chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Tenderness at injection site; Little swelling at injection site; Rash site; Fatigue; Lymph nodes in front of right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Lot number: EW0183) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ACETAMINOPHEN. Past drug history included: Codeine, reaction(s): "Allergies: Codeine", notes: codeine. Vaccination history included: Bnt162b2 (Dose 1, Product=COVID 19, Brand=Pfizer, Lot number=ER8730, Administration time=04:00 PM, Vaccine location=Left arm), administration date: 27Mar2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "tenderness and a little swelling at injection site", "Tenderness", "Fatigue". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Apr2021, outcome "recovered" (May2021), described as "Tenderness at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 26Apr2021, outcome "recovered" (May2021), described as "Little swelling at injection site"; VACCINATION SITE RASH (non-serious) with onset 26Apr2021, outcome "recovered" (May2021), described as "Rash site"; FATIGUE (non-serious) with onset 26Apr2021, outcome "recovered" (29Apr2021), described as "Fatigue"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Lymph nodes in front of right ear". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, vaccination site rash, fatigue, lymphadenopathy. Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She also mentioned that her stepmom received the vaccine and was really sick for a couple of days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: ILLNESS (non-serious), outcome "unknown", described as "She also mentioned that her stepmom received the vaccine and was really sick for a couple of days".  Additional info: She also mentioned that her stepmom received the vaccine and was really sick for a couple of days. Consumer also mentioned that she could not get the shingles vaccine before since she has other health problems.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: experienced mild fatigue and some dizziness; experienced mild fatigue and some dizziness; injection site pain and overall body aches; injection site pain and overall body aches; The body aches were worse as the evening progressed.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05May2021 09:30 (Lot number: EW0167) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG; ASPIRIN (E.C.); CARVEDILOL; LISINOPRIL; ATORVASTATIN; VIT D [COLECALCIFEROL]; VIT E NAT; CALCIUM. Vaccination history included: Bnt162b2 (Proprietary medicinal product name: Pfizer, Batch/lot number: EW0169, Route of administration: Intramuscular, Anatomical Location: Arm Left, Dose Number: 1), administration date: 14Apr2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), DIZZINESS (non-serious) all with onset 05May2021 13:00, outcome "recovering" and all described as "experienced mild fatigue and some dizziness"; VACCINATION SITE PAIN (non-serious), PAIN (non-serious) all with onset 05May2021 13:00, outcome "recovering" and all described as "injection site pain and overall body aches"; CONDITION AGGRAVATED (non-serious) with onset 05May2021 13:00, outcome "recovering", described as "The body aches were worse as the evening progressed.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The vaccination was given at about 9:30am on 05May2021. At about 1:00pm on the same day he experienced mild fatigue and some dizziness. At about 9:00pm he experienced more fatigue, injection site pain and overall body aches. The body aches were worse as the evening progressed. No prolonged hospitalization. The patient was diagnosed with COVID-19, prior to vaccination and has not been tested for COVID 19, since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experienced mild fatigue and some dizziness; experienced mild fatigue and some dizziness; injection site pain and overall body aches; injection site pain and overall body aches; The body aches were worse as the evening progressed.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05May2021 09:30 (Lot number: EW0167) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG; ASPIRIN (E.C.); CARVEDILOL; LISINOPRIL; ATORVASTATIN; VIT D [COLECALCIFEROL]; VIT E NAT; CALCIUM. Vaccination history included: Bnt162b2 (Proprietary medicinal product name: Pfizer, Batch/lot number: EW0169, Route of administration: Intramuscular, Anatomical Location: Arm Left, Dose Number: 1), administration date: 14Apr2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), DIZZINESS (non-serious) all with onset 05May2021 13:00, outcome "recovering" and all described as "experienced mild fatigue and some dizziness"; VACCINATION SITE PAIN (non-serious), PAIN (non-serious) all with onset 05May2021 13:00, outcome "recovering" and all described as "injection site pain and overall body aches"; CONDITION AGGRAVATED (non-serious) with onset 05May2021 13:00, outcome "recovering", described as "The body aches were worse as the evening progressed.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The vaccination was given at about 9:30am on 05May2021. At about 1:00pm on the same day he experienced mild fatigue and some dizziness. At about 9:00pm he experienced more fatigue, injection site pain and overall body aches. The body aches were worse as the evening progressed. No prolonged hospitalization. The patient was diagnosed with COVID-19, prior to vaccination and has not been tested for COVID 19, since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Ringing in ears/tinnitus in his ears/popping sound in his ear/after that the ringing started, the sound goes higher and lower; Popping in ears, after first vaccine; 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 22Apr2021 (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: TINNITUS (non-serious) with onset 22Apr2021, outcome "unknown", described as "Ringing in ears/tinnitus in his ears/popping sound in his ear/after that the ringing started, the sound goes higher and lower"; EAR DISCOMFORT (non-serious) with onset 22Apr2021, outcome "unknown", described as "Popping in ears, after first vaccine".  