chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Maternal exposure during pregnancy
Clinical narrative: pregnant; feeling so bad; feeling terrible; 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 female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "pregnant"; MALAISE (non-serious), outcome "unknown", described as "feeling so bad"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling terrible". The events "pregnant", "feeling so bad" and "feeling terrible" were evaluated at the emergency room visit.  Additional information: The caller stated she took the first dose of this vaccine and when she got home, like the second or third day, she was feeling so bad and terrible and went to the ER and found out she was pregnant. She does not know how far along she was, but she will be seeing her OBGYN on the 28th. She wanted to know if she should continue with her second dose. Consumer called in stated that she had her first shot. Said that she was experiencing some symptoms; didn't specify, just said symptoms. She went to the ER and found out that she was pregnant. She doesn't know how far along she was. She wanted to know if it is safe for her to get the second shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: Three days after second vaccine, acute depression; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2021 14:30 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, administration time=04:00 PM, vaccine location=Left arm), administration date: 18Dec2020, when the patient was 52 years old, for Covid-19 Immunization. The following information was reported: DEPRESSION (non-serious) with onset 09Jan2021, outcome "not recovered", described as "Three days after second vaccine, acute depression". The event "three days after second vaccine, acute depression" was evaluated at the physician office visit. Therapeutic measures were taken as a result of depression.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient Was treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Magnetic resonance imaging, Positron emission tomogram, Rash
Clinical narrative: Red splotches up both of his arm; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 26Aug2021 13:30 (Lot number: EW0173) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lung cancer", start date: 2017 (ongoing); "Stroke", start date: Sep2001 (ongoing); "COPD" (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Anatomical site of Location: upper arm, Batch/Lot number: ENG198, Route of administration: Intramuscular), administration date: 06Mar2021, when the patient was 79 years old, for Covid-19 immunization; Bnt162b2 (dose 2, single, Time(24hr): 8: 40 A.M., Anatomical site of Location: upper arm, Batch/Lot number: ER8732, Route of administration: Intramuscular), administration date: 27Mar2021, when the patient was 79 years old, for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Red splotches up both of his arm"; RASH (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter stated, "her husband got the booster shot on 26 Aug and he had these red splotches up both of his arms." When asked if want to know about the side effects, reporter stated, "Yes." Patient stated, "he was taking other medications and he was treated for Lung cancer for that his Pulmonologist wanted him to get the booster shot." Reporter want to know what to do about your vaccine causing these spots on her husband and would like to speak to the department that can give that answer."  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: chills; feeling totally unwell; nauseated; sleeping a lot; Soreness in the arm; slight headache; Fatigue; get tired after lunch; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zonegran, reaction(s): "bad reaction of weight loss"; Dilantin, reaction(s): "rash"; Dilantin, reaction(s): "itching burning"; Dilantin, reaction(s): "darkening of the skin"; Dilantin, reaction(s): "sick"; Tegretol, reaction(s): "rash"; Tegretol, reaction(s): "itching burning"; Tegretol, reaction(s): "darkening of the skin"; Tegretol, reaction(s): "sick"; Botox, reaction(s): "rash down neck shoulders and scalp". Vaccination history included: Flu shot (1988 anaphylaxis shock and hospitalized due to a flu shot), administration date: 1988, reaction(s): "anaphylaxis shock". The following information was reported: CHILLS (non-serious) with onset 20Mar2021 01:30, outcome "recovering", described as "chills"; MALAISE (non-serious) with onset 20Mar2021 01:30, outcome "unknown", described as "feeling totally unwell"; NAUSEA (non-serious) with onset 20Mar2021 01:30, outcome "unknown", described as "nauseated"; SOMNOLENCE (non-serious) with onset 20Mar2021, outcome "unknown", described as "sleeping a lot"; PAIN IN EXTREMITY (non-serious) with onset 20Mar2021, outcome "unknown", described as "Soreness in the arm"; HEADACHE (non-serious) with onset 20Mar2021, outcome "unknown", described as "slight headache"; FATIGUE (non-serious) with onset 20Mar2021, outcome "recovering", described as "Fatigue"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "get tired after lunch".   