chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACHY BODY; VOMITED; FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced achy body. On MAY-2021, the subject experienced vomited. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, achy body and vomited was not reported. This report was non-serious. This case, from the same reporter is linked to 20210521685.
This spontaneous report as received from a physician via a company representative refers to a currently 25 year old female patient who was a mother in nursing. On an unknown date the patient was vaccinated with PROQUAD, (lot#, expiry date, dose and route not reported), while she was nursing. Patient was informed by the physician to stop nursing for 2 weeks. The patient had seek medical attention by seeing the doctor. Follow-up information has been received from a consumer who refers to his 25 year old female wife who was a lactating and nursing mother. On 14-OCT-2014, the consumer reported that his wife was vaccinated with M-M-R II (conflicting information, previously reported by the physician that the patient was vaccinated with PROQUAD, (lot#, expiry date, dose and route not reported), while she was lactating and nursing her infant 9see MARRS # 1410USA011961). On the evening of 14-OCT-2014, the consumer and his wife were notified by the health care professional's staff, that his wife should discontinue breast-feeding their infant immediately. On 14-OCT-2014, the patient started to become depressed upon being instructed by the health care professional's staff to discontinued breast-feeding. The consumer stated that after his wife received PROQUAD, on 14-OCT-2014, she breast-fed their infant "4 or  times" during that day, on 14-OCT-2014, before being instructed to discontinue breast-feeding. The consumer stated his wife followed the instructions of the health care provider's office to immediately stop breast-feeding their infant and he purchased a breast-pump and formula so that the mother and infant could make the transition to formula-feeding. The consumer stated that this disruption in his family's process has caused great distress for his wife. He reported that his wife has been crying more frequently, and he thinks that he may need to take her to see a psychologist. The consumer was concerned about his wife's well being. The patient did seek medical attention (not otherwise specified). Additional information has been requested.
Patient experienced seizure-like symptoms a few minutes following flu vaccine. The patient's body became stiff with minor jerking movements throughout his body. The mouth had minor foaming and body was mildly sweaty. Patient had difficulty breathing but did not lose consciousness. Patient's wife state that patient's eyes rolled back. No treatment were given. 911 was called and EMS arrived. Protocol MD also contacted.
Rash to upper extremities, anterior trunk and groin, upper thighs, pruritic, starting 2 days after administration and progressive over 9 days.
Pt. in observation lane.  Was complaining of chest tightness.  Paramedics assessed vitals.  Pt. had increased BP 190/75 (history of hypertension).  Once symptoms and vitals stable pt. was released.
welts; was feeling flu-ish; arm was sore; raised rash about 2x3 inches in size near the injection site; welts are red; welts are / hot; welts are / itchy; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2020, less than a week after receiving Shingrix, the patient experienced raised rash, erythema, skin warm and itchy rash. On 17th November 2020, the patient experienced influenza like illness and pain in arm. On 18th November 2020, the patient experienced welts. On 19th November 2020, the outcome of the influenza like illness was recovered/resolved and the outcome of the pain in arm and welts were not recovered/not resolved. On an unknown date, the outcome of the raised rash, erythema, skin warm and itchy rash were unknown.   It was unknown if the reporter considered the influenza like illness, pain in arm, welts, raised rash, erythema, skin warm and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The next day, her arm was sore and she reports that she was feeling flu-ish.  On 18th November 2020, the patient had welts or raised rash about 2 by 3 inches in size near the injection site.  The welts are red, hot and itchy.  The patient was still experiencing the welts but that they seem to be improving and look less red. The reporter did not consent to follow up.
