chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MA states that she was helping room nurse visits. Both patient (12 years old) and brother (11 year old) were on the schedule. MA stated that she thought she needed two pediatric doses, and grabbed two pediatric doses since she saw the 11 year old on the schedule.  MA  went to administer under immunization tab, since there were no orders entered. She states that she realized the mistake AFTER she administered the vaccine, and was not documenting in real time. Per her email to me, she notified Dr., attending, and , RN. Also told mother of parent of the mistake.  No treatment. No reactions or adverse events.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (3 to 5 glasses of wine weekly).    On 03-Mar-2021 at 2:00 PM, 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-Nov-2020 and the estimated date of delivery was 20-Aug-2021. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 03-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2020, Pregnancy test: positive (Positive) positive. On 25-Dec-2020, Ultrasound scan normal:. On an unknown date, Gene sequencing: normal (normal) normal. On an unknown date, Ultrasound scan normal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up information received on 30-Apr-2021 contains non-significant information.
Post vaccination (approx 2 hrs) individual developed itchy, large red blotch rash to arms and legs ((R) arm) injection site). Father administered BENADRYL by month upon returning home. (Father)guardian) did not seek medical attention.
Pt reports 8/22/2010 swelling noticed in axillary area & she used MOTRIN 8/26/2010 (R) arm with small fingertip size red area noted at injection site. Lymph node in (R) axillary area with swelling noted.
unable to sit up or roll over;temp, withdrawn;dx spasic diplegia-transverse myelitis;hosp
Seriousness criteria: other Medically significant (OMIC). Initial report received from a health care provider on Nov 29 2005. A 61 year old female with a medical history of psycho affective disorder received an injection of Fluzone SV 2005-2006, lot number unknown, on a unspecified date in mid Nov 2005. Route and site of administration, and illness at the time of vaccination were unknown. The patient has a history of allergies to penicillin, gentamycin, latex and strawberries. No other pre existing conditions were reported, although the patient is on multiple other medication. Two weeks post vaccination, on Nov 28 2005, she became unresponsive and was examined in an ER. Per the reporter, the cause of the event was diagnosed as due to mercury derivative in the flu vaccine. The patient was released from the hospital. At the time of this report. the recovery status was not reported.
Received ZOSTAVAX injection 10-8-12. On 10-10-12 noticed 28 mm x 40 mm area at site of injection that was red, warm, & itchy. No tx indicated.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 02-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K014833 and Expiry: 14-SEP-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Swelling, rash, and mild itching at vaccine site started 8 days after vaccination. I applied steroid cream to affected area.
pt recv vax 19AUG96 & suddenly fell back & landed on head;RN noticed jerking movements all over & pale skin;pt immed woke up given cola & v;oriented x3;small round nodule palpated @ base of skull;BP106/68 HR76, RR20;poss concussion;dizzines
Pfizer vaccine was reconstituted with sterile water instead of normal saline and administered.  The patient has not reported any adverse effects at this time
Aborted sudden cardiac arrest and VT/VF storm requiring 13 shocks and sedation/intubation.  Sinus rhythm was restored with each shock, but the patient would promptly go back into VT, with rapid degeneration to VF, such that ROSC was obtained only twice over the course of 10 shocks delivered.  The patient had no further VT/VF after sedation & intubation.  He suffered an encephalopathy and remained unresponsive for several days, but ultimately recovered and an ICD was placed.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 34 years old female with unspecified ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 204B21A and expiry: 11-DEC-2021) dose was not reported, dose number in series 1, 01 total administered on 22-JUL-2021 on right arm for prophylactic vaccination. Concomitant medications included fluoxetine for anxiety, bupropion hydrochloride for unknown indication, levothyroxine for thyroid, and ascorbic acid/calcium pantothenate/cyanocobalamin/ergocalciferol/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin sodium phosphate/thiamine mononitrate/tocopheryl acetate for unknown indication.  On 18-JAN-2022, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (cough, congestion, froggy voice). On 19-JAN-2022, Laboratory data included: coronavirus disease (COVID)-19 virus test (NR: not provided) positive. On 22-JAN-2022 The patient felt much better (dose number in series 1). The patient confirmed she had not yet received a booster vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213953.; Sender's Comments: V0:20220150411-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. 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
