chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), HYPERTENSION (Hypertension aggravated), PAIN (Ache) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044b21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN (DIOVAN) for Hypertension.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HYPERTENSION (Hypertension aggravated). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing), PAIN (Ache) and PYREXIA (fever). The patient was treated with HYDROCHLOROTHIAZIDE on 07-May-2021 for Hypertension, at a dose of 12.5 milligram once a day. At the time of the report, DYSPNOEA (difficulty breathing), HYPERTENSION (Hypertension aggravated), PAIN (Ache) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) within a week after the shot, increase was around 140-150s over 80-90s and 120/80 (normal) 120/80. On an unknown date, Oxygen saturation: 91-92 (Low) lasted several hours and then returned to normal..         The patient had not yet started treatment with hydrochlorothiazide.    This case was linked to MOD-2021-089262 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter information was updated.
My first menstrual period after the second dose lasted for 32 days.  Bleeding varied between heavy and light, but remained present for 32 days.
This spontaneous report was received from a physician via a field representative referring to a 12 year old female patient. The patient's concomitant medication, medical history and drug allergy were unknown. The patient received a dose of GARDASIL (dose, route not reported, lot# and expiration date unknown) on 07-NOV-2014, a dose of GARDASIL 9 (dose, route not reported, lot# and expiration date unknown) on 27-AUG-2015, and another dose of GARDASIL 9 (dose, route not reported, lot# and expiration date unknown) on 05-JAN-2016 for vaccination. In September 2016, the patient stopped menstruating. The patient had sought medical attention and was seen by physician. No treatment was given to the patient. Just recently (in 2017), the patient started menstruating again and recovered from the event. The causality between "stopped menstruating" and suspect vaccines was not reported.
chills when went to bed around 10 pm, headache around 2 am, up around 7 just felt blah, went back to bed at noon, slept til 6 pm. Felt alot better, nothing to eat, drank some 7up and back to bed by 10. Much better on Friday
This case was reported by a healthcare professional and described the occurrence of lost consciousness in a 15-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 4 October 2008 at 10:45 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. Immediately after vaccination with FLULAVAL, the subject reported that things sounded funny and looked funny. An emergency room visit was noted. The events resolved the same day. The healthcare professional considered the events were unrelated to vaccination with FLULAVAL. This was also considered to be a case of medication error as FLULAVAL is not indicated for use in children. Follow-up information received on 19 November 2008, via healthcare professional considered the events probably related to vaccination with FLULAVAL and associated them to erroneous administration, being FLULAVAL is not indication for those under 18-years old.
I had a fever, a bad headache, and chills for 24 hours. I was back to normal in about 3 days.
Left arm red and warm to touch, swollen. Ice and Benadryl given at ER visit on 7/14/01. Cape Hospital called in Keflex.
About 15 to 20 min. (when Pharmacist was notified) after her shot, the patient reported in Spanish, through her daughter, numbness around the mouth.  The Pharmacist had advised her to sit and wait 30 min. after the shot, due to her anaphylaxis history from multiple things. The Pharmacist monitored her and she continued to report itching on the forearm where she got the shot (not around the site) and slight shortness of breath. The patient never appeared to be in distress. As the symptoms continued, the Pharmacist decided, though an Epipen was ready to use, to call 911.  Paramedics arrived within 5 to 7 min., questioned her, took her BP, Oxygen level and listened to her breathing (all were good). She said she was feeling better and said "no" when they asked her if she wanted to go to the hospital. The paramedics stayed with her about 10 minutes longer and she left with her family. She did not receive any Epipen or Benadryl (is allergic to it) but wanted to take a box of Claritin 10 mg with her (said it always helps). The paramedic told her Claritin will not help anaphylaxis (for future). The patient was advised to contact her physician because she probably would be at high risk for a second Covid vaccine.