Additional information: Patient received the first dose of the Pfizer Covid 19 vaccine on 22Apr2021. 18 hours later he hear a pop in his ears but didn't think much of it.  He now has ringing/tinnitus in his ears for over 2 weeks. The ENT has confirmed he has no hearing loss and he was the first patient he has had present with tinnitus after the vaccine. His audiologist states he has had other patients with tinnitus after the vaccine. States he was calling about the Covid vaccine, and confirms the Pfizer Covid vaccine. Reports that he got the first dose over 2 weeks ago, on 22Apr2021. States he has seen an ear, nose and throat doctor and an audiologist. States that the audiologist reported that he had no hearing loss. States that the ear, nose and throat doctor, gave him no information on what he should do about the ringing. The doctor did not tell him if he should take medications like steroids, or if the ringing in his ears, will be temporary or permanent. States that the doctor did not tell him what to do about taking the second dose of vaccine. Reports that the popping sound in his ear, had equalized and went back to normal. States after that the ringing started, the sound goes higher and lower, and has lasted for two weeks. States that he just wanted to report his event and to see if Pfizer had any information about the side effect of tinnitus. States that he went online and found a social media group about people that had tinnitus, after the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Pain in extremity, Ultrasound scan
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: ER8730) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: VALTREX; LEVOTHYROXINE taken for hypothyroidism. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Apr2021, outcome "recovered" (09Apr2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated the first dose shot went fine, just had sore arm. The patient was taking the concomitant products Valtrex for the outbreaks.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: ER8730) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: VALTREX; LEVOTHYROXINE taken for hypothyroidism. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Apr2021, outcome "recovered" (09Apr2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated the first dose shot went fine, just had sore arm. The patient was taking the concomitant products Valtrex for the outbreaks.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Fatigue, Ocular discomfort
Clinical narrative: her 29 y/o son has Aspergers and received his 2nd Pfizer vaccine dose 9 days ago.; fatigue; pressure behind the ayes/pressure behind his eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asperger's" (unspecified if ongoing), notes: Patient history: Asperger's; "congenital myopathy" (unspecified if ongoing), notes: Caller states her son was diagnosed with a "congenital myopathy a few years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "her 29 y/o son has Aspergers and received his 2nd Pfizer vaccine dose 9 days ago."; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "pressure behind the ayes/pressure behind his eyes"  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: headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05May2021 (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: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache. Additional information: Treatment included paracetamol (TYLENOL) (regular Tylenol).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the 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 18 year-old female patient received bnt162b2 (BNT162B2), administration date 10May2021 (Lot number: EW0183) at the age of 18 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 (FIRST DOSE), administration date: 17Apr2021, when the patient was 17 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10May2021, outcome "unknown", described as "pain in the arm". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: Patient took Ibuprofen 15 minutes after the second vaccine. Patient took it to reduce the pain in the arm. After she came home, she took the pamphlet and read the paper and it said to wait 2 hours after the vaccine before taking anything. She wanted to know if this will cause her to have to retake the vaccine. Dates for took Ibuprofen and did not wait 2 hours was unspecified. Reporter seriousness for took Ibuprofen and did not wait 2 hours was unspecified. She just got home after receiving the Pfizer Covid-19 Vaccine. Caller was a consumer that went home after receiving the Pfizer Covid-19 Vaccine and she took Ibuprofen and did not wait 2 hours. Patient looked at her paperwork and it stated to wait 2 hours before taking any over the counter products. Patient wanted to know if there is a problem with taking that.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle and joint pains; muscle and joint pains; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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 1), for COVID-19 immunisation. