chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said that she felt like she had a bad case of the flu. Aching joints, low grade fever, under eye redness and puffiness, slight nausea, fatigue and headache. Recommended treatment was BENADRYL, increase hydration, and MOTRIN to treat symptoms. Patient was told that duration was 1 to 3 days after the shot when symptoms may subside. We called 5/28/18 at 10:30 AM to check on patient and she is reported that she is doing fine with no signs/symptoms that she presented with on 5/27/18.
Headache, vertigo, body aches, rash from injection site across chest and back, metallic taste, meat aversion, fever 100.4, tremors, tachycardia, loss of appetite, nausea, increased intensity of tinnitus, muscle and balance issues, numbness in limbs, skin on fire in patches, increased nerve pain in feet
Information has been received concerning an adult patient who was vaccinated with 2 doses of varicella virus vaccine live. The patient sought medical attention and failed to seroconvert. Additional information has been requested.
Body aches; Diarrhea; Chills/Shaking chills; Headache; Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DIARRHOEA (Diarrhea), CHILLS (Chills/Shaking chills), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Urinary tract infection (urinary track infection on 03-JAN-2021 in the morning and given an antibiotic at urgent care.) since 03-Jan-2020. Concomitant products included LOVASTATIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills/Shaking chills), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea). On an unknown date, the patient experienced PAIN (Body aches). At the time of the report, PAIN (Body aches), DIARRHOEA (Diarrhea), CHILLS (Chills/Shaking chills), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 99 degree Celsius (Inconclusive) 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications were taken for blood pressure and other antibiotics. Treatment information in response to events was not provided.  Received Moderna vaccine while on antibiotic
feels unwell; joint pain; fever; nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feels unwell, joint pain, fever and nausea; all the events were considered as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Dizziness starting 20 minutes after vaccination. Slightly fast heartrate, sweating, anxiousness starting within 1 hour of vaccination. All of the aforementioned symptoms went away by approximately 5.5 hours after vaccination. Left arm sore starting several hours after vaccination, increasing during the 24 hours after vaccine, then went away by roughly 48 hours after vaccination.
First: April 25~27: Sore Arm, similar to a bruised muscle. Second: April 27 my right forehead just below the hairline and in the right ear area where the top of the ear meets the head, had minor itching and were turning red. On April 28. Hives began on my left arm's lower wrist and in the general area of my right leg's knee. The hives became more numerous in these areas until a general red rash condition was appearing  between them as well. By Saturday Morning May 1 the knee and wrist areas were noticeably red like a rash and hives were also appearing with itching below the right knee on the upper half of my shin, above this knee, on my right lower wrist and on my left lower fore arm.  My right ear was starting to swell at just the top. I tried putting Gold Bond Medicated Powder on these areas, but it didn't reduce the itching much.      Sunday May 2, I called my mom who is a Registered Nurse about this. She advised going to my health care provider to substantiate these symptoms. Monday May 3 I visited my health care provider's office after work and got an appointment for Tuesday at 10:15 from a cancellation. One of their RN's looked at my hives and rashes. New hives had now also formed on my left leg just below the knee on the back side. It was a red string of itching a couple inches long. I called my boss Tuesday so I could take the day off for the appointment and he agreed that I should do  this. At the doctor's office, PA-C after extensive questioning and examination said he thought this was an allergic reaction possibly related to the polyethylene content of the vaccination. He further advised that I not get the second shot until I was checked by an allergist. He put in a referral for this. I think I picked up cold-like symptoms (sore throat and cough) from the doctor's office that were minor.      Wednesday morning I had much worse symptoms. I was weak, groggy, couldn't think without great effort, was more itchy, and my right knee was starting to ooze. I called my boss at work to take the day off since I was quite sure driving would be risky, and that I would have to leave work early for lack of energy. My right front thigh had a new area of hives along with my right and left fore arms. I started treating all my affected areas with Caladryl topical Analgesic and taking generic Benedryl. I had breakfast and then slept until 2:30 PM, had lunch and slept until evening. By then my forehead and right ear areas had reduced in severity. I had lost (2) days of work. The rest of the week, all my symptoms diminished. As of this writing Sunday May 9, my knee is still tender, sore, and red, and left wrist hives are still pronounced.
