chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This Nurse reported similar events for 2 patients. This is 1st of two reports. An elderly patient (over 65) of an unspecified ethnicity and gender received PREVNAR 13 lot M35761 Exp date May2017, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced a large circular swelling hot to the touch several days after injection on an unspecified date with outcome of unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
SICK TWICE; 102 FEVER; This spontaneous report received from a consumer concerned a 40 year old male. 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: Unknown) dose was not reported, administered on 15-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-OCT-2021, the patient experienced 102 fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On an unspecified date, the patient experienced sick twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick twice and 102 fever was not reported. This report was non-serious.
I received my flu vaccination in my left arm on 11/13/2018 as a requirement for work.   I did not feel the injection, but I began to feel increased pain before I left the exam room.  Soon after the injection I felt pain in my upper arm and tingling going down my arm into my hand.  Over the next hours and days the pain in my arm increased and tingling increased down to my 4th and 5th fingers. Arm movement, especially above my head and lifting,  became very painful. My arm and grip felt weak.  At the time of injury, Dr. recommended I start taking NSAIDS. However, I was already taking due to my Ankylosing Spondylitis. So I continued. I started physical therapy 1/2019.  I had worsening symptoms after 9 PT sessions and was referred to a sports med MD, in March 2019, Pain at 8/10. Tingling to 4th and finger continued, but was not as severe. Started Medrol Dose pack. Numbness/tingling improved steadily after  steroids lessening up my arm. Pain in upper shoulder continued.  3 PT sessions starting on 5/8/19 with dry needling.  Some improvement following. Pain at 2/10. Continued home exercise program. Pain was consistent at 2/10 and increased to 4-8/10. Steroid injections x 1/2020, 5/2020. Started PT6/2020 with iontophoresis. Had good results. Pain at 2/10 following Pt. Continued on home exercise program.   10/7/2020 aggressive shoulder exam followed increased pain (6-7/10 at times). Shoulder steroid injection 11/6/2020.  NSAIDS- Meloxicam 15mg daily PT- 9 sessions home exercises 12/27/18-2/27/19 Medrol Dose pack-3/15/19 PT-3 sessions(dry needling)  5/8/19-6/3/19 home exercise program Steroid injection left shoulder 1/28/20, 5/25/20 PT-5 sessions (iontophoresis)  6/10/20-7/14/20 continued home exercise program Steroid injection 11/6/20
5 days later patient comes in the pharmacy present with swallow arm and redness at the site that vaccine was given. Patient also stated she was feeling tired/weakness on the 2nd day. Treatment to take pain reliever and if the doesn't get better to contact your Dr. or hospital.
Felt very tired.  Had lots of redness around vaccinated area.  3 inches in diameter.  Developed a fever of 102 for 1 day/night.
One day prior to my second Covid shot I started feeling very off. I had major vertigo. I went to urgent care the morning or 8/31/21, the day I was to get my second shot, and was told I did have a double ear infection. I was given an antibiotic and was told I still could receive my second shot. I now an 5 weeks and 2 days from the start of the vertigo with no relief.  I found that this could be a side effect of the Covid shot.
My back started hurting early evening and continued to worsen.  Was very uncomfortable in my bed.  Awoke Saturday morning and my back was VERY uncomfortable.  As the day progresses, so did a temperature, 101.3, nausea came and went and just totally exhausted.  Took some anti-inflammatory medicine prior to bed and slept on and off.  Woke around 4am, Sunday, June 27, and now was feeling alright.  Temperature and back back were gone.    Injection site is red swollen hard and feverish even now?8:20pm, 6/27/2021
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown.            No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-373311 (Patient Link).
More than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Patient reports facial redness, and facial welts with burning sensation. Denied facial edema or respiratory distress.
Patient was in the waiting area for about 10 minutes then turned pale and passed out. They fell out of the chair they were in and hit their head on the floor. They regained consciousness within about 10 seconds. EMT was called and responded to help treat and advise the patient on the next steps.