This patient received both PENTACEL and PEDIARIX today in clinic. Instead of ordering hepatitis B I ordered PEDIARIX and both were given. No adverse reaction. Mother of child informed of this by ordering physician.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot number not reported). Subsequently the patient experienced syncopal after the vaccination. At the time of the report, the outcome of the patient was not reported. Follow-up information has been received from the physician concerning the 18 year old female patient with no pertinent medical history and no known allergies who on 27-AUG-2009 at 11:35 am was vaccinated in the right arm with the first dose of GARDASIL (lot number 655617/1447F). Concomitant vaccination included Hep A vaccine (manufacturer unspecified). On 17-AUG-2009 at 11:35 am, the patient experienced dizziness and nausea lasted for 3-5 minutes. The patient got better without treatment. The patient recovered on the same day. Additional information is not expected.
Patient presented to ED with palpitations after receiving the second dose of the Pfizer vaccine. Overnight he reported chills and aches (unknown if febrile) with palpitations. Since then, patient felt some improvement but went to ED for further evaluation. Patient was observed overnight for persistent tachycardia with ID and cardiology evaluations. The following day, tachycardia improved and patient was discharged.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna vaccine booster dose after 30 day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17-Jun-2022 and administered on 21-Jul-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 019F21A and 025A21A) for COVID-19 vaccination. The patient never had been diagnosed or tested positive for COVID-19. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Immunocompromised, Drug allergy (Compazine) and Drug allergy (Reglan). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 21-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 21-Jul-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna vaccine booster dose after 30 day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17-Jun-2022 and administered on 21-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna vaccine booster dose after 30 day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17-Jun-2022 and administered on 21-Jul-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had received the first booster on 21-Jul-2022. On 06-Apr-2021, the patient received second dose (manufacturer unknown), full dose, with lot number 031A21A. Concomitant medication list was not provided. Number of doses per vial was 1 vial per 1 dose. The vial was initially stored in the refrigerator on 17-Jun-2022. The vial had not undergone any temperature excursions. The patient had not reported any reactions after being observed for 15 minutes. Treatment information was not provided.
throbbing sensation in back tricept of the vaccination arm; arm was hurting a bit on Sat/Sun; dots around the edges; rash has expanded; hard, red, slightly itchy; arm at the injection site was swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DYSAESTHESIA (throbbing sensation in back tricept of the vaccination arm), PAIN IN EXTREMITY (arm was hurting a bit on Sat/Sun), RASH (dots around the edges), RASH (rash has expanded) and VACCINATION SITE ERYTHEMA (hard, red, slightly itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DYSAESTHESIA (throbbing sensation in back tricept of the vaccination arm), PAIN IN EXTREMITY (arm was hurting a bit on Sat/Sun), RASH (dots around the edges), RASH (rash has expanded), VACCINATION SITE ERYTHEMA (hard, red, slightly itchy) and VACCINATION SITE SWELLING (arm at the injection site was swollen). At the time of the report, VACCINATION SITE DYSAESTHESIA (throbbing sensation in back tricept of the vaccination arm), PAIN IN EXTREMITY (arm was hurting a bit on Sat/Sun), RASH (dots around the edges), RASH (rash has expanded), VACCINATION SITE ERYTHEMA (hard, red, slightly itchy) and VACCINATION SITE SWELLING (arm at the injection site was swollen) outcome was unknown.        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 medications were reported. No treatment medications were reported.
