chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report 2002019889-1 describes bilateral orchitis and spididymitis in a 40-year-old male who received Lyme disease vaccine recombinant OsPA (Lymerix). The pt had no known drug allergies and received no concomitant medications. His medical history included sialoadenitis in 1996. On 06/18/2001 the pt received his 1st injection of Lymerix, without adverse event. On 07/17/2001, the pt received his 2nd of Lymerix. At 18:00 on 07/18/2001, approximately 24 hours post-immunization, he began to experience chills, aches, and fatigue. The aches included sore throat, achy ribs with radiatin down his back and painful inspiration, pressure in his face and head, pressure behind the eyes, headache, abdominal pain on the right side, and right low back pain. All aches reportedly subsided with rest. On 07/25/2001, ten days post-immunization, he developed fever of 99.9 degrees F., myalgia and severe pain and swelling of the right testicle. On 07/26/2001 he was seen by his physician. A diagnosis of right epididymitis was made and the pt was sent to the ER, where an ultrasound of the testicles showed right-sided epididymitis and small right hydrocele. The pt was prescribed a 10-day course of ciprofloxacin hydrochloride (Cipro) 500 mg and acetaminophen with codeine (Tylenol with Codeine). The fever, myalgia and right testicular pain and swelling resolved by 08/04/2001. On 08/04/2001, the pt developed severe pain and swelling of the left testicle. On 08/06/2001, the pt was seen by his physician. A diagnosis of bilateral orchitis and epididymitis was made. The pt was treated with doxycycline and ibuprofen. On 08/14/2001, the pt was seen by the physician. The bilateral orchitis and epididymitis had resolved. The most recent info was received on 11/05/2001. The physician considered the bilateral orchitis and epididymitis to be severe in intensity, disabling/incapacitating, and relating to Lymerix administration. As a result of this info, the report has been reclassified as serious, unexpected.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/08/21 pfizer,Lot#EL3248 2nd dose: 01/29/21Pfizer,Lot# EN5318 Diagnosed covid positive:07/27/21 Symptom onset:07/21/21 Exposure: Home Symptoms:Diarrhea, stuffy nose, fatigue
Symptoms- Bumps on back, chest and behind ears. TX with Zovirax 1 3/4 tsp QID x 5
I had lock jaw for 24 hours following my 1st dose in addition to fever, sore throat and headache, as well as tightening of the chest.
This is a spontaneous report from a contactable physician. A 74-year-old female patient received the PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 31Oct2017, the patient experienced raised and erythematous rash near the injection site, which was assessed as medically significant. The clinical outcome of the event, raised and erythematous rash near the injection site, was not recovered. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of vaccination site reaction cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Patient's Covid-19 vaccine dose #1 was Moderna. Patient inadvertently received the Pfizer COVID-19 vaccine for dose #2 in the series. No adverse reaction noted within the 30 minute post-vaccination observation period.
Soreness and swelling at the injection sight followed by a mild fever the evening of the vaccine. As early as the next day she began stimming: arm flapping, rocking, bouncing. She started refusing eye contact, ignored speech, and her babbling stopped. By her next well visit, our pediatrician raised concerns over missed milestones and recommended us to an in home therapeutic program to test for possible Autism Spectrum Disorder. Her sensory issues increased: mouthing, sensitive to many types of touch, sensitivity to noises. She suffers from chronic constipation. Her verbal ability is extremely diminished and primarily relys on "scripting" (memorization of movies/scripts) to express herself. Has OCD tendencies and food sensitivities. She obtained an educational diagnosis of ASD in July 2013, and an official medical diagnosis in 2015. She is expected to require assistance and therapeutic treatment for the duration of her life.
Positive for COVID-19/had a break through infection PCR; Positive for COVID-19/had a break through infection PCR; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from product quality group. The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Feb2021 14:15 (Lot number: EL3247) at the age of 37 years as dose 2, single and intramuscular, administered in arm left, administration date 28Jan2021 15:15 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Dec2021 15:00, outcome "recovering" and all described as "Positive for COVID-19/had a break through infection PCR". It was reported that Patient was infected due to 5 yo unvaccinated child testing positive after exposure at school- of note the first and second vaccines were given only days apart and that was too early according to EUA. Patient did not have covid prior to vaccination. Patient had no known allergies. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2021) negative, notes: Nasal Swab; (23Jun2021) negative, notes: Nasal Swab; (07Aug2021) negative, notes: Nasal Swab; (22Sep2021) negative, notes: Nasal Swab; (29Nov2021) negative, notes: Nasal Swab; (02Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Conclusion of previously completed investigation was reported as follows: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventa tive actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.
