chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SPOT ON HER LEFT LEG THAT LOOKED LIKE A VEIN HAD RAISED UP/RED SPOT ON HER LEG; FEELS LIKE ITS MOVING UP AND DOWN; WHOLE BODY HURT; DIZZINESS; FAST HEART RATE; SHORTNESS OF BREATH; ARM PAIN ON INJECTION ARM; PAIN IN ARM WHEN INJECTING; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-smoker, and latex allergy. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced dizziness. On 26-JUN-2021, the subject experienced fast heart rate. On 26-JUN-2021, the subject experienced shortness of breath. On 26-JUN-2021, the subject experienced pain in arm when injecting. On 26-JUN-2021, the subject experienced arm pain on injection arm. On 27-JUN-2021, the subject experienced whole body hurt. On 02-JUL-2021, the subject experienced feels like its moving up and down. On an unspecified date, the subject experienced spot on her left leg that looked like a vein had raised up/red spot on her leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart rate on 30-JUN-2021, and shortness of breath on 01-JUL-2021, had not recovered from whole body hurt, feels like its moving up and down, pain in arm when injecting, and arm pain on injection arm, and the outcome of dizziness and spot on her left leg that looked like a vein had raised up/red spot on her leg was not reported. This report was non-serious.
Swollen lymph node on the left side of her neck; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on the left side of her neck) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (stomach upset), Drug allergy (Hives), Adhesive tape allergy (hives) and Migraine. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy NOS, ALMOTRIPTAN MALATE (AXERT) for Migraine, ESTRADIOL for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node on the left side of her neck). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN) for Swollen lymph nodes, at an unspecified dose and frequency. On 31-Jan-2021, LYMPHADENOPATHY (Swollen lymph node on the left side of her neck) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LYMPHADENOPATHY (Swollen lymph node on the left side of her neck) to be possibly related.    The patient reported lymph node in clavicle area on left side became very enlarged and swollen on the same side as the injection. It got smaller as the weeks went on. She reported the same thing happened with second dose of vaccine. She reported no long term issues at this point. Additional concomitant medication included allergy shots.     This case was linked to MOD-2021-086524 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient details, medical history, product details, concomitant medications and event outcome updated
Less than 1 min after inj burning, numbness, tingling started down right arm  about 20 min's after inj tingling into right shoulder, chin, and both lower jaws.  next day, stumbled, fell against bathroom wall.  On May 28th felt electric shock behind left eye, white and blue s wave across left eye., left sided weakness, stumbling, stuttering, and left upper eyelid slower to open when blinking sometimes.  Think I have had a stroke.  Tried to get into Dr, no appt available.  Tried to get into Dr for 2 weeks.  Finally called Dr office and told registrar I am scared.  Left work and went to work in appt. Had lab work, clear.  Had MRI, clear.  Was told TIA does not show up on CT scan.  Now have to take low dose ASA for rest of my life.  Still have residual symptoms.  When tired find myself veering off slightly to left when walking, or sometimes I stutter words.
Pt returned to clinic 3 days after receiving ZOSTAVAX vaccine. C/o increasing redness, swelling, warmth & tenderness at injection. Approx 7 dm area of erythema swelling seen at (L) post arm at injection site. Area warm & tender to the touch. Pt saw primary care doctor today & was prescribed AUGMENTIN.
Moderna dose #3 (booster dose #1) was administered 3 weeks prior to the immunization schedule. The immunization schedule as of today 5/10/2022 states that individuals can receive the first booster dose at least 5 months after the second dose of the primary series.  The patient received dose #2 (second dose of the primary series) on 1/3/2022. Today, 5/10/2022, she received her first booster (Moderna dose #3). The adverse event was that the patient received the first booster (Moderna dose #3) 3 weeks early. The patient waited in the waiting area at the vaccination clinic for 15 minutes after the vaccine was administered, and then left the clinic to go home. No symptoms or reactions were observed or witnessed at the vaccination clinic.
The patient did not have an adverse reaction to having been given Quadracel instead of IPV.
Back Ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Ache) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BACK PAIN (Back Ache) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back Ache) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Swelling, redness, lump/hardness  at 1.5 inches below injection point.  This has continued  for one week as of today, and the lump, redness still present with slight itchiness. However, my body temperature and blood pressure is at normal.
