chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician regarding a 14 year old female patient with no pertinent medical history reported. On 16-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies or concomitant medications were reported. The physician stated that the patient immediately felt dizzy, faint, tired and then fell "asleep". However, the patient was arousal, vitals were all stable. Blood glucose (finger prick) also done, incase the patient had not eaten yet today. It was 90 (units not reported). The physician gave the patient smelling salts and patient sat up. One hour after the dose and subsequent symptoms, the patient did go home. At 3:00pm the physician called the mother and the mother reported the patient was still "in and out of it" in terms of sleepiness. The outcome for the above mentioned events was unknown at the time of the report. The physician did not assess the relatedness between GARDASIL and the above mentioned events. Additional information has been requested.
Received routine immunizations at 4 yr check up 1/30/15 was on d9 of amoxicillin for (R) otitis media, Amox ended 1/31/15. Onset rash 2/1/15, seen at hospital ER 2/1/15 and diagnosed allergic reaction to Amox. Treated BENADRYL and ORAPRED. Seen in office 2/2/15 and diagnosed erythema multiforme minor.
Initial report received from a health care professional on 09 Feb 2010: It was reported that a 3 year old child was vaccinated with H1N1 vaccine (batch no: 102143P1), 0.25 or 0.5 ml IM dose, inadvertently. It was also reported that, the patient was unsure of dose administered because it was done at another facility, but the patient knows that it was a Novartis product. The outcome of the event was not reported.
rash and hives in different parts of the body. Symptoms are similar to chronic urticaria.  Other potential allergens have been removed, such as switching to hypoallergic soaps, shampoo, laundry detergent, and dryer sheets.
Side pain in lower right quadrant, nausea, vomiting; ER diagnosis appendicitis- had appendectomy on Dec. 1, 2015.
Approximately 4 hours after vaccine administration, child became extremely listless. Started screaming uncontrollably every time he tried to move. Right thigh was notably swollen and progressively got worse. Ibuprofen was administered and after 1.5 hours child finally settled down. Still very fussy but improved. Ibuprofen was continued for 24 hours. Right thigh continued to swell until it was approximately 1 inch larger in diameter compared to the left thigh. Small amount of heat noted but no redness. Blotchy redness began on the evening of 1/28. Child returned to normal on 1/29.
Fever of 102 degrees. Very weak. Better the next day without elevated temp., but weak until 5:30 PM.
In October 2000, the patient developed asthma and it was noted that he was "forced to use steroids". On 10/27/2000 or 10/28/2000 the patient developed an outbreak of varicella. On 10/28/2000 the patient presented to the physician's office and it was reported that there were close to 50 lesions spread over his trunk, legs and arms. The patient was afebrile. There were no complication. The patient was treated with acyclovir. It was reported that at the time of the outbreak, the patient's steroids were being tapered. On an unspecified date, the patient recovered. No further information is expected.
Pain in the arm; Rash in the arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash in the arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash in the arm). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided; Reporter'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.
hives after varicella vaccine. Had previous diagnosis of similar reaction after immunization Pt. allergic to gelatin.
3/3/2003 - patient describes feeling malaise with poss. elevated temperature, hoarseness and generally  not feeling well. 3/3/2003 thru 3/5/2003 was unable to come to work due to symptoms. 3/4/2003 - home visit by Health Department nurses to evaluate patient condition.  "take" responses was major; laryngitis, malaise noted.
Case number PHEH2015US026950, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 45-years-old-male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into right deltoid on 17 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
I had the vaccine on 9/27/00 and I felt nauseous the next 2 days. I was extremely dizzy and nauseous and called my doctor; then went to ER because I threw-up and was so dizzy. On 9/30/00, I felt a little better and ask to be discharged and went back home.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 27-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1404 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Parents noticed that left thigh was getting swollen and reddened and child was starting to limp some. Continued to monitor and then contacted clinic on the morning of 12 Jan 2011 because seemed to be getting worse. Was placed on oral steroids for 5 days.
did not receive their second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive their second dose) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive their second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive their second dose) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported. It was reported that, patient who had received first dose of Moderna vaccine more than 35 days ago without getting second dose.
