chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PERIOD CRAMPS; ABDOMINAL CRAMPS; ACCELERATED HEART RATE; RASH AT INJECTION SITE; HEADACHE; TIRED; ITCHY ON ARMS; This spontaneous report received from a consumer concerned a 33 year old female. The patient's weight was 140 pounds, and height was 61 inches. The patient's concurrent conditions included allergic to polyethylene glycol, allergic to red dye, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced itchy on arms. On APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced period cramps. On 10-APR-2021, the subject experienced abdominal cramps. On 10-APR-2021, the subject experienced accelerated heart rate. On 10-APR-2021, the subject experienced rash at injection site. On 10-APR-2021, the subject experienced headache. Laboratory data included: Heart rate high (NR: not provided) accelerated, and Pain scale (NR: not provided) 8 (unit not reported), 6 (unit not reported). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, abdominal cramps, accelerated heart rate, rash at injection site, itchy on arms, and period cramps, and the outcome of tired was not reported. This report was non-serious.
Physician asked that we do a FAERS form, just in case Hosp did not do. Child hospitalized 10/8/10. (Arterial stroke).
On 6-6/2021 at 3:35 am woke up hard to breathe heart rate elevated to 212 and blood pressure 180/100 was taken to ER and heart restarted, again on 6/7/2021,, 6/10/2021 and was hospitalized on 6/11/2021 to 6/13/2021 they said I had inflammation around my heart took over 20 blood tests and 4 heart X-ray and could not find anything else. Went home after being on heart monitor for 2 days and had to find a cardiologist and they also hook me up to monitor but could not find out what the cause was and did not want to say it was the shot. It is now 3 months later and I have not had another issue. No issue before no issue after only thing I did different was a Covid shot. I want you to know that this shot could have killed me not the virus.
I have been having swelling in the lymph nodes at the base of my skull on the back of my neck. This has been happening nearly every day since 2 days post my second dose. I am taking Tylenol to alleviate the issue. I have been told by a nurse friend it might be relieved by having a lymphatic massage. I have seen a chiropractor with little relief.
2-1-7 2" size redness with brown center at injection site. No hard not hot, no pain. 2-2 Benadryl for same signs/symptoms-cancelled MD appt. 2-5 at MD appt 4 x 5 cm area of swelling, redness with sloughing of skin in stellate pattern.  No signs/symptoms infection
Case number PHEH2015US018509 is an initial spontaneous report received from a health care professional on 17 SEP 2015. This case refers to a 60 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2015/2016 (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 SEP 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error (incorrect storage of drug). The reporter declined further follow up contact. Follow up information received from the health care professional on 27 OCT 2015: Clinical notes updated.
Severe watery diarrheal stools (>15x/day) developed within 2-3 days of dose (no blood seen). After initial dose developed prolonged diarrhea ->failure to thrive (extensive work-up for infectious causes (-) - finally responded to probiotics, FLAGYL.
Received shot 1-28-13 in AM -> woke 11:15pm covered with puffy circles - red. Scratching. Gave BENADRYL. Went back to sleep. Woke up next day - puffy areas went down on trunk but not on arm where shot was given. Puffiness went down but looked like circles on arm. Used BENADRYL q day later that day. F/U phone call x2. No diff breathing or swallowing. Rash totally resolved by Monday PM Feb 4th.
Patient felt like she was going to pass out so laid down on floor. Staff responded assessed and helped into wheelchair and took her to observation area. Vital signs were stable. Gave patient juice, water and granola bar.  Patient stated that she has had episodes like this in the past when getting injections. Also stated she had not had lunch or fluids prior to COVID injection. At 2:17 pm sat patient up and dangled her legs. Patient became dizzy and laid her back down. Rechecked vitals and blood pressure had dropped. Kept her for another 15 minutes and set her up, reviewed blood pressure and nurse assisted her to observation area. Patient was fine and left to go home with mother.
Patient received P23 vaccine in right arm on 9/4/2020.  The daughter of patient reported redness under the arm area on 9/6/2020 to RPh.  Daughter indicated that under the arm from the injection site was red going down to elbow.  Daughter was contacted 9/7/2020 for reporting purposes and followup on reaction indicated.  Daughter verified redness was decreased and no further reactions.  Daughter drew margins on patient and indicated that redness on area had decreased.  Daughter stated that there was never pain or swelling at injection site or where redness was located.  Daughter stated that patient had slept extra day after injection.
