chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case, reported by a consumer, concerning an adult male patient with current medication of Adalimumab, who experienced the unexpected non-serious adverse event of special interest SARS-CoV-2 test positive, reported as COVID-19 virus test positive, in the context of the a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event was not resolved. The co-suspect drug Adalimumab, which is an immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an adult male patient with current medication of Adalimumab, who experienced the unexpected non-serious adverse event of special interest SARS-CoV-2 test positive, reported as COVID-19 virus test positive, in the context of the a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event was not resolved. The co-suspect drug Adalimumab, which is an immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a physician concerning a 16 year old male pt who on 9/12/00 was vaccinated with a dose of Hep-B and subsequently, on 9/13/00, the pt developed bilateral orchitis. The pt sought medical attention and no treatment was given; he was seen for observation only. Additional information has been requested.
From initial information received on 06/25/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 17 year old female patient received a Menomune A/C/Y/W-135 vaccination in the right deltoid on 06/23/04. Two hours later, the patient developed nausea, vomiting and lower back pain. on 06/24/04, she was seen at the doctor's office with continued nausea, vomiting and lower back pain. She was seen again in the doctor's office on 06/25/04, where she continued to complain of nausea and weakness and had a temperature of 100 degrees Fahrenheit. Her vomiting had resolved. She was treated with Advil and advised to increase her fluids. It is unknown if the patient recovered from these events. From additional information received on 08/27/04 from the initial reporter and through a telephone contact, additional patient, vaccine, adverse event and lab information was provided. The Menomune A/C/Y/W-135 vaccination was given subcutaneously in the right arm ( previously reported as intra-muscularly in the right deltoid). The patient also received a Tubersol 5 TU skin test, lot number C1677AA, administered intra dermally in the left arm on 06/23/04. It was also reported that the patient developed malaise and headache after receiving the Menomune vaccine (exact date not reported. The patient's recovery status was noted to be "feeling better." On 08/30/04, a fax was sent to the reporter's office requesting the patient's recovery status. From additional information received on 08/31/2004 from a fax received from the reporter's facility, it was reported that the patient is doing well and has recovered from the adverse reactions. No further information is anticipated, this case is considered closed.
For my second dose, I took extra potassium. I experienced horrible fatigue, had the worst migraine headache which lasted one full day.  I had horrible chills, my temperature was 98.7F and took Tylenol as pain medication.  I did not go to the hospital.  I am still having fatigue that comes and goes when performing my exercises.
Patient given an expired dose of the COVID19 Pfizer Biontech vaccine. Vaccine expiration date was 9/30/2022 and vaccine administered on 10/6/2022. No adverse reactions.
injection site inflamation redness around  injection about the size of a quarter, itchy with raised bumps,  tin taste in mouth, irrated tongue.  severe tiredness.  sore arm.
I had the Pfizer, the first one I just had chills for three days; This is a spontaneous report from a contactable consumer (patient). An 81-year-old patient with unknown gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on 22Mar2021 (at the age of 80-year-old) as dose 1, single for covid-19 immunisation. The patient medical history included arthritis (Verbatim: Arthritis). Concomitant medications included influenza vaccine (INFLUENZA VACCINE) taken for an unspecified indication, start and stop date were not reported.  On 22Mar2021, the patient experienced chills for three days. The patient stated with the first shot got chills four shot on the same day, the patient had the chills for about three days, it was for first three days, and then it was okay. The patient had no other symptoms, and the patient had no other symptoms, and the patient had no swelling of the injection area, or redness nothing the patient did not even feel it. The outcome of event was recovered on 25Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
swollen arm; was feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and FATIGUE (was feeling tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm) and FATIGUE (was feeling tired). At the time of the report, PERIPHERAL SWELLING (swollen arm) and FATIGUE (was feeling tired) had resolved. Not Provided          No concomitant medication was reported.  Patient experienced events after second dose. Events lasted only two days and she was fine at the time of reporting.  No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 contain no new information.
Mom is requesting VAERS done...one month after receiving MENACTRA & 1st GARDASIL on 9/10/08, Pt had blurred vision. 3 months later diagnosed with Type 1 Diabetes.  3/16/09  MR received from PCP including endocrine consult.  Seen for !# yr WCC 9/10/08.  Assessment:  healthy.  PE WNL.  Vax given.  Seen by ophth for intermittant blurry vision with visual acuity OK. Seen 1/29/09 with c/o onset excessive thirst, recent weight loss and increased UO. Reports feeling tired. Dx:  New onset Diabetes Type I after labs. Referred to endocrine. Dx: IDDM.
