chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm for a couple days; Not feeling well/malaise/overall not feeing well; Localized reaction; Severe headache; Body aches; Significant amount of redness; Swelling; Arm felt itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for a couple days), MALAISE (Not feeling well/malaise/overall not feeing well), PRURITUS (Arm felt itchy), VACCINATION SITE REACTION (Localized reaction) and ERYTHEMA (Significant amount of redness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Arm felt itchy), ERYTHEMA (Significant amount of redness) and SWELLING (Swelling). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for a couple days), MALAISE (Not feeling well/malaise/overall not feeing well), VACCINATION SITE REACTION (Localized reaction), HEADACHE (Severe headache) and PAIN (Body aches). At the time of the report, PAIN IN EXTREMITY (Sore arm for a couple days), MALAISE (Not feeling well/malaise/overall not feeing well), PRURITUS (Arm felt itchy), VACCINATION SITE REACTION (Localized reaction), ERYTHEMA (Significant amount of redness), SWELLING (Swelling), HEADACHE (Severe headache) and PAIN (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-031347 (E2B Linked Report).; Sender's Comments:  MOD-2021-031347:Babycase
I had pink eye maybe 3 days after the vaccine; Fever; Fatigue; This is a spontaneous report from a contactable consumer. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 18Aug2021 (age at vaccination 53 years) as dose number unknown, single for covid-19 immunisation. Medical history included High blood pressure. Concomitant medication(s) included amlodipine besilate (AMLODIPINE BESILATE); valsartan (VALSARTAN); hydrochloorthiazide (HYDROCHLOORTHIAZIDE). The patient had no known drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Aug2021 the patient experienced he had pink eye maybe 3 days after the vaccine, fever, fatigue. Patient visited doctor or other healthcare professional office/clinic visit. Patient reported, he was told that this is a common side effect and should end within 10 days. he still has fever and fatigue about twice that long. The patient received treatment of eye Rx. The outcome of event was recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt recvd 1 dose of Engerix-B & 19JUN92 exp a rash on neck, chest, abdomen & back;
I get up it is like real shot pain through my legs and my ears; Not enough sleep; like real shot pain through my legs and my ears; shot pain on my side; chill; it's like I got full muscle or something or I hit nerve; shot pain on my side where I got my shot at. It is like in my back, in my leg, full muscle; shot pain on my side where I got my shot at. It is like in my back, in my leg, full muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Sep2021 (Lot number: 301308A) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Sep2021, outcome "not recovered", described as "I get up it is like real shot pain through my legs and my ears"; INSOMNIA (non-serious) with onset Sep2021, outcome "unknown", described as "Not enough sleep; like real shot pain through my legs and my ears"; VACCINATION SITE PAIN (non-serious) with onset Sep2021, outcome "unknown", described as "shot pain on my side"; CHILLS (non-serious) with onset Sep2021, outcome "unknown", described as "chill"; MYALGIA (non-serious) with onset Sep2021, outcome "unknown", described as "it's like I got full muscle or something or I hit nerve"; BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Sep2021, outcome "unknown" and all described as "shot pain on my side where I got my shot at. It is like in my back, in my leg, full muscle".  Additional information: Consumer stated, "I got my first shot about the 3-4 weeks ago and ever since then 'I am feeling' on my left side where I got the shot at, muscle or something like in my leg and my back and 'chill' (Not clarified) you know all on the left side every time. Not enough sleep and I get up it is like real shot pain through my legs and my ears. Can you hear me now? It is shot pain on my side where I got my shot at. It is like in my back, in my leg, full muscle, ever since I got the shot that is when I am 'dealing with this'." Consumer further stated, " I need to know should I be concerned about it. I mean you know anything, you are getting any more calls about what's this is, what's wrong with me. Do you got any more calls. Well, I just need to know if you are getting any calls about scientific things that I got. Should I be concerned or what. I mean I don't know anything about that." Consumer stated, "The date when I got it's 12Sep21, that's when I got it and my next was supposed to got was 03Oct2021, I didn't get the next because the way my arm feel, 'I think I didn't get the next one'." Consumer stated, "My second shot, what about my second shot. I didn't get my second shot. I supposed to get it on 3rd but I didn't get it on October 3rd but I didn't get it. I feel better 'if' I get it. I said my arm could hurt if I might get it." No vaccination prior 4 weeks    No follow-up attempts are possible. No further information is expected.
