chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized redness, swelling, and pain on the right arm, not located at the injection sight. The location is approximately two inches below the injection site.
Pain & swelling starting in upper arm, extending from shoulder to elbow. Gradually improved over 6 weeks, but continues with some pain.  MD visit 11/3/09. Pain medication ordered.
This case was reported by a physician via an injectables and vaccines distributor and described the occurrence of convulsion in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 October 2008 the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced convulsion. It was suggested that the subject was seen in the emergency room. Limited information was available. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The person reporting this event was a distributor who sold the product to another distributor who then sold it to a medical doctor's office. The medical doctor's office contacted the second distributor with the limited information. It was reported that three subjects experienced convulsions and a female subject experienced a drop in her blood sugar and weakness and was taken to the emergency room. Linked case numbers include A0754328A and A0754339A.
This case was reported by a healthcare professional and described the occurrence of rash in a 58-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  The subject had consumed tuna fish and wore latex gloves prior to vaccination with BOOSTRIX.  She had previously received flu vaccination (vaccine details unknown) on an unknown date with no known adverse reaction.  The subject's medical history included poison ivy the previous week and used CLARITIN and local application.  Concurrent medications included CLARITIN.  On 27 April 2009 at approximately 09:00 the subject received a dose of BOOSTRIX (0.5 ml, unknown route, left arm).  On 07 May 2009, 10 days after vaccination with BOOSTRIX, the subject experienced rash and tingling of lips.  The healthcare professional considered the events were clinically significant (or requiring intervention).  The subject was treated with PREDNISONE by her dermatologist.  At the time of reporting the outcome of the events were was unspecified.  Follow-up information received on 01 June 2009 indicated that the subject experienced an undetermined sensitivity reaction with rash and tingling of lip.  The outcome of these events was not known at the time of follow-up.  In the reporter's opinion, the events were possibly related to treatment with BOOSTRIX.
Woke up on Sep 30, 2021 with a large swollen lump at injection site. Lump is hard, warm to the touch, and slightly itchy. No visible bite mark to suggest bug bite, and no recollection of incident that could have caused lump (e.g., no recent trauma to the area that could explain the lump). Unsure if related to AE, but started menstrual period on Sep 29, 2021. No lump has appeared at injection site during other menstrual periods between vaccine and now.
I woke up throughout the night first night with left arm very sore feeling like an elephant trunk. In AM I woke up and felt ill. Throughout the day my temperature went up to 102 by the afternoon. I had headache, bad muscle pain and aches and generally felt miserable. Also, the gland under my arm pit was extremely swollen for 3 full days the size of a baseball. It hurt to rest my arm to my side. That second night, I took fever reducer before I went to bed. Fever broke and I soaked through 3 pairs of pjs. The next day my fever went up to 100.7. I didn't take any more fever reducer.  Third day it went up to 99.7. Fourth day normal temp but then I had extreme fatigue starting fourth day to where I barely had energy to sit up or even walk to the bathroom. I tried to do my online remote work that week but only worked 1/3 my schedule due to extreme fatigue. One day I was in the kitchen and had to drop to the floor and rest to get enough energy to walk back to my bedroom. The extreme fatigue lasted a good 5-6 days then the following week I pushed through my online work without reducing my hours but would go straight to bed right afterwards due to fatigue. I have struggled with Epstein Barr virus since I was 23 and get fatigued after getting strep or exercising too much or other illnesses so chalked it up to the EBV. I still had minor stabbing pain under my armpit until the past couple of days. My energy is now back to normal.
report completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/31/21 2nd dose01/21/21 Diagnosed covid positive:09/01/21 Symptom onset:09/01/21 Exposure:Home Symptoms:fever, cough,runny nose,HA,chills, nausea.
developed swelling in the unspecified arm where she was administered the dose; This spontaneous report was received from a physician via company representative referring to a female patient of unknown age (reported as over the age of 65). Information about patient's concurrent condition, medical history, concomitant medication, drug allergy/reaction was not reported.   On 25-NOV-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose number, route, anatomical location, lot/batch #, expiration date was not reported) for prophylaxis (reported as vaccination).  On 25-NOV-2019, the patient experienced swelling in the unspecified arm where the dose of vaccine was administered, from her shoulder to elbow(peripheral swelling). No product quality complaint was involved. The outcome of peripheral swelling was unknown. Reporter's causality assessment was not reported.
