chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upset stomach, fever of about 101, aches, pains in muscles. Injection area sore to touch and move.  Took tylenol. Fever gone by morning. Aches gone by noon on next day.
Pt has a red blistery rash on her (L) arm where her vaccine. It measures 8cm x 10cm. It is painful. Pt Rxd prednisone 10mg.
Subsequently pt developed an injection site reaction characterized by an 8 in area of urticaria, itching, swelling, redness, and induration. She was treated with a Medrol dose pack and recovered. This is 1 of 4 patients from this facility who developed and injection site reaction.
22mins post vaccination pt had a syncopal event Vitals: 105/64, 67, 18 Pt taken to med bay and assisted to a recovery position.  VSS.  Educated pt that if other vaccines are warrented, to have them administered in the supine postion. Pt stable and released from the vaccination site.
pt has enlarged lymph nodes and redness at site, says there is pain coming from the red site under the arm that makes it hurt to lift arm high , no pain in shoulder or top of arm per mother
Blood clot in leg - first dose; This is a spontaneous report received from a contactable consumer, the patient. A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: CR2613), via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 77-years-old) as a single dose for COVID-19 immunization. Medical history included broke femur of right leg on 09Nov2020 and hospitalized from 09Nov2020 until 15Nov2020 or 16Nov2020, surgery to repair broken right femur on 12Nov2020, rehabilitation following hospital discharge and got out of the rehab facility on 14Dec2020, been in either a walker or a wheelchair and still not fully recovered (ongoing); chronic obstructive pulmonary disease (COPD), asthma diagnosed at least 13-14 years ago,  bronchitis, all ongoing from an unspecified date diagnosed at least 13-14 years ago. Concomitant medications were not reported. There were no other vaccinations within 4 weeks of the vaccine. On an unspecified date, the patient experienced a blood clot in the leg. The clinical course was follows: After he was discharged from rehab, the patient went to his own family doctor on 30Mar2021 because his ankle and leg were still swollen. The physician sent him to have a vascular done, on an unspecified date after 30Mar2021, with unknown results. The patient reported that the physician determined that he had blood clots in his leg. The patient was sent to the emergency room and started "that stuff" for about a week until he went to a regular vascular doctor and the physician determined what the patient should be doing. The patient reported that he was diagnosed with the blood clots after he got out of rehab. The patient received apixaban (ELIQUIS) from Apr2021 for blood clot in leg. The clinical outcome of blood clot in leg was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021478767 same patient, different dose/event
Very mild fatigue all day and at 5pm until now at 9pm experiencing abdominal pain?hard to stand straight.
My daughter reported intense pain at injection site, then folded over and began to shake and tremor all over. She was not responding to me I laid her down on the bed, the nurse came in and took her vital signs. My daughter started to respond to me after as the nurse entered the room.  My daughter was pale and sweating. When she tried to get up a few times later she had to lie back down as she became pale lightheaded and her blood pressure was low. She was given crackers and a gingerly which she was able to keep down and began to feel better. Her blood pressure seemed to be better and her other vital signs seemed to be normal. The doctor came in to examine her and released her to go home but not to school and call if anything else happened.
Patient stated that she woke up on 2/14/20 with a large, warm, red, upper arm. The redness, swelling, and warmth extended along the entire upper arm. Advised patient to contact her primary doctor who diagnosed her with a delayed type 2 hypersensitivity reaction. She was given Cephalexin 500 mg q6h for 7d
Information has been received from a registered nurse concerning an 80 year old male patient, with an unknown medical history and unknown drug reaction/allergies, who on Oct 12 2005 was vaccinated (route unknown) in his right arm with a dose of pneumococcal 23v polysaccharide vaccine (650453/1791P). Concomitantly he was vaccinated in his left arm with a dose of influenza virus vaccine (unspecified). Subsequently, on an unspecified date, the patient developed chills, swelling of his arm, fever, and coughing. The patient was treated with gatifloxacin (Tequin), 400 mg, daily for 7 days. On an unknown date the patient recovered. The patients experiences were considered to be other medical events by the reporter (OMIC). Additional information has been requested.
