chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two months old female patient who was vaccinated with ACT-HIB (lot number: UI822AAA, expiry date: 05-Jan-2019) in right thigh, which was reconstituted with sterile water instead of saline diluent on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and FLUZONE QUADRIVALENT for Immunisation. It was an actual medication error due to Inappropriate reconstitution technique. Patient did not have any side effects. 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. List of documents held by sender: none.
1 1/2 days p/recvd vax pt had temp to 103 w/APAP, irritable, sweating, lifting legs, unable to sleep, taking PO poorly; Seen by MD 24FEB92 who felt it was due to vax but put pt on ATB; 2MAR92 pt still irritable w/low grade fever 100F
loss of hearing; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 12:00 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if patient had COVID prior vaccination. The patient experienced loss of hearing the day after vaccination administered on 19Jan2021. It was unknown if treatment was received and unknown if patient had tested COVID post vaccination. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Patient began having lower lip numbness approximately 10 minutes after vaccine was given, along with associated lightheadedness and a "hot flash." All vital signs were within normal limits. MD was brought to patient to assess. Patient was  given 20 mg ODT cetirizine after 10 minutes of increasing lip numbness and tingling.  All symptoms resolved within 10 minutes after receiving medication. Patient was observed for 30 minutes and released home.
Client verbalized feeling lightheaded.  Client was evaluated by Fire Rescue and released to go home at 12:47 pm accompanied by spouse.
Child was given 0.5ml of the Moderna vaccine for 6 month to 5 years.  This was the first dose of a primary series.  The container that holds the vaccine in the fridge was mislabeled by staff and states to give 0.5 ml instead of 0.25ml.  This was immediately changed once this happened and we realized the error.
The day after my vaccination I felt very fatigued and a lymph node on the left side of my neck was swelling - it was painful to move my head around. For treatment I put ice on it and just decided to do a bed rest and the next day my fatigue was gone but the swelling lasted 3-4 days.
Developed tinnitus.  High pitched ringing in ears. It has been about two weeks.
Pt received Pfizer dose #1 and was stable/asymptomatic after 15min monitoring period. she reports on the way to her car she began to feel tingling on the left side of her neck that radiated to the jaw/cheek/lower eye on the left. VSS on check x2. Case discussed with doctor and Pt deemed stable to DC home
About 30 to 60 second after, burning sensation spreading from injection point. Within about 5 minutes light headedness, shortly after confusion occurred. About 10 minutes after a headache start and mild nausea. Headache and nausea progressively got worse, while light headedness and confusion stayed about the same. Lightheadedness and confusion subsided about 4 to 6 hours later. Nausea and headache continued for 5 to 7 days. A sore throat and stuffy nose developed about 2 days after receiving the vaccine, and continued for 3 to 4 days.
Localized LUE reaction. 11cm x 13cm area of redness and swelling.
Myocarditis; Chest pain; high fever; Inflamed lymph nodes; This is a spontaneous report from a contactable other hcp.A male patient of 43 years old received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Jan2021 13:00 (Batch/Lot Number: EL3249) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included splenectomy from 1995 to an unknown date, mildly high cholesterol.He gets the Pneumovax because he is immunocompromised and gets kind of sick feeling. He gets it every 5 years and does get a fever afterwards; he got the Flu vaccine in Sep2020 or early Oct2020.he got the Flu vaccine in Sep2020 or early Oct2020.The patient's concomitant medications were not reported. Patient previously received the first dose of bnt162b2 on 05Jan2021 for covid-19 immunization. The patient experienced myocarditis in Mar2021 with outcome of recovered, high fever on 27Jan2021 with outcome of recovered, inflamed lymph nodes on 27Jan2021 with outcome of recovering, chest pain in Mar2021 with outcome of unknown. Stated that he received his 2nd dose on 26Jan2021 and had really inflamed lymph nodes and a very high fever. He didn't have chest pain until 4-6 weeks later; around Mar2021. Stated that his lymph nodes were really inflamed for about 2 months after the 2nd dose. They were so inflamed that he said he had a hard time turning his head. States that the other day he was saying that his lymph nodes were still inflamed. He had a very high fever for about 2 days. States this was concerning because they were told that if he had a high fever he would need antibiotics right away because of his splenectomy.  He was having chest pain every night when he laid down, but then it got severe, and normally he doesn't complain of anything. He went to the doctor the next day and had an EKG and blood work. Caller states that she doesn't remember the date this occurred, only that it was probably sometime in Mar2021. States that they weren't worried about anything on the EKG, and he had mildly high cholesterol. His doctor put him on Lipitor and Prilosec OTC, but now they are questioning whether he needs to be on them. Stated that about a month later it came out that myocarditis was a side effect of the vaccine. When they read the symptoms they realized that's what he had because every symptom matched, but at the time the doctor didn't know to be looking for that.Stated that the symptoms have gradually gone away. The patient underwent lab tests and procedures which included blood test: unknown, electrocardiogram: unknown. Therapeutic measures were taken as a result of myocarditis, chest pain. The causality between BNT162B2 and Inflamed lymph nodes,  high fever was related.
