chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated that she did not feel well after vaccine administration. Patient was advised to wait in waiting are for observation.  15mins post vaccination, mother advised patient was not feeling well, Patient was observed by staff to be pale, and patient advised staff that she feels like she wanted to pass out and throw up.  Patient was escorted to exam room, and was examined by Pediatrician. Patient was discharged by Physician without further incident with ER precaution.
24hrs after the second vaccine I had the usual reactions: fatigue, nausea, body aches. On the 2nd day I woke up without any discomfort and was fine for 6-7 days.  SEVEN DAYS AFTER THE 2ND VACCINE: Jabbing, throbbing pain, itching and "running ants" located in: hands, (knuckles, wrists, palms, both sides), forearms, armpits and under breasts, upper back between shoulder blades, upper ribs, thighs, behind knees, and bottoms of the feet. Ongoing, all over, both sides of the body going on now for 48hrs.  I do not have any history of fibromyalgia.   Constant urination. Difficult to sleep. Fatigue.
This spontaneous report as received from a physician refers to a 62 year old female patient with pertinent medical history of hypertension. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route unspecified) on her right arm. The patient developed an area of redness, swelling, soreness, and induration 6 inches below the injection site on the right arm after administration of ZOSTAVAX. The patient was evaluated in the office today, on 14-MAR-2014, and was prescribed KEFLEX to treat cellulitis. The outcome of cellulitis was reported as not recoveered/not resolved. Additional information has been requested.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5/9. Patient will consider getting revaccinated.
Vaccination given IM in right deltoid on 8/26/2016. On 8/27/2016 patient experienced swelling of left deltoid with heat, mild pain, and localized redness. Patient stated on 8/29/2016 that Sx were all getting better and going down. Patient had been using Ibuprofen as directed and a few Tx with ice. I educated the patient on possible causes as well as advising the patient to come back if Sx do not get better or get worse in the next few days.
Patient admitted to hospital on 3/12/2023 for respiratory distress and tested positive for Covid.  He subsequently died in the hospital on 3/21/2023.
Case number PHEH2014US024962, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 63-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 16 OCT 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided.
Every joint was hurting including her artificial ones,she was in such horrible pain/both arms, both wrists, both ankles and all of her joints are all hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Every joint was hurting including her artificial ones,she was in such horrible pain/both arms, both wrists, both ankles and all of her joints are all hurting) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced ARTHRALGIA (Every joint was hurting including her artificial ones,she was in such horrible pain/both arms, both wrists, both ankles and all of her joints are all hurting). At the time of the report, ARTHRALGIA (Every joint was hurting including her artificial ones,she was in such horrible pain/both arms, both wrists, both ankles and all of her joints are all hurting) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.
FLU VACCINE REC'D 09-26-08. BEGINNING 9-27-08 PT HAD LOW BACK PAIN, MUSCLE ACHES ALL OVER; HAS BEEN VERY COLD AND ACHES & PAINS HAVE INTENSIFIED EVERY DAY SINCE.  oCTOBER 2, 2008 HAS BEEN THE "WORSE DAY YET". STATES SHE IS ALLERGIC TO THIMERSOL, BUT PMD SAID OK TO TAKE FLU VACCINE.
Initial and follow-up information has been received from a medical assistant concerning a 23 year old female with prior papilloma viral infection and no known drug allergies who on 27-APR-2010 was vaccinated IM with the first dose of GARDASIL (lot number 665768/1377Y). No other vaccines were administered at the time of the GARDASIL vaccination. At that time, the patient also received Monsel's solution topically to cervical area to stop bleeding, where a biopsy was performed. On 01-MAY-2010 the patient complained of trouble breathing, chest pain and outbreak of hives. The patient was sent to an emergency room (ER, name unknown), where the patient received a cortisone injection. This cortisone treatment was the intervention used to prevent serious criteria. The trouble breathing and chest pains resolved. On 11-MAY-2010, when the office spoke with the patient by phone, the patient was still resolving from the hives. Trouble breathing, chest pain and an outbreak of hives were considered to be other important medical event and disabling by the reporter. The health care professional contacted during telephone follow-up could not supply the following information: hospital name. Additional information has been requested.
About 21 minutes after my injection, while I was driving, I felt neurologically altered, slowed, drunklike, sedate. Had tingling sense of euphoria, and breathing slowed and felt more and more relaxed and then more and more sleepy. Concerned for my driving, and afraid I might pass out, I started to formulate a plan to pull over...I was on the interstate, and then as quickly as it came it was gone. Lasted 1 to 2 minutes. I wish I would have waited 30 minutes before driving.
