chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, SARS-CoV-2 antibody test
Clinical narrative: tingling/pain in my left leg; tingling/pain in my left leg; This is a spontaneous report from a contactable consumer. The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 16:00 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma. Concomitant medication(s) included: LAMICTAL; BUSPAR. The following information was reported: PARAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 12Mar2021 23:30, outcome "not recovered" and all described as "tingling/pain in my left leg". The event "tingling/pain in my left leg" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, pain in extremity.  Additional information: No other vaccine received in four weeks. Other medications in two weeks: Lamictal and buspar. Patient tested post vaccination. Tingling and numbness in patients left thigh. It started after the first shot and got worse after the second. It's causing serious discomfort.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain, Peripheral coldness
Clinical narrative: felt achy and it was like her allergies were acting up; Severe headache; Chills; feet are cold; Sleepy; general feeling of unwell; 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 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 05Apr2021 14:30 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset 08Apr2021, outcome "recovering", described as "felt achy and it was like her allergies were acting up"; HEADACHE (non-serious) with onset 08Apr2021, outcome "unknown", described as "Severe headache"; CHILLS (non-serious) with onset 08Apr2021, outcome "recovering", described as "Chills"; PERIPHERAL COLDNESS (non-serious) with onset 08Apr2021, outcome "recovering", described as "feet are cold"; SOMNOLENCE (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Sleepy"; MALAISE (non-serious) with onset 08Apr2021, outcome "recovering", described as "general feeling of unwell". Therapeutic measures were taken as a result of pain, headache, chills, malaise.  Additional information: It is reported that Severe headache Dates for (From: 8 Apr 2021 To: 8 Apr 2021).Her symptoms are hard to explain as she is very healthy and does not even get colds and for 62 years old and getting no colds, nothing this is unusual for me her to feel like this. She took Tylenol and she is not as achy. Severe headache; she woke up last night to take Tylenol like she was told she was supposed to do and it feels like a fluish feel. she is unsure of the outcome as since she took Tylenol and does not know if that is subsiding it. she is sleepy and she usually gets up around 7 or 8 o'clock in the morning no later and works all day and she is tired and that is just not like her. Chills: she stated she is under a blanket and she has a heating pad to her feet. Treatment: Tylenol, under blanket, and heating pad to her feet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: felt achy and it was like her allergies were acting up; Severe headache; Chills; feet are cold; Sleepy; general feeling of unwell; 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 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 05Apr2021 14:30 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset 08Apr2021, outcome "recovering", described as "felt achy and it was like her allergies were acting up"; HEADACHE (non-serious) with onset 08Apr2021, outcome "unknown", described as "Severe headache"; CHILLS (non-serious) with onset 08Apr2021, outcome "recovering", described as "Chills"; PERIPHERAL COLDNESS (non-serious) with onset 08Apr2021, outcome "recovering", described as "feet are cold"; SOMNOLENCE (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Sleepy"; MALAISE (non-serious) with onset 08Apr2021, outcome "recovering", described as "general feeling of unwell". Therapeutic measures were taken as a result of pain, headache, chills, malaise.  Additional information: It is reported that Severe headache Dates for (From: 8 Apr 2021 To: 8 Apr 2021).Her symptoms are hard to explain as she is very healthy and does not even get colds and for 62 years old and getting no colds, nothing this is unusual for me her to feel like this. She took Tylenol and she is not as achy. Severe headache; she woke up last night to take Tylenol like she was told she was supposed to do and it feels like a fluish feel. she is unsure of the outcome as since she took Tylenol and does not know if that is subsiding it. she is sleepy and she usually gets up around 7 or 8 o'clock in the morning no later and works all day and she is tired and that is just not like her. Chills: she stated she is under a blanket and she has a heating pad to her feet. Treatment: Tylenol, under blanket, and heating pad to her feet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Chronic head pain; headache; This is a spontaneous report received from a contactable consumer.  A female patient received BNT162B2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. 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) with onset 02Apr2021, outcome "unknown", described as "Chronic head pain; headache".  Additional Information: The patient got the second dose of Pfizer the day before the reporting and right now, she was having really chronic head pain. The patient's husband was wondering (can't find anything to the patient) if he can give her anything like paracetamol (TYLENOL) or ibuprofen (MOTRIN) to help it first. The patient's husband can actually go down to the whole list if the company wants him. The patient's husband needed to know what type of medicine that he can give for her headache, she has a bad headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Mar2021 (Lot number: EL3247) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR taken for hypersensitivity, asthma (ongoing); BYSTOLIC taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); LEVONORGESTREL AND ETHINYL ESTRADIOL taken for contraception (ongoing); FLU VACCINE VII, start date: 06Oct2021, stop date: 06Oct2021. Vaccination history included: Pfizer/biontech covid-19 vaccine (Anatomical site: Right arm, Route of administration: Intramuscular, Lot number: EL3247, Onset date: 24Feb2021, AE. Outcome: Recovered, Treatment received: No), administration date: 24Feb2021, when the patient was 50 years old, for Covid-19 immunization, reaction(s): "Injection site soreness". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 16Mar2021, outcome "recovered" (2021), described as "flu-like symptoms". Therapeutic measures were not taken as a result of influenza like illness.  Additional information included: Patient later received third dose of BNT162B2 (Lot number: 33030BD), intramuscular administered in right arm , administration date 10Dec2021 as dose 3 (booster), single for covid-19 immunisation. Booster dose was given due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Specific relevant test for thromboembolic events with thrombocytopenia was reported as None.  Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 14Jan2021 14:50 (Lot number: EL8982) at the age of 87 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was a little sore". Additional information: Patient did not received any other vaccination within 4 weeks prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045522 same reporter and drug, similar event, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyskinesia, Headache, Pain
Clinical narrative: body aches; headache; lower back pain; She is having a hard time moving around; back started hurting the day after she received the Covid 19 vaccine/back is hurting like she's lifted something heavy but she hasn't lifted anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 14:00 (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 51 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: PAIN (non-serious) with onset 07Apr2021, outcome "recovered" (08Apr2021), described as "body aches"; HEADACHE (non-serious) with onset 07Apr2021, outcome "recovered" (08Apr2021), described as "headache"; BACK PAIN (non-serious) with onset 07Apr2021, outcome "not recovered", described as "lower back pain"; DYSKINESIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "She is having a hard time moving around"; BACK PAIN (non-serious) with onset 07Apr2021, outcome "not recovered", described as "back started hurting the day after she received the Covid 19 vaccine/back is hurting like she's lifted something heavy but she hasn't lifted anything". Therapeutic measures were taken as a result of pain, headache.  Additional information: Her mother has been taking Tylenol but it doesn't really help. The Tylenol is 500mg and she takes 1 tablet at a time. Tylenol Lot# SSA101 Expiry Oct2022. 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) none. No additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. No any AE Prior Vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Diarrhea; Exhaustion; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 84 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Mar2021 09:10 (Lot number: EM9809) as dose 2, single for covid-19 immunisation. Relevant medical history included: "remove gall baldder", start date: Dec2018, stop date: Dec2018; "bleeding ulcers", start date: Dec2020, stop date: Dec2020, notes: taken care of; "arthritis", start date: 1970 (ongoing), notes: radio frequency ablation12Mar21. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose,, batch,lot-EM9809, route-intramuscular,, Anatomical location-arm right.), administration date: 10Feb2021, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 05Mar2021 10:00, outcome "recovered" (06Mar2021), described as "Diarrhea"; FATIGUE (non-serious) with onset 05Mar2021 10:00, outcome "recovered" (06Mar2021), described as "Exhaustion"; HEADACHE (non-serious) with onset 05Mar2021 10:00, outcome "recovered" (06Mar2021), described as "headache". Therapeutic measures were not taken as a result of diarrhoea, fatigue, headache.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastroenteritis viral, Pain in extremity
Clinical narrative: has a stomach virus; his arm was a little sore; 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 male patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (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, Single), for COVID-19 Immunization.  The following information was reported: GASTROENTERITIS VIRAL (non-serious) with onset 08Apr2021, outcome "not recovered", described as "has a stomach virus"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "his arm was a little sore".  Additional information: The patient stated that he had the second dose of the Pfizer COVID-19 Vaccine on Wednesday, 07Apr2021 and had no issue with the COVID-19 vaccine. The patient sold stated that he did not have any issue with the COVID-19 Vaccine, except his arm was a little sore on an unknown date in Apr2021. The patient stated that he had a stomach virus this morning (09Apr2021), and last night (08Apr2021). The patient stated wants to know if he could take Imodium AD. The patient said he did not want to take the Imodium AD if the Imodium AD was going to be in conflict with the COVID-19 Vaccine. The patient advised he would be transferred to Pfizer Medical Information for further assistance with his question and was referred to HCP. The patient declined to answer any additional questions. He stated his grandbabies, and his wife, all had the stomach virus, and they had not had the COVID-19 Vaccine. He said he went to his doctor last night, and his doctor told him there was a stomach virus in the area, and his stomach virus was not caused by the COVID-19 Vaccine. He said what he was calling about was just related to the stomach virus. He said he was feeling better and wanted to make sure the Imodium AD was not in conflict with the COVID-19 Vaccine. The case was assessed as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastroenteritis viral, Illness
