chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with MMR II (lot #: K005431, expiry date: 15-APR-2017) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Hep A and Dtap was given before recommended date. Hep A due 10/18/2023 and Dtap due 11/16/2023. No known adverse events reported. Reporting incident as it was given early.
swelling & pain in area where vax given w/in 6-8hrs;APAP for pain & warm compress for swelling;sxs disappeared w/in 1 to 2 days;
Joint aches about 9 hours post vaccine, vomiting at 10 hours (possibly motion induced), fever/chills/general flu like symptoms from 14 to 26 hours post vaccination
Case number PHEH2011US06958 is an initial spontaneous report received from a health care professional on 10 Oct 2011: This report refers to a male child. He was given only the CYW-135 liquid component MENVEO (batch number: unknown) intramuscularly on 03 Oct 2011. No other adverse event was reported.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 13-NOV-2012 at 08;55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient was below the age of 16, unbeknownst to us.  DOB was not checked by facility..
expired Moderna vaccine administered to patients; Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Reporter reported that the administration of vaccine occurred from 6-Apr-2022 to 9-Apr-2022. Patients have not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 1-Dec-2021. Vial was initially placed in refrigerator on 5-Apr-2022. The product didn't undergo any temperature excursion issue.  No treatment drug information was reported.
client was in observation area post vaccine complained of anxiety and headache.  NP and EMT were called to monitor client. Vitals obtained at 1:29pm BP 131/93 HR 66 and 02sat 97%. Client remained in observation until 1:57pm left with husband at her side, no further complaints noted.
Sore arm (LA) for several months not heated since the shot in Jan 2011.
Shots received at 9am approx, at 2pm child noted to be fussy, ate, noted red feet, soles and red bit swollen penis glans -  no other swelling, rash.
really sick fr the 2 nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (really sick fr the 2 nd vaccine) in a patient of an unknown age and gender 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 MALAISE (really sick fr the 2 nd vaccine). At the time of the report, MALAISE (really sick fr the 2 nd vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Pt given Moderna dose number 2 - one week to early. First dose was given on July 27th and second dose was given on August 17th (1 week to early). The second dose will not count toward the series and an additional dose will need to be given on or after September 14th to count as his second immunization to complete the series.
Client called 7/14/03 approximately 8:15am and spoke with nurse. Stated she had travel vaccines on 7/10/03. Client received yellow fever, typhoid on right arm and Td on left arm. Client reported that her right posterior arm was swollen, redden, warm to touch, itchy and had a hive or harden area at the site of injection. Client reported that he redden, and hard area to be approximately 3 inches long by 1 inch in width. Client states she has taken Advil for discomfort. Nurse suggested to continue Advil and cool compress at site to help with discomfort. Client currently denies discomfort. Client advised to have primary MD further evaluate site if no improvement or if condition worsens.
Pt symptoms included numbness from feet to mid thigh, hands, face, and tongue. Difficulty articulating speech due to numbness. Dizzy, "foggy mind," nausea, diaphoretic. Pain reported in pectoralis major in the clavicular head bilaterally.  Pt assessed by provider and observed until symptoms subsided, VS assessed and WNL, offered Benadryl and pt refused. He took an Allegra in the AM that day. Drank juice and refused crackers. Pt refused to go to ED.
Information has been received from a medical assistant concerning a 17 year old female with no pertinent medical history who on 30-OCT-2008 was vaccinated with the first dose of GARDASIL, on 8-JAN-2009 was vaccinated with the second dose of GARDASIL (LOT# 0947X) IM into the left deltoid.  There was no concomitant medication.  On 12-JAN-2009, the patient had an injection site reaction including swelling, pain and bruising after vaccination with her 2nd dose of GARDASIL.  The patient's injection site reaction including swelling, pain and bruising persisted. The patient did not have an AE after her first dose.  it was reported that the patient sought medical attention:  phone call.  Additional information has been requested.
received only the adjuvant portion; received only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   On 26th October 2022, the patient received the 1st dose of Shingrix. On 26th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-NOV-2022 Reporter's comment:  The office manager stated that the four patients received only the adjuvant portion of Shingrix.  The reporter did not have the demographics of the patients at the time of the call but would have if follow up were made.  These were the first dose for all four patients.  The reporter consented to follow up. Additional Supportive Information: The patient was received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with US2022AMR169910, US2022AMR169911, US2022AMR169909 same reporter.; Sender's Comments:  US-GSK-US2022AMR169909:same reporter US-GSK-US2022AMR169910:same reporter US-GSK-US2022AMR169911:same reporter
Took the vaccine a week before my period date. My period was delayed. Yesterday I only had 2 spots on my underwear. Today it came a bit more but not like it used too.; This is a spontaneous report from a contactable consumer. A 25-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration administered left arm 02Jul2021 20:00 (at the age of 25-years-old) as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient previously took aspirin and experienced allergies. On 09Jul2021, the patient experienced took the vaccine a week before my period date. my period was delayed. yesterday I only had 2 spots on my underwear. today it came a bit more but not like it used too. The patient did not received any treatment for the adverse event. The outcome of event was not recovered.
