chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate vertigo; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date the patient experienced moderate vertigo. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate vertigo was recovered on an unknown date.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
started w/itching initially, felt warm and red on 11-12-19 used HCT and cool compresses, on 11-12-19 redness spreading and hard and swollen.  On PE 16x13 cm erythematous warm to touch area of right upper extremity.  Treated with Cephalexin 250mg TID x 7 days and well as Benadryl po PRN.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated at a health center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Swelling, heat at injection site. Pain. reported to pharmacy 08/29/2020. Advised to monitor and see if getting better by 72 hours. Tylenol for pain/discomfort.
THIS WAS THE PATIENT'S 2ND DOSE FOR MODERNA BUT SHE WAS ERRONEOUSLY GIVEN JOHNSON AND JOHNSON AS HER 2ND DOSE. SHE STATES SHE HAS HAD HEADACHES AND CHILLS THAT COME AND GOES . SHE ALSO STATES THAT SHE IS CONTINOUSLY TIRED.
A friend of got the first dose of  Pfizer Vaccine on 12/31 and she tested positive for COVID on Jan 11.  She lost send of smell and taste . She is scheduled to get the 2nd dose on 1/21 .
She reports having diarrhea 4 times a day for 2 days after both doses; Patient states she is allergic to the sugar in the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (She reports having diarrhea 4 times a day for 2 days after both doses) and FOOD ALLERGY (Patient states she is allergic to the sugar in the vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergy to sugar in vaccine). Relevant concomitant products usage were not reported by the reporter.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (She reports having diarrhea 4 times a day for 2 days after both doses) and FOOD ALLERGY (Patient states she is allergic to the sugar in the vaccine).  At the time of the report, DIARRHOEA (She reports having diarrhea 4 times a day for 2 days after both doses) and FOOD ALLERGY (Patient states she is allergic to the sugar in the vaccine) outcome was unknown.     No treatment information  was reported.   The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.
patient <18 yo when he got his first covid vaccine. He was meant to get Pfizer but got signed up for the Moderna clinic. He managed to get by registration unnoticed with age and recieved a shot at a mass covid vaccine event. He did not have any side effects. His mother would like him to get the 2nd dose
02/02/22 presents to Birth Center Triage for "contractions". PMHx of "Motion sickness, CESAREAN SECTION"
He received his vaccine, everything was fine, waited the 15 minutes and left with no problems, did a few errands and came home.  As the afternoon progressed, toward the later part he was feeling more and more exhausted, tired.  He had to lay down and could not stay awake anymore.  He did feel a more rapid heart beat, not pounding, but notable more rapid heart beat than normal.  He got up around 6:00 for dinner, did not feel like eating much.  He was going to bed, felt more body aches, and had a horrible night with body aches and pains all over, he could not roll  over easily without the pains, and could not lay on the injection site arm.  Earlier vaccines that he had had a more stronger localized pain or punch and that was it.  He had a system wide reaction instead and the heart.  He did have a fever around 99-100 and could not sleep at all, was up 6 times during the night and some staggering around.  This morning he got up around 8:30 and got a little more sleep in the later hours of the morning and to get up and moving around he was dragging.  He was able to eat breakfast, still feeling fatigued, and can feel localized pain on the arm, but nothing to complain about.  It was mainly the severe reaction during the night and the fever, which he did not have with the other vaccines.  Other vaccines the arm injection site pain disappeared within 3 days.   His major concern in this regard is due to his health status with his health conditions, and people not wearing masks, etc., worries him as the virus continues to mutate and if this is his 4th vaccine with the same as the past 3 times then what's going to happen if he has to get more vaccines to cover other mutations if he's reacting this way.  He is a microbiologist that has retired.    He did have COVID back in January of 2022, and those symptoms happened about a month with the fatigue, ongoing hacking cough and malaise.  Also had a runny nose but not like a cold.  It started with a severe sore throat that disappeared and about a month later his cough disappeared.   He does have a rising aortal aneurysm diagnosed in the past, which also concerns him.
Patient does have a history of fainting after vaccination. He stated he has a fear of needles. I gave the patient the flu shot intramuscularly and continued to speak with him to distract him. Patient was seated during the administration and afterwards.Five minutes after vaccination, the patient started to slurr his words, his eyes rolled back and started to fall over. I ran out of the pharmacy, to catch him before he fell to the ground. Patient fell, and did hit his head. I elevated his legs, and head and called 911. About a minute later, patient woke up and stated that he was expecting this to happen. EMS recommended patient go to the emergency room since patient hit his head, but patient refused. Patient waited for his father to pick him up from pharmacy. As patient was waiting for father to pick him up, patient did vomit. I recommended patient go to the emergency room, but patient did not refused. Patient left with father and I called him about two hours later, to check up on him, and he was doing fine. He just had a little bit of a headache. Patient went to emergency room later in the night, and stated he did have a skull fracture, but that was from hitting his head on the ground.