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "muscle and joint pains". Therapeutic measures were taken as a result of arthralgia, myalgia.  Additional Information: She mentioned that she already received her 2nd dose of the Pfizer COVID Vaccine and had a hard time with it and had muscle and joint pains going over 2-3 weeks. She has already consulted with her HCP and has been given anti-inflammatories and muscle relaxants. She mentioned that it has been very hard and has scared her. She was asking if there have been reports of her situation and would there be a possibility for the vaccine to cause arthritis.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: He states that he had taken NSAID medication around that time for tendonitis; 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) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TENDONITIS (non-serious), outcome "unknown", described as "He states that he had taken NSAID medication around that time for tendonitis". Therapeutic measures were taken as a result of tendonitis.  Additional information: previously had both doses of the Pfizer covid vaccine. He states that he had taken NSAID medication around that time for tendonitis and that he had recently heard on the radio that the use of NSAIDs could have effects with the vaccine. Caller is requesting any information on the use of NSAIDs with the Pfizer 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: Rhinitis allergic
Clinical narrative: stuffy nose due to allergies; 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 patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: she is having a stuffy, nose due to allergies. The patient's concomitant medications were not reported. The following information was reported: RHINITIS ALLERGIC (non-serious), outcome "unknown", described as "stuffy nose due to allergies".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Vomiting
Clinical narrative: I have an underlying condition; the first shot that I took made my condition episodes longer and much more intense; I was extremely fatigued; like not getting out of the bed for days; I had very strong headache; vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Lot number: EN6203, Expiration Date: Jun2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 11Mar2021, outcome "unknown", described as "I have an underlying condition; the first shot that I took made my condition episodes longer and much more intense"; FATIGUE (non-serious) with onset 11Mar2021, outcome "unknown", described as "I was extremely fatigued; like not getting out of the bed for days"; HEADACHE (non-serious) with onset 11Mar2021, outcome "unknown", described as "I had very strong headache"; VOMITING (non-serious) with onset 11Mar2021, outcome "unknown", described as "vomiting".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021523905 same patient/drug, different dose/event
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Joint range of motion decreased, Limb discomfort
Clinical narrative: She feels uncomfortable.; discomfort under her arms/hard to lift her arms; hard to lift her arms; 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 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Lot number: EW0162) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: LIMB DISCOMFORT (non-serious) with onset May2021, outcome "not recovered", described as "discomfort under her arms/hard to lift her arms"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset May2021, outcome "not recovered", described as "hard to lift her arms"; DISCOMFORT (non-serious), outcome "unknown", described as "She feels uncomfortable.". Therapeutic measures were taken as a result of limb discomfort, joint range of motion decreased, discomfort.  Additional information: Patient was going to receive the second dose of the covid vaccine today 10May2021 at 5:00PM. Within her head, she is concerned. She has been having discomfort under her arms. Certain days, it is both of her arms, and others it is just one arm. She has been taking Tylenol, and it takes the discomfort away. She is asking would that have anything thing to do with the covid vaccine. Patient received first dose on 19Apr2021 between 5:00-5:30PM. Patient did not receive any vaccination within 4 weeks. Patient took vitamins.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: tooth situation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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 (First dose), for COVID-19 Immunization. The following information was reported: TOOTH DISORDER (non-serious), outcome "unknown", described as "tooth situation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Decreased appetite, Fatigue, Malaise
Clinical narrative: Symptoms progressively got worse; She did not eat; Tiredness; Weakness; Feeling unwell; Nauseated/Nauseous; 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 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: EW0176) at the age of 80 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: ER8730 , Route of administration: Injection in the left), administration date: 30Mar2021, when the patient was 80 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 07May2021, outcome "not recovered", described as "Tiredness"; ASTHENIA (non-serious) with onset 07May2021, outcome "not recovered", described as "Weakness"; MALAISE (non-serious) with onset 07May2021, outcome "not recovered", described as "Feeling unwell"; NAUSEA (non-serious) with onset 07May2021, outcome "not recovered", described as "Nauseated/Nauseous"; DECREASED APPETITE (non-serious) with onset 09May2021, outcome "not recovered", described as "She did not eat"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Symptoms progressively got worse".  