chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022; We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. The vial was initially stored in the refrigerator 12-May-2022. The vial did not undergo any temperature excursions. Reporter asked whether patients needs to be revaccinated. No treatment were reported.   This case was linked to MOD-2022-568784 (Patient Link).
hives on hands and legs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on hands and legs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced URTICARIA (hives on hands and legs). At the time of the report, URTICARIA (hives on hands and legs) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.  On an unknown date. the patient went ahead and was administered with the second dose of vaccination and was fine. The patient requested a call back from safety to provide contact information.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information was received on 13-Jul-2021: Contact information updated. Patient got second dose of Moderna vaccine.
Red, feverish, swollen at site.  Swollen & raised area is 7.5cm x 9cm.  Pt doesn't c/o pain just itches.  Still getting larger also.  Told pt to use cold packs on site.
Patient was seen on 6/18/23 and received the third dose of the HPV vaccine in error due to the immunization record in the EMR not being completely up to date. Patient had already received two doses of the HPV vaccine (on 08/11/2020,  03/10/2021) at another location. There was no adverse reaction.
(R) arm pain + discomfort w slight swelling Pt reported fever Recommended tylenol PRN, ice application, apt w provider offered, hydration
This spontaneous report was received from a registered nurse refers to numerous patients. Nurse reported that she observed an unspecified physician's office, storing ZOSTAVAX (lot# unspecified) (route, dose and location unspecified) which improperly, at room temperature, approximately 3 years ago on an unspecified date. She stated that numerous patients might have been administered improperly stored vaccines. No adverse effect reported. Additional information has been requested.
Diminished urine output even after regular water in take; diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 16Feb2021 at 18:00 (lot number: EN6200) (age at vaccination 70-year-old) as dose 2, single dose for COVID-19 immunization. The patient medical history included hypertension, chronic venous insufficiency from an unknown date and unknown if ongoing and 2 replaced hips hysterectomy on an unknown date. The patient concomitant medications included Norvasc, Famotidine 81mg and aspirin.The patient had known allergies with oxycontin from an unknown date and unknown if ongoing. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm on 26Jan2021 at 06:00 pm (lot number: EL9264) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 had diminished urine output even after regular water in take and diarrhea 17Feb2021 at 11:00 am. The patient did not receive any treatment to the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Developed chest pain and right armpit pain 1-day after vaccination.  Condition has persisted and now includes indigestion and vertigo.
pt recv vax 2NOV95 & exp lupus flare 8DEC95 required Pred;Lupus (SLE) first dx 18JUL91 was in remission until 8DEC95;reporter feels flare d/t flu vax;visible swollen lymph nodes in neck;
Janssen COVID-19 Vaccine EUA Injection site bruising, swelling, redness, burning General - headache, very very tired, bloating/puffiness, muscle aches, nausea, low grade fever, light dizziness  Took ibuprofen and drank lots of water... cold compress on arm...rest when needed As of Wednesday morning, the reactions are lowering and slowing down. The site is still swollen some and bruised and red.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' drug reactions or allergies and concomitant medications were not reported. Since December 2016, the patients might have been vaccinated with unknown doses of ROTATEQ orally (lot # M034799, expiry date 01-FEB-2018), that had been improperly stored. Temperature of storage was 33 F for 40 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005756:
Swollen lymph node under arm shot given in, swelling back of neck, severe body aches.  Sx lasted 3 days. Severe enough to miss work.
