chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had 4 immunization today approximately 10 minutes after injections patient very pale, weak, sweating in waiting rm had good breakfast at home before shots - BP decreased 86/48 - No radial pulse - carotid pulse 86- took too long for patient to recover-MD advised go to ER/EMS.
STATES SHE FELT HOT AND THIRSTY STATES LOST HER HEARING FELT NAUSEATED
Had COVID 2 months earlier and reported joint pain pronounced and reports extreme pain.  Patient reports she felt as if pain after vaccine was worse and as if he had covid again.   Patient reports pain was severe again not versus having other immunizations.
This spontaneous report as received from a medical assistant refers to 12 months infant patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a safe visit from local health department on an unspecified date. No adverse effects was reported. Additional information has been requested.
Incorrect dose administered after CDC changes discontinue monvalent.  Patient received Moderna Bivalent Pink cap/yellow label. 0.2ml/10ug.
This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 18-year-old male patient who received BEXSERO for prophylaxis. Concomitant products included BEXSERO. On 17th July 2018, the patient received the 2nd dose of BEXSERO. On 17th July 2018, less than a day after receiving BEXSERO, the patient experienced injection site lump and injection site discoloration. On 19th July 2018, the patient experienced neck pain. On 3rd August 2018, the patient experienced coldness of lower extremities, lower extremities weakness of and tingling of extremity. The patient was treated with ibuprofen and Warm Compresses. On an unknown date, the outcome of the neck pain, coldness of lower extremities and lower extremities weakness of were not recovered/not resolved and the outcome of the injection site lump was recovered/resolved and the outcome of the injection site discoloration and tingling of extremity were unknown. It was unknown if the reporter considered the neck pain, coldness of lower extremities, lower extremities weakness of, injection site lump, injection site discoloration and tingling of extremity to be related to BEXSERO. Additional details were provided as follows: The reporter was the patient's mother. The patient received BEXSERO in the right arm and that afternoon the injection site looked splotchy and there was a lump the size of a grapefruit. On 19th July 2018, 2 days after vaccination the patient experienced neck pain in the back at the hairline above the spine. The neck pain was worse in the morning. The doctor recommended warm compresses and ibuprofen for the neck pain. It did not resolve and was worse the following day. A day before the reporting date, the doctor examined the area ruled out the cause as muscle related. On the reporting date, 17 days after vaccination the patient's left leg felt weak and cold from the shin down to the foot. She described it as feeling colder than the right leg and slightly tingly. The patient had denied permission to contact their physician. This case has been linked with US2018140221, reported for same patient for 1st dose.
Relates "This was the worst Migraine I have ever had in my life"  Reports she had chills and temp of 100.0 Had dizziness and sensitive to light Reports she was told not to take any Tylenol or Ibuprofen for 3 days Phone call to her provider and was told she could take something for her HA
This spontaneous report as received from a registered nurse refers to a 12 months old patient. The patient was accidentally received two doses of live (Merck) VARIVAX (lot number unspecified) on 29-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The patient's outcome was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Shortly after administration, patient reported sensation of swelling in the neck arear and tongue. Administered 25mg benadryl with no relief after 10 minutes, patient extremely anxious. Received consent to administer Epipen, administered with no change in symptoms. Contacted EMS and patient was transported to ER. Approximately 3 hours later, followed up with patient and she reported she was okay .
pt recvd vax exp pain in shoulder which comes & goes;sx have cont over 6months;
C/O sudden onset of dizziness and nausea, resolved over time. Immunization site red, raised, warm. Approx. 1" x 2" area, painful. Took 25 mg oral BENADRYL @ 4:45 PM.
red circle under arm; itchy circle under arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red circle under arm) and RASH PRURITIC (itchy circle under arm) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red circle under arm) and RASH PRURITIC (itchy circle under arm). At the time of the report, ERYTHEMA (red circle under arm) and RASH PRURITIC (itchy circle under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No Treatment medications reported.
weak; Dizziness; very nauseous; Nervous; This is a spontaneous report from a contactable .  A patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3248, Expiration date: unknown), via intramuscular, administered in top of left arm on 23Jan2021 around 09:30am  as 1st dose, single for COVID-19 immunization. Second dose was due on 11Feb2021. The patient medical history and concomitant medications were not reported. On 02Feb2021, 9 days and 14 hours after the vaccination, the patient experienced very nauseous, weak, nervous, dizziness. The events are assessed as non-serious.  Mostly she feels weak and very strong nausea. Now and then she has dizziness, but it is mostly strong nausea and weakness. She thought it was an anxiety attack and she realized today it was probably a reaction to the vaccine. Patient declines any treatment taken. The outcome of the events was recovered in 2021.  No follow-up attempts possible. No further information expected.