A Moderna Bivalent BOOSTER shot was given today instead of a Moderna PRIMARY series. Patient intended to begin his covid series today and  a miscommunication led to the patient receiving the booster vaccine ahead of a primary series first dose.
not signs or symptoms reported. No other AE or PQC reported; a temperature excursion on ROTATEQ, ROTATEQ was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 27-OCT-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength was not reported, lot # T040208, expiration date was 19-JUL-2022)  1 time dose, orally for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 34.03 F for a time frame of 5 minutes (occurred on 26-OCT-2021). There were no previous temperature excursions. No digital data logger was reported. There was no not signs or symptoms reported. No further adverse event (AE) information was provided (no adverse event).   This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2111USA000689: US-009507513-2111USA000286:
Dizziness, Lightheadedness, right throat started after 2 minutes and continued to get worse. Altered consciousness began. Anaphylaxis started approximately 25 minutes after vaccine.
Received flu vaccien at flu clinic - 10-26-13 developed face swelling, esp eyelid swelling, some SOB, itchiness, noted hives on chin - approx 8 hours after vaccine - took BENADRYL 50mg at 21:00, woke up on Sunday 10-27-13 still had swelling took another 50mg BENADRYL -Monday 10-25-13 symp resolved.
After receiving a second anthrax vaccine, I suffered a severe allergic reaction that required hospitalization. The symptoms included skin rashes, hives and difficulty breathing. I will provide more details after receiving my records.
p/vax pt exp swelling, pain & redness @ the site of inj (which was the size of an orange);pt was seen by MD 5/21/99 who said that pt inj site looked like cellulitis;pt outcome unk;
broke out in spots that are red and raised like pumped up on her belly; her skin is turning red; itch on the spots; This is a spontaneous report received from a contactable consumer (patient's husband). A 77-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number: EM9810; Expiration date were not reported), via an unspecified route of administration in the right arm on 11Feb2021 16:00 (at the age of 77-years-old) as dose 2, single for COVID-19 immunization at a clinic. Medical history included allergy to shellfish from an unknown date and unknown if ongoing. The patient has no concomitant medications. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3246) via an unspecified route of administration in the right arm on 21Jan2021 16:00 (at the age of 76 years-old) as dose 1, single for COVID-19 immunisation and experienced broke out in spots that are red and raised (that were like little bites, like welts that stay for two or three days and then they go down). No other vaccine was received by the patient in four weeks. On an unspecified date after the second dose, the patient broke out in spots that are red and raised like pumped up on her belly and her skin was turning red and itch on the spots. Events resulted in a physician (dermatologist) office visit. Treatment with a cream and rubbing alcohol were taken for the events.  The outcome of the events was not recovered. The reporter was querying if the events were normal and how long will the events last.  No follow-up attempts are needed. No further information is expected.
Patient came into the office on 4/30/2020 for their well child visit. The patient was due for Dtap. The physician ordered Dtap but Pediarix was given. This unfortunately was not caught until I came back from leave on this week. A physician will be calling  the patient either today or next week to discuss what happened and to answer any questions the parents may have and to determine if the child would need to be re vaccinated. At this time, the parents have not reported any adverse reactions from the vaccine given. My manger is aware of the situation and the employee that is responsible for the error will be counseled.
Severe pain and stiffness in shoulder, arm, muscles, and fingers of injection site lasting over a week.
No adverse event; The patient received the first dose on 27-Feb-2023 and second dose on 20-Mar-2023; The patient received only 0.2 ml of second dose; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received the first dose on 27-Feb-2023 and second dose on 20-Mar-2023), UNDERDOSE (The patient received only 0.2 ml of second dose) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1417B and AS1417B) for COVID-19 prophylaxis.     The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 27-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .2 milliliter. On 20-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received the first dose on 27-Feb-2023 and second dose on 20-Mar-2023) and UNDERDOSE (The patient received only 0.2 ml of second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received the first dose on 27-Feb-2023 and second dose on 20-Mar-2023), UNDERDOSE (The patient received only 0.2 ml of second dose) 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 assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received the first dose on 27-Feb-2023 and second dose on 20-Mar-2023) and UNDERDOSE (The patient received only 0.2 ml of second dose).    No concomitant medications were provided. The patient had received Influenza vaccine also on 27-Feb-2023. The medical assistant needs to know if there were any contraindications of getting the COVID vaccine 7 days early.  The patient did not experienced any adverse reactions. No treatment medication was provided.
Information has been received from a hospital nurse concerning an elderly female pt who was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. The nurse reported that the pt at a hospital became very ill and turned gray after being administered pneumococcal 23v polysaccharide vaccine. It was noted the therapy was discontinued and no treatment was required for the adverse event. It was noted the supervising physician info was not known and no other info was available. There was no product quality complaint reported. Unspecified medical attention was sought. Upon internal review became very ill and turned gray were determined to be other important medical events (OMIC). Additional info has been requested.
