chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per RN, patient "almost immediately" after receiving vaccine, stated she wasn't feeling well. Patient became diaphoretic and pale. Patient assisted to supine position.  Vitals at 1227 BP 113/78. 100% O2Sat, 61 HR.  Placed cool compress on forehead.   Continued to monitor. At 1235 BP 115/65, 99% O2Sat, HR 59.  Offered Gatorade and given pretzels. Color improving, continued to lay supine. At 1240 BP 114/68, 99% O2Sat, HR 65.  Patient slowly assisted to sitting position and assisted to chair.  Remains slightly pale, awake & alert. Sipping Gatorade and eating pretzels, conversive with Mom and sister. Patient left Observation at 1:00pm, ambulatory with Mother and sister.
Lip numbness and blurred vision.  BP: 142/90 HR: 94 Sp02: 98%
Pt developed large warm rash to injection site, skin eventually began to blister, patient also developed cellulitis to Right leg as well
pt recvd vax 10AM 5OCT93 & the same day pt had fever 104.3; pt also had vomiting & diarrhea; vomited all day long; able to keep down small amt of pedialite; pt taken back to hosp was crying continously & hoarse;
Booster; Noted missed periods following each vaccine shot and booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 31Oct2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: LEVOTHYROXINE; METFORMIN; TYLENOL; ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose Number: 2), administration date: 10Apr2021, when the patient was 42 years old, for COVID-19 immunization, reaction(s): "missed periods following each vaccine"; Bnt162b2 (Dose Number: 1), for COVID-19 immunization, reaction(s): "missed periods following each vaccine". The following information was reported: IMMUNISATION (non-serious) with onset 31Oct2021, outcome "unknown", described as "Booster"; MENSTRUAL DISORDER (non-serious) with onset 31Oct2021, outcome "unknown", described as "Noted missed periods following each vaccine shot and booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder. The device date was given as 12Dec2021.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was noted that missed periods following each vaccine shot and booster. Last shot was on 31Oct2021 as of 12Nov2021 no period. Occurred with after each shot in series as well. No hospitalization prolonged. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The device date was given as 12Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse reactions noted immediately following that were reported to Health Dept.  Found incidently on next office visit 11-6-08 that MMR II was given on 2/12/08.  Vaccine was given 8 days beyond expiration date.
Localized inflammatory irritation with proximal radial to shoulder perceived redness and warmth. Well circumscribed and mild palpable fever over lateral upper arm without induration. Local reaction to vaccination, possible mild early cellulitis.  Cephalexin 500mgm Qid x5 days. RTC 7-24-09. Client assessed by PA-C.
itchy rash & throat felt swollen are rprtd in a pt who recvd 1 dose of flu vax recvd on 20O6CT93 & w/in 15 mins exp pruritis of neck, hands, head & rash appeared on hands & over the chest; pt went to ER because rash increased w/swelling
Pt to ED for respiratory distress and cough. Oxygen saturation on room air was less than 50%, improving to 81% on 12 L of non-rebreather and 100% on 15 L non-rebreather.  In severe respiratory distress with rhonchi and had some peripheral edema.  Labs showed a creatinine of 1.25.  WBC count of 19.0, hemoglobin 9.1.  ABG showed a pH of 7.28, PO2 264.  BNP level was 406.  Chest x-ray showed pleural and parenchymal opacity in the right lung base suggesting a combination of a small pleural effusion and right lower lobe infiltrate.  A 12-lead EKG was reviewed showing sinus tachycardia with diffuse ST-segment depressions.  Admitted for management of pneumonia COVID + 1/6/21.  Found to have troponin elevation. Discharged.
itchiness; broke out into rash inside bilateral upper thigh; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and RASH (broke out into rash inside bilateral upper thigh) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PRURITUS (itchiness) and RASH (broke out into rash inside bilateral upper thigh). At the time of the report, PRURITUS (itchiness) outcome was unknown and RASH (broke out into rash inside bilateral upper thigh) had resolved.            No concomitant medications were provided.  No treatment information was provided.     This case was linked to MOD-2021-054503 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received on 16 JUL 2021 contains significant information which includes events and out come of  events .
