chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sweats; had lymphedema in her left arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of Hyperhidrosis (sweats), Vaccination site lymphadenopathy (had lymphedema in her left arm), Headache (headache) and Chills (chills) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      On 4 Feb 2021, the patient experienced Hyperhidrosis (sweats), Vaccination site lymphadenopathy (had lymphedema in her left arm), Headache (headache) and Chills (chills).  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (COVID 19 Vaccine Moderna) administered intramuscularly, the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Vaccine event: higher volume given. Approx 0.6 to 0.65 ml given for Janssen vaccine instead of 0.5 ml.  No adverse consequences reported.
shortness of breath; chest tightness; hives; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0198), via an unspecified route of administration in left arm on 30Jul2021 at 14:15 (at the age of 54-years-old) at dose 1, single for COVID-19 immunisation. Medical history included diabetes type 2 and asthma. She has no history of COVID prior to vaccination. Concomitant medications included metformin, dulaglutide (TRULICITY), empagliflozin (JARDIANCE), and omeprazole (PROTONIX). The patient previously took lisinopril and IMITREX and experienced allergies to both. There were no other vaccines administered in four weeks. The vaccine was administered at a pharmacy or drug store. The patient was not tested for COVID post vaccination. On 30Jul2021 at 14:45, the patient experienced shortness of breath, chest tightness, and hives which required doctor or other healthcare professional office/clinic visit and treatment with steroids, BENADRYL, and ZYRTEC. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events dyspnea, chest discomfort, urticaria and the suspect drug  BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.
Vaccine given at 3:20pm. Employee noted numbness in her left side of her face. Was referred to ER for evaluation. Employee was able to move her facial muscles. Denied pain, discomfort, dizziness, shortness of breath. Evaluated by Physician Assistant. Prescribed Benadryl 25mg. She took that once she got home. Called the next day stating that she was back to normal, no further problems with numbness.
Vaccination at 4pm 8/21. At 4:30 am 8/22 pt reports she woke up in a cold sweat, fever, headache, and was dizzy. After self-administration of Ibuprofen patient felt better but continued to suffer with malaise.
Pt receive Tdap 06-09-10. Noticed on 06-15-10 arm sore with red area. Red area 2.25cm x 2.25 cm slightly raised with knot under skin. No SOB, no other signs of anaphylaxis or serious reaction.
heart rate went up from 83 to 103; it solved on its own; This is a spontaneous report from a contactable consumer received via Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 20Jan2021, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Jan2021, 2 or 2.5 hours later, her heart rate went up from 83 to 103; it solved on its own. Her HCP told her it was okay. Second dose was scheduled four weeks after the first one and enquired whether it was recommended. She enquired about the timing of the second dose of vaccine. Follow-up received on 28Jan2021 is being submitted to notify adverse events as elevated heart rate and scheduled to receive second dose 4 weeks after first dose, instead of 3 weeks. Patient measured her heart rate with an oximeter she keeps to measure oxygen levels. Even though she does not have COVID she know that decreased oxygen levels are a sign of COVID so she keeps the oximeter around. She thinks that the heart rate elevation is a much more miniscule risk as opposed to actually getting COVID. She wanted information of whether Pfizer feels that this event is normal or serious and if there is information on getting second dose after that event. She also asked if it is ok to get the second dose 4 weeks after first dose instead of 3 weeks. She has been scheduled to receive her second dose 4 weeks after first dose. She talked to her Pharmacist, Primary Care Physician and Cardiologist about the elevated heart rate event. Outcome of the event was recovered. Lot/batch number was not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
pt recv vax 1DEC94;6DEC devel erythema, tenderness & induration @ DTAP site;7DEC MD visit, rxn 2" in diameter;rx w/ATB & warm compresses;9DEC erythema & induration resolved;area tender;MD suspects sterile abscess or hypersensitivity rxn
excursion which the Ipol needed to be discarded; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA129403 (same reporter).  This case involves a 13 years old male patient who received a IPV (VERO) [IPOL] vaccine (vial lot P1A17, Box Lot # P1A171M, and Exp. Date 24-Apr-2020) via intramuscular route in the left arm after an excursion, on 03-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation.  It was an actual medication error case due to incorrect product storage.   It was reported that MA wanted to gather stability information on ActHIB, IPOL(open), Penatcel and Tdap vaccines exposed to a temp of 46.6 degrees F for 30 mins. This Happened on 03 Apr 2019.  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 holders 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.  List of documents held by sender: none.
