chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 Days after injection, Left arm became tender and slightly swollen, aprox 1 hour later became itchy and developed small red raised area(1"x1") at injection site. About 12 hours later developed large red, swollen, warm, tender and painful area at injection site in aprox  5"x3" in size. Took Ibuprophen for paina nd iced for 20 minutes Called Primary in AM who prescribed Keflex. I was also instructed to take Claritin in AM, follow prescribed course for Keflex, Ibuprophen as needed and Benadryl in PM. Ice when possible
Received Moderna Dose #2 on  3/10/2021.  About 1-2 weeks after, he started experiencing swollen leg (unsure if left or right), had shortness of breath, and looked pale on 4/22 he was seen by a provider  and was prescribed oxygen,  later that night he passed.
Injection site became very swollen, red and hot to the touch. Over the period of a week, redness "bled" to inner arm, down towards inner elbow with some tenderness to touch and warmth. Injection site remained swollen (raised area about 3" x 4") hot and very tender touch for about a week. Could not sleep on that arm.
Immediately after the vaccine was given in my left arm muscle I felt a sensation down my arm.  After about 5-7 minutes I started sweating, felt dizzy and hard time breathing.  Notified nurse and she called for security to get a wheel chair and was taken to the emergency room.  I was unresponsive for minutes and my heart rate went down to 42.  I came awake hearing the head nurse yell he was going to get the crash cart.  They did an EKG, bloodwork and other tests.
After administering vaccine and upon entering Lot # and expiration date, it was discovered vaccine had expired on 10.18.2021. Pt was notified and reports sore arm and low grade fever which are normal immune response for her following vaccine administration.  Pt advised to wait at least 28 days and re-start 2 dose series to ensure adequate immunity.
I got my first Covid-19 Booster, which was the Pfizer one, and my brain cleared up... better than it's been for years; Feel sick; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 32196 (BioNtech).  A male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 02Apr2021, outcome "recovered" (08Apr2021), described as "Feel sick"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I got my first Covid-19 Booster, which was the Pfizer one, and my brain cleared up... better than it's been for years". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got his shot on Friday 02Apr2021, around noon and his lungs do feel "sick" which was fine in the sense he didn't enjoy or wanted to smoke marijuana. He was smoking marijuana through what felt like COVID symptoms. He would have contracted COVID before any tests were around and tested negative when the tests were produced, given he thinks he got COVID in 2019. It was unknown if the Health Authority was notified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given Tdap and Menveo and was not due for them. Error was not discovered until 11/3/2021.
No additional AE; Vaccine administered after temperature excursion.; This spontaneous report was received from a certifies medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 01-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5 ml, subcutaneously lot number W005206 and expiration date of 14-FEB-2024 for prophylaxis (anatomical location was not reported). The vaccine was exposed to a temperature excursion of  13.8°C with a time frame of 1 hour and 22 minutes. There was no previous temperature excursion. No additional adverse events were reported.
1/8/20201  2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter 5:30pm Shivering muscle pain temp 101 took motrin  1/9/2021 Felt 80% ok 1/10/2021 and 1/11/2021 95% better  Appetite decreased from 1/8/20201-1/11/20201 ( dry mouth, fever, chills, lightheadedness, muscle pain)
Seemed like an ear infection and went to doc and had found no issue of infection. This occurred during this allergy season so I just wrote it off as allergy pressure. On 03/22 took an antigen COVID test that resulted in negative result and again on 03/27 which resulted in a positive result. This effectively kept me from going on a work trip and I took another COVID test on 3/28 but this time PCR test from a lab and it showed positive. Was advised to quarantine and am currently doing so.
