chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had my period since I was 13 years old, and I am now 20, almost 21 in four days. I am fully up to date with all my vaccines and have NEVER had an effect like this before. Since the second dose of my Pfizer vaccine, I got my period four days after, which was normal at day 31. After this immediate period, my periods have been REMARKABLY LATE FOR THE PAST THREE, ALMOST FOUR MONTHS. Once this initial period was over, it took me 50 days to get my next period, and I am now on day 40 with no period. For the past seven years, my periods have been EXTREMELY regular like clockwork, 28-32 days every month. I called my OBGYN office, as I thought I must be pregnant even though I cannot recall engaging in vaginal intercourse. They told me if I skipped two cycles then I should come in and get checked out, and to take another pregnancy test the next week. I ended up taking five pregnancy tests, and they were all negative. I have tracked my periods on an app on my phone for years, and I have never been this late in my entire life. I am not exceedingly stressed, I am not strenuously exercising, I am not taking part in any sexual activity that would lead to pregnancy- I am not doing anything I can think of that would make my periods late. I cannot imagine any other reason for why my periods have been irregular for the past three months other than the Pfizer vaccine as this effect started after I received this vaccination. I have read accounts of this happening with other women, but only for one cycle. This has now not only effected me for one cycle but now two, and I am growing increasingly concerned. I will be bringing this up with my OBGYN.
Patient received flu vaccine 10/1/12 - (R) upper arm became sore later that day, 10/2/12 - (R) axillary node enlarged & painful, 10/3/12 right 3rd & 4th fingertips numb.
A report was received from a health care professional on 1/27/04 concerning a 30 year old female vaccinee who developed soreness in her arm after she received Fluvirin on 12/10/03, while she was 15 weeks pregnant. On 12/10/03, the vaccinee received Fluvirin into her right deltoid. The vaccinee reported that her arm was sore for a week afterwards and then resolved completely. After Christmas holidays the vaccinee developed a minor cold and reported that her arm began to feel sore again. The vaccinee experienced 2 additional episodes of minor cold/illness during which the soreness in her arm returned. This was the vaccinee's first experience to the influenza vaccine. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
No adverse reaction, patient was given Moderna vaccine a first dose, patient returned to clinic and disclosed returned for 2nd dose, which she believed was Pfizer vaccine. Pfizer vaccine administered. Documentation at end of day showed patient received Moderna as dose 1 and Pfizer was given as dose 2. No adverse reaction noted, no side effects note. Patient was discharged after 15 minutes
Immediately after vaccine given site was swelling with a red flare.  Red rash developed within 1 minute & skin swelling continued.  Gave BENADRYL 50 mg po.  No diff breathing or itchiness.
Arm was very swollen and red; Skin and the muscle were red; Skin and the muscle were hard; Skin and the muscle were red and hard and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm was very swollen and red), VACCINATION SITE ERYTHEMA (Skin and the muscle were red), VACCINATION SITE INDURATION (Skin and the muscle were hard) and VACCINATION SITE WARMTH (Skin and the muscle were red and hard and hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A., 017B321A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D NOS, IRON, VITAMIN B12 NOS and CALCIUM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Arm was very swollen and red), VACCINATION SITE ERYTHEMA (Skin and the muscle were red), VACCINATION SITE INDURATION (Skin and the muscle were hard) and VACCINATION SITE WARMTH (Skin and the muscle were red and hard and hot). At the time of the report, VACCINATION SITE SWELLING (Arm was very swollen and red) and VACCINATION SITE ERYTHEMA (Skin and the muscle were red) outcome was unknown and VACCINATION SITE INDURATION (Skin and the muscle were hard) and VACCINATION SITE WARMTH (Skin and the muscle were red and hard and hot) had resolved.            The patient also took Centroid drug and an unknown medication for high blood pressure as Concomitant medication.  No treatment information was provided.  The patient post receiving the Moderna booster shot reported that their arm was very swollen, red, and the skin and the muscle were red and hard and hot for 8 days. On 05-Nov-2021 it began to go down. The patient stated that they did not have any reactions after the first two doses and wondered if this should be reported and if this time the injection was correctly administered.
