chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling; redness about size of pancake; Soreness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness about size of pancake) and VACCINATION SITE PAIN (Soreness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness about size of pancake) and VACCINATION SITE PAIN (Soreness). At the time of the report, VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness about size of pancake) and VACCINATION SITE PAIN (Soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not provided.    Reporter did not allow further contact
SICK; FEVER; THROWING UP; MASSIVE HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sick, fever, throwing up, massive headache, and fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103, 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throwing up, was recovering from fever, had not recovered from massive headache, and fatigue, and the outcome of sick was not reported. This report was non-serious.
30 minutes after MMR vaccine (R) arm - hives/urticarial rash: face-behind ears, upper torso and back-then resp. disorder. BENADRYL elixir given - Epi-pen JR x 1 given.
Immediate reaction within seconds after injection. I felt this whoosh sensation, something shoots up into my head. Was it blood shooting up into my head?   It happened so quick, 1 or 2 seconds, then ended.  After a minute or so, I felt some tightness in the area around my eyes. Tightness lasted for about 3 hours.   No shortness of breath,  No itchiness, No hives. I am now concern what to do.  Shall I take the 2nd dose of Pfizer vaccine? Note:  This was my first Pfizer covid vaccine
All over itching and mild nausea began about 4 to 5 hours after dose.  Itching was bad enough to prevent sleep that night.  The itching subsided by morning.  The nausea continued for 2 days.  Dizziness occurred after 24 hours and continued for an entire day.  General fatigue occurred withing 4 to 5 hours of the shot and continued for 2 days.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 19th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, fever and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site erythema, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, fever and chills to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. Less than 24 hours later, the patient called to report redness at the injection site, fever and chills. The batch number reported for SHINGRIX (3V4KL), did not exist and was updated to 3Z4KL, as per sales database. The reporter was unable to provide much details.
a relative who experienced T along with some other symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).   A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "a relative who experienced T along with some other symptoms".  Follow-up attempts completed. No further information is expected.
Pinky finger and ring fingers are numb and tingly. Went to doctor. She stated it was OK and that it would subside in 2-6 months.
Large localized swelling at injection site, progressed to the point of causing circulation concern, tingling in fingers.
Swollen lymph node under that arm and pain up to neck, extreme fatigue for two months after, on and off fever 1 night. Brain fog- months after...overall unwell feeling.
Stiffness of the neck, pain on the back of the head. As per doctor, inflammation due to the vaccines cause the neck stiff neck
arm sore for a few days-trouble breathing;mucus (excessive in throat);pimple like formation in nose;muscles sore, ankles, legs joints, rt fingers progressive;
This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old male patient who experienced intussusception. At 15 months of age, the patient received the first dose on 06-Oct-2010. The patient also received a dose of DTP (manufacturer unknown), a dose of Influenza vaccine (Not Specified) and a dose of HIB (manufacturer unknown) on 06-Oct-2010. The patient experienced intussusception on 07-Oct-2010 with symptoms of lower quadrant pain and swelling accompanied by vomiting. On 08-Oct-2010 he was taken to the emergency room and a tube was inserted into his rectum so that air could be introduced to the bowel. The treatment was successful and the patient recovered and was discharged to home. The patient was not admitted to the hospital. The physician suspects that any of the vaccinations received on 06-Oct-2010 could have a causal relationship to the events that followed, however he has never heard of these events associated with PREVENAR 13. No additional information was available at the time of this report.
Patient reported a burning sensation at time of administration, then reported soreness of her arm. Patient reported that arm from elbow to shoulder was sore, and that she could not lift that arm. Soreness persisted for 3 days before patient sought medical attention.
1.  Tingling down left arm down into forearm, followed by tenderness.  Began having muscle spasms in arm.   2.  Headache and body aches developed, felt like she was being electrocuted.  Low grade fever. 3.  Later in the evening, began feeling hot with unbearable headache.  Temperature 104.5 F. 4.  Became dizzy.  Went to ED with severe pain in rib cage on inspiration and unbearable body pains..  elevated HR, tachycardia. 5.  Exhaustion and fatigue.