NUMBNESS IN HAND; HEADACHE; BRAIN FOG; INSOMNIA; BODY PAIN; NAUSEA; CHILLS; TIREDNESS; PAIN AT SITE OF INJECTION; RAPID HEARTBEAT; RESTRICTED BREATHING; INCREASED BLOOD PRESSURE; HEAT SENSATION THAT WENT FROM HER FEET TO HER HANDS; LIGHT HEADEDNESS/DIZZINESS; SWEATS; ANXIETY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and over weight, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced rapid heartbeat. On 09-APR-2021, the subject experienced restricted breathing. On 09-APR-2021, the subject experienced increased blood pressure. On 09-APR-2021, the subject experienced heat sensation that went from her feet to her hands. On 09-APR-2021, the subject experienced light headedness/dizziness. On 09-APR-2021, the subject experienced sweats. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced pain at site of injection. Laboratory data included: Blood pressure (NR: not provided) Increased. On 10-APR-2021, the subject experienced insomnia. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced brain fog. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced numbness in hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, restricted breathing, increased blood pressure, heat sensation that went from her feet to her hands, light headedness/dizziness, and sweats on 09-APR-2021, brain fog on 12-APR-2021, anxiety on APR-2021, chills, and nausea on 10-APR-2021, was recovering from pain at site of injection, insomnia, body pain, and headache, and had not recovered from tiredness, and numbness in hand. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Patient stated that he had swelling of the throat and right hand with in 24 hours of vaccine. Patient then began experiencing right-sided neck pain and complains of complete hearing loss of the right ear. Patient called and visited his primary care physician. He was given a steroid shot and methylprednisolone 4mg twice daily.  The steroids reduced the neck pain, throat swelling, and hand swelling with in 2-3 days of initiation. However, patient states the he is still experiencing hearing loss of the right ear two weeks after shot was received.
The day after the injection area was red, raised and warm to touch - about baseball size.  During the next 7 days the area grew in  size with a bruised spot at the injection site.  Right arm stayed very warm to touch and area spread to almost completely go around the arm.  Arm felt like it had fever in it.  I did not go see my APRN, FNP at Clinic but I did phone and was informed by staff to take benadryl for the next several days.  I do have pictures of my arm if you would like to see.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. It was reported that the patient never had COVID positive test or diagnosis and patient didn't received any other vaccines within 1 month prior to Moderna COVID-19 vaccine. No treatment medication was provided. This case was linked to MOD-2022-548975 (Patient Link).
Speech was slurring, son told me he was just tired. Went on to bed, woke up next morning dropping his regular meds, hand not working right, I took him to the ER.
This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as: since August 2014) unspecified number of the patients were vaccinated with PNEUMOVAX 23 (dose, route, lot # not provided). On an unknown date in 2014 (reported as: since August 2014) the patients were vaccinated with doses of PNEUMOVAX 23 that had been exposed to supported temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
No symptoms. Hep A & Hep B were right beside each other in immpact. I read it wrong & gave Hep A at 6 months with the Hep B, DTAP, Rotavirus.
No additional adverse event; The patient received MMRII intramuscularly instead subcutaneously; This spontaneous report was received from a Healthcare Business Professional and refers to a 26-year-old patient of unknown gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     On 13-AUG-2021, the patient was vaccinated with a dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II), intramuscularly, lot # S036662, expiration date 14-NOV-2021, (dose not reported)  for prophylaxis. No additional adverse event and no product quality complaint.  This is one of two reports from the same source.; Sender's Comments:  US-009507513-2108USA004588:
Fever 103,migraine,passed out twice,throwing up,diareeah, rash,chills,dizzy,
developed a rash on her arm; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (developed a rash on her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced RASH (developed a rash on her arm). On 04-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, RASH (developed a rash on her arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
The syringe leaked between needle and plunger when giving injection to the patient.  They did not get a full dose. Re-injected the patient.
