chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up feeling nauseous and having muscle aches, vomited. Slept fitfully & didn't go to work because I had all the classic flu symptoms when I got out of bed. Didn't eat but drank small quantities of water. Vomited again around 2 PM. Sipped water & PEDIALYTE until around 6 PM and vomited again. Continued sipping water & PEDIALYTE throughout evening & went to bed about midnight. Woke up feeling much improved & hopefully over the adverse reaction.
Mom states child c/o of sore arm evening of vaccination. She went to bed earlier than normal. She woke up at approx. 0600 with nausea/vomiting/fever of 101. Mom states her cheeks looked swollen and chapped. Her lips were also slightly swollen. We instructed client to go to PCP. Client saw APRN who states it was a reaction to Flu vaccine. Mom denies client has any allergies to food or meds.
Fever, arm pain, injection site red and hot. Diagnosed with severe cellulitis, admitted to hospital for IV antibiotics. Sx began 24 hours after injection.
4/8/21 am: red rash from axilla extending down to elbow, mild swelling,  itchy, warm
Numbness and tingling of tongue and lips 20 min after immunization. Received SQ ep; BENADRYL; steroids. Observed x 20 min. Sent home on steroids; BENADRYL.  12/3/09 Medical records received for date 11/16/09. DX: allergic reaction H1N1 vax. Pt. c/o numbness/tingling tongue and lips after H1N1 vax.
The pain started in the upper left arm right after the injection (which I felt was placed unusually high in the arm). I waited for it to stop after a couple of days, but 10 days later I was still in pain. It has not subsided ever since. The pain wakes me up several times every night. I can no longer perform normal tasks like looking at my wrist watch or putting my clothes on in a normal way or opening a car door with my shoulder. I can no longer do yoga or dancing. This has affected my health enormously.
fever 100.6 21AUG-23AUG;swelling, soreness, hard area under arm;
expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number abxb36aa, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's comment: Register medical assistance reported that the patient was administrated an expired dose of Bexsero. No adverse event was reported. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Bexsero which was already expired, which led to expired vaccine used.
Patient administered COVID-19 vaccine. After waiting for observation patient complained of slight swelling below ear and not difficulty swallowing but "funny". Patient was offered and counseled on Benadryl. He accepted and was given 25mg oral diphenhydramine. Patient was observed for 30 minutes post administration. No further effect or complaints were observed.
This spontaneous report as received from an other healthcare worker refers to a patient of unknown age and gender. On an unknown date, an unspecified number of patient were vaccinated with an unsupported temperature doses of ROTATEQ (strength, dose, route and lot numbers were not reported). Concomitant medications were not reported. No adverse effects was reported. Additional information has been requested.
immediate localized reaction: swelling around injection site that lasted throughout duration of visit. Patient was given an ice pack to try to reduce swelling. Patient denied pain, dizziness, or nausea.
Widespread rash on trunk and arms. Timing suspicious for rxn to H1N1 vaccine. Little change in rash with Benadryl.  72 hours after onset, still present
Swollen lymph nodes on collar bone and under under.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 01Apr2021 at 11:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 10Mar2021 at 16:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 14:00, the patient experienced swollen lymph nodes on collar bone on left side and reportedly under under. The patient had lymphadenopathy on the same side as the vaccine administered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event swollen lymph nodes on collar bone was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Information has been received from a 66 year old female patient who was involved in a Market research project referring to herself. Information about medical history and concurrent conditions were unspecified. On an unknown date, the patient was vaccinated with one dose of pneumococcal vaccine (manufacturer unknown)(lot number, dose and route were unknown). Concomitant medications were unspecified. On an unknown date, the patient experienced unspecified adverse event. She was hospitalized on an unknown date and almost died. The outcome of the event was unknown. The causality between the event and pneumococcal vaccine (manufacturer unknown) was not reported. Additional information is not expected because the reporter was not consented to be contacted.
muscle pain in arm, shoulder and scapula; tightness of neck; some tingling in arm, all on left side; This is a spontaneous report from a contactable patient.   A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 14:30 (at the age of 54 year old) as dose 1, single for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mitral valve prolapse from an unknown date. Concomitant medications included ergocalciferol (VITAMIN D); and topical minoxidil (ROGAINE FOR WOMEN) both for an unspecified indication. The patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Prior vaccination, patient did not receive any other vaccines within four weeks and was not diagnosed with COVID 19.  On 23Mar2021 02:00, the patient experienced muscle pain in arm, shoulder and scapula, tightness of neck, and some tingling in arm, all on left side. Since the vaccination patient took COVID-19 test (Nasal swab) on 10Mar2021, where result was negative. No treatment was received in response to the events. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
devel rash on rt thigh;had lesions on rt knee;no temp not ill;rash & lesion only lasted 2-3 days;
headache; A spontaneous report was received from a Consumer concerning a 57 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Headache.  The patient's medical history was not provided. Relevant concomitant medications were not reported.   On 02 FEB 2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 03 FEB 2021, the patient experienced Headache.  No Laboratory details were provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  On 03 FEB 2021, the outcome of the event Headache was considered as unknown.  Unknown outcomes: At the time of this report, the outcome of the event's Headache was considered as unknown.
