chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and redness of arm that persisted for 3 weeks. Believed to possibly be infection  but resolved on its own without antibiotics
Pt developed facial tingling, throat tightness and anxiety. She mentioned that she may be having anxiety issues. BP 200/120, HR 80 and SP02 98%. 911/EMS evaluation and transport to ER recommended. Pt declined and is aware of the risks of leaving AMA. She improved without intervention. Family picked her up and she departed at 735pm.
a hx of Hashimoto Thyroiditis and Monoarthritis of the left knee received Covid Moderna Vaccine on 1/13/21. Developed chills, then joint pain, headaches and on 1/15 swelling around face and eyes. 1/19/21 Eyes are still itchy and had been taking Benadryl for it. Had video visit with MD, changed to Zyrtec and also refresh tears to the eyes but sx's not getting better with redness and itchiness.  Pt put hydrocortisone cream under her eyes and SX's got better.
The pt came into the flu vaccine clinic today at 1435 to receive her annual influenza vaccine. The writer administered the pt's vaccine in her right deltoid. The pt stated she felt good and thanked the writer for her vaccine and started to walk back to her office. Five to six minutes later the pt returned with a coworker stating that she had chest pain, SOB and a swollen tongue feeling in the back of her throat. The writer took the pt's BP, O2, Temp, pulse and respirations. The pt's blood pressure at 2:47PM was 151/108, her pulse was 78, respirations were 20, temperature was 98.7 and O2 was 98%. The pt was still clearing her throat and appeared cool and clammy. The pt respirations were labored but WNL at 20 respirations per min. The pt stated that her chest was tighter then before. The writer was trying to find the PO Benadryl, but none was available. Therefore, the writer had to administer 50mg/ml of Diphenhydramine via IM injection in the pt's left deltoid. The pt tolerated the injection well. The writer waited 10 mins later to take another set of vitals. The pt's BP was 161/113, respirations were 20, pulse was 72 and O2 level was 98%. The pt stated she was starting to feel woozy from the Benadryl but that her SOB felt better. The writer also gave the pt two apple juice boxes and a small bottle of water. The pt drank all of these liquids. The writer took the pt's vitals again 15 mins later at 1514. The pt's BP was 128/88, respirations were 18, pulse was 68 and O2 level was 99%. The pt stated that her SOB and chest pain was a lot better. The pt stated that she felt tired from the Benadryl but overall felt better. The writer suggested that the pt go to the emergency room to be seen in case anything else were to occur. The pt stated that she would just like to go home and rest and stated she will go in if anything changes. The writer told her to call if anything else changes or if she has any further questions. The pt agrees with this plan and communicated with her manager that she would be leaving for the day. The pt will not be taking the influenza vaccine next year through clinic. If the pt would like her vaccine she will need to go to her PCP or an allergist.
102.2 fever; severe fatigue; severe chills; moderate headache Onset approx 24 hours after vaccine administered. Lasted ~12 hours. 48 hours after vaccine only mild fever, mild fatigue, mild headache.
Daughter had what doctors described as a brain blowout.  She had 9 strokes plus?. She is completely bed ridden.
Patient became diaphoretic, reported feeling anxious. Patient stated her throat felt like it was "turning" and that her tongue "felt big." Patient began exhibiting slurred speech.
Case number PHEH2011US01408 is an initial spontaneous report received from health care professional 09 Aug 2011. This case refers to a boy. He was vaccinated with Menveo intramuscularly on unspecified date. But, the patient received the Menveo lyophilized powder component of Menveo reconstituting with sterile water (Men A CYW). No adverse reaction had occurred following this drug administration error.
Chronic numbness in the face and chronic gallbladder infection/inflammation. There was a gallstone before vaccine but after vaccine the gallbladder became inflamed and numbness on the face was chronic.
Itching after 30 minutes.  Full body hives  after 45 minutes.  Facial swelling and itching.  Racing heartbeat.   Took Tylenol at the one hour mark.  The hives itching lessened after three hours.  The facial swelling and under skin full body itching, extreme tinnitus and racing heart lasted at least 10 days.  Two blood pressure readings during the first week confirmed higher blood pressure.  Everything was normal after 14 days.  My allergist recommended not taking the 2nd Moderna shot.  I am now seeking his guidance on getting the J&J shot - hopefully a test on whether I can tolerate its polysorbate.
