chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; body ache; felt so cold; Shaking; A spontaneous report was received from a Healthcare Professional Dear concerning a 72 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, very strong chills, shaking, body ache, and felt so cold.  The patient's medical history was not provided. Concomitant medications reported were Humaira Once a week (last injection Monday 01 Feb 2021), Atorvastatin: 20 mg Once daily in the morning, Lisinopril HCTZ 20-12.5 mg Once daily, Amlodipine: 5 mg Once daily, Baby aspirin for drug use for unknown indication.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events, very strong chills. shaking, body ache, and felt so cold.  Treatment details included Tylenol Extra Strength Rapid Release gel 500 mg: 2 tablet in the morning at 9 am.  Action taken with mRNA-1273 in response to the events, very strong chills, shaking, body ache, felt so cold was not reported.   On 4 Feb 2021 the outcome of events, very strong chills was resolved and shaking was resolved. On an unknown date the outcome of events include body ache and felt so cold was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Extreme fatigue, achiness, in . some arm discomfort, bed for 5 days, pain in back, neck, no appetite, weakness - still not feeling well after 2 weeks - pain in back , neck and shoulders
I went to get my first dose of the Pfizer shoot, and  during the first 15 minuter felt minor swelling in my throat but nothing alarming. I then left the facility and 30 min later I felt strange tingling sensations in my face, and after that a numbness spread across my left side of  the  body. Through my arm, shoulder, neck, face and down  my leg. I experienced soreness in my left calf. Even my touge was divided in two sides. Numbness was slight but feeling sense are different on  each side. This has now persisted for 48 hours, and I have a slight fever. I experienced occasional pressure in my head  and muscle twitches in my left calf.
hard time breathing; Rash all over body; This is a spontaneous report from a contactable pharmacist.  A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), intramuscular at arm left on 24Jan2021 at 13:30 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 24Jan2021 at 13:30, the patient experienced rash all over body and hard time breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL and EPIPEN. The patient outcome of the events was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea and rash cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.
12/21/21 presents to triage for "decreased fetal mvoement since this afternoon. Patient scheduled for induction tomorrow morning". PMHx of "asthma, left breast mass"
Pt received vaccine in AM at approximately 0845. Then, she returned to clinic at 1515 on the same day reporting pruritic hives (one on her left arm- lateral surface, 2nd on the superior area of her L shoulder, and 3rd on the top of her R shoulder. Lesions are erythematous, edematous, and not open or draining. The lesions are the size of dime or a nickel. Pt denies dyspnea and denies SOB. No facial or oropharyngeal edema.
developed Granuloma Annulare all over even had to have some biopsied, only topical steroids stop severe itching
Patient with 3 COVID vaccinations who admitted with positive COVID PCR.  Provider d/c summary below:  "93 YO female with hx of depression, weaker when urinary tract infection, thyroid disease CHF, vascular dementia to the hospital with confusion and generalized weakness. Per daughter patient is weak and confused.  Suspecting acute metabolic encephalopathy and generalized weakness related to acute COVID infection. Patient denies any respiratory distress, no indication for remdesivir and steroids at this time.  Patient has failure to thrive, recommended for SNF."
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. Patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L013190, expiration date: 16-NOV-2016, (Strength and dose were unknown by the reporter), orally. Patients' concomitant medication was not reported. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
disseminated erythematous rash 10 days after vaccines; 19-jun-95-no response to request for additional information.
