chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe swelling at injection site. Nerve involvement - tingling and numbness in whole arm and extending up to neck. Pain scale 7-8 near injection site. Moderate headache and scratchy throat with mucus. Slowly getting worse (24 hours after injection).
Chest pain, Elevated blood pressure, elevated cardiac enzymes,  Acute myocarditis
pt who devel fever to 102 w/brief episode of stiffening;by the time MD was informed pt was fine;
Mother reports the morning after receiving varicella vaccine her child could not move the right side of his face. Seen by MD who diagnosed with Bell's palsy. Put on Pediatred et (x5 days) and Ceftin (x10 days). NO improvement by 8/12/02. To get MRI of head 8/14/02.
Severe eczema flare up; This is a spontaneous report from a contactable consumer. This 31-year-old female consumer reported for a patient that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173), via an unspecified route of administration, administered in left arm on 04Jun2021 (at the age 31-year-old), as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not diagnose with COVID-19 prior to vaccination. It was unknown if the patient has not been tested for COVID-19 since the vaccination. Since 11Jun2021, the patient had severe eczema flare up, which requiring steroid shot. Prescribing doctor said she was the second patient to have this reaction to the vaccine that he had seen just that day. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Reporter reported event as non-serious. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021695206 same reporter/drug/AE with different patient
crying for 3-4hr not high pitched;no fever;pt dx w/hydrocephalus, metabolic acidosis, pyloric stenosis p/this episode;
7cm x 4.5cm swollen, reddened area at injection site which was warm to touch. Sharp intermittent pain from R shoulder elbow to R fingers. Saw PMD morning of 10/18/02 who instructed pt to take Benadryl. Redness and swelling minimal by pm or 10/18 but pain persists.
Ten minutes after receiving vaccine patient had syncopal event. He was unconscious approximately 5-10 seconds. After event patient was extremely diaphoretic, pale and slightly confused for <5 minutes. He complained of feeling very tired. Patients systolic bp unable to be detected, HR 57, O2 97%. Patient was laid in modified Trendelenburg position. BP rechecked after 5 minutes and was in the 90s systolic. Mother said he had a history of a heart murmur that nothing needed to be done about until he was an adult. Advised to go to ER for EKG d/t unknown cardiac condition.
Pt. says he had rash like chicken pox, itching, no pain. Took BENADRYL, rash right side chest belly, inside thigh for 10 days.
Swelling, redness, fever on injection site. Half of both thighs are angry red, puffy, and feverish. Knots in leg.
Fever 102 day of vaccination Fever 101 day 2 +3 post vaccination Fever 100 day 4+5 post vaccination
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 48 year old  female of unspecified ethnicity. 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 not reported, batch number: 1802072 and expiry: 23-AUG-2021) dose was not reported, 1 total administered to left arm on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient underwent antibody test: SARS-CoV-2 IgG antibody test, SARS-CoV-2 IgM antibody test (Immunoglobulin SARS-CoV-2 IgG and IgM immunoassay) and results were found to be no antibodies (confirmed immunological vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000193209.; Sender's Comments: V0: 20210923714- Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Lymph node enlargement near collar bone sixe of nickle/quarter. Resolved in ~3 weeks.
Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 12-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter.Original report is MARRS#1507USA011233.  Additional information has been requested.
Nausea, arm pain/soreness x4 days, headache x2 days, red patch on skin x5 days, swelling/warmth x4 days
Pt received IPV only on 7/25/01 and broke out in a rash on 7/26/01. In for appt on 7/27/01, because no improvement; had urticaria rash. Probable reaction to IPV.
First had itching around chin and lower jaw lines; scratched at for couple days while thought was dry skin. Around day 4, blisters formed encompassing same area; continued itching. Once noticed blisters, began using Hydrocortisone cream 3-4 times/day. After 1.5-2 weeks after first sign, rash had resolved with continuous topical treatment. Didn't seek medical attention as believed it was possibly poison ivy; thought that was suspicious as I've never had poison ivy in my lifetime. Approximately two weeks later, my brother (also an MD) mentioned a patient he had that experienced blisters on her neck that resembled poison ivy. Her rash subsided under the same conditions and timeframe.
Eighty four hours after vaccine I developed fever of 101-102 degrees, chills and night sweats. I was not able to work for two days. I also developed lower back pain and had Urinary Frequency with bad urine odor. This started 48hours after having the other symptoms. I started to take antibiotics Levaquin and tested negative for Covid-19. The urinary symptoms and other symptoms were reduced after three days. I felt like the illness was coming and going in three hour increments. I had mostly recovered by the sixth day. I got the second dose of the vaccine and had no symptoms that were similar.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
approx 5 mins p/vax pt turned pale; pt instructed to lower head to knees; pt responded but lost bladder control; appeared to have sz like activity;
dizziness; sweats; sore body; chills; fever; fatigue; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERHIDROSIS (sweats), PAIN (sore body), CHILLS (chills) and PYREXIA (fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jul-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 DIZZINESS (dizziness), HYPERHIDROSIS (sweats), PAIN (sore body), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HYPERHIDROSIS (sweats), PAIN (sore body), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications provided. No Treatment medications provided. The patient did not experienced cough. The patient received the second dose of the Moderna COVID-19 vaccine on 18-Aug-2021 and both doses were given in the patients left arm. The second doses lot number was 939901.   This case was linked to MOD-2021-292178 (Patient Link).