pain neck and back; pain neck and back; body chills; fever; throat swollen little bit; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat swollen little bit), NECK PAIN (pain neck and back), BACK PAIN (pain neck and back), CHILLS (body chills) and PYREXIA (fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PHARYNGEAL SWELLING (throat swollen little bit). On an unknown date, the patient experienced NECK PAIN (pain neck and back), BACK PAIN (pain neck and back), CHILLS (body chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 26-Feb-2021, PHARYNGEAL SWELLING (throat swollen little bit) had resolved. On 05-Mar-2021, NECK PAIN (pain neck and back), BACK PAIN (pain neck and back), CHILLS (body chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
swelling down toward elbow & up toward shoulder hardness to area the size of adult palm of hand-warm to touch lasted 2 days & gone;
9/6/20197 AM body aches, including neck, hips, low back. Fatigue. 1,000 mg Tylenol taken at 8 AM . Within 45 mins, symptoms abated. 6 hours later, symptoms reappeared. Another dose of Tylenol 1,000 mg taken at 2:30 PM. 6:00 PM fever 100.5 (normal temp 97.4).  Slept through the night  6/7/19 Awoke 7 AM, fatigued, less achyness, but some,  sore arm, large hot red area at injection site. Tylenol every 6 hours through the day.   9/8/19 symptoms gone, except for redness and heat at injection site. Still sore to the touch 1000 mg tylenol taken at 1 PM  9/9/19 all symptoms except redness and heat at injection site gone
This spontaneous case reported by a consumer, describes the occurrence of constipation (two days without bowel movements) and decreased appetite (can't eat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011A21A) for COVID-19 immunization. Concurrent medical conditions included diabetes. Concomitant products included insulin for an unknown indication. On Feb 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 27, 2021, patient experienced constipation (two days without bowel movements) and decreased appetite (can't eat). At the time of the report, constipation (two days without bowel movements) and decreased appetite (can't eat) outcome: unknown. Diagnostic results: On Feb 27, 2021, blood glucose: elevated (high) other. Treatment information included: Laxative.
My arm became swollen to the size of a baseball and was hot to the touch.  It has a red spot about one inch long and 3/4 of an inch wide.
Abdominal Pain; Nausea; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 02Jul2021 at 16:30 (at the age of 20-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 23Jul2021 at 16:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and migraine. The patient was allergic to cephalosporin. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), and paracetamol (TYLENOL) for migraine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was 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 03Jul2021 at 08:00, the patient experienced abdominal pain, nausea, headache and fatigue. The clinical outcome of the events abdominal pain, nausea, headache and fatigue was not resolved at the time of this report.
Starting 2 days after injection the arm became very sore from injection site all the way to tips of fingers. Fingers became numb and couldn't hold things. Very severe body pain at night that is lingering. Skin on middle fingers is sore to touch. Gradually able to grasp things again after 2 weeks.  Primary care physician appointment 9/9/19.
