chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore and achy body, no energy, slept for two days straight. Also right side of my face swelled up and became super itchy on the day after the vaccine, by the second day it was only my eye (swelled shut and looked like black eye). One day three after swelling down but still looks like black eye. Now on day 4 after- less swollen but still itchy and swollen and black.
First / dose in October of 2019 and have not received their second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (intramuscular) 0.5 ml in unknown arm in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not applicable for this report.   Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case had been linked with US2021103257, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021103257:same reporter. wife case.
8 days after shot my arm started itching. 9 days after shot hard knot, minor redness, tender and itchy.
Moments after receiving flu vaccine, patient passed out for a few seconds. I applied a cool, damp cloth to the patients neck and gave him water as he woke up.
Patient was given Pfizer 5-11 for second dose of vaccine series and he is 12. No adverse symptoms observed.
had three doses of Pfizer/ received a fourth dose, which was Moderna COVID19 Vaccine on 18Nov2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had three doses of Pfizer/ received a fourth dose, which was Moderna COVID19 Vaccine on 18Nov2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer, Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Myeloma. Concomitant products included DEXAMETHASONE for Myeloma.    On 18-Nov-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had three doses of Pfizer/ received a fourth dose, which was Moderna COVID19 Vaccine on 18Nov2021). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had three doses of Pfizer/ received a fourth dose, which was Moderna COVID19 Vaccine on 18Nov2021) had resolved.            No treatment information was reported.  Patient stated that he has myeloma and has been on dexamethasone for a number of years.   Patient had 3 doses of Pfizer, but tested negative for the antibodies and then received a fourth dose from Moderna and developed antibodies.
Patient called the pharmacy and stated she has had symptoms of clogged ears.  It bas been bothering her even though she has cleaned her ears afterwards.   It just happened after getting her vaccine.  I recommended to give it another day or two since symptoms will subside usually after 72 hours.  If not, she may need to see her provider.  Patient understood.
The vaccine injection produced moderate muscle ache at the injection site,  mild hardness to the touch, noticeable heating in the muscle.  Before going to bed, anticipating mild fever and pain, I took one oxycodone/Tylenol tablet with ~8 ounces of water.  I slept well, normally.  small separate pale red hives spread in a 2-3 inch by 4-5 inches rectangular area of skin around the injection site.  I did not notice the initial appearance of the rash until Saturday afternoon, September 18, (approximately 24 hours after vaccine injection), when I began scratching the hives (idly, unaware, not vigorously). The rash was only mildly irritating
Meningitis at day 9 after first Moderna vaccine.  The meningitis came and went quickly, within 3 days I was normal again.  I went to he ER 24 hours after intense headache.  I was hospitalized overnight for observation and given dexamethasone, anti bacterials and antivirals. No virus or bacteria was found in CSF. Clearly this occurred right during the 10-14 day maximum immune response from vaccine:  Aseptic meningitis. Moderna vaccine may be too robust for some , like me.  (I wonder if it should be administered and dosed based on weight?)  (FYI I am a molecular virologist-- not an anti vaxxerr!!). My husband is a physician.  We understand science.  I have told no one because I don't want to scare anyone, but my fellow scientists should be alerted.  Clearly this is a rare adverse effect, but valid nevertheless.
Patient reported feeling dizzy after receiving dose. Bp 122/66 pulse 68 temp 98.1. Given water, patient felt better after 10 minutes of monitoring
mild soreness day of injection (12/31); 01/16: red spot at the injection site, getting bigger, rash on injection side upper arm, not raised; somewhat itchy x 1 day (01/15) 12/31/2020 injection site soreness ? mild;  itchiness around injection site 01/15/2021; 01/16/2021 noticed other symptoms
Within 24 hours of MENVEO administration, pt developed urticarial rash over L deltoid measuring 9 x 6 cm that was persisting at the time of revisit, approximately 48 hours after administration. Also reported mild tenderness at site. No edema observed.
fatigue, arm soreness for 6 days; chills and extreme pain in back, legs and arms on second day, red and extremely swollen arm starting on 3rd day and still swollen on day 6
Severe leg and knee aches. Lasted 24 hrs. Treated with ibuprofen, rest and Ultram.
12OCT c/o pruritic back area;13OCT c/o itchy & red w/a rash;14OCT 2:35 overall body rash, raised, deep pink to red in color, ankle swelling;14OCT;ache all over;t100.2;skin pain on chest & abd;?thimerisol allergy;
After receiving my 2nd dose, I started feeling unwell. I also started hearing voices, which has never happened before. On 09/22/2021 around 6 pm, I started shaking and I fell to the ground. When I went to the ER, I was diagnosed with epileptic seizure.
