chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who was vaccinated with a third dose of GARDASIL vaccine and experienced pelvic pain. Unspecified medical attention was sought. At the time of reporting, the patient's outcome was unspecified.
1-1/1/2 HRS AFTER RECEIVING VACCINE DEVELOPED SORE THROAT. AS DAY PROGRESSED DEVELOPED NASAL AND SINUS CONGESTION, COUGH, HEADACHES, FATIGUE, LARYNGITIS. VOMITED X1 IN THE EVENING. HAD SORE THROAT FOR 48 HRS. SYMPTOMS PROGRESSED INTO THE CHEST: COUGH, CHEST TIGHTNESS, PRODUCTIVE COUGH OF YELLOW/TAN SPUTUM, FATIGUE. ON 05/07 DIAGNOSIS OF BRONCHITIS AND PLACED ON 5 DAY COURSE OF AZITHROMYCIN. ON 05/11 VENTOLIN INHALER QID PRESCRIBED FOR CONTINUOUS COUGH AND CHEST TIGHTNESS.
1FEB96 pt recv vax & 8FEB96 fever 103.2, rash, soreness in joints, irritable, glands tender, 9FEB fever 103.1, vomiting, diarrhea, very irritable, achy;10FEB high fever, rash devel on face;tenderness in joints lasted about a month
17 hours post dose, pt started with low grade fever, chill and nausea.  22 hours post dose she began vomiting and complaining of on and off stomach pain.  36 hours later on Sat June 6, she presented with severe lower right quadrant pain and we went to ER.  Diagnosis was perforated appendix requiring emergency appendectomy and treatment for 72 hours with IV Cipro and Flagyl.  She was discharged from hospital on Tues, June 7th on Cipro 500 mg BID po for 3 days.
By noon on day of shot deep pain in arm in immediate area where shot was given, no rash or redness occurred. I couldn't move arm more than 45 degree angle anyway. I had absolutely no problems with arm before shot was given.  Was on work restrictions, went thru 18 physical therapy treatment. Arm is better but not near full recovered. Arm bothers me thru the night I wake up with pain quite often. I can't reach up or back or lift anything too heavy without pain.
Large swollen lump, red, hot, tender, painful @ inject site; no abscess.
Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter contact information was added.
R arm area of induration/erythema. started 2 days after vaccine now enlarging, seen today at urgent care (9 days post vaccine) with large area of erythema/induration measuring 9 cm x 4 cm around injection site
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot#, expiration date, dose and route of administration were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Approximately 5 minutes after being given immunizations listed below pt started to cough and wheeze- was examined per RN and NP. Pt was given Abutenal Neb tx. Prior to Neb lungs were tight, bronchi and bilateral lobes and wheezing in right upper lobes. after neb tx. lungs were clear and patient was calm.
Woke up from nap /w continous &unusual crying lasting 3 hrs until arrived @ ER(800pm)this coincided /w lt leg spasms.Crying & leg spasms cont for 1 more hr.APAP given @ 100pm;300pm;730pm.ER T 100.ER described lt leg as"knot @ shot site ...
Three days after my 2nd shot, I had some cramping/ period pain at night on June 11th. Strange and out of the ordinary as I have regular periods. the next day, the 12th I began bleeding. I bled for 5 days. The blood looked different than normal mentstrual blood and I did not have any regular period pain with the bleeding.  Then I got my 'regular' period on July 1st and had it longer than usual, 7 + days. There was very heavy bleeding at the beginning and for a longer time than usual. Usually heavy bleeding lasts 1-2 days, this lasted 3-4 days.   Then I had bleeding on July 28th, just once and then none the next day. Had more bleeding and cramps on the 30th, but not like usual and then my 'normal' period came the next day, the 31st.  Period started again on August 28th.  Did not get a period in September. Period started again on October 2nd and it seemed 'normal.'
approx 14 days p/vax pt exp nausea, vomiting, swelling & a rash at the inject site. addl info requested
6.5cmX6.0cm erythematous induration on left lateral thigh, non-tender to touch slightly warm.  Treated with clindamycin.  Recheck in three days.
Extreme pain in bicep muscle muscle and tendon attaching at the elbow. Usually caused by lifting something with that arm but sometimes it flares up with no cause.  Gradually getting better but still have lots of pain 2 1/2 months after injection which is limiting the use of right arm.
