chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Parent states baby was fussy Friday evening (12/8/17) after receiving above vaccines. Baby was up five times that night, behavior was different, randomly crying, clingy, could not be put down per parent. Not eating solids as well, shorter naps, felt warm but no fever, some cough, no runny nose per parent. No vomiting or diarrhea, no ill contacts at home, TYLENOL does not help per parent.  Parents very upset, mom crying and unable to hold baby for exam here in office on 12/12/17. Parents refused to have baby weighed or measured and state baby is a different baby since vaccines were given on 12/8/17. No bruising or swelling at imm sites.
Hives/rash present  over faces, eyes, upper and lower extremities, and back. Symptoms noticed the evening of 10/1, one week after first dose. Reaction currently remains with no change in diminishing.
After one week, my left arm became red at the shot site. It was swollen, and itchy.  This lasted for a couple days.
Pt had significant edema of left arm and urticarial rash approximate 10 cm in diameter.
had 140/87 mmhg of blood pressure; chills; nausea; headache; sore right arm; A spontaneous report was received from a consumer who is 53 year male who experienced a headache, chills, nausea, vaccination site pain, and increased blood pressure.  The patient's medical history was not provided. Concomitant product included losartan 100 mg daily, atorvastatin 40 mg daily, and baby aspirin.  On 25-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 25-FEB-2021 the patient reports experiencing soreness in the his right arm until 27-FEB-2021. On 28-FEB-2021 he developed a headache, then on 01-MAR-2021 he began having chills and nausea, and also mentioned having a blood pressure of140/87 mmhg (reports his normal levels are around 126-129/79 mmhg)  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, headache, chills, nausea, pain in right arm, and increased blood pressure, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Hard red patch at injection site, noticed 10 days after shot. Continues to grow larger 5 days later, forming ring.
Tdap was given to 4 yr old child stead of DTaP. No adverse reaction.
This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a adult male patient who received Rabies Vaccine for prophylaxis. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Rabies Vaccine. Additional information was received as follows: The age at vaccination was not reported. The patient received pre-exposure prophylaxis with an unknown brand of rabies vaccine at an unknown time. The titers were drawn recent to the reporting date, and they were fount to be low, thus leading to the therapeutic response decreased. Lab Comments: In 2018, the patient underwent serology test which was resulted as low antibody titer for rabies.
Received flu shot and within 5 minutes had rash.  dry mouth and headache.
This spontaneous report as received from a other health professional refers to a 16 year old patient.    On 12-JUL-2012 the patient was vaccinated with GARDASIL dose 1 for prophylaxis. Other suspect therapies included GARDASIL 9. On 15-AUG-2017, 5 years 1 month 4 days after onset of therapy the patient experienced inappropriate schedule of drug administration and interchange of vaccine products. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration, no adverse event and interchange of vaccine products is unknown. The reporter considered inappropriate schedule of drug administration, no adverse event and interchange of vaccine products to be not related to GARDASIL 9 and GARDASIL.
After  exercise (typical for my lifestyle) I experienced my first instance of what seemed to be orthostatic hypotension. After standing up from bending over in the shower, roughly 10 minutes after exercise, my wife had to catch me from falling over as I became lightheaded, dizzy and lost color to my face. After 10-15 seconds I regained full neurological function.
Fever 102.2,  coryza, cough, maculopapular eruption, sparsely, mostly in limbs, 2mm red, raised papules.
Moderate to severe arm pain. Tingling sensation running down the arm. Occurring within 1 hour of administration. States vaccine given too close to shoulder. (reported by representative)
35 patients exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported.
