chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in both feet), PERIPHERAL SWELLING (Swelling in both feet), BURNING SENSATION (Burning sensation in both legs) and CHILLS (Periodic chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 007M204) for COVID-19 vaccination. Concurrent medical conditions included Gout, High cholesterol and Arthritis. Concomitant products included PREDNISONE for Arthritis, PRAVASTATIN for Cholesterol high, ALLOPURINOL for Gout. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness in both feet), PERIPHERAL SWELLING (Swelling in both feet), BURNING SENSATION (Burning sensation in both legs) and CHILLS (Periodic chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Redness in both feet), PERIPHERAL SWELLING (Swelling in both feet), BURNING SENSATION (Burning sensation in both legs) and CHILLS (Periodic chills) outcome was unknown. Other concomitant medications included Tylenol to treat arthritis. Action taken with mRNA-1273 in response to the events were not applicable.This case was linked to MOD-2021-123813 (Patient Link).
Pt comes back into office complaining of local reaction. Redness and swelling area around the injection site. 90x90 erythema and 30x30 swelling.
Pt recv vax on 9/30/98; 5 min post vax pt exp numb tingling of LA x 15 min, bad feeling x 1 hr
Profuse sweating of the head for about 45 min. Stopped as fast as it started. I was playing cards - 3 others were aware of it.
Customer complained of right arm tingling  (not the arm receiving the vaccine) on 5/15/21.  Customer complained of a pain in chest for about one second,  took a breath and pain was resolved on 5/14/21.  Blood pressure was normal (125/70 pulse 68).
p/vax pt devel an inj site rxn characterized by swelling, redness & warmth;
Fever 101 for a few days/Fever now down to 99; armpit swelling; spine pain; pain in joints; This is a spontaneous report from a contactable consumer via a sales representative. A patient of unspecified age and gender received bnt162b2 (Pfizer-Biontech COVID-19 vaccine, Lot number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for an COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever 101 for a few days, armpit swelling, spine pain, and pain in joints. Fever now down to 99. The outcome of the events was unknown.  Information about lot and batch number was requested.
First symptom was pain at shot site.  Woke up early in morning feeling a bit nauseous and chilled but not too bad.  very tired when walking dog at 7:30 a.m. and on way to work, heart seemed to be racing.  Was concerned but not overly so.  Have had a headache all day long and a bit nauseous and chilled throughout evening.  Fairly lethargic all afternoon, and left work early. 9:30 p.m. and head still aches. Arm still quite sore. Did not have any side effects with first shot except sore arm.
DTAP administered IM right leg on 03/29/05, mom advised to bring child to office after description of inj site red area 4cm.
At injection site R buttock area swollen red, bruised  3 days after injection. Rash-macular on both forearm and torso.
I started having problems with my nose, stuff was draining at the back of my throat and I started feeling really bad. I didn't have a temperature because I kept taking my temperature. I did a lot of sleeping cause I was feeling so bad. 3 1/2 days it was over with, it was as if I had a cold. I called the Doctor came over and the second time they came they and gave me a COVID test and it came out positive. My daughter and her family tested positive for COVID. My back still hurts all the time now. My lungs and everything is clear.
Information has been received from a physician concerning a patient who was vaccinated with Zostavax .65 mL injection (Oka/Merck).  Subsequently, 48 hours after receiving on 06-DEC-2007 the vaccine the patient developed a mild case of shingles.  The patient sought unspecified medical attention.  Further information has been received regarding this 84 year old retired male who was vaccinated on 03-DEC-2007 with Zostavax (Oka/Merck) ( Lot # 658602/1080U) sc in the right arm.  The physician reported that on 06-DEC-2007 the patient developed shingles involving the left C2-3 dermatome.  Culture was positive for varicella zoster detected by immunofluorescent monoclonal antibody.  The physician did not report the outcome of the patients experience.  Additional information has been requested.
Difficulty breathing; Swelling; Rash; This is a spontaneous report received from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation; and ziprasidone hcl (GEODON), via an unspecified route of administration, from an unspecified date, at an unknown dose and frequency for an unspecified indication. Medical history included ongoing chronic arthritis. The patient had an arthritis related illness and was receiving biologic treatment. Concomitant medications included unspecified biologic treatment for chronic arthritis. On 18Apr2021, the patient received the first dose of the BNT162B2 vaccine.  On an unspecified date, after vaccination, the patient developed a rash, followed by difficult breathing and swelling. The patient was hospitalized for the adverse events. The action taken in response to the events for ziprasidone hcl was unknown and for the BNT162B2 vaccine was not applicable. The outcome of events rash, difficulty breathing and swelling was unknown.   Information about lot/batch number has been requested.