After several hours, my lips and throat began to swell, the next day, my lips were incredibly swollen and I could barely swallow , went to urgent care and was given an injection of a steroid which helped
Rash (Back); Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash (Back)) and MYALGIA (Body Aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RASH (Rash (Back)) and MYALGIA (Body Aches). At the time of the report, RASH (Rash (Back)) and MYALGIA (Body Aches) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Onset of sore throat, runny nose, body aches, malaise beginning 1 week after flu shot. fever 103 for three days, vomiting. Test for strep -negative. Red bumps on torso, peeling of hands. 10 days later progressed to ear infection. Eymin RX for ear infection.
tingling sensations in hands and fingers the day after, leg cramping especially at night became progressively worse, top of right foot became sore and painful couldn't walk, a lot of fatigue
The patient arrived at the pharmacy on 10/23/23 and filled out a consent form for a covid-19 vaccine. After completing the consent form, the pharmacist processed the form incorrectly as Fluad Quad flu vaccine and failed to verify the vaccine with patient. The vaccine was then given to our staff nurse to administer to the patient and again was not verified with the patient. As a result, the patient was given a flu shot and not a covid-19 vaccine as requested. The patient then contacted the pharmacy later after noticing their paperwork talked about the influenza and not covid-19. The pharmacist on duty verified the error after pulling the original consent form and inquired about side effects or other issues. The patient reported no side effects or ill harm, however, was frustrated that the wrong vaccine had been given. After talking with the on-duty pharmacist, the patient  was very understanding of the error and decided to come back to the pharmacy on 10/25/23 to receive his covid-19 vaccine. This vaccine was given without any incident.
Patients father filled out an online form to sign his child up for a vaccination at pharmacy. When the dad put the DOB in the system registered patient as a 12 year old. DOB was actually five years younger, when the technician went to change the DOB the system did not alert us of the age change and the technician did not catch the change going from 12 to 7. So a child should have received the pediatric pfizer got the adult dose.
Mmr vaccine 9/12/19 to twin one year old boys. 8 days later have rash, 102 fever, projectile vomiting.
Acute deep vein thrombosis (DVT) of popliteal vein of left lower extremity
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: PATIENT EXPERIENCED NUMBNESS ON ONE SIDE OF FACE FOR A FEW DAYS AND HAD A HEADACHE AND SAID POTENTIAL RACING HEART/TIGHTNESS BUT ALL RESOLVED WITHIN A FEW DAYS TOLD HIM TO GO IN TO DOC IF IT REOCCURS
Injection site swollen, red. Adverse events. Pharmacist counseled patient to monitor for 24 hours. If symptoms persist, go to MD office/ER.
Dose 1: Seven days after the injection the injection site became red, swollen, and itchy.  Dose 2: The night of the injection 1/20/2021 there was redness at the injection site, swelling, and itching. The employee also had a head ache, muscle pains, fatigue, nausea, cough, and swollen gland for about 48 hours.
Nausea, bad headache, stomach ache, inability to sleep, sore arm starting 8 hours after second shot and continuing throughout the night and following morning.
