chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Menstrual yet (late); Vertigo; Dizziness; Headache; Tongue and gum swelling; gum swelling; Fever; Fever blisters in my mouth; Fever blisters in my mouth; Tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 14:45 (Lot number: FD0809) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 3:00 PM,Dose Number: 1, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 3:00 PM), administration date: 09Sep2021, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "Injection site pain", "No Menstrual yet (late)", "Vertigo", "Dizziness", "Headache", "Tongue and gum swelling", "Tongue and gum swelling", "Fever"; Bnt162b2 (Dose Number: 1, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 3:00 PM), administration date: 09Sep2021, when the patient was 38 years old, for Covid-19 Immunization, reaction(s): "Fever blisters in my mouth", "Injection site pain".  The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 2021, outcome "not recovered", described as "No Menstrual yet (late)"; VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizziness"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache"; SWOLLEN TONGUE (non-serious) with onset 2021, outcome "not recovered", described as "Tongue and gum swelling"; GINGIVAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "gum swelling"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "Fever"; ORAL HERPES (non-serious), ORAL MUCOSAL BLISTERING (non-serious) all with onset 2021, outcome "not recovered" and all described as "Fever blisters in my mouth"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation delayed, vertigo, dizziness, headache, swollen tongue, gingival swelling, pyrexia, oral herpes, oral mucosal blistering, fatigue.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. No  other medications the patient received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101302213 same reporter/patient/product, different dose/event.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever gets to 103 to 104.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  Her sisters fever gets to 103 to 104 when she got the vaccines. Sister had mostly Pfizer but may had one Moderna. She had covid more than once.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:34 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 61.85 No concomitant medications were reported.  On 03-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 30-Mar-2021 and beyond use date was 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Migraines, extreme fatigue and joint pain, nausea and muscle cramps, much worse than on a daily basis
Pt recvd a series of 3 Engerix-B vax 9OCT90, 14NOV90, 16APR91; 5JUN91 Anti HBS test indicated pt was non reactive; pt did not continue w/further vax; 4th Engerix vax given 29AUG91;
Pt recvd a series of 3 Heptavax-B inject 9JUL89, 22AUG89, 30MAR90 & 14NOV90 p/testing titer found to be a non-responder; Engerix-B will be given as a booster & then titers will again be checked;
body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (The patient said that in December had breast cancer and had surgery). Concurrent medical conditions included Breast cancer (The patient said that in December had breast cancer and had surgery and radiation for it.). Concomitant products included METOPROLOL for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-354379, MOD-2021-354380 (Patient Link).
Pt experienced generalized malaise, water retention, vomiting, elevation of blood pressure, tachycardia, general feeling of ill being, threw up blood, and weakness.
LEFT UPPER THIGH WITH 4-5 CM FIRM, TENDER, RED AREA 1 CM
9:30pm, got dizziness when sitting down, felt a little warm, headache, nausea and vomited once.
Starting about 4 hours, post vax, child fell into a deep sleep. Wouldn't wake on her own for 3 days. ER visit at 36 hours, post vax. Symptoms included extreme sleepiness and fever (102F rectally). Blood culture and CBC done and all were normal. No treatment. Child recovered on her own after about 3 days.
Numbness in both feet... primarily between toes. Has not increased or diminished since late May 2021.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with MMR II (route, dose and lot # not reported) when she was a child. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the recent titer was negative, no adverse effect reported. At the reporting time, the outcome of event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old male patient who received SHINGRIX for prophylaxis.  The patient's past medical history included scoliosis. Previously administered products included Zocor and tramadol. Concurrent medical conditions included back pain. On 19th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, throbbing pain, shoulder pain and neck pain. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the throbbing pain was not recovered/not resolved and the outcome of the shoulder pain and neck pain were unknown. It was unknown if the reporter considered the injection site erythema, throbbing pain, shoulder pain and neck pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The patient received SHINGRIX in left arm. He experienced some redness at the injection site after the injections. Some days later, he started having throbbing pain in his shoulder and neck on the same side he got the injection. The reporter remembered that since the patient's birthday, he was miserable with the pain. The patient had a history of back pain and scoliosis, so it was thought to be related to that. His physician had him go off Zocor, but that did not help. He was put on tramadol, but that did not help. Therapy for his back was delayed due to cataract surgery, but now that had been done he had been started.
