chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SICKNESS FOR UNDER 48 HOURS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sickness for under 48 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness for under 48 hours was not reported. This report was non-serious.
1/16/21, Covid vaccine injection at 12:09 PM Minute 1: dizzy and light headed (like drinking a beer on an empty stomach) Minute 10: Nausea Minutes 23-25: Neck tightness (like doing unsupported crunches and holding my head up) Minute 27: Inability to swallow and inability to speak EMS on site administered EpiPen auto-injection to left thigh, immediate improvement in symptoms Transport to hospital via ambulance Hospital monitored me for several hours and discharged same day
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Patient suddenly experienced nausea, dizziness, passed out, vomited, called 911, taken to hospital by Ambulance.
Pt was given Moderna vaccine for dose one.  Pfizer vaccine administered as dose two.  Not interchangeable.  No reports of harm to pt.
Shingrix was administered into the left arm on 8-26-20 in the afternoon. Fluzone Quad was administered in the right arm at the same time of 8-26-20. Patient showed up at the pharmacy on 8-27-20 in the afternoon to report he was experiencing swelling at the site of injection, a possible low grade fever, and tingling in the injection arm and fingers (left arm). Patient reported the side effects started on 8-27-20 after he awoke for the day. Left a message for the protocol Dr. and spoke with his primary care physician. Neither doctor provided a treatment plan. I told the patient he could take Tylenol for the fever and any pain/discomfort. Patient did not report any additional side effects.
Shortness of breath; Patient received the second dose of the vaccine less than 26 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine less than 26 days after the first dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 043D21A) for COVID-19 vaccination.     The patient's past medical history included Sickness (before receiving the vaccine).   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced DYSPNOEA (Shortness of breath) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine less than 26 days after the first dose). On 13-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine less than 26 days after the first dose) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-255958.
Large area of swelling and redness at injection site. Patient took 25mg of BENADRYL OTC and reported some decrease. Instructed to continue BENADRYL and take MOTRIN, return if fever or increased swelling.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 16-MAR-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 360 hours with 34 degrees C and 168 hours with 33 degrees C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint (PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a medical assistant concerning a 20 month old female patient who on 11-JUL-2005 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
30OCT98 trouble breathing;pt felt was from asthma;31OCT98 arm swollen w/redness & red streaks down arm;2NOV98 saw PMD d/t same;tx pred, DPH, cephalexin;
This report was received from CSL Behring and was assigned manufacturer report number 2010021861 for VIVAGLOBIN, concerning a 61 year old female who was also a physician, with hypogammaglobulinaemia, allergic asthma, allergic rhinitis, allergy to montelukast sodium (WAES 1002USA01909), recurrent pneumonia and a history injection site cellulitis from other injections including the flu shot (brand name unspecified) and an increased liver function test, who on approximately 05-APR-2009, was vaccinated with PNEUMOVAX 23 (route and lot # unknown). It was reported that on 05-APR-2009, once after the vaccine, the patient experienced cellulitis. It was unspecified if the patient sought medical attention. At the time of the report the patient's outcome was unknown. The nurse also reported that in December 2009, after the second dose of VIVAGLOBIN, the patient developed minor cellulitis at the infusion site which then resolved. Concomitant therapy included SYMBICORT, NASACORT, ASTELIN, CYMBALTA, XOPENEX, COUMADIN, ADVAIR, TEKTURNA, MODURETIC, PREVACID, REGLAN, LEXAPRO, DARVOCET-N, steroid injection, RECLAST IV,  QVAR, MICARDIS, CELEBREX and BONIVA. This was originally reported by a registered nurse. No further information is available.
Narrative: Moderna bivalent booster 10/5/22 at the clinic, he was given half a dose of the vaccine which is 0.25 ml instead of 0.5 ml.
