chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spoke with patient regarding symptoms. Per patient symptoms presented on 8/1/22. Patient states had a raised bump, itchiness, and tenderness at the injection site. Patient states contacted primary physician on 8/3/2022 to make primary care physician aware of symptoms. Per patient primary care physician stated symptoms were normal after receiving the Jynneos Vaccine and would take about 3 weeks to heal. Patient states no longer has itching and tenderness. Patient currently states only has raised bump at injection site. Patient encourage to follow up with primary care physician regarding any other symptoms. Patient verbalized understanding.
FEVER 101F; RUNNY NOSE, THICK DISCHARGE FROM NOSE; SORE THROAT; COUGH; This spontaneous report received from a patient concerned a 39 year old female. 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: 211D21A, and expiry: 10-JUL-2022) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2022, the patient experienced runny nose, thick discharge from nose, sore throat, and cough. On 21-MAR-2022, the patient experienced fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F, and COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from runny nose, thick discharge from nose, sore throat, cough, and fever 101f. This report was non-serious.
I received the vaccine around 12:15 pm and this reaction started around 9 pm that evening. I felt soreness and significant warmth 2 cm above the injection site. I felt a raised lump, the size of a quarter. It was very tender to touch. The actual injection site was not painful. This lasted for about 1 week, until complete resolution.
Information has been received from a registered nurse concerning a 22 month old black female who on 07/24/99 was vaccinated with the first dose of varicella virus vaccine live in the left arm (lot 630407/0292J).  Concomitant vaccinations included measles mumps rubella vaccine (Lot# 630407/0292J) and oral poliovirus vaccine.  On 04/05/00, the patient developed small bumps on shoulder, back and legs. No further information is available.
This medically confirmed spontaneous report (initial receipt 03-OCT-2014) concerns a 40-year-old female patient. On 17-SEP-2014 at 10:00 AM, the patient received AFLURIA injection (batch number: 10249211A) at 0.5 ml annually via intramuscular route. On 17-SEP-201, one hour after vaccination, the patient experienced a wheal at injection site with redness and itching. The patient had not sought treatment. The symptoms resolved next morning. The outcome was reported as recovered on 18-SEP-2014.
Had jab and had it again/suspected vaccination failure; had it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had multiple times before age fifty).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had jab and had it again/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 29-MAR-2023 The case was received from the patient  interactive digital media. The patient had the jab and had it again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Headache, achy, itching over entire body. Took Benadryl.
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009O21A) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Body temperature: 101 (High) 101 F.     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. Treatment medication was not reported.
Patient said rash start showed up two days after the shot then progressed to the whole body after one week.
4/25/2022 I had a scratchy throat, very congested, coughing and felt miserable. I did not have a fever. I was very tired and fatigued. I could feel the cough going into my chest which caused me to be seen. I had a positive Home COVID test. I went to the pharmacy and tested positive. They called in a prescription of the Pfizer covid pill.  I took that for 5 days, and I feel fine now, but still positive for COVID.
My arm hurt,  swelled- up, and was very sore. I continued to experience pain in my left arm which spread to my shoulder. Making lifting my left arm virtually IMPOSSIBLE.  The site of the shot became hot to the touch and swelled. This continued through the present day. I did call the covid hot line and was referred to physical therapy which helped some, however it is an on going problem. It has spread more to my shoulder, since I have additional health issues namely fatigue and neurological problems it is difficult to seek help for my arm and shoulder.
Pain in the arm; A spontaneous report was received from a consumer concerning a 39-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain in the arm.   The patient's medical history, as provided by the reporter, included fibroids. Concomitant product use was not reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.    On 05 Jan 2021, after vaccine administration, the patient experienced pain in the arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, pain in the arm, was unknown.; Reporter's Comments: This case concerns a 39-year-old, female, with medical history of fibroids, who experienced non-serious expected event of injection site pain. The events occurred 1 days after mRNA-1273 (Lot# 011J20A). Treatment details were not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Itchy, fine, red, rash that eventually turned into hives. Fine rash began minutes after vaccine given. Rash turned into hives approx. 8 hrs. after inj. Rash only on frontal trunk-greatest amount on abdomen.
Patient was given PENTACEL and a separate DTAP vaccine (INFANRIX) with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Physician via Medical Information (Reference number- 00613527) and transmitted to Sanofi on 24-May-2021.  This case involves a 6 months old male patient who received a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ390AAA and expiration date: 12-Oct-2021) via intramuscular route in the right thigh and a separate dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX] (lot number and expiry date were not reported) via unknown route at an unknown administration site (extra dose administered) for prophylactic vaccination on 24-May-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Immunisation.  The reporter asked for what to look out for and if the patient will be ok. They also questioned on the duplicate DTAP dose and what they need to do and what to expect.  It was an actual medication error case due to extra dose administered (latency: same day).  At the time of reporting, the patient experienced no adverse event.   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 the 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.