1st Moderna Vaccine given on Left Arm one week ago.  Arm is now red in a red area that is 4x4 inches and hot to the touch.  It is slightly painful to the touch.
Information has been received from a pharmacist concerning 3 patients, who on unknown dates, were vaccinated with a dose of ZOSTAVAX (dose, route and lot numbers not reported). It was reported that, on unknown dates, the patients experienced injection site reactions which included redness and swelling. At the time of the report, the patients' outcome was unknown. Additional information is not expected.
Admitted 5/10/06 discharged 5/17/06. Received pneumococcal vaccine (routine). Developed L arm rash, swollen arm. Treated with Tylenol, Keflex PO, warm compresses.
Developed an infection with pus discharge in my left bicep where the injection was given; Developed an infection with pus discharge in my left bicep where the injection was given; Developed an infection with pus discharge in my left bicep where the injection was given; abdominal pain; diarrhea; IBS-M; This is a spontaneous report from a contactable consumer (Patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0164), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 at 17:00 (at the age of 31 year) as dose 1, single for COVID-19 immunisation at Public Health Clinic/ Medical history included asthma and ongoing irritable bowel syndrome. Patient had known allergies to Augmentin, Biaxin. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Concomitant medication(s) included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D) and almasilate (GELUSIL [ALMASILATE]). The patient previously took augmentin [amoxicillin;clavulanic acid] and biaxin and experienced drug hypersensitivity. On 15Apr2021 at 23:00, patient experienced severe abdominal pain, diarrhea, worst abdominal pain that patient have ever had and patient have IBS-M that was well controlled. This happened within 6 hours of the vaccine. Developed an infection with pus discharge in left bicep where the injection was given. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment Anti-diarrheal, anti-spasmodic, antibiotic. The outcome of events was recovered with sequel.  No follow-up attempts are possible. No further information is expected.
Headache, fever developed approx 7 hours post injection without nausea, visual changes, MS changes or localized reaction. Fever of 102 approx 11 hours post injection. Sx resolved w/in 24 hrs with Tylenol and supportive home care otherwise.
RIGHT AFTER THE VACCINE ADMISNITRATION THE CHILD FELT DIZZY AND FAINTED.
Patient presents with chills and nausea without vomiting x 0230. Patient received J&J vaccine yesterday at 1630. Reports he took Tylenol at 0230. Patient also reports feeling achy to back but believes because he had ACFT yesterday.
soreness; swelling; This case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th November 2019, less than a day after receiving Shingrix, the patient experienced pain and swelling. The action taken with Shingrix was unknown. On an unknown date, the outcome of the pain and swelling were not recovered/not resolved.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient stated she was only experiencing some pain and a little swelling. The reporter consent to follow up.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8734), on Apr 6, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient experienced fatigue (he thought he was tired due to the vaccine), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. No follow-up attempts possible. No further information expected.
Fever x 4-5 days post-DTAP/IPV vaccination - Local severe reaction x 7 days post-DTAP/IPV vaccination.
During the 15 minute post vaccination observation period patient developed a significant headache and did not feel well.  His blood pressure was taken - 190/130 - and he was placed on a gurney in the vaccination area for observation.  His blood pressure continued to remain elevated with a persistent headache.  He was taken to the emergency department for further workup  - triaged there at 1317 with a BP of 190/114.  Medications given:  APAP 1000mg p.o at 1335.  Hydralazine 10mg IV at 1335.  Hydralazine 25mg p.o. at 1350.  Hydralazine 25mg p.o. at 1530.  Discharged in stable condition to home at 1553 with a new prescription for Hydralazine 50mg TID (double his previous dose).  Dx included non-compliance and anxiety.
Approximately 7 hours after receiving vaccine, severe lower abdominal pain; nausea and persistent vomiting from 7:00 pm-4:00 am next morning; kidneys were not producing urine; chills.
Patient received his 2nd dose of moderna in May of 2021 and in August of 2021 he started to get a red bumpy rash on right arm that he got the vaccine in.  The rash has moved down his arm to his face, chest, abdomen, full body over time.  He has been to his primary care dr and they have not been able to locate the cause of the rash.  I told him all I could do is report the reaction.
Pallor, dizzy, patient felt like everything was going black. Treatment was to lay flat and elevate legs.
Pt with type 2 diabetes requiring insulin and obstructive sleep apnea presented with shortness of breath, cough, and fever.
After approximately two days my eyes were itching profusely. Exactly 7 days later my eye completely swelled up and was beet red.
Other than a sore arm, felt great all day - even had more energy than usual.   At 7 p.m., shortly after eating for the first time of the day, I started getting chills and feeling like I was coming down with the flu.  By 9 I took 2 tylenol and went to bed.  Spent the next day doing nothing and sleeping, but don't know if it was because of the vaccine or just lazy because it was sooo cold outside.  By Monday, back to normal.
