chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: a spot that could either be a "pimple" or possibly an injection spot; This is a spontaneous report from a non-contactable consumer (patient) reporting himself.  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) via intramuscular route of administration, administered in arm on 28Jan2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a spot that could either be a pimple or possibly an injection spot. The patient received the first dose of the Pfizer COVID-19 vaccine 28Jan2021 (yesterday) and reports that he has no arm pain at all, the vaccination provider pinched the skin while administering the vaccine and when patient got home, he removed the Band-Aid and saw no blood and could not find a hole that would indicate where the injection went into his deltoid muscle. Patient stated that when he was looking for a hole in his arm where the injection could have gone in, he found a spot that could either be a pimple or possibly an injection spot, but it was not on the deltoid muscle. Patient questioned if the vaccine will still work if it was administered subcutaneously instead of intramuscularly and queried, if there was any difference in strength between the first and the second doses of the vaccine and what he should do regarding revaccinating in the event that he did receive an subcutaneous administration of the Pfizer COVID-19 vaccine yesterday. The outcome of the event was unknown.  No follow-up attempts were possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: chills; fever; diarrhea; nausea; sore shoulder; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient indicated receipt of first dose on Tuesday. Starting Wednesday night, the patient experienced chills, fever, diarrhoea, nausea and sore shoulder. Outcome of all the events were unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Glossodynia, Pain, Pain in extremity, Tongue discomfort
Clinical narrative: having difficulty breathing because of her tongue; tongue started burning about 2 hours after receiving the vaccine; tongue as "burning up" and painful; body aches; arm pain; This is a spontaneous report from a contactable consumer (patient's child). An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on 28Jan2021 as first dose, single for an Covid-19 immunization (At the age of 84 years). The patient medical history and concomitant medications were not reported. On 28Jan2021 (yesterday), the patient received the first dose of the Pfizer COVID-19 vaccine, and noticed her tongue started burning about 2 hours after receiving the vaccine. On 28Jan2021, she was also experiencing body aches and arm pain. The patient described her tongue as "burning up" and painful and she was having difficulty breathing (start: 28Jan2021) because of her tongue. The reporter was taking her mother to the hospital now (29Jan2021). The outcome for all the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Achy body; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration on 26Jan2021 at 09:00 am on the right arm as unknown, single for COVID-19 immunization. Patient's medical history included Stroke, Allergy to Lisinopril and Latex allergy at an unspecified date. Patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications include Aspirin (325mg), Atorvistatin, Flomax and Famotadine at an unspecified start and stop date. On 27Jan2021 at 10:00 pm, the patient experienced Soreness at injection site after 36 hours of vaccination and 48 hours post injection experienced achy body. Patient confirmed that he had no fever. Treatment was received with Tylenol. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. An unspecified age female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lor number and Expiration date were not reported), dose 1 via an unspecified route of administration on 14Jan2021 as SINGLE for Covid-19 immunization. The patient medical history included palpitations. The patient concomitant medications were not reported. It was reported that patient had the first dose of the Pfizer vaccine on 14Jan2021, followed by a strange surge in the body and experienced heart palpitations throughout the day until the night. Patient mentioned that she had palpitations in the past, but she described the adverse event as consistent. She experienced the palpitations until the next day (15Jan2021) and it was recovered. Patient was scheduled to take the second dose on 04Feb2021. She asked if she should be concerned in getting the second shot. The outcome of event palpitations was recovered on 15Jan2021 and outcome for other event feeling abnormal was unknown.  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Nausea
Clinical narrative: being nauseous and having a few bowels movements each day; being nauseous and having a few bowels movements each day; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female received second dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9262 expiry date: unknown) via an unspecified route of administration into the right arm, on 24Jan2021, as a single dose for covid-19 immunization. Medical history included Mitral valve replacement and GERD from unknown date and unknown if ongoing. Concomitant medications included WARFARIN SODIUM (COUMADIN) 9mg four days a week, 5mg three days a week, by mouth for Mitral valve replacement; and DEXLANSOPRAZOLE (DEXILANT) 60mg, once daily by mouth for GERD since Oct2020. Historical vaccine included patient's first dose of BNT162B2 (Solution for injection, Batch/lot number: EH9899 expiry date: unknown) via an unspecified route of administration, on 03Jan2021, as a single dose for covid-19 immunization. On Sunday 24Jan2021, she got her second dose of the COVID vaccine, and starting on 25Jan2021 Monday, going on through the day of this report, the patient had been nauseous, and she was having quite a few bowel movements, although did not have diarrhea. The patient did not undergo any investigation. she received no other vaccines on the same day as the COVID vaccine. The outcome of the events was not recovered.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Breast tenderness
