chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had pressure in my chest, uncomfortable, some pain. I went to my doctor; she referred me to a cardiologist, ordered a heart catheterization and found some clogged arteries, he placed stents in my heart during surgery. I am feeling much better since the catheterization.
Patient states that he is having pain that started in his arm at injection site and continues up into his neck.  There is no localized swelling or rash.  No signs of anaphylaxis.
States 24 hours after receiving vaccine he developed redness & swelling at injection site, fever & chills, and extreme fatigue.
Breakthrough case admission after three vaccines Pfizer 3/4/21 Lot# EN6205;  Pfizer 3/25/21 Lot# EP6955;  Pfizer 9/30/21 Lot# FC3181
Chills, body aches, Headaches, fatigue, muscle twitches. Pain and swelling at vaccine site Lt upper arm.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: patient received the 2nd dose of the covid 19 pfizer vaccine, lot fd8448, moments after injection he did faint.  He regained consciousness after maybe 30 seconds, but then began to vomit.  After sitting for maybe 15 minutes said he was feeling better and refused an ambulance to be called.
Fever at home 103(R), in office 101.4(R), rash all over body, noticed by mom in AM of 12/30/99. Called office in afternoon & child brought in by mom.
I have been tired; my heart races occasionally; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I have been tired) and PALPITATIONS (my heart races occasionally) 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 FATIGUE (I have been tired) and PALPITATIONS (my heart races occasionally). At the time of the report, FATIGUE (I have been tired) and PALPITATIONS (my heart races occasionally) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Initial unsolicited report received from a nurse on 26 August 2015. This case involves a male (age not reported) patient who was vaccinated with a dose of FLUZONE (batch number unknown, expiration date, dose, dose number and site of administration were not reported) intramuscularly on an unspecified date. The patient had medical history of Postural orthostatic tachycardia (POTS) syndrome, asthma, migraines, developmental disorders and food allergies. There were no vaccinations within four weeks of vaccination with FLUZONE and no illness at time of vaccination. On an unspecified date in past, the patient has received many doses of FLUZONE vaccine. It was reported that with the last few flu shots her son received he had tachycardia and dizziness starting 24 hours after the vaccination and lasting for a week or more before resolving spontaneously. The patient did not perform any laboratory investigation. Corrective treatment was not reported. On an unspecified date, the patient recovered from the events. List of documents held by sender: none. Follow up report received from a nurse on 17 September 2015. This case involve 12 years old male patient who received intramuscular dose 12 of FLUZONE (batch number UI231AA) in left arm on 15 November 2015.
pt recvd series of vax & tested neg 1 mo p/completing sereis; pt recvd 2 boosters 1 mo apart; tested neg p/both;
shipment of Fluzone QIV 0.5 mL pre-filled syringes was shipped on Monday (11Nov2019) and received on 14Nov2019, shipment experienced an extended time frame and was out of temperature compliance, NO AE; shipment of Fluzone QIV 0.5 mL pre-filled syringes was shipped on Monday (11Nov2019) and received on 14Nov2019, shipment experienced an extended time frame and was out of temperature compliance, NO AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 29 years old female patient who was vaccinated with 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) that had temperature excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Nov-2019, patient received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number: UJ299AA, expiry date: 30Jun2020) via intramuscular in the right arm.   It was reported that vaccine pre-filled syringe that was shipped on Monday (11Nov2019) and received on 14Nov2019. The shipment experienced an extended time frame and was out of temperature compliance (no exact temperature was available).  It was a case of actual medication error due to incorrect product storage and Product shipment delay.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
The patient felt very sleepy, lightheaded (head was "floating), had a headache, and was dragging in the afternoon.  She felt like she wanted to dose off after she finished work, and drank water throughout her shift.  She got a normal amount of sleep the previous night.  She felt better the next day, on 10/6.