Patient experienced chest pain with shortness of breath 3 days after 2nd covid vaccine. He also noted "teeth hurting" during episode. Phys exam - (+) for midsternal pain. Stable VS. Chest pain/dyspnea resolved at time of 1st visit.  TRoponin 2.4 (resulted 2d later) thus went to ER for further w/u & repeat troponin on 6/9/21 Troponin 0.23 & ESR 16. Plt 555K. EKG nl except possible in III, AVF. Seen by cardiologist 6/10 -> echo normal, EKG normal (unchanged from 6/9). Myocarditis workup ordered. Holter monitor placed. Activity restrictions x 6 mos F/u cardiology 6-8 wks 6/14 - Follow up in office - normal. TRoponin <0.01
No adverse effects at the time the shot was given or after .  The 3 dose was given 4wks to soon.
I woke up around midnight to go to the bathroom and my heartbeat felt like it was coming out of my chest.  I was seeing a cardiologist as I had already another incident in March where my heart rate was 147 and it was fast all day long.  So my primary doctor sent me to the heart doctor after she had done an EKG
I had no immediate reactions. However, the next day I noticed a rash on my chest, which quickly spread to my entire body. It is small red bumps that are very itchy. I had has this rash for over a week now, and it doesn't seem to be getting any better.
Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 08-Nov-2021, the vial was initially stored in the refrigerator. It was stated that, there were 36 doses per vials and the vial did not undergo any temperature excursions.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-380380 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-380380:master case
I was given adult doses of the Pneumococcal vaccine and ZOSTAVAX in my upper left arm. They were administered in my physicians office on 10/30/24. In less than 8 hours following the vaccinations I experienced chills, shakes and fever that went as high as 101.2. The area of the Shingles immunization swelled to the size of my hand, turned bright red and was hot to the touch. Approximately 24 hours later the site of the Pneumococcal vaccine swelled, turned red and was hot to the touch however the swelling and redness were limited to an oval shaped area that was only 2 inches at its widest point. The lymph glands under my left arm swelled and were tender to the touch. By 11/9/14 all of the visible signs of the vaccination had pretty much dissipated with the exception of a slightly bruised skin color in the area of the Shingles vaccine. My doctor checked in with me multiple times during the week following the vaccines with advice to take TYLENOL to reduce the fever which lasted 4 days. I later took ALEVE for the swelling and body aches. It was also recommended that I not get the Flu vaccine for a few weeks.
Lip tingling starting a few minutes after vaccine and continuing for 45 minutes to 1 hour
COVID breakthrough case. I received my 2nd booster shot on 04/12/2022 and my COVID symptoms started on 05/15/2022 at night around 8:00PM ET. I had a lot of flamed build up. In the morning of 05/16/2022 in the morning I took a home COVID test which was negative. I had body ache, tired, mild headache, mild chills. On the 05/17/2022 I took a COVID home test again and this time it was positive. Continues of the same symptoms along with a mild cough. On 05/17/2022 at noon I called my doctor through tele health and she prescribed PAXLOID for 5 day. I started taking it in the evening my first does. All the symptoms I felt was mild. I took ibuprofen 1 time before my medication and 1 during my prescribed med. Today 05/25/2022 I will be going to a local facility to get a PCR test done.
Patient has been having focal seizures in his sleep.  We only happened to notice it on the date listed in this application because he was in our bed that night.  We have monitored him and he has been having them occasionally in his sleep up till now.
slight headache last evening (2-2-21) headache this am with low grade fever (99.5F) and mild body aches and joint pain-took Ibuprofen/tolerable
4/25/2021 went to ER with headache that was over 24 hours, CT scan showed nothing was sent home where head still persisted in total over 48 hours.  Veritgo the immediate week after was horrible. Shoulder pain at injection site persisited for 8 weeks. Random burning spots of pain began in injected right arm a couple days after, random burning pain spread to both thighs and continued in thighs and arm for 6-8 weeks after.  Periods are heavier than ever before.
