chrisvoncsefalvay/vaers-outcomes huggingface dataset:
14 hrs after injection I was freezing, three hrs later I was burning up this was at 3am, 4am still burning up and not able to sleep, 5am sat up and had a headache that was at least a ten on the pain scale, I went down our flight of stairs to get water and ibuprofen, I had to sit down before I could get the water, when I finally got up I went to the counter and was getting this stuff out and I started to sway and white spread across my field of vision and I grabbed for the counter to lower my self down and passed out before I could grab the counter, I laid there burning up and with a headache that was killing me. I finally got the water and 800mg of ibuprofen went back to bed and slept until 11am, got up no headache but since then I have been experiencing hot flashes daily the rest of March and into April a few in May. I realize that I am of the age to experience hot flashes heading into menopause but this was to coincidental and I had never had hot flashes before.
This spontaneous report as received from a Licensed Practical Nurse refers to a 9 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 29-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286.
Dose 1 given 2/5/2021 lot # N/A Patient died in the hospital on 12/29/2021 from failure to thrive, multiple comorbidities Patient did not have Covid 19
pt recvd vax;3-4 wks p/ dose 2 was dx w/ Epstein Barr synd;no tx;subsequently,recvd 3rd dose;outcome: not subsided;
Patient felt awful!  She experienced body aches, intense pain in spine and bones, chest swelling, chills, nausea, headaches (her "brain hurt"), fatigue, dry heaving, and loss of consciousness.
Patient received a shingrix dose # 1 vaccine on Saturday 8/21/21 at around 3:00 pm using aseptic technique.  She was asked and stayed 30 minutes after to monitor for anaphylaxis because of previous delayed onset arm swelling reaction to a vaccine.  She called Tuesday & stated she had a quarter sized red area around the injection site on Monday morning & it increased to red swollen area about 3 inch by 5 inch on Tuesday.  She said she iced it and used Benadryl which had prevoiusly helped her to a vaccine reaction in the past.  She stated that she also felt nauseous & vomited after eating on Tuesday her stomach wasn't feeling good.  It was recommended she follow up with her primary to which she stated she wasn't going to unless she got worse the next day.   She had vaccine without reactions after last vaccine reaction & her provider to her it was ok to get her Shingrix vaccine.  Her primary doctor office was contacted & informed of her reaction & asked if they would be ok for the patient to get a second dose of the vaccine in 2 to 6 months & they stated they would follow up with the patient & let us know.
Was good for a few days then have had such a bad head ache that I can not get rid of.
PATIENT RECEIVED HIS FLU SHOT AND JANSSEN SHOT BOTH IN RIGHT ARM AND A FEW MINUTES LATER HE FELT DIZZY AND FELL TO THE GROUND BUT WAS STIL CONSCIOUS.  WE RAISED HIS LEGS ON THE CHAIR TO HELP HIS BLOOD PRESSURE STABILIZE AND HE FELT BETTER.HE ALSO SAIDHE FELT NASUOUS, WE GAVE HIM WATER AND HE FELT BETTER. HE SAT DOWN FOR 15 MINUTES AND FELT BETTER AFTER.
Vaccine error administered Tdap instead of DTaP.  Vial labels looked very similar.  No reported by time report was filed.
Swelling, erythema () at injection site. Area swollen approximately 3 inches in diameter.
Area of injection (upper arm) became reddened and somewhat hard to the touch about 24 hrs post injection. No itching, no discomfort. Pt applied mild heat to area and over the course of 6 days the area had softened and much less red. No ill effects were noted. This was probably a normal reaction - no allergic signs noted.
Within 10 minutes of receiving her first Gardasil injection the patient blacked out.  SHe was treated with smelling salts to try and rouse her and was placed in an exam room where her vital signs were measured over a 45 minute period.  Her father was then called to come and picke her up as doctor did not want her to drive.
Comvax given 10/29/2001 - IM, left thigh. Mom reports on 11/02/2001 - red area with hard knot, pt seen in clinic on 11/02/2001 by Dr.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication of the patient was not reported.  The patient had no other side effects.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-498658 (Patient Link).
Case was tested on 4/26 for covid 19- test ordered SARS-CoV Ag (Presence) in Respiratory Speciman by Rapid Immunoassay.  results were "Detected" resulting on 4/26.  Case was in close contact with a family member who had tested positive- exposure occurred approximately 4/15/21- 4/16/21.  Case started having symptoms with onset of  4/20/21 starting with congestion, headache that increase in severity during course of illness and then case developed a loss of taste and a loss of smell.