Within a couple hours my arm become visibly swollen, red splotchy rash, and felt like my arm was asleep (all the way to my finger tips), the most intense aching pain for 3-4 days  I had a fever over 101.5 degrees F about 18 hours later, I continued to wake up having night sweats for about 10 consecutive nights along with diarrhea for multiple days,  the following two weeks at least I struggled with numerous episodes of light headedness, orthostatic hypotension to the point of my vision going dark.  I also experienced extreme headaches, fatigue, weakness that I have never felt from previous flu vaccine shots  I finally took acetaminophen for the fever which helped it come down to 100 F, all fluids ran right through me for multiple days, and I am still dealing with fatigue and my blood pressure dropping at random times .  The rash is no longer there and swelling has subsided
Everything hurts; Ankles were in pain; Knees were in pain; Hips were in pain; Shoulders were in pain; Arms were in pain; Has pain ever since; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), PAIN IN EXTREMITY (Arms were in pain), PAIN (Has pain ever since), MYALGIA (Everything hurts) and ARTHRALGIA (Ankles were in pain) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001R21$) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Hyperlipidemia.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Has pain ever since). On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arms were in pain), MYALGIA (Everything hurts), ARTHRALGIA (Ankles were in pain), ARTHRALGIA (Knees were in pain), ARTHRALGIA (Hips were in pain) and ARTHRALGIA (Shoulders were in pain). In April 2021, the patient experienced INSOMNIA (Couldn't sleep). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INSOMNIA (Couldn't sleep), PAIN IN EXTREMITY (Arms were in pain), PAIN (Has pain ever since), MYALGIA (Everything hurts), ARTHRALGIA (Ankles were in pain), ARTHRALGIA (Knees were in pain), ARTHRALGIA (Hips were in pain) and ARTHRALGIA (Shoulders were in pain) outcome was unknown.            Concomitant product included blood pressure medications and cholesterol medications. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated vaccine information, Concomitant medications were added, and  Event added.
This spontaneous report as received from a healthcare worker who is a medical assistant refers to a 17 year old female patient. The patient had no concurrent conditions, pertinent medical history, drug reactions or allergies. On 06-AUG-2015, the patient was vaccinated with the first 0.5 ml dose of GARDASIL lot # K010574, expiration date 08-APR-2017, intramuscular in the left deltoid. Concomitant therapies included MENACTRA which the patient was vaccinated with in her right arm on the same day, prior to GARDASIL. Immediately after the administration of GARDASIL the patient vomited, passed out and was "jerking". No further explanation of "jerking" was provided. The patient recovered from the events on the same day, after 30 seconds. The patient has been instructed by her physician not to receive further dosing with GARDASIL, due to the adverse events, the patient would not be completing the series. The relatedness between GARDASIL and the events was not reported. Additional information has been requested.
1325- Pt presented to observation room, mom was supporting her as she walked. I got to the patient and supported her to the ground as she started to fall. Pt did not lose consciousness, appeared diaphoretic and pale, stated nauseated and didn't feel good. Mom said she has done this in the past when has had injections or blood draws. Laid pt with feet up on a chair. Ice pack placed on forehead. Answering questions appropriately. 1328- BP 112/72, HR 68, RR 20 1330- pt stated feeling better and sat up slowly 1333- felt well enough to sit on the chair 1338- pt and mom opted to leave premises, pt appeared neurologically intact, stable and walking independently
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. Information on their concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD lot # L024122, expiry date 30-DEC-2016 (dose number, dose units, route and anatomical location were not reported). Concomitant medications were not reported. There was no Product Quality Complaint (PQC) involved. This case is linked to MARS # 1607USA012830 (same reporter link). Additional information has been requested.
Dizziness Feeling throat swelling - no voices, nowhere Feeling shaky. No respiratory distress. Nurse assessment. VSS. No wheezing Benedryl 25mg PO Pepcid 40mg PO
Headache. Aleeve X2 taken Thursday 12.17 at 2p. went away after several hours. Have another headache this morning
Adult dose given to 9-year-old child. Monitored for 30 minutes. Child stated he felt okay. Counseled mom on possible side effects: flu-like symptoms, fever and muscles aches.
Headache, Myalgia, Arthralgia,  lump right axillae; pain on arm Narrative:
30" after shot pt felt pain (R) side f neck, shot (L) deltoid. Felt better after 3 hrs.
My child complained of his arm hurting that night after receiving the Flu shot, the next morning his entire bisep was swollen and warm, the next day his whole arm was swollen, he had no fever...this swelling was not local, his entire arm was swollen, it appears to be resolving now.
Pt recvd a 2 series of vax (total of 6 injectins) & was determined to be a non-responder;
At 1730 she started having generalize and moderately intense "hot flashes". Denies SOA/CP, or edema of mouth, tongue, or lips. Around 1845 took 25mg BENADRYL. Hot flashed were coincidentally resolved by the time she took the po meds. While changing for bed at 2200 noticed bilat rashes on inner aspect of calves. No other S/S. The rashes was in same place as a "poison ivy" type reaction earlier in the summer, but long ago resolved. No other s/s overnight and resolved by morning.
Pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-year-old female patient (gravida 1) who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Apr-2021. On 15-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On 15-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment medications provided by the reporter.
red, itchy, painful, swelling of left arm, near injection site, hives on forearms, starting about a week after first injection
Initial report received from a healthcare professional on 05 September 2014. A 85-year-old female patient, whose medical history and concomitant medication was not reported, had received a dose of FLUZONE HD (batch number-U4997AA) dose, dose in series was not reported intramuscularly in left deltoid on 04 September 2014. On 05 September 2014, one day after vaccination, the patient developed 3 and 1/2 inch red rash area about 1 inch below injection site. Laboratory investigations and corrective treatment was not reported. At the time of this report the patient was not recovered from the event. Documents held by sender: none.
ADDENDUM: 08/05/2021 1305: Pt notifies Health Center at 1305 stating she "feels funny." Screening completed over the phone and was instructed to RTC now. 1316: pt RTC ambulating and no acute distress noted. 1323: VSS: 118/76, 80, 14, 98.1 oral, 99%RA. Breath sounds CTA, Heart RRR. Pt suffers with increased stress and anxiety and is concerned this could possibly a reaction to the Moderna first dose vaccine she received at the Health Center earlier this am around 1025. Explained to pt this is likely an anxiety attach. Pt states she recently started taking Wellbutrin 150 and Ativan 0.5 about 3 weeks ago, currently sees PA at clinic. Denies any chest pain, tongue or throat swelling. Continues to say " My face feels funny." Pt states she had cardiac workup on yesterday with labs, EKG and CXR are was told " all normal." 1331: Zyrtec 10mg po x 1 given in clinic. Tolerating talking and drinking water. Pulse ox remains on pt and continues to be 99-100%RA. 1351: 116/72, 76, 14, 99%RA 1355: pt states " that funny feeling comes and goes. I am getting flushed." Pt unable to reach family or ex husband to bring to ER or urgent care. 1408: police were notified. 1415: police transferred pt to urgent care of patients choice. Vital signs remained stable. Pt AAOx3. Ambulates without difficulty. No physical signs of distress noted.
Redness, heat, itching, pain, about a 2x2 patch on arm  around vaccination site growing slowly over course of the day  Similar to other vaccinations I've had like like shingles but a week later not immediately
pt recv flu vax & site of inj w/in 3hr became swollen, warm & tender to touch;
Approximately 30 minutes after vaccination, patient had localized rash at admin site with severe localized itching. Patient did not want Benadryl as it makes him vomit. Patient denied throat/tongue swelling.  SOB. pulse ox at 99% on room air with radial pulse of 106 bpm. 911 was called when EMS arrived patient complained of throat itching with no SOB and rash spread to chest and neck. Care transferred to EMS and they administered epi and patient transferred to hospital via ambulance.
Had vaccine 01/05/05, on 01/17/05, mom called stated child broke out with generalized chicken pox.
After a few minutes in observation pt was brought into special event room due to chest tightness, metallic taste in her mouth, and a "lump" like feeling in her throat when attempting to swallow.  1st Bp/pulse: 142/86 / 88   2nd Bp/ pulse: 140/84  /  77 patient also reported having cardiomyopathy only after RN started assisting her currently taking multiple medications including: Metoprolol, Glucophage, atorvastatin, gabapentin.  After RN evaluated the pt she was given 50 mg benadryl PO and after 20 mins symptoms were no improving and worsening slightly. Epipen not administered because lungs remained clear and BP/HR were stable. Also chest pressure remained 6/10 and with the history of cardiomyopathy, it was felt that patient should be seen at emergency department.  Ambulance was called and pt was taken to the hospital at 2:55.
Rash began 2/20/03. Rash on both arms, progressed to whole body, itchy, red, slightly raised rash. Seen by allergist who determined that rash was not a result of vaccine.
Patient reported extreme weakness and pain to left arm after receiving PVC 13 vaccine. Pain and weakness to left arm progressed throughout the afternoon and evening, by evening she reported she was unable to lift her left arm. Denies fever, swelling and redness at injection site. Pain and weakness resolved within 24-36 hours after immunization had been administered.