Patient was 15 years and 5 months at time of receiving the vaccine. Clinic nurse had patient's mother sign a consent form to receive the vaccine, but she did not realize that the patient was 15 and the vaccine was only approved for patients 16 and older. Patient's mother stated that the patient had obesity and other comorbidities that put him at high risk and that his physician had recommended that he get the vaccine. Patient had no issues or adverse events from the vaccine. Notified patient's mother, and patient will wait to receive 2nd dose until he is 16 per clinical guidelines.
This spontaneous report as received from a healthcare worker/certified medical assistant refers to 3 patients of unknown demographics. The patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L027733, expiry date: 13-SEP-2017) that was exposed to the following conditions: Temperature of 47.3F for 1 hour and 24 minutes. There was no previous temperature excursion. The temperature excursion was because of a data logger. It was confirmed that the improperly stored vaccine was administered to the patients. No adverse symptoms reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax 2JUN95 & 11JUL95 pt presented w/five generalized lesions which the nurse felt were related to vax;No further details were provided;
Approximately 2 hrs after receiving vaccination she broke out in a fire rash on her neck, face and arms. Says rash is similar to the one she gets with erythromycin. She reported that her throat felt tight. Instructed to take Benadryl which helped symptoms.
pt recv vax;fainted,became pale & clammy, appeared to have sz type movements, was disoriented when regained consciousness; pupils dilated but not fixed;
Initial event of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial event of COVID-19) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Obesity. Concurrent medical conditions included Drug allergy (Name of the drug was not reported.). Concomitant products included OMEPRAZOLE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    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 COVID-19 (Initial event of COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial event of COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19. The patient previously did receive a COVID-19 Vaccine. Reporter reported Paxlovid Rebound 4 days after treatment ended.  Device date was reported as 04Jun2022. Company comment: This spontaneous case concerns a 42-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment SARS-CoV-2 test was positive as on unspecified date. It was reported that Paxlovid rebound 4 days after treatment completed. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 42-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment SARS-CoV-2 test was positive as on unspecified date. It was reported that Paxlovid rebound 4 days after treatment completed. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
1st dose 02Mar2021; 2nd dose 14Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 02Mar2021; 2nd dose 14Apr2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 02Mar2021; 2nd dose 14Apr2021). On 14-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 02Mar2021; 2nd dose 14Apr2021) had resolved.            No concomitant medication were reported. No treatment medication were reported.  Did not have the reactions after she got the 1st 2 doses, were reported.   This case was linked to MOD-2021-403149 (Patient Link).
Dizziness from time to time; Irregular menstural; Headaches; This is a spontaneous report from a contactable healthcare professional, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced dizziness from time to time, irregular menstrual and headaches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, irregular menstrual and headaches were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patient of unknown age. The nurse reported that the patients might have received PROQUAD (Merck) (lot#H015787, exp 24-FEB-2014) that was exposed to 45F for 3 weeks (504 hours). The temperature excursion had been determined to be unsupported by in-house stability data. There were no adverse symptoms reported. Follow up information received which reported that lot number H015787 was verified as valid lot number for PROQUAD (Merck). Follow-up has been received from a healthcare worker, who reported that, on 21-MAY-2013, a patient was administered a dose of PROQUAD (Merck) that had been exposed to 45 F for 3 weeks (504 hours). No adverse symptoms were reported. This is one of three reports from the same source. The other linked reports are: MARRS# 1305USA016986 and MARRS# 1306USA001036. Additional information has been requested.
Just below left knee and knee joint. Hard to walk. Placed ice pack on to relieve pain. Lasted into next day and then pain was gone.
6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; 6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; This is a spontaneous report from a non-contactable consumer (patient herself). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on the left arm, on 26Feb2021 10:15, at a single dose, for covid-19 immunization. Medical history included allergies: bee stings and sulfa drugs, AFIB (not had AFIB for 3 years) and, had a confirmed case of COVID on Jan2021 (reported as 1 month before vaccination). Concomitant medication included unspecified medication for AFIB. The patient experienced 6 hours of AFIB on 27Feb2021 10:15, 24 hours after first dose. The patient was taking a medication for AFIB (concomitant medication) and have not had AFIB for 3 years. The patient recovered from the adverse event on 27Feb2021 16:15 with no treatment received for it. The patient was not covid-tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
I95.9 HYPOTENSION 11/22/2021 ATRIAL FIBRILLATION, UNSPECIFIED I95.9 HYPOTENSION 11/22/2021 ABNL LIVER ENZYMES I95.9 HYPOTENSION 11/22/2021 PROCTITIS