2 hrs p/vax pt exp unconsolable crying for an hr & a stiff rt leg for 3 to 4 hrs; pt was taken to the MD the following morning & had recovered;
Patient woke on 7/5/19  up with "reaction" on upper right arm that included the area from her elbow to her shoulder, extremely swollen and red, the entire area, not at the site of injection. Patient went to primary physicians office, they told her the pharmacy should report, but no treatedment recommended .  On 7/6/19, the reaction continued and got worse. The patient went to an urgent care and was diagnosed with cellulitis.
Vaccine exposure via breast milk; This spontaneous case was reported by a physician and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a male neonate of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): On 04-JAN-2021, parent had Normal ultrasound, on 06-JAN-2021 Glucose test Normal 107.  Previously administered products included for Pregnancy: Prenatal vitamin (Daily via per oral route). Concurrent medical conditions included Exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother's last menstrual period was on an unknown date and the estimated date of delivery was 19-Aug-2021. On an unknown date, the neonate was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). The mother had a cesarean delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, with an APGAR score of 7 and 8 at (1, 5 minutes). The outcome was reported as Term Birth NOS. Head circumference  34 cm. At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.  This report concerns a child who experienced the unexpected event of vaccine exposure via breast milk. The event occurred after an unknown duration following the mother's exposure to mRNA-1273 vaccine. The mother has no relevant past medical history. The patient was delivered by full time birth by cesarean section. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This report concerns a child who experienced the unexpected event of vaccine exposure via breast milk. The event occurred after an unknown duration following the mother's exposure to mRNA-1273 vaccine. The mother has no relevant past medical history. The patient was delivered by full time birth by cesarean section. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Codeine), Drug allergy (Allergic to Phenergan), Allergy to chemicals (Allergic to Contrast dye) and Peanut allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, CLOPIDOGREL, CARVEDILOL, ASPIRIN [ACETYLSALICYLIC ACID], TAMOXIFEN, TRAMADOL and PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient experienced a sore arm after the first dose.  The patient claimed that the patient never got Covid19 even though their granddaughter got covid19 after having the Pfizer vaccine.  It was also reported that the patient was allergic to codeine, Phenergan, contrast dye, peanuts, and others and denied past medical history. The patient was taking Clopidogrel, carvedilol 6.25, allergy medicine Benadryl, aspirin 81 mg, tamoxifen at the time of the vaccinations and was also on tramadol and arthritis strength Tylenol but couldn't remember if these were started after the vaccination.  No treatment information was provided.   This case was linked to MOD-2022-500353 (Patient Link).
Fever ACHES & PAINS, CHILLS, DIZZY, FATIGUE, POOR APPETITE, INJECTION SITE PAIN Narrative:
Injection site pain; Arm pretty sore; This is a spontaneous report from a contactable physician who reported for himself. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EJ1685) via an unspecified route of administration on 23Dec2020 at 09:00 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included a history of anaphylaxis to latex which predated treatment with the Pfizer COVID-19 vaccine, heart rate control, hypertension and high cholesterol; all from unspecified dates and unspecified if ongoing. It was also reported that the patient's medical history was "none" and that the patient had no illness at the time of vaccination. Family medical history was reported as "none". Concomitant medications included ongoing metoprolol taken for heart rate control taken from an unspecified date ("taking for two years"), ongoing telmisartan taken for hypertension orally from an unspecified date ("taking for two years") at 1x/day (take once daily by mouth) and ongoing rosuvastatin calcium (CRESTOR; strength: 40mg) taken for high cholesterol from an unspecified date ("taking for 10 years") at 40mg, 1x/day. The patient did not receive any additional vaccines on the same date of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 the patient experienced "injection site pain" and "arm pretty sore". It was reported that "a physician called regarding the Pfizer COVID-19 vaccine. The patient reported that he received the second dose of the vaccine on Thursday and was advised by his medical director to call Pfizer to report his symptoms. He reported that he received the first dose of the Pfizer COVID-19 vaccine three weeks prior to the second dose. The patient first stated that was about 14Dec2020, but then clarified that per his vaccine card, he received the first dose of the vaccine on 23Dec2020 at 0900AM in the left arm. The patient stated that he noticed injection site pain that lasted about two days and his arm was pretty sore. Both events completely resolved before the second dose." It was reported that the events did not require a visit to the physician or to the ER. It was reported that there were no relevant tests. The clinical outcomes of the events "injection site pain" and "arm pretty sore" were both recovered/resolved on 15Jan2021.  The reporter considered that there was reasonable possibility (method of assessment: Global introspection) that the events "injection site pain" and "arm pretty sore" were related to BNT162B2.