This is a spontaneous report from a contactable consumer. A 18 year-old female patient of unspecified ethnicity received the first dose of TRUMENBA via an unspecified route of administration, on 23Dec2015, at a single dose. Relevant medical history and concomitant medications were not reported. About 8 hours later the vaccination, on Dec2015, the patient experienced arm very sore, and 16 hours later she had chills, she felt a lot of tingling, the brain felt tingly. On unknown date the patient was laying next to her mom and she was nauseous, she had diarrhea, the injection site was sore and fell asleep after 2 hours. The outcome of the events was unknown. Follow-up (04-FEB-2016): Follow-up attempts are completed. No further information is expected.
Approximately 10 mins post vaccination, staff was alerted by bystander that patient was not responding despite seated position in chair with eyes open. Patient noted to be cool, clammy, weak pulse (radially), dilated pupils. States felt lightheaded. BP stable in 120's systolic. EMS called. By EMS arrival (approximately 5 mins post staff notification of patient condition), color was returning to face. Patient stating felt much better. Transported to local ER and discharged after approximately 2.5 hours. Patient did report had traveled (about 5-6 hours in car) day before, had minimal liquid intake during and after travel, and did not sleep well in local hotel. Reports did eat breakfast prior to vaccination.  Spoke with patient around 1140am. Stated was returning from ER. Feeling much better. Discharged without follow up and instructed to ensure he was hydrated, ate, and slept well before 2nd dose. Also instructed  to wait 30 mins post vaccination for monitoring after covid #2.
I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasms; Headache; Tired; I had a 100.4 temperature for 2 days; This is a spontaneous report from a contactable consumer (reporting for herself). A 52-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unspecified indication. On 30Jan2021, the patient stated that "I slept all day, I could not eat, I could not get out of bed, I hurt so bad and has body aches, muscle spasms, headache, tired and I had a 100.4 temperature for 2 days." The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Nov2020. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Cellulitis; Pain; oxygen saturation decreased; Headache; Chills; Pyrexia; This case was received on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bypass surgery in July 2020. Concurrent medical conditions included Type 2 diabetes mellitus, High cholesterol and Hypertension. Concomitant products included METFORMIN, ERTUGLIFLOZIN PIDOLATE (STEGLATRO), LOSARTAN, METOPROLOL, VITAMIN D NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), PAIN (Pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia). 10-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen saturation decreased). At the time of the report, CELLULITIS (Cellulitis), PAIN (Pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved and OXYGEN SATURATION DECREASED (oxygen saturation decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Chest X-ray: clear (Inconclusive) Clear. On 10-Feb-2021, Oxygen saturation: 92% (Low) 92%. On 10-Feb-2021, Pyrexia: 102 degrees (High) 102 degrees. On 10-Feb-2021, SARS-CoV-2 test: no results (Inconclusive) no results and inconclusive (Inconclusive) Inconclusive.     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.   The patient was injected on 08-Feb-2021. He began getting headache the afternoon of the 10-Feb-2021 and developed sever night chills by 11.30 pm the night of the 10-Feb-2021, along with fever of 102 degrees, body aches and pain.  He experienced low O2 saturation at 92%. Though possibly unrelated the patient developed cellulitis at incision on left knee which was being treated with unspecified antibiotics. The patient was directed to and seen by urgent care facility. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
68 year old male who presented to clinic 11/09/15 for herpes zoster vaccine administration at 0900; patient had no history of previous drug/vaccine/food allergies or reactions in the past. Patient was administered herpes zoster vaccine (0.65mL, manufacturer Merck, SQ, left-deltoid, lot L021609, Exp. 10/Sept/2016) by RN and provided current V.I.S. in print. Approximately 1 hour post administration patient phoned clinic reporting "swelling to his lips and scratching in his throat", which appeared approximately 30 minutes after vaccine administration. Patient spoke to volunteer who referred patients call to RN, who consulted physician and had patient return to clinic immediately. Patient reported to clinic at approximately 1000 and was found to have right-sided facial swelling, right-sided mouth drooping, bilateral jaw discomfort, slight voice changes, and mild dizziness upon standing from a seated position. Patient's vitals were BP 136/71, P 63, O2 saturation 99%, and RR 18. Patient was administered dexamethasone 4mg IM and diphenhydramine 50mg PO. After 15 minutes of observations symptoms showed no worsening and patient was instructed to have a companion drive him home with instructions to report to ER or call 911 if symptoms worsened. Patient's symptoms had resolved upon follow-up on 12/08/15 at clinic.