I got the vaccine last Thursday but it's still swollen, red, and hurting; I got the vaccine last Thursday but it's still swollen, red, and hurting; I got the vaccine last Thursday but it's still swollen, red, and hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (I got the vaccine last Thursday but it's still swollen, red, and hurting), VACCINATION SITE ERYTHEMA (I got the vaccine last Thursday but it's still swollen, red, and hurting) and VACCINATION SITE PAIN (I got the vaccine last Thursday but it's still swollen, red, and hurting) 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 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION SITE SWELLING (I got the vaccine last Thursday but it's still swollen, red, and hurting), VACCINATION SITE ERYTHEMA (I got the vaccine last Thursday but it's still swollen, red, and hurting) and VACCINATION SITE PAIN (I got the vaccine last Thursday but it's still swollen, red, and hurting). At the time of the report, VACCINATION SITE SWELLING (I got the vaccine last Thursday but it's still swollen, red, and hurting), VACCINATION SITE ERYTHEMA (I got the vaccine last Thursday but it's still swollen, red, and hurting) and VACCINATION SITE PAIN (I got the vaccine last Thursday but it's still swollen, red, and hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Pfizer dose administered based on beyond use of date 9/26/2022. Expiration 8/31/2022. Mother was notified. Pfizer report summited received notification vaccine is viable to use until 9/28/2022. updated parent
I took the second dose on the 01/20/21 on my left arm at 3pm. My arm started feeling very sore at 9pm, on the following day had headaches, low grade fever, body aches, nausea and very tired. I took Tylenol and fell asleep.
Patient had Syncope.  No treatment needed, Patient responded immediately. 911 medical help arrived, but patient said she is feeling good. She stayed in the pharmacy for while and then she left with the person who came with her.
I got the vaccine and then less than a week later I started having symptoms. Then today I found out I had covid. So the vaccine actually gave me covid.
Face swelling/ face is still swollen/ swelling on the face; This is a spontaneous report received from a contactable consumer (daughter of patient). An 83-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route in the arm on 28Jan2021 (LOT: EL9265) and the second dose on 19Feb2021 (LOT: EN6198) in the arm, both as single doses, both at the age of 83-years-old, for COVID-19 immunization. Medical history included kidney condition, heart issue, liver problems, hard of hearing, and he's getting older and shrinking. Concomitant medications were not reported. The patient experienced swelling on the face right after receiving the first dose of the vaccine, since Feb2021. It's been 4-5 months and it's growing bigger and bigger. Reporter described that if she put a big plate on patient's face, his face would look like that, it's huge. She reported that the swelling is so much to the point she can't even see his eyes; his eyes are so small right now, she can hardly see his eyes. The lady who took the patient to get the second vaccine, saw his face was a little bit bigger, but she thought he had gained weight. The patient has seen the doctor and per doctor he is fine, doctor told him there's nothing wrong, it's normal. Reporter added that patient didn't tell the doctor about the vaccine. The reporter (daughter) stated that her dad was normal, his body was fine until he got the (company) vaccine and time after time he is starting to get worse. The clinical outcome of face swelling was not recovered.
Fever and chills 30 hours later continuing to present time (from 7:00pm 4/9 to 12:05pm 4/10)
The first week widespread hives on arms/back/legs for 2 up to 7 hours at a time. After the first week random locations of arms/legs. hives are itchy and spread when itched. React to  Benadryl. This has been ongoing nearly every day for 2.5 months since 4 days after vaccine.
Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in underarm and body aches.  Overnight I was restless and unable to sleep well, body aches and hot and then chilled and cold.  By morning my arm was so sore and swollen it was difficult to move it, continued with all over body aches, fatigue to the point of unable to sit up, no fever but alternated chills/cold and hot/sweat.  I did take ibuprofen every 4-6 hours throughout the day.  This is the same type of reaction I had to tetanus when a teen.
