chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179), via an unspecified route of administration in the left arm on 13May2021 at 09:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), sunflower lecithin (MANUFACTURER UNKNOWN), birth control (MANUFACTURER UNKNOWN) and PRENATA; all from unknown dates for unspecified indications. The patient previously took amoxicillin on unknown date for an unspecified indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 22Apr2021 at 09:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021 at 20:00, the patient experienced fever 101+, chills, body aches and headache. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in May2021, the patient underwent lab test and procedure which included body temperature and result was shown as 101+. The clinical outcome of the events fever 101+, chills, body aches and headache were resolving at the time of reporting. No follow-up attempts are possible. No further information is expected.
ACHES; FLU LIKE SYMPTOMS; FEVER; This spontaneous report received from a consumer concerned a 55 year old female. 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) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced aches. On 21-MAR-2021, the subject experienced flu like symptoms. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature increased (NR: not provided) 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, aches, and flu like symptoms. This report was non-serious.
patient informed pharmacist that she has a history of fainting after administering the vaccination. Patient was feeling light headed after the vaccination  and asked if the pharmacist can talk to her. After a few minutes of talking, patient fainted for a few seconds. Patient woke up and was coherent but did not know she fainted for a few seconds.
Vaccine was administered on Saturday afternoon, patient stated that on Sunday night he started shaking uncontrollably for 3 minutes. He stated he was very cold, but he did stop after putting on multiple layers of clothing and covers. Advised patient to contact doctor for follow up- he said he would contact his doctor.
Local reaction. Mother declined for child to be seen by doctor. She described area size of a baseball, swollen, red, and warm to touch
Arm has swollen up as big as a softball/swell up; Extremely hot; Big bruise; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm has swollen up as big as a softball/swell up), FEELING HOT (Extremely hot) and CONTUSION (Big bruise) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, 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 experienced PERIPHERAL SWELLING (Arm has swollen up as big as a softball/swell up), FEELING HOT (Extremely hot) and CONTUSION (Big bruise). At the time of the report, PERIPHERAL SWELLING (Arm has swollen up as big as a softball/swell up), FEELING HOT (Extremely hot) and CONTUSION (Big bruise) outcome 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.
Red, well circumscribed, slightly raised, lesion at site of injection. Approx 2 inches in diameter. Not itchy or painful. The lesion appeared this morning at 9am and is still present 8 hours later.
pulsating pain, lower back, numbness of hands/legs, diaphoretic, waited 15 minutes, resolved.
Booster; has Covid; has Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "has Covid"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster". The event "has covid" was evaluated at the emergency room visit. Reported that she had the primary series vaccination and the booster. Her sister recently visited her at her home and stayed there for about ten or fifteen minutes and now her sister had Covid. Her sister had also had her complete vaccination series. Sister went to the emergency room, and they told her that taking antibiotics wouldn't help and to keep taking ibuprofen. She was concerned that she can get infected by her sister. Asked if she should get a fourth dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Migraines started and lasted for 2 days. Chest pain and shortness of breath started on 26 May 2017 approximately 1700 and lasted until the next day. Took Ibuprofen that evening.
Patient was administered Pfizer bivalent dose for second dose within primary series, instead of Pfizer monovalent dose.
severe chills during night after injection. body aches for 2 days leading to muscle spasms in neck.
I had just gotten my COVID-19 shot and was still sitting there waiting to be released. I suddenly got this flush feeling and I wear an apple watch and I got an alert that my heart rate was up at about 120-140. I got up and asked for help, they got me water and a snack, and it came down and then it went back up. This kept happening and it would not come down. They finally decided that I needed to go to the ER, and I was taken via an ambulance. At the hospital they did give me an IV and something to help me relax and a beta blocker. I then had a follow up with a cardiologist and they did an echocardiogram, they put me on 24-hour heart monitor and some other tests. I was diagnosed with tachycardia and given medications that I am now on to control my heart rate and avoid these heart rate spikes.
Nausea HA neck pain wt loss chronic fatigue hair loss memory loss chest pain. Auto immune dg Hpylori x 2 Dizzy since 1st vaccine 3/09.
Patient felt faint, was diaphoretic, and pale 10:15 AM Blood Pressure 82/45 Pulse 52. Patient given juice and water. Patient's Mother was called 10:35 AM Patient Blood Pressure 84/63 Pulse 60.
