chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I've been in chemo induced menopause for almost 5 years. Following the second vaccine, my menstrual cycles began again, were very heavy and less than two weeks apart.; I've been in chemo induced menopause for almost 5 years. Following the second vaccine, my menstrual cycles began again, were very heavy and less than two weeks apart.; I've been in chemo induced menopause for almost 5 years. Following the second vaccine, my menstrual cycles began again, were very heavy and less than two weeks apart.; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 19Mar2021 (Batch/Lot Number: en6199) at the age of 39-year-old as single dose for covid-19 immunization. The patient was not pregnant. Medical history included breast cancer, chemotherapy induced menopause for almost 5 years. The patient had no known allergies. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (Lot number: EN6198) on 25Feb2021 at the age of 39-year-old, at right arm, as single dose for Covid-19 Immunization. There was no other vaccine in four weeks. The patient had been in chemo induced menopause for almost 5 years. Following the second vaccine, her menstrual cycles began again, were very heavy and less than two weeks apart. No treatment received for the events. The outcome of the events was unknown. No Covid prior vaccination. No Covid tested post vaccination.
Patient received a 3rd dose of Moderna. 1st dose on 3/18/21, 2nd dose on 6/22/21, and 3rd dose on 7/20/21.
Information has been received from a medical assistant concerning multiple unspecified patients (ages and genders were not indicated). The pertinent medical history of patients and their concurrent conditions were not provided. It was reported that on an unknown date multiple unspecified patients were administered improperly stored doses of ROTATEQ per oral route, lots # L033548 and L013206 with expiration dates 14-MAY-2017 and 29-JAN-2017 respectively, (concentrations and dosages were not provided). There were no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 88 F for 735 hours and 15 minutes. There was no data logger or previous exposures. No product quality complaint (PQC) was involved. This is one of five reports from the same source (MARRS # 1608USA009575, 1608USA010369, 1608USA010370, 1608USA010372). Additional information has been requested.
Client had large and reddened area on outer aspect of upper arm. 4 inches x 4 inches with a 1 inch x 1 inch center. Area is inflamed, warm to touch and client stated the area itches. Went to urgent care Dx cellulitis, receiving BACTRIM.
Swelling at vaccination site with redness and hardness of approx 4 inch diameter.
product=COVID 19 Treatment; product=COVID 19 Treatment,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 21Nov2021 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CITALOPRAM, start date: 01May2021, stop date: 18May2022; ZYRTEC ALLERGY, start date: 01Nov2021, stop date: 18May2022; SPIRONOLACTONE, start date: 05Feb2022, stop date: 18May2022. The following information was reported: VACCINATION FAILURE (medically significant), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "product=COVID 19 Treatment"; COVID-19 (medically significant), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "product=COVID 19 Treatment,". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Within 20 minutes of my first dose, I had a horrible taste in my mouth. It is temporarily relieved by eating/drinking, but it immediately comes back. It's especially bad in the mornings when I wake up. I'm concerned I'm going to vomit. I would not take Paxlovid again because of this side effect. It's worse than being sick.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed severe headache at 2:00 am day following the vaccine administration on 06/08/19 and whelps on her chest.  Tylenol and Benadryl taken on day of symptoms and symptoms completed resolved on Sunday 6/9/19.  No further treatment taken.
Headache, Fever, Diarrhea, BODY ACHES, CHILLS Narrative:
At 6 PM yesterday,02/22/05, mom noticed redness, child had lots of itching and  high fever. Left arm was measured it was 4.5" across and 5" down arm.
