chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: First dose of the vaccine, just there was little swelling on the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm, administration date 07Mar2021 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 58 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: PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "First dose of the vaccine, just there was little swelling on the arm".  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hyperhidrosis, Hypoaesthesia, Muscle spasms
Clinical narrative: pain in arm; cramps and it was very intense, it was really bad , I had it like at several points, five different points; it was cold / i was cold; sweating a lot; it felt less pain / feeling like I was drunk pain; mouth ache; headache; feeling my hands numb; numbness grow in my hand, the numbness in both; 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 patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 (Lot number: ER8733) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid", start date: 2011 (unspecified if ongoing); "cholesterol", start date: 2014 (unspecified if ongoing); "COVID virus", start date: Nov2020 (unspecified if ongoing); "Congenital problem" (unspecified if ongoing), notes: heart that is something the patient was born with like Congenital, but it works perfectly. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "unknown", described as "pain in arm"; MUSCLE SPASMS (non-serious) with onset 28Mar2021, outcome "unknown", described as "cramps and it was very intense, it was really bad , I had it like at several points, five different points"; FEELING COLD (non-serious) with onset 28Mar2021, outcome "unknown", described as "it was cold / i was cold"; HYPERHIDROSIS (non-serious) with onset 28Mar2021, outcome "unknown", described as "sweating a lot"; PAIN (non-serious) with onset 28Mar2021, outcome "unknown", described as "it felt less pain / feeling like I was drunk pain"; ORAL PAIN (non-serious) with onset 28Mar2021, outcome "unknown", described as "mouth ache"; HEADACHE (non-serious) with onset 28Mar2021, outcome "unknown", described as "headache"; HYPOAESTHESIA (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "feeling my hands numb; numbness grow in my hand, the numbness in both". Therapeutic measures were taken as a result of pain in extremity, muscle spasms, feeling cold, hyperhidrosis, pain, oral pain, headache, hypoaesthesia.  Additional information: It was further reported that the patient got the vaccination on the 27Mar2021 and got the all the symptoms on 28Mar2021, patient was cold, was sweating a lot and reported that it felt less pain. Patient had mouth ache and then had headache and had a feeling like patient was in "drunk pain", that's the feeling that the patient had after the numbness grow in the patient's hand that he had for like fifteen minutes." Patient received paracetamol (TYLENOL).  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Oral pain, Pain, Pain in extremity
Clinical narrative: pain in arm; cramps and it was very intense, it was really bad , I had it like at several points, five different points; it was cold / i was cold; sweating a lot; it felt less pain / feeling like I was drunk pain; mouth ache; headache; feeling my hands numb; numbness grow in my hand, the numbness in both; 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 patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 (Lot number: ER8733) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid", start date: 2011 (unspecified if ongoing); "cholesterol", start date: 2014 (unspecified if ongoing); "COVID virus", start date: Nov2020 (unspecified if ongoing); "Congenital problem" (unspecified if ongoing), notes: heart that is something the patient was born with like Congenital, but it works perfectly. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "unknown", described as "pain in arm"; MUSCLE SPASMS (non-serious) with onset 28Mar2021, outcome "unknown", described as "cramps and it was very intense, it was really bad , I had it like at several points, five different points"; FEELING COLD (non-serious) with onset 28Mar2021, outcome "unknown", described as "it was cold / i was cold"; HYPERHIDROSIS (non-serious) with onset 28Mar2021, outcome "unknown", described as "sweating a lot"; PAIN (non-serious) with onset 28Mar2021, outcome "unknown", described as "it felt less pain / feeling like I was drunk pain"; ORAL PAIN (non-serious) with onset 28Mar2021, outcome "unknown", described as "mouth ache"; HEADACHE (non-serious) with onset 28Mar2021, outcome "unknown", described as "headache"; HYPOAESTHESIA (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "feeling my hands numb; numbness grow in my hand, the numbness in both". Therapeutic measures were taken as a result of pain in extremity, muscle spasms, feeling cold, hyperhidrosis, pain, oral pain, headache, hypoaesthesia.  Additional information: It was further reported that the patient got the vaccination on the 27Mar2021 and got the all the symptoms on 28Mar2021, patient was cold, was sweating a lot and reported that it felt less pain. Patient had mouth ache and then had headache and had a feeling like patient was in "drunk pain", that's the feeling that the patient had after the numbness grow in the patient's hand that he had for like fifteen minutes." Patient received paracetamol (TYLENOL).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 9, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following information was reported: influenza/flu, onset Mar 2021, with outcome of unknown. Additional information: Patient was supposed to receive the second dose of the vaccine today, Mar 30, 2021 but developed a bad case of the flu. Patient asked whether she should push through with the shot or put it on hold for another date. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain
Clinical narrative: girl administering the shot went to high on his arm and appeared she injected into his bursa; pain; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 06Mar2021 (Lot number: EN9581) at the age of 74 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, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Mar2021, outcome "unknown", described as "girl administering the shot went to high on his arm and appeared she injected into his bursa"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain".  Additional information: It was also reported that the second dose was received on 06Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: rising temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 27Mar2021 (Batch/Lot number: unknown) at the age of 62 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, SINGLE (Batch/Lot No: ER8732)), administration date: 06Mar2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "rising temperature".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Had a swollen gland in my left jaw; 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 10Mar2021 (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) with onset 12Mar2021, outcome "unknown", described as "Had a swollen gland in my left jaw". The event "had a swollen gland in my left jaw" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of lymphadenopathy. Additional information: The patient was prescribed six days supply of Medrol (treatment).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) for a Pfizer sponsored program .  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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 "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: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: experienced tiredness in the evening and soreness in the arm for a few days after receiving his 1st dose of the Pfizer COVID19 Vaccine on Monday 22/Mar/2021; experienced tiredness in the evening and soreness in the arm for a few days after receiving his 1st dose of the Pfizer COVID19 Vaccine on Monday 22/Mar/2021; 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 43 year-old male patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Mar2021, outcome "unknown" and all described as "experienced tiredness in the evening and soreness in the arm for a few days after receiving his 1st dose of the Pfizer COVID19 Vaccine on Monday 22Mar2021. Additional Information: He is asking if he will experience more serious side effects after getting his 2nd dose on 13Apr2021 as that is what he has heard. 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
Clinical narrative: got the COVID vaccine and the second shot threw her for a loop and she developed flu like symptoms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 55-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "got the COVID vaccine and the second shot threw her for a loop and she developed flu like symptoms.".  Additional information: The reporter reported on behalf of her mother. Patient's mother got the covid vaccine and the second shot threw her for a loop and she developed flu like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: little bit tender; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8727) at the age of 62 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: TENDERNESS (non-serious), outcome "recovered", described as "little bit tender". Additional information: Events were described as follows: Patient had the first dose and everything was going fine. It was little bit tender at first but now everything was fine. The patient was due for second dose on 16Apr2021, 3 weeks later.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: after her husband got his 1st dose of the COVID-19 Vaccine on 29Mar2021, his sense of smell was fully restored; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 08:10 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lost his sense of smell", start date: Feb2020, stop date: 30Mar2021. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 30Mar2021, outcome "not recovered", described as "after her husband got his 1st dose of the COVID-19 Vaccine on 29Mar2021, his sense of smell was fully restored".  Additional information: Caller (Patient's Wife) stated she wanted to give Pfizer some positive feed back on the COVID-19 Vaccine. She said her husband had gotten vaccinated (on 29Mar2021), clarifying it was her husband's first COVID-19 Vaccine dose. She said her husband had lost his sense of smell in Feb2020. She said it wasn't documented that her husband had the COVID-19 Virus in Feb2020, but he thought he probably had the COVID-19 Virus because of losing his sense of smell. She said at that time, in 2020, it was difficult to get COVID-19 Virus testing. She said the day after her husband got his first COVID-19 Vaccine dose (30Mar2021), his sense of smell was fully restored. She said both her and her husband found it to be interesting that he got his full sense of smell restored after getting his first COVID-19 Vaccine dose. Patient woke up in the morning on 30Mar2021, and his full sense of smell was restored and he was so excited.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site rash
Clinical narrative: Red blotches at injection site; arm soreness; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 09:00 (Lot number: EP6955) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 24Mar2021, outcome "recovered" (2021), described as "Red blotches at injection site"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovered" (2021), described as "arm soreness"; FATIGUE (non-serious) with onset 24Mar2021, outcome "recovered" (2021), described as "exhaustion". Therapeutic measures were not taken as a result of vaccination site rash, pain in extremity, fatigue.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity, Sinus congestion, Vertigo
