chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial (via a company rep) and follow up information has been received from a RN concerning a retired 85 yr old white female, with a penicillin allergy, an allergy to alendronate sodium, codeine, aspirin and chlorpheniramine maleate (+) phenylpropanolamine hydrochloride (Ornade), and a history of immunization and vaccination adverse reaction, who at 11:30am on 31Jan06 was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 650456/0974P). There was no illness at the time of the vaccination. The nurse previously reported that on approx 01Feb06 the pt experienced itching at the injection site and neck pain, and developed redness at the injection site. The pt had indicated that the neck felt like they hit a nerve when they gave the injection. The pt said she had this pain with a previous unk vaccination. The nurse reassured the pt it was IM and not nerve pain. The nurse also reported that on 01Feb06 at 10:00PM the pt's arm became red, swollen and painful. No product quality complaint was involved. Outcome unk. Additional information is not expected.
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031620A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medications was reported. No laboratory information was given. No treatment information was given.
Became hypotonic and pale right after vaccination, lasted 2 to 3 minutes.
Arm swelled up with huge hard lump, itchy and sore, turned red with welts spreading around arm for 2 days.
Patient fainted this morning after receiving pfizer booster yesterday. She said she fell and hit her head and doesn't know how long she was unconscious. I asked her how she is feeling now, if she is having any symptoms of concussion, syncope etc, she just reports muscle soreness. I encouraged her to seek medical attention and not drive herself to her provider. She had not had anything to eat this morning so I encouraged her to eat something and keep drinking fluids.
pt exp vax near underarm & within hours developed swelling & induration at inject site, extended from shoulder to elbow. then developed blister surrounded by rash,  area painful & nodule size of quarter. tylenol  no relief
Patient came into facility on 6/24/2022 at 1:45 p.m. for 3 vaccine (booster dose). Patient was to receive partial dose of 0.25 mg but instead patient received full dose of 0.5 mg. Patient was immediately called after discovery around 4:00 p.m. and notified of the event. Patient at that time was doing fine and had no side effects. When called and checked on Monday spoke to wife after confirming consent, patient's wife stated his arm did get a knot and was slightly red and warm to touch. Otherwise, patient has had no other symptoms.
When the nurse gave me the injection, I felt it go down the nerve in my arm.  I assumed the pain would go away, but it has not.  It hurts all of the time from my elbow and down into my hand and sometimes it hurts up my arm and into my shoulder.  There is also a tingle similar to my hand and arm being "asleep" most of the time.  In the past couple of days I have also had the feeling of numbness in my hand.
Pt had diarrhea stools up to several per hour.  Diarrhea resolved on 08/07/2014.
patient was fully vaccinated but tested positive for covid. He is recovering now. I don't know if he had his booster shot or not.; patient was fully vaccinated but tested positive for covid. He is recovering now. I don't know if he had his booster shot or not.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/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: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 21Jan2022, outcome "recovering" and all described as "patient was fully vaccinated but tested positive for covid. He is recovering now. I don't know if he had his booster shot or not.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical information: Unknown patient received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown prior to vaccination, was the patient diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever of 100.9 at 11:30am on 1/7/2021. I took tylenol 975mg. Also heart rate 115 at 11:30am and Blood pressure 138/82.
Injection site it was sore; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN) on 11Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medication were not reported. patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 11Jan2021, he was scheduled to receive the Moderna vaccine however the Pfizer vaccine was available and he received it (he was originally scheduled for Moderna and Moderna is 28 days where Pfizer is 21 days and he's having a hard time moving his 2nd appointment). He's scheduled to receive the second dose of the vaccine on 08Feb2021, which is 28 days after the first dose instead of the 21 days recommended. He would like to know if there's a problem with waiting because he doesn't want to lose the effectiveness of the vaccine. He wanted to know what happens if he can't get it on the 21st day. He also stated that he had no side effects, no pain, the only thing was when he pushed around the injection site it was sore, like when one got a normal shot. Outcome of the event was unknown.  Information about lot/batch number has been requested.
ENLARGED/SWELLING OF HEART; This spontaneous report received from a consumer via a company representative concerned an adult male of probably about 27 years old. 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, and batch number were not reported) dose was not reported, 1 total administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in SEP-2021, patient lived across the street, probably about 27 or so. A few days later patient was in hospital in intensive care section because of heart problems, swelling or enlarged heart. Patient spent 4 days there, then patient was sent home with medications. Patient visited emergency department and was hospitalized for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from enlarged/swelling of heart on SEP-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220306547.; Sender's Comments: V0: 20220360257-COVID-19 VACCINE AD26.COV2.S -Enlarged/swelling of heart. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
pt recvd vax;devel a vesicle like rash;md did not see pt;
back muscles are hurting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (back muscles are hurting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and unknown) for COVID-19 vaccination.     medical history was not reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), FERROUS SULFATE and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (back muscles are hurting). At the time of the report, MYALGIA (back muscles are hurting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No treatment medications were provided.    This case was linked to MOD-2021-101228 (Patient Link).
