chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional via a sales representative and described the occurrence of headache in a 31-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates, the subjects received 1st and 2nd dose of ENGERIX B (20 mcg, unknown). At an unspecified time after vaccination with 1st and 2nd doses of ENGERIX B (20 mcg), the subjects experienced headache, dizziness, nausea and could not function. The healthcare professional reported that the subjects received two doses of 20 mcg of ENGERIX B and experienced a headache, dizziness, nausea and the subject said she "couldn't function". All events resolved without intervention on an unspecified date. No additional information was known at the time of reporting.
3" area of erythema, induration at Iz site - VARICELLA Iz right thigh
Pt rec'd KINRIX, MMR, PCV 13, VARIVAX on 8/21/2012 - child developed facial swelling, rash all over & difficulty breathing prior to leaving office. Swollen face, maculopapular rash & wheezing noted on exam. VSS treated with EPI, O2, BENADRYL, prednisone, albuterol (2 nebs). TX to ER for observation.
The COVID-19 Vaccine vials were reconstituted with 1.6mL vs. 1.8mL of normal saline.  This resulted in the patient receiving 33mcg of active vaccine component in the 0.3mL dose instead of the EUA labeled 30mcg.  This has been disclosed to the DOH and the patient.  Patient reports feeling fine, no adverse side effects. Reporting is required by the  DOH given the increase in dose administered.
Whole body rash and inflammation delayed reaction. I believe it?s cytokine reaction to spike
This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a patient who received BEXSERO. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO and not applicable after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb, arm discomfort, erythema of extremities and incomplete course of vaccination. On an unknown date, the outcome of the extensive swelling of vaccinated limb, arm discomfort, erythema of extremities and incomplete course of vaccination were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, arm discomfort and erythema of extremities to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable. The reporting nurse practitioner did not have any patient data or vaccine data to share. The patients received BEXSERO on the unknown arm. The patients experienced local reactions such as redness, extensive swelling of vaccinated limb, and discomfort on the whole arm above and around the injection site. The nurse reported that the patients were not returning for the 2nd dose in the BEXSERO series because of adverse reactions, which led to incomplete course of vaccination.
Not pregnant, I woke up the next day and could not move my arm. It took 6 months to be able to raise my arm above my head. 3 weeks ago my entire body broke out in what looks like herpes. Itched real bad and scabs grew over, some spots turned into raised bumps that look like moles.
Moderna COVID?19 Vaccine EUA. On 6/30/21 I started having pain in the neck then gradually down the right shoulder and arm. After a visit to the ER and several doctor appointments, it was determined that I have parsonage turner syndrome.
This spontaneous report as received from a other health professional refers to a female patient of unknown age with no pertinent medical history. On 25-JUL-2012, the patient was vaccinated with 0.5 milliliter (ml) GARDASIL, intramuscularly. On 02-APR-2013 the patient was vaccinated with dose 3 GARDASIL (lot # 0555AE, expiration date 14-DEC-2014). On 03-APR-2013 the patient developed severe headache. She stated that the patient did not have a history of headache or migraine. The patient experienced nausea and vomiting with headache. The patient was not getting relief from ibuprofen and TYLENOL, and was seen in the Emergency department of unspecified hospital. The patient was given a CT scan of her head, and no abnormal findings were determined. She was not admitted. She was prescribed TYLENOL with CODEINE which patient stated gave some relief. The outcome of severe headache, vomiting and nausea was unknown. Causality was not reported. Additional information is not expected.
Caller states she received the first dose of the Moderna vaccine on April 11, 2021. On day three she was fatigued and noted joint pain. On April 19th she noticed a swollen lymph node and  hives and a rash, slight SOB and intermittent sharp chest pain, headache and is "foggy" states she has a hard time forming words. Caller is currently at her work at a doctors office and states she will get checked out by one of them now.
pt devel lt arm nerve damage following vax w/Hep B vax; No further details were provided;
Approx 6 hrs after ingesting PO Typhoid vaccine, pt noted onset itchy rash on trunk and thighs. Pt had no other new exposures that day. Pt examined on 10/5/04 found to have diffuse erythematous papulovesicular eruption. Rx'd topical Acetaminophen dipropionate cream and Loratadine 10mg PO. Rash resolved in 24 hours.