ARM SORENESS LASTING UPTO A WEEK AFTER THE SHOT, BOTH MUSCLE ACHES AND BODY FATIGUE  THAT HAVE CONTINUED AND WORSENED. LEFT ARM HURTS WHEN LIFTED EARLY DURING THE DAY. BRAIN FOGGINESS, SPORADIC BLURY VISION, NIGHT SWEATS AND OVERALL NOT FEELING WELL. COUGHING AND SHORTNESS OF BREATH, CONGESTION, POSTNASAL DRIP,  RHINORRHEA AND SORE THROAT.
The son now has myocarditis; This is a spontaneous report received from a contactable reporter(s) (Other HCP: Nurse) from medical information team. A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administration date 03Jun2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset Jan2022, outcome "unknown", described as "The son now has myocarditis".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and MYOCARDITIS cannot be completely excluded. 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.
Tender red and swollen left upper arm not just around injection site. Tender and swollen lymph nodes left axilla. Low grade fever of 100.4 with myalgias , arthralgias, fatigue , and headache . Took extra strength Tylenol to treat symptom of fever, Symptoms lasted three days.
Immediate severe pain in left arm, 'as though someone just broke it'; headache developed; 24 hours of joint and muscle pain; within weeks, sharp stabbing pain in the stomach that radiates throughout the upper abdomen and shoots toward the back and left shoulder; persistent upset 'sour' stomach that complicates her ability to eat.  Now, 2 months later she is losing hair and weight.  5/4/09 Received PCP medical records of 1/5/08-4/30/2009 including GI, Ortho & ENT consults. FINAL DX: acid reflux, inflammatory gastropathy, ulcerative tonsillitis, exercise intolerance, dyspnea Records reveal patient experienced usual state of health on 2/23/09 for HPV#1. RTC 4/29/09 w/c/o of injection site pain, HA & joint pain since 2/23/09.   Hx of persistent abdominal pain. GI referral 8/08.  Dx w/pneumonia 12/08.  RTC 1/09 w/exhaustion, sore throat, loose stool x 2 days.  Exam revealed 4+ red exudative throat w/bilateral node tenderness.  Strep & mono neg.  RTC 2/09 w/chest tightness & difficulty breathing x 2 yr.
I felt an immediate flush to my whole body and my throat started to tighten and swell.  But it stopped after about 1 minute.  I felt the same thing again after maybe 5 minutes and then about 45 minutes (on my way home).  Since then, I have been experiencing allergic reactions to many foods and medicines that I have eaten/taken for years.  I feel constant pressure/swelling on my throat and neck.   I was hoping it would calm down after a few days.  On monday April 12th I accidently consumed a few drops of milk, which normally would just cause stomach upset, but this set off another round of pressure in my throat.  I tried to rest and took some benadryl, but on Tuesday I went to the walk-in clinic.  They prescribed me some steroids (3 pills),  and gave me a steroid shot.  I have stopped taking the pills, as I seem to be reacting to something in them.  The reaction is the same, throat swelling, flushed feeling, red face.  This does not seem to be fading, as I had hoped.
Nerve pain; very ill; intense pain in their back, their hip and down their leg; rash on their chest and stomach, that did not last long, and was not itchy nor burning; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain), ILLNESS (very ill), PAIN (intense pain in their back, their hip and down their leg) and RASH (rash on their chest and stomach, that did not last long, and was not itchy nor burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-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 NEURALGIA (Nerve pain), ILLNESS (very ill), PAIN (intense pain in their back, their hip and down their leg) and RASH (rash on their chest and stomach, that did not last long, and was not itchy nor burning). At the time of the report, NEURALGIA (Nerve pain), ILLNESS (very ill), PAIN (intense pain in their back, their hip and down their leg) and RASH (rash on their chest and stomach, that did not last long, and was not itchy nor burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.
Mid sternal chest pain on 7/13/21 after the 2nd dose of COVID vaccine ( 7/9/21), symptom last for 1 hr, spontaneous resolved.  hx of shortness of breath  at night on 7/10, completely resolved the next morning.  headache and muscle aching after vaccination on 7/9/21, last for 3 days.  no palpitation.  he is seen in office on 7/13/21 due to hx of chest pain in the morning, no current chest pain/symptoms, normal CVS exam, normal EKG. Elevated troponin I/ESR/CRP and normal CBC Troponin I 1.92 ( 0.00-0.04) , ESR  20 ( <15), CRP 3.3 ( <0.9)  he again seen in ER the same day for abnormal troponin I results, recheck EKG normal., troponin down to 1.73 he was seen in pediatric cardiology clinic on 7/14/21, troponin 0.68, normal EKG and normal echocardiogram. his symptoms self resolves without medical intervention.
