chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Obese female patient with history of diabetes and seizure came to our pharmacy for second Moderna  covid dose.  A few minutes after receiving the vaccine, she was feeling lightheaded and nausea. I asked the patient to come back in to the consultation room where she could sit or lay down on the floor. The patient was able to walk back into the room with a little assistance from her mother. She sat on the floor for a bit, still breathing fine, and said she wanted to throw up. I grabbed a trash can, napkins, and a pedialyte bottle for her. She did not throw up but started breathing a little heavier and said she was about to faint. I got the epi pen ready and told her please lay down if she has to. At this point she fell to her right side and slightly hit her head against the wall. It appeared that she stopped breathing for few seconds, but  I still felt a pulse on her wrist. It also appeared that she went into a seizure, her upper body stiffened up and her arms were slightly flailing. I immediately called 911  and about 1 minute later, both the mother and I could clearly see the patient breathing as indicative by the rising/lowering chest. I also felt a stronger pulse on her wrist. I did not inject the epi pen. Paramedics arrived shortly and after about 5-10 minutes of talking to her, the patient began to gain conscious but looked exhausted. They transported her to the hospital. Per the mother, patient was completely fine after the first dose of Moderna;  also just had a seizure a few days before the second Moderna dose. The whole incident was about 20 minutes from administering the vaccine to paramedics transporting her away.
Intractable body pain and burning, seizure, worsening of depression. multiple suicide attempts SUICIDE
Patient developed redness and soreness that occurred 1 day after vaccination. This resolved in 2 days. Patient developed numbness in fingers. Three and a half weeks post vaccine, the patient awoke with excruciating pain in right shoulder that did not respond to muscle relaxants or ibuprofen.
her son experienced seizures on unspecified dates before his first birthday; unspecified speech issues his whole life; minor unspecified cognitive issues; asthma; was born 4 to 6 weeks prematurely; a rash in his genital area; excessive crying; His mother received GARDASIL near the end of the second trimester of pregnancy; This spontaneous report was received from the patient's mother and refers to a neonate male patient. The patient's concurrent conditions and concomitant therapies were not reported. The patient's mother was vaccinated approximately in 2007 near the end of the second trimester of pregnancy, with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, frequency, route, vaccination site and dose number were not provided), for prophylaxis (captured on 1911USA012638). Her concurrent conditions included asthma and premature labour in 2008 with a Last Menstrual Period (LMP) was calculated as 20-JUN-2007.  On 13-FEB-2008, the patient was born 4 to 6 weeks prematurely (premature baby). The patient weighed 5 pounds when he was discharged from the hospital (low birth weight baby) wich was prolongued due to the event, after that he also had a rash in his genital area (genital rash) and experienced excessive crying when he was discharged from  the hospital after his birth approximately in 2008.   On unspecified dates before his first birthday, the patient experienced seizures and he was resuscitated at the time of a seizure on two separate occasions which occurred on unspecified dates. Therefore, he underwent  several electroencephalograms (EEGs) and no brain damage from the seizures was found and no treatment was ever given for the seizures and the seizures stopped occurring on an unspecified date.  On an unknown date (reported as "recently"), he began taking an unspecified medication for asthma and he has had some minor unspecified cognitive issues (cognitive disorder) and has had significant unspecified speech issues his whole life (speech disorder).  At the time of reporting, the patient had not recovered from premature baby, cognitive disorder and speech disorder. The outcome of genital rash,  low birth weight , asthma and crying  was unknown.   The reporter did not provide a causality assessment between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) and the events. It was reported that the doctors believed his speech problems were a result of his premature birth.   Upon internal review, seizure was determined to be a medically significant event.   This is one of two cases from  the same reporter.; Sender's Comments:  US-009507513-1911USA012638:
PT had first dose of Pfizer vaccine and waited 15 minutes past vaccination at 3:38.  PT complained of tingling in the arm and lightheadedness.  RN proceeded to sit PT and take first set of vitals.  HR 70  O2sat 100  BP 172/68 Water bottle was provided.  Assessment PT stated she has no allergies, had a meal earlier but no water lately.  PT was observed for another 15 minutes.  Second set of vitals HR 65  O2Sat 99  BP 110/68.  PT was released and stated she did not feel light headed anymore then RN instructed PT to seek medical attention if symptoms returned.