Raised bumps on arm; Red, swelling on neck and throat; Burning and itchy feeling; dizziness; Swelling on neck and throat; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Raised bumps on arm), ERYTHEMA (Red, swelling on neck and throat), PRURITUS (Burning and itchy feeling), DIZZINESS (dizziness) and SWELLING (Swelling on neck and throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-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 PERIPHERAL SWELLING (Raised bumps on arm), ERYTHEMA (Red, swelling on neck and throat), PRURITUS (Burning and itchy feeling), DIZZINESS (dizziness), SWELLING (Swelling on neck and throat) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Raised bumps on arm) was resolving and ERYTHEMA (Red, swelling on neck and throat), PRURITUS (Burning and itchy feeling), DIZZINESS (dizziness), SWELLING (Swelling on neck and throat) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient states the bumps were fading as of today and she felt fine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: NNI
Chills, headache, malaise, diarrhea Symptoms began with chills approximately 12 hours after the shot. Symptoms lasted about 24 hours
Lymph nodes on the' left side of her left breast blew up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Aug2021 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. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "only 'fluey' symptoms"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "lymph nodes below her chin blew up". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Lymph nodes on the' left side of her left breast blew up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Lymph nodes went down after a few weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201346192 Same patient and drug; different dose and event;US-PFIZER INC-202201346626 Same patient and drug; different dose and event;
Information has been received from a pharmacist concerning a 67 year old female with a cardiac history (unspecified) and no drug allergies who on 24-SEP-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (LOT# 663889/0632Y). Concomitant vaccination included a dose of FLUZONE in same arm as PNEUMOVAX 23 about an inch apart on the same day. On 26-SEP-2009 the patient experienced a reaction after receiving vaccine. The patient had fluid in the tissue above her shoulder, her neck area showed soft tissue swelling and was "jelly like and tender", legs was sensitive to the touch and just didn't feel right. The patient was placed on doxycycline. The patient was not recovered. Additional information has been requested.
Patient came in for a booster and on her form said that she had cancer but did not indicate that she had any current anticancer meds or treatments that would suppress her immune system. We administered a booster shot (0.25 ml).  She came back today (2/10/22) and asked whether it was time for her 4th shot.  I asked her what she meant and she told me that she was immunocompromised and that she had 3 doses and needed a booster.  I investigated and determined that she was indeed immunocompromised due to anti-cancer meds and that she should have received an additional dose on 11/3/21  of 0.5 ml rather than a booster dose of 0.25 ml.  According to the CDC website when you administer a dose that is lower than the recommended dose you should immediately administer the correct dose.  I administered the 0.5 ml dose on 2/10/22 as an additional dose and scheduled her for a booster of 0.25 ml in 5 months.
pt husband called about 2 hrs p/shot given to report 3" swelling & pain to rt arm advised to use ice & call in AM if worse; next day came to clinic w/whole arm swollen & redness to upper arm; still sore @ elbow;
Pt recvd 1st dose of Hep B vax on 30OCT90 & about 1 to 2 wks following vax pt exp severe hair loss; pt recvd 2nd dose of vax on 30NOV90 & hair loss was most severe from DEC90 to MAR91; On 2MAY91 pt recvd a 3rd dose of vax & noted relapse;
This is a spontaneous report from a contactable reporter who reported on behalf of her mother. An 81-year-old female patient received a dose of PREVNAR-13 at 0.5 ml single dose in the upper arm on 14Feb2013 in the morning, using a prefilled syringe as she was immune-compromised. The vaccine was administered in a public health clinic. The relevant medical history included ongoing immune-compromised and ongoing chronic obstructive pulmonary disease (COPD) both since an unknown date. The relevant concomitant medications were unknown. The consumer was diagnosed with pneumonia on 14Mar2013 in her chest X-Ray. The relevant laboratory data included chest X-ray on 14Mar2013 and the patient was diagnosed with pneumonia. Therapeutic measures taken for the reported event included albuterol inhaler (dose unknown) as needed, AUGMENTIN or amoxicillin since an unknown date at an unknown dose and frequency and breathing treatment, all since an unknown date. The consumer was still suffering from pneumonia at the time of report. Follow-up (17May2013): Follow-up attempts completed. No further information expected.
