chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This is a spontaneous report received from a contactable physician (patient). A 39-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EK5730), at the age of 39, intramuscularly, in left deltoid, on Dec 19, 2020, at 08:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had a migraine, onset Dec 19, 2020 20:00, with outcome of recovered. No therapeutic measures taken as a result of migraine. The reporter believed the product had a causal effect to the adverse event. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: had a little bump in her arm and she feels movable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 03Mar2021 (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: SKIN DISORDER (non-serious), outcome "unknown", described as "had a little bump in her arm and she feels movable".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: toothache; 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 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "toothache".  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, Nausea
Clinical narrative: headaches; feels very nauseated; 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 25Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 25Mar2021, outcome "unknown", described as "headaches"; NAUSEA (non-serious) with onset 25Mar2021, outcome "unknown", described as "feels very nauseated".  Additional information: The patient got the vaccine on 25Mar2021 and since then she been having headaches and felt very nauseated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 13Mar2021 (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm.". Additional information: They have given her a return date for the second dose on 30Mar2021, which is 17 days. The patient questioned the nurse and the nurse said it was close enough and a couple people have told her she should call and verify prior to going for that dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Wife has been nauseous and throwing up every 15 minutes since she received the covid19 vaccine; Wife has been nauseous and throwing up every 15 minutes since she received the covid19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 11:00 (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 immunisation, reaction(s): "no reaction". The following information was reported: NAUSEA (non-serious), VOMITING (non-serious) all with onset 30Mar2021, outcome "unknown" and all described as "Wife has been nauseous and throwing up every 15 minutes since she received the covid19 vaccine".  Additional Context: After second vaccine patient has been nauseous and throwing up every 15 minutes since she received the vaccine. This started 15 minutes after the vaccine which was given at 11:00 on 30Mar2021. Reporter states there were no reactions after the first vaccine and does not know of anything she was allergic to.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I took the Pfizer vaccine (Covid-19 vaccine) and I still have been feeling a little loopy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER2613) 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I took the Pfizer vaccine (Covid-19 vaccine) and I still have been feeling a little loopy".  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: muscle pain/muscle pains in her left arm; Muscle weakness: it is only in the arms right now, but she did have it in the legs; muscle pains in her left arm and that was the arm she got the shot in; bad pain in right arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: started at least four years ago; "Anaemia" (ongoing), notes: been about a year that she has had it; "Allergies" (unspecified if ongoing), notes: the allergies are pretty much year-round. Concomitant medications included: AMLODIPINE taken for blood pressure abnormal (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity (ongoing); IRON taken for anaemia (ongoing). The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "muscle pain/muscle pains in her left arm"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Muscle weakness: it is only in the arms right now, but she did have it in the legs"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "muscle pains in her left arm and that was the arm she got the shot in"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "bad pain in right arm". Additional Information: She was wondering how long does the side effects muscle pain and muscle weakness last. She has been having it since the first shot and it is time for her to get the second. She was still having muscle pains in her left arm and that was the arm she got the shot in. She also had bad pain in right arm. She was still feeling muscle pains in her left arm. It was a week after getting the vaccine when muscle pains and muscle weakness started. Both the muscle pain and muscle weakness were ongoing. The muscle pain in the right arm it was pretty bad, but it improved. In the arm she got the shot it has worsened. Her left arm was fine after the shot, but now she was having muscle pain in it. The muscle weakness was only in the arms right now, but she did have it in the legs. The muscle weakness was staying the same. The patient has no history of all previous immunization and has no additional vaccines administered on same date with COVID Vaccine. The adverse events did not require emergency room nor physician office visit. The patient has no prior vaccinations within 4 weeks and has no adverse events following prior vaccinations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laryngeal pain