The day after my first vaccine, early morning, I started feeling headachy, fatigued, slight fever.  Since then I have felt like I have a low grade flu.  It has been 10 weeks now since my first vaccine and I still have headaches, sinus pressure, jaw pain, neck pain, fatigue, general malaise.
Information has been received from a consumer concerning his 6 month old son who was vaccinated PO with a dose of rotavirus vaccine (human-bovine). Concomitant therapy included dextrose (+) electrolytes (unspecified) (PEDIALYTE SOLUTION). The patient was also receiving fluids. The patient subsequently developed rotavirus. Unspecified medical attention was sought. At the time of this report, the patient's rotavirus persisted. No further information is available.
Myalgia, Fever, Purpura, BRUISING/PURPURA NEAR LEFT INNER THIGH, REPORTS VEINS IN LEGS LOOK MORE "PRONOUNCED" AS WELL Narrative: SENT TO OUTSIDE URGENT CARE TO EVALUATE
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with VARIVAX lot # L046888, expiration date: 23-NOV-2017, lot # M024680, expiration date: 18-MAY-2018, lot # M0101484, expiration date: 01-MAR-2018 (strength, dose, frequency and route of administration were not reported) which were improperly stored at 8.6 Fahrenheit degrees for 1 hour and 15 minutes. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
I don't know which vaccine was given at pharmacy. You will need to follow up with them. Chills started around 3 AM accompanied by nausea. Vomiting occurred around 5 AM. Fever spiked at 102 and broke 24 hours later. I am still achy but recovering.
My arm hurt last night and this morning; This is a spontaneous report from a contactable consumer(patient). A 44-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247; Expiration Date: May2021, at the age of 44 years), dose 1 intramuscular, administered in Arm Left on 18Feb2021 10:30 as dose 1, single for covid-19 immunisation at workplace clinic. The medical history and concomitant medications were not reported. No Prior Vaccinations administered. The patient reported left arm hurt last night and that morning on 18Feb2021 17:00 but it was improving. The event did not require the initiation of new medication/ other treatment/ procedure. The outcome of the event was recovered on 19Feb2021.  No follow-up attempts are possible. No further information is expected.
Swelling  of the arm, redness, tenderness, hard, painful Chills, fever - 101.5, headache, muscle pain, joint pain, sweating, severe neck and head pain, swelling face and arm
admitted to the hospital for malaise, fever, unsteadiness, tested positive for COVID on admission.
PT REPORTED TO LOCAL URGENT CARE WITH REDNESS/SWELLING OF INJECTION SITE. PROVIDER HAD DX OF "CELLULITIS" ON HER CHART, BUT FELT SHE PROBABLY HIT HER ARM TO CAUSE THE ISSUE
at 11:10 PM last night 02/03 my neck was starting to itch. I was on my way home from work and at 11:30 the itching was going down my chest. At 11:45. I took my shirt off and it was spreading across my chest and my breast. I called the toll free number and left a voicemail, I tried to access the website and was unable to. My son had generic Benadryl so I took 2 of those and I laid down to go to bed. I had a restless night but I didn't get out of bed until about 5:30. I went to the bathroom and looked and the rash was spreading more I was still tired so I laid back down and got up about 8:00 am and I was itching and burning from head to toe. I went to the bathroom and took off my pajamas. And I am covered with a red bumpy rash all over my body. I didn't want to take anymore of generic Benadryl because obviously it didn't work. I waited till 9 am until Dr. office opened and I called them and they told me to take over the counter Benadryl and to get Benadryl cream from over the counter. They told me they were cancelling my 2nd vaccine because they thought I was having an allergic reaction to the 1st vaccine.  I asked if I could get steroids, prednisone, they said the doctor advised against it because it would suppress my immune system. And he told me if I started wheezing or any shortness of breath to go to the ER and they told me to call in if I have any more side effects. So I got dress and went to pharmacy and bought Benadryl cream and Benadryl tablets and lidocaine spray. I did take the  Benadryl, sprayed the spray and rubbed the cream and it is only helping a little.
