chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt my face swollen; Felt my tongue swollen; Eyes tearing up; Feeling not well; Shaking; Eyes sensitivity; I couldn't sleep at Night; Fatigue; Headache,Slight headache; Couldn't breathe; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Couldn't breathe), SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up) and MALAISE (Feeling not well) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Milk allergy, Food allergy, Latex allergy and Fibromyalgia since 2009. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) from 2017 to an unknown date for Thyroid disorder NOS.    On 01-Mar-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (Couldn't breathe). On 01-Mar-2021 at 10:15 AM, the patient experienced HEADACHE (Headache,Slight headache). On an unknown date, the patient experienced SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up), MALAISE (Feeling not well), TREMOR (Shaking), EYE DISORDER (Eyes sensitivity), INSOMNIA (I couldn't sleep at Night), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Couldn't breathe), SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up), MALAISE (Feeling not well), TREMOR (Shaking), EYE DISORDER (Eyes sensitivity), INSOMNIA (I couldn't sleep at Night), HEADACHE (Headache,Slight headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient mentioned  there was good and bad days.   This case was linked to MOD-2021-404475, MOD-2021-406425 (Patient Link).
pain in his shoulders, arms and legs; pain in his shoulders, arms and legs; soreness at injection site; full body myalgia; This spontaneous report was received from a physician and refers to a 72-year-old male patient. His concurrent conditions included hypercholesterolaemia. His medical history included microcytic anaemia. The patient had no known drug allergies. His concomitant medications were not reported.  On 20-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 injection, intramuscularly (IM)  (lot # T017385 and expiry date 01-SEP-2021 verified to be valid) for prophylaxis against pneumococcal disease.  On the same day, the patient experienced soreness at injection site and full body myalgia. Additionally, after 5 minutes of post-administration observation, the patient walked to his car and experienced pain in his shoulders, arms and legs, requiring him to return to the clinic. He was given intravenous (IV) acetaminophen (dose undisclosed) and recovered after 30-40 minutes. The physician reported he felt comfortable letting the patient leave. No lab diagnostics/studies were performed.  The relatedness between the events and the suspect vaccine was not reported.
Patient requested flu shot today 3/2/22. T/W administered high dose Fluzone Quadrivalent. T/W was informed thereafter by supervisor that patient had already had a Flu shot 10/2021.
w/in 1 hr of immun rash accompanied by severe itching appeared on face & quickly spread to entire body; short time later exp moderate difficulty breathing; 17MAR94 pt c/o greater difficulty breathing was treated in Er w/Epi & Pred;
Patient was sitting in chair for 15 minutes and started to feel dizzy and tried to get up from chair and passed out for 5 to 10 seconds, hitting her head on the aisle as she went down. Myself the Pharmacist ran down the aisle to her where I instructed her to remain laying down on her side as we called 911 for help! She was alert and oriented with no rash or breathing difficulties! I sat with her until paramedics arrived and evaluated her and recommended that she get checked out by someone at a hospital or her own doctor. She was released without future assistance from us! She did complain of a headache and was told by paramedics that it maybe the vaccine or the head injury and needs to seek medical attention.
12/28/2021:  Event occurred after 2nd vaccine.  82 yo M with PMHx of dementia and COPD who presents via EMS after his grandson found him sleeping in his garage next to his car. pt was alert but confused and noted to be wheezing. He is incontinent to feces at baseline. Was hypoxic at 88% doing well on 4 L.
Severe chills and shivering for 2-3 hours followed by fever for 4-5 hours. Now just lethargic and queazy.
Swelling, erythema, pain to right upper arm, Rash noted to upper arm, shoulder and face. Patient took BENADRYL with improvement. Symptoms improved each day.
The following Saturday, my right leg started exhibiting symptoms similar to restless leg syndrome.  It felt like electricity running continuously through that leg for 4 months. Now I just minor pain in there pain.  In July, my hair dresser noticed I have a patch of hair missing.  I researched it to be alopecia areata.  That has also been linked to the vaccine.  I've never had issues with my hair before the vaccine.
