chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 87-year-old patient who received SHINGRIX. The patient's past medical history included leukemia. Concomitant products included IMBRUVICA. On 21st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 23rd March 2018, the patient experienced bloodshot eye. On 27th March 2018, the patient experienced injection site erythema and erythromacular rash. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the bloodshot eye was not recovered/not resolved and the outcome of the injection site erythema was unchanged and the outcome of the erythromacular rash was unknown. The reporter considered the pain in arm, bloodshot eye, injection site erythema and erythromacular rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received her first SHINGRIX injection at pharmacy. On day 2, 2 days after receiving SHINGRIX, the patient experienced left eye bloodshot and was unresolved at time of report. On day 6, 6 days after receiving SHINGRIX, the patient experienced the arm soreness returned with some red spots around the injection site and about 2 to 3 in total size of the arm area.
Late afternoon on 10-8-09, left arm with pain at injection site.  Very painful at night while in bed.  Pain improves at times with position change at time no improvement with position change.  Saw physician on 10-19-09 due to on going pain to L Deltoid.
p/vax pt exp chickenpox w/a rash & mult lesions around the neck, chest & head area;the lesions count was less than 50;
62-year-old male with history of hypertension presented to the hospital with chest pain.  Chest pain centrally located, pressure-like sensation radiating to the left upper extremity and left side of the jaw.  Associated with sweating.  He had difficulty breathing when he had the chest pain.  Patient was nauseous. NSTEMI. Cardiac Catheterization performed.
(L) arm - erythema possible side effect from DTAP/Polio combined.
I had severe soreness at injection sites and was weak and in bed for 48 hours after receiving the vaccines I felt muscular aches and pains and a headache as well.
Metallic taste in mouth approximately 2 minutes after injection. Itching in the inner ear approximately 3 minutes after injection. Rash / hives / small bumps in the back of throat after about 5 minutes. Itching in inner ear dissipated after about 4 minutes. Metallic taste disappeared after about 30 minutes, but has come back intermittently over the next 24 hours. Rash / hives / small bumps in the back of the throat dissipated after about an hour, took 25 mg of Benadryl. No changes in breathing. Minor elevation and heart rate.
Left arm tingling a small amount after 5 minutes but not bad...  pain the next day at injection site. Pain has continued every day. and still aches 3 weeks after shot
Internal brain bleeding; Bad headaaches; A spontaneous report was received from a consumer concerning a 74-year-old, elderly female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad headaches/headache and internal brain bleeding/cerebral haemorrhage.  The patient's medical history was not provided. Past medication included unspecified blood thinner. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On 18 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, after second dose of vaccine, the patient bad headaches due to which patient had an MRI (magnetic resonance imaging) which showed internal brain bleeding. The event led to hospitalization. She had been in and out of the hospital two more times before since getting a shot. No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, bad headaches and internal brain bleeding was not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
diarrhea; Tired; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 78-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9809), via an unspecified route of administration on 25Feb2021 in left arm as 1st dose, single for COVID-19 immunization. Medical history included allergic to soy and dairy products, allergic to naproxen, diabetes, high blood pressure, supplementation therapy. Patient previously took and statins and developed joint pain. Concomitant medications included metformin 500mg 2 tablets in the morning and 1 tablet at night for diabetes, lisinopril 20mg twice a day by mouth for high blood pressure, vitamin d3 at 50mcg once a day by mouth as supplementation therapy. It was reported that metformin, ER > She said that she thinks she is over medicated. No further details provided. Vitamin D3, extra strength. stated that they put white writing on a white label. 31Jan2022, Lot 20123519, natures way. Patient was calling about the Covid-19 vaccine. She said that she had a reaction she believes. She said that she had the shot between 10-1030 today (25Feb2021) and left the facility and was home by about 1130 and all of a sudden she had a overwhelming diarrhea attack with no warning or anything. She did not eat anything to cause it. She said that she is afraid to take the next shot. She said that she had allergies to Statins and Naproxen and they make her throw up. Patient clarified that Statins gave her joint pain, but she does not remember what the drug names are. There was another drug that she got muscle cramps and joint pain, but she was unable to provide that information. She can not take Zetia and had a reaction. She said that she always throws up from pain killers. Patient had no NDC, lot, or expiration date for any of the above mentioned medications. It was samples that the doctors gave her. She said that some of them made her joints locked up and the others caused muscles cramps. No further details provided. She said that she was tired and did not sleep last night. Patient said that she shrunk. Patient said that it was just one episode of diarrhea at this time. She said that she was also very tired. She was tired for about a hour and it went away,. She is still a little tired, not the overwhelming tiredness she had earlier. She said that she was doing a puzzle and could not even focus on it. She had to lay her head down on the table to rest. She said that there was a little bit of pain when they stuck the needle in her arm, but no pain since. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Pt reported onset of back pain on 21 April 21. Patient went to ER on 22 April 21. Currently remains hospitalized.