Fatigue that I first noticed about 4 and 1/2 days after receiving the vaccine that lasted for about 10 days. Very unusual for me. Slept 15-17 hours a day, and on day 9, I was unable to even to go work and spent the entire day in bed, sleeping  22 hours and spent the other 2 hours on the couch. I had headache on days 5-9 and loose stools, 3-4 times a day on days 5-9. All symptoms resolved by day 10. On the first 1-2 days I had a sore arm at the injection site, but did not interfere with any activities and I expected that.
Pt has a history of fainting. Pt felt faint. Pt fainted and was unconscious for 15-20 seconds. Pt is CAOx3. Pts vitals are stable. Pt didn?t require transport to hospital.
Information has been received from a nurse who reported that a female was inadvertently administered a dose of PROQUAD (Merck) and a dose of VARIVAX (Merck) on 03-DEC-2014. No adverse effects reported. No further information provided. Additional information has been requested.
chest pain, rapid heartbeat, headache, body shaking, nausea, back pain, cold sweat, lightheadedness, dizziness, fast heartbeat, shortness of breath, choking episodes,
confused and tired; confused and tired; ear infection as well as an ongoing infection; ear infection as well as an ongoing infection; This is as spontaneous report received from a contactable consume. A patient of 101-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: Not reported) via unspecified route on 20Jan2021 at 12:00 PM, as a single dose in the right arm for COVID-19 immunization. Patient's medical history included conjunctive heart failure, can't walk, allergies, chronic infection in hip. The patient was not allergic to medications, food and other products. Concomitant medications included spirolactone, Asprin (acetylsalicylic acid), Ceflex (cefaclor), Lasik (furosemide) and Esclaminapin. The patient did not receive other vaccines in four weeks. The patient had not diagnosed with COVID-19 prior vaccination and was not tested since the vaccination. On 28Jan2021 at 04:45 PM, 7days after the vaccination, the patient experienced confusion and tired. The patient also had ear infection along with ongoing treatment which included Keflex. The patient visited to clinic due to events. Event of ear infection was not sure if it was caused by vaccine. Outcome of events was resolved with lasting effects.   Information on the lot/batch number has been requested.
First I felt feverish. By the end of the day, my right arm where I was shot was throbbing. This type pain has continued. Today is Dec 1 and my arm still pains. I have never had this type reaction from a flu shot before.
Patient developed trembling of hands and then progressed into muscle twitching. Given BENADRYL by ER physician and then next day symptoms resolved.
Mom called office 2:00 pm next day and stated patient started vomiting on 10/12/16 in early evening, aching, hurting all over, feeling tired. On 10/14/16 was a little better still feeling achy and tired but vomiting subsiding.
Rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH (Rash on her arm). At the time of the report, RASH (Rash on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: follow up email received on 25-jun-21 with NNI
COVID 19 Treatment/Tested positive on 26Apr2022; COVID 19 Treatment/Tested positive on 26Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 09:00 as dose 1, single (Lot number: EL0142), in left arm, on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL9265), in right arm and on 17Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 33130BA) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "arterial plaque" (unspecified if ongoing). Concomitant medication(s) included: IRON. The following information was reported: VACCINATION FAILURE (medically significant) with onset 26Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 26Apr2022, outcome "recovered" (04May2022) and all described as "COVID 19 Treatment/Tested positive on 26Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Negative; (20Apr2022) Negative; (26Apr2022) Positive; (04May2022) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Second vaccine dose caused gastric bloating and ultimately anemia. After seeing a half-dozen mds, convinced my GP to prescribe a steroid dose. Have been taking iron pills for a year. Blood levels after the steroid dose began climbing and are back to normal. Had Covid rebound. After negative tests on 17Apr2022 and 20Apr2022 felt a bad cold hit me on 25Apr2022. Tested positive on 26Apr2022. Began a steriod and antibiotic dose with minerals and vitamins. Tested negative 4May2022. Patient had no other medication in 2 weeks. AE treatment with Methypredisone, azithromyican, vc, vd3, Turmeric. No Known allergies. Other medical history includes High BP, arterial plaque.  Anti viral details: Product=COVID 19 Treatment; Treatment start date=13Apr2022; Treatment stop date=17Apr2022; Lot number=Didn't keep this information; Indication=Treatment of COVID-19.
Patient started getting extreme upset stomach, vomiting, diarrhea, fever and fatigue. Lasted 4 days. 11/27/07 Reviewed hospital medical records which reveal patient experienced a syncopal episode.  After having diffuse abdominal cramps & straining to have BM, got weak, dizzy & passed out.  Then had nausea, vomiting x 3 & diarrhea.  Admitted to ER on 10/12 & kept overnight for observation, d/c to home 10/13/2007. Cardiac consult done. FINAL DX: vasovagal syncope.
