chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to a 16 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 05-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
I had a sore throat, upset stomach, headache, chills & fever.  I vomit until my stomach was empty.  Felt achy all night, & this morning. I could not go in to work.
Patient reported to me that she has had extreme soreness in her injection arm ever since she received the vaccine.  (2 1/2 months) She said it is so severe she can't lift her arm to dress herself.  She saw her doctor about it, and he told her he thinks I hit a nerve when I administered the vaccine and that it will resolve itself over time.
DURING VACCINATION, ADMINISTRATOR SEEMED RUSHED. PUSHING PRE-SCREENING PAPERWORK IN ORDER TO BEGIN VACCINE PROCESS. ADMINISTRATOR DID NOT CLEAN AREA WITH ALCOHOL PRIOR TO ADMINISTERING TYPHOID, ANTHRAX BOOSTER, AND SMALLPOX. WAS BRIEFED THAT SMALLPOX VACCINE WOULD CONSIST OF 15 SMALL PRICKS, BUT SEVERAL OTHERS WERE ADMINISTERED. " WITHIN SEVERAL DAYS, SWOLLEN GLANDS UNDER SMALLPOX ARMPIT WITH ACHY FEELING AND STREAKING. SYMPTOMS PROGRESSIVELY WORSENED OVER TIME. SAW MEDICAL PERSONNEL FOR STREAKING AND WAS SENT TO ER. WAS ADMINISTERED VANCOMYCIN (2 GRAMS) VIA IV WITH PERSCRIPTION FOR CLINDAMYCIN 150 MG 2 CAPSULES EVERY 6 HOURS. (# 56 CAPSULES) MAINTAINING FOLLOW UP WITH MEDICAL DOCTORS EVERY 2-3 DAY IN ORDER TO MONITOR SITE AND TREATMENT PLAN.
Patient has a history of thrombotic thrombocytopenia purpura. Last flare in 2019. He had a flare of TTP about 7 days after his second Pfizer COVID-19 vaccine.
Hours after the shot, I experienced soreness in my right arm requiring pain medication to sleep.  The next morning, I have experiencing mild flu-like symptoms and diahhrea.
ran temp 104 gave APAP & cried for 6 hrs p/shot; taken to ER & adm to ped unit for 12-16 hrs; fever came down & was released;
General body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US187443_NS (Novartis).  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 09Oct2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization; Bnt162b2 (Second dose), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "General body aches".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
No adverse events or treatment. Dtap vaccine expired 12/18/06 and was given. CDC notified and no adverse site effects expected.
Extreme dizziness; A spontaneous report was received from a consumer in the United States concerning herself, a 74-year-old female patient. She reports that she was fine at time of vaccination and even stayed for 15 minutes to be sure there were no side effects. Approximately two hours later, she began to experience extreme dizziness. Patient reported being fine at the time of the phone call. She was questioning whether the extreme dizziness could be from her blood pressure being high at time of injection.   The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included Ibandronate 150mg, Atenol (dosage not reported,) hydrochlorothiazide (dosage not reported) and Ezetimibe (dosage not reported.)  The patient received their first of two planned doses of mRNA-1273 batch number 0256200 on 6-Jan-2021. On 6-Jan-2021, approximately two hours after dose was given in the left arm, for prophylaxis of COVID-19 infection, patient experienced extreme dizziness. She reported that the symptoms got better after taking her after-lunch medication for her blood pressure and was feeling fine at the time of the phone call. Patient denies taking any medication to treat her dizziness.  Action taken with mRNA-1273 in response to event is unknown. Outcome of event appears to have resolved per the patient.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever at 100.1. Enter arm was sore and aching not just at the spot of the shot but the entire arm.
