chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm tenderness; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL9262, Expiration Date: 31May2021) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: had breast cancer like 7 years ago. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm tenderness"; CHILLS (non-serious) with onset 2021, outcome "unknown". Additional information: She did not have any significant reaction to any of them regarding her Pfizer covid vaccines and states she had no reactions just some local arm tenderness and one time that she can't tell when it was she had some chills but no fever at night and thinks the tenderness of the arm she had that from all of the Pfizer Covid vaccines and the chills might be from the first dose but she cannot remember.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271774 Same reporter/patient, same drug/different dose, different AE (dose 1);
Diagnosed with POTS. INTERCRANIAL HYPERTENTION...ALLERGIC REACTIONS
VACCINE ARM SORE, TENDER AND SENSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced vaccine arm sore, tender and sensitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine arm sore, tender and sensitive. This report was non-serious.
There has been significant weakness in my left arm since the first COVID vaccine shot. It has progressively gotten worse over the course of the three shots (I received the two original shots and one booster). The left arm now really struggles to do exercises that I could do very easily before the vaccine.
They both had COVID after the 15th, after the first shot; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. This consumer (wife) reported similar events for herself and her husband. This is 2nd of 2 reports.   A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure measurement. Concomitant medications were not reported. The wife reported that on 25Jan2021, she and her husband both had COVID after the 15th, after the first shot. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 25Jan2021. She reported that they were done with quarantine that day, 03Feb2021. Therapeutic measure was taken as a result of the event that included Zepac. And then, her husband took an additional like a steroid. She did not know what he took. But they both took Zepac and their doctor prescribed Zepac, and then her husband took a steroid too. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111355 same reporter/product, events, different patients.
11/5/2021 04:00PM vaccination. About 2 weeks after vaccination, I started to experience heart palpitations. It got progressively worse, prompting my visit to the doctor. Increase dose of hypertension medications. He changed my medications to metoprolol-titrate. He scheduled me for an EKG later in 12/2021 (I do not have the date) and follow up visit with the doctor.; TBD. He has also ordered blood work.
No adverse effects; inadverdently administered expired dose of VARIVAX; This spontaneous report was received from a nurse prescriber referring to a 02-year-old patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 17-JUL-2019, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # N017396, expiry date: 07-JUN-2019) (anatomical location and route were not reported) for prophylaxis (expired product administered). Other suspect therapies included sterile diluent(MERCK STERILE DILUENT) (lot#R032351, expiry date: 02-JUN-2021). No adverse effects were reported (no adverse event). No PQC was involved.
Tres meses después de la última dosis inicio un cuadro con el siguiente diagnóstico presuntivo: Polineuropatía sensitivo motor leve.
Sore left eye after the 2nd dose; Both eyes are watery and tired that she can't keep them opened after the 2nd dose; Eyes are weird and not normal after the 2nd dose; Right ear from the outside tender and not painful after the 2nd dose; Sore arm after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after the 2nd dose), EYE PAIN (Sore left eye after the 2nd dose), LACRIMATION INCREASED (Both eyes are watery and tired that she can't keep them opened after the 2nd dose), OCULAR DISCOMFORT (Eyes are weird and not normal after the 2nd dose) and EAR DISCOMFORT (Right ear from the outside tender and not painful after the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 044B21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, VITAMINS NOS for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after the 2nd dose). On 03-Jun-2021, the patient experienced EYE PAIN (Sore left eye after the 2nd dose), LACRIMATION INCREASED (Both eyes are watery and tired that she can't keep them opened after the 2nd dose), OCULAR DISCOMFORT (Eyes are weird and not normal after the 2nd dose) and EAR DISCOMFORT (Right ear from the outside tender and not painful after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Jun-2021, EAR DISCOMFORT (Right ear from the outside tender and not painful after the 2nd dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm after the 2nd dose), EYE PAIN (Sore left eye after the 2nd dose), LACRIMATION INCREASED (Both eyes are watery and tired that she can't keep them opened after the 2nd dose) and OCULAR DISCOMFORT (Eyes are weird and not normal after the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took  hydration drinks as a treatment medications. Expiration dates for both doses are unknown.   This case was linked to MOD-2021-207611 (Patient Link).; 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.
Pain, stiffness and sometimes very restrictive movement in left rear neck area. Upper back and pain and some stiffness seems to have lessened.
Patient arrived on 1/3/2023 with his grandmother (legal guardian) and godfather to receive the pediatric Pfizer bivalent vaccine. Everything was managed correctly. Today, 1/9/2023, one of the pharmacy technicians realized that the "beyond use day" for pediatric vaccines was 12/26/2022, therefore they could not be used. Pharmacy manager, called the manufacturer Pfizer to obtain information on the stability of the vaccines in question and they asked her for information on the vaccines and temperatures, which she sent by email. We are waiting for responses from them via email in order to establish a protocol, if any.
