chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a currently 17-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # R002344, expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA001303: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA007947.
pt received first dose pfizer vaccine, was nervous, did not wait and went to the bathroom and became dizzy, but he made it back to the pharmacy without falling or injuring himself. had him lay down with feet elevated and gave water. he waited an additional 15 min, was fine and left home. recommended staying 30min after 2nd dose
Given 0.5 ml TDAP in (R) deltoid IM, 0.5 ml MENACTRA (L) deltoid IM. Pt slumped over 30 seconds after 2nd vaccine, was unresponsive with a few body jerks x 20-30 seconds. Became aware but argumentative for 1 or 2 minutes.
This patient initially had 2 doses of the Pfizer COVID vaccine- on 3/29/2021, and 4/21/2021 She chose to get Moderna as her 3rd/booster shot She has never been diagnosed with COVID-19  She presented to the hospital 12/20/2021 with chest pain, dyspnea, arthralgias- had elevated troponin, reduced EF on ECHO with global hypokinesis- diagnosed with myocarditis. This was presumed from the Moderna vaccine- no other cause was established.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.
Initial symptoms - double vision and drooping eye-lid. Diagnosed as Myasthenia Gravis by blood test. Over two months, symptoms have gotten severe. Severe double vision. More generalized muscle weakness. Choking, and some difficulty swallowing.
Patient words: per MOC has a reaction to a vaccine he got 2 days ago. The patient is a 12 year, 5 month old male who presents with an allergic reaction. The child is an established patient. The patient presents with mother. Symptoms include other (localized swelling and redness). The rash is located on the arm(s). The rash is described as red, raised and swollen. Onset was 2 day(s) ago. Onset followed other (vaccine injection). Symptoms are described as worsening. The patient is not currently being treated for this problem. Note for "Allergic reaction": patient has redness, swelling and warmth on his right deltoid the area is 10.5 cm in width and 9 cm in height has progressively enlarged since he got his mining vaccine on the site 2 days ago, the reaction is localized denies any respiratory distress, no rashes, no hives, no oral swelling, or difficulty swallowing, (note; reported to VAERS System) by staff. Area is itching. No vomiting. Denies any prior reactions to any vaccines. Mom does report that patient has significant skin reactions to things like bug bites.
Mom stated that PM of 4/27/06, pain, redness, tenderness and hardened area on thigh "that rec'd 2 shots", limb swelling, started 4/28/06-"from hip to knee". Taken to ER by father with concerns on 4/29/06. Placed on antihistamine and ABX. Child better on 4/30/06 per mom. As of 5/2/06, child "fine".
Client received flu vaccination at 9 AM in the morning on 2/9/18. She starting having itching and throat swelling at 5 PM that evening. She took 3 separate doses of BENADRYL during the night and the next morning. By noon, 2/10/18, she was not better and her throat was swelling more. She called EMS who transported her for treatment at Medical Center. The emergency room prescribed ATARAX and PEPCID. The medications help with itching and swelling, however, she is still having itching and swelling on 2/16/18 when the medications wear off.
I received the vaccine on Nov 5th at 8:30 AM.  At 9:15 PM on November 6th, I had an episode of severe dizziness. What I was looking at was percieved to be spinning rapidly as if on a disc. Standing was impossible.  This has continued through today, Nov 15, 2002, although slightly letting up in intensity. The percievd motion now is a back and forth rather than a spinning disc. It is most prevalent in the morning and evening when getting up or laying down, although it does occur during the day, but less intensly.  Additionally, there is a constant, but low level, sense of dizzyness (although no spinning is associated with this)-- similar to a "light headedness" sensation.
Loss of eye contact, words, repetitive odd behaviors, crying, sick, diarrhea. Pt was given 18 vaccines until 18 months. Pt was born with a twin-his sister is NT. At birth swallowed fluid-mild pneumonia- given antibiotics and Hep B- another Hep B 2 months later- more vaccines- MMR, Flu, chicken pox all given 11-3-06. (5 vaccines in total notice next month patient lost all skills, words, etc...   7/21/09 Medical records received DOS 11/14/05 to 6/20/08. Assessment: Not verbal. Patient presented with coughing, wheezing. Speaks single words. Reluctant to make eye contact at times. Later not verbal / sign communication. Blisters in mouth - apthous ulcers. Fever. Autism (per mother).
