chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient became very faint with severe syncope and briefly blacked out.  This was after administration of 4 vaccines.  Patient rested and was given orange juice and crackers.  Blood pressure was checked and was 120/79.  Patient felt weak and jittery.  Did not display signs/symptoms of anaphylactic reaction. No effect on breathing. No rash.  Lasted about one hour total and the patient was able to walk out with her mother.
He was diagnosed with HSP at 4:30pm the day after the vaccine.  His elbow joint was swollen and immovable.  He also had the classic red dots on his butt and lower extremities.
Vaccines given 8-11-10. Grandmother called 8-12-10 at 12:10 pm. Stating child last night had swollen face & lips and fever/chills, but temp NOT taken. Today, c/o headache, sore throat & swollen tongue. Denies fever/chills today. Denies difficulty breathing. Also c/o stomach ache. Decided not to go to ER or MD. Gave TYLENOL and sent back to school on 8/13/10.  Advised she take her to her physician or ER for further evaluation. Advised the grandmother to call the Health Department to report results of her evaluation. August 13, 2010 - Client's grandmother did not call to report status. Called grandmother and she stated she did not take her to the doctor or the emergency room on August 12th but had given pt TYLENOL. She states that she was okay during the night and she sent her to school today and the school had not called her to come and get her so she thought she did okay.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with more then recommended number of doses of PNEUMOVAX 23 (strength dose, route of administration, anatomical location, lot # and expiration date were not provided). The physician did not provided how many doses of PNEUMOVAX 23 these patients had received. This is one of two reports received from the same reporter. Additional information is not expected as the physician did not wand to be contacted.
Body broke out in extremely itchy rash in armpits, hips, butt, obliques  and legs. Hands and fingers also developed small irritated and itchy blisters. Mouth also developed sores on tongue and inside of lips. In addition feelings of achiness and fatigue. Visited dermatologist on 2/16/21 and was prescribed prednisone, prescription cortisol and hydroxyzin. Some improvement seem in 24 hours since then. Dermatologist was unable to determine source of rash and reaction, thought could be related to vaccine.  Follow up phone call scheduled for 2/19/21
Expired booster dose administered more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered more than 12 hours post puncture) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered more than 12 hours post puncture) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 15-feb-2022. Date and time vial was first punctured: 21-feb-2022 at unknown time. Vial was stored post puncture in refrigerator. Vials did not undergo any temperature excursion. Punctured vial was kept in the refrigerator 3 hours more than 12 hours post puncture. No treatment medications were reported.
Hives; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 20Aug2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (the patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EW0164), intramuscular, administered in the left arm on 02Jun2021 09:00 as dose 2, single (age at vaccination 37-years-old) for COVID-19 immunization. The patient's medical history included COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications included: norethisterone (NORLYDA), loratadine, famotidine (PEPCID AC) all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EW0164), intramuscular, administered in the left arm on 12May2021 08:45 as dose 1, single (age at vaccination 37-years-old) for COVID-19 immunization. The patient had poison ivy on 29May2021 until 06Jun2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had a very bad case of poison ivy when she received her second vaccine dose. The patient stated that on the Sunday, after her vaccine, on 06Jun2021 04:00, she woke up with hives all over her torso. By Monday, they were from the soles of her feet to the top of her head. They were very itchy and red. She ended up getting a steroid injection and steroid taper pack Monday. That definitely helped, but she ended up having to take another taper pack a week later. They knocked them out but then they came back another week later. They were still lingering over a month later. On 20Aug2021, the patient reported she had no side effects from her second dose until 5 days (as reported) after the dose. She woke up Sunday morning (06Jun2021 04:00) with her torso covered in hives. She had never had hives before, and they were very itchy. She had a bad case of poison ivy where she got the second dose, so she thought her immune system may have been over stimulated. The next day, the hives were from the bottom of her feet to the top of her head. She went to the urgent care, and they gave her a steroid injection plus taper pack. That helped, but 1 week after the steroids were done, she still had hives between her fingers and toes. She took another taper pack. Then they mostly went away. Then another week later, she went swimming and the "clame" in the pool must have aggravated her skin, and she got hives again. She has been taking loratadine and famotidine in double dose for the past 5 weeks. Two weeks into that regimen, the hives went away. Treatment was also reported as 2 courses of steroids plus high dosage antihistamine. The patient reported hives as an important medical event. The clinical outcome hives was recovered with sequelae on 30Jul2021. Since the vaccination, the patient had not been tested for COVID-19.
