chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Golf ball sized knot; Swelling of arm; hives; rash; Slow Breathing.; This is a spontaneous report from a contactable consumer. A 35-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 21Jul2021 11:00 (age at vaccination 35 years) as dose 1, single for covid-19 immunisation. Medical history included known allergies: Latex. There were no concomitant medications. The patient previously took codeine and experienced drug hypersensitivity, historical vaccine flu vaccine vii and experienced drug hypersensitivity. 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 29Jul2021 the patient experienced golf ball sized knot, swelling of arm, purple colour hives, rash, slow breathing. Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient received treatment of 40Mg prednisone, benadryl every 3 hours, zyrtec 2x. The outcome of events was recovered with sequelae.  No follow-up attempts are possible. No further information is expected.
I received the 2nd dose of the COVID-19 vaccine on 9/23/21 at 5:30 pm. I had no side effects for the rest of that day. On 9/24/21 I had a sore arm upon waking. I continued with my normal routine and went to work. The only medication I take is Lexapro 10 mg and a daily multivitamin. I ate meals and snacks this day, drank a normal amount of water and nothing changed in my routine. Around 10:00 AM I started to experience extreme muscle aches, chills, and fatigue. I took 400 mg of Ibuprofen which reduced the severity of these symptoms. Around 3:30 PM I left work and felt the Ibuprofen start to wear off. I was driving on a main road where the speed limit is 55 mph. My body became extremely achy again and I got the chills. As I was driving home from work, my vision started to disappear. A black shadow came from the left into my field of vision and I had just enough time to start pulling over to the side of the road before I passed out. When I came to, my car was on a grassy shoulder of the road, still in park, just inches from a fence. I was able to put my car in park and felt confused. I was sweating and had chills. I got out of my car to inspect for damage and luckily did not hit anything before my car rolled to a stop. I got back into the car and became very tired. I fell asleep for an unknown period of time. When I woke up I still felt clammy and had to sit for a while until I felt oriented. I was scared and confused as to what had happened as I have never experienced a fainting episode in my life. Due to the fear of the unknown, I drove myself the rest of the way home feeling fatigued, achy, and chills. Upon arriving home I took my temperature which was 101. I spent the rest of the night and whole next day in bed or sleeping. I was afraid to drive for days after this in case it should happen again. I was unaware there was a system to report this until now, which is why I am just completing this report today. In hindsight, I should have went to the hospital or doctor and had someone drive me home but I was unable to think logically and was scared.
Cranky, very quiet, stopped babbling and talking, loss of interest in parents, limited eye contact.
nausea; vomiting; thought she was going to die,; This is a spontaneous report from a contactable other healthcare professional via Pfizer-sponsored program.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 03Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included antibody therapy from Oct2020 to an unknown date. Concomitant medications were not reported. On an unspecified date, after first dose, patient had nausea, vomiting and thought she was going to die. The patient had her second dose scheduled for 24Feb2021. Patient wants to see if it was ok to receive second dose. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
w/in 6hr of lt thigh IM vax devel severe induration, erythema of entire lt thigh spreading to lt hip area & lt groin;
Swelling at the injection site and swollen lymph node under in arm pit area on left arm (same arm as injection)
2 inch diameter that is warm; angry; 2 inch diameter that is red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (2 inch diameter that is warm), ANGER (angry) and INJECTION SITE ERYTHEMA (2 inch diameter that is red) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L70A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (2 inch diameter that is warm), ANGER (angry) and INJECTION SITE ERYTHEMA (2 inch diameter that is red). At the time of the report, INJECTION SITE WARMTH (2 inch diameter that is warm), ANGER (angry) and INJECTION SITE ERYTHEMA (2 inch diameter that is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medication was reported.  Patient said she doesn't want to provide any details.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20 JUL 2021: No new information.
Feeling very unwell starting on Saturday morning.  Could not do usual activities like picking up sticks in the yard.  Heart Attack very late Sunday night.  Went to the Emergency room and had stents placed late Monday.
