chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was seen on 3/8/19 at medical practice for a well child check with CRNP. At the time of service, patient was 36 days old. CRNP put orders in for DTaP/Hib/IPV, Pneumococcal 13, Rotavirus and Hep B (2nd dose). The MA administered the vaccines per the CRNP orders. These shots were given too early. First round of vaccines should not be given until 2 months old. Dr was on call for the weekend and mom, called into medical to advise that the baby was vomiting through her nose after having her bottle. Mom took her to urgent care prior to Dr responding to the call and urgent care advised shots were given too soon. Dr spoke to mom and he said if she continues to vomit to taker her to the ER. Mom took patient to ER and potassium levels were increased, but per Dr this would have been due to the vomiting and not the vaccines. Patent has a follow up with Dr on 3/14/2019. Per mom, patient seems to be doing fine and baby was eating normally.
felt so cold; chills/ teeth chattered; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt so cold), CHILLS (chills/ teeth chattered) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FEELING COLD (felt so cold), CHILLS (chills/ teeth chattered) and PYREXIA (fever). At the time of the report, FEELING COLD (felt so cold), CHILLS (chills/ teeth chattered) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported. Treatment information included electric blanket. patient applied electric blankets for the symptoms developed after the 1st dose The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    This case was linked to MOD-2021-104231 (Patient Link).
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had first dose of the vaccine on 21-Jan-2021 and later discovered on 01-Feb-2021 that she was pregnant. she wanted to know if she can still go ahead with the second dose
Myalgia, Fever, Diarrhea, Tachycardia, chest tightness, SOB, 12/29 After vaccination felt chest tightness, shortness of breath, tingling in her throat, heart racing. She stayed and was monitored for an hour. When she got home she took Benadryl which helped her sleep. She continues to have mild shortness-of-breath today. Her left arm is sore and she has body aches. Her temp is 100.6 today. 12/30 1712: While speaking on the phone with her she is speaking in full sentences without apparent dyspnea. 12/31 had bad night - high fever 101.5 at 0100 overnight last night. This morning feels tired, lethargic, and no appetite. She still has body aches. No fever this morning. 1/4 - employee reports she is doing much better today. She says she had a rough weekend but is much better today. She able to get back to her running usually runs 25 miles/week.
His arm felt like it was punched 100 times; He had cold sweats; This is a spontaneous report from a contactable consumer (reported for himself). A 40-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date (at the age of 40-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date for COVID-19 immunisation. With his 1st dose, consumer said he did not feel anything, and did not have any side effects. On an unspecified date in 2021, the consumer stated that his arm felt like it was punched 100 times and he also said he had cold sweats. He wanted to know if it is possible that the arm would hurt worse after the 2nd dose. He said he known that the cold sweats are worse after the 2nd dose. The consumer wanted to know if it is possible that he did not receive the 1st dose since he did not feel anything. He also wanted to know if his arm should have hurt after the 1st dose. The consumer wanted to know if there is a way to test immunity after receiving both doses of the Pfizer-BioNTech COVID-19 Vaccine in response received 'Antibody tests are used to see if you have some level of protection against the virus. If your body developed an immune response, which was the goal of vaccination, there was a possibility you might test positive on some antibody tests after receiving the Pfizer-BioNTech COVID-19 Vaccine'. The outcome of the events was unknown.  Additional information about Batch/Lot number has been requested.
A week after the vaccination I had fever of 103 and chills that was going away. I went to the doctor and was given an Echocardiogram (04/13/2021) where it showed I developed pericardia infusion. In June I went for a second Echocardiogram is it was less than what it showed in April.
Had the vaccine and every time, she got very very sick; After second dose, she got the shakes, and could not stop shaken, and had to get  into the water to stop shaking,; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Had the vaccine and every time, she got very very sick) and TREMOR (After second dose, she got the shakes, and could not stop shaken, and had to get  into the water to stop shaking,) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Had the vaccine and every time, she got very very sick) and TREMOR (After second dose, she got the shakes, and could not stop shaken, and had to get  into the water to stop shaking,). At the time of the report, ILLNESS (Had the vaccine and every time, she got very very sick) and TREMOR (After second dose, she got the shakes, and could not stop shaken, and had to get  into the water to stop shaking,) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unspecified thyroid medication.  The patient never had COVID positive test or diagnosis.  No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine  AE caused patient to seek medical care.  The patient had not experienced a similar event in the past.  Unknown if symptoms improved or worsened.  Treatment information was not provided.   This case was linked to MOD-2022-619371, MOD-2021-009124 (Patient Link).
pt recvd vax; fever 104 7 days p/ vax; lasted 5 days & also got the shingles at the same; took about 1 mo for pt to be nl;
only ones that ended up with dementia; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had experienced an event, only ones that ended up with dementia while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination (flu).  On an unknown date the patient had experienced an event, ended up with dementia (dementia) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (only ones that ended up with dementia).  At time of reporting, the outcome was Unknown for the event only ones that ended up with dementia.; Sender's Comments: Sanofi Company Comment dated 14-Jan-2022: This case involves an unknown age female patient who had experienced an event, only ones that ended up with dementia while receiving vaccine Influenza Vaccine. Further information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Pt. has swelling and redness at site (per patient phone call). Itching.