Friday, initially after injection, my son became lightheaded, ringing in ears, cold sweat, wet forehead, pale face, vision changed to dark cloudy where couldn't see well, tired mentally. Waited 30 minutes to leave office. Went home and had 100 degree temperature.  Saturday, Woke up with pressure in head, headache, pain at shot site, stiff neck opposite side of shot, 100.5 temp, treated with Tylenol. Sunday, Swollen arm, red and blotchy with rash at the site. Lethargic. 100 degree temperature treated with Tylenol.  Monday, Arm very sensitive to touch, difficult to lift. 99 degree temperature
immed following flu vax pt reports feeling weak; also c/o sore knees, lt arm sore, just pushing to get everything done;no appetite
Patient received Pfizer bivalent booster on 11/18/22 and also in error on 1/25/23.  Patient did not have any symptoms.
2.5x2.5 reddened area. Sore up into axillary area right arm.
Nose bleed; gum bleed; headache; chest tightness; SOB.
this is 1 of 5 employees @ this site to have an unspecified adverse exp following vax;
Increase HR & BP, dizzy, tightness in chest initially.  Rph called 911 at store but the patient felt stable  after 30 minutes so she was able to drive home.  Per patient, it took couple hours for the symptoms to subside at home.
A few minutes after receiving HPV #2, patient fainted and fell from exam table to floor. He was unconscious for just a few seconds. Doctor checked him over, administered O2. Patient started to hyperventilate. Breathed through paper bag. Felt better after 20 min and was discharged. Ambulated without assistance.
Patient had fever starting at night on 10/15/21, parent brought patient to ED on 10/17/21 at which time patient had 105 degree F fever and had a 20 second seizure and then vomited, ibuprofen and acetaminophen was given at ED
Headache which lasted for two hours, eight hours after injection. Second day had a mild dheadache for entire day and had body aches. Mild headache presently on day three following injection.
The paitient had a fever of 103-104F lasting 3 to 4 days post vax.
Elevated Temp 7-28-10 (same night of vaccines) Temp up to 102.4 degrees F Ax. Next day pt developed pinkish slightly raised 3mm - sized lesions all over his body head to toe rash resolved next day with resolution of fever.
Left arm swollen red into armpit, painful, felt like a blister under arm, achy, hot to the touch. Took Advil and icing.
Information has been received from a consumer reported that "her former student's sibling was diagnosed with autism after receiving MMR II the patient was withdrawn, did not want to be cuddled, several behavioral problems and perseverating. The patient was in a special needs school". No further adverse event information provided. The patient sought unspecified medical attention. Upon internal review, the patient's autism was considered an other important medical event. Additional information is not expected.
This spontaneous report was received from a 65 year old female patient regarding herself. Medical history and drug allergies were reported as none. On 04-SEP-2013, the patient was vaccinated with a standard dose (0.65 ml) of ZOSTAVAX, subcutaneously. On 06-SEP-2013, the patient experienced redness at the injection site with the center of the area becoming very hard, swollen, and hot to the touch in about a 1.5 inch diameter. The patient also had developed stiffness in her knee joints to the point that she couldn't extend the leg easily or without pain and it had become hard to walk. The stiffness had spread to the muscles in her calf and has continued to spread below that calf area. Patient received treatment with ADVIL. Patient sought medical attention-talked to the doctor. No laboratory tests were performed. The outcome of the events were reported as not recovered. Additional information has been requested.
On 1/1/2021 I went for a walk  and was having a difficult time breathing and talking.  bronchial spasms. It went away after went in house.  1//2/2021  around 3pm was taking dog for car ride and window was down.  Started having breathing issues again and couldn't complete a sentence.  My husband drove me to Urgent care and they told me to go to ER.   After started medication prescribed at ER I was fine on 1/3/2021 but on 1/4/2021  I was just talking to my husband around 11 am and I started having bronchial spasms again. It went away in about an hour.
FELT LIKE SHE WAS IN FOG; LIKE NOT TOO QUICK TO THINK; This spontaneous report received from a patient via a company representative concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for psoriatic arthritis.  On 20-MAR-2021, the patient experienced felt like she was in fog. On 20-MAR-2021, the patient experienced like not too quick to think. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like she was in fog and like not too quick to think was not reported. This report was non-serious.
