chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT CALLED PHARMACY COMPLAINING OF LIP SWELLING AND PAIN. HAD RECEIVED SHINGRIX VACCINE LESS THAN 24 HOURS PRIOR. HAD FORWARDED CALL TO NURSE TRIAGE LINE WHERE THEY RECOMMENDED PATENT BE SEEN  RIGHT WAY. PATIENT WAS AMENDABLE TO THIS AS ALLERGIC REACTION CAN PROGRESS QUICKLY, WILL FOLLOW UP.
Dizziness 15 minutes post vaccination, soreness & swelling  at site for 2 hours, severe exhaustion after 3 hours, achiness all over body after 4 hours, chills after 8 hours, leg & back pain between shoulder blades as well as ankles and right wrist  for 48 hours with continued exhaustion. Intermittent hand numbness for 72  hours. 15 days post vaccine new spider veins in legs as well as worsening pre existing spider veins with moderate leg pain.
6JUN98 (exposed to chickenpox-family has) broke out w/small rash-mild;
This patient possibly received the adult vaccine in a 0.2ml dose (20mcg) which is double the dose indicated. There were no adverse events, patient tolerated fine
Within a few minutes felt dizzy, then felt as if had to go to bathroom but couldn't, felt weak all over, felt nausea.. Arm felt numb. Then felt severe abdominal pain like cramps but much worse than ever felt before, staff commented that her face looked like she was experiencing contractions, her throat felt pain but not like closing (like asthma) just felt tight/sore. Symptoms passed after about 25 minutes or so. Doctors commented they had never seen such a severe reaction. Patient fine rest of day. We are still in the same day. Patient had zero symptoms after first dose; in opposite arm previously.
This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 27-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Client presented to Vaccine Site on 1/22/2022 to receive his 1st dose COVID Pfizer Pediatric vaccine. The mother of the client disclosed to vaccinator RN at the vaccine station that "my son has special needs". RN advised the client be vaccinated in a private area to reduce stimulation but the client's mother declined accommodation. At 1050 RN attempted to vaccinate the client on the L deltoid, however client pulled arm away abruptly resulting in a needle stick to the client's arm. No vaccine was administered upon attempt. RN notified Lead RN, who advised RN to vaccinate on the other arm if the client's arm can be safely stabilized by the mother. RN advised the mother on how to hold the client safely and provided assistance in distraction to the client to allow for safe administration of the vaccine. RN successfully vaccinated the client with 1st dose COVID Pfizer Pediatric vaccine (lot#FK5618) in the R deltoid at approximately 1100. No adverse reaction was reported during client's 15 minute observation.
Horrible chest paint to the point I thought I was having a heart attack.  It felt like a knife was was going in my heart.  The chest was tight, aching and spread to my right side of chest.  It's worse when lying down.  I can feel my heart beat, palpitate and throb.  I am short of breath, cough and easily tire.  My heart rate is increased.  After two ER visits and being admitted over night to the hospital I was diagnosed with Pericarditis. Leading up to this I visited urgent care and they suspected I had a heart attack based on EKG and sent me to the ER.  I had EKG, chest X-ray, MRI, stress test and numerous blood panels.  I was put on colchicine and Ibprophen.
5 days post vax, the pt developed easy bruising and petechiae over entire body. Fever less than 101 3 days post vax for a few hours. Decreased appetite and thirst, 3 to 4 days post vax. Walking with less stability. Diagnosed with thombocytopenic pupura
10/2021 vaccination. 03/15/2021 Started to experience in both ears, mostly right; tinnitus. Gets worse when lying down or around other loud noises. After the 3rd dose, I had a high fever and vomited. I found this all rather alarming. I haven't vomited in 2 decades and body was in a lot of pain. History of migraines, recently being treated to hypertension. 04/08/2022 -  The doctor didn't really know what was causing the ringing in the ears.