About 30 minutes after receiving the booster, the left side of my throat  became very sore and painful when swallowing.  The right side was fine.
Patient received her Janssen COVID 19 vaccine at approximately 12:22pm and then was instructed to wait 15 minutes to be observed for adverse reactions.  At the end of of her 15 minute observation approximately 12:37 she reported she was experiencing pounding in her ear.
fatigue; still having lower intestine cramping; Votimed 3 times starting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the arm left on 25Mar2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux (esophageal), and diverticulitis. The patient did not receive any other medications within 2 weeks of vaccination. The patient was allergic to penicillin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6202) via an unspecified route of administration in the arm left on 4Mar2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any 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.  On 25Mar2021, at 17:00 the patient experienced vomited 3 times. From 25March2021 at 17:00 to 26March2021 at 18:00, patient experienced diarrhea and again diarrhea started from 28March2021 at 18:00 to 29March2021. On 26March, the patient experienced fatigue, lower intestine cramping and still have it and forwarded on. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events diarrhea, vomited, fatigue and lower intestine cramping were not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Intense injection site pain.  Fatigue, chills, vomiting, body aches.
ERYTHEMA, ITCHING, BRUISING, SLIGHT SWELLING, FATIGUE.
Site at left deltoid, erythema, warm to touch and edema (5cm X 5cm) area. Treated with Zyrtec 10mg and Singulair 10mg both bid X 3 days. Use ice X 1 hour X 3 days and Tylenol X 3 days.
Pt c/o rash & raised erythema on L triceps that continued to spread all over body (large erythematous plaquer) No SOB, No respiratory problems.
I have had mild tinnitus for the last 12 years.   I received the 1st dose of Pfizer Covid 19 vaccine on March 31 2021.  Around 12 PM April 1st I noticed a distinct increase in the sound level of the tinnitus which has continued since.  I contacted my personal physician's office by phone and was told nothing could be done and to go ahead for the 2nd dose on April 21 2021.
CP, tightness; leg tingling (Hx Anxiety)- subsided 16:41 Txment: None. hydrate prior to 2nd vaccine, 30min obs allergy review recommend- elevated recommended hydration, longer obs time
Finished 2 dose series in February. Tested + for COVID on 3/29 as outpatient. Admitted to- hospital on 4/14 w/ respiratory distress/dyspnea.  Transferred to ICU level care for increasing hypoxemia on 4/15.
Blood glucose levels increased about 3 hours post vaccination and continued to be elevated, despite correction insulin administered, for around 36-48 hours. About 12 hours post vaccination had chills/shaking for around 30 minutes to an hour.
My mother contracted Covid-19 in mid-December, with symptom onset around 12/13/21 followed by a positive test and then treatment including antibody infusion and steroids. I do not live with her.  I visited my mother for Christmas, arriving 12/24/21 and what we thought was after the 10-day window past onset of symptoms. Her symptoms were better at that time but not fully resolved yet.   Thus it's more likely I merely had a breakthrough infection after staying in her home for several days at Christmas -- not a reaction to vaccine / booster.   My own symptom onset began around 1/2/2022 with sore throat, mild fever, and fatigue. Symptoms escalated around 1/16/2022 to include diarrhea, nausea, abdominal pain, more fever, fatigue, and mild shortness of breath.   Oxygen symptoms continue, if only mild and intermittent, to this date: Blood oxygen according to fingertip pulse oximeter readings drops to 95% or sometimes lower, fatigue, mild shortness of breath, and "brain fog".
Loose teeth; waking up and my hands are numb / asleep; Waking up and my hands are numb / asleep; Tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LOOSE TOOTH (Loose teeth), HYPOAESTHESIA (waking up and my hands are numb / asleep), SOMNOLENCE (Waking up and my hands are numb / asleep) and FATIGUE (Tired) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOOSE TOOTH (Loose teeth), HYPOAESTHESIA (waking up and my hands are numb / asleep), SOMNOLENCE (Waking up and my hands are numb / asleep) and FATIGUE (Tired). At the time of the report, LOOSE TOOTH (Loose teeth), HYPOAESTHESIA (waking up and my hands are numb / asleep), SOMNOLENCE (Waking up and my hands are numb / asleep) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.    Reporter did not allow further contact
Patient was given her 2nd Pfizer vaccine 6 days before the recommended time between the 1st and 2nd dose.