About 25-30 minutes after receiving the vaccine, patient stated she felt dizzy, had a "lump in my throat" and had difficulty breathing.  She had already left clinic and drove to the Emergency Room.  At the hospital, they gave patient and EKG and chest Xray and an injection of Benadryl. Patient stated she felt better within 10 minutes of receiving the Benadryl injection.  Difficulty breathing and "lump in throat" went away.  Patient stated that she was diagnosed with an allergic reaction to the vaccine and was advised not to get another COVID vaccine.
None. Patient received two Hep B vaccines on the same  day. Patient received Pediarix, Hep B and Prevnar 13  vaccines. Did not receive Hib vaccine that was due.  Should have been Pediarix, PedVax Hib, Prevnar 13.
I have got really sick; horrible tinnitus, 'sizzling' and ringing in my ear; inability to want to eat; 'excess' fatigue; small fiber neuropathy; I have just been barely able to walk; intense brain fog; I started to get racing heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I have got really sick"; TINNITUS (non-serious), outcome "unknown", described as "horrible tinnitus, 'sizzling' and ringing in my ear"; DECREASED APPETITE (non-serious), outcome "unknown", described as "inability to want to eat"; FATIGUE (non-serious), outcome "unknown", described as "'excess' fatigue"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "small fiber neuropathy"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I have just been barely able to walk"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "intense brain fog"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "I started to get racing heart". The patient underwent the following laboratory tests and procedures: heart rate: racing heart.  Additional information: reporter stated that got the first 2 COVID vaccine, patient was fine with them and got the booster 23Dec (Not clarified) and from the day patient got that booster, I have got really sick, horrible tinnitus, 'sizzling' (not clarified) and ringing in my ear which patient never had before and started to get racing heart, inability to want to eat, 'excess' fatigue, and had small fiber neuropathy (further clarifications unknown) which had been managed and patient had just been barely able to walk and intense brain fog and was hoping that actually go away but it's been few months now and Patient was trying to investigate what could have happened from the booster since it happened that same night.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A few scattered papules on trunk/ext that started on 10/18/08 unsure of time no fever no problems otherwise, no tx given, RTC on 11/3/08.
Received vaccine in left arm and was sore 1st day. Late in the evening the arm became sore/swelling some. Took Tylenol. By the next AM, the swelling doubled in size and had very limited ROM, without discomfort. No redness at site, unable to lean or lay on arm. I had to leave work due to severe nausea, dizziness, palpitations and limited arm movement. Able to move arm but laterally abduction 2"-3" before pain won't allow me to move it any further. Examined by infection control MD who labeled me as severe reaction. Given Benadryl and Motrin. ER MD also saw me and symptoms had improved. On 17th, left arm still sore to touch and with movement. Glands in neck are sore and swollen. On 19th, glands worse. Under the tongue swollen on left side and also neck. By the 24th, able to swallow with minimal pain.
Extreme change in menstrual cycle. I got cramps the same day as the vaccine, more than a week early, which has never happened before in my life. I have already had my period for over 9 days, and it is not done yet, which is already much longer than normal. Stronger cramps and stronger flow. It also started differently than normal, with light bleeding for days at the beginning. I also felt much stronger depression than I have ever felt in my life before. It was overwhelming. I was about to change my birth control method before I put the two together because the pain, flow, and depression were so bad it was unbearable. I was unable to work. I did not report these symptoms on my follow-up survey that I received every day for a week after because I did not know it was connected to the vaccine. I feel so relieved to understand what is going on.
He ran fever for one day keeps vomiting everyday with severe fatigue. He started to have bad congestion, sneezing, sore throat, abdominal pain I have given him Flonase, Mucinex, Dayquil and Tylenol. I took him to the clinic he prescribed nausea medication. As of 9/9/2021 he is still still exp the symptoms.
Patient came to the pharmacy for her 2nd COVID -19 vaccine. She received the vaccine and then was told to wait the 15 minutes in the store for observation. The administration of the vaccine went normal. She walked over to the cooler shortly after receiving the vaccine to get a drink and fainted at that time. The pharmacist on duty called 911 and checked for pulse and breathing. The paramedics arrived within minutes and performed vitals and tests within the store and then as a precautionary measure decided to take the patient to the hospital for a more thorough evaluation.
