chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nasal allergy/nasal rhinitis/She has had rhinitis since she was 3 years old, and she had these symptoms with the first dose; Coughing a little bit/if she drinks water she starts coughing; Her throat feels irritated from time to time/it's slightly irritated; Throat feels irritated from time to time, it's not very sore; This spontaneous case was reported by a consumer and describes the occurrence of RHINITIS ALLERGIC (Nasal allergy/nasal rhinitis/She has had rhinitis since she was 3 years old, and she had these symptoms with the first dose), COUGH (Coughing a little bit/if she drinks water she starts coughing), THROAT IRRITATION (Her throat feels irritated from time to time/it's slightly irritated) and OROPHARYNGEAL PAIN (Throat feels irritated from time to time, it's not very sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. Concurrent medical conditions included Rhinitis (has had rhinitis since she was 3 years old) and Nasal allergy. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINITIS ALLERGIC (Nasal allergy/nasal rhinitis/She has had rhinitis since she was 3 years old, and she had these symptoms with the first dose), COUGH (Coughing a little bit/if she drinks water she starts coughing), THROAT IRRITATION (Her throat feels irritated from time to time/it's slightly irritated) and OROPHARYNGEAL PAIN (Throat feels irritated from time to time, it's not very sore). At the time of the report, RHINITIS ALLERGIC (Nasal allergy/nasal rhinitis/She has had rhinitis since she was 3 years old, and she had these symptoms with the first dose), COUGH (Coughing a little bit/if she drinks water she starts coughing), THROAT IRRITATION (Her throat feels irritated from time to time/it's slightly irritated) and OROPHARYNGEAL PAIN (Throat feels irritated from time to time, it's not very sore) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication list was not provided. Treatment information was not provided. This case was linked to MOD-2021-385974 (Patient Link).
Excessive high pitched crying, hives, throwing up, unusual body jolts and unusual body movements in pain, redness of skin all over body, eyes rolling up, not sleeping ...
Narrative: Someone called Primary Care clinic on 2/10/21 to report that pt had COVID immunization on Monday 2/8/21. She reports he woke up on  the 9th . very confused and unable to perform his eye care that he normally does independently . He became very agitated . He has no redness / edema/ or soreness in arm where he received the vaccine . She states he also could not tell her his last  4. He is better today (2/10/21) .
After almost a week of persistent symptoms from the vaccine, I went to a local health clinic. Thw health care professional who treated me said the vaccine made my body believe that it had COVID. I was diagnosed with severe tinnitus from severely irritated eardrums, irritated throat and nose, ear pain, Estachian tube disfunction, and headaches.  Recommended treatment was Afrin nasal spray, prescription-strength Sudafed, and Zyrtec.   I have never had any prior ear problems in my life.
3/17/2023 coughing all night, 18th sore throat and felt unwell, 19th Didn?t feel well, chills, 20th Felt awful, strong sinus headache and deep cough productive.  Doctor Proscribed Betamethasone, Rocephin, and a Z-Pak.  Medrol Pack, and Doxycycline on 3/24, Albuterol inhaler.    Rapid COVID-19 test, positive at doctor?s office.  Developed Dyspnea as well.  Symptoms lasted an additional 2 weeks from there gradually improving with cough lingering especially at night at the time of reporting.
Pt reported severe/extreme pain at injection site in both arms; no redness/swelling, increased BP; "pain all over body."
Person developed swollen right thumb probably 4 hours after vaccination. At this moment, 17 hours passed and still experiencing some pain due to swollen right thumb. As of now, I don't think this is a serious issue
Patient's mother reports that patient has a small red spot at site of which flu vaccine was administered on the rt arm. Area is not hot or tender. Area 1 inch in diameter.
Patient received first dose of MODERNA vaccine.  While in the immunization observation area, he fainted. I gave him water and observed him for a moment and he was starting to feel better within 5 minutes. I offered him an ice pack for his neck to cool off and he did not feel like he needed it.
The patients shoulder area is very swollen and somewhat painful, she states. She says it hurts to try to raise her arm over her head. The vaccine was placed in a normal position on the shoulder and pt has never had this reaction to any vaccine previously. Pt has not seen a doctor or any other medical professional for this event at this point, other than returning to the pharmacy.
