chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed) 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 DIZZINESS (light headed). At the time of the report, DIZZINESS (light headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not provided.
patient was administered Pentacel that was not diluted with no reported adverse event; Initial information received on 22-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that was not diluted with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination. Information for batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of was administered pentacel that was not diluted with no reported adverse event (wrong technique in product usage process) (latency: unknown). Repoirter was inquiring if the patient needs to be revaccinated   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was administered Pentacel that was not diluted with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient was administered pentacel that was not diluted with no reported adverse 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.; Sender's Comments:  02230423:
First felt nauseous at 1103.  Was moved to area where patient was able to lay down. At 1119 blood pressure was 139/78, pox 99 and HR 84. At 1124  sat up and was given diphenhydramine 25mg solution.  At 1144 was able to stand without any change in symptoms.  Blood pressure, pulse ox and heart rate were monitored throughout and remained normal.
Dry eyes, for several days since the day after the vaccine to today 1/26/2022
Lose of muscle function.  Lose of muscle strength.  Lose of muscle flexibility  in the are where the shot was administered
p/vax pt was seen by MD & dx w/post vax varicella w/over 200 vesicles;
THE PATEINT SAID THAT SHE HAD BLISTERS ALL OVER HER BODY, ON HER BACK, STOMACH, LEGS, HANDS AND FEET.  SOME OF THE BLISTERS TURNED INTO BLOOD BLISTERS AND HAVE SINCE SCABBED OVER.  THE PATIENT ALSO HAD RED BRUISES ALL OVER HER BODY TOO.
10/21/02 Patient called clinic to inform provider that she was sick after getting Pneumovax. Had a 4"x4" size local reaction in the left arm and temperature at 100 degrees F. Also lost several days at work.
Fever or Chills  Cough  Headache  Sore throat  Congestion or running nose
rash all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over) 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.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced RASH (rash all over). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 400 mg. At the time of the report, RASH (rash all over) outcome was unknown. Not Provided          No concomitan
This spontaneous report was received from a pharmacist and refers to a 2 month old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-JAN-2016, the patient was vaccinated with an adult dose of RECOMBIVAX HB strength 10/1.0 mcrg/ml, as her first dose (lot #, dose and route were not provided). No adverse symptoms were reported. Additional information has been requested.
First siting of eczema/rash on right hand within a month after second dose of vaccine.  Eczema/rash will not go away now even with medication
03/20/2021   That morning I woke up with a fever of 102 and a headache. By that evening , I was feeling exhausted. I could not focus or concentrate.  The next morning, my headache was worse and had 105.6 temperature. I could barely stay awake.  I was coughing and having difficulty breathing.  I also had congestion with a runny nose, but it felt clogged. I had a tele-health visit with my doctor on 3/23/2021. He said to take fluids, and ibuprofen.  The next Monday, he ordered prednisone to help with my lungs.  I stayed in that state, with the high fever, for about a week.  It slowly started going away. It was about 2 weeks before I felt normal again.
Patient admitted from the ED with complaint of chest pain, chest heaviness, numbness and tingling sensation.  Patient was diagnosed with myopericarditis secondary to COVID vaccination. No treatment was indicated. Patient already receiving aspirin 81mg for stroke treatment. Patient was monitored outpatient.  Symptoms resolved by 1/10/21 cardiology outpatient visit.
pt. c/o of tingle on her lip & back of her throat a little redness on nose & cheeks.   no shortness of breath.  lungs all clear & vitals    BP=142/88;  P=82;  O2=95%.    Hx= tachycardia
Drug-type rash primarily on the torso with some extending to the upper arms, thighs and neck.
I had a tetanus shot last week and my arm is red and sore. Left upper arm redness noted approximately 1 below shoulder to medial aspect above elbow, warm to touch. Afebrile 98.4 po and cellulitis. Cephalexin 500 mg QID.
