chrisvoncsefalvay/vaers-outcomes huggingface dataset:
His whole arm is tingling; arm is tingling and is numb.; This is a spontaneous report from a sponsored program. A contactable male consumer (patient) reported that:  A male patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 07Apr2021, for Covid-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 05May2021, outcome "unknown", described as "His whole arm is tingling"; HYPOAESTHESIA (non-serious) with onset 05May2021, outcome "unknown", described as "arm is tingling and is numb.".  Additional information: patient had his vaccine about 2 hours ago, my second dosage. About 10 minutes after patient had tiny tingling down my injection arm down to his elbow and then actually after he let the pharmacist know just make sure if this is a reported thing or something. he left as they told me it was, you know normal. After that it spreads to my full arm to knuckles of his hand like patches, numbness and tingling and little bit on my other arm. he wanted to know if this was normal or if I need medical attention."   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients received unknown number of doses of GARDASIL 9 lot# M028323 with expiry date: 26-SEP-2018, lot# M023169 with expiry date of 13-JUN-2018 and lot# M009378 with expiry date of 23-APR-2018 following temperature excursions to -1 C for 30 minutes and 9C for 13 minutes, for prophylaxis (dosing details were not reported). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported in any patients. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 YEARS); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age (17 years), and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient of inappropriate age (17 years) and off label use was not reported. This report was non-serious.
Information has been received concerning a pt who in approximately January of 1999 was vaccinated with varicella vaccine. Subsequently, the pt developed chickenpox four different times. With each outbreak she had been exposed to wild type virus and the lesions did not scab. the lesions did come to a head and resolved within a couple of days. The pt sought unspecified medical attention.
Approximately 3 months after my booster shot (Dose 4), I contracted COVID-19 and had the following symptoms: Sinus Infection, Lingering Cough, Headache, Sore Throat, Low Grade Fever. I called my doctor after I tested positive. She told me to take Zinc, Advil, Vitamin C, and Vitamin D for recovery and was prescribed with Paxlovid. As of today 05/10/2022, I will be taking my last dose of Paxlovid and I'm starting to feel better except for the headache that's still lingering.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, 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 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    No concomitant medications were reported. Patient was over 18 years of age. Staff gave patients vaccines past the use date of 18 Jun 2023. On 28-Jun-2023, 5 doses were administered at administration site 2. Treatment medications were not reported.  This case is for 41st patient out of 47 patients reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live significant follow up received: Vaccine administration date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case
Similar episode our daughter had after her 2 month well visit and shots. Report #136105 - Screaming due to pain, 105 fever, lethargic for the following day.
Immediately after vaccine patient felt dizzy and felt like vomiting. She had nausea for a day after too.  He arm was in excruciating pain form day one through day 5. Advil did not take the pain away completely and she said that she felt like she had nerve damage, it hurt so much. Day 8 she had very bad pain in her stomach, gas that could not be released. This pain caused her to miss 3 days of school and on day 16 she still has the gas and loose bowels. The pain is not as severe, but still very uncomfortable. She also developed an itchy rash on her torso somewhere around day 8. She is also complaining of bad back pain on the spine, slightly below middle back.
Arm hurt, tiny bit sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt, tiny bit sore) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt, tiny bit sore). At the time of the report, PAIN IN EXTREMITY (Arm hurt, tiny bit sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that On an unknown date, patient had received regular flu shot two weeks ago.  No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-369269 (Patient Link).
The month after my second dose of the covid vaccine I skipped my period which has never happened before in my life.   I got my period the following month which was heavier and longer. The next month it was heavier and longer than the previous month until the end of March 2022 I got my period and it lasted a month and a half. I had never in my life had my period more than 5 days and it was always regular. Never late or early. My period finally stopped the end of June and I skipped my period again for the month of July and now in august my period came on august 1st and ended after 12 days of heavy bleeding.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 17-aug-21) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) 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.   Concomitant product was not provided by the reporter  Treatment information was not provided   This case was linked to MOD-2021-305779 (Patient Link).
Following the third dose of Lymerix, the patient experienced nausea, was "ill at ease" and "turning green",  and was anxious. An emergency room visit was required. As of 05/14/2001, the outcome was unknown.
Nurse states vaccine leaked from patient's left arm during ID administration; patient did not receive a full dose.  Same nurse repeated ID dose on the same arm (left arm) successfully. No patient complications noted.
Sore arm; Legs were so sore; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Legs were so sore) and HEADACHE (Headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Legs were so sore) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Legs were so sore) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-032136 (Patient Link).