more than 11 months after first shot & not received 2nd shot; Pregnant after first vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 11 months after first shot & not received 2nd shot) and MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after first vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after first vaccine). On 05-Jan-2022, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 11 months after first shot & not received 2nd shot). In 2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after first vaccine) had resolved. On 05-Jan-2022, PRODUCT DOSE OMISSION ISSUE (more than 11 months after first shot & not received 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment Medication Were Reported.   Reporter did not allow further contact
chills; couldn't stand; disoriented; wobbly/he had to hold on to sink to keep from falling; skin was acting crazy all over body; sweating horribly; heart beat was racing; felt unwell; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 09Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included surgeries (38 surgeries in his lifetime), arthritis and pain. Concomitant medication included temazepam (MANUFACTUTERE UNKNOWN, 15mg Capsule) and diphenhydramine hydrochloride/naproxen sodium (ALEVE PM, 220mg); both to help him sleep. The patient stated he received his first dose of the Pfizer COVID Vaccine yesterday (09Feb2021) at 4 pm and felt perfectly fine afterwards. The patient stated at night before bed he usually takes a prescribed sleeping pill called Temazepam capsule 15 mg, Aleve PM 220 mg and a couple drinks. The patient stated he has had 38 surgeries in his lifetime, and he has a lot of arthritis and pain, so he takes those medications and drinks every night to help him sleep. The patient stated he took his nightly routine of medicines at 7:30 pm last night and went to bed at 10 pm and he felt fine when he went to bed. The patient woke up at 1:50 am and he was disoriented and very wobbly, was going to the bathroom and he had chills and he couldn't stand to urinate. The patient skin was acting crazy all over body. While he was washing hands, he had to hold on to sink to keep from falling. The patient made his way back to the bed he put one hand to right and one hand to left and his pillow was wet and down below was wet and stated he was sweating horribly and did not want to lay down on the bed so he laid on the floor. The patient heartbeat was racing, and he just felt unwell. He laid on the floor from 2-4 am because his phone was not near, and he could not get to the phone until after 4 am. The patient stated at 4 am he got up and felt much better and he was able to tale his temperature and it was 97.8°F. The patient started feeling back normal and he has been feeling well ever since. The patient thought he did something wrong by taking his night medications and alcohol after receiving the vaccine and this caused him to have a reaction. The patient just wanted to report his adverse reaction. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Pt did not have an adverse reaction. The patient received the vaccine in her Left Gluteus.
On the 6th day following my 2nd booster shot (Pfizer), I was visiting my sister and came down with 32 red spots on my chest & both arms.  Two days later I went to facility.  They did not know what caused it, and prescribed Mometasone Furoate, a topical steroid cream to provide relief from the itching.   Frustrated by not knowing what could have caused the spots, I researched an found an article in Journals. The article contained two photos of Urticaria which closely resembled the spots (or hives) which appeared on my chest and arms.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. VARIVAX: On 14-MAR-2016, the patient was vaccinated an improperly stored dose of VARIVAX (Merck) (lot number L035124, expiration (exp) 14-SEP-2017), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in VARIVAX (Merck) immunization series were improperly stored in a temperature of -5.9 degrees C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-201. The vaccines involved included VARIVAX (Merck) private stock: Lot # L035124 exp 14-SEP-2017 and VARIVAX (Merck) VFC stock: Lot # L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Miscommunication b/w prescriber, patient, and/or pharmacy regarding the vaccine that was intended to be administered
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 02-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Jul-2020 and the estimated date of delivery was 03-May-2021. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2020, Glucose tolerance test:. On 28-Aug-2020, Pregnancy test: positive (Positive) Positive. In February 2021, Glucose tolerance test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml; This is a spontaneous report from a contactable healthcare professional.   A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 26-years-old) as a  0.5 ml single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reaction data (updated event to overdose), treatment (NO), and outcome (UNKNOWN).
SM presented to the Troop Medical Clinic on 7/7/07 with c/o smallpox rash to his neck and upper torso. Red lesions present to neck with pruritis, smallpox site + for blister with exudate and very small white head papular lesion around adhesive. Orders given for Claritin and Motrin at time of visit.
Paxlovid beginning on day 4 of positive test (for full 5 days).  Benzonatate for cough for 14+ days.
Started having cold symptoms of congestion and a sore throat; Tested positive for COVID-19 with a home and a PCR test;  Also started having chest tightness and a racing heart, called doctor and was told that if it got worse to go to an emergency room; I started feeling worse, so I went to the ER because the Cardiac symptoms; At ER got an EKG, Chest X-ray and complete blood testing; Didn't find any abnormalities; also had an Influenza vaccine one month after COVID-19 vaccine.
This case was reported by a consumer and described the occurrence of allergic reaction in a adult female patent who received FLULAVAL. On 24th December 2013, the patient FLULAVAL. On 24th December 2013, an unknown time after receiving FLULAVAL, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FLULAVAL. The caller was asking for a 2013 PI so her allergist could see what the ingredients were.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16-Apr-2022) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16-Apr-2022) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided. The patient did not had COVID positive test or diagnosis ever.
