chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling muscle tension in the back of her neck that spread up to her eyebrows; it was like a tension headache; discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TIGHTNESS (non-serious), outcome "unknown", described as "feeling muscle tension in the back of her neck that spread up to her eyebrows"; TENSION HEADACHE (non-serious), outcome "unknown", described as "it was like a tension headache"; DISCOMFORT (non-serious), outcome "unknown", described as "discomfort". Therapeutic measures were taken as a result of muscle tightness, tension headache, discomfort. Additional information: The patient experienced 7-10 days ago, began to feel muscle tension in the back of her neck that spread up to her eyebrows. She stated that it was like a tension headache. The patient has been taking Motrin to treat the events, the headache goes away but then returns. Patient reported that she had a friend who went the same day as her to get the vaccine and she reported the same discomfort. The patient was scheduled to get her second dose of the Pfizer Covid vaccine on 28Mar20201 and wanted to know how long to expect this side effect to last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021337114 Same reporter, suspect drug and events; different patient.
On 02/14/2023, I felt fine in the morning. I had a runny nose, but nothing more than that. Around 02:30PM, I began feeling feverish. I was able to get into a local clinic by around 05:30PM. I was tested for flu and COVID-19 and was positive for COVID-19. They prescribed Paxlovid. My fever got up to around 102 degrees. I had extreme fatigue and would sleep any time I closed my eyes. They runny nose persisted for a few days. By the third day, I was still fatigued, but was feeling better. I developed a cough in my upper chest which lasted around a day. For around five days, I felt dull. I self-isolated for five days and wore a mask when I went out for four or five more days after that.
On 11/17/23 I experienced a slight fever, fatigue and weakness throughout the day.  On Saturday evening 11/18/23  and during the day on Sunday 11/19/23, I experienced rashes on my arms, legs and trunk in the form of red, itchy spots and raised areas that had not blistered. In addition, I experienced swelling and numbness in my lips.  The swelling in my lips lasted un til Monday, 11/19/23.  I was able to manage the condition through topical application of Benadryl on my skin and through taking Benadryl orally.  On 11/19/23 I was prescribed Prednisone 20mg, to be taken daily for 5 days, and loratadine 10 mg, to be taken daily for 30 days.  The symptoms have abated.
I woke up with a sore throat on Tuesday and I took a COVID-19 test and it was negative but was experiencing congestion, runny nose, and sore throat and draggy just a little tired. On Thursday I had the same symptoms plus a headache, and again I took a COVID-19 test and was negative. On Friday I still had the same symptoms but wasn't tired and tested again and I was positive. That is when I called my doctor and she prescribed Paxlovid for 5 days and I took my first dose that day and immediately went to quarantine and Sunday night I had a great deal of coughing from 1AM to 6AM while I was in bed and that went away after that one bad time. As of right now a week later I am mostly symptom free, I have a desire to cough but cough every once in awhile and have 1 dose left of the medication and have test negative today.
3 days after influenza vaccine 7am, red, itchy flare around site, some swelling.
Injection site presented as a Lyme Bullseye the size of a half dollar on day 3. Then outer red ring blistered with some breaking and scabbing over. Coloring faded over time and blisters went away after a week or  two. But as of today the site painful to touch like a bruise and I can still feel weird skin in the circular area.   Did nothing but monitor but wonder how many others with Chronic Lyme (which the CDC still says doesn?t exist) had this weird reaction.
Information has been received from a physician concerning a 5 year old male who on 30-Aug-2007 was vaccinated with a dose of PROQUAD (Lot #658033/0986U).  On 08-Sep-2007, 9 days after vaccination, the patient developed a vaccine rash.  Unspecified medical attention was sought.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Pt vaccinated on 3/28/21 and 4/25/21. Covid positive on 7/27/21. Runny nose, congestion, dry throat
30 hours later, headache starts, arm ache at site, body aches, no fevet, virtigo, body chills, shaking, diarrhea,  dizziness,  discomfort, joint aches, runny nose, hearing got worse. Loss appetite, no eating. I drank water andtook one 300mg tylenol anout every 8 hours to reduce pains and aches. It helped some.
This spontaneous report as received from a patient's wife refers to a 66 year old (at the time of the report) male patient. The reporter stated that on an unknown date in 2009 (reported as "when he was 61 years old") the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose not reported). No concomitant medications were reported. On an unknown date in 2011 (reported as "when he was 63") the patient developed a case of shingles. The reporter stated that the case of shingles her husband had lasted 6 weeks. The outcome of developed a case of shingles was reported as recovered/resolved. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a medical assistant concerning a 18 months old male child patient. Pertinent medical history or drug reactions/allergies were unknown. In approximately September 2011, the patient was vaccinated with one and only dose of VAQTA 25/0.5 (unit unknown) (intramuscular, lot number was 670835/0628AA, expiration date 13-MAR-2014). On the same day, "within a few hours" of being administered this dose of VAQTA, the patient presented to the emergency room with a high fever, a generalized rash, and angioedema. The patient was treated with BENADRYL and steroids and was released from the emergency room that same day, a few hours after these symptoms completely resolved. The patient was never admitted to the hospital. This medical assistant noted the physician associated with this Adverse Event (AE) requested a lot check for this dose of VAQTA. The causality between VAQTA and high fever, generalized rash, and angioedema were not provided at time of reporting. Additional information has been requested. Lot number 670835/0628AA has been verified to be a valid lot number for VAQTA.
