chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old patient who was vaccinated with a second dose of VARIVAX (Merck) (dose, route and lot number not reported). Physician reported that the patient received the second dose and still experienced chickenpox (20 or less vesicles). This physician was not the one that administered the vaccine, he only diagnosed the chickenpox in the patient. Patient sought for unspecified medical attention. Additional information has been requested.
Patient received his influenza vaccine on Wednesday October 19th. On Thursday October 20th, he reportedly did not feel well and developed a cough, shortness of breath, and a fever. He was seen at a local urgent care where he received a breathing treatment and a prescription for Albuterol HFA and Capron DM. The provider told the patient to "take it easy". On Monday October 24th, the patient called his primary care physician's office, with the primary complaint of shortness of breath. A nurse instructed patient to get checked out at the ER. Patient reported his oxygenation level was 85 at the ER and was the reasoning for his admission to the hospital. His fever was reportedly 102.8F. He underwent multiple tests and received a steroid shot before being released the following day, Tuesday October 25th. He was discharged with a prescription for Azithromycin 500mg - Take one tablet by mouth once daily (2 day supply).  Patient is currently at home monitoring his oxygenation with a finger pulse oximeter. He reports his oxygenation level is around 90. His follow-up appointment with Dr. is on November 3rd.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Welts), PRURITUS (Itches), SWELLING (Swelling), PAIN (Hurt) and MOBILITY DECREASED (Barely move) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Welts), PRURITUS (Itches), SWELLING (Swelling), PAIN (Hurt), MOBILITY DECREASED (Barely move), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), RASH (Breakout in rash/breakouts) and ARTHRALGIA (Joint pain). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE) for Adverse event, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Welts), PRURITUS (Itches), SWELLING (Swelling), PAIN (Hurt), MOBILITY DECREASED (Barely move), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), RASH (Breakout in rash/breakouts) and ARTHRALGIA (Joint pain) outcome was unknown. Concomitant medications reported include Blood pressure medication. Patient consulted several doctors including her primary care, dermatologist, and allergist. Treatment information reported includes being treated with steroid shots, steroids pills, and stuff for her stomach acid reflux.
I had pain in the area where I received the vaccine. I tested positive for COVID-19 on 05/23/2022. My symptoms sinus infection with a fever. I lost my sense of taste and smell but returned within 5 days. Contacted doctor and was prescribed PAXLOVID but I did not take it because I was feeling better and I was concerned about the side effects. One concern was the reports of patient's rebounding. I feel better but the fatigue is still lingering.
Person received 1st dose on 2/20/2021 and 2nd dose received on 3/11/2021.  Dose received earlier than recommended.
Patient brought in by mother due to headache and dizzy since last night after the re-immunization: feels dizzy but able to walking around by herself, had mild headache, but pt said more like dizzy since last night, unable to eat solid food, only had porridge for BF, water for lunch no fever, no SOB, no rash, no other pain. BP=84/50, unable to PO hydration in the clinic, 4PM sent to HSP ER, Had BP 86/50, T=38.7C, Had NS IVF 1000ml, D/C home at 2 am.
Pharmacist has determined that more than half of the Moderna Covid-19 vaccine was given to the patient; Pharmacist administering a second dose of the Moderna Covid-19 vaccination to a patient when the needle fell off; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Pharmacist has determined that more than half of the Moderna Covid-19 vaccine was given to the patient) and DEVICE CONNECTION ISSUE (Pharmacist administering a second dose of the Moderna Covid-19 vaccination to a patient when the needle fell off) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    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 UNDERDOSE (Pharmacist has determined that more than half of the Moderna Covid-19 vaccine was given to the patient) and DEVICE CONNECTION ISSUE (Pharmacist administering a second dose of the Moderna Covid-19 vaccination to a patient when the needle fell off). At the time of the report, UNDERDOSE (Pharmacist has determined that more than half of the Moderna Covid-19 vaccine was given to the patient) and DEVICE CONNECTION ISSUE (Pharmacist administering a second dose of the Moderna Covid-19 vaccination to a patient when the needle fell off) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Reports a latex glove sensitivity (ie. dentist uses latex gets welts). Received H1N1 2009 monovalent vaccine (multidose vial) at 8:30 AM, R deltoid. At 4:30 PM noted itchy, lacey rash at neck, arms, trunk and thighs. Denied difficulty breathing, shortness of breath, tongue thickness or swelling at time of reaction reporting at 7:30 PM. At 7:30 PM I noted light lace-like rash on neck, arms and abd. Associate denied treatment.