This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). On 28-SEP-2104, the patient was vaccinated with first dose of PNEUMOVAX 23 (dose and lot # unknown) intramuscularly. On 02-OCT-2014 the patient was inadvertently administered a second dose of PNEUMOVAX 23 (dose and lot # unknown) intramuscularly. No adverse effects reported. Additional information is not expected as reporter could not be contacted.
Moderna Bivalent Booster administered to 17 years 6 months of age.
Presented with pain at injection site for days1-4 followed by flat, blanchable welt on left deltoid that was warm to touch and erythemic, approximately 1.5?x2.5? in size, on day 10.  Afrebile.
Pt was given Varicella vaccine IM instead of SQ. Pt bruised after vaccine was administered.
Base on the patient's age, patient should have received the adult dose of the covid vaccine, instead the pediatric dose was administered inadvertently. The error was discovered during processing of the paperwork. Patient did not have any adverse reaction from receiving the incorrect dose during the time he was observed in the store.
Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Calf feels tight, stiff, it feels like dead weight; Pain running up the right arm up to the shoulder/Calf pain; He asked if someone can tell him if it is a blood clot in the back of his calf; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm (shoulder) on 12Mar2021 10:07 (Lot Number: EN6202) as single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient has no prior vaccinations within 4 weeks. The patient was not sick at time of vaccination. The patient reported that on 12Mar2021, he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes. However, he said that the last few days (2021), there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping. His calf feels tight, stiff, it feels like dead weight. It wakes him up at times. He also reported pain running up the right arm up to the shoulder on unknown date in 2021. He was just curious in terms of what that might be. He asked if someone can tell him if it is a blood clot in the back of his calf. The headache went away after 2-3 days. He also reported that his eyes also hurt a little bit and was the same time frame as the headache (onset date reported as 12Apr2021: after the second dose, pending clarification). He stated that those things were just mild, nothing major. He did not take anything for these. He confirmed he no longer had muscle pain. He just has pain behind the calf and right arm up to his shoulder. His calf pain, started to feel tight, started within the last 2- 3 weeks (2021). The arm pain in right arm up to shoulder started maybe within 2 days. The patient received the second dose on 02Apr2021. Outcome of the events muscle pain and headache was recovered in Mar2021, events pain running up the right arm up to the shoulder/Calf pain was not recovered, and outcome of other events was unknown.
I have recently had a marked increase in general leg pain after walking about one half mile, usually must stop after 1 mile.   It started after my Covid booster on 10/25.  I initially discounted it as knee pain from increased tennis (3 times/week with stronger players, and move to indoor hard courts - harder on knees than clay.)  But the pain is not localized to my knees, extends from shins/ankles through lower thighs.   I normally walk over 6 miles per day.  Now I get aching legs after about 1/2 mile.   Slowing my walking pace seems to reduce the pain.  I have stopped running (usually 3 miles), but doubles tennis seems OK (avoiding singles.)   It has been a very sudden and significant change, very life affecting.  I used to frequently walk 2-4 miles around the city, not possible now.   My symptoms seems to imply Peripheral Artery Disease.   I have a doctor appointment scheduled for 12/8 to further assess.
