chrisvoncsefalvay/vaers-outcomes huggingface dataset:
buzzing on her ears; headache; chills; vaccine put her in bed; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzing on her ears), HEADACHE (headache), CHILLS (chills) and BEDRIDDEN (vaccine put her in bed) in an 86-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS716AB) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) and Pfizer (Received other vaccines in the 4 weeks prior to COVID-19 vaccine. All previous 4 doses were Pfizer.). Past adverse reactions to the above products included No adverse event with Flu shot and Pfizer.  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 01-Dec-2022, the patient experienced TINNITUS (buzzing on her ears), HEADACHE (headache), CHILLS (chills) and BEDRIDDEN (vaccine put her in bed). At the time of the report, TINNITUS (buzzing on her ears), HEADACHE (headache) and CHILLS (chills) had not resolved and BEDRIDDEN (vaccine put her in bed) had resolved.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient stated that she received the vaccine on 01-Dec-2022. She stated the vaccine put her in bed. 3 hours after receiving the vaccine she had buzzing in her ears, she also started with headache and chills. All symptoms except buzzing in her ears had stopped.  Treatment information was not provided.
She has a hx of igA nephropathy, but no hematuria in the last 7 or 8 years. The next day after getting her second vaccine she developed hematuria. This has happened to her before when she was ill but not with a vaccine that she can recall. She developed muscle aches, fatigue, headache, fever the next day which was not concerning and has resolved.
Headaches for at least 48 hours following, back pain, muscle pain, joint pain, extreme fatigue, nausea
Got shots 11/15/07 at 8:45am.  Mo. found rash on chest, legs, arms, face & back of neck.  States big red splotchy areas with white blanching & severe whelps.  No new foods.    To ER at 5am.  Pediapred given.  Temp not checked but given Tylenol before & after shots & at 4am.  Saw PCP but when he got there, the rash was completely gone.  Mo. left & returned later in day to PCP who Dx'ed child with hives.
A70yo , male with PMH of Depression, Obesity, DM, HTN, Disorder of Electrolytes, multiple Myeloma, History of Autologus Bone Marrow Transplant, CKD, primary Malignant Neoplasm of Kidney, Renal Cell Carcinoma Papillary Type Nursing note documented he received Pfizer Covid - 19 vaccine per Policy and protocol without complication first dose on February 23, 2021 and the second shot on March 16, 2021, he was reported with Pfizer Covid - 19 vaccine indicted historical ADR of Chill, Dyspnea and Fatigue by the oncology attending. The report included that the patient tested SARS Cov-2 +ve on April 23, 2021 despite being fully vaccinated earlier this year
Stored in the freezer exceeded 5F and client involvement; 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 PRODUCT STORAGE ERROR (Stored in the freezer exceeded 5F and client involvement) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) 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 PRODUCT STORAGE ERROR (Stored in the freezer exceeded 5F and client involvement). At the time of the report, PRODUCT STORAGE ERROR (Stored in the freezer exceeded 5F and client involvement) had resolved. Not Provided      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 information was not provided.   Reporter did not allow further contact
Severe diarrhea worsening to Clostridium difficile colitis (C. diff). Patient went to ER on 9/26/21 and returned to the ER on 9/29/21. Patient admitted to the hospital.
Information has been received from a website concerning a female who on an unknown date, was vaccinated with a dose of GARDASIL (lot # not reported). On an unknown date, the patient experienced "horrific pain". It was reported that the patient 's brothers witnessed "the horrific pain and suffering" after the patient received GARDASIL . At the time of the report the outcome of the patient was unknown. This is one of two reports from the same source. No further information is available.
About 11:40 am pt receives vaccine at pharmacy. Patient waits around store about 20 minutes. Leaves and comes back about 5 minutes after vaccines given with itchy, red rash on chest, neck, arms. Patient saw physician about 3:10 pm.
10x10cm circular area of significant swelling & warmth around injection site. Also pain around injection site. (Possible cellulitis vs. allergic reaction).
erythema to injection site 2 days post vaccine. warm compresses. rx for Keflex for cellulitis
Tested positive to COVID 9/6.  Cough, congestion, and low grade fever noted few days prior.