C: Hives Had vaccine on wed and broke out with rash on Sat  HPI: Patient presents with recent onset of skin rash. Rash has moved to different areas of the body. Rash is erythematous, raised and very itchy. Patient is not sure about what caused the rash. Denies an insect bite, recent exposure to new meds, cloth, cologne, food or other allergens. No recent use of new meds. No trouble breathing, no wheezing, no cough, no chest pain, no palpitations, no dizziness. No problem swallowing or swelling in the tongue or throat. No recent Hx of upper respiratory infection or other illnesses. under sterile conditions the the buttock was prepped with alcohol prep and patient was given a combination of decadron 4mg im with depo medrol 40 mg im Patient tolerated the injection well witho side effect prescribed for steroids to take benadryl and zyrtec will repeort possible adverse effect to regulatory authority.
Severity of symptoms increase .  Symptoms from shot 1 (lot 330268D (also reported) Severe nausea, increase sensitivity in eyes, ears, skin, taste fever, excessive sweating, severe headaches  Pressure in ears / sinuses/ head, ears ringing, muscle spasams, confusion, altered mental status.  Required to receive Pfizer vaccination at Medical center. Unable to currently work due to confusion, headaches, light sensitivity and ringing in ears.  Unable to  stay home alone when symptoms are severe.  Had to go to a doctor to receive care of symptoms.  I notified work of symptoms and told me they would let me off with ?COVID? pay.  I do not have COVID.  I?ve been tested 2 times with a negative result.  I was under care with newly diagnosis of Lupus in October 2021 and was started on Lupus medicine.  COVID shot has caused my symptoms to worsen.  Family took me to doctor and he was able to assist with my symptoms.  Will follow up on Monday 12/6.  Possible MRI/CAT scan of head if symptoms continue.  No hospitalizations since 2019.  Minor procedure for neuropathy in Lower extremities in Oct 2020-April 2021
Patient c/o left-sided facial and arm tingling about 5 min after receiving 2nd dose of Pfizer.  RN noted pt to be diaphoretic, anxious, and hypertensive on assessment.  BP 198/118 at 0905.  Pt states she has been diagnosed with borderline htn in the past, but hasn't seen a provider since before 12/2019.  Numbness/tingling subsided after about 5 minutes and did not return.  BP 162/104 30 min after event, patient reported feeling better.  Upon follow-up, patient stated her bp did not improve.  She will be seen at Health Department in primary care on Monday, 05/24/2021 for follow-up.
After 4th day of receiving J&J Covid Vaccine to present, I have dull headache, fogged brain, equilibrium seems off, slight loss of balance, increased heart rate of 170-190 BMP, my normal rate is 70 BPM,  I took 25Mg of Metoprolol which brought my rate down to 70 BPM.  I have increased wheezing and feeling  shortness of breath, whereby having to using my albuterol inhaler quite often and I  also took 20MG of Prednisone after which my breathing has improved.
Pt's guardian called us and notified her child had a fever of 102.6 after receiving 4 month shots yesterday. Her daughter was also scratched a bit at the site.
swelling in arm, quarter size has not gone away in 10 days. also itching.
At 10:50 AM, patient received her second dose of Pfizer Covid Vaccine, denies any complication with her first dose. Ten minutes post vaccination, she complains of lightheadedness and dizziness. RN obtained her vitals as HR 86, O2 99, BP 138/80. Patient stated that she did not eat breakfast, RN gave patient an apple fruit and drinking water. Fiver minutes afterwards, patient stated that she feels much better and denies any symptoms. Patient was held for 30 minutes and discharged stable.
just mild pain in her left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (just mild pain in her left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031k20A and 039K20A) for COVID-19 vaccination.     No Medical history Information was reported.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 04-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (just mild pain in her left arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, INJECTION SITE PAIN (just mild pain in her left arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up received and Updated patient demographic details,Concomitant drug is added, Updated Second dose details On 21-Jul-2021: Follow up received and contains Significant information Event, Address updated; Sender's Comments:
After receiving 4 vaccines, patient reportedly passed out while waiting for copy of vaccine record. Code called by front staff at 1342, and medical staff responded to scene immediately with crash cart. Upon arrival, patient was standing up next to father and brother alert. Patient was diaphoretic, saturated from his urine, and stated "I'm okay." Patient brought back to clinic room with father and brother for further assessment. Dr. reported to clinic room and assessed patient. Dr. reported patient lungs clear and normal heart sounds. Initial vital signs: BP 119/82, HR 79, RR 22 breaths/min, pulse ox 99% on room air. Patient given apple juice and crackers. Repeat vital signs at 1354: BP 74/47, HR 61; RR: 18/min. Patient stated feels sick to his stomach and dizzy. Patient drank to small cups of water and ate another cracker. Repeat vitals at 1403: BP 104/75, HR 75, RR 18/min. Patients states "I'm feeling good now" and denies feeling dizzy or sick to his stomach. Patient is alert and oriented X3 and conversing with father and myself. Patient escorted to car with family at 1411 and they were instructed if further syncopal episodes to call EMS and to call our clinic if they have any questions or concerns. Family verbalized understanding.