This spontaneous report was received from a currently 62 year old female patient (health care professional) concerning herself via a company representative. In approximately December 2013 (reported as one and a half year ago), the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot # unspecified). On an unknown date the patient experienced injection site erythema and injection site mass. It was reported that the patient developed a four inch, round, red, raised area around the injection site. Patient did not seek medical attention. No treatment was given. The red raised area around the injection site disappeared (reported as resolved) in 2 weeks on an unspecified date. Causality assessment was not reported. Additional information has been requested.
Patient went to the emergency room with itching and rash on the face. Was given Benadryl and Zyrtec.
This spontaneous report was received from a 87 year old female patient concerning on herself. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route of administration, anatomical location, lot number and expiration date were not reported). There were no concomitant medications reported. On an unknown date, the patient experienced swelling and pain in her arm and the pain eventually moved into her shoulders. The patient mentioned that she went to see her physician (unknown date) and the doctor thought she had bursitis. At the time of the report, the outcome of bursitis, peripheral swelling and pain in extremity was unknown. The reporter did not assess the relatedness of bursitis, peripheral swelling and pain in extremity with PNEUMOVAX 23. Additional information has been requested.
During store wellness event day, Patient came and completed form attesting that it has been six months since 2nd dose was administered to receive booster dose. Booster dose was given. After returning from event to enter data and submission to insurance, claim was rejected for not covered since it has not been 6 months since last dose. After checking immunization records, record shows last dose was April 26, 2021. Spoke to patient's wife over the phone, and she stated that their cardiologist said her husband and her both have heart disease and need to get booster dose as soon as possible.
Swelling at the site that lasted a week, mild fever, and SEVERE RINGING IN THE EAR
After I got the injection, I was fine until that night. My arm was feeling sore and I developed a bump on the site. It was terrible on the second night. On the fourth night, I felt run down. On the fifth night, I had a whole ache and felt like I was in a car accident. I started having nausea, fatigue, headache, leg cramps and I wanted to sit down. This is when the blood pressure went off the charts. I was very high on my blood pressure. I almost fainted and the ambulance checked me and said it was 110/104. I took a sublingual pill under my tongue and did it 3 times. That calmed down my blood pressure. They gave me a temporary blood pressure and this happened on the 7th day. After time had passed, everything started subsiding. I had insomnia and I was very fatigued but I could not sleep or rest. I also experienced runny stool for 2 days which was on the 5th and 6th day along with stomach pains and was very uncomfortable.
Tested positive; Tested positive; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8732), in left arm, on 26Apr2021 as dose 2, single (Lot number: GR8731), in left arm and on 05Nov2021 as dose 3 (boosster), single (Lot number: 320308D) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Apr2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa". There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "recovered" (20May2022) and all described as "Tested positive". Patient became sick with Covid. Tested positive on 02May2022. Experienced symptoms before testing positive. Symptoms included fever, chills, vomiting, diarrhea, sore throat, cough, and then secondary infection which was treated with Azithromycin, albuterol, benzonatate. Strange thing was patient seemed to improve, tested negative for three days in May2022, and then her symptoms returned on 13May and she tested positive again for more than a week. Adverse event treatment included received Paxlovid then other meds after rebound.
Fever 100 degrees - 101 degrees beginning PM of 11-17-09 continuing through 11-24-09. Was seen by Dr 11-24-09 and received Rx for ZITHROMAX 11-25-09 - Improved.
Jerking Motion on Right side arm and leg. Eyes deviating to right.  Lasting approximately 30 seconds.  Child first brought in for this by parents on October 17, 2014.
hot at the injections site; ACHY; INFLAMED AT INJECTION SITE; Itchy at injection site; RED AT INJECTION SITE; Achy; Tired; FEET AND HANDS REAL COLD; feels light headed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feels light headed), PERIPHERAL COLDNESS (FEET AND HANDS REAL COLD), INJECTION SITE WARMTH (hot at the injections site), PAIN (ACHY) and INJECTION SITE INFLAMMATION (INFLAMED AT INJECTION SITE) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL COLDNESS (FEET AND HANDS REAL COLD), PAIN (ACHY), INJECTION SITE INFLAMMATION (INFLAMED AT INJECTION SITE), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE ERYTHEMA (RED AT INJECTION SITE), MYALGIA (Achy) and FATIGUE (Tired). In April 2021, the patient experienced DIZZINESS (feels light headed). On 24-Apr-2021, the patient experienced INJECTION SITE WARMTH (hot at the injections site). On 15-Apr-2021, PERIPHERAL COLDNESS (FEET AND HANDS REAL COLD), PAIN (ACHY), INJECTION SITE INFLAMMATION (INFLAMED AT INJECTION SITE), INJECTION SITE PRURITUS (Itchy at injection site), MYALGIA (Achy) and FATIGUE (Tired) had resolved, INJECTION SITE ERYTHEMA (RED AT INJECTION SITE) outcome was unknown. At the time of the report, DIZZINESS (feels light headed) and INJECTION SITE WARMTH (hot at the injections site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.