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 26-month-old male patient received PREVNAR 13, (lot #: R41774), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had had multiple cases of otitis ending in tubes after use of product on an unspecified date. The patient saw an allergist and discovered that he did not respond to the PCV 13 series. He may or may not have an immunodeficiency. The reporter planned to give him a booster of PPV 23 and repeat immunoglobulin levels. The outcome of all events was unknown.
On 4/26/00, within 24 hours post vax, the pt experienced severe tenderness, swelling and redness at the injection site extending into the right axilla. Follow up information reports that on 5/1/00, the pt recovered.
No additional AE/no PQC; MMRII was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      The vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) underwent temperature excursions of 8.9 degrees Celsius for 12 hours 20 minutes on 14-AUG-2023 and 9.4 degrees Celsius for 8 hours 20 minutes on 28-AUG-2023. There were no previous temperature excursions and both reported at time of temperature excursion call. On 25-SEP-2023, the patient was vaccinated with one dose improper stored vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # W021191, expiration date: 29-MAR-2024; strength and route were not reported) for prophylaxis (product storage error). Healthcare professional (HCP) provided multiple lot numbers that did not appear to be similar to other Merck vaccine lot numbers; confirmed with HCP multiple times that these were the correct lot numbers and the products were Merck branded vaccines. No additional adverse event (AE) reported.
Chills, Throwing up, Fever of 100.3F, Loss of appetite, Headache, Upset stomach
Fever, sweats, chills, vomiting, diarrhea 12 hours after vaccine. Rested all the following day. Day two was fine. Day three, fatigue, aches and chills.
Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over the body) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash all over the body). At the time of the report, RASH (Rash all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (company employee) concerned a 41 year old female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, alcohol use (1-2 glasses per month), non-smoker, seasonal allergies, and keflex allergy (hives), and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 20-JAN-2022) dose was not reported, 1 total, administered on left arm on 03-APR-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported. On 14-FEB-2022, Laboratory data included: COVID-19 rapid POC test (NR: not provided) positive which led to suspected clinical vaccination failure (dose number in series 1). The outcome of suspected clinical vaccination failure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect moderna covid-19 vaccine as a booster (dose number in series 2) (form of admin not reported, route of admin not reported, and batch number: 034F21A expiry: UNKNOWN) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination.  On 14-FEB-2022, the patient was really sick and had bad symptoms such as really bad fatigue, fever for 3-4 days and lost taste and smell for 3 weeks, tested positive for covid and experienced suspected covid-19 infection (dose number in series 2). The patient recovered from suspected covid-19 infection on 24-FEB-2022. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000230748.; Sender's Comments: V0: 20220525852- covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
March 22nd: ~6pm: Received 2nd dose of Pfizer Vax. March 23rd: ~12am:  Started to notice irregular heartbeats.  Used iWatch ECG feature and confirmed irregular heart beats. March 24th: 11pm: Went to urgent care for 12 lead EKG.  EKG showed signs of PAC and referred me to see cardiologist for further follow-up March 25-April 13th - Irregular heart beat episodes can last from 15 min - 12 hours.  Period between episodes varies from few hours to several days.  April 14: Met with healthcare provider at healthcare facility.  He prescribed an event monitor, stress test, and echocardiogram April 21: Started wearing heart monitor (ZioXT).  During 2 week wear period, experienced several episodes.  Monitor results showed 1st degree AV Block, SVT, Atrial Flutter (<1% burden), 2nd degree AV Block - Mobitz I May 19: Return to healthcare facility for stress test, and echocardiogram.  During stress test, experienced SVT. doctor referred me to another doctor for further evaluation.  Doctor recommended cardiac MRI - scheduled for Jun 7, 2021
This nurse was called to the monitoring area to assess a patient post vaccination. Patient received Covid 19 Vaccine dose #1 (LotER2613, Exp. 7/31/21). Upon arrival patient was sitting in chair, pale, diaphoretic and lethargic. Patient was able to state her name and DOB. Initially unable to obtain a blood pressure on left arm. HR 52, Pulse 0x 91%. Ice pack was applied to patient's neck. Patient advised to take slow, deep breaths. Patient became more alert. Patient was given water. BP was obtained on right arm: 118/70. Pulse ox increased to 98%, HR increased to 77. Patient monitored closely entire time. Patient started to feel better after hydrating and applying the ice to her neck. Patient was advised to stay in monitoring area for additional 20 minutes. Patient was thankful and stated she felt much better. She inquired if she should take the second shot. Patient was advised to contact her PCP to discuss her options. Patient remained in monitoring area for additional time and left without further incident.