Chest and upper back pain. Soreness when breathing, shortness of breath, elevated blood pressure. Visited Urgent Care, EKG was normal, oxygen normal, heart rate normal. After advice of primary care, visited emergency room. Blood test showed negative for blood clot, chest x-ray was normal. Blood pressure elevated, oxygen and heart rate normal. Sent home, symptoms subsided by Saturday morning.
This spontaneous report was received from a pharmacist who referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # N021571 with expiration date 29-APR-2020 or lot# N021475 with expiration date: 31-JAN-2020 (dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of -1 degree Celsius (C) or colder (-10 C) for 6 days, through 6 cycles multiple temperature excursions were involved. The temperature excursion was detected by a digital data logger. No adverse event was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA002441: US-009507513-1712USA002499: US-009507513-1712USA002527: US-009507513-1712USA002540: US-009507513-1712USA002556: US-009507513-1712USA003006: US-009507513-1712USA003166: US-009507513-1712USA003175: US-009507513-1712USA003176: US-009507513-1712USA003170.
Began having strong heart palpitations 4 days after 2nd vaccine every hour that would occur up to 15 times a day. Theses symptoms continued for about 2 months and eventually subsided.
No additional AE's; VARlVAX had been administered to 3 patients after undergoing multiple temperature excursions; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-DEC-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S033952, expiration date: 24-OCT-2021, frequency reported as 3 (exact dose, injection site and route of administration were not provided) for prophylaxis.  The administered vaccine experienced multiple temperature excursions (exact temperature and time frame were unknown). No additional adverse events were reported.   This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA007466: US-009507513-2103USA003643:
Patient has a history of portal vein thrombosis, pancytopenia and esophageal varices.  She was admitted to the hospital on 12/21/03 with hemetemesis and was banded for esophageal varices. She required a blood transfusiion. She has been stable since then. Discharge summary states melana, abdomenal pain, anorexia. msv
On the second day after i received the first dose of the Covid vaccine I started having tightness in my chest with a cough. On a scale of 1-10 the symtoms were 7-8 I also developed a rash on my arms as if I had been burned.  I had to use  an inhaler that I already  had and I ussed Hydocortisone cream on the rash  I saw the Nurse Practicioner on 2/10 2021 and was given Medrol 4mg tabs Today I am still coughing with slight tightness in my chest and the ras is resolving but scars linger.
Localized reaction near injection site 5 days post vaccination.  Red/defined/raised/itchy.  Improved on day 6, still some itching which pt took antihistamines for.
I received the second dose of the Pfizer vaccine on 4/2/2021 @,10 :30 am & on 4/3/2021 @ 10:00 am ( or when I woke up) I had a bad sore throat and a persistent cough. As the day went on the coughing became worse and chest tightness began. On 4/4/2021 I went to the local ED of Hospital as I was having an asthma episode,  which I had not had in 14 months.
I have now tested positive 3 times; I have now tested positive 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant), outcome "unknown" and all described as "I have now tested positive 3 times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I have now tested positive 3 times, being vaccinated (before the 1st) and boosted (before the 2nd and 3rd).  Clinical course: I am interested in signing up for the research study with COVID.I was vaccinated with Pfizer. Please let me know how I can be of service.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
cranky in evening p/receiving vax-woke up 12MN crying, unconsolable then had febrile sz, vomited x2 taken to ER-t104 R;
Received 0.25 ml of bivalent dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose).    The concomitant medication was not reported. No treatment medication was reported.  For the past month, nurse had been giving 0.25 ml to the patients. Nurse wants to know recommendation for the 19 patients who received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973, US-MODERNATX, INC.-MOD-2022-662974 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662974:Same reporter US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter US-MODERNATX, INC.-MOD-2022-663147:Same reporter
Pt. given DTaP on 4-24-08. 24 hrs. later pt. developed fever, injection site red, swollen, tender. 72 hrs after injection. Pt had episodes of hyporesponsiveness. no eye contact no abd. movement. No fever. Pt went to E.R. No treatment.