Clinical narrative: Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; This is a spontaneous report from a contactable other HCP reported for himself.  A 52-years-old male patient received second dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9261; Expiration date: Unknown) via intramuscular route of administration, in left arm on 25Jan2021 at 06:45am as single dose for COVID-19 immunization. No Medical history was reported. There were no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnose with COVID-19. No other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (solution for injection, Batch/Lot number: unknown) on an unknown date for COVID-19 immunization and experienced no adverse event.   On 27Jan2021, the patient experienced left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore. It was reported that the events were four days after patient 2nd dose. No treatment was received for the adverse event. The most recent COVID-19 vaccine was administered in hospital. Since the vaccination, the patient has not tested for COVID-19. Events were reported as non-serious. The outcome of the events was not recovered.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her face, upper body, both arms all the way to hands, abdomen, but not on the back; This is a spontaneous report from a contactable nurse reporting for herself. A 72-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 11Jan2021 as single dose for COVID-19 immunization. The patient medical history included allergic to penicillin. Concomitant medications were not reported. The patient stated that, she received the first dose of the Pfizer covid vaccine on 11Jan, on the 14Jan she developed rash on her face, upper body, both arms all the way to hands, abdomen, but not on the back (as reported). She was concerned if she should take the second dose or not and if she does take the second dose would her symptoms be more severe or delayed reaction like she got with the first dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: tiredness; joint and muscle pain; joint and muscle pain; This is a spontaneous report from a non-contactable consumer (Patient). A 8-decade-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 13Jan2021 as 1st dose, single for covid-19 immunization. Medical history included bone cancer from 2007 to an unknown date, plasma cell myeloma from 2007 to an unknown date, he has been living with bone cancer and Myeloma since 2007 when he was diagnosed with this condition. On an unspecified date the patient experienced tiredness, joint and muscle pain. The Consumer reports that these symptoms are very mild and not limitating. The Consumer reports that he is currently under treatment with a medication that suppresses his immune system and he got clearance from his Physician for the administration of the vaccine on the week where he rests of the treatment after 21 days of the treatment. The Consumer reports that as a consequence of this treatment he might be anemic with low red and white blood cell counts. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: very tired; headache; muscle pain; This is a spontaneous report from a contactable other HCP (patient, self-reporting). A 52-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3249, expiration: not reported), via an unspecified route of administration in arm right on 28Jan2021 10:30 as second dose, single for covid-19 immunisation (at the age of 52-years and the patient was not pregnant) at Hospital. The patient medical history and concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and expiration: not reported), via an unspecified route of administration on unspecified date, as first dose, at single for covid-19 immunisation. No other vaccine in four weeks, no other medications in two weeks. No COVID prior vaccination, no COVID tested post vaccination. No known allergies. On 28Jan2021 patient had a headache, muscle pain and was very tired. No treatment taken for events. The outcome events were not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: None, just a sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 28Jan2021 13:30 (Batch/Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included Sjogren's, auto immune disease, mixed connective tissue syndrome, osteoporosis, osteoarthritis and Known allergies: Latex and MSG (monosodium glutamate). The patient previously took MSG and experienced allergy. Concomitant medications included misoprostol, omeprazole, rosuvastatin, and cevimeline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Approximately on an unknown date in 2021, the patient experienced "None, just a sore arm" (reported). No treatment was provided for the adverse event. The outcome of the event was recovered approximately on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a Non-contactable Physician.   A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown), and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 Immunization. Patient's medical history and concomitant medications were not reported. On an unknown date, the patient had an Urinary tract infection (UTI) after patient had received two doses of Pfizer-BioNTech Covid19 vaccines. The reporter wanted to check and make sure that the patient was able to take the antibiotics for the UTI after receiving the vaccines. The reporter wanted to know whether there would be an interaction. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: had pretty severe back pain that lasted about 10 days; This is a spontaneous report from a contactable consumer reporting for son-in-law via Medical Information Team. A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as a single dose for an COVID-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date after vaccination, patient had pretty severe back pain that lasted about 10 days. Patient had to call out of work for 2 days because of it. Patient was scheduled to get his second dose on Monday (unspecified date). The outcome of the event unknown.   Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Nausea, Vertigo
