chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Headaches; Feeling sick like a cold; Cold; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 27Apr2021 at 16:45(at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included heart murmur and hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO), hydroxyzine (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all on unknown dates for unspecified indications. The patient had no known allergies to food, medication or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 16:45(at the age of 19-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 00:00, the patient experienced sore arm, headaches and feeling sick like a cold. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, headaches and feeling sick and cold were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Menstrual cycle shortened by a week.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient had no known allergies to medications, food, or other products. 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 did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07May2021, the patient experienced menstrual cycle shortened by a week. The patient reported that her regular cycle was exactly 26 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event menstrual cycle shortened by a week was resolved on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer or other non hcp.   A 59-years-old male patient received bnt162b2 (bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 6207; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 12:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus for about 10 years ago, Back surgery in 2021. Past drug included Lidocaine. Concomitant medication(s) included cefalexin (CEPHALEXINE) taken for an unspecified indication from 11Mar2021 and ongoing. On 17Mar2021, it was reported he had received his first COVID-19 Vaccine, and had an allergic reaction. He said he had a rash all over his body. He clarified his rash had started about 7-8 hours after he had received his COVID-19 Vaccine on 17Mar2021. He said the rash started on the inside of his arms and around his upper thighs and waist last night (17Mar2021). He said today (18Mar2021) in the morning and throughout the day, his rash got worse. He said his rash went down both of his arms and legs, and on his chest and back. Reported approximately 2 weeks ago he had minor back surgery with a local anesthesia. He said he believed the anesthesia was something like Lidocaine for pain. He said he had just started an antibiotic (Cephalexin 500mg capsule) about a week ago (Thursday, 11Mar2021). He stated he had a 14-day prescription for the Cephalexin 500mg capsule with instructions to take 1 500mg capsule by mouth, twice a day. He said he was about halfway through his prescription with 6 more days to go. He said the Cephalexin 500mg was dispensed in a pharmacy bottle with no NDC, Lot, and Expiration Date. It was reported that his saw his doctor today, and his doctor prescribed over-the-counter medications for his rash. He said he was told to take one tablet a day of the Zyrtec and Pepcid AC. He said he was already feeling better since he had taken a dose of the Zyrtec and Pepcid AC. He said he needed to use an eye loop and put the Zyrtec bottle under light, so he could see the product label information better. He said it wasn't that the Zyrtec product label information was really, really, tiny, but that he wanted to make sure he provided the information correctly to the Pfizer agent. His doctor recommended he not get the second Pfizer COVID-19 Vaccine. He said his doctor told him to wait three months and then get the Johnson & Johnson COVID-19 Vaccine shot. Therapeutic measures were taken as a result of rash all over (rash), his rash got worse (condition aggravated). The outcome of the event allergic reaction was unknown, rash all over was recovering , his rash got worse was unknown.    No follow-up attempts are possible. No further information is expected.
Day after second vaccine, I had a slight stomach ache, which worsened as the evening progressed. I woke up a few time during the night of 3/5 and early morning 3/6 with a horrible stomach ache. At about 6:00 in the morning, I couldn?t stand the pain, and my husband took me to the ER. I was found to have acute perforated appendicitis and had my appendix removed.
Information has been received from a medical assistant concerning four patients who were vaccinated with 0.5 ml doses of PNEUMOVAX (lot #655290/0959F).  Subsequently the patients experienced redness, swelling and pain at the injection site.  The patients contacted the physician's office.  At the time of the report, the patients outcome were unknown.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided when available.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  The medical assistant is requesting a lot check.
COVID 19 Treatment; 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 37-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), as dose number (unknown), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Grandmother caught her and laid her down on the  floor as it looked like she was about to pass out. She had a whole body shaking episode that lasted ~ 2 minutes.  She vomited one time.  She does not remember this. After this episode she was groggy for ~15 minutes.  Then she was back to baseline which is achy. She was brought to the E.D.
Vaccine was not diluted before 0.3mL was administered from MDV of 3 doses  No known adverse reaction As of 10/21/23 ~5pm - No reported side effects                          per mother
Confirmed Breakthrough   COVID-19 (Moderna) 1   1/20/2021 Pharmacy Moderna 012L20A   COVID-19 (Moderna) 2 2/16/2021 Pharmacy Moderna 004M20A   COVID-19 (Moderna) 3 03/04/2022 Nursing and Rehab Center Moderna 007J212A
Patient was admitted to hospital for COVID-19 + pneumonia. In ER patient had temp of 100. Patient received steroids and remdesivir. Patient was discharged on oxygen.