This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 68-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and pain. On an unknown date, the outcome of the chills and pain were recovered/resolved. It was unknown if the reporter considered the chills and pain to be related to SHINGRIX. Additional details were provided as follows: The registered pharmacist was a patient. The age at vaccination was not reported, but it could be 67 year or 68 year. In 2018, the registered pharmacist received SHINGRIX vaccine at his pharmacy in left arm. He received the SHINGRIX vaccine 2 to 3 months ago from the date of reporting (9th July 2018). In 2018, the patient experienced chills and aches that lasted 12 to 18 hours after receiving the vaccine.
Information has been received from a nurse concerning a 9 year old patient who in 1997 was vaccinated with varicella virus vaccine live (Oka/Merck). In May 2007 through 18-JUN-2007, the patient experienced a mild case of chickenpox. The symptoms were mild, rash on the torso. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2016 to 09-SEP-2016 the patients were vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M025563, expiry date: 06-NOV-2017), which was stored at temperature of 33 degree Fahrenheit, for a time frame of 4 days 1 hour 30 minutes there was a previous temperature excursion of 25 degree Fahrenheit for 15 minutes, orally. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Upon injection, had a vagal response and a syncopal event during which time she had tonic movements and postured upper arms. Within 30 seconds of lying down, she regained consciousness and had good color. Shaky but returned to normal state with water and carbohydrates.
This spontaneous report was received from a licensed practical nurse refers to an unspecified patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The Licensed practical nurse informed that on an unspecified date, approximately 40 doses of ZOSTAVAX (route, dosage and lot# were not reported), were improperly stored and were administered to unspecified patients. No adverse effects reported. This is one of several cases received from the same reporter. Additional information has been requested.
some fatigue; dizziness; nausea; slight headache; she had dry heaves for a few minutes; broke out into a sweat; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional).  A female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 25Feb2021 09:30 (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: FATIGUE (non-serious), outcome "unknown", described as "some fatigue"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; HEADACHE (non-serious), outcome "unknown", described as "slight headache"; RETCHING (non-serious), outcome "unknown", described as "she had dry heaves for a few minutes"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "broke out into a sweat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021240734 Same reporter, event/different patient
Patient was leaving the country the next day(Sept 7th) and stated he HAD to have a covid booster.  I did not have any Bivalent vaccine in house and so gave him Pfizer grey cap that just the day before had been given as a booster dose but apparently could no longer be given as such.  He did not have any adverse reactions.  His parents were notified that he should receive a bivalent dose of covid vaccine 2 months after he received this dose.
At 11:01 Patient stated that she was sweating and nauseated. Applied cold compress pact to the neck and gave a bottle of water. o2 Sat was 99% on room air, Respirations 18, equal bilateral, Apical pulse x 1 minute 69, blood pressure 142/68, Lung sounds clear. At 11;30 patient stated no nausea or feeling sweaty. She stated that she felt much better and feeling fine. Pt. sent home and instructed to go to local ER if nausea, sweating, SOB, or chest pain occurs.
Sore, aches and pains; Eyes are red, glazed; Back spasms; Her head feels like it's going to explode; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program support. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 05Apr2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Apr2021, the patient reported that her eyes were red, glazed, her head felt like it was going to explode, she was sore, she had aches and pains. She took an allergy pill and decongestant, but it didn't work. She had back spasms. She took a half of a narco. No unaddressed medical questions referred or forwarded to medical information. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 37-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in April 2017, Live birth (Full term) on 20-Apr-2018 and Alcohol use (glass every 2 weeks). Concurrent medical conditions included Migraine (Intermittent) since 2003. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), MAGNESIUM, DOCUSATE and PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Aug-2020 and the estimated date of delivery was 25-May-2021. On 26-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 26-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2020, Pregnancy test: 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.   The previous pregnancy included 1 live birth on 20 Apr 2018 and 1 miscarriage on Apr 2017. Treatment information was not provided.   Reporter did not allow further contact; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
GRADUAL SORENESS THAT RADIATED UP TO THE NECK FOR NINE DAYS THAT WORSEN EACH DAY.
At time of injection had shooting pain down arm to below elbow. Since vaccine have had arm pain and cannot move arm in full range of motion.