legs and feet have ballooned today; not my arm that is swollen, it is my legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (legs and feet have ballooned today) and JOINT SWELLING (not my arm that is swollen, it is my legs and feet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OEDEMA PERIPHERAL (legs and feet have ballooned today) and JOINT SWELLING (not my arm that is swollen, it is my legs and feet). At the time of the report, OEDEMA PERIPHERAL (legs and feet have ballooned today) and JOINT SWELLING (not my arm that is swollen, it is my legs and feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported
Paining like a hit by something at the left side back shoulder; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 12Sep2021, the patient had paining like a hit by something at the left side back shoulder and the pain was there for three days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event paining like a hit by something at the left side back shoulder was resolved on 15Sep2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
3:20PM PT NOTICED FACIAL RASH - REDNESS TO CHEEKS, LIPS, NOSE AND CHIN. NO SOB/DYSPNEA.  3:22PM BENADRYL 50MG NO DIFFICULTY SWALLOWING. A/O, W/D, RESP REG WITH EASE.
Got shot Sunday on Wednesday my breast started swelling, so much that my blouse would not button, Felt like somebody was pinching my breasts breast implants became very hard, chest became heavy and tight and pulling.
Patient Crying, redness/edema from feet to middle of shins. Small blisters noted to both lower extremities. Edema to eyelids. Q-dryl 12.5mg/5 ml 3ml given orally at 2:35pm. Patient taken too emergency room where treatment and evaluation was continued at 2:45pm. ER was called patient recovered all edema/redness/and blisters gone before going home (about 45 minutes. ER treated patient with Predisalone.
On June 8, 2021 at 2:30 AM, about fourteen hours after vaccination, I started feeling chills and pain throughout my entire body. From my fingertips to my toes, every muscle and joint was hurting. As a result, I was kept up all night from the pain. Hours later I began sweating and feeling feverish with a headache. Out of everything, the pain throughout my entire body was the worst thing next to the headache. Pain was an eight out of ten. I also had sporadic hot flashes along with inner ear pain. It wasn?t until June 11, 2021, that I felt the pain in my joints and muscles had subsided. Treatment included: Tylenol, Excedrin, Pain Relief Medication  On Monday, June 14, 2021, exactly one week from vaccination, I awoke with really bad vertigo, inner ear pain, nausea, and sporadic hot flashes. Symptoms coincide with vestibular neuritis. Treatment included: Excedrin, Dramamine, Tylenol, Naproxen  Currently, on June 16, 2021, I am still having pressure in my head and behind my eyes, like a migraine, along with sporadic ear pain. There is still a slight dizziness but not complete vertigo. Currently taking Excedrin Migraine.
Following hep b vaccine #1, episodes of crying uncontrollable for up to 2 hours several times over 2 days. Seen at ER and in office.
Information has been received from a certified medical assistant concerning a 21 year old female with a history of menstrual migraine who on 08-JAN-2007 was vaccinated with her first dose of Gardasil (lot # 655165/1425F). Concomitant therapy included duloxetine hydrochloride (CYMBALTA). On 08-JAN-2007 the patient experienced redness of the arm and itching at the site of injection, which spread to itching around the injection site. The patient also had pain radiating down the right arm for a few weeks. Unspecified medical attention was sought. Subsequently, the patient recovered after 3 weeks. The medical assistant also mentioned that the patient had been vaccinated on 09-Mar-2007 with her 2nd dose of Gardasil (lot# 656372/0243U) and received less than 1/2 the normal dose for reason unknown. It was reported that the injection site was immediately itchy. No product quality complaint was involved. Additional information has been requested.
Possible kidney infection or inflammation in the kidneys. Blood in urine and raised creatine levels in blood. Fever, light headed, near faint incident.
12/18/2001-took child to E. R. He had lumps/redness @injection site then lumps/bumps to his chest (Hives) per Mother. E. R. instructed to give Benadryl as directed on package. Also to watch for s/s resp. distress and return to E. R. prn.
Rash & local inflammatory reaction around injection site. Ibuprofen 800 mg TID.