Pt complaint of  pain right after Twinrix vaccine administration on the right arm. Pt had x1 episode of Vomiting  . Pt complaint of  s/s  dizziness and felt clammy after the  injection , Pt felt better within minutes and VS were WNL. Pt fully recovered before discharge .
Patient is a 58y.o. male with HF with recovered EF, hx NICM, hx ETOH dependence currently being worked up for cirrhosis of the liver, BPH, HTN who presents to the emergency department for dyspnea on exertion x 3 weeks. States he developed progressive, insidious shortness of breath with exertion, especially going up the stairs, over the past three weeks. He denies fever/chills, sick contacts, chest pain, or cough. He is vaccinated and boosted from COVID. Denies known COVID exposure. Denies orthopnea or PND, reports good diuretic response with BID Lasix. States he stopped drinking alcohol about two weeks ago, had cut down about six weeks ago. Went through minor withdrawals but has been doing well lately. Pt is a nonsmoker, admits to occasional marijuana use.
Pain in the stomach; Very Weak; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in the stomach) and ASTHENIA (Very Weak) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, TAMSULOSIN, CALCIUM, METOPROLOL, LOSARTAN, METFORMIN and VITAMINS NOS for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in the stomach) and ASTHENIA (Very Weak). At the time of the report, ABDOMINAL PAIN UPPER (Pain in the stomach) and ASTHENIA (Very Weak) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-054385 (Patient Link).
PATIENT COMPLAINS OF SUNDAY NIGHT STARTING TO FEEL RANDOM NAUSEA IN WAVES THROUGH THE DAY/NIGHT WHEN DRINKING WATER; GATORADE GOES DOWN FINE BUT WATER CAUSES NAUSEA
Mother states 30 minutes to 1 hour after shot the baby was fussy, so she fed him and the baby took a nap. At 1130, temp was 99, at 1230 PM, temp was 102. The baby was given Tylenol and a cool bath. At 130PM, temp 104 and baby was crying so the mother gave him Motrin and a cool bath. At 230 PM, temp 100. The baby was seen by a doctor. The doctor told the mother it was a reaction to the flu shot. She was instructed to give Motrin and Tylenol alternating every 2hours as needed for temp. The mother states she did this all night, keeping the temp at 100. It remains at 100 today at 1000 AM.
pt had a positive COVID test in Nursing Home in on 1/25/22; placed on O2; lethargic, agitated; dyspnea at rest; poor oral intake; pt continued to deteriorate and passed away in the nursing home
Extreme ache at injection site started an hour after injection.  Within a few hours my entire body started aching.  The next day I could barely get out of bed and function.  I also could not sleep.  Aches lasted for two days.
This spontaneous report as received from a registered nurse refers to a child of unknown age. On 24-JUL-2012 the patient was vaccinated with the second dose of oral ROTATEQ (lot number was unknown, expired date 21-JUL-2012) (dose, route and injection site were not reported). The patient was not experiencing any known symptoms. The outcome was unknown. The action taken and causality were not provided. It was not specified if the patient sought any medical attention. Additional information has been requested.
Immediately after the vaccine, I had difficulty breathing, feeling a little numbness, heart racing, nausea, dizziness, headache, nausea. I was waiting in the holding area until I felt better. That evening, I felt tired, chills, felt cold, blurry vision, chest discomfort, difficulty breathing, and stomach pains, body aches and joint pains. Most of these symptoms did resolve by day 3. Then in February, I started having chest discomfort, chest heaviness, flutters, vision changes, headaches, stomach pains, back pain and I made an appointment with my doctor. I was sent to get an ultrasound of my gall bladder; I did blood work and a HIDA scan. Everything came back normal. I was prescribed a medication (which I cannot remember) to help with my stomach issues. The doctor also prescribed a new medication called Rosuvastatin for my cholesterol, which I took but could not tolerate so I stopped taking it. In March 2021, I started noticing more chest discomfort and flutter and made an appointment with my doctor for Oct 2021. In July 2021, I noticed my arthritis pain is increasing. I am currently just waiting to get an appointment to see my doctor.