left lymph nodes swelled up and were painful; left lymph nodes swelled up and were painful; some swelling where they gave her the shot- little knot there; Numbing next to left breast / left her feeling numb as well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 23Mar2021 (Lot number: EL9266) at the age of 76 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing); "Obesity" (ongoing); "Thyroid problems" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 02Mar2021, for COVID-19 immunisation, reaction(s): "right lymph nodes swelled up and were very very painful ", "right lymph nodes swelled up and were very very painful", "Numbing next to right breast / feeling numbish / lymph nodes feeling kind of numb ".  The following information was reported: LYMPH NODE PAIN (non-serious) with onset 23Mar2021 20:00, outcome "recovered", LYMPHADENOPATHY (non-serious) with onset 23Mar2021 20:00, outcome "recovered" (18Mar2021) and all described as "left lymph nodes swelled up and were painful"; VACCINATION SITE SWELLING (non-serious) with onset 23Mar2021 20:00, outcome "unknown", described as "some swelling where they gave her the shot- little knot there"; HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "recovering", described as "Numbing next to left breast / left her feeling numb as well".  Additional information: The patient reported that with the second dose, it did the opposite; she had the shot in her right arm, but her left lymph nodes swelled up and were painful and left her feeling numb as well.  The patient stated that she is also still having some swelling where they gave her the shot- little knot there, but she is sure it will go away. The patient reported that the pain and swelling started within 24 hours both times.  The patient stated that on her right side, the pain stopped and the numbing is not as bad; on her left side, the lymph nodes stayed numb for about a week, but they stopped.  The patient mentioned that both times she got the shot, it didn't start hurting or numbing until later on that night. The patient clarified that the pain has stopped from the second dose. events did not require a visit to emergency room and physician office. The patient did not receive prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 669692/0615 expiration date 02-JUL-2012) that was expired on 05-JUL-2012. No adverse event reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. The report was received from the same reporter with other 3 cases, and their MARRS# are 1207USA002230, 1207USA003758, 1207USA003760, respectively. Additional information is not expected.
Case number PHEH2016US025981 is a spontaneous report initially received from a healthcare professional on 05 Oct 2016. This report refers to a 62 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with single dose of FLUAD (batch number: 165803) at the age of 60 years (patient under age 65) at a dose of 0.5 ml intramuscularly on 28 Sep 2016. No adverse event was reported following this medication error (inappropriate age at vaccine administration). Non significant information received from a healthcare professional on 05 Oct 2016: Updated reporter information.
Sore throat; cough; mucus in lungs; Felt tired after second dose; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (cough), PRODUCTIVE COUGH (mucus in lungs) and FATIGUE (Felt tired after second dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, METOPROLOL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and CETIRIZINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (Felt tired after second dose). On 09-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (cough) and PRODUCTIVE COUGH (mucus in lungs). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), COUGH (cough) and PRODUCTIVE COUGH (mucus in lungs) outcome was unknown and FATIGUE (Felt tired after second dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: sars-cov-1 test (Positive) COVID 19 positive.         No treatment medication was provided by the reporter.   This case was linked to MOD-2021-261738 (Patient Link).
See copy file. Patient is a 51 y/o male is complaining of numbness in the left hand.
Initial unsolicited case received from a physician on 09 Oct 2017. This case involves 41-year-old female patient who was vaccinated with 0.1 ml one dose of FLUZONE INTRADERMAL QUADRIVALENT (Batch number: UT5903AA, Expiry date: 06 Mar 2018, dose in series not reported) via Intradermal route in left deltoid on 09 Oct 2017. Patient had a history of Alpha Gal allergy and other medical history was not reported. Concomitant medications were not reported. On 09 Oct 2017, immediately after the vaccination, patient experienced wheezing, hypotension, abdominal pain, and hives below the injection site. Relevant lab tests were not reported. As a corrective treatment patient was treated with epinephrine and Benadryl (diphenhydramine hydrochloride) with resolution of symptoms, and was discharged home. On an unknown date, patient recovered from all the events. The case was considered as serious by the reporter due to life threatening events. List of documents held by sender: none.; Sender's Comments: Reported symptoms (immediate wheezing, hypotension, abdominal pain, and hives below the injection site) and time to onset are consistent with anaphylaxis. Anaphylaxis is listed following FLUZONE QIV ID and time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode and allergic test result are needed for complete assessment. It has to be noted that the patient has an history of alpha Gal allergy. Based on the available information and considering the time to onset and nature of the event, a role of vaccine cannot be excluded.
C/o vomiting and diarrhea after shots. Before-very nervous, anxious. Vital signs monitored, fluids given. Monitored by public health nurse for 30 minutes - CLW Ambulated out
Erythema 3 x 8cm edema at injection site. Pt states itches, swollen lymph node under R arm pit. Yellow fever injection was administered on 9/30/02.
High fever, 101.4, headache, body aches, fatigue, sore arm
COVID-19 virus infection; Acute hypoxemic respiratory failure due to COVID-19; Malignant neoplasm of right lung stage 4; Acute kidney injury
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2008, the patient was inoculated with ZOSTAVAX in a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # and expiration date were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 06-JAN-2009, the patient was treated by a physician for a persistent vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, pain, suffering and other damages. At the time of this report, the outcome of the events was unknown. The causal assessment between the aforementioned events and vaccination with ZOSTAVAX was reported as related.
I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/22/21 after the completion of a full Moderna vaccine series (Dose 1 on 2/11 and Dose 2 on 3/11). The patient later died on 5/13/21 . Cause of Death is listed as ?Intestinal Obstruction?.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 14:00 as dose 5 (booster), single (Lot number: GJ3277), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Protonex, reaction(s): "Known allergies: Protonex"; Nexium, reaction(s): "Known allergies: Nexium"; Vioxx, reaction(s): "Known allergies: Vioxx"; Celebrex, reaction(s): "Known allergies: Celebrex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information Anti-viral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=04May2023, Treatment stop date=09May2023.