Rash looks worse in morning; Symptoms spread to stomach; Blotchy; Told by Medical Doctor "its a reaction to the vaccine; Itched like "crazy"; Red; Rash from shoulder to hands on injected arm; Symptoms spread to right arm; This case was initially received via European Medicines Agency (Reference number: 128231) on 26-Mar-2021. The most recent information was received on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchy), VACCINATION COMPLICATION (Told by Medical Doctor "its a reaction to the vaccine), PRURITUS (Itched like "crazy"), ERYTHEMA (Red) and INJECTION SITE RASH (Rash from shoulder to hands on injected arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH MACULAR (Blotchy), VACCINATION COMPLICATION (Told by Medical Doctor "its a reaction to the vaccine), PRURITUS (Itched like "crazy"), ERYTHEMA (Red), INJECTION SITE RASH (Rash from shoulder to hands on injected arm) and RASH (Symptoms spread to right arm). On 25-Mar-2021, the patient experienced RASH (Symptoms spread to stomach). On 26-Mar-2021, the patient experienced RASH (Rash looks worse in morning). The patient was treated with TRIAMCINOLONE at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Blotchy), VACCINATION COMPLICATION (Told by Medical Doctor "its a reaction to the vaccine), ERYTHEMA (Red), INJECTION SITE RASH (Rash from shoulder to hands on injected arm), RASH (Symptoms spread to right arm) and RASH (Symptoms spread to stomach) outcome was unknown, PRURITUS (Itched like "crazy") had resolved and RASH (Rash looks worse in morning) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient said she had some breaking out in February, 2021 from the first shot of the  vaccine. She had to go to the hospital to receive an antibody shot. Treatment medication include Steroid cream(unknown name), Steroid injection, Steroid taper and Zyrtec. Patient had allergies to food and environmental. Rash was exacerbated by heat/sunlight     Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant information picked from initial source document such as Vaccine information. Treatment medication added from  initial. Product indication for Synthroid updated. Event outcome for iching was added from  initial. Event Rash deleted.
Later that night I felt ok, but the next morning I was just done. It lasted about 3 or 4 days. I had a fever that came and went and had chills all night the night of the vaccine. I just felt really sick and didn't want to do anything and had flu like symptoms. I rarely get sick so this was strange for me.
Patient went to the Emergency room in distress and was diagnosed with  Pulmonary Embolism secondary to  Deep Vein Thrombosis.  The patient was started on Eliquis.
Customer came in 3/5/16 and stated that she suffered from immobility in her vaccinated arm. Stated it started gradually and got worse. Had to Dr for Xray/cortisone shots/therapy. Completed therapy 3/1/16 and is feeling better. Stated she was told IMZ should have been given in back of arm. Stated she couldn't raise her arm but had no pain or swelling.
104.1f fever; Violent shaking; Terrible stabbing headache over eyes; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE0153) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 02Apr2021 at 07:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 05:00, the patient experienced 104.1f fever, violent shaking and terrible stabbing headache over eyes. On 23Apr2021, the patient underwent body temperature test and the result was 104.1 fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, 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 104.1f fever, violent shaking and terrible stabbing headache over eyes were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Flu like symptoms occurred day after vaccination lasted 24 hrs. 48 hrs after vaccination experienced facial rash. Rash is still active 6 days later.
Severe agitation resulting in no or minimal sleep for 5 days, hair loss on various parts of my body, and tinnitus.
the booster; blood sugar rise; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization, reaction(s) Blood sugar rose after they've had the shots each time; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization, reaction(s) Blood sugar rose after they've had the shots each time. The following information was reported IMMUNISATION (non-serious) with onset 2021, outcome unknown; BLOOD GLUCOSE INCREASED (non-serious) with onset 2021, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-202101742491 same vaccine, and different patient; US-PFIZER INC-202101742407 same vaccine, AE, and different patient; US-PFIZER INC-202101742765 same patient, different dose/AE. US-PFIZER INC-202101744009 same vaccine, AE, and different patient; US-PFIZER INC-202101744010 same vaccine, AE, and different patient.
Unusual feeling in her feet/Ice running through feet,iciness in hands and feet; This case was reported by a physician via call center representative and described the occurrence of abnormal sensation of limbs in a 68 years old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in October 2021).   On 8th March 2022, the patient received the 2nd dose of Shingrix. In March 2022, 24 hrs after receiving Shingrix, the patient experienced abnormal sensation of limbs. On an unknown date, the outcome of the abnormal sensation of limbs was not recovered/not resolved.   It was unknown if the reporter considered the abnormal sensation of limbs to be related to Shingrix.  Additional details were provided as follows:  This case was reported by patient's husband, who was physician. The patient received the 2nd dose of Shingrix vaccine in left upper arm, 2 days ago from the day of reporting and 24 hours later experienced an unusual feeling in her feet ice running through her feet (iciness in hands and feet), that was still on going.  The reporter would like to know if this had been reported.  Health care professional (HCP) did not had lot number and expiration date available.  The representative spoke from content and provided package insert (PI).  The reporter was provided Medical Information's telephone number and website.  Call abandoned by reporter whist transferring call. Consent obtained from reporter to contact for follow-up with consumer and HCP. The reporter gave consent for safety team to follow up.