Patient is only 16 and the Moderna vaccine is only approved for those 18 and over.   Her 23 year old sister, was forced by her father to take Patient with her to get the vaccine because Sister already had an appointment and it was "convenient" and less of a hassle for him.  It is believed that they lied about Patient's birth date because the forms (consent, registration, etc.) provided for the vaccine CLEARLY state the minimum age to receive the Moderna vaccine is 18. However, there should have been some accountability and proof of age should have been required (ie a birth certificate). It is believed that Patient is experiencing side effects, and that they may be serious. Her father and her sister,  as well as her grandmother, (the court-mandated "Supervisor" for custody) refuse to provide me, Patient's mom with any information regarding Patient's well-being at this time- 1 1/2 days after the administration of the vaccine---and they have refused my attempts to contact them by simply not replying---which is unlike them. In the past, Patient has been hospitalized for several days and they did not advise me (again, this is against the court mandate.) It is not only illegal that Patient was vaccinated with the Moderna Covid 19 vaccine- and that Sister, Dad, and Grandma are liable  (her grandma, knew in advance they were going to have the vaccine administered) but it is also illegal and unethical that my daughter may be quite unwell at this time and may be wanting and /or needing me and yet, I do not know where she is or how to get to her to help her. If she is okay, I want and deserve to know this information as well.
Pediatric dose given to adult; Pediatric dose given to adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 39-year-old female patient who received HAV (Havrix 720) (batch number 2X2EJ, expiry date 14-OCT-2024) for prophylaxis.   On 20-APR-2023, the patient received the 1st dose of Havrix 720. On 20-APR-2023, an unknown time after receiving Havrix 720, the patient experienced underdose (Verbatim: Pediatric dose given to adult) and adult use of a child product (Verbatim: Pediatric dose given to adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter was a medical assistant. The reporter reported that the adult patient received pediatric dose of Havrix vaccine. The reporter did consent to follow up. The adult patient was administered a pediatric dose of Havrix, which led to underdose and adult use of a child product. This case had been linked with US2023058972 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023058972:Same reporter
Cellulitis where Anthrax injection was given. Arm is very red warm tender & edematous.
Information has been received from a physician concerning a 6 month old male who, "about one month ago", on approximately 21 Oct 2006, was vaccinated orally with 1 tube of Rotateq (human bovine) (Lot # 655175/0849F). No symptoms were noted. No other information was provided. Additional information has been requested.
Pt was shaking around 2pm. Shot was given around 9:30 am.
Information has been received from a physician concerning a 17 year old female with no medical history or allergies, who on 14-AUG-2006 on 02-NOV-2006 was vaccinated IM with a first and second 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  There was no concomitant medication. In December 2006, the patient had a false positive HIV result.  It was noted that the physician stated that the patient had no risk factors for HIV.  Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved.  Additional information has been requested.
Mom said on the evening of vaccine date, the child had become flushed in the face and very irritated. The next day she noticed a large area, approx 2/3" in size, around injection site, it was red, swollen and hot to touch. Fever. She said very elevated, but she did not record it. She took the child to medical center for evaluation, given antibiotics. Today, her right is still red but less erythematous and hot.
Had when I woke up at 6 am set on Jan 22, 2021 still ongoing  Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic
Received a tetanus shot with whooping cough vaccine two days later Right arm began hurting went to ER received pain meds Went to reg. DR.
My 20 year old daughter had the mederna vaccine The following morning she fainted and blacked out for 4minutes She now has tiredness ,pain in her neck and swelling in her neck Heart rate increased also
Pt has had intermittent chest pains, palpitations, extreme fatigue. Has had extensive cardiac work up including, holter monitor, echo cardiogram, stress test, cardiology consult, CBC, BMP, TSH, hemogram.  All test results have been within normal limits but pt continues to have these symptoms. Symptoms occurred after first dose of Pfizer vaccine.  She has not had her second dose due to side effects with the first.
Developed a rash on my buttocks and down my legs. Saw Dr and he prescribed MethyIPrednisolone Tablets
On 09/14/2022 I received my Covid-19 vaccine. On 10/05/2022 I started experiences Palpitations. On 02/13/2023 I reached out to my doctor I was diagnosed with a PVC. I was given Holter monitor for 72 hours. Symptoms ongoing.
Immediately after receiving his varicella vaccine in his L thigh, child broke out in redness around administration site; when I re-evaluated him, he had a 9 cm area of flat splotchy erythema involving his L upper thigh; not itchy; no hives; no swelling; no SOB; no vomiting; otherwise acting fine; appeared consistent with a localized reaction; of note, this was the second child who had a reaction to varicella vaccine in my clinic this day.
Pt has had 5 Hepatitis B vaccine injec since '85. Test reveals  still nonimmune