Mother states noticed patients right arm was very hard and swollen after picking him up from school today.  Arm swollen to about the size of a "tennis ball" according to mother.  Mother states child is not experiencing any pain and is not have any other signs/symptoms other than itching to the site. Instructed mother to first measure the reaction, then to apply cool compresses for 15minutes on and 15minutes off, and to administer 2.5mL of Benadryl by mouth, every 4-6 hours.   Instructed mother if any worsening signs/symptoms or no resolution is observed after treatments, follow up with urgent care clinic immediately.
This spontaneous report was received from a physician and refers to an unspecified number of female patients of unknown age. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot #, expiration date, exact doses and route of administration were not reported). It was reported that the patients were females over the age of 26 years old. The physician reported, that on unknown dates, there were fewer cases of human papilloma virus (HPV) infection after receiving the full series of GARDASIL 9. No PQC (product quality complaint) was involved. The outcome of HPV infection was unknown. The relatedness between the event and GARDASIL 9 was not reported. This is one of several reports received from the same source. Additional information has been requested.
This study case was received from the investigator on 27 September 2012. A 43 year-old male subject with no reported medical history was found to have "other and unspecified angina pectoris" 16 days after the subject had received an injection of ACAM2000, typhoid vaccine, anthrax vaccine, and hepatitis B vaccine (lot numbers, routes and sites of administration not reported) on 21 May 2012. Relevant laboratory data included: not available Troponin I, not available ECG, not available Echocardiogram, not available MRI (brain, spinal cord, heart) and a not available Lumbar puncture. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
I experienced a breakthrough case of COVID-19 with myalgia, muscle aches, lower back pain, fatigue, and fever.
Patient has had rash and increased fussiness. Patient had rash that progressed to hives. Hives have lasted for 3 weeks. Patient continues to have poor naps.  Overall sleep is improving but parents state that patient continues to be acting abnormally.
Monday pm had very sore arm. Tuesday, I had a temp of 99.9 (my normal is 97.8), all over body aches, and fatigue .   This lasted  24 hours. Wednesday everything was gone except the fatigue. Thursday I was back to normal.  I took Tylenol on Tuesday.
Day of vaccine- buzzing/vibrating headache, fatigue 22 hours after vaccine- fingers went numb, chills, aches, fever and fatigue 6 days after vaccine - skin rash that started on my left arm (not by the shot site) the next day the severe rash spread to both arms, both legs and eventually my abdomen, chest, breasts, neck and side of my left face.
Area around vaccination became red, hard, itchy, hot. Area measured 5cm x 6cm.
Patient received second round of inactivated vaccines s/p allogeneic stem cell transplant on 11/19/2018. Shortly thereafter, patient reports developing worsening shoulder pain and now with some limited range of motion. Aspiration performed under ultrasound today (12/10/2018) to elucidate cause. From site of entry demonstrated by patient after vaccine, concern that IM injection accidentally injected into subacromial subdeltoid bursa.
Patient received second dose of Moderna vaccine on 5/10/2021. Patient had routine lab work done prior to an MRI with contrast on 5/11/2021. Patient reports BUN and Creatinine were elevated. Labs were redrawn on 5/12/2021 and remained elevated. Patient reports she had routine lab work with physical six months ago and labs were within normal range. Patient is under the care of her primary doctor. Her labs will be redrawn on 5/18/2021.
The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.; The patients did not report any adverse reactions; Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (The patients did not report any adverse reactions) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (The patients did not report any adverse reactions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (The patients did not report any adverse reactions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (The patients did not report any adverse reactions) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.).    No concomitant medications were reported.  Dose administered after 30-day Use By Date or after manufacturer date of expiry.  Number of doses/vials were 7 doses/1 vial.  The Healthcare Professional was not knowing the date the vial was initially stored in the refrigerator but stated that vaccines were usually put in refrigerator a week before administration.  The vial had not undergone any temperature excursions.  The reporter wanted to know about the stability of this lot number and recommendation for next steps for the patients impacted due to this.  The patients had not reported any adverse reactions.  No treatment medications were reported.
Client reports on 10/23/2020 developed a red rash on chest and up to neck, had burning & itching with rash.  Client called 10/27/2020 and was advised to be seen by a provider who could exam rash. 10/28/2020 - called client, she reports rash is now also on face and around eyes are slightly swollen, reports chest & neck are improved somewhat. Doctor told her to take Allegra & a prescription cream. Client to call with any new symptoms or othrt problems.