Sterile abscess formed in right leg at injection site. Mother reports lump formed right after injection and is coming in today, one week later, to have the lump looked at.
Stated the buildup of inflammation of not taking the Celebrex made her very sick, nausea, headache.; very sick; nausea; headache; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took CELEBREX. It was reported that the patient took Celebrex and was advised to abstain from taking that for 72 hours before, the day of and 72 hours after receiving 1st Pfizer vaccine. She stated the buildup of inflammation of not taking the Celebrex made her very sick, nausea, headache. She would receive the 2nd shot on 19Apr2021. Events outcome was unknown.  Information on the lot/batch number has been requested.
Information has been received from a licensed visiting nurse concerning a 11 week old male with no medical history or allergies who was vaccinated with a 2 ml oral first, second and third dose of Rotateq on 24-OCT-2007, 07-NOV-2006 and 09-JAN-2007. There was no concomitant medications. There was no problems reported with administration. Unspecified medical attention was sought. No laboratory test were performed. There was no product quality complaint involved. Additional information is not expected.
This spontaneous prospective pregnancy report was received from a healthcare worker concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 09-DEC-2015, the patient as vaccinated with VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On 29-DEC-2015, the patient became pregnant; the reporter stated that it was the patient's conception day. The date of last menstrual period and the estimated delivery date were not known. The pregnancy outcome was pending. No adverse symptoms were reported. Additional information has been requested.
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. In August 2015, the patients were vaccinated with PEDVAXHIB (lot # K019701, expiration date 17-JUL-2017). It was reported that the vaccine administered underwent an temperature excursion which occurred on 15-AUG-2015. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Client's Mom called in to health department to report fever of 102 and sore right arm. Mom denies any swelling or erythema. Mom describes child as having general malaise as well.
Fever to 101F, which resolved with acetaminophen 625mg PO and did not recur. Flare of existing hidradenitis lesion in left armpit, resulting in 24 hours of pain and drainage. Within 24 hours returned to baseline condition.
fever; cough; This is a spontaneous report from a contactable consumer. A 73-year-old male consumer (Patient) received second dose BNT162B2 (Solution for injection, lot number: EL3246) via an unspecified route of administration in Arm Left on 03Feb2021 at single dose for Coronavirus Vaccination. The patient medical history was not reported. Patient had historical vaccine at 73-year-old BNT162B2 on 13Jan2021 for Coronavirus Vaccination and had just fatigued the rest of the day and heart palpitations (Admission to hospital due to the event was No, Any treatment Received was No, Still Experiencing was Fine now) and heart palpitations stated as he woke up early 14Jan2021 with some minor heart palpitations/they got more frequent and lasted longer (had one every hour and half and they lasted 20 to 30 minutes). Concomitant medication included dexlansoprazole (DEXILANT) on 2016 and enalapril maleate (ENALAPRIL MALEATE) on 2004 and both were ongoing. He had his 2nd vaccination 03Feb2021. He woke up 04Feb2021 with a 101 fever. He also had a cough. By the end of the day fever was down to 99.5. When he woke up 05Feb2021 his fever was gone. Outcome of event fever was recovered on 05Feb2021, while with other event was unknown.
pt vax in 1995 & in 1996 pt exp mild atypical chickenpox
No further adverse event (AE) was reported.; a dose of PROQUAD that experience temperature excursion was administered to 1 patient; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not provided.    On 17-MAR-2022, the patient was vaccinated with the first dose of an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) administered as prophylaxis (lot number U029320 was verified to be a valid lot number, expiration date: 19-MAR-2023; therapy type rHA (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) (product storage error). No further adverse event (AE) was reported.
This child had redness, warmth, size 5 x 5 cm at the left deltoid area. Non tender, no fever. Over the counter Benadryl, topical Cortisone cream.