Information has been received from a 71 year old female with hypothyroidism and chronic dry eye and a history of ulcer and no allergies who on 15-JUN-2007 was vaccinated SC with a single dose of Zostavax (Oka/Merck). Concomitant therapy included PREVACID, estrogens, PREMARIN, SYNTHROID and RESTASIS. on 18-JUN-2007 the patient experienced a bad headache and a dry mouth. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of the report the patient had not recovered. A product quality complaint was not involved. No further information is available.
At injection site my arm is red, swollen and itchy.  The swollen area is larger then 2 inches
Redness and pain and swelling and itching spreading over upper arm over hours, starting about an hour after injection, with a mild fatigue and chills for the first few hours, improving by next morning with icing and naproxen
Fatigue, headache, acute low back pain, joint pain, chills, acute nausea, acute diarrhea, vomiting, fever, bloodshot eyes, loss of appetite, and blood in urine.
1.  Right humeral shaft fracture 2.  Left shoulder dislocation - Pt was admitted for hypoxia and hypertension.  Pt hospital course was uncomplicated.  Pt continued to progress with physical therapy.  Pt pain was controlled on oral medications. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
04/07/21 @ 11pm - cold, aches in joints, chills, weakness, overall general feeling of unwellness 04/08/21 @ about 1am - extremely cold, chills, shaking, feeling very unwell, weakness, slight nausea, aches in joints (knees, hips, low back, arms, ribs) and a fever of 99.8F *took 2 Tylenol* 04/08/21 @ about 6am - second wave of extreme coldness, aches, headache, weakness, fever of 99.8 F but feeling slightly better than first wave *took 2 Tylenol* 04/08/21 @ 9 AM Continuing ache in body, ongoing slight headache, and slightly weak and cold
Difficulty breathing; Bad Nausea; General body pain- worse in stomach area; Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), NAUSEA (Bad Nausea), PAIN (General body pain- worse in stomach area) and DECREASED APPETITE (Loss of appetite) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), NAUSEA (Bad Nausea), PAIN (General body pain- worse in stomach area) and DECREASED APPETITE (Loss of appetite). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency; Tylenol at an unspecified dose and frequency and Maalox at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty breathing), NAUSEA (Bad Nausea), PAIN (General body pain- worse in stomach area) and DECREASED APPETITE (Loss of appetite) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Computerised tomogram: Negative. On 15-Feb-2021, SARS-CoV-1 test: Negative. On 15-Feb-2021, X-ray: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient went to the ER, chest XRAY, COVID 19 test and CT scan were done and they were all negative.  Patient  has taken Tums, Maalox and Extra Strength Tylenol and lots of water however, he is still having all the symptoms
Received Moderna COVID booster.  1st two doses were Pfizer.  That evening potato chips suddenly tasted like gasoline.  Made a cup of coffee which tasted like rotting garbage.  Following morning had slight headache, but house smelled like diesel exhaust.  Headache became intense (migraine) with violent projectile vomiting starting at noon and continuing for about eight hours, including dry heaves.  In the following two weeks continued to have odd olfactory and taste events as well as classic visual migraine disturbances lasting a few minutes to several hours.   Have a history of migraines typically associated with hormones, sleep deprivation, flashing lights, and a few other triggers.  Very few migraines since menopause.  Have had olfactory precursors in the past, but only two specific, rather pleasant smells.   These odors were all unpleasant, reminiscent of when I had a concussion.    This was miserable enough that I would think long and hard about a fourth shot/booster.
