chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Malaise; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2021, several hours after receiving Shingrix, the patient experienced malaise and fatigue. In August 2021, the outcome of the malaise and fatigue were recovered/resolved.   It was unknown if the reporter considered the malaise and fatigue to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient's wife. The patient received 0.5 ml of 2nd dose of Shingrix in the second week of August 2021 and after hours of vaccination, the patient had malaise and fatigue. The malaise and fatigue were resolved after a day and a half. The reporter did not consented to follow-up. The case was linked with case US2021194319 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021194319:Same reporter.
11 days after the dose I have very warm to the touch, red welts surrounding the area around the injection site.
After my first vaccination, I head headaches off and on for about four days , but they did go away.  Approximately 3 hours after the second vaccination was given, I started experiencing blurred vision in my right eye.  Approximately 10 minutes later I started having shooting pain from my left eye, down the side of my head, and down my neck.  The intense pain remained for about 24 hours.  Regular headache medicine did nothing for the pain, but stronger headache medicine dulled the pain a little.  I am still having head pain in a less severe intensity four days later with accompanied decline in energy.  I am extremely tired, and then I have trouble sleeping when I try to sleep.
did not receive 2nd dose between day 25-35 of receiving the 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose between day 25-35 of receiving the 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose between day 25-35 of receiving the 1st dose). On 22-Apr-2021, PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose between day 25-35 of receiving the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Dizziness; Weakness; Tired; cant sleep; Nausea; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 14:30 (Lot number: EW0164) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shell fish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovering", described as "Dizziness"; ASTHENIA (non-serious), outcome "recovering", described as "Weakness"; FATIGUE (non-serious), outcome "recovering", described as "Tired"; INSOMNIA (non-serious), outcome "recovering", described as "cant sleep"; NAUSEA (non-serious), outcome "recovering", described as "Nausea"; CHILLS (non-serious), outcome "recovering", described as "chills"; HEADACHE (non-serious), outcome "recovering", described as "headache". It was unknown if therapeutic measures were taken as a result of dizziness, asthenia, fatigue, insomnia, nausea, chills, headache.  No follow-up attempts are possible. No further information is expected.
The day after my arm was just very sore, now it?s two days after and I have nausea, fatigue, and the chills.
only get the flu when get the shot; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted on 08-Dec-2020.  This case involved a patient of unknown demographics who only got the flu when got the shot (Influenza), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on an unknown administration site for prophylactic vaccination.  On an unknown date, the patient only got the flu when got the shot (Influenza), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was only got the flu when got the shot (Influenza).  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
"8:55AM about 1min p/vax completing immun pt stiffened, became pale & lips cyanotic & shook briefly;placed on exam table in shock position & immed relaxed & responsive verbally;color improved & VS stable;parent report no prior such episode;
11/05/22 presents to ED for "SOB and chest pain". PMHx of "COPD, DM type 2, hypertension" "DVT/PE"
Pt did not disclose prior history of eczema throughout screening process and was given the smallpox vaccine. Pt had an eczema flair with small plague on L flexural arm.
No sx until p/48 hrs @ which time devel nausea x 7 days then devel sore throat, generalized aches, sore eyes & ears, tiredness; pt will phone MD w/sx;
PATIENT STATED THAT AFTER 3 HOURS OF RECEIVING THE FIRST DOSE OF THE COVID-19 VACCINE, HER LEFT EYE BECAME RED AND PART OF HER CHEECK BECAME SWOLLEN, PT STATED THAT SHE TOOK BENADRYL AND IBUPROFEN. DIDN'T SEEK MEDICAL ATTENTION.
Chills especially all night. Bad body aches which felt like the flu. Headache.
