chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia; rapid heart rate 90-105 sleeping; sitting/ Walking through my house as high as 125; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533) via an unspecified route of administration, administered in arm left on 12Apr2021 at 13:00 (at the age of 56-years-old) as dose2, single for COVID-19 immunization. Medical history included, hypertension, type 2 diabetes mellitus and hyperthyroidism. The patient had known allergies of Levaquin and Norvasc. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207) via an unspecified route of administration, administered in left arm on Mar2021 at 13:00 (at the age of 56-years-old) as dose 1, singe for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Two weeks after initial dosage on 30Mar2021, she woke up 2 am to a series of palpitations. Her blood pressure was 156/106, heart rate 60 bpm, very lightheaded and shortness of breath. Her normal average blood pressure was 125/85 sitting heart rate 80-85 bpm. She went to the emergency room. They have performed EKG and CHEST X-RAY (resulted nothing). She continued to have same symptoms for 2 weeks. After 3 more emergency room Visits and 2 more EKG's; CT Scan on Abdomen; 2 Chest X-Rays; Multiple Lab Blood work including Troponin; 2 Different Cardiologist; Bluetooth Heart Monitor; Echocardiogram even a Gastroenterolo-gist thus far no explanation for Bradycardia. After second dose of vaccine, in Apr2021, she had a rapid heart rate 90-105 sleeping: sitting. walking through her house as high as 125. She was still wearing the heart monitor to record the now Tachycardia. Covid test post vaccination on 09Apr2021, Nasal Swab COVID-19 (STANDARD NAA), resulted Negative. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Developed mildly pruritic rash of erythematous papules mostly on hands and feet. Some with central vesicles.
This spontaneous report was received from a physician via field employee regarding a 70 year old (reported as in her late 70s) female patient. The patient has rheumatoid arthritis and was immunocompetent. There was no information on drug allergies or reactions. On an unknown date in 2013 (reported as about 1 year ago), the patient was vaccinated with ZOSTAVAX vial (product lot number, expiry date, dose, frequency, route not reported). Concomitant medications were not reported. On an unknown date in October 2014 (reported as this week on an unspecified date), the patient was seen by the physician regarding what appeared to be a small breakout of shingles on the patient's left torso. The patient was complaining of pain below her shoulder blade and mid-back pain. The patient was evaluated for a kidney stone. The patient also had blood in her urine. A urine analysis and X-ray was completed on an unspecified date in October 2014. On unknown date in October 2014, the patient was diagnosed with a kidney stone (hospitalisation) as well as shingles outbreak (hospitalisation). The patient ended up in unspecified emergency room with severe case of shingles and a significant amount of pain (hospitalisation) from shingles outbreak. The physician stated that it was the worst case of shingles he had seen in his career. It was also reported that it was unknown if the patient was admitted. Patient scheduled for follow up visit with the physician on 24-OCT-2014. The outcome and causality was unknown. The patient sought medical attention by visiting the physician. There was no product quality complaint involved. Additional information has been requested.
Post vax, at 16:00, eyes watering and light cough noted by pt. Took Benadryl and symptoms were relieved some. On 11/29/00 at 08:00, had facial swelling, lips and tongue were tingling, no SOB. Took 50mg of Benadryl at home with good results. Started on Prednisone 20mg 2D X 4D and Claritin 10mg QD X 2-3 months, Pepcid 20mg QD X 8D.
cannot use my left arm where i had first shot. severe pain at all times. cannot lift arm. shoulder pain is such that i cannot tell you how disdisabling this is.
Pt reports her left arm is sore and 2 days after the immunization she has developed a circular redness around immunization site the size of a half dollar coin.
high pitch scream 3-4 hr p/vax; unable to console; reportedly appeared white almost gray p/crying ceased; no sz; temp 101; complete recovery;
On day post vax, pt developed a swollen, red, warm, firm area approximately 4 cm, right upper arm.
Pt experienced syncope. Upon recovering Pt's blood pressure was 92/62 pulse 64. Pt was out approxiamately 1-2 seconds.
Tested positive for Covid virus after both vaccines; Tested positive for Covid virus after both vaccines; Tested positive for Covid virus after both vaccines on an unspecified date in Feb2021; This is a spontaneous report from a contactable consumer (patient wife) reported for a male patient (reporter husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 1, SINGLE and dose 2 (Lot number: not reported) via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were not reported. Other products, patient history and investigation assessment was not provided. Caller states that her family caught COVID, reclarified her husband did also. The patient experienced tested positive for COVID virus after both vaccines and inappropriate schedule of vaccine administered on an unspecified date in 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date in 2021. The outcome of the events were unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
upon reviewing the patients immunization history it was noticed that she received prevnar dose at age 64 which is prior to indicated age of  65 .
Persistent ringing in ears. I checked with my primary care and ENT, and I don't any hearing loss or ear damage.
Mom reports child went ot sleepover after appt with CPNP on 8-10-07. When pt was picked up next am, child was vomiting, had oral temp 101.4, chills, lethargy, muscle aches and pains, headache, was seen at medical center, lab work done, dx'd as reaction to "shot", sx's improved in 24 hr except lethargy which continued to 8/15/07.