16NOV95 pt recvd vax & devel sore arm;Saturday went into neck & back & kidney area;arm very sore;now arm & back still sore;took Excedrin helped a little
pt recv vax 2DEC98 & mom noticed reddened area w/in 1inch of immun;24hr later 4cm area of induration 11x5.5cm erythema;all off to lt lower side of original inj site;seen in office 3DEC98;
Information has been received from a pharmacist concerning a patient who was vaccinated with two doses of PNEUMOVAX 23 (Lot # not provided) within a year. The patient was admitted in hospital for unspecified reason and was administered with PNEUMOVAX 23 and experienced cellulitis at the injection site. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
does not feel good; hives on her neck that itched; This is a spontaneous report from a contactable consumer or other non hcp.  A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Feb2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated right after she had the shot she had just a couple hives on her neck that itched but they went right away. She stated she took a Benadryl the night before so she thinks this is why it went away. She did not feel good for probably two weeks. The outcome of the event hives on her neck that itched was recovered and the outcome of the other event was unknown.    Follow-up attempts are needed. Information on the lot/batch number has been requested.
Fever of 103.1 for two days ,body aches, loss off appetite. Missed work. Arm sore for 1 week.
I did not have an adverse reaction to the vaccine. Two weeks later on the morning of 10/17, the muscles in my left arm tightened up to the point I couldn't move. I saw my doctor and I was given a prescription for high dose oral steroids for 2 weeks. After the steroids, I can move it a little, but it is very sensitive. I continue to have problems, but I am able to move it.
lethargic; soreness, Pain; redness; swelling; warm to touch; still having red border at injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PAIN (soreness, Pain), ERYTHEMA (redness), SWELLING (swelling) and VACCINATION SITE WARMTH (warm to touch) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN (soreness, Pain), ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (still having red border at injection site) and HEADACHE (headache). On 11-Mar-2021, the patient experienced LETHARGY (lethargic). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic) and HEADACHE (headache) had not resolved and PAIN (soreness, Pain), ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE ERYTHEMA (still having red border at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.
Arm red, swollen, itching from injection site to shoulder (elbow to shoulder). Pt has headache. Knot in arm.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 5-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 07-FEB-2014 at 11:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). Parent of the patient was going to discuss with physician and declined to repeat dose. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Immediately when I received the vaccine I felt a burning sensation in two nerves, one on base of skull and one on top of skull. Subsided after one day. But came back a week later. Pain was also behind my ear and lymph node. My husband that is a doctor prescribed me VALTREX and prednisone, 5 days. Around a month later I felt burning in my left breast, severe enough that all clothing was sensitive. This lasted about 2 months.
Pt reports redness @ left deltoid that spreads about 3 inches around the site. Pt notes a lump underneath the injection as well.  The erythema has spread. Pt does not note a red streak extending down her arm. Afebrile. Very prutitic for the last 2- 3 days.
Tenderness at injection site and itching on upper arm appearing about 7 days after vaccine.
Second dose of the Hepatitis A series given was the adult vaccine and not the pediatric vaccine. No adverse reactions or events.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, POOR QUALITY PRODUCT ADMINISTERED (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as received from a pharmacist refers to a 67 year old male patient. On 21-JUL-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 intramuscular, right arm, 0.5 ml, lot # H021941 and expiration date 11-JUL-2014. No adverse effects reported. Additional information is not expected because the pharmacist refused additional contact.
Lethargy, fussiness, spaced out, would not put her left foot down and could not walk. 102.1 fever. Screaming over and over her leg hurt until after she was given Tylenol and then again after 4 hours from the dose of Tylenol.
This case was reported by a consumer via call center representative and described the occurrence of unwell in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The reporter stated that the patient received a dose of SHINGRIX and became ill soon after.
Information has been received from a registered nurse concerning a female patient who in 2003 was vaccinated with a dose of PNEUMOVAX and had no reaction. On an unspecified date, the patient was vaccinated with another dose of PNEUMOVAX. It was reported by the registered nurse that the patient had an injection site reaction after PNEUMOVAX was given. The patient had a "softball size red swollen area and had fever". At the time of the report, the patient was recovered on an unspecified date. Follow up information has been received from a registered nurse on 27-JAN-2009. It was reported that on 11-SEP-2008, the 82 year old female patient was vaccinated intramuscularly with a second dose of PNEUMOVAX into the left arm (Lot # 660685/0619X) at 11:16. The patient called back to office to stating that on 12-SEP-2008 had swelling at injection site (left arm), very warm to touch. The patient stated that the area was the size of a softball. The patient felt feverish and had flu-like symptoms. On 15-SEP-2008, the patient had recovered. This is one of several cases from the same source. Additional information is not expected.