Information has been received concerning a pt with no known drug allergies, who at the end of 9/01 was vaccinated IM with the 2nd dose of hepatitis B vaccine recombinant. (PI: 8/01). approx 30 minutes after receiving the vaccine, the pt experienced dizziness and weakness and developed a redness at the injection site and blotchy patches on his neck. One day later the reaction resolved. The pt experienced no side effects after the 1st injection.  No additional information is expected.
Sudden Idiopathic Hearing Loss; clogged ear feeling; Hearing whistling noises; approx. 30-50% of hearing in right ear; This is a spontaneous report from a contactable consumer (patient).   A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 at 18:30 (Lot Number: EP6955) (at the age of 42-year-old) as single dose for COVID-19 immunisation.  Medical history included eosinophilic oesophagitis, hypertension and enlarged prostate, all from an unknown date and unknown if ongoing. The patient did not test positive to COVID-19, pre or post vaccination. Concomitant medications included clonazepam; lisinopril; omeprazole and tamsulosin, all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient previously took erythromycin and experienced allergy. On 17Apr2021 at 09:00, the patient was diagnosed as "Sudden Idiopathic Hearing Loss" in right ear. He woke up to clogged ear feeling. Hearing whistling noises and approx. 30-50% of hearing in right ear. The events were serious, disabling. The events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the events and included treatment with prednisone. The patient outcome of the events was not recovered.
Report taken 2-11-2021 @ 15:33 Patient reports that she had itching at the site immediately flowing the vaccine, she advised that 3 days out she had 3 inches in diameter redness and hot to touch 4th day was better but then on 2/8/2021 she advised site was 6 inches in diameter and the temperature at the site was 101.9. She advised that she has taken Benadryl and applied ice.  I encouraged patient to seek care. Update: 2-15-2021 15:28 Spoke with patient who advised 3X3 area on arm purple in color much better no temperature at site, she did not seek care but just continued with Benadryl.
States had pain at site of injection (left deltoid) immediately after shot; gradually worsened to "excruciating pain", not able to use arm normally, not able to raise arm, by 4/8/2016; to PCP for evaluation, Dx possible bursitis or allergic reaction; started on Prednisone PO. To check back with PCP on 4/11/2016.
Hives that looks like urticaria near both knees and both elbows. Took Benadryl and hives gone after 30 minutes.   8 house later hives developed on upper thigh and side of lower back.  Took another Benadryl and cleared up again after 30 minutes.  That is where I am now, unsure if cycle will repeat. Will see my primary car doctor if continues.
This spontaneous report as received from a nurse prescriber and refers to a female patient of unknown age. The patient's concurrent conditions included hypersensitivity. On 07-AUG-2017 the patient was vaccinated with GARDASIL 9 lot # N007931 in the right arm for prophylaxis. Concomitant therapies included fluticasone propionate(FLONASE) and cough, cold, and flu therapies (unspecified)(COUGH, COLD, AND FLU THERAPIES (UNSPECIFIED)). On 21-AUG-2017, 15 days after onset of therapy the patient experienced injection site abscess, vaccination site movement impairment and injection site pain. The outcome of injection site abscess, vaccination site movement impairment and injection site pain was reported as not recovered/not resolved.
Pain in right arm at the injection site, beginning 16 days approx. after the shot and  continues to this date  (3/31/21).
Pt breathing hard before immunization leaning forward. Administered vaccine, asked pt if they wanted a Band-Aid. Turned to grab a Band-Aid and pt fell to the ground face first. Pt MD told him to come in.
This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 02-FEB-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (strength and dose were not reported). The lot number and expiration date were unspecified (K011952 with expiration date of 17-JUN-2016 or lot number L010844 with expiration date of 16-NOV-2016), which were stored at 32.06 Fahrenheit Degree for 40 hours and 69.85 Fahrenheit Degree for 33 hours and 32 hours and 32 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases form the same reporter. Additional information has been requested.