I had the shot of Pfizer (Pfizer Covid-19 Vaccine) and I have Covid; I had the shot of Pfizer (Pfizer Covid-19 Vaccine) and I have Covid; This is a spontaneous report from a contactable consumer(patient).  A 50 years old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Feb2021(vaccination at age of 49 years old) (Batch/Lot number was not reported) as  single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Anatomical site of vaccine administration reported as in the arms, in the upper arms, both arms, on in the right and then one in the left upper arm. Medical history included Hiatal hernia, gastrooesophageal reflux disease, Fibromyalgia, Covid. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA), omeprazole and duloxetine for Fibromyalgia, taken for an unspecified indication, start and stop date were not reported. The patient underwent lab tests and procedures which included covid-19: positive on unknown date.  Consumer stated "I had the shot of Pfizer (Pfizer Covid-19 Vaccine) and I have Covid. And this is the second time that I have had Covid. This time it has been the worst. I guess, the weird thing was that I got it twice and I don't know if there is something like they should do, like check me or to see if I should have like to check me or to see if I should have like, if I would have scared if I would have to get it again. I just think now that there is something that you guys needed to know because like I work in a hospital in withheld and I am like the first person who has gotten sick, it is like, my whole hospital has like turned away freaky now." (Further clarification unknown), I am a Certified Nursing aide, I would be willing to like your study or something to figure out why, I got sick. I don't want to get sick again, it is weird." Consumer stated, "My first symptoms started. I had a headache on Monday, the 09Aug2021. They put me on withheld what they call it, which is Azithromycin Tablet that is what I am on now."  Outcome for events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Racing heart, fluttery heart, fatigue, lack of energy, feeling stressed, nausea
RED AT INJECTION SITE; SWOLLEN AT INJECTION SITE; ITCHING AT INJECTION SITE; HOT AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (RED AT INJECTION SITE), INJECTION SITE SWELLING (SWOLLEN AT INJECTION SITE), INJECTION SITE PRURITUS (ITCHING AT INJECTION SITE) and INJECTION SITE WARMTH (HOT AT INJECTION SITE) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (RED AT INJECTION SITE), INJECTION SITE SWELLING (SWOLLEN AT INJECTION SITE), INJECTION SITE PRURITUS (ITCHING AT INJECTION SITE) and INJECTION SITE WARMTH (HOT AT INJECTION SITE). At the time of the report, INJECTION SITE ERYTHEMA (RED AT INJECTION SITE), INJECTION SITE SWELLING (SWOLLEN AT INJECTION SITE), INJECTION SITE PRURITUS (ITCHING AT INJECTION SITE) and INJECTION SITE WARMTH (HOT AT INJECTION SITE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
she was allergic to in the vaccine; Initial information received on 22-Apr-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves a female patient of unknown age who was allergic to in the vaccine (hypersensitivity), while she received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED, suspension for injection (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a she was allergic to in the vaccine (hypersensitivity), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient was hospitalized for this event (seriousness).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available regarding batch number in this case.; Sender's Comments: This case concerns a female patient who presented with allergic reaction after vaccination with FLUZONE. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
unrelenting and cannot focus; arm is still tender; arm feels a little swollen; aches, pains (Muscle pain specifically); fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (unrelenting and cannot focus), TENDERNESS (arm is still tender), PERIPHERAL SWELLING (arm feels a little swollen), MYALGIA (aches, pains (Muscle pain specifically)) and FATIGUE (fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Insect sting allergy.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (unrelenting and cannot focus), TENDERNESS (arm is still tender), PERIPHERAL SWELLING (arm feels a little swollen), MYALGIA (aches, pains (Muscle pain specifically)) and FATIGUE (fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping). At the time of the report, DISTURBANCE IN ATTENTION (unrelenting and cannot focus) and MYALGIA (aches, pains (Muscle pain specifically)) outcome was unknown and TENDERNESS (arm is still tender), PERIPHERAL SWELLING (arm feels a little swollen) and FATIGUE (fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping) had not resolved.            No relevant concomitant medications were reported.  Treatment details included aspirin and diphenhydramine.
Blocked tear ducts in left eye, inflamed right jaw. After second shot had inflamed right jaw with teeth sensitivity. Needed antibiotic eye drops for a month for left eye and a root canal for tooth #29 on right side. There were no issues before 1st shot was administered. Root canal done on May 3.
2:00 pm Chest tightening, achy all (Friday) over, dry cough and chills. Saturday morning doing fine, tired
Severe arm pain at and around the injection site 6 hours after the injection. Nausea and slight headache during the  night at about 3:00 AM that went away in a couple of hours. Arm pain persisted the next day. The following day the pain also involved the armpit, possibly lymph glands. Lesser pain at the injection site and arm pit areas the following day and was very slight the third day after the injection. Can?t wait for my second dose and despite the side affects will happily stand in line for my next dose.