thrombocytopenia; I started to feel pain on the inner part of my left arm; A red circle formed and it swelled; A red circle formed and it swelled; I have a lump that feels hard to the touch; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient, non-pregnant received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FF2589), via an unspecified route of administration, administered in left arm on 11Sep2021 15:00 (at the age of 62-years-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included arthritis rheumatoid, fibromyalgia, type 2 diabetes, sick cell trait, and Sjogren's. Concomitant medications included duloxetine hydrochloride (DULOXETINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin; and previously received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced thrombocytopenia on 17Sep2021 17:00. The patient also started to feel pain on the inner part of her left arm, a red circle formed and it swelled and she had a lump that felt hard to the touch, all on 17Sep2021 17:00. Events resulted in Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Therapeutic measures were taken as a result of all events except for the lump that felt hard to the touch. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events were not recovered. The clinical course was reported as follows: Six days later, the patient started to feel pain on the inner part of her left arm (very close to the elbow). A red circle formed, and it swelled. She called her doctor and her doctor told her that it could be a thrombocytopenia. Her doctor recommended to kept her arm up and put ice on it. The pain continued very strong. She went yesterday (reported as 21-Sept) to the emergency room. She was given an antibiotic and anti-inflammatory by intravenous (IV). She was not at home taking clindamycin and ketorolac. Although the inflammation has reduced a little, she continued with the pain and she had a lump that felt hard to the touch. She had no other symptoms.
PATIENT TESTED POSITIVE FOR COVID TODAY AFTER RECIEVING BOTH DOSES OF COVID VACCINE
Pt. fainted after standing and walking after vaccine administration. Pt. observed for 1 hour after administration. Client reported hx of anxiety with vaccination prior to administration.  Response to incident:  Pt. did not hit head ad reported to RN next to pt. Ammonia wipe woven by pt. nose. Pt. responsive, eyes in focus, VS 1:09PM: BP 144/90, HR 68, RR 16. 1:10PM: BP 127/91, HR 62. Damp, cool paper towel applied to pt. forehead. Pt. complained of dry mouth. 1:11PM VS: 140/92, HR: 73, RR 17. At 1:12 PM pt. sat up with nurses assisting and drank sips of water. Pt. had improved orientation and focus. Pt. denied dizziness, nausea, chest pain. BP decreased: 85/68, HR 76. Pt. reported hx of low BP. Encouraged pt. to drink water. BP increased: 146/91. 2 nurse assist to stand pt. and move to chair. 1:18PM BP: 160/94, HR 72, denied dizziness. Stayed with pt. to continue to monitor. 1:25PM: BP: 112/84, HR 70. Pt. consumed 16oz of water. 1:37PM, BP: 128/80, HR 68. Pt. states she feels better and wished to go home to eat. 1:40PM when asked, pt. refused EMS/further care and stated she wanted to stay home. Requested pt. stay until 2:00pm to continue to monitor. Last sitting BP: 103/89, HR 64, RR 17 & standing BP: 138/80, HR 76. Pt. was sent home in wheelchair from facility, event point of contact, wheeled her home to apt at approx. 2:00pm.  Followed up with pt. on 11/5/21 1 day after incident. Pt. reported vaccine side effects of headache, neck pain, chills. Encoruaged to hydrate and Tylenol if needed.  Recommended PCP/medical follow up about incident/if side effects continued past expected time period.
Mild rash and mild swelling and itch  in location of injection site appearing 8 days after receiving injection and continuing as of the date of this report. Note; no initial rash appeared before this date including the day of injection.
sore arm from 1st covid vaccine 2 weeks ago but improved.; This is a spontaneous report from a contactable other healthcare professional. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm from 1st covid vaccine 2 weeks ago in Jan2021 but improved. The outcome of the event was recovered in Jan2021.  Information on the lot/batch number has been requested.
My symptoms started on May 09, 2022. I was coughing and had a runny nose. On Tuesday, May 10, 2022, I went to a clinic. They tested for COVID-19. The result was positive. I quarantined for five days. The symptoms stayed mild. I was still active.
day of vax pt exp painful scratchy throat, severe cough, laryngitis, low grade fever 100.2-(nl for pt 97), severe cold-sneezing & running nose & chills;saw MD said pt had flu
About 2 hrs after administration localized rash noticed over both legs. Pruritus all over body.
pt recv vax 22JUL95 & 12MAY97 pt exp a mild fever;also devel spots & three on chest;14MAY97 pt devel more spots including on scalp;spot were red, raised, bumpy;pt scratching like crazy;chickenpox;scattered papules & scabs;viral or impetigo;
Sore to touch at injection site and mobility difficulty injection arm, both starting around 2 AM after the injection was received. Soreness level and mobility difficulty has persisted through 4 PM next day. Very light chills, body aches, and fever started around 3 PM, day after injection (around 23 hours later).
Muscle and joint pain. The worst headache I've ever had made me feel nauseous.
4/7/21.Swelling in head, eyes (both), and stye in eye on  Sudden onset. Dr visit 4/8/21Continued swelling - Dr visit 4/9/21 Jaw pain, continued face swelling.   4/14/21 Throat swelling (lymph nodes) - Dr. visit 12/06/21 Continued lymph node swelling in throat and occassional loss of voice, sore throat