Patient who got her vaccinations on Day 0 and Day 9; Case reference number US-BN-2021-002082 is a spontaneous case report initially received on 08-Jul-2021 from pharmacist via Agency (reference number: USBAV21-0339) and concerns 31-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 18-Jun-2021, the patient was vaccinated with first dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch number: not provided) at unknown dosage regimen, administered intramuscularly, for pre-exposure prophylaxis.   On 26-Jun-2021, nine days after receiving the first dose, the patient received a second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch number: not provided) at unknown dosage regimen, administered intramuscularly, for pre-exposure prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered').   At the time of this report, it was unknown whether the patient developed any adverse event.  The reporter assessed the case as non-serious and not related to RabaVert.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed for RabAvert by convention. Reportedly, the patient received second dose of vaccine on day nine after first dose, which is considered as inappropriate schedule of product administration. No information regarding medical history and concomitant medication were provided. No adverse event was reported. Reported event is not related to the suspect product but to a human action. The case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration is listed for RabAvert by convention. Reportedly, the patient received second dose of vaccine on day nine after first dose, which is considered as inappropriate schedule of product administration. No information regarding medical history and concomitant medication were provided. No adverse event was reported. Reported event is not related to the suspect product but to a human action. The case is considered as non-serious.
9MAY94 pt's mom called & states pt seen in ER secondary to what mom described as petit mal sz; also states dx hepatitis;
24 hrs p/inject t103, @ site of inject had 4" diameter swelling lasting 12 hrs;
tiredness after 2 hours; then lethargy after 3.5 hours; then chills followed by temperature of 100.2F on forehead reading for 4 hours; soreness at injection site; This is a spontaneous report from a contactable consumer. A 63-years-old female patient (Non-pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Unknown), via intramuscular, administered in Arm Left on 22Feb2021 13:30 as single dose for covid-19 immunization. On an unspecified date medical history included asthma, blood pressure increased, reflux gastritis, food allergy, drug hypersensitivity. Concomitant medication(s) included taken on an unspecified date fluticasone propionate, salmeterol xinafoate (ADVAIR); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); dexlansoprazole (DEXILANT); cetirizine hydrochloride (ZYRTEC); fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication. On 22Feb2021 15:30 the patient experienced tiredness after 2 hours (fatigue), then lethargy after 3.5 hours, then chills followed by temperature of 100.2f on forehead reading for 4 hours, soreness at injection site. The patient underwent lab tests and procedures which included pyrexia: 100.2 Fahrenheit on 22Feb2021. The outcome of the events were recovering.  Information on the Batch/Lot number has been requested.
9 days p/vax devel fever & subsequent febrile sz; temp in ofc p/sz 103 R;102? tm; no focus on exam; nl CBC symptomatic tx w/Ibuprofen
On 04/15/22 visited primary care physician .  Abnormal EKG, extra beat.  That evening went into A-Fib at 7:00 pm & laster until 1:00 am.
5JUL fever 103-104 36 hrs; 7JUL no fever; 7JUL fever; uncontrollable crying & pain thru 9JUL; 8JUL rash;
hard time breathing. it gets worse at night . heart rates are very fast. ekg shows abnormal; hard time breathing. it gets worse at night . heart rates are very fast. ekg shows abnormal; hard time breathing. it gets worse at night . heart rates are very fast. ekg shows abnormal; This is a spontaneous report received from a contactable consumer (patient himself). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in left arm on 23Apr2021 15:30 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient medical history included Cardiac failure. Concomitant medications were not reported. Lab data includes EKG was Abnormal on an unspecified date and Nasal Swab was Negative on 30Apr2021. On 23Apr2021 15:45 patient stated that he had hard time breathing. it gets worse at night. heart rates are very fast and EKG shows abnormal. Patient visited with physician office visit and emergency room/department or urgent care. Patient did not receive any treatment for events. Outcome of events was not recovered.  Follow-up attempts have been completed and no further information is expected.
sore arm; redness of arm; swelling; fever of 101 degrees Fahrenheit; diarrhea; nausea; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness of arm), VACCINATION SITE SWELLING (swelling), PYREXIA (fever of 101 degrees Fahrenheit) and DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness of arm), VACCINATION SITE SWELLING (swelling), PYREXIA (fever of 101 degrees Fahrenheit), DIARRHOEA (diarrhea), NAUSEA (nausea) and ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness of arm), VACCINATION SITE SWELLING (swelling), PYREXIA (fever of 101 degrees Fahrenheit), DIARRHOEA (diarrhea), NAUSEA (nausea) and ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-114704 (Patient Link).
