chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 3 days after immunized, developed sweats, fever, body aches in muscles, decreased appetite, headache to look around and a rash over legs and trunk. On exam has five thinly distributed papular rash and subauricular adenopathy feeling better by 12 days after shots.
Consistent arm/shoulder pain lasting entire 9 months since injection.  Including mild loss of strength and mobility.
Patient called and said she received her second dose of the shingles vaccine on 6/3 in her left arm. She states that she woke up the next day with soreness, redness and swelling at the injections site and then felt extremely fatigued with fever, chills and headache. She took an epsom salt bath but not OTC medication. Today she states the swelling is in her entire left arm and even in her bilateral legs more pronounced on the left leg. She states she has a funny feeling of numbness in her left neck down her left arm to her fingers. She denies difficulty breathing. Recommend she visit Urgent care or ER for further evaluation for severe swelling and numbness. Let know could take OTC benadryl but warned of drowsiness. Patient verbalizes understanding and will visit urgent care.
Opened vial for ipol is to be stored at 2 Celsius to 8 Celsius.  Temperature excursion for this opened vial at 46.9 F converted to Celsius is 8.28 Celsius for 30 minutes while door was opened to store vaccines in fridge unit.  After the excursion the ipol was administered to the patient.
A pediatric dose of VAQTA was given to an adult; No additional AE information; This spontaneous report was received from a medical assistant referring to an adult patient of unspecified gender whose medical history, concurrent conditions, previous adverse drug reaction, or family adverse drug reactions were not provided.  On an unknown date, a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, for prophylaxis (strength, lot number, expiration date, route of administration, anatomical location, and vaccine scheme were not provided) was not confirmed by the reporter whether it was given to an adult patient (incorrect dose administered). No additional adverse event (AE) information was reported (no adverse event).
Pt recvd MMR vax & 24 hrs following vax pt devel nausea, aches, pain, & flu-like sx; no further details were provided;
Pt was exposed to her son who was vaccinated with varicella virus vaccine live. One day after her son was vaccinated, pt developed shingles through possible secondary transmission.
Patient felt flushed/warm and chest heaviness. Patient was then observed for 40 minutes and then discharged home. Patient was in stable condition at time of discharge. Patient advised to go to ER if symptoms persist.
Fever Narrative:  PAIN AT THE INJECTION SITE X 2  WEEKS.  Other Relevant History:
Swollen, red, sore at injection site. Started 1 day after went away after 4 days then returned with red, hot to touch, itchy at injection site and went away after 48 hours and has returned again with a circular red, rash.
Patient had not eaten or drank anything prior to vaccination.  Received vaccine at 9:10 am.  At 9:25 began feeling dizzy and was pale.  BP checked and noted to be:  131/92, 149/102, 154/98, and 149/85.  O2 was 99%.  Pulse fluctuated between 80 and 101.  Was given a drink and a snack.  At 9:38 was feeling better and left.
Exacerbation of postheretic neuralgia; This is a spontaneous report from a contactable Physician. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN9581), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. It was reported that he did not received any other vaccine within 4 weeks. He was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On an unspecified date, the patient experienced exacerbation of postherpetic neuralgia. It was stated that, patient had received the treatment for the event Gabapentin. Patient had visited physician office. The seriousness of the event was considered as non-serious. The outcome of the event was not recovered.
Narrative:  COVID infection following COVID vaccine series 01/29 Janssen, dose #1 08/09 pt cc: cough, diarrhea, fatigue, nausea exposure: spouse 08/10 - 8/15 pt symptoms continue 0810 COVID swab, result: detected
Person of contact  spent around 10 minutes in the room, spoke with the resident, left the room. When the caregiver came into the room with the resident lunch the resident was without vital signs. Dxn: Atherosclerotic Heart Diseases
The morning after receiving FLUMIST pt. woke up with whelps on arms, itching. The next day spread to trunk, genital area, legs. Seen in ED. Prescribed ZYRTEC, BENADRYL, prednisone.
Pt has COPD with chronic dyspnea on 2L NC PRN at home.  She has squamous cell lung cancer.  Pt admitted due to acute on chronic microcytic anemia, and was COVID positive on admission.