Pt c/o of weakness in legs in the afternoon that resulted in a fall. He later was hospitalized for 3 days.
Fever up to 102.2 for 36 hours, severe chills, nausea, stomach ache, headache, muscle soreness throughout, injection site became quite red, swollen
Phlebitis, UrticariaPruritus,  INJECTION SITE WARM RED SWOLLEN AND ITCHY SUDDENLY 8 DAYS AFTER VACCINE Narrative:
No other AEs; PNEUMOVAX 23 was administered after expiration date; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, intramuscularly, lot # T010293 (has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) formulation vial), expiration date: 30-AUG-2021 (dose number and anatomical location were not reported) for prophylaxis after expiration date (expired product administered). No other adverse event was reported (no adverse event). The outcome was unknown.
The patient developed vomiting approximately 2 hours after vaccination and intermittently the next 6-8 hours, then intermittent gagging. The patient had no fever and was instructed to keep fluids down. There was a similar reaction with all triplets.
Tingling in legs, increased to shooting nerve pains in legs and also memory loss. Treated with Amoxicillin po X 6-8 weeks; IV antibiotic X 8 weeks.
Hive with itching on body.  Vaccine given at PCP.  Other clinic filling form.
achy and tired 24 hours; achy and tired 24 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), PAIN (non-serious), outcome "recovered" and all described as "achy and tired 24 hours".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Soreness started the date of injection.. getting severe next day and starting spreading through the whole arm and it was very painful when pt raised her arm up.
Patient experienced severe pain, swelling and redness at the injection site on 10/18/18.  Patient then started having severe cases of dizziness starting 10/22/18 and continues to this day.
Saturday night started with severe chills, shaking, upset stomach, headache, hard vomiting  four time thru the night, right arm sore and hot to touch, muscle aches, and stomach around rib area, hard to cough Sunday, started to feel better by Monday except for muscle aches and upset stomach.
Patient received a 3rd dose of Moderna. 1st dose on 1/25/21, 2nd dose on 4/12/21, 3rd dose on 6/17/21.
This case was reported by a nurse via sales rep and described the occurrence of injection site lump in a adolescent female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site lump and injection site erythema. On an unknown date, the outcome of the injection site lump and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site lump and injection site erythema to be related to BEXSERO. Additional details were reported as follows: The patient developed a lump at injection site and redness. The reaction went down the arm and left side of the body. The patient was seen at a local medical center for treatment. No further information was reported regarding the event.
Fatigue and tiredness, after the first vaccine; Chills, after the first vaccine; Joint pain, after first vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), dose 1 via an unspecified route of administration, administered in Deltoid Left on 19May2021 11:00 as dose 1, single for COVID-19 immunisation. Medical history included lung neoplasm malignant from an unknown date and unknown if ongoing Verbatim: Lung cancer, ongoing sickle cell anaemia Verbatim: Sickle cell anemia. There were no concomitant medications. On 20May2021, the patient experienced joint pain, after first vaccine, chills, after the first vaccine and fatigue and tiredness, after the first vaccine on 20May2021 08:00. The outcome of all the events was recovered.  Information about lot/batch number has been requested.
periorbital and peribuccal swelling, mom gave Benadryl 25 mgm and Pepcid 10 mgm took her to ER and was given 0.3 Epi.IM, Benadryl 25 mgm IM, Solumedrol 50 mgm IM Pepcid 20 mgm PO
patient received expired dose IPOL (expiry date- 13-Mar-2021)/no AE; Initial information was received on 16-Mar-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional .  This case involves child patient (age and gender unknown) who received a expired dose of IPV (VERO) [lot number: R1B251M and expiry date: 13-Mar-2021] via an unknown route at an unknown administration site on 15-Mar-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I got the shot at 1:50PM and when I woke up that night (maybe 2AM), my arm was in extreme pain and i could not move my arm at all. I was able to have my husband help me out of bed and starting taking advil. it continued for 3 days with minimal movement and lots of pain, by day 4-5 I could move my arm more and more and stopped the advil. it is 2 weeks later and I have almost all the movement back but there is still some pain (almost like my bicep). The pain is not at the injection site. I did note that the injection seemed to be given very high on my arm, like in higher up in my shoulder.