Patient is a 68 y.o. female patient of, DO with history of chronic respiratory failure with hypoxia, anemia, cardiomegaly, duodenal ulcer, convulsions, hypothyroidism, muscle wasting, protein malnutrition presented to Hospital with cough, fatigue, and altered mental status.   Acute on Chronic Hypoxic and Hypercapnic Respiratory Failure Community acquired pneumonia COVID-19 Cough, fatigue, and altered mental status on presentation Requiring 6L O2 on admission, now weaned to 2 L(baseline 2-3L) Initial VBG with pCO2 elevate CT with mild right and trace left posterior lower lobe lung consolidation reflecting atelectasis or pneumonitis Similar presentation about 2 months ago Treat suspected PNA; completed steroids Lactic acid normal Urine antigens negative Tested positive for COVID 1/6. End iso 1/16.  MRSA screen negative. Vanco discontinued 1/07.  Augmentin at discharge.    Acute metabolic encephalopathy Uncertain etiology, possible related to PNA vs decreased respiratory drive with hypercapnia Some mild improvement with treatment in the ED Somnolent on exam VBG: pH 7.40, PCO2 66, HCO3 40.3, consistent with respiratory acidosis with metabolic compensation UDS negative, ammonia normal, other labs grossly normal Continue treatment of pneumonia as above Mental status improving and at baseline   Chronic congestive heart failure Cardiomegaly Echo 10/27 with LVEF 65%,  LV with grade 1 diastolic dysfunction BNP elevated but CXR clear.  Does not appear fluid overloaded on exam Continue home lasix and metoprolol  Holding K supplementation given initial  hyperkalemia TTE LVEF normal   Hyperkalemia - Resolved K 5.8 in the ED Treated in the ER, resolved   Duodenal Ulcer Gastritis Continue home PPI   Convulsions Continue Depakote
erythema, itching & swelling @ site of inj;DPH given per MD order;med was effective;
Client reports a reaction to the paper tape as early as 4/26/03, which began to blister.  She has been more gentle when removing the tape and not placed it on the same location repeatedly.  On 4/30/03 she had onset of headache about bedtime and rates the pain at "5-6" on a scale of 1-10, "low grade temp and fatigue".  She took Lorcet 10, 2 po and went to bed.  Upon waking 5/01/03 she had headache "10+", stayed home from work, experienced fatigue and states she felt worse than she has ever felt before.  Looking back she believes she should have called 911.  She took Lorcet 10, 2 po and Ambien. For 5/02/03 she rates her headach @ "4" daily through 5/05/03.  Today her headache is at "5" and began having lymphadenopathy to Left axillary region 5/02 - 5/05 and then bilaterally thru today 5/06.  Her paper tape reaction is "almost completely healed".  She saw the facilities medical director on 5/02/03 for skin assessment and c/o headache.  She told the doctor about AE encephalitis and he was not concerned with this case.  She was seen by ER on 5/05/03 and he also reportedly was not concerned with that as an adverse effect of vaccination as reported by this client. Today 5/06/03 she states that she has had "pustules, papules, 'zits'" on her breasts and back that she relates to stress.  She states they do not look like her arm.  Dr.  assessed these as well on 5/05/03. Client has no history of headaches and continues to experience pain but  is back at work. It is reported that she is one to never miss work.
