chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 2 days of MMR/DTaP at right arm, the right arm ?, proximal 1/3 of right forearm became 4 times swollen, tender, red, hot with streaks. Patient admitted; given IV Rocephin, steroids, antihistamines and released 2 days later doing well. The discharge summary states allergic reaction.
This spontaneous report as received from a registered nurse (R.N) refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported). On an unknown date the patient received the second dose of GARDASIL. Concomitant therapy was not reported. It was reported that on an unknown date, the day after the two doses of GARDASIL, the patient experienced axillary adenopathy that lasted approximately 4 to 5 days. The outcome of axillary adenopathy was reported as recovered. Additional information has ben requested.
Fainted Dizzy Rested with legs elevated. Juice and crackers BP back to normal
Patient had a knot, redness, and hot feeling at injection site. Her arm was so sore that she could not turn over in bed. She states that her fingertips are numb and the entire arm is painful.  The had a Medrol dospak prescribed on 10/27/2017 and on 11/07/2017. On 11/22/2017, she still expresses discomfort.
My gums have been swollen and sore since the day I received the vaccine.  Gums have been bleeding since I received the vaccine when I brush my teeth, Large amounts of blood everytime I brush. Developed a stye on my left eye 2 days after the vaccine.  Had fever, chills, headache, body aches for the first 3 days after the vaccine.  Still experiencing fatigue from the vaccine.
Information has been received from a physician office manager, via a company representative, concerning the office manager's 23 year old daughter, who was vaccinated with a dose, 0.5ml, of Gardasil (date unspecified). Subsequently the patient experienced dizziness and menstrual bleeding. At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. No further information is expected.
Patient developed hives the day after receiving the vaccination 3/6/2021. Hives come and go, very itchy. Continues to have sporadic hives on 3/10/2021. She is using Benadryl PRN. Recently prescribed prednisone for Hives.  She also had a swollen throat day after receiving the vaccination without difficulty swallowing. Took Benadryl PRN, this has since subsided.
hot to the touch; more than a rash, it was above the skin level like a plateau 3 inches; arm is really sore; feels very tired; rash/more than a rash, it was above the skin level like a plateau 3 inches for 5 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE SWELLING (more than a rash, it was above the skin level like a plateau 3 inches), VACCINATION SITE PAIN (arm is really sore), FATIGUE (feels very tired) and VACCINATION SITE RASH (rash/more than a rash, it was above the skin level like a plateau 3 inches for 5 inches) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced VACCINATION SITE RASH (rash/more than a rash, it was above the skin level like a plateau 3 inches for 5 inches). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE SWELLING (more than a rash, it was above the skin level like a plateau 3 inches), VACCINATION SITE PAIN (arm is really sore) and FATIGUE (feels very tired). The patient was treated with FISH OIL for Adverse event, at an unspecified dose and frequency and BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE SWELLING (more than a rash, it was above the skin level like a plateau 3 inches), VACCINATION SITE PAIN (arm is really sore) and FATIGUE (feels very tired) outcome was unknown and VACCINATION SITE RASH (rash/more than a rash, it was above the skin level like a plateau 3 inches for 5 inches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  The patient experienced the first symptoms one week after the first dose. The rash appeared exactly one week after the vaccine and lasted one week also. The patient described it as more than a rash, it was above the skin level like a plateau 3 inches for 5 inches. It was spread in an unusual manner and was rising up from the skin. The reporter said it was like a blob.   This case was linked to MOD-2021-317936 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up information included no new information.
