chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from healthcare professional refers to a pediatric patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2009, the patient was vaccinated with first dose of VAQTA. On 10-MAY-2016, the patient was vaccinated with second dose of VAQTA (inappropriate schedule of drug administration). No adverse event reported. There was no product quality complaint. Additional information has been requested.
LEFT SHOULDER PAIN SINCE 01/05/2022. PER THE  NURSE AT THE PATIENT'S PRIMARY CARE PROVIDER, IT WAS STATED THAT HE IS EXPERIEING NERVE DAMAGE AND THIS TEMPORARY.
Breakthrough case admission after two vaccines Moderna 1/11/21 Lot# 026L20A;  Moderna 2/8/21 Lot# 007M20A
Delayed cutaneous hypersensitivity, I assume. Rash around injection site appeared today, 9 days after dose 1 of Moderna COVID  vaccine. So far just rash. Does not hurt or itch, but just noticed it this morning.
Received IPV, MMR on 8/21/02 and had seizure 8/28/02. Was not initially aware of vaccination but should have reported this earlier. Had 1 day hospitalized and all work ups were negative. Fever of 102 deg-103 deg noted at time of seizure.
severe menstrual irregularity started post vaccination. period has been tracked and regular for 10+ years and now is irregular, painful, and extremely heavy and has resulted in life altering effects
Felt nauseous and light headed immediately after the shot, that faded when i ate 40 minutes later. Got a headache and fever (101) that started 3 hours after the shot and lasted 30 hours.
A 60 year old female experienced transient vertigo and soreness in her arms after receiving her first and second doses of RabAvert and experienced tingling after her third dose. The pt received RabAvert for pre-exposure prophylaxis on 11May04, 18Mary04 and 18Jun04. The pt's medical history included fibromyalgia. Concomitant medication included Norvasc, Advair Diskus, Atenolol, HCTZ/Triam, Neurotin, ASA and Vitamins, which have not been changed in the last 2 years. Approx 9 to 10 days after her third dose the pt experienced tingling in her hands and feet. The tingling was continuous and over the next 5-7 days progressed to her left shoulder, right elbow and both calves. The sensation worsened to the point of waking her up at night. Around July 10th-15th her symptoms improved in her feet and legs and subsequently resolved. Although the tingling in her right arm resolved, the tingling in her left arm continued just above the elbow, especially when she moved or lifted objects.
MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen.; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.   This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193302, 2019SA193303, 2019SA193304, 2019SA193307, 2019SA193306 and 2019SA158240 (same reporter).   This case involves 12 years old male patient with who was vaccinated with 0.5 ml first primary dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 03-Jun-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  At the time of reporting, no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of document held by sender: none.
Headache, Myalgia, Arthralgia & Fever Narrative:  Other Relevant History:
PATIENT WAS LESS THAN 18 YO AND RECVD THE FLUCELVAX INJECTION THAT IS INDICATED FOR 18 AND OLDER. NO RETURN VISIT OF COMPLAINT FROM CUSTOMER.
light chest pain - swelling to l arm no SOB no sweating  pain subsides after few minutes  BP: 155/95  pulse 72 second reading BP: 179/130 pulse 77  CODE CAMPUS ACTIVATED  patient sent to the ER via 911 for further evaluation
This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 2 month old patient (gender not provided) who on 03-JAN-2018, was vaccinated with improperly stored dose of ROTATEQ, orally, lot number: N011648 and expiration date: 01-DEC-2018, (strength, dose and frequency were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1808USA010633: US-009507513- 1808USA010635: US-009507513-1808USA010642: US-009507513-1808USA010637: US-009507513-1808USA010638: US-009507513-1808USA010639: US-009507513-1808USA010640: US-009507513-1808USA010641: US-009507513-1808USA010634: US-009507513-1808USA010636.