Flushed, Sweating, decrease drastically in HR, and almost passing out. Treatment with icepack on nape of neck, cold water and frequent HR checks with observation. Time allotted for patient to return to normal state was 34 minutes.
Presented to ER on 12/6/21 and admitted. 77-year-old male, retired physician with past medical history with anemia, asthma, atrial fibrillation, Chronic systolic CHF, status post aortic and mitral valve replacements, status post pacemaker for high-grade heart block, diabetes mellitus, hospitalized since 12/06/2021 for worsening shortness of breath, diagnosed with COVID-19 pneumonia.  He has been vaccinated against COVID-19 twice. Patient has completed course of Decadron, remdesivir and antibiotics. He has been transitioned to the floor since 12/17. He developed what appears to be asymptomatic ventriclar tachycardia on telemetry but asymptomatic. He was seen by cardiology; no significant of VT confirmed, probably a-fib with abberantly conducted beats and some runs of paced rhythm with wide-complexes.  He remains on beta-blocker.  Discharged on 12/2021
Information has been received from a registered nurse concerning an approximately 80 or 90 year old immunocompromised female who was in the same room where the other residents of the retirement community were vaccinated with a dose of Zostavax (Oka/Merck). It was reported that the patient had spouse of contact (s) who lived in the independent residences within the community and who were vaccinated with a dose of Zostavax (MSD). The patient was not vaccinated with the vaccine. On approximately 09-OCT-2007 the patient developed shingles and had lesions on the back of the scalp. The patient was treated with valacyclovir hydrochloride (VALTREX) but the scalp area got infected and was draining so the resident was sent to the hospital. The patient was put on IV vancomycin. At the time of report the patient had not recovered. The patient's experience was considered to be an other important medical event and disabling by the reporter. Additional information has been requested. This is one of several reports received from the same source.
Fever, body aches, sweat, headache, exhaustion, nausea, diarrhea
Pt came in asking for the flu shot and covid vaccine, but only wanted flu shot that day. He received covid 19 booster instead-- per pt he experienced body aches that evening
Information has been received from a physician concerning a female with unspecified reported drug reactions/allergies with Behcet's Syndrome and a history of colitis, who in late April 2009 (approximately 30-APR-2009), was vaccinated with ZOSTAVAX (Oka/Merck) (route and lot number unspecified). The physician stated, the patient developed "pericarditis CHF", 2 weeks post vaccination of ZOSTAVAX (Oka/Merck) and she was hospitalized (hospital demographics and dates unspecified). The patient sought medical attention with her physician. The outcome of the patient was unknown. No further information was provided. Additional information has been requested.
About 30 min post vaccination got a call from staff members. Employee waiting to clock in sitting in Bistro. C/o numbness back of throat, dizziness, lips and mouth burning. Weakness bilateral leg.
This is a spontaneous report from a contactable Physician via Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling and pain where he had given the injection on an unspecified date and it lasted like a month with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Noticed rash on 9/16 on upper part of arm that she received flu shot-no itching just redness.
PATINET WAS GIVEN AN INJECTION AROUND 11:00 AM.  PATIENT STARTED HAVING SEIZURES THAT NIGHT A A FEW MORE SEIZURES FTER THAT ENDED UP IN HOSPITAL FOR WEEKEND.
10:05  PT C/O ITCHING AND REDNESS ON RIGHT HAND AND FOREARM.  PT STATES HIS NOSE FEELS CONGESTION. 10:11 PT DENIES ANY SHORTNESS OF BREATH 10:15 AM PT STATES HE CAN DRIVE HOME AND WILL TAKE SOME BENADRYL
Received phone call from pt's mother on 11/6/03 at 11:50am. She reported pt's left upper arm significantly red, some swelling, hard to touch at vaccine site. Redness extended shoulder to 1" above elbow, sensitive to touch but no complaints of pain otherwise, activity wnl.