Clinical narrative: pain in her larynx; numbness, like a "Novocain feeling" in her neck and jaw; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: EP7534, Expiration Date: Jul2021) at the age of 29 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: LARYNGEAL PAIN (non-serious) with onset 30Mar2021, outcome "recovering", described as "pain in her larynx"; HYPOAESTHESIA (non-serious) with onset 30Mar2021, outcome "recovering", described as "numbness, like a "Novocain feeling" in her neck and jaw". Therapeutic measures were taken as a result of laryngeal pain, hypoaesthesia.  Additional information: Patient was given Diphenhydramine (BENADRYL) and that BENADRYL helped. The patient said she was feeling better when she left. Event pain in her larynx was assessed as related to BNt162B2.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: chills; very tired; sore arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 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: CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "very tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: It was reported that the events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight soreness in arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44 year-old male 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 "Slight soreness in arm".  Additional information:  Slight soreness in arm 24 hours after receiving Pfizer/BNT COVID-19 vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 77 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 (1st dose), for Covid-19 Immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; muscle aches; headache for 24 hours mild-moderate intensity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 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: CHILLS (non-serious), outcome "recovered", described as "chills"; MYALGIA (non-serious), outcome "recovered", described as "muscle aches"; HEADACHE (non-serious), outcome "recovered", described as "headache for 24 hours mild-moderate intensity".  Additional information: The duration of events was 24 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Somnolence
Clinical narrative: Slept all day Saturday and felt fine on Sunday; Felt a little dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, administration time: 13:00, lot number: ER2613, expiry date: 31Jul2021, administered in left arm), administration date: 05Mar2021, for COVID-19 immunisation, reaction(s): "Dizzy", "Headache". The following information was reported: DIZZINESS (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Felt a little dizzy"; SOMNOLENCE (non-serious) with onset 27Mar2021, outcome "recovered" (28Mar2021), described as "Slept all day Saturday and felt fine on Sunday". Therapeutic measures were not taken as a result of dizziness, somnolence.  Additional information: The patient had no additional vaccines administered on the same date of BNT162B2 and had not received any other vaccines within 4 weeks prior vaccination. The patient denied any medications, medical conditions, labs, testing or treatments relevant to the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: has severe migraines, and the COVID vaccine has greatly reduced them; 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. Relevant medical history included: "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "has severe migraines, and the COVID vaccine has greatly reduced them". Additional information: Patient stated that she got the Pfizer COVID vaccine, and got amazing results from it. Patient has severe migraines, and the COVID vaccine has greatly reduced them. She stated that she was sure that she was not the only one that has experienced the reduction of migraines from the COVID vaccine. She wanted this to be known and would like to participate in any clinical trials for this. Patient was not involved in any clinical trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Neck pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer. A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 29, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain in extremity/pain in her arm that went up into her neck, neck pain, malaise/doesn't feel well and influenza-like illness/flu like symptoms; all onset Mar 2021, with outcome of unknown. Additional information: Event took place after the vaccination. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information  expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: pain at injection site; her arm still hurts, not bad but it is still sore; 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 received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 24Mar2021 (Lot number: EN6200, Expiration Date: 30Jun2021) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergic to coconut and mushrooms" (unspecified if ongoing). Concomitant medication included: EUTHYROX, start date: 2021.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "not recovered", described as "pain at injection site"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "not recovered", described as "her arm still hurts, not bad but it is still sore".  Additional information: The events did not require a visit to emergency room and physician office. There were no prior vaccinations within four weeks.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: felt dizzy shortly after vaccine but did not last long; This is a spontaneous report received from a non-contactable reporter (Consumer).  A 25 year-old female patient 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: DIZZINESS (non-serious), outcome "recovered", described as "felt dizzy shortly after vaccine but did not last long".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a contactable consumer from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizzy; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 05Mar2021 13:00 (Batch/Lot number: unknown, Expiration Date: 31Jul2021) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "Dizzy"; HEADACHE (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "Headache". Additional information: It was reported that the events occurred about an hour or two after the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction, Drug level increased, Pain in extremity