Only had sore arm symptoms until 12:30am following vaccine. Woke up at that time very cold and sweaty, noticed body ached terribly, especially in areas I've previously had recent injuries (that had since healed). For next 6 hours this continued, fever of 101 degrees Fahrenheit. Ended up taking an ibuprofen at 5am which was only way to resolve pain.
Redness, extreme inflammation around injection site, and itching that has continued until 3/7
proquad administered intramuscularly; No adverse effect; This spontaneous report was received from a Licensed Vocational Nurse (LVN) via medical assistant referring to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug allergies/ reactions were not reported.      On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection (strength, dose, anatomical location not reported) with lot # S021623 and expiry date 09-JAN-2021, intramuscularly (incorrect route of product administration) for prophylaxis. Co-suspect therapy included sterile diluent (STERILE DILUENT) with lot # S029574 and expiry date 29-MAY-2022. No adverse symptoms reported. No product quality complaint was involved in this report.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
30 minutes after vaccine administered, pt had irregular heart beat (felt like it was going to come out of his chest through his neck). Lightheadedness, and terrible headache.   Skin of chest and stomach were red.   Pt received treatment in the ER, received IV benadryl, IV steroids, and anti-nausea medicine, and IV fluids.   Pt was cold and shaking, couldn't stay warm.  4 days later, patient is still cold and fatigued.
Expired vaccine given. Lot 013F21A expired on 12/24/21 based on date & time removed from freezer to refrigerator storage.
Fever; reaction at site; excessive crying/fussiness; Initial information received on 17-Jun-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves patient of unknown age and gender who experienced fever (pyrexia), reaction at site (vaccination site reaction) and excessive crying/fussiness (crying), while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number UJ214AAA) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever (pyrexia), reaction at site (vaccination site reaction) and excessive crying/fussiness (crying) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No laboratory data reported.  Final diagnosis was crying, vaccination site reaction and pyrexia.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown.  There will be no information on the batch number for this case.
After 1st Shot 4/13/2021 - minor arm pain, then about 3rd week breathlessness and cough, Doctor prescribed Albuterol Sulfate inhalation Aerosol and Benzonatate capsules which relieved the symptoms; After 2nd Shot 5/4/2021 - minor arm pain, followed by more breathlessness and cough and severe and painful cramps in left calves and left hand; these symptoms came and went every other day or 2 through 5/22/2021 when they became severe and I sought medical help from Urgent care 5/26/2021. Referral to Emergency Room - diagnosis Hypertension/Heart Failure. Symptoms occur every other day or 2, additional symptoms severe shivering followed by uncontrollable shaking of right arm and leg and prior symptoms severe
Patient experienced an episode of syncope within 45 seconds of administering vaccine. Patient lost consciousness for approximately 20 seconds. Patient did not hit head or sustain any other injuries. Medical alert response was activated and patient vital signs were monitored until WNL. Patient was taken in wheelchair to curbside for discharge. Patient stated prior to vaccine that he had a history of anxiety and fainting.
Ache at the site of application; joint pain; barely walk; hip pain; back pain; can't even get out of bed and can't even turn when she lay down; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Not reported) 21 days before the second dose for covid-19 immunisation. On an unspecified date, a few days after the second one, she had ache at the site of application but then she felt a little better. After that Friday she got very bad joint pain, she took a pain med, Aleve, and felt better. She still has joint pain and can barely walk. She also had back pain for which she applied Salonpas, and hip pain, stated she can't even get out of bed and can't even turn when she lay down. The patient inquired if was this because of the vaccine. She was wondering if she will have this pain her whole life. Therapeutic measures were taken as a result of joint pain (arthralgia) and back pain. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unspecified date in 2014, unspecified number of patients received unspecified doses of M-M-R II, 0.5 ml once, subcutaneous, (lot/batch number not available) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also GARDASIL, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1406USA000955, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
On my left arm bothers me it is not a pain that I cannot tolerate but it is lot more than I had first day; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (unspecified if Pfizer product), via an unspecified route of administration at left arm in Jan2021 at single dose for COVID-19 immunization. Patient had the vaccine (unspecified vaccine) on Friday on his/her left arm it didn't bother her/him that much very little. patient knew it was there, but nothing happened but after last night patient knew have like it bothers her/him it was not a pain that she/he cannot tolerate but it was lot more than she/he had first day (Jan2021). Patient was taking paracetamol (TYLENOL). Outcome of the event was unknown.  Pfizer is a marketing authorization holder of COVID-19 VACCINE in the country of incident or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 VACCINE has submitted the same report to the regulatory authorities.  Information about batch/lot number has been requested.