I started getting paralysis in the arm; My arm got really sore; Pain is excruciating, on 1-10 its 9.5, its from the injection site up a little and all way down to my arm; Fever; cannot move it/ can barely move; I was moving it very slowly and its very painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for immunisation. The patient's relevant medical history included: "Pulmonary fibrosis" (unspecified if ongoing). Concomitant medication(s) included: OFEV taken for pulmonary fibrosis. The following information was reported: PYREXIA (non-serious) with onset 25Aug2023, outcome "unknown", described as "Fever"; MONOPLEGIA (medically significant) with onset 25Aug2023, outcome "unknown", described as "I started getting paralysis in the arm"; PAIN (non-serious) with onset 25Aug2023, outcome "unknown", described as "I was moving it very slowly and its very painful"; PAIN IN EXTREMITY (non-serious) with onset 25Aug2023, outcome "unknown", described as "My arm got really sore"; VACCINATION SITE PAIN (non-serious) with onset 25Aug2023, outcome "unknown", described as "Pain is excruciating, on 1-10 its 9.5, its from the injection site up a little and all way down to my arm"; MOBILITY DECREASED (non-serious) with onset 25Aug2023, outcome "unknown", described as "cannot move it/ can barely move". Therapeutic measures were taken as a result of monoplegia, pain in extremity, vaccination site pain, pyrexia, mobility decreased, pain. The patient got a shot of that Prevnar 20 the day before 26Aug2023 and it was in 3 hours his arm got really sore. He had excruciating pain up to like a number 10. He had this shot around 4 O'clock, 5 O'clock, pain started about 7 O'clock and then around 9 O'clock he started getting paralysis in the arm, he cannot move it and I was moving it very slowly and its very painful and he got a slight fever he thought from that. The pain was excruciating, on 1-10 its 9.5, it was from the injection site up a little and all way down to his arm and he can barely move. He had a lab test when prescribed the medication, it was physical. The treatment included Excedrin.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to a 13 years old patient. On 12-JUL-2013 the patient was vaccinated with a dose of PROQUAD (Merck) (lot #, dose and route unspecified). No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient received the 1st dose of GARDASIL (dose, route and lot# not reported) on 22-OCT-2013, the 2nd dose of GARDASIL (dose, route and lot # not reported) on 11-MAR-2014 and was in the office today, 02-MAY-2014, attempting to get the 3rd dose of GARDASIL. No adverse effects were reported. Additional information is not expected.
suspected vaccination failure; got the shot. & they got shingles; He said it was very painful; left scar tissues were he got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient 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 vaccination failure (serious criteria GSK medically significant), shingles, pain and scar. On an unknown date, the outcome of the vaccination failure, shingles, pain and scar were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and scar to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient got the shot and had shingles, it was very painful and it left scar tissues where he got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
PATIENT REPORTED THAT SHE HAS BEEN GOING TO THERAPY DUE TO SHE STILL HAS A LOT OF PAIN IN HER ARM.
Pt states about 18 hrs after receiving the vaccine she developed hives, itching & chest tightness. Pt presented to the ER. Treated with steroids. Follow up care given at office. Was IM BENADRYL & IM DEPO-MEDROL.
patient indicates he had a sore shoulder since. HAs seen his PCP who indicated a nerve may have been hit accidentally
It was reported that patient had been experiencing  difficulty breathing, walking and delusions as per his fiancé . Fiance notified Manger that they sought medical attention earlier in the morning on 1-Apr-21 at the Clinic and they refused to evaluate patient beyond performing a PCR swab test so, they went back to their apartment. An SMS notification was sent on 1-Apr-21 indicating that patient was COVID-19 positive which was not seen by patient or fiance who reported the result to Mgmt. on 6-Apr-21. He was contacted by patient's friend and advised him the patient was sick, not able to walk, and having difficulty.
Swollen quad at injection site. Area has swelling, mild erythema, and tenderness. Currently 28 hours post-injection, site is improving with warm compress. No other treatment or investigative imaging/studies done at this time.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
28nov89 pt vax hepta B. pt ex pain at inject site.  28dec89 pt vax 2nd hepta B. pt ex prolonged pain an tenderness at inject site which lasted 2 days to 1 week. pt recovered.