temperature excursion due to a power outage. The highest temperature reached 59.4 F and the total excursion lasted 59 hours and 10 minutes with no reported adverse event; a patient received IPOL, with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA046769.  This case involves a patient of unknown age and gender and it was reported that temperature excursion due to a power outage; the highest temperature reached 59.4 f and the total excursion lasted 59 hours and 10 minutes and the patient received ipv (vero) [IPOL], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, temperature excursion due to a power outage, the highest temperature reached 59.4 f and the total excursion lasted 59 hours and 10 minutes with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient received an unknown dose of ipv (vero) [IPOL] suspension for injection (batch/lot number, expiry date, strength, route: not reported) in unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (poor quality product administered) (latency: 1 day).  It was reported "A temperature excursion due to a power outage. The highest temperature reached 59.4 F and the total excursion lasted 59 hours and 10 minutes. However, the products were removed from the fridge and left at room temperature after they discovered the temperature excursion so the products have now been out of range for over 72 hours. No previous temperature excursions to report. None of the products have been administered post excursion. None of the products are supported by the extended stability information post excursion.  She is asking if she should complete the paperwork since no patient was involved during the temperature excursion, but a letter preceeding it says that aside from the temperature excursion, she had been involved with a patient that received ACTHIB and IPOL, but no patient were vaccinated."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 24-Mar-2023: Event added. Corresponding fields updated; text amended accordingly.
From 72 hr post 1st dose, experienced severe joint pain in elbows and knees and moderate pain/stiffness in neck. Condition has remained steady for 3 weeks since the first dose. Impacting daily routine and work ability. Was informed that any side effects generally fade after 72 hrs but these symptoms have remained persistent.   Taking extra strength Tylenol 500mg 2X daily.
Erythema multiforme within 72 hours of vaccines. The morphology of this rash is most consistent with that of erythema multiforme which could be vaccine related given the temporal correlation or could be due to infection acquired from the community. I discussed the natural history of erythema multiforme with the parents, explaining that most of the rash will erupt within 72 hours and then will gradually resolve with 2 weeks' time. I did advise them to monitor for any mucosal and ocular involvement and explained that some of the centers could turn into crusted blisters. The child currently does not seem to be bothered at all but I did recommend doxepin 0.5 mL p.o. q.h.s. for itch and to help with sleep. Reassurance was provided. This rash will likely resolve. However, if it is worsening, I advised the parents to call our office and let us know. Rarely postinflammatory hyperpigmentation can develop. I also recommended that this should be reported as a vaccine adverse event by her PCP.
This case was reported by a physician via sales rep and described the occurrence of adverse event in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The case was reported during SHINGRIX Event. The reporter was an Adult Immunization Specialist. The age at vaccination was not applicable. The physician had patients who had experienced adverse events after receiving SHINGRIX. The field representative stated that he was unable to reach the physician due to the physician's schedule. He stated he had tried several times to get additional information from the provider, but had not been able to speak with him. No other information was provided at the time of reporting.
Patient reports soreness and weakness in arm after getting vaccination that she still had when she got her 2nd vaccination more than a month later. Also reports a burning sensation but is not sure if that is from 2nd dose vaccination received today.
Pfizer BioTech COVID-19 vaccine   patient received the first dose of COVID vaccine 01/22/2021, second dose administered 02/09/2021 ( which was not the recommended 21 day interval). On  03/19/2021 patient tested positive for COVID-19. He was asymptomatic, tested so he  could visit his wife in another state.
LOSS OF HAND GRIP; NUMB HANDS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced loss of hand grip, and numb hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numb hands and loss of hand grip was not reported. This report was non-serious. This case, from the same reporter is linked to 20221243261, 20221243356, 20221243340, 20221245816, 20221245881 and 20221243606.
The dose 1 vaccination on 3/12/21 was done around the time of ovulation or early luteal phase of the menstrual cycle. Severe lower abdominal pain starting the evening of 4/4/21 with significant pain lasting 10 days. Diagnosed with hemorrhagic ovarian cyst by ultrasound on 4/8/21. Informed by doctor that it is possible the cyst had ruptured. Treated with NSAIDs for pain relief until 4/14/21 when pain diminished. No prior history of ovarian cysts.
Patient in for a flu shot today, reported her last vaccine done at our site in February caused severe rash. Her entire upper arm and into her mid forearm was red and swollen. She took a photo two days post-vaccination, which she showed to me. The rash was the only effect she remembers and was clear after about one week.