Info has been received from a health professional concerning a male pt who in approximately October 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy at the same time in the opposite arm included a dose of influenza virus vaccine, "flu vaccine". The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently, in approximately October the pt developed "severe" soreness to arm, the pain was rated "10" on a pain scale of 1-10. It was noted he had to go to bed and take pain medication for 48-72 hours. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.
17 years was given the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (17 years was given the vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C51A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced OFF LABEL USE (17 years was given the vaccine). On 20-Jul-2021, OFF LABEL USE (17 years was given the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Expire Date: Product Was schedule to expire on 17AUG2021 after removal from freezer.
dizzy; feeling drugged; numbness; loss of most use in hands; took extreme amount of planning and effort to speak a singular word or move any part of body; nausea; vomitting; Hands/ fingers, legs, eye, all developed tics; Legs were twitching all night; little achey; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 40-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: UNKNOWN), via an unspecified route of administration in the left arm on 06Feb2021 at 16:30 PM (at the age of 40 years) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications taken within two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN), gabapentin, fluvoxamine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took cephalexine and experienced drug hypersensitivity. On 06Feb2021 at 17:30 PM, the patient started to get dizzy, feeling "drugged", numbness, then loss of most use in hands (significant weakness- could not hold a cup), took extreme amount of planning and effort to speak a singular word or move any part of body, nausea, vomiting, hands/ fingers, legs, eye, all developed tics, legs were twitching all night, little achy. No treatment was taken for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had  been tested for COVID-19 on 18Feb2021, Nasal Swab: Negative.  Information on the lot/batch number has been requested.
chills, fever (101.8), muscle cramps, shivering, headache, body aches
Saturday,Shot at 10:00am: within 15 minutes- migraine, joint pain and slight swelling in left wrist and hand, fatigue (took frova for migraine) Around 7:00PM- chills and issues with temperature regulation (still had migraine, took 2nd frova) 9:00 9PM: nausea, chills, burning sensation on throat, lower-half of face (no swelling or difficulty breathing), burning spread over enitre body- felt like being boiled alive and still had chills throughout the night. Sunday, about 9:00am- walked around for a few minutes and then experienced dizziness and blacked out-my face hit something on the way to the floor.  couldn't stand up because everything would turn black again.  had to crawl or be dragged under my armpits to the bed (took reglan for nausea because I felt like I was going to vomit but couldn't safely get to the bathroom)  about 12:00pm- dizziness when standing but no blackouts.  migraine and nausea remained, fatigue, arm soreness Monday, fatigue, nausea,  and migraine- in bed entire day- eating but no appetite Tuesday: out of bed but still have nausea, fatigue, slight dizziness
Projectile Vomiting starting 1 hour after vaccination, continuing at varying intervals for the rest of the night
Next day muscle sore, redness around arm, puncture site still there Raised rash eight days later puncture site still there round red mark elevated blood sugar going down but still elevated
Information has been received from a nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (route, dose, Lot# and expiration date not reported), which were improperly stored. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
The pt developed a high fever (106F highest), chills, hiccups, joint pains and swelling. Discharge summary states additional diagnoses of pancytopenia, myalgia, mild maxillary sinusitis, cyst of L lobe of liver, and mildly enlarged spleen.
Information has been received from a physician concerning a patient who on unspecified dates was vaccinated with two doses of VARIVAX (Merck). On 29-JUL-2009 the patient developed a case of breakthrough chicken pox after getting two doses of VARIVAX (Merck). The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
One week post vaccine a doctor's visit identified my blood pressure was significantly high. I had had a headache since the day of the vaccine, although it started before the vaccine.  Two days prior to my vaccine I had a doctor's visit and my blood pressure was 118/78, the range it has been in for the last several years. Since learning that my BP was elevated my primary care doctor has doubled my Olmesartan to 40mg and three weeks post my vaccine it is still running high, in the 135-150/85-95 range. In the two months leading up to the vaccine I have been exercising regularly, controlling my diet, and losing weight. The vaccine is the only change in lifestyle at the time of the sudden increase in blood pressure. I have spoken to three other women who have had similar experiences with their blood pressure post the vaccine but they didn't make an association until I mentioned it.