Injection site started to feel itchy; Warm to touch; A spontaneous report was received from a consumer  concerning a 75-year-old , female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site itchy and injection site warm.   The patient's medical history, was not provided.Concomitant medications was not reported.  On 12 Jan 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown)  for prophylaxis of COVID-19 infection.   On 13 Jan 2021 the patient felt injection site itchy and injection site warm. Treatment for the events  was unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events injection site itchy and injection site warm was unknown.
pt devel rash/urticaria the morning p/vax;rash started over face moving toward the trunk then to extremities;lesions lasting from minutes to several hr w/complete resolution from prev sites;erythematous macules sl raised 1-5cm, +blanching;
Bleeding; reversed effects; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) and FEELING ABNORMAL (reversed effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) and FEELING ABNORMAL (reversed effects). At the time of the report, HAEMORRHAGE (Bleeding) and FEELING ABNORMAL (reversed effects) outcome was unknown. Not Provided          CRM number was mentioned as 2348.  No concomitant medication information was provided.  It was reported that patient had bleeding and reserve effect after taking the moderna vaccine booster dose.  No treatment medication was provided.  Company comment- This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected event of Haemorrhage which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected event of Haemorrhage which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
1 of 4 pts vaxed from same Tetramune lot exp a fever 102-103, irritability (crying) w/in 1 hrs p/vax & inject site react described as swelling & redness; pt recovered;
No other AE occurred; The patient received a dose of MMRII that was expired; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medication were not reported.  On 28-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number s015427, had been verified to be a valid number; expiration date 20-MAY-2021). No other adverse events occurred.
Within 2 hrs, injection site became very painful, very hard and a red rash appeared.  Ignored for 48 hrs.  Did not get any better, so went to Pharmacy to show on 9/10/23.   Started applying cool compresses 4 times a day for 3 days.   Pain and hardness went away, but red rash expanded and moved down the bicep and continues to be present.
On 9/12 I saw 4 red marks on my face & then more small red dots/circles (at least 20) appeared on my body primarily on my arms & back. Red circles/dots are not itchy.  Slight Fever but not sure if it's due to immunization. I'm fighting off a cold.   We called our doctor & they said to drink lots of fluids & stay out of the sun & use cortisone if necessary.
I feel pain on my left arm, and my chest and I feel like my heart is going to pump out. Sometimes I feel the heartbeats on my hand and neck, and this cause me headache.
11/16/2021 Around 3:30 pm, I started getting a bad headache. Around 6:30pm, I then began having body aches, chills, hot then cold and I had a fever. I was exhausted and went to sleep. The next day as the day went on, I improved and felt better. 02/21/2022, I started having a sore throat and an earache. I tested positive for COVID on 2/22/2022. From 02/22/2022-02/24/2022, I had body aches throughout my entire body. I had a slight cough and upper respiratory discomfort. Earache sore throat, like a sinus infection and very tired. I had a fever of 101 degrees. The cough was on and off. The body aches started to dissipate. I had tightness in my chest and a lingering cough. I felt tired, like a lingering feeling of fatigue. I went to my PCP on 3/2/2022 because I was still not feeling well and she prescribed a 5-day course of prednisone. She said I had dullness in my right ear. I was improving while on steroids. After I got off the steroid, I started to feel bad again, so I talked with my allergy doctor. She said she has a lot of patients with COVID and asthma who end up with long COVID. I started on Advair for 30 days. After the 30 days, I stopped it and I still was not feeling great. She put me back on Advair I am still on it now.
gardisal was administered at 220pm. Patient felt lightheaded. Pt was layed flat BP 74/38 Pulse 52. Blood prersure + pulse were monitored intermittently - 80/60, 89/51 HR 61, 93/58 HR 88 89/51, 100/62. Patient sat up and no longer felt lightheaded BP 100/62. Patient was given, orange juice, sucker, peanut butter, water. Patient left office. Dr. evaluated patient
Information has been received from a physician concerning a 29 year old female with sulfonamide allergy who on 06-MAY-2009 was vaccinated with a 0.5 mL first dose of VARIVAX (Merck), subcutaneously. There was no concomitant medication. The patient was seen on the physician's office on 09-MAY-2009, and seven days after receiving the VARIVAX (Merck) dose, on 13-MAY-2009 the patient developed generalized vesicular rash. No laboratories studies performed. The patient recovered from generalized vesicular rash on an unspecified date without requiring treatment. Additional information is not expected.