This spontaneous report was received from a nurse and refers to an unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored doses of ROTATEQ lot # K004432 with expiration date 27-JAN-2016, lot # K007243 with expiration date 13-DEC-2015, lot # K004921 with expiration date 25-FEB-2016 and lot # K006456 with expiration date 08-MAR-2016, route defaulted to oral (dose was not reported). No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
Head congestion with a cough and a low grade fever. I had some body aches. I took ibuprofen and Nyquil and some Benadryl. I also took, later on, oxymetazoline, for nasal decongestant. Good food/smoothies and vegetable soups. I am mostly recovered now. I still have a cough and am still in quarantine. I have some fatigue but that is improving Note: I had a flu vaccine, September 21st, I had that.
Worsening menstural symptoms and pain, length of cycle irregular, pain in uterus
rash, sore arm, cant lift arm above shoulder height, rash traveling to elbow.
Arm started to hurt; Chills; High temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started to hurt), CHILLS (Chills) and PYREXIA (High temperature) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Allergy: PCN), Sulfonamide allergy (Allergy: Sulfa), Drug allergy (Allergy: Aleve) and Crohn's disease since 31-May-1999. Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease.   On 05-Apr-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PAIN IN EXTREMITY (Arm started to hurt), CHILLS (Chills) and PYREXIA (High temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-May-2021, PAIN IN EXTREMITY (Arm started to hurt) and CHILLS (Chills) had resolved. At the time of the report, PYREXIA (High temperature) had resolved.            The action taken with mRNA-1273 was not applicable.   This case was linked to MOD-2021-068520 (Patient Link).
Patient reported limited movement in opposite arm (right arm) stating he could not lift his arm above his head and had trouble using his hand (such as grasping glass). He stated he would be going to the doctor tomorrow to get it looked at.
After my second vaccine,  the morning after I began to have symptoms  of swelling under my left armpit with general pain, no body aches or chills or fever.  Right away I contact my physician over telehealth, and did not recommend any prescriptions at the time. The swelling took about a week to go down.  Though I have not had any issues other than that, I still have local tenderness in the affected area.
Pt broke out with a mild case of chicken pox with approx. 30 marks.
Within 24 hour I began  to bleed and ultimately had a complete miscarriage of baby. I was  at 6 weeks, with 2 healthy children (3 1/2 and 1 1/2 years old) with no prior pregnancy issues or complications.
Patient had dark circles under their eyes and did discuss at the drop off window they had a needle phobia. Immediately after the immunization, he said he felt lightheaded. I, pharmacist, sat in the booth and talked to him for a couple minutes then asked if he felt he could finish his observation outside the booth.  I notified technician to hand him off to her for observation , sharing by observation that the patient did not look well but he said he was doing a little better. He said he felt better and he did wait in the chairs outside the immunization booth. While I was in the pharmacy discussing this information with my pharmacy technician when I heard yelling and I stepped back out of the pharmacy to observe the patient was sliding out of his chair, stiff straight. My other technician came to my assistance and we both tried to get him to the floor and he was making incoherent noises and his arm was bent behind him and not relaxing to where we could get him to the floor. He then came to and startled a bit, with a bewildered look on his face. He asked what happened and said he felt he was dreaming.  A witness waiting on her prescriptions for pickup said that it originally appeared he was having a seizure which was my concern as well. We called code white and 911 and store manager assisted us at the scene. Patient denied the ambulance.
2 HR. AFTER ADMINISTRATION PT. LT. ARM BECAME RED, RAISED AREA HOT TO TOUCH FELT LIKE FLU SYMPTOMS. LEFT WORK TO GO HOME AND REST. REPORTS ICE PAK PLACED ON LT. UPPER ARM. LATE EVENING REPORTED 100.9 TEMP, RECOMMENDED PT.TAKE TYLENOL AS SHE IS ALLERGIC TO IBUPROFEN.  NEXT MORNING PT PHONED TO REPORT AREA IS LARGER AND SHE FEELS PAIN IN THE PELVIC REGION AND KNEES,STILL FEELING EXHAUSTED, REPORTS HEADACHE AND STATED SHE DOES NOT USUALLY GET HEADACHES.  ENCOURAGED PT TO USE ICE PAK AND BENADRYL PT. DECLINED TO USE BENADRLY AS IT MAKES HER TIRED AND SHE WAS ALREADY TIRED. PT THEN REVEALED SHE WAS GIVEN A B12 SHOT ON THE SAME DAY AS THE OTHER 2 INJECTIONS.   B12 WAS GIVEN IN SAME ARM AS SHINGRIX  (RT DELTOID) . Td WAS GIVEN IN LT. DELTOID AS LISTED.
