chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GOLF SIZE LIGHT PINK MARKING  AT THE INJECTION SITE; QUARTER SIZE BRUISING WITH YELLOW SPOT ON THE LEFT ARM, UNDER RIGHT NIPPLE AND BROWN SPOT ON CHEST AND ON LEFT THIGH; CRAMPING OF THE NECK, FINGERS AND TOES; ARM HURT; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, and poison oak allergy, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. patient stated that, he sometimes bruises but it is minor and did not have any medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 24-JUL-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced flu-like symptoms. On 08-JUL-2021, the subject experienced arm hurt. On 11-JUL-2021, the subject experienced cramping of the neck, fingers and toes. On 22-JUL-2021, the subject experienced quarter size bruising with yellow spot on the left arm, under right nipple and brown spot on chest and on left thigh. On 26-JUL-2021, the subject experienced golf size light pink marking at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and cramping of the neck, fingers and toes on 11-JUL-2021, and arm hurt on 10-JUL-2021, was recovering from golf size light pink marking at the injection site, and had not recovered from quarter size bruising with yellow spot on the left arm, under right nipple and brown spot on chest and on left thigh. This report was non-serious.
I was having a really hard time breathing and I was having a runny nose as well I was so exhausted. I ended up going into urgent care and they tested me for COVID-19 which was positive. At this point I was having symptoms for a number of days, so I did not get anything for treatment. This has made my asthma really bad, and my pulmonary doctor has increased one of my medications and given me a second rescue inhaler as well.
Patient admitted to the hospital with COVID-19 breakthrough  case.  SOB, cough. From a group home with multiple positive patients.
PATIENT GAVE FALSE VACCINATION HISTORY, CLAIMING HE HAD RECEIVED 2 DOSES OF MODERNA IN JAN AND FEB OF 2021 IN ORDER TO RECEIVE A BOOSTER DOSE. UPON CHECKING THE MAINE REGISTRY, PATIENT HAD RECEIVED JANSSEN IN MARCH 2021.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a 58 year old male unspecified race and ethnicity. 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, and batch number were not reported) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-AUG-2021 07:20, the patient underwent blood test (COVID-19 Antibody Test, Semi-Quantitative) to determine the level of antibodies. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) less than 1.00 (Negative) (confirmed immunological vaccine failure) which means there were no detectible antibodies in patient. 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).; Sender's Comments: V0:20210846558- 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
This spontaneous report as received from a healthcare worker via a company representative refers to a baby patient of unknown age. On 24-NOV-2012 and 24-JAN-2013 the patient was vaccinated with the first and second dose of RECOMBIVAX HB (5 mcg/0.5 mL) (lot#, dose and route not reported). Concomitant therapies included PEDIARIX (on 12-JUN-2013). On 12-NOV-2013 a hepatitis B titer was negative. The outcome of patient was reported as not recovered/not resolved. Additional information has been requested.
No adverse effect; Patient used expired VAQTA; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 17-JUN-2019, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated(VAQTA) injection (dose and frequency were not reported) (lot # R009954, expiry date: 12-JUN-2019) intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Erythema nodosum; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA NODOSUM (Erythema nodosum) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)    No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA NODOSUM (Erythema nodosum) (seriousness criterion hospitalization). At the time of the report, ERYTHEMA NODOSUM (Erythema nodosum) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: 23.5 mg/l 23.5 mg/L. On an unknown date, Laboratory test: negative (Negative) negative ANA, rheumatoid factor, ESR, thyroid panel, upper respiratory viral panel including SARS-CoV-2.. On an unknown date, Physical examination: abnormal (abnormal) examination was benign other than multiple, tender, non-blanchable 6-8 cm erythematous nodules present on the bilateral calves and shins..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ERYTHEMA NODOSUM (Erythema nodosum) to be possibly related.    Prior to emergency department presentation, patient had been seeing her primary care physician for her ongoing symptoms. Her vital signs in the emergency department were stable. She had progressively worsening lower extremity rash. The rash started 7 days after the second administered dose of the SARS-CoV-2 vaccine (Moderna series).  She was discharged from the ED and continued supportive care with nonsteroidal anti-inflammatory drugs.  Concomitant product and treatment medication use was not provided by the reporter.  This case concerns a 44 year-old, female patient with no relevant medical history, who experienced the serious (due to hospitalization) unexpected event of Erythema nodosum. The event occurred approximately 7 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 44 year-old, female patient with no relevant medical history, who experienced the serious (due to hospitalization) unexpected event of Erythema nodosum. The event occurred approximately 7 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt presented with rash started on left thigh area and then spread to whole of body, not much on face.