12 hours of headache, body aches, and low grade fever (99.5 - oral)
Patient was given Bivalent COVID immunization but not received primary series with monovalent COVID vaccine. No known injury to this point.
on the left side of my face, tingling and numbness in jaw and cheek and half of my tongue; on the left side of my face, tingling and numbness in jaw and cheek and half of my tongue; on the left side of my face, tingling and numbness in jaw and cheek and half of my tongue; on the left side of my face, tingling and numbness in jaw and cheek and half of my tongue; I get really stressed; my cheek and jaw will start to hurt on the left side; my cheek and jaw will start to hurt on the left side; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of an unspecified age (Age: 27, Unit: not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced on the left side of my face, tingling and numbness in jaw and cheek and half of my tongue, I get really stressed, and my cheek and jaw will start to hurt on the left side on an unspecified date. Patient stated she was experiencing "weird" symptoms following the first dose of the Pfizer covid vaccine within 30 minutes, and stated turns out her mom  had the same symptoms but worse, it was called trigeminal neuralgia. Patient was worried about getting the second dose tomorrow . Patient still had symptoms, on the left side of her face, tingling and numbness in jaw and cheek and half of her tongue. Patient went to urgent care when it first started and stated that the urgent care doctor did not give a shit about anything. Patient asked for an MRI to scan her head, or a CT scan and she was not sure which one they did. She stated that everything came back fine. Patient called her doctor and his doctor said if it gets worse call him back. Patient stated it got a little better, but it was still there. Patient also reported that when she gets really stressed, her cheek and jaw would start to hurt on the left side and this just started up a week ago. Patient tried to get through to her doctor, but could not get through. Patient was scared that she may get the same diagnosis as her mother and asked if she will be okay if she will not get the second shot because she was worried about not getting the second shot. Patient stated that these symptoms had not gone away, and not as severe like her mothers. The outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Injection was given very close to the shoulder joint in my left arm, as a result within a few hours a very sharp pain in my shoulder caused me to be unable to lift my left arm without extreme pain, not muscle pain. By 4:00 pm I was sapped of energy. During the night I developed chills and ran a fever of 100.4 F. By Sunday morning I felt nauseous, but did not vomit. At 2:00pm 12/10/2020 my fever has lowered and the nausea has subsided, but the shoulder joint is still very sore.
Information has been received from a licensed practical nurse concerning a 23 year old female patient with a history of panic attacks who on 19-JAN-2007, was vaccinated into the left deltoid with a first dose of Gardasil (Lot# 658094/0524U). Concomitant therapy included hormonal contraceptives (unspecified). On 26-JAN-2007, the patient experienced dizziness and numbness on the left side of her body. Unspecified medical attention was sought. At the time of this report, the patient has not recovered. No product complaint was involved. Additional information has been requested. 8/1/07-copy of report received includes lot #0524U left deltoid. C/O dizziness, vertigo, numbness left side of body, palpitations, pain in jaw, ongoing intermittent to date.received for DOS 01/25/07-clinical information included pain left groin lymph nodes increasing in size and number, right lower quadrant pain, evaluate for lymphoma. Impression: bilatareal adnexal cystic lesions, improved on right with an increased 2.5 cm left adnexal cyst for which follow up is suggestion. No other records available from facility. This is in follow-up to report(s) previously submitted on 7/16/2007.  Information has been received from a licensed practical nurse concerning a 23 year old female patient with vertigo from oral contraceptives and a history of panic attacks, vestibulitis and pelvic pain who on 19-JUN-2007 at approximately 13:00, was vaccinated IM into the left deltoid with a first dose of GARDASIL (Lot# 658094/0524U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 26-JUN-2007, the patient experienced (dizziness, numbness on the left side of her body, vertigo, palpitations and pain in the jaw.  Unspecified medical attention was sought.  Laboratory diagnotic studies included an electrocardiogram and an magnetic resonance imaging (MRI) which were both reported to be normal.  It was reported that these experiences have been intermittantly ongoing to date.  No product quality complaint was involved.  Additional information is not expected.
4 hours after injections she started to develop rash on face. 24-48 hours rash spread to entire body. Txt: Prednisone Taper.
This spontaneous report was received from a Nurse refers to 8 week old infant patient. On 30-APR-2014, the patient was vaccinated with first dose of GARDASIL (dose, route and frequency were not reported). No adverse symptoms reported. No further information provided. Additional information has been requested.