Additional information: Patient reported that her symptoms progressively got worse and on 09May2021 she did not eat. She did eat today, but still does not feel like eating. She started out feeling tired like she did not sleep enough or needed more coffee and stated that nothing worked.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Symptoms progressively got worse; She did not eat; Tiredness; Weakness; Feeling unwell; Nauseated/Nauseous; 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 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: EW0176) at the age of 80 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: ER8730 , Route of administration: Injection in the left), administration date: 30Mar2021, when the patient was 80 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 07May2021, outcome "not recovered", described as "Tiredness"; ASTHENIA (non-serious) with onset 07May2021, outcome "not recovered", described as "Weakness"; MALAISE (non-serious) with onset 07May2021, outcome "not recovered", described as "Feeling unwell"; NAUSEA (non-serious) with onset 07May2021, outcome "not recovered", described as "Nauseated/Nauseous"; DECREASED APPETITE (non-serious) with onset 09May2021, outcome "not recovered", described as "She did not eat"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Symptoms progressively got worse".  Additional information: Patient reported that her symptoms progressively got worse and on 09May2021 she did not eat. She did eat today, but still does not feel like eating. She started out feeling tired like she did not sleep enough or needed more coffee and stated that nothing worked.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Breast tenderness, Limb discomfort
Clinical narrative: discomfort  under her arm pit in both arms; Her breasts feels tender and swollen; Her breasts feels tender and swollen; 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 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Apr2021 09:50 (Lot number: ER8736) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 02May2021, outcome "not recovered", described as "discomfort  under her arm pit in both arms"; BREAST TENDERNESS (non-serious), BREAST SWELLING (non-serious) all with onset 02May2021, outcome "not recovered" and all described as "Her breasts feels tender and swollen".  Additional information: On 02May2021 caller began to experienced discomfort under her arm pit in both arms to days later. Pain radiates to her breast, breast are tender and swollen. Caller would like to know if this was a common side effect. Caller would like to know if she would experience the same side effects with second dose. When probed for outcome, she explains its about the same, it's better in the morning and as the day goes on it, it gets a little worse. However, it was not worsening, it was not excruciating or anything, it was just something she does not have before receiving the vaccine. The caller clarifies the discomfort was under both armpits, but more so under her right armpit, radiating to her right breast. Her right breast is more bothersome than her left. She explains she had a little discomfort under her left armpit and left breast, but not much- that kind of was better. She explained she used her right arm more, she was right-handed, which she does not know if that has anything to do with it. No additional vaccines administered on same date of the Pfizer Suspect. Adverse event did not require emergency room or physician office. No prior Vaccinations (within 4 weeks). No adverse event following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was sore that was it; 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 74 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Neuropathy" (unspecified if ongoing), notes: I have Neuropathy and Venostasis and I fell and fractured my leg; "Venostasis" (unspecified if ongoing), notes: I have Neuropathy and Venostasis and I fell and fractured my leg; "Fell" (unspecified if ongoing), notes: I have Neuropathy and Venostasis and I fell and fractured my leg; "fractured my leg" (unspecified if ongoing), notes: I have Neuropathy and Venostasis and I fell and fractured my leg; "Diabetes" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: INSULIN. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm was sore that was it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen glands under left armpit after a few days after first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: FR8734) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Antibiotics, reaction(s): "Known Allergies", notes: antibiotics. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Swollen glands under left armpit after a few days after first dose". The event "swollen glands under left armpit after a few days after first dose" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Swollen glands under left armpit after a few days after first dose have remained swollen for over a month. The patient did not had other vaccine in four weeks.The patient did not had COVID prior vaccination and was not tested for COIVD post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hangover, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: I have a hangover or head cold, stuffy head; I have a hangover or head cold, stuffy head; I have had a lingering "Vaccine Brain Fog"; I am still consistently tired as well; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 10:30 (Lot number: EW0133) at the age of 49 years as dose 1, single and administered in arm left, administration date 29Apr2021 12:00 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy:Sulpha-based antibiotics" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VITAMIN C ACID. Past drug history included: Cephalexin for Drug allergy: Cephalexin. The following information was reported: HANGOVER (non-serious), NASOPHARYNGITIS (non-serious) all with onset 07Apr2021 12:00, outcome "not recovered" and all described as "I have a hangover or head cold, stuffy head"; FEELING ABNORMAL (non-serious), FATIGUE (non-serious) all with onset 07Apr2021 12:00, outcome "not recovered" and all described as "I have had a lingering "Vaccine Brain Fog" since my shot-after the first shot and it is noticeably worse after the 2nd shot. It feels like I have a hangover or head cold, stuffy head. I am still consistently tired as well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hangover, nasopharyngitis, feeling abnormal, fatigue.  Additional Information: The patient had a lingering "Vaccine Brain Fog" since shot, after the first shot, and it is noticeably worse after the 2nd shot. It feels like patient have a hangover or head cold, stuffy head. still consistently tired as well. The patient had medications in two weeks were Vitamin D, Daily Multivitamin, Vitamin C. The patient had not received any treatment for AE. The patient had no Covid prior vaccination. The patient tested Covid post vaccination. The facility type where patient was administered vaccine was Public Health Clinic/Veterans Administration facility. The patient had not received any other vaccine in four weeks prior COVID-19 vaccination. The patient had known allergies to Sulpha-based antibiotics, Cephalexin.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms
Clinical narrative: on 23Apr, I spotted and had terrible cramping and lower back pain; on 23Apr, I spotted and had terrible cramping and lower back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 14:00 (Lot number: EW0164) at the age of 53 years as dose 1, single and administered in arm left, administration date 04May2021 13:15 (Lot number: EW0176) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; PROGESTERONE; ESTROGEN. Past drug history included: Levaquin, reaction(s): "known allergies: Levaquin", notes: Levaquin; Compazine, reaction(s): "known allergies: Compazine", notes: Compazine. The following information was reported: MUSCLE SPASMS (non-serious), BACK PAIN (non-serious) all with onset 23Apr2021 07:00, outcome "not recovered" and all described as "on 23Apr, I spotted and had terrible cramping and lower back pain". The event "on 23apr, i spotted and had terrible cramping and lower back pain" and "on 23apr, i spotted and had terrible cramping and lower back pain" was evaluated at the physician office visit.  Additional information: My first vaccine was on 13Apr2021.I have not had a period in 9 years. On Apr23, I spotted and had terrible cramping and lower back pain (as if I was going to have a period) The cramping was on and off and ended around 02May. On 04May I received the second covid vaccine. The cramping and lower back pain began again the next day. The symptoms have been on and off but quite severe on 09May and still continue.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Somnolence
Clinical narrative: headache; feels sleepy after taking it; 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 patient. A female patient received bnt162b2 (BNT162B2), administration date 07May2021 (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: HEADACHE (non-serious) with onset 07May2021, outcome "unknown", described as "headache"; SOMNOLENCE (non-serious) with onset 07May2021, outcome "unknown", described as "feels sleepy after taking it".  Additional information: The patient got the 1st shot of the Pfizer Covid19 Vaccine today, but started having  headache and feels sleepy after taking it. She enquired if that's normal in taking the vaccine. Prior to vaccination, the patient  was not diagnosed with COVID-19 nor Since the vaccination, has the patient been tested for COVID-19   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Nausea, Tinnitus, Vertigo
Clinical narrative: Nauseated; head is spinning; right ear is ringing constantly; felt like she was going to fall; 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), administered in arm left, administration date 30Apr2021 09:25 (Lot number: EW0179) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: NAUSEA (non-serious) with onset 01May2021, outcome "not recovered", described as "Nauseated"; TINNITUS (non-serious) with onset 30Apr2021, outcome "not recovered", described as "right ear is ringing constantly"; VERTIGO (non-serious) with onset 01May2021, outcome "not recovered", described as "head is spinning"; FALL (non-serious) with onset 2021, outcome "unknown", described as "felt like she was going to fall".  