1 hr after receiving Pneumovax & Zostavax, pt began having head fullness/pressure, ears tingling, walk fatigued.  Some lightheadness.  1 wk later still weak.  No fever etc.  No local reaction.
Swelling, redness, warmth from middle of upper arm to below elbow (R arm) started on the evening of the vaccination which persisted with redness and warmth until seen on 04/18/2002.
First day was Friday. I had a sore throat all day and took throat drops. In the evening I felt bloated and super full. At night I felt chills, and super hot. No thermometer available to take temperature. I went to restroom at 2AM and had a loose stool. I went about 2-3 times that night which was unusual. The next day cruise line medical staff came to do a COVID-19 test and test was positive. On and off during next few days chills, nausea, loss of appetite and stomach issues. Each day got to be a little better. The second week I was just really tired. I was getting like 12 hours of sleep per day. I was congested. I took DAYQUIL and NYQUIL. Today I took COVID-19 at home test and results were negative.
PT RECEIVED VACCINE IN STORE 10/19. (THURSDAY). STARTING THE NEXT DAY THE PT STARTED TO EXPERIENCE TINGLING/NUMBNESS DOWN LEFT ARM. HER LAST 2 FINGERS WERE FEELING NUMB, PINKY AND RING FINGER.  PT CALLED PHARMACY AND SPOKE TO STAFF PHARMACIST. SHE WAS GIVEN ADVICE TO TAKE IBUPROFEN AND AND ICE THE AREA OF THE INJECTION. ALSO ADVISED THAT THIS SENSATION COULD LAST UP TO 7-10 DAYS.  I WAS INFORMED OFF THE CALL MY FOLLOWING SHIFT ATTEMPTED TO CALL THE PT ON 10/30 WITH NO CONTACT/ANSWER.  PT CALLED BACK 11/2, STILL HAVING TINGLING IN THE TWO FINGERS OFF HER LEFT ARM.  I ADVISED TO CONTINUE WITH IBUPROFEN FOR COMFORT, IF SYMPTOMS DID NOT IMPROVE THEN SHE SHOULD FOLLOW UP WITH HER PCP.
Onset of severe left leg pain 3 days after the vaccination that has persisted for more than 5 weeks now.
TESTED + FOR COVID  2-23-22  DECEASED 7-14-22;
Information has been received from a 35 year old female with no allergies or medical history who in May or June 2005 was vaccinated with a dose of Varivax (Oka/Merck) (lot # 648087/0099P). There was no concomitant medication. "Last week", in approximately March 2006, the patient had "lab work" done which showed she had no antibodies. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Severe heart palpitations for two days; This is a spontaneous report received from a contactable physician (Patient) reported for herself. A 73-year-old non pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 123) via an unspecified route of administration in right arm on 19Jan2021 14.30 single dose for covid-19 immunisation. The patient medical history included irregular heart beat. Concomitant medication included diltiazem. Allergies to medications, food, or other products were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since vaccination. On 21Jan2021, the patient experienced severe heart palpitations for two days. No treatment was received for the adverse events. The reporter considered the event as non-serious. The outcome of events was recovered.   Follow-up attempts are completed. No further information is expected.