Patient inadvertently given 1st dose of of Moderna covid 19 vaccine on 3/1/21 and was approved by EPFD Chief, EPFD Medical Director, and TDEM, to receive his 2nd dose of Moderna Covid 19 vaccine on 3/25/21.
localized rash on upper left arm, approximately 5 inches in diameter. recommended diphenhydramine for rash and acetaminophen if needed for pain/fever
Patient received vaccine on Saturday morning 2/4/23. Monday 2/6/23 patients skin was sensitive to the touch on the whole left side of his torso. Tuesday he started noticing the blisters  on his left back and left abdomen.  Saturday Feb. 11 patient went to urgent care and was diagnosed with Shingles. He was prescribed Valtrex and Gabapentin.
got a fever,; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (got a fever,) 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 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PYREXIA (got a fever,). At the time of the report, PYREXIA (got a fever,) had resolved.            No concomitant medications were reported. No treatment medications were reported. Patient experienced the symptom after receiving second dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow- up contains significant information where patient reported that she has been recovered. On 04-Nov-2021: the follow up document contains non significant information( email updated)
There was no adverse event. FDA approved the administration of the Pfizer COVID 19  vaccine on 5/10/2021  for the age group of 12 to 15 years old.  However, ACIP haven't stated anything yet.  Pharmacy Intern acted accordingly and vaccinated the 14 years old female.  The patient had no issues nor any adverse events.  However, our employer required us to submit this form.  Thank you.
like you're feeling when you're sick; temperature of 100; weaker; not feeling himself; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (like you're feeling when you're sick), PYREXIA (temperature of 100), ASTHENIA (weaker) and FEELING ABNORMAL (not feeling himself) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced MALAISE (like you're feeling when you're sick), PYREXIA (temperature of 100), ASTHENIA (weaker) and FEELING ABNORMAL (not feeling himself). At the time of the report, MALAISE (like you're feeling when you're sick), PYREXIA (temperature of 100), ASTHENIA (weaker) and FEELING ABNORMAL (not feeling himself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Tylenol
Significant increase in volume of my tinnitus in my left ear  - about 2 octaves higher than it was prior to vaccination.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Pt was unresponsive appr 5 mins after receiving COVID Vax. Pt was sitting next to husband and husband called for help. Upon galncing at the pt, pt appeared unconscious and shaking, possibly seizing. EMS (911) was called and in the mean time RPH attended to pt. By the time EMS arrived pt was starting to respond and gradually aware of environment and self. Pt was recommended visit ER for further check up, but pt and husband declined, she stated she is doing fine and much better and husband agreed
Received vaccine approximately 1pm on 2/1/21, at 11pm I felt fatigued, took two Tylenols.  I awakened with chills on 2/2/21 at 4am, took Tylenol. Around 11am on 2/2/21, I became nauseated, fever of 99.8, severe muscle aches over entire body, headache. Nausea subsided by 2/3/21, all other symptoms continued and new symptom of breast tenderness. On the evening of 2/3/21,approximately 6pm,  lower lip began to swell. The lip swelling subsided by next morning on 2/4/21. I alternated Tylenol and Ibuprofen from the evening of 2/1/21- 2/3/21.
Erythematous patch shortly after injection, followed by an area of raised induration. Knot felt underneath arm. Pain and warmth at site.
Coughing; RUNNY NOSE; CONGESTION; SNEEZING; Itching under my tongue; Hard to swallow; lips started puffing up; difficulty breathing; Anaphylactic reaction; Itching on both sides of her jaw; Itching in my eyes; Sore arm; A spontaneous report was received from a consumer, concerning a female patient of 70 years age, who received Moderna's COVID-19 vaccine and experienced itching on both sides of her jaw, but not at her chin, and itching in her eyes.He had sore arm, coughing, runny nose, congestion, sneezing, itching under my tongue, had to swallow, lips started puffing up, anaphylactic reaction.  The patient has SIRS(Systemic Inflammatory Response Syndrome) and is being treated for mold toxicity. Patient was receiving an IV treatment for mold toxicity. Patient took Benadryl (diphenhydramine) as a treatment for events such as itching on both sides of her jaw, but not at chin, and itching in eyes and sore arm.Concomitant product use was not provided by the reporter.  On 20 Jan 2021 prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (042L20A) via unknown route for COVID-19 infection prophylaxis.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, such as itching on both sides of  jaw, itching in eyes, sore arm were considered as resolved and events such as coughing, runny nose, congestion, sneezing, itching under tongue, had to swallow, lips started puffing up, anaphylactic reaction were considered to be not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
07/02/22 presents to regulatory authority for "dog bite wounds on her left arm, forearm and right hand/wrist". PMHx of "COVID-19 infection 6/27/22 with mild symptoms" "HTN, HLD, CKD-III, anxiety/depression"
Shortness of breathe, fever, dehydration, diarrhea, abdominal pain, chest pain, chills,
5 minutes after vaccine given, patient fainted while seated.  She was aided to the floor where in a supine position she quickly came to.  After 15-20 minutes she felt well enough to sit up.  She was able to walk out of the clinic after another 10 minutes.