Administered invalid dose; she tried to administer a dose to a patient, certain dose leaked out of the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Administered invalid dose) and ACCIDENTAL EXPOSURE TO PRODUCT (she tried to administer a dose to a patient, certain dose leaked out of the syringe) in a 30-year-old female patient who received mRNA-1273 (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Administered invalid dose) and ACCIDENTAL EXPOSURE TO PRODUCT (she tried to administer a dose to a patient, certain dose leaked out of the syringe). At the time of the report, INCORRECT DOSE ADMINISTERED (Administered invalid dose) and ACCIDENTAL EXPOSURE TO PRODUCT (she tried to administer a dose to a patient, certain dose leaked out of the syringe) outcome was unknown.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Reporter said that after she tried to administer a dose to a patient, certain dose leaked out of the syringe.   No concomitant medication was reported.                   No treatment medication was reported.
SHORTNESS OF BREATH; LEG SPASMS; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced shortness of breath, leg spasms, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, shortness of breath, and leg spasms. This report was non-serious..
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 21-year-old male patient 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 at 1:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 1:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.   The age of patient was provided as 21.23 years. No concomitant medications were reported.  Batch number 007C21A underwent temperature excursion on 27-Apr-2021 with temperature 35 degrees Fahrenheit at 09:00 AM. The vial was initially moved to the fridge on 19-Apr-2021 and proposed beyond use date was 19-May-2021. Product moved to clinic on 27-Apr-2021. 8 vials were sent to clinic. 42 doses given for the day. 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).
This study case was received from the investigator in a trial on 16 March 2013, with follow-up information on 21 March 2013. A male subject (age and birth date not reported) with no relevant past medical history, (also reported as distant history of Hodgkin's Lymphoma) developed possible myopericarditis, five days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported); and concomitantly, ANTHRAX, manufacturer unknown (lot number, route, site and side not reported) on 25 October 2012. On 30 October 2012, five days post vaccination, the subject developed possible myopericarditis, considered mild in severity. The subject reported a single episode of mild chest pain and pressure while seated for 20-30 minutes, in the absence of other symptoms. Rapid Troponin I was reported as normal on unspecified date. On 01 November 2012, central lab Troponin I was reported as less than (<) 0.10 ng/mL and an electrocardiogram (ECG) reported as normal. The subject was referred for medical follow-up (also reported as unable to reach subject for information about referral). No treatment medications were prescribed. No concomitant medications were reported. The stop date of possible myopericarditis was reported as resolved on same day, 30 October 2012. The subject was reported as recovered, resolved on 30 October 2012. According to the investigator, the event of possible myopericarditis was considered an other important medical event and possibly related to the trial product. Documents held by sender: Medical Record.
Patient presented to clinic on 6/7/2021 stating he was here for a 1st dose of a Covid-19 vaccine. A Janssen covid-19 vaccine was administered to the patient on that date. On 10/29/2021 patient returned to clinic for a Moderna booster where it was discovered that the patient had received 2 doses of Moderna's covid-19 vaccine on 3/7/2021 and 4/5/2021 at a local pharmacy. A booster dose was not administered to patient by CDC guidelines.
Hep A given at 9 months old - vaccine approved for 12 months and older.  No health symptoms or signs at this time
After the second vaccine, my right arm fingers get numbed, at first I thought I had slept on my arm, but then I noticed that it would also happen when awake. Never the left arm only right where I got my shot, is something I never experienced before, so am guessing it has something to do with the vaccine, this morning my fingers were extremely numb, I am thankful for the vaccine but angry as well that I we don't know the consequences of taking it.None
She had a 100.5 F temperature for a couple of days; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (She had a 100.5 F temperature for a couple of days) and VACCINATION SITE PAIN (Soreness at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (She had a 100.5 F temperature for a couple of days) and VACCINATION SITE PAIN (Soreness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (She had a 100.5 F temperature for a couple of days) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: 100.5 (High) 100.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 25-JUN-2015 was vaccinated with a dose of GARDASIL lot # K006960 (dose and route were not provided) which were exposed to temperatures outside of the recommended range during 63 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
HEADACHE, GENERAL ACHINESS, ARM SORE:  REPORTER INDICATED "WILL CONTINUE HEP-B SERIES...DO NOT CONSIDER REACTION VERY SIGNIFICANT...FEEL BENEFITS OUT WEIGH THE RISK."