Case number PHEH2011US03474 is an initial spontaneous report received from a consumer on 01 Sep 2011: This report refers to a 16-year-old male patient. He was vaccinated with MENVEO (batch number: unknown) intramuscularly on an unknown date. After vaccination, he experienced seizure. No further information was available at the time of this report.
Patient developed a fever. It got up to 101 F. She went to doctor and tested positive for Covid. Hospitalized.
Cold chills, body aches, headache, arm soreness and severe itching at injection site
03/18/2021 starting getting a headache and noticed he was getting swelling on the side of face and near his eye -shingles. Went to Urgent care. Visual observation and prescribed medication for shingles. Swelling on the side of face and near his eye.Took a few weeks to get better. Was referred to eye specialist due to the shingles impacting area around the eye. Eye specialist prescribed eye drops and some omit to put on eye for swelling since eye was swollen shut.
Patient was okay immediately following the vaccine, but after standing up and trying to leave he got very hot and sweaty and light headed. He sat down for a period of time and was supplied with an ice pack and cold water and everything subsided.
8  days after vaccination I awoke to a large red lump on my arm at the vaccination site.  It was hard and swollen and looked like a rash.  It was painful to move (the same as it was the day after the shot).  The next morning the swelling had gone down and the red was fading.  It is almost completely back to normal as of 1/13/21.
Rash on chest.  Treatment : Triamcinolone Acetonide Shingles  on back of neck/.  Treatment Valacyclovir and  Methylprednisolone mg
Same day- 4 hours later had breathing difficulty, hives, swelling on hand, severe pain in lower abdomen. My brain felt very strange out of sorts. 1 week later on 10/16, I had to go to ER because I had difficulty breathing all week.
I had a breakthrough case of COVID in the first week of November 2021. The symptoms I had were basically like a bad cold. No fever and no loss of taste and smell but I did have fatigue and congestion. My O2 is reading in mid 80's I contacted my doctor and they did a PCR test. He immediately prescribed Monoclonal Antibodies Infusion a few days after my positive result. It did make a difference and I took OTL Mucinex and Antihistamine Generic Claritin D.  It took a couple of weeks for symptoms to subside. I didn't take my Booster until February because I did Monoclonal Antibodies. My O2 is still reading in the mid 80's. I will contact my PCP or take another COVID Test.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Low grade fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Low grade fever). At the time of the report, CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided.   No treatment information was provided.
Chest feels like it is a vise and can't catch breath,  pulse ox below 90 but ekg is normal slightly sinius rhythm
A territory representative reported that an 8 month old female received Prevnar and Acel-Imune vaccines on 8/29/00. On 9/2/00, she developed a generalized rash. She was treated with oral diphenhydramine and recovered.
Client had hives on body the day after the nasal mist, 10-15-09. On 10-18-09 c/o swollen eyes and swollen lip. Went to urgent care that day and received IV meds and Benadryl by mouth every 6 hours - also oral.  10/26/09 PCP medical records received service dates 10/16/09. Assessment: Hives probably allergic reaction to H1N1 mist vaccine. Woke up with itching, later hives.
she wasn't sleeping well/awake multiple times.; her hands were especially horrible; her temperature was fluctuating; sweated; fever; fatigue; muscle pain; joint pain; mild case of COVID.; headache; chills; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in the left arm on 04Mar2021 09:30 (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation.  The patient had received the first dose of vaccine on 11Feb2021 at the upper left arm. Medical history included ongoing arthritis (She says she has had this condition for probably 15 years maybe, it's not rheumatoid, it's the other kind, she forgets what to call it), ongoing urinary tract infection (She says she had some bleeding with one of them, they thought it was a tumor but it was just a good old urinary tract infection. She says she used to get it when she worked, for about 20 years even, she hasn't had many, she rarely gets them), ongoing glucose tolerance impaired , ongoing atrial fibrillation , ongoing weight abnormal , ongoing thyroid hormones decreased , cold-stimulus headache from an unknown date and unknown if ongoing , sleep apnoea syndrome from 2006 and ongoing , blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medications included metformin hcl taken for glucose tolerance impaired, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; olmesartan taken for hypertension, start and stop date were not reported; levothyroxine taken for thyroid hormones decreased, start and stop date were not reported. The patient experienced headache on 11Apr2021 with outcome of recovered, chills on 11Apr2021 with outcome of recovered, fever on 12Apr2021 with outcome of recovered, fatigue on 11Apr2021 with outcome of recovered, muscle pain on 11Apr2021 with outcome of recovered, joint pain on 11Apr2021 with outcome of recovered, sweated on 14Apr2021 with outcome of recovered, she wasn't sleeping well/awake multiple times on an unspecified date with outcome of unknown, her hands were especially horrible on an unspecified date with outcome of unknown, her temperature was fluctuating on an unspecified date with outcome of unknown. The patient suspected covid-19, but there is no positive antigen test to confirm COVID-19. The patient underwent lab tests and procedures which included blood test: negative on 15Apr2021, body temperature: 99 on 11Apr2021, body temperature: 101 on 14Apr2021, urine analysis: negative on 15Apr2021.
