chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up that morning to hot and cold flashes, extreme nausea and vaginal discharge.  Started having "joint seizures" to the point she couldn't move her hands.  Lost full function of the hands, but was systemic to all joints in body.  Lasted 2 hours.  Went to the ER.  They were vague, stated they couldn't link symptoms directly to vaccination.  Went to her PCP.  Patient didn't realize she was pregnant, but miscarried on 7/12/15.  Her PCP felt her symptoms and miscarriage were related to MMR vaccination.  "PCP drew MMR titer, and patient claims her Rubella titer returned with extremely high numbers.  The other components of the titer were in normal ranges.  My PCP feels I'm extremely susceptible to Rubella vaccination and should claim medical exemption".  Episode lasted 4 days total.
Fever 104 degrees, chills, sweating, shaking uncontrollably symptoms  lasted approximately 24 hours. I treated myself with tylenol.
I experience tingling, pain in limbs/ joints, numbness through out body, including face. Pain very intense.
Patient called reporter on 3/7/23, and stated that she had a red blotchy area surrounding injection site and then spread around her arm but remained localized, denied raised areas or itching and resolved in about 1 week.
Event 1) Epididymitis, stent placed. Severe pain in groin. 5 weeks Event 2) Reactive Arthritis, steroid treatment. Severe swelling in knee, hip and joint pain, eyes, and skin rash from October 2021 to PRESENT
Pain in muscle day/day after. Went away.  Close to two weeks after shot, periods of dizziness began. Don't know if related or not but isn't a usual thing in my life. Has been lasting close to a week so far. Sometimes severe, sometimes not at all.
No adverse event; Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.).    The case was regarding Patient number 4 out of 6 patients.  No concomitant medications were reported.  Pharmacist stated that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD. The lot number of the vaccine is AS7173B, the date it was pulled out of the freezer was 24-Apr-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-726797 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2023: Live follow-up appended with no new information. On 30-May-2023: Live Significant follow-up appended: Patient details updated and Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726797:Patient 1
chills, fever, 101 temp, weezing, sweating, fatigue, cough, heart racing over 100 bpm
Blood pressure immediately dropped.   Continued dropping.  Told to go home and drink plenty of liquids and get rest.  Began vomiting that evening.  The vomiting,  being dizzy and sleeping continued for days.  Went to Urgent Care on April 20, 2021.  They gave me nausea medicine and said I should expect to feel this way for about one week.  The nausea medicine helped with the vomiting, but did not help with being dizzy and sleepy.  Making a trip to the ER for more answers.
Vomiting starting on 12/2/08 - led to hospitalization. Final diagnosis was intussusception.  01/02/08 MR received for DOS 12/4-5/2008 with D/C DX:  Intussusception. Pt presented with 2 day hx of emesis, loose stool most recent was black in color and and inability to tolerate po feeds. Upper GI (+) for IS which was reduced by barium enema. D/C next day when tolerating po feeds well.
Hives, cough, tongue tingling, possible throat swelling near syncope. Required oral BENADRYL and oral steroid course, ER visit, PCP visit.
Patient received the Moderna COVID vaccine on 4/20/2021 at 11:19 AM in her left arm. At 11:30 AM patient began to complain of nausea, vomiting, and general unwell feeling. She did vomit a small amount around 11:35 AM. Patient was then monitored with blood pressure, blood glucose and oxygen saturation. Her fasting blood glucose at 11:45 AM was 230 mg/dL. Between 11:45 AM-11:59 AM patient's blood pressure began at 157/96, then began to drop starting at 102/64, 82/59, and 90/62, at 12:01 PM it was 85/60, then 85/57, then at 12:09 her blood pressure was 73/53 in her right arm, and in the left arm at 12:10 PM it was 83/58.  EMS was called at 11:50 AM when patient's blood pressure started to decline. EMS arrived at 12:10 PM and took patient to the ER via EMS.
itching, redness, peeling, indurated area/bruising still present 4 weeks later
administered Kinrix to 7 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Sept-2022 Reporter's comment: The medical assistant reported that Kinrix was administered to 7 years old patient. The reporter unable to provide additional adverse event details at the time. The adverse event report contains all information. The reporter was ok for safety team to follow-up. The reporter consented to follow-up. Additional supportive information: The patient received Kinirx at inappropriate age which led to inappropriate age at vaccine administration.