large lump axillary area same side as vaccine (left deltoid); rash on his left arm near the site of the vaccination and moving down his arm,; fatigue; dizziness; diarrhea; fever; bone/joint pain; he began experiencing a headache; This non-serious case was reported by a nurse via call center representative and described the occurrence of axillary lump in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 17-AUG-2023, 1 days after receiving Shingrix, the patient experienced axillary lump (Verbatim: large lump axillary area same side as vaccine (left deltoid)), rash (Verbatim: rash on his left arm near the site of the vaccination and moving down his arm,), fatigue (Verbatim: fatigue), dizziness (Verbatim: dizziness), diarrhea (Verbatim: diarrhea), fever (Verbatim: fever), joint pain (Verbatim: bone/joint pain) and headache (Verbatim: he began experiencing a headache).  The outcome of the axillary lump, fatigue, dizziness and headache were not resolved and the outcome of the rash and fever were resolved and the outcome of the diarrhea and joint pain were resolving.   It was unknown if the reporter considered the axillary lump, rash, fatigue, dizziness, diarrhea, fever, joint pain and headache to be related to Shingrix.     It was unknown if the company considered the axillary lump, rash, fatigue, dizziness, diarrhea, fever, joint pain and headache to be related to Shingrix.   Additional Information: GSK Receipt date: 22-AUG-2023 A nurse practitioner reported that her patient received a Shingrix vaccination and the next day he began experiencing a headache, bone/joint pain, fever, diarrhea, a rash on his left arm near the site of the vaccination and moving down his arm, dizziness and fatigue.  On 17th August 2023 he noticed a large lump under his axillary area of his left arm measuring 8 cm x 9 cm.  The rash and fever had resolved, and the joint pain had decreased, and the diarrhea had improved, but as of today (reporting day), the other symptoms remain. She had drawn CBC and CMP today and plans an Ultrasound to the lump.  The reporter consented to follow up.
I woke up at 3:00 am out of a sound sleep on 3/19/21 with a very, unusual headache, whereby I could hardly keep my eyes open. I also had a stuffy nose, and felt slightly nauseous. I was exhausted and had difficulty going back to sleep. Around 10:00 pm on 3/20/21, I noticed a rash on my upper chest and my midriff was bright red. On 3/21/21 most of my front and back torso began to itch.  On 3/22/21 the itching stopped.
felt a bump in my right neck located on the supraclavicular area on my neck; I felt another bump at the back of my right ear; makes my neck stiff a little bit; swollen and painful for like 4-5 days; swollen and painful for like 4-5 days; This is a spontaneous report from a contactable Nurse(patient).  A 39-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported) via intramuscular, administered on upper Arm Right on 18Jan2021 18:00 (age at vaccination: 39 years) as Single for COVID-19 immunization at Hospital. The patient Medical history included diabetes mellitus. No known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient Concomitant medications in two weeks included metformin (MANUFACTURER UNKNOWN); glimepiride (MANUFACTURER UNKNOWN). The patient has not received any other vaccines within four weeks. On 20Jan2021 18:00, the patient experienced 3-4 days after felt a bump in her right neck located on the supraclavicular area of her neck. It was swollen and painful for like 4-5 days. Today she felt another bump at the back of her right ear. It is a little sore and makes her neck stiff a little bit. She was not concerned of getting the second dose on 08Feb as this side effects had been happening to her. Therapeutic measures were taken as a result of event and included treatment with over the counter Tylenol. The outcome of the events was not recovered.  Information about 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
