chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot to touch; Dizziness; Weakness; Sinuses are closed up; feels like she has a hangover; Head is very full; she has soreness in her waist, hips and back; she has soreness in her waist, hips and back; sinus issues; itching; palm-sized swelling at injection site; body soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up) and FEELING ABNORMAL (feels like she has a hangover) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL), METOPROLOL, TORSEMIDE, POTASSIUM CHLORIDE, BUPROPION, LEVOCETIRIZINE, FLUTICASONE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ALBUTEROL [SALBUTAMOL] and L-ARGININE [ARGININE] for an unknown indication.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up), FEELING ABNORMAL (feels like she has a hangover), HEAD DISCOMFORT (Head is very full), MUSCULOSKELETAL DISCOMFORT (she has soreness in her waist, hips and back), BACK PAIN (she has soreness in her waist, hips and back), SINUS DISORDER (sinus issues), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (palm-sized swelling at injection site) and MYALGIA (body soreness). At the time of the report, VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up), FEELING ABNORMAL (feels like she has a hangover), HEAD DISCOMFORT (Head is very full), MUSCULOSKELETAL DISCOMFORT (she has soreness in her waist, hips and back), BACK PAIN (she has soreness in her waist, hips and back), SINUS DISORDER (sinus issues), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (palm-sized swelling at injection site) and MYALGIA (body soreness) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Other relevant medication history included l-glulisine,multivitamin,eye vitamins for for macular degeneration. No treatment information was provided.   This case was linked to MOD-2021-035083 (Patient Link).
Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right arm) limiting the use of this arm and causing excruciating pain and discomfort.
Seven days following the vaccine administration awoke with 6 cm  macular papular erythematous pruritic rash at the injection site that lasted 7 days
A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information was received from a health care professional indicated that a 1.5 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.
24 hrs following the chickenpox shot on 4/29/04 child developed erythema from shoulder to elbow, very hot to touch. Mother of child contacted PHN at home on 4/30/04 in PM. RN advised giving 1/2 tsp Children Benadryl Elixir along with Motrin for shoulder 1 tsp & continue for 4-6 hours. RN contacted MOC 5/3/04 total resolved in 24 hours with Benadryl & Motrin.
07:00 PM  260 lbs BP 122/074 I was very irritable, confused, and felt violent
Red splotches to face (forehead, right cheek and right eyelid) similar to hives but barely raised.  Didn't appear to be itchy.  Started within one minute of giving PO vaccine.  No wheezing, difficulty breathing or vomiting.  Gave Benadryl and observed.  No further symptoms noted.  Discharged home with Benadryl Rx.   Held IM vaccines for today.  Mom will bring pt back for a nurse visit in 2-3 days for remainder of 6 month vaccines.
Began having chills around 3pm, then began running fever. Around 5pm fever was 102 degrees. Was nauseous and weak. Went to bed, took Advil, then Nyquil at bedtime. Next a.m., felt fatigued, but a lot better. By afternoon on day after, patient was fine. Had been given the enhanced vaccine (extra strength) for persons over 65. Previous years had taken regular dose and had no symptoms.
feeling chilled within several hours, then woozy, then marked chills, made better with acetaminophen.  Awoke at 2 am with physical shaking of hands, chills.  Sleepy most of next day.  Appetite remained okay.  Symptoms subsided by next evening (about 36 hours after vaccine was given).
On the day of - after few hours felt little bit of internal prickly sensation in the forearm area no other redness or swelling in the arm at all.  On the 2nd day after the shot (5/3/21), woke up with Severe swelling in the upper arm the shot area, redness and swelling spread up to 7" below the shot area (7+" down and 4+"wide area) and continues to exist.  Couldn't fall asleep that night until 3am of next day (no pain except for swelling sensation).  No other symptoms to report at this time.  Just reporting for research data
Unusual headache, rapid onset at about ten hours after vaccine. Muscle aches. (And expected arm soreness.)
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA002453: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
03/06/22 presents to EC ED for "lightheadedness and one episode of syncope with head injury". PMHx of "obesity, CAD, HTN, HLD, T2DM (not on insulin), COPD, asthma, history of inhalation injury, and OSA (CPAP at night)"
Information has been received from a registered nurse concerning 13 months old female with no past medical history and no known drug allergies who on 06/28/2001 was vaccinated with a dose of varicella vaccine and a dose of MMR vaccine in the same leg, two inches apart. Concomitant therapy included a dose of Comvax, a dose of diphtheria toxoid/pertussis vaccine/tetanus, a dose of poliovirus vaccine and a dose of Prevnar and the pt was given Tylenol two hours prior to being vaccinated. There were no other concurrent medications. On 06/28/2001, within five minutes of being vaccinated, the pt developed a 10-15 mm hive at both the varicella and MMR vaccine injection sites. The pt was immediately treated with Benadryl, IM and the condition was resolved within one hour. The reporter questioned whether it may have been a gelatin or allergic reaction. Additional info has been requested.
Dizziness, sweating, cold, clammy, BP 118/69 (pulse 73). Lay down, given water.
