chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulty breathing; feeling under the weather and arm was sore; arm was tender, tough to the touch, and hot to the touch; injection site was red/purple; size of a palm; arm swelled up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (difficulty breathing), TENDERNESS (feeling under the weather and arm was sore), VACCINATION SITE REACTION (arm was tender, tough to the touch, and hot to the touch), VACCINATION SITE SWELLING (arm swelled up) and INJECTION SITE ERYTHEMA (injection site was red/purple; size of a palm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included PARACETAMOL (TYLENOL) for Migraine.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm swelled up). On 06-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site was red/purple; size of a palm). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing), TENDERNESS (feeling under the weather and arm was sore) and VACCINATION SITE REACTION (arm was tender, tough to the touch, and hot to the touch). On 23-Feb-2021, VACCINATION SITE SWELLING (arm swelled up) had resolved. At the time of the report, DYSPNOEA (difficulty breathing), TENDERNESS (feeling under the weather and arm was sore), VACCINATION SITE REACTION (arm was tender, tough to the touch, and hot to the touch) and INJECTION SITE ERYTHEMA (injection site was red/purple; size of a palm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information provided   This case was linked to MOD-2021-030077, MOD-2021-032239, MOD-2021-032129, MOD-2021-032177 (Patient Link).
Selling of lips, tingling and numbness of the inside of mouth. Lasted for 8 hours.
Mother said severe reaction to the ROTATEQ given to child later in the day. He was crying, pulling up his legs  and abdominal  tightness. Mom said she took him to emergency room where they kept child overnight. He was fussy and ran temp for several days and she said doctor thought it was reaction to this vaccine and requested that child receive no further doses.
Received pneumovax on 10/20/06, 10/23/06 reported on 10/21 developed fever and chills, hurts to abduct shoulder and arm, cellulitis DX'd Keflex 500 mg 4x daily started, 10/24/06 no improvement pt insisted on referral to dermatologist seen same day, recommended watchful waiting, to call if edema increased, 10/25/06 CBC drawn appt with DR suspect immunization reaction, cellulitis, no evidence of systemic reaction.
Got dizzy and light headed. Passed out 5 minutes after vaccine. Heart rate dropped to 39. Threw up once after waking up.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. The physician reported a case of syncope or fainting following the vaccination. The patient also had Hep A (manufacturer unknown) and Tdap that same day. The physician reported that the patient fainting 5 to 10 minutes after the injection. The patient did not need any medical care, or going the emergency room, and did not die. The patient fully recovered. Additional information has been requested.
Tenderness at injection site; Redness at injection site; Swelling at injection site; Rash little down at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash little down at injection site), VACCINATION SITE PAIN (Tenderness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L220A) for COVID-19 vaccination.     No medical history reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash little down at injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (Tenderness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE RASH (Rash little down at injection site), VACCINATION SITE PAIN (Tenderness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included Tylenol (acetaminophen) and topical Benadryl (diphenhydramine).
Temporary loss of vision in left eye for about 1 min (called Amaurosis Fugax) . Afterwards enhanced dryness of both eyes with feeling of solids at both ends of eye but is getting better with 5 min heat pad over eyes and using eye wetting solutions about 4 times a day. Dryness getting better each day. These effects 4 days after  Moderna Vaccine first dose.
Injection given at 3:56.  Pt seated in chair at 4:05,  Pt complained of dizziness, became diaphoretic, fainted. Regained consciousness. Alert and oriented x3. At 4:05  -Vital Signs- 113/57-56-20 Pulse Ox  100% At 4:25- 130/83 - 59 - 20 patient eating and drinking without difficulty. At 4:50- 131/91-64-20 Temp 97.1
Got lower back pain  and joint pain the next day after first does ,  lower back pain sometimes better sometimes worse for more than one month. At the six  week post vaccine,  lower back pain almost gone, and got the second dose of the vaccine. Got fever, chill , joint pain and  lower back pain the next day of the second dose. Fever, chill,  joint pain went away within two days. Lower pack pain do not go away., still hurting now, and 5 days ago pain  go down to  legs, feel leg  weakness,  leg muscle pain and tense. Had to take days off from work due to the lower back pain.
Shortly after vaccine administration, the pt  honked her car horn for help and was noted to be minimally responsive. Initial BP was noted to be 60/palp. She was promptly given a dose of epi (epipen) at appx. 0830. She did not improve immediately and required a second dose of epi.  Prior to transport by EMS, she improved slightly and denied any respiratory symptoms or skin involvement. She complained of feeling weak and tired only. SP02 was 89% and HR was in the 70s and regular. 02 was administered by EMS and she was given a dose of Benadryl, 25mg as well.  While EMS was still on scene with the pt, BP improved to 130 systolic and she was noted to be significantly improved.  She had a significant period of hypotension for appx. 20 minutes however (prior to improvement).  Unclear if she had a prolonged vasovagal response  or possibly anaphylaxis. She did not have clear mucosal, respiratory or GI involvement to suggest a definite diagnosis of anaphylaxis.  She was transported to local ER by EMS in improved condition.
