chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 20Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: EW0217), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Down syndrome" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Gastric reflux" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN taken for contraception. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient received treatment of Paxlovid from 14Jul2022 to 19Jul2022 for COVID 19 Treatment. Positive home rapid test on 28Jul2022 at 11.00 PM. Patient was recovering.
Symptoms: Severe Shivering Nausea Vomiting Muscle Weakness Joint aches Muscle Pain Lethargy Severe Headache
Injections given on 3/3/23.  In the evening of 3/5/23 parents noted redness around deltoid injection site.  Redness still present on the morning of 3/6/23 and had spread down the upper arm.  Mom reports that the skin was red, but no noticeable swelling .  Skin warm to touch.
Red, hot swollen right arm from inside of elbow up to mid-section of upper arm. They visited the urgent care next door as it was difficult/painful for her to put her arm in the sleeve of her coat. They gave her a steroid and antibiotic. I called patient today (3/1/19) and she is doing better. The swelling has gone down some.
Patient felt light headed within 5 minutes and developed a headache. Patient took 2 regular strength Tylenol for the headache.
COULD NOT FOCUS; SKIN HARD AT INJECTION SITE; POSSIBLE SEASONAL ALLERGIES; LITTLE BIT OF STIFF NECK; NECK PAIN; LITTLE RASH AROUND INJECTION SITE; TOP SHOULDER SORE; SORE ARM; RAISED RED SPOT AT INJECTION SITE; FATIGUE; HEADACHE; NAUSEA; LIGHT SENSITIVITY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included thrombocytopenia, and concurrent conditions included allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced light sensitivity. On APR-2021, the subject experienced skin hard at injection site. On APR-2021, the subject experienced possible seasonal allergies. On APR-2021, the subject experienced little bit of stiff neck. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced little rash around injection site. On APR-2021, the subject experienced top shoulder sore. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced raised red spot at injection site. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Treatment medications included: cetirizine hydrochloride, paracetamol, and rizatriptan benzoate. On 21-APR-2021, the subject experienced could not focus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, top shoulder sore, nausea, and neck pain, had not recovered from sore arm, fatigue, and light sensitivity, and the outcome of little rash around injection site, could not focus, raised red spot at injection site, skin hard at injection site, little bit of stiff neck and possible seasonal allergies was not reported. This report was non-serious.
Expired Vaccine Adminitered by LPN:  Patient was administered first booster dose (0.25ml) Moderna (lot #058A22-2A) on 07/16/2022. This Moderna vaccine had an "expiration date" of 09/10/2022 and "beyond use date" of 07/13/2022. Therefore, this vaccine was expired by 72hrs.  I, was the Staff member Team Lead on shift; however, two LPNs on shift drawing up and administering vaccines on this day
Extreme coldness, violent uncontrollable shaking for three hours.  Muscle weakness has lasted, so far, through 5:50 on 10/03/2014.  Mild nausea continues along with extreme fatigue.
Low grade fever, with-in one hour of injection.  Moderate fever with-in 6 hours of injections. Treated with fever reducers. High fever 2 and three days after injection.  Treated with fever reducers. Odorous urine with-in 24 hours of injection. Intense pain at injection site immediately after injection and for 2-3 days afterward.  Treated with pain medicine.
Within two hours of receiving flu shot, broke out in rash over arms and trunk and had severe itching. No respiratory symptoms.
bronchospasm, dyspnea, minimal throat swelling. symptoms duration, 3-4 hours after onset. I took a Benadryl.
The evening of the vaccination I wasn't able to move my arm at all, It was very painful.
Patient came in for a TB test and the medical assistant grabbed the polio vaccine instead of the TB and gave the polio intradermally in patient's right forearm. The patient came back in the next day and now has a red area that is raised and is the size of a nickel.
day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, woke up in wet clothes from sweat, headache, runny nose Day 3- sore arem, red and swollen, warm to touch, felt lethargic day 3-  arm just red and warm to touch. big red circle where shot was given day 4- sitting down and out of nowhere a sharp pain felt in back by neck and shoulders. could not move my neck. arm still a   little red but not warm to touch. swelling went down.  (went to ER on day 4. blood work and xrays were negative for anything. was given muscle relaxer.) day 5 sore muscles but on muscle relaxer to help day 6 until day 10 - just fatigue and sore muscles/joint pain but tolerable.