Additional information: The caller denies being sick at the time of vaccination. No relevant tests. No family medical history relevant to AE. No prior vaccinations within 4 weeks. No additional vaccines administered on same date of the Pfizer suspect. The caller wants to report that after the Pfizer vaccine she had events. The caller declines to provide her primary care physician information. She says she had the vaccine last Friday 01May2021 morning and at night her ear started ringing. She says she felt like she was going to fall. She corrects herself and says her vaccine was on 30Apr2021. She says it has worsened because she had nausea yesterday and could not work; she had to ask work to take her off and today still called in sick because of the nausea. She says the ringing in her ear still going. She says the ringing started 30Apr2021 at night. She says the nausea started, 01May2021 in the evening. She says her head is spinning as well. She says it started the same time as the nausea, she confirms 01May2021 in the evening as well. This spinning started little and then now it is like more heavier, she confirms it has worsened. She says her appointment was supposed to be at 9:25 am but she might have gotten it earlier than that. She says this was her first dose. The events did not result in emergency room or physician office visit. The caller says she is set to return to get the second dose. She says she has ringing in her ear and queried is she going to take the second dose or is she going to skip it. She queried will the ringing in her ear go away or she has to ask anyone else experienced this ringing.  No follow-up attempts are needed; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Vision blurred
Clinical narrative: it is like blurred vision in one eye and then a little tiny sore on the corner of the eye; it is like blurred vision in one eye and then a little tiny sore on the corner of the eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 01May2021 (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: VISION BLURRED (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "it is like blurred vision in one eye and then a little tiny sore on the corner of the eye".  Additional information: Reporter stated think Vaccination date of first shot was on 28. It was reported that, patient got both of her shot for the vaccine and the last one was Saturday, May 1st. So, from the last couple of days, patient have had, it was like blurred vision in one eye and then a little tiny sore on the corner of the eye. she want to know if there was any recommendations on what to do about it and queried that Is it COVID-19 or it is just a separate thing going on. Reporter seriousness for "I have had, it is like blurred vision in one eye and then a little tiny sore on the corner of the eye" was Unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; 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 patient.  A male patient received bnt162b2 (BNT162B2), administration date 07May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 16Apr2021 (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: MYALGIA (non-serious), outcome "unknown", described as "Muscle pain".  Additional information: Reporter received Pfizer Covid-19 vaccine 1st dose on 16Apr2021 and received the 2nd dose today 07May2021 and experienced muscle pain. He asked if he could take pain medications.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: sick; feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 14:30 (Lot number: EWO473) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Caller had a cold when took the shot." (unspecified if ongoing), notes: Caller had a cold when took the shot. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 04May2021, outcome "recovering", described as "sick"; FEELING ABNORMAL (non-serious) with onset 04May2021, outcome "recovering", described as "feeling bad".  Additional info: She had the Covid-19 vaccine on Monday. She had been feeling bad ever since. Patient was improving a little bit. The patient had not received any other vaccinations within 4 weeks prior to Covid-19 vaccine. Caller reported that caller think she will not take the 2nd dose if it does like this.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea
Clinical narrative: I feel worst every day; Nauseous; Little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: AMLODIPINE taken for hypertension; ESCITALOPRAM; FAMOTIDINE; TRAZODONE. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I feel worst every day"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nauseous"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Little tired". Additional information: Reason for no lot number: of Covid19 Vaccine: Other: LOT#: Consumer stated, "EW, I think it's a Q167." Expiry Date of Covid19 Vaccine: Unknown. Patient history: Blood pressure high (From: Unspecified To: Unspecified) Additional Context: When probed for concern, consumer stated, "I got my first Pfizer shot on May 3 and I am just like, I don't know if it's side effects or what but I feel worst every day. I am feeling nauseous and really tired." Consumer confirmed it was the Pfizer BioNTech Covid19 vaccine.Consumer was informed about Pfizer drug safety. LOT#: Consumer stated, "EW, I think it's a Q167."Consumer confirmed it was the first shot. Date of second dose vaccination scheduled, 24May2021. When probed if consumer is suffering from any medical condition, consumer stated, "I have high blood pressure."Concomitant Products: Consumer stated, "Well, I also take Depakote, the generic Divalproex."(Further not clarified. Hence, not captured in tab.) Consumer stated, "I also take Xanax and Trazodone as needed. When asked to spell the name, consumer stated, "Alprazolam and Trazodone."(Further not clarified. Hence, not captured in tab.) When probed for anatomical site of administration, consumer stated, "It was on my left shoulder, upper arm." Consumer was informed about the Pfizer Medical Information Department for the concern and was provided with the number as # and was requested to select option 3, timings as 8am to 8pm Monday to Friday and 9am to 3pm Saturday and Sunday as per Standard Time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.