Patient:  27 September 2021: 38 y/o m patient received his first Pfizer vaccine. Pt states while sitting for 15 minutes he was having difficulty swallowing; felt like lump in his throat and that he thought his throat was tight and itchy. He states he was also feeling dizzy.  Initial vitals at 1321  bp: 137/90, rr: 18, o2: 99, pain : 0. Pt denied ER transport. Vitals at 1340 BP 134/87, RR 18, O2: 98. Pt states symptoms were getting better, no other symptoms to report.
On 4/8/07, 10 days after receiving his 15 month shots.  The child developed some redness on his left thigh near the injection site where he received his MMRV vaccination.  On 4/9/07 he developed bumpy blisters on the left side.  Mother was advised that the child should be treated as though he had chicken pox and isolated from other kids as he is contagious.
Patient received covid shot, was sitting in chair after shot, felt sudden urge to have BM, stood up and passed out. Bradycardia (Per ems reading of 58 and then 41, current in hospital 62), and Hypotension (Per ems 88/64 and then 68/42)   He was required to stay for 15 mins afterward for symptom monitoring. He then proceeded to feel ill after the vaccine, became sweaty, lightheaded, and felt gassy. He then stood up to use the restroom, and stated he felt he was going to pass out and fell to the ground, hitting his head against the ground. He denies any full LOC. Did sustain a laceration to L forehead. He denies any preceding vertigo, chest pain, or DIB.
1st dose 9Mar2023, 2nd 16Mar2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 29-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7MH39, expiry date 18-NOV-2023) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 16-MAR-2023, the patient received the 2nd dose of Boostrix (intramuscular) .5 ml. On 16-MAR-2023, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 9Mar2023, 2nd 16Mar2023). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-MAR-2023 A site manager reported that a patient received their first dose followed by a second dose only 7 days later, earlier than recommended interval, which led to shortening of vaccination schedule.  Information about the patient and vaccine was given.  The vaccine administration facility was the same as primary reporter. The call was escalated to second line. No additional clarifying statements or adverse event (AE)details were provided and no PQC. The reporter agreed to be contacted via e-mail by a second line agent.
This is a spontaneous report from contactable Other HCP (registered medical assistant). This Other HCP reported similar events for 2 patients. This is 2nd report of 2 reports. The reporter was calling on behalf of both of the physicians who administered Prevnar 13 to the 2 patients. An 80-year-old female patient received the 1st dose of PREVNAR 13 (Lot # N47827, Expiry date Nov2017, NDC number: 0005197101, UPC # 005197102) at 0.5ml single dose at and the 2nd dose of FLUVIRIN (Novartis, Lot # 1619801), both IM at Left upper quadrant of the gluteus on 20Oct2016 2:38 pm for immunization, in the doctor's office. Medical history included ongoing hypertension taking MAXZIDE, ongoing thyroid disorder taking SYNTHROID. Concomitant medication included hydrochlorothiazide, MAXZIDE 37.5/25 mg, tablet, orally, once daily ongoing for Hypertension, SYNTHROID 75 mcg, tablet, orally, once daily ongoing for thyroid PNEUMOVAX. The patient never have received one (Prevnar 13). No other vaccines were given 4 weeks prior to the day of suspected vaccine. On 22Oct2016 the patient had pretty moderate to severe reaction: she experienced greater than 10 cm redness and swelling, normal malaise and headache on 22Oct2016 all with outcome of not recovered. On an unspecified date the patient had like a depression spot in the middle where with the needle had been injected with outcome of unknown. Treatment received: Keflex, 500 mg. No AE required an emergency room or doctor visit. The patient was still experiencing redness and swelling, malaise and headache as far as 25Oct2016. In the reporter medical opinion, there a reasonable possibility this events were related to this suspect product. Sender's Comments: Linked Report(s): US-PFIZER INC-2016501596 Same reporter/drug, different patients, similar event.
pt recvd vax & devel fever; pt exp also febrile sz; taken to hosp;
Starting around 1:00 on the day of getting the vaccine, I developed a headache. It never went away. I have tried ibuprofen, over the counter, but it did not help the pain. I finally to see my doctor today, May 12, 9 days after receiving my second dose of the covid 19 vaccine. The headache has been consist since I got the shot. My doctor prescribed a steroid pact to see if that will clear up the headaches.
after getting vaccinated pt stated that he was feeling dizzy. he sat in chair later he asked for vomit bag. Later I offered him 911 , at this time he said he was getting better. He said he vomited just a little. He later left the store.
Pain in the left arm swelling of lymph nodes in both armpits, neck and Inguinal.
High fever, lethargy,severe edema and Paralization of the left side of face. Drooping of the muscles and pain in the nerves in face in particular when tired or stressed. Directly following injection of typhoid booster.
Chills; Stomach pain; Diarrhea; Aches; Heavy period; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included iron (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and citalopram hydrobromide (CELEXA); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient previously took cefuroxime axetil (CEFTIN) and experienced drug allergy. On 23Mar2021, the patient experienced chills, stomach pain, diarrhea, aches and heavy period. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, stomach pain, diarrhea, aches and heavy period was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediate pain from left arm after injection. Continuous pain in arm/shoulder since the day of the shot during the day and night. Limited mobility as it is painful to reach for items or hold any weight in left hand. Pain is still continuing. Birth information: Due date is July 30th 2020
Individual fully vaccinated with COVID19 Pfizer vaccines on 12/26/20 and 1/14/21 and tested positive for SARS-CoV-2 on 4/16/21.