Post vax, the patient experienced a "hypersensitivity reaction" described as "swelling and redness at the injection site which spread to his chest". The patient was treated with ibuprofen and Benadryl. It was also noted that the patient also broke out with "a few pox". Follow up information from a registered nurse indicated that there is no additional information.
medical history most significant for hypertension, type 2 diabetes, hypothyroidism, pacemaker, who presents to the Emergency Department today due to shortness of breath that began approximately 2 days ago. The patient reports that the shortness of breath had a gradual onset and is getting worse.  She normally wears 1.5 L of oxygen at night.  However, she has been wearing it throughout the day.  Upon EMS arrival, she was satting well.  However, with any exertion, she dropped her sats for which they started her on non-rebreather.  She also reports bilateral knee pain that has been chronic along with chronic back pain.  She denies chest pain, abdominal pain or fevers.  She is COVID vaccinated.  She received her 2nd doe
pneumonia; Initial information received on 17-Sep-2020 regarding an unsolicited valid serious case received from a consumer non-healthcare professional.  This case is linked to case 2020SA257965 (same reporter).  This case involves a 72-years-old female patient who experienced pneumonia, while she received INFLUENZA VACCINE.  The patient's medical history included smallpox, pneumonia and allergy to eggs due to which she had the reactions of abdominal pain, peripheral swelling and rash macular.  The patient's past vaccination included smallpox vaccine (when studied abroad and came down with cowpox) and Influenza vaccine (unknown manufacturer).  The patient's past medical treatment and family history were not provided.  At the time of the event, the patient had ongoing food allergy.  Concomitant medications included two part and booster PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  On an unknown date, the patient received a once 0.5 mL dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from pneumonia.  Batch number has been requested for suspect product for this case.; Sender's Comments: An 72-years-old female patient who presented with pneumonia following the vaccination with INFLUENZA VACCINE (unknown manufacturer).Time to onset is not clearly defined. Medical history include smallpox, pneumonia, abdominal pain, peripheral swelling and rash macular. Patient also had ongoing food allergy. Concomitant medication include PNEUMOCOCCAL VACCINE. Patient's past vaccination included smallpox vaccine and Influenza vaccine. Precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
a dose of Adacel was administered to a 5 year old patient instead of Daptacel vaccine/ No AE; a dose of Adacel was administered to a 5 year old patient/ No AE; Initial information was received on 04-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves a five-year-old female patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6638AA and expiration date 12-Apr-2022) via an intramuscular route in the right thigh on 03-Aug-2020 for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient had received four doses of DAPTACEL vaccine in the past on unspecified dates for prophylactic vaccination.  The patient's medical history, past medical treatment and family history were not provided.  The patient concomitantly vaccinated with a dose of POLIO VACCINE for prophylactic vaccination.   It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  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.
Information has been received from a pharmacist concerning a patient who on 15-AUG-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  On 15-AUG-2007 the patient developed redness and swelling at the injection site.  Unspecified medical attention was sought.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
shot was administered on the 12 of january..... immediately after vaccine: pain, swelling, redness, heat, hard lump: this lasted until friday.... Friday Jan , injection site had less redness and swelling but had turned to a bruise........ Tuesday the  19th the area was bright red, warm to the touch, hard, swollen and itchy..... This lasted til wednesday. Thursday the 21 it seemed to get better... Friday it looked just like a bruise like it had the previous friday..,.... Today, Saturday the 23, the area is getting red again, itchy, hot, and the redness is spreading.... almost looks like ringworm. I have had multiple nurses and nurse practitioners as well as a dr tell me it looks like cellulitis?
Day 1-fussiness, slight fever, not herself. Day 2-vomiting, diarrhea. Injection site raised and red for 3 days.
Information has been received from a certified medical assistant (CMA) concerning a 4 yr old male with no medical history or allergies who on 16Jul02 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy or illness at the time of vaccination. The CMA reported that on the evening of 13Oct05, the pt developed itchy, red bumps on his head that began spreading. On 14Oct05, the pt presented to physician's office with a few erythematous papules and vesicles on his head, hand, scalp, and neck and nasal congestion. No fever was noted. A diagnosis of breakthrough chickenpox was made. The pt was treated with oral diphenhydramine HC1 (Benadryl) and acetaminophen (Tylenol) as needed. No laboratory/diagnostic tests were performed. Subsequently, the pt's chickenpox resolved. Additional information is not expected.