Joint pain; achy, throbbing; Tingling in hands, feet, arms, knees; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route, administered in arm left on 15Mar2021 at 02:00 PM (age at vaccination was 25 years) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. Facility type vaccine was other. No other vaccines were received within four weeks prior to the administration of bnt162b2. Medical history included hypothyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID), paracetamol (TYLENOL); both taken within two weeks for an unspecified indication, start and stop date were not reported. The patient previously took zithromycin (Z-pack) and experienced allergies. On 22Mar2021, the patient experienced a lot more joint pain since first dose (achy, throbbing, tingling in hands, feet, arms, knees). Adverse events resulted in visit to doctor or other healthcare professional office/clinic visit. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Swollen throat; Feels her body is swelling; No energy; Her stomach hurts every time she eats or drinks; Gaining weight even thought she is not eating; A spontaneous report was received from a consumer in the concerning a 65-year-old female patient who experienced swollen throat/MedDRA PT: pharyngeal swelling, no energy/MedDRA PT: asthenia, feels her body is swelling/MedDRA PT: swelling, stomach hurts every time she eats or drinks/MedDRA PT: abdominal pain upper and gaining weight even though she is not eating/MedDRA PT: abnormal weight gain after she was administered mRNA-1273 vaccine   The patient's medical history includes kidney transplant. Concomitant medications include (2) anti-rejection medications, high blood pressure medication, cholesterol med and vitamins NOS.  On 11-Feb-2021, five days prior to start of symptoms, this patient received their first planned dose of mRNA-1273 solution for injection (Lot/Batch number: 031l20a) in her right arm for prophylaxis of COVID-19 infection.   On 16-Feb-2021, this patient developed swollen throat and has experienced no energy, her stomach hurts every time she eats or drinks, is gaining weight even though she is not eating and feels her body is swelling. She was tested for covid-19 and for white blood cell count, results are pending. The patient is scheduled next week for her second dose and wonders if she should wait.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome for the events, swollen throat, no energy, feels her body is swelling, stomach hurts every time she eats or drinks,and gaining weight even though she is not eating were not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
p/vax pt exp chickenpox described as water blisters;pt devel a red rash on legs, arms as well as blisters in mouth;also exp vesicles on throat, hands & feet;had a fine maculopapular rash on extremities;
After first dose I experienced severe L shoulder pain for 2 days. Couldn't move it well, could not sleep on it. Pain started 4h after injection.  After second dose I started experiencing L shoulder pain after 40 minutes. Pain was so severe I could not put my hand into the packet. In the evening the same day I started running temperature 101F that last 3 days non stop. I started experiencing severe chills, could not stop at times shaking! I was hot and cold every so often. I started experiencing same evening severe body ache which was constant and felt like I was squeezed by some machine. I could not sleep, I felt just terrible,  couldn't find comfortable position. My heart beat resting was 110 per minute and it stayed like that first night. My normal resting pulse is 60-70 bps. I did not have headaches or nausea. At night everything felt worse. After 3 nights temperature subsided but I was exhausted and my temperature dropped 95.9F my normal temperature is 97.88F. ( 36.6C) . Since April 2nd I have been tired and I want to sleep all the time.
Fever 12 hours after vaccine given which lasted 5 days inflammation of arm, rash, redness, hot and hard treated with antibiotics and nausea medication.
Pt received his second dose of MCV4, after administration pt fainted and had a seizure. Pt was not responding to this nurse verbally. Dr was called and assesed the pt. Pt was then alert and oriented X3. Dr ordered some tests and blood work. BP was checked 127/72 P 72 RR 20, BP 116/67, P 70 RR20. Pt left the clinic on stable conditions with dad.
Pt was inadvertently administered a dose of Hep B instead of ACT-HIB along with PEDIARIX.
Changed to menstrual cycle: unexpected menstrual bleeding associated with cramps, not expected (14 days in advanced). I have always had an almost extremely regular cycle.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX. On 19th September 2018, immediately after receiving SHINGRIX, the patient experienced general body pain, pain in arm, sleeplessness, chills, headache, diarrhea, fever, feeling hot and feeling cold. The patient was treated with ibuprofen. On an unknown date, the outcome of the general body pain, pain in arm, sleeplessness, chills, fever, feeling hot and feeling cold were unknown and the outcome of the headache and diarrhea were not recovered/not resolved. It was unknown if the reporter considered the general body pain, pain in arm, sleeplessness, chills, headache, diarrhea, fever, feeling hot and feeling cold to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on right arm. The wife of the patient called to report that after her husband had the injection, he started to experience the side effects throughout the day. The body ache began right away in his arm and then spread throughout the body. Within eight hours, he started having diarrhea. Twelve hours after receiving the vaccine, he started having a fever, chills and a headache. She stated that he would go back and forth with being hot and cold. He took some ibuprofen for the body aches and headaches. He still had diarrhea and the headache, but both were not as bad as they were yesterday. He was unable to sleep last night because of the side effects. The wife called his physician this morning for advice on what to do about the side effects.
reported COVID negative 4/14 where he was admitted for myocarditis 3 weeks after COVID-19 vaccine.  F/U with cardiologist on 4/28 with diagnosis of myopericarditis.
Today (1) high heart rate while resting (normal 70) was at 100-110. Sat Levels dropped to 90% (while resting). Slight walking would elevate heart rate to 130. All over body pains and tiredness. Sat was not sustained at 90%, would fluctuate to 96% (all readings while resting) my normal readings are 99-100.