Clinical narrative: has a stomach virus; his arm was a little sore; 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 male patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (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, Single), for COVID-19 Immunization.  The following information was reported: GASTROENTERITIS VIRAL (non-serious) with onset 08Apr2021, outcome "not recovered", described as "has a stomach virus"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "his arm was a little sore".  Additional information: The patient stated that he had the second dose of the Pfizer COVID-19 Vaccine on Wednesday, 07Apr2021 and had no issue with the COVID-19 vaccine. The patient sold stated that he did not have any issue with the COVID-19 Vaccine, except his arm was a little sore on an unknown date in Apr2021. The patient stated that he had a stomach virus this morning (09Apr2021), and last night (08Apr2021). The patient stated wants to know if he could take Imodium AD. The patient said he did not want to take the Imodium AD if the Imodium AD was going to be in conflict with the COVID-19 Vaccine. The patient advised he would be transferred to Pfizer Medical Information for further assistance with his question and was referred to HCP. The patient declined to answer any additional questions. He stated his grandbabies, and his wife, all had the stomach virus, and they had not had the COVID-19 Vaccine. He said he went to his doctor last night, and his doctor told him there was a stomach virus in the area, and his stomach virus was not caused by the COVID-19 Vaccine. He said what he was calling about was just related to the stomach virus. He said he was feeling better and wanted to make sure the Imodium AD was not in conflict with the COVID-19 Vaccine. The case was assessed as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastroenteritis viral, Pain in extremity
Clinical narrative: stomach virus; illness; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunization. The following information was reported: GASTROENTERITIS VIRAL (non-serious), outcome "unknown", described as "stomach virus"; ILLNESS (non-serious), outcome "unknown", described as "illness".  Additional Information: Patient wanted to know if he could take Imodium AD for illness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastroenteritis viral, Illness
Clinical narrative: stomach virus; illness; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunization. The following information was reported: GASTROENTERITIS VIRAL (non-serious), outcome "unknown", described as "stomach virus"; ILLNESS (non-serious), outcome "unknown", described as "illness".  Additional Information: Patient wanted to know if he could take Imodium AD for illness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: Poison ivy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. The reporter is the patient. A 67-year-old male patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: Unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS CONTACT (non-serious) with onset Mar2021, outcome "unknown", described as "Poison ivy".  Additional information: Patient was scheduled to receive his second dose on 20Apr2021. The caller stated that he has poison ivy and he needs a steroid injection. He would like to know if it's okay to take this steroid shot prior to receiving the second dose of the Pfizer COVID-19 vaccine.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 18Mar2021 17:00 (Lot number: EP6955) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not have any allergies to food, medications or other products. The patient did not receive any other medications within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: The event did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: She had swollen lymph nodes under her arm pit; I had like node under my armpit hurting; 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 46 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6203) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2017 (not ongoing), notes: Not right now but I had it in 2017 at age 42.; "Blood pressure high" (unspecified if ongoing); "Cough" (unspecified if ongoing). Concomitant medication(s) included: ATACAND taken for hypertension; CELEXA [CELECOXIB]; TESSALON PERLE; LETROZOLE taken for breast cancer.  The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "She had swollen lymph nodes under her arm pit"; AXILLARY PAIN (non-serious), outcome "not recovered", described as "I had like node under my armpit hurting". The events "she had swollen lymph nodes under her arm pit" and "i had like node under my armpit hurting" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, axillary pain.  Additional information: the reported stated from the first vaccine she had like node under her armpit hurting, to the first dose. It was painful under the armpits like lymph nodes under the armpits. She took Motrin and Tylenol for swollen lymph node.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sickness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: EN6204) 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: ILLNESS (non-serious), outcome "unknown", described as "Sickness".  Additional information: The patient stated that he received the first dose of the pfizer covid 19 vaccine on 20Mar2021 and his second dose was tomorrow. The patient stated he was sick earlier this week and was on day three of being over the sickness. Caller wanted to know if he can get the vaccine, specifically stating he was wondering if the sickness lowered his immune system and how this would affect the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Influenza
Clinical narrative: head splitting; couldn't move; freezing with chills; sick/ she felt sicker and sicker by the minute; tiredness/She left work and came home and went straight to bed; nausea all the time/wanting to vomit; muscle pain; feeling unwell; she has the flu, the regular flu; achy; 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 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 12:15 (Lot number: ER8732) at the age of 86 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: ILLNESS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "sick/ she felt sicker and sicker by the minute"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "tiredness/She left work and came home and went straight to bed"; HEADACHE (non-serious) with onset 08Apr2021, outcome "not recovered", described as "head splitting"; MOVEMENT DISORDER (non-serious) with onset 08Apr2021, outcome "not recovered", described as "couldn't move"; CHILLS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "freezing with chills"; NAUSEA (non-serious) with onset Apr2021, outcome "not recovered", described as "nausea all the time/wanting to vomit"; MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "muscle pain"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "feeling unwell"; INFLUENZA (non-serious) with onset Apr2021, outcome "not recovered", described as "she has the flu, the regular flu"; PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "achy".  