Clinical narrative: left arm and back were a little achy; sinuses were slightly stuffy; felt fatigued; had mild vertigo; left arm was slightly sore /left arm and back were a little achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Mar2021 11:30 (Lot number: EL3248) at the age of 53 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "latex" (unspecified if ongoing); "betadine allergy" (unspecified if ongoing); "seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; ZOLOFT; D3 VITAMIN; EXCEDRIN MIGRAINE. Vaccination history included: BNT162B2 (lot number:EN6203, administration time:11:30 AM, vaccine location: Left arm, dose number :1), administration date: 02Mar2021, when the patient was 53 years old, for COVID-19 Immunisation, reaction(s): "slightly stuffy nose", "fatigue", "Earache", "mild vertigo". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "left arm was slightly sore /left arm and back were a little achy"; BACK PAIN (non-serious) with onset 27Mar2021, outcome "recovered" (Mar2021), described as "left arm and back were a little achy"; VERTIGO (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "had mild vertigo"; SINUS CONGESTION (non-serious) with onset 27Mar2021, outcome "recovered" (Mar2021), described as "sinuses were slightly stuffy"; FATIGUE (non-serious) with onset 27Mar2021, outcome "recovered" (Mar2021), described as "felt fatigued". Therapeutic measures were not taken as a result of pain in extremity, back pain, vertigo, sinus congestion, fatigue.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The vaccine was administered in a workplace clinic.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: I just had my first Covid vaccine shot and I am experiencing frequent urinations; 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 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POLLAKIURIA (non-serious), outcome "unknown", described as "I just had my first Covid vaccine shot and I am experiencing frequent urinations".  Additional information: Clinical Trial Information (provide if caller indicated they are enrolled in a Pfizer Clinical Trial remove if not applicable): NA. Any other additional information provided (sample size, etc.): None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Middle insomnia, Thirst
Clinical narrative: Woke up very thirsty; Woke up very thirsty; Body felt very warm like it was radiating heat; it was cold and hot, hot, and then cold; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 48-year-old female patient received BNT162B2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP6955) at the age of 48 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL, start date: Dec2017. The following information was reported: MIDDLE INSOMNIA (non-serious), THIRST (non-serious) all with onset 29Mar2021 01:00, outcome "recovered" (29Mar2021) and all described as "Woke up very thirsty"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 29Mar2021 01:00, outcome "recovered" (29Mar2021), described as "Body felt very warm like it was radiating heat; it was cold and hot, hot, and then cold".  Additional Information: The patient wanted to report side effects from the vaccine. Overnight after the third night, the patient woke up very thirsty and her body felt very warm like it was radiating heat. It was a form of blinking light, it was cold and hot, hot, and then cold. It was overnight and the patient went to sleep, and she woke up and it was better.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain
Clinical narrative: fatigue; nausea; left arm tenderness (administration site); This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "left arm tenderness (administration site)".  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
Clinical narrative: Extreme nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Extreme nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: she noticed huge lump under armpit of her left arm/Have a big lump a swelling lump under my armpit and in the same arm that I had the COVID shot; 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 62 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (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: AXILLARY MASS (non-serious) with onset 03Apr2021, outcome "unknown", described as "she noticed huge lump under armpit of her left arm/Have a big lump a swelling lump under my armpit and in the same arm that I had the COVID shot".  Additional information: She wanted to know if that was something that was reported with the vaccination. She indicated that a lump was going down. NDC number, UPC number and expiry date were reported as unknown. She had a big lump a swelling lump under armpit and in the same arm that she had the COVID shot and she still feel the swelling and it left but she was a little concern and believed that it could be a side effect from the 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: Decreased appetite, Fatigue, Nausea
Clinical narrative: I felt tired/exhausted all day; didn't really felt hungry; I felt a little noxious; This is a spontaneous report received from a contactable healthcare professional.  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: FATIGUE (non-serious), outcome "unknown", described as "I felt tired/exhausted all day"; DECREASED APPETITE (non-serious), outcome "unknown", described as "didn't really felt hungry"; NAUSEA (non-serious), outcome "unknown", described as "I felt a little noxious".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: Poison ivy; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "Poison ivy". Therapeutic measures were taken as a result of dermatitis contact.  Additional Information: The patient got poison ivy and is taking prednisone. The patient was scheduled already for her second shot and wanted to know if it is okay to get it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: he had the same experience with the tin taste after getting the COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (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: TASTE DISORDER (non-serious) with onset 01Apr2021, outcome "unknown", described as "he had the same experience with the tin taste after getting the COVID-19 Vaccine".  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: Pain in extremity
