chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US005016 is an initial spontaneous report from a healthcare professional on 07 MAR 2014. This report refers to a 11 year  old male child. His past medical history and concomitant medications were not reported. It was reported that the patient under age 18 years of age was vaccinated with FLUCELVAX (batch number: not reported) intramuscular at a dose of 0;5 ml in DEC 2013. No adverse events were reported following this medication error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 07 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
I tested positive for Covid-19 on 08-16/2021. Mild fever for about four days. I had a mild fever and a stuffy head I was prescribed Regeneron and I got the infusion on the fourth day. I also felt very tight in the chest and I had low energy. I had a dry cough but no sore throat. I started to feel better after a couple of weeks but after three weeks I still have low energy and some congestion. I started to get negative tests after two and a half weeks.
Pt. recieved double dose (1.0 mL) Typhoid vaccine. Developed nausea, vomiting, fatigue, abdominal pain and passage of bloody stools about 2-3 days after recieving vaccine, and continued until today (4 days later).
Information has been received from a 66 year old patient with a history of spinal stenosis who on 08/19/2002 was vaccinated with a booster dose of hepatitis A virus vaccine inactivated.  There was no concomitant medication.  The patient indicated that about "9 days after the shot", approximately 08/28/2002, she experienced a cold feeling on her tongue, loss of appetitie, bloated feeling, her body gets cold and hot "very" easily, and her temperature is kind of low.  It was unknown whether medical attention was sought.  Additional information has been requested.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 31 year old male.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Not reported), and other pre-existing medical conditions included: Patient had no relevant medical history and concurrent condition.  The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 30 years old. Concomitant medications included cetirizine hydrochloride, dextromethorphan hydrobromide/ guaifenesin/ paracetamol/ pseudoephedrine hydrochloride, and paracetamol.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received non-company suspect vaccine included: Pfizer Biontech covid-19 vaccine (tozinameran, dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 06-NOV-2021 in left arm for covid-19 prophylaxis.  On an unspecified date in 2022, patient had COVID-19 for which patient was prescribed with non-company suspect drug Paxlovid (form of admin, route of admin, and batch number were not reported, expiry: Unknown) dose not reported, administered on 13-JUL-2022 till 18-JUL-2022 for treatment of covid-19.  On 22-JUL-2022, patient had patient had rebound 3 days after first negative test (suspected covid-19 infection, dose number in series 2). On an unspecified date in JUL-2022, Laboratory data included: COVID-19 virus test Negative  The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable and with paxlovid was discontinued.  The patient had not recovered from suspected covid-19 infection.  This report was non-serious.
anaphylaxis: extreme dizziness, nausea, stomach pain, full body swelling, decreased O2 levels, heightened BP, burning sensation on the inside, flame red skin tone. ambulance was called and taken to ER. The ER was covered-up with Covid and other patients and my symptoms improved so I elected to leave without treatment.  The next day I saw the Dr. who provided a steroid shot (I still had minor swelling) and her made a referral to an allergist it is important to note that on the day of my reaction I had not eaten anything out of the ordinary for me. I have used the medications I ingested that day (diclofenac and Methocarbamol) for years. I never have experienced anaphylaxis or anything similar ever.
Pain and swelling in lymph nodes; Pain and swelling in lymph nodes; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Heart palpitations; dizziness; fatigue; body aches; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 15:00 (Lot number: Fh8030) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ff2590, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 22Oct2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "not recovered" and all described as "Pain and swelling in lymph nodes"; NECK PAIN (non-serious), FACIAL PAIN (non-serious), EAR PAIN (non-serious), SWELLING (non-serious), SWELLING FACE (non-serious), EAR SWELLING (non-serious), outcome "not recovered" and all described as "Pain and swelling in lymph nodes, neck, face and ear on right side"; PALPITATIONS (non-serious), outcome "not recovered", described as "Heart palpitations"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; PAIN (non-serious), outcome "not recovered", described as "body aches"; HEADACHE (non-serious), outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy, neck pain, facial pain, ear pain, swelling, swelling face, ear swelling, palpitations, dizziness, fatigue, pain, headache. Additional information: Patient received no other vaccine in four weeks and no covid prior vaccination.   No follow-up attempts are possible. No further information is expected.
rash of herpes zoster-2 1/2mo p/vax; culture +;
Rash, UrticariaPruritus, Rash/itching at injection site Narrative:
About 12 hours post-immunization, child complained of chest pain, then had 2 episodes of retching/small yellow/mucousy emesis.  FOC put her into the bathtub, then got MOC, then they returned, child appeared to have lost consciousness- noted to be pale, limp and not responsive.  Able to be awakened within 3-5 seconds (total duration of event <15 sec) but was still shaking.  Not disoriented following event. Temp 100.1 at the time, later climbed to 103.
Adverse events : lightheaded and dizzy Treatment: patient claimed that she did not eat anything all day and did not drink enough fluid all day. Gave patient some water and orange juice  Outcome : Patient feel better after 15 minutes of orange juice and water, symptoms went away after 30 minutes.