1. Muscle weakness 2. Red blotching and red bumps on skin. Severe itching.
Information has been received from a registered nurse concerning a 29-year-old adult female who in 1995 was vaccinated with the first and second dose of varicella virus vaccine live. It was notedt that the patient failed to seroconvert after a titer was drawn and was negative in 2001. The patient was then revaccinated in May 2001 an June 2001 with the third and fourth doses of varicella virus vaccine live. A titer drawn one month later in July 2001 was positive. In 2003, the patient requested an additional antibody to be drawn before becoming pregnant, and it was noted that the titer was negative. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a registered nurse indicated that the patient noted that in July 2001 the titer was positive, although there was no report of this on the chart. A titer done in 08-Sep-2003 was negative for antibodies (0.61 ISR). The patient indicated that she received the chickenpox vaccine on 17-Jun-1995 and 28-Jul-1995, however there is no record of this and no titer drawn. No further information is expected.
About four to five hours following the vaccine, I developed a headache and a severe bloody nose with passing clots, I packed my nose with gauze, pinched my nose and put ice on the back of my neck, and it took about 45 min for the bloody nose to stop.
Right axillary area swollen and very tender to touch or movement. Area feels inflamed. Tylenol and Aleve used as directed. Ice packs placed. Pain and swelling still present 24 hours later but slightly less discomfort.
Woke up 2 days post vaccination with hives, was take to urgent care and given steroids
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In April 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On 06-DEC-2017, the patient was inadvertently administered a second dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). There were no adverse effects reported.
He had chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "He had chills".  Additional information: Patient stated that after 1st vaccine he had chills for 2 days. He went to an urgent care and to his doctor and they were unable to find anything that could be wrong and the Covid shot was the only thing different from his regular routine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse referring to a female patient of unknown age (reported as old enough to drive). No concurrent or historical conditions were reported. On an unknown date of May 2015 (reported as last week), the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, dose number and route unknown) at the facility here this nurse worked. There was no concomitant medication reported. On an unknown date of May 2015, the patient felt faint as she was walking out of the facility. Another nurse was with her and guided her to the ground. The patient got up quickly and was able to walk and talk; the patient said she had not eaten prior to this happening." The outcome of the event was recovered. This is one of several reports received from the same reports received from the same reporter. Additional information has been requested.
IPOL administration of vaccine post temperature excursion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 03-Oct-2022. number: 01304843   This case involves a 5-year-old female patient to whom experienced IPV (VERO) [IPOL] administration of vaccine post temperature excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA409280.   Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) for Prophylactic vaccination; Hepatitis A Vaccine for Prophylactic vaccination; and Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar RA 27/3), Varicella Zoster Vaccine Live (OKA/Merck) (Proquad) for Prophylactic vaccination.  Health care professional office inquired about the stability of vaccines after a temperature excursion of IPOL at 54.3 degrees Fahrenheit for 2 hours and 45 minutes cause by power outage not due to a human error.   On 29-Sep-2022, the patient administration of vaccine post temperature excursion a 3rd dose of suspect IPOL vaccine at dose 0.5ml once (lot: V1A022M, expiry date: 17-Feb-2024) via subcutaneous route in the left thigh for prophylactic vaccination with no reported adverse event (poor quality product administered) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient stated that she has been getting these migraine headaches. They come with other things such as eye twitching and confusion.
Was diagnosed with Hashimoto's thyroiditis within one year.  Treated with Synthroid and NP thyroid. No remission.
2 x seizures, father states axillary fever 103 degrees. 1st ED visit pm 6-12, 2nd ED visit mid day 6-13/ then admit hospital. Medical Records recived on 9/09/2002 states ear infection.
Shortly after injection rash occurs, this time we pre  treated him with benadryl and he still had a rash within minutes after injections
Approximately 1 hour after I received the shot I pressure and stiffness on the left half of my head and face. I did not have muscle weakness any where or slurred speech. That sensation was not painful, but it was very noticeable like someone's hand was on your face. That was present for about two days at a significant level. Five weeks later it is still present but at a much milder degree. Also persistent over the entire 5 weeks since the shot is mild dizzyness off and on each day, along with increased headaches. Since i have chronic post concussion syndrome, it is normal for me to get headaches, but since the vaccination I have been getting headaches more frequently and I am a lot more sensitive to the usual triggers. I have a persistent mild pain in or around my left eye that never existed before.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. Doses of (Oka/Merck) PROQUAD that were exposed to a supported temperature excursion on 05-SEP-2014 have been administered to unspecified patients on unspecified dates since 05-SEP-2014. Concomitant therapy was not reported. No adverse effect has been observed or reported. This is one of several reports from the same source. Additional information has been requested.
pt recv'd vax & exp pain in arm of inject site; site not red or swollen;
Nausea, diarrhea, fever , body aches ,pains sweats from a few hours after vaccine 24 hours, headache three days , swollen red and purple toes and feet about ten hours after vaccine for two days, shooting stabbing nerve pain in feet for 4 days.