This spontaneous report was received from a consumer referring to herself, a 71 year old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.     On an unknown date in 2011, reported as "five years ago in the fall", the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU injection, for prevention of shingles (route, anatomical location, dose, lot/batch number and expiration date were not reported). On 15-NOV-2016, reported as "five weeks ago", the patient was diagnosed with shingles that were around her rectum and down her "left cheek and left leg". She reported that she could not "stand her clothes touching the left side of her body". The patient sought medical attention and was treated with an unspecified antiviral medicine and topical cream for seven days. Finishing this treatment the patient was prescribed an unspecified lidocaine and TYLENOL for pain, and an unspecified "antibiotic because the blisters were opening" and the physician "wanted to prevent an infection". The patient referred that the rash was almost gone, but "they (the shingles) upset her whole system", she felt that the shingles "might have gone internal" and may see a gastroenterologist. The outcome of herpes zoster, herpes zoster and herpes zoster cutaneous disseminated was not recovered/not resolved. The relationship between Herpes zoster disseminated, and herpes zoster and therapy with ZOSTAVAX was not reported. Upon internal review, the event of herpes zoster disseminated were considered to be medically significant events. Additional information is not expected as there is no consent to follow up.
Pt reports she had her first dose of Pfizer Covid vaccine on 5/17/21. The following week she had a very heavy period that lasted longer than usual with severe cramps and occasional lightheaded/dizzy spells. After her cycle ended, she continued having  brief episodes of dizziness, usually when going from sitting to standing, usually resolved quickly (after a few minutes) with rest. Over the past two weeks, the episodes have become more frequent and intense, and over the past few days episodes also include s/s of seeing spots and having blurred vision with nausea, SOB, and palpitations/tachycardia. Tonight while at lacrosse practice, pt suddenly became dizzy and felt like she might pass out, became diaphoretic and pale.
p/vax pt exp chills/rigors; chills tx w/tylenol;
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history reported.   On 18-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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. already had back pain prior but does have a headache    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
HOSPITAL COURSE :  74 yo chr ill wm, with hx as below, including ILD on imuran, with dose increased last month, not norm on O2, coming in with cong cough, sob, doe and gen weak Patient tested negative for Covid.  Consulted by pulmonary for acute exacerbation of pulmonary fibrosis, treated with intravenous Solu-Medrol at high dose which has been gradually tapered.  He also had some evidence of lower respiratory tract infection treated empirically with Levaquin Zyvox and tobramycin.  His cultures had remained negative.  At this point continues to show improvement with reduction in oxygen flow rate with preservation of saturations.  At this point he requires 4 L oxygen through nasal cannula.  At this point stop her Solu-Medrol and will place him on prednisone 40 mg for a week, sequentially tapered to 30 mg and 20 mg/week.  Social work to arrange oxygen flow rate will be 6 L/min.  At this point though he requires oxygen, his requirement has become much less and will discharge him home.
Headache started Friday night, Saturday am fever and body aches started temp has high as 102.6.  Head congestion,  symptoms resolved by Saturday afternoon - just wiped out.  Sunday just tired.  Went to bed Sunday night headache started became severe  - kept me awake till 12:30 pm.  Awoke twice during night drenched in sweat.  Did not believe I had a fever.  Got up at 4:30 am and felt like I was on boat, gait disturbance, had to hold things to walk to bath room. No other neuro symptoms.  Went to ED later in morning.
It was discovered that the MA was improperly giving the rotavirus monovalent vaccine and only giving the diluent of rotavirus vaccine instead of mixing the diluent with the vial of the rotavirus vaccine and administering that. The clinic was able to track back which patients this affected. Patients on this date may have gotten the diluent only or the proper vaccine based on counts of abnormal diluent and reconstitute vaccine vials. The mother of patient was notified 10/29/21. Provider discussed with patient family the need to vaccinate between Nov 29th and Dec 6th in case this will be the first dose as well as in case this was the second dose. Provider documentation also notes the patient will then get another dose at either the 4 month or 6 month visit. Scheduled for Dec 3rd.
itchy eyes, gave dhist JR about and hour later, face itchy, lips hurt-gave zyrtec-symptoms improved  July 28th:  Her eyes are still bothering her. We have had to repeat the zyrtec yesterday which makes sense, usually I can get 2 days out of 5mg in my girls. She was up in the middle of the night saying they were super itchy.  --July 29th: Eyes are still itchy, we almost had to fo another zyrtec last night but she powered through and fell asleep.-------------------------------------
Was sore for a few days burned bad being injected two months give or take had two small strokes
I was lightheaded after receiving the shot, remained at the site for approximately 45 minutes. I continue to have a rash on my upper back indicative of an allergic reaction. Left arm was sore for first two days, soreness has dissipated. Still have a small lump on left arm where shot was received.
Nausea, vomiting, diarrhea, general malaise, fever, elevated WBCs. Patient received IV fluids and PHENERGAN on 10/23/15 in physician office. Also received antibiotics due to increased WBC. Patient also reported warm, red injection site.