This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of PROQUAD (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of -13 degree Celsius for 5 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
There was no adverse event that we have known of.  This form was filled out bc manufacturer has sent notice to recall the pfizer 5-11 primary series after the date  of injection indicating that the lot was having stability issue.
Prior to the Moderna vaccine series, I have always had a very regular cycle.  It was so regular that even my phone's health app would tell me when my period was coming and was always right!! I used to get a normal, 5 day period, every single month; even on birth control years past.  The period after the 2nd dose of Moderna was normal, but was only 5 days after 2nd shot. The 2nd period after the shot (April 21st) came super light and brown. The 3rd period after the Moderna shot occurred May 14th.  On May 14th, I bled for 13 days straight.  The bleeding was heavy and would not stop. I was living in the bathroom, bleeding through a super PLUS tampon every 45-60 minutes (and I usually just use regular size).  I had huge blood clots- clots the size of a cookie.  I eventually telephoned the doctor and told her that I needed something, anything, to stop the bleeding.  I was given Progesterone to take.  After 13 days of bleeding it finally stopped.  I then had to take Progesterone at a lower dose the entire month.  After the Progesterone, my doctor suggested I start birth control pills to "regulate" my period.  Now I have been on birth control for June and July.  In June, I spotted the entire month with brown blood, but did not get a regular period.  I have not gotten a period at all since this process.  I do take the placebo pills as instructed to with the use of birth control pills.  I am not even getting a period on the placebo pills. I used to be extremely regular.  My doctor's office sent me for a blood test to make sure I wasn?t pregnant and I am not.  Still, I do not get a period.  I was NOT on birth control when I got the Moderna vaccine.
C/O pain in arm at time of injection-stated he felt injection was given "too high." C/O soreness in deltoid area which has led to decreased ROM. Denies redness, swelling, warm at injection site. Has not taken any medication. Not used ice/heat treatment, not sought medical care.
Patient woke up this morning and felt very dizzy, fell and hit her face, causing a nosebleed and possible fracture of nasal bones. She was seen at ER where they ran testing, observed her for an hour  and sent her to our office
On day after vaccine, patient had a red, swollen, and hot leg with initial concern for cellulitis by Dr. but symptoms resolved with Benadryl and time and no antibiotics were started.  The next day, patient developed a fever which he has now had for 3 days, one day of vomiting, and full body rash.
Confusion, Headache, Myalgia, Chest tightness, SOB, HA, "feel off kilter"  Narrative:
HURT GOING IN, DIDNT FEEL GOOD 30 MINUTES AFTER, HURT MORE ON 2ND DAY WITH A RED ITCHY LUMP/RASH NEAR INJECTION SITE. ITCHINESS HAS SUBSIDED BUT STILL HURTS AND TENDER TO TOUCH.
given a patient a dose that went out instead if the patient's arm; given a patient a dose that went out instead if the patient's arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE CONNECTION ISSUE (given a patient a dose that went out instead if the patient's arm) and UNDERDOSE (given a patient a dose that went out instead if the patient's arm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (given a patient a dose that went out instead if the patient's arm) and UNDERDOSE (given a patient a dose that went out instead if the patient's arm). At the time of the report, DEVICE CONNECTION ISSUE (given a patient a dose that went out instead if the patient's arm) and UNDERDOSE (given a patient a dose that went out instead if the patient's arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI 10/28/2022 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/28/2022 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI CARDIOGENIC SHOCK 10/28/2022 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI
Chills, fever, nausea, headache, aches in joints.  Lasted 36 hours. Did not take any meds to reduce pain.
Dizzy, light headed, sweats, confusion, inability to walk due to dizziness, nausea. Lasted until 4/9.
Information has been received from a registered nurse concerning her friend, an adult female patient, who was vaccinated as a child with her dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Subsequently, the patient developed measles as an adult. Unspecified medical attention was sought. Additional information has been requested.
testing positive for Covid; testing positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mold and lyme" (unspecified if ongoing), notes: Mold and lyme; "Mold and lyme" (unspecified if ongoing), notes: Mold and lyme. There were no other medication in 2weeks. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "testing positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I felt better Day 5, 6 and 7 after testing positive for Covid and taking Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient felt better Day 5, 6 and 7 after testing positive for Covid and taking Paxlovid. On day 8 however her headache returned along with stomach pains and vomiting.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Augmentin: Allergy"; Septra, reaction(s): "Septra: Allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 30Oct2023 to 03Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202300366003 Same patient, different product/event;
Symptoms began with the left side of my upper lip swelling about 2 hrs after the vaccine. The swelling spread across the full upper lip, and the inner orbit area of my left eye. The left side of my face looked as if it had swelled a bit. I had a welty rash on my thighs, stomach and inner arms. The rash went away after two 50mg doses of BENADRYL 4 hrs apart. The facial swelling took a full 24 hrs and 25 mg of BENADRYL every 3 to 5 hrs.