Additioinal information: It was reported that after about a week of taking Covid 19 vaccine, on 07Apr2021 the patient experienced feeling sick. The next day, the patient woke up with splitting head ache and couldn't move, She was freezing with chills and she had nausea. The patient reported that she just has old age and she takes her regular medications in the morning and in the night. She doesn't think they are relevant. She reports it feels like she has the regular flu and was achy. The patient has a feeling like she is wanting to vomit and has nausea all the time. The patient clarified that had no episodes of vomiting.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Movement disorder, Myalgia, Nausea, Pain
Clinical narrative: head splitting; couldn't move; freezing with chills; sick/ she felt sicker and sicker by the minute; tiredness/She left work and came home and went straight to bed; nausea all the time/wanting to vomit; muscle pain; feeling unwell; she has the flu, the regular flu; achy; 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 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 12:15 (Lot number: ER8732) at the age of 86 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: ILLNESS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "sick/ she felt sicker and sicker by the minute"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "tiredness/She left work and came home and went straight to bed"; HEADACHE (non-serious) with onset 08Apr2021, outcome "not recovered", described as "head splitting"; MOVEMENT DISORDER (non-serious) with onset 08Apr2021, outcome "not recovered", described as "couldn't move"; CHILLS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "freezing with chills"; NAUSEA (non-serious) with onset Apr2021, outcome "not recovered", described as "nausea all the time/wanting to vomit"; MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "muscle pain"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "feeling unwell"; INFLUENZA (non-serious) with onset Apr2021, outcome "not recovered", described as "she has the flu, the regular flu"; PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "achy".  Additioinal information: It was reported that after about a week of taking Covid 19 vaccine, on 07Apr2021 the patient experienced feeling sick. The next day, the patient woke up with splitting head ache and couldn't move, She was freezing with chills and she had nausea. The patient reported that she just has old age and she takes her regular medications in the morning and in the night. She doesn't think they are relevant. She reports it feels like she has the regular flu and was achy. The patient has a feeling like she is wanting to vomit and has nausea all the time. The patient clarified that had no episodes of vomiting.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm was little sore; he was tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a Corporate(Pfizer) Social media platforms. The reporter is the parent.  A 14 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was little sore"; FATIGUE (non-serious), outcome "unknown", described as "he was tired".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Influenza like illness, Lethargy, Loss of personal independence in daily activities
Clinical narrative: Teeth chattering shivering/I had shivering; I was very lethargic; Could barely move; Could not function; flue like symptoms; and I have never been that sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 15:00 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (10Mar2021, 3oclock, 1st in the left arm), administration date: 10Mar2021, when the patient was 55 years old, for Covid-19 immnunisation. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Teeth chattering shivering/I had shivering"; LETHARGY (non-serious), outcome "unknown", described as "I was very lethargic"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Could barely move"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Could not function"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flue like symptoms"; ILLNESS (non-serious), outcome "unknown", described as "and I have never been that sick". Therapeutic measures were taken as a result of chills, lethargy, mobility decreased, loss of personal independence in daily activities, influenza like illness, illness.  Additional information: Reporter stated, "So, my reaction for the shot-2 of the Pfizer vaccine was, a lot more severe than has been advertised. I had shivering even though my space was around 100degree, I was still shivering and it was like I was kicked out of the car in minus 50 degree weather. It wasn't the reactions for shot -2 that are reported. Supposedly flue like symptoms. Its really played down. I literally could not function. I was very lethargic. I could barely move. I was shivering like teeth chattering shivering and finally Tylenol is your friend but the reaction was wow. I am 55yrs old and I have never been that sick. So, it was quite an experience. I would do it all over again but I want to add to the data that some people have stronger reactions than others." Treatment was received with Tylenol; reporter said, they are just the regular Tylenol tablets, 2 Tylenol tablets. I don't know the dosage. I think I might have been 1000 mg."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Teeth chattering shivering/I had shivering; I was very lethargic; Could barely move; Could not function; flue like symptoms; and I have never been that sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 15:00 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (10Mar2021, 3oclock, 1st in the left arm), administration date: 10Mar2021, when the patient was 55 years old, for Covid-19 immnunisation. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Teeth chattering shivering/I had shivering"; LETHARGY (non-serious), outcome "unknown", described as "I was very lethargic"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Could barely move"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Could not function"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flue like symptoms"; ILLNESS (non-serious), outcome "unknown", described as "and I have never been that sick". Therapeutic measures were taken as a result of chills, lethargy, mobility decreased, loss of personal independence in daily activities, influenza like illness, illness.  Additional information: Reporter stated, "So, my reaction for the shot-2 of the Pfizer vaccine was, a lot more severe than has been advertised. I had shivering even though my space was around 100degree, I was still shivering and it was like I was kicked out of the car in minus 50 degree weather. It wasn't the reactions for shot -2 that are reported. Supposedly flue like symptoms. Its really played down. I literally could not function. I was very lethargic. I could barely move. I was shivering like teeth chattering shivering and finally Tylenol is your friend but the reaction was wow. I am 55yrs old and I have never been that sick. So, it was quite an experience. I would do it all over again but I want to add to the data that some people have stronger reactions than others." Treatment was received with Tylenol; reporter said, they are just the regular Tylenol tablets, 2 Tylenol tablets. I don't know the dosage. I think I might have been 1000 mg."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain in extremity, Peripheral swelling
Clinical narrative: When I got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; My arm and the lymph node and everything was sore; When I got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; My arm and the lymph node and everything was sore; When I got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; My arm and the lymph node and everything was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown, Expiration Date: 03Apr2021) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "When I got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; My arm and the lymph node and everything was sore". The event "when i got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; my arm and the lymph node and everything was sore", "when i got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; my arm and the lymph node and everything was sore" and "when i got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; my arm and the lymph node and everything was sore" was evaluated at the physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: in my left under arm area, in my arm, its sore there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EM6208) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE. The following information was reported: AXILLARY PAIN (non-serious) with onset 04Apr2021, outcome "not recovered", described as "in my left under arm area, in my arm, its sore there". Therapeutic measures were not taken as a result of axillary pain.  Additional information: Patient had the first vaccine on March 24 ( further clarification unknown), and today Patient woke up and in left under arm area, in arm, its sore there. It's been 10 days.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Bilateral intermittent tinnitus / ranges from low hum to high screech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN6205) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: to PN; "Topical adhesive allergy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; ESCITALOPRAM; TEMAZEPAM; VALSARTAN; VITAMIN C; VITAMIN D NOS. Past drug history included: Claritin, reaction(s): "Drug allergy"; Bactrim ds, reaction(s): "Drug allergy". The following information was reported: TINNITUS (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Bilateral intermittent tinnitus / ranges from low hum to high screech". It was unknown if therapeutic measures were taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was reported that three days after vaccination the event was experienced.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tinnitus, Vertigo
Clinical narrative: More prolonged periods of bilateral tinnitus; vertigo; occasional nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8732) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "known allergies: PN" (unspecified if ongoing); "Adhesive allergy" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; ESCITALOPRAM; TEMAZEPAM; VIT D [COLECALCIFEROL]; VIT C; CALCI [CALCIUM CARBONATE]. Past drug history included: Bactrim ds, reaction(s): "allergy"; Claritin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6205, vaccine location: Left arm), administration date: 09Mar2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Bilateral intermittent tinnitus, ranges from low hum to high screech". The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "More prolonged periods of bilateral tinnitus"; VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "vertigo"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "occasional nausea". It was unknown if therapeutic measures were taken as a result of tinnitus, vertigo, nausea.  Additional Information: The facility where the most recent COVID-19 vaccine was administered was reported to be "other". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Events did not result to death, was life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect. Since vaccination, the patient has not been tested for COVID-19. Primary care physician has been notified.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204), administration date: 16Mar2021, for COVID-19 immunization, reaction(s): "Adrenal disorder", "Urine analysis abnormal". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Patient states she is to have MRI/radiology with contrast and asking about concomitant use. Patient states she received second dose and experienced no adverse event other than a sore arm. Asking if that indicates less efficacious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.