chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spike in her blood sugars; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Spike in her blood sugars) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Spike in her blood sugars).   At the time of the report, BLOOD GLUCOSE INCREASED (Spike in her blood sugars) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication information was provided.  No treatment product information was provided.
LEFT LEG RED AND ERYTHEMETOUS AT CLINIC; PT PLAYFUL; AFEBRILE; TREATED WITH TYLENOL Q 4-6 HOURS PRN; ICE; MASSAGE; RTC IN 2 DAYS OR GO TO ER IF S/S WORSEN OR DO NOT IMPROVE; A PEN WAS USED TO DRAW AROUND THE SITE OF ERYTHEMA AND PARENTS INSTRUCTED THAT WITH TIME AND MEDS, SHOULD GET BETTER. IF RASH GET WORSE AND ERYTHEMA INCREASES TO GO TO ER.
she is not feeling the same as she had before the drug; skin itchy in my head like hives and rash; skin itchy in my head like hives and rash; rash; breathing was labored it felt like a tube or band around chest and back; hot and cold flashes; fatique and exhaustion; she had heaviness with her chest she felt like she couldn't breathe; exactly like this one with swelling in her face; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: er8732), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 12:00 (age at the time of vaccination 67-year-old) as dose 1, single for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID); and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]) all for unknown indications from unknown dates and unknown if ongoing. On 26Mar2021 14:00, the patient experienced skin itchy in my head like hives and rash, breathing was labored it felt like a tube or band around chest and back, hot and cold flashes, fatigue and exhaustion, she had heaviness with her chest she felt like she couldn't breathe, exactly like this one with swelling in her face. On 31Mar2021, the patient experienced she is not feeling the same as she had before the drug. The outcome of the event exactly like this one with swelling in her face was recovered on an unspecified date in 2021, while the event she is not feeling the same as she had before the drug was unknown, and other events were not recovered.  No follow-up attempts are possible.
C/O hives approximately 17 minutes after injection. Progressed to difficult breathing and difficult swallowing. EMS summoned, Epi pen used, O2, Benadryl.  10/22/2007 MR received for ER visit 8/8/2007 for DX allergic Reaction-drug. Within 15 of receiving Hep B vax pt had SOB, trouble swallowing, and swelling of arm.  Similar reaction to bee stings.  Pt used own epipen and was given po Benadryl.  Transported by EMS to ER.  Still feeling lump in throat and SOB upon arrival to ER.  PE (+) for distress and tachypnea.  Txd with solumedrol with improvement and short steroid burst with ranitidine for home.  Weaned to RA and d/cd home.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown gender and age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2013, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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 is unknown. Additional information has been requested.
6-18-07 Mom reported increase irritability, T 108.7. Taken to hospital 6-11-07 also reported SOB. Mom states child improved 6-17-07, but "bump" continues at injection sites. Monday 6-18-07 mom reports injection no longer red, warm, tender but "bump" continues. Ask to call MD and relate all information to her.
Fatigue; body aches; fever; chills; headache for 4 days; nausea; entire left side of body from arm pit to hip felt like I was beaten up; fainting; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2023 at 10:30 as dose 1, single (Lot number: GJ6743) at the age of 64 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. Concomitant medication(s) included: RESTASIS; ROSUVASTATIN. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Apr2023 at 10:30, outcome "unknown", described as "Wrong vaccine administered"; FATIGUE (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered"; PAIN (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered", described as "body aches"; CHILLS (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered"; DISCOMFORT (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered", described as "entire left side of body from arm pit to hip felt like I was beaten up"; SYNCOPE (medically significant) with onset 22Apr2023 at 05:00, outcome "recovered", described as "fainting"; PYREXIA (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered" (26Apr2023), described as "headache for 4 days"; NAUSEA (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered". Therapeutic measures were not taken as a result of syncope, fatigue, pain, pyrexia, chills, headache, nausea, discomfort. Clinical course: If other vaccine in four weeks: No. Other medications in two weeks: Yes, Restasis and Rosuvastatin & vitamin supplement. No covid prior vaccination and covid not tested post vaccination. No known allergies or other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client fainted after vaccination, fell out her chair. She did not appear to sustain injuries from falling she recovered in a few minutes with O2 + juice. BP 122/68, pulse 72 Resp. 12. Afterwards she reported a history of fainting with blood draws + allergy injections.