Pt received bivalent booster around 1130am on 10/7/22-Pt at baseline at this time and most of day. Around 2200 hrs this evening resident developed fever first of 102, then 104 after taking Tylenol. Pt sent to ED for evaluation, diverted to one Hospital to another hospital where diagnosis with acute appendicitis. Appendix removed via surgical intervention on 10/8/22
Discovered alopecia areata on scalp behind right ear on May 1, 2021 by hairdresser, about 2" diameter.  Think must have started a couple of weeks earlier.  Since then, discovered several other smaller areas of alopecia on top back of scalp.  Scheduling visit with dermatologist after visit with PCP.   Do not think stress is involved.  Just wondering IF this might be an adverse immune system response to the vaccine.
Grand Mal sz lasting approx 30 min assoc w/temp to 103F; Occurred 3 hrs post inject; hospitalized; past hx of sx occuring post-cardiac surgery; Hx of congenital heart disease;
FELLING WARM TO TOUCH AT INJECTION SITE; INJECTION SITE SWOLLEN ARM; INJECTION SITE PAIN; REDNESS OF INJECTION SITE; This spontaneous report received from a patient concerned a 26 year old female. 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced felling warm to touch at injection site, injection site swollen arm, injection site pain, and redness of injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site swollen arm, redness of injection site, felling warm to touch at injection site and injection site pain was not reported. This report was non-serious.
Information has been received from a consumer concerning "friend of a friend" who was vaccinated with ZOSTAVAX (Merck) a long while ago. The patient developed a rash which had since gone away. The outcome of the patient's rash was not reported. This is one of several reports from the same source. Attempts to verify the existence of an identifiable patient have been unsuccessful.
1 July (35 days post immunization) developed chest pain, Troponin elevated, sent to cath lab who removed thrombus in LAD without plaque formation.  Possible that clot related to vaccine.
After vaccination, she was ok that day. The next day, she had a headache, I gave her a tylenol. Then the next day, she had a runny nose, and complained of being tired. And states that her leg was wobbly and she was having trouble walking. She also had a nose bleed. Blood work was done at ER in medical center. No bloodwork was taken. Went to doctor and had blood work done at doctor's.
Night sweats post vaccine for 4 weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of NIGHT SWEATS (Night sweats post vaccine for 4 weeks) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (Night sweats post vaccine for 4 weeks). At the time of the report, NIGHT SWEATS (Night sweats post vaccine for 4 weeks) 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 was reported. Treatment medication was not provided.
moderate headache, fever, arm pain, fatigue, body pains for last approximately 2 days and continuing
A mother reported that her 19 month old daughter received her 2nd injection of Prevnar on 5/1/01. Approx. 6 hours, post vax, the child developed a fever of 102F and 20 to 25 episodes of diarrhea. She was treated with Advil, Tylenol and Anusol (hydrocortisone). This child developed rotavirus gastroenteritis following receipt of her 1st dose of Prevnar. See HQ1046118MAY2001.
Pt completed Pfizer COVID -19 vaccines series dx with COVID 08-30-2021
Erythema Multiforme Minor occuring 8 days after administration of MMR and Chicken Pox vaccines at 12 month well child visit.  No other triggers could be identified (patient had no medication, infections, illnesses, or foods that could have caused reaction).  Required doctor's office visit.  Erythema Multiforme minor has not yet resolved in patient, but continuing treatment with Zyrtec in hopes that it will resolve soon.
Abnormally high fever 103-104, constant screaming and inconsolable crying had to take ambulance to the hospital were they said she had an adverse reaction to her 4 month immunizations so we are unsure exactly which one she reacted to so now we are going to space out her vaccines but I am very worried and concerned about another adverse reaction for her 6 month visit.
Received the first shot of the Moderna vaccine while pregnant; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the first shot of the Moderna vaccine while pregnant) and PAIN IN EXTREMITY (Sore arm) in a 35-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (4 drinks/week, Stopped on 12Aug2020) on 12-Aug-2020. Concurrent medical conditions included Penicillin allergy. 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Jul-2020 and the estimated date of delivery was 20-Apr-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the first shot of the Moderna vaccine while pregnant) and PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy. The vaginal delivery occurred in April 2021, which was reported as Full-term. For neonate 1, the birth weight was 3620 grams (7lbs 16oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Unknown. Head circumference 34. On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received the first shot of the Moderna vaccine while pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2020, Pregnancy test: positive (Positive) Positive. On 25-Nov-2020, Ultrasound scan: (normal) Anatomy Scan. On an unknown date, Ultrasound foetal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided   This case was linked to MOD-2021-201600 (Parent-Child Link).   See case MOD-2021-201600 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up appended to AER on 2-jun-2021: Patient Race ,Ethnicity, Medical history ,Allergies , LMP ,lab test, Delivery Date , and Infant details updated.