Clinical narrative: extreme nausea; vomiting; extreme vertigo; extreme dizziness; chills; a general feeling of weakness; This is a spontaneous report from a contactable consumer. This consumer (Patient's son) reported for a 71-year-old female patient (mother) who received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as first dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced extreme nausea, vomiting and extreme vertigo to the point she could not function, extreme dizziness, chills and a general feeling of weakness. Reported enquired if these side effects were known and if she was a good candidate for the second dose. The outcome for all the events were unknown.  Follow-up (29Jan2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient. No new information found.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: extreme nausea; vomiting; extreme vertigo; extreme dizziness; chills; a general feeling of weakness; This is a spontaneous report from a contactable consumer. This consumer (Patient's son) reported for a 71-year-old female patient (mother) who received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as first dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced extreme nausea, vomiting and extreme vertigo to the point she could not function, extreme dizziness, chills and a general feeling of weakness. Reported enquired if these side effects were known and if she was a good candidate for the second dose. The outcome for all the events were unknown.  Follow-up (29Jan2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient. No new information found.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Loss of personal independence in daily activities, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: swelling in my arm; I had lower back pain, it was excruciating.; Then the next morning the pain started radiating to my left leg. It was more like my left thigh; then the next morning the pain started radiating to my left leg. It was more like my left thigh; The pain was so bad I could barely walk; This is a spontaneous report from a contactable consumer or other non-HCP. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 70-years-old) as SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had experienced swelling in her arm. After that she had lower back pain, it was excruciating. She took some Motrin and it stopped hurting but then the next morning the pain started radiating to her left leg. It was more like her left thigh. The pain was so bad she could barely walk. It is going on 4 days now and she would like to know if this has been reported with the vaccine. Therapeutic measures were taken as a result of she had lower back pain, it was excruciating. The outcome of event the pain was so bad she could barely walk was not recovered. The outcome of other events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Headache
Clinical narrative: /She felt a thing brush her arm, like a finger but no needle plunging inShe did not feel any penetration from the needle; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration on 26Jan2021 02:15 as SINGLE DOSE for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced she did not feel any penetration from the needle, she felt a thing brush her arm-like a finger but no needle plunging in and headache. She received the 1st dose of the covid vaccine on Tuesday at 2:15. She was told by the nurse that it was all practice or something like that. When it came time for him to inject the vaccine, she looked straight ahead and did not feel anything. She did not feel any penetration from the needle. She asked him if he was done and he said yes and asked her to just go sit over there for 10 minutes. She did not think she got it. Assuming she did not get the vaccine. She is scheduled to receive the second one 23Feb2021. She would like to know if it would be ok for her to get the second one if she did not actually receive the first one. His name was not specified at the fire and rescue. She wondered why they would do that. Maybe he thought it would be harmful for her and did not want her to get it. She did not wish to provide an address or email. She did not wish to complete report and requested to be transferred to have her question answered. No further details provided. She felt a thing brush her arm, like a finger but no needle plunging in. She was then told to come back on the 23Feb2021 for her second dose. She believed he did not actually give her the vaccine. She was experiencing a mild headache but thought it was from distress rather than a side effect of the covid vaccine. She did not wish to provide an address or email. She did not wish to complete report and requested to be transferred to have her question answered and no further details provided. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, SARS-CoV-2 test, Swelling, Throat tightness, Vaccination site pain
Clinical narrative: left axilla swelling and tenderness; left axilla swelling and tenderness; pain at the injection site; throat closing; This is a spontaneous report from a contactable physician (Patient, Self-reported). A 47-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an intramuscular, administered in left arm on 06Jan2021 12:00 as 1st dose, single and  dose 2, (Batch/Lot number was not reported), in Arm Left, on 27Jan2021 for covid-19 immunisation. Medical history included patient was infected with covid back in April2020, neoplasm malignant (patient scared I might have had breast cancer at the time, as there is family hx of cancer). The patient previously took acetylsalicylic acid and experienced hypersensitivity, lactose and experienced hypersensitivity, lactose and experienced reaction to excipient. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination and did not receive Other medications in two weeks of vaccinations. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination.Reportedly, left axilla swelling and tenderness 4 days after the 1st injection with pain at the injection site. (she scared might have had breast cancer at the time, as there was family history of cancer). Repeatedly swelling and pain to the left arm occurred less than 1 day after the 2nd injection. Concerned of the hot flashes and disturbed sleep consistent to the time when she was infected with covid back in April 2020. One more thing, slight feeling of throat closing both times with the injections. With the first injection occurred 3-4 days afterwards with no SOB. With the second injection it occurred the within 24 hrs. On 10Jan2021 22:00, the patient experienced left axilla swelling and tenderness, pain at the injection site and throat closing. Treatment was not received for the adverse events. The patient underwent lab tests and procedures which included COVID-19 (sars-cov-2) test was negative on 08Jan2021. Outcome of the events was recovering.  