Severe, constant chills; headache; fever of 102.8; BP 158/98; pulse 150; This is a spontaneous report from a contactable consumer.   A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 18:15 (Age at vaccnation63 years old) (Batch/Lot Number: EN6202) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included thrombosis, covid-19 from Nov2020 to Nov2020 , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included allopurinol (ALLOPURINOL), lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. on 28Feb2021 10:00 Severe, constant chills for approximately 22 minutes. Approximately 1 hour later, headache and fever of 102.8, BP 158/98 pulse 105. Took 3 Tylenol every 3-4 hrs. Fever broke after 12 hours. Next morning chills again (not as severe) with no fever. Headache continued for another 24-36 hrs. The patient underwent lab tests and procedures which included blood pressure measurement: 158/98   on 28Feb2021, body temperature: 102.8 on 28Feb2021, heart rate: 105 on 28Feb2021.  Therapeutic measures were taken as a result of severe, constant chills (chills), headache (headache), fever of 102.8 (pyrexia). Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
This patient had already received a Pfizer vaccine at a local pharmacy 10 days prior to the Janssen given today. I advised the patient to not receive anymore Covid vaccines.
several pts recvd Engerix-B & had flu-like sx following dose; 3-4 days p/dose had dizziness, weakness, SOB, tachycardia; seen by MD;
Janssen COVID-19 Vaccine EUA - Severe headache w/ nausea, severe myalgias, fever, weakness X 14 hours.
Reported by mother on 11-10-03 - Large swollen arm 2 days after shot given on 10-29-03.  Patient slept 48 hours and ran fever.  Was taken to family physician.
HX ANXIOUS/NEEDLEPHOBIA, FAINT WITH SIGHT OF BLOOD. DURING OBSERVATION, PT STARTED TO WOBBLE AND COLLAPSED ON THE FLOOR, WOKE UP RIGHT AFTER, PROVIDED GATORADE, VSS, NO TRANSPORT
Two days post vax, site became erythematous, hard and warm. Diagnosis at that time was sterile abscess. Pt followed up with PMD and advised to use warm compress and Motrin recommended.
Developed a minor fever blister on upper lip 4 days after first injection. But experienced no other symptoms. No fever or fatigue.  Then experienced swollen,  itchy red rash around injection site 8 days after first injection. Again no other symptoms.
This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and BALANCE DISORDER (Lost balance) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VERTIGO (Vertigo). On 08-Jan-2021, the patient experienced BALANCE DISORDER (Lost balance). At the time of the report, VERTIGO (Vertigo) and BALANCE DISORDER (Lost balance) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M039318, expiration date 20-SEP-2018 (dose and route not reported) for prophylaxis. The vaccines were exposed to Total time in the range 15°F to 46°F (-9°C to 8°C) (7°C actual temperature) for 24 hours and 50 minutes. The vaccine doses had been exposed to a previous temperature excursion of a total time in the range 15°F to 46°F (-9°C to 8°C) (7°C actual temperature) for 5 hours and 47 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA011935: US-009507513-1703USA011934: US-009507513-1703USA011932: US-009507513-1703USA011933:
Pt vaccinated with Pneumococcal/FLU ZONE developed malaise, vomited x 1, redness across site rt arm w/swelling. Improved by 12/26/90.