Additional information: The patient took the first dose of the Pfizer Covid 19 vaccine on 17Mar2021. The following Friday night she went to bed and woke up at 1:30am with chills and feeing totally unwell, little area of feeling nauseated, sleeping a lot which is unusual for her, get tired after lunch yawning and nodding my head, was really hard to wake me up from a nap. Soreness in the arm slight headache. Fatigue has increase. Chills. Fatigue decreased 4 days ago. On 1988 anaphylaxis shock and hospitalized due to a flu shot. Patient had a bad reaction of weight loss to Zonegran a couple of years ago. My first severe reaction was to dilantin and later tegratol: rash and itching burning darkening of the skin, got really sick. Patient had a severe reaction to Botox rash down neck shoulders and scalp.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: chills; feeling totally unwell; nauseated; sleeping a lot; Soreness in the arm; slight headache; Fatigue; get tired after lunch; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zonegran, reaction(s): "bad reaction of weight loss"; Dilantin, reaction(s): "rash"; Dilantin, reaction(s): "itching burning"; Dilantin, reaction(s): "darkening of the skin"; Dilantin, reaction(s): "sick"; Tegretol, reaction(s): "rash"; Tegretol, reaction(s): "itching burning"; Tegretol, reaction(s): "darkening of the skin"; Tegretol, reaction(s): "sick"; Botox, reaction(s): "rash down neck shoulders and scalp". Vaccination history included: Flu shot (1988 anaphylaxis shock and hospitalized due to a flu shot), administration date: 1988, reaction(s): "anaphylaxis shock". The following information was reported: CHILLS (non-serious) with onset 20Mar2021 01:30, outcome "recovering", described as "chills"; MALAISE (non-serious) with onset 20Mar2021 01:30, outcome "unknown", described as "feeling totally unwell"; NAUSEA (non-serious) with onset 20Mar2021 01:30, outcome "unknown", described as "nauseated"; SOMNOLENCE (non-serious) with onset 20Mar2021, outcome "unknown", described as "sleeping a lot"; PAIN IN EXTREMITY (non-serious) with onset 20Mar2021, outcome "unknown", described as "Soreness in the arm"; HEADACHE (non-serious) with onset 20Mar2021, outcome "unknown", described as "slight headache"; FATIGUE (non-serious) with onset 20Mar2021, outcome "recovering", described as "Fatigue"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "get tired after lunch".   Additional information: The patient took the first dose of the Pfizer Covid 19 vaccine on 17Mar2021. The following Friday night she went to bed and woke up at 1:30am with chills and feeing totally unwell, little area of feeling nauseated, sleeping a lot which is unusual for her, get tired after lunch yawning and nodding my head, was really hard to wake me up from a nap. Soreness in the arm slight headache. Fatigue has increase. Chills. Fatigue decreased 4 days ago. On 1988 anaphylaxis shock and hospitalized due to a flu shot. Patient had a bad reaction of weight loss to Zonegran a couple of years ago. My first severe reaction was to dilantin and later tegratol: rash and itching burning darkening of the skin, got really sick. Patient had a severe reaction to Botox rash down neck shoulders and scalp.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Foreign body, Paraesthesia, Vaccination site discolouration, Vaccination site pain
Clinical narrative: where she got the second dose shot of the Pfizer-BioNTech COVID-19 Vaccine, turned black and blue; Left arm hurts; fingers on her left hand are tingling; and her arm's killing her and her arm's killing her; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, had no issue ), for Covid-19 immunization. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset Apr2021, outcome "unknown", described as "where she got the second dose shot of the Pfizer-BioNTech COVID-19 Vaccine, turned black and blue"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Left arm hurts"; PARAESTHESIA (non-serious) with onset Apr2021, outcome "unknown", described as "fingers on her left hand are tingling"; FOREIGN BODY (non-serious) with onset Apr2021, outcome "unknown", described as "and her arm's killing her and her arm's killing her".  Additional information: She had both the first and second dose shots of the Pfizer-BioNTech COVID-19 Vaccine. The first dose of Pfizer-BioNTech COVID-19 Vaccine she really had no issue with. The second dose of Pfizer-BioNTech COVID-19 Vaccine she was administered on 28Mar2021, she had no issue with until a week into it. A week into it suddenly, her left arm, which is where she got the second dose shot of the Pfizer-BioNTech COVID-19 Vaccine, turned black and blue, left arm hurts, and the fingers on her left hand are tingling. She not known if the events she was experiencing were normal or bizarre. She thought the whole process sucks. When she got the shots of the Pfizer-BioNTech COVID-19 Vaccine no one ever told her a phone number to call. She was sort of annoyed that a week into it, her shot left arm was killing her. She thought that was a problem with Pfizer. She felt in her fingers. She had never had any issues at all and she has never had covid or any issues but now she had this foreign body in her arm and her arm's killing her so she was not really happy about that. She was a woman who didn't want the vaccine and 2-3-4 weeks later she was having a huge issue with her arm and hand. She was a righty so that was not an issue. She believed that these events go totally together with the vaccine because she never had any issues with her arm or hand before this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Malaise, SARS-CoV-2 test