Encephalactic -first 12 hours brain swelling with severe head pain, used an ice pack for pain (far worse than any headache); fever,chills, nauseau, dizziness (had to crawl); second 12-24 hours mild headache (used tylenol) chills (could not get warm) and tiredness; day 3 very tired, day 4 couch potato. At 6121 my arm is mildly sore and still itches at the injection site.  Had the same reaction to Fluarix Quad 2020-2021 given 09/19/2020.  To what common ingredient am I allergic?
pt recv vax 9JUN98 & JUL98 pt dx w/diabetes mellitus, Type I; diabetes mellitus was considered an other medical event;
34 percent PVC after the 5 th dose; This spontaneous case was reported by a patient and describes the occurrence of VENTRICULAR EXTRASYSTOLES (34 percent PVC after the 5 th dose) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No allergy and no diseases.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose lot 029K20A) on 27-Jan-2021, Moderna COVID-19 Vaccine (1st Booster, Lot number 003F21A) on 22-Oct-2021, Moderna COVID-19 Vaccine (2nd booster lot number 054A22A at Walgreens 6165 on June 10th. 2022) on 10-Jun-2022 and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse reaction with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (34 percent PVC after the 5 th dose). At the time of the report, VENTRICULAR EXTRASYSTOLES (34 percent PVC after the 5 th dose) was resolving. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant products reported. It was reported that the Second dose Batch Lot No was 031M20A mentioned in source document. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 34 % Premature ventricular contractions after the 5th dose. No treatment products reported.  Company comment: This regulatory case concerns a 71-year-old male patient with no medical history reported, who experienced the adverse event of special interest of ventricular extrasystoles an unknown time after the fifth dose of mRNA-1273.222. The patient had previously experienced 12.4% premature ventricular contractions, but after the fifth dose the patient experienced an increase to 34%. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2023-694244 (Patient Link).; Sender's Comments: This regulatory case concerns a 71-year-old male patient with no medical history reported, who experienced the adverse event of special interest of ventricular extrasystoles an unknown time after the fifth dose of mRNA-1273.222. The patient had previously experienced 12.4% premature ventricular contractions, but after the fifth dose the patient experienced an increase to 34%. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
went to ER w/c/o severe local rxn to DTP/HIB (redness, swelling, fever);also had inconsolable crying, for 1 1/2-2hrs
I was at home, my significant other had stomach and cramps. I did not. I worked out I went on a 3 mile run. I drank a protein shake,  within 20 minutes I had unbelievable cramps. I had diarrhea so bad that I took tums and Gas X. After about 40 minutes the pain went away, about 5 or 6 pm. That night I had cramps and diarrhea and vomiting this is completely out of realm for me. I did not go to work the next day, I had no fever. Those symptoms continued over the next days and weeks, the diarrhea and cramping. After about a week I would just eat soup and everything would just go through my system. My significant other was over her symptoms within an hour, hers was a 24 hour bug. After a week 1/2, I went to see my physician. He prescribed Imodium. He also started me, loperamide 2 mg on 05/27/2021, ondansetron hcl 4 mg, and I also took Imodium and Pepcid AC as needed. I also had to change my diet and I still have some issues as of today. After a couple of more days I met with an gastroenterologist, He prescribed: ziafaxan. I was on a modified diet for another week. I continued to have diarrhea . On instances I would have vomiting,  mostly at night or evening, 4 total times. I don't remember vomiting in my adult life from food. This is completely out of the norm for me. I was on a modified diet, if I tried to introduce something different, I would vomit. These heavy symptoms went on for at least 5 weeks. I'm a healthy person, I lost about 30 to 35 pounds through covid in July and August of 2020, I started working out regularly. From the high to my low before I took the vaccine. I had lost 40 pounds, I was in great shape. I was working out 3 or 5 days a week. I had to completely had to stop working out to rest my digestive system and track. The cramping and vomiting  I was experiencing has gone away. 95 percent recovered from the AE. I never took sick days my whole life. I can't overstate that I had never been sick until this happened. I am not attributing this to the vaccine. I am just reporting what happened after the vaccine. I was eating healthy, I was not eating out, when the lockdown and everything started opening up, I started eating out again, maybe my digestive system, was used to be eating home cook meals at home.