had some soreness which was expected on arm with the first three arm injections; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (had some soreness which was expected on arm with the first three arm injections) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 prophylaxis.     The patient had not ever been diagnosed with/ tested positive for COVID-19.  Patient had no acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Penicillin allergy, Contrast media allergy (IV dye allergy), Drug allergy (Vicodin allergy), Blood pressure high (No recent changes in condition status), Thyroid disorder (No recent changes in condition status), High cholesterol (No recent changes in condition status), GERD (No recent changes in condition status), Rheumatoid arthritis (No recent changes in condition status) and Arthritis (No recent changes in condition status). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for Blood pressure high, OMEPRAZOLE for GERD, SIMVASTATIN for High cholesterol, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Rheumatoid arthritis and Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, AMLODIPINE BESYLATE, VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS], FISH OIL and UBIDECARENONE (COQ-10) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (had some soreness which was expected on arm with the first three arm injections). At the time of the report, VACCINATION SITE PAIN (had some soreness which was expected on arm with the first three arm injections) outcome was unknown.            Treatment medications were not reported.   This case was linked to MOD-2022-580164, MOD-2022-585302, MOD-2022-585328, MOD-2022-580263.
The next day I got chills, etc.  I expected that.  But then got a heavy head and buzzing in my ears.  It is better but still on my left side.  I saw ENT and she said I have tinnitus.  Thankfully, my earing is  ok, but it's annoying.
Palm sized Red welt on left anterior subclavian area. Inflamed lymph nodes in axilla for 2 days
Immediately - Sore arm  18 hours to 24 hours after - Fatigue, dizziness, headache, nausea
expired dose of ADACEL it was administered with no adverse event; 31 week pregnant patient who had adacel expired dose with no adverse event; Initial information received on 25-Apr-2022 regarding an unsolicited valid non-serious case received from a Nurse via call center.  This case involves a 28 years old female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of expired dose of adacel it was administered in 31 week pregnant patient with no adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The gestation period at onset was 31 week. The date of last menstrual period was reported as 06-Feb-2021. The estimated due date is 16-Jun-2022. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.    On 22-Apr-2022, the patient received a Dose: 1, 0.5 ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5669AA (formulation, expiry date: unknown) via intramuscular route in the left deltoid for immunization.  On 22-APR-2022 the patient had expired dose of adacel it was administered with no adverse event (expired product administered) and 31 week pregnant patient who had adacel expired dose with no adverse event (exposure during pregnancy) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Relevant prenatal testing after exposure was not reported.  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for both events.  Additionally, at time of reporting, the pregnancy is still ongoing.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient experienced swelling, redness, itchiness in right arm within 24 hours of injection. Follow up received on 07/23/2004:  Physician said that the patient recovered.
First shot on 8/27/2019?..no adverse events Second shot 12/5/2019, woke up at about 5:30 to use bathroom and was 100% paralyzed in bed, for up to about 30 minutes, before I could crawl out of bed
pinched my arm hard and had to wipe my arm (vaccine spilled); Inadvertent exposure to vaccine; This case was reported by a consumer via call center representative and described the occurrence of exposure via skin contact in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2021, the patient received the 1st dose of Shingrix. On 10th May 2021, unknown after receiving Shingrix, the patient experienced exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient was vaccinated with dose of Shingrix yesterday from the date of reporting and reported that the health care professional pinched the arm had and had to wipe the arm, which led to exposure via skin contact and accidental exposure to product. The vaccine spilled. The consent to follow up was denied.
Severe nausea, cramps, fatigue, and muscle ache the whole next day. It was almost unbearable the morning of that next day.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 05Jan2021 as dose 2, single (Lot number: EK4176), in right arm and on 11Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (unspecified if ongoing); "myotonic muscular dystrophy" (unspecified if ongoing), notes: myotonic muscular dystrophy; "Asthma" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing). The known allergies reported as none. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient has taken Paxlovid form 29Jun2022 to 04Jul2022 as treatment of COVID-19. The patient has taken other medication within 2 weeks of starting COVID-19 treatment are Dimethyl Fumarate, omeprazole, montelukast, fexofenadine hydrochloride, progesterone, estradiol, acetaminophen, ibuprofen and vitamin D3. On 12Jul2022, the patient had Covid rebound (Fever, body aches, Cough, Headaches, stuffy nose) and it has been treated with prednisone. The patient is recovering.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.