Hives on the thigh/still having hives every night; Feeling warm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on the thigh/still having hives every night), FEELING HOT (Feeling warm) and PAIN IN EXTREMITY (Sore arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced URTICARIA (Hives on the thigh/still having hives every night), FEELING HOT (Feeling warm) and PAIN IN EXTREMITY (Sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on the thigh/still having hives every night), FEELING HOT (Feeling warm) and PAIN IN EXTREMITY (Sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Initial Additional-1 : Pictures of AE event and updated verbatim for event hives
Patient received Moderna COVID booster dose on 3/11/2022. Blood was noticed in patient's brief on 3/12/2022. Bleeding continued to become increasingly significant and the patient was sent to the ER on 3/13/2022 and diagnosed with a UTI.
reactive airway symptoms (disease) with acute exacerbation   Decadron, Tessalon Peries and Bromfed    Prednisone 20mg , Albuterol HFA inhaler with spacer 2 puffs every 6 hours     Decadron 4 mg  2x daily for 5 days
patient said she had a high fever 101-102 for 5 days after shot. patient said she had mild-moderate headache for 7 days. Did not have any breathing problems like she had when she was in hospital with Covid. Dr recommended she not get second shot.
Fever started at 11:30pm 4/6/2021. Fever ~100 degrees F. Had chills and couldn't get warm, then was hot and drenched in sweat. Repeated all throughout the night (Hot/cold). Took 500mg Tylenol at 12am that night. Woke up at 2am with a ~102.4 F fever. Took another Tylenol. Got out of bed around 8am 4/7 drenched in sweat. Felt nauseous and vomited almost right away and couldn't stop for a few minutes. Still had around 102 F so took 2 more Tylenols. Throughout that night and until Friday, I was achy all over my body. Also, lymph node under left arm pit was swollen and was sore along with my left arm. Throughout the day on 4/7, laid in bed trying to get rest and too nauseous to eat anything other than some cereal in the morning and plain noodles later in the day. Took another Tylenol in the afternoon because I was still staying at 102 F fever. Was slightly dizzy when standing up or moving too fast. I slept the next night and felt fine 4/8 morning (no fever), but felt worse as the day went on, aching everywhere and feeling more and more dizzy. Friday 4/9, I woke up in the morning and when I first started walking, I fell on the floor because of extreme dizziness. The whole day I was extremely dizzy and I've never had vertigo before, but it seemed like that based on explanations of it. Also had painful headache every time I stood up, but was fine when I wasn't moving. The next day it was mild dizziness and completely gone the day after that.  Also, Thursday 4/8 around 7:30pm, I noticed I had hives on the back of my right hand. Not 100% sure if it's due to the vaccine, but I'm not sure what else would have caused it and it's worth noting. It was gone the next day.
CLIENT BECAME LIGHTHEADED 15' POST VACCINATION.  12:00PM PRESENTED WITH MILD DIAPHORESIS AND FEELING LIGHTHEADED AND FAINT.  SHE BECAME FLUSHED AND REPORTED CHILLS AND FATIGUE.  HR54, R99% SAT, BP 130/70.  12:10 HR 57, R 96%, BP 108/72.  12:30 HR 64, R 96%, BP 122/70.   SHE RESTED ON A COT FOR 45-50 MINUTES.  NO MEDICATION GIVEN.  SHE REPORTED A HEADACHE AT 12:15 BUT STATED THATS TYPICAL FOR HER.  ABLE TO STAND AND WALK TO RR @ 12:50 WITHOUT DIFFICULTY.  RECEIVED SNACKS @1:15 AND REPORTED FEELING BETTER WITH FOOD AND STATED SHE THINKS HER BS WAS LOW AND CAUSING INCREASED ANXIETY.  RETURNED TO REST ON COT FROM 1-1:30PM.  SHE WAS ABLE TO LEAVE AFTER FEELING MUCH BETTER AND REPORTED OK TO LEAVE.
During 6 hours following vaccination upper left arm became increasingly sore and headache developed.  This was followed by chills, intense nausea and periodic vomiting over a 5 hour period.  18 hours after vaccination patient  recovered but with lingering mild headache.   Note: Patient experienced no adverse reaction to previous seasonal flu shots received in 2006, 2007, and 2008.