Body aches; Joint Pain; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (Lot number: EJ1685), via intramuscular, in arm left, on 21Dec2020 15:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included HTN(Hypertension). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. Known allergies included PCN. No other vaccines were received within 4 weeks prior to the COVID vaccine. The other medication that the patient received within 2 weeks of vaccination was HCTZ, alprazolam(XANAX), paracetamol(TYLENOL), colecalciferol(VITAMIN D), Ibuprofen, naproxen sodium(ALEVE). The patient experienced body aches, joint pain, low grade fever on 22Dec2020 09:00 AM. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovering.
I had severe migraine.; yesterday, vomiting every 10 mins and non stop; I felt like someone has taken a bat to hit my head; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (I had severe migraine.), VOMITING (yesterday, vomiting every 10 mins and non stop), HEADACHE (I felt like someone has taken a bat to hit my head), PYREXIA (fever) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0457321A and 039AZIA OR 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 04-May-2021, the patient experienced MIGRAINE (I had severe migraine.), VOMITING (yesterday, vomiting every 10 mins and non stop) and HEADACHE (I felt like someone has taken a bat to hit my head). At the time of the report, MIGRAINE (I had severe migraine.), VOMITING (yesterday, vomiting every 10 mins and non stop), HEADACHE (I felt like someone has taken a bat to hit my head), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-106518 (Patient Link).
PATIENT PRESENTED TO STORE FOR A COVID-19 IMZ 9/3/2021. REGISTRY QUERY DOESN'T SHOW ANY IMMUNIZATIONS ON FILE. PATIENT DID NOT REPORT ANY PRIOR COVID IMZ. MODERNA WAS GIVEN. 10/1/2021, PATIENT PRESENTED TO STORE FOR A REPEAT DOSE. UPON CHECKING IMZ REGISTRY, THE RPH WAS ABLE TO SEE THE PATIENT GOT A DOSE OF PFIZER ON 5/5/2021. THE DOSE FROM OTHER PHARMACY DID NOT SHOW UP. WHEN SHE ASKED THE PATIENT ABOUT IT SHE SAID SHE REMEMBERED GETTING A VACCINE AT HER FORMER WORKPLACE BUT DIDN'T REMEMBER WHAT IT WAS. HOWEVER, PATIENT PRESENTED A COVID VACCINE CARD FROM A STORE. PATIENT DIDN'T HAVE A COVID CARD FROM HER WORK.  SO IT ENDED UP THAT PATIENT RECEIVED PFIZER 1ST DOSE IN MAY, AND MODERNA 2ND DOSE IN SEPTEMBER. PATIENT WAS TOLD SHE COULD NOT RECEIVE A 3RD VACCINE AT THIS TIME.
Systemic: Nausea-Mild, Additional Details: Patient claim she felt nauseous after the vaccine. She and her husband believe that it may have been attributed to anxiety of the vaccine instead of the vaccine itself. We gave her a water and she went to the bathroom. She and her family had to go. She said she felt a little better and I told her to call us later and see how she is doing. .
Visual aura, predominately in right eye,  1.5 hours after receiving vaccine.  Resolved in 10 minutes,  with no lasting effects.  I did have a headache for 2 hours prior to receiving vaccine,  but never in my life experienced an aura.
Dermatitis; This is a spontaneous report received from a contactable consumer reporting for herself. A 48-year-old female patient received 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number # EN5318 via an unspecified route of administration, administered in Arm Left on 29Jan2021 12:30 at the age of 48 years as SINGLE DOSE for covid-19 immunisation. Vaccine administered facility type: Skill nursing facility(clinic). The patient medical history and concomitant medications were not reported. The patient experienced dermatitis on 29Jan2021 16:00 with outcome of recovered on unspecified date. Seriousness criteria: Important medical event. Therapeutic measures were taken as a result of the event.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 69 year old white, Not Hispanic or Latino male. 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: 1805022, and expiry: 25-MAY-2021) dose was 0.5 ml, one total administered on 09-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that physician had tested patient 4-6 weeks after receiving the vaccine and tested for immunity levels. Patient received vaccine on 9-MAR-2021. On 26-APR-2021 Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative (no antibodies present, no immunity, and no protection against COVID). The range goes from less than 1 to greater than 20, noting that less than 1 was negative for antibodies. On an unspecified date, the patient had confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179999 The suspected product quality complaint has been confirmed to be the suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Based on the PQC evaluation/investigation performed.  This case, from the same reporter is linked to 20210534629, 20210535317 and 20210536071.  Additional information was received from a consumer on 19-MAY-2021 and from on 20-MAY-2021.; Sender's Comments: V0:20210536064-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
dizziness and stated "feeling heart palpitations or PVC's" . stated she had a history of PVC's before and had an ablation in 2012.
headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (patient is reported to be a heart patient).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: real low blood pressure in morning, but it had stabilized. On 05-Feb-2021, Heart rate: rapid heart beat of around 122ppm, then it was at around 98ppm.     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.   Concomitant products included heart medication and sinus infection medication. Treatment information was not provided.