Shingles; This is a spontaneous report from a contactable other hcp. A 49-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Right on 05Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. I got Shingles within one day of the 2nd vaccination. About 2 weeks after the first vaccination, I started itching and having back and side pain. I didn't think anything of it. The week before my second vaccination I broke out with a rash. I thought something bit me. After the second vaccination within 2 days, I had full blown Shingles. On 06Feb2021, the patient experienced shingles. No treatment was received for the adverse event. The outcome of events was recovering.
Severe reactions/still experiencing problems; Greater than 35 days between doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reactions/still experiencing problems) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses). On an unknown date, the patient experienced VACCINATION COMPLICATION (severe reactions/still experiencing problems). At the time of the report, VACCINATION COMPLICATION (severe reactions/still experiencing problems) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-322780 (Patient Link).
Racing heart beat, chest pain, back pain, tooth pain, abdomen pain, head ache, vision problems, face turn real hot.
evaluation of chest tightness.  She reports chest pain?described as tightness in her left chest.  Pain does not radiate.  She states she experienced symptoms about 10 minutes after taking her first Pfizer Covid?19 vaccine at 14:10 today.  She also reports mild shortness of breath and lightheadedness.   She states symptoms feel like anxiety. No rash, throat discomfort, leg swelling.  Patient states she is starting to feel better at this time. Presentation likely consistent with anxiety.  Vaccine adverse/allergic reaction was also considered but less consistent at this time.  Patient states feels like anxiety reaction.  Discussed consideration for as needed medication for intermittent anxiety attacks?safety precautions were discussed.
PRODUCT STORAGE ERROR; VIAL OF THE VACCINE WAS PUNCTURED AND WAS LATER ON STORED IN THE REFRIGERATOR FOR 25 HOURS (UNDER 40-41 DEGREES F) AND WAS GIVEN TO 1 PATIENT; OFF LABEL USE; This spontaneous report received from a consumer concerned a female of unspecified age. 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 admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced product storage error. On JUL-2021, the subject experienced vial of the vaccine was punctured and was later on stored in the refrigerator for 25 hours (under 40-41 degrees f) and was given to 1 subject. On JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error, vial of the vaccine was punctured and was later on stored in the refrigerator for 25 hours (under 40-41 degrees f) and was given to 1 patient and off label use was not reported. This report was non-serious.
pt was vaxed 2APR93; arm was so heavy; 8APR93 big rash on arm where vax was given; 9APR93 felt very sick & had fever; rashes become very reddish w/fever & felt very very sick; treated w/DPH & PCN; pt recovered;
localized pain in arm; Headache; Dizzy; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration on unknown date (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had allergy to eggs and bovine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient received magnesium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), D3 (MANUFACTURER UNKNOWN), b complex (MANUFACTURER UNKNOWN) all started from an unknown date, for unknown indication, taken within 2 weeks of vaccination. On 25Mar2021 at 14:00, the patient experienced headache, dizzy, localized pain in arm and nausea. The patient did not receive any treatment for events. The patient events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of headache, dizzy, localized pain in arm and nausea were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Age at Vaccination was updated to 36 years old per DOB and PRD. Leading sentence also was updated. 2. Final sentence was updated to "No follow-up attempts are possible. No further information is expected." 3. Verbatim of Relevant Med History was updated to "Allergy to bovine".
On Tuesday, 12/7/21, client came to Covid-19 vaccination POD for a Covid-19 vaccine. Client was vaccinated with Covid-19 Moderna first dose (LOT #: 035C21A) at 5:10 PM in his left deltoid. Ancillary alerted Vaccinator after vaccination that appointment could not be completed in system due to client being 17 years old. Per CDC guidelines, Moderna is only authorized for 18 and up. Vaccinator alerted Lead who elevated to Vaccine Operations Leads via phone call. Instructed to let client know he will come in 28 days for his second dose but will receive Covid-19 vaccine Pfizer, which is authorized for 5 years and up. Client verbalized understanding. Client denied any underlying medical conditions or allergic reactions and was to be a 15 minute observation. Client was also educated by RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at approximately 5:30 PM.
bad side effect of tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (bad side effect of tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, the patient experienced TINNITUS (bad side effect of tinnitus). At the time of the report, TINNITUS (bad side effect of tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not reported. The reporter considered the pain in arm to be related to SHINGRIX. Additional information were reported as follows: The age at vaccination was not reported. The patient reported that in October 2018, her first dose of SHINGRIX caused very minor arm pain. The patient did not consent to follow up.