RECEIVED A PHONE CALL FROM DOCTOR'S NURSE ON 8-3-04 AROUND 4:15 P.M.  THE INFANT WAS BEING SEEN IN THE OFFICE BY THE DR. AND WAS GOING TO BE ADMITTED FOR OBSERVATION.  THE MOTHER SAID THAT THE BABY WOKE FROM HER NAP CRYING AROUND 2:45 P.M.  SHE HAD SOME FOAM AROUND HER MOUTH AND STIFFENED HER BODY.  HER PUPILS WERE DILATED AND SHE DIDN'T BLINK.  SHE APPEARED TO BE STARING.  THE MOTHER WAS UPSET, BECAUSE SHE THOUGHT THAT THE BABY HAD A SEIZURE.  THE BABY WAS ALSO SWEATING.  THE MOTHER DIDN'T THINK THAT THE BABY HAD A FEVER, BUT SHE DIDN'T GIVE A FEVER REDUCER AFTER THE SHOTS OR CHECK THE BABY'S TEMPERATURE.  THE BABY DIDN'T HAVE A TEMPERATURE AT THE DRS. OFFICE.  THE INFANT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND WAS DISCHARGED THE NEXT MORNING WITHOUT ANOTHER INCIDENT.  THE DR. IS GOING TO GIVE THE BABY DT INSTEAD OF DTaP FROM NOW ON, ACCORDING TO THE BABY'S MOTHER.
p/vax pt exp chickenpox, a fever of 103.0, jerking of limbs, lethargy & loss of appetite;chickenpox were confirmed by MD;tx w/antihistamine for itching;
Treatment of COVID-19; Treatment of COVID-19; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL3302), on 12Mar2021 as dose 2, single (Lot number: EN6207), in right arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 30145BA) and on 08Apr2023 as dose 5 (booster), single (Lot number: FK9893) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Proxysmal AFib (post ablation)", start date: 2019 (unspecified if ongoing); "Proxysmal AFib (post ablation)", start date: 2019 (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "CAD" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Oct2021, stop date: 19Apr2023; METOPROLOL SUCCINATE, start date: Oct2021. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 08Apr2023, outcome "unknown", described as "Wrong vaccine administered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Apr2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2023) positive, notes: due to positive Ag rapid test; (25Apr2023) negative; (26Apr2023) negative; (27Apr2023) positive, notes: COVID-19 Ag rapid test positive too; (18Apr2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: Took Paxlovid for 5 days due to positive Ag rapid test and positive PCR. Cold-like symptoms that started on 18Apr2023 disappeared on 20Apr2023. COVID-19 Ag rapid test negative on 25Apr2023 and 26Apr2023. On 27Apr2023 rebound of cold-like symptoms starting, COVID-19 Ag rapid test positive too.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300173740 Same patient, different event/drug;US-PFIZER INC-202300175119 Same patient and product, Different dose and events;
This was my first vaccine. I had Covid last March. As of Jan 2021 i still had some antibodies in my body. After 12 hours i began to get chills and my skin was very achey. I took advil because when i was very sick with covid and too tylenol every 6 hours it didn't lower my temperature or take away any of my pain. two hours later, i had a stomach ache. While having a bowel movement i fainted onto the floor and ended up with a black eye. i do not pass out from having bowel moments otherwise. My cheekbone was sore to the touch for a week.
I seemed to develop fairly quickly a SLAC wrist I did not initially believe it had anything to do with the vaccine, however it came on rather quickly and unexpectedly my PCP referred me to a physical therapist for exercises to do at home but when that wasn't helping she referred me to an Orthopedist. He took x-rays and diagnosed SLAC wrist and shoulder tendinitis and sent me to an OT to have a long splint put on and a Physical therapist for two sessions per week plus exercises at home. After three weeks of PT I started to notice similar pain in my other wrists and ankle and knees not as severe but still there, I was diagnosed in my mid twenties with RA that just disappeared in a couple years.
Client  received the Booster COVID vaccine (Pfizer, Lot #FL3197) at approximately 1235.  At 1238,Observation RN was alerted by client,  that she was feeling lightheaded and warm.  Client was moved to anti-gravity chair and provided snacks and water.  Co-lead was requested by  Observation RN.  At 1241, vitals assessed (BP 123/71, P 67, color wnl). Client reports feeling nervous and a little lightheaded.  Client also reports she had not eaten anything recently.  At 1256 vitals assessed (BP 125/86, P 68, color wnl).  Client  reports that she is feeling better.  Client  continues to eat snacks and drink water.  Client  has hypothyroidism and currently taking 60mg armour thyroid daily.  No known Allergies. At 1303 client reports feeling good and feels ready to leave. Vitals assessed (BP 127/88, P 69, color wnl).  Client educated on signs/symptoms when to seek medical care and to follow-up with primary care provider.  Client left with steady gait and with husband present.