Swelling and soreness/tenderness under right arm.; Swelling and soreness/tenderness under right arm; Swelling and soreness/tenderness under right arm; Numbness in right arm (elbow to hand); This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on 10May2021 at 17:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 19Apr2021 at 04:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021, the patient experienced swelling and soreness/tenderness under by right arm and numbness in right arm (elbow to hand). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling and soreness/tenderness under by right arm and numbness in right arm (elbow to hand) was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
had a lot of reactions; had brain fog; bad headaches; covid arm; tingling in hands and feet that lasted for weeks; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (had a lot of reactions), FEELING ABNORMAL (had brain fog), HEADACHE (bad headaches), PAIN IN EXTREMITY (covid arm) and PARAESTHESIA (tingling in hands and feet that lasted for weeks) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ADVERSE DRUG REACTION (had a lot of reactions), FEELING ABNORMAL (had brain fog), HEADACHE (bad headaches), PAIN IN EXTREMITY (covid arm) and PARAESTHESIA (tingling in hands and feet that lasted for weeks). At the time of the report, ADVERSE DRUG REACTION (had a lot of reactions), FEELING ABNORMAL (had brain fog), HEADACHE (bad headaches), PAIN IN EXTREMITY (covid arm) and PARAESTHESIA (tingling in hands and feet that lasted for weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
redness, swelling, itch of right thigh. Keflex 250/5 1.5tsp po BIDx 10 days 150 ml
6-21-07 AM mother phoned reporting large knot with redness and warmth to right arm - at that time Benadryl and ice if area became worse and not improved to bring her in later in day. At 6:30pm mom brought child to doctor at our clinic - diagnosed allergic reaction to Varivax --> treatment = Atarax, Augmentin and follow up in AM. 6/22/07 AM condition improved continue treatment: If worse return otherwise follow up in Thursday.
11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizziness, she denied any SOB or breathing difficulty. Assisted Pt. back to sitting in chair. 11:50 AM ? Client states she had her vaccine at 11:20 AM and stayed for 30 min at which time she started to experience the numbness and tingling of lips.  B/P 150/70, Pt had own O2 Sat monitor which included pulse, O2 sat was 96%, pulse 92, no respiratory distress noted.  11:51 AM- 12.5mg Benadryl given P.O. Pt states she gets very tired with ?full dose?. Pt states she is ?queasy?, light-headed, dizzy and has vasovagal responses to vaccines. She carries an Epi-pen for various food allergies, an O2 sat monitor and emesis bags in case she has a vagal response which she states this is what she feels like. 12:00 PM ? B/P 156/90, HR ? 92, O2 sat 97%, RR ? 20, No swelling, redness or irritation at Right Deltoid injection site. 12:06 ? Pt denies any dizziness or lightheadedness at this time but continues with tingling at lips and thick front of tongue, numbness B/P 152/92, HR 76, o2 sat 95%, RR- 20, cool cloth applied to back of neck, lower legs elevated on chair. Pt wearing compression hose. 12:20 PM ? Consult with Pharmacist who stated another dose of Benadryl would not be recommended and suggested lying down on stretcher and possible anxiety reaction.  Pt refuses to lie down on stretcher and states is fine sitting with legs elevated. 12:24 PM B/P 146/90, P ? 64, RR ? 20, O2 sat 97%, Pt has flushed face and states her cheeks feel tight. She states she has Rosecea but her cheeks aren?t usually very flushed. She c/o warmth on cheeks and numbness in front area of tongue. No difficulties noted with swallowing water. Daughter arrived. Site director consulted to determine next steps and decision made to transfer to ED. Discussed transfer to ED with pt who verbalized agreement. 12:34 PM Pt states dizziness resolved however she now has a H/A and possible onset of a migraine. 12:35 PM B/P 162/90 P- 80, RR-20, O2 sat 98%. Pt denies any respiratory distress, refuses food due to many food allergies. Continues to tolerate water without swallowing difficulty or emesis.  12:40 PM Assisted Pt to wheelchair and transferred to Emergency Department for further evaluation and observation. Dtr present and verbal report given to ED RN.
pt recv vax 23DEC96 & 4AUG97 pt devel shingles on both legs & was seen by MD;pt recovered;
20Jun2020 along with immunoglobulin and dose 2 on 27Jun2020; Incomplete course of vaccination; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 9-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 27th June 2020, the patient received the 2nd dose of RabAvert. On an unknown date, the patient received RabAvert. On an unknown date, unknown after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced drug dose administration interval too long and incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.  Additional details were reported as follows: The patient received 1st dose of post exposure RabAvert vaccine on 20th June 2020 (on day 0) and 2nd dose received along with immunoglobulin on day 7th instead of day 3 which led to drug dose administration interval too long and till the time of reporting the patient did not received 3rd dose which led to incomplete course of vaccination.
Reports Left arm became painful with swelling and itching around injection site following vaccination on Thursday (9/7/2023). States she developed hives on Friday (9/8/2023). Still had swelling around injection site and arm painful to move on 9/11/2023. Denies fever, difficulty breathing, or other generalized symptoms. Was advised by Triage to follow up at Urgent Care for Assessment.