chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; MUSCLE ACHES/ BODY ACHES; PURPLE MOUTH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and batch number: 1802068 expiry: 25-MAR-2021) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced muscle aches/ body aches. On 05-MAR-2021, the subject experienced purple mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscle aches/ body aches, and purple mouth. This report was non-serious.
Got immunizations 08/15/17 was warm and fussy 08/16/17 up until appointment. Parents did not give TYLENOL. He was not eating as well as normal. Slight cough this morning. No fever, nasal discharge; cough; vomiting; diarrhea. Decreased appetite. Rash on legs and back.
mom described lt thigh swelling w/erythema & axillary temp @ 102.0;
Anxious - after the 1st dose; Lightheaded - after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Anxious - after the 1st dose) and DIZZINESS (Lightheaded - after the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxious - after the 1st dose) and DIZZINESS (Lightheaded - after the 1st dose). At the time of the report, ANXIETY (Anxious - after the 1st dose) and DIZZINESS (Lightheaded - after the 1st dose) outcome was unknown.        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.   No concomitant medication reported. No treatment medication reported.
mild myopericarditis based on EKG, MRI, and troponin findings starting about 2-1/2 days after his 2nd dose of vaccine  presented to an ER due to chest pain, which started the workup
Pt received FLUZONE HD morning of Tues 9/13/11. About 6-7 hrs later, husband called stating pt had itchy throat & chest pressure. Advised to go to ER. Received BENADRYL IV & series of tests & went home.
Swollen lymph nodes on left armpit and left side of neck. Ibuprofen taken for discomfort. No further actions needed at this time.
About 5 pm the day of the vaccine (Friday) I was getting chills and achy.  Two days later I was so weak I couldn't even walk up the stairs. By Monday I was feeling a little better, by Tuesday the headache went away.
Patient has had pain since SHINGRIX vaccine administered 3/9/18 left deltoid, Patient has limited range of motion.
HYPOTENSION 11/4/2021 BILAT CAROTID ARTERY STENOSIS
throat tightened after 1st shot 9-5-08 and some SOB. After 2nd Hepatitis B 10/15/08 throat tightened up again was SOB, worse than first shot. Called Dr 10/23, Apt 10/24. throat remains tight and scratchy. SOB remains. Decreased UA output and swelling.
My spouse came home from work travel on 03/10/2021. He showed symptoms on 03/13, tested positive and isolated. My 8 month old daughter then exhibited symptoms the  following Saturday, 03/20. I took her to urgent care to be tested. She tested positive as well. The following Wednesday, 03/24, I had Covid testing for exposure through my employer for day 12 of my husbands case and day 5 of my daughter's. I took my 3 year old son, both of us asymptomatic at the time, for an exposure test as well. We received positive results that evening. I started to get a headache, congestion, dizziness and some minor muscle pains in my right arm. My 3 year old is still asymptomatic.
Very bloody injection site, dime size bruising and bump, seen for vertigo/dizziness 01/11/2022  felt faint, dizzy, pale skin 4:15pm at lacrosse practice-this never happened before. Reports legs felt wobbly and tingly. Vision  fuzzy Coach made her sit, trainer examined her. She remained pale so sent her down the hall to urgent care.
Red swollen silver dollar sized circle at injection area. Itchy and hot to the touch.  8 days after injection.
Heart Rate and blood pressure increased after 2nd dose within 12 hours. HR did not return to normal since 2nd vaccine.  3 months after 2nd dose, visits to doctor and emergency room for chest pain, increase heart rate and short of breath showed 2 blood clots, one in each lung (bilateral pulmonary embolism)
GARDASIL #3 given 3-14-12. Site of injection painful that day. Next day, 3-15-12, fever and various body aches. 3-16-12 and 3-17-12 no fever, but body aches. Aching would resolve after acetaminophen or ibuprofen, then return. No rash, no swelling, no nausea.
7 hours after 2nd inj developed fever 101, headache, exhaustion and severe body aches nausea. lasted 24hour, better now
Has had heavy period for 14 days after getting second pzifer covid vaccine Previously regular periods only hasting a couple days
Discomfort relating to every menstrual cycle, inability to predict hormonal spikes & drops throughout the month resulting in suicidal ideation, migraines, anxiety I am seeking hormonal contraception to help level out my hormones; I take Excedrin migraine pill or ibuprofen for pain.
Pt vaccinated w/DTP experienced screaming, stiffness off & on in route home, was limp & unresponsive, lethargic, quivered, pale & gray around mouth.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive, Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210700575.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
2 vaccines given (R) deltoid - nickel size reaction present, No antibiotics needed.