He tested positive for COVID on 03May and has only minor congestion.; He tested positive for COVID on 03May and has only minor congestion.; minor congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6205), on 20Mar2021 as dose 2, single (Lot number: EN6204) and on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High blood pressure and cholesterol" (unspecified if ongoing), notes: High blood pressure and cholesterol; "asthma" (unspecified if ongoing); "High blood pressure and cholesterol" (unspecified if ongoing), notes: High blood pressure and cholesterol. Concomitant medication(s) included: LISINOPRIL; ATORVASTATIN. The following information was reported: NASAL CONGESTION (non-serious) with onset 01May2022, outcome "not recovered", described as "minor congestion"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "not recovered" and all described as "He tested positive for COVID on 03May and has only minor congestion.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: Nasal Swab covid test name post vaccination: Binax. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasal congestion. Facility type vaccine reported as Pharmacy or Drug Store. If other vaccine in four weeks reported as no. Other medications in two weeks reported as Lisinopril, Atorvastatin. If covid prior vaccination reported as no. If covid tested post vaccination reported as yes. Known allergies reported as no.
2 weeks recation around the injection site in the left arm; Arm of the injection  still swollen, getting bigger; Arm is warm; Arm of the injection red/Redness/erythema; Was very nauseous; Had chills; vomiting; Arm of the injection itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm of the injection itching), VACCINATION SITE REACTION (2 weeks recation around the injection site in the left arm), VACCINATION SITE SWELLING (Arm of the injection  still swollen, getting bigger), VACCINATION SITE WARMTH (Arm is warm) and VACCINATION SITE ERYTHEMA (Arm of the injection red/Redness/erythema) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction to drug (Had an anaphylactic reaction to compazine) in 1981. Concurrent medical conditions included High cholesterol, Hypothyroidism, Allergic reaction to bee sting (Bee sting allergy) and Allergy to antibiotic (Neomycin allergy). Concomitant products included SIMVASTATIN for High cholesterol, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Hypothyroidism, METFORMIN and VITAMIN D3 for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Arm of the injection itching), VACCINATION SITE SWELLING (Arm of the injection  still swollen, getting bigger), VACCINATION SITE WARMTH (Arm is warm), VACCINATION SITE ERYTHEMA (Arm of the injection red/Redness/erythema), NAUSEA (Was very nauseous), CHILLS (Had chills) and VOMITING (vomiting). On an unknown date, the patient experienced VACCINATION SITE REACTION (2 weeks recation around the injection site in the left arm). On 16-Feb-2021, VACCINATION SITE SWELLING (Arm of the injection  still swollen, getting bigger), VACCINATION SITE WARMTH (Arm is warm), VACCINATION SITE ERYTHEMA (Arm of the injection red/Redness/erythema), NAUSEA (Was very nauseous), CHILLS (Had chills) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm of the injection itching) and VACCINATION SITE REACTION (2 weeks recation around the injection site in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-276618 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Additional reporter details, vaccine facility information, additional patient information, prior vaccination history, additional medical history and additional events were added.
I had soreness in my arm at the shot site for about 2 days which then went away. Then, 8 days after my shot, mild soreness in my arm returned, and there is now swelling and a red rash around the site shot. Today I am 9 days after my shot and my left arm is still swollen and the rash is still there. It is slightly painful and itches very slightly. It also feels warm to the touch. I also feel fatigued today and have allergy symptoms (which may be just normal to the season).
74 Y old female with history of Hypertension, Hyperlipidemia, hypertensive CKD stage IIIb, PMR, CAD by cardiac CT 9/8/20  (severe prox RCA stenosis, moderate-severe distal RCA, mild disease of LAD & LCx) medically managed, history of PE 10/7/2021 tx'd with Pradxa for 4 months . She presented with generalized weakness associated with nausea and dry heaving since 4/9/22 PM. Patient received covid booster 4/9/22 and she experienced intermittent chills and "fever".  Patient had temp of 100.3 F at triage in ED. EKG showed mild TWI and trop peak at 5.11. patient has significant FMH of sudden fatal MI 2020 (twin sister).  She was transferred to a facility for further cardiac cath ad hoc. The patient underwent coronary angiography. Pt tolerated the procedure without any complications. No adverse events during recovery either.