Clinical narrative: received the 1st dose of the vaccine on her right arm and it hurt a little bit; She takes coumadin regularly and measured her coumadin level to be at 1.6 after getting the 1st dose. 2 weeks after, she mentioned that her level was 3 point something which was too high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "strokes" (unspecified if ongoing), notes: had 2 bad strokes a few years ago; "heart attack on the left side" (unspecified if ongoing), notes: heart attack on the left side; "chronic pain" (unspecified if ongoing); "bone issues" (unspecified if ongoing); "leukemia in the bone" (unspecified if ongoing); "TIH" (unspecified if ongoing); "thyroid" (unspecified if ongoing). Concomitant medication(s) included: COUMADIN. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "received the 1st dose of the vaccine on her right arm and it hurt a little bit"; DRUG LEVEL INCREASED (non-serious), outcome "unknown", described as "She takes coumadin regularly and measured her coumadin level to be at 1.6 after getting the 1st dose. 2 weeks after, she mentioned that her level was 3 point something which was too high". Relevant laboratory tests and procedures are available in the appropriate section.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head colds; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The consumer reported for himself and his wife (patient). This is second of two reports.  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (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: NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "head colds".  Additional information: Product: Pfizer-Biontech Covid-19 Vaccine. The consumer and his wife (patient) had their 1st Pfizer vaccine dose on 10Mar2021, and the next vaccine dose is due tomorrow. The consumer stated he and his wife had head colds, no fever. The patient asked if they should reschedule their 2nd dose and if it is ok to have a cold when they get the vaccine.  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-2021350558 Same reporter/vaccine/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: Pre-existing condition improved
Clinical narrative: I just notice that after my Pfizer covid vaccination 4 days ago my symtoms just got better.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Carpal Tunnel" (unspecified if ongoing), notes: have been diagnosed with Carpal Tunnel about 1 1/2 year ago. The patient's concomitant medications were not reported. The following information was reported: PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown", described as "I just notice that after my Pfizer covid vaccination 4 days ago my symtoms just got better."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral
Clinical narrative: bad stomach flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 11:00 (Lot number: ER2613) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure measurement" (unspecified if ongoing), notes: for 5 years ; "crippled" (ongoing), notes: for about 2 years, she is on walker . The patient took concomitant medications. The following information was reported: GASTROENTERITIS VIRAL (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "bad stomach flu". Therapeutic measures were not taken as a result of gastroenteritis viral. Additional information: It was reported that the patient had Benzpriel (20 25 every day once a day by mouth, for blood pressure) as concomitant medication.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: She says that "milk aggravates her stomach" but says she doesn't have an allergy to it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 97 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "She says that "milk aggravates her stomach" but says she doesn't have an allergy to it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Unknown arm sore at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Unknown arm sore at injection site". Additional information: The reporter mentioned that her mother had arm soreness after receiving the COVID vaccine. She had both doses and soreness was after first one.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Influenza like illness, Lymphadenopathy, Pain
Clinical narrative: really tired; the next day her daughter felt a little lightheaded; felt like she had flu symptoms; some body aches; under her daughter's armpit where her lymph nodes were swollen; she had a sore arm that night; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 21 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Jan2021 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's" (ongoing), notes: diagnosed when she was 15 years old. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "she had a sore arm that night"; FATIGUE (non-serious), outcome "unknown", described as "really tired"; DIZZINESS (non-serious), outcome "unknown", described as "the next day her daughter felt a little lightheaded"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "felt like she had flu symptoms"; PAIN (non-serious), outcome "unknown", described as "some body aches"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "under her daughter's armpit where her lymph nodes were swollen". It was unknown if therapeutic measures were taken as a result of pain in extremity, fatigue, dizziness, influenza like illness, pain, lymphadenopathy. Additional information: Patient was not taking medication for her Hashimoto's. She's right on the cusp of needing medication. She's being followed by a specialist. Reporter thought her daughter who was in nursing school received her vaccine a while ago, in Jan2021 and into Feb2021. By the third day, her daughter felt better. She was totally fine. Reporter thought her daughter may have reported her experience online. She remembered her daughter received her second Covid-19 vaccine right before Valentine's Day. Special details regarding this report were not known by the reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: really tired; the next day her daughter felt a little lightheaded; felt like she had flu symptoms; some body aches; under her daughter's armpit where her lymph nodes were swollen; she had a sore arm that night; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 21 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Jan2021 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's" (ongoing), notes: diagnosed when she was 15 years old. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "she had a sore arm that night"; FATIGUE (non-serious), outcome "unknown", described as "really tired"; DIZZINESS (non-serious), outcome "unknown", described as "the next day her daughter felt a little lightheaded"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "felt like she had flu symptoms"; PAIN (non-serious), outcome "unknown", described as "some body aches"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "under her daughter's armpit where her lymph nodes were swollen". It was unknown if therapeutic measures were taken as a result of pain in extremity, fatigue, dizziness, influenza like illness, pain, lymphadenopathy. Additional information: Patient was not taking medication for her Hashimoto's. She's right on the cusp of needing medication. She's being followed by a specialist. Reporter thought her daughter who was in nursing school received her vaccine a while ago, in Jan2021 and into Feb2021. By the third day, her daughter felt better. She was totally fine. Reporter thought her daughter may have reported her experience online. She remembered her daughter received her second Covid-19 vaccine right before Valentine's Day. Special details regarding this report were not known by the reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Slightly feeling Nausea; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 47 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; NAUSEA (non-serious), outcome "unknown", described as "Slightly feeling Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Tremor
Clinical narrative: Shaking; Could not get warm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  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 (1st dose), for COVID-19 immunisation. The following information was reported: TREMOR (non-serious), outcome "recovered", described as "Shaking"; FEELING COLD (non-serious), outcome "recovered", described as "Could not get warm".  Additional information: The events subsided within 36 hours.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes in his armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen lymph nodes in his armpit". Therapeutic measures were taken as a result of lymphadenopathy. Additional information: Clinical course: The patient got swollen lymph nodes in his armpit after the Covid 19 vaccine and the pharmacist told him to rub it. He kept rubbing and the swelling went away. It was reported that the patient received both of his Covid 19 vaccines.   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-2021349262 Same reporter and drug; similar event; different patient.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Bladder disorder, Flatulence
Clinical narrative: Acute onset extreme lower left abdomen pain, but also entire abdomen, lasting for several hours, painful to the touch; Bloating; gas; Feels like I have a full bladder, but urinating does not relieve the pressure; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 09:15 (Lot number: EP7533) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "endometriosis resulting in hysterectomy" (unspecified if ongoing); "bladder & bowel issues" (unspecified if ongoing); "bladder & bowel issues" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA; BYSTOLIC; LINZESS; DULCOLAXO; GAS X. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer BioNTech, lot number=en6205, administration time=10:30 AM, vaccine location=Left arm, DOSE 1, SINGLE), administration date: 08Mar2021, when the patient was 50 years old, for COVID-19 immunization.  The following information was reported: ABDOMINAL PAIN (non-serious), outcome "not recovered", described as "Acute onset extreme lower left abdomen pain, but also entire abdomen, lasting for several hours, painful to the touch"; ABDOMINAL DISTENSION (non-serious), outcome "not recovered", described as "Bloating"; FLATULENCE (non-serious), outcome "not recovered", described as "gas"; BLADDER DISORDER (non-serious), outcome "not recovered", described as "Feels like I have a full bladder, but urinating does not relieve the pressure". The events "acute onset extreme lower left abdomen pain, but also entire abdomen, lasting for several hours, painful to the touch", "bloating", "gas" and "feels like i have a full bladder, but urinating does not relieve the pressure" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abdominal pain, abdominal distension, flatulence, bladder disorder.  Additional information: It was reported that the patient had already have bladder and gastrointestinal issues that she take medication for, but with both doses, this extreme and onset of pain was after the vaccination shot. The pain was severe and lasts several hours. It was reported that, the patient had no covid prior vaccination. The patient was not tested covid post vaccination. The patient received no other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021349025 same reporter/patient, different events/doses
