chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site pain; This case was reported by a physician via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Bexsero.  Additional details were reported as follow: The age at vaccination was was not applicable. The reporter reported that the several patients received 1st dose of Bexsero and had injection site pain. No further information was available. This case has been linked with case ID US2020AMR185349 and US2019AMR199127, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR199127:same reporter US-GLAXOSMITHKLINE-US2020AMR185349:same reporter
Almost immediate fever (about an hour after injection). High to the point of melting the ice pack I used to help cool down. Injection site swelled to the size of a grapefruit. Dehydration. Severe headache. Chills and sweats
1/1/2022  Covid exposure.  She says that is the only reason she was here.  Does not want to wait any longer for any other testing.  This wants her Covid swab and to go home.  Says she was having a cough and low-grade fevers.  This is improved.  Has had a vaccine.  Not pregnant.  No headaches or neck pain.  No chest pain pressure or tightness.  No difficulty breathing or shortness of breath.  Overall feels well. Review of Systems  Constitutional: Positive for fever. Negative for chills.  HENT: Negative for neck pain and neck stiffness.   Eyes: Negative for pain and visual disturbance. Review of Systems  1/1/2022 Cardiovascular: Negative for chest pain and leg swelling.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Genitourinary: Negative for dysuria, flank pain and vaginal bleeding.  Musculoskeletal: Negative for myalgias, back pain and gait problem.  Skin: Negative for color change and rash.  Neurological: Negative for dizziness, weakness, light-headedness, numbness and headaches.  Psychiatric/Behavioral: Negative for confusion.  All other systems reviewed and are negative. Respiratory: Positive for cough. Negative for chest tightness and shortness of breath.
Pt called 5/13/2021 regarding of rescheduling of 2nd covid vaccine. Pt stated pt got 1st covid vaccine Pfizer at 12:05 4/23/2021 and next day pt felt soreness on left arm injection site and chest muscle soreness. pt stated it's not chest pain but felt subtle chest muscle soreness. Pt visited MD and done blood work, chest x-ray, ECG;normal. Pt stated pt feels slightly better chest muscle soreness than last week but still carry chest muscle soreness. Pt has scheduled allergy specialist at outside facility 5/19/2021. Noted pt is not taking any medication, no known allergies. Pt requested to reschedule 2nd covid vaccine d/t pt has scheduled allergy specialist.
Awoke at 4 am feeling slightly nauseated, had received Moderna vaccine at approximately 4PM on Feb 17, 2021. Arose and walked to the bathroom, sat on the toilet and was in the process of urinating as a huge wave of nausea then vertigo(room spinning) hit me.  I sat through it, thinking it had passed I stood to pull up bottoms and same feeling repeated, my mind said call my husband, and get on the floor. Next thing I knew he was at my side and I was on the floor. I do not remember falling. I did incur injury to my head and lower back. I was assisted back to bed, feeling very weak, could not walk on my own, too unsteady on feet. Feeling of weakness remained for the morning hours. Chills set in with fever, as I expected, a few hours after my fall. Highest temperature 101.5 F Due to Snow storm I did not go to my physicians office that day, but did speak to him on the phone. Hydration and safety measures reviewed as well as concussion signs and symptoms.
Received DTaP and Prevnar in left thigh 9/3/03. Several hours later Mom noted redness around sites. Redness spread with swelling of thigh persisting today despite Benadryl.
Intense headache, dizzy spells, high Temperature - 38.7. Bad ribs and pains in the legs.. Also no Energy and shaking due to being really cold. All started at 07:10 and hasn?t gone away.
