chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 15 June 2011 from a health care professional which involved a case of misuse. This case also represents one of a cluster of three patients who experienced adverse events after receiving ADACEL, lot number C3898BA. The other two patients have been captured in case numbers 2011-03459 and 2011-03462. A 37-year-old female patient had received two intradermal left forearm injections of ADACEL, lot number C3898BA (instead of TUBERSOL) approximately one inch apart (the first injection was administered too deep0 on 13 May 2011 and 24 hours later, the patient developed a large red, swollen, blistered area. The event required a doctor's visit. AT the time of report, the blisters had resolved, but soreness and a knot remained at the site. Outcome was not recovered. Follow-up information was received from a health care professional on 19 July 2011. The dosage the patient received was 0.1 ml x 2. The patient was seen by a physician on 10 June 2011. The patient received treatment with BENADRYL as needed (PRN). The outcome remained not recovered. The reporter for this case is the same as case number 2011-03460. Documents held by sender: none.
The injection site had light green bruise for the first 3-4 days and soreness.  On the day of beginning of the event, about 3" below the injection site, I developed an oval (4"x2") red blotch.  While there was no fever, the red area was warmer/hotter on touch.  It did not itch.  The condition lasted for several days before I contacted my doctor.  She stated that some patients had experienced similar condition.  Asked me to take Benadryl.
Severe pain 4 inches down and 4 inches up on left elbow, pain in left arm down to fingers, tingling in left hand. Soreness at injection site.
Day 2, morning I had the redness, pain, and swelling at the injection site. My arm looked like a golf ball was in it. I took an ibuprofen at 10am and the pain and swelling went down tremendously.   By around 6pm, I discovered my left armpit lymph node was extremely swollen and protruding. I also started getting sporadic feelings of heat on the inside of my left foot, almost like running hot water down my ankle. This has happened at least 10 different times, and hasn?t happened to me before, it?s a very strange feeling! I?ve also had a pretty heavy discharge, it?s milky and very sweet.. I normally suffer from vaginal dryness.
Resting heart rate rose from a standard of 100bpm to 180bpm. Was able to bring it below 110bpm after ten minutes of meditating. Used a watch to keep track of my bpm.
Redness at injection site a week after injection; Fever; Chills; Felt like death for 24 hours after dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like death for 24 hours after dose), VACCINATION SITE ERYTHEMA (Redness at injection site a week after injection), PYREXIA (Fever) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt like death for 24 hours after dose), VACCINATION SITE ERYTHEMA (Redness at injection site a week after injection), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Felt like death for 24 hours after dose) had resolved and VACCINATION SITE ERYTHEMA (Redness at injection site a week after injection), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
This is the 2nd dose of moderna covid vaccine for this patient.   The patient is 16 years old and received moderna vaccine which is not indicated for her age.  she is not experiencing any adverse events.
Temperature 103.9, starting same day of vaccine, lasting 48 hours Morbilliform rash starting at hair line 48 hours after vaccine.  lasted 4-5 days, resolved x 48hours then began again at hair line, spread down trunk, arms to groin and upper thighs.
AFTER GIVE THE VACCINE, PT WAS TOLD TO SIT FOR 15 MINUTES TO WATCH FOR SIDE EFFECTS. AFTER ABOUT 2-3 MINUTES PT GOING TO BATHROOM PASED OUT AND FELL TO FLOOR HITTING BACK OF HEAD. PT WAS AWAKE AND EYES OPEN AS SOON AS RPh GOT TO HER WITHIN A COUPLE OF SECONDS. 911 WAS CALLED ICE PLACED ON BACK OF HEAD OF PT, AND TALKED TO PT TO MAINTAIN ALLERTNESS TILL PAREMETICS GOT THERE. WHEN PAREMETICS ARIVED THEY SAT PT UP, EXAMINED BACK OF HEAD, CHECKED HER TO BE ABLE TO STAND,. SHORTLY AFTER THE PT LEFT STORE WITH MOTHER.