pain on the left hand, second finger; joint pain; swelling; This is a spontaneous report from a contactable consumer, the patient. A (age: 73, unit: unknown) male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 06Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced pain on the left hand, second finger, joint pain and swelling. Reporter stated that he saw his HCP and had been advised to take Tylenol. Reporter also stated that he was not sure if this was from something else or the vaccine. The outcome of the events was unknown.   Follow-up attempts were completed. No further information was expected.
3 vccines administered on 4/3/2014. Pain in left upper arm; inability to raise arm fully. After 5/3/2014 vaccine, pain in right upper arm as well but also into shoulder and up neck.
NOT FELT WELL; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (NOT FELT WELL) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Rheumatoid arthritis.    Concurrent medical conditions included Hidradenitis suppurativa and Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (NOT FELT WELL). At the time of the report, MALAISE (NOT FELT WELL) had not resolved.            No information on concomitant medication were reported. It was unknown if patient was enrolled in COVID-19 vaccine trial. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event (s) NOT FELT WELL was not provided. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
COVID-19 Moderna vaccine given as 2nd dose vaccine  when Pfizer vaccine was given as 1st dose COVID-19
I experienced the day after my vaccine my right breast hurt so bad that I could not sleep.  I also had a total breast reconstruction January 2012.  My symptoms lasted a couple of days then they resolved.
Tired beginning 10 hours after injection.  chills beginning about 12 hours after injection continuing for 4-5 hours. fever was only 99.5 degrees but shivering was very strong.  minor headache next day.
uncontrollable crying for 2 1/2 to 3 hrs p/shot low grade fever;
Chills, extreme shivering, 100°fever started in 23 hours and lasted about 10 hours. Took tylenol.  Also have very sore arm with  large red spot. Painful to lay on. Slept 9 1/2 hours at night then 3 hour nap the next day.
Fetal demise on 01/04/2040 at 16 weeks gestation.  Mother is concerned that the H1N1 vaccination is responsible for the fetal demise.
Chills, severe fatigue, weakness, dizziness, unstable on feet , nausea , GUM SWELLING, roof of mouth burning and pain  Tingling in hands and feet, loss of appetite.
He was seen in our clinic on February 12, 2021 and stated that he started having symptoms on Saturday 02/06/2021.  Unknown as to where he received treatment but stated that they put him on steroids.  When seen in our office, had slight droop to right side of mouth.  Patient states symptoms are almost resolved at that time.
9/18 HEADACHE, LIGHT MENSTRUAL BLEEDING 9/19 HEAVY HEADACHE PARACETAMOL 1 GRAM + IBUPROFEN 200 MG, LIGHT TO MODERATE MENSTRUAL BLEEDING 9/20 MODERATE TO HEAVY MENSTRUAL BLEEDING 9/21 HEAVY MENSTRUAL BLEEDING
No adverse event occured, however 2nd dose of pfizer pediatric 0.2mL vaccine was administered early on day 15. Standard interval is 21 days,. Pt reported no adverse events.