Clinical narrative: She also felt sick .; After first dose her lips started swelling that evening and they were huge; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: FF2588) at the age of 13 years as dose 2, single and administered in arm left, administration date 23Aug2021 14:00 (Lot number: FC3182) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Azythromcin, reaction(s): "Allergy"; Erythromycin, reaction(s): "Allergy". The following information was reported: LIP SWELLING (non-serious) with onset 23Aug2021 17:00, outcome "recovered" (24Aug2021), described as "After first dose her lips started swelling that evening and they were huge"; MALAISE (non-serious) with onset 23Aug2021 18:00, outcome "recovered", described as "She also felt sick .". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lip swelling, malaise.  Follow-Up (20Oct2021): Follow-up attempts are completed. No further information is expected.  Follow-up (29Oct2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (daughter) in response to Non-HCP letter sent to another consumer that included:Dose-2 information was added.  Additional information:The evening of getting my daughter's first shot she had severe swelling in her lips. The reporter's father called the pharmacy to see what needed to be done, which they had told to give Benadryl and if not better tomorrow then take her to the doctor. In the morning her lips were improving and swelling had subsided.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Hyperhidrosis, Night sweats
Clinical narrative: hot & cold sweats at night; hot & cold sweats at night; hot & cold sweats at night; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Jan2021 (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: HYPERHIDROSIS (non-serious), COLD SWEAT (non-serious), NIGHT SWEATS (non-serious), outcome "unknown" and all described as "hot & cold sweats at night". Additional Information: The patient was reported to be of age 42 (unit unknown). The patient received his first Pfizer BioNTech Covid 19 vaccine on 24Jan2021 and experienced hot & cold sweats at night.  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-2021355591 same patient, different event, different dose of vaccine
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Fatigue, Pain in extremity
Clinical narrative: inflammation and pain in the wrists; inflammation and pain in the wrists; very sore arm; mild tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 05Mar2021 (Lot number: EN6198) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Common Variable Immunodeficiency (CVID)" (ongoing), notes: immunocompromised; "sports injuries" (unspecified if ongoing); "osteoarthritis in both knees" (ongoing). Concomitant medication(s) included: IGG taken for immunodeficiency common variable (ongoing); CORTISONE taken for osteoarthritis (ongoing). Vaccination history included: Flu shot, for influenza immunization, reaction(s): "sore arm". The following information was reported: ARTHRITIS (non-serious), ARTHRALGIA (non-serious) all with onset Mar2021, outcome "unknown" and all described as "inflammation and pain in the wrists"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "very sore arm"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "mild tiredness". Additional information: Duration of event "very sore arm" was 3-4 days, while the event "mild tiredness" was 2 days (energy level went to 100%).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Experiencing extreme headache; 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 male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Experiencing extreme headache".  Additional information: Patient wanted to know if he can take paracetamol (TYLENOL).  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: Asthma, Dizziness, Pain in extremity, Tinnitus