Patient started experiencing allergic reaction about 30 mins after immunization when she was at home. Reported swollen tongue, droopy face, tachycardia. Went to MD and received BENADRYL, EKG and was monitored for approximately 2 hours before sent home.
On Day 2, I had chills and a bit of temperature (100.6), nauseousness for 2 days, on day 3 and 4, I experienced stiffness in my neck and left ear intermittent pain.  Also a tightness feeling around my neck and head.
Per patient, he has had shoulder pain since the first injection.  He got a second injection of Shingrix 10/8/19.  He says he has needed physical therapy for that arm.  His son suggested he get the name of the manufacturer to report this to them.  We have reported it internally at pharmacy.  Our pharmacists are thoroughly trained to ALWAYS have both patient and pharmacist seated to ensure proper placement into to deltoid muscle.
Pain and swelling at injection site 2 months after immunization (3/20/14).
Pt received the 2nd dose of HAVRIX 1 month after first dose instead of 6 months later. Spoke with the manufacturer and the protocol is to recommend the patient get the 2nd dose again but six months later. Spoke with patient and pt understands.
Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam e home from work around 4:30 and laid down til 5:30 and I woke up feeling a little better but around 6:15 I felt the same as earlier that day and then it got worse. My ears were ringing loudly and I had shortness of breath, I had difficulty breathing, and my chest was tight and I had pain in the center of my chest and I was nauseous and hungry but really couldn't eat anything. I checked my BP at home and it was 189/127 and then 192/122. I was well hydrated but I drank 2 16 ounce glasses of water and sat down to try and relax. An hour later the ringing stopped and I was feeling much better. I took my BP again and it was up to 202/126. I decided to go to the ER at this time. around 11pm it was 143/89.    Ringing and flushed still present with some stomach issues (4/9)
fever; chills; body aches; fatigue; This is a spontaneous report was received from a non-contactable consumer or other non-HCP (Patient). A 20-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration on 01Feb2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had taken 1st dose of vaccine and had no side effects. On 01Feb2021, after second dose, the patient had experienced fever, chills, body aches and fatigue. Symptoms lasted 24 hours and she is now feeling well. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Feb2021, the patient had recovered from the events.  No follow-up attempts are possible; No further information expected.
102 degree fever Body aches Pulled muscles due to chills Chills Insomnia
SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Experiencing symptoms of COVID and he tested positive today after a home test.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: COVID-19 (non-serious) with onset 21Sep2022, outcome "unknown", described as "Experiencing symptoms of COVID and he tested positive today after a home test.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of COVID-19.  Additional information: The reporter's husband got the COVID-19 bivalent booster vaccine 2 days ago. However, he's been experiencing symptoms of COVID and he tested positive at the time of report after a home test. The doctor prescribed Paxlovid and reporter knew it's a protease inhibitor that prevents viral replication. The reporter asked if Paxlovid will interfere with patient's immune response to the vaccine, thereby making him develop a less-strong immunity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
gen macular pap rash x 3 days; t100.5; ER visit 22APR95 11AM; given APAP;
The whole underside of my upper arm (fr armpit to elbow) turned into red, hot welt - that itched and hurt. I had to take CLARITIN and BENADRYL for 2 weeks (per my doctor). My doctor told me never was I to take another shingles vaccine - ever. Nor am I to get any other vaccines with any of the shingles vaccine ingredients. My daughter took pictures of my arm (did not print so well) but I would be able to email one if you like. It has now been exactly 4 weeks since the vaccine and I still have a large area of discoloration on my underarm. I consider this an adverse reaction. Apparently, because my arm did not fall off the pharmacist does not think so - but I had to contact my doctor - twice - take medicine that cost $ - it is an adverse reaction. My husband also had the shingles vaccine and he only had a small welt - nothing like mine.
Moderna 2/13/21, 3/18/21, 10/24/21. Positive on 1/29/22
About two days after I received the vaccine, two days later in the morning I woke with hives on the left side of my body.
ended up in Emergency dept with  weakness, falls, dx with shingles also, after being seen they transferred him to Hospital where he was admitted and dx with Guillain Barre syndrome
patient had a large red area of erythema, warm and tenderness, spreading down arm, on lateral and medial site for several days past injection. Shingrix and Pneumovax administered in the same arm