I got the vaccine on Monday 11/09/09, on Monday 11/16/09 I developed Bell's Palsy. They are both -Bell's Palsy and Shingles - caused by the same virus. My question is did the vaccine cause my Bell's Palsy? I also had just gotten over a sinus infection and have had Bell's Palsy before in 1982.   11/24 and 11/25 Medical records recieved for DOS 11/17-11/24 Final DX: Bell's palsy L side facial weakness. Seizures. Eye discomfort, dryness. L eye ptosis. Altered taste sensation, facial pain. Stable. Improving. ICD9 codes:  351.0, 374.31, 345.80, 070.54
Received Hib and Prevnar on 8/1/2006. Had a febrile seizure 12 HOURS AFTER GETTING VACCINE.  Seen in ER.  BLOOD WORK DRAWN AND ALL WAS NORMAL. He alo developed a fever since getting the vaccines that he has had persistantly, running at 102-103 degrees F.
Nauseous; I did start throwing up; Headache; This is a spontaneous report from a contactable consumer (patient herself).   This 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 27Dec2020 at 07:30 AM at single dose for COVID-19 immunisation.  The patient was vaccinated at hospital, age at vaccination was 65-year-old. Relevant medical history included diabetes, blood pressure abnormal and thyroid disorder. Relevant concomitant medications included insulin for diabetes, levothyroxine for thyroid disorder, and lisinopril for blood pressure abnormal. She was a MRI tech. She stated ''I had COVID Vaccine this morning at 7:30 and a little while ago like about 4'o clock. I work mid night, I got up from bed and I stand little nauseous and I did start throwing up and I have bad headache now but that's it. It is not emergent, but I just want to make sure, I am just checking in because I haven't. I can't get my smart phone to work because it keeps discharging so fast, but I was in bed. I am all right.' She stated ''there is no rash or anything. I just got nauseous which surprised me.'' The second dose is planned for 19Jan2021.  No therapeutic measures were taken as result of the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pt. received her 2nd dose of the vaccine and while waiting in the pod  she complained the left side of her tongue was tingling. She was given some water to sip. Then stated that she felt her left cheek droop and her left eye is not focusing as well as before. Stated she did not have a reaction after her first dose. A droop was not noted on her face.  Pt. initially refused (thought it would take too long) but then agreed to be taken to the E.D. and ambulated instead of using a w/c. Upon arrival, she stated that her tingling seemed to have worsened and it was now on her buttocks, she reported to an RN who came to triage her.
Employee stated she did not feel well after injection. Was experiencing some chest heaviness and later informed me that her tongue felt thick. Later that evening, she experienced chills alternating with feeling of being hot.
49-year-old patient vaccinated on 4/9/2022, but wasn't eligible at that time for second booster.
Pt recvd 1st dose of Hep B vax on 27JUN91; the following day pt exp fatigue, anorexia, & devel fever of 99; missed 1 day of work; 1JUL91 sx resolved-pt recovered;
Myocardial infarction Narrative: PMH significant for aortic valve stenosis, mitral valve stenosis, CKD, CHF, DM, HTN, obesity, hypothyroidism and dyslipidemia. Per report from primary care - the patients wife reports that the patient went on Saturday (1/30/21 - about 1050) morning to receive his COVID vaccine. He returned home and told her about the experience and denied any side effects. He then proceeded to sit in his easy chair for a while and around 1:30, she asked him if he wanted any lunch. The patient's wife reports he "grumbled" at her, and then got up to go to the bathroom. She then heard a loud crash and found him lying on the floor of the bathroom, with his head knocking hole in the wall as he fell. She could not detect a pulse. She called 911 and began compressions. First responders to the scene likewise tried to revive him but were not successful in her efforts. Per primary care documentation - Uncertain if related to Pfizer vaccine; vaccine administered on 1/30/21 and approximately 3 hours later suffered fatal MI at home.
2FEB98 employee noticed lt arm redness x 15x15mm & induration x 6x6mm;
Patient noted to by hypotensive during routine clinic follow up visit and sent to ER for further evaluation.
Rapid heart beat for 45 minutes, shortness of breathe, light-headed, nausea
headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Hypercholesteremia. Concomitant products included METFORMIN for Diabetes, ATENOLOL for Hypertension, OMEPRAZOLE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported. Other concomitant medications included Blood thinner and Cholesterol pill.   This case was linked to MOD-2021-364084, MOD-2021-364085 (Patient Link).
PT CAME IN FOR MMR VACCINE FOR NON IMMUNE MMR STATUS, MMRV (PROQUAD) WAS PULLED AND ADMINISTERED TO THE PT INSTEAD OF MMR. NO TREATMENT GIVEN TO PT, PT NOTIFIED OF EVENT.