Some of the vaccine it ran down his arm; Some of the vaccine it ran down his arm; A spontaneous report was received from a consumer concerning a 79-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and some of the vaccine ran down his arm (Vaccine underdose, exposure via skin contact).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number 030l20a) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the nurse administered vaccine to the patient and some of the vaccine it ran down his arm (Vaccine underdose, exposure via skin contact).  No treatment information was provided.   The patient received both scheduled doses of mRNA-1273, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event the vaccine ran down his arm (Vaccine underdose, exposure via skin contact) was considered resolved on 22 Jan 2021.; Reporter's Comments: This report refers to a case of Vaccine underdose and exposure via skin contact for mRNA-1273, lot # 030I20a with no associated AEs.
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age and race/ethnicity received PREVNAR 13 on 03Oct2016 at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 03Oct2016 the patient felt that the nurse put the needle in the wrong place (bone maybe), experienced pain immediately and since an unspecified date she had trouble walking, sitting, pain in lower back, felt shot has affected her muscles (buttocks, toes, back). Events outcome was unknown. No follow up attempts possible. No further information expected.
Initial report received from a health care professional on 02 Jul 2010: This 2 year old infant inadvertently received 0.5 ml dose of MENVEO (batch no: 091001), intramuscularly on 01 Jul 2010. No adverse effects were noted following this administration.
Persistant & inconsolable crying of longer than 3 hrs duration; Onset 3-6 hrs p/inject; Fever 100.6F; admited to Hosp; DC the following day in good condition;
Started feeling that my heart was racing. I have a watch that reads my heart rate and it was saying that my heart rate was evaluated. Then, a few hours later, I started having chest pains. I went to the ER. They did an EKG, normal results. They referred my to a cardiologist. The cardiologist gave me a heart monitor to wear for a few days. That showed that I had tachycardia but he don't think that it is anything serious. The tachycardia is still ongoing as of today.
On January 5 I received the Moderna Vaccine to my right Deltoid  On January 13th I developed cellulitis to that area
Shingles one day after receiving 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) for prophylaxis.   On 24-MAR-2023, the patient received the 2nd dose of Shingrix (right arm). On 25-MAR-2023, 1 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles one day after receiving 2nd dose). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-MAR-2023 The pharmacist reported that a patient received shingles one day after receiving the second dose of the Shingrix vaccine. The reporter consented to follow up.
MODERNA COVID VACCINE #3 GIVEN 01/04/2022, LOT #033H21A; pt had a positive COVID test on 2/14/22; lethargic, weakness; found also to have UTI - treated with ABX and IV fluids; supplemental O2 as needed; DNR; poor oral intake
Swelling from just below shoulder to just above elbow (left arm). Tricep was red, hot to the touch, accompanied by low grade fever (101 degrees for 36 hours). Followed by bruising. (Recovering 6+ days).
Patient came back from the unit after returning back to work stating that he "felt like he had run a marathon".  Upon assessment, patients vital signs were BP 152/110,  P 83, O2 sat 99% although patient stated that he felt "short of breath".  Patient reported a history of anxiety and HTN, but was not taking medications for blood pressure as he had not "picked them up".  Doctor assessed and called EMS.  When they arrived, they did ask him if he wanted to go to which he replied "it would probably be best".  No further complaints or treatment reported at this time.
Patient experienced significant pain and discomfort at site of injection after a short period. She described spasms in deltoid (R) that projected to her neck. Lasted 3-4 hours.
Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presents with anaphylaxis & hypertension. Staff gave ALS care and administered 50mg Benadryl IM  & EPI 0.3 mg IM. Due to no improvement, staff gave O2 prior to 2nd EPI dose. Staff transported pt to Hospital. EOR.
Large reddened, raised area to injection site, approximately 8cmx5cm in size to right upper deltoid. Pain, swelling and itch noted to site, treated with PO Keflex for cellulitis which was effective.
Urinary Tract Infection - painful urination and frequency symptoms. I was treated with antibiotics (Cephlex) for 10 days. I started those on the 11th (February). By day seven or eight, I wasn't feeling better so they switched my antibiotics (might have been Bactrim) to a different kind and that didn't help either. I was still taking antibiotics when I had my second dose of the vaccine on the 17th of February. On the 22nd of February, I went in to the doctor's and they gave me one single dose of antibiotic (Monurol) that was super strong and that it would work. I took that and it stopped my symptoms right away.