After 12 hours from getting the vaccine. I had chills, bad body aches and a fever of 101.6 twice. Started feeling bad at 11pm on 1/21/21 and didn?t start feeling better till 1/22/2021 around 6pm
Patient was given a dose of Pediatric Pfizer that was not diluted prior to injection.
pain & limited ROM rt hip;limping, unable to participate in any physical activity x/walking;
No other adverse effects were reported.; a patient received an expired dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 29-JUN-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, lot # S001832, expiration date 12-MAY-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. No other adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
On 08/27/19  After administered all vaccines at 09:39 am, pt. c/o mild dizziness at 09:40 am, found pt's face & lips turn pale, responsive & alert. Instructed to put his head down. After 2 minutes, pt. straighten his body in the chair & yerked his head back with his eyes closed. Father called his name, after 30 second he opened his eyes & turned to his father, & verbalized that he felt dizziness. Then pt awake, responsive, but face & lips looked pale. Nurses assisted pt. to elevate his both feet. Nurse checked BP 117/53,P 79, SPO2 98 at 09:48 am & pt. verbalized that he had no dizziness. Nurse stayed with pt. & assessed pt. Nurse checked BP 119/50, P 70, SPO2 99 at 09:52 am. in sitting position. Nurse checked BP 128/62, P 74, SPO2 98 in standing position at 10:00 am. Pt awake, alert, responsive & no more dizziness. Pt left the facility without acute distress noted at 10:45 am.
Information has been received from a consumer reported on behalf of her daughter, concerning a 12 year old female with a history of "sugar goes down a little low" (hypoglycaemia), who was vaccinated on unspecified dates with 2 doses of GARDASIL. The mother reported that after her daughter started receiving her first and second doses of GARDASIL her menstrual cycle became severely heavy and required her to take birth control pills, ORTHO-NOVUM 1/35. The patient sought unspecified medical attention and had an MRI performed with no abnormal results found. The patient reportedly recovered. No product quality complaint was involved. Additional information is not expected.
Severe red knot showed up and got bigger as the day progress, so bad with pain and inflammation ended up going to ER on Saturday, doctor said she had a severe allergic reation to vaccine.
Information has been received from a nurse concerning a 10 year old patient with allergy to unspecified medication who on 28-Dec-1999 was vaccinated with the first dose of VARIVAX (Oka/Merck). In July 2008, the patient had a full blown chicken pox. On an unspecified date the patient recovered from a full blown chicken pox. The patient sought medical attention and saw the physician. Additional information has been requested.
Patient reports the day after vaccine given her arm got red, swollen around the injection site and was that way for 4 days. She went to her doctor the next day who told her to take ZYRTEC but she didn't want to. Instead she treated it with calamine lotion. Patient also reports having stomach upset not yet resolved as of 1/9/2012 when she reported the incident to me.
2 days p/vax rt arm hand & arm began to swell w/pain-cont to present-swelling & pain subsiding how he has good ROM
Fever, very tired, chest tightness, shallow breathing, Got really hot then cold sweat ,fainting and extreme diarrhea, Anosmia
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. It was reported that M-M-R II and VARIVAX (Merck) were prescribed. On 14-APR-2015, the patient was vaccinated with PROQUAD (Merck) (dose 0.5 ml, subcutaneous, lot# and expiration date were not reported) instead of M-M-R II. The nurse practitioner stated the she felt that the PROQUAD box and M-M-R II box were so similar especially in color, that this might had contributed to the confusion. No adverse effect was reported. Product quality complain (PQC) was not involved. Additional information has been requested.
Local symptoms: Pain-discomfort. General symptoms: headaches, fatigue, nausea. Narrative:
Racing heart: confirmed as her heart is beating fast; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that, since she got the shot, she has had a racing heart (heart is beating fast) in the morning, when she wakes up. she was just curious as to what she could do about her racing heart. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pinpoint itchy rash on stomach,back,arms and thighs. Not on face. No temperature, no problems breathing. Saw private Dr. on 1/29/07, benadryl prescribed. 1/31/07 rash is improving.