Clinical narrative: She said her left arm was sore after her first COVID-19 Vaccine dose; 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 02Mar2021 (Lot number: EN6198) at the age of 72 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Oral lichen planus" (ongoing), notes: Verbatim: Oral lichen planus, 10-15 years ago.; "Rheumatoid arthritis" (ongoing), notes: Verbatim: Rheumatoid arthritis; "Spinal leak" (ongoing), notes: Verbatim: Spinal Leak, 1-1/2 year ago; "Gluten" (unspecified if ongoing), notes: triggered her rheumatoid arthritis; "fractured her L4 vertebrae", start date: 2020 (unspecified if ongoing), notes: in last summer 2020; "Sciatica", start date: Feb2020 (unspecified if ongoing), notes: pinched sciatic nerve since Feb2020; "Bone density issue" (unspecified if ongoing). Concomitant medication(s) included: EXTRA STRENGTH TYLENOL PM; ADVIL [IBUPROFEN]; GABAPENTIN  (3 capsules in the morning, 2 capsules 5 hours later, 3 capsules after another 5 hours, and 3 capsules before bedtime). Vaccination history included: Flu vaccine, reaction(s): "mouth sores". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Mar2021, outcome "recovered" (Mar2021), described as "She said her left arm was sore after her first COVID-19 Vaccine dose".  Additional information: she had a flu vaccine about 15 years ago, and the day after the flu vaccine, she got mouth sores, and the mouth sores got worse. She said her local doctors didn't know how to treat her mouth sores, so she went to the (Privacy). She said the (Privacy) doctors told her she had Oral Lichen Planus, and the Oral Lichen Planus was caused by the flu vaccine she had received. She stated she did not have any information (NDC, Lot, & Expiration Date) for the flu vaccine she received back then. She stated she has not had a flu vaccine since that time. Reported she had medication she takes every day, and she continued to take the medication to help her symptoms. She said she took Extra Strength Tylenol, Advil, and Gabapentin.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cytomegalovirus test, Polymerase chain reaction, Therapeutic response unexpected
Clinical narrative: It (Covid-19 vaccine) killed cytomegalovirus as unintended side effect; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN3602) at the age of 55 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "heart transplant", start date: Jul2019 (unspecified if ongoing); "Cytomegalovirus", start date: Jun2020 (unspecified if ongoing). Concomitant medication(s) included: TACROLIMUS; MYCOPHENOLIC ACID; VALGANCICLOVIR. Past drug history included: Acyclovir, reaction(s): "didn't do anything.". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "It (Covid-19 vaccine) killed cytomegalovirus as unintended side effect". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She was heart transplant recipient and her donor gave me Cytomegalovirus. She has had it for 10 months. She first diagnosed in June 2020. That was when the virus became a problem. When she got the Pfizer shot, it got rid of it. It killed cytomegalovirus as unintended side effect.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2021-089399.  A 76 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. Relevant medical history included: "endometrial carcinoma" (unspecified if ongoing). Concomitant medication(s) included: LENVIMA, start date: 03Mar2021. Past drug history included: Keytruda infusions, start date: 04Feb2021. Vaccination history included: Covid-19 vaccine (dose 1), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm at injection site". The action taken for bnt162b2 was unknown.  Additional Information: Stated resumed Lenvima 14 mg on 3/29/21. Is now taking nausea medication routinely. Is feeling better. Received Keytruda infusion on 4/2/21. Will follow up with oncologist again in three weeks unless needs anything before then. Received second COVID vaccine(Pfizer) recently. Noted with sore arm at injection site. Unknown date of vaccine site. Diagnosis Endometrial Carcinoma, Lenvima 20 mg once daily, start date 3/3/21, temporarily stopped on 3/12/21 and resumed Lenvima 14 mg on 3/29/21. Relevant history includes endometrial carcinoma, Keytruda infusions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in. Left armpit 3 days after second dose of Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6207) 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes in. Left armpit 3 days after second dose of Pfizer covid vaccine".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: she had bad diarrhea after her first covid vaccine/She says a nurse she spoke to had a similar reaction; 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 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "she had bad diarrhea after her first covid vaccine/She says a nurse she spoke to had a similar reaction". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: First COVID-19 vaccine: arm sore; First COVID-19 Vaccine: body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 15:40 (Lot number: ER6207) at the age of 32 years as dose 1 single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DUPIXENT taken for dermatitis atopic. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "First COVID-19 vaccine: arm sore"; PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "First COVID-19 Vaccine: body aches".  Additional information: Anatomical Location: Left shoulder.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vasodilatation
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 1, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), on Mar 10, 2021, for COVID-19 immunisation. The patient experienced vasodilatation (patient and her mom experienced veins popping-up on their arms after taking the COVID-19 vaccine), with outcome of unknown. Additional information: Reporter and her mom experienced veins popping-up on their arms after taking the COVID-19 vaccine. Patient  experienced this symptom after taking the 1st dose. Her mom experienced the symptoms after taking the 2nd dose. Her mom got the 1st dose of COVID-19 vaccine on Mar 10, 2021 and her mom's 2nd dose was taken on Apr 1, 2021. Patient asked if this is a normal symptom. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vasodilatation