pt recvd vax; went to sleep & would not wake up;, unresponsive, "semi conscious"; to er, T 103; adm to hosp for 2 days;
Patient reported muscle aches in her legs the day following her vaccination. She said that the general aches gradually turned into muscle pains in her legs that were severe and kept her up at night for 3 nights. At this time the pain has decreased and she is only having pain in one leg. She said she was going to go into her doctor today to have her legs looked at to hopefully get some relief.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 8/12/2022,  9/13/2022,  10/7/2022,  1/7/2023 -- RECURRENCE OF SAME SYMPTOMS
PT STATED THAT SHE HAD A REACTION TO BIVALENT MODERNA. NEXT DAY STABING BURNING PAIN UNDERNEATH THE LEDT BREAST IN THE LUNG, WITH THROBBING. FOR 2 MONTHS PT WAS UNABLE TO LAY ON LEFT SIDE. PT WAS COUGHING THROUGH OUT EXPERIENCE. MD ODER BLOOD TEST FOR HEART AND AN ECHOCARDIOGRAM WHICH SHOWS NARROWING AND MITRAL VALVE LEAKING. PT WILL NEED A HEART CATH TO SEE WHAT IS HAPPENING.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Polycystic ovary. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Sep-2020 and the estimated date of delivery was 23-Jun-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2020, Ultrasound scan: normal (normal) Normal. On 24-Feb-2021, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported. On 09 Jan 2019 patient had previous pregnancy which was live and full term birth.
Onset of fever, chills, body ache, and general malaise within approximately 7 hours after receiving the second dose. This lasted for a full 20 hours, with a maintained temperature between 100 F and 101 F despite regular doses of ibuprofen.
About 30 minutes after my injection, I started to feel a tingly feeling in my throat, then felt like my throat was slightly tightening. I was driving and pulled over to monitor. It stayed the same for about 10 minutes, then started resolving. I never had any trouble breathing and I could sip water. When I returned home, my husband commented that I looked  ?flushed.?  I called my PCP who recommended to monitor myself, but that I was probably fine and no need for any treatment. I have not had any issues since and now am 24 hours post injection. There is no phone number to the site in which I received my vaccine. I have been trying to connect with someone who can advise on whether it is safe for me to receive my second dose. I would be so grateful for any advice on how to proceed as I really want to get the second shot, but also am concerned if there is a risk that I could have a severe allergic reaction upon receiving it. I have searched the agency website and see where a second dose is not recommended for anyone that has had a severe or non-severe allergic reaction to the first dose. What I had was not severe, but I am unclear if it was enough to preclude me from receiving a second dose. I would so appreciate any insight, guidance, or connection to someone who can advise on how to proceed. Thank you.
ped DT given due to pt on phenobarb for sz disorder related to MVA 26MAY92;  no adverse react post vax due to fact p/MVA sx started-wasn't given DPT since;
Patient received Pfizer COVID vaccine on 2/8/21 and 3/1/21 out of state. On 11/16/21, patient admitted to our facility for acute respiratory failure with hypoxia due to COVID-19. As of today (11/18/21), patient is still admitted in our med/surg unit.
3-18-21 3:09PM 'TIPS OF 4 FINGERS  ON RT HAND TINGLE'.  NO MOTER OR SENSORY DEFICIT. GOOD CAP REFILL.  A/O, PINK, W/D, RESP REG WITH EASE. NO ACUTE OR OBVIOUS DISTRESS.  3:11PM AMBULATORY TO EXIT - GAIT BRISK AND STEADY. 3-19-21 9AM: 'TINGLING LASTED SEVERAL HOURS AND TONGUE WAS ALSO TINGLING - BUT NOW IT'S GONE'.
Severe headaches, joint pain, night sweats, chills, nausea, fatigue, soreness in throat, extreme soreness at injection site on left arm causing limited movement.  It started about four hours plus or minus after injection.
the patient started to have symptoms of headache, low grade fever, muscle aching and wheezing 12 to 15 hours after receiving the Pfizer 2nd booster.
Vertigo and dizziness started about 7 days after shot.  On  Jan 4 at 8:30am a Ischemic stroke on right side of brain occurred.
Received 4th dose of vaccine not in accordance w/CDC guidelines. Patient has no criteria for meeting 2nd booster at this time
Information has been received from a registered pharmacist concerning a female who on an unknown date was vaccinated with a dose of PNEUMOVAX.  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently the patient developed and injection site reaction that was described as PNEUMOVAX vaccine site swelling up to the size of a baseball.  All the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  This is one of tree reports from the same source.  Additional information has been requested.
pt recvd vax 24MAY93 & 27MAY93 lab eval was pos for hep b surface antigen; 31MAY93 & 7JUN93 lab eval was neg for hep b surface antigen; No further details were provided;
Loss of hearing, loss of blood flow to brain, lack of oxygen, passing out, pressure in head.