All listed possible side effects including vomiting, severe body and joint aches, fever, dizziness, etc
1st dose of Pediarix on 14-Feb-2023, 2nd dose of Pediarix on 5-July-2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 12-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number HS4F9, expiry date 11-APR-2025) for prophylaxis.   Previously administered products included Pentacel (received 1st dose on 6th September 2022), Pentacel (received 2nd dose on 2nd November 2022), Pediarix (received 1st dose on 14th February 2023) and Hepatitis B vaccine (received birth dose of Hepatitis B).   On 05-JUL-2023, the patient received the 2nd dose of Pediarix. On 05-JUL-2023, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose of Pediarix on 14-Feb-2023, 2nd dose of Pediarix on 5-July-2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUL-2023 The reporter was the medical assistant. The reporter who stated a patient received an extra dose of Pediarix and the patient was doing fine.  According to reporter, the system for the state did not record the 3rd dose of Pediarix administered to the patient on 14th February 2023 when the Pediarix dose series was completed and they gave the shot to the patient by mistake.  The reporter was transferred to medical information per request. The reporter consented to follow up. The patient received 2nd dose of Pediarix later than the recommended schedule, which led to lengthening of vaccination schedule.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) and on 02Jun2023 as dose 6 (booster), single (Lot number: GJ6743) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), on 21Mar2021 as dose 2, single (Lot number: ER8727), on 11Oct2021 as dose 3 (booster), single (Lot number: 2593) and on 26Apr2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Atherosclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment from 14Jul2023 to 19Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300259116 Same patient, different drug/AE.;US-PFIZER INC-202300259186 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Information has been received from a registered nurse concerning a 3rd grade male elementary school student who on 04/28/1997 was vaccinated with a dose of varicella virus vaccine live.  In mid December 2004 the student developed chickenpox.  According to the school nurse, there were 58 other students who developed chickenpox in mid December 2004 and 34 of them had previously been vaccinated with a dose of varicella vaccine live.  Unspecified medical attention was sought.  There was no information regarding the present status of the 3rd grade student.  No product quality complaint was involved.  Additional information has been requested.
Chills, extreme fatigue, joint aches, headache, localized redness, swelling, tenderness.  Positive appetite, subjective fever.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 66-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced red and sore arm, with outcome of unknown.
After the first dose of Moderna, experienced Co-Vid arm 9 days later. The itching was fierce! Itching had not been a previous symptom. It got extremely more red, swelled more, got hot to the touch more, and hard to the touch more. The first 8 days I had mild redness, mild swelling, mild hotness to touch, mild hardness to touch, but no itching. Also on 9th day and a couple of days thereafter, experienced a lot of diarrhea which had not been an issue in the first 8 days.   I have been told my heart rate is slightly high since visiting doctor offices in May, June, July for unrelated CoVid issues.
my arm swelled up; flaming hives around rectal area; thirsty; could'nt swallow; tongue was swelling up; a hive showed up between my middle and index finger and on my palm which was itchy and sore; lethargic; no stamina; fever of 100.7; general body aches; rash; pruritus; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (pruritus), VACCINATION SITE SWELLING (my arm swelled up), PYREXIA (fever of 100.7), PAIN (general body aches) and LETHARGY (lethargic) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fever. Concurrent medical conditions included Allergy (Allergic to Sulphur medications) and Angioedema.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 05-Apr-2021, the patient experienced PRURITUS (pruritus), PYREXIA (fever of 100.7), PAIN (general body aches) and RASH (rash). On 07-Apr-2021, the patient experienced LETHARGY (lethargic) and ASTHENIA (no stamina). On 08-Apr-2021, the patient experienced URTICARIA (a hive showed up between my middle and index finger and on my palm which was itchy and sore). On 09-Apr-2021, the patient experienced URTICARIA (flaming hives around rectal area), THIRST (thirsty), DYSPHAGIA (could'nt swallow) and SWOLLEN TONGUE (tongue was swelling up). On an unknown date, the patient experienced VACCINATION SITE SWELLING (my arm swelled up). The patient was treated with IBUPROFEN at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at an unspecified dose and frequency; FAMOTIDINE at an unspecified dose and frequency and LEVOTHYROXINE SODIUM (THYROXINE) at an unspecified dose and frequency. On 06-Apr-2021, PYREXIA (fever of 100.7) had resolved. On 07-Apr-2021, PAIN (general body aches) had resolved. On 08-Apr-2021, LETHARGY (lethargic) and ASTHENIA (no stamina) had resolved. On 09-Apr-2021, URTICARIA (a hive showed up between my middle and index finger and on my palm which was itchy and sore), URTICARIA (flaming hives around rectal area), THIRST (thirsty), DYSPHAGIA (could'nt swallow) and SWOLLEN TONGUE (tongue was swelling up) had resolved. At the time of the report, PRURITUS (pruritus), VACCINATION SITE SWELLING (my arm swelled up) and RASH (rash) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter has also mentioned the following events: felt like poker was on my hand; feels like it is in my lymps, like an infection and totally wiped out and puffy,itchy and warm arm.