A report has been received from a Pharmacist concerning a 31 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 02-JAN-2015. It was reported that patient was inadvertently administered expired FLUMIST Quadrivalent on 02-JAN-2015. The outcome of the event of inadvertently administered expired FLUMIST Quadrivalent was unknown. The report was considered to be non-serious.
Bloody nose, happened after I sneezed after I woke up from a nap, pretty heavy blood flow and didn?t stop, started coming out of both nostrils. The left nosebleed kept going but the right nose bleed stopped after a little while. Kept on bleeding for maybe 8 to 10 minutes as I cooked lunch, I plugged the nostril with a paper towel until it clotted three or four times but the flow still didn?t stop. I used to have nose bleeds frequently when I was a young child but don?t really have them often anymore. After plugging it with a paper towel was not successful, I tried pinching my nose bridge and leaning forward which worked a little bit better but I could tell that the flow hadn?t stopped because the blood and the bloody mucus would collect in my throat and I had to spit it out. I applied a Vaseline like jelly balm in order to moisturize the skin in my nostrils. About maybe around half an hour after my nose bleed started the flow has abated and I am able to do my tasks without having to spit out the bloody clotted mucus that slides into my mouth and throat. I think I have only had a few nose bleeds that I can remember that were as bad as this, probably only two or three. I ate lunch and did not notice a change in my perception of taste. Currently experiencing a very mild headache.
Severe and extensive erythema over injection site (not yet resolved after 72 hours); headache and nausea (starting ~6 hours and beginning to resolve after 72 hours); fevers starting ~18 hours post-injection, peaking at 100.2 F max at 24-30 hours post-injection, and mostly resolved at 72 hours; arthralgias and myalgias starting ~6 to 8 hours post-injection and peaking ~60 hours post-injection; brain fog starting ~6 hours post-injection and peaking ~48 hours post-injection
Rash noted several days after vaccination.  Rash noted to occur to hands and upper chest.  Benadryl taken to help control the rash with some effectiveness.  Rash on chest has resolved now.  Rash on hands noted to persist.  Once Benadryl wears off the rash comes back.  This has occured for 3 days in a row.
In error: Administered 0.1 ml Td ID instead of PPD. Left forearm with 30 mm x 20 mm with 10 mm induration. Mild itch and pain reported.
approximately 2 months after the 2nd dose (May 2021) I began having outbreaks of herpes (cold sores) around my mouth. I have taken several rounds of valtrex oral medication, which reduces the symptoms, but before they are fully healed another one breaks out. It has been about 5 months now, and I have had possibly 10-15 outbreaks on my chin and the corners of my mouth. Each individual outbreak lasts for about 7-10 days, and on about day 7 as one is healing, another one is starting in a different location. I have had cold sores in the past, and these feel similar, however the duration and frequency is much increased.
