chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness on my arm; now it started to spread down my arm and it itches pretty bad; Redness on my arm; now it started to spread down my arm and it itches pretty bad; This is a spontaneous report from a contactable consumer (reported for herself). A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179/Batch number was not reported) via an unspecified route of administration, administered in left arm on 27Jun2021 (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. Medical history was not reported. Concomitant medication included unspecified "just birth control". The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jun2021, the patient experienced redness on my arm; now it started to spread down her arm, and it itches pretty bad (erythema, pruritus). It was reported that patient got the shot on 27Jun2021, (Pfizer shot) and maybe a couple of days later, she noticed that the redness on her arm 'right away kind of like where the bandage was' (Further clarification was unknown) but now it started to spread down her arm, and it itches pretty bad. Therapeutic measures were taken as a result of event erythema which included treatment with 1 percent hydrocortisone (yesterday). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
After administering this first dose from the reconstituted vial, it was determined that the vial was reconstituted with 0.8ml normal saline rather than the required diluent quantity of 1.8ml.   This vial was discarded, no further doses administered.    per CDC guidance, patient informed and advised to observe for side effects.  No further modifications indicated.
Golf ball sized swelling. Arm bruised/turn black all the way down to elbow and was warm. Was seen by a doctor and has improved. Treatment was icing and elevating.
Cellulitis of right thigh; 6cm X 4cm. Treat with Keflex 1 tsp tid X 5 days/cool rags.
soreness in her left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received the 1st dose of Shingrix in the left arm on 29th December 2020, refer case US2021073779). Concurrent medical conditions included vitamin d deficiency. Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 3rd March 2021, the patient received the 2nd dose of Shingrix. On 3rd March 2021, 4 hrs after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The lot numbers and expiration dates of all vaccines were not known. The patient received Shingrix in left arm and 4 hours later experienced soreness in her left arm. The reporter consented to follow up and gives permission to contact Facility.  The reporter refused offer to email Shingrix PI but did take MI telephone number to give to HCP.  The patient received another dose of Covid vaccines on 18th March 2021.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073782:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2021AMR074237:Same reporter US-GLAXOSMITHKLINE-US2021073779:same reporter
The main symptoms was fever 101 for up to 10 hours, chills, and headache.
After the 1st shot her arm got really sore, could  not sleep that night; After the 1st shot her arm got really sore, could  not sleep that night; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A 76 (Units: Unknown)-female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration date: not reported), via an unspecified route of administration, administered in arm on an unspecified date as 1ST SINGLE DOSE for COVID-19 immunisation. The patient medical history included insomnia. The concomitant medications were not reported. It was reported that after the 1st shot her arm got really sore, could not sleep that night. The patient tried treatment with Melatonin and Benadryl, but it worked backwards on her. the patient received treatment for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021142435 same product, different patient and event.
This spontaneous report was received from a licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored (temperature excursion: 8.2 C, time frame: 13 hours) doses of PROQUAD (Merck) of lot/batch # L042818 with expiry date 26-APR-2017 and lot/batch # L041629 with expiry date 22-APR-2017 (Dose, strength, dose number, vaccination site and route of administration not provided) on unspecified dates. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports from same reporter link. Additional information has been requested.
Patient received the powder portion of Menveo mixed with Pfizer COVID diluent. Both the Menveo and Pfizer pediatric COVID vials have same colored top. Patient observed for 15mins with no adverse event and/or outcome. Patient will be advised to return to repeat COVID vaccine.