Per mom's report, within 24 hours at back of right arm, presumed site of varicella, became red and hard. States site is not painful and is approximately 8-10 cm round.
Patient received dose 2 of the Pfizer COVID vaccine (EW0185, Exp 8/2021) at 1110. At 1122, patient reported to EMT Representative that she was experiencing "throat tightness." Vital signs: blood pressure 108/palpated, pulse 79, O2 99%, respirations 18. Patient reported eating a large breakfast with a large amount of coffee. Patient reported feeling anxious. PHN approached to assess. No noted shortness of breath, difficulty breathing or swallowing noted. Patient was given cold water bottle provided by vaccine site. Patient reported medical conditions to include seasonal allergies, medications include Claritin. At 1133, patient reported no change in symptoms with "throat tightness" on right side only. At 1133 vital signs: blood pressure 125/77, pulse 79, O2 99%, respirations 16. PHN offered patient Benadryl. Patient took 50mg liquid Benadryl at 1135. Patient reported medical conditions also included mitral valve prolapse after taking Benadryl. At 1140, patient reported symptoms had resolved and was noted yawning. Patient left walking with steady gait at 1202 with family member driving patient home.
Approximately 6 hours post vaccine, patient developed redness and pain in upper arm. She was seen in the clinic on 6/8/01 and had an 11 x 11 cm red, warm area. She was given ibuprofen for pain and Keflex.
Per pt family member, patient was found unresponsive in home on 11-9-23. Patient was rushed to local hospital where he passed away later that same afternoon.  Cause of death unknown at this time.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 10-NOV-2015 the patient was vaccinated with expired dose of ZOSTAVAX (strength, dose, frequency and route were not reported) lot # K010732 with an expiry date of 31-OCT-2015. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
On 03/21/2021 I took the 1st Pfizer vaccine with no abnormal side effects besides a sore arm.  On 04/11/2021 I took the 2nd Pfizer Vaccine with a delayed onset of about 24 hours  with sore arm, body aches and chill.  I also signed up for vaccine side effects - reporting symptoms and incorrectly selected no side effects because I thought that my lesions were yeast induced - later to find out this was not the case.  On around 06/06 I developed an itchy lesion on my inner thigh believed to resemble yeast or bacterial infections. I treated this with over the counter topical yeast medications. 3 weeks later I developed lesions on both breasts also resembling what I believed was yeast and attempted to treat it the same way, but it did not go away.  After developing more lesions on my back, legs, breast, arms I decided to visit a dermatologist 07/23/2021 where I had a punch biopsy completed using samples from my arm and back.  These samples came back as lichen Planus on 08/04/2021 a condition no one in my family has, nor have I had prior to the vaccine. By 08/08/2021, it is completely widespread with lesions on every single limb of my body  After speaking with my dermatologist and other dermatologists we?ve decided due to no changes within my everyday life, and I have not yet contracted Covid 19 after being extremely cautious, there is a great possibility that the leading cause could be from the Pfizer Vaccine and this should be reported as I have now developed a chronic untreatable auto immune disorder with lesions all over my body that itches to where I have to take a daily steroid and antihistamine  and have developed a lot of emotional distress.
Redness, puffed or swollen, about size of a baseball, soreness, difficulty swallowing, glands in the neck swollen, almost Blacked out, continued dizziness, and elavated blood pressure.
Information has been received from a consumer concerning her husband with fibrosis of the lungs who was vaccinated with ZOSTAVAX (Oka/Merck). The patient developed shingles and his lidocaine patches (manufacturer unknown) and NEURONTIN put into a cream did not aid in soothing his shingles. This is one of several reports received from the same source. No further information is available.
11/19/2021 six hours after my vaccine, I had a fever that got up to 103.6. I had chills, was shaking and heartburn. This lasted about 28 hours. 11/30/2021 I have a history of hypertension, but stable on medication. I had a headache early in the morning which I had been having for the past 2 nights. I took my blood pressure that morning and I noted my blood pressure was elevated to 160/100 and I still had a headache. I watched it and spoke to my provider. They had me increase my metoprolol and it did not change my blood pressure. We continued to watch my blood pressure and I ended up seeing my provider because it would not come down. We changed the dosages of my metoprolol. I had a scan on my carotid arteries and my kidneys. The tests were normal. I was referred to a cardiologist to do a full workup. She had me increase my baby aspirin and make sure they were chewable. I had a cardiac stress test and blood work which were both fine. A year out from my booster, my blood pressure is doing well. My doctor recommended not to get another vaccine. On October 22, 2022, I had an ultrasound on my left leg and discovered a blood clot and am on medication for that. I have only been on the medication for a week. A repeat ultrasound will not be done for another 2 months.