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Hypertension-Medium, Error: Infection / Cellulitis (diagnosed by MD)
7 days post vaccine complained of red blotchy rash to chest torso arms legs with itching; taken Benadryl as needed; rash still present 5 days later; denies any other symptoms
I am an RPh and I administered the pneumovax 23 vaccine to this patient in his left deltoid. Within 2 minutes of receiving the vaccine, his head and face became bright red and he indicated he felt very hot and that his throat felt slightly constricted. I administered 50mg of benadryl PO to the patient and he said he felt better right away. He then complained that his back felt very tight and painful. The medics were called upon the administration of benadryl and arrived shortly after. Despite talking and refusing transport the hospital, this patient's blood pressure and pulse was very low so the medics trandported him to hospital. About an hour later, the ER called me and we spoke about the incident and she informed me the patient's pulse had risen and he wanted to leave the hospital.
Patient lives in Nursing Home. We called there previously to ask if pt. would be getting vaccine. We were told that they were unsure if or when they would be getting it. On 04/16/2021 We asked pt. if he ever received Moderna or any Covid vaccine. He said no , but would like to get it. We gave him the Moderna vaccine. When putting info into  system we noticed he had received the 1st dose 03/30/2021 -only 17 days before . Patient has not shown any adverse reactions but we are reporting due to the timing of 2nd dose less than 28 days.
pt recv vax 11APR95 & the same day 2 1/2hr p/vax pt exp fever, chills, muscle aches & pains, back pain, & poss serum sickness-like rxn x  3 days & then resolved;repeat titers in AUG95 were neg for hepatitis antigen & antibody
"Patient received her second dose of Moderna vaccination on 6/11. She was sent to the ER on 6/12 with SOB, respiratory distress. Diagnosed with CHF. VS: POX 72% and placed on O2, BP 168/106, HR 120, Resident was diaphoretic. DNR, DNH but family wanted her sent out. Doctor notified, ordered Lasix 20 mg and Coreg 3.125mg given immediately and 911 called. Went to hospital, diagnosed with CHF. Returned and family requested hospice and that was initiated. Resident is back to her baseline?up, participating in Bingo and other activities, eating in the dining room.  Did not have fever."
MOM REPORTED "HIVES ON LEFT THIGH." RESOLVED UPON ARRIVAL TO OFFICE. LEFT THIGH SOFT WITHOUT HIVES OR REDNESS PER MD.
Patient was given a ROTATEQ vaccine. The vaccine that was given expired 10/31/10.  Vaccine was expired one day before it was given.
Dose received in right arm and within 15 -20 min I started clearing my throat then started having a raspy voice and realized I was having difficulty breathing. I immediately took Benadryl 50mg. After 20 min my symptoms improved and I was sent home and after 6 hours similar symptoms returned and I took additional Benadryl. No other throat/breathing issues returned at that time. I did end up with from that time with a change in my health and get dx with Myasthenia gravis and autoimmune neuropathy.
Child received 0.5 cc of pediatric Moderna vaccine that was labelled as  a "single-dose vial" but should have received 0.25 cc
I went into the ER twelve hours after receiving vaccine as my resting heart rate was at 150.  It did go as high as 170 while in the ER.  I was admitted to the hospital and diagnosed with Tachycardia due to the vaccine.  I was on a beta blocker for 20 days.  At which time, my heart rate returned to normal.
Fever 102.4 decreased appetite all day. Had pain at injection site and low back ache but did not take anything for it. Started getting chills at work, (nurse), checked temp x3, consistently 102.4 Took Advil. 40" later temp 101.9 aches and pain gone. Took Tylenol and ate. Temp continues to decrease. Advised by pharmacist to fill out this report. Pretty sure I'm fine. I think I took Advil for pain with the first dose of this vaccine a couple months ago so never noticed a fever.
Soreness of deltoid resolved 2 days after vaccine. Normal shoulder for 7 days. Day 8 post vaccination onset of itching, swelling and redness of left should, continuing now x2 days. No other systemic symptoms. No pain.