This spontaneous report as received from a couple of nurses via company representative refers to an unspecified number of patients (age and gender not reported). On an unknown date the patients were vaccinated with GARDASIL (strength, dose, dose number, lot #, application site were not reported), intramuscularly for routine recommendation. On an unknown dates the patients experienced "hurt". The outcome of event was not reported. The causality was not reported. Additional information has been requested.
Breakthrough case admission after 3 vaccines Pfizer 2/2/21 Lot# EL9261;  Pfizer 2/23/21 Lot# EL9265;  Pfizer 10/18/21 Lot# FF2589
Developed a chronic cough 3 days after receiving vaccine.  Did not have this symptom with prior doses of vaccine.
On 9/23/00, th pt experienced a fever of 103. He was treated with ibuprofen (Motrin). As of 10/05/00, the outcome of the event is unknown.
Right after leaving hospital.  Pain down back of left side down to knee. After an hour or so, it went away. Then, next day, many aches and pains; Chest pain and aphasic; Called 911. EMS came and examined her. They stayed awhile. Gave her liquids. Pt slept rest of day Saturday. Next day, Sunday, she still had some minor symptoms. On Monday, she felt better.
No adverse reaction First dose given on 3/9/2021 and second dose given on 3/29/2021 given to soon. No signs and symptoms
Pt died-SIDS on death certificate; Pt died evening p/immun were given; MD requested vax adverse rxn report be filed; Mom states pt did not seem to have had any reactions to the immun;
Right knee flare-up, consistent with previous Rheumatoid Arthritis flare-ups.
Headache, chills, generalized body aches, sweats/chills x 24 hours- full resolution of sx
She got the vaccine, when they put the needle in she said it was far in.  The pain was bad, but she could deal with it.  Then 5 days later something hit her and hit her bad.  She went to the ER and they gave her Bentyl, diarrhea medicine as she was vomiting, not eating anything, and they gave her some anti-vomiting medicine.  They sent her home and said she would feel better.  The diarrhea and vomiting stopped but she then started with a rash.  it's all over her hands, arms, back, itching, and taking Claritin for it.  it won't go away.  Her symptoms continued to worsen, and woke up one morning and had so much pain that she could not move or breath and her husband called an ambulance and they took her hospital and diagnosed with a blood clot.  She was in the hospital for 3 days and now discharged on Eliquis.  She has bruises all over her coming out and very upset that she is still feeling bad and doesn't know how the rash is going to go away.   She was also prescribed Oxycodone for pain and also Tessalon Perls to take for coughing.
Information has been received regarding a case in litigation concerning a child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the period from October 1995 through September 1999. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Follow up info included immunization as follows: hep B vaccine recombinant on 10/10/95 (610586/0363A) in left leg, 11/17/95 (52B-invalid) and 6/10/96 (618834/0014D). Concomitant therapy included Tetramune on 11/17/95 (5H61047) in the left leg, 1/22/96 (5261101/5H61002) in the left leg, 3/18/96 (480116/45M6114) and 3/20/97; Orimune on 11/17/95 (72702), 1/22/96 (734E1) and 3/20/97; diphtheria toxoid+pertussis vaccine+tetanus toxoid (manuf unk-no lot # reported) on 9/22/99; MMR II on 12/19/96 (618389/0888D) in left arm and 9/22/96 (not reported); varicella virus vaccine live (manuf unk-lot # not reported) and on 9/22/99 (lot # not reported). Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). No further info is available.
I had an extreme sore throat. The next day my sore throat was worse, and I was extremely fatigued. I developed a cough. I took two COVID-19 tests that came back negative. On July 4th I was still feeling really fatigued so I took another test that came back positive. I called my doctor the next day, and they advised me to take over the counter medicines. A couple days later my sore throat went away. My cough lasted for a couple weeks.
Fever chills; This is a spontaneous report from a contactable Nurse (patient)  A patient (demographics unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient stated, 'I received the vaccine without knowing I had COVID 19'.  After vaccination, she developed the symptoms fever chills. She performed swab and was positive.  Information on the Lot/Batch Number has been requested.
it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and chin felt like I had razor burn.; My head itched; left eye felt dry; salivate more than usual from the left side of my mouth; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; feel pain in my left ear; My lymph nodes on the left side of my face became swollen; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 12:45 (Batch/Lot Number: EN6202), at the age of 65-years-old, as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included calcium; magnesium; colecalciferol, menadione (VITAMIN K+D); glutathione; all taken for an unspecified indication, start and stop date were not reported. Within 45 mins (also reported as 20-25 minutes) of receiving the shot, she began to feel her left cheek tingle. In the intervening days, her left forehead, cheek, side of lip and chin felt like she had razor burn. Her head itched. Her left eye felt dry, but that went away. She began to salivate more than usual from the left side of her mouth. The left side of her face began to feel heavy, sometimes also my sinuses, but more often my lower jaw. Sometimes, she would feel pain in her left ear. Her lymph nodes on the left side of my face became swollen. Her doctor on Zoom said it sounded like a form of Bell's Palsy (medically significant), though she does not have the drooping eye or mouth. She had an MRI of her left lymph node that did not reveal any issues. Her symptoms, while they have abated, are still present five weeks after the shot. The events started on 26Feb2021 13:30. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event left eye felt dry was recovered while other events was not recovered.