MMR 6/7/12 c/o right ear/jaw/face pain started on 6/27/12.
redness on arm 6 inches long by 2 1/2 inches wide. redness, swollen like a pancake under the skin. very itchy. hot to touch
Warm, fine, itchy maculopapular rashes all over body, extremities and face two days after flu vaccine was received. (1st time received)
Urticaria, face swelling. 9/20/21 Primary Care visit; hives. Given prednisone injection and 5 day course. 09/27/21 Follow up, hives are back; more prednisone. 10/17/21 ER hives/severe swelling. Given epinephrine. 10/24 ER visit hives/swelling. 10/26/21 Allergist visit. 11/10/21 Allergy testing. 12/13/21 Dermatologist. Diagnosed as Urticaria.  Given several antihistamines and prednisone taper. 12/23/21 Dermatologist visit. Given longer prednisone taper. Told to go back to Allergist to explore Xolair.  01/26/22 have appt with allergist.
May 6 metallic taste within 10 to 15 minutes. Same day: Headache, nausea, arm pain. Around May 17 noticed swollen ankles, developed trash under chin and around neck (like a collar) , more fatigue then usual,  breathing a little worse,  constant neck pain with very increased ridiculopathy, sore throat. Feeling of fullness in my throat. I feel that my lyme and ebv symptoms are worse.
Patient received first dose of Moderna vaccine today at 2:20pm. She was asked to wait in observation area for 30 minutes which went without incident. At 3:10pm husband came into clinic to notify staff was feeling unwell. Recipient was found in car to be alert and oriented X3 but complaining of scratchy throat with difficulty swallowing and  10/10 headache. VS at 3:15pm were HR 78 BP 142/84 and O2 SAT 97% RA.  Patient able to verbalize her condition and able to follow instructions. Denies dizziness or loss of consiousness. Denied nausea, vomiting. Epinephrine on hand but not administered as patient declined and patient was responding to commands appropriately. 911 called and assessed patient at scene. After being assessed in ambulance, patient declined being transported to hospital and signed release with ambulance staff.
22FEB2023 I tested positive for COVID-19 symptoms were scratchy throat and headache I contacted a local HCF and they prescribed PAXLOVID and I recovered in five days but continued to test positive for ten days.
heart flip-flopped; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart flip-flopped) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart flip-flopped). At the time of the report, PALPITATIONS (heart flip-flopped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was provided by the reporter.
At first, I had first body aches. Then, the next few months I could not move my shoulders. Then, my hands got numb.  Then, it went into my neck and back. Then, my whole body hurt. I could not move my fingers. I could not cook, eat, or get dressed. I went to my family doctor. He wanted to do research on it and gave me medicine. It seemed to help a little bit. Then, I went to see a hand specialist. He said to get an x-ray and MRI to rule out arthritis. It shows that my hands had inflammation, swelling, and tightness. He put me back on Prednisone. The MRI came back, I had to go back and get a steroid shot. The other arms and legs have improved but my right hand still is not working right. He completely ruled out arthritis. I am now in the 5th month of this.
The after taste after taking COVID is like rust; 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 patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "The after taste after taking COVID is like rust".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Participant became diaphoretic, hypotensive, bradycardic and lightheaded 10-12 minutes post vaccination. EMT on site assessed participant and ambulance called to site.
I got bruises all over my body, non-stop period (abnormal vaginal and nose bleeding), oral and neck purpura started to appear. I was urgently sent to nearest emergency room and had a blood test. My platelet level dropped to only 5 and I got immediately internalized. I was treated with: Plasma, Immunoglobulin, Dexamethasone 4MG Tablet (10 tablets by mouth daily, total 40 tablets), Sulfamethoxazol-E-TMP DS Tablet (1 tablet by mouth, twice a day, total 10 tablets)
Spots all over the skin lasted for about 2 weeks. Reported by mother of Pt.
Information has been received froma health professional concerning a 4 year old female who on 11/26/1997 was vaccinated with one dose of varicella virus vaccine live (site unknown). Subsequently, it was reported that on 05/16/01, the pt was diagnosed with "a mild case of chicken pox". Unspecified medical attention was sought . Subsequently, the pt recovered. It was reported that in the Spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that vaccine was not given close to the expiration date and that vaccine lot numbers wer not similar in the other cases reported. No further information is available.