1 of 2 pts who exp an inject site reaction described as local erythema, tenderness & warmth from shoulder to elbow lasting approx 5 days; no treatment initiated; pt recovered w/no residual sequelae;
Presented to Emergency Center later in the day of immunization complaining of right arm pain & swelling.   Patient admitted to hospital for sickle cell anemia with hypoxia (O2 sat to 80%).  Acetaminophen, morphine,empirically started on antibiotics, ketorolac.   "Edema was possibly secondary to a reaction to Pneumovax."
W/in 40-45mins of receiving DTP/OPV face flushed c/o h/a, vomited x 1, no fever;
This spontaneous report as received from a consumer refers to the consumer him or herself, a patient of unknown age and gender. The patient's medical history was unknown. On an unknown date, the patient was vaccinated with (one shot of) ZOSTAVAX. No co-suspected or concomitant medications were reported. The patient complained that the vaccine didn't work (onset date 04-SEP-2013), and complained that he or she got a raging case of shingles (onset date 04-SEP-2013). The outcome of shingles was unknown. The reporter did not provide a causality assessment. Additional information has been requested.
Information has been received from a nurse concerning a female patient with no medical history who on 13-APR-2009 and 20-JUL-2009 was vaccinated with her first and second 0.5ml dose of GARDASIL (lot # not provided) respectively. The patient developed a rash on her hands, foot and mouth after getting the first and second dose of vaccination. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Extreme irritability 7 X 4-5 d, decrease feeds, decrease weight, decrease sleep. Inconsolable. No fever.
2nd dose 6/17, R hand joint pain 6/20, abdominal pain 6/22
Case number PHEH2016US026017, is an initial spontaneous report received from a nurse on 06 Oct 2016. This report refers to an adult female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 29 Sep 2016. The nurse stated that, the patient was administered with FLUCELVAX QUADRIVALENT that was frozen. No adverse event was reported following this administration error.
patients were vaccinated with expired vaccine doses; Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 11-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 11-Apr-2022) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 11-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 11-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, however the vaccine expired on 01-Apr-2022.  It was confirmed that the vial didn't undergo temperature excursion issue.  Vaccine was placed in refrigerator on 04-Apr-2022.  No treatment medication were reported.
Headache, arm pain about 4 hours post injection, still having arm pain and injection site reaction, redness, raised and warm to the touch. Vertigo, fever, chills about 12 hours after vaccine lasted about 36 hours.
Patient states that she has pain at the injection site that radiates up toward her neck. She says it is painful to raise her arm and limits her ability to raise it. She also states that pain has worsened over the last month since receiving her vaccine. She has used tramadol, acetaminophen, and ibuprofen with no relief.
11-11-13 flu shot, then 15 mins later 11-11-13 shot to get rid of rash/itch 11-14-13 shingles onset. Got antiviral 11-27-13 hands and feet swollen and red like burned.
mom called & stated noted pt had facial rash;recvd vax called clinic @ 1445;mom reports no resp distress, edema, fever or high pitched cry-playing, active, alert but w/facial rash
Fever (99.8), congestion, runny nose, cough, sore throat, myalgia, arthralgias. Treated with ibuprofen 600mg PO q8hx3 doses, phenylephrine 10mg PO x1 dose, phenylephrine nasal x1spray each nostril once.  Fever, myalgia, arthralgias resolved in 36 hours. Cough, congestion still resolving.
Patient took 2nd dose on 3 may and 3rd dose on 16 may 2021; Body pain after covid vaccine; Tiredness after covid vaccine; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 3 may and 3rd dose on 16 may 2021), PAIN (Body pain after covid vaccine), FATIGUE (Tiredness after covid vaccine) and INJECTION SITE RASH (Rash at injection site) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, received third 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) Citrate free. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 3 may and 3rd dose on 16 may 2021), PAIN (Body pain after covid vaccine), FATIGUE (Tiredness after covid vaccine) and INJECTION SITE RASH (Rash at injection site). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 3 may and 3rd dose on 16 may 2021), PAIN (Body pain after covid vaccine), FATIGUE (Tiredness after covid vaccine) and INJECTION SITE RASH (Rash at injection site) had resolved.            The reporter's causality for the event(s) of Rash at injection site with HUMIRA(ADALIMUMAB) was a reasonable possibility.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   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.   This case was linked to MOD-2022-624664 (Patient Link).
Flu; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).      On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.