feeling discomfotable at the injection site; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer, the female patient of an unspecified age received BNT162B2 (Comirnaty) via an unspecified route of administration on 05Feb2021 (Batch/Lot number: UNKNOWN) as single dose for covid-19 immunisation. The patient medical history and concomitant medication was not reported. The patient had the vaccine this morning and was feeling discomfortable at the injection site on an unspecified date and wanting to know what pain relievers she can take. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
acute kidney injury; Initial information received on 22-Jan-2021 regarding an unsolicited valid serious case received from a pharmacist.  This case involves a patient of unknown age who was currently being in the hospital with acute kidney injury (acute kidney injury), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history included stem cell transplant.  Medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date (a year ago), the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(MRC5)/ HIB(PRP/T) VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) the patient currently being in the hospital with acute kidney injury (acute kidney injury) following the administration of suspect vaccine. The patient was hospitalized for this event.  Seriousness criteria was assessed as medically significant as per important medical event (IME) list.  It was reported Pharmacist had a patient in the hospital needing vaccinations prior to discharge and wanting to know if there was any information on using Pentacel on a patient post Stem cell transplant from a year ago. Pharmacist asked if Pentacel could be used in an adult who has had a stem cell transplant.  Lab data was not provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  Information on batch number was requested.; Sender's Comments: Sanofi company comment dated 28-Jan-2021: This case concerns a patient of unknown age who had acute kidney injury after vaccination with company suspect PENTACEL. The time to onset was compatible. However, patient's concomitant medications and laboratory data ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 03-NOV-2013, the patients were vaccinated with 9 improperly stored doses of VARIVAX, expiration date 27-MAR-2015 (dose, route of administration and lot# were not reported). There was no adverse effect reported. Data logger was not involved. There were no information about previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA007805.
pt recv vax 10AM & came back a/715PM to clinic p/being inconsolable since 1Pm-crying-fussy, t101.2, leg swollen & bruised;
Patient received 2nd COVID vaccine (Comirnaty), approximately 10 minutes after receiving vaccine patient reported dizziness, headache, shortness of breath, throat tightness, nausea. Lungs CTA.  Pulse 120, O2 95%, BP 129/87  Patient placed in wheelchair, taken to private exam room. Lungs CTA. Pulse 114, O2 95%, BP 178/84  Patient reports trouble swallowing and throat dryness, airway patent, small amount of water provided, trouble swallowing water- nausea and heaving without vomiting. Lungs CTA.  Patient taken to the ER for evaluation, syncopal episode at ED while waiting for evaluation- evaluated and discharged.
Pt in his mid-50's developed confusion, weakness and shakiness and was hospitalized with a dx of encephalopathy.  Pt remained hospitalized as of 04/12/1999.
Received PPV23 in left deltoid on 1-12-04.  Patient states that on morning of 1-13-04, her arm directly below injection site became "very red and hot to touch".  Presented at health dept. on 1-15-04.  Observed reddened from below site to midway upper arm into inner arm.  Hot to touch and sore per patient.  Sent to PMD.  Was given an antibiotic and instructed to return if no improvement. Patient states arem is "better" today with less soreness and redness.
Initial misuse report received from a pharmacist on 24-Sep-2013. A 80 year old female patient had received intramuscular (IM) FLUZNE HD (lot # U4713AA and expiration date unknown) on left deltoid on 10-Sep-2013., On 18-Sep-2013, she has experienced nausea, body aches, chills, tender injection site and lethargy for unknown length of tie. On 21-Sep-2013, she felt better but not completely. Documents held by sender: none
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of unspecified age and race/ethnicity received a single dose of TRUMENBA on an unknown date for immunization. Concomitant medications and medical history were not reported. On an unspecified date, the patient had a seizure. Outcome was unknown. The physician commented that the event did not occur directly after the dose of meningococcal group b rlp2086 and that the patient had other medical conditions. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
sweats; Coughs a lot; Feels like when you have the flu; No appetite; Big rash on the injection site; Chills; Itches a bit at injection site; Redness of the arm at injection site; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), COUGH (Coughs a lot), INFLUENZA LIKE ILLNESS (Feels like when you have the flu), DECREASED APPETITE (No appetite) and VACCINATION SITE RASH (Big rash on the injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included High cholesterol. Concurrent medical conditions included Seasonal allergy.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HYPERHIDROSIS (sweats), COUGH (Coughs a lot), INFLUENZA LIKE ILLNESS (Feels like when you have the flu), DECREASED APPETITE (No appetite), VACCINATION SITE RASH (Big rash on the injection site), CHILLS (Chills), VACCINATION SITE PRURITUS (Itches a bit at injection site), VACCINATION SITE ERYTHEMA (Redness of the arm at injection site) and VACCINATION SITE RASH (rash at injection site). At the time of the report, HYPERHIDROSIS (sweats), COUGH (Coughs a lot), INFLUENZA LIKE ILLNESS (Feels like when you have the flu), DECREASED APPETITE (No appetite), VACCINATION SITE RASH (Big rash on the injection site), CHILLS (Chills), VACCINATION SITE PRURITUS (Itches a bit at injection site), VACCINATION SITE ERYTHEMA (Redness of the arm at injection site) and VACCINATION SITE RASH (rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided patient has taken cough syrup but unknown
Patient received Pfizer COVID vaccine on 5/24/21 and 6/14/21. On 1/24/22, patient admitted to our inpatient med/surg unit with EKG changes s/p syncopal event during CT guided lung biopsy for RLL cavitary lesion, right apical pneumothorax, and incidental COVID positive status upon admission. As of today (1/26/22), patient is still admitted in our med/surg unit and patient did have fever on 1/25/22 (even though repeat COVID test was negative on 1/25/22).