Clinical narrative: severe asthma attack; very bad ringing in right ear; arm pain; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 10:30 (Lot number: ER8727) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Reflux" (ongoing); "skin issue" (unspecified if ongoing); "Estrace for balance of body hormones" (ongoing); "Asthma" (ongoing); "Ringing in ears" (ongoing). Family history included: "Thyroid issue" (unspecified if ongoing); "cancer" (unspecified if ongoing), notes: Mother cancer; "Heart attack" (unspecified if ongoing), notes: Father Heart attack. Concomitant medication(s) included: DEXILANT taken for gastrooesophageal reflux disease (ongoing); FLOVENT HFA taken for asthma (ongoing); PROHAIR taken for asthma (ongoing); CLOBETASOL taken for skin disorder. The following information was reported: ASTHMA (medically significant) with onset 2021, outcome "unknown", described as "severe asthma attack"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "very bad ringing in right ear"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm pain"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness". Therapeutic measures were taken as a result of asthma. Clinical course: It was reported that, patient had severe asthma attacks not controlled by inhalers. I needed to go to a clinic. It caused very bad ringing in my right ear dizziness Arm pain. Dizziness still on and off, ringing in ears is loud. Vaccine Administered at Military Facility. Patient also received dose 2 on 15Apr2021 and dose 3 on 18Dec2021. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: She states this time there was a little bit of blood on the bandaide; 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 04Oct2021 (Batch/Lot number: unknown, Expiration Date: 31Jan2022) 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 (1st dose), for Covid-19 immunization; Bnt162b2 (2nd Dose), for Covid-19 immunization. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious) with onset 04Oct2021, outcome "unknown", described as "She states this time there was a little bit of blood on the bandaide".  Additional information: It was reported that there was no blood at vaccination site after previous 2 Covid-19 Vaccine doses.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: numbness, burning and tingling in the feet/ankles and hands; numbness, burning and tingling in the feet/ankles and hands; numbness, burning and tingling in the feet/ankles and hands; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Oct2021 08:00 (Lot number: FF8841) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 08:00, Route of Administration: Intramuscular), administration date: 22Dec2020, when the patient was 52 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 12Jan2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA (disability), PARAESTHESIA (disability), BURNING SENSATION (disability) all with onset 04Oct2021 06:00, outcome "not recovered" and all described as "numbness, burning and tingling in the feet/ankles and hands". The event "numbness, burning and tingling in the feet/ankles and hands", "numbness, burning and tingling in the feet/ankles and hands" and "numbness, burning and tingling in the feet/ankles and hands" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, burning sensation.  Clinical course: It was reported that three days After the booster shot, the patient developed numbness, burning and tingling in the feet, ankles and hands and has persisted for four months. The patient reported that he received treatment for adverse events with Gabapentin but it has not been helpful in treating symptoms. The patient reported he had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested negative for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Hypoaesthesia, Paraesthesia, Burning sensation and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myositis
Clinical narrative: Severe muscle inflammation under left breast; patient thought she broke a rib; Severe muscle inflammation under left breast; patient thought she broke a rib; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Mar2021 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM. The following information was reported: MYOSITIS (non-serious), RIB FRACTURE (non-serious) all with onset 10Mar2021 12:00, outcome "not recovered" and all described as "Severe muscle inflammation under left breast; patient thought she broke a rib". The event "severe muscle inflammation under left breast; patient thought she broke a rib" was evaluated at the physician office visit. Therapeutic measures were taken as a result of myositis, rib fracture. Additional information: Treatment included tramadol (TRAMAL) 50 milligrams. Vaccination time was reported as 08:45. The patient doesn't have a history of allergies to any food or medications or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Culture, Headache, Influenza like illness, Pain in extremity