Pt provided with lollipop before vaccines. Pt c/o of dizziness, blurred vision after HPV vaccine. OJ and water provided, pt placed in Trendelenburg position, cool compress to head. BP taken, 105/86, 96/58, 108/71. Pt observed for 25 min, verbalizes dizziness is gone, vision is improving. Spoke with mom 11/23, states pt felt better 11/22, arm is sore, no more c/o dizziness or blurred vision.
I had no reaction to the vaccine. In 03/2023, I was diagnosed with chronic laryngitis that lasted about 3 weeks. I saw a doctor and was advised that it was viral and treated as it was viral. I had chronic laryngitis in 12/2021 too. As of today, I am feeling better but my voice is still not the same.
After several days my knees began to hurt. They continued to worsen until i was unable to use stairs in my home and severely reduced my ability to ambulate anywhere. Pain was severe and constant and caused me to sleep very poorly and very little.
AFTER THE ADMINISTRATION, A WEEK LATER A ROUND RED RASH APPEARED, ITS BEEN OVER 1 MONTH, RASH IS STILL THERE BUT LIGHTENED
Acute onset hypertension, insomnia, palpations, cold sweats, difficulty breathing, shortness of breath, diagnosed with hypertension, Hypertrophic Cardiomyopathy and sleep apnea
This spontaneous report as received from a physician refers to a patient of unknown age. On unspecified dates in April 2013, "the last 2 to 3 weeks", unspecified number of patients was vaccinated with VAQTA, 0.5 ml, intramuscular. Lot# was unspecified. Physician called to report that his nurse was stating that the plunger rod was falling out of an unspecified number of VAQTA pediatric prefilled syringes as they pull back on the plunger to aspirate during administration of product to an unspecified number of unspecified patients the last 2 to 3 weeks, PQC filed. Physician noted that the nurses had had to use unspecified syringes (manufacturer unknown) to administer VAQTA, pediatric doses from these prefilled syringes because of the issues with the plunger rods. No adverse effect reported. Additional information has been requested.
c/o lightheadedness 10 mins p/vax; BP 124/74; HR 68+ reg VSS; BP 120/60 HR 60 & reg; pt states feeling better
31OCT93 devel chills, fever (temp not ck'd), vomiting, diarrhea, generalized weakness; seen by MD 1NOV93, was told sx due to allergies; sx lasted 1 wk;
After being vaccinated on 6/20/00, the following day (6/21/00) the pt experienced swelling around the injection site and inflammation medially towards the elbow. Complaints of itchiness also.
When I woke up on Dec 31 (the day after my shot), my face was swollen and my the area around my eyes was very swollen. I began taking Benedryl and continued to take Benedryl every 4-6 hours over approximately the next 48 hours. Also, I originally had no injection site reaction, however, on Jan 9th, my right arm began to itch. Upon assessment, I noted a 1.5" diameter red, warm area where the vaccine had been administered. This lasted for three days, and now, January 12th it no longer itches, and looks more like a bullseye that is approximately 2.5" in diameter around where the redness was. I have also noticed that since the vaccine I feel cloudy or like I have a constant mild headache.
Itchy; Hives on legs/ on back/ on scalp of head/ on butt; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and URTICARIA (Hives on legs/ on back/ on scalp of head/ on butt) 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 PRURITUS (Itchy) and URTICARIA (Hives on legs/ on back/ on scalp of head/ on butt). At the time of the report, PRURITUS (Itchy) and URTICARIA (Hives on legs/ on back/ on scalp of head/ on butt) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
CHILLS; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a male 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, route of admin not reported, batch number not reported) dose was not reported, administered on 25-MAR-2021 13:10 on left arm for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101 (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and nausea. This report was non-serious.