Noticeable soreness in forearms, both forearms, beginning the following morning from second injection. First noticed apart from expected muscle soreness when lifting a water bottle with opposite are that received shot was difficult and painful in the brachioradialis and surrounding area, top of forearms middle to near elbow. All other associated soreness after shot subsided within 24 to 30 hours. Muscle soreness in these muscle groups have persisted through today and continue to do so. Lifting or moving objects that use these muscles is difficult or painful, and causes fatigue rapidly. Soreness not present prior to second injection, and would have been noticeable.
my face started getting numb and my arms,legs and face feel heavy and tingly. The heaviness went away yesterday. My whole face feels numb.  The patient is a 60 year old female who presents for preventive health care. Preventive health care scheduled includes other.  Note: denies slurred speech/facial weakness. denies cp/sob/edema/rashes/anaphaltic reaction headache resolved.
Adverse effects to report after 5 minutes of observation, Pt started having shortness of breath/asthma symptoms 5 minutes after vaccine. Nurse checked pt's O2 at 93%, BP 183/159, Pulse 108. Offered Epi-Pen Pt Declined and said they had their own but only felt asthma symptoms, . Pt used albuterol inhaler. Offered to call EMS Pt declined Wife drove to ER. When we opted to call 911 but Pt declined several times and had partner take them right up the street to ER
the person who took the 1st dose of the vaccine and still tested positive; the person who took the 1st dose of the vaccine and still tested positive; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A non-contactable consumer reported that a patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. ~The patient took the 1st dose of the vaccine and still tested positive on unspecified date. They would like to know if the patient still needs to take the 2nd dose of the vaccine or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Developed Cellulitis at injection site.  grew to 2 inch round hot red welt.  Had to get Bactrim antibiotics
had covid and prescribed Paxlovid; had covid and prescribed Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had covid and prescribed Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: They stated their symptoms resolved and tested negative (using rapid test); Positive, notes: within less than a week, their covid rebounded - their mild covid symptoms returned (fever, flush) and they tested positive again (using rapid test). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Male and female Consumers (married couple) mentioned they had covid and were prescribed Paxlovid. They stated their symptoms resolved and tested negative (using rapid test), however within less than a week, their covid rebounded - their mild covid symptoms returned (fever, flush) and they tested positive again (using rapid test). It was reported that both of these people are fully vaccinated and boosted with Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax on approx 1OCT95 & 5wk post vax pt exp Bell's palsy & was hosp;sx persists;pt expects to be discharged from hosp soon;addtl info is being sought;
pt recvd measles vax on 1MAY92 & on 10MAY92 exp myalgia & low grade fever;
pain in joints and muscles over whole body, fatigue, starting 6 hours after vaccination, ending 48 hours after vaccination
Ached all over; Weak; Headache; Nauseous; Feels very tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ached all over), ASTHENIA (Weak), HEADACHE (Headache), NAUSEA (Nauseous) and FATIGUE (Feels very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills). On 04-Apr-2021, the patient experienced PAIN (Ached all over), ASTHENIA (Weak), HEADACHE (Headache), NAUSEA (Nauseous) and FATIGUE (Feels very tired). On 03-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN (Ached all over), ASTHENIA (Weak), HEADACHE (Headache), NAUSEA (Nauseous) and FATIGUE (Feels very tired) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  Treatment medication was not provided by the reporter.
As of 12:30 PM on Monday 10/4/21 I am experiencing lightheadedness and dizziness at rest and with weight bearing activity.  I've avoided the gym the last two days for this reason as I am not fit to be lifting weights or doing cardio. I thought I was okay to workout today, starting driving, and turned around to home.  I am able to sleep and eat without issue. No other known symptoms, just the feeling of being high or in other words the feeling you get when you wake up from anesthesia after having surgery and are not fully awake. Symptoms have lasted for over 24 hours and started 5 days after injection into the left deltoid. A day after the shot I felt slightly weak but nothing significant. I avoided working out the day after the shot because of the slight weakness just to be safe.  I rarely go to the MD so the next section does not really pertain to me. Unless I am dying, I will go; perhaps I am from this.