muscle weakness; hand tremors; difficulty getting out of a chair; sleeping up to 14 hours a day; pain in extremities-epecially the left arm; puffiness in her feet; extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness), TREMOR (hand tremors), HYPOKINESIA (difficulty getting out of a chair), HYPERSOMNIA (sleeping up to 14 hours a day) and PAIN IN EXTREMITY (pain in extremities-epecially the left arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dementia since 2013, Hyperlipidemia and Arthritis. Concomitant products included DONEPEZIL for Dementia.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness), TREMOR (hand tremors), HYPOKINESIA (difficulty getting out of a chair), HYPERSOMNIA (sleeping up to 14 hours a day), PAIN IN EXTREMITY (pain in extremities-epecially the left arm), OEDEMA PERIPHERAL (puffiness in her feet) and FATIGUE (extreme tiredness). At the time of the report, MUSCULAR WEAKNESS (muscle weakness), TREMOR (hand tremors), HYPOKINESIA (difficulty getting out of a chair), HYPERSOMNIA (sleeping up to 14 hours a day), PAIN IN EXTREMITY (pain in extremities-epecially the left arm), OEDEMA PERIPHERAL (puffiness in her feet) and FATIGUE (extreme tiredness) had not resolved.            No concomitant medication was provided No treatment received by the patient   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow up document received  and contains no new information On 28-Sep-2021: ADR received on 28 Sep 2021,mentioned AE  outcome On 28-Sep-2021: follow up received  no new information; Sender's Comments: This case concerns a 91-year-old female patient with a relevant n medical history of dementia, who experienced the unexpected non-serious events of muscular weakness, tremor, hypokinesia, hypersomnia, pain in extremity, oedema peripheral and expected non-serious event of fatigue. The event covid19 occurred on the 8 months after receiving second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the event Covid-19 occurred only after second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
received both scheduled doses of Pfizer's COVID vaccine (Feb/Mar 2021). Recently I was infected with the virus; received both scheduled doses of Pfizer's COVID vaccine (Feb/Mar 2021). Recently I was infected with the virus; I am now healthier than I have felt in months and months prior to my infection and no longer need to take daily doses of allergy or cough variant asthma meds; This is a spontaneous report from a contactable consumer. This 66-year old female consumer patient reported that:  A 66-year old female patient received both scheduled doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) in Feb2021/ Mar2021 a single dose for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medications were unknown.  The patient reported that recently was infected with the virus (2 times tested positive) and subsequently recovered from the infection (tested negative). She was now healthier than she has felt in months and months prior to her infection and no longer need to take daily doses of allergy or cough variant asthma meds. Perhaps this is an area of research to pursue.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Lot number: EW0171) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Melanoma (treated)" (unspecified if ongoing), notes: Melanoma (treated), family history of breast cancer; "Known allergies: Sensitivity to Penicillin" (unspecified if ongoing). The patient's family history included: "Breast cancer" (unspecified if ongoing), notes: family history of breast cancer. Concomitant medication(s) included: LISINOPRIL; TRIAMTERENE/HCTZ. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EP7533; Anatomical location: Right arm), administration date: 03Apr2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 14May2021, outcome "not recovered", described as "Increase in cramping in calves, in hamstrings in back of thighs, and occasionally in hands"; MUSCLE TWITCHING (non-serious) with onset 14May2021, outcome "not recovered", described as "Non-stop twitching in both left and right calves". The events "non-stop twitching in both left and right calves" and "increase in cramping in calves, in hamstrings in back of thighs, and occasionally in hands" required physician office visit. Therapeutic measures were not taken as a result of muscle twitching, muscle spasms.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Twitches are visible on the skin as well as felt internally. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "diabetes type 2" (unspecified if ongoing); "obesity" (unspecified if ongoing); "migraines" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine", notes: Known allergies: Morphine; Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet; Vicodin, reaction(s): "Known allergies: vicodin", notes: Known allergies: vicodin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) Negative, notes: after taking Paxlovid with multiple negative Covid tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient took other medication in 2weeks.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 , BNT162b2 omi ba.4-5 to the reported Drug ineffective and COVID-19 cannot be ruled out.