Pt devel contralateral tendinitis of the biceps in the rt arm (humeral head) p/receiving Typhoid vax;
Onset of spontaneous rapid, erratic pulse/heartbeat.  First occurrence 11/5/2021 - (Mild) Duration 10 minutes and self-corrected Second occurrence 11/11/2021 (Mild/Stronger than first occurrence) Duration 1 hour and self-corrected Third occurrence 12/2/2021 resulted in hospitalization.  EKG performed - pulse exceeding 200BPM. Diagnosis is AFIB.   Initial medication administered by IV - Diltiazem - had no affect on elevated heart rate.  Second medication administered yIV - Digoxin - heart rate converted from AFIB to normal sinus rhythm after 6 hours.  Ultrasound performed 12/3/2021 showed no issues with heart, valves, arteries.  Released 12/3/2021
pt recvd vax & 24hrs post vax exp flu-like sx which lasted 2-3days;
he had a headache the second day after getting vaccine; third day he is having chest pain; he thinks his son is having an allergic reaction to the Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient's father). A 15-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunization. Reporter (patient's father) reported that he thought his son was having an allergic reaction to the Pfizer vaccine. Patient has received the second dose of the vaccine and he had a headache the second day after getting vaccine and the third day he was having chest pain. Reporter asked if he should take patient to the ER and has not talked with patient's doctor about symptoms. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Information has been received from a nurse practitioner and a healthcare worker for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female with no medical history who on 26-OCT-2007 was vaccinated with the first dose of GARDASIL (lot# not reported). There was no concomitant medication. In March 2008, the patient became pregnant. It was reported that the patient did not complete the pregnancy and had TOP (termination of pregnancy) but the reason was unknown. It was unspecified if the patient sought medical attention. Upon internal review, the pregnancy termination was considered to be an other important medical event. Additional information has been requested.
Patient seen in office for scheduled vaccine due appointment.  Medical Assistant pulled and prepared the vaccine, administered the vaccine.  It was discovered when the vaccine was being documented that the vaccine given was expired.  Management was notified immediately.  Contact was made to the Immunization Coordinator and a variance report was started following the company policy.  Director of Nursing will review and provide actions.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 at 07:00 as dose 2 (booster), single (Lot number: 3313OBA) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 09Apr2021 at 08:00 as dose 1, single (Lot number: 042A21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies:gluten" (unspecified if ongoing); "Known allergies:dairy" (unspecified if ongoing); "Known allergies:mri dyes" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin"; Delaudid, reaction(s): "Known allergies: Delaudid"; Cardura, reaction(s): "Known allergies: Cardura". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; positive, notes: Began getting symptoms again and tested positive 17 days after first positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid has been taken for the treatment of COVID 19 from 21Jun2022 to 25Jun2022. Adverse event start date: 05Jul2022. Adverse event start time: 06:00 AM
Reports later pm 10-17-13 arm started hurting and by next am was having problems raising (L) arm - after several days she called doctor and was advised to use ice and ibuprofen. Has been doing this. Is able to lift arm - higher now then when 1st started. Is to call doctor but if it doesn't resolve.
Syncopal Episode: lightheadedness, dizziness  After about 7 seconds the patient regained consciousness. Feet was elevated and ice packs applied to back of the neck to cool down. Patient was alert and oriented x4. Vital signs taken every 10 mins and were WNL. Patient left in stable condition with partner approximately 35 minutes after adverse event.
RECIEVED VACCINE 1/8/21 EXPIRED UNEXPECTED 1/10/21, NO ADVERSE REACTIONS NOTED