Extreme fatigue, starting about 4 hours after injection. Still suffering today. Muscle aches, started about 7 hours after injection. I think these have subsided almost completely. Nasal congestion, started about 9 hours after injection. Not sure if its related to injection, or if related to seasonal allergies. Still occurring today.
Around 0400 on 2-6-2021  (I received the vaccine at 1515 on 2-5) I had a severe headache 10 out of 10, and mild body aches 3 out of 10 on a 0-10 pain scale. I took 600mg Ibuprofen.  At 1000 am I took 400 mg of ibuprofen because I still had the headache 8 out of 10 and body aches now about a 5 out of 10.  By noon on the 6th I had chills and severe body aches 10 out of 10, around 1530 on the 6th I spiked a fever of 99.8 F.  The fever broke around 2200 on the 6th.  I took NyQuil that evening around 2200.  I woke up around 0330 on the 7th still with a headache 8 out 10 and took 400 mg ibuprofen.  Body aches continues into the 7th as well.  The morning of the 8th I had diarrhea and nausea around 0830.
Patient experienced swelling in the throat, difficultly breathing, Blood Shot Eyes.......Was taken to the ER by a neighbor and was given epinepherine and Benadryl.
patient reported a metallic taste in mouth but no other symptoms, around 9:46 (11 minutes after onset) the metallic taste was resolving
patient showed signs of allergic reaction including rash,dizziness, nausea, chills, loss of sensation, and difficulty breathing. Administered 50mg of benadryl and 1 epipen 0.3mg , was taken by EMS to local hospital for evaluation and medical treatment.
Numbness on left side of face.  Still persisting since vaccination - currently about 8 1/2 hours
Patient vaccinated at 9:29 a.m. and at 9:40 patient reported feeling facial numbness and arm numbness and swelling in left side  and was seen by medical team Patients vitals were stable but the numbness and swelling sensation begun radiating to the right side of face and tongue Patient transferred via ambulance to hospital
Shot on thursday 1 pm. pst and reaction on friday 8pm pst.  It was swollen the size of four fingers and hurt to the touch and couldn't raise my arm without pain and loss of use due to weakness.
Reported feeling lightheaded within 5 min of receiving flu shot. BP 120/80 P 82, breathing shallow, began shaking BP 130/90 P 96. 911 called. Pt reported had dental work yesterday-didn't feel well. Pt stated had not eaten in > 12 hrs. Transported to hospital ER.
pt c/o pain, swelling, redness, inability to use arm x 2wk
Joint, muscular pain. Pain was so intense could not sleep. ADVIL helped but very little. Lasted a little more than 24 hours.
7 Mar 04 mbr received annual booster for Anthrax. Aching & swelling in left upper arm. Mbr exercised (wt training) on 7 Mar 04. 0n 8 Mar 04 swelling increased extending to left wrist. No nausea/vomiting/fever. Mild numbness in left posterior forearm.
On 8/23/00, arm sore, erythematous with swelling, tingling noted in hand. No temperature elevation. Itching all over. Seen in ER and instructed to alternate hot and cold packs. Given Benadryl, ibuprofen and Tylenol #3 Rx's.
Patient was given 1ml instead of .5 ml. I have tried calling the patient x 2 and will try again tomorrow to make him aware.
Given PNEUMOVAX 7/8/16. Called on 7/11/16 reported severe arm soreness, redness, joint pain, headache and backache. Unable to get out of bed due to joint pain. Continued pain left shoulder x 4 mo.
8 days /p immun /w MMR/OPV, pt was in care of babysitter, dev a T of 102 & seizure occurred as per account of babysitter, taken to ER & MD called to ER, MD RX Amoxicillin 250 mg po tid X 10 days, Mom reports WBC count 21,000.