Migraines that were previously under control have returned.  Experience migraine symptoms multiple times weekly.  Currently treating with over the counter medication and biofeedback techniques.  Outcomes:  slowing work productivity, increase in social/emotional withdrawal.
patient could only eat a little bit of food; diarrhea; very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours; woke up with no appetite; in bed until 2:30PM as she was so lethargic.; Patient woke up with a dull headache; nausea; muscle aches; Got chills at 10:15 PM, could not get warm; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (patient could only eat a little bit of food), DIARRHOEA (diarrhea), ASTHENIA (very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours), DECREASED APPETITE (woke up with no appetite) and LETHARGY (in bed until 2:30PM as she was so lethargic.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 017B21A and 014M2CA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced CHILLS (Got chills at 10:15 PM, could not get warm). On an unknown date, the patient experienced FEEDING DISORDER (patient could only eat a little bit of food), DIARRHOEA (diarrhea), ASTHENIA (very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours), DECREASED APPETITE (woke up with no appetite), LETHARGY (in bed until 2:30PM as she was so lethargic.), HEADACHE (Patient woke up with a dull headache), NAUSEA (nausea) and MYALGIA (muscle aches). At the time of the report, FEEDING DISORDER (patient could only eat a little bit of food), DIARRHOEA (diarrhea), ASTHENIA (very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours), DECREASED APPETITE (woke up with no appetite), LETHARGY (in bed until 2:30PM as she was so lethargic.), CHILLS (Got chills at 10:15 PM, could not get warm), HEADACHE (Patient woke up with a dull headache), NAUSEA (nausea) and MYALGIA (muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Information was provided by the reporter.
Patient stated he developed a red rash that went around to the inside part of his arm starting at the shoulder and going down to about half way down his bicep. He said it was a little bit itchy. He did say it has gotten better the last couple days, but is still slightly red.
Patient says that later in the evening of 10/20/17 he spiked a slight fever, did not give the temperature as he did have thermometer.
Information has been received from a physician concerning a very few patients who were vaccinated with GARDASIL vaccine (yeast) (Lot# not reported). Subsequently the patients experienced sore arms after vaccination. The patients' outcome were unknown. No further information is available.
the day p/vax pt felt hot & cold & @ the same time was lightheaded & dizzy;
Patient is 40 years and and got second moderna booster 0.25 ml dose.  AT the time of emergency use authorization, patient is supposed to be 50 and older or have certain medical conditon for second moderna booster.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
02/13/2021-pt could not stand/walk or support body weight, balance off, weak, brain fog
had a cold for a couple of days; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (had a cold for a couple of days), CHILLS (chills) and PYREXIA (fever) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ESCITALOPRAM for an unknown indication.    No medical history was provided by the reporter.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient started ESCITALOPRAM (unknown route) at an unspecified dose. On 27-Mar-2021, the patient experienced NASOPHARYNGITIS (had a cold for a couple of days), CHILLS (chills) and PYREXIA (fever). In April 2021, NASOPHARYNGITIS (had a cold for a couple of days), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101 (High) temperature above 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ibuprofen or paracetamol (didn't remember). The patient was recovered on either 05-Apr-2021 or 06-Apr-2021.   This case was linked to MOD-2021-095786, MOD-2021-095578, MOD-2021-095613, MOD-2021-095705 (Patient Link).
Enlarged and tender lymph nodes in both arm pits; Enlarged and tender lymph nodes in both arm pits; Joint stiffness; Soreness in spine; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 09:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient medical history included heartburn, overweight and fruit allergy (allergy to pears). The patient previously took Reglan on an unknown date for unknown indication and experienced drug allergy. The patient previously took Levaquin on an unknown date for unknown indication and experienced drug allergy. The patient previously took Monistat on an unknown date and unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included PEPCID, ZYRTEC and ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication; on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced enlarged and tender lymph nodes in both arm pits, joint stiffness and soreness in spine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events enlarged and tender lymph nodes in both arm pits, joint stiffness and soreness in spine were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
On 2/16/21 area on arm became red, hot and swollen.  Area approximately 4 inches across and 6 inches in length . Not itchy  Ice applied
I got a little sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Apr2021 (Lot number: ER8732) 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: ILLNESS (non-serious) with onset 22Apr2021, outcome "unknown", described as "I got a little sick".  No follow-up attempts are possible. No further information is expected.
