chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Constant Tinitus; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Constant Tinitus) and FATIGUE (Extreme fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007m20A and 017L20) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics (Sulfa allergy).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (Constant Tinitus) and FATIGUE (Extreme fatigue). At the time of the report, TINNITUS (Constant Tinitus) had not resolved and FATIGUE (Extreme fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab Data include Hearing test, ECHO and Lab investigations.  No Concomitant medications were reported. No Treatment information was reported.
Vaccine at 11:;50 am.  9:30 pm severe pain in left leg with cramps. then right leg but not as severe. pain all night, no sleep. Next day, severe pain back, upper left started about 4:30pm. then pain all over, muscular.  lasted al night.  Better next morning but still muscular pain.
17 yo patient with redness, swelling at site of BEXSERO injection. Erythema approx 10cm diameter with swelling/lump approximately 3cm size. Pt otherwise well - Supportive care with Ibup, Ice.
Diarrhea, Nausea, Dizziness, Lathargy, Was given regular flu and H1N1 at work.  Became sick next day with diarrhea.  Called family physician on 10/23/09 and they stated probably reaction to both flu shots at same time.  Still feeling dizzy and fatigued 10/24/09.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 05 February 2013. A 41-year-old female subject, who had a past medical history of: high blood pressure, chest pain, chest pressure, abnormal electrocardiogram (ECG), dizziness or fainting spells, shortness of breath, eczema, headaches and numbness or paralysis, developed other and unspecified angina pectoris, eleven days after receiving a injection of ACAM2000, SP Biologics Co., (lot number not reported) on 18 October 2012. On 29 October 2012, eleven days post vaccination, the subject was diagnosed with other and unspecified angina pectoris (ICD-9 Code 413.9). Troponin I result was reported as not available. On 21 November 2012: an ECG was reported as normal and an echocardiogram was reported as normal. Magnetic resonance imaging, (MRI) of brain, MRI of spinal cord, MRI of heart and lumbar puncture (spinal tap) were reported as not performed. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
6 1/2" x 13" area of erythema;infected inj site rx keflex;
The reason for this submission is due to patient stated verbally that she was here for 1st covid shot and also indicating on questionaire that she has not received any covid vaccines. I was documenting vaccination in chart when red flag popped up indicating that she was complete for covid vaccine. She had previously received the Johnson and Johnson vaccine on 04/28/21. She failed to mention this 3 times when asked. She then said that she wanted to get vaccinated with the Pfizor or Moderna due to the Delta variant and wanted better protection.  We informed her that this shot should not have occurred and she will need no further vaccination. She then requested to receive the 2nd pfizer shot and we informed that it was not necessary.
Janssen COVID-19 Vaccine EUA Roughly 1 hour after vaccination I started to experience nausea and fatigue. The fatigue continued for several hours until about 6-8 hours after vaccination. At that point I started to experience chills, muscle aches, and rash on my left arm (at injection site region) and over other parts of my body. Temperature at that time was still within normal range but close to 10 hours after I began to run a fever. Highest temperature at its peak was 100.3F. These symptoms continued into the night but began to considerably subside in the morning, close to 24 hours after vaccination. At this point, 26 hours after, I still feel mild muscle aches and a mild headache.
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Gas trapped causung tightness in chest.; Gas trapped causung tightness in chest.; Maternal Exposure During Pregnancy, third trimester; This is a spontaneous report from a contactable consumer, the patient. This is a maternal report.  A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7535), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took escitalopram (LEXAPRO) 25 mg, on unknown date for unspecified indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 13:30, the patient was exposed to vaccine during pregnancy (gestation period of 33 weeks) and last menstrual date was reported as 26Jul2020. On 20Mar2021 at 12:00, the patient experienced trapped gas causing tightness in chest. Therapeutic measures were taken as a result of chest tightness and included treatment with two antacids. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event chest tightness was recovering and of the maternal exposure during pregnancy was unknown at the time of pregnancy.  Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.
This is a refugee.  He developed a rash throughout his body that developed the day after the vaccination.  He was sent to the ED for evaluation and was diagnosed clinically with Measles.  PCR testing was completed and was PCR positive.  Sample was sent to CDC that confirmed PCR positive was from the vaccine.
Patient admitted with COVID-19.  He has had a total of 5 vaccines and boosters.