The pt experienced swelling, heat, redness and pain on 6/10/00. Seen in ER on 6/12/00. Treated with Keflex. On 6/13/00, the pt had a marked improvement.
Patient developed urticarial rash on 3/13/21 which began on her lower extremities and progressed to most of her body by the following day.  She was seen on 3/15/21, and had no other symptoms besides the rash and was treated with zyrtec and benadryl but prescribed an Epipen (Auvi-Q) in case of worsening.  The next day, 3/16/21 she awoke with swelling in her mouth and worse rash, used her Auvi-Q and called 911 and was taken to ER where she was treated for anaphylaxis with IV solumedrol,, IV fluids and IV benadryl and was sent home on Prednisone and benadryl and Pepcid.
At 7:30 am, Dr. received the vaccine (Afluria, Lot # N56606) in her Left upper deltoid region as directed by her Department Chief. Approx. 1 hour later she complained of  fatigue, mental slowing, red eyes with thick discharge, nasal and chest congestion, shortness of breath, photophobia, dizziness, neck stiffness on the right side, and flushing. She was sent home from work for 2 days. Upon her return, she did not improve with Motrin 800 mg. She reported a change in gastro activity: increased bowel frequency. Her breathing improved following fluids and Benadryl 50 mg every 4 hours. Vaccine site appeared normal.
Narrative: 8/21/2022 - Pt presented to ED with Bilateral lower extremities swollen. Left appears blue and pale - pulse present. Right lower extremities red / swollen / hot. Complains of SOB at rest, loose stools, cough, decreased appetite, and swelling all over especially bilateral legs x 1 week, left leg appears pale and blue / right leg appears red / warm / swollen. Covid positive at home according to patient. Patient complains of all over body aches. Patient states he has nose CA - Nose appears blue in color. Patient placed on cotninous bp pressure / pulse ox / cardiac monitoring. Respirations remain tachypneic ~28-30 with sats 94% on 4 l/nc. Pt to be admitted to SDU. Primary Diagnosis: Severe sepsis. community acquired pneumonia. Covid 19. UTI. right lower extremity cellulitis, respiratory alkalosis. demand ischemia troponemia. acute renal insufficiency. Patient is a 57 yo gentleman with RA on etanercept and prednisone, admitted the SDU on 8/21/22 with sepsis & acute hypoxic respiratory failure due to COVID, RLE cellulitis and UTI, and started on empiric cefepime and vancomycin. On 8/22/22, patient developed new onset aflutter with RVR, hypotension, worsening hypoxic respiratory failure requiring HFNC. The patient was transferred to MICU, he was started on an amiodarone gtt. Chest CTA showed evidence of bilateral PE/septic emboli and started on lovenox. The patient has persistent MRSA bacteremia, no evidence of vegetations on TTE. Pt transferred to the SDU this morning. PT treated with decadron and remdesivir.
Local erythema to L upper arm mostly inner arm onset upon awakening AM after rec'd Pneumovax L deltoid. R ankle tender to Bilateral malleoli and R achilles. Treatment Ibuprofen, tylenol PRN & recheck in 24 Hrs.
I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before; I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before; This is a spontaneous report received from a contactable consumer (who is also the patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunization. Medical history included inflammatory bowel disease. Concomitant medication included diphenoxylate from 14Jan2021 for inflammatory bowel disease. The patient stated, "I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before. I never had that before and it feels like I have a hard time when I lay down to breathe and I was wondering if that has anything to do with the side effect of this vaccine." When asked for treatment, patient stated, "No, because it just started yesterday (15Jan2021). That is why I called you. I wanted to know if that dangerous. Do I have to go to an emergency clinic because today is Saturday and everything is closed or should I just do not worry about it." The outcome of the events was unknown.