I just developed a very sore throat; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 28Dec2020 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications included multivitamins (unspecified). The patient just developed a very sore throat on 29Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was unknown.  Information about lot/batch number has been requested.
Facial paralysis developed 15-17 days post immunization.  Private MD Dx. Bells Palsy and tx with Antivirals x 7 days
Information has been received from a female consumer who on an unspecified date was vaccinated with a "combination formulation" of hepatitis A virus vaccine inactivated and hepatitis B virus vaccine rHBsAg (manufacturer unspecified) which contained thimerosal. Subsequently, she had an unspecified "reaction". There was no product quality complaint involved. No further information was available. Additional information has been requested.
discomfort; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 08Jan2021 as dose 2, single (Lot number: EL1284), in left arm and on 03Sep2021 as dose 3 (booster), single (Lot number: EW0151), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INDERAL; LANSOPRAZOL; ROSUVASTATIN. The following information was reported: DISCOMFORT (non-serious), outcome "unknown".  Additional information: This is the first time that I got this side effects, the first three were great, just a little discomfort.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200764756 Same patient and drug, different event separated in time
Within 24 hours of immunization patient experienced slurred speech, syncope, and seizure like episodes.
Diarrhea; This is a spontaneous report from a contactable 36-year-old female healthcare professional reported for herself that she received bnt162b2 (BNT162B2) on 23Jan2021 02:45 PM for COVID-19 immunization Medical history was not provided. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Concomitant drugs were reported as none. The patient experienced diarrhea on 24Jan2021. Event was reported non-serious and no treatment was received for it. The patient has not tested for COVID-19. Outcome of the event was resolving.  Information on the lot/batch number has been requested.
C/o severe pain in upper left arm-from deltoid up to shoulder and across upper back and neck-swelling, redness warmth and difficulty raising arm.
Back pain; Spasm and contractions around rib cage with a lot of discomfort and pressure; felt like he was losing his breath and breathing really shallow; pulse ox in the 90's; This is a spontaneous report from a contactable consumer (patient's mother).     A 26-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 17:00 (Batch/Lot Number: EW0186) as single dose for covid-19 immunisation  .  The patient medical history was not reported.  In the past the patient received tetanus vaccine.   There were no concomitant medications.  The patient experienced spasm and contractions around rib cage with a lot of discomfort and pressure  on 17May2021 with outcome of unknown , felt like he was losing his breath and breathing really shallow  on 17May2021 with outcome of unknown , pulse ox in the 90's  on 17May2021 with outcome of unknown , back pain  on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included electrocardiogram: unknown result,  oxygen saturation: pulse ox in the 90's   on 17May2021  .  Therapeutic measures were taken as a result of the reported events.  Course of the event. Really bad muscle spasm and contractions around rib cage with a lot of discomfort and pressure: It was interfering with his breathing, like, he couldn't breathe and breaths became really shallow. It felt like he was losing his breath. 17May2021 was the day he ended up in the hospital, in the ER. He had the vaccine the Saturday before, in the afternoon. A few days later, he did have other pain, back pain. When he was back at work, when this started, he had pain in the back and ribs. He was treated with  a ton of stuff. They gave him Diazepam, steroid or something, troponin, valium.  They had it marked as emergency level 5, thinks it was a pretty high one.  They had prescribed him cyclobenzaprine (FLEXERIL) after that visit and naproxen sodium 500mg.  Follow-up activities closed: Follow-up attempts are completed. No further information is expected.
Pt experienced N&V, diarrhea, low grade fever, and chest pain.  Taken to ER @ apx. 9pm.  Given fluids, Ativan, Benadryl, Toradol, and Reglan.  Final dx:diarrhea, vomitting, & febrile illness. Differential dx: side effect of immunization.
Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a female who was vaccinated with GARDASIL.  The patient became pregnant after getting GARDASIL vaccine.  The patient sought unspecified medical attention.  Follow up information received from a physician indicated that she was a 25 year old female patient (weight 132 lb) smoker (one and half packs per day (PPD) now down to half PPD), with no pre-existing allergies, birth defects or medical conditions, and no illness at time of vaccination and no history of previous pregnancies who on 16-FEB-2009 was vaccinated IM in her right deltoid with the first dose of GARDASIL.  Concomitant vaccination received the same day included a dose of TDAP (unspecified) (lot # A014).  The physician indicated that the patient was pregnant at time of vaccination but it was too early to detect it.  Her LMP was 26-JAN-2009, her EDD was 09-NOV-2009.  From 17-FEB-2009 to 03-MAR-2009, the patient took on CHANTIX to quit smoking.  On 04-MAR-2009, the patient had a positive urine pregnancy test.  Subsequently on 18-MAR-2009 and on 20-APR-2009, two ultrasounds were done respectively to verify dates and pregnancy viability, and confirmed that vaccination occurred around conception, her estimated conception date was 16-FEB-2009 (+/- 1 week).  Follow-up information has been received from medical records concerning the now 26 year old female who at 37 weeks, on 21-OCT-2009, at 17:59 delivered a 2862 grams baby girl.  The Apgar score was 7 in 1 minute and 9 in 5 minutes.  The patient was admitted on 20-OCT-2009 and was discharged on 23-OCT-2009.  The patient experienced cystitis, abnormal cervical cytology, chorioamnionitis and labial laceration during this pregnancy.  The cystitis was resolved prior to delivery.  The infant experienced intrauterine growth restriction, baseline fetal tachycardia, loss of fetal heart rate variability and fetal gastroschisis during labor and delivery.  Laboratory diagnostic studies while the patient was in labor and delivery were: blood type, A positive, antibody screen was negative, Pap smear was abnormal, Rubella immune, Venereal Disease Research Laboratory (VDRL) non reactive, GC negative, urine culture/screen positive, HBsAG negative, HIV negative; HGB performed at 24 weeks was 10.9; O'Sullivan test performed during 24-28 weeks was 99.  Fetal gastroschisis is considered a congenital anomaly.  The infant's experience has been captured in WAES 0904USA01023B1.  Additional information is not expected.
This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient receive PREVNAR 13, intramuscular in left arm on 11Jun2018 09:00 at single dose at the physician office for pneumonia prevention. Medical history was none. There were no concomitant medications. On 11Jun2018, around 13:00 the patient left arm, where the injection occurred she experienced arm pain. Also at 13:00 on 11Jun2018 she began to have a horrible, pounding headache. Then at 14:30 she had to leave work because of the headache and went home to bed. The next day, 12Jun2018 around 06:00, she experienced body aches and fatigue. A couple hours later round 10:00-11:00 she experienced dizziness and nausea. On 13Jun2018 the patient was finally feeling better. Her headache was minor and she barely notices it. Her left arm pain has since improved as well, before she couldn't lift her arm above her head but now she can, she just can't touch her arm still. Before she could barely get out of bed but on 13Jun2018 the fatigue, dizziness, nausea, and body aches have subsided. The patient started feeling better at around 06:30 on 13Jun2018. The outcome of the events horrible, pounding headache and Left arm pain/where the injection occurs she experienced arm pain/couldn't lift her arm above her head was recovering. The outcome of the event fatigue was recovered with sequel on 13Jun2018. The outcome of other reported events was recovered on 13Jun2018. The information on the batch number has been requested.
Chicken pox like rash appeared 10 days after VARIVAX vaccination with 1 day of a low grade fever. Mother brought toddler into office. BENADRYL prescribed PRN. Spoke to mother of child this morning, 9/24/18. Mother states rash improving and no reported fevers.
eye started twitching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 23 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 11:50 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLEPHAROSPASM (non-serious) with onset 08Apr2021, outcome "not recovered", described as "eye started twitching".  Additional information: Reported she was calling on the behalf of her boyfriend, who had his first COVID-19 Vaccine on 08Apr2021. She said a couple minutes after her boyfriend received his first COVID-19 Vaccine, he had eye twitching right away and it lasts a couple of seconds and it happens every couple of hours. Reporter states his received the injection in his left arm. She stated her boyfriend's eye twitching was like if a person was tired or had too much caffeine From: 8 Apr 2021 To: Ongoing). She said the eye twitching stopped at the time, but her boyfriend still had eye twitching that happened a couple times during the day since then. The caller asked since her boyfriend was still experiencing the eye twitching, was he at risk if he got the second COVID-19 Vaccine. She said her boyfriend wanted to know if he should still get the second COVID-19 Vaccine, because he wanted to be fully vaccinated. Had this type of side effect been reported before?.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came into pharmacy about one week after receiving shot. She reported radiating nerve pain that shot down her arm that she received the shot in. She was unable to sleep and went to the local urgent care where she was given a cortisone shot that relieved her pain. Pain lasted for 3 days.