1/6/21  Moderna vaccine given  1/13/21   7 days post  administration  site became itchy, hot, red, firm, swollen. circle drawn around site demarcated increase in redness and swelling  1/16/21   12 days post administration  seen by PMD  symptoms were beginning to level off, prescribed antibiotics if no improvement over weekend. 1/18/21   14 days post administration, small lump at injection site, interm itchy, sl pinl, Did not begin antibiotics
woke w/hives all over body 18AUg, was puffy & swollen; 19AUG also reported aching swollen joints; Md initiated DPH & seldane on 18AUG;
This patient had a fever of 104 - 102 over the course of one week. Also having headache and stiff neck first 2-3 days. On day 9 diagnosed with Right otitis media.
Localized red, raised area 10 cm with hardness present.  Recommend warm packs.
1st dose  2 ½ years ago and 2nd dose 2 weeks ago; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 and half year prior to the reporting date).   On 9th May 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 9th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 23-May-2022 Reporter's comment:  The case was reported by the patient himself. The patient reported he received his second Shingrix vaccine 2 weeks prior to the reporting date on an unknown arm. The reporter did not consent to follow-up. Additional Supportive Information:  The patient received 2nd dose later than recommended schedule, which led to lengthening of vaccination schedule.
Migraine (lasted 24 hours). Severe pain in the hips and legs (lasted 12 hours). Full body skin sensitivity (a few hours). Left armpit lymph nodes swelling and painful 36 hours after injection. Nausea (lasted length of migraine). Severe fatigue and muscle weakness (24 hours).  1500mg of OTC acetaminophen taken. No doctor consultation sought.
I experienced chills, sweats. Fever of 102.3 F. and body aches. My stomach became upset, went to bathroom and passed out. Syncope around 6:00am. Spouse took me to the ER around 8:00am. EKG was clear and I was observed for about 6 hours. Ondansetron was given for nausea.
Hives on legs, back, and under left arm 3 hrs. after getting GARDASIL vaccine.
Pt received TDAP & INFLUENZA inj approx 20 min later developed trouble breathing & bad taste in mouth.
sick; This is a spontaneous report from a non-contactable other HCP reporting for a patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported.  The patient experienced was hospitalized after receiving first COVID vaccine. Physician is okay with patient getting the second COVID shot. The patient and physician had no reason to believe that this was related to the COVID shot.  No follow-up attempts are possible; information about lot number cannot be obtained.; Sender's Comments: Medical Evaluation Comment: This patient had fatigue after therapy with apixaban and COVID-19 vaccine. Considering the onset of event after starting vaccine; considered related to COVID-19 vaccine. Not related to apixaban. Pfizer comment: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported event cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Received vaccine on 2/3/23 and then on 2/6/23  in am when up for breakfast was noted to cyanotic and unresponsive, was assisted into bed and passed away.  There is no evidence that her death is related  to vaccine other than timing.
Patient's son age 7 (dob 6/5/1997) has come down with rash on chest 7 days after visiting patient.
Started with body aches and lethargy at about 1800, then progressed to temperature sensitivity-felt cold. I went to bed but awoke hot, then alternated with cold frequently. I began having twitching in my hands which kept me awake.  These symptoms continued until morning. Toward the AM, about 0500, I had fluttering sensations in my body.
Left upper arm swollen, red, warm - started approx 14 hrs after injection - lasted til visit 24 hr after injection.
Sore throat 2 days after vaccine for 2 days, headache after vaccine for 2 days for 1 day, chest pain for a few hours 4 days after vaccine, joint pain for 4 days, body aches for 5 days, blue feet and grey nails for 30 seconds 3 days after vaccine, couldn't walk for 5 days after vaccine,  a lot of weakness everyday for 5 days, bruises on both feet 4 days after vaccine for 3 days.
Information has been received from an approximately 22 year old nurse concerning a female patient who on 22-APR-2010 was vaccinated with a first 0.5 mL dose of GARDASIL. The nurse reported that on 22-APR-2010 after getting the first vaccine, the patient experienced headache. On the same date, the patient recovered from headache. Patient sought unspecified medical attention. Additional information has been requested.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. This was dose 2 for the patient. At this time the patient has not been revaccinated.
Information has been received from a healthcare professional concerning a female who on an unspecified date was vaccinated with her second dose of GARDASIL (lot number unspecified). On 29-FEB-2008 the patient was vaccinated with her third dose of GARDASIL (lot number unspecified). Subsequently after the second dose the patient felt warm and sweaty, felt faint and felt like she needed air. The nurse reported that the patient did not wait 10 minutes after receiving the dose because she had to leave. The nurse reported that the office did not hear about this event until patient came into the office on 29-Feb-2008 for her third dose. The nurse reported the patient sought unspecified medical treatment. No adverse experience was reported after receiving her third dose. Subsequently, the patient recovered. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-DEC-2018, the patient was vaccinated with improperly stored dose of VARIVAX (strength and dose were not reported) (lot # R018931 and expiry date: 02-JUL-2020), via subcutaneous for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degree Celsius (C) to -10 C (-14 C) for 27 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This report is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1812USA005671.
