, for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "Hives on head and stomach"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss on head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID -19. Since the vaccination, the patient had been tested for COVID-19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a contactable Consumer. A 75 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 24Jan2021 12:00 (Batch/Lot number: unknown), at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included cholesterol and blood pressure (unspecified) from unspecified dates, for which she was on cholesterol medication and blood pressure medication. The patient's concomitant medications were not reported. Vaccination history included the flu vaccine (She did have a flu vaccine, but it was more than 4 weeks before covid vaccine, for Immunization. The patient experienced stroke on 24Jan2021, at 18:00, and has very little use of left leg, half vision in her left eye and she has no use of left arm, all since an unspecified date in 2021. The patient was hospitalized for stroke seven days, and it also involved an emergency room visit. Details were as follows: On 24Jan2021, the patients spouse took her for the first Covid shot. At twelve noon, she got the shot and at 6 pm, she had a stroke. She went to rehab for three months. Now the doctor was saying the stroke was caused by the vaccine. When the patient  had the stroke, the fire department was called, a sent rescue squad was called. The rescue squad took her, and she was there for 4 hours. Then they discharged her to a stroke unit of a hospital. She spent a week there. Then she was admitted to another institute. She spent five weeks there. Then she was at another institution. While she was there, they didn't strap her in her wheelchair and she fell and bumped her head. She spent a week in the hospital and then went to another institution for a week and a half. All together she was missing from home for three months. The outcome of the event, was that the patient had no use of left arm. She had very little use of left leg. Half vision in her left eye. She has to have 24 hour nurse with her. The reporter was taking the patient to rehab. The patient was on cholesterol medication and blood pressure medication at the time she received the vaccine, and had stroke. The patient was previous healthy, had a treadmill in the house and she would walk five days a week.  The patient was given an unspecified injection to help within 4 hours of stroke there was no family medical history.  The patient has not  had any further doses of Covid shot. All doctors have said not to get the second shot. The clinical outcome of stroke was recovered on 24Jan2021.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymph node pain
Clinical narrative: Headache, slight for a month still continues; lymph node pain under arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 24Feb2021 13:30 (Lot number: EN6200) at the age of 77 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "heart attack" (unspecified if ongoing); "bypass surgery" (unspecified if ongoing). Concomitant medication included: VICTOR [AMOXICILLIN SODIUM;SULBACTAM SODIUM]; ATORVASTATIN; GLIMEPIRIDE; METOPROLOL; QUI-LEA MONODOSIS. Past drug history included: Cipro, reaction: "known allergies: Cipro". Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL9264, Administration time: 02:00 PM, Right arm), administration date: 05Feb2021, when the patient was 77 years old, for Covid-19 immunisation, reaction: "headache", "muscle cramps", "lymph node pain under arm". The following information was reported: HEADACHE (non-serious) with onset 24Feb2021, outcome "not recovered", described as "Headache, slight for a month still continues"; LYMPH NODE PAIN (non-serious) with onset 24Feb2021, outcome "not recovered", described as "lymph node pain under arm". Therapeutic measures were not taken as a result of headache, lymph node pain.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vomiting
Clinical narrative: Tiredness; Had a sight sore right arm; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 14:15 (Lot number: EN6206) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: FATIGUE (non-serious) with onset 01Apr2021 06:30, outcome "recovered" (Apr2021), described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 01Apr2021 06:30, outcome "recovered" (Apr2021), described as "Had a sight sore right arm"; VOMITING (non-serious) with onset 01Apr2021 06:30, outcome "recovered" (Apr2021), described as "Vomiting". Therapeutic measures were not taken as a result of fatigue, pain in extremity, vomiting.  Additional information: Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not tested for COVID-19 prior and post vaccination. After about 3 hours from first dose patient was incredibly tired and slept it off. This was not that bad. He woke up for a little while and then went back to sleep. At around 6:15 AM the following day patient woke up with a massive headache. He took a couple Ibuprofen and tried to relax. About 15 minutes later patient was about to vomit; and he did. Patient kept vomiting for about the next 20 minutes or so till there was nothing left. Patient slowly sipped water for the next hour. After that he had no adverse reactions. Patient had not vomited in at least the past 7 years and this episode was violent. Patient could not control it. Patient only had a sight sore right arm and tiredness the evening before. After vomiting the following morning patient slept for the next 5 or so hours. His arm was still slightly sore but really didn't bother him. After around 2 PM (about 24 hours later) patient felt totally fine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre Syndrome". Additional information: The pharmacist wanted to know if there's any information on the relationship between the Pfizer-BioNTech COVID-19 Vaccine and Guillain-Barre Syndrome. The pharmacist knew of a person (close relationship; the patient) who got diagnosed with this syndrome. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, the causal relationship between the reported Guillain-Barre Syndrome and the  use of BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: felt very buzzy; maybe anxiety; My heart rate is elevated; Woke up in the middle of the night and I felt achy; 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 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: ER2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt very buzzy"; ANXIETY (non-serious), outcome "unknown", described as "maybe anxiety"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "My heart rate is elevated"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Woke up in the middle of the night and I felt achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, pain.  Additional information: The patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 06Apr2021 at around 1PM. Mentioned she woke up in the middle of night (usually does so) and felt achy. When she woke up this morning and had a cup of tea, noticed that she was "somewhat sensitive to caffeine" which was unusual because the patient mentioned she liked drinking coffee. She mentioned that her heart rate (HR) was 96 beats per minute (BPM), which was high because her usual HR is 60 BPM. She checked and her oxygen levels were normal (98%). She asked about this possible side effect to the vaccine, aside from her sore arm. She mentioned that before getting the second dose, she "felt very buzzy"; "maybe anxiety". Also stated that her friend who also got the 2nd dose of the vaccine had "the same reaction". Question: "Can I take Ibuprofen?". States she had not had anything to eat. States her heart rate was elevated, usually she had HR of 68 BP (Clarification unknown), now 96. She had a pharmacist and her oxygen was good it was 98 and so she just read that elevated heart rate was something that was severe allergic reaction but she was fine right after she got the shot.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pain
Clinical narrative: felt very buzzy; maybe anxiety; My heart rate is elevated; Woke up in the middle of the night and I felt achy; 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 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: ER2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt very buzzy"; ANXIETY (non-serious), outcome "unknown", described as "maybe anxiety"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "My heart rate is elevated"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Woke up in the middle of the night and I felt achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, pain.  Additional information: The patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 06Apr2021 at around 1PM. Mentioned she woke up in the middle of night (usually does so) and felt achy. When she woke up this morning and had a cup of tea, noticed that she was "somewhat sensitive to caffeine" which was unusual because the patient mentioned she liked drinking coffee. She mentioned that her heart rate (HR) was 96 beats per minute (BPM), which was high because her usual HR is 60 BPM. She checked and her oxygen levels were normal (98%). She asked about this possible side effect to the vaccine, aside from her sore arm. She mentioned that before getting the second dose, she "felt very buzzy"; "maybe anxiety". Also stated that her friend who also got the 2nd dose of the vaccine had "the same reaction". Question: "Can I take Ibuprofen?". States she had not had anything to eat. States her heart rate was elevated, usually she had HR of 68 BP (Clarification unknown), now 96. She had a pharmacist and her oxygen was good it was 98 and so she just read that elevated heart rate was something that was severe allergic reaction but she was fine right after she got the shot.   No follow up attempts are possible. No further information is expected.