Nausea; Fatigue; Tingling in left arm (both injections in left arm); Headache; Itchy skin all over but no rash; metallic taste in mouth; light headedness; Heart palpitations; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 31Mar2021 15:45 (at the age of 61-years-old), at dose 2, single for covid-19 immunization. Medical history included GERD (gastroesophageal reflux disease)/acid reflux. The patient had no known allergies. Concomitant medications included dexlansoprazole (DEXILANT); simvastatin; zolpidem; sertraline hydrochloride (ZOLOFT); ibuprofen (ADVIL). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6204, expiration date was not reported) via an unspecified route of administration, in left arm, on 10Mar2021 16:00 (at the age of 61-years-old), at dose 1, single for covid-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. After three months (as reported) on 14Apr2021, the patient experienced nausea, fatigue, tingling in left arm (both injections in left arm), headache, itchy skin all over but no rash, metallic taste in mouth, light headedness, heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test and EKG (electrocardiogram) with unknown results on an unspecified date. Therapeutic measures taken for the events included: blood work and EKG. The outcome of the events was not recovered.    Follow-up attempts completed. No further information expected.
On 5/29/10 Injection site red, hot and swollen. Patient treated with Amoxicillin.
pt recvd vax 26OCT93 & 27OCT93 around 530AM pt awoke w/ringing in ears, which persists; pt described sx as ringing in ears which is worse @ noc; fullness in ears, which seems worse on rt side & h/a;
Headache, confusion, muscle and joint pain, inflammation, fatigue, etc etc.  Including LUPUS FLARE- aggravated Systemic Lupus- which still continues 2 months later..  Also, developed DVT?s in both arms- previously dx.ed with APS- Antiphospholipid Syndrome and was already on anticoagulant therapy.   Possible clot in/near artificial heart valve- further testing being done next week.    After 2nd dose Also increase in Lupus Flare, as well as severe Fibromyalgia Flare- aggravated FMS.  Extreme muscular pain/neurological pain, confusion, fatigue, etc etc.
Successfully chronic migraine treatment of several years stopped working all together. Returned to daily migraines without successfully way to ease or stop migraines for following  three months. Attempting infusing next week as alternative  treatment to Botox and monthly Aimovig.  Crohn?s flare after 10+ years in remission. Daily GI problems: cramping, multiple rounds of diarrhea, fecal incontinence, bloating, nausea, constipation, and joint point.
Narrative:  62 YOM with hx of obesity, ex-smoker, hyperPTH s/p parathyroidectomy, t2dm, cad s/p cabg, htn copd, depression, psoriasis, MNG, osa, ckd. Pt died on 6/27/21 and death was reported to facility by daughter. Pt received COVID vaccines on 3/3/2021 and 3/31/2021. It appears death was unrelated to vaccines.
got a lump in her above ankle; she got sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got sick and got a lump in her above ankle on an unspecified date. Escalating because the caller got sick after her 1st dose. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Chills Aches Headache Fever Diarrhea Knee pain Using Tylenol
Swollen painful lymph nodes in same side of neck and in arm of injection; Swollen painful lymph nodes in same side of neck and in arm of injection; This is a spontaneous report from a contactable pharmacist (patient). A 65-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, the first dose on 23Dec2020 at 10:00 AM, and the second dose on 13Jan2021 at 10:00 AM in right arm, both at a single dose, for COVID-19 vaccination. The patient had no medical history. The patient's concomitant medication included acetylsalicylic acid (ASPIRIN). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On an unspecified date, the patient experienced swollen painful lymph nodes in same side of neck and in arm of injection. No treatment was administered for the events. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the events.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Client reports that on 4/23/2021 received Pfizer vaccine in left arm. Client reported that around 1:00 pm started with symptom of diarrhea, next day chills, fevers, mild sweats and coughing. Client stated the coughing may be from his smoking. Client expressed that he is still experiencing diarrhea now for four days. Per Client does have underlying medical condition. No follow up MD and no medication taken for symptoms. Client has been drinking Pedialyte to try and stay hydrated. PHN suggested that Client follow up with PCP, urgent care, ER and call 911 for medial emergency. Client verbalized understanding information provided by PHN during TC and plan to follow up with ER, due to, no longer having a PCP.
chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (muscle pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 9 JULY 2021 and contain non significant information.