feeling real hot; feel sweaty and that they didn't sleep; Feeling real cold; they had chills; experiencing severe headache,massive headache; fever; they cant sleep; pain in the arm; their joint hurt; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (they cant sleep), VACCINATION SITE PAIN (pain in the arm), FEELING HOT (feeling real hot), HYPERHIDROSIS (feel sweaty and that they didn't sleep) and FEELING COLD (Feeling real cold) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00521a and 043l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Hypertension).   On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (pain in the arm), ARTHRALGIA (their joint hurt) and NAUSEA (nausea). On 26-Aug-2021, the patient experienced INSOMNIA (they cant sleep), FEELING HOT (feeling real hot), HYPERHIDROSIS (feel sweaty and that they didn't sleep), FEELING COLD (Feeling real cold), CHILLS (they had chills), HEADACHE (experiencing severe headache,massive headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Aug-2021, HYPERHIDROSIS (feel sweaty and that they didn't sleep) had resolved. At the time of the report, INSOMNIA (they cant sleep), VACCINATION SITE PAIN (pain in the arm), FEELING HOT (feeling real hot), FEELING COLD (Feeling real cold), CHILLS (they had chills), PYREXIA (fever), ARTHRALGIA (their joint hurt) and NAUSEA (nausea) outcome was unknown and HEADACHE (experiencing severe headache,massive headache) had not resolved.            The patient received 3rd dose of COVID-19 vaccination and experienced events, patient concomitants include high blood pressure medication and vitamins and started taking Tylenol for side effects.   This case was linked to MOD-2021-300932 (Patient Link).
Patient with progressive hypoxemia throughout the day despite multiple changes in ventilator settings/modes.  HFOV discussed with family, but functional oscillator not available and was awaiting arrival of donor oscillator.  She is not a candidate for ECMO due to pulmonary hemorrhage and thrombocytopenia with recent chemotherapy as well as BMI (morbidly obese).  Trial on nitric oxide performed with minimal improvement (sats increased from 60% to 65-68%).  She was noted to have increasing peaked T waves as well as development of Q waves concerning for hyperkalemia and worsening cardiac function consistent with multiorgan failure; perfusion was quite poor with mottled extremities and difficult to palpate central pulse
PERSISTENT DRY COUGH AFTER VACCINATION; SEVERE PAIN UPON COUGH IN AREA OF LOWER LEFT LOBE (OF LUNG); FEVER; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 AUG-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the patient experienced persistent dry cough after vaccination, severe pain upon cough in area of lower left lobe (of lung), and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent dry cough after vaccination, fever, and severe pain upon cough in area of lower left lobe (of lung). This report was non-serious.
Started feeling worse on 9/13/2021 with cough and muscle aches, lost taste and smell, headache, fatigue, nausea and diarrhea.
Pt reports sinus congestion, laryngitis, heaviness in chest, redness warmth and edema at injection site.  Symptoms resolved and 1 wk later pt developed same symptoms along with itching at vaccine site.
Patient reported feeling lightheaded and dizzy after sitting in post vaccine observation area following vaccination at 18:12. Patient states she only ate a bag of chips and some water around 1 or 2 in the afternoon prior to vaccine administration, since she was planning to go out to dinner following vaccination. Patient had been screened by RN prior to administration and provided juice before entering clinic for vaccination. 18:18 Sitting VS: BP 64/37 HR 82 SPO2 98%, patient assisted by RNs into wheelchair then transferred to cot to lay down with legs elevated. Additional apple juice provided, 18:20 VS laying: BP 87/57, HR 73, SPO2 98%. Patient reported feeling like she was sweating RNs provided ice pack. 1825 VS laying 107/65, HR 69, SPO2 98%. Patient reports symptoms resolving assisted to sit at bedside to dangle before attempting ambulation. 18:28 VS sitting 95/55, HR 69, SPO2 99%. Patient provided education to be well nourished and hydrated prior to 2nd dose appointment. Patient monitored an additional 10 minutes, reports resolution of symptoms and able to ambulate independently out of clinic accompanied by friend.