Clinical narrative: headache; After my first dose after 4 hours I could not move my arm from the pain and the next morning I had phlegm, irritated throat and some blockage of the nose (flu-like symptoms) and headache.; After my first dose after 4 hours I could not move my arm from the pain and the next morning I had phlegm, irritated throat and some blockage of the nose (flu-like symptoms) and headache.; flu-like symptoms; I could not move my arm from the pain; Fever for 24 hours that reached 102 Fahrenheit; General feeling of weakness and feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 13:00 (Lot number: ER8729) at the age of 31 years as dose 1, single and administration date 09Apr2021 13:00 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HPV VACCINE, start date: 02Mar2021, stop date: 02Mar2021.The following information was reported: HEADACHE (non-serious) with onset 10Apr2021 03:00, outcome "recovering", described as "headache"; PRODUCTIVE COUGH (non-serious), THROAT IRRITATION (non-serious) all with onset 10Apr2021 03:00, outcome "recovering" and all described as "After my first dose after 4 hours I could not move my arm from the pain and the next morning I had phlegm, irritated throat and some blockage of the nose (flu-like symptoms) and headache. These lasted for 24 hours."; INFLUENZA LIKE ILLNESS (non-serious) with onset 10Apr2021 03:00, outcome "recovering", described as "flu-like symptoms"; PAIN IN EXTREMITY (non-serious) with onset 10Apr2021 03:00, outcome "recovering", described as "I could not move my arm from the pain"; PYREXIA (non-serious) with onset 10Apr2021 03:00, outcome "recovering", described as "Fever for 24 hours that reached 102 Fahrenheit"; ASTHENIA (non-serious) with onset 10Apr2021 03:00, outcome "recovering", described as "General feeling of weakness and feeling sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, productive cough, throat irritation, influenza like illness, pain in extremity, pyrexia, asthenia.  Additional information: Patient was not diagnosed with COVID-19 prior to vaccination.Patient received other vaccine within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, SARS-CoV-2 test, Throat irritation
Clinical narrative: headache; After my first dose after 4 hours I could not move my arm from the pain and the next morning I had phlegm, irritated throat and some blockage of the nose (flu-like symptoms) and headache.; After my first dose after 4 hours I could not move my arm from the pain and the next morning I had phlegm, irritated throat and some blockage of the nose (flu-like symptoms) and headache.; flu-like symptoms; I could not move my arm from the pain; Fever for 24 hours that reached 102 Fahrenheit; General feeling of weakness and feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 13:00 (Lot number: ER8729) at the age of 31 years as dose 1, single and administration date 09Apr2021 13:00 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HPV VACCINE, start date: 02Mar2021, stop date: 02Mar2021.The following information was reported: HEADACHE (non-serious) with onset 10Apr2021 03:00, outcome "recovering", described as "headache"; PRODUCTIVE COUGH (non-serious), THROAT IRRITATION (non-serious) all with onset 10Apr2021 03:00, outcome "recovering" and all described as "After my first dose after 4 hours I could not move my arm from the pain and the next morning I had phlegm, irritated throat and some blockage of the nose (flu-like symptoms) and headache. These lasted for 24 hours."; INFLUENZA LIKE ILLNESS (non-serious) with onset 10Apr2021 03:00, outcome "recovering", described as "flu-like symptoms"; PAIN IN EXTREMITY (non-serious) with onset 10Apr2021 03:00, outcome "recovering", described as "I could not move my arm from the pain"; PYREXIA (non-serious) with onset 10Apr2021 03:00, outcome "recovering", described as "Fever for 24 hours that reached 102 Fahrenheit"; ASTHENIA (non-serious) with onset 10Apr2021 03:00, outcome "recovering", described as "General feeling of weakness and feeling sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, productive cough, throat irritation, influenza like illness, pain in extremity, pyrexia, asthenia.  Additional information: Patient was not diagnosed with COVID-19 prior to vaccination.Patient received other vaccine within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: expected the area to be warm to touch, hot to touch and red with the 1st dose; expected the area to be warm to touch, hot to touch and red with the 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "expected the area to be warm to touch, hot to touch and red with the 1st dose".  Additional Information: Caller stated she is calling from her desk and is providing her cell number. Stated she has a question, she got her 2nd dose of the vaccine on Monday and on Tuesday she had arm swelling and redness in the area and yesterday swelling and irritated and it was itchy. Stated she expected the area to be warm to touch, hot to touch and red with the 1st dose and is asking if we have been getting reports of that on the 2nd dose also. Stated she knows some is normal the 2nd day and several days out like this another day or 2 and is wondering when to call out to her healthcare provider as she doesn't want to freak out and call and thought she would ask the question. Caller declines to make a report at this time. Caller stated she got the Pfizer Covid 19 vaccine 12Apr2021. Caller stated what she is hearing is she may not get more information that what she has already read and not going to get information about windows of time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site bruising