diagnosis of Guillain-Barre syndrome/ right hand paresthesias/ progressive lower extremity weakness; This is a spontaneous report received from a contactable reporter (physician).  A 51 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration date 30Jan2022 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Vitamin D deficiency" (unspecified if ongoing); "remote history of Breast cancer" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication included: ERGOCALCIFEROL. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization,Medically Significant ) with onset 28Feb2022, outcome "recovering", described as "diagnosis of Guillain-Barre syndrome/ right hand paresthesias/ progressive lower extremity weakness". The patient was hospitalized for Guillain-Barre syndrome (start date: 08Mar2022, discharge date: 15Mar2022, hospitalization duration: 7 days). The patient underwent the following laboratory tests and procedures: CSF test: (08Mar2022) negative, notes: diagnosis of Guillain-Barre syndrome based on CSF analysis, negative imaging findings, and examination; SARS-CoV-2 test: (08Mar2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of Guillain-Barre syndrome. Additional information: Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received ergocalciferol within 2 weeks of vaccination. The patient reported an onset of right hand paresthesias on 2/28/22, with progressive lower extremity weakness, leading to hospitalization on 3/8/22 and diagnosis of Guillain-Barre syndrome based on CSF analysis, negative imaging findings, and examination. The patient received treatment of intravenous immunoglobulin (IVIG) for the adverse event. The patient was diagnosed with COVID-19 prior to vaccination and the patient has been tested for COVID-19 since the vaccination.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient reports ulceration right lower lip has not had history fever blisters or Herpes Simplex outbreak.
SORE BUMP ON INJECTION SITE; CHILLS; PAIN AT INJECTION SITE; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore bump on injection site. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, fatigue, pain at injection site, sore bump on injection site, and nausea. This report was non-serious.
Hives on buttocks, thighs, elbows 48 hours after first dose.  Severe itching.  Has lasted 3 days so far, prescribed prednisone and Zyrtec by her pediatrician today.
Pt recv vax & lab eval revealed undetectable titer levels; This is in follow-up to report (s) previously submitted on 10/16/1997; 4/15/1998. Information has been received from a health care professional concerning an otherwise healthy 29-year-old female who was vaccinated with the first dose and second dose of VARIVAX vaccine on 08-JUL-1996 and 08-AUG-1996. Subsequent laboratory evaluation on 02-SEP-1997 revealed undetectable titer levels. The final laboratory report noted, "varicella: not immune". No further details were provided. This is an amended report. The patient's age now reads 29-years-old instead of age 35 year-old. Updates were made to the patient's date of birth and medical history, as well as the adverse event onset date. This report has been corrected as amended.
High temperature (101, 102F), extreme fussiness, non-stop crying for 1 week. Hard lump at injection site.
hard red knot approximately 3" in diameter;very tender and itched for approximately 7 days
Significant swelling of left arm 9 x 12 cm warm with erythema. Started few hrs post injection.
A sore arm; Just didn't feel well; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (A sore arm), MALAISE (Just didn't feel well) and HEADACHE (Headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Diagnosed twice.). Concurrent medical conditions included Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (A sore arm), MALAISE (Just didn't feel well) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (A sore arm), MALAISE (Just didn't feel well) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-403250 (Patient Link).
I was losing strength on my arms and feet; Tingling on my feet and arms; Numbness on my feet and arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (I was losing strength on my arms and feet) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PARAESTHESIA (Tingling on my feet and arms) and HYPOAESTHESIA (Numbness on my feet and arms). On 02-Apr-2021, the patient experienced ASTHENIA (I was losing strength on my arms and feet) (seriousness criterion hospitalization). The patient was hospitalized on 02-Apr-2021 due to ASTHENIA. At the time of the report, ASTHENIA (I was losing strength on my arms and feet), PARAESTHESIA (Tingling on my feet and arms) and HYPOAESTHESIA (Numbness on my feet and arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received his first dose of the Moderna COVID-19 vaccine on his left non-dominant arm on 11 March 2021. About two weeks later, he started to experience tingling and numbness on his feet and arms. He went to the Emergency Room (ER) twice, on 22 Mar 2021 and on 26 Mar 2021. On 02 Apr 2021, he was admitted to the hospital because he was losing strength from his feet and arms. He did not want to stay longer, so he was discharged the next day. His healthcare professionals are still running tests. He was still experiencing numbness and tingling on his feet and arms. at the time of the report.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
arm pain, shooting up to neck; arm pain, shooting up to neck; This is a spontaneous report from a non-contactable physician (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 23Dec2020 at single dose for Covid-19 immunization in a hospital facility. Medical history included Covid-19 diagnosed prior to vaccination. Concomitant medications included "OCP" (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 23Dec2020, the patient experienced arm pain, shooting up to neck. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events arm pain, shooting up to neck was recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  No follow-up attempts are possible, information about batch number cannot be obtained.
Tinnitus became greatly amplified the next morning after the 1st dose of Moderna Covid-19 vaccine. The amplified Tinnitus is still present 3.5 months later in both ears.
Pt. received a Flu vaccine in (L) arm and approximately 5-7 mins later, while writing on a chalkboard, she fell and had 1-2 tonic jerks (she fell on a padded surface). When I reached the room, she was alert and spoke to me (1-2mins later) PE wnl.