Information has been received from a pharmacist referring to a 3 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2015 the patient was vaccinated with expired doses of MMR II HSA, lot # J006953, (dose and route were not reported). This dose of MMR II had an expiration date of 07-JUN-2015. No adverse events were reported. This is one of several cases from the same reporter. Additional information has been requested.
J18.9 - Pneumonia FATIGUE FEVER CHEST PAIN COUGH
12/26/22- Sudden onset PSBO, hospitalized three times with PSBO, then bowel resection 1/25/23. no blockage found.  Motility study confirms gastroparesis.   Currently idiopathic.  Unable to tolerate solid foods.  Trying to find treatment , tried raglan, currently n linzess.  Unintentional weight loss of 55 pounds from 12/27/22-4/19/23.  Have been unable to return work at my career as a pharmacist.
Patient received flu shot in left deltoid and immediately began to have pain at site. Swelling and redness started after 30 minutes of receiving flu shot. Patient was in pain all through the night. When patient came into office his left arm, shoulder, armpit was swollen, red and patient was in pain.
The afternoon after the H1N1 injection vaccine was given I had fever and body aches which improved a little 10/21 & 10/22, but then the fever came back on the am of 10/23.  In the evening of 10/23 I broke out in macular red spots that blanch and are not itchy.  The spots are located mainly on my back, chest and abdomen, but some spread to my arms and upper legs on 10/24.  The fever resolved 10/24, but the spots persist at this time -10/25.  The area where I received the injection is bruised about 2cm in diameter and has been since with day after the shot with no improvement in the bruise - worsened until 10/24.  I work in a peds clinic so it is also possible that I picked up a weird virus the day before I got the shot.
NORMAL SORENESS OF THE ARM AT THE INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced normal soreness of the arm at the injection site (Dose number in series 1). The reporter called to ask which vaccine the patient should take after getting primary and booster dose with the Janssen COVID-19 vaccine during the call the reporter mentioned the patient was seeking answers to avoid getting any side effects. The caller confirmed with the reporter that the reporter means potential AE (adverse event) and not that the patient experienced an AE following JNJ vaccinations. The reporter answered by explaining that the reporter was seeking advices to know which was reporter's best choice as a vaccine following the JNJ vaccine and that the patient only had the normal soreness of the arm at the injection site nothing more or no other side effects other than that. The patient received additional covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on unspecified date for covid-19 prophylaxis. No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of normal soreness of the arm at the injection site was not reported. This report was non-serious.
No additional AE; A medical assistant reported an expired ROTATEQ was administered to a patient. The vaccine had no temperature excursions. No additional AE reported. No PQC.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's concurrent conditions or concomitant medications was not provided.  On 28-MAR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters, for prophylaxis (route of administration, vaccination scheme frequency were not provided; valid lot #1741375 with an expiration date: 05-MAR-2022) (expired product administered). No adverse event was reported. The vaccine did not have previous temperature excursions and no additional product quality complaint (PQC) was reported.
Nausea and body aches 24hours after second vaccine dose. Bruising and mild pain at vaccine site. Very swollen lymph nodes on right clavicle and Supra clavicular fossa beginning at 48 hours. Joint pain in right clavicle, shoulder, and upper hip after 72 hours.
pt recv vax 17OCT95 & that evening pt devel inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax;
Upon registration, pt informed staff she normally gets hives and itching with flu vaccine. Pt received COVID vaccine at 1205. Pt sat down in monitor area at 1209. At 1221, pt stated she started to feel slight itching. At 1230, pt stated itching had increased. RN also noted redness to neck. Pt denied any SOB, difficulty breathing, tingling in mouth, or any other anaphylactic symptoms. At 1234, RN gave 25mg Benadryl orally. Pt requested to receive smaller dose instead of the entire 50mg. Pt stayed to be monitored until 1255. No other symptoms noted. Pt educated to monitor for further signs of anaphylaxis.
Referred pt to urgent care. Swollen, red, hot & very painful arm, from the elbow to shoulder.
I did not feel well after receiving my second dose vaccine. On 08-08-2021, I was in bed all day because I felt sick. I was diagnosed with COVID on Monday 08-09-2021. I started with body aches and chills, mild fever and some congestion. My fever then started to get worse, but I started taking Tylenol and Advil, and right now my fever is manageable. I had a fever for 48 hours without any Advil and Tylenol. When I was diagnosed with COVID, Monday morning, I went and had an infusion at the hospital. I am still sick although my fever is manageable, still have cough, congestion and body aches.