After PFIZER 2023-24 COVID 12YR+ SYR 0.3 ml injection, patient became sick with congestion, runny nose, cough, sore throat, head and body aches, and fever. Patient was healthy prior to injection and has had numerous COVID-19 antigen tests before and after injection - all were negative. Patient received 2023-2024 flu shot four weeks prior to this COVID-19 vaccination. Patient had five prior Pfizer COVID-19 vaccinations (two in 04/2021 spaced three weeks apart, 10/2021, 04/2022, and a bivalent Pfizer vaccination in 09/2022) without any adverse effects and has never contracted COVID-19.
Pt states he didn't feel right after vax. The next day a knot the size of an egg developed and arm was painful. Pt directed to treat with warm compress, Advil and to rest arm. Pt seen in the office the next day for swelling, redness and pain in upper left arm. Pt treated with Biaxin. Symptoms didn't improve and pt was seen in the ER 10 days post vax. Pt was treated with Augmentin.
Approximately 10 seconds after receiving 2nd vaccination, patient lost consciousness and slumped backward in chair, She roused to verbal stimuli within 5 seconds and was assisted to lie down per nurse and her mother. Skin pale and dry. Pulse slow but strong and steady at 56. B/P 92/58. Mother and pt stated she has a low B/P and pulse rate normally. Patient and mother reported that patient did not eat or drink anything today and is on her menstrual period. When fully alert, given crackers and fruit juice which pt consumed and within 10 minutes felt better. Nurse stayed with patient during entire episode and after 10 more minutes, pt felt well and ambulated out of clinic with mother and nurse at her side.
About ten minutes after vaccination I developed parathesia.  The pharmacist told me that should go away in a day or so.  Within twenty four hours, I developed a fever, swollen lymph nodes in my right axillary and arm, the vaccination site became swollen and red.  I couldn't straighten my right arm fully for 48 hours and the pain was so bad that pain medication did not help.  I also experienced joint pain and myalgia that is atypical of my chronic conditions.  The fever and swollen lymph nodes resolved within twenty four hours.  It's been five days and my arm is still painful to move, swollen slightly at the injection site, and the redness has not gone away.  It has gotten smaller though.  Currently having parathesia again, but in my left leg and arm this time.  I've also been suffering from extreme fatigue.  I have not been able to see a doctor yet, but I have called one.  I am still waiting for a call back.  I have not been able to return to work since receiving the vaccine.  It's been hard to move with the fatigue and the painful arm.  The pain in my arm is anytime I move it or if any pressure is put on it (ex: laying down).
Hives developed overnight. She woke up and notices hives at injection site, on neck and on face. She took zyrtec and put benadryl ointment on hives. Hives went away. Employee states she felt tired and achy mid day 3/4/21. Employee has follow up schedule with PCP 3/4/21.
Patient was fully vaccinated and boosted, developed COVID19 on 12/09/2021, admitted to the hospital on 01/04/2022, and passed away on 01/04/2022. Patient is currently under investigation by the mortality review team to determine if death was COVID related.
Fever, body ache, headache, pain in Arm Symptoms went away the next day, however I had a mild fever around 3pm the next day.
After receiving immuniz., pt. was in the parking lot with mom chatting with an acquaintance. Pt felt dizzy/unsteady-fainted. Came to within a few seconds. EMS called & pt was assessed - Mom refused transport. Pt. stated no food/liquid intake for last 4 hrs. Water given-pt left with mom - ambulating without difficulty. Color natural no distress noted.
Saturday at 1200 I got body aches, and chills, and sweats, and went to sleep  Sunday 0700 woke up, still tired but managable with ibuprofen  Monday 0600 wake up with blisters/cold sores on the L top lip, applied abreva  Monday 1200 noticed swelling on the L side of face  Monday 1400 started tingling and numbness in the face  Was taken into ER at 1530 and discharged around 1645, sent home to pick up antibiotics  Been taking them since Monday evening at 1800, every 4 hours awake  No relief in the amount of pain in the sores on the face and still have tingling sensation.