Arm that had shot got extremely sub burnt from driving home with window down, fever 100.6 for 12 hours, extreme fatigue and chills. Very swollen lip where cosmetic fillers were injected 9 months ago
Employee received Pfizer booster 10/19/21. Employee states her mentrual period had just ended before the vaccine was given.   10/23/21, mentrual cycle resumed. Employee complaining of unusual heavy flow which has not stopped since.
Information has been received from a nurse practitioner concerning a female who on 02-APR-2007 was vaccinated with a first dose of Gardasil. On 02-APR-2007 the patient experienced soreness at the injection site. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Inflammation of arm where injected. A lot of arm pain day after vaccine. Little nausea. Very tired. Night sweats.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA308949 (same reporter). This case involves Adult patient (age and gender not reported) who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (Lot number: UT6258MA and expiry date: 30-Jun-2019) (dose in series, route and site of administration were not reported) on 05-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to incorrect product storage because the vaccine thawed out in the refrigerator door and kept their freeze at 31.0F-32.0F. It was unknown if any adverse event occurred or not following the vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
soreness; Headache; Chills; mild fever; body aches; pain in major joints; fatigued; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (soreness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (mild fever) and MYALGIA (body aches) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE PAIN (soreness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (mild fever), MYALGIA (body aches), ARTHRALGIA (pain in major joints) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-May-2021, VACCINATION SITE PAIN (soreness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (mild fever), MYALGIA (body aches), ARTHRALGIA (pain in major joints) and FATIGUE (fatigued) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took 2 dosed of Tylenol.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-181504 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
costumer calling to ask about what to do if a patient is late to get seconded dose of gardasil 9; This Spontaneous report has been received from a pharmacist regarding a 31-yeard-old female patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, frequency, route, lot # and expiration date were not reported). The reporter wanted to know what to do if the patient is late to get the second dose of the vaccine and also wanted to know if the patient needed a different series due to the patient's age.
Course started 8/8/17. Patient started complaining of headache after dose 2 (on day 3) that responded to ibuprofen. After dose 3 (day 5) complaint of headache returned - more severe this time. On day 6, developed low grade fever (approx. 100 F) and vomiting along with stomach aches and muscle aches.
Began as two small red dots at injection site and grew into a new extremely red, sensitive, hot patch the size of a fist. It looked as though her leg had been scalded.
Admitted (again) on 9/8 with brady cardia, A Fib with slow ventricular response, and found to be COVID_19 Ag POS
1. Dose 1:  - Fire/burning sensation in to arm when injected - Tender to the touch for 1 week following injection - Flu like symptoms, temp, chills, sweating - Next day extreme fatigue - 1 week following - subcutaneous itching at injection site and down to wrist. There was no rash, not red marks, no blemish, the itching felt like it was within my tissue. Course was moderate and not constant, it would come and go and last about 30 days.  1. Dose 2:  - no burning sensation when injected - Tender to the touch for 1 week following injection -Next day extreme fatigue - no itching until recently (I felt the same subcutaneous upper arm itch at injection site this week and  I feel it again today. -yesterday I woke up and there was a red 3 inch diameter circle on my stomach and it has 6 red lines radiating outward. It almost looks like a paw print and it was not itchy. It went away after I put aloe on it. I mention this because it is strange that the subcutaneous arm itching cam back and then the next day I woke up with that strange paw print pattern
Several hours after the vaccine, eyes were burning, arm very sore.  Woke up during the night with chills, body aches, nausea.  Woke up in the morning later than usual, was unable to go to work.  Felt like I had been run over by a truck.  Took 1 advil in the middle of the night and 1 in the morning.
Extraordinary chills and body shakes, painful joints, burning sensation of skin all over, fever of 103.6, slight nausea - all lasting 12 hours and then subsiding.