I have rarely seen HSV outbreaks, but I had a significant one 5 days after the vaccine and then again 3 weeks later. I had no other symptoms (almost zero pain from the injection) of any kind.
pt recv vax 18OCT97 & 2 days later hair fell out in large quantities;
Severe rash on left forearm, rashes onright forearm, rash on neck, back andleft thigh; Difficulty breathing; Itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the right arm on 08Feb2021 at 11:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies, blocked arteries (stent).  Concomitant medications included mold & pollen allergy injections, Synthr and alirocumab (PRALUENT). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E1 3248) via an unspecified route of administration in the left arm on 18Jan2021 at 10:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation and sulfamethoxazole, trimethoprim (BACTRIM) and nicotinic acid (NIACIN) on an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Feb2021, the patient experienced severe rash on left forearm, rash on right forearm, neck, back and thigh, difficulty in breathing and itching. Symptoms began a day or two after the second vaccine, continued for two months, and still continue at this point. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with prednisone (MANUFACTURER UNKNOWN). The clinical outcome of severe rash on left forearm, rash on right forearm, neck, back and thigh, difficulty in breathing and itching were not recovered.  No follow-up attempts are needed. No further information is expected.
fever 104+ w/convuls on 18DEC95, father called 911 & pt transported to ER;f/u visit 19DEC95
area 10x15cm red, swollen, warm to touch, very sore lt deltoid to bicep, lasted 96hr took advil for 96hr;
Received influenza vaccine at 2 PM came back to clinic via triage RN at 4:50 PM. C/O rash on bilateral upper arms. Rash is itchy - vaccine given rt upper deltoid. No other SX. Suggest use of Benadryl as directed by manufacturer and 24 hr antihistamine product two days.
No adverse event; Received booster pediatric vial (6Y-11Y)  instead of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received booster pediatric vial (6Y-11Y)  instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received booster pediatric vial (6Y-11Y)  instead of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received booster pediatric vial (6Y-11Y)  instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Received booster pediatric vial (6Y-11Y)  instead of Bivalent Booster).    This case pertains to adult patient 4. Concomitant products were not provided. Treatment medication were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660841 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow up received. IRD of initial version updated to 17-OCT-2022. On 17-Oct-2022: Follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660841:Adult patient 4
Fevers up to 105.2 began 2 days after vaccination. Mom gave TYLENOL and IBU. As of 9/13/17, mom reported fevers have decreased to 100.5.
Pancreatic Cyst; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Jan2022 10:00 (Lot number: FJ1611) at the age of 54 years as dose 1, single for covid-19 immunization in medical facility. Relevant medical history included: "Gout" (unspecified if ongoing), Known allergies: No; "Covid" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) in 2 weeks included: ALLOPURINOL. The patient did not receive other vaccine in 4 weeks. The patient did not test Covid-19 post vaccination. The following information was reported: PANCREATIC CYST (disability) with onset 27Jan2022 16:00, outcome "recovering", described as "Pancreatic Cyst". The event "pancreatic cyst" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pancreatic cyst.; Sender's Comments: Pancreatic Cyst onset 20 days after the administration of COVID 19 vaccine, BNT162B2. Apart from the  reasonable temporal association, there is no element suggesting the reported event is related to the suspect vaccine.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA as appropriate.
Sore arm for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for a day) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Blood pressure high, Diabetes and Obesity.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm for a day). In 2021, PAIN IN EXTREMITY (Sore arm for a day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant product use was reported.  The patient reported that after the 1st dose, the patient had sore arm for a day.  No treatment information was provided.   This case was linked to MOD-2022-494502, MOD-2022-494503 (Patient Link).
Dizziness, Vertigo-type vomiting with ringing in the ear. The vertigo dissipated 2 weeks after they started, the ringing in the ears still continues to this day with sudden small dizziness. It all started with the second vaccine that was received on May 4, 2021.
Patient did not state when onset started but contacted pharmacy on 4/2/2010 ~9:30am.  Stated that she was hot and cold but no fever.  The site of injection was red and swollen.  She said a cold compress did help and we suggested an antihistamine as well as calling her physician.