COLD; HOT OVERNIGHT; REALLY TIRED; ARM SORENESS; BACKACHES; UPPER BODY ACHING SHOULDER; PARTIAL DOSE; MEDICATION ERROR; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight was 150 pounds, and height was 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, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced backaches. On 07-APR-2021, the subject experienced upper body aching shoulder. On 07-APR-2021, the subject experienced partial dose. On 07-APR-2021, the subject experienced medication error. On 07-APR-2021 16:00, the subject experienced arm soreness. On 07-APR-2021 18:00, the subject experienced really tired. On 07-APR-2021 21:30, the subject experienced cold. On 07-APR-2021 21:30, the subject experienced hot overnight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from backaches, arm soreness, cold, hot overnight, and upper body aching shoulder on 08-APR-2021, had not recovered from really tired, and the outcome of partial dose and medication error was not reported. This report was non-serious.
Flu shot administered 10/21/13 a little before 8 am. By 10am - having chills and sweats, diarrhea. Fever by 5 pm these symptoms lasted until 10/23/13. Now as of 10/28/13 still congestion. Feeling sluggish, (1st time ever getting flu shot).
administered an expired Fluzone qiv pfs (expired on 30-Jun-2023) with no reported adverse event; Initial information was received on10-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was administered influenza quadrival a-b vaccine [Fluzone Quadrivalent] (expired on 30-jun-2023) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Nov-2023, the patient received a dose of 0.5 ml of suspect Influenza Quadrival A-B Vaccine (lot number: UT7716MA and Expiry date:30-Jun-2023)(Unknown Formulation and strength) via intramuscular route in in the right arm for immunization.   On 09-Nov-2023 the patient was administered an expired influenza quadrival a-b vaccine (expired on 30-jun-2023) with no reported adverse event (expired product administered) (Latency: same day).  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.
Moderna  COVID-19 Vaccine EUA. Severe dizziness and passing out.  Vomiting, chills, nausea. Came on fast.
chills and sore calves starting midnight; chills and sore calves starting midnight; headache morning of 17- Dec-2021; Felt warm; dose number = 3; This is a spontaneous report from a contactable reporter (consumer or non-HCP).   A 17-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Dec2021 at 10:00 (Lot number: FL3197) at the age of 17 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE Lot number: EP6955 Route of administration: unspecified), administration date: 12Apr2021, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE Lot number: DP6955 Route of administration: unspecified), administration date: 22Mar2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 10:00, outcome "unknown", described as "dose number = 3"; FEELING HOT (non-serious) with onset 16Dec2021 at 22:00, outcome "recovered" (an unknown date in Dec2021), described as "Felt warm"; CHILLS (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 17Dec2021 at 00:00, outcome "recovered" (17Dec2021), and all described as "chills and sore calves starting midnight"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (17Dec2021), described as "headache morning of 17-Dec-2021". Therapeutic measures were not taken as a result of feeling hot, chills, pain in extremity and headache.   Additional Information: On 16Dec2021 at midnight, the patient experienced chills and sore calves and on 17Dec2021 at morning, the patient experienced headache.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Doesn't think she got the full dose either time/underdosed/only received 5cm of the Moderna Covid-19 vaccine each dose; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Doesn't think she got the full dose either time/underdosed/only received 5cm of the Moderna Covid-19 vaccine each dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced UNDERDOSE (Doesn't think she got the full dose either time/underdosed/only received 5cm of the Moderna Covid-19 vaccine each dose). At the time of the report, UNDERDOSE (Doesn't think she got the full dose either time/underdosed/only received 5cm of the Moderna Covid-19 vaccine each dose) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Patient stated that she only received 5cm of the Moderna COVID-19 vaccine for each dose. Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-090494 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-Jun-2021 contain significant information.
eustachian tube dysfunction; pain after the injections; This spontaneous case was reported by a consumer and describes the occurrence of EUSTACHIAN TUBE DYSFUNCTION (eustachian tube dysfunction) and INJECTION SITE PAIN (pain after the injections) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (two years ago) in 2019.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced EUSTACHIAN TUBE DYSFUNCTION (eustachian tube dysfunction) and INJECTION SITE PAIN (pain after the injections). At the time of the report, EUSTACHIAN TUBE DYSFUNCTION (eustachian tube dysfunction) and INJECTION SITE PAIN (pain after the injections) 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 treatment medications were provided. Concomitant medications included medications for the heart condition since two years following heart attack.   This case was linked to MOD-2021-382440, MOD-2021-382441 (Patient Link).
Initial misuse report received from a healthcare professional on 27 January 2014. The cases were received on 21 March 2014. A patient had received a dose of Tetanus Toxoid, manufacturer unknown on an unspecified date. It was reported that the patient receivd vaccine which had expired on January 3. No adverse events were reported. List of documents held by sender: none.