100-102 F degree fever; Chills; Tinnitus; Nausea; Minor dizziness; Headache; Dose received: 3/ Dose number =3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 25-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 21Dec2021 at 13:00 (Lot number: 331308A) at the age of 25 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Prehypertension" (unspecified if ongoing), notes: Pre-hypertension (~127/77) and "Protein S deficiency" (unspecified if ongoing). The patient did not take any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, 0.3 ML SINGLE, Lot Number: ER8734), administration date: 01Apr2021, when the patient was 24 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, 0.3 ML SINGLE, Lot Number: EN6207), administration date: 22Apr2021, when the patient was 24 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 at 13:00, outcome "unknown", described as "Dose received: 3/ Dose number =3"; PYREXIA (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "100-102 F degree fever"; CHILLS (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Chills"; TINNITUS (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Tinnitus"; NAUSEA (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Nausea"; DIZZINESS (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Minor dizziness"; HEADACHE (non-serious) with onset 22Dec2021 at 04:00, outcome "recovering", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, tinnitus, nausea, dizziness and headache. Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Vaccine temperature excursion.  Vial was beyond use date. Vial should have been removed from freezer on 7/1/2021 and placed in refrigerator.  Vial was removed from freezer on 7/5/2021.
approx 2wk post vax pt devel macular rash consist w/lupus type butterfly rash-over next few weeks;pt devel photosensitive rash including Gottron's pap hypertrichosis & diffuse arrythroderma-over sun exposed;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Bladder Cancer" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Thrombocytosis" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish, Levaquin. The patient took concomitant medications. Patient received other medication in 2 weeks. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin", notes: Known allergies: Shellfish, Levaquin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19; negative, notes: positive Covid test after testing negative; positive, notes: positive Covid test after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment from 11Jul2022 to 15Jul2022. Adverse event: Experiencing Rebound Covid and positive Covid test after testing negative.
This spontaneous report has been received from a licensed practical nurse referring to a 2 year old patient of an unknown gender. There was not information regarding the patient's pertinent medical history, drug reaction, allergies or concomitant therapies. On 11-JAN-2017,  the patient was vaccinated with an improperly stored  dose of VARIVAX (strength, dose, route of administration, and frequency were not provided), lot # M034584 and expiration date 27-JUL-2018, for prophylaxis. The vaccine doses were exposed to a temperature excursion of  -7 Celsius (C) degrees for a time frame of 1 hour and 20 minutes, also she stated that there was not previous temperature excursion; this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011002: US-009507513-1701USA011003: US-009507513-1701USA011004:
Information has been received from a medical assistant referring to two patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On 17-SEP-2015 the patients were respectively vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L018001, expiration date: 19-MAY-2017, dose, route unspecified). Other suspect and concomitant therapies were not reported. No symptoms reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 8 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter
COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO PREVENT FALLING, PT WAS NERVOUS AND ANXIOUS
Patient reported at second dose of moderna covid vaccine that he had developed a red itchyrash about 8-12 days after his vaccine on one side of his face, scalp,  and trunk. He is not sure if it is from the vaccine, but wanted to report it. It is improving but has not gone away. He plans to see his doctor if it worsens with dose two of vaccine or if it doesn't continue to clear up.
Developed a rash on front of both legs between ankles and knees; Constant itching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number FN 6200 RA), via an unspecified route of administration, in right arm on 25Feb2021 at 13:00 (at the age of 79-year-old) as first dose, single for COVID-19 immunization. Medical history included high blood pressure and occasional lower extremity edema. The patient had no known allergies. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) and nifedipine (NIFEDIPINE). The patient received no other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On 28Feb2021 the patient developed a rash on front of both legs between ankles and knees and constant itching. No treatment was received for the events. The events had not resolved.  No follow-up attempts are possible. No further information is expected.
18OCT96 fussy, cranky, fever ax 101;10-20 maculopapular rash on face, back & chest;spread to arms & legs by 21OCT;appetite sl down;no cough, no coryza, no conjunctivitis, no enlarged nodes;extreme itching;saw PMD;
This spontaneous report was received from a certified medical assistant concerning an unspecified number of patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored dose of ROTATEQ, oral liquid, (dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 29Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALEVE, start date: 25May2022, stop date: 26May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Adverse event Return of symptoms and testing positive (on Binax rapid test) after previous cessation of symptoms and negative tests. Symptoms returned on Day 10 of infection. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Other medication in 2 weeks. Patient took treatment of Paxlovid started on 28May2022 and stopped on 02Jun2022.  No follow-up attempts are possible. No further information is expected.