56 y/o female, with history of Adult Onset Diabetes, presents with left arm itching and faint rash post vaccination administration. Patient vaccination site was the left deltoid. NP and Paramedics at patient side. Patient denies sore throat, difficulty breathing or chest pain. Patient states that she had the same reaction with the initial vaccination and Benadryl was given. Patient given Benadryl 25 mg PO x1 and patient was observed and within 20 minutes symptoms resolved. Patient felt better, rash resolved and was discharged home in stable condition. ------------------------------------------------------------------------------------------------------END
bleeding at side of injection.  Patient felt weak and sick for around half an hour.  She remained sitting and resting while we waited for paramedics.  By the time the paramedics arrived she was recovered enough to stand and walk out.
Localized pain and redness at the injection site on left deltoid stating about 24 hours after injection. 1" size hard lump at injection site. Patient cannot lie on side without pain.
Patient reported severe redness 4 days after the vaccine was given - the redness was lower than where the vaccine was injected. Patient reports it has gotten better. It is not bothering her, but if it was she could take some Benadryl. I advised the patient that if it does not get better in the next day or two, to contact MD.
About 1 hour after patient received vaccine from here, she called and said her throat and tongue started to itch and swell. She was experiencing itching all over her body as well. She said she took some benadryl and the symptoms got better, but wanted to report the event. At the time that she called and notified me she was doing fine.
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. On an unknown date, "over the last couple years", the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) subcutaneously. The pharmacist reported that on an unknown date, "over the last couple of years", the patient experienced bruising around the injection site as she described as profuse bruising between the elbow and shoulder. The patient did not receive treatment for the adverse event. The outcome of bruising around the injection site was reported as recovered/resolved. This is one of several reports received from the same source. Additional information is not expected.
Pt states she developed nausea and vomiting in the evening after H1N1 vaccine. States this subsided within 48 hours, but she then developed left neck/shoulder pain which persists, but is improving as of 11/5/09.
hands were shaking; very bad hot and cold flashes; legs was hurting; fever of 101 point five; body aches/belly aches; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (hands were shaking), FLUSHING (very bad hot and cold flashes), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (legs was hurting) and PYREXIA (fever of 101 point five) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced TREMOR (hands were shaking), FLUSHING (very bad hot and cold flashes), PAIN IN EXTREMITY (legs was hurting), PYREXIA (fever of 101 point five) and MYALGIA (body aches/belly aches). At the time of the report, TREMOR (hands were shaking), FLUSHING (very bad hot and cold flashes), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (legs was hurting), PYREXIA (fever of 101 point five) and MYALGIA (body aches/belly aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (Unknown-98): 101.5 (Inconclusive) INCONCLUSIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Had Trumenba vaccine in left arm, next day had large red area on left upper arm. that seemed to worsen for a few days, today woke up and is less red and faded from the top of the shoulder and only on the lower part of the arm, is a little sore and can move the arm fine
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in 2014 (reported as "since 28-OCT-2014), an unspecified number of patient were administered with doses of ROTATEQ, oral route of administration (doses, lot numbers and expiration dates were not reported) that were improperly stored, No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a Registered Nurse via Company Representative concerning a female patient of unknown age. The patient was not pregnant. On 12-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml intramuscular (dose and route were not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. According to the nurse, a patient developed an injection site reaction to ZOSTAVAX, which included itching, redness and severe pain after the ZOSTAVAX, was administered intramuscularly rather than subcutaneously on 12-OCT-2013. The patient sought medical attention by speaking with the nurse. At the time of the report, the patient was recovering. Additional information has been requested.
Information has been received from a nurse concerning a 5 year old male who on 23-MAY-2007 was vaccinated with Proquad. After receiving the vaccine, in May 2007, the patient developed swelling, erythema, induration and discoloration of the injection site. The area was "silver dollar sized". At the time of this report, the patient had not recovered. No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.