Pt exp fever, cough, sore throat, & weakness p/recvd flu vax;
On Thursday - four days after the shot, I felt an itch that did not stop.  I kept wanting to scratch it.  There was also a BIG bruise.  I had checked the box on the form that I take Xarelto.  The area was also warm to the touch.  But Sunday, now, the area is quite HARD, still warm and itchy.I am getting worried about it but did not want to go to urgent care if I did not need to .I am hoping to get advice from the agency.
rash was on neck and torso; rash at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash was on neck and torso) and VACCINATION SITE RASH (rash at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (rash at the site of injection). On 04-Apr-2021, the patient experienced RASH (rash was on neck and torso). On 05-Apr-2021, RASH (rash was on neck and torso) and VACCINATION SITE RASH (rash at the site of injection) had resolved.            The doctor recommended Benadryl for rash. The action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-072620 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2021-072620:1st dose
8/12 and 8/13 she had no stools, then on 8/14 had a large mucousy stool with streaks of blood. Some liquid stools since, very fussy, very gassy. 8/19 was feeling better and had normal appearing stools.
he is also not drinking; pain at injection site; coughing/cough; chills; not wanting to eat and fatigue; not wanting to eat and fatigue; feeling of being drowsy, like he is going to get a cold; This is a spontaneous report from a contactable consumer (patient himself). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (arm left), on 04Jan2021 at 14:15, at a single dose, for COVID-19 immunization. Patient has no relevant medical history. Concomitant medications included metformin, empagliflozin (JARDIANCE), lisinopril, and pravastatin. Historical vaccine included shingles; and flu shot for flu vaccination both administered in Jan2020. Patient is Behavioral Health Technician. Patient received the first dose of vaccine on 04Jan2021 (Monday) at 14:15 and went through cough, chills, not eating, fatigue. Today (Wednesday) he is better; he asked if he can take ibuprofen after having the vaccine. He also asks how long do these symptoms typically last. All the symptoms he mentioned started around 8:00 p.m. the same day, it was that feeling of being drowsy, like he is going to get a cold. He also had excruciating pain on the arm that got the vaccine, it was pain at the injection site. He added that he was also not drinking, he knows he should drink fluids. His second dose is on 26Jan2021 at 8:45PM. He has no positive COVID test before the vaccine. He did not have antibody test before the vaccine. He has had no issues with vaccines in the past. Outcome of the events not wanting to eat and fatigue was not recovered, for event "he is also not drinking" was unknown, while for other events was recovering.  Information about lot/batch number has been requested.
My son was given his vaccinations on November 2, 2009 at around 9am. He was vaccinated for hib, hep b, polio, pneumococcal, and DTAP. On November 3, 2009, he became very fussy and quite lathargic. About two in the afternoon he had developed a fever of 102.1 and started developing a rash as well on his face and tummy area. It took about one hour for the fever to break. He did not want to eat any formula or cereal but would drink water. By the end of the night he seemed a little better. The morning of 11-4-09 however, he became extremely fussy. Crying inconsolably and still not eating. He had a little of the rash left but no fever.  He cried from about six thirty am until close to two thirty pm. Finally at about 3pm on the fourth, I finally got him to eat four oz of a formula bottle, mind you this is a child who normally eats at least 8oz at all feedings. So far he seems a little better "knock on wood" but the day is not over. I thought that I should report this because my child is just not himself.
After receiving MCV4 vaccine pt. c/o dizziness, became pale, had a 1 min LOC with 10 sec of tonic-clonic movements. RN's reclined pt., placed ice pack at back of neck -> pt. became conscious. BP 88/58. After 5-10 min, given ginger ale & BP=98/66.
p/vax pt itchy; blotchy; urticarial rash w/tachycardia; anxiousness
PATIENT WAS ADMINISTERED ROTOVIRUS ORALLY AFTER 1 YEAR OF AGE. PATIENT NOTIFIED. NO ADVERSE EFFECTS.
Chest Discomfort, Pain, tightness, very tired, headache, irregular EKG, low blood pressure, stress test - no results yet. All this done end of February. Now better on 3/3.
Left arm pain, decreased ROM, localized erythema and pus filled papule approximately 48-72 hours after injection provided. Treated with ice, ibuprofen. Resolved approximately 1 week later.