Vail expired on 30-Jun-2022, Thawed on 29-Jul-2022 and kept in the refrigerator.; No adverse event; Patient received expired booster dose after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022, Thawed on 29-Jul-2022 and kept in the refrigerator.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022, Thawed on 29-Jul-2022 and kept in the refrigerator.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022, Thawed on 29-Jul-2022 and kept in the refrigerator.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022, Thawed on 29-Jul-2022 and kept in the refrigerator.).    No concomitant medications were reported.  Patient received booster dose.   Vial did not undergo any temperature excursions.  No treatment information was provided.  This case contains information for the 7th of 8 adult patients described by the reporter.
low-grade fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low-grade fever) and MYALGIA (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (low-grade fever) and MYALGIA (body aches). On 16-Apr-2021, PYREXIA (low-grade fever) and MYALGIA (body aches) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395556 (Patient Link).
covid; covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2, on 30Jan2021 as dose 1, single (Lot number: EL9265), on 12Mar2021 as dose 2, single (Lot number: EN6207), on 16Sep2021 as dose 3 (booster), single (Lot number: 30145BA) and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "she has a lot of back problems" (unspecified if ongoing), notes: taking some unspecified back medications prior to her back surgery; "back surgery" (unspecified if ongoing), notes: few years ago. Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement; AMLODIPINE [AMLODIPINE BESILATE] taken for blood pressure measurement. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "covid". Caller states then she got Covid for a third time, it was a mild case, but she was so upset about getting it. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: test that was negative; (Jun2022) Positive, notes: Caller states that in June she took two home tests that were positive; (Jun2022) Positive, notes: Caller states that in June she took two home tests that were positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.
This case was reported by a other health professional via call center representative and described the occurrence of upset stomach in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included herpes zoster (or shingles especially when immunocompromised). In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, immediately after receiving SHINGRIX, the patient experienced upset stomach, malaise and fatigability generalized. On an unknown date, the outcome of the upset stomach, malaise and fatigability generalized were recovered/resolved. It was unknown if the reporter considered the upset stomach, malaise and fatigability generalized to be related to SHINGRIX. Additional information was received as follows: The reporter was the Director of Medical Affairs at GlaxoSmithKline. The age at vaccination was not reported. GlaxoSmithKline employee reported that the patient received the SHINGRIX on an unknown arm. The patient experienced significant stomach upset and gastrointestinal upset with general fatigue which was described as very tired and malaise for four days, immediately following the SHINGRIX vaccine. The patient indicated that she reported her experience to the pharmacist at the pharmacy, where she was vaccinated. The reporter was concerned that the product was defective.
Arrived with SOB and possible aspiration of vomit. COVID + in ER and dx with aspiration pna and COVID-19. Critically ill on arrival to ER in septic shock; intubated and on multiple pressors. Expired approx. 10 hrs after arrival; no COVID specific treatment initiated.
She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; she is lactating, and is currently weaning her 19 month old son; she is lactating, and is currently weaning her 19 month old son; This is a spontaneous report from a Non contactable Nurse. This Nurse reported events for mother and baby. This case is for the mother. A 34-year-old female patient (mother) received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Jan2021, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. At the time of vaccination, the patient was lactating and was currently weening her 19-month-old son. The reporter stated that on Saturday (30Jan2021) and Sunday (31Jan2021) the patient ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021). Reporter does not know exact date of birth, but reporter believe she was 34 years old. Outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122449 Child and Maternal case
Information has been received from a consumer's mother concerning her 24 month old daughter with no pertinent medical history or drug allergies who on 20-DEC-2007 was vaccinated with a first dose of VARIVAX (Merck), 0.5 ml, SC.  There was no concomitant medication.  A week after receiving VARIVAX (Merck) (on 27-DEC-2007) the patient was diagnosed with acute spinocerebella ataxia.  Blood work, lead test, CBC and MRI were performed (no results provided).  The patient's acute spinocerebellar ataxia persisted.  Unspecified medical attention was sought.  Additional information has been requested.
I had full-blown flu like symptoms: headache, nausea, muscle body aches, fatigue. Hit me super hard for one day and then -- boom  -- gone.
Rash not at the inject site but around the bicep and upper shoulder (rash is traveling down my arm and up my shoulder and back)  swollen arm, severe itching, throbbing pain at injection site, bruising at injection site.