Sensation in throat, followed by mild SOB, and seemingly troubles ?clearing? throat.  Took a Claritin about 45 mins after injection with complete symptom relief
Information has been received from a nurse practitioner concerning a 24 year old female with no medical history and a penicillin allergy, Biaxin allergy, Cephalexin allergy, and sulfonamide allergy, who on approximately 18-OCT-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Concomitant therapy included ORTHO TRI-CYCLEN. Five days post vaccination on approximately 23-OCT-2007 the patient developed "small grape size" bumps under her skin. During the next three weeks the bums had appeared 6-10 times. The bums appeared in the morning and then resolved within 2-3 hours. The bumps were located either on the patient's lips, fingers, or feet. The patient was seen at the office. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Received Vaccine 10/17/09; began to feel ill 10/31. Saw physician for jaundice 11/6=AST=1455, ALT=2543, T Bili=2.8. No risk factors, husband and children Hep B(-). 11/12= AST=295, ALT =434, T Bili = 13.1 11/18/09 Medical records received for date 11/6/09 to 11/9/09. DX: hepatitis B. Chief c/o nausea, dark urine, low grade fever, low back pain, fatigue. Assessment: WNL except abnormal lab findings. OV 11/9/09 DX: f/u acute hepatitis. Assessment: (+)yellow skin, pt states feeling a little better. Consult 11/12/09 GI: DX: acute hepatitis B. Assessment: jaundice(+), otherwise WNL.
Within 10 minutes of injection - light headed, very pale - near fainting lasting over 1 hr; 36 hrs later red hot swollen quarter sized swelling - 4 days later 2 silver dollar size with bruising same size underneath with pain and itching - 6 days later minimal itching, swelling, bruising
Vaccine received on dec 22nd, on dec 23rd I had a red itchy welt at vaccine site that was warm to touch, the next day the welt doubled in size, but on day 3 it was gone. Then on dec 30th the welt came back and it is again red, itchy and warm to the touch and about 2.5inches in diameter.
Narrative:  03/29/2021 COVID vaccine dose #1 04/19/2021 COVID vaccine dose #2 04/19/2021 Seen in ED for tongue swelling, shortness of breath Per SW note on 4/21/21: Patient reports following COVID-19 vaccine he developed swelling of his tongue and limited breathing and subsequently went to non-affiliated hospital. Treated with "steroids" and symptoms resolved. Not admitted.
Patient received both shingrix and flu shot on 10/23/20.  She reports to writer today that within 12 to 24 hours of receiving the vaccinations, she had a fever and was immobile in bed for 96 hours. She is declining a 2nd dose of shingrix to avoid a repeat of this reaction.
expired dose of IPOL was administered with no reported adverse event; Initial information was received on 17-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 years old female patient who reported expired dose of ipol was administered with no reported adverse event after receiving vaccine ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, MUMPS VACCINE, rubella vaccine (MMR VACCIN) for Prophylactic vaccination.  On 16-Mar-2023, the patient received 0.5 ml Total dose (once) of suspect ipv (VERO) (Suspension for Injection) (lot: U1A452M, expiry date: 20-Feb-2023) unknown strength via intramuscular route in left deltoid for Immunisation.  On 16-Mar-2023 the patient developed a non-serious event of expired dose of ipol was administered with no reported adverse event (expired product administered) same day following the administration of ipv (VERO).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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 guidelines. 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.
her blood sugar is 260's; This is a spontaneous report from a Non-contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter indicated that she received her first dose of vaccine yesterday (14Jan2021) and her blood sugar is 260's on an unspecified date. She ate a slice of toast and exercised, asking if steroids are in vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Pt received vaccine (L) deltoid - less than 1 minute later he fainted - falling face first off exam table to floor. He came to within 2 minutes & was responsive. Injury to head from fall. (No redness or swelling at injection site).
The day after my first dose, my heart was hurting all day. I noticed that my heart hurt worse when I leaned forward. I went to the ER and the doctor told me I probably had pericarditis and wrote me a prescription for aspirin.
Rash on arms and legs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of RASH (Rash on arms and legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. 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 RASH (Rash on arms and legs). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) ongoing since an unknown date at a dose of 10 mg. At the time of the report, RASH (Rash on arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Zytec 10mg x1.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Rash is consistent with the product known safety profile
Tremors and body shaking; itching; numbness in the mouth; flushing; localizing or generalized urticaria; swelling of the mouth and throat; swelling of the mouth and throat; abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (pregnant no) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 39-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 08Oct2021 13:00 (Lot Number: 30135BA) as SINGLE for covid-19 immunisation. Medical history included Sjogrens Syndrome, Fibromyalgia and hypoglicemic, Allergies Sulfa. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported; tizanidine taken for an unspecified indication, start and stop date were not reported. The patient previously took acyclovir, valtrex and prozac and all experienced allergy. The patient experienced Tremors and body shaking, itching, numbness in the mouth, flushing, localizing or generalized urticaria, swelling of the mouth and throat, abdominal pain, headache, all on 08Oct2021 14:15 with outcome of recovering. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was Benadryl 25mg (2 pills). Serious: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Patient received influenza vaccine on 10/1/08. 15 minutes after the injection, patient reported her lip went numb and her jaw went numb. Vitals were checked and were WNL. Symptoms resolved. No other vaccines in past month and never had a reaction to the influenza vaccine.