Clinical narrative: Caller and her mom experienced that veins are popping up on their arms after taking the Covid-19 vaccine; 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 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VASODILATATION (non-serious), outcome "unknown", described as "Caller and her mom experienced that veins are popping up on their arms after taking the Covid-19 vaccine". Therapeutic measures were not taken as a result of vasodilatation. Additional information: Reporter states patient experienced that veins are popping up on their arms after taking the Covid-19 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: Potentiating drug interaction, Vaccination complication
Clinical narrative: her husband had a reaction after 1st dose of Covid Vaccine.. Clarified husband is on warfarin had a potential reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; warfarin (WARFARIN) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "her husband had a reaction after 1st dose of Covid Vaccine.. Clarified husband is on warfarin had a potential reaction". The action taken for warfarin was unknown.  Additional information: Clarified husband was on warfarin had a potential reaction Wanted to know what were they supposed to be looking for as potential reactions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I got the Pfizer COVID vaccine and had no side effects except some tingling in my fingers. I already reported it to VAERS; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "I got the Pfizer COVID vaccine and had no side effects except some tingling in my fingers. I already reported it to VAERS".  Additional information: Described tingling in her fingers after receiving the Pfizer COVID vaccine that has already subsided. It was mentioned this to reporter in casual conversation. Paraphrased "I got the Pfizer COVID vaccine and had no side effects except some tingling in my fingers. I already reported it to VAERS." Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: has not been feeling well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "has not been feeling well".  Clinical information: The patient stated that she had a reaction from a second COVID-19 vaccine shot that she recently received and has not been feeling well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After receiving your COVID shot I accidentally ingested 3 pieces of wheat based pizza. I had absolutely no reaction; 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 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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "After receiving your COVID shot I accidentally ingested 3 pieces of wheat based pizza. I had absolutely no reaction".  Additional information: As an adult patient acquired an allergy to wheat. This has been for over 20 years. Just a small amount of wheat ingested caused a dangerous reaction, after receiving your COVID shot patient accidentally ingested 3 pieces of wheat based pizza and had absolutely no reaction. patient  intentionally ate a cupcake to see if again there would be no reaction. No reaction at all. Patient wanted to share this info. For patient this is definitely life changing.  No follow up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: felt like I was coming down with Covid again effects lasted 3-4 days; 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), intramuscular, administered in arm left, administration date 03Mar2021 13:15 (Lot number: EN6205) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT D3; ASPIRIN LOW; PROBIOTICS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: EL3247, Date/Time: 08:15, Anatomical Site: Left arm, Route of administration: Intramuscular), administration date: 10Feb2021, for COVID-19 immunization, reaction(s): "body aches", "fatigue", "low grade fever", "I felt like I was coming down with COVID again". The following information was reported: SUSPECTED COVID-19 (non-serious) with onset 2021, outcome "unknown", described as "felt like I was coming down with Covid again effects lasted 3-4 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concomitant drugs included Multivitamins. Vaccination facility type was Hospital. Prior vaccinations was None. For both injections, patent felt like she was coming down with COVID again. Effects lasted 3-4 days. Patient did not take any medications for symptoms. Spoke with someone who got the same manufacturer shots at the same location who did not have COVID. they had no effects from the injections. Weird. Patient Would like to know if she was still eligible to donate convalescent plasma.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Musculoskeletal stiffness, Red blood cell sedimentation rate
Clinical narrative: had a hard time picking things up and doing things with his hands/had a problem with his hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 83 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 83 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthropathy" (ongoing); "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis, psoriatic arthropathy, start date: 18Mar2021. Past drug history included: Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Weak and had abdominal pain and diarrhea/Was too weak without Enbrel"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Weak and had abdominal pain and diarrhea"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Weak and had abdominal pain and diarrhea"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Pain in his hands, weakness, arthritis in back and hands was effecting him more without the Enbrel"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Pain in his hands, weakness, arthritis in back and hands was effecting him more without the Enbrel"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Pain in his hands, weakness, arthritis in back and hands was effecting him more without the Enbrel/Still has problem with his hands"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Sedimentation rate increased". Vaccination history included: Bnt162b2 (dose1), administration date: 2021, for COVID-19 Immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "had a hard time picking things up and doing things with his hands/had a problem with his hands". 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.