I was sitting there throughout the day and a sharpe pain would come into my temple area and then just go away. This has been happening for a couple of weeks now. I have an appointment to see my MD next week.
Then I started my period, I am post menopausal and have been for 5+ years; breast hurting/first it was more my nipples but then it was the whole area/hurt to be touched, or even hurt when given a hug; breast hurting/first it was more my nipples but then it was the whole area/hurt to be touched, or even hurt when given a hug; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 19May2021 10:45 (lot number was not reported), as 1st dose, single dose, at age 44 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient has no medical history and no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported "Intense, I noticed my breast hurting, first it was more my nipples but then it was the whole area. They hurt to be touched, or even hurt when given a hug. Then I started my period, I am post-menopausal and have been for 5+ years." The onset date of the events was 22May2021. No treatment was given for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
I was tired the next day. I had a slight headache on and off the following day. I had a stroke on the 25th of June. I went into the ER, my right leg and my right arm were being weird. My leg was wiggly and floppy. Like Jell-o. My right arm - I went to grab my tea and I didn't have control in where my arm was going - it had strength - it just was floppy. I couldn't touch my nose when I brought my hands out. My left hand could but my right hand couldn't - it would just fall to my chest. I'm on a regimen of aspirin daily - for blood thinning, I think. They gave me Plavix - to help prevent collapse and something else - Atoravastin - 40 mg; Gave me something for cholesterol - my cholesterol was borderline. Clopidogrel -take for 18 days to help prevent clotting - but not a blood thinner. I still have a little bit of weakness in my right arm and I get tired easy.
Information has been received from an 18 year old female consumer, who on an unspecified date was vaccinated with the second dose of Gardasil (lot # not reported). The consumer reported "I got very sick just after I received my second Gardasil shot." The outcome and duration of the event were not specified. The consumer did not seek medical attention. No further information is available.
he feels lethargic; pain at the injection site; This non-serious case was reported by a dentist via call center representative and described the occurrence of injection site pain in a 93-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (the patient received first dose on an unknown date and had no pain or other effects after first dose).   On 22-MAY-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 22-MAY-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site). On 23-MAY-2023, the patient experienced lethargy (Verbatim: he feels lethargic). The outcome of the injection site pain and lethargy were not resolved.   It was unknown if the reporter considered the injection site pain and lethargy to be related to Shingrix.     It was unknown if the company considered the injection site pain and lethargy to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 The reporter was the patient who was a dentist.  The patient received second dose of Shingrix and experienced pain at the injection site that continues today and one day after vaccination the patient felt lethargic. Nothing else was reported. The reporter consented to follow up.
Pt recvd 3 doses of Engerix-B 29NOV90, 27DEC90, & 28MAY91 & it was determined that pt was a non-converter; No treatment was given;
Five minutes after vaccine administration, during observation period, complained of dry mouth, feeling lightheaded.   Placed in chair with both feet elevated, provided juice.  BP 116/65.   Finished juice at 1340, put legs down for 3 minutes then reported feeling well.  1343 stood for about a minute, then was able to walk while being observed, with no further complaints of being lightheaded.  Left observation area at 1345.
This spontaneous case was reported by a patient and describes the occurrence of AMENORRHOEA (Since the 1st dose my period is missing) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. On 02-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 AMENORRHOEA (Since the 1st dose my period is missing). At the time of the report, AMENORRHOEA (Since the 1st dose my period is missing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, Heart rate: 95 (Inconclusive) Heart rate is 95bpm. Country of patient/reporter was Unknown and so, it was put as UNKNOWN. Source document states hyperthyroidism /hypothyroidism both (under medical history), so, it was unclear what thyroid disorder patient has. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2021-246768 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Non-Significant Follow-up appended.