Rash on the right side where I had the Pfizer vaccination, rash on both arms; Seem like it has fever in because that area is warm, to the touch is warm and a little sore; Pain towards my ear, to my head; pain in my left ear and head; Itching; Headache; Swelling like almost that part of the arm where the injection site is; still was a little redness; where the injection site is, still was a little redness and still a little sore; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021(at the age of 82-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Rash on the right side where I had the Pfizer vaccination, rash on both arms , Seem like it has fever in because that area is warm, to the touch is warm and a little sore, Pain towards my ear, to my head; pain in my left ear and head, When I lean down I got like pump bump, but when I raise up it wouldn't be there it wasn't a continuous thing, Itching , Headache, Swelling like almost that part of the arm where the injection site is, still was a little redness and still a little sore. Consumer stated, It look like EN and then it look like X2O3, that's what it looks like I am not sure about that, I think it's ENX2O3. It might not be that, it might be 62O3, it might be that. All I know that last number is 62O3, it's EN something. Consumer stated, With the Itching I still have the little rashes on my arm and my arm is still a little sore, not as sore as it was yesterday but still a little sore with my head when I stoop down is not as bad. The event was not worsened. Patient did not take anything for that because that happened during the night while she was asleep. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included aspirin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 21:00, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
About 30  mins after, I had tingling in my left side of my face and arm. Next day started with body aches, then turned into flu like symptoms. Fatigue, low grade fever, chills
PATIENT REPORTED ABOUT 2 HOURS AFTER RECEIVING VACCINATION A TINGLING SENSATION IN ARM THAT RADIATED DOWN THAT OCCURS INTERMITTENTLY.  HE REPORTS THAT IT WAS MORE FREQUENT IN THE DAYS IMMEDIATELY AFTER THE SHOT & HAS NOW DECREASED IN FREQUENCY TO MAYBE ABOUT 4 TO 5 TIMES DAILY LASTING 2 MINUTES EACH TIME BUT HAS PLATEAUED.  HE DOES NOT NOTICE ANYTHING THAT PRECIPITATES THE TINGLING SUCH AS PHYSICAL ACTIVITY, AS HE IS PHYSICIALLY ACTIVE MULTIPLE DAYS A WEEK.  HE DOES NOT REPORT PAIN, JUST A WEIRD SENSATION.  HE HAS HIS YEARLY APPOINTMENT WITH HIS PRIMARY CARE DOCTOR MONDAY NOVEMBER 1ST & WILL DISCUSS WITH HIS PROVIDER THEN AS IT IS NOT CAUSING HIM ANY SIGNIFICANT ISSUE.
Drop in hearing and intense fullness along with worsening tinnitus on day 11 post vaccine.  Left ear is better ear and after all 3 covid vaccines, tinnitus in left ear increases to a much stronger and loud sound that can drown out voices.   Tinnitus in right ear worsens but not as dramatically as the left ear.  This has led to 15 day course of 50-60 mg prednisone that is not improving the pressure, hearing or tinnitus.  This same reaction happened with both Pfizer vaccines reported by the Facility on Day 10 1st vaccine and day 12 second vaccine.  Symptoms improved over the course of a year (however left ear never return to baseline) until receiving booster on 4/25/22.
I had 4 gallbladder attacks. I ended up getting gall bladder removal surgery.
Moderna COVID-19 Vaccine  Large red warm rashy itchy area around the injection site from upper arm towards the elbow on 4/1/2021, approx  15 days after injections; lasted about 3-4 days - self medicated with Claritin for a few days after reading on the web about Covid Arm as a side effect and suggestion of taking an antihistamine which I had in the house
Syncope with head injury, concussion, chin laceration. At 4AM when walking back from the bathroom, suddenly syncopized with head strike on the floor. Subsequently required 6 stitches in the emergency room for her chin. Required CT head/neck and MRI head as well as she was confused and had amnesia.
Around midnight my right shoulder was swollen and hurt at about a nine or 10 so much so that I was approaching hysteria. We called for an ambulance and they took me to the er where they gave me an anti-inflammatory shot and then I was fine thank goodness.
Information has been received from a registered nurse concerning an 11 year old male with no allergies or medical history who on 01-DEC-1998 was vaccinated SC with a 0.5 mL dose of Varivax (lot # "613881/1257A"). There was no concomitant medication. On 23-JAN-2007, the patient developed approximately 10 lesions and a low grade fever. It was that the patient had breakthrough varicella. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. It was also reported that the patient's sister had a similar experience after therapy with Varivax (Oka/Merck).