Moderna COVID-19 Vaccine EUA Fever 36 hours, muscle aches 36 hours, fatigue 48 hours,  partial loss of taste 5 days
Initial report was received on 23 November 2011 from a health care professional. A female patient (date of birth not reported) with a history of "back pain and abdominal a few months ago" had received on 15 November 2011 ADACEL (lot number, route and site of administration not reported) and FLUZONE (lot number, route and site of administration not reported) and on the night of vaccination, complained of a cold sensation and her voice cutting in and out. The patient was hospitalized a few days later and was diagnosed with pancreatitis. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Heavy menstrual cycles / prolonged period of bleeding.  Prior to vaccine in October 2021, average time been menses was 28-30 days, with very light bleeding. Now menses begins at any time during the month, with very heavy bleeding.
redness 10cm x 10cm rt deltoid on 10/15/99;induration 6cm x 6cm;T99.7 small amount of redness noted;c/o arm being sore on10/13/99;
got a rash all over my chest, and back of head. given: Triamcinolone 0.1-1 topical cream
very intense flu-like symptoms; very sick; aches; chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (very intense flu-like symptoms), ILLNESS (very sick), PAIN (aches), CHILLS (chills) and VOMITING (vomiting) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021 at 7:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021 at 7:00 AM, the patient experienced INFLUENZA LIKE ILLNESS (very intense flu-like symptoms), ILLNESS (very sick), PAIN (aches), CHILLS (chills) and VOMITING (vomiting). At the time of the report, INFLUENZA LIKE ILLNESS (very intense flu-like symptoms), ILLNESS (very sick), PAIN (aches), CHILLS (chills) and VOMITING (vomiting) was resolving.            It was reported that the symptoms got intense around 3 PM, and then it started to get better. Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-437865, MOD-2022-437822, MOD-2022-437834 (Patient Link).
Pt received DTP/OPV vaccine developed rash in groin area, became wide spread, DX rash, erythema multiforme (E.R. report indicates due to OPV vaccine) At 6 mon. child received DTP w/ no problems.
Swollen lymph node in armpit and neck; Swollen neck on side of body (left); This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 29Mar2021 at 0930 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included allergy. Concomitant medication included Zyrtec (MANUFACTURER UNKNOWN). The patient received this medication (Zyrtec) within two weeks of vaccination. The patient had no known allergies to food, medications or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 08Mar2021 at 0830 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 31Mar2021 at 0700 the patient experienced swollen lymph node in armpit and neck on side of body (left) where she received the vaccine. The lymph node swelling started 48 hours after second dose and lasted over 24 hours. The patient did not receive any treatment for the event. It was reported that the adverse events resulted in none of the above. On 30Dec2020, the patient underwent nasal swab test and the result was negative. The clinical outcome of swollen lymph node in armpit and swollen neck was not recovered.  No follow-up attempts are needed. No further information is expected.
sick; It was like a bad flu; This is a spontaneous report from a Pfizer-sponsored program, COVID 19 from a contactable consumer. This consumer reported same events for 3 patients. This is 2nd of 3 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Everyone that the reporter knew that has gotten the vaccine so far have all gotten sick for 24 to 48 hours. The patient was one of them. The way they described it was it was like a bad flu. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : same reporter, suspect drug and event; different patient; same reporter, suspect drug and event; different patient
Sometime between the first and second shot, my left eyelid slowly started swelling. By the second shot, my eyelids became extremely itchy and swollen to edema.  First eye dr. gave 1 week antibiotic pill which somewhat made swelling go down but the itching never stopped.  Also gave me lotemax which I only took 1 day before going to second eye doctor. Got script for neomycin and polymyxin b sulfates and dexamethasone ophthalmic ointment which I took in May.  It makes symptoms go away while taking it but within a few days without the prescription the symptoms return. Took lotemax in June which also made symptoms go away until I stopped taking the lotemax.  At this point, the symptoms are moving upward to eyebrow swelling like a caveman brow in a few days then I get a headache and throw up in the morning and need to find another dr. In July, I go to Dermatologist and get Tacrolimus (prograf) and took that the last 2 days but it does not help the symptoms are returning plus the prograf burns on top of the itching and swelling. Telemed with primary care physician this week saying I need something when the current presciption doesn't work. I stopped taking the prograf today because it doesnt help and Ill need something else soon because the swelling wont stop.
A report was received from a health care professional on 24Oct03, concerning three female vaccinees of unk age who were inadvertently administered last years vaccine (2002-2003) on an unk date. On an unk date three female vaccinees were inadvertently administered last years vaccine (2002-2003). No adverse reactions had occurred at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1:10Dec03, Follow up report was received from a health care professional on 10Dec03 which indicated that a 50 year old female vaccinee inadvertently received 1ml of expired Fluvirin on 23Oct03. No adverse events were reported to date. Follow up pending. Cross referenced to PJP200300917 and PJP2003200400033.
Maculopapular erythematous itchy rash in clusters in the thigh where the VARIVAX was given then spread to abdomen.
Rash left arm started 3 days and continued to increase in size to about 6", started rash around neck area, and what I thought was sore throat around day 7, sore throat because more of trouble swallowing and tightness in throat over weekend. Called Dr office Monday morning, told to go to ER. ER diagnoses allergic reaction,  given Epipen, Benadryl, Prednisone.
Injection site is hot to the touch and a different temperature than the rest of my arm and body. My mensuration cycle was delayed by a week.