Pain in my right hand and I could not write while I was studying also had a swollen arm.
RA; This is a spontaneous report from a contactable consumer reported for herself. This female patient of unspecified age received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient was watching the news last night and saw having a booster trial coming up. The patient had RA and also had some antibodies. The patient's husband and she were vaccinated against covid and were both interested in participating in this booster trial. Outcome of the event was unknown. Lot number has been requested.
Legs began to blister; Felt like a sunburn from inside out; legs look like raw meat; Could hardly walk; Legs are still swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (Legs began to blister), BURNING SENSATION (Felt like a sunburn from inside out), ERYTHEMA (legs look like raw meat) and GAIT DISTURBANCE (Could hardly walk) in a 60-year-old female patient 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 information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced BLISTER (Legs began to blister) (seriousness criterion hospitalization), BURNING SENSATION (Felt like a sunburn from inside out) (seriousness criterion hospitalization), ERYTHEMA (legs look like raw meat) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Could hardly walk) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERIPHERAL SWELLING (Legs are still swollen). The patient was treated with Manual therapy (treated legs with silver pads) for Peripheral swelling. At the time of the report, BLISTER (Legs began to blister), BURNING SENSATION (Felt like a sunburn from inside out), ERYTHEMA (legs look like raw meat) and GAIT DISTURBANCE (Could hardly walk) outcome was unknown and PERIPHERAL SWELLING (Legs are still swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated her legs began to blister, felt like a sunburn from the inside out. Patient states legs look like raw meat and she could hardly walk. The patient was admitted to hospital for an overnight stay. The patient stated to physician treated legs with silver pads and antibiotics. The patient stated she was due to visit physician on 03-Jun-2021 for a check up. The patient stated she was wearing compression socks on both legs currently and legs were still swollen.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
1-2 hrs post vaccination employee felt very itchy. 3-4 hrs post vaccination broke out in generalized hives. Received 25mg Benadryl at clinic then another 25mg Benadryl at immediate care. Resolved.
This spontaneous report was received from a physician (who was also the patient's mother) and refers to a 12 month old male patient. No medical history, concurrent conditions or concomitant therapies were reported. On 28-SEP-2015, the patient was vaccinated with a dose of M-M-R II (lot #, dose and route of administration were not provided). On 02-OCT-2015, the patient had a fever of 106 F and was lethargic. He was not moving around and only lying in one place. His face was red and he had some red bumpy spots on his feet. The patient was given TYLENOL, ADVIL, dextrose, Pedialyte and probiotics as a treatment for the events. The fever did not go below 102 F even with the TYLENOL, ADVIL and sponging him down in bath. On 03-OCT-2015, the patient was taken to his physician's office, where he was diagnosed with mild middle ear infection but the patient's physician did not feel the ear infection could had made the fevers go that high. The outcome of fever was recovered on 08-OCT-2015, the patient was afebrile, while the outcome of other events was unknown. The reporter did not specify whether any of the other symptoms had resolved. The relatedness between the events and M-M-R II was not reported. Additional information is not expected, as the reporter denied any further contact.