Was sick; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Was sick". Additional information:  pharmacist has a patient there who is to get the second vax but is at 45 days mark, She is asking if this is ok or redo the series. She stated the patient was sick and her HCP told her to wait 2 weeks before getting the second vax The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021447906 same patient same drug different dose and event
Patient presented to urgent care on 8/1/13 with 2 day history of diarrhea, possible fever, decreased energy, and jaundice.  She also developed a disseminated flesh colored papular rash which would rapidly scab over. She was found to be profoundly anemic to 5.4 and was admitted to hospital. She required nearly daily transfusions due to new onset warm Ab hemolytic anemia which only improved slightly with a burst of high dose steroids as well as two treatments with IVIG.  She also developed three other rashes during this hospital course.  She had a massive diagnostic workup at Hospital, and had a skin biopsy of a lesion that appeared to be consistent with a herpes virus infection but was negative for HSV1 or HSV2.  She was treated with IV acyclovir at meningitic dosing for 14 days. She also developed worsening encephalopathy with decreased ability to clear her own secretions.  It was determined that she was deteriorating clinically and required further diagnostic workup at a tertiary care center.  She was transferred to another hospital on 9/4/13. She was admitted to the PICU due to worsening neurologic status and has required prolonged intubation due to concern for neuromuscular weakness. LP on admission and subsequent skin lesion sample was positive for VZV DNA by PCR, and MRI brain and neck has shown diffuse cerebral atrophy and hyperintensity of basal ganglia, medulla, and cervical spine.  She was treated with a burst of high dose steroids and 3 back-to-back doses of IVIG with improvement in her transfusion requirements. She was also treated with acyclovir and subsequently foscarnet with improvement in symptoms.  Of note, she has had multiple infections during her hospital courses including rhinovirus, adenovirus, Pseudomonas, Ambiotrophia, and Klebsiella.
pt reported by 9PM day of vax exp vomiting, muscle spasms, SOB, chills, hyperventilation;went to clinic next afternoon;told was vaccine reaction;
Information was received from a nurse concerning a patient of unknown age and gender. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-JUN-2017 the patient was administered a dose of M-M-R II (lot number, dosage, and route of administration unknown). It was reported that the M-M-R II expired on 25-JUN-2017. No adverse events were reported. No additional information was provided. Outcome of event was unknown. Additional information has been requested.
immed pain p/receiving Td which got progressively worse over the next 24 hr & cont w/severe sharp pain, aches, swelling, weakness & blisters; saw MD 25JUl given med; still has much pain swelling & blisters;
Fatigued/tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued/tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigued/tired). At the time of the report, FATIGUE (Fatigued/tired) outcome was unknown.            No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
On 10/3/2022 I received a booster of the bi-valent COVID vaccine as described above. At the same time I received a seasonal influenza vaccine. I do not have documentation at present on the manufacturer of the flu vaccine.   Initially I experienced normal side effects of the vaccines.   Four days  after receiving the vaccinations I began to experience a full body inflammatory response.   This response built over the next few days and triggered an  episode of atrial flutter that I was unable to correct using prescribed medications. After a couple of weeks I consulted with my cardiologist and was scheduled for a cardioversion to restore normal heart rhythm. The cardioversion was performed on 11/8/2022 and was successful in returning my heart to its normal function.
About six hours after receiving Fluzone high dose quad flu vaccine I experienced shaking chills and vomiting that lasted about 8 hours and tiredness that lasted about 36 hours
labored breathing; heart rate elevated; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Apr2021 at single dose for COVID-19 immunisation. Medical history included dyslexia. Concomitant medication was not reported. The patient received her first dose of Pfizer vaccine last Monday (19Apr2021). She went to the ER Saturday (24Apr2021) experiencing symptoms when she got home and last week. Is for the Covid 19 vaccine.  She had dyslexia which was before vaccine. She had labored breathing after the vaccine and her heart rate was elevated. She was unable to bring her heart rate down. It was difficult to walk upstairs and read warm ups for her senior citizens. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Tinnitus in right ear. Noticed them the evening after the shot and have been persistent since then.
Temp 103 degrees within hours of injection. C/O severe pain to right leg, nearly intractable pain. Unable to bear weight on leg x 36 hrs. Post injection significant redness et swelling to groin et all of upper right leg. See photos included.
On 3/13  Fever between normal and 101, felt very heavy and tired;  on 3/15 below injection site I had a red patch that itched badly and shot the itch down my arm