achy-ness, soreness to touch, chills, shakiness grew intensity into the evening, fever broke mid-morning after sleep and ibuprofen
Patient was due for her second Hep A and Hep B vaccines. I had patient fill out the vaccines consent form, and administered both of the vaccines in the patient's right deltoid.  She did not report any adverse reactions. Patient left after receiving vaccines, and I noticed the vaccine was expired while charting that they were given.
frozen shoulder sick in bed w/flu;muscle relaxant & osteopathy,ultrasound 12NOV94,14NOV94,15NOV94 ER severe pain in shoulder,diaphoresis,shaking (like a leaf on a tree in the wind);adm ER to ICU;t101.4;staph aureus septicemia;emphysema
Patient who was fully vaccinated against Covid-19 presented to the ER with cough and shortness of breath.  He was found to have covid and was admitted for further management.    Patient was treated with remdesivir and dexamethasone.  His hypoxia improved and he was discharged home with home o2 and virtual hospital.     Pt is on warfarin for a h/o afib, inr is supratherapeutic, pt was advised to hold warfarin and have inr check in 1-2 days.    Pt discharging home in good condition.
Mother states she had diarrhea 1x  and  vomited 1x after the vaccine on March18,,2021.Today , patients' mother states baby has been eating a little less than normal but  she has  no diarrhea and  no vomiting. After 4 days from last  visit, mother noticed  a small, round, nodule  nickel size inflammation on the  rt. anterior thigh.
The side effects began with a low-grade fever and general achiness all over the body. This progressed to a high fever (~103.5 degrees F) with chills and extreme achiness. The fever was controlled with over-the-counter medication, but continued to spike up with the same intensity over the following 48-72 hours when left untreated. The injection site, including the left arm and armpit, were sore and achy over the next 96 hours. Some swelling in the lymph nodes occurred during the affected period, particularly in the left armpit and under the left-side jaw. There was achiness and soreness through the limbs, accompanied by a "restless legs"-type feeling occasionally in the legs. Headache was present on-and-off for 96 hours after the effects onset, with concentrated pain in the neck and brow area. Some vomiting and digestive upset occurred only in the first 24 hours after the injection. Other minor side effects include a cold feeling in the left side hand and fingertips, mild dizziness, and mild nasal congestion. Overall, the side effects were intense, but were generally flu-like and presented no discernable threat to safety or wellbeing.
This report is concerning a 29 year old female who on 2/13/01 was vaccinated with Hep-A and Japanese encephalitis vaccines. On 2/13/01, at 19:40, the pt complained of feeling hot, sweaty and slightly faint. The pt was placed in a supine position; BP was 134/70 and pulse was 94. The physician was notified immediately. At 19:41 the pt's BP was 131/70 and pulse was 70. The pt complained of tightness in the chest, very anxious and a funny feeling in he chest. Epinephrine was given IM at 19:45 and at 19:53 the pt stated she was not feeling good, Bp was 155/67 and pulse was 111. At 19:57, her BP was 163/75 and pulse was 101. The pt was still shaking. The pt had the following BP and pulse measurements: 163/75, pulse 117; 136/68 pulse 101; 149/67, pulse 113, 142/57. At 20:20, Benadryl was given IM with an immediate BP of 120/67 and pulse of 141. At 20:23, oxygen given 2L via nasal cannula. The pt's BP was 154/57 and pulse 127, 145/60 and pulse 119, 154/62 and pulse 129, 155/64 and pulse 131. The pt was transferred to the hospital. The pt reportedly recovered from the experience. This was originally reported by a health care professional. Additional information has been requested.
patient stated she had a headache about 15 minutes after the vaccine. she took Tylenol and the headache was relieved
This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown demographics. There was no information about concurrent condition, historical medication and concomitant medication. On an unknown date the patient was vaccinated with improperly stored VARIVAX lot # M031970/ expiration date- 30-JUN-2018, for prophylaxis. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Severe nausea, vomiting, eye pain, left flank pain, diarrhea , headache,  muscle aches, extreme fatigue for 3 day
The patient bled slightly upon immunization. About an hour later she noticed some bleeding under her skin. She returned to pharmacy approx 5:15 PM. She was instructed to apply pressure and seek medical attention if bleeding got worse. The patient was asked to return to pharmacy the next day. The arm looked better but I still contacted her physician due to her coumadin therapy. The doctor ordered a PT/INR and will adjust coumadin accordingly.