SORE FEELS TENDER [BRUISED AREA]; BRUISING ON RIGHT UPPER THIGH TOWARDS THE KNEE CAP/CLUSTERS OF BRUISES; DIZZINESS; HEADACHE (ON AND OFF); ACHING ALL OVER SIMILAR TO AFTER FLU SHOT; TIRED [FOR 3 DAYS POST VACCINE] /EXHAUSTION; SORE INJECTION ARM SITE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 09-APR-2021, the subject experienced aching all over similar to after flu shot. On 09-APR-2021, the subject experienced tired [for 3 days post vaccine] /exhaustion. On 09-APR-2021, the subject experienced sore injection arm site. On 10-APR-2021, the subject experienced headache (on and off). On 24-APR-2021, the subject experienced dizziness. On 25-APR-2021, the subject experienced bruising on right upper thigh towards the knee cap/clusters of bruises. On 25-APR-2021, the subject experienced sore feels tender [bruised area]. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching all over similar to after flu shot on 12-APR-2021, and tired [for 3 days post vaccine] /exhaustion, and sore injection arm site on 14-APR-2021, and was recovering from bruising on right upper thigh towards the knee cap/clusters of bruises, dizziness, sore feels tender [bruised area], and headache (on and off). This report was non-serious.
feeling a little bit sick; feels a little bit funny once she got the vaccine; her head is hurting, Headache; shoulder is hurting; a little bit of trouble breathing; also feels in her stomach; sometimes like it is Anxiety attack; She started to fall asleep, she started to have Shivers; Dizzy; gas problems reappear; This is a spontaneous report from a contactable consumer or other non hcp (patient's son). A 47-years-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0179; Expiration Date: 31Aug2021) via an intramuscular route of administration arm left on 04Jun2021 as 1st dose, single dose for COVID-19 immunization. Medical history included some gas problems from an unknown date and unknown if ongoing while taking Simethicone. Patient has not had any vaccine in 4 weeks prior COVID vaccinations. Concomitant medication(s) included simeticone (SIMETHICONE, 125 mg; twice a day, one in the morning, one in the night; Chew Capsule), indication for Simethicone, Reporter stated, well it's also related to her symptoms because she feels, well she used to have the symptoms before she spoke to the doctor and she told her that it was some gas problems and the doctor told her that she could take this medication. But after she started taking it and then she stopped feeling it but then after she got the shot, she had started to reappear all the symptoms again. And now she has started to take the Anti-gas medication and the Aspirin pill. On 04Jun2021, the patient experienced feels a little bit funny, head is hurting, her shoulder is hurting and she had a little bit of trouble breathing, she also feels in her stomach, headache, feels sometimes like it is Anxiety attack, maybe and she feels them almost like in period, started to fall asleep, she started to have shivers, dizzy and on an unspecified date in Jun2021, experienced gas problems reappears. Reporter stated, calling for mom, she was feeling a little bit sick. She was feeling, well we got our Pfizer Vaccine on Friday and ever since then caller's mom had been telling me that she feels a little bit funny once she got the vaccine. It was like her head was hurting, her shoulder was hurting and she has a little bit of trouble breathing. She said that she also feels in her stomach. Reporter stated, she was still concerned about the side effects that she has, that she was feeling right now. The patient underwent lab tests and procedures on an unspecified date in Mar2021 she did not receive the test because her doctor told her that everything was fine and that everything was under regulation. Therapeutic measures were taken with 81 milligrams for the Aspirin and for the Ibuprofen it is its 220 milligrams. She says that the Aspirin she took it on the night that she had the vaccine. She is telling me that whenever she started to fall asleep, she started to have Shivers and she started to feel a little bit Dizzy. And for the Ibuprofen, she had it on the morning after, so June 5th and on the night of the June 5th and today morning. The outcome of the events was not recovered.
atrial fibrillation episode; This is a spontaneous report from a contactable consumer, the patient, from the Pfizer-sponsored program.  A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included heart problem and tachycardia. Concomitant medications included metoprolol succinate (MANUFACTURER UNKNOWN) for heart problem and tachycardia from an unknown date and unknown if ongoing.  On an unknown date, 6 days after the first dose, the patient experienced atrial fibrillation episode which required hospitalization for a few days. The patient mentioned her medication was going to be changed to sotalol (MANUFACTURER UNKNOWN) due to the event (unspecified if treatment started). The clinical outcome of the atrial fibrillation episode was unknown. The patient also mentioned that nobody thought her experience was related to the Pfizer vaccine.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The event atrial fibrillation episodes is attributed to an underlying medical condition and assessed unrelate to BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE0.