Provider gave Pfizer instead of requested Janssen. Provider did not dilute the Pfizer thinking it was Janssen. Patient notified of error, advised to watch of sign/symptoms of adverse reactions and to seek medical attention if necessary. Patient advised nurse from clinic will call for next four days to check in.
This case was reported by a healthcare professional and described the occurrence of fever in a 41-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), and Yellow fever vaccine (Sanofi). Concurrent medical conditions included hypothyroidism. Concurrent medications included LEVOXYL. On 21 August 2008 the subject received the 1st dose TWINRIX (1 ml, unknown, left arm), and the 1st dose of Yellow fever vaccine (unknown, left arm). Four hours after vaccination with TWINRIX and Yellow fever vaccine, on 21 August 2008, the subject experienced fever, chills and body pain. The subject was treated with TYLENOL and bedrest. As of August 2008, the events were resolved. The reporting nurse stated that the vaccination subject attributed the events to vaccination with TWINRIX, and does not want to continue the vaccination series. The healthcare professional considered the events were possibly related to vaccination with TWINRIX, but stated that the likely cause of the events was the Yellow fever vaccine instead of TWINRIX.
This spontaneous report was received from a pharmacist refers to a 52 year old female patient. Patient has no drug allergies. On 01-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001007, expiry: 24-APR-2014) 0.65 ml, subcutaneously in the arm. On 02-AUG-2013, the patient experienced redness and pain at the injection site on her unspecified arm. On 03-AUG-2103, the patient experienced a pain shooting up into her neck and called to inform the pharmacist. No treatment was given. Patient sought medical attention. The pharmacist called this patient back today (05-AUG-2013) to inquire on her status. The patient stated that she was recovering and no longer has any pain. The pharmacist advised the patient to seek medical attention if she experiences any further difficulties. Additional information  has been requested.
Symptom of intense chest pain and some side pain begin early evening of Feb 18, and grew in intensity throughout much of the night.  Relieved slightly by pressing on side; and leaning forward (always sitting up).    Chest pain was crushing, and did not allow me to breath deep or even normal depth, but only shallow.   Conditions resolved gradually starting 24 hrs later, and no symptoms after a couple days.  I did not associate this with my 2nd Moderna mRNA vaccine shot until recently when study reports began to surface this past fall.   Therefore I did not have reason to associate this bout of peridcarditis or mycarditis with the vaccine at the time.   IMPORTANT:  Because I had an identical episode, diagnosed as pericarditis 4 years prior, included a trip to the ER and approximately 8 hours monitoring and treating me there, it for sure was inflammation of my heart muscle or sack.   For sure.     Treatment?  I followed the same treatment regiment I received from the doctors in the ER back in Feb 2017.   NSAIDs.
Patient had severe chills. Pt. used warm blanket & warm pack but it took a few hours to keep her warm the next day pt. still felt achy/tired.
Immediate pain in left shoulder; muscle spasm to left shoulder and cervical spine,reduced range of motion to head/neck and left Shoulder that is ongoing one month following 2nd vaccine; This is a spontaneous report from a contactable nurse. A 39-year-old female nurse non-pregnant received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL1283 ), dose 2 via an unspecified route of administration, administered in the left arm on 13Jan2021 at 08:00 am as a single dose for (at the age of 39-year-old) COVID-19 immunisation. The patient previously received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL1284) dose 1 via an unspecified route of administration, administered in left arm on 23Dec2020 at 07:30 pm as a single dose for (at the age of 39 year) COVID-19 immunisation in hospital. The patient's medical history included headache. She previously took bnt162b2, amoxicillin and experienced drug hypersensitivity. Concomitant medications included sulfamethoxazole, trimethoprim (MOTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and received other medication in two weeks include motrin. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient experienced Immediate pain in left shoulder, muscle spasm to left shoulder and cervical spine. Ongoing pain, severe in nature. muscle spasm, reduced range of motion to head/neck and left Shoulder that was ongoing one month following 2nd vaccine. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events include Cervical x-ray, prescriptions and Physical therapy. The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.