Pt reported thigtness in throat approx. 1 hour after vaccine given.  Then lip swelling and eye lid swelling within the next 30 minutes.  Also throat scratchy and headache. She talked to a friend that is a nurse and was told to take benadryl.  The pt took the benadryl and noted an improvment in symptoms.  Didn't see a MD.  I saw the pt on 9-25-09 and symptoms were not noted.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        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.   Concomitant medication information not provided by the reporter.  Date refrigerated: 20-Apr-2021. Temperature changes (in F): 40.  Treatment information not provided by the reporter.
Patient arrives to back to school vaccine clinic with mom. Mom indicates that patient is in need if a bivalent vaccine. Mom has patients vaccine card in hand which have 3 vaccines listed- non listed as bivalent. Per vaccine card and Mom indication patient given bivalent vaccine dose per CDC guidelines. After clinic it was discovered that patients 3rd COVID vaccine dose was in fact a bivalent dose therefore dose given on 8/19/23 was not needed. Patient was monitored post vaccine per protocol with no adverse event noted.
Malaise, temp of 100.7 through the night of 08/03/2011. Nodules appearing that were hard to touch and hot below injection site on 08/04/2011. Called triage nurse 9:30 PM for Dr. office. She said give Tylenol and cool compress. We did that, next morning several more hot nodules appeared. Went to the Doctor's Office 08/05/2011, the pediatric side was closed, the walk in clinic was open and called Dr. She called in an antibiotic, suggested Zyrtec in case of allergic reaction. I outlined the nodular swelled area on his leg to monitor further spread. Directed by dr to keep eye on it, continue cool compresses and if still not looking right on Monday to bring him in.
Sore throat, cough, rapid heart rate and difficulty breathing. Went to emergency room.
crying for over 5hr;erythema & induration @ site larger than silver dollar size;
Patient, was 7 weeks and 5 days pregnant with an estimated due date of 9/16/2022 when she received her COVID19 (Moderna) Booster shot.  On the morning of February 22nd, patient began to experience significant vaginal bleeding and passing clots.  Patient contacted OB clinic and an ultrasound and follow up appointment were scheduled for that afternoon.  Ultrasound found no fetal heart beat.  At the follow up appointment, the patient continued to experience worsening symptoms and a miscarriage was confirmed.  her Midwife provider was concerned about extensive bleeding so patient was sent to ED for IV fluids and evaluation of a possible D&C.  Patient passed a significant clot while in the ED and when the bleeding decreased, it was decided that a D&C was not required and the patient was discharged.
On 5/23 resident began complaining of not feeling good, had experienced nausea, diarrhea, reported to nurse that he can't pee and thinks thats why his back and belly hurt, Dr. notified. Bladder scan was zero, resident refused catheter, complains of belly being sore and tender to touch, then resident voided after nurse left the room. Then resident complains of the pain being sharp, dull, cramping and hurting so bad that he cannot stand it, abdomen is distended, pain worse when you touch it, resident had a formed stool the day before, resident agreed to go to ER to be seen. Resident sent to Medical Center and was transferred out to alternate medical center for ischemic colitis, no surgical interventions done, resident sent back to our facility on 5/30 with 3+ edema to feet, 2+ edema to lower legs, non pitting edema to hands, abdomen distended non tender, bowel sounds hypoactive, lungs with crackles at bases, course ronchi  in upper lobes on expiratory, resident alert and oriented, oxygen on 3L via nasal cannula. 5/31 residents abdomen distended further, resident hallucinating, sent to Medical Center ER, RN reports resident had abdominal abscess and leaky bowel and was transferred out and admitted on 5/31 to alternate location. Resident remains out of facility at this time.
CHILLS; This spontaneous report received from a patient concerned a 68 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, batch number: not reported) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on APR-2021. This report was non-serious.
February 11, 2021  Arm pain  He starts taking Tylenol as prescribed on day of Vaccination. February 13, 2021  Stabbing pain on the left side of the head (above his ear)  Poor sleep the next 2 days  February 14, 2021  Spoke to Dr  He ordered a CT Scan and recommended for him to take Tylenol Extra Strength. The headache continues to escalate. February 15, 2021  He is taken to ER (Hospital) February 16, 2021  He is released with pain/insomnia medication February 20, 2021  He is confused, disoriented, repeats things, forgets things, has difficulty functioning normally and sleeping February 21, 2021  He has difficulty standing, he falls, he has difficulty swallowing. He is taken to ER (Hospital) February 21-26 - He is still at the Hospital. Was diagnosed with Viral Meningitis/Shingles
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at physician's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated at the same physician's office for a vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.