Pt devel erythema & induration surrounding the inject site p/receiving Typhoid vax; This adverse event was previously reported to FDA by the reporter;
Starting about 9 hours after the injection I developed a fever, aches, chills, nausea, abdominal pain, and fatigue. The severity of symptoms increased overnight with severe aches which were so bad it was painful to walk. I also became dizzy and felt like I might fall while walking. I could eat very little for about four-five days after the injection due to nausea and abdominal pain. The aches stopped after three days but the fatigue, nausea, and abdominal pain continued (but slowly improved) for about ten days.
Pt experienced lethargy, fever, poor feeding for 60 hours; difficult to arouse. Examination revealed no other findings. Seen at outside ER.
HIVES; RASH; FATIGUE; CHILLS; HEADACHE; 101F FEVER; COLD SWEATS; SHORTNESS OF BREATH; DIZZINESS; TINGLINESS; SEVERE BODY PAIN; DEHYDRATION; CHEST TIGHTNESS; FINGERS CURLING UP; TOES CURLING UP; SWEATING; 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: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced cold sweats. On 13-MAR-2021, the subject experienced shortness of breath. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced tingliness. On 13-MAR-2021, the subject experienced severe body pain. On 13-MAR-2021, the subject experienced dehydration. On 13-MAR-2021, the subject experienced chest tightness. On 13-MAR-2021, the subject experienced fingers curling up. On 13-MAR-2021, the subject experienced toes curling up. On 13-MAR-2021, the subject experienced sweating. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced 101f fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 14-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced rash. On 15-MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, shortness of breath, dizziness, tingliness, and chest tightness on 13-MAR-2021, and severe body pain, dehydration, fingers curling up, toes curling up, sweating, chills, headache, and 101f fever on 14-MAR-2021, and was recovering from fatigue, rash, and hives. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Muscle ache/pain starting evening of day shots were given. Pt. complains of hot, aching sensation. Bumps that are hive-like were also seen/developed. Pain not relieved by ibuprofen use. On 12/15/12 evening patient said her pain is subsiding and she is not going to Dr's office.
she just had a sore arm after injection; Mild discomfort in arm; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205 and expiration date not provided), intramuscular, administered in Deltoid Left first dose on 28Feb2021 16:30 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. In 2021, the patient experienced just had a sore arm after injection and mild discomfort in arm. The outcome of the events was unknown.
Patient developed rash that started on right calf then spread to left calf. Rash is tingly, painful, itchy, and red in color. Patient claims she had an adverse reaction to Boostrix. Pharmacist recommended to have physician visit and report outcome to pharmacy.
Woke up feeling like I had the flu. Very achy and tired. Very sore head and horrible back ache. Next day added hives all over my legs.
Employee was given 2nd Moderna injection 7 days early (in error)  No side effects 15 minutes after injection.  Next day, employee came to work @ 8am but left home early due to achy all over and right arm was sore/swollen.   He stated he had chills and felt tired for next 48 hrs and then felt better.  Did not seek medical care until he was advised in order to return to work  (per Perdue policy) he needed a doctor note.  He was not seen until 10/12/2021 (due to no transportation) at local urgent department center.  Released back to work 10/13/2021 and has had no complaints of illness. CDC notified  10/08/2021 and advised to fill out VAERS form.
Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pregnant; second dose on  the 22 nd day from her first dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on  the 22 nd day from her first dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on  the 22 nd day from her first dose). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on  the 22 nd day from her first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.  This case concerns a 34 year-old female patient with no reported medical history, who experienced the unexpected events of Maternal exposure during pregnancy and Inappropriate schedule of product administration. The event s occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The seriousness criteria of the event Maternal exposure during pregnancy was downgraded from Medically significant to non-serious based on medical judgement and review of available report without information supporting seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 34 year-old female patient with no reported medical history, who experienced the unexpected events of Maternal exposure during pregnancy and Inappropriate schedule of product administration. The event s occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The seriousness criteria of the event Maternal exposure during pregnancy was downgraded from Medically significant to non-serious based on medical judgement and review of available report without information supporting seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.