Case tested positive 04/18/2023 and was hospitalized at Hospital A few days after discharge case experience difficulty breathing, went to Hospital and was admitted on 05/04/2023. Case continued to test positive for COVID-19 on 05/04/2023.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The pharmacist stated that the patient had blood work completed on an unspecified date and the results of the blood work stated that the patient was positive for Hepatitis B. The patient had received ZOSTAVAX on an unspecified date prior to the blood work being completed. The outcome of the adverse event was unknown. Additional information has been requested.
Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment product use was provided by the reporter.    This case was linked to MOD-2021-408551 (Patient Link).
Mar90 pt vax; 01May90 was inadvertently vax w/ 2nd vax.  07May90 devel fever 103F, vomiting, & D which lasted 2 days.
Patient developed heart palpations since 02/14/2021, shortness of breath and increase in heart palpitation severity and length in Aug 2021. 2 ED visits Dec 2022 for chest tightness/ pain.
Acute encephalopathy. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Patient came through the drive thru stating they had just gone out for ice cream had swelling in the corner of the mouth stated only thing different was flu shot. No difficulty breathing/swelling. Patient contacted MD MD instructed them to take a Benadryl. Follow up with the pt on 10/19/20 said swelling resolved and feeling good.
Information has been received from a physician concerning a 10-year-old immunocompromised female with Crohn's Disease and no allergies to food or medication who on 03-SEP-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # "0424"). Concomitant therapy included Remicade and Imuran (both for Crohn's Disease). The patient had demonstrated the appropriate immune response after vaccination. Subsequently, the patient experienced disseminated varicella. The reaction was noted to be a rash of greater than 200 lesions on her face, trunk, groin and extremities. A specimen was obtained on 20-NOV-2007, and sent to the laboratory on 04-DEC-2007. The specimen was a vesicle. The PCR analysis was positive for wild type. It was noted that the patient had no recent immunization. The patient did not have a recent exposure to chickenpox or shingles. The patient recovered. Additional information has been requested.
Headache, Myalgia, Fever, Tachycardia, temp 104.0, chills, fatigue Narrative:
had a great deal of swelling; had a great deal of heat; had a great deal of uncomfortableness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (had a great deal of swelling), FEELING HOT (had a great deal of heat) and MALAISE (had a great deal of uncomfortableness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (had a great deal of swelling), FEELING HOT (had a great deal of heat) and MALAISE (had a great deal of uncomfortableness). At the time of the report, SWELLING (had a great deal of swelling), FEELING HOT (had a great deal of heat) and MALAISE (had a great deal of uncomfortableness) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-344973 (Patient Link).
Prevnar 13 was to be given. Due to staff error Trumenba was given.
I had severe headaches for the first 5 days that Tylenol would not help.  One day, I had what I would consider a migraine (light and sound were painful). I also had bubbly feelings in my stomach that came in waves.  The headaches have gotten better in the last 2-3 days.
SEVERE LIP SWELLING.  TREATMENT: BENADRYL, STEROIDS  HOURS AFTER SHOT, BODY ACHES, CHILLS AND NO ENERGY. 19 HOURS LATER, LIPS STARTED TO SWELL AND GOT SIGNIFICANTLY WORSE.   THERE ARE JUVADERM LIP INJECTIONS 7 MONTHS PRIOR TO 2ND DOSE OF COVID SHOT.
pn 10/11/21: Patient had been growing progressively weaker, having more problems with chest pain, chest pressure, shortness of breath. She was brought to the ER and evaluated. Found to have COVID-19 and what appeared to be elevations of her troponin felt to be secondary to COVID related myocarditis. She was hospitalized, monitored, with steady decline in her troponin. She did appear to have some resolution of her hypoxia and did not appear to be in any acute distress at this time. By the sixth day of admission she was feeling stable and back to baseline, ready to discharge to home. Her labs this morning show hemoglobin stable at 10.4. White count 5,870. Platelets 221,000 and come back up again. Her renal profile showed a glucose of 77. BUN 20.1. Creatinine 0.81. Her BNP had shown steady decline from a high of 9,580 down to 3,020. Her troponin had gone from 0.431 down to 0.178 and her CRP was 3.14.
Terrible headache for about 16 hours that started about 14 hours post vaccine. Day 3 developed rash and pain at and below injection site with itchiness, has not subsided yet, day 5 post
Patient wanted the moderna vaccine.  Before giving the shot I confirmed with the patient that she is getting maderna as requested.  In the process of completing the paperwork I found out the patient is less that 18 and this shot is not approved for children under 18 yet.