the reaction began about 45 minutes after Moderna vaccine. I began to notice tingling in my hands and feet first. My right foot felt a little stiff when picking it up from the gas to the break while driving home. I noticed shortly after I arrived home itching and tingling all over and more pronounced picking, burning, numbness in my mouth(tongue and chin), hands and feet,  No rash, no shortness of breath. I took a Benadryl hoping just a mild reaction that would clear up. Next morning my feet and hands woke me up from the tingling and cramping. Other symptoms off and on were spasms in my feet and pain in index and middle fingers when touching cold. I called my doctor on Monday morning to get in for an appointment after I was awakened with some cramping in my calves and was more concerned. Was told if it worsened or I had any SOB or weakness in extremities to go to the ER. My reflexes were checked and normal and no weakness in my muscles. No other tests done at that time. The symptoms persist with buzzing feeling in them off and on, feeling of stiffness and stabbing feeling on occasion, no more cramps in calves. It remains mostly ankles to feet but some numbness to below knees. Hands, no further than wrist, along with chin and tongue remain numb and tingling at times.
Vasovagal Syncope within 5 minutes of administering dose. (Fainted)  Caused "unwitnessed" fall where no-one was able to catch the patient before they hit the ground. Caused Urgent Care visit and barely avoided an ambulance ride.
chills, fatigue, rash. red induration at injection site, rash Narrative: took ibuprofen for AE
Very sick for 48 hours / wasn't able to work for two days; Body aches; Chills; 103 fever for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick for 48 hours / wasn't able to work for two days), PAIN (Body aches), PYREXIA (103 fever for 48 hours) and CHILLS (Chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Previously administered products included for Product used for unknown indication: Shingles (Patient had a worse reaction) in February 2021. Past adverse reactions to the above products included Adverse event with Shingles.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick for 48 hours / wasn't able to work for two days), PAIN (Body aches), PYREXIA (103 fever for 48 hours) and CHILLS (Chills). At the time of the report, ILLNESS (Very sick for 48 hours / wasn't able to work for two days), PAIN (Body aches), PYREXIA (103 fever for 48 hours) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (Inconclusive) Fever of 103F for 48 hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After receiving the 1st dose vaccine, patient had a fever of 103 F for 48 hours along with chills and body aches. Patient also reported that, he was sick for 48 hours and was not able to work for two days.  Concomitant medications were not reported.  No treatment details were provided    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up was received and it contain significant information: new event added, very sick for 48 hours and wasn't able to work for two days.
infection site pain, tiredness, headache, chills, joint pain, fever, foggy thinking, feeling unwell
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 08-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # K016966, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
At 2:34p Pt. passed out after HPV vaccine was administered.  Pt. was passed out for a few minutes and  was taken to clinic by EMT for further evaluation.
myocarditis; chest hurt; fastheart beat; blood pressure is not stable; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, after a couple of days the patient felt side effects like myocarditis, chest hurt, fast heart beat and blood pressure was not stable. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Had aches from the lower back of his head towards sinuses/sinus headache still happens on and off; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Had aches from the lower back of his head towards sinuses/sinus headache still happens on and off) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 12-Mar-2021, the patient experienced SINUS HEADACHE (Had aches from the lower back of his head towards sinuses/sinus headache still happens on and off). At the time of the report, SINUS HEADACHE (Had aches from the lower back of his head towards sinuses/sinus headache still happens on and off) had not resolved.            Concomitant medications were not reported  Patient took migraine treatment but sinus headache still happens on and off. He went to doctors and he did scan of sinuses and were clear     This case was linked to MOD-2021-201458, MOD-2021-201439 (Patient Link).
it was rpt by MD concerning pt who was vax & subsequently devel a rash. rpt felt rash was not related to therapy w/varicella
Raised rashes on wrist,  forearm, behind bilateral legs, stomach and breast. Left breast extremely enlarged and injection site warm to touch and swelling down arm and red. Sweating profusely, extremely fatigue, unable to get out of bed, no appetite, and headache
2nd Dose - Supraclavicular lymphadenopathy 1st Dose - 30 minutes after injection experienced ache across clavicle.  Lasted short time, approximately 1 hour.
Pt developed erythema, induration, and pain right upper arm at site of injection. Site of erythema is 10 X 12 cm. Injection was given on 11/5/01 and pt developed symptoms on 11/07/01. Also had a fever to 101 F. Expect complete recovery. Pt treated with antibiotics for presumed cellulitis.
Face rash and redness on Cheeks , nose and forehead. Breakout in same areas as redness.
Patient received Moderna as a 1st booster and experienced side effects; got achy for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient received Moderna as a 1st booster and experienced side effects) and PAIN (got achy for 24 hrs) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient received Moderna as a 1st booster and experienced side effects) and PAIN (got achy for 24 hrs). At the time of the report, IMMUNISATION REACTION (Patient received Moderna as a 1st booster and experienced side effects) outcome was unknown and PAIN (got achy for 24 hrs) had resolved.            Patient birth year was reported as .  No concomitant medication was reported.  Reportedly, patient had 4 shots, 2 shots and 2 boosters. Patient would be going for fifth shot when available. Patient had no side effects from Pfizer.  No treatment information was provided.