Patient stated he felt really dizzy all of a sudden.  Became very pale and diaphoretic.
the area between the eyes became swollen and sore; the area between the eyes became swollen and sore; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 27Feb2021 16:00 (Batch/lot number: EN6198), at age 45 years old, as dose 2, single, for COVID-19 immunisation; and Botulinum toxin type A (BOTOX), via an unspecified route of administration, on 24Feb2021, at an unspecified dose and frequency, for an unspecified indication. The patient was not pregnant at the time of vaccination. Relevant medical history included multiple sclerosis and penicillin allergy both from unknown dates, not reported if ongoing or not. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included suvorexant (BELSOMRA), gabapentin, escitalopram, and levonorgestrel (MIRENA), all taken for unknown indications, start and stop dates were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, on 07Feb2021 15:15 (Batch/lot number: EL9269), at age 45 years old, as dose 1, single, for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks. On 01Mar2021 at 04:00 (reported as "approximately 36 hours after the second dose of the vaccine"), the area between the eyes became swollen and sore. This was the same area the patient received Botox approximately 5 days earlier. The patient did not receive treatment for the events. The action taken in response to the events for Botulinum toxin type A was unknown. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Temperature over101 Body aches Severe headache Projectile vomiting Dizziness/vertigo Rash on arm
Patient had vaccine about 10 minutes prior and was seated in vaccine observation area. At 11:25 am pt then seen laying on floor face down. Turned patient over to back and elevated legs. Pt initially not alert for 2 to 3 seconds than became alert afterwards. Pt body was initially stiff for 2 to 3 seconds then normal tone after. Pt complained feeling dizzy. Initial VS at 11:25am was 140/100, P71 O2 sat 99%. Pt C/o of right side of head tender to touch and rt knee tenderness. Ambulance called and PT taken to ER for assessment.
This spontaneous report as received from a pharmacist refers to a 56 year old male patient with diabetes. The patient had no allergies. On 04-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # reported as M033086, expiration date reported as 05-MAY-2018, intramuscular (dose was not reported). Concomitant therapies included glimepiride, LOTREL, metformin and NASONEX. On 04-OCT-2016, the injection site had redness and a large baseball size knot. There was redness and swelling around the arm and down to the elbow with pain in the armpit. On 06-OCT-2016, the injection site was red, warm and raised less than baseball size knot. The patient did not seek medical attention. No laboratory diagnostics studies were performed and no treatment was given. The outcome of events was reports as recovering/resolving. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis, lot #R00298 and expiration date 29-JUL-2019 (strength, dose, frequency and route of administration were not reported), that was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The temperature of excursion was reported as 6°F to 14°F during a time frame of 14 hours. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one of several reports received from the same source. Lot number R00298 not valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.
severe pain in left leg/it's painful and swollen.; 10-fold worse pain since booster dose; cannot walk, it's painful; swollen left leg about 1/5 to 1/6 bigger in size (from the thigh to ankle)/left calf was also bigger/it was painful and swollen; pain at inside of knee/pain at back of  knee; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in left leg/it's painful and swollen.), PAIN (10-fold worse pain since booster dose), GAIT INABILITY (cannot walk, it's painful), PERIPHERAL SWELLING (swollen left leg about 1/5 to 1/6 bigger in size (from the thigh to ankle)/left calf was also bigger/it was painful and swollen) and ARTHRALGIA (pain at inside of knee/pain at back of  knee) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 039A21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain in leg. Concomitant products included TRAMADOL for Pain, ROSUVASTATIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced PAIN IN EXTREMITY (severe pain in left leg/it's painful and swollen.), PAIN (10-fold worse pain since booster dose), GAIT INABILITY (cannot walk, it's painful), PERIPHERAL SWELLING (swollen left leg about 1/5 to 1/6 bigger in size (from the thigh to ankle)/left calf was also bigger/it was painful and swollen) and ARTHRALGIA (pain at inside of knee/pain at back of  knee). The patient was treated with IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (severe pain in left leg/it's painful and swollen.), PAIN (10-fold worse pain since booster dose), GAIT INABILITY (cannot walk, it's painful), PERIPHERAL SWELLING (swollen left leg about 1/5 to 1/6 bigger in size (from the thigh to ankle)/left calf was also bigger/it was painful and swollen) and ARTHRALGIA (pain at inside of knee/pain at back of  knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Heart racing, Fever, Terrible Headache, Chills, Nausea, Weakness, and Fatigue for first 48 hours or so; continued fatigue even now.
Patient was given Pfizer 5-11 vaccine on 1/14/23 that had a 10 week fridge expiration date of 1/11/23.   No adverse reaction.  Just given expired vaccine.
On right leg a bullseye appearance 7 inches in size, itchy, painful, hard and hot to touch. Went to  Medical Center on 5/5/18. Was seen at primary care on 5/8/18 with some improvement to area.
11 y/o male presented with urticaria on all limbs, abdomen and face.  Urticaria present for 3 days after vaccine.  No breathing issues.  Vomiting and malaise.