rigors; headache; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "rigors"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigue".  Additional information: Patient received 1st dose of Pfizer Vaccine in the 1st Quarter of 2021. Patient experienced rigors, headache and fatigue for 4 hours, then adverse events subsided. Patient received 2nd dose of the Pfizer Vaccine and experienced injection site pain. Patient is male and over 50.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J221A) for COVID-19 vaccination.  Concurrent medical conditions included Neutropenia, Thrombocytopenia, Thyroiditis chronic and Drug allergy (unspecified drug allergy).  On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported. It was unknown whether the patient received any medications/products or not within 2 weeks of starting COVID-19 treatment. The patient had rebound COVID-19 after testing negative following Paxlovid treatment. The device date was 31-May-2022.  Company Comment: This spontaneous case concerns a 78-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid on 17-May-2022 to 21-May-2022 for Covid-19. She had rebound covid-19 after testing negative following Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 78-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid on 17-May-2022 to 21-May-2022 for Covid-19. She had rebound covid-19 after testing negative following Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
No itching, burning @ injection site. Site is red & swollen, warm to touch, pt worked out in yard all day, day after receiving vaccine.
Developed very red swollen area at the site of MMR (SQ L thigh) five minutes after receiving the vaccine approx. 7-8 cm in diameter. Redness fading within 10-15 minutes.
Multiple patients (25) vaccinated with batch/lot number FK9894, but the number was erroneously entered in the system and on vaccine card as FK9729.
Information has been received from a 61 year old female with a history of "more sinus infections than usual this year" who on 19-FEB-2008 was vaccinated with a dose of ZOSTAVAX.  Concomitant therapy included enalapril maleate (VASOTEC).  On approximately 21-FEB-2008, 2 days after the vaccination the patient experienced sinus infection.  The patient's sinus infection persisted.  No product quality complaint.  Additional information has been requested. 02/17/2010 Follow-up information received by the patient indicating that she was received the vaccination on 13-Feb-2008. She went to the MD office on 27-Feb-2008 because she had tenderness at the injection site and her allergies were bothering her for a few days after the injection and that she "felt that she was developing a sinus infection". (Since she takes allergy shots once a week, she could not take her allergy injection the week of vaccination). On 22-Feb-2008, the patient went to see her ENT specialist and at the time her thought she had just chronic sinusitis. On 27-Feb-2008, the MD prescribed her an antibiotic, because she was still had muscus. On 27-Feb-2008, she was treated with "Paeudovent" 120-200mg BID for 14 days. On 27-FEb-2008 she received Aug,emtom 375mg BID for 14 days. My March 13, 2008 all medication  was completed and she was "feeling good". The patient doesn't think it had anything to do with zoster vaccine live (Oka/Merck). She has been having a roght winter (since early December 2007) with sinus problems and infections. She asked her MD if she could have zoster vaccine live (Oka/Merck) vaccination and he said "Yes",  he believes in the vaccine. The patient has no regrets receiving the vaccination and wanted to be protected from from Shingles.  Additional information has been requested.
Administered 3 vaccine around 11:20am on 11/9/22. At around 11:24am patient passed out while sitting in the chair. Did not fall or hit her head. Per one of the sisters, the patient did not eat today. The patient frequesntly refuses to eat or drink. Called an ambulance due to low BP and oxygenation. Vital signs have been taking every 2-3 minutes. Stable, A&O x3. When the ambulance arrived- stable vital signs. The family chose to have the patinet evaluated at the ED.