Ever since have the shot I'm feeling worse/Each day seems to be getting worse; Burning feeling on the bottom of the right foot/ and burning in my muscle; Something is happening to the muscle that never happened before; Muscle pain/Aching in my muscle; Shooting pain into my brain; Rash on my bottom; Burning feeling on the bottom of the right foot/ and burning in my muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle) and HEADACHE (Shooting pain into my brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to vaccine.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle), HEADACHE (Shooting pain into my brain), RASH (Rash on my bottom) and MYALGIA (Burning feeling on the bottom of the right foot/ and burning in my muscle). At the time of the report, VACCINATION COMPLICATION (Ever since have the shot I'm feeling worse/Each day seems to be getting worse), BURNING SENSATION (Burning feeling on the bottom of the right foot/ and burning in my muscle), MUSCLE DISORDER (Something is happening to the muscle that never happened before), MYALGIA (Muscle pain/Aching in my muscle), HEADACHE (Shooting pain into my brain), RASH (Rash on my bottom) and MYALGIA (Burning feeling on the bottom of the right foot/ and burning in my muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No Treatment information was provided.  The patient stated that she is scare to death and high risk patient.
I had - as soon as she gave me an injection - I felt like it was a little bit hot. I told her that. I knew I had a lot of allergies so I was being careful. Within a minute of sitting down, my right arm became swollen and bright red and felt burning and itchy. And it spread across my chest and went to my left arm. The rash or hives continued up my  neck up to my face and that all happened within first five minutes. Immediately after that, I had excessive coughing - couldn't cough up anything. I couldn't catch my breath and my throat started swelling a bit. they gave me 25 mg of Benadryl - capsule over the counter - and the 9-1-1 operator advised not to use the epi- pen. Paramedics came - gave me addition 50 mg of Benadryl - and they took me to the ER across the street and I was administered another 25 mg of Benadryl and also some steroid - Solumedrol - and after receiving these - then these symptoms went away. I continued on Benadryl and prednisone for a few weeks - the very next week - I had a large streak that went from injection site to left chest and I had a second red streak from left chest that ran down to my left arm. For two weeks, that burning fire rash would just come. No rhyme or reason as to when or why - arm, neck, chest, legs and sides. And I'd have to take extra Benadryl every time it would happen and I was still on the high dose of steroids as well. I also had - the next day - 24 -48 hours after vaccine - I had a severe headache and it lasted all day long. And about 24 hours after the vaccine- extreme fatigue, body aches and headache and weakness and that lasted for about three days. Fatigue lasted three to four weeks. Joint aches lasted three to four aches. Headaches have still continued. They have almost been worse actually. I had two headaches that I was so concerned about that would not go away - worst headaches I have ever had: one on May 1 and one on May 9 - and I took Maxalt and some Benadryl - the Benadryl did help a little bit (enough for me to go to sleep). Each headache lasted 12 -15 hours and they were the most severe headaches I had ever had. I didn't have anyone to take me to take me to hospital so I just tried to sleep. I saw my primary care doctor - virtual visit. I took the prednisone for two to three weeks. I still contend with the headaches.
This spontaneous report was received from the consumer's wife referring to her husband, a 60 year old male patient. The patient had no pertinent medical history and he had VICODIN allergy. On 31-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date were unspecified, route of administration was reported as vaccine) one time vaccine. Concomitant medications included unspecified medications. On 05-SEP-2015, the patient developed chickenpox symptoms on his chest (varicella) which itch (pruritus). It was reported that the patient sought for medical attention. No product quality complaint was involved. The patient underwent blood and urine tests on approximately October 2015 (reported as 2 weeks ago), but the results were not provided. At the time of the report, the outcome of pruritus and varicella was unknown. The relatedness of ZOSTAVAX with the adverse events was not reported. Additional information is not expected since there is no consent from the physician to be contacted.