Swollen lymph node in left neck base, left and right armpit; discomfort and second day is the same with arm pit discomfort; This is a spontaneous report received from a contactable consumer, the patient. A 58- years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533) via an unspecified route of administration administrated in the left arm on 25Mar2021 at 13:00(at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to sulpha drugs. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration administrated in the left arm on 04Mar2021 at 13:00 as a single dose for COVID-19 immunisation. The patient was also allergic to epinephrine and codeine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Mar2021 at 16:00 the day after the vaccine the patient experienced lymph nodes in left neck base swelled and were very uncomfortable. Then lymph nodes in left armpit swelled and caused discomfort, second day was the same with right armpit discomfort. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests which included nasal swab on 20Mar2021 and tested negative post vaccination. The clinical outcome of the event swollen lymph node and discomfort was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recvd vax 23JAN92 & on 14FEB92 pt awoke @ 3AM w/pain in neck & back; pt went back to sleep & tossed & turned most of night; next morning pain in neck, back & arms; unable to walk, flaccid transverse myelitis;
began frequent urination, urticaria, mild burning in peri area began on 12/24/2021, and still is experiencing it - began drinking cranberry juice to relieve symptoms - did not visit medical provider , lower back pain, lower abdominal  cramps began on 12/25/2021 and lasted for week
Presented with stroke like symptoms at 10:30, right sided weakness and slurred speach. 911 was call, patient was transported to hospital. Per ED note, patient experienced TIA which resolved, actue exacerbation of CHF.  Patient was admitted. Discharge summary on 1/22 indicates same diagnosis, plan was home with hospice. Family notified hospital on 1/25 that patient had expired on 1/23 at home.
3/12/03. Pt reports headweak, ? by phone (works at clinic). "Feels like back of head will lift off." T 98.5, no relief with any Advil 2-3x ? contacted MD by phone. 3/13/03 con't to have headache. 3/14 headache, going to md.
Gave Tdap to 10 week patient gestation, EDD:11/14/2023
Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 08-Apr-2022 which had got expired on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. It was reported that total of 173 doses were administered having Lot number has 070H21A. HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information.
This spontaneous report as received from a 71 years old female consumer refers  herself with high blood pressure, hypothyroidism and drug reactions/allergies to sulfa and tricycle antidepressants. The patient's medical history included paradoxical reaction. The patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 10-DEC-2012. Concomitant medications included HTZ, ATENOLOL and LEVOXYL. On 13-DEC-2012 the patient experienced extreme fatigue, headache, muscle aches and mild bloody noses 2 to 3 days after immunization. She sought medical attention by calling her physician and visiting office and they did not prescribe treatment. No lab diagnostics study was performed. She reported that the symptoms had gotten less intense, but persisted. Additional information has been requested.
patient was sitting in waiting area and felt dizzy and fainted. was on ground for 30-40 seconds and had nurses and paramedics attend to her. blood pressure was high at first and then she felt fine after 30 minutes and denied ambulance and went home
Quarter-sized area of enduration 2-4 inches above right elbow.  Nickel-sized area of enduration 2-4 inches above left elbow.  Slight erythema to both arms.  Patient states slight tenderness to left arm.      5/26/2009--telephone call to patient.  Patient not at home.  Dad states patient has recovered.
COVID-19 test came back positive; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 test came back positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 test came back positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 test came back positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Hepatitis A vaccine administered approximately 12:15 pm on 4.19.17. Upon awakening on 4.20.17 pt. reports BLE pruritic macular rash, spreading from hands superiorly to mid bicep. BLE macular rash knee to thigh.
04/15/21 I woke up extremely tired, very warm, not feeling well and severe pain in arm. Took tylenol which didn't help with pain so I started with ibuprofen and benadryl. Slept most of the day and night no energy pain in arm. 4/17/21 Developed a large lump under left arm in arm pit. Very painful and my fingers would go numb. My arm and face looks like I have been sunburn this comes and goes. I went to Urgent Care 4/17/21 they gave me Prednisone 20mg 2 tablets for three days. My armpit swelling went down. Now i have weakness and my fingers go dumb and my arm feels like its dead weight.
Pt noticed swelling on the site of injection on the right arm and was advised to take BENADRYL. As of 1/7/2015, pt's arm has a big bruise but pt has itches and hives (body). Pt is advised to consult prmary MD.
Child presented in our office 07/11/2003 with erythema to left medial thigh (1/5 x 1 in ) firm, but not tender.  child also with some vomiting per mother.