Patient received PPSV 23 at her visit on 10/12/2020 at 10:45am, by dinner time that day the injection site was itchy and sore with rash on inferior upper arm. The rash then continued to spread to back, abdomen and chest. Was seen in office on 10/14/2020 for evaluation.
Pt reports he woke the next morning feeling extremely dry and dehydrated "as though I had had a fever". Later in the day he thinks he took ibuprofen or ALEVE for body aches. Then around 5 AM on 12/2/18 he woke with drenched sheets - he got up and toweled off, then returned to bed for another hour or two.
Pt had entire arm swollen from site of injection to wrist after Proquad vaccine.
The first vaccine I only had mild arm pain which went away after a few days, exactly 7 days later I had a delayed localized reaction (extreme swelling size of a golf ball, redness, itching, hot to the touch). I spoke with my primary and he recommended to still get the second vaccine. The second vaccine the swelling came on almost immediately (about 2 hours after). It has now been two days since I have had the shot and my arm is now double the size of my muscle. (I am petite, 5?3 and 107 lbs) so my arms are tiny. My arm is red, hot to the touch, swollen and itchy. I have had a fever of 102.8, the lowest I have gotten it down is 101.2 with around the clock Tylenol. Other side effects: vomiting, chills, high fever, EXTREME joint pain. I?m concerned about the localized reaction (I would call it localized allergic reaction). I have photos I?m not sure if I can send them.
Patient received Tdap vaccine during school Tdap clinic on 5/13/09.  On 5/18/09 PHN received phone call from school nurse.  She reports patient's arm is swollen and warm to touch with a red rash about 3/4 the circumference of swollen area.  Rash is about 1 and 1/2" in diameter.  Left arm involved.  Patient saw her PCP.  No treatment indicated.  PCP dx immune response to vaccine.
Hot area, raised area, itchy, size of donut, red painful for 1 week. used anti itch cream, ice, 21/2 Hydrocortisone cream, nerve pain down arm sensitive to touch.
Developed a hardmlump at injection site within 1 hour of receiving.  Several days later, lump subsided, but area because itchy. On 12-26-20 noticed a discoloration or pigmentation at injection site.
Mother called to report increased redness and warmth at injection site no vesicles on 3/27.  We will treat with Keflex and apply cool compress to affected area using cool wet as patient can tolerate.
felt fatigue; aches; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and pain. On an unknown date, the outcome of the fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was unable to recall the details other than female patient who felt fatigue, aches for two days. The reporter agreed to follow up from GlaxoSmithKline (GSK).
On 01/10/07 received #2 dose of MMR (client states this was actually her #3 dose of MMR becasue she did not have documentation of the #1 dose)and #2 dose of Hepatitis A/B (Twinrix). On the same day after receiving the immunizations, the client used a tanning machine set on the lowest setting for 8 minutes. On the morning of 01/12/07 she developed a headache, occasional hot flashes and a burning type pain that is sore to the touch on her left side that extends from her abdomen to her back just below her rib area. Denies receiving a sunburn from the tanning machine, also denies skin discoloration at the pain site, rash, fever, nausea, vomiting, joint pain or joint swelling. Has a history of headaches, occasional hot flashes and chickenpox. Took Tylenol for her headache and it helped but is uncertain if it helped  to relieve her side pain. The side pain continues and is not getting better. MD recommended.