developed memory and behavioral issues; developed memory and behavioral issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02174538.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious), BEHAVIOUR DISORDER (non-serious), outcome "unknown" and all described as "developed memory and behavioral issues".  Additional information: Reporter reports that after her niece received the first dose of the COVID-19 vaccine she developed memory and behavioral issues. Reporter was unable to provide any additional information for this report. No additional reported. No PQC reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient received first dose of Pfizer covid-19 vaccinegiven second dose of Moderna Covid-19 vaccine today in left arm; patient received first dose of Pfizer covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received first dose of Pfizer covid-19 vaccinegiven second dose of Moderna Covid-19 vaccine today in left arm) and INTERCHANGE OF VACCINE PRODUCTS (patient received first dose of Pfizer covid-19 vaccine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received first dose of Pfizer covid-19 vaccinegiven second dose of Moderna Covid-19 vaccine today in left arm) and INTERCHANGE OF VACCINE PRODUCTS (patient received first dose of Pfizer covid-19 vaccine). At the time of the report, INCORRECT DOSE ADMINISTERED (patient received first dose of Pfizer covid-19 vaccinegiven second dose of Moderna Covid-19 vaccine today in left arm) and INTERCHANGE OF VACCINE PRODUCTS (patient received first dose of Pfizer covid-19 vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment information was provided  no concomitant medication were reported
feel like choking; I am almost dead in the kitchen, because I can't breathe; stuck my food everything; dizzy; Muscle pain; had for 2 night 3 days a lot of saliva; saliva comes from my gland; she spit saliva with in combination with mucus; felt almost dead; Water come see through saliva, I cannot sleep for 2 or 3 days; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8734 and expiration date was not reported) via unspecified route on left arm on 30Mar2021 (at the age of 57-years-old) at single dose for covid-19 immunisation. Patient did not take any concomitant medications. Patient had no medical history. No investigation assessment were done. Reportedly, patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6205 and expiration date was not reported) on 06Mar2021 (at the age of 57-years-old). Patient reported that she got very bad experiences in the first. She was almost dead in the kitchen, because she could not breathe, stuck her food everything, she go somewhere, she was choking almost she feel dead. Patient got very bad experience from the Pfizer vaccine, so the experience was, In her first vaccine one day after she was feeling like choking, breathing air, shortness of breath and choking I can't eat anything if all food I eat they go different ways. This is her first shot muscle pain, this was normal okay and this choking she could not eat food very well because the food goes different ways in my trachea, this is her first experience in her first shot. Patient reported that her second shot was terrible, she got same symptoms and she got muscle pain she got dizzy, then most hard time again she had for 2 night 3 days a lot of saliva, saliva comes from my gland. For saliva, she think you wanted to see water come see through saliva, I cannot sleep for 2 or 3 days. Patient had same thing almost choking, she had expel, expel choking in the day and when she lay down the other night. The spit saliva started Friday, she spit saliva with in combination with mucus, mucus and saliva. Patient wanted to report that, because you know what happen, all the information stated was false. They don't, they didn't stated everything. Patient wanted to report that she was in a hospital. The outcome of the events was unknown.
Became very weak, had a fever of 101.6  with chills lasting about 18 hours
WBC was 2.0; no taste; no smell; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Lot number: 30125BA) at the age of 76 years, in arm 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: EN6201), administration date: 12Feb2021, when the patient was 75-year-old, for COVID-19 immunization, reactions: "WBC was 3.4 and has been dropping since", "no taste", "no smell", "very sick", "tiredness", "anemic"; BNT162b2 (dose 1, single, Lot number: EL9262), administration date: 22Jan2021, when the patient was 75-year-old, for COVID-19 immunization, reactions: "no taste", "no smell". The following information was reported: ANOSMIA (non-serious) with onset 2021, outcome "unknown", described as "no smell"; AGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "no taste"; WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset 17Mar2022, outcome "recovered" (27Jun2022), described as "WBC was 2.0". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of white blood cell count decreased.  Additional information: On 17Mar2022 white blood cell (WBC) 2.0. On 06Apr2022 WBC 2.2. On 26Apr2022 WBC 2.06. On 08Jun2022 WBC 2.19 (13Jun2022 started prednisone 20 mg). On 27Jun2022 WBC 4.9.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300037577 same patient/vaccine, diff dose/event;
Post vax, the pt developed chest discomfort described as an elephant on my chest. The pt recovered after 4 to 6 hours. This is one of two pts who experienced this event.
Systemic rash with hives over entire body, scalp to feed with itching and pain requiring oral steroids, topical steroids and antihistamine