localized adverse reaction to administration of drug, told parent swelling should slowly resolve, if any increased swelling redness etc call
Right arm red and swollen, warm to touch: from shoulder to elbow. Right arm reddened and swollen, warm to touch from shoulder to elbow.
beginning 6NOV92 felt dizzy, lightheaded, listless, didn't want to do anything; late 7NOV92 began to have diarrhea; no cramping still having diarrhea; still weak 16NOV92;
no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 16-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA005873: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients' pertinent medical history or concurrent condition was not reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot #L035127, expiration date 14-SEP-2017, lot  #L008269, expiration date 11-MAR-2017, lot # reported as L032396, expiration date 26-AUG-2017, lot # L025208, expiration date 07-JUL-2017, lot # reported as L039093, expiration date 06-OCT-2017, dose, strength, route, frequency and indication were unknown). No adverse effects were reported. Temperature: 27F for 2 hours and 40 minutes Data logger: yes Was it administered (AE)? Yes Was it previous temperature excursion? No This is one of several reports received from the same source. Additional information has been requested.
Swelling and redness of face, neck and throat appeared about 30 minutes after vaccine. Patient took hydroxyzine hydrocloride 25 mg within 45 minutes after vaccine. Redness and swelling receded about 30 minutes after taking hydroxyzine HCL, but symptoms came back after about 6 hours and a second does of the Hydroxyzine HCL was taken. Symptoms did not reoccur after second does of Hydroxyzine HCL.
On 10/15/2001, pt received MMR vaccine at 12 noon. Mother stated seizures started at approximately 8 pm and continued through the night. There were 5 seizures;each lasted 5-10 minutes long; pt arched back, eyes rolled back into head, spitting, shaking and sweating.
At injection site on left arm, the skin was red, hot, and swollen. After not getting better, I went to urgent care a week later. Was prescribed Cephalexin 500 MG capsules and Hydrocortisone 2.5% cream. Returned to normal within a few days.
dizzy, headache, nausea BP 130/80 P 78 improved with water and snacks
This spontaneous report was received from a registered nurse via a company representative concerning a female patient who is also a registered nurse of unknown age. On 15-OCT-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date and dose unspecified), subcutaneously in the left arm (it was unknown if this was the first dose). Approximately on an unknown date in October 2013 (reported as sometime over the weekend), following vaccination, the patient developed a couple of lesions. The patient sought medical attention (unspecified clinic physician). It was unspecified if any treatment was given or if any lab tests were performed. The patient was not recovered from couple of lesions. The relatedness for couple of lesions was unknown for VARIVAX (Merck). This is one of the two reports from the same source. Additional information has been requested.
Received the Tdap vaccine in my left arm on Friday 4/6/07.  Had flu -like symptoms on Saturday and Sunday (Achy, fever, chills) and sore arm muscles around injection site.  On Monday 4/9/07, I woke up with severe left shoulder girdle pain and a marked decrease in range of motion of that shoulder.  The injection site was never red or inflammed.  I saw Dr. on Wednesday 4/11/07 who gave me a sling to wear for 10 days and prescribed Indomethicin and Darvocet for the pain and inflammation, as I was having trouble sleeping and concentrating during the day and could not use my arm without severe shoulder pain.  Started Physical Therapy on 4/24.  Got a second opinion from Dr. who is strongly suspicious of an autoimmune reaction to the vaccine that led caused marked stiffening of my left shoulder.
Flushot. Pt got h1N1 at school - developed hives almost immediately after H1N1 flushot. Seen at his pediatrician office -> placed on steroids and antihistamines.
After 2nd dose Right Arm Deltoid, within 1 day firm knot subcutaneous grew in same location of injection. Lesion kept growing and getting Harder. Size 1.5 cm. Led to surgical Excision- Apocrine Cystadenoma. Will now Require second surgery. Since tumor was not completely excised will need second surgery to prevent malignant transformation. Second surgery will need to be in operating room.
Symptoms: fatigue, body aches, headache, sore throat, nausea, diarrhea, dizziness
The day after the vaccine was given, subject experienced tenderness, irritation, and swollenness in her left arm.  Tenderness and swelling has decreased substantially since.