Nausea, severe intractable headache, chills, extreme body aches and fatigue.  Lasted through 9/13/21.
urticaria (hives) or drug eruption; urticaria (hives) or drug eruption; disrupting sleep; allergic reaction to COVID vaccine; Severely swollen left hand; rash bounced between hands and feet/ Rash kept moving randomly around all over body; Itchy rash inner left arm/ itchy rashes on left palm; Lump on left arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose of BNT162B2 (Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 13Apr2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 19Mar2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 15Apr2021 (Day 2), patient had lump on left arm at injection site. On 16Apr2021 (Day 3), itchy rash inner left arm. On 17Apr2021 (Day 4), itchy rashes on left palm. Over next few days rash bounced between hands and feet. On 21Apr2021 (Day 8), patient went to clinic for severely swollen left hand. They almost cut off wedding ring. Tested for Limes Disease. Next major swelling and rash traded between Rt hand, Left foot, Rt foot. At one point left fingertips felt burnt. On 29Apr2021 (Day 16), family doctor told the patient Lyme disease test was negative. Doctor suggested he was having allergic reaction to COVID vaccine. Rash kept moving randomly around all over body, disrupting sleep. Took antihistamines Benadryl, Loratadine and used steroid cream. On 04May2021 (Day 21), dermatologist took skin sample from rash to test. Rash continued. On 19May2021 (Day 36), dermatologist said test suggests urticaria (hives) or drug eruption. Told me to take 4 Loratadine, 2 Benadryl, 1 Pepcid. Rash almost totally disappeared (4 days ago). Supposed to continue regimen for two months. The adverse event resulted in Doctor or other healthcare professional office/ clinic visit, emergency room/ department or urgent care. The outcome of events was recovering.  Follow up needed, further information has been requested.
Nausea, headache, Fever 100.4- 101.0 lasting 2 days, sore throat, tired, pain, redness at and around injection site, R upper arm muscle pain  into armpit lasting 3 days, rash on R arm appearing on day 3 warm to the touch.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Drug taken out of freezer on 9/8/2021 contains 2 vials were administered  to 12 patientsas1st dose to 1 patient,  2nd dose to 9 patients and 3rd doses (immunosuppressed) to  2 patients under no temperature exclusion.  No concomitant medications were reported. No treatment medications were provided.
Arm has dark red circle around injection, with a large ring of red around injection, warm to touch and arm very painful. Pt took BENADRYL and felt relief after 1 day. Was allergic reaction according to Dr.
This spontaneous report was received from a registered nurse who refers to an unknown number of patients of unknown age and gender. The nurse reported that patients might have been vaccinated with a doses of GARDASIL (dose, route and lot# not reported) which were improperly stored (vaccines were exposure to 31 F for 1 and 1/2 hours). No adverse event reported. This is one of several reports from the same source. Additional information has been requested.
Hives bilateral upper extremities. No SOB, dyspnea, chest pain, dizziness, lightheadedness or any other concerning symptoms.
Vomiting began at 10am, continued all day. No food was consumed, and small sips of water not tolerated until 7:00pm
There is no adverse event, was given Menveo (3rd dose) by mistake when it should've been Bexsero.
Soreness/tenderness around the injection site the reappeared days after the injection and is still tender now (13 days later)
Tinnitus.  Continued after dose 2.  Still exists at 5/24/21.  Slight improvement.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 27-OCT-2015, the patient was vaccinated with an dose of expired PNEUMOVAX 23 lot# K004542 with expiration date 19-AUG-2015 (dose, dose number and route were not reported) (expired product administered). No adverse symptoms were reported. Additional information has been requested.
I was given Tetanus shot left arm on 9-29-06. And after 7 months it still aches at times and has a needle mark=raised little bump with scab on it.
Fever or Chills  Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Sore throat
One week after receiving the vaccination I got shingles.  They were located on the right side of my head.
Hives and lip filler swelling 1/11/21 at 8:30am
This spontaneous report was received from a licensed practical nurse, referring to a 14 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 03-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Less than 5 minutes after vaccination, patient experienced syncope and fell from the chair she was waiting in.  She was feeling light-headed and dizzy and remained laying down until the paramedics took her to the hospital.  She did not lose consciousness.