. INJECTION SITE PAIN, SWEATING AND  LOW BLOOD PRESSRE. Patient was given cold pack to apply to forehead and to injection site . pt was feeling better after 5 minutes
Headache, sweating at night, brain fog, light headed started two days after vaccine. 8 days after vaccine I had a big red hot welt the size of a. Baseball on the injection sight - it is itchy and swollen
Initial case report received from a pharmacist on 13 NOV 2009. An 81-year-old male patient was vaccinated i.m with 0.5ml FLUVIRIN 2009/2010 (influenza virus vaccine, batch no. 98448P1) on 12 NOV 2009. Immediately after vaccination the patient became ill and was reported with a blood sugar close to 0 mg/dl. He was admitted to hospital, where his blood sugar was treated and subsequently improved. The patient had recovered at time of this report.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  09/18/2021 Is this your first or second dose- 1st Date of symptom onset - ? 9/18/2021 Symptoms - ? Fever of 101, body aches, and chills Last day of work and shift - ? NA Home remedies- Employee stated she took Tylenol/ibuprofen for fever and body aches Any improvement- Symptoms have resolved Recommendation- Advised to employee to inform us if symptoms return Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns  No  Employee's questions answered to employee's satisfaction -Yes
This spontaneous report was received from a pharmacist regarding a male patient of unknown age with no pertinent medical history and no drug reactions or allergies. ON 22-AUG-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, intramuscular). There were no other suspect therapies or concomitant medications. After administration, on 22-AUG-2013, the patient complained of soreness at the injection site. The outcome of soreness at the injection site was reported as not recovered. No treatment was given for the event.  No laboratory diagnostic studies were performed. The patient sought medical attention by reporting the event to the pharmacist. The pharmacist did not assess the causality between soreness at the injection site and ZOSTAVAX. Additional information has been requested.
Numbness/tingling right arm/hand, numbness right side of face, dizziness, confusion, nausea, vision disturbance, vertigo, headache, lethargy
Within 3 hours of receiving the vaccine, I feel heaviness and numbness both arms and fever, body arches afterwards.  Next morning, I am waking up with fever blister on my lips, diarhhea, cough and cold like symptoms (runny nose, cough, body ache).  I anticipated these might be just side effects for 1-2 days or so.  But then I developed mouth sores and my gum lines were red and irritated.  Fever continues to be on and off, worsening at night.  I've been faithfully taking ibuprofen, zyrtec, drinking a lot of fluid, resting.  Every day since I feel fast heart rate (105 per min)  and develop short of breath feeling chest pain for jogging few seconds when I can usually run fast for at least 1 block with no problem.   I feel like my body is too hypersensitive.
With both shots I had extreme body aches, pains, headache, nausea, chills and fever. I missed a day of work for both shots. Ever since the vaccine, I have had constant joint pain and heart flutters. Shocking pains in wrists ankles, knees and constant pains in hips. I can't run or trail hike any more. Lifting weights like I did a year ago is too painful.
Progressively worse muscle and body aches, shortness of breath upon exertion,  aggressive behavior, insomnia, confusion,
Patient stated  "lips feeling numb and thirsty". RN and EMT were called for evaluation and called onsite EMS. Pt was evaluated by onsite EMS, pulse 75 bpm. Pt released bt EMS at 11:05AM.
4/23/04 - irritated ("cranky"), rash (sl. raised, pinpoint) on tunk and face. 4/24/04 -> 4/28/04 - rash faded, then reappeared, temperature to 101 degrees, lack of appetite, cranky. 4/30/04 - no fever, very irritable, rash continues. Rash gone 5/1/04.
It started fever imidiatley after vaccine, and 4 days later I woke ip at 4 in the morning and my body was just numb, When I went to pull my legs over the side of the bed I just fell straight to the floor. I had to crawl to my roommates door and can barely knot on his door for help. EMS picked me up  My right leg feels like a bag of cement and pins and needles but my left leg is totally paralized and now have dropped foot. Physical therapy gave a drop foot support and can use a walker. I am trying to use a cane but I can't use a cane that well. I'm waiting to see if i can get IgG injection done. I was admitted to the Clinic. on 7/24/22 to 8/22/22  and diagnosed there by Dr. with GBS.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 47-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. No adverse event was reported. Treatment information was not provided.