Swollen arm/pit/lymph node, rash on ankles, diarrhea
broke out w/chickenpox 10/2 p/fever w/h/a approx 30-35 spots;
Patient came in to pharmacy to receive immunizations. She was with her mother and was requesting Tdap, flu shot, and GARDASIL. Patient had no prior history of adverse reactions to vaccines. The pharmacist administered the flu shot and Tdap in one arm with no issues. She then proceeded to administer the GARDASIL in the other arm. A few minutes later patient began seizing and lost consciousness for several minutes. We called 911, the EMT arrived, and she was taken to the ER.
Redness, pain, and warmth of the skin near the injection site. Began 2 days after vaccination.  On the 3rd day post-vaccination, rash had grown to approximately 4" x 5".  Has not yet resolved.
This spontaneous report was received from a pharmacist and refers to a 72-year-old female patient of unknown race. The patient's concurrent conditions, medical history, and concomitant medications were not reported. The patient had not had any reaction to any previous vaccination. The patient had not illness at the time of vaccination. On 23-OCT-2017, the patient was vaccinated at a pharmacy with an expired dose of ZOSTAVAX (lot number: M033335, expiration date: 11-OCT-2017; the dose was not provided) on sterile diluent (DILUENT MRK) (lot number: M046372, expiration date: 08-JUL-2019) applied on the left arm subcutaneously for prophylaxis. The patient had normal inoculation and no adverse reaction was reported. There was no temperature excursion regarding the digital data logger.  No other vaccine was administrated within the 4 weeks prior to the vaccination with ZOSTAVAX. The patient's physician was notified.
Pt developed redness, swelling and a "bullseye" effect surrounding injection site. She also had an ache. This lasted from 6/26/01-7/80/01.
Daptacel that expired on Sep 18 was administered to a patient, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who was inadvertently vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (frequency once) lot C5254AA, expiry date: 18-Sep-2019 via intramuscular route in the left arm on 20-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
I have a horr ble metallic taste in my mouth, it's truly awful.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (I have a horr ble metallic taste in my mouth, it's truly awful.) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Patient had no known allergy.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced DYSGEUSIA (I have a horr ble metallic taste in my mouth, it's truly awful.). At the time of the report, DYSGEUSIA (I have a horr ble metallic taste in my mouth, it's truly awful.) had not resolved.            No concomitant medication were reported. No treatment information were provided. Device Date is 07-May-2022
Client reported feeling like she was in a "dream-like state" that began approximately 45 minutes following her vaccine. Client also described feeling "peaceful and calm" but was unable to move her arms or legs. Client reported symptoms resolving on their own after a few hours. Client did not seek medical treatment for these symptoms.
Limited information available. Patient had an office appointment and allergies were updated to include the Moderna COVID mRNA vaccine with a reported reaction as angioedema.
Initial report received on 27 December 2010 from an investigator participating in a trial. A 13-month-old male subject with an ongoing medical condition of constipation developed croup four days after receiving a first dose injection (route and site not reported) of either, INFLUEZA VIRUS VACC QUAD A & B or INFLUENZA VIRUS VACC NO PRESERV. TRIVAL A&B SV-U ALT-B or FLUZONE No Preservative 2010-2011 on 22 December 2010. Lot number was not reported. On 26 December 2010, four days after receiving the vaccine, the investigator received a call from the subject's mother who stated that the subject was being admitted to the hospital the same day for croup. At the time of the report, the event remained ongoing and the subject continued in the study. According to the investigator, the event was considered to be related to the study vaccine. The investigator planned to request medical records for review and more information. Documents held by sender: None.
Gave MMR, IPV, DPT 11:30, 12:30 mom called ears red, face, hands swelling. Brought back gave Benadryl. Seen by doctor. Instructions & released. Whole body was red & swelling.
Patient reports initial soreness at the site of injection, then today noticed a large amount of localized inflammation, says it "looks infected".
Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse.   A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021  at single dose via an unspecified route of administration in right deltoid  for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially.  At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
About 90 min post vaccine employee called stating she was feeling light headed, dizzy, flushed, feeling faint and had blurry vision. Employee went to the ED for evaluation. She received a normal saline bolus of 1000 mL. Vitals upon arrival were WNL and did not change. CT of head done for complaints of Headache. Discharged at 13:43 completely asymptomatic.