Vaccines were stored in the fridge on 30Jun2021 and administered on 31-Aug-2021; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 31-Aug-2021) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 31-Aug-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 31-Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 31-Aug-2021).    No concomitant and treatment medications were reported.  Reported that 40 patients received the Moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge. Vaccines were stored in the fridge on 30Jun2021, there are different administration dates, starting on 02Aug2021 until 20Sep2021 being the last one. Patients did not report any side effects.   This case reported for patient 25 of 31 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
I don't know if this was from the vaccine but it has been abnormal for me. Three days after the vaccine I got a cold sore. I took acyclovir and it subsided. Two days later I got another cold sore in the same location. That was very different. Usually when I take acyclovir it clears up very well. I took acyclovir again.  Then today (1/24) I have another cold sore, this time in a different location.  I have not had excessive stress or bad sleep which can sometimes trigger cold sores for me.  I have never had multiple in a week. I will get one cold sore every 6 months or so on average. I wondered if it is due to an immune response from the vaccine.  Also, I have some large cancer sores inside my mouth.   (I had arm pain for three days after the vaccine  and some fatigue the day after)
Raised rash all over the body. Started 4 days ago. Urticaria.
Patient reported swelling and 3 inch diameter lump in left arm after being vaccinated starting the next day and persisting for 3 days, after which she called to report the adverse effect. She did not report any signs or symptoms of anaphylaxis.
Within 15-minutes of vaccination, the patient reported feeling lightheaded. EMS managed the patient's care on-site.
Patient Reported continuous pain in upper arm since administration of vaccine (over 1 month) duration.
devel pain, swelling, erythema @ site of inj 2 days p/vax;
Very very painful when injected (in the shoulder) I gritted my teeth most painful shot I ever hard.  Immediately I could not put my left arm backwards without extreme pain.  I waited a week to go to my doctor to see if pain would go away. I went to my primary dr. on Nov. 12, 2021. He put me on steroids called methylprednisolone tablets. You take doses for 6 days. It has been 6 days and still in pain and can not move my arm backwards without extreme pain.
Patient was mistakenly given a 2nd dose of the seasonal influenza vaccine.  He received his first dose on 10/8/21.
TIRED; HEADACHE; MILD FEVER; ARM SWOLLEN AT SITE OF INJECTION; BODY ACHE; CHILLS; SORE ARM AT SITE OF INJECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 at left arm for prophylactic vaccination.  No concomitant medications were reported. On 23-MAR-2021, the subject experienced sore arm at site of injection. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced mild fever. On 24-MAR-2021, the subject experienced arm swollen at site of injection. On 24-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 97.6 degrees F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, mild fever, chills, body ache, arm swollen at site of injection, tired and sore arm at site of injection was not reported. This report was non-serious.
Information has been received from a consumer concerning his 11 year old son with no pertinent medical history and no known allergies, who about 10 years ago ("1997), received his first and only dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included methylphenidate hydrochloride (CONCERTA). On 14-FEB-2008, the patient developed a chicken pox break through. No laboratory or diagnostic studies were performed. A product quality complaint was not reported. Additional information has been requested.
sx-trouble breathing, sore throat, coughing, mucous, chills, fever, diarrhea, vomit, head pain, neck pain, abd pain, leg pain, trouble walking, agitation;
12 year old client in for his booster recieved 0.2 ml of the pfizer pediatric 5-11 dose instead of the 12 and up dosage.
I had dizzy spells one day after the 2nd vaccine,  aches in my knees (which I had recovered from an injury 2 months prior and had stopped hurting), a sore arm at site of injection,  and tiredness.    After receiving my 1st vaccine I did not have any side effects other than a sore arm at site of injection.
Information has been received from a physician concerning a 15 year old female patient, who on 09-SEP-2008, was vaccinated with the first dose 0.5 mL dose of GARDASIL vaccine (route and lot number not provided). On 12-SEP-2008, the patient experienced purple bruising around the legs and ankles. The patient went to an infectious disease specialist and was diagnosed with Henoch-Schonlein purpura (HSP) (form of purpura). It was reported that therapy with GARDASIL was discontinued and the patient received only the first dose. The patient's outcome was unknown at the time of reporting. The patient sought medical attention through an infectious disease specialist. Upon internal review, Henoch-Schonlein purpura was considered to be an other important medical event. Additional information has been requested.
he is experiencing a fever which he suspects is due to a blocked saliva gland.; he is experiencing a fever which he suspects is due to a blocked saliva gland.; This is a spontaneous report received from a non-contactable consumer via a Pfizer-sponsored program.A male patient of an unspecified age received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient stated that he was experiencing a fever which he suspects is due to a blocked saliva gland on an unspecified date.The outcome of the events was unknown.Patient wanted to know if that would be a problem for receiving the second dose.