Fever- 101.2 at highest, chills, sweating, extreme body aches, extreme fatigue, injection site pain
Pt felt dizzy, anxious 10 min after administration of vaccines. Reported 2/10 pain in (L) arm radiating to hand. Facial pallor. BP=84/60; pulse 90. Observed pt in clinic for 15 mins. All sx resolved.
my muscles were so weak; it has been hell; I took a fall on my knee; now I can not drive; now I can not get around at all; twisted groin muscle pain; it feels sore; twisted groin muscle pain; This spontaneous case was reported by a patient and describes the occurrence of the first episode of GROIN PAIN (twisted groin muscle pain), MUSCULAR WEAKNESS (my muscles were so weak), FEELING ABNORMAL (it has been hell), JOINT INJURY (I took a fall on my knee) and IMPAIRED DRIVING ABILITY (now I can not drive) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 019M209) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced the first episode of GROIN PAIN (twisted groin muscle pain). On 30-Mar-2021, the patient experienced MUSCULAR WEAKNESS (my muscles were so weak), FEELING ABNORMAL (it has been hell), JOINT INJURY (I took a fall on my knee), IMPAIRED DRIVING ABILITY (now I can not drive), DISTURBANCE IN SOCIAL BEHAVIOUR (now I can not get around at all), the second episode of GROIN PAIN (twisted groin muscle pain) and MYALGIA (it feels sore). At the time of the report, MUSCULAR WEAKNESS (my muscles were so weak), FEELING ABNORMAL (it has been hell), JOINT INJURY (I took a fall on my knee), IMPAIRED DRIVING ABILITY (now I can not drive), DISTURBANCE IN SOCIAL BEHAVIOUR (now I can not get around at all), the last episode of GROIN PAIN (twisted groin muscle pain) and MYALGIA (it feels sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter   This case was linked to MOD-2021-230003 (Patient Link).
pt recv vax DEC96 & approx 17JUL97 pt devel a severe case of varicella consisting of greater than 500 lesions & a fever greater than 39C;pt also devel super infect cellulitis or rt cheek;pt hosp 21JUL97;
Began vomiting 1 hour after administration of vaccines as well as being lethargic. Hospitalized for dehydration.
The day after getting the booster shot, I started experiencing pins and needles and numbness in my left thumb and it has since spread daily up my entire arm, left leg from my knee down and the left side of my faced and tongue. I felt like my face was sagging last week.  My Primary care dr didn't see me since they have no list of adverse reactions.  I dont know what to do at this point.
Patient had shortness of breath, stridor, chest pain 10 minutes after 2nd COVID-19 vaccine dose. Received epi-pen, nebulized bronchodilators, steroid injection, diphenhydramine and famotidine. Patient was in ER about 7 hours for observation, improved and was discharged home with supportive care.
itching feeling all over; crawling skin; pin-poking skin; drowsy; body rash; aches; chills; 100.8 F. fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching feeling all over), FORMICATION (crawling skin), SKIN DISCOMFORT (pin-poking skin), SOMNOLENCE (drowsy) and RASH (body rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A221B and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RASH (body rash), CHILLS (chills) and PYREXIA (100.8 F. fever). 27-Mar-2021, the patient experienced MYALGIA (aches). On 01-Apr-2021, the patient experienced PRURITUS (itching feeling all over), FORMICATION (crawling skin), SKIN DISCOMFORT (pin-poking skin) and SOMNOLENCE (drowsy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. On 28-Mar-2021, MYALGIA (aches), CHILLS (chills) and PYREXIA (100.8 F. fever) had resolved. At the time of the report, PRURITUS (itching feeling all over), FORMICATION (crawling skin), SKIN DISCOMFORT (pin-poking skin) and SOMNOLENCE (drowsy) outcome was unknown and RASH (body rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Body temperature: 100.8 (High) 100.8.         No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: No new information was received.
patient commonly experiences vasovagel responses to vaccinations, could tell me it was starting  and refused EMT care. Patient was laid prone on floor with feet elevated and attended too until response passed and was able to rise without issue.
Vaccine administered after vaccine was punctured and left at room temp for over 2 hours.  Vaccine administered about 3&3/4 hours after initial puncture.