4 Hours after injection, shoulder and upper right arm swelled and aered  making it impossible to rise or sleep with.
9/17/21: Patient arrived at the ER due to the last couple days she has had persistent nausea with multiple episodes of nonbloody, nonbilious vomit as well as generalized weakness and reports feeling more shaky than usual.  She states she spoke with her nephrologist in regards to her symptoms who referred her to the ED for further management.  She reports over the last week she has had upper respiratory symptoms of a cough, nasal congestion, chest congestion and states she saw her PCP who prescribed her antibiotics, a Medrol Dosepak and albuterol inhaler and reports her symptoms have actually improved.  She states during the visit with her PCP she tested negative for COVID at that time. Please note: Patient received J&J vaccine on 4/05/2021 Lot # 1805025  Blood pressure with borderline hypotension, and O2 saturations ranging between 92 and 94% on room air. At this time will admit patient under inpatient status for continued monitoring and treatment.
Can't get the next one because they said it will kill her; Seizures; Slurred speech; the vaccine ruined her vocal cord; Tremors; cant bend; Son noticed that her voice was not right; Her life is ruined/cant drive/The shot really messed her up; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) and DYSARTHRIA (Slurred speech) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant), DYSARTHRIA (Slurred speech) (seriousness criterion medically significant), VOCAL CORD DISORDER (the vaccine ruined her vocal cord), TREMOR (Tremors), MOVEMENT DISORDER (cant bend), SPEECH DISORDER (Son noticed that her voice was not right) and IMPAIRED QUALITY OF LIFE (Her life is ruined/cant drive/The shot really messed her up). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can't get the next one because they said it will kill her). At the time of the report, SEIZURE (Seizures), DYSARTHRIA (Slurred speech), VOCAL CORD DISORDER (the vaccine ruined her vocal cord), TREMOR (Tremors), MOVEMENT DISORDER (cant bend), SPEECH DISORDER (Son noticed that her voice was not right) and IMPAIRED QUALITY OF LIFE (Her life is ruined/cant drive/The shot really messed her up) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Can't get the next one because they said it will kill her) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported. Patient ran all types of test, the test indicated that stroke was not involved. Patient has to use wheelchair and walker. Patient can't get the next one because they said it will kill her. patient can't drive. patient  can't bend, patient has 6 seizures a day.  Company comment -This case concerns a 51-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of seizure and dysarthria. The events occurred the same day after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 51-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of seizure and dysarthria. The events occurred the same day after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
BURNING SENSATION ON LEG; SEVERE ABDOMINAL PAIN; HEADACHE; FATIGUE AND TIRED; This spontaneous report received from a parent concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included low platelet count, and concurrent conditions included leukemia, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 01-JAN-2021, Laboratory data included: PCR (NR: not provided) NEGATIVE. On 20-APR-2021, the subject experienced burning sensation on leg. On 20-APR-2021, the subject experienced severe abdominal pain. On 20-APR-2021, the subject experienced headache. On 20-APR-2021, the subject experienced fatigue and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation on leg, severe abdominal pain, headache, and fatigue and tired. This report was non-serious.
Passed away; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) The patient is the reporter's mother.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DEATH (death, hospitalization) with onset 2021, outcome "fatal", described as "Passed away". The patient date of death was unknown. The reported cause of death was "Passed away". No autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Passed away
4/22--HA, vomiting, fatigue, sinus congestion, nonproductive cough; symptoms started mildly and progressively got worse i.e. sinus congestion and cough then HA, and finally vomiting.  Symptoms resolved 4/24 5/13--severe myalgia, arthralgia, fatigue, slight sinus congestion; 5/15--severe radiating left arm pain; 5/16--myalgia and arthralgia improved; severe left arm pain continues today  APAP and ibuprofen tried for pain without improvement in symptoms.
This spontaneous report was received from a healthcare worker via company representative refers to an approximately 65 year old patient of unknown gender. No medical history was reported. On 13-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # J015868, exp date 25-FEB-2015) (.0.5 ml, intramuscular). No concomitant therapy was reported. It was reported that PNEUMOVAX 23 was administered post expiry. No adverse effects were reported. The outcome of the events was unknown. The events were considered to be not related to PNEUMOVAX 23. No product quality issue was involved. Additional information has been requested.