49 days after the single injection of the Covid Johnson & Johnson vaccine I was diagnosed with Shingles even though I had been vaccinated with the Shingles vaccine in October and December in 2019
On about 1/20/2021, I began to get diarrhea. I thought that maybe it was a sign of impending flu. The diarrhea became more frequent and more explosive as time progressed, however. I thought that maybe it was a sign I was getting older, since so many of my friends have various GI issues themselves. The problem continued for the next several months, however. I then went to get a physical from my PCP, Doctor on 9/7/2021. During the checkup, I mentioned my diarrhea to him, and he told me there was a remote possibility that the COVID-19 vaccine had triggered an autoimmune response if I was a carrier of the gene for celiac disease. Doctor then ran a Tissue Transglutaminase IgA Test, and I was then diagnosed with celiac disease. Doctor also ordered a colonoscopy for me on 11/11/2021 at Gastroenterology. When I went there, though Doctor.  was unable to do the colonoscopy, as there was a polyp that was large, flat, and in a "tricky" part of the colon. Doctor then referred me for a colonoscopy at Hospital, as he felt they had better equipment that would enable them to access the polyp. Unfortunately, though, I have not been able to get the colonoscopy, as Hospital has stopped all non-emergency procedures on account of staffing issues caused by the COVID-19 pandemic. I am reporting this, because I feel that my case of celiac disease would possibly be of interest to the CDC, since it was possibly triggered by the vaccine. If you call Doctor he would definitely confirm my report.
Pfizer vaccine was administered outside of our facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------- I95.9 HYPOTENSION 7/12/2021 ADULT DERMATOMYOSITIS W MYOPATHY J96.00 ACUTE RESPIRATORY FAILURE 7/12/2021 ADULT DERMATOMYOSITIS W MYOPATHY I95.9 HYPOTENSION 7/12/2021 RECTAL BLEEDING J96.00 ACUTE RESPIRATORY FAILURE 7/12/2021 RECTAL BLEEDING
extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 90-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the right arm on 04Mar2021 at 13:30 (at the age of 90-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma. Concomitant medications included timolol maleate, dorzolamide hydrochloride (COSOPT), tafluprost (ZIOPTAN), losartan (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), simvastatin (ZOCOR) and vitamin d (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810), via an unspecified route of administration in the right arm on 11Feb2021 at 02:30 (at the age of 90-years old) as a single dose for COVID-19 immunisation and betahistine mesilate (DARVON) and indometacin (INDOCIN) on an unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 06Mar2021, the patient experienced extreme fatigue since the second dose. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of extreme fatigue was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Onset 8/28/11 with fever near 102 degrees, difficulty breathing, wheezing, dizziness, pounding HA. Feels like arms going to sleep. Pt saw Dr (chiropractor) on 8-29-11 & told pt from Hep A/B #1.
6SEP 1PM inject-sore leg; 4PM APAP given; 130AM temp AX >106; Taken to ER given PO APAP; vomited x 2; Blood test done-non-bacterial infect; concluded Pertussis induced fever;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 10Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 68 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: other medical history : Diabetes; "Hypertension" (unspecified if ongoing), notes: other medical history : Hypertension. Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid for COVID 19 Treatment was received from 30Aug2022 to 03Sep2022.No known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Vaccination failure and Covid-19 cannot be excluded for the suspect drug. The case will be reassessed once new information is available.
London has had an acute onset of stuttering.  He was seen for a 3 year old screening in October in which his articutlation was tested and he had no problems with stuttering and passed articulation tests for all sounds but 3.
Patient said that she had diarrhea for 1 day after. Then a few days after the shot she developed a rash on the left side of her face, under her chin, and on her fingers.
A non-serious spontaneous report of a nurse inadvertently gave expired FLUMIST was received from a health professional concerning a 48-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. On 01-Dec-2011, the patient received expired product. 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.
Shingles outbreak over left upper abdomen wrapping around to left mid back. Symptoms began with tingling sensation in area on 9/26 followed by development of rash. Treated with 7 day course of Valtrex 1000mg TID.  Rash and symptoms (tingling/burning) unresolved as of 10/18.