Inappropriate schedule of vaccine administered- dose 1  28Mar2021; dose 2- 11Apr2021; Fever - 101 during first two days; muscle pain; muscle chill; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 13:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient had no allergies to medications, food or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 14:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation and experienced no side effects. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 11Apr2021 patient experienced fever 101 (unspecified units) during first two days, muscle pain for one day and muscle chill for 5 days. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle pain was recovered on 12Apr2021 after the duration of 1 day. The clinical outcome of the event fever - 101(unspecified units) was recovered on 13Apr2021 after the duration of 2 days. The clinical outcome of the event muscle chills was recovered on 16Apr2021 after the duration of 5 days.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: 78 yo man incidentally tested positive for COVID. Patient with no signs or symptoms of COVID infection. Patient with history of major depression with psychotic features and a complex medical history of T2DM, MGUS, GERD, OSA, restrictive lung disease, CAD, neuropathy, chronic afib who presented to a HCF due to worsening delusions past several days, such as winning lottery, as well as disorganized thoughts.
noc post vax awakened w/t103;severe chills, achiness all over body, very weak-felt this was serious side effect-caused pt to have sz d/t high temp;
This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. On 20-FEB-2013 the patient was vaccinated with the first dose of GARDASIL, intramuscularly (dose, lot number and expiration date not reported). The second dose of GARDASIL was administered on 09-SEP-2013 and the third on 11-OCT-2013 (lot #, expiration dates and doses not reported). No adverse effect was reported. Additional information has been requested.
This spontaneous report has been received from a medical assistant referring to multiple patients of unknown age or gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, route and anatomical location were not reported), strength of 10/1.0 micro-gr/ml, lot # L038018 and expiration date on 13-SEP-2017, for prophylaxis; which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 50 minutes. Previous temperature excursion was between 47 and 77 Fahrenheit degrees for 3 hours. Data logger was involved. No adverse effects were reported and no additional information was provided. A product quality complaint was not involved. This is one of the multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001034: US-009507513-1706USA001035: US-009507513-1706USA001033.
The wife of the pt reported that her husband received the flu vax 5 to 6 years ago and subsequently developed fever, chills, aches, nausea, and vomiting. He was deathly ill for 2 weeks. The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Flu vaccines was administer at 1300, at around 1400 associated complain of pain on site, redness and swelling. 8cm x 10cm localize reaction. No anaphylaxis. Swelling and redness decrease still pain on site.
measles-type rash on chest, trunk x 7-9d p/vax;mom took pt to PMD for eval;t104
This spontaneous report was received from a pharmacist regarding a 7 year old patient of an unknown gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. ON an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number were not provided). Concomitant medication was not provided. On an unknown date, the patient was diagnosed with shingles after received VARIVAX (Merck). At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Additional Details: Patient receieved vaccine. After about 5-10 minutes the patient stated she was very nauseous. I went to grab a trash can for her and within the 20 seconds or so it took to grab she had what seemed like a single muscle spasm or convulsion then she slid out of her chair onto the floor. She was breathing and coherent right away however she did not remember getting on the floor. Called 911 and EMS came out and took her vitals. She stated she felt fine afterward and did not go with them.
2 days after having the vaccine my daughter started having headaches and episodes of vomiting. She does not feel nausea, will just have random episodes of emesis. This continued for 4 weeks, the vomiting has subsided but headaches have not.
had Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19. At the time of the report, COVID-19 outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  Patient had two initial shots of Moderna. Patient had COVID-19 before patient could get the booster. The COVID-19 was during Thanksgiving week and patient was out of the quarantine period. This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Pt received first dose of Pfizer vaccine at 1503 and reported feeling dizzy and lightheadedness immediately following the injection. Patient did not lose consciousness and was able to lower herself to the floor. Healthcare providers were able to help her raise her legs onto a chair above the level of her heart until she was able to stand and sit in a wheelchair. Patient was wheeled to medical bay to have vitals signs Q10 minute intervals. Patient vitals were stable for all 3 cycles of vitals and was  able to walk herself to her car at 1534, reporting that she "felt much better."
12/28/2020: Received first dose Moderna COVID-19 vaccine. No significant reactions to report. 01/27/2021: Received second dose of COVID-19 vaccine. However, patient received Pfizer BioNTech vaccine. No significant reactions reported.