12 hours after injection: fever of 102.5 with Tylenol, severe rigors nonstop for 8 hours, extreme thirst, drank a quart of water over 3 hours, extreme headache & Total body aches for 48 hours. Four days after injection, swelling at injection site with fluid build up the size of half of a softball with heat & painful tenderness
Right arm where shot was given got extremely sore & began throbbing and began to feel very tired. Next day got chills, blood pressure 220/185 and pulse of 103. Body temperature was 93.4. Went to bed and spent all of 11/5 and most of 11/6 in bed with body aches, headache, dizziness and weakness.
Within 48 hours of receiving Pfizer vaccination on 4/7/21, I developed a significant DVT blood clot in my right leg, which I've been receiving treatment for ever since. No prior condition/diagnosis of this. Noticed on 4/9/21, didn't hurt, but it felt like there was something in my leg. Woke up 4/11/21 and could barely walk. Thought I strained my calf/leg. Had to travel for work. Returned home on 4/25/21. Took myself to ER on 4/27/21 and received treatment, including diagnosis, ultrasound, eliquis. Have been seeing vein doctor monthly ever since.
onset ca. 5 hours after vaccination for about 36 hours: severe muscle pain - injected muscle ca. 12 hours after vaccination for about 32 hours: flu-like symptoms: shivers, fever (101), fatigue, moderate to severe full-body muscle aches, (low back, legs, feet, head, neck).
I was extremely dizzy and fell back into bed after getting up on the morning of 12/21. After this event found it only happened when getting up or laying down. Positional Vertigo seems to be what I have but I have yet to see my doctor. I am scheduled to see my doctor on  01/18 about this issue. Seems that everything I do goes toward the left.
Beginning 09/25/12 experienced frequent intense heart palpitations, flip-flopping feeling, (8-10 per minute) whenever sitting or lying down (visited Dr. for this on 09/27/12). Beginning 09/28/12 experienced extreme fatigue (even tired by things such as walking to the kitchen or upstairs) and general malaise which did not improve with sleep or lying down. I have a daily work-out routine and a very healthy lifestyle and was not able to work out or do much at all except lay down and try to rest or sleep. Beginning 09/29/12 experienced low grade fever (99-99.9 degrees F) which was intermittent throughout the days. All symptoms lasted until 10/03/12 PM. Fever and fatigue resolved on 10/04/12 and less frequent heart palpitations occurred on 10/04/12. All symptoms resolved by 10/05/12.
After vaccination I had a sore arm for 2-3 days and now this started where I cant walk I have to use the walker and it hurts real bad.
During a review of a local Department of Health?s internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
04APR95 immun given afternoon; that evening mom gave bubble bath & put pt to bed; pt c/o itching soon afterwards & mom checked & found rash covering whole body; pt taken to ER-t99; MD ? roseola; rash gone by next day;
None- vaccine given 17 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported   This case was linked to (Patient Link).
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302866. (Same reporter). This case involves a 28 month old female who received 0.5 ml of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number: UJ009AA)  (expiry date:30-Jun-2019) (dose in series were not reported) instead of 0.25 ml via intramuscular route in right thigh on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to Overdose. It was not reported that if any adverse event was experienced or not. 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 set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Patient felt faint and moved her self to the floor. She was unconscious and began to have  witnessed seizure activity, which lasted approximately 3 minutes. When she did become conscious again, she was disoriented and urinated on herself. 911 was called but when the ambulance arrived, they asked her if she was okay, and she said she was ok . Information relayed to the drivers of what was witnessed but they declined to take her to the hospital. Her  husband came and took her home about an hour later. No further seizure activity. Vitals were stable
Tingling in her left side of the face including mouth and nose area started about 30 minutes after vaccination. Patient took benadryl 2/15 and 2/16/2021 and it helped. it is better now
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 29-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # L044694, expiration date 04-FEB-2018), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness and swelling at injection site 10 cm. Tender axilla, body aches, fatigue. No fever. Patient given ciprofloxacin and Benadryl. Unknown outcomes.