This spontaneous report was received from the patient's mother regarding her non-pregnant  16 years old daughter. The patient did not had any medical history or concomitant medications. The patient had allergy to Sulfa medication. On an unspecified date in April 2007, the patient received a dose of GARDASIL per intramuscular route (frequency, strength, lot number and expiration date were not reported) for prophylaxis. That day, within 4 hours after vaccination, the patient experienced a fever of 105 degrees (units not provided). The patient contacted her physician and was treated with unspecified medications. The patient recovered from the event a week later, on an unspecified date in 2007. The causality assessment between GARDASIL and pyrexia was unknown. There was no Product Quality Complaint.
Arm hurts so badly/still having the pain; Injected the dose too high; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (Injected the dose too high) and PAIN IN EXTREMITY (Arm hurts so badly/still having the pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (Injected the dose too high). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts so badly/still having the pain). On 10-Feb-2021, ACCIDENTAL OVERDOSE (Injected the dose too high) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts so badly/still having the pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment details were provided    Reporter did not allow further contact
Still now sometimes I get my, in my left arm slight pain; After 8 to 9 months I still get the slight pain; I get pain in my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EL9265) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Still now sometimes I get my, in my left arm slight pain; After 8 to 9 months I still get the slight pain; I get pain in my left arm".  No follow-up attempts are possible. No further information is expected.
4 to 5 hrs. after my daughter received her second H1N1 shots she started to become red. After another hour she was red hot from head to toe. She also started to get welts on her back and stomach. She had a fever of 102.5. She complained her stomach hurt. I took her to the ER. They gave her BENADRYL. She was red for about 2 days.
Information has been received concerning a case in litigation concerning a female patient who was vaccinated with a dose of Recombivax HB on an unspecified date.  Subsequently, the patient experienced a psychological injury.  No outcome information was reported.  No further information is available.
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates between 01-MAY-2016 and 22-AUG-2016 the patient were inadvertently vaccinated with improperly stored PROQUAD (rHA) (dose unknown, lot # M004892, expiration date 25-OCT-2017, subcutaneous). Not adverse effects were reported. Additional information has been requested.
COVID dose 1: Moderna, Lot# 042B212A, 4/17/21 @ 3:45pm, R arm COVID dose 1: Moderna, Lot# 022C21A, 5/15/21 @ 3:00 pm, R arm Sat 5/15/21 @ 1500: 2nd dose administered. 5/15/21 @  Evening: pt states light fever, took OTC Aleve, fever decreased (symptomatic, temp not measured) Sun 5/16/21 @ 5am: intense chills. Daytime: fevers, pt took Aleve, temp of 102.1 F. Evening time: pt reports having flu-like symptoms, head fog, slept most of day. Mon 5/17/21: felt fine, took morning off from work.  Tues 5/18/21 0630am: woke up with chest tightness/pressure, diaphoresis. Pt presented to BI-Milton Hosptial ED, found to have an elevated troponin to 0.35. Cardiac workup for myocarditis.
On April 5 2021, Approximately 2 weeks after the J&J Covid vaccine I noticed the area around my left knee had become discolored (dark brown). I feel no pain, pressure, or discomfort from it. It?s not swollen either-just discolored.
This spontaneous report was received from a patient's mother and refers to an 11 year old male patient. The patient's concurrent conditions included attention deficit/hyperactivity disorder (ADHD). He did not have any drug reactions or allergies. On 16-NOV-2016, the patient was intramuscularly vaccinated with a dose of GARDASIL injection (site of administration, dose, lot number and expiration date were not reported). Concomitant therapies included unspecified medication for ADHD. On 16-NOV-2016 (also reported as 16-NOV-2017), within a half an hour after receiving the vaccine, the patient developed headache. On 17-NOV-2016, he developed vomiting overnight and nausea. The patient was also having a fever of 100.5 (units not reported) (onset date approximately in November 2016). The patient did not seek medical attention (the reporter stated that she did not contact the responsible physician for treatment). Apart from body temperature, no other lab diagnostic studies were performed. No treatment was given for the events. The outcome of headache, vomiting, nausea and fever was reported as not recovered. The relatedness between these events and the vaccination with GARDASIL was not reported. Additional information has been requested.
