chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was not supposed to start my period for 17 days; i started heavily bleeding; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6203) via an unspecified route of administration in the right arm on 22Mar2021 at 06:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patients medical history included suspected COVID-19 prior to vaccination. The patient was allergic to sulfa medications. Concomitant medications included norgestimate/ethinyl estradiol (ORTHO TRI CYCLEN LO) and fluoxetine (MANUFACTURER UNKNOWN) both for unknown indications started on an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EM9809) via an unspecified route of administration in the left arm on 25Feb2021 at 06:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient was not tested for COVID-19 since the vaccination. On 23Mar2021 at 09:00 hours the patient reported that she was on birth control that regulates her menstrual cycle and she was not supposed to start her period for 17 days but the patient experienced heavily bleeding on the same day of the vaccination. The patient never had periods earlier than scheduled in the past 8 years. The patient did not receive any treatment for the events reported. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events irregular periods and heavy periods was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a licensed vocational nurses and refers to a multiple unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, during an unspecified two week period, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot number: M022086, expiry date: 09-OCT-2017) (dose and route of administration were not reported). No concomitant therapy was reported. Temperature excursion was 32 degree of Fahrenheit through 7 days during 2 weeks period. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA000292.
Back ache started after first shot which deteriorated into severe sciatic pain immediately following the second shot.  This got worse and worse, culminating with a month of severe (10/10 on pain scale) sciatic pain in June.  It was severe enough that I was unable to lay down for more than 2 hours, even with pain medication (10-12 ibuprofren / day for almost 3 months).  I had several days in a row where I was unable to sleep at all even with medication.  I was under the supervision of my PT but none of her treatments provided relief (she recommended I go to the hospital and consider an epidural during those most intense periods).  Things started to improve in July and I was more or less back to normal by end of August.
Beginning 05/04/2003- complains of extreme fatigue. Sleeping 12-15 hours at bedtime and then having to nap during the day. Complains also of low back pain, mostly noticed when first getting up. The follow up received on 5/23/03 states pt has improved and is doing fine.
A non-serious spontaneous report of fell, hit his head, headache after hitting his head and vomiting after hitting his head has been received from a health professional concerning a seven-year-old male, subsequent  to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date in 2009, the patient received FLUMIST. On 29-Sep-2010, the patient fell and hit his head. Later on the same day, the patient experienced headache and vomiting. The outcome of the events fell, hit his head, headache after hitting his head and vomiting after hitting his  was resolved.
vision blurriness; a severe headache; a fever of 102; chills; body aches; nausea; lethargy; dizziness; not feeling all that great/was pretty sick; This is a spontaneous report from a contactable other health professional (patient). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Aug2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Aug2021, the patient experienced a severe headache, a fever of 102, chills, body aches, nausea, lethargy, vision blurriness and dizziness. She was still experiencing a dull headache and vision blurriness. Patient reported she had several unpleasant side effects and still not feeling all that great. Patient was wondering if the second dose was more severe because she was pretty sick this time, and if she should get the second dose. Patient's second dose was due on 01Sep2021. The patient underwent lab tests and procedures which included body temperature was 102 in Aug2021. The outcome of events "vision blurriness, headache" was not recovered; of other events was unknown.   Information on the lot/batch number has been requested.
This spontaneous report as received from a Doctor of pharmacy refers to a 65 years old female patient with codeine allergy and no pertinent medical history. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (Lot # not reported) IM on 05-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 10-SEP-2012, the patient experienced redness, swelling and warmth at the injection site, and was having difficulty moving her arm. The patient was recommended to take ADVIL and TYLENOL. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
On 10/8/99, had severe local reaction, site swollen and tender to touch. Feels feverish and nauseated. On 10/13/99, still about 50 cents-sized lump. On 6/12/00, injection site was again sore and stinging and tender to touch after having a cold.
Client received Pfizer vaccine as Dose #2 on 3-23-21 after having received Moderna vaccine (Lot# 014M20A) as Dose #1 on 3-3-2021.  Client was monitored after immunization by nursing staff for 15 minutes. Client was alert and responsive and was discharged from the clinic with instruction to report any problems or seek medical attention if needed.
Fever of about 101 degrees; Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 (Lot number: FF2588) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish. Concomitant medication(s) included: ATORVASTATIN; FOLIC ACID; BIOTIN; VIT C. Past drug history included: Neomycin, reaction(s): "allergies: topical neomycin", notes: known allergies: topical neomycin; Formaldehyde, reaction(s): "allergies: formaldehyde producers", notes: known allergies: formaldehyde producers. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 03Mar2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 24Mar2021, when the patient was 67 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 21Sep2021, outcome "recovering", described as "Fever of about 101 degrees"; MIGRAINE (non-serious) with onset 21Sep2021, outcome "recovering", described as "Migraine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, migraine.  Additional information: The clinical course was reported as the patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications within 2 weeks of vaccination with centrum. Reported stated, fever of about 101 degrees beginning the next morning. Migraine the morning after the third and fourth dose. Severe constipation and nausea the morning after the fourth dose. OTC antipyretics and sumatriptan as treatment was received for the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (Lot # L041457, expiry 22-OCT-2017 and Lot # L009544, expiry 19-MAR-2017). The temperature and time frame that the M-M-R II was exposed to were as follows, Temperature: 14.9F, Time frame: 1 hour. There were no previous temperature excursions. Data Logger was involved. The medical assistant confirmed that the improperly stored vaccines were administered. No adverse effect was reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Information has been received from a health professional concerning a 36 month old female with no known medical history or allergies who on 25Mar03 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot0966). There was no concomitant medication. On 17Apr05 the pt developed breakthrough chickenpox with itchy papular lesions on her face and arms, then on her neck and buttocks. On 19Apr05 the pt was seen in the office. Treatment included calamine lotion and diphenhydramine hydrochloride (Benadryl). There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a physician referring to an unspecified number of patients of unknown ages and genders. The patient's concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDIVAXHIB (lot # J016188, expiration date 02-OCT-2016), dose, route and anatomical location were unknown. There was no concomitant medication reported. The vaccines experienced the following temperature excursions on unknown dates: 29 F for 21 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were not identified due to a data logger. It was reported that PEDVAXHIB was not supported, the product was not suitable for use. This is one of three cases received from the same source. Additional information has been requested.