Patient returned about 4 hours after receiving vaccine with hives and itching on arm. No other symptoms. Got benadryl to take
* within the first  12 hours post-vaccination: Fever up to 101.7, joint pain, muscle aches, not able to move off the couch. ended by about 48 hours post-vaccination.  * about 36 hours post vaccination developed a large enflamed, (inflammation, pain at rest and at touch, and heat) red area about 7cm by 7cm on the upper left arm.  Itching started about 24 hours after enflamed area appeared. enflammed area took about 6 days to resolve, itching continued for another 2 days.  Reached out to my provider on 8/24 as enflamed area was >2 x the size that I'd developed post 2-nd vaccination dose in March. Was advised to watch and reach out if it spread or got worse. It spread a tiny bit, but did not get worse in terms of pain, heat, itching, or redness.  Provider followed up on 8/30, but site was largely resolved.
15 minutes after receiving vaccine, nurse was summoned to hallway by group leader in reception, who was informed by another donor that a lady had lost consciousness and fell. Donor reports that she did not hit her head and no injuries noted. Donor that witness accident reported that loss of consciousness was less than 10 seconds. Nurse noted that donor was incontinent of urine. Donor assisted to office where down laid down on exam table, was fanned and a cold compress applied to donor's chest. After 3 minutes donor reported feeling better.
pt recvd vax;mom report fever noc of 29nov & all day 30NOV;fussy on 1dec;t not known;mom relates antipyretic seemed to bring fever down;
A non-serious spontaneous report of inadvertently administered H1N1 LAIV to 73-year-old was received from a physician concerning a 73-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 11-Dec-2009, the patient received the vaccine for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Severe breathing issue, noted at ER:breathing treatments as far as 7 months out (present) Skin rash and hair loss, noted at dermatology : steroid shot, oral and cream  Vision issues and changes, noted with eye Dr: went a couple times a week for about 6 weeks. Ended up having to change script. Autoimmune diseases flared immediately and have continued
Headache (doesn't go away after Tylenol), fast heart beat, tight in the chest, ears ringing, feeling throwing up, high blood pressure150/93 pulse 83 (measures twice a day)
Approximately 2 and a half weeks after receiving the 2 doses of Pfizer's vaccine, on May 28th, 2021, I had a routine check-up appointment with my primary care doctor. My blood pressure reading at that appointment was 165/120. Before this appointment, I had never had high blood pressure, and I never had a reading above 120/80. I have been taking amlodipine-besylate 5 mg to lower it since then. My blood pressure is still above normal, averaging around 135/90 on most days with exercise.
no additional AEs reported; reconstitued with the adjuvant suspension component for SHINGRIX; This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  The reporter stated, that on 14-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) at the dose of 0.5 ml, subcutaneously, lot # U002400, expiration date reported and also validated as 22-JAN-2023 (strength and anatomical location were not provided) for prophylaxis, but the vaccine was reconstituted with the adjuvant suspension component for varicella zoster vaccine rge(cho) (SHINGRIX) at the dose of 0.5 ml, lot # 7S3NF, expiration date 18-DEC-2022 (strength was not reported) instead of sterile diluent supplied with the varicella virus vaccine live (oka/merck)(VARIVAX) (wrong solution used in drug reconstitution).  The Merck sterile diluent was was not administered. The reporter denied further adverse event (AE) (no adverse event). No additional information was provided.
rash on my neck and around my eyes; warm around injection site; itchy around injection site; Red blotch on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red blotch on upper arm), RASH (rash on my neck and around my eyes), VACCINATION SITE WARMTH (warm around injection site) and VACCINATION SITE PRURITUS (itchy around injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (sulfur allergy).    On 29-Jan-2021 at 4:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced ERYTHEMA (Red blotch on upper arm), VACCINATION SITE WARMTH (warm around injection site) and VACCINATION SITE PRURITUS (itchy around injection site). On an unknown date, the patient experienced RASH (rash on my neck and around my eyes). At the time of the report, ERYTHEMA (Red blotch on upper arm) had not resolved, RASH (rash on my neck and around my eyes) outcome was unknown and VACCINATION SITE WARMTH (warm around injection site) and VACCINATION SITE PRURITUS (itchy around injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: VAERS Form received on 10-MAY-2021
I noticed a painful lump in my left breast Thursday 5/20/2021. I went to  Urgent Care Friday 5/21/2021, they were going to refer me to get an ultrasound and mammogram....the Ultrasound facility would not be able to see me until August 2021. The pain increased and throughout the week redness was noticeable on the skin. I went to Emergency Room 5/26/2021...they gave me antibiotics, performed an ultrasound and set and appt for a biopsy the next day. I went in 5/27/2021 for an ultrasound guided biopsy, where they drained the abscess. I took antibiotics for ten days and the lump went down. The culture results came back as 2+ Beta Hemolytic Streptococci, Group B, no white blood cells (PMNs) seen and no organisms seen. I have a follow up appt with my PCP 6/18/2021. I am unsure if this is related to the vaccine...but I have never experienced anything like this before and it was the same side I had the vaccine.
Patient initially felt dizziness and headache within 15 mins of receiving the vaccine.  Blood pressure was 180's/96.   About 1 hour after vaccine, patient's blood pressure was 160's/90.  Around 1pm  BP was 201/102. Patient went to EC and was treated with Klonopin and Benadryl.  After Klonopin, BP was 150's/80's.  Patient was discharged home from EC. BP on 12/23/2021 was 110/60.