Mom, called 8-5-16 at approx. 11am to report that her daughter,  was experiencing a reaction to the vaccines she received two (2) days ago.  Our records indicate that she obtained the HAVRIX and INFANRIX in her (R) vastus lateralis.  Mom reports that the (R) leg is twice its normal size, that there is a rash around the thigh and her fever last night was 101.8.  She has given Benadryl and Tylenol for treatment.  Reports temperature of 101.4 this am.  Employee states that she contacted her pediatrician, but no appointment was available and  was advised by her MD to go to Urgent Care or the ER.  She states she went to Urgent Care and was told that they would be unable to treat patient for the reaction and that she should come back to the Health Dept. for treatment.  Discussed situation with the mom and it was decided that she would go to Medical Center ER for further evaluation.  I spoke with mom at 2:00 pm the afternoon of 8/5/16 and she states that she was treated and advised if no improvement she was to go straight to a pediatric hospital in case it was infected.  Gave mom my cell number to contact me over the weekend if she needed to do so.  Spoke with mom 8-8-2016 at 10:50 am and mom reports that she is doing much better.
This spontaneous report as received on 02-MAR-2017 from a female healthcare worker (Not further specified if a healthcare professional), refers to 10 patients (age and gender not reported) who received unspecified doses in VARIVAX (Lot number M033905, expiration date 20-JUL-2018) immunization series that were improperly stored. The site and route of VARIVAX administration were not reported. The vaccinations occurred between 22-FEB-2017 and 01-MAR-2017. The vaccines were exposed to temperature of 18.5F (Fahrenheit) for a time frame of 5.3 hours. There were no previous temperature excursions reported. The temperature excursion was recorded by a data logger. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. It was further specified that on 27-FEB-2017, this patient (age and gender not reported) received administration of VARIVAX. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001788.
Arm- red and swollen with a knot around injection site; Vomiting-every morning since receiving the vaccine.; swollen with a knot around injection site.; Arm- red; This is a spontaneous report from a non-contactable other hcp (patient). A 27-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation (age at vaccination: 27-years-old). Medical history included food allergy (Pumpkin and mushroom), covid-19 (If Covid prior vaccination: Yes). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced arm- red and swollen with a knot around injection site, vomiting-every morning since receiving the vaccine, swollen with a knot around injection site and arm- red on 27Aug2021 at 08:30. Outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I am kind of tired here; Received a booster shot; Received a booster shot; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 3 via an unspecified route of administration on 14Aug2021 (Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization (at the age of 69-year-old). The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 (Lot number: ER6213) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date in Mar2021 (Lot number: EN6201) as dose 2, single for COVID-19 immunization (at the age of 69-year-old). The patient received a booster shot on 14Aug2021. On an unspecified date, the patient was a kind of tired. The clinical outcome of the event was unknown.  QR Comment: AE filed conservatively.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
pt recv vax 27MAY97 & caused swelling of the thigh & crying off & on for 6hr;SOB in sleep;
Information has been received from a physician concerning a 5 year old male with asthma, speech delay, and sensory issues in early childhood and no drug allergies who a week or two ago was vaccinated with a second dose of MMR. Concomitant therapy included pimecrolimus, alclometasone dipropionate , montelukast sodium, and citirizine hydrochloride. Subsequently, within 10 minutes, he experienced itchy hands, swelling, generalized hives and swelling of the face. It was noted that there was no respiratory symptoms. The patient was treated with epinephrine and diphenhydramine HCl, both by injection. The condition resolved while in the office with no further episodes. It was noted that the child received first dose of MMR at one year of age with no adverse symptoms. The reporter considered itchy hands, swelling, generalized hives, and swelling of the face to be other important medical events (OMIC). Additional information has been requested.