Louder cry than usual - not high pitched. Very irritable. Fever up to 101.8.
I received the Moderna shot around 2pm 03/02/2022. Within a hour of receiving the shot the right side of my face was twitching. Then it stopped after about 30 minutes. I continued with my day about 44 hours later on 03/04/2022 around 11 am I noticed the right side of my face was parilized. I thought I was having a stroke! I went to the E.R. I was shaking. My blood pressure was 158 over 114. Which is extremely high for me as my blood pressure is usually 114 over 74. I had my head cat scanned and a stroke was ruled out. I was diagnosed with Bells Palsey . I am currently reporting to you then I will report to the Heath department where the shot was adminstered and I am scheduling a fallow up appointment with my regular physician.
Client had just received a flu shot in the right deltoid muscle by Nursing Student.  Fluzone vaccine by Sanofi, Lot # UH478AB, Exipration 6/30/12.  Client leaned forward in a faint, but was caught and lowered to the floor by Student Nurse.  This nurse was then called over with the Emergency Kit.  This nurse's assessment showed the client awake, alert, and orientated.  Her skin was pale and cool to the touch.  She stated she felt "fine" and had no complaints.  Vital signs at 1755 hours by this nurse: Blood Pressure 110/70, Pulse 60, Respirations 16.  Client was encouraged to stay resting and lying on the floor.  Vital signs at 1804 hours by this nurse: Blood Pressure 110/72, Pulse 60, Respirations 16.  Client was assisted into a reclined sitting position resting against her mom.  Mom reported the client had just finished playing basketball before coming to get her flu shot and had not eaten yet.  The client's mom gave the client a Fruit Punch Powerade to sip on.  Client stated still no complaints, but was still pale in color and cool to the touch.  Client was assisted up to sit in a nearby chair.  Vital signs at 1815 hours by this nurse: Blood Pressure 110/70, Pulse 60, Respirations 16.  Client's mom gave her a granola bar to eat.  Client stated still no complaints and her color was still a little pale, but was improving.  Client was assisted to stand.  She stayed standing without difficulty.  Client left the clinic with her mom, but was escorted to their car by Student Nurse.  11/16/11 1040 hours This nurse called to follow up on the client's condition today, but had to leave a message.  This nurse also spoke with Dr's. to report the incident.
Pt got pfizer vaccine 5-11 yo 0.2 ml on 6/24/22 at 0910. After vaccine administration LVN was alerted on database that dose was given a month too early. The father was notified of the mistake and provided education. Father verbalizes understanding of education received. No physical harm was noted post vaccination.
Patient first received Adacel in left arm - had no reaction. Then about 1 minute later patient  received Fluzone in right arm - within about 30 seconds reported not feeling well - was pale and proceeded to have a syncope event. Patient was kept in chair with head supported - tried to get her on her back on the floor in order to elevate feet, but she stated she was feeling better - this happen all within about 3 minutes. Gave her water - since she was feeling better, she denied a cool compress and did not end up laying on floor, although it was suggested.  Patient looked as if she was holding breath  during shots - unknown regarding last time she ate. Patient did state she did not have allergic reaction to shots in the past.
Patient received the vaccine and fainted shortly thereafter. He became very sweaty and came to in a couple of minutes. Paramedics attended to him and deemed it necessary to take him to Medical Center for further evaluation due to irregular heart rate.
Narrative:  59 YO female with PMH significant for HTN, near syncope, vertigo, bipolar depression, panic disorder, insomnia, cognitive disorder, hypothyroidism, hyperlipidemia, and obesity received her first dose of the Moderna COVID-19 vaccine on 07/29/21 at her clinic. Ten minutes after receiving her dose she was found to have a blood pressure of 76/48, pulse 108 and complained of lightheadedness, therefore she was taken to an exam room. Patient remained hypotensive, was started an oxygen, and EMS was notified. She was transported to the ED and her BP was normal upon arrival. She was released in stable condition with prescriptions for diphenhydramine and methylprednisolone. Of note, she complained of hypotension and lightheadedness to PCP on 07/18/21.