Uveitis on left eye causing extreme pain. Prednisolone Acetate (hourly) and Atropine were prescribed. A periocular corticosteroid injection was done less than a week later and medication stopped. Within 48 hours the uveitis flared and I was back to hourly Prednisolone. I was gradually weened off weekly for the subsequent four weeks. Then synechiae formed 360 degrees around the iris, causing iris bombe and pressure topping out at 63. An emergency laser peripheral iridotomy was performed creating a hole in the iris; Diamox 250 and Combigan were prescribed (3/day & 2/day respectively) in conjunction with Prednisolone (4/day). Two days later with the pressure again elevated, we attempted to break the synechiae via dilation (Diamox stopped). This process was repeated two more times in the following two weeks. Within this time frame, pressure escalated to 45 and I was put back on Diamox (4/day) and Latanoprost was prescribed (1/day). Also Tropicamide 1% and Phenylephrine 2.5% were prescribed (3/day each) to attempt to keep eye dilated. With the dilation not working, the hole completely sealed due to inflammation and the bombae yet again returning, another iridotomy was done. This time reopening the original and producing two additional holes. Currently I am off Diamox, Latanoprost, Tropicamide and Phenylephrine - but still on Atopine (3/day), Combigan (2/day) and Prednisolone Acetate (hourly). One day after the second laser, my pressure is currently at 6 with mild inflammation. I have another appointment with both Dr's on 7/19 to see if it will hold without the Diamox.
test + 4/2/21, hospitalized 4/7/21 due to increase weakness, fatigue, runny nose,  headache, shortness of breath, vomiting and diarrhea
With one one day showed extreme  bruising and petechiae all over body  Developed ITP, platelet count dropped to 2,000  Suffered a brain bleed 4 days after symptoms started, and started having seizures
I received the SHINGRIX vaccine on 2/1/19 at 6pm and than night/morning I awoke at 2am with moderate aches and pains and I was unable to go back to sleep. Later that day, I experienced other flu-like symptoms (fever, extreme fatigue, chills, and aches) and malaise for approximately 36 hours until the symptoms resolved.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On 13-JUL-2015, unknown doses of VAQTA were improperly exposed to 32F for 63 hours. Then, on unspecified dates since 13-JUL-2015, an unspecified number of patients may have received the improperly exposed VAQTA (lot# was reported as K026529, expiration date 02-JUN-2017, dose and route were unspecified). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
pt exp a small rash on arm @ inject site on 11MAR92 p/recvd 1st dose of Engerix-B;
Approximately 10 minutes after injection was given, patient complained of burning sensation at site of injection. When examined by RN, he had localized urticaria above site of injection and on upper chest wall. Parent was notified of reaction and came and transported child to local ER. He was then seen in ER and given Benadryl by mouth and advised Ibuprofen for discomfort and discharged home.   Approximately 3 hours later, RN called to check on patient and mother stated that he was improved and rash was almost gone.
Patient is an employee and was scheduled to receive her 3rd final dose of Hepatitis B vaccine series. 1 ml administered. Shortly after receiving vaccine the employee had complaints of dizziness which did not subside. Employee further began to develop throbbing chest pain. Vital signs remained stable. EMS called for hospital transport.
Developed a hard knot at the site of injection and it is blackish-blue in color; Developed a hard knot at the site of injection and it is blackish-blue in color; This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site induration and injection site discoloration. On an unknown date, the outcome of the injection site induration and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site induration and injection site discoloration to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient got her first Shingrix shot two or three days ago.  She developed a hard knot at the site of injection and it was blackish-blue in color. The reporter did not consent to follow up.
with in 45 min to 1 hour after my 2nd dose of Pfizer Covid shot I began itching.  Bodywide.  Continuously.  After 2 weeks I started taking Benadryl and or Zrtec and this tamped the itchy down.  I am 4 weeks out and still a few itching spots throughout the day but am also still taking Zyrtec.  Also broke out into a rash/sores body wide (but not covering al skin, it was sporadic) about 10 days after the vaccine.
got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; This is a spontaneous report from a contactable consumer via the Pfizer sponsored programt. This consumer reported similar events for five patients. This is the fourth of five reports. A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patients got covid within a few days of getting the immunization. Also, the reporter assumes that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown.   Information about Lot/batch number is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317500 same drug/AE, different patient
Initially had left arm pain post vaccine. I thought that this was normal vaccine site pain. The pain has subsided but I now have left arm weakness and an inability to lift arm to previous height.