Information about Batch/Lot number has been requested  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Just a sore arm in the area of injection; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262, expiration: not reported), via an unspecified route of administration, administered in arm left on 28Jan2021 13:45 as single dose for Covid-19 immunization (at the age of 73-years and the patient was not pregnant). Medical history included diabetes from an unknown date and unknown if ongoing, kidney function from an unknown date and unknown if ongoing. Concomitant medication(s) included triamterene taken for an unspecified indication, start and stop date were not reported; valsartan taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported (all as other medications in two weeks). No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 29Jan2021, the patient experienced just a sore arm in the area of injection. No treatment taken for event. The outcome for event was recovering.   No follow up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: She bled a little bit; A 'black and blue mark on the arm (as big as a tangerine, and is still there)'; When she vaccination provider put the needle in, it really hurt/soreness; Her arm ached; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself that . A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Right on 24Jan2021 13:00 as 1st dose, single for covid-19 immunisation. Medical history included for her belly. Concomitant medications included fish oil (OMEGA XL) (Has been taking for years) ongoing and glycopyrrolate [glycopyrronium bromide] taken for her belly, (Once a day) ongoing. On 24Jan2021 the patient experienced Black and Blue mark on arm, when she vaccination provider put the needle in, it really hurt/soreness and her arm ached. On an unknown date the patient experienced she bled a little bit. The patient stated that She got the vaccine on as confirmed Sunday 24Jan2021 and later that day her arm ached. She has heard a lot of people had ache, arm ache after getting the vaccine, but no specific patient details provided.She looked at her arm and she had a black and blue mark as big as a tangerine. She is not too happy that happened. She has to get the second dose of the vaccine 14Feb2021. She is not sure if she wants to get the second one. If this occurred with the first one. She also hurt with getting the vaccine. She is not sure where the needle was placed when getting the vaccine, but it hurt, and she bled a little bit. The nurse had to place a Band-Aid on it. Her arm is still black and blue. She noticed the black and blue mark on the same date she got the vaccine. It was later that day in the evening. She does not know the exact time. The black and blue mark is on her right arm. She noticed her arm ache shortly after she got the shot. It was a few hours after getting the vaccine, but she does not know what time. She stated this seems to be a complaint of a lot of other people, but no other specific patient details provided. It is her right arm that aches. She stated she is wondering if she needs to be concerned about these events. Should she be concerned about what her arm looks like. She is still having soreness. Therapeutic measures were taken as a result of a 'black and blue mark on the arm. The outcome for the events black and blue mark on the arm (as big as a tangerine, and is still there) and her arm ached was recovering. The outcome for the event when she vaccination provider put the needle in, it really hurt/soreness was not recovered. The outcome for the event she bled a little bit was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: The day after the vaccine was administered, the patient reported fever/chills and body aches.; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp.   An adult female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), via an unspecified route of administration, administered in right arm on 28Jan2021 14:45 as 1st dose, single for an for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.The patient's concomitant medications were not reported.   On 29Jan2021, at 08:00 AM, the patient experienced the day after the vaccine was administered, the patient reported fever/chills and body aches. the treatment reported as an unknown. The outcome of the events was recovering.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient himself). A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in left arm on 27Jan2021 at 08:30 as single dose for COVID-19 immunisation at Workplace clinic. The patient medical history was not reported. No known allergies were reported. Concomitant medications in two weeks were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 27Jan2021, the patient experienced sore arm 8 to 36 hours post injection, chills and aches 24-36 hours post injection. No treatment was received for the events. The outcome for all events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever of 100.8-100.9 the next day.; Fatigue; Arm soreness; This is a spontaneous report from a contactable other healthcare professional. A 40-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via intramuscular route of administration on 28Jan2021 (Lot Number EL3247), 13:30 in right arm (age at vaccination: 40 years) as, single for COVID-19 immunization. The patient medical history included allergic to drug included bactrim. Concomitant medications included fish oil, gotu kola [centella asiatica] (GOTU KOLA [CENTELLA ASIATICA]), bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) and multivitamins; all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination and post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via intramuscular route of administration on 07Jan2021, 13:30 in left arm (age at vaccination: 40 years) as, single for COVID-19 immunization. On next day (i.e. 29Jan2021) at 09:00, the patient developed fever of 100.8-100.9, fatigue and arm soreness for which the patient did not received any treatment. The events were assessed as non-serious. The patient underwent lab tests and procedures which included body temperature: 100.8-100.9 on 29Jan2021. The outcome for all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain in extremity