Approx 4-6 hrs p/inject, c/o sore arm, achy feeling all over, bronchial irritation; Has hx of asthma; No rash, stridor, swelling; No hx egg intolerance; c/o tingling & numbness of fingers servere h/a next day admitted to hosp;
Information has been received from a company representative concerning a 6 year old male who in 2005 was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). Then, the patient contracted chicken pox on an unspecified date in the last four weeks. The patient sought medical attention via visited to urgent care clinic. No further information is available.
Initially pain in mid back, they thought he had a muscle strain, urgent care gave him a shot of some kind, then went to the ER a day or two later on 9/4 because of the same back pain but it was much worse. His d/c summ says there was chest pain, which he did have but went  away. When I saw him 9/8/17, he reported the pain as everywhere, upper and lower back, hips and legs. Stated he has noted that he can't close his eyes all the way to sleep for 3 days. He can't swallow, food keeps coming back up. Drank water with a straw only and small amounts. Hadn't eaten in 6d, but in the last day sister had made him have 1/2 bowl of soup and some Gatorade. Not urinating much as a result. He was reporting numbness in his fingertips and feet for 3 days. L eye has abnormal vision for 3 days. Things are "moving around", poss blurry.  He is deaf and the interpreter had a tough time understanding his meaning. He has had issues with dysphagia and had a 30lb weight loss over several months. He was sent to the ER again and admitted. Found to have pneumonia, suspected aspiration. Found to have GBS.
Within 24 hrs patient developed non productive cough, over 5 days had increased shortness of breath, stridor.  CT of neck demonstrated soft tissue swelling around false vocal cords.  Patient had a bronchoscopy which showed edema and erythema.  Patients developed further respiratory distress and underwent intubation. 12/19/08-records received-for DOS 6/26-7/11/07-DC DX: 1. Stridor secondary to upper airway edema and laryngospasm. 2. Diffuse endobroncial and pulmonary parenchymal inflammatory process. 3. Both of the above are felt to be due to adverse immunologic reaction to recent typhoid and anthrax vaccinations received through the military. Oral thrush secondary to steroid and antibiotic therapy. Generalized rash felt most likely to be steroid induced acneform process versus part of the immunologic reaction to vaccines. Acute respiratory failure requiring prolonged mechanical ventilation due to #1, #2 and #3. Staph aureus bronchitis felt to be a secondary infection clinically resolved at time of discharge. Presented with C/O laryngospasms/laryngoedema.
The day of the vaccine I had a dead arm. Fever and shivers. Headache followed second and third day along with heart palpitations after coughing in the shower, I went really lightheaded, emotional and my heart was pounding heavily
Headache, SkinRash, Rash, NauseaVomiting, HIVES, CHILLS. Narrative:  Allergic to Sulfa- break out in hives. Pt. went to primary doctor jan, 14. Pt. was given steroid cream for the hives, oral steroid 7 day treatment, Benadryl prn for itching. Day 6: Still currently experiencing hives and itching
So severe sinus congestion started on 2/6/2021 and on 2/7/2021 woke up with continued with congestion and body aches and flu like symptoms. Quite uncomfortable, then at about 5:00PM I started taking Tylenol. Mainly just body aches, no fever, some chills. I felt better after about 24 hours. I think I contacted my DR or something but I do not remember it was so long ago. I think I just went to my DR at the urgent care just to make sure everything was okay, he is very close to my house.
My son immediately lost the ability to speak coherently, and became very agitated. He remained this way for months and it took about a year for his language to return to where it had been.
Information has been received from a certified medical assistant concerning an 85 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 645852/0685N). The reported indicated that a nurse went to vaccinated the patient and some of the vaccine leaked out of the syringe and it smelled like glue. Therefore, they tested pneumococcal 23v polysaccharide vaccine from another lot (647660/0945N) on a gauze pad and it smelled like glue too. The reporter noted that the patient experienced a three inch lump on her arm that was tender. Unspecified medical attention was sought. A product quality complaint was not involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.