Nurse manager was notified by the person drawing the vaccine that she thought she had a new vial for the last two vaccines that had been drawn but when Nurse manager and medical assistant tallied all the doses that had been drawn/given, it was discovered that she had pulled dose 21 and 22 from the same Moderna vial. She noticed because her vial was close to empty. By the time the discovery had been made the two extra doses had already been administered. Education provided.
swelling of lymph node(?) or gland under left arm about 12 hours after injection, swelled to about 3 times normal size, any movement or pressure cause intense pain, started to decrease in size after 2 days
On 2-8-21, she had the chills, and on 2-9-21, she developed double-vision which has continued. Documentation double-vision still present on 2/12/21. Patient sought treatment in the emergency department 2/12/21 dx. Binocular vision disorder with diplopia .
Pounding heart, 168-179 bpm for approx 15 minutes, at rest. Light headed feeling.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 02-NOV-2018, the patient was vaccinated with PNEUMOVAX 23, with the valid lot # N004564 and an expiry date of 22-OCT-2018 (strength, dose, route, and frequency were not provided) for prophylaxis. So, the reporter stated that the patient received a properly stored, but expired vaccine dose of PNEUMOVAX 23. No adverse effects were present. No additional information was provided.
Large red welt at the site of the vaccine appeared the morning of the 8th day following the vaccine. Warm to the touch but not painful.   Still present as of 4/11/2021.
8 days after administration, itching, then pink, swollen, hot to the touch hive-like area that grew in size over about 6 days .  19 days after administration area is still discolored and slight itching occasionally but has improved significantly.
Pt returned to clinic on 10/5/2018: Pt reports initially had site swelling and redness; report redness did subside but has noticed increased left upper arm swelling primarily to left AC fossa; no pains to left arm; injection site was without any inflammation or redness.
On the second evening after the shot i was experiencing chest pains for about 90 minutes.  They did subside and I fell asleep.  No other adverse effects other than fatigue.
This spontaneous case reported by a consumer, describes the occurrence of malaise (felt sick) in a patient, of an unknown age and gender who, received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 26, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 26, 2022, patient experienced malaise (felt sick). At the time of the report, malaise (felt sick) outcome: unknown. No concomitant medication or treatment information provided. The patient wanted to clarify if there is a laxative in the Moderna COVID-19 vaccine. She mentioned from the start she felt sick. This case linked to MOD-2022-552252 (patient link).
two round, fairly large swollen areas on lower portion of upper arm. Reaction is lower than where I remember receiving the flu shot.
Dizziness; Loud ringing in ears; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 09Apr2021 at 12:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. The patient previously received DPT shot (MANUFACTURER UNKNOWN), Novocaine (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 19Mar2021 at 12:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. 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 10Apr2021 at 07:30, the patient experienced dizziness and loud ringing in ears. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness and loud ringing in ears was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
He has got a 100 fever; He got up this morning with a high fever; Very bad headache in his head and in the front of the head, it hurts a lot; The face, the top and the front is hurting a lot going through the eyes; sleeping a lot; bodyaches; This is a spontaneous report from a consumer (patient's father). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient's medical history included low potassium. Concomitant medication included potassium. On an unknown date, patient had got a 100 fever and very bad headache in his head and in the front of the head, it hurts a lot. And the face, the top and the front is hurting a lot going through the eyes. He has got fever and what I did is I gave him Tylenol treatment, patient also experiencing minor side effects such as sleeping a lot due to bodyaches from the second dose. The outcome of the event He has got a 100 fever; He got up this morning with a high fever was not recovered and unknown for the other events.
On Sunday, 1/24/21, was feeling tired, had soreness from injection site, took temp, it was 99.6, normal is 97.3.   Woke up this morning, temp was 98.6, went to work at 11:30 stomach felt sour, got home around 2:00, had diarrhea.  At 2:45 took temp and it had gone up to 99.7.   Still having fever, stomach is better but has some pangs, no diarrhea.