2 hr post inject had weak, warm sensation; room spinning; BP incr to 160/108; HR 100 & bounding acc to examining MD;
Her eyes were black like she was punched, she wouldn't play, eat, and she couldn't walk straight. Two days later, she fell and cut her head open needing 9 stitches. At the time, she had been walking for 4 months, so she could walk well. I told her doctor about the event at her 15 month visit and stated that I didn't want to vaccinate her anymore and was kicked out of their office.
Presented with seizures and lethargy 1 week after vaccine administration. Had CNS pleocytosis but negative cultures. Diagnosed with meningoencephalitis.
6 cm Rash and swelling on left deltoid, chills occurred on 8th day after vaccination. chills resolved but still have rash on arm. had left eye pain occur on 9th day after vaccination that lasted for 1 day. also had  left arm soreness that started 3 hours after vaccination and lasted 2 days. cold sore developed 2 days after vaccination.
Patient comes in today and shows me her arm. The injection site is swollen and red. I advised her to go see her physician. Called her later that night. Her physician siad she was going to be ok and gave her some instructions. She didn't elaborate. I think she was tired and just wanted to go to bed so she didn't want to talk any longer.
pt did well p/immun until 6AUG98AM;mom noted reddness, swelling, lt leg especially area around inj site;7AUG pt had fever 99.2, redness 15cm area & swelling lt thigh & sl swelling lower leg & ankle;
Pt should have rec'd PNEUMOVAX 23.  WAS GIVEN pREVNAR IN ERROR
redness & itching in deltoid area where vaccination had been given approx 2x3inches;dx rxn to DT tx ATB;
Patient received a third dose of covid vaccine by mistake. no immediate reaction and observed for 30 minutes. patient reported to be fine and not experiencing any signs or symptoms. educated patient that the following day will most likely feel like they did after receiving the second dose.
Increased SOB, chest tightness & light headedness. 9 am unlabored but shallow respirations, tight breath sounds. Rest 9:25 am PROVENTIL (2 inh) inh & ADVAIR Diskus puffs 250/50mg. 9:45 am improved ease of respiratory effort & breath sounds unL.
Injection - site reaction, left deltoid, 20 X 20 cm sized, swelling, itchy and redness.  Pt. stated "I am fine now" 2 days later.
I woke up 7 days later with my feet and hands itching real bad and after going to the Dr. I was told that I had severe hives all over my body. It lasted about 8 weeks after I was prescribed steroids.
sore throat; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient) reported that a 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0181, Expiry date: unknown), dose 1 via an unspecified route of administration on 12Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. He was scheduled to receive his second Pfizer Covid 19 Vaccine this Friday. Per caller he started having a sore throat on Sunday. The patient experienced sore throat on an unspecified date of 2021. Caller asking if it's okay to take an antibiotic prior to his second Pfizer Covid 19 Vaccine if the doctor prescribes one. Caller advised to call back if needed once he was seen by the doctor if a medication was prescribed and he had questions. Transferring agent stated his concern is he had a sore throat, he was thinking of taking an antibiotic (Treatment medication not clarified) so he wanted to if it will effect vaccine since he will be having his second dose of the vaccine on Friday. On paraphrasing the concern: Consumer stated Yes, the antibiotic before that second shot. Confirmed the vaccine as Pfizer Covid-19 vaccine. On confirming the first shot of Pfizer Covid19 vaccine: Consumer stated yes I did. Patient got that back on 6/12. (Not clarified hence not captured in tab) Consumer stated, Patient was scheduled for second shot this Friday at 10 O' clock. I started getting a sore throat on Sunday but it is getting little progressively little worse may be a Wednesday before Friday I wanted to take an antibiotic for my sore throat but I just want to make sure that this not gonna also effect the second shot. Consumer was informed about Pfizer medical information department. The call was disconnected while transferring to medical information department. Further probing was not done hence limited information available over the call. The outcome of event was unknown.
Child receive flu vaccine on 1-4-07 at 10:00 am. Child was put on Amoxicillin on 12-26-06. Mom noticed some bumps on child's inner thigh and this AM child's right knee was swollen and reluctant to walk. She has latex egg, egg products. Physicians diagnosis: allergic reaction with serum sickness like reaction. Patient came back in on 1-6-06. Patient is to follow up if no better.