Large red swollen area immediately after injection was given. Began to subside 15 to 20 minutes after injection. 01/07/05, arm is sore and slight swelling remains.
went sick/got sick again; This is a spontaneous report from a contactable pharmacist (patient) received via a Pfizer-sponsored program.  A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown) on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. Patient said she received both doses of BNT162B2 in Jan2021. In Jun2021, she went sick, but tested negative for COVID-19. She had an antibody test, and it came out positive for IgG. Then, she got sick again and tested negative for COVID-19. This time, when she got tested in Sep2021 for antibodies, it came out negative. Patient wanted to know if that meaned she didn't have antibodies to protect her. She wanted to know how to calculate antibodies. Event was reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive in Jun2021, COVID-19 antibody test: negative in Sep2021, COVID-19 test: negative in Jun2021, COVID-19 test: negative in Sep2021.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Dizziness, body aches, headache, nausea, low grade fever.  all started on 04/23/2021 at around 8:00am.
Pt recv vax on 2/3/99; 1/2 hr post vax pt exp pain & edema w/ no visual signs
child recv vax & mom  dx w/shingles;the reporting MD felt that secondary transmission & shingles were not related to vax;
A little over a week after receiving the vaccination the small red spot turned into 2 knots under the skin that were itchy and slightly red.  They remained there for approximately a week then started swelling and getting very red and swollen. I went back to pharmacy on 7-1-19 and she said I had cellulitis. Gave me Keflex. By 7-3-19 the area on my arm was much more swollen and the redness had spread more. I then went to see Dr at Urgent Care and she said I need a different antibiotic to try to get it under control. She put me on Doxycycline. I am currently on day 3 of this new medication and not much improvement. If it is not better by day four I will be going to the ER to make sure that I don?t need more extensive treatment.
HARD TO WALK AS LEFT FOOT TENDON WAS BOTHERING; HEADACHE; MUSCLE ACHE; FEELING TIRED; INJECTION SITE PAIN; SMALL LUMP OVER INJECTION SITE; 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, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced small lump over injection site. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced muscle ache. On 06-APR-2021, the subject experienced feeling tired. On 06-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced hard to walk as left foot tendon was bothering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling tired, and had not recovered from headache, muscle ache, injection site pain, small lump over injection site, and hard to walk as left foot tendon was bothering. This report was non-serious.
Patient is age 11 years and was given the Grey cap (12 and older) formulation of covid vaccine.   No adverse reactions. Patient age 11 years old was given the grey cap formulation of the covid vaccine (Pfizer manufacturer) as his booster vaccine.   Pfizer was contacted who reported no repeat dose is needed and patient can continue on normal trajectory of series.
Back aches. Muscle aches. Light pain in stomach. Slight head ache. Chills.
excursion lasted for 2 hours and 20 minutes. The minimum temperature of the refrigerator reached 29.1 degrees Fahrenheit with no reported adverse event; MENACTRA was given to patient post excursion with no adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 16 years old female patient who reported excursion lasted for 2 hours and 20 minutes. the minimum temperature of the refrigerator reached 29.1 degrees fahrenheit with no reported adverse event and menactra was given to patient post excursion with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included althaea officinalis root, cinnamomum camphora essential oil, citrus aurantium oil, eucalyptus globulus leaf essential oil, mentha x piperita essential oil (GARDISIL); and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 26-Jul-2022, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of 0.5 ml once (lot U7483AB, expiry date: 20-Oct-2023) via intramuscular route in the left arm for immunisation.  On an unknown date there was excursion that lasted for 2 hours and 20 minutes. The minimum temperature of the refrigerator reached 29.1 degrees fahrenheit with no reported adverse event (product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 26-Jul-2022 the patient developed a non-serious menactra was given to patient post excursion with no adverse event (poor quality product administered, latency same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event excursion lasted for 2 hours and 20 minutes. the minimum temperature of the refrigerator reached 29.1 degrees fahrenheit with no reported adverse event and was Unknown for the event menactra was given to patient post excursion with no adverse event.     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 the guidelines. 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.
Patient checked in stating as having Moderna as 1st dose.  Was not checked in THOR.  PHN states "there are two Moderna Vaccines today.  I assumed patient was checked and double checked, they were not. Patient was roomed and given Moderna Vaccine.
Body aches and pains, began the next morning after my dose about 24 hours later, I  felt like I was coming down with the flu. I also had pain and redness at injection site. I increased fluids and took Tylenol and symptoms lasted 10 to 12 hours and subsided completely.