Clinical narrative: Tired; Sore joints; Injection site bruise 2 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 13:45 (Lot number: ER8727) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple myeloma" (unspecified if ongoing), notes: Multiple myeloma. Concomitant medication(s) included: ZOMETA. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: EL9266 , Location of injection: Arm Right , Vaccine Administration Time: 04:00 PM, Event verbatim: lost taste and smell), administration date: 24Feb2021, for COVID-19 immunization, reaction(s): "lost taste and smell", "lost taste and smell". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Tired"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Sore joints"; VACCINATION SITE BRUISING (non-serious) with onset 2021, outcome "recovered" (2021), described as "Injection site bruise 2 weeks". It was unknown if therapeutic measures were taken as a result of fatigue, arthralgia, vaccination site bruising.  Additional information: The most recent COVID-19 vaccine was administered at a clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Zometa infusion. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient received third dose of Pfizer (lot Ew0179) in arm left on 26Aug2021 at 01:30 PM as dose 3 (booster), single for covid-19 immunisation and experienced tired joints sore, on 31Aug2021 at 02:45 AM woke freezing cold, then dizzy. Then nausea and wanted to vomit at 3am. Got up but could not walk collapsed with outcome recovering. The patient reported allergy with an unspecified drug.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Tremor
Clinical narrative: shaking; experienced fever; chills; a bright red rash on face; a bright red rash on face; uncontrollable urine; aching; cough; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 12Nov2021 11:45 (Lot number: FD0809) at the age of 81 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Coronary Artery Disease" (unspecified if ongoing); "Kidney disease" (unspecified if ongoing); "Urinary Infection", stop date: Jan2011; "Pecans" (unspecified if ongoing), notes: Known allergies: Pecans. Concomitant medication(s) included: CLOPIDOGREL (ongoing); LISINOPRIL (ongoing); EXEMESTANE (ongoing); METOPROLOL TARTRATE (ongoing); AMLODIPINE (ongoing); EZETIMIBE (ongoing). Past drug history included: Haldol, reaction(s): "known allergies: Halodol"; Sulfa, notes: Known allergies: Sulfa. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Route of Administration: Intramuscular), administration date: 03Mar2021, when the patient was 81 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Route of Administration: Intramuscular), administration date: 10Feb2021, when the patient was 81 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Nov2021 03:00, outcome "recovered" (2021), described as "experienced fever"; CHILLS (non-serious) with onset 13Nov2021 03:00, outcome "recovered" (Nov2021), described as "chills"; RASH ERYTHEMATOUS (non-serious), RASH (non-serious) all with onset 13Nov2021 03:00, outcome "recovered" (Nov2021) and all described as "a bright red rash on face"; POLLAKIURIA (non-serious) with onset 13Nov2021 03:00, outcome "recovered" (Nov2021), described as "uncontrollable urine"; PAIN (non-serious) with onset 13Nov2021 03:00, outcome "recovered" (2021), described as "aching"; COUGH (non-serious) with onset 13Nov2021 03:00, outcome "recovered" (2021), described as "cough"; TREMOR (non-serious), outcome "recovered" (Nov2021), described as "shaking". Therapeutic measures were taken as a result of pyrexia, chills, rash erythematous, rash, pollakiuria, pain, cough, tremor.  Additional Information: About 12-15 hours post booster dose, patient experienced fever/chills, a bright red rash on face, uncontrollable urine, aching, and cough. Patient took tylenol and benadryl to alleviate symptoms. Symptoms resolved about 24-36 hours post onset. It was unknown that the patient had covid prior vaccination and not tested for Covid post vaccination. It was unknown that the patient received prior vaccination (within 4 weeks). Patient started experiencing chills, shaking and a red rash on her face approximately 12 hours post Injection. She also had trouble controlling her urine during this time as well. She took some Benadryl and her symptoms subsided around 36 hrs post Injection.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Anger, Behaviour disorder, Disturbance in attention, Electroencephalogram