Information has been received from a consumer concerning her 36 month old child who on an unspecified date was vaccinated with 0.5 ml MMR II (lot # not reported).  On an unspecified date the patient experienced autism.  It was unspecified if the patient sought medical attention.  At the time of reporting, the patient's outcome was unknown.  Upon internal review, autism was considered to be another important medical event.  Additional information has been requested.
no adverse effects reported; expired pneumovax 23 was administered; This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. The patient's medical history, concurrent conditions, drug allergies or reactions and concomitant therapies were not reported. On 15-MAR-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly, lot # N020501, expiration date:03-MAR-2019(dose, dose number not reported) for prophylaxis. The pharmacist stated that expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was administered(expired product administered). No adverse effect was reported. The outcome of expired product administered and no adverse event were unknown. No product quality complaint was involved.
Pt received vaccine 10/25/21. On Tuesday 10/26/21 had body aches & fever while going down the stairs to get some medication got hot, sweaty, lightheaded and passed out hit her head. Her fiancé called 911 and she was taken to the ER for evaluation.
lips swelling started wheezing by the time pt got home went to ER was given epi & steroids IM was better by late afternoon; SOB-diff breathing; some trouble swallowing; anaphylactoid rxn to MMR;
Onset of fever, chills, abdominal cramps and diarrhea, progressed to severe diarrhea and vomiting and by Tuesday morning 09/30/14 he was so dehydrated and had not urinated since Sunday night. I took him to the ER for fluids and they drew lab work that came back positive for campylobacter. Not sure if this was related to the immunization but I wanted to make sure it was reported.
Patient experienced headache after shot. She also had a little dizziness. Had her sit for a while. Gave her 2 ibuprofen OTC for headache. Gave her some water. Took blood pressure and was normal. Patient felt weak. Feeling better after an hour or so.
This spontaneous report as received from an other health professional refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # M036057 or N000238 or with improperly stored dose GARDASIL 9 lot # M032650. No adverse effects were reported. Additional information has been requested.
fever 103.4 x 3 1/2 days; lethargic, yet fussy & irritable;
22AUG91 fever to 104 during nite; Given APAP & sponged w/ cool water; continues to have fever 103;
Narrative: COVID infection following COVID vaccine series 08/12 Janssen, dose #1 09/13 pt cc: chills, cough, diarrhea, fatigue, fever, headache, rhinorrhea, sore throat exposure; unknown 09/17 COVID swab, result: detected
Patient had first generalized seizure 1 mos after receiving 3rd HPV shot has had severe subsequent seizures.
This spontaneous report was received from a pharmacist via company representative, and refers to an elderly male patient in his 70's or older. Concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot and expiration date were not provided) by "injection" route). There were no concomitant medications and co-suspect therapies reported. On an unknown date, after the vaccination with ZOSTAVAX, the patient developed shingles in his eye, herpes zoster disseminated and herpes zoster infection neurological (reported as "spread to the optic nerve and brain). A year later, on an unspecified date, the patient died. It was unknown if an autopsy was performed. The outcome of ophthalmic herpes zoster, herpes zoster disseminated and herpes zoster infection neurological were unknown. The causality between the events and the use of ZOSTAVAX was not reported. Upon internal review, the events of ophthalmic herpes zoster, herpes zoster disseminated, herpes zoster infection neurological and death were considered medically significant. Additional information is not expected due to permission to contact the reporter was not granted.
Bexsero administered instead of Menactra; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB02BA, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 30th August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The reporter was a clinic administrator. Age at vaccination was not reported. The patient received a dose of Bexsero instead of Menactra which led to wrong vaccine administered. The reporter consented to follow up.
Patient reported red, swollen sore (~5 inches in diameter) that developed the same night she received the vaccine. She also reported a fever that lasted for 5 days. Outcome unknown.