Swollen Lymph Node; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph Node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph Node) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen Lymph Node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is treated with Tylenol. No concomitant list is provided. Event developed 10 days later.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Headache, muscle aches, fatigue, chills, congestion, over the course of 24 hours from injection.
24 hours after the 2nd injection I experienced the following:  Slight soreness at sight Low grade fever 101  Extreme fatigue Brain fog - or difficulty focusing on work related tasks These symptoms resolved within 24 hours, 3 days after the 2nd injection I developed a lemon sized nodule in my arm pit that was mildly painful to touch. This resolved within 3 days.
sick from the shot; Initial information regarding an unsolicited valid non-serious social media case through global digital media received from a patient 07-Dec-2020.  This case involves Adult patient of unspecified gender who was sick from the shot (sickness), while patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site as a prophylactic vaccination.  On an unspecified date, (latency unknown) after the administration of vaccine, the patient got sick from the shot (sickness).  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information regarding the batch number of the case.
Started with nausea, then fever/sweating. Had help getting up to walk and then passed out.  Followed with chills and a temperature of 93. Reaction was from about 2:00AM to 4:00AM
first injection of the Pfizer BioNTech COVID-19 vaccine 2 weeks ago and the only side effect she experienced was some mild pain at the site of injection; I was told we had no side effects at all thank goodness just the sore arm; This is a spontaneous report from a contactable consumer.  A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously had a flu and shingles shot. The patient asked the side effects after the second shot compared to the first in older people. She wanted to known if they need to be monitored more after the second shot. The consumer reported receiving her first injection of the Pfizer BioNTech COVID-19 vaccine 2 weeks ago and the only side effect she experienced was some mild pain at the site of injection that lasted only a day. The consumer reports the pain was similar to what she experienced in the past after a flu shot and a shingles shot. The consumer reported when she was told by people where she received her injection that people react more to the second shot compared to the first, and younger people react more to the injections that older people for side effects like headache and fever. The consumer also stated, "Here is the question, my mother who is going to be 97 and I, who is going to be 70 received the first Pfizer Shot a couple (Covid-19 Vaccine) of weeks ago, we are due for the second shot for next Thursday actually and I was told we had no side effects at all thank goodness just the sore arm. Now I was told for the second shot that you usually do get some kind of side effects, so my question is my mother and I taking a shot at the same time, I live along with her and should I have somebody with me just what are the odds we are going to have side effects from the second shot, I guess that's my question." The outcome of the event mild pain at the site of injection was recovered while other event was unknown.  Information on the Lot/Batch Number has been requested.
Patient came in the office with facial drooping of the left eye and left upper and lower lip. Differential diagnosis of bells palsy. patient was treated with Prednisone 50 mg orally x 1 week, then prednisone 10 mg orally x 2 weeks, valacyclovir 1 gm orally TID x 7 days. Condition has finally resolved 3/31/21, improvement noted. Patient was placed on temporary disability for two weeks, deemed safe  to return to work.
Patient received shot on Fri. then on Sun. had tingling and numbness to face and R arm. Called PCP saw the Dr. who then sent patient to hospital. Patient was in hospital for 6 days with tests being done and treatment. Stated Dr. told her it was a severe allergic reaction. 11/10/09 DC summary and medical records received for dates 11/2/09 to 11/7/09. DX: Somatization, psychogenic paralysis, allergic rhinitis.Pt. presented with c/o rt. sided paralysis. Pt felt it was an allergic rx to H1N1 vax. Assessment: inconsistent examinations at time confusing. Neuro consult WNL.Physical medicine consult WNL. Observed that pt. was symptomatic when spouse was present and asymptomatic when not. Pt dc in good condition.
Extremely sore right arm, swollen underarm lymph node, headache for 3 days, entire body aches, lethargic, diarrhea
Fever, diarrhea, stomach upset. Swelling redness, inflammation, severe itching at vaccination site
Patient became itchy.  Given 25 mg diphenhydramine suspension.  EMS took vital signs and checked BS.  Patient monitored from 10:030-11:05.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On or about 10-SEP-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a health department for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a clinic for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
vasovagal reaction with pre-syncopal episode, diaphoresis following  vaccine administration.
jerking movements involving arms & sometimes legs w/o loss of consciousness; @ worst pt was having 3-4 episodes/day; often @ rest but not asleep; mom observer is a MD;
L arm vaccine site 3 x 4 cm raised erythemia treated with BENADRYL.
headache; migraine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; MIGRAINE (non-serious), outcome "unknown".  Additional information: The patient noticed, after second dose of the COVID vaccine, headache within the hour and it induced a migraine within the same day. That migraine lasted a few days. Also noticed an increase in frequency and duration with migraines and migraine symptoms since after receiving the second dose, and all boosters of the COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arrhythmia. Irregular heartbeat. Heartbeats are visible with shirt on, very pronounced, very inconsistent in timing. This came after a strenuous workout with 30 minutes of running but normally would have a normal heartbeat at this amount of time after working out.
After vaccine administration on 11/4/19, the patient's deltoid muscle became quite sore. The soreness waned over two weeks but worsened significantly on 11/19/19 and still hurts significantly today 11/20/19. The patient denies swelling, redness, should joint pain, fever, chills.