Clinical narrative: behavioral changes; sudden weight loss; random giggling; self-talking non-stop; not sleeping at all; getting angry and violent; getting angry and violent; lost of focus and attention lost of focus and attention not even able to action on one step instructions at school and at home; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 12:15 (Lot number: FC3180) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 06Aug2021, when the patient was 12 years old, for Covid-19 Immunization. The following information was reported: BEHAVIOUR DISORDER (non-serious) with onset 10Sep2021, outcome "not recovered", described as "behavioral changes"; WEIGHT DECREASED (non-serious) with onset 10Sep2021, outcome "not recovered", described as "sudden weight loss"; INAPPROPRIATE AFFECT (non-serious) with onset 10Sep2021, outcome "not recovered", described as "random giggling"; SOLILOQUY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "self-talking non-stop"; INSOMNIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "not sleeping at all"; ANGER (non-serious), AGGRESSION (non-serious) all with onset 10Sep2021, outcome "not recovered" and all described as "getting angry and violent"; DISTURBANCE IN ATTENTION (non-serious) with onset 10Sep2021, outcome "not recovered", described as "lost of focus and attention lost of focus and attention not even able to action on one step instructions at school and at home". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of behaviour disorder, weight decreased, inappropriate affect, soliloquy, insomnia, anger, aggression, disturbance in attention.  Additional information: Treatment received for the adverse event is brain MRI scan, EEG test, Lumbar Puncture procedure. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine and patient was not diagnosed with COVID 19.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate affect, Insomnia, Magnetic resonance imaging head, SARS-CoV-2 test, Soliloquy
Clinical narrative: behavioral changes; sudden weight loss; random giggling; self-talking non-stop; not sleeping at all; getting angry and violent; getting angry and violent; lost of focus and attention lost of focus and attention not even able to action on one step instructions at school and at home; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 12:15 (Lot number: FC3180) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 06Aug2021, when the patient was 12 years old, for Covid-19 Immunization. The following information was reported: BEHAVIOUR DISORDER (non-serious) with onset 10Sep2021, outcome "not recovered", described as "behavioral changes"; WEIGHT DECREASED (non-serious) with onset 10Sep2021, outcome "not recovered", described as "sudden weight loss"; INAPPROPRIATE AFFECT (non-serious) with onset 10Sep2021, outcome "not recovered", described as "random giggling"; SOLILOQUY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "self-talking non-stop"; INSOMNIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "not sleeping at all"; ANGER (non-serious), AGGRESSION (non-serious) all with onset 10Sep2021, outcome "not recovered" and all described as "getting angry and violent"; DISTURBANCE IN ATTENTION (non-serious) with onset 10Sep2021, outcome "not recovered", described as "lost of focus and attention lost of focus and attention not even able to action on one step instructions at school and at home". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of behaviour disorder, weight decreased, inappropriate affect, soliloquy, insomnia, anger, aggression, disturbance in attention.  Additional information: Treatment received for the adverse event is brain MRI scan, EEG test, Lumbar Puncture procedure. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine and patient was not diagnosed with COVID 19.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: behavioral changes; sudden weight loss; random giggling; self-talking non-stop; not sleeping at all; getting angry and violent; getting angry and violent; lost of focus and attention lost of focus and attention not even able to action on one step instructions at school and at home; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 12:15 (Lot number: FC3180) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 06Aug2021, when the patient was 12 years old, for Covid-19 Immunization. The following information was reported: BEHAVIOUR DISORDER (non-serious) with onset 10Sep2021, outcome "not recovered", described as "behavioral changes"; WEIGHT DECREASED (non-serious) with onset 10Sep2021, outcome "not recovered", described as "sudden weight loss"; INAPPROPRIATE AFFECT (non-serious) with onset 10Sep2021, outcome "not recovered", described as "random giggling"; SOLILOQUY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "self-talking non-stop"; INSOMNIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "not sleeping at all"; ANGER (non-serious), AGGRESSION (non-serious) all with onset 10Sep2021, outcome "not recovered" and all described as "getting angry and violent"; DISTURBANCE IN ATTENTION (non-serious) with onset 10Sep2021, outcome "not recovered", described as "lost of focus and attention lost of focus and attention not even able to action on one step instructions at school and at home". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of behaviour disorder, weight decreased, inappropriate affect, soliloquy, insomnia, anger, aggression, disturbance in attention.  Additional information: Treatment received for the adverse event is brain MRI scan, EEG test, Lumbar Puncture procedure. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine and patient was not diagnosed with COVID 19.  No follow-up attempts are possible. No further information is expected.