Clinical narrative: arm soreness; headache for 7 hours following injection; lethargy following morning; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247), via an unspecified route of administration administered in arm right on 28Jan2021 11:15 AM as single dose for COVID-19 immunization. Medical history was reported as None. No Other vaccine in four weeks. Patient was not pregnant at time of vaccination. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. Concomitant medication included ibuprofen for about two weeks. On 28Jan2021 11:30 AM, the patient experienced arm soreness, headache for 7 hours following injection, lethargy following morning. No treatment for adverse events. The outcome of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vision blurred, White blood cell count, White blood cell count increased
Clinical narrative: Left arm, she is noticing that her left arm is sore too.; she has an elevated White blood Cell Count; Blurry vision right eye; tiredness; This is a spontaneous report from a contactable consumer(patient). A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 14:45 (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia, accident, blindness. There were no concomitant medications. The patient reported, blurry vision upon waking up, and tiredness on 29Jan2021. She clarified that she actually only has vision in one eye. The blurry vision is in right eye. With the Left eye, she had an accident as a child and lost her vision in the left eye. She is noticing that her left arm is sore too and had an elevated white blood cell count on an unspecified date. Outcome of the event for blurry vision right eye was recovering and for the other events it was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. As per description, it was reported that he already received first dose last Saturday (i.e. 23Jan2021) and due for the next on 12Feb2021, He was asking to take Motrin be-fore my second dose to prevent arm soreness (occurred in Jan2021). Also, for use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The patient asked is a sore arm a common side effect after the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Headache, Pain in extremity
Clinical narrative: Fever 102 Fahrenheit; Severe leg and foot pain; Short of breath; Headache; Chills; This is a spontaneous report from a contactable other HCP (Patient). This 51-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an Intramuscular route, administered in Arm Left, on 20Jan2021 at 09:00 AM (at the age of 51-year-old) as a single dose for COVID-19 Immunization, at hospital. Patient's medical history was not reported. Patient had no Known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC), lamotrigine (LAMICTAL) and ergocalciferol (VITAMIN D); which were administered within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an Intramuscular route, administered in Arm Left, on 31Dec2020 at 09:00 AM (at the age of 50-years-old), as a single dose for COVID-19 Immunization. Patient did not receive other vaccines in four weeks of vaccination. Patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID since post vaccination. On 20Jan2021, at 09:00 PM, the patient experienced Fever 102 Fahrenheit, severe leg and foot pain, short of breath, headache and chills. No treatment was given for the events. Outcome of the events was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102 Fahrenheit; Severe leg and foot pain; Short of breath; Headache; Chills; This is a spontaneous report from a contactable other HCP (Patient). This 51-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an Intramuscular route, administered in Arm Left, on 20Jan2021 at 09:00 AM (at the age of 51-year-old) as a single dose for COVID-19 Immunization, at hospital. Patient's medical history was not reported. Patient had no Known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC), lamotrigine (LAMICTAL) and ergocalciferol (VITAMIN D); which were administered within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an Intramuscular route, administered in Arm Left, on 31Dec2020 at 09:00 AM (at the age of 50-years-old), as a single dose for COVID-19 Immunization. Patient did not receive other vaccines in four weeks of vaccination. Patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID since post vaccination. On 20Jan2021, at 09:00 PM, the patient experienced Fever 102 Fahrenheit, severe leg and foot pain, short of breath, headache and chills. No treatment was given for the events. Outcome of the events was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspepsia, Nausea
Clinical narrative: nauseous; terrible abdominal cramps; indigestion; This is a spontaneous report from a contactable consumer or other non hcp. An 81-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunization administered in Hospital. Medical history included hypersensitivity, compromised immune status, respiratory disorder. There were no concomitant medications. The patient reported, she got the 1st dose of the vaccine yesterday and woke up today with terrible intestinal cramps, indigestion on 29Jan2021 15:30 and is nauseous on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event for nauseous was unknown and for the other events it was not recovered. Follow-up attempts are completed. No further information is expected
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; The VAQTA expired on 15 APR 2021 and was administered on 17 MAY 2021; Information has been received from a nurse referring to a patient of unknown age and gender. Information of pertinent medical history, concomitant therapy and drug reactions/allergies was not reported.  On 17-MAY-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # T014590, expiration date was 15-APR-2021, 1 milliliter, strength, frequency and route were unknown) for prophylaxis (Expired vaccine used).  No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; he got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The reporter was patient's wife. The age at vaccination was not reported.  The patient received Shingles vaccine and got the shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: received the 1st Shingrix dose in February 2020; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The reporter asked if the patient need to restart the series.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not yet received their second dose of Shingrix / more than a year since the first dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than a year ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient did not provide a specific date for when the first dose was received; they simply stated it had been more than a year. After call catch; limited demographics were obtained. The reporter did not consent to follow up.