On 10-29-2021, in the afternoon after my 2nd Moderna dose, my feet got numb, it feels like I have heavy wrinkled socks on the bottom of both feet, whether I walk or lie down with no shoes, my feet are very cold to this day. It is more on the right leg. It starts at my waist and goes down. I was having a problem going to the bathroom.
Fever and aches for next day, feeling so awful had to stay in bed the next day, tiredness lasting a week, pain in arm where shot administered, rash at site of shot (might have had to do with the antiseptic bandaid), pain in lymph node in armpit lasting a couple days, canker sore 2 days after, constipation on the day after, depression lasting at least a week after.
Has had 2 days of fever and last night noted with a couple of red bumps on face and body and today with more on trunk.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild
Covid 19- I tested positive on May 30th. I experienced runny nose, mild headache, sore throat, fatigue, & cough symptoms lasted for about 5 days. I wasn't taking any medication at all.
I got the shot Friday in my left arm and it was achy, it hurt that night and the next day somewhat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EN6200) at the age of 79 years as single dose for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I got the shot Friday in my left arm and it was achy, it hurt that night and the next day somewhat". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The reporter stated that she is not really, basically very healthy, few little things but very healthy. Concomitant medications included Vitamins, herbs and minerals some and try to eat healthy. The reporter stated that she got the shot Friday in her left arm and it was achy, it hurt some that night and the next day somewhat but that was it. The patient received treatment with Tylenol.  No follow-up attempts are Possible. No further information is expected.
Well I did get Covid arm. I got a big swollen spot on my arm, that happened about 9 days after the vaccine. I want to tell you, I did run a fever and was very tired for four weeks following the vaccine. I seemed to have a little bit of a temperature as well. Well in July I also went to the DR because I had noticed a protruding bump in my neck. It doesn't hurt, but at urgent care the DR said it just can come and go and they said bodies are asymmetrical and it is fine they said.
Narrative: Patient reported itching shortly after vaccine administration. Received cetirizine and was discharged at 1:20p stating she felt better and the itching was decreased. The patient has her own epi-pen for her pre-existing allergies if needed after discharge.
Severe joint pain 24-48 hours after shot. Hard Lump at shot sight for 4 days after shot.
This spontaneous report as received from a physician via a company representative refers to a 35 year old female patient who is not pregnant. The patient's pertinent history included diabetes mellitus and had a lot of allergies. On an unknown date the patient was vaccinated with PNEUMOVAX 23, single 0.5 ml dose, subcutaneously. On 26-SEP-2016, after receiving PNEUMOVAX 23 patient experienced a lot of swelling and pain around the injection site. The patient sought medical attention by visiting a pharmacy. On an unknown date in September 2016, the patient recovered/resolved from the events. The reporter did not provided the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
On Sunday 10/09/2016, patient noticed some swelling, redness and pain at the site of injection and it was getting larger.  She also experienced some fever and the site of injection is hot to touch.  She then saw her PCP on Monday, who prescribed her with Claritin, Prednisone, and Benadryl for possible allergic reaction.  She was also instructed to ice the area.  She then reported that the swelling and pain getting worse even though the redness and the fever had subsided.  She then saw her PCP again on Wednesday who had instructed her to continue the prescribed treatment, but suspected possible cellulitis!  However, the PCP did not prescribe any antibiotic.  On Thursday, the patient then self-treated her with some antibiotic that she had (she claimed) and felt better!