On January 12, 2022, I went for routine dental appointment for x-rays and cleaning and exam by the dentist. That appointment was over an hour long. Afterwards, a few days later, I saw what I thought was a cold sore on my lower lip. 3 days after that, I saw irritation coming through my nose that was growing in size and severity. I went to the doctor and was diagnosed with impetigo. Also a negative Covid test. I received some ointment and oral antibiotics. Mupirocin ointment 2%. The ointment helped, I don't think the antibiotic did. It did go away.
Very painful L shoulder immediately following flu vaccination. Pain shifts from shoulder to elbow area and radiates to lower arm. Pain is worse after strenuous movement. It has not subsided since the vaccine was injected. Especially painful when arm is lifted.
Pt recvd vax & exp sjogren synd Anti-Ro; sx included swelling of parotid gland & dry eyes; also exp swollen neck, swollen parotid glands, h/a & ataxia; dx sjoren synd anti-RO;
Patient was given a moderna booster while only 17 years of age, there have been no reported adverse events.
MMR immunization was ordered along with a Varicella immunization. However, a VARIVAX and a PROQUAD was given instead.
got Covid; got Covid; This is a spontaneous report from a non-contactable consumer (patient) received from a Pfizer sponsored program.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) at dose 1, single and dose 2, single (lot number, expiry date not reported); both via an unspecified route of administration, on an unspecified date, for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got both of his doses of the Covid vaccine and then experienced Covid, he also had some symptoms with Covid such as fever, coughing, little weak and lost the sense of smell on an unspecified date. The patient stated that he could still taste, and he never got short of breath. Therapeutic measures included Nyquil for a couple of weeks. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received shot at 2pm, at 5:30pm started getting large bumps and whelps. Went to ER at 7:30pm. Was given prednisone & BENADRYL, et continues prednisone.
Patient was given Pneumococcal on 10/24/13, by late day arm was very sore, could not sleep on that side. Site red, warm. By the next day was much better, day after that fine.
Patient received a booster dose of Pfizer COVID vaccine (lot #FE3590) on 10/13/21. Patient was admitted to the hospital on 10/22/21 with COVID infection (positive nasal swab for COVID-19 RNA on 10/22/21) . Patient had previously been vaccinated with two doses of Pfizer vaccine (on 3/15/21, lot #EN6204,  and 2/22/21,  lot #EL9265). At the time of this report, the patient remains admitted to the Progressive Care Unit, and is being treated for COVID infection.
Patient did have an allergy to pertussis at age 4 and had a "seizure" at that time. He did have a Tdap done in 2010 and had no reaction.
arm sore; numbness; red place on arm size 2 by 4; tenderness; injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red place on arm size 2 by 4), VACCINATION SITE PAIN (tenderness), VACCINATION SITE PRURITUS (injection site itching), PAIN IN EXTREMITY (arm sore) and INJECTION SITE HYPOAESTHESIA (numbness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Depression. Concomitant products included GABAPENTINE for Depression.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red place on arm size 2 by 4), VACCINATION SITE PAIN (tenderness) and VACCINATION SITE PRURITUS (injection site itching). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore) and INJECTION SITE HYPOAESTHESIA (numbness). At the time of the report, VACCINATION SITE ERYTHEMA (red place on arm size 2 by 4), VACCINATION SITE PAIN (tenderness), VACCINATION SITE PRURITUS (injection site itching), PAIN IN EXTREMITY (arm sore) and INJECTION SITE HYPOAESTHESIA (numbness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
Pt recvd DTP booster 230PM burning the noc parents noted generalized twitching, w/eye rolling lasting 1-2min; multifocal type of twitching; In AM also had episode of cyanosis of arms; legs w/no sz activity; t103;
Flumist - seasonal given and in 18 hours developed red macular rash cheeks/trunk and buttocks. No other symptoms.
Mother called 9/18/09 @ 1:46p to report symptoms of: sore throat, sneezing, cough, headache, fever, achy, no appetite. Mom states "He gets this every year.