Employee given TB screening with Tetanus injected instead of PPD. Local reaction to left forearm with raised lesion in center. No specific treatment given.
Patient accidently received 1st dose at age 17 years and 10 1/2 months.  No adverse reactions at this time identified
1/2 inch red area around injection site.  10:00 PM noticed a lighter pink area around the previously red area.  1/13/2017 noticed the area around site darker red and lighter red area appeared larger. came into health dept.  Dark red area noted to Left upper arm around injection site 35 mm diameter, light pink area surrounding red area was 70 mm in diameter. slt induration and swelling noted to darker red area, slt warmer to touch. encourage to see MD re: as patient was to get second injection in one month.
After I got vaccinated I went into a semi state of shock. I felt dizzy, I felt like I couldn't move and I didn't have a good sense of balance. I lay in bed the rest of the day because I couldn't move. For 3-4 days all I wanted was to lay around. On day 7 I had a huge rash on my upper right arm. I did reported to my doctor I didn't go see him I just rested a lot. I did not have a fever so he said not to worry to much. I had that rash for about a week. I felt much better by the end of the second week.
Pt had severe swelling at inj site.  Treated by Dr WITH ANTIINFLAMATORY and STEROIDS.
05/08/2021 I Noticed while working outside, if I bumped my arm, these huge purple spots would come up. My skin would tear very easily, my skin was very thin. Went to my family doctor, he looked at my medications. Said there is nothing on there that would cause this. I went to my dermatologist. He looked at my medications and said, no, unfortunately, I think it is because you are getting older. Then I noticed, I have had Plaque psoriasis it has been contained to my scalp. Still to this day, I worked outside two weeks ago, and just bumping my skin, I have purple spots on my forearm and tops of my hands.
PNEUMOVAX 23 given 12/2/08 between 1-3pm.  On 12/3/08 am T 100 and soft ball sized warm, red area noted at injection site (LD).  MD called by pt and advised to apply cool compresses, s+s resolved on 36 hours.
INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED; This spontaneous report received from a health care professional concerned a 44 year old male. 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: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 12-SEP-2021 for prophylactic vaccination. Age at time of vaccination 44 years old. No concomitant medications were reported. On 12-SEP-2021, the patient experienced incorrect product storage, and the janssen covid 19 vaccine was refrozen and administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and the janssen covid 19 vaccine was refrozen and administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220540524, 20220540420, 20220540688, 20220540570, 20220540324, 20220540536, 20220540611, 20220540642, 20220540765, 20220540474, 20220540814, 20220540816, 20220541085, 20220537548, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538437, 20220539045, 20220538666, 20220537688, 20220538693, 20220540853, 20220541180, 20220538316 and 20220538347.
Pt administered HPV injection into right arm. MAII left room and mom immediately ran out of room stating that patient was having a seizure. Pt immediately responsive when staff arrived at bedside.
7PM while w/grandma had szs of all extremities shaking & eyes rolled back; lasted for 1 1/2 min; had prev seen given APAP; no further apparent sx as of today's date;
This spontaneous report was received medical assistant regarding unspecified number of patients of unknown age and gender. The pertinent medical history of patients and their concurrent conditions were not reported. On an unknown date, unknown number of patients were inadvertently administered with improperly stored GARDASIL lot, dosing details unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to a temperature excursion of 46.7 degrees F for a time frame of 2 hours. It was reported that the vaccines were not subjected to previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two cases received from the same source. Additional information has been requested.
adult patient given one pediatric dose of Havrix; adult patient given one pediatric dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old male patient who received HAV (Havrix pediatric) (batch number 3HR79, expiry date unknown) for prophylaxis.   On 13th July 2021, the patient received Havrix pediatric. On 13th July 2021, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The nurse reported that, adult patient given one pediatric dose of Havrix, which led to adult use of child product and underdoes. The reporter consent to follow up.