Pt has PMH of anaphylaxis to PO sulfa drugs, red-syndrome to IV vancomycin and multiple food and environmental allergies. Physician and patient underwent shared decision making process in regards to getting vaccination.  - 13:10, pt received shot. - 13:20, pt reports L orbital swelling and numbness/tingling in L upper lip. Given 50mg diphenhydramine. Lungs CTAB. Airway non-edematous. No visible abnormalities or facial edema. O2 sat 98%. HR 77.  - 13:30, pt states that tingling has not subsided. Reports that symptoms are mild compared to historical allergic reactions. - 13:35 - pt discharged with instructions to take diphenhydramine Q 4-6 hours for 24 hours and to discuss reaction with PCP (pt already had appt scheduled on same day).
Bruising after 1 day of injection on injection arm, not site but other areas of arm. 8 days later rash, swelling on injection site.
Mom called office at 10:09 06/18/2003.  States babysitter called, temperature 102 and patient was lethargic.  At 19:42 06/18/2003, dad called back.  Temperature to 104.9.  Not eating, rash at injection site.  Red, flat.  Spread down to inside of elbow.  Phone advise given for tylenol and motrin.  Fever broke and rash resolved 06/19/2003 at 10:30.
2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, noticed the armpit lymph nodes swollen and slightly sore to the touch. Symptoms same on 03/23. On 03/24/21, noticed a red rash on outer part of upper arm to the elbow. Sweats and chills in PM and 2 fever blisters appearing on moth on left side.  Morning of 03/25/21, rash worsens, sweats and chills continue. Toward afternoon, lightheadedness and trembling in hands. Felt better after lunch, some lightheadedness, still.
Symptoms of myocarditis. Tight chest, felt pulse irregularities, new pronounced lack of stamina during any exercise, tire very easily.
2 days following administration, (36 h post adm), site of injection of hep Hib (dose #3) was swollen to the "size of a silver dollar," non tender. Slightly bruised.
Redness and swelling around Injection site, high Fever 103, Chills and sweats. Rapid heart beat and increased blood pressure. Er visited on 9/23/07 administered Clindamycin iv. Returned to Primary Care Physician on 9/24/07 and was admitted to Hospital for treatment from 09/24/07 to 09/27/0711/28/07-records received for DOS 9/24-9/26/07 DC DX: Left upper arm cellulitis, resolving.  Presented to ED with C/O left arm proximal area swelling. Redness around injection site and redness strated spreading around area. Fever 102 associated with heartbeating too fast. Pain and ache at site of injection.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 76 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 14-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 14-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016.
Received the booster at 10:15 am. Intense nausea, headache, body aches, fever (101-102 degrees) started that evening and continued overnight. Around 11am the next day I felt better (including no fever); however, several hours later the fever returned (102 degrees) and it took another 24 hours to return to normal.  The booster side effects were worse than what I had experienced with the second dose, which is why I'm reporting it. The available information suggests that the booster's effects would be milder, but that wasn't the case for  me.
Pruritis and red splotchy rash--treated immediately with Benadryl 25mg IM and resolved by 02:30 PM 11/14/2011.
Client was having increased seizures prior to clinic, but that was not reported during the screening process.  After vaccination, client had continued seizures that were refractory and did not stop with PRN diazepam and VNS treatment.
Got injection on 7/24/18. Injection was painful. Later in evening felt pain to my Lt arm going down arm  into my fingers & down my Lt leg. Did not look at injection site until next day 7/25/18, noted redness and swelling at site 2x 1.5 inch, H/A, Stomach upset, Fever, Tired, weak, Felt so bad Unable to go to work or do normal activity day after injection, spent most of the day lying around & sleeping. Feeling better the next day 7/26/18. I did not call my PCP.
01/11/23 presents to ED for "shortness of breath". PMHx of "COPD, diabetes, hypertension, CVA, arrhythmia"
devel fever-T101 & irritability, 3 hrs p/vax; rt thigh was swollen, warm & tender @ site of inj; pt was consolable as long as leg was untouched
This is in follow-up to report (s) previously submitted on 1/12/2009.  Information has been received from a licensed practical nurse concerning a 4 month old male patient with a milk allergy and no other medical history who on 22-JUL-2008 was inadvertantly vaccinated SC with a 0.5 mL dose of PROQUAD (Oka/Merck upgrade process). The patient also received a PEDVAXHIB (manufacturer unknown). There were no other concomitant medications. The patient has had diarrhea since vaccination. No diagnostic laboratory tests were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 1/12/2009.  Information has been received from a licensed practical nurse concerning a 4 month old male patient with a milk allergy and no other medical history who on 22-JUL-2008 was inadvertantly vaccinated SC with a 0.5 mL dose of PROQUAD (Oka/Merck upgrade process). The patient also received a PEDVAXHIB (manufacturer unknown).  There were no other concomitant medications. The patient has had diarrhea since vaccination. No diagnostic laboratory tests were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.