Info has been received from an RN concerning a 5 year old white male who on 8/25/00 was vaccinated, SC, in the right thigh with a 1st dose of varicella virus vaccine live. On 3/22/05, the pt was seen in the physician's office for break through varicella after exposure to a child with chickenpox. The pt had about 10 lesions. No further info is expected.
Round rash at injection site; Itchy, but not bad.; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the right deltoid on 13May2021 at 11:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included methylphenidate hydrochloride (CONCERTA) 54 mg used for an unknown indication from an unknown start date. The patient previously took tetanus shot (MANUFACTURER UNKNOWN) when younger for unknown indication and had a swelling of site reaction on an unknown date. Prior to 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 vaccine. On 20May2021, the patient experienced round rash at injection site which appeared 1 week post vaccination and it was itchy, but not bad. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events round rash at injection site and itchy, but not bad were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
nausea & itching @ inj site rt upper arm 30min p/vax;bruising 6cm x 6cm w/tender to touch (to date of report);c/o soreness & aching of arm & legs joints started 30min p/vax & cont to date of report;
Headache (80 hours), blurred vision (36 hours), brain fog (72 hours), fatigued (72 hours), chills (24 hours).
1st dose - sore arm - 10 day. 2nd dose - sore arm, tired 1 day. 4/21/21, sore arm, headache, chills, fever, achiness whole body, all joints seized up. 5/4/21 walk in clinic prescribed prednisone. Felt great until it wore off. 5/21/21 General practitioner ordered cyclobenzaprine and meloxicam. order x-ray, MRI, neurologist, rheumatologist, physical therapy. 6 mths of pain
Both arms errupted with pinkish maculopapular rash vaccinated L arm > right arm.  Central clear area with mild scaling
syringe failure. needle was placed into arm. then when plunger was pressed vaccine squirted out of syringe at hub . ran down pts arm and also squirted on chair
Increasing daily dizziness over the course of first and second week.  Third week in and  less frequent and much more mild dizziness.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 23Apr2021 at 16:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any other medical history. The patient had no known allergies to medications, food, or other products. Other medication within two weeks of vaccination was not reported. 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 vaccination. On 24Apr2021 at 14:00, the patient experienced increasing daily dizziness over the course of first and second week. Third week in and less frequent and much more mild dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event increasing daily dizziness over the course of first and second week, third week in and less frequent and much more mild dizziness was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever,  chills to sweats, dizzy, really fast small breaths, full body aches, extreme fatigue, strong headache. This started at 7:30 pm on April 9. Most Side affects went away by morning when I woke up at 5:30 am,  except for sore body and slight headache. Felt much better at 11:30 am with still sore body and even smaller head ache
Flu vaccine given in (L) upper thigh and with 12 hours, (L) upper thigh was swollen pink, warm and tender. Swelling continued and increase from thigh to knee and doubled in diameter from (R) thigh.
sore throat; swollen lymph nodes; chills; feeling unwell; tiredness; headache; joint pain; pain in injection site; This is a spontaneous report from a contactable consumer. A female patient (age: 30, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb201, this morning patient experienced sore throat, swollen lymph nodes, chills, feeling unwell, tiredness, headache, joint pain and pain in the injection site. Patient side effects have not gone away. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old female patient who experienced dizziness, weakness, diarrhea, lost conscientiousness briefly twice, has a feeling of floating, thoughts not clear and cheeks are flushed, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had not known allergies. Her last period was the third week of September. On 10-Apr-2018, the patient received a single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6293DA; expiry date: 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious dizziness, weakness (asthenia), diarrhea (diarrhoea), lost conscientiousness briefly twice (loss of consciousness), a feeling of floating (feeling abnormal), thoughts not clear (thinking abnormal) and flushed (flushing) three-hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No lab data reported. Final diagnosis was cheeks are flushed, thoughts not clear, has a feeling of floating, lost conscientiousness briefly twice, diarrhea, weakness and dizziness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for all the events.