Tested positive on 30-Sep-2021 by PCR.; Tested positive on 30-Sep-2021 by PCR.; This is a spontaneous report from a contactable consumer.   A 17-year-old male patient received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers not reported), on 02May2021  (first dose, at 17 years) and on 23May2021 (second dose, at 17 years), both at single doses for covid-19 immunisation .  The patient medical history included allergy. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported.  Symptoms initiated on 28Sep2021 and included nasal congestion, cough. He was tested positive on 30Sep2021 by PCR (Nasal Swab). Symptoms began to subside about "2Sep2021" (as reported).  Patient attended on 25Sep2021 (as reported). No treatment given. Patient recovered on an unknown date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Moderna vaccine dose #1 given within 15 minutes of administration patient started to experience warmth at the site of the injection all the way down her left arm with some tingling and numbness all the way to her chest and left leg.  Vaccine was administered by the LAPD academy. Benadryl IV was given when en-route to the hospital by EMS.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-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 at 9:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 9:59 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.92 for dose administered on 11-JAN-2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion 11-JAN-2021 with temperature 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge 08-JAN-2021 and beyond use date for the vial was reported as 07-FEB-2021. Product moved to clinic on 11-JAN-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Employee experienced nausea and headache the same day as vaccine. Employee experienced swelling and pain in joints and hands the next day following the vaccine. The employee experienced pain at the injection site the day following the vaccine. All were reported the day following the vaccine.
Extreme Paleness (entire body).  Tingling sensation in head.  Chills.
Diagnosed with Type 1 Herpes - Bumps - Sores - Painful urination
Sore arm and fatigue all day after vaccine. At some point in the middle of the night, roughly midnight or 1am I woke up feeling sick. I was extremely dizzy to the point I could hardly stand up. I was nauseous and felt dehydrated. My head was pounding and I had a fever. My fever broke around 2am and ai broke into a sweat. I had terrible chills. The upper part of my arm was hot to the touch and swollen and red. My arm was very painful, it hurt to even barely touch it.  I had to call in to work for the day. I couldn't get out of bed until 1pm. By 2pm I was able to stand and walk but was still experiencing chills and pain and the head ache. By evening I was about 50% better. The next morning I only had the red, sore arm and felt fatigue that whole day. I was at about 80% okay. Sunday I was fine. The soreness in my arm lasted five days.
Severe, intense, excruciating throbbing in shoulder to elbow area of right arm. Shot was given very high into shoulder area. Not the upper area of arm. This was the pneumonia vaccine into my Rt. arm. The flu shot in my left arm showed no reaction.
Patient presented to pharmacy with a rash at the injection site.  Pain to touch and itching.
Chest pain middle of the night, went to ER of Hospital.  Chest pain lessened but lingered for eight weeks.
This spontaneous report was received from a medical assistant refers to a newborn of an unknown age who on 21-AUG-2012, was vaccinated intramuscularly with the first 0.5 ml dose of RECOMBIVAX HB and on 24-AUG-2012, inadvertently was administered with a second 0.5 ml dose of RECOMBIVAX HB intramuscularly (lot numbers not reported). No adverse effects were reported. Additional information has been requested.
Patient underarm was inflamed.  There is a noticeable swelling under the armpits.  Patient was vaccinated in the Deltoid muscle of the right arm.
The pt received injections of Lymerix on 5/22/00 and 6/19/00 (lot numbers not recorded). On 2/11/02, in a Statement of Injuries, the pt's attorney alleged that the pt "suffers from severe joint and muscle pain and weakness in her hips and knees. In addition, she suffers from numbness in her hands and arms. She also experiences fatigue, headaches, swelling in her joints and nerve spasms. (She just found out her thyroid in under active). The following information was obtained from medical records. On 11/8/00, the vaccine provider referred the pt to a chiropractor for the treatment of "right cervical spine pain". On 4/14/01, the pt presented to the vaccine provider for Work-up Lyme". The pt was evaluated by another physician. Pharmacy records indicated that this physician prescribed Paxil, doxycycline, cyclobenzaprine and tramadol (Ultram) between 5/21/01 and 10/15/01. The pt present to the vaccine provider on 10/20/01 with chief complaints of dizziness, visual changes, nausea and vomiting after meals and lethargy which was worse in the "PM". She reported that she was being treated by another physician for "Lyme". On 10/29/01, the vaccine provider prescribed Levoxyl. Following the administration of Lymerix, the pt experienced bronchitis, UTI and Lyme disease. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The most recent information, received 2/11/02, did not provide the outcome of the reported events. The adverse events of nerve spasms, joint pain, weakness, numbness, headache and joint swelling do not meet ICM serious criteria.
extreme fatigue, body aches, fever of 101.9 and 102.0. soreness at injection sight followed by full body aches, heavy hands and legs. fever today starting this morning and getting worse progressively. still feel ill now at 5:30pm.
An 8 year old male developed a fever and injection site pain following post-exposure RabAvert administration. The pt received rabies immune globulin, human, and RabAvert on day 0 and RabAvert on days 3 and 7. Following the 1st 2 doses of RabAvert, the pt experienced some minor pain at the site of the injection. Approx. 24 hours, after the 3rd dose of RabAvert, the pt developed a fever of 103F. Within 24 hours, the fever subsided.
Patient is allergic to Bactrim, hence she was told to wait 30 minutes after she was vaccinated.  About 15 minutes waiting time she started c/o numbness to her left leg.