Got 1st COVID Vaccine (Moderna) 3/4/21  3 days later started w/facial itching redness 3/7/2021 next Day woke up w/facial swelling too.   Dx facial swelling Rx Solumedrol 125mg/IM    Prednisone 10 Day Taper 20 mg
Pain reports pain that bothers patient at site of injection. Patient states she has never experienced pain like this from any of her other vaccinations. Informed patient to see MD if pain is bothersome.
pt recv vax; presented to MD w/ measles sx; pt had a migratory measles looking rash over entire body;
Left upper arm developed circumferential swelling then redness, warmth, mild pain, within 24 hours of injection.  In the left deltoid area. Swelling and redness maximized at 36-48 hours with swelling extending distally to mid-line arm. No neurologic or vascular compromise occurred.
patients were vaccinated with expired vaccine doses; Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was JUNE 2022, However the vaccine expired on 01-Apr-2022.  It was confirmed that the vial didn't undergo temperature excursion issue.  Vaccine was placed in refrigerator on 04-Apr-2022.  No treatment medications were reported.
pt recvd vax;5 min later became dizzy & was passing out;also exp a low irregular heart rate & low BP;sx resolved w/in 10 mins;
He developed hives on his entire body and was given Benydryl. Hives subsided with Benadryl but reoccurred again the next morning. Unsure of whether this is temporary or chronic at this point. We will not proceed with other shots in the series, as this is definitely an allergic reaction. My son also says he is experiencing weakness in his legs.
pain, redness, swelling at the injection site, pt reported chills/fever on following day (but she also tested positive for COVID-19 on the day she reported symptoms)
Swelling to injection site, presents similar to cellulitis, pt states no significant history of adverse reactions but discloses sensitive skin and recurrent reactions with various environment exposures.
Acute left thumb pain, joint swelling and tenderness with palpable nodule. Ongoing over the course of 10 days requiring treatment with NSAIDS and steroids.
This form is being completed because the CDC rep said mine is a breakthrough case.  I had no unusual reacations to any of the two Pfizer vaccines or the Pfizer boosters.  June 14, exactly two months after the second booster, I developed Covid (variant unknown) while visiting our daughter and her family.  Seven of us came down with it.  All were fully vaccinated for their ages.  The three-year-old was not.  He was hit hard, but recovered.  Being that we were from out of state, my husband and I visited an urgent care facility to receive the (generic) Paxlovid combo drug.  Prior to the visit, I had been getting worse each of three days, so decided to seek out the pills.  After that I began to improve.
The night of the vaccine, I noticed that I was achy. I woke up the next day in pain at 5AM. I was in extreme pain. I had aches and pain all throughout my whole body that was severe. It affected my normal activities. I tried marijuana to help with the pain. The pain did go away. I went to bed but then by noon, about 24 hours later I was achy again but not as severe. I tried marijuana again and the second dose of that of that helped and the pain went away.
Pt tested positive for COVID-19 after vaccination. Pt experienced SOB requiring supplemental oxygen.
Very sore and red at injection site. Flu-liike symptoms (fever, chills, muscle pain, headache, malaise). Lost a whole day feeling sick. Happened with first shot and was worse with this second shot. Worst side effects of vaccine I've ever had. Told by pharmacist reaction might be worse because I I received ZOSTAVAX several years ago.
The day after receiving immunizations, the patient developed swelling of the upper arm and a 105 degree F fever. The patient went to his doctor and was referred to the hospital. The patient was kept in the hospital for 3 days until the symptoms subsided.
blisters; cold sores on her lips; This case was reported by a other health professional via call center representative and described the occurrence of blister in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number TJ35Z, expiry date unknown) for prophylaxis.   The patient's past medical history included cold sores (cold sores in her 20's).   On 3rd March 2020, the patient received the 1st dose of Shingrix. On 3rd March 2020, immediately after receiving Shingrix, the patient experienced blister and cold sores lip. On an unknown date, the outcome of the blister and cold sores lip were recovering/resolving.   It was unknown if the reporter considered the blister and cold sores lip to be related to Shingrix.  Additional details were provided as follows:  The reporter did not had the expiry date till the time of reporting.  The patient had history of cold sores when she was in her 20's was treated with a series of small pox shots and it was resolved  around 1968/69.  The patient received the dose of shingrix on and experienced blister and cold sores lip.  The patient did not had any other cold sore breakouts until she received Shingrix, treatment for this breakout was unknown.  The patient was suffering from cold sores and blisters are ongoing but the frequency was less.  The patient stated that would she get the 2nd dose.  The reporter consented to follow up
itchy rash; Redness on my face; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old male patient received unknown single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no:  Ep6955) via unspecified route of administration on the left arm on 17Mar2021 at 15:15, for COVID-19 immunisation. No medical history and the patient concomitant medications were not reported and he had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, at 12:30 the patient had itchy rash on the wrist about 30 hours after the vaccination, the rash spread overnight and itching felt worst and also the patient developed redness on the face. Treatment medications for the events included the use of BENADRYL. Also, it was reported that the redness on face improved after taking half a pill of Benadryl. The clinical outcome of itchy rash was not recovered and redness in the face was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Patient received the vaccine on Tuesday, and on Thursday morning he woke up and couldn't speak and was taken to the hospital and diagnosed with an ischemic stroke