After the vaccine I was fine, but when I became very tired, at least 2 weeks, cough a lot, blow my nose; the cold began, it was real bad, I tested for COVID-19 at home, Friday night, the 18th, the next day I went to urgent care and confirmed that I had COVID-19 and prescribed PAXLOVID; for the November holiday I felt good but the 28th I woke up miserable I went to urgent care again and gave another prescription, I just completed and today will be my last day. I also have pain in the lower back of my hip. I have been taking aspirin for the pain and for headache.
Right arm sore, red and warm to the touch. Patient came into pharmacy on 10/21/15 and reported.
The evening after I received the second shot there was no problem at all. But later that night when I went to bed, I had trouble breathing. It was so bad I had to go to an emergency room. I never thought that the shot had anything to do with that feeling but the medical people in the ER said it was the shot. I must say it did not resolve in anything very serious. They did several tests, but I do not remember which ones. After the tests they told me everything was fine. They gave me medicine at the hospital, but I was not prescribed anything.  I never had a trouble with breathing after that.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a baby who was born without arms and legs. The baby's mother was a 17 year old female student who might have been vaccinated with GARDASIL when she was in her first trimester (lot # is not available). This baby was her first with no previous pregnancies. The baby's mother had sought physician for medical attention. The mother's experience has been captured in WAES# 0905USA03655. This information was previously reported to the agency in WAES # 0905USA03655. Additional information has been requested.
DIARRHEA; STOOL BECAME WHITE; TOOK 1 PILL OF BOTH IMODIUM MULTI SYMPTOM RELIEF AND IMODIUM AD AT THE SAME TIME; CAN'T SEE THE LOT NUMBER WITHOUT MY GLASSES. IT'S HARD TO SEE; This spontaneous report received from a patient concerned a male of an 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 (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, first dose administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, the patient experienced diarrhea (dose number in series 2). The patient received loperamide/simethicone (coated tablet, route of admin not reported, batch number: AJF051 expiry: 30-JUN-2023) dose and frequency were not reported from 13-JAN-2022 for diarrhea; and loperamide hydrochloride (coated tablet, route of admin, and batch number were not reported) dose and frequency were not reported from 13-JAN-2022 to 13-JAN-2022 for diarrhea. No concomitant medications were reported.  On 14-JAN-2022, the patient experienced stool became white (dose number in series 2). On JAN-2022, the patient cannot see the lot number without glasses and it was hard to see.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with loperamide/simethicone, and loperamide hydrochloride was not reported. The outcome of the stool became white, took 1 pill of both imodium multi symptom relief and imodium ad at the same time, can't see the lot number without my glasses. it's hard to see and diarrhea was not reported. This report was non-serious. This case, involving the same patient is linked to 20220401524. This report was associated with a product quality complaint: 10000935997.   Additional information was received from patient on 14-JAN-2022. The following information was updated and incorporated into the case narrative: concurrent condition of diarrhea was removed, new event added (diarrhea), suspect and past vaccines added (Janssen Covid-19 vaccine) as dose number in series 1 and 2, new due diligence for vaccine was scheduled.
1. I could feel the vaccine going down my arm into my fingers; causing them to become tense. I stretched out my hands to relieve the pressure.  I had on latex gloves and my hand started to sweat with water trickling down my arm. Tight feeling across the back of my head and a tense slight spasm in my sinus. This lasted for 30 minutes; I continued to drink water and I took a Tylenol I had and within an additional 30 minutes a student nurse was given me permission to walk me to my car.  2. At night I felt cramps in my left ovary - I have no issues or ailments with my reproductive system. I have not had a period since 2014. The slight ovary pain continue thru today, Sunday,
AFTER ADMIN PATIENT WENT TO POST-ADMIN WAITING AREA. AFTER A FEW MINUTES HE FLAGGED ME SAYING HE FELT LIGHT-HEADED.  I IMMEDIATELY WENT TO RENDER AID.  PATIENT'S HEAD WAS BOBBING AND HE STARTED TO SLUMP IN CHAIR.  I KEPT HIM IN CHAIR AND TALKED TO HIM TO GET HIM TO FOCUS AND REMAIN AWAKE.  I UNZIPPED HIS OUTDOOR VEST AND APPLIED ICE PACK TO THE BACK OF HIS NECK.   HE BEGAN TO FELL BETTER.  ANOTHER ICE PACK WAS RETRIEVED AND ONE WAS PLACED UNDER EACH ARMPIT.  HE BECAME MORE RESPONSIVE  AND HIS COLOR RETURNED.  I HAD HIM STAY SEATED AND REMAINDED WITH HIM FOR A FEW MINUTES MORE.  HE FELT WELL ENOUGH TO LEAVE AT THIS POINT.  HE WAS HERE WITH HIS SISTERSO I SUGGESTED SHE DRIVE HIME HOME.  I CALLED HIM LATER THAT EVENING.  HE SAID HE FELT BETTER AND THANKED ME FOR TAKING CARE OF HIM.  IF FURTHER ISSES HE IS TO SEEK MEDICAL CARE.