chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and swelling at injection site  The Clinic told me to come in immediately (at no charge), to their NP who handles all things COVID;  she said there was no way to tell definitively by looking, what the case was, but to apply ice, take Zyrtec antihistamine, NSAIDs if I could tolerate them, and to pick up the Rx for Keflex only if the redness and swelling started going up my arm or around it, because they didn?t want a bacterial cellulitis spreading.  She outlined the red area with black Sharpie.  Then she said to return in 3 to 5 weeks so they could test me for antibodies to COVID-19  to see if my body had responded.  She said that symptoms of illness similar to coronavirus itself were a good sign that the vaccine had triggered an immune response.  But so far, I?ve had no sign of headache, fatigue, fever, nausea, rhinorrhea, or pharyngitis.  The redness and swelling have moved an inch and a half beyond the Sharpie outline in a horizontal direction, but I?m watchfully waiting, and still holding off on the Keflex, because I don?t want to take antibiotics unnecessarily.
After 1 week of administration , the patient called us to say that she had pain at the site -We told her that this could happen . HOWEVER , the site of injection started to bruise and it turned purple and black . A blister started to form in that area and it grew bigger to where it popped and a yellow discharge oozed out .The patient came back around 7.13.22  to show the pharmacist  who told her to see a doctor immediately .
Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Initial report was received on 05 June 2013 from a health care professional. A female patient (date of birth not reported) had received on 29 May 2013 ADACEL (lot number, route and site of administration not reported) and on 04 June 2013, developed myocarditis. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Vaccine site got really swollen almost to her knee and back of her leg got swollen and red and Hot She got Benadryl and prednisolone and cephalexin
red, watery eyes, injection site redness swelling half dollar size, continues into the second day, chills on first day, tired, fatigued, decreased energy into second day
Devel fever to 102 & high screeching cry, starting about 2PM on 21APR until 10PM 21APR; Pt recvd vax about 10AM DTP/HIB/OPV/Recomb; fever resolved 10PM 22APR;
Arm pain, fever, headache, body aches, low energy.   Lasted 5 days.
The evening of the vaccination, pt arm became very sore.  The next day arm was red and swollen 4" X 2".  Generalized body aches and temp around 100F.
On 8/9/99, the pt received her first injection of Lymerix with no apparent ill effects. On 5/21/99, the pt received the second dose and sometime thereafter experienced nausea, vomiting, pain and warmth at the injection site. The information received on 3/6/00 reports the symptoms as resolved.
Discovered on second shot that patient receiving Moderna which is not approved for patients under 18 YO.
Pt. experienced redness day of vaccine at site, itching, hot to touch, uncomfortable. Continued to swell thru day 5, then reducing in size, but all symptoms still present day 6. Pt. to ice, treat w/BENADRYL itch cream or hydrocortisone.
On September 11, 202 I started to have a hard time breathing. I felt very ill and felt like I was going to pass out. I thought I was going into an Asthma attack. That same night I went down to the urgent care, and they tested me for the Flu and COVID-19. I tested positive for COVID-19 but negative for the flu. They sent the positive report over to my primary care doctor and she prescribed me PAXLOVID and another steroid on September 12, 2022.
inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient).  A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events.   Information about Lot/Batch number has been requested.
Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004627: US-009507513-1709USA004633: US-009507513-1709USA004630: US-009507513-1709USA004631: US-009507513-1709USA004632: US-009507513-1709USA004628.
Suspected vaccination failure; Have another round of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 4 rounds of internal shingles since 2019).   On an unknown date, the patient received Shingles vaccine. In April 2022, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-Apr-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got the Shingrix vaccines last year from the reporting date and now, had another round of shingles, it was very miserable. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
3 days after 1 shot developed shingles sytarted getting better with medication and topical meds 3 days after 2nd shot it flared up again; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Mar2021 at 15:00 (at the age of 61-years-old) as a single dose and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure but controlled. The patient had no known allergies to medications food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021, 3 days after first shot, the patient developed shingles which started getting better with medication and topical medications, 3 days after 2nd shot it flared up again. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with valtrex and gabapentin. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event 3 days after first shot developed shingles started getting better with medication and topical meds and again 3 days after 2nd shot it flared up was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sciatic nerve pain started appx 2-3 weeks after the shot. Sciatic pain has gotten steadily worse since and pain has propagated to other areas of the lower back.