Chills, headache, fever (100.3 degrees), muscle cramps on left foot -  on 03/06/21 Severe skin rash (burning itching) on both posterior aspect of lower extremities - on 03/06/21
Within 15 minutes of getting vaccine I had a severe headache, nausea, and was falling asleep. I had to go home and lay down for 3 hours to feel good enough to stand up. Felt sick until the following morning. Had a red bullseye around injection site for about 15 days.
patient forgot about the second dose, so it has not yet been administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on July 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient forgot about the second dose, so it has not yet been administered).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 05-OCT-2023 The pharmacist stated that a patient received their 1st dose of Shingrix. The patient forgot about the 2nd dose, so it has not yet been administered, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
pt recv vax 18SEP97 & 29SEP97 pt devel a diffuse rash all over body;
12hrs after shot- pain at injection site, fever, body aches, headache, and shivering. 36hrs- only a mild headache persisted. No medical treatment sought.
palpitations; She has trouble breathing once in a while; she had pain in her lower back; She continues with the pain; she had pain under her armpit; She also has fatigue; was very sleepy; a sore arm; a numb arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm), HYPOAESTHESIA (a numb arm), SOMNOLENCE (was very sleepy), PALPITATIONS (palpitations) and DYSPNOEA (She has trouble breathing once in a while) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm) and HYPOAESTHESIA (a numb arm). On 19-Mar-2021, the patient experienced SOMNOLENCE (was very sleepy). On an unknown date, the patient experienced PALPITATIONS (palpitations), DYSPNOEA (She has trouble breathing once in a while), BACK PAIN (she had pain in her lower back), PAIN (She continues with the pain), AXILLARY PAIN (she had pain under her armpit) and FATIGUE (She also has fatigue). At the time of the report, PAIN IN EXTREMITY (a sore arm), HYPOAESTHESIA (a numb arm), SOMNOLENCE (was very sleepy), PALPITATIONS (palpitations), DYSPNOEA (She has trouble breathing once in a while), BACK PAIN (she had pain in her lower back), AXILLARY PAIN (she had pain under her armpit) and FATIGUE (She also has fatigue) outcome was unknown and PAIN (She continues with the pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
Vaccine administered expired on 11/25/2022 per box and vaccine administered on 12/01
Information has been received from a registered nurse refers to an unknown number of patients of unknown age and gender. On unknown dates, 30 dose of improperly stored VARIVAX (Merck) (lot number, dose and frequency were unknown) were administered to the patients. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
chest pain with radiation into arms bilaterally, shortness of breath, intermittent chest discomfort 2x days prior to hospitalization.
The following morning, I felt really nauseous after breakfast. My husband found me passed out, and he said it took awhile to rouse me. He called 911. They took my vitals and said they looked fine. I called my doctor. I had an appointment on October 3, 2022. They did an EKG. My heart rate was 47. I usually have low blood pressure and low heart rate, but it's never been that low. They also did a Basic Metabolic Panel. The results were normal. My A1C was 5.8 and has slowly been creeping up a little at a time. I have a heart monitor on right now. I see the cardiologist on the October 25, 2022.
Feels like alien in me; Can't lift arm; Arm much more sore; Migraine; Joint Pain; pain in injection site; Instantly felt the headache; Fatigue; Extreme nausea; Extreme vomiting; Fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels like alien in me), MOVEMENT DISORDER (Can't lift arm), PAIN IN EXTREMITY (Arm much more sore), MIGRAINE (Migraine) and ARTHRALGIA (Joint Pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (Feels like alien in me), MOVEMENT DISORDER (Can't lift arm), PAIN IN EXTREMITY (Arm much more sore), MIGRAINE (Migraine), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (pain in injection site), FATIGUE (Fatigue), NAUSEA (Extreme nausea), VOMITING (Extreme vomiting) and PYREXIA (Fever of 102). 14-Apr-2021, the patient experienced HEADACHE (Instantly felt the headache). At the time of the report, FEELING ABNORMAL (Feels like alien in me), MOVEMENT DISORDER (Can't lift arm), PAIN IN EXTREMITY (Arm much more sore), MIGRAINE (Migraine), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (pain in injection site), HEADACHE (Instantly felt the headache), FATIGUE (Fatigue), NAUSEA (Extreme nausea), VOMITING (Extreme vomiting) and PYREXIA (Fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 102 (High) Fever of 102.         Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-079103 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Email of patient updated.; Sender's Comments:  MODERNATX, INC.-MOD-2021-079103:first dose
3 inch swelling and pain at injection site, severe diarrhea, light-headedness/dizziness, nausea, fever, cold sweats, painful rash from top of neck down front of body to navel & under arms. Next morning, felt very weak and tired. Rash started to itch by that evening. 48 hours later rash is starting to subside with tenderness/redness at injection site. All other symptoms disappeared.
DIZZY, WEAK, NAUSEA, MUSCLE PAIN, BONE PAIN