I got the normal flu like symptoms became very fatigue and woke up to a conjunctival hemorrhage in my right eye . Eye showing signs of a stroke . Blood pressure has since been elevated since the vaccine was given . Suffer from panic attacks .
Approximately three weeks after the 2nd Moderna vaccination on 6/22/2021 I noticed that when reclined in my chair watching television both my feet began to tingle and go numb.  I had to stand up and walk around for about 10 minutes for the numb feeling to lessen.  When I sat down again it started over again.  Over the next several days the numbness continued and began to progress.  The next day on 6/23/2021 when sitting at my desk working on my computer my entire leg began to feel numb starting around my calves and especially my left leg.  My toes felt about 80% numb and my leg below the knee felt 20 to 50% numb.  This numb feeling progressed to a burning throbbing pain in left foot.  I had to stop working and stand
At the time the vaccine, I felt significant weakness in my legs.  This was followed by tremors in leg (for 3 weeks) that has moved to upper body.  Weakness in my legs occurs off and on.  This has impacted my ability to sleep, my daily functions, and work.  Increase in appetite with shaking. I have to eat especially protein immediately otherwise the shaking gets worse.
Subsequent to receiving varicella virus vaccine live the pt developed full blown chickenpox with more than 30 lesions.
Rash to back, tummy, arms, neck x 24 hours, increased itching, afebrile.
Patient was given a dose of Daptacel by mistake along with Pentacel with no adverse event; Patient was given a dose of Daptacel by mistake along with Pentacel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00776955).  This case involved 2 months old (unknown gender) patient who was given a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] by mistake along with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered and extra dose administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX) for prophylactic vaccination.  On 20-Sep-2021, the patient received first 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot: C5743AA and expiry date: 06-Jun-2022) (Frequency: once) via unknown route in unknown administration site by mistake along with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ528AAA and expiry date: 10-Jul-2022) via intramuscular route in the deltoid for prophylactic vaccination (wrong product administered and extra dose administered).  It was reported "dose of DAPTACEL (not ordered). Patient was given a dose of Daptacel by mistake and would like to know how to proceed. Caller also had questions on if the double dose of DTaP was okay for the patient? Two siblings were getting routine childhood vaccinations first Sibling had an order for Daptacel and Sibling second had an order for Pentacel. Only Sibling second received two doses of DTaP."  This case was an actual medication error due to wrong vaccine administered and extra dose administered (latency: same day).  At the time of reporting, 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. 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.
the vaccine was about 80 per cent effective; I also know the vaccine is safe; in the review of the HPV studies, severe adverse; Information has received from a physician. The physician concerned unspecified number of female patients of unknown age (also reported as older) who was beyond the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination age and they missed the opportunity to get the vaccine as kids. The patients' concurrent conditions, medical history and concomitant medications were not reported.  By coming through the data from one of two big drug industry-funded studies to measure the effectiveness of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine in older women, the physician realized that the vaccine was about 80 percent effective at preventing infection with Human papillomavirus (HPV) 16 and 18 in women whose cervical swabs were negative for these strains, regardless of past exposure (therapeutic product effect incomplete). The physician reported that in the review of the HPV studies, severe adverse events were rare and were not significantly higher in vaccine recipients than in those who received a placebo injection (adverse even).   The outcome of therapeutic product effect incomplete and adverse event was unknown. Causality assessment was not provided.
Broken blood vessel in her right eye; A spontaneous report was received from a consumer concerning a 61-year-old, adult female patient who received Moderna's COVID-19 vaccine and experienced broken blood vessel in her right eye/eye haemorrhage.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number 014M20A) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection.   On 06 Mar 2021, after receiving the first dose, the patient observed broken blood vessel in her right eye. She had no pain and no vision impairment. The event broken blood vessel in her right eye was considered as medically significant. No treatment information was provided for the event.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event broken blood vessel in her right eye was unknown 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 the event, a causal relationship cannot be excluded.
Fever, chills, muscle aches starting 48 hours after shot. Diarrhea and headache also prominent.