Extreme headache began about 1 day after vaccine.  Sharp pains in head and behind eye began about 4 days after vaccine and have continued now to 8-9 days after vaccine.  Pain is extremely debilitating, was in bed for hours and sought medical care with concern for stroke or tumor.  May need head MRI or CT yet.
Patient was given the 2nd covid booster one month early. Information known at the time of injection was he had only had the first dose of the covid vaccine. After administration, patient informed nurse he had already received the initial 2 doses and the booster. Patient did not have his covid card. Nurse did inquiry, found dates and patient confirmed. Historically,  has not been accurate. MD notified immediately. Patient has not had any adverse reaction from receiving dose early. Per CDC patient does not need to be revaccinated if given early.
Given 3 doses; This case was reported by a physician via sales rep and described the occurrence of extra dose administered in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number T5T79, expiry date 24th November 2023) for prophylaxis.   Previously administered products included Shingrix (received first dose on 10th May 2022). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 28th November 2022, the patient received the 3rd dose of Shingrix. On 28th November 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 and 29-Nov-2022 Reporter's comment: No adverse events currently but wanted to report. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was inadvertently administered third dose of Shingrix, which led to extra dose administered.
Bruising on the back of my right hand. Headache. Dizzy. Nausea. Mild fever.
Sore arm, severe body aches and pains, chills, fever. Sore arm was immediately, body aches started about 9 hours after vaccine was given. Chills started next morning, and fever started around 10:30 AM on 2/23/2021.
Information has been received from a Doctor of osteopathic for (Merck), a Pregnancy Registry product, concerning a 29 year old female patient with no allergies and a history recently discovered of heart murmur an asymptomatic an atrial septal defect who on 09-JUL-2011 was vaccinated with a SQ dose of VARIVAX (Merck) (Lot # 669920/0342AA,  Expiry date 07-MAR-2013) (does not reported). There was no concomitant medication. The doctor stated that the patient had been exposed to varicella by a co-worker who had chickenpox. The doctor mentioned that the patient might or might not had been pregnant when administered the VARIVAX (Merck). On 11-OCT-2011 via positive pregnancy test, the doctor confirmed that the patient was pregnant. The doctor also described that two positive pregnancy tests were performed. The patient performed a home pregnancy test and the physician had a "positive blood serum HCG". The patient was seen in the physician's office. At the time of the report, the patient had 6 weeks of gestation (LMP on 28-AUG-2011; EDD on 03-JUN-2012). Follow up information has been received from the clinic coordinator indicating that the patient had a healthy full term baby boy in June 2012 without any congenital anomalies. There was no other information received about her pregnancy or her child. Additional information is not expected.
No additional AE was reported; The caller states her daughter is two and a half years old and received her second dose of the VARIVAX vaccine yesterday, November 22, 2022.; This spontaneous report was received from a consumer (patient's mother) and refers to a 2,5-year-old female patient. Her concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On an unknown date in 2021, also reported as during 12-month check up, the patient was vaccinated with 1st dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, exact dose, lot #, expiry date, site and route of administration were not provided) for prophylaxis. On 22-NOV-2022, the patient was vaccinated with 2nd dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, exact dose, lot #, expiry date, site and route of administration were not provided) (Product administered to patient of inappropriate age). The consumer was inquiring about the information on the dosing schedule of the vaccine. No additional adverse event was reported.
about 3-4 months after vaccination, I started getting skin itch with many red bumps like hives, some of bumps are as big as thumb size, it started the whole body, then day after day, it moved from legs to body to arm, mostly on the thigh, buttocks areas, and then groin area.  One thing that I noticed is that around evening / dinner time 6,7 ish, that is when the itch start.  It's so itchy that I have to scratch then after about 45 minutes, it goes away, and if I take hot shower or oatmeal bath it helps to stop the itch.  Now a day, thru out the day, I have the itch some where on my body, mostly on the arm or leg.