DEVELOPED HIVES ON BACK, THAT THEN WENT DOWN THE RIGHT ARM. ARM GOT VERY HOT TO THE TOUCH AND INJECTION SITE GOT HARD. LAST A FEW HOURS AND THEN HIVES WENT AWAY. NO MEDICINE WAS TAKEN TO HELP RESOLVE.
mar. 11 - covid-19 vaccine 1st dose, pfizer, slightly sore arm for 2 days mar. 15 - left shoulder is sore, feels like arthritis, or maybe the vaccination mar. 23 - left shoulder still stiff first thing in the morning, bothering me once I get going for the day mar. 28 - left shoulder still sore upon movement into certain positions april 16 - MAYBE left shoulder is getting a little better april 22, 5 pm - covid-19 vax #2 at pharmacy, in right arm april 25 - left shoulder is worse, frequent pain, still good range of motion - no pain when at rest but MANY positions and movements cause INTENSE pain, sometimes hard to find a good position in bed for sleep.
Patient developed subjective itching and airway tightness after vaccination.  On physical exam, no airway edema noted or visible rash observed.  Patient was transferred to urgent department for observation given history of allergy to influenza vaccine.
Blurry vision  Sensitivity to light Fatigue  Nausea  Itchy arm and legs
Bad headache, fever, muscle spasms in hands, dark vision, shaking, not hungry, hips are sore.
Significant swelling and warmth of left arm from elbow up.  Treated with Prednisone.
Information was received from a health care professional on 30 October 2009 and 02 November 2009 which consisted of a cluster of 14 identified patients who experienced adverse events after receiving H1N1. This case represents one patient out of the cluster of 14 identified patients. A male patient (age and date of birth not reported) with a medical history of asthma and GERD (gastroesophageal reflux disease)had received an injection of H1N1 (route and site of administration not reported), lot number UP006AA on 30 October 2009 and one hour later, he experienced a sore throat and cough. Recovery status was reported as unknown. No additional information was provided at the time of the report. The reporter for this case is the same as for case numbers 2009-04661, -04662, -04663, -04664, -04665, -04666, -04667, -04668, -04669, -04670, -04671, -04672 and -04673. Documents held by sender: None.
This case was reported by a consumer and described the occurrence of allergic reaction in a 35-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to erythromycin, penicilline allergy and sulfa allergy. The subject had sensitivity to formaldehyde. Historic vaccination included hepatitis A or B vaccine; manufacturer unspecified given at last 10 years ago. On 14 April 2014 at 01:00-01:30 pm, the subject received unspecified dose of TWINRIX adult (left arm; unknown route and lot number not provided). On 14 April 2013, about 3 hours after vaccination with TWINRIX adult, the subject experienced an allergic reaction that started with her ears burning, getting red and hurting. About 15 minutes after her ear symptoms, her lips and tongue started to go number. The subject consulted an allergist about the reaction, and she was currently undergoing testing for Galactosealpha-1,3-galactose, or alpha-gal, allergy. The subject was treated with BENADRYL and this helped her symptoms. At the time of reporting the events were resolved. This case was identified as duplicate of A1073512A. Case A1073512A was voided and all the future correspondence will be added in the present case which stands as case of record for this subject.
Left arm swollen, red and hot to the touch.  This started on 08/22/19 and has progressed slightly since parent first noticed it.  Parent treated child with Benadryl.
Pt recvd vax 3JUL95 & 23JUL95 pt devel a generalized macular papular rash;No further details were provided;
Patient received her vaccination around 730 am on her left deltoid. Patient approached the observer around 735 am about concern of dizziness. Patient also states that she has cancer. Patient was then escorted to the bed stretcher. Patient vital signs were taken in which her BP was 181/91, O2 sat 79%, HR: 104. Patient was also noted to be anxious and states that she does not take any oxygen at home. Patient was encouraged to relax and lay down comfortably on the bed stretcher. Patient was cold upon touch. There was an attempt to warm the patient but the patient was still cold upon touch. Vital signs were taken again in which her BP was 179/84, O2 sat fluctuating between 80-90's. The decision was then made to take the patient to the emergency department.