Stated could not hear- but able to follow commands and answer questions. Pale, diaphoretic, legs tingling- 4:10 was taken to ER. Walked unassisted from w/c to vehicle: Evaluated at ER 1hr and 20 min- No meds intervention drank several bottles of water.
nurse diluted vaccine with 0.8ml of diluent, and administered to 3 individuals. Patients inadvertently received a higher dose; nurse diluted vaccine with 0.8ml of diluent, and administered to 3 individuals. Patients inadvertently received a higher dose; Tender arm; redness; This is a spontaneous report from a contactable other hcp. This nurse reported for 3 patients (1 male and 2 female). This report is for a female patient (second female):  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Feb2021, the patient experienced nurse diluted vaccine with 0.8ml of diluent, and administered to 3 individuals. patients inadvertently received a higher dose. On an unspecified date in 2021, patient experienced tender arm, redness. 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) : US-PFIZER INC-2021224135 same drug/ event, different patient;US-PFIZER INC-2021224939 same drug/ event, different patient
Seizure on 7/9/05 transported to ER, seen by neurologist, EEG done.
Shingles on his forehead; pneumonia; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). In March 2021, the patient experienced HEADACHE (Headache). On 30-Mar-2021, the patient experienced HERPES ZOSTER (Shingles on his forehead). At the time of the report, PNEUMONIA (pneumonia), HEADACHE (Headache) and HERPES ZOSTER (Shingles on his forehead) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 11Mar2021, he went to the urgent care and was diagnosed to have pneumonia for which he was given Doxycycline 100 mg for 10 days. For experiencing headache. He was prescribed with Valacyclovir.
Janssen vaccine on 3/31/21- later that day started with fatigue and myalgias- coinciding with these expected symptoms she also started with heavy menses that persisted until she came to the on-site health clinic on 4/13/21 to report a possible vaccine reaction. She reports that prior to start of most recent menses; last was 1.5 weeks prior. Has outside PCP and last had normal PAP 4 months ago per her report. She DOES have history of heavy and frequent menses (every 21 days) but states usually only heavy for first two days and subsides after 5-7 days. She reports using 4 tampons/ day 13 days from start of menses; no abdominal pain or dizziness. Last labs- 4 months ago- normal per patient. She declined further
a partial dose of Fluzone High Dose was given to patient, No AE; syringe leaked from end of syringe where needle is attached, hub area while injecting, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 65-years-old female patient who was administered with partial dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (lot UJ456AA, expiry date: 30-Jun-2022) via an intramuscular route in left deltoid for prophylactic vaccination (underdose and syringe issue) on 23-Sep-2020.  Medical history, past medical treatments, vaccinations and family history were not provided. Patient had no concomitant medications.  It was a case of vaccine underdose and syringe leak. It was reported that partial dose of Fluzone HD was given to patient, as much as half the vaccine may not have been administered because it ran out of the hub area where the needle was connected, just prior to injecting into patient's skin  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a registered nurse referring to a patient of currently 66 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt recvd immun 27JUN91 exp t103 continuing to higher during night; MD contacted instructed to give cool baths; By 29JUN91 temp normal; 1JUL91 continues fussy still doesn't feel well;
Approximately 8 hours after being injected, I broke out in an itchy rash.  The raised rash covered my abdomen, my back, and the backs of my legs. The rash persisted for about 4 hours and then subsided.
Dose administered after 30-day Use By Date; The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 12-Jan-2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-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 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 12-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 12-Jan-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 12-Jan-2023).    No concomitant medications was provided. The vial was initially stored in the refrigerator on 01-Sep-2022. BUD was reported as 01-Oct-2022. The vial did not underwent any temperature excursions. It was unknown patent received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.  Company Comment This spontaneous case concerns an 69-years-old-female patient, with no medical history reported who experienced the unexpected seriousness criterion hospitalization event of expired product administrated, the unexpected events of product storage error and no adverse event after a dose of  mRNA- 1273 bivalent vaccine. The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 12-Jan-2023 The benefit-risk relationship of mRNA-1273 bivalent  vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
After about a week my lymph node in my left collarbone was enlarged. I started to experience fatigue as well.  As time went on, my lymph nodes in my neck and head became enlarged and very tender. Fatigue lasted a week but enlarged lymph nodes that are tender are still there.