Dizziness, confusion, aches, bone pain, headache, fatigue, tinnitus
June 11, 2021 ? Visited urgent care for ear infection in right ear. Doxycycline prescribed to treat ear infection as well as Fluticasone Propionate nasal spray.  June 20, 2021 ? Woke up with right ear filled with fluid and significant -complete loss of hearing in same ear. June 23, 2021 ? Visited PCP for fluid in ear. Prescribed prednisone steroid pack. Fluid dissipated and hearing improved slightly, tinnitus began. July 7, 2021 ? Followed up with PCP due to no further improvement in hearing. Referred to visit ENT / Otolaryngologist. July 28, 2021 ? Seen by Otolaryngologist. Concurred fluid had dissipated. He scheduled an MRI of brain (with and without contrast) and an Audiogram. Diagnosed with sudden hearing loss / sensorineural hearing loss and tinnitus. July 31, 2021 ? MRI evaluated and determined Noncontributory, no tumors present, no observable nerve damage. August 2, 2021 ? Otolaryngologist recommended intra-tympanic steroid injections (3). August 6, 13, & 20, 2021 ? Received one intratympanic injection of decadron (dexamethasone) on each of these days. September 8, 2021 ? Followed up with ENT / audiologist. Audiogram performed with no further improvement in hearing noticed and tinnitus continued. September 14, 2021 ? Fitted for hearing aide. November 20, 2021 ? Over the course of a few hours during a long drive, all remaining hearing was lost, tinnitus continued.
This spontaneous report as received from a nurse practitioner refers to an 11 weeks old male patient. The patient had no pertinent medical history or drug reactions/allergies. The patient was vaccinated with ROTATEQ oral on 26-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. On 16-JUL-2012 the patient experienced intussusception, 21 days after onset of therapy. He was admitted to hospital for medical attention on 17-JUL-2012 and he received an air enema. The patient was performed with ultrasound (result unknown). The patient recovered and was discharged from the hospital on 18-JUL-2012. The reporter considered intussusception as life threatening. Additional information has been requested.
Body aches; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-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 18-Feb-2021, the patient experienced PAIN (Body aches), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN (Body aches), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Seven days exactly after my first injection I developed an itchy rash at the injection site. The rash was raised and look like long , narrow hives. The itchiness eventually subsided but it turned sore and swollen. My arm hurts similarly to the 2nd day after my first dose of the Moderna vaccine.
large rash on face, back and chest; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 24Feb2021 13:30 (Batch/lot number: EN6202), at age 35 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included asthma, obesity, and bipolar disorder, all from unknown dates, not reported if ongoing or not. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); levocetirizine dihydrochloride (XYZAL); and cariprazine hydrochloride (VRAYLAR), all taken for unknown indications, start and stop dates not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the left arm, on 03Feb2021 14:00 (Batch/lot number unknown), at age 35 years old, as dose 1, single, for COVID-19 immunisation. On 25Feb2021 18:00, after the second dose, the patient developed a large rash on face, back and chest. The patient did not receive treatment for the event. The patient recovered from the event on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Bone aching pain and headache started about 12hrs after 2nd dose. Dizziness and lethargy 24 hours after 2nd dose of vaccine. No adverse events after the first dose of COVID vaccine. Taking 600mg ibuprofen every 6 hours.
Arm very sore after the first dose. After the 2nd dose my arm was sore after a few hours. Woke up at 3 am with slight fever and chills. Fever kept going up and when it reached 102.2 with a mercury thermometer (the accurate ones) I took 2 extra strength Tylenol and fever is still at 102.2.
Numbness left side of face and left side of mouth, numbness with tingling to left side of face Tightness on left face and irritation inside cheek tongue on left side
physician ordered moderna 6m-5y booster, moderna 6-11y booster was given
Injection site pain; This is a spontaneous report from a contactable consumer (the patient).  A 27-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 16Dec2020 14:15 at single dose for immunisation. The patient medical history and patient's concomitant medications were not reported.  The patient experienced injection site pain on 17Dec2020 07:00. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The event was non-serious with outcome of recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptoms: High fever (~102 F), chills, loss of appetite, tiredness, body aches, head aches, dizziness, slight difficulty breathing. Time course: 11:30pm 03/24/2021 to present (9:27am 03/25/2021). Treatment: Advil, emergency inhaler
Received vaccine 3/4/21 second dose. On 4/2/21 got soar throat and both glands swollen. Called doctor right away and was given prescription for Z Pack. Felt better in 2 days.