PT said "I feel really confused today". He had difficulty focusing on things. Couldn't remember recipe contents that he had cooked multiple times in the past. Wife noted other subtle changes in his mental status.   1 acute mental status change-sent patient to outside hospital for further evaluation.    While at outside facility had CT scan of the head was normal, CTA of the  carotids which was negative for significant blockage, was found to have  orthostatic hypotension, lisinopril was decreased, metoprolol tartrate dose was  changed from 25 mg daily metoprolol succinate 12.5 mg twice a day.  Developed rash over entire body approximately 36 hours after hospitalization, not sure if related to CT scan contrast for Prevnar or flu vaccine he received.  Saw non-VA PCP was treated with Solu-Medrol followed by a Dosepak. Blood sugars elevated due to this. He followed by non-VA PCP Also notified cardiology hospitalization was scheduled a 48 hour Holter monitor,  Feeling better other than the rash which is improving per patient and family.
Pt has a PMH of T2M, COPD, and CHF. Arrives to the ED with cough, congestion, and shortness of breath. Pt is admitted to the hospital due to acute on chronic respiratory failure and COVID-19.
There is an area in arm that was red and warm to touch. The red area was measured 4" wide and 7" long. Reported the red spot also is itchy and felt like having a cold with no fever. Advised Ibuprofen, Benadryl, ice pack and see MD.
This spontaneous report has been received from a registered nurse refers to an unspecified patient of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On an unknown date, the patient was vaccinated with an improperly stored PEDVAXHIB, (route of administration, dose and frequency were not provided)  lot # M020101, and expiration date 07-MAR-2019 for prophylaxis. The reporter stated that the temperature range of the vaccine was 32F and 36F and the time frame was 24 hours, also she stated that there was not previous temperature excursion, this information was administered in a data logger. No adverse effect was reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA000713: US-009507513-1701USA000712.
PERICARDITIS; This spontaneous report received from a health care professional (parent) concerned a 19 year old white female (daughter) of an unspecified ethnicity. The patient's height, and weight were not reported. The patient had minor allergies and nothing major. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered at left arm on 29-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 19 years old. No concomitant medications were reported.  On an unspecified date, on MAY-2021 (after 3 to 5 days of vaccination), the patient experienced pericarditis with deep chest pain. The patient saw the cardiologist (physician office) and found it was pericarditis. The deep chest pain now got resolved probably after 5 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pericarditis on an unspecified date in 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230122084- pericarditis. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
This spontaneous report was received from a supervisor, referring to a currently 4 years old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 19-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (°F) to 14°F, during 2 hours 20 minutes. However, a previous temperature excursion of 15°F to 46°F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported.; Sender's Comments: US-009507513-1903USA000678: US-009507513-1902USA012055: US-009507513-1903USA000677: US-009507513-1903USA000680: US-009507513-1903USA000682: US-009507513-1903USA000683: US-009507513-1903USA000684: US-009507513-1903USA000685:
About 1 month after my second Moderna Vaccine I began to have ringing in my left ear with ended with substantial sudden hearing loss.
immediately felt "heaviness" spread throughout whole left side of body, later in day developed pain in arm at injection site. Next day fever, whole body aches (especially on left side), tiredness, brain very foggy, and headache. 2nd day nausea & pain in arm continues.
My period started 8 days early (this made it an 18 day cycle rather than my standard 26 days). I felt very hormonal leading up the the early menstruation and also with hot and cold flashes which is abnormal for me.
On 03-26-2021 I went to see my doctor and I was diagnosed with having shingles. I do not know if this is related to the vaccine.  I had no rash after my  vaccine.
Patient received flu shot (Flublock) that is indicated for those 18 years of age and older. Patient is 17 years old. Patient's father called tonight approximately 4 hours after the shot was given, and his son's chief complaint is muscle pain and swelling.
pt w/a 3 day hx of numbness & tingling of the legs,hands & tongue hosp 30OCT w/severe weakness & inability to walk;dx GBS;plasmapheresis done;
Fevers, sweats, hallucinations, chest pains, malaise for many days, loss of appetite, headache, anxiety, body aches, unable to work for several days.
Severe body aches, joint pain, fever (100f), nausea, nightmares, cramps in the back of calves