Extremely heavy menstrual  cycle after 1st dose 6 days after  Large amounts of hair loss  4 days after and continuing daily
Greater than 35 days since first dose; Sore arm; Mild headache; Inadvertently administered dose to a teenager; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager), PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose), MYALGIA (Sore arm) and HEADACHE (Mild headache) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager), MYALGIA (Sore arm) and HEADACHE (Mild headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose). On 29-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager) had resolved. On 30-Jul-2021, MYALGIA (Sore arm) and HEADACHE (Mild headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first 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 provided. No treatment medication provided.
Information has been received from a registered nurse concerning an 11-year-old female who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child developed a mild case of varicella. The child was treated with calamine (+) camphore (+) camphor (+) pramoxin hydrochloride (AVEENO), diphenhydramine hydrochloride (Benadryl), and acetaminophen (Tylenol) prn. Unspecified medical attention was sought. Additional information is not available at this time. The reporter indicated that 4 other females were vaccinated with a dose of varicella virus vaccine live from different lot numbers and experienced varicella (WAES #0304USA00358, WAES #0304USA00480, WAES #0304USA00481, WAES #0304USA00482). Additional information has been requested.
sore arm; arm still touchie; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and arm discomfort. On an unknown date, the outcome of the pain in arm and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-NOV-2022 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient received a dose of Shingles vaccine four days ago and reported arm was still touchy and sore and asked was that normal. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Dizziness; This case was reported by a other health professional via call center representative and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced dizziness following the Shingrix.  No additional information was provided.
Pt woke up next day, , confusion, and spiked fever to 102.1
11:15 reported chest tightness - used her inhaler b/p 12/80 heart rate 86. reported slightly light headed had two masks on placed in private room so she could remove masks.  11:21 breathing better masks removed   11:35 b/p 130/90 heart rate 94 breathing easy.  Informed to only wear one mask. Instructed to Call 911 for further breathing difficulty.
Excruciating lower back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Excruciating lower back pain) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced BACK PAIN (Excruciating lower back pain). At the time of the report, BACK PAIN (Excruciating lower back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included steroid shot in lower back.  The scheduled date for the second dose was on 19-apr-2021.The patient discussed with his orthopedic doctor potential implications of having a steroid combination with a Covid vaccine and he was confused that will the steroid shot increase risk of getting Covid under the circumstances.
Sore arm, cold chills, irritable skin all over, achy muscles, headache
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with VARIVAX lot#, dosing details and route unknown for prophylaxis which was reconstituted with 0.9% sodium chloride (wrong solution used in drug reconstitution). Concomitant medications were not reported. No adverse symptoms were reported. Additional information has been requested.
Her right breast got extremely sore; Aching; Leaking; Very painful; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Her right breast got extremely sore), PAIN (Aching), BREAST DISCHARGE (Leaking) and BREAST PAIN (Very painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes mellitus.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced BREAST PAIN (Her right breast got extremely sore), PAIN (Aching), BREAST DISCHARGE (Leaking) and BREAST PAIN (Very painful). At the time of the report, BREAST PAIN (Her right breast got extremely sore), PAIN (Aching), BREAST DISCHARGE (Leaking) and BREAST PAIN (Very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI
Two days after COVID vaccine, patient suddenly lost a tooth, despite having no prior dental issues. Then her face ended up developing a long last swelling and rash episode that lasted for 1.5-2 months. Patient thinks it was a reaction to the amoxicillin she was given, but it persisted despite not being on the medicine, being given steroids, and antihistamines. Patient was in the ED twice for the facial swelling. Also saw Dermatology. Pt later saw an allergist and she is not allergic to amoxicillin, only other new thing had been the vaccine when it all started. Then the patient suddenly develops severe bradycardia to the point of syncope and episodes of sinus arrest. Patient then ended up requiring a pacemaker to be placed.
Reproducible herpes simplex lesions on upper lip. Service member experienced a cluster of fever blisters on upper lip 7-10 days after AVA#1. The lesions were reproduced and increased 7-10 days after AVA #2. He states he has no prior history of these lesions and had no intimate contact with others that were infected. He sought no treatment and they resolved in 2 weeks. He had no other systemic symptoms.
Itchiness; Red circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Red circle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Red circle). At the time of the report, VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Red circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.