she feels "flush everywhere, especially her chest and warm/hot feeling; she feels "flush everywhere, especially her chest and warm/hot feeling; she feels "woozey, like my eyes are glazed over; red; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 30Mar2021 as dose 1, single for COVID-19 immunisation. Patient stated she had her first Pfizer vaccine on 30Mar2021 she felt flush everywhere, especially her chest and warm/hot feeling and red everywhere. She also stated, she felt woozey, like her eyes are glazed over.The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
exhaustion; headache; difficulty breathing; sweating; tired; could not concentrate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 17Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1,single , MANUFACTURER UNKNOWN.), for Covid-19 immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 18Apr2022, outcome "unknown", described as "could not concentrate"; DYSPNOEA (non-serious) with onset 18Apr2022, outcome "unknown", described as "difficulty breathing"; HYPERHIDROSIS (non-serious) with onset 18Apr2022, outcome "unknown", described as "sweating"; FATIGUE (non-serious) with onset 18Apr2022, outcome "unknown", described as "tired"; FATIGUE (non-serious) with onset 19Apr2022, outcome "unknown", described as "exhaustion"; HEADACHE (non-serious) with onset 19Apr2022, outcome "unknown".  Additional Information: On 20Apr22, at 7:04 reported receiving 2nd dose of COVID vaccination on 17Apr22. She said on 18Apr22, she was experiencing difficulty breathing throughout the day and night, Sweating, tired, and could not concentrate. On 19Apr22, she said that she was experiencing sweating, exhaustion, headache, and difficulty breathing in the morning. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This report of hives is being submitted in an expedited time frame as requested by the FDA. Follow up information from the pediatrician provided event outcome (patient recovered). Information regarding Flumist nasal solution was received from a pediatrician's office regarding a 10 year old male patient who developed hives all over his body. The patient received the first dose on 12/11/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/11/03. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 12/14/03, 3 days post immunization, the child developed hives all over his body. A nurse advised the parents to give Benadryl. The pediatrician reported that the patient recovered. (OMIC)
Anxiety is something I have never had and since the first of June 2021 I have had bad reaction with water pustules popping up under my skin on my hands and severe itching in those areas . I have never had this problem ever and the shit has done something to my skin.
red patch/rash around the injection site; red patch/rash around the injection site; injection site that is warm to the touch with slight swelling and is about 3.5 inches in diameter; injection site that is warm to the touch with slight swelling and is about 3.5 inches in diameter; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 07Oct2020 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced red patch/rash around the injection site that is warm to the touch with slight swelling and is about 3.5 inches in diameter on 08Oct2020. The action taken in response to the event(s) for pneumococcal 13-val conj vac (dipht crm197 protein) was not applicable.  No follow-up attempts are needed. Information about lot/batch number can not be obtained.
Began having palpitations after 3 weeks.  Developed Ventricular Bigeminy which then persisted
Syncopal episode less than 15 minutes postvaccination; BP as low as 86/60.  Patient recovered within 30 minutes and was released to home.
Felt generally ill as if I had gotten the flu; Broke out with fever blisters on lips; Ran slight fever on first night; Body aches more than normal; Headaches; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: 1000784118, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 12:00 (Age at vaccination 42-years-old) as dose 2, single for covid-19 immunization at hospital. Medical history included Hbp, kidney cyst from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), clonidine (CLONIDINE) taken for hypertension, start and stop date were not reported; meloxicam (MOBIC), paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for hypertension, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: 1000784118, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:00 (Age at vaccination 42-years-old) as dose 1, single for covid-19 immunization. The patient experienced after first shot I felt completely fine had no adverse reaction. Felt generally ill as if I had gotten the flu. Broke out with fever blisters on lips. Ran slight fever on first night. Body aches more than normal and headaches on 08Apr2021 at 07:00. Began to feel better by day 3 then felt completely fine by day 5. The patient underwent lab tests and procedures which included body temperature: unknown results on 08Apr2021. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had receive Suboxone, lisinopril Clonidine(hbp), mobic, tylenol other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the events. The clinical outcome of the events was recovered on an unspecified date Apr2021.  Follow-up attempts are completed. No further information is expected.