I had joint pain which started at approx 2pm which intensified by the hour followed by a low grade fever with chills starting at approx 5pm. My fever climbed quickly for a high of 102.6. I started treatment with Ibuprofen 600mg with plenty of water and later Tylenol 650mg. My fever broke at approx 1am as well as body aches and chills subsiding. I felt weak and tired for approx 12 hrs later. I was checked by an MD for a possible ear infection, UTI, pneumonia, strep throat and flu. All tests were negative. I had no congestion or sinus drainage nor cough.
a recent cardiac event that they experienced (heart attack); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "a recent cardiac event that they experienced (heart attack)".  Clinical information: I overheard this conversation but I do not know who this individual is. It sounds like they were talking about a recent cardiac event that they experienced (heart attack). I think they were talking about just getting cleared for some activities - I think exercise. Since they were not wearing a mask in the building I think they are vaccinated, but I do not know the details like which vaccine, dose number, or how to confirm. Think they are of (Withheld) ethnicity and seemed older.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Patient reported to public health nurse on 11/14/14 that she had to take herself to medical center on 11/10/14 at 6:00 PM because of symptoms of shortness of breath, itching on arms, legs, torso and throat. she was treated at medical center with 1x BENADRYL-50ml IV, 1x BACTRIM IV and prednisone 20mg x 6 days.
pt recvd vax & w/in 5 mins became pale, eyes rolled back, started to collapse but did not lose consciousness; pt was hypotonic but recovered w/o treatment; pt was not hyporesponsive; episode lasted 5 mins;
Systemic: Visual Changes/Disturbances-Mild, Systemic: pain in multiple locations-head, back, knee, armpit-Mild, Additional Details: Patient called into the pharmacy to report various body pains and changes multiple days after getting his first Moderna COVID vaccination. "lower left back of head", "lower right back pain", "knee pain", "right eye blurred peripheral vision", "Left armpit pinching pain"
administered booster of Moderna vaccine, however patient had already received a booster in August 2021
bruise at left arm got very large; left under arm was swollen under armpit; big red spot at left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise at left arm got very large), LYMPHADENOPATHY (left under arm was swollen under armpit) and VACCINATION SITE ERYTHEMA (big red spot at left arm injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruise at left arm got very large), LYMPHADENOPATHY (left under arm was swollen under armpit) and VACCINATION SITE ERYTHEMA (big red spot at left arm injection site). At the time of the report, CONTUSION (bruise at left arm got very large), LYMPHADENOPATHY (left under arm was swollen under armpit) and VACCINATION SITE ERYTHEMA (big red spot at left arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Initial and follow-up information has been received from a retired nurse and a physician, concerning the retired nurse, a 78 year old female with hypertension, who on approximately 13-Mar-2008 or 14-Mar-2008 was vaccinated subcutaneously with 0.65ml dose of ZOSTAVAX. Concomitant therapy included diphtheria toxoid and pertussis whole cell vaccine and tetanus toxoid. The physician reported that on 13-March-2008 for annual exam, the patient received the prescription for the ZOSTAVAX but it was administered elsewhere. Laboratory tests showed that she had increased Bilirubin. However, hepatitis A, B, C has been ruled out. On 04-Jul-2008, the patient was diagnosed with gall stones. On 29-July-2008, the patient was seen by doctor. She had abdominal pain and jaundice. Tests revealed increased liver function tests. gallstones and dilated bile duct. A surgery for her was pending. At the time of reporting, her gall stones persisted. The patient herself did not report to PCP any adverse reaction to ZOSTAVAX. No further information is available.
This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K010465, expiration date 23-MAR-2016 (dose, dose number, route and anatomical location were not reported). Concomitant medications were not reported. The physician did not have any previous temperature excursions. No adverse symptoms were reported. A product quality complaint was not involved. Additional information has been requested.
Redness and Swelling ? 70 mm x 70 mm Slightly warm to the touch