covid symptoms; covid symptoms; Dose1 JANSSEN COVID-19 VACCINE/ BNT162B2 (DOSE 2, (BOOSTER) SINGLE); This is a solicited report received from contactable reporter (Consumer). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4160608 (Company). A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Oct2021 as dose 2, (booster) single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation;  coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1165521), subcutaneous for psoriatic arthropathy, hidradenitis.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "covid symptoms"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "Dose1 JANSSEN COVID-19 VACCINE/ BNT162B2 (DOSE 2, (BOOSTER) SINGLE)".  The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect vaccines (BNT162b2, BNT162b2 omi ba.4-5 and BNT162b2) and all events.
Patient took booster vaccine on 3/15/22 and started have side effects of headache shill and body aches on next day 3/16/22. Patient took Tylenol, outcome symptoms expected to last 1-2 days.
Malaise, alternating sweats and chills, and 1.5cm left axillary tender lymphadenopathy persisting > 72hrs after vaccination without any evidence of erythema, edema at administration site
She had a itchy rash around the injection site; She had a itchy rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (She had a itchy rash around the injection site) and VACCINATION SITE PRURITUS (She had a itchy rash around the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Contrast media allergy (Injectable MRI dye).    On 26-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 VACCINATION SITE RASH (She had a itchy rash around the injection site) and VACCINATION SITE PRURITUS (She had a itchy rash around the injection site). At the time of the report, VACCINATION SITE RASH (She had a itchy rash around the injection site) and VACCINATION SITE PRURITUS (She had a itchy rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-367456 (Patient Link).   Reporter did not allow further contact
Mild swelling, warmth, and redness around the injection site, on the day he got the shot. The next day, the redness, heat, and swelling spread more. The tiny hole from the injection started looking more like a line instead of a dot. The night of November 6, the swelling, warmth, and  redness spread. Covering his arm  from top of shoulder down to his elbow.  He also began to have a yellow colored ring (about the size of a donut)  in the middle of the red area. The yellow colored part slowly started turning into small bubble like things. Some of those bubbles got much bigger. Some about the size of a dime. They were filled with clear yellow liquid. It was very itchy (according to my 4 year old). I very carefully put hydrocortisone ointment on it. A few minutes later, we noticed the largest bubble had started leaking the yellow fluid out and deflating a bit. When he did not improve, his doctor asked for us to bring him in to the office so he could look at it and see what was going on. He gave us an antibiotic for my son to take for 10 days. The bubbles slowly started to deflate and dry out that night. Even after the 10 days of medication, there was still scars from where the injection was given and where the bubbles had been. Ever since the day of vaccination , my child has had extremely emotional reactions, of all kinds, almost every day? which he wasn?t having frequently before this.
Dear Covid auto form:) I?m a teacher and have been around middle school students (few wear masks)? we have Covid in school? I?m not sure when to worry about having Covid vs. vaccine side effects.  I?m thinking I should call to get tested if I?m still having ?side effects? on day 4. Day 1 Start of Fever, headache with in 24 hours, sore arm; Day 2: fever peaked at 103, chills, exhausted, arm has burning spot about the size of a softball at injection site which is hot and hard, shirt was damp from sweat; Day3: not as exhausted so I went to school? fever, (99.3) sweat poured off me during the day a couple times, but I made it through an IEP, arm is worse (hotter and itches), cold sores have also showed up this afternoon?I?ve had them in the past and have started to take Valtrex (100mg) and have googled what to do for my arm? took a Benadryl and used ice pack (didn?t seem to help much.. the ice?we?ll see how things shake out with the Benadryl , mild sore throat.
Red raised oblong rash at injection sight and upper arm. Slightly itchy.  Sore armpit and breast left side