Patient is a 84 y.o. male patient of, MD with history of spinal cord stroke, history of chronic tracheostomy and chronic hypoxic respiratory failure, PEG tube, DVTs, type 2 diabetes mellitus insulin requiring, hypertension, PUD, chronic anemia, hyperlipidemia and sacral and heel wounds who presented to Hospital with fevers, found to have COVID.   Sepsis Chronic hypotension COVID-19 Virus Infection Date of onset of symptoms: 3/25/23 Symptoms present on admission: Subjective fevers, chills, diaphoresis Date of covid positive test: 3/27/23 Vaccination status: vaccinated with booster Imaging: CXR with no acute process Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: unable to use paxlovid as cannot be crushed for PEG therefore started on remdesivir by ID as high risk for severe disease, completed 3 doses and after discussion with patient/family given that patient is doing well and wants to leave hospital, will discharge after 3 doses CRP elevated to 117, procal negative Consultants followed: ID Anticipated special isolation end date: 10 days after symptom onset   Hyponatremia Sodium of 131 on admission with element of dehydration Improved with IV fluids   History of tracheostomy Chronic respiratory failure with hypoxia Patient has been on room air for the past several months and doing well, no subjective shortness of breath CXR no acute process Monitor given COVID as high risk   History of CVA Chronic PEG Tube History of spinal cord and medullary/cerebellar infarcts History of CVA, initially on DAPT and no only on coumadin due to history of GIB Previously noted to be on tracheostomy with supplemental oxygen but recently noted to weaned down to RA On PEG tube, continue tube feeds and warfarin   Elevated LFTs Minimally, likely mild viral hepatitis from COVID vs possibly due to remdesivir Repeat LFTs 3-4 days   IDDM2 Home regimen of Lantus 14 units + SSI TIDAC Resume home regimen on discharge   History of DVT Diagnosed in Sept 2022 with DVT to LLE and LUE and SVT Continue home warfarin    Sacral/Coccyx Pressure Wound, POA  Left Heel Wound, POA  Wound care
STARTED WITH SWELLING OF PALMS AND DORSAL HANDS THEN FEET. SWELLING BEGAN AFFECTING LIPS AND FACE ON 12/15. ON EXAMINATION 12/17/20089, PATIENT HAND MILD SWEELING AND ERYTHEMA OF PALMS AND SOLES, MILD EDEMA WITHOUT ERYTHEMA OF DORSAL L HAND AND HIVES ON RIGHT>LEFT FACE AND LIDS, PLUS ANGIOEDEMA TO A MILD DEGREE OF RIGHT SIDE OF UPPER LIP. HE HAD NO SYSTEMIC, CARDIOVASCULAR, OR NEUROLOGIC SIGNS OR SYMPTOMS. hE HAD BEEN DIRECTED BY ME TO TAKE ORAL DIPHENHYDRAMINEBEGINNING AFTER NOON OF 12/15/2009 AND REPORTED VARIABLE BENEFIT WITH THIS. aFTER MY OFFICE EXAMINATION OF HIM AT 1:20 PM ON 12/17/2009, i PRESCRIBED pREDNISONE 60MG/D X 3D, 40MG/D X 3, 20MG/D X 3D; CETJIRAZINE 10 MG QHS; AND FAMOTIDINE 20 MG QAM. hE REPORTED NEAR COMPLETE RESOLUTION OF HIS SYMPTOMS BY 9:00AM 12/19/2009.
Vertigo and vomiting for about 1 hour on 1/26. A bit dizzy this am, but much better.
SWELLING AND REDNESS ON ARM,12CMX10CM OVER DELTOID WARM TO TOUCH. VERY PAINFUL, PT ALSO FELT VERY SICK WITH FEVERS AND BODY ACHES.
I was contact from the school secretary that the child was feeling short of breath after receiving the flu vaccine. They were able to assist her to the ground, laid her down and applied a cool wash cloth to her head. I instructed her to check the child's oxygen level and continue to monitor and let me know what the results were. Her sats were fine, she continued not to feel good, so they called the child's mother and she went home for the day. No other information or symptoms were reported thereafter. Prior to the injection the child was anxious, crying and did not want to receive the injection as she was scared.