Adverse event: moderately itchy hives on and off on arms from wrists to armpits (NOT near injection site), neck, and belly, for approximately 72 hours (Benadryl taken PRN, approx 1x/day), then reoccurrence of hives/swelling/itchiness for 2 hours near injection site 1 week after the dose was administered (no meds taken.)  Also of note, increased fatigue, mild lower back ache, mild diarrhea, slight abdominal cramping noted several hours before reoccurrence of hives observed this morning, so perhaps a stress response since I was anxious about those symptoms.  Current Pregnancy: 36 weeks, 3 days. Planned c-section at 37 weeks 2 days (11/16/2021), current healthy.   Previous Pregnancies: 2019 planned c-section at 37w 3d, no complications; 2017 full term stat c-section s/p complete placental abruption with neonatal death
Pain in his body and head; Pain in his body and head; His muscles are hurting; This is a spontaneous report from a Pfizer sponsored program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. Medical history included diabetes. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's concomitant medications were not reported. since the 2nd dose he has had pain in his body and head and said it's not going away and that his muscles were hurting. The outcome of pain in his body and head was not recovered while his muscles are hurting was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
According to my daughter, the following happened: 1.  Shot was given between 1100-1115 am 2.  Proceed to wait a few minutes with doctor in room and then went to check out 3.  Between 1120-1125 am...she passed out in doctors office. 4.  Day 2-4:  tightness in muscles especially around lower legs.  Also tigtness in arms, but not as bad as legs. 5.  Hard time walking after first waking up in morning and gradually loosens up after she starts moving around. 6.  I suggested to her to take a Tylenol to help with muscle tightness and to massage calves prior to getting out of bed to help loosen them up.
Tested positive for COVID on 26Sep2023; Tested positive for COVID on 26Sep2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Sep2023 at 16:00 as dose 1, single (Lot number: HH7595) at the age of 45 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: PAMELOR; LIPITOR. Vaccination history included: Covd-19 vaccine (DOSE UNKNOWN; MANUFACTURER UNKNOWN; (more than 3 doses received)), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Sep2023, outcome "recovering" and all described as "Tested positive for COVID on 26Sep2023". The patient was vaccinated on 16Sep2023 for COVID boost. He began being symptomatic on 24Sep2023 and tested positive for COVID on 26Sep2023 with Flowflex Nasal Swab. The patient stated there likely was not enough time to build up anti-bodies before he was exposed. The patient was treated with PAXLOVID.  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Sep2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Pt recvd 3 doses of Engerix-B on 19JUL90, 23AUG90, & 11JAN91 & it was determined that pt was a non-responder; no tx given;
Slight numbness in face and arm on side where shot was given; 1st dose Moderna, 2nd dose Moderna; 1st dose Moderna, 2nd dose Moderna; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 (Lot number: FJ1620) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 037A21B, Location of injection: Arm Right), administration date: 13Apr2021, when the patient was 45 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 031A21A, Location of injection: Arm Right), administration date: 18Mar2021, when the patient was 45 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 28Nov2021, outcome "unknown" and all described as "1st dose Moderna, 2nd dose Moderna"; IMMUNISATION (non-serious) with onset 28Nov2021, outcome "unknown", described as "Booster"; HYPOAESTHESIA (non-serious) with onset 28Nov2021 11:30, outcome "unknown", described as "Slight numbness in face and arm on side where shot was given". It was unknown if therapeutic measures were taken as a result of hypoaesthesia.   Additional information: Follow-up attempts are completed.  No follow-up attempts are possible. No further information is expected.
ear pain, lip numbness, cannot close eyelid Narrative: 2nd 3/4/2021- on 3/8/21 pain right ear that for 3-4 days, next week drank Coke, it tasted different & experienced numbness of upper lip right side;as of 3/16/21 unable to close right eye lid. ER 3/17-Dx Bells Palsy.
1/8/2021 soreness/pain at the injection site, fever, muscle ache, malaise, headache. Tylenol 1000mg was taken around the clock every 6 hours. It helps with the fever and also for the headache. 1/9/2021 woke up at 4:00 am with vertigo plus the above side effects. In addition to the Tylenol, I had taken dramamine in the morning and had been taking Meclizine 25-50 mg for the dizziness/vertigo. I also had done epley maneuver to help get rid of the vertigo since I am more dizzy turning on my right side and thinks that it is positional vertigo. 1/13/2021 still dizzy and taking Meclizine because it helps for the dizziness. I don't have anymore fever, the pain at the injection site is now mild, still moderate pain for the headache, some body aches but not as much as before. I had gone to the urgent care at this point to be seen since the vertigo is still there since Saturday 1/9 and it is now Wednesday 1/13. The doctor at the urgent care told me to continue taking Meclizine, hydrate and rest for a total of one week since the onset of the vertigo.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Headache-Severe