Information has been received from a licensed practical nurse and a medical assistant concerning a patient who on 03-AUG-2007 was vaccinated PO with a dose of Rotateq (Lot # 656838/0968U) then spit up. The nurse mentioned that the infant was given a bottle prior to the administration of the vaccine. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Symptoms started with a "halo" headache and slight upper respiratory congestion.  Second day, headache was gone and a severe sore throat started and lasted for 5 days.  I tested positive for Covid on Sept 5, 2022.  On day three, i went to Urgent Care facility because my sore throat was so severe I could barely swallow and it was hard to eat.  I tested postiive for Covid at the facility.  I was also tested for strep throat, that was negative but the swab swipe was extrremely painful.  The doctor prescribed a five day prescription for Paxlovid which I only took for 3 days as I started to get very nauseous.  I also started a regiment of taking  Advil then switching to Tylonol  every 8 house. I finally tested negative on September 16th.  During the seond week of my illness, the halo headache returned for about 5 days.  It is now November, and I continue to have minor issues such as upper respirtory congetion and coughing from the sinus drainage.
This spontaneous report was received from a medical assistant regarding a 6 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 22-FEB-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L019128, expiration date-27-MAY-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 8F, Time Frame- 3 hours and was back in range. There was no previous temperature excursion before and yes call was because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
14 year old EPSDT/physical on 12/07/11. Dx Cellulitis. Rx DURICEF/capsules 500 mg.
Patient with no prior otologic history presented to clinic 2-3 days after first dose of vaccine with bilateral tinnitus and aural fullness. No associated hearing loss or vertigo.
pt recv vax 24JUN96;pt went limp, pale, eyes rolled back;spontaneous recovery, no obvious sequelae
This spontaneous report was received from a health care worker regarding four patients of unknown age and gender. The demographics were reported. On an unknown date, the four patients were vaccinated with GARDASIL (dose, frequency, product lot#, expiry date, route not reported) that were improperly stored. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Tip of tongue - tingling Narrative:  Famotidine given. HTN hx forgot to take BP meds today: 160/95 P 8 RR 18 97%. No wheezes
Recieved vaccine on 03/11/2021 @ 4:40pm. Experienced Flu like symptoms (body aches, chills, muscle soreness, headache,) also injection site swelling and pain the day after vaccine for entire day (03/12/2021). Flu like symptoms subsided by the following morning (03/13/2021). Woke up the 2nd morning after vaccine (03/13/2021) with a swollen bottom lip on the left side only(no pain or itching, but had a tingling sensation), a  red rash on my neck (no pain or itching) and continued injection site soreness, but much reduced from previous day.
Pt was given the flublok by MA. MA stated he documented the flu immunization but it was not in the immunizations charting. Pt came to different bldg and was scheduled for another flu vaccine. Pt rcv'd a second flu vaccine d/t previous flu immunization not shown in patient's chart.
Patient has experienced continued soreness and stiffness since the vaccine was administered over 3 weeks ago.
Patient reports, fever (slight), Painful lump to injection site x 1 day (since vaccination).
Left arm sore for 3 days; Very tired; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 19Apr2021, the patient experienced left arm sore for 3 days and felt very tired for 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very tired was resolved on 21Apr2021, after the duration of 2 days and of left arm sore was resolved on 22Apr2021, after the duration of 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial consumer report received on 03 Nov 2010: This polymedicated patient with an unknown medical history was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient also received VIVELLE DOT 0.05 mg patch, CIPRO and MUCINEX for unspecified indications since non-reported dates. About one and half month after vaccination, the patient became sick with flu-like symptoms with pain and presented with cough, breathing difficulty and sinus. The patient felt like sinus cold or allergies from outsides and experienced stiffness and chest tightness. The patient experienced full blown episode of a bad sinus infection or cold. The patient was sick and could not seem to shake it. Also the patient lost her voice for few days. The patient also presented with hot flashes. It was reported that medicines are not working. The patient got flashes every 25 minutes. The patient took antibiotics and other cold medicines which did not work. The physician advised the patient to try the patch first. Final outcome of the events was not reported.
pt developed a rash after the administration of Varivax; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. The patient had no known allergies. His medical history and concomitant therapies were not provided.   On 20-NOV-2018, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot # and expiration date were not provided) as immunization. On the same day, the patient experienced rash. The outcome of the event was reported as recovered.   Causality assessment was not provided.
Presented at clinic in AM with raised, dry rash on forehead and arms. Mother stated he had been scratching it and had had for undetermined amount of time. Received immunizations, infant slept off and on in PM and had poor appetite. About 6:30 PM mother noticed redness on cheeks that spread to neck, armpits, trunk and back. At 9:40 PM vomited, brought to local ER. Given prednisone and ___ at ER. 03/09/05, redness gone but bumps remain. 03/17/05, rash gone.
felt dizzy and faint, became pale and sweaty, brought to cot to lay down,  felt better and left on own, VSS