Mild headache; aches and pains; Rashes around right arm and his eyes; Second dose administered on day 50; A spontaneous report was received from a healthcare professional who was also a 48-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced aches and pains, rashes around eyes and right arm, headache and received 2nd dose on day 50/ inappropriate schedule of vaccine administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced aches and pains which resolved on 28Feb2021. During this time he also noted rashes around his eyes and right arm. On 28 Feb 2021, he had mild headache. Treatment information included Benadryl, prednisolone pack, and Tylenol  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcomes of the events inappropriate schedule of vaccine administration, aches and pains, and headache were considered recovered. The outcome of the event, rashes, was considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
extremely itchy lichenoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000067.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization, reaction(s): "extremely itchy lichenoid rash". The following information was reported: LICHENOID KERATOSIS (non-serious), outcome "unknown", described as "extremely itchy lichenoid".  Additional information: On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date in Jun2022 with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1, dose 2, dose 3 (booster dose) and dose 4 (bivalent booster) for Covid-19 immunization. Reportedly, the individual experienced an extremely itchy lichenoid rash after taking the original two-dose Pfizer COVID vaccine. The rash improved with time but got worse after the first Pfizer booster, improved again, and got worse after the bivalent Pfizer booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed COVID Symptoms within <24 hours of receiving vaccine (Sore throat, mild fever, headache the morning after the vaccine). Patient had minimal to no contact with any other people prior to vaccination, and had not been around any individuals exposed to COVID in the past 2 weeks. Symptoms included fever, headache, nausea, joint & muscle pain, difficulty breathing, low oxygen stats, and vomiting.    Patient was taken to medical facility on September 6th, was admitted to the hospital, and later transferred to the MICU. Patient pronounced dead September 18, 2021.
pt says she had a hot red swollen right leg that was very painful.  On 4/16/21 she went to the Hospital ER.  She had blood test and was given an US of the right leg where they found 2 blood clots. She was started on blood thinner. She was discharged and told to FU w/ PCP.  On 4/21/21 she saw the doctor.  She increased the blood thinner because she found a abdominal hematoma this size of two grapefruits.   On 4/25/21 she was having trouble breathing and her leg was red and inflamed.  She went back to the Hospital ER they thought she was having a pulmonary embolism.  They did more blood work and chest x-ray.  She was given Lovenox shots and took her off the blood thinner. She was discharged to go home and give herself these shots.  On 4/27/21 she had a reaction to the Lovenox shot so she called her PCP.  She saw the doctor on 4/29/21 she was told to continue using the Lovenox.  She went back to Dr. on 5/4/21 and she was taken off Lovenox and put back on blood thinner Eliquis with doubled dosage.  She was monitored. On 5/8/21 both of her legs were red and swollen and she went to her Doctors office. They did a blood test and was sent home.  On 5/10/21 she went back to her PCP.  Dr. office where she was sent to Hospital ER for direct admit.  They did another US and a CT.  They found she had blood clots in both legs.  She was given IV fluids, antibiotics, was given heparin and taken off Eliquis. On 5/13/21 she was given warfarin along w/ heparin.  She was discharged on 5/16/21.  She still has pain and redness in both feet and legs and has been diagnosed w/ Cellulitis.  She is now taking Oxycodone and Coumadin.  She will see her PCP on 5/21/21.
Woke up with fever 10:30AM 4-9-14 100.4. Was irritable 4-9-14. Patient cried for 1 hour non stop.
Severe migraine headache associated with visual distortion, nausea/vomiting, and prolonged word-finding difficulty lasting at least a few days. No prior history of migraines. TIA work up ongoing.
Soreness at injection site, fatigue, body aches and tenderness/swelling at lymph node near collar bone on same side as injection site.
Received her 1st dose on 27Mar2021 and experienced pain on the arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 17Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Received her 1st dose on 27Mar2021 and experienced pain on the arm.".  Additional information: Reporter was asking when she was allowed to take medicine for headaches such as Ibuprofen, Tylenol or Advil after she receives her 2nd dose on Saturday,17Apr2021. She was inquiring just in case, because she read that vaccine recipients are not allowed to take any Ibuprofen, Tylenol or Advil after dosing. She also mentioned that she received her 1st dose on 27Mar2021 and experienced pain on the arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event  occurred. An expired vaccine was administered.  MOC was notified and advised to return for revaccination in 2 months.
A physician reported that an 8 year old female inadvertently received an intradermal injection of Pnu-Imune 23 on 03/22/02, instead of a Tuberculin test. That same day,she developed an injection site reaction characterized by a "large" area of redness, swelling and pain. Additional information received from the reporter on 04/02/02, provided the lot number and stated that the patient recovered.
My son first developed an inability to swallow then profuse and frequent nosebleeds (throughout the eight days he was quarantined to his room). While this was going on he began crying that his ears hurt. Once tended to, he awoke the next morning to his eyes crusted over. He was horse and lethargic, achy and had a high fever.
nauseous, light-headed, flushed, hot, sweaty  laid on floor with feet up, started to feel better after about 10 minutes
Site of injections was hot, swollen and sore.  4 weeks later, site is still swollen and sore.
Flu shot right deltoid 11/14.  Within 24 hours had local reaction, redness, itching, some whole body hives.  No anaphylaxis, no shortness of breath.