Right after my injection, my arm became sore, but then by 6 hrs, I could not use my arm due to extreme pain.  Spouse had to dress me.  Then I was able to start using my arm by day three.  My arm is still having pain and I have limited use of it and it's 4/30/21
Child received DTAP on 9/14/2009 - two days later @ 12 noon grandmo noticed weakness in all 4 limbs continuing x 5 days. - Occurring 2-3x/day. When crawling arms gave out and she hit floor. When walking leg gave out (either leg) causing how to fall to floor. Also had fever being controlled with TYLENOL lasting 24 hrs highest 100 - with TYLENOL.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 11:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Diflurcan, reaction(s): "known allergies: Diflurcan", notes: known allergies: Diflurcan; Ultram, reaction(s): "known allergies: Ultram", notes: known allergies: Ultram. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Negative; (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had received Paxlovid for covid 19 treatment from 18Jan2023 to 23Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Provider and Mom were both notified of Men B being given inadvertently. Patient had no side effects or reactions at time of call. Mom was informed to let us know if anything appears.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with one dose of PNEUMOVAX23 (lot #: M032635 with expiration date: 05-MAY-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine had been improperly stored at temperature greater than 32°F but less than 36 °F for 12 hours without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported.  Additional information has been requested.
It's like a pain in my right side bellow my shoulder, and that radiated towards my arm all the way to my hand. It makes my pain feel numb and it hurts. Right under my underarm by the breast it hurts. It feels sore. It started on the right side and it went to the left side. I'm still experiencing the pain. When I went to the 26th I went to an emergency room with no hospital, the doctor prescribed me a medicine called Cyclobenzaprine 10mg one tablet by mouth 3x daily. I already finished this one, and they also prescribed me Prednisone 50mgs tablet, one table by mouth every day. I also finished this one; it was only for 5 days for this one. As of the 11th of November, I visited my doctor; they gave me an X-ray and prescribed me with acetaminophen COD#3 tablet, take 2 tablets every 6 hours by oral route, Methylprednisolone- one 4mg dose Dosepk take 6 tablets and decrease by one tablet for each day for a total for 4 days.
pt recv vax 27AUG94 & the following day pt devel mild sx of fever & lethargy;these sx progressed to severe abd cramps, vomiting, dehydration & a productive cough for which pt was hosp (date unk);
The morning after the vaccine, I woke up and my eyelids were severely red and almost looked like I had blood clots in my eyelids. The redness is slowly going away but hasn't completely gone away yet. My symptoms are very similar to transient eyelid edema which was seen in 46 other patients after receiving the Pfizer Covid-19 vaccine.
Child had prevnar with increasing erythema, edema over 24 hours. 4 cm induration.
Red lesion around injection site, hardness, warm to the touch and itchy. Started taking Benadryl 2/9 and it?s not as red but still very itchy around the injection site, even to my underarm and backside of my arm.
Parent noted the morning after immunization that the child had swelling growth on right thigh at vaccine injection site. This grew over the subsequent three days. Went to ER. Treated for cellulitis. Seen in PCP office five days after vaccination with signs that looked consistent with injection site reaction.
Shingles vaccine is also commonly known to cause it (GBS); This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient got GBS(Guillain barre syndrome) each time and the shingles vaccine was commonly known to cause it. Additional supportive information: According to narrative verbatim the causality was conservatively captured as possible. This case had been linked with US2023AMR017295 by same reporter for different patient Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR017295:Same reporter
Information has been received from a nurse concerning an unspecified patient. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On an unknown date an improperly stored dose of VARIVAX (lot # M005974, expired date 02-FEB-2018) (dose and frequency were unknown) was subcutaneously administered to the unspecified patient. The VARIVAX was exposed to -14 C for a time frame of 1 hour and 0.3 C for a time frame of 12 hours. Data logger was involved. Additional information has been requested.
Information was received from a pharmacist concerning two patients of unknown age. On an unknown date the patients were vaccinated with ZOSTAVAX. It was reported that the patients felt "so tired" after receiving the ZOSTAVAX. No further information was provided. Additional information has been requested.