Mother called on 8/23/2017, the day after he received this vaccine, stating that there was a  3 inch area  of splotchy redness around injection site, as well as swelling on the outside of the arm, and is warm to the touch. He was seen in our pediatric clinic on that same day and the provider noted that  left upper arm had 1 large wheal just distal and medial to injection site; wheal is pink, raised, minimal tenderness, no drainage, no fever, no SOB or anaphylaxis. He was advised to take Benadryl and do cold/warm compresses to area.  On 8/25/17, this patient was seen again in our office for no improvement and the provider seeing him wrote" 11 yo male presents w/mom with increased redness/swelling of L deltoid region following a Tdap vaccine which was given 8/22 (3 days ago).  Was evaluated the day after injection and area was warm, red and tender.  Area now more red, spreading down arm, cont to be warm to touch, tender. Was using heat packs to area, which made it very itchy.  He does not tolerate benadryl well, so none use. Denies diff breathing, swelling in or around mouth, HA, tiredness, nausea/vomiting/diarrhea/abd pain, chills, swollen joints, body aches, swollen glands." She advised him to to cold treatment, elevation of limb, and to use caution with Tdap vaccines in the future. No other sx were reported after this
It makes me droopy every time; Initial information regarding an unsolicited valid non-serious social media case from a consumer (patient) via 10-Dec-2020.  This case involved patient with unknown demographics, who reported that It makes me droopy every time (Discomfort), while he/she received vaccine Influenza Vaccine.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that It makes me droopy every time (Discomfort), following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Shaking with chills onset 10:30pm.  Fell asleep midnight, awake 2:30 am 102.2 fever, asleep 4:00 awake 5:30 101 fever, asleep 7am awake 8:30 am 100 fever, sweating and very nauseated.  Fever remained 99-100 all day, felt weak stayed in bed.  Midnight muscles began to hurt, rib  cage felt tight and heart seemed to be fast, asleep 2 am awake 5 am with severe pain at the end of a deep breath, heart rate 95-108 (normal resting heart rate 57-64).  Asleep 7 am awake8:30 with milder chest pain when breathing in.  Out of bed 9am, 99 temperature.  3pm temperature 98.9, heart rate normal, no chest pain, extremely fatigued.  7:30pm slight diarrhea  with  three itchy welts the size of a quarter down inside of upper arm that was vaccinated.  Burning pain on bottom of feet.  Next day ok but took a full two weeks to be able to exercise my normal 50 minutes per day without having to take breaks.  For two days in the first week I had severe joint pain in all old injuries in different parts of my body which rendered me unable to do normal activity.  I have been fine since.
Pt states she had s/sx two hours after injection achey, all over body, H/A, fever lasting 24 hours.
it was rpt fr HCP concerning pt who was vax & subsequently pt devel a rash which was dx as herpes zoster.
Patient developed a red raised are approx 2 cm on 8/4/15.  Pateint then was seen on 8/7/15, patient was seen again and the area was 3.5 cm.  Needed to have an I and D completed due to infection at the site.  Was placed on antibiotics and seen again on 8/11/15 for recheck.
This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adolescent female patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced influenza-like symptoms and respiratory symptom. On and unknown date, the outcome of the influenza-like symptoms and respiratory symptom to be related to Seasonal Influenza vaccine. It was unknown if the reporter considered the influenza-like symptoms and respiratory symptom to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient who presented to her clinic experienced flu like symptoms after receiving the flu shot. The symptoms were described as respiratory in nature. The patient required emergency room visit. This case was one of the 3 cases, reported by the same reporter.
A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that while administering FLUMIST quadrivalent, the child moved their head the second half of the dose was sprayed into the eye which started on 10-Oct-2013. The outcome of the event of second half of the dose was sprayed into the eye is unknown. The report was considered to be non-serious.
No additional AE reported; patent was administered improperly storgae VAQTA; Spontaneous information had been received from a nurse, referring a patient of unknown age or gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.   A dose of Hepatitis A Vaccine, Inactivated (VAQTA) (with a valid lot # U024504 with expiration date on 15-OCT-2022) experienced a temperature excursion at 0.8 degree Celsius on 05-FEB-2022 during 35 minutes. On 22-FEB-2022, the patient was vaccinated with the improper stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) (exact dose, formulation and route were not reported for prophylaxis. The vaccine had not experienced previous temperature excursion. No additional adverse event reported. This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2203USA003814:
pt recv vax;elev T & dec appetite;irritable x 2 days;tx w/ amoxicillin;
Vertigo NOS on 2020-12-17, Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-17, Unspecified abdominal pain on 2020-12-22.