the injection site started to heat up and felt itchy; the injection site started to heat up and felt itchy; The injection site was sore with a large red, hot, itchy rash, about 6 inch in diameter around injection site; The injection site was sore with a large red, hot, itchy rash, about 6 inch in diameter around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (the injection site started to heat up and felt itchy), INJECTION SITE PRURITUS (the injection site started to heat up and felt itchy), INJECTION SITE ERYTHEMA (The injection site was sore with a large red, hot, itchy rash, about 6 inch in diameter around injection site) and INJECTION SITE RASH (The injection site was sore with a large red, hot, itchy rash, about 6 inch in diameter around injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 042B21A) for COVID-19 vaccination.     The patient's past medical history included Rash (broke into rash from drink colored with red food dye) in 1986 and Itchy throat (lingonberry sauce; throat started to swell and itch) in 2010. Concurrent medical conditions included Egg allergy (minor allergy to egg), Hypersensitivity reaction, Hay fever and Urticaria. Concomitant products included SERTRALINE for Anxiety.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form once. On 20-May-2021 at 12:30 PM, the patient experienced INJECTION SITE WARMTH (the injection site started to heat up and felt itchy), INJECTION SITE PRURITUS (the injection site started to heat up and felt itchy), INJECTION SITE ERYTHEMA (The injection site was sore with a large red, hot, itchy rash, about 6 inch in diameter around injection site) and INJECTION SITE RASH (The injection site was sore with a large red, hot, itchy rash, about 6 inch in diameter around injection site). On 23-May-2021, INJECTION SITE WARMTH (the injection site started to heat up and felt itchy), INJECTION SITE PRURITUS (the injection site started to heat up and felt itchy), INJECTION SITE ERYTHEMA (The injection site was sore with a large red, hot, itchy rash, about 6 inch in diameter around injection site) and INJECTION SITE RASH (The injection site was sore with a large red, hot, itchy rash, about 6 inch in diameter around injection site) had resolved with sequelae.            No treatment information was reported. After 30 minutes to 1 hour of receiving second dose, the reactions occurred. The patient recovered with residual effects of occasional itching at site. The itching prolonged for over a month.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information included no new information. On 13-Aug-2021: Follow up received on 13-AUG-2021: Reporter address information was updated. Suspected drug second dose, added concomitant medication, events of injection site rash, warmth, redness and itching were also added.
Has received both vaccines with it being greater than 14 days from second dose. Tested positive on 4/5
Pt received Moderna vaccine, 2nd dose on 2/15/2021.  She was subsequently admitted to the hospital for fever and Seizure on 2/16.  Pt also noted to have fever ~104F.  She does have a history of seizure disorder and is maintained on anti seizure medication.  Suspect the seizure related to high fever ~104F possibly from her vaccination.
Hospitalization: 1/3/2023 - 1/5/2023 (2 days) Presentation to the ED: epigastric/left-sided chest and left shoulder pain. COVID + date: 1/3/2023. Treatment: no current indication for remdesivir or steroids. Discharge to: Home. 044A21A 3/9/2021 031B21A 4/5/2021 059H21A 1/6/2022 moderna bivalent AS7166B 12/22/2022
6cm induration tenderness erythema unable to move arm without pain. Vaccine site was apparently not in deltoid. more posterior tricep area
Patient reports about 10:00 pm she started eating supper and her lips swelling. She then reports she took BENADRYL and lip swelling improved and she went on to bed. This was not visualized by a medical care giver.
Rash started right side of neck (15Apr)midday, clear up and rash appear left top side on back and lightly in vaccine arm area; Rash start right side of neck (15Apr)midday, clear up and rash appear left top side on my back andlightly in vaccine arm area.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 04Apr2021 at 08:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia and periodontal disease. Concomitant medications included iron (MANUFACTURER UNKNOWN) and probiotic (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date and unknown if ongoing. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021 at 12:00, the patient experienced rash started right side of neck, clear up and rash appear left top side on back and lightly in vaccine arm area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rash started right side of neck, clear up and rash appear left top side on back and lightly in vaccine arm area was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 70 year old female with diabetes, hypertension, coronary artery disease who two weeks ago was vaccinated with Pneumococcal 23v polysaccharide vaccine. Subsequently, 10 days post dose the patient developed weakness in her lower limbs. She also developed rhabdomyolysis and renal dysfunction. The patient had elevated CPK. The reporter was awaiting the muscle biopsy. At the time of the report, the patient was hospitalized in the intensive care unit. At the time of the report, the patient was considered to be not recovered. The reporter considered the patient's experience to be disabling and other medical event (OMIC). Additional information has been requested.
RASH ON HAND; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rash on hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on hand. This report was non-serious.
Patient experienced pain on the arm around the injection site (not directly at the injection site). Also, tenderness to touch, redness, swelling, and warmth that was not subsiding after 7 days post-vaccination. Doctor was called and advised to consult with patient due to concern for possible cellulitis. MD called in 2 prescriptions (see below), which were picked up a day later on 4/20/23. No outcomes have yet been reported by patient.