After 3rd Gardasil shot had swollen lymph under arm then got a planters wart on foot had it removed then both lymph nodes in throat swelled took blood work many times showing lymphs high and then found Epstein Barr after 4th bloodwork.
Pt had immediate swelling in deltoid shot was given.  Pt also had swelling in his lips. 2nd MMR was given sq in same arm as 1st pneumococcal polysaccharide IM.  Both in right arm.  Left arm 4th IPV was given sq and 5th Dtap was given IM.  Due to reaction Benedryl 12.5mg was given IM in right thigh.  No further reactions have occurred.  Benedryl brought down all swelling.
ADMINISTER TO 16 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced administer to 16 year old subject. On 13-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administer to 16 year old patient and off label use was not reported. This report was non-serious.
sore shoulder; pain in legs; pain in calf; pain in bottom of feet; swelling of ankles; swollen foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore shoulder), PAIN IN EXTREMITY (pain in legs), PAIN IN EXTREMITY (pain in calf), PAIN IN EXTREMITY (pain in bottom of feet) and JOINT SWELLING (swelling of ankles) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Prostate cancer.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (sore shoulder), PAIN IN EXTREMITY (pain in legs), PAIN IN EXTREMITY (pain in calf), PAIN IN EXTREMITY (pain in bottom of feet), JOINT SWELLING (swelling of ankles) and OEDEMA PERIPHERAL (swollen foot). At the time of the report, PAIN (sore shoulder), PAIN IN EXTREMITY (pain in legs), PAIN IN EXTREMITY (pain in calf), PAIN IN EXTREMITY (pain in bottom of feet), JOINT SWELLING (swelling of ankles) and OEDEMA PERIPHERAL (swollen foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were unknown Treatment was included tub soak
Mother stated that 30 minutes after visit, was in drive thru and patient began to drool, shook for about 12 seconds then blacked out and went limp for about 8-10 seconds, hand curled up towards her chest, eyes rolled. ER provided IV fluids, no medication.
CVA with residual hemiparesis - C-Diff, diarrhea, weakness. AKI
Migraine symptoms began about 4.5 hours after administration of Moderna Covid booster. Blurred vision, headache, nausea. Migraine lasted for approx 7 hours.
The first dose I was fine. The 2nd dose immediately after receiving it I could feel the pain.  Fever, chills, fatigue, pain in my left arm, minimum movement in my left arm, nauseous. I felt like a had the flu. I called the pharmacist and she said it was normal. The flu like symptoms lasted for about 48 hours. I then went and seen a doctor when I developed a rash it looked like a sores, now they are like white blotches on my skin. The fatigue, limited movement and pain in the left arm are still happening as of now, these symptoms     Has a call in to the pharmacy for the lot number will call back when she has it.   First dose was 11/13/2019
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: WITHIN 5 MINUTES OF FIRST PFIZER COVID INJECTION PATIENT COMPLAINED OF RACING HEART RATE/PALPITATIONS,  TINGLING SENSATION OF ROOF OF MOUTH AND CHIN, DIZZINESS AND LIGHT HEADEDNESS, FAINTNESS. PATIENT SHOWED SIGNS OF ANXIETY AND HIGH PULSE RATE - EMS CAME - PATIENT HAD ELEVATED BLOOD PRESSURE AND WAS TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION.  PATIENT NEVER LOST CONCIOUSNESS.
First dose resulted in intense itching in legs and arms; panic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 (Lot number: EW0167) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe environmental allergies" (unspecified if ongoing); "OAS" (unspecified if ongoing); "acute asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "chronic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA. Past drug history included: Azithromycin, reaction(s): "allergies"; Pediazole, reaction(s): "allergies"; Rynatan, reaction(s): "allergies". The following information was reported: PRURITUS (non-serious) with onset 14May2021, outcome "recovered with sequelae" (2021), described as "First dose resulted in intense itching in legs and arms"; PANIC ATTACK (non-serious) with onset 14May2021, outcome "recovered with sequelae" (2021), described as "panic attack". Therapeutic measures were taken as a result of pruritus, panic attack.  Additional information: If other vaccine in four weeks: No. other medications in two weeks: Allegra 180 mg Adverse event: First dose resulted in intense itching in legs and arms which brought about a panic attack. If patient recovered: Recovered with lasting effects. if Covid prior vaccination: Yes. if Covid tested post vaccination: No.   Follow-up attempts are completed. No further information is expected.
Woke up on 5/7 with pleuritic chest pain, and admitted to the PICU on the same day. Found to have myopericarditis confirmed by MRI, now with residual low-normal EF of 56%. Discharged from hospital on 5/11.