Patient c/o feeling achy and glands swelling, under (R) arm. Onset evening of shot (6/19/14). Has been taking TYLENOL. Patient states she had similar rxn to flu shot yrs ago.
Light fever; sore throat; chills; feeling unwell; tiredness; Sleepy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 28Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included open heart surgery and being diabetic. Concomitant medication included metformin, sitagliptin (JANUVIA), acetylsalicylic acid (ASPRIN), atorvastatin, and fenofibrate (TRICOR). The patient previously took moxifloxacin (AVELOX), levofloxaxin (LEVAQUIN), ciprofloxacin (CIPRO), and cloxacillin sodium (LOXACIN) and experienced allergies. The patient experienced light fever, sore throat, chills, feeling unwell, tiredness, and sleepy on 28Jan2021 16:45. The patient did not receive treatment for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
IMMEDIATELY AFTER SECOND SHOT, CHILLS/ACHES/TIRED/SICK FOR 3 DAYS  5 MONTHS AFTER SECOND SHOT, CONTRACTED COVID, FEVER/CHILLS FIRST 4 DAYS, HEADACHE/BODY ACHES/LOSS OF SMELL AND TASTE/CONGESTION/COUGH THROUGHOUT FIRST 2 WEEKS. CONTINUE TO HAVE LOSS OF TASTE AND SMELL/HEADACHE/COUGH THROUGH TODAY.
Acute change in systolic BP < 90 mmHg or > 200 mmHg and numbness
This case was reported by a physician via call center representative and described the occurrence of heart rate increased in a 81-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included blood pressure high and blood cholesterol increased. On 20th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th June 2018, less than a day after receiving SHINGRIX, the patient experienced heart rate increased (serious criteria disability and life threatening), increased blood pressure (serious criteria disability and life threatening), feels awful and shaking. The patient was treated with beta blocker nos (Beta Blocker). On an unknown date, the outcome of the heart rate increased, increased blood pressure, feels awful and shaking were recovering/resolving. The reporter considered the heart rate increased, increased blood pressure, feels awful and shaking to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitiant medicine included blood pressure medication and cholesterol. In morning, the patient's blood pressure 126 systolic and diastolic was in the 74 The patient received SHINGRIX on left arm. The patient stated that, 10 minutes after receiving the SHINGRIX, while he and his wife were on the way home, he started feeling terrible and shaking. The patient stated that when he got home, he took his blood pressure and his blood pressure had increased to 170 systolic and his diastolic was in the 90's. The patient did not remember the exact number. The patient stated that his heart rate was increased to 118 bpm, possibly higher, and his pulse is normally around 54 bpm. The patient reported that that he laid down in trendelenburg position and took 12.5mg of a beta blocker. The patient reported that approximately 10 minutes later, emergency medical service (EMS) arrived and his heart rate and blood pressure were starting to return to normal. The patient did not go to the hospital but had called his physician and was waiting for his physician to call him back. The patient reported that he was completely disabled during this episode and at the time felt like this event was life threatening. The patient had denied contacting their physician. Lab comments: On 20th May 2018 in morning the patient's blood pressure was 126 systolic and diastolic was in the 74 On the same day. the patient blood pressure was increased to 170 systolic and his diastolic was in the 90.
Felt light headed after she got the vaccine. Later on that night she felt a strain in the back of her neck on the right side. She was extremely weak and bad pain. About a week later she had a high temp, she became weak and dizzy and her oxygen was sky high. She called 911 and was taken to the ER.
Mother called physician office on Feb 9, 2018 stating she took child to ER on Feb 8, 2018 due to fever, limping, lethargy, and decreased appetite.
Ringing in both ears and high blood pressure. Ear nose/throat doctor said this will not go away without hearing aids for tinnitus.
Extreme nausea more then usual and vomiting Saturday morning. I am 6 weeks pregnant and due on December 28th.
Leg red, warm, hard lump to left deltoid, rash and red to neck, throat. Face red.