70 year old female had pneumovax 5/2/03. Developing redness and swelling at site extending to elbow. Low grade fever and pain.
11/19/21-Patient states 4 days ago developed fatigue, chills and sporadic dry cough.  This morning states that her chest felt tight.  mucinex and motrin helping with symptoms.  Husband recently tested + for covid.  Patient took at home covid test and positive.  covid vaccinated.   11/19/21  Albuterol HFA inhaler;  Referral for EUA Covid antibody treatment
Patient appeared fine immediately after vaccination.  He shopped around the store.  He was talking to his the staff at the front counters and then passed out.  He came to rather quickly.  An ambulance was called.  He refused to go to the hospital and appeared fine.
This spontaneous case was reported by a consumer and describes the occurrence of OVARIAN CYST (two very large cyst (size of base ball and the other one was oblong like two golf balls put together)/ovaries could barely be seen because the cyst was so big/vaccine spiked proteins and activated them and made the cyst grow) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 031B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Postmenopause (Postmenopause in 2002/2003) and Partial hysterectomy (partial hysterectomy's in 2018/2019). Concurrent medical conditions included Penicillin allergy. Concomitant products included OMEPRAZOLE, ASCORBIC ACID (C 1000), B COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE], BIFIDOBACTERIUM INFANTIS, LACTOBACILLUS ACIDOPHILUS (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]), TOCOPHEROL (E 400), ZINC, COLECALCIFEROL (D3) and FLAXSEED for an unknown indication.
full dose of Moderna booster [not immunocompromised]; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (full dose of Moderna booster [not immunocompromised]) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 627L20A and 031120A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (full dose of Moderna booster [not immunocompromised]). On 22-Oct-2021, ACCIDENTAL OVERDOSE (full dose of Moderna booster [not immunocompromised]) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
Info has been received from an LPN concerning a 12 month old female with no pre-existing allergies or medical conditions who on 3/30/05 was vaccinated, SC, in the left thigh with the 1st dose of MMRII (lot 648475/0315P). On 4/8/05, the pt developed a low-grade fever and red spots on her outer right thigh. On 4/9/05, it appeared to be a sparsely scattered rash across her body and more heavily in her skin folds, very tiny bumps. 4/11/05, it was reported that the rash looked like a measles rash all over. The "breakthrough" was mostly on her upper torso with some on her arms and legs. She even had some lesions on the mouth. The pt had a low-grade fever of approximately 99.7F. Unspecified medical attention was sought. The pt was given Tylenol and Benadryl. Subsequently, the pt recovered. Additional info is not expected.
~6 hours after shot started to feel body pain and headache. Got worse and added in fever, weakness and nausea. Was the worst 9-12 hours after the shot. For the rest of the next day I still felt bad but condition slowly improved. Took Tylenol a few times which helped a bit
60-year-old female with a history of hyperlipidemia, increased BMI family history of cardiovascular disease (father had CEA in 1996, CABG in 1998 and likely died at age 77 of an MI) book keeper for local podiatrist who came to the emergency room with complaints of chest tightness. Patient was initially placed in observation and then flipped admission troponins came high patient was seen by Cardiology in his awaits transferred for angioplasty patient is chest pain-free at this time.  Transfer held as PCR came back POSITIVE for COVID-19
herpes zoster rash 16APR97 & 19JUN98;had vax 11DEC96;currently trying to identify if zoster is from wild-type or vaccine strain of varicella;
Client experienced a brief episode of chest tightness and shortness of breath immediately after receiving vaccine. She gave herself her own albuterol at 935. Her chest tightness resolved within 5 minutes and was able to leave by the end of her 15 minute wait time.
Came down with severe chills that evening, vomiting and upper body trunk weakness. I needed help sitting up in bed; my wife had to sit behind me to keep me upright in bed. Due to upper body weakness, walking was difficult to the point of using a walker to help me be mobile.
3FEB97 cut finger & recv vax 1 day later had pain in arm red, swelling, h/a, n/v;1 wk 10 days still felt bad-aching pains upper right quad of chest; muscles aches;joint pain;arm pain in lt arm @ site was a silver dollar;rash;jaw pain;h/a;
Chills, temp (100.3), headache, fatigue, very sore at injection site.  These lasted approx. 36 hours.
After injection, patient begin to feel faint, fell out of chair onto floor. Pt never loss consciousness Assist child onto exam table, placed on  (?) Position Monitors vitals B/P 85/60-  Remains stable, O2-stable-98% Pt was talking and coherent. Observed for  45 minutes.(?)  Tylenol 325 (?). Pt left clinic with mother.