Headache, NauseaVomiting, severe HA; muscle tightness; ringing in ears; light sensitivity with blurred vision; nausea Narrative:  employee self-reported she got vaccine this morning. States she has taken Tylenol w/o resolution of noted symptoms.
not feel well/ felt not great; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2023, outcome "unknown", described as "not feel well/ felt not great".  Additional information: Patient Had her COVID Vaccine and her Flu vaccine at the same time and she said she just did not feel well. Patient felt not great on Monday, but she felt better yesterday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chest tightening; Chills; Heat all over the injected arm; Sweating; Hand shaking (on injected arm); Difficultly breathing; Nauseous; Lingering chest pain; Heat all over the injected arm, chest and head area; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 9655) via an unspecified route of administration in the left arm on 02Apr2021 at 14:45 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple allergies and pollen allergy. Concomitant medications included mometasone furoate (FLONASE) and cetirizine hydrochloride (ZYRTEC); both taken for allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 21:00, the patient experienced chest tightening, chills, heat all over the injected arm, chest and head area, sweating, hand shaking (on injected arm), difficultly breathing, nauseous and lingering chest pain. The adverse events 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 did not receive treatment for the reported events. The clinical outcome of the events chest tightening, chills, heat all over the injected arm, chest and head area, sweating, hand shaking (on injected arm), difficultly breathing, nauseous and lingering chest pain was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
On Friday night I noticed my arm was extremely sore. I woke up Saturday morning at 530 and the injection site was red and extremely swollen. Around 1130 am I noticed I had swelling and soreness in my left collarbone area. Sunday morning the swelling in my left collarbone area was worse. The injection site is still swollen and red and itching. I have emailed my primary care doctor with pics  of the affected sites so see what if anything we should do.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient may have been vaccinated with improperly stored ZOSTAVAX (lot number was H022152, expiry date was 18-MAR-2014). Concomitant medications were not reported. No adverse events were reported. Additional information is not expected.
I took the covid vaccine booster shot in the clinic brought to office, and  started having severe back pain, I wasn't not able to move at all. I couldn't stand, walk, or even sit.
This spontaneous report received from a pharmacist refers to a female patient of unknown age and ethnicity. Medical history were not reported. On 03-DEC-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot # H018421 with expiration date 08-Oct-2014, 1 DF, subcutaneous. Other suspect therapies included MMR II lot # H020255, with expiration date 08-Nov-2014. On 03-DEC-2014, 1 day after onset of therapy the patient experienced expired dose and no adverse effect. Concomitant medication were not reported. The outcome of expired dose and no adverse effects is unknown. The reporter considered expired dose to be not related to MMR II and (Oka/Merck) VARIVAX. The reporter considered no adverse effect to be not related to (Oka/Merck) VARIVAX and MMR II. No further information was provided.
SLIGHT FEVER; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: generalized neuropathy, and fatigue syndrome, and other pre-existing medical conditions included: patient had no known allergies and no drug abuse or illicit drug user. The patient was in hospital prior to receiving the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 06-APR-2021, the patient experienced slight fever. Treatment medications included: paracetamol. On 05-AUG-2021, Laboratory data included: Antibody test (NR: not provided) positive for spike. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) natural antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight fever on 06-APR-2021. This report was non-serious.
slight fever (99.5 degrees), ache in left arms, fatigue,body aches
pt recvd vax & on 26APR93 & 10 mins p/vax fell to the floor & was stiff but had no signs of sz activity; w/in a few moments woke but was pale;
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 19-SEP-2012, the patient was administered with a dose VARIVAX (Lot # 0435AE, expiry 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
I took the first dose of the vaccine(lot number) on 05/19/2021, and I took the second dose (lot number EW0196) on 06/16/2021,The injection site started to swell and be very painful and the lymph nodes under the armpit were very swollen and painful, I also had tiredness and a headache and I don't really get headaches. The whole left arm was also very painful. This lasted for two and a half days.
Erythema, induration, & swelling of (L) deltoid area, within 24 hours of vaccine administration. Lasted 2-3 days. (I let mom know this is not a reportable event - but she requests the report).