Fevers > 101 for > 24 hours Chills Headache Eye pain  Chest heaviness  Fatigue
Swelling and bruised feeling in arm pit and collar bone.  Joints and tender points inflamed.  Worse on the left side of the body.  Can not raise left arm up as stiffness and pain in underarm is intense.   Expected, but tenderness, swelling, and pain at injection site.   Feels like body was ramped up into a flare up (agin worse on the left side - same as injection side).   Headaches.
On 3/19/2021 at approximately 10:55am, I received the first dose of the Moderna vaccine in my right, upper arm. At approximately 11:39am, I began to feel my face flush hot. I could feel the same sensation shortly thereafter in the center of my chest. It radiated outward into my lungs, shoulders and upper arms. It felt very much like the sensation a person has when the contrast is introduced during a CT scan, only it wasn't quite as hot. I've had many, many CT scans, so I'm familiar with that sensation. The heat intensity lasted until about 1am the following morning (3/20) and remained mostly in my chest. I coughed a little during this time period as well. The following day I still felt a tiny bit of the hot feeling in my chest during the day, but by the time I went bed, it was gone.
Severe headache ? like the flu is coming, body ache, muscle pain, pain at site of injection. This happened at the first injection a few months ago, too.
Body ache; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 024M20A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE, CARVEDILOL, LISINOPRIL, SIMVASTATIN (ZOCOR), CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache) had resolved.            This case was linked to MOD-2021-371024 (Patient Link).
patient reports her arm was red, swollen and sore the day after her shot and lasted for 3 days. She said sore into her left breast and even down into her left leg. Today 09/20/2005 arm was fine no redness or pain.
Patient received DTaP and MMR vaccines in Left deltoid and arm.  Patient also received IPV in Right deltoid.  Patient's left arm was very red and swollen from the elbow to the shoulder.  Patient was given Tylenol regularly and is starting to improve.
not feeling well; fever; soreness left arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd June 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell and fever. In June 2019, the patient experienced pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling unwell, fever and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: In the morning, the patient received Shingrix in the left arm and developed a fever of 101 degree F in the afternoon. The patient also stated that she was not feeling well and that started in afternoon of vaccination day. The patient's fever increased to 102.9 degree F in the morning of reporting day. The patient was taking Tylenol for the fever. The outcome of adverse events were reported as recovering resolving while it was discrepantly captured as not recovered. The reporter gave consent to follow up.
A non-serious spontaneous report of administration of H1N1 to 2 elderly patients was received from a consumer concerning a male patient who was in his 80's. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown, the patient received H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
66 year old female patient received a two doses of Fluzone Quadrivalent High Dose, no AE; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 66 years old female patient who received vaccine two doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] [extra dose administered]..  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included CYANOCOBALAMIN (B12-VITAMIN).  On 12-Sep-2020, the patient received a 0.7 ml first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ552AA and expiry date: 30-Jun-2021) and on 23-Nov-2020, the patient received same vaccine 0.7 ml second dose (lot UJ552AA and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  Reporter relationship: health care professional (HCP), Product used: used, First time product used: no, Still using product: no  At the time of report, 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.
After receiving vaccine,  I became sick with flu like symptoms. These symptoms have not gone away. It has been 12 days.  In the past 2 years I have come in contact with several people with Covid. No issues, but once I got vaccine I have been sick.
product storage error; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT STORAGE ERROR (product storage error) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. Reporter stated that The box of vials was received from the state of Colorado on Oct  14 2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use.
Incorrect brand of second dose given. Administered Pfizer, when should have received Moderna for second dose because received first dose of Moderna. No known adverse events related to this. Patient is aware and has been in contact with her PCP. Initially incorrectly documented this dose in the incorrect patient's chart. Just added this dose of Pfizer to the correct patient's chart.
About about an hour after shot, (given in left arm) I had what felt like a jab pain the area inside my left wrist.  It was a sharp pain like being stung.  Thus happened for two days, woke me up at night.  I took a picture of my left wrist on Feb  11 and my right, both in the same minute.  The structure and size of vein enlarged on the left side,  as well as the color of skin.  The right side was normal.  As of today, the difference in the veins is still there, yet the jabbing pain has stopped.
Moderate Dizziness and  Fatigue.  Went to bed and slept almost 5 hours. No adverse effects after waking up, however I am still somewhat tired.