dizziness; sweating; fever (T102-103F) for five hours/running a low grade temperature; extreme nausea; extreme chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERHIDROSIS (sweating), NAUSEA (extreme nausea), CHILLS (extreme chills) and HEADACHE (headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced NAUSEA (extreme nausea), CHILLS (extreme chills) and HEADACHE (headache). On 11-Mar-2021, the patient experienced PYREXIA (fever (T102-103F) for five hours/running a low grade temperature). On 12-Mar-2021, the patient experienced DIZZINESS (dizziness) and HYPERHIDROSIS (sweating). On 10-Mar-2021, CHILLS (extreme chills) had resolved. On 12-Mar-2021, NAUSEA (extreme nausea) had resolved. At the time of the report, DIZZINESS (dizziness), HYPERHIDROSIS (sweating), HEADACHE (headache) and PYREXIA (fever (T102-103F) for five hours/running a low grade temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Pain in both arms/ pain in legs; Pain in upper and mid back; Pain in neck; Redness in left arm; Swelling in left arm; Pain in upper shoulder; Muscle pain over entire body; Strong fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm) and PERIPHERAL SWELLING (Swelling in left arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Aspirin), Drug allergy (Ibuprofen), Drug allergy (Hydrocloroquine), Drug allergy (Chloroquine) and Drug allergy (Hydroxychloroquine). Concomitant products included VITAMIN D [VITAMIN D NOS] and IRON for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm), PERIPHERAL SWELLING (Swelling in left arm), ARTHRALGIA (Pain in upper shoulder), MYALGIA (Muscle pain over entire body), FATIGUE (Strong fatigue), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) on 30-May-2021 for Adverse event, at a dose of 1 dosage form and MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) for Pain, at an unspecified dose and frequency. On 13-Jun-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm), PERIPHERAL SWELLING (Swelling in left arm), ARTHRALGIA (Pain in upper shoulder), MYALGIA (Muscle pain over entire body) and FATIGUE (Strong fatigue) outcome was unknown.            Treatment include : hot compresses, ice.  In July, patient went to urgent care and then her primary care physician, who switched her low dose of ibuprofen.   This case was linked to (Patient Link).
Fainted 5 times in 1 hour starting 4 hours after receiving vaccine Fainted in bathroom and was injured. Called 911. Went to  ER.  Treated at hospital for 5 days -repeated fainting spells.  Released  3/30/21, Remains very weak.
Injection was administered very high on shoulder next to what feels like a bone. As injection was being administered I felt pain on inside upper arm down to wrist. Pain subsided. Day progressed. I used my arm to grocery shop. About 6:30 -7:00pm I noticed stiffness and inability to lift arm with extreme pain in attempts to lift arm. During the night had restless sleep. Had to use other hand to move arm into resting positions. No comfortable position.  Saw general practitioner on 4/12/2021. Received a paper with physical therapy exercises. Today, 4/13/2021, Still extreme pain to stretch arm to side and in front. If raising arm overhead with help in range of motion exercises (abduction) cannot lower arm without severe excruciating pain in inner shoulder area. New symptom includes numbness in wrist and forearm.
It was noticeable swelling, puffiness, soreness, and tenderness in my armpit. Sore to the touch, hurt to put my arm down. There was no treatment, but just dissipated over several weeks. The gynecologist noted that it was likely due to the vaccine due to timing and reports they had been receiving, but because of the previous monitoring in that particular area and arm, she said she would send for a diagnostic mammogram - came back normal. 2nd dose was received in right arm with immediate swelling, soreness, tenderness. Booster had also caused the same effect.
8 hours after vaccination minor arm stiffness and headache.  At about 29 hours after vaccination became sleepy, warm without a temperature followed by shaking and alternating very cold and very warm.  Slept 2 1/2 hours and though a little shaky then felt fine.
This was a duplicate vaccination- Patient received Fluzone High Dose on 10/3/2023 Patient also received duplicate COVID-19 vaccine -- received Spikevax on 10/3/2023
pt devel acute loss of vision in both eyes 17 days p/vax;dx bilat optic neuritis made & pt treated w/IV corticosteriods;hosp is presumed, although not documented;visual acuity in rt eye returned to 20/30;only able to perceive light in lt ey
Patient 10 to 15 minutes after the shot said she felt like passing out and wanted to lie down on the floor.  I ran to get a water and towel.  We took her blood pressure and it was 96/46.  Five minutes later we retook it and  it was 70/46.  I called 911 to have medic assistance.  She called her husband.  The medics came right after we took her blood pressure again and it was 85/54.  The medics took over.  She felt better after she threw up.  The medics walked her out because we didn't have a wheelchair.  She was going to go to the clinic down the road last I heard.