This spontaneous report as received from a nurse refers to a child patient of unknown gender. On 13-FEB-2015, the patient was vaccinated with a dose of VAQTA 0.5 ml, intramuscular which was expired on 24-JAN-2015 (lot number was not reported). No adverse effects were reported. Additional information has been requested.
This child and his parents volunteered to participate in a CDC sponsored study: "Extensive Swelling Reactions After Booster Doses of Acellular Pertussis Combined with Diptheria and Tetanus: 5th Dose Revaccination." The child developed swelling measuring 90mm(ht)x70mm(w)on the evening of the vaccination. Complete resolution by Day #5 morning. A diary and digital pictures were obained.
about 12 hours after receiving his vaccinations, he developed poor intake of his feeds, and became limp and unresponsive (CPR was initiated).  He did not have any fevers, vomiting, or diarrhea. He was admitted to the PICU and placed on nasal CPAP and oxygen.    About 2 days before he died, while on the ventilator he had 2 -3 episodes of seizure like activity but remained stable on the ventilator.  on the day of his death he had a sudden drop in his heart rate to 40 and was unresponsive. CPR was performed but were never able to obtain a heart rate or rhythm. There were no signs of  seizure before this last event.  5/28/09 autopsy report received DOS 9/18/09. FINAL DIAGNOSIS: I. Complications of Prematurity A. Chronic Lung Disease B. Gliosis, Medullary Nuclei. II. History or Maternal Abruptio Placenta and Delivery by Caesarian Section. CAUSE OF DEATH: Compications of Prematurity. MANNER OF DEATH: Natural.
FEVER; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER) and HEADACHE (HEADACHE) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM, LOSARTAN, HCTZ, BUPROPION, METOPROLOL and PANTOPRAZOLE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (FEVER) and HEADACHE (HEADACHE). At the time of the report, PYREXIA (FEVER) and HEADACHE (HEADACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided. Concomitant product includes Centrum Multivitamins for men.
My first menstrual cycle post 2nd vaccine was extremely abnormal. I had very painful cramping prior to my period and during the period. In addition, I had the heaviest period of my entire life. I was bleeding so much I had to use ultra sized tampons and change them ever 1-2 hours. This has never happened to me before and was very concerning. The heavy bleeding lasted 3-4 days.    My second period post 2nd vaccine has still been a little heavy but is mostly back to normal.
Information has been received from a physician concerning a 14 year old female with no pertinent medical history or drug reaction/allergies, who on 27-SEP-2007 was vaccinated with the first dose of Gardasil vaccine (0.5 mL). There was no concomitant medication. On 27-SEP-2007 the patient experienced Guillain-Barre Syndrome and was hospitalized. Hospitalization time was unknown. No further details were provided. The Guillain-Barre Syndrome was considered to be immediately life-threatening and disabling. At the time of this report, the patient was recovering.
Extreme limited mobility of right arm and sharp pain in muscle directly where shot was administered. Pain has increased daily since the shot was given. Tingling and numbness in lower arm and fingers is beginning to set in. Visited urgent care on 11/28/2014, 3 weeks after the shot, as symptoms were getting worse. Doctor diagnosed as an adverse reaction to the flu shot and said there was nothing he could do. His quote was "You are one of the unlucky ones who will most likely have pain in your arm the rest of your life. There is nothing I can do."
DIZZINESS. CHEST TIGHTENING. MUCUS. LETHARGY.
within 5 minutes of receiving flu mist pt states that she had swelling of her eys, redness and tearing and nasal congestion
This case was reported by a nurse via other manufacturer and described the occurrence of allergic reaction in a female patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to DTaP vaccine. Additional details were reported as follows: On an unknown date, an unspecified patient experienced an allergic reaction to DTaP. No further information was provided.
Hives (neck, chest, back and arms);  swollen right upper lip,  swollen under eye (right);  vice-like headache, fever of  102.8,  stiff neck, neck spasms, general aches and pains.