Rheumatoid Arthritis flare up in hands and knees; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4371883-00.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 61 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 vaccination. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid Arthritis flare up in hands and knees". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up in hands and knees" not related to BNT162b2.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (Adalimumab):  The reporter's causality for the event(s) of Rheumatoid Arthritis flare up in hands and knees was not provided.  Seq.No.: 1  Drug: Humira (Solution for injection in pre-filled pen) (Adalimumab) Causality  1) Rheumatoid arthritis flare up (Rheumatoid arthritis)   Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  Seq.No.: 2  Drug: Pfizer BioNtech Covid-19 Vaccine (Tozinameran) (Tozinameran) Unknown, unknown Causality 1) Rheumatoid arthritis flare up (Rheumatoid arthritis)   Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not related Dechallenge: N/A    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event rheumatoid arthritis flare up in hands and knees and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further 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 RAs, Ethics Committees, and Investigators, as appropriate
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: ~1.5 weeks after administration, patient had delayed numbness/tingling that came and went in left arm. At about 2 weeks out, she also had a swollen, red rash (no itching) at site of injection. Tylenol, Advil, Benadryl provided no relief.
12/6/21 presenting today for Cough (congestion, ear pressure x 4-5 days) and Covid-19 Positive Review of Symptoms:   Review of Systems  Constitutional: Negative for chills and fever.  HENT: Positive for congestion, rhinorrhea and sore throat. Negative for ear pain, sinus pressure and sinus pain.   Respiratory: Positive for cough. Negative for shortness of breath and wheezing.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for nausea and vomiting.  Musculoskeletal: Negative for myalgias.  Neurological: Negative for headaches.
headache; muscle pain; joint pain; chills; will throw up any second; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (will throw up any second) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (will throw up any second). At the time of the report, HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (will throw up any second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
pt recvd 1st & 2nd dose of Pneumococcal 1990 & 29OCT91; On the evening of 29OCT91 pt devel t101 & exp tenderness of the rt deltoid area; treated area w/cold compresses & took unspecified non-steroidal, anti-inflammatory meds;
Information has been received from a pharmacist concerning a patient who in approximately January 2010, "within the last week or within the last 30 days", was vaccinated with PNEUMOVAX 23 (lot # 664478/1191Y) through subcutaneous injection (dose and site not reported). In approximately January 2010, "within the last week or within the last 30 days", the patient experienced injection site reaction soon after. The patient was in the hospital before receiving the vaccine and hospitalization was not due to vaccination. The outcome of injection site reaction was not reported. All telephone attempts to obtain follow up information have been unsuccessful. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
Severely elevated LFT?s ALT 1,221, AST 677, Alk Phos 244 and acute onset confusion, aphasia.
Pt wife tested positive for COVID-19. Pt tested positive 9/15/21. Presented to ED 9/17/21 with SOB. Intubated upon arrival. Terminal extubation on 9/22/21. Deceased 9/23/21. Discharge Dx: Sepsis d/t COVID-19. Acute hypoxemic resp failure, Moderate ARDS, Acute metabolic encephalopathy, Elevated d-dimer, Afib, Bradycardia, CKD Stage 3a, moderate protein calorie malnutrition, hyperkalemia. HO smoking, afib, hyperlipidemia
Tdap and Varicella vaccines administered in left upper am on 7/8/15. Parent noticed redness and itchiness to LUA same day. The next day, 7/9/15, the area looked more red and was more painful. Also became hot to touch, unable to sleep on left side due to pain. Patient followed up in the office 7/10/15 and diagnosed with cellulitis-noted to have a 2inch diameter warm, erythematous area with tenderness to touch, firm, indurated, no fluctuance. Central area of swelling, paleness.  Bactrim was prescribed for patient.
Late on evening of 4/19/19 developed swelling of L arm. Markedly worse on 4/20/19 with itching and erythema continued spreading down upper arm through 4/22/19 when seen in the office. No fevers (Tmax 100F). Left upper eyelid swelling only on 4/20/19, then resolved.
Patient's written statement "Severe allergic reaction to CoVID 19 shot 25 minutes after injection"
pt states she has had arm pain for years, it comes and goes, she does not associate with getting pain directly after vaccine, however she does not know what caused it so thinks maybe it was this shingles vaccine or either of her pfizer vaccines from 2021, however, the pain started before the shingles vaccine and she doesnt know when it started, she says she saw doctor who told her no tests could help and didnt think it was a big deal, i advised she see a doctor again, reporting just to be on safe side, she was not sure which arm she got any of the shots in