TOOK SECOND DOSE WITHIN 1 HOUR AFTER THE MEAL; This spontaneous case (PVX2019-1145) was received from a pharmacist on 08-May-2019. It describes an adolescent female consumer who "took second dose within 1 hour after the meal", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on Saturday correctly, but took the second dose on Monday within 1 hour after eating a meal. She did not know the exact dates on which the doses were taken.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took second dose within 1 hour after the meal" was unknown.  Company's Comment: The causality of the event "took second dose within 1 hour after the meal" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose within 1 hour after the meal" was considered as not applicable.
I had gotten sick with strep throat before receiving my fourth dose of Moderna. I still had antibiotics in my system from the strep at the time of the vaccine, but I was feeling well. On 08/10/2022, my strep throat returned, indicating that my antibiotics had basically failed. I received a second course of antibiotics from my doctor and again, they were failing. I was really sick and continued to get sicker as I went through the antibiotics. Around halfway through the second course, I had to go to the emergency room because I was running a fever and was very sick. They put me on a much higher course of antibiotics than is typically used to treat strep throat because the virus was so resistant. They gave me the highest dosage that they could prescribe orally for antibiotics which I am currently still on. If for some reason, this course does not work, they will have to treat me intravenously. I feel that my symptoms are slowly improving. Today is the first day that I have not run a fever so far, so I am hopeful that means that the infection is starting to subside. I still have 7 more days of my antibiotic though.
Feet tingled, then burned, then went numb. Entire skeleton felt like it was melting. Accompanied by fever, body aches, chills, headache, dizziness, nausea.
sore arm after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm after 1st shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 MYALGIA (sore arm after 1st shot). At the time of the report, MYALGIA (sore arm after 1st shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.   This case was linked to MOD-2021-375399, MOD-2021-375404.
I received my first vaccination on February 11, 2021.  On February 17th I was rushed to my local ER with a massive heart attack.  I was rushed by helicopter to second hospital where I underwent an emergency Heart Catherization.  It was discovered that I will need a triple bypass surgery.  However, there is a HUGE blood clot that formed in my heart, and further treatment is on hold for now, until the massive clot has safely dissolved.
This spontaneous report as received from an office manager refers to an 18 year old patient of unknown gender. On 26-JUN-2015, the patient started series and was vaccinated with a dose of GARDASIL 9 (lot # K026246., exp. date: 28-JAN-2017) 0.5 ml injection, intramuscularly. On 17-AUG-2015, the patient was vaccinated with the second dose of series, with GARDASIL (lot # K016966, exp. date reported as 10-MAY-201) 0.5 ml injection, intramuscularly. No adverse reaction were reported. Additional information has been requested.
Large local reaction right thigh 10x7 area of redness, warm to touch, negative for groin nodes
Fevers to 102 with chills, myalgias for 6 days. Responsive to Tylenol and ibuprofen.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Additional Details: Patient was awake the entire time, just felt very weak and was not able to sit up on her own. Husband was helping her sit up. She did vomit a few minutes after the start of the event. Husband did say she was starting to feel a little light headed after getting the shot. Was taken to ER by EMS and given fluids to raise bp. not admitted to hospital per operator. Spoke to pt next day and she only felt a sore arm, fatigue, very little nausea.
Patient fainted and became pale. Patient was unresponsive to verbal queues for approximately 5 seconds.
Redness, itchiness, burning, hot to touch, area included entire upper arm of left arm which was given a SQ dose of PNEUMOVAX 23. Treated with oral BENADRYL - symptoms lasted approx. 5 days.
Grandmother called in and reported that patient had 2 seizures after receiving Imm. Also had fever 103.8 to 104.1 Taken to Hosp where parents were instructed to alternate Tylenol and ibuprofen for next 48 hours.
As soon as patient received the injection he began to feel lightheaded and dizzy. He was instructed to pull vehicle to parking space. He was diaphoretic with pallor noted. He stated he throat felt like it was closing up a little. His BP was 80/56. He was shaking. He was given injection of epi. BP increased to 88/64 and approximately 8 minutes after the epi was 100/64. 911 was called and pt was evaluated and instructed to go home.