Vascular rash; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 22-years-old patient of an unspecified gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 04Aug2021 (Batch/Lot Number: FA6780, Expiry date was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. No other vaccine was taken within four weeks prior to the first administration date of COVID vaccine. On an unspecified date, the patient experienced vascular rash. Consumer wanted to report a side effect from the shot and confirmed the name of the product name as Pfizer COVID-19 vaccine. When probed for the side effects experienced, consumer stated, It was a vascular rash. The patient took Benadryl for the reported event.  The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Hurt stomach; Hair fell out; Doctor stated there was no other drug that could be taken with Humira/patient had been on Humira and also had taken other meds; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Hurt stomach), ALOPECIA (Hair fell out) and CONTRAINDICATED PRODUCT ADMINISTERED (Doctor stated there was no other drug that could be taken with Humira/patient had been on Humira and also had taken other meds) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for an unknown indication, METHOTREXATE for an unknown indication, SULFASALAZINE for an unknown indication and LEFLUNOMIDE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, UNK, METHOTREXATE (unknown route) at an unspecified dose, SULFASALAZINE (unknown route) at an unspecified dose and LEFLUNOMIDE (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Hurt stomach), ALOPECIA (Hair fell out) and CONTRAINDICATED PRODUCT ADMINISTERED (Doctor stated there was no other drug that could be taken with Humira/patient had been on Humira and also had taken other meds). At the time of the report, ABDOMINAL PAIN UPPER (Hurt stomach) had resolved and ALOPECIA (Hair fell out) and CONTRAINDICATED PRODUCT ADMINISTERED (Doctor stated there was no other drug that could be taken with Humira/patient had been on Humira and also had taken other meds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. The reporter assessed the event Abdominal pain upper as not related to Humira, related to Methotrexate and Sulfasalazine. The reporter assessed the event Alopecia as related to Leflunomide. 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.
This is a spontaneous report from a contactable nurse through a Pfizer sales representative who reported similar events for two different patients. This is the second of 2 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot M35761) on 11Feb2016 at 12:00, at 0.5 ml single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a severe reaction with redness, fever and cellulitis, all on an unspecified date in Feb2016, with outcome of unknown. The reporter added that subsequently they just quitted administering any vaccine from that lot.
Rash all over my torso and my face/dots on my face; Achy body; Fever/goes up and down; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over my torso and my face/dots on my face), MYALGIA (Achy body), PYREXIA (Fever/goes up and down) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN for High cholesterol, VITAMINS NOS, FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6) and UBIDECARENONE (COQ 10) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced RASH (Rash all over my torso and my face/dots on my face), MYALGIA (Achy body), PYREXIA (Fever/goes up and down) and CHILLS (Chills). On 07-Feb-2021, RASH (Rash all over my torso and my face/dots on my face), MYALGIA (Achy body), PYREXIA (Fever/goes up and down) and CHILLS (Chills) had resolved.            .Treatment  information include Tylenol 500 mg. The reporter enquired whether this rash is normal and how long it will last. Also asked whether want to make an appointment with doctor.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 23-APR-2021 and included information of Patient demography, Both doses information, Concomitant medication
6 days after receiving 2nd vaccine, I started having bleeding ( menstrual) after being in menopause for 21 months.
4 to 8 hours after IZZs had fever and seizure. After administration of Tylenol was afebrile and in no apparent distress.
Information has been received from a registered nurse concerning a female who was vaccinated with a second dose of VARIVAX (Merck) 0.5 mL. More than 42 days post vaccination of the second dose, the patient experienced chicken pox. The patient did receive both doses of VARIVAX (Merck) and this occurred after the second dose. There were other chicken pox information in the community. This is one of several reports from the same source. Additional information has been requested.
The minute after the vaccination I had fainted, vision went, low blood pressure, after  laying down became better. Rested almost an hour in order to be able to walk. next day, I had severe headache, with nausea, and a day later I had bleeding. Bleeding became severe, I had miscarriage. I was 7 weeks pregnant.
Saturday and was fine until Tuesday evening I felt discomfort in my stomach and started having diarrhea all day on Wednesday and it's slowed down some but very uncomfortable and its coming out almost black. And today I've gone four times since 3:30am.
Pt reporting painful/swollen joints beginning the week of vaccine, specifically knee & ankle. Has seen DR several times & has been prescribed Naproxen, Prednisone, Hydrocodone & Ibuprofen. 1/26 pt called & said L/elbow & wrist pain & edema.