103.4 fever, severe body aches, headache,chills, muscle pain, extreme fatigue and tiredness, nausea, diarrhea, feeling unwell, muscle weakness, arm pain with swelling and itching and now possible shortness of breath
Patient was seen date:  3/8/2021 Subjective is a 66 y.o. female who was seen at Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience lightheadedness.  She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, rapid progression of symptoms and respiratory distress. Past Medical History: Diagnosis  Date: Depression, Dysplasia of cervix, GERD (gastroesophageal reflux disease), Headache, Incontinence of urine, Insomnia, Interstitial cystitis, Rash. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, vomiting, abdominal pain, dizziness, and headaches; lightheaded: Previous Reactions: none. Objective Vitals: 03/08/21 1101 - 03/08/21 1106 BP: 130/66 - 135/63 BP Location: Left arm Patient Position: Sitting Pulse: 56  64 SpO2: 96% Physical Exam; Constitutional:  General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT:  Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Pt with slight hyperventilation when arrived to the bay. Pt asked to take off mask and take deep breaths in/out. Reports great improvement in symptoms. Mask placed back on. Eupneic breathing noted on discharge. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal.  Behavior: Behavior normal. Thought Content: Thought content normal.  Judgment: Judgment normal. Assessment/Plan Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). Anxiety Pt monitored in the bay for approx 15 minutes.  Pt improved with treatment as described in physical exam and with water.  Pt denies issues with dizziness/lightheadedness in standing up from wheelchair here in the bay.  She feels well and is ready to go home. Husband with her. Pt accompanied out by pharmacist. Electronically Signed 3/8/2021 11:10 AM.
This spontaneous report was received from a pharmacist via poison and drug center refers to a 63 year old female patient. The patient's medical history includes being fairly healthy. The patient's concomitant medication include "not a large drug profile". On 09-NOV-2017, the patient was vaccinated with expired ZOSTAVAX (strength, dose and frequency were not reported) lot # M032141 with expiry date 02-OCT-2017 for vaccine against herpes zoster. The outcome of expired product administered was unknown.
EMPLOYEE GIVEN HEP B VACCINE 07/11/2019. EMPLOYEE CALLED CENTER SPOKE WITH MEDICAL SPECIALIST AND STATED THAT AT 7:45AM THAT HE WAS HAVING STOMACH CRAMPS, AND COLD SWEATS. INFORMED MEDICAL SPECIALIST HE VOMITED ONE TIME. EMPLOYEE DENIES ANY OTHER SYMPTOMS. INFORMED IF SYMPTOMS WORSED TO SEEK MEDICICAL ATTENTION. AND TO INFORM CENTER OF ANY CHANGES. EMPLOYEE VERBAILIZED UNDERSTANDING. DENIES ANY QUESTIONS AT THIS TIME. 071219
Severe Covid.  Fever, muscle aches, cough, sneezing, headaches.
GIVEN THE JANSSEN VACCINE. EUA. THE PATIENT STARTED DEVELOPING A RASH IMMEDIATELY AFTER VACCINATION AND SHE STARTED TO FEEL ITCHY.  SHE WAS GIVE 25MG OF BENADRYL ORALLY AND WATCHED FOR 30 MINUTES.
Pt exp baseball size erythematous area below inject site on day 1, dark inner circle of area day 2 in morning rash on cheeks & chin erythematous swelling evening on day 2, taken to ER seen by MD;
Pt states his arm became red and warm within 90 minutes of receiving the injection. Pt was told to come back here (ED) if the redness and swelling crossed the line the Dr. made. Skin rash and pruritus.
02/22/203, I felt generally poor, headache, fever and cough. I tested on 02/22/2022 with aCOVID-19 Home Test and the results were positive. The evening of the 02/22/2023, I went to an urgent care. They did an EKG, chest x-ray, and they prescribed a cough medicine, and I chose not to take the Paxlovid after I heard the pros and cons of taking it. After I started feeling better, I had a couple of days of diarrhea.
Patient experiencing hives and rash on center of chest and face (cheek bone area) patient denies any difficulty breathing