Sunday I had al little ache and pain. On the 21st I had to leave work with a fever 101.4 also had body ache. It progressed from there then I tested positive for Covid. I went to a clinic to get tested was given Zpac, Zythrimac, steroids' .
pt recv vax & pt stated nurse had diff getting airgun to fire;shot painful, blood immed w/arm pain;leg & head pain by bed time;joints sore;fatigue;tired, low energy, hot shivering, arm diff to raise;pain lower back & pain inj site;
68 days away from the FIRST shot and she still has not received the second shot; Sick; High Blood Pressure; Tired; Weak; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days away from the FIRST shot and she still has not received the second shot), ILLNESS (Sick), HYPERTENSION (High Blood Pressure), FATIGUE (Tired) and ASTHENIA (Weak) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced ILLNESS (Sick), HYPERTENSION (High Blood Pressure), FATIGUE (Tired) and ASTHENIA (Weak). On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days away from the FIRST shot and she still has not received the second shot). On 08-Feb-2021, ILLNESS (Sick), HYPERTENSION (High Blood Pressure), FATIGUE (Tired) and ASTHENIA (Weak) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days away from the FIRST shot and she still has not received the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   No treatment medication reported
Very sleepy; 5cm by 7cm diffuse, circular erythema at the injection site; Pain at the injection site; stuffy nose; A spontaneous report was received from a 45 year old female consumer who was participating in the mRNA-1273 Emergency Use Authorization and developed stuffy nose, injection site pain, sleepiness, and circular erythema at the injection site.   The patient's medical history, as provided by the reporter, included food allergies. Concomitant medications were not provided.   On 5 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 026L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 5 Jan 2021, approximately 1.5 hours after the injection, patient states her nose started to feel stuffy which persisted through 6 Jan 2021. On 6 Jan 2021, she experienced pain at the injection site. On 7 Jan 2021, she was very sleepy and developed a 5cm by 7cm diffuse circular erythema at the injection site. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, stuffy nose, sleepiness and injection site erythema, were considered resolved. The other event outcome, injection site pain, is unknown.; 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.
Patient stood up to walk. Fainted and fell.  This was about 5-7 minutes post-vaccine. Patient was taken to hospital by ambulance after stabilized and having vitals taken.
Patient fainted within 15 minutes of vaccination.  She regained consciousness, then fainted again.  She vomited.  She was transported to Hospital ER by ambulance.
Symptoms: sweating, dizzy, lightheaded, pale. Pt experienced these symptoms within 1-2 minutes following vaccination. EMTs took pt to hospital. Dr described event as vasovagal reaction (Pt had recently eaten).
a sore arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (a sore arm at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergies to medications, food.), Penicillin allergy and Sulfonamide allergy. Concomitant products included LISINOPRIL for Hypertension, HYDROCHLOROTHIAZIDE, METFORMIN HCL and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (a sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (a sore arm at injection site) outcome was unknown. Not provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: positive (Positive) Test-Rapid antigen.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided   This case was linked to MOD-2021-051513 (Patient Link).
NO adverse event; Expired vaccine that was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (NO adverse event) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (NO adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (NO adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (NO adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients).    Concomitant medications were not reported.  Patient age was reported as 67 years and 4 months.  NDC number was reported as 80777027399. Completion date reported as 07 Jul 2022. Reportedly, the number of patients at facility that received this Moderna vaccine between 08Apr2022 and 15Dec2022.  Treatment medications were not reported.
This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient received a dose of sterile diluent injection (strength, dose, frequency, route of administration, lot# and expiry date were not reported) when she was supposed to receive a dose of ZOSTAVAX. The nurse reported that the patient was not vaccinated with ZOSTAVAX, as she received only the sterile diluent. There were no concomitant therapies reported. No adverse symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Pt reports that 3 days after injection the site was itchy and she scratched it and a red patch developed.  Pt reports a concurrent sore throat.
Received immunizations at 2PM by 6PM that evening uncontrolled crying for 3 hrs. No fever, just crying.