Very rapid heartbeat - 99 BPM/high blood pressure, flushing, weakness.  Rapid heartbeat has slowed somewhat but is still rapid compared to what is normal for patient who is very athletic.
Info has been received from a pharmacist concerning a male child who "tow to three weeks ago" in approximately 3/05, was vaccinated with a dose of varicella virus vaccine live. "Shortly after vaccination", the pt developed "about" 15 chickenpox lesions. Subsequently, the pt recovered. It was unknown if medical attention was sought. There was no product quality complain involved. Additional info has been requested.
Case number PHEH2014US018961 is an initial spontaneous report received from a pharmacist on 19 SEP 2014. This report refers to a 64 year old female patient . Her medical history and concomitant medication were not reported. She was supposed to get a dose of FLUVIRIN and a shingles shot (varicella zoster vaccine). But she was inadvertently vaccinated with two does of FLUVIRIN 2014/2015 (batch number: 1413301) one subcutaneously and other intramuscularly on 19 SEP 2014. No adverse event was reported following these administration errors (wrong vaccine administered and overdose).
Pain; Scratchy Throat; headache; Nausea; Fever; Case reference number MOD-2021-008855 is a clinical trial case report which refers to a 68 Years old Female patient.  The patient experienced Headache which resulted in .  This occurred while participating in Protocol   -   .  The patients relevant medical history included: No adverse event   .  The patients started Moderna COVID-19 Vaccine on  .  Some  11 days  later, the patient developed Headache.'  Relevant laboratory results included   and relevant physical signs . The patient experienced the following serious criteria:   The eventual diagnosis made was Headache .  The patient was treated for the event with TYLENOL .The action taken for Moderna COVID-19 Vaccine was  Unknown on  . The event(s) were:   . An autopsy was performed on  . .  The investigator considered the Headache  did not declare related to the study drug/placebo.  In the investigators opinion other possible factors included and the patients age/history or other factors.
Chest burning, swelling of tip of tongue and lips, nausea, light headed, course rails and threads pulse, high BP
Low-grade fever on 12/5/00. On 12/6/00, fever of 102F-105F and very tired. Physician exam was entirely negative. Fever lasted for 24 hours.
After 10 minutes of injection, feeling like low blood sugar, sounds and sights feeling farther away, lasted an hour and a half after, tingling lips about 45 minutes after the injection. Several episodes of this feeling in weeks and months after injection
Case number PHEH2012US007908 is an initials spontaneous report received from a nurse on 06 Apr 2012 with a follow up information received on 07 May 2012. This case refers to a 25-year-old female patient. She was vaccinated with only the MenCWY-135 liquid conjugate component of MENVEO (batch number: M11061) intramuscularly on 05 Apr 2012 and did not receive the MenA lyophilized conjugate. This maladministration was noted on 06 Apr 2012 and MENVEO (batch number: M11041) was re-administered through unspecified route and site on 11 Apr 2012. It was reported that on an unspecified date, her arm became sore, tender and red. She was advised to visit the primary care provider and was diagnosed with an infection at the vaccination site. She was treated with antibiotics. The outcome of the event was reported as recovered with sequelae. The causality of the events was assessed as suspected to vaccine administration. Follow up received on 07 May 2012: Batch number of MENVEO updated, infection at vaccine site, sore, tender and red arm coded as events. Re-vaccination details updated.
Sciatica on the left side became inflamed, 6 days after shot, same side as shot
2 days after PENTACEL, PREVNAR & ROTATEQ vaccines, roughly, 1 day persistent. Irritability & crying which resolved; TYLENOL some benefit (-) fever.
Fever of 104.2 at 10:30pm day of vaccination. Day after at 7am fever was 102.1. Acetaminophen was taken after the first to temperature recordings. 4pm day after vaccination temperature was 100.0, no acetaminophen taken after this recording. Temperatures taken after this varied between 100.0 to 100.4 then went back to my normal ~98.2 after six more days. All temperatures recordings were taken by ear thermometer.  A rash developed on the left arm at the injection site with a radius of 1 inch lasting for three weeks. It was slightly raised and light red, hurt to touch.