Jynneos administered intramuscularly; Case reference number US-BN-2022-001688 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *23-year-old male patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *left deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 23-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 23-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Unable to walk well; Couldn't eat; Weakness; Insomnia; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of GAIT DISTURBANCE (Unable to walk well), DECREASED APPETITE (Couldn't eat), ASTHENIA (Weakness), INSOMNIA (Insomnia) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 03-Feb-2021, the patient experienced GAIT DISTURBANCE (Unable to walk well), DECREASED APPETITE (Couldn't eat), ASTHENIA (Weakness), INSOMNIA (Insomnia) and CHILLS (Chills).   At the time of the report, GAIT DISTURBANCE (Unable to walk well), DECREASED APPETITE (Couldn't eat), ASTHENIA (Weakness), INSOMNIA (Insomnia) and CHILLS (Chills) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Case number PHEH2014US024959, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 55 years old male patient. Historical conditions were not reported. No concomitant medications was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 04 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Patient was accidentally given a non-diluted dose of 0.3ml. She did feel faint before 15 minutes of waiting. Staff gave patient water.
SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from consumer on 10 Jul 2017. This case involves 10 years old female patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DTP) (batch number, expiry date and site of administration were not reported) intramuscularly on an unspecified date in 1998. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medication was not reported. On an unspecified date, following the vaccination, the patient had high fever with a seizure after this incident, she developed respiratory issues that she never had and severe food allergies with anaphylaxis. Patient required emergency room or doctor visit. Patient did not perform any laboratory investigation. Patient was not recovered from events. Upon internal review the case was considered as serious because of important medical event: anaphylaxis and high fever with a seizure. List of documents held by sender: none. Sender's Comments: Severe food allergies with anaphylaxis, febrile seizure and nonspecific respiratory disorder are reported after vaccination with DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) from unknown manufacturer. Time to onset is unknown. Cause of Anaphylaxis was reported as food allergy hence role of the vaccine can be ruled out for the event severe food allergies with anaphylaxis. More details on patient's medical history, previous vaccination history, concurrent condition, name of the vaccine administered time to onset, type of Respiratory disorder and investigation reports are needed for complete assessment of the case. Based on the available information role of vaccine cannot be drawn.
spots noted 2 days ago (2-10-07) on thigh.  Scratched -scabs mom noted 2-11-07
Drug effect decreased; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Panuveitis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second 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) at an unspecified dose. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced Humira not working well as well as it did. No treatment medications were reported.  Company comment  This is a spontaneous case reported by a consumer, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious event of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) unknown days after receiving the second dose of mRNA-1273 Vaccine in the covid 19 vaccination series. The primary 2 doses of m RNA1273 vaccine was given at an interval of about 01 month. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for ulcerative colitis, which remains as a confounder.  Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious event of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) unknown days after receiving the second dose of mRNA-1273 Vaccine in the covid 19 vaccination series. The primary 2 doses of m RNA1273 vaccine was given at an interval of about 01 month. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for ulcerative colitis, which remains as a confounder.  Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (tested positive). At the time of the report, COVID-19 (tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Redness and swelling at injection site. Itching and discomfort in effected area.  Applied cortizone cream and ice to relieve itching and swelling started fading within a few hour. Minor redness remained about 12 hours
FEELING BAD; SICK; JOINT ACHE; HEADACHE; INJECTION SITE PAIN; SEVERE CHILLS; SEVERE BODY ACHES; TROUBLE REGULATING BODY TEMPERATURE; HOT AND COLD FLASHES; SEVERE BREAST TENDERNESS; INCORRECT ROUTE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 175 pounds, and height was 155 centimeters. The patient's concurrent conditions included drug allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. the patient was not breastfeeding at the time of vaccination. no history of drug abuse. the patient had no illness at the time of vaccination. no history of similar event in the past. the patient had no adverse events after any previous vaccination(s). the patient was allergic to amoxycillin. no pre-existing acute illness prior to vaccination. no history of hospitalization 30 days prior to vaccination. no family history of any disease relevant to vaccination or allergy. The patient was previously treated with amoxicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced incorrect route of drug administration. On 08-MAR-2021, the subject experienced severe body aches. On 08-MAR-2021, the subject experienced trouble regulating body temperature. On 08-MAR-2021, the subject experienced hot and cold flashes. On 08-MAR-2021, the subject experienced severe breast tenderness. On 08-MAR-2021, the subject experienced severe chills. On an unspecified date, the subject experienced feeling bad, sick, joint ache, headache, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, trouble regulating body temperature, hot and cold flashes, severe breast tenderness, and severe chills on 22-MAR-2021, was recovering from sick, had not recovered from joint ache, headache, injection site pain, and feeling bad, and the outcome of incorrect route of drug administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318992.
pt recvd vax & was unconscious x 10 days,in icu; numbness in feet & fingertips; difficulty walking,needs braces,canes,walker; tx w/ plasma pheresis; has recurring sxs;