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). An 88-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 88, single dose, for COVID-19 immunisation. The patient's medical history not reported. The patient took concomitant medications. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization; and experienced no reaction (nothing occurred after the first dose). The patient reported pain in extremity (a little sore arm), with outcome of unknown. Additional information: Reporter's son said his mother is in pretty good health. His mother had the second vaccination three weeks ago. She takes unspecified blood pressure medicine. Her legs are bad but she is in pretty good health. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore right arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 03Mar2021 (Lot number: EN6198) at the age of 66 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "stroke", start date: Dec2015 (unspecified if ongoing); "stroke", start date: Feb2016 (unspecified if ongoing), notes: has had a problem with her left side, having weakness since she had a stroke at age 62. Family history included: "her mom had one really bad stroke" (unspecified if ongoing), notes: she was in her 80s. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "not recovered", described as "sore right arm".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia
Clinical narrative: a muscular pain or tightness sensation around the back area around "the bra line"; a muscular pain or tightness sensation around the back area around "the bra line"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (ongoing). Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis (ongoing). The following information was reported: MYALGIA (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset Mar2021, outcome "recovered" (Mar2021) and all described as "a muscular pain or tightness sensation around the back area around "the bra line"". Additional information: The events lasted for at least a few days (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Vaccination site pain
Clinical narrative: felt cold-like symptoms; the location of the injection was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 29Mar2021 15:30 (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: NASOPHARYNGITIS (non-serious) with onset 30Mar2021 06:30, outcome "unknown", described as "felt cold-like symptoms"; VACCINATION SITE PAIN (non-serious) with onset 30Mar2021 06:30, outcome "unknown", described as "the location of the injection was sore". Additional information: Vaccinated with COVID vaccine at 3:30pm on 29Mar2021 and approximately 15 hours later, the patient felt cold-like symptoms and the location of the injection was sore.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got super sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) 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: ILLNESS (non-serious), outcome "unknown", described as "Got super sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Headache
Clinical narrative: really bad headache; chills; dry mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in deltoid left, administration date 29Mar2021 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 52 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "anemic" (ongoing), notes: unsure of when she was diagnosed, probably since birth; "pre-menopausal" (ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "really bad headache"; CHILLS (non-serious) with onset 29Mar2021, outcome "not recovered", described as "chills"; DRY MOUTH (non-serious) with onset 29Mar2021, outcome "not recovered", described as "dry mouth".  Additional information: The patient had no prior vaccinations within 4 weeks. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The vaccine was also reported as left shoulder as anatomical location. The vaccine was given between 11:30 and 12:00. Clinical course: Patient stated she got her first shot of Pfizer yesterday and now she had a really bad headache. Patient stated all of her symptoms began after her vaccination. Patient stated she also had chills and a dry mouth. The events did not result to emergency room or physician's office visit. The patient did not undergo any relevant tests.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Right hand side shoulder down to about 3-4 inches was really sore, it was down her right arm, it feels like somebody pulled the nerves or the tendons and is suffering; 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), administration date 11Mar2021 (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: ARTHRALGIA (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Right hand side shoulder down to about 3-4 inches was really sore, it was down her right arm, it feels like somebody pulled the nerves or the tendons and is suffering ". The event "right hand side shoulder down to about 3-4 inches was really sore, it was down her right arm, it feels like somebody pulled the nerves or the tendons and is suffering " was evaluated at the physician office visit. Therapeutic measures were taken as a result of arthralgia.  Additional information: The patient took one to two 200 mg unspecified pain relief medication but didn't help and was a little better only for 3-4 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.