EYE BEGAN TO CLOUD, PATIENT FELT WEAK, DIZZY, WITHIN 3 HOURS OF RECEIVING PREVNAR 13 INJECTION, SIGH IN 1 EYE COMPLETELY GONE.  MD SPECULATES A CLOT BLOCKED BLOOD SUPPLY TO EYE, LEADING TO RETINA FAILURE AND LOSS OF VISION.
Rash on arms, legs, shoulder, neck and legs. Took antihistamine to reduce itching.
I am a woman who has PCOS. My cycle is extremely inconsistent and never last more than a day maybe once every year or 2. Two weeks after my 2nd dose of the Covid vaccine I started my menstral cycle , experiencing cramps, discomfort, pressure in my uterus, blood clots daily, and so far it?s been for 8 days. I am not alarmed yet because I understand this might be natural but I am documenting this because it is out of the ordinary in my unique case.   I also experienced what seemed like a stomach flu for about 2 days On the 6th and 7th of June. Experiencing diarrhea, nausea, no fever, but heavy fatigue. I no longer feel sick but my period is still active.
Skin rash on day 3 this report was done on day 4. Rash is still their.
Subsequent to receiving vax, the pts right upper arm red from shoulder to elbow with no pain or swelling. The next day the redness subsided in the upper arm and went to lower arm with evidence of water under the skin (not blisters).Subsequently the pt recovered.
headache, nausea, loss of smell, gastric upset...patient tested positive for covid-19  on 09/03/21...this patient recieved  Janssen  told us it was her first dose, she had recieved a dose of moderna on 3/05/21
Erythema, warmth, swelling left upper arm <24 hours after  dT administered.
Debilitating headache; chest hurts; kidneys hurt; stuffed head (but dry stuffed head); balance issues; extreme fatigue; eyeballs BURNING; body skin warm (no temp) BUT bones freezing and aching; body skin warm (no temp) BUT bones freezing and aching; body skin warm (no temp) BUT bones freezing and aching; Dose Number : 3; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FH8028), via an unspecified route of administration, administered in Arm Left on 03Nov2021 12:00 (at the age of 65-year-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included hypothyroidism, drug hypersensitivity (known allergies: I avoid sulfa drugs). Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 15Apr2021 (at the age of 64-year-old) as dose 2, single and received dose 1 (Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (at the age of 64-year-old) as dose 1, single for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. On 04Nov2021 at 04:00, patient experienced debilitating headache, chest hurts, kidneys hurt, stuffed head (but dry stuffed head), balance issues, extreme fatigue, eyeballs burning, body skin warm (no temp) but bones freezing and aching. Patient did not receive any treatment for adverse events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Pt developed an injection site reaction characterized by pain and redness.  Received unspecified treatment from a physician and recovered.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-533734, MOD-2022-534186, MOD-2022-534194, MOD-2022-534279, MOD-2022-534307, MOD-2022-534308, MOD-2022-534309, MOD-2022-534377, MOD-2022-534378, MOD-2022-534379, MOD-2022-534400 (Patient Link).
01/05/2007 3:30 - complain of reaction to vaccine given on Wednesday 01/03/2007 x 3" noted 9 1/2 cm red circular area on left anterior thigh. Also noted inner circle of 3 cm, red rash. Mom states "Baby has increase temperature - 99 - 100". Cold compress was applied as advised. 01/05/2007 Advised to take baby to see MD.
high fever over 104 degree , body aches, strong/ severe headache, nausea body chills , lasted over 2  weeks and body aches and headache for another week and half . took Tylenol extra 500 mg and ibuprofen 800 mg every 4 hours. then called for medical advice and was seen by a health Care professional. took couple of IVs and meds at the clinic which helped a little. I I'm still not feeling well the back pain and chills always here. Don't have full energy to perform any small work and i'm loosing lots of hair.
Pt has had body ache and pains since injection. These include scalp (combing hair causes pain), back of neck, shoulders and arm (deltoid area mostly), chest, back (pain when lying down), legs (lower more than thighs), rectum and scrotum.