Started on the morning of 6/25/2021. I received my second dose of Pfizer COVID vaccination after my menstrual period ended and this morning when I woke up, I noticed that there was blood on the toilet paper. There was no blood in the urine and throughout the day, there continues to be an increase in the amount of blood left on my pad and tissue paper. Haven't had issues with spotting in the past and this is a new occurrence. Also feel that my left posterior auricular lymph node is harder and more swollen and left sinus is more congested.
itching @ inj site;rash thighs;rash on chest, arms & legs;hives-severe on thighs;states applied hydrocortisone ointment;did not take anything by mouth;came to clinic-no hives or rash;
Patient received Pfizer as booster but completed Moderna series (Shot 1 and 2)
pt devel mild swelling/erythema distal to inj site 48hr p/inj;presented to MD ofc 17JUN96 w/improving edema & itching;tx w/DPH & cool compresses (inj was LUE 13JUN96);urticaria only involving LUE,  no SOB
Chills, fever (101.4), tiredness, nausea.  These lasted the course of the day and were no longer present the next day.
child recv vax 16JUN97 & 23JUL97 child grandma felt ill w/flu like sx;saw MD 24SEP97 hosp 26JUL97-ICU & thought to be GBS but dx as polio p/hosp x1mo;pt paralyzed from waist up traced vented still on ventilator-some rt sided movement
We were at lunch and just after sitting down I started to get an upset stomach, within minutes I started to feel light-headed and dizzy.  That lasted for maybe 2 or 3 minutes and then I passed out.  According to my 17yo son I was out for about 30 to 45 seconds.  Upon coming around I was having difficulty breathing, and continued to feel light-headed, weak, and overheated.  The difficulty breathing went away after about 10 minutes, the reset with a hour.  However a couple of hours later I developed rectal bleeding that lasted for about 24 hours.  Since then I have have muscle weakness, sore joints (major joints - knees, shoulders and minor - wrist and ankles), and major fatigue, which I have never had in the past.
Patient arrived to the local ER with complaints of blood pressure problems from the facility.  Patient was hypotensive and unresponsive.  Poor po intake at the facility and scheduled for a PEG tube placement on 4-18-23.
diarrhea; lip swelling; slight muscle twitching in the left leg; Caller reported bottom lip rash and puffiness.; Caller reported bottom lip rash and puffiness.; had a cramps in both legs and slight muscle twitch in the left leg; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included apple cider vinegar, calcium, iron. The patient previously took allegra (180 mg, Lot: 1145968, Expiration: Aug2014). The patient reported bottom lip rash and puffiness, had a cramps in both legs and slight muscle twitch in the left leg on 15May2021, diarrhoea, lip swelling, slight muscle twitching in the left leg on an unspecified date. Treatment received for events. Clinical information includes; Two days prior, 15May2021 the caller noticed her bottom lip was getting rashy and puffy.  The caller stated around the edges of lip has a little rash. Noticed calf cramps in both legs: Also, during the same time two days ago on 15May2021, the caller noticed calf cramps in both legs.  The caller thought that was maybe a lack of Magnesium and the caller took Magnesium and Calcium tablets. Had slight muscle twitching in the left leg: The caller had slight muscle twitching in the left leg. The caller reports this was a slight muscle twitch on and off, not all day, just a little twitch. Drank some really strong tea a while back during the first week of the month and had diarrhea, not sure if related to the first dose Pfizer Covid Vaccine: The caller drank some really strong tea a while back during the first week of the month and had diarrhea, not sure if related to the first dose Pfizer Covid Vaccine.  The caller stats the diarrhea only lasted for one day. The outcome of event had a cramps in both legs and slight muscle twitch in the left leg was recovered on 16May2021, slight muscle twitching in the left leg was not recovered, diarrhoea, lip swelling, bottom lip rash and puffiness was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Usual expected soreness at the injection site.  But, I woke up with extremely low blood pressure 86/47.  BP slowly recovered over 12 hours to 120/80.
Pt received his 1st Pfizer vaccine on 3/31/21 and presented to the emergency room with chest pain on 4/16/21 that was ongoing x 1 week. he also reported some shortness of breath. he reported a cold feeling on the side of his chest as well. he also was feeling his heart racing at times. he denied any recent illness, fever or chills or hx of covid 19 infection, he was evaluated and sent home to follow up with his primary care and cardiology if his chest pain returned. He then received his 2nd pfizer COVID-19 vaccine on 4/21/21 and called the hospital on 6/18/21 reporting that since the second vaccine he was experiencing a weird feeling of coldness to his ears, vertigo and dizziness and has suddenly developed a fixed, hard, kidney bean sized lymph node to the r side of his neck. he now has to have imaging and work up with possible biopsy of the lymph node. He reported he has not felt right since his vaccines were given .
Full body hives, raised welts x5 days. Benadryl given PO x3.