Small joint pain. Bilateral hands, starting 24 hours after administration, worsened at 36 hours after administration. Bilateral SI joints, starting 36 hours after administration.; Small joint pain. Bilateral hands, starting 24 hours after administration, worsened at 36 hours after administration. Bilateral SI joints, starting 36 hours after administration.; This is a spontaneous report from a contactable physician (the patient).  A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number  Ej1685) via an unspecified route of administration on 23Dec2020 at 13:45 (at the age of 31-years-old) at an unspecified dose in the right arm for COVID-19 Vaccination. Medical history included Crohn's Disease (currently in remission) and Phenylketonuria from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was administered the vaccine in the hospital. Concomitant medication included mesalamine (MESALAMINE),pegvaliase pqpz (PALYNZIQ), vedolizumab (ENTYVIO), budesonide (UCERIS) and omeprazole (OMEPRA). The patient did not receive any other vaccines within four weeks prior to the vaccination. Starting twenty-four hours after administration, the patient experienced small joint pain in his hands bilaterally on 24Dec2020; this worsened at thirty-six hours after administration. The patient also experienced bilateral pain in sacroiliac joints (reported as "SI joints"), starting thirty-six  hours after administration. Treatment was received and included the administration of celecoxib (CELEBREX). The clinical outcome was reported as not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
patient had seizure the evening of receiving the vaccine; 11-Year-Old male patient; This is a spontaneous report from a contactable consumer or other non hcp. A 11-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at the of 11 years old, dose 1 via an unspecified route of administration on 11Nov2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had seizure the evening of receiving the vaccine on 11Nov2021 with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a Registered Nurse concerning her approximately 12 month old male with no medical history or drug allergies, who in 2006 was vaccinated SC with a 0.5 ml dose of VARIVAX (Merck) (lot # not reported). There was no concomitant medication. About a week later, the patient presented with a rash on his diaper line. No treatment was initiated. No labs/diagnostics studies were performed. On an unspecified date, the patient recovered from a rash on his diaper line. The patient sought medical attention via telephone call. Additional information has been requested.
24 Hours after admin, Pt developed arm swelling, diffuse hives. Seen in ER, diagnosed with cellulitis and allergic reaction. Treated with Rocephin, Benadryl I saw 12 hours after that, no signs of Cellulitis left, still with some hives increased slight swelling left UE.
This spontaneous report as received from a certified medical assistant refers to a male patient in his forties. Information regarding the patient's current conditions and medical history was not provided. On an unknown date in October 2015 and 07-APR-2016 the patient was vaccinated with RECOMBIVAX HB, dosing regimen, lot number unspecified) dose 1 and 2 respectively. No adverse events were reported. No laboratory tests were reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
On Thursday 19th, around 6pm I started to feel my face itching and there were hives around my eyes. Similar to mosquitoes or aunts bits. At 10pm on the same day my lips got swollen and I decided not to take anything for it since I thought it was just an allergic reaction. When I went to sleep, it seemed to have gone better; however the next day when I woke up to go to work. Not only I had my face swollen and with hives but it had spread towards my arms and legs, still similar to mosquitoes bits. I decided then to take Benadryl and around 10 AM while I was working my chest got tight and my throat started to close. It was difficult for me to breathe and speak. They took me to the ER were I was given an IV with anti inflammatory and an allergy medication.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. 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 not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient got sick with Covid (suspected clinical vaccination failure, and suspected covid-19 infection).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210955985-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a licensed practical nurse and refers to a 66 years old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-OCT-2015, the patient was erroneously vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, dose, route of administration and anatomical location were not reported) instead of ZOSTAVAX with the intention to prevent shingles. No adverse symptoms were reported. Additional information has been requested.
Patient returned on Friday 7/27 saying that her arm was red and sore, which had started the day after the shot. I advised her to keep an eye on it, ice if necessary and if it continued or worsened to contact her MD. Patient called again on Thursday Aug 3 and stated it hadn't gotten worse, but she now started itching and feeling like she had "shingles".
Left arm swelling and redness below injection site. 10/10 left shoulder/neck pain and throbbing
Headache; Body ache; Fatigue; Chills; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache), MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The Nurse did not have information such as dates of administration or lot numbers on the patients three previous Moderna Covid-19 vaccinations. Patient received her bivalent Moderna Covid-19 vaccine via the gluteal muscle on 28 OCT 2022. No treatment medications were reported.   This case was linked to MOD-2022-666065 (Patient Link).