chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered FLUBLOK QUADRIVALENT to a patient who is 1 years old (under the age of 18), with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from physician and other health professional via (Reference number: 00821061) and transmitted on 20-Oct-2021. This case involved a 12-month-old female patient (under the age of 18) receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination.  The patient medical history, medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing egg allergy.  On 16-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [Strength: standard, frequency: once, lot QFAA2111, Expiration Date :02-Jun-2022] via an intramuscular route at a thigh site for prophylactic vaccination.  This was actual medication error case due to Inappropriate age at vaccine administration (latency same day)   It was reporter "Caller states that a patient that who is under the age of 18 received a FLUBLOK QUADRIVALENT vaccination in her clinic on 16-Oct-2021. Caller stated that the patient received the FLUBLOK QUADRIVALENT because they had an egg allergy. Caller states that the patient received a flu vaccine in 2020 that contained eggs and did not experience any adverse events."  No other vaccines.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Night sweats/Woke up in the middle of the night just drenched; Woke up in the middle of the night just drenched; sore throat; Congested; Received a primary series dose of the Pfizer covid-19 vaccine, then received a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (Congested), NIGHT SWEATS (Night sweats/Woke up in the middle of the night just drenched), HYPERHIDROSIS (Woke up in the middle of the night just drenched) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a primary series dose of the Pfizer covid-19 vaccine, then received a booster dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer covid -19 vaccine (primary series dose of the Pfizer covid-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer covid -19 vaccine.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a primary series dose of the Pfizer covid-19 vaccine, then received a booster dose). On 10-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (Congested). On an unknown date, the patient experienced NIGHT SWEATS (Night sweats/Woke up in the middle of the night just drenched) and HYPERHIDROSIS (Woke up in the middle of the night just drenched). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 23-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a primary series dose of the Pfizer covid-19 vaccine, then received a booster dose) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (Congested), NIGHT SWEATS (Night sweats/Woke up in the middle of the night just drenched) and HYPERHIDROSIS (Woke up in the middle of the night just drenched) outcome was unknown.            No concomitant medication were provided.  Patient was driving and had a sore throat, and became very congested.
Patient given 2nd Varicella vaccine 1 week early. Patient had received first dose on 5/26 and dose #2 on 6/16. Patient walked into clinic during a busy time and requested 2nd doses of all vaccines, other vaccines requested were due. Nurse did not realize the Varicella vaccine was not due for 1 more week and internet was not working properly.
Pain at vaccine sight, feeling of burning inside of body from waist up, jewelry is burning skin, anything touching my body feels as though it is burning, heart is racing, bad headache, pain across the waistline of my back, lungs hurt
Swollen and mildly sore right upper arm and lymph nodes are enlarged and mild pain under left axilla. Symptoms less than 24 hours. Will monitor.
Presented DOA at hospital 5/20/04. Received immunization records from health dept. 6/8/04 Received Autopsy Report which revealed COD as SIDS.
reaction / Slightly itchy; red, macular; red, macular; This case was reported by a physician via call center representative and described the occurrence of pruritus in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced pruritus, erythema and macule. On an unknown date, the outcome of the pruritus, erythema and macule were unknown.   It was unknown if the reporter considered the pruritus, erythema and macule to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The 5 days after 1st dose of Shingrix, patient  started with mild to moderate reaction, red, macular and slightly itchy but the temperature was normal. Consented to follow up.
The following week my skin became easy on my torso and I small rash broke out on the 17th. I went to see my doctor on April 19th and they confirmed it was shingles. I was given medicine for my shingles. I called the County Health Department and they suggested that I push my second dose back until the outbreak was better. I also let me doctor know about this. They thought it was fine to push back and still get the second shot later. Currently planning to get second shot on 4/13.  My age at time of the shot was 44  that auto calculator rounded up to 45 years old. I still have shingles now, but they are healing but still very painful. I had never had them before and was not and am not aware of any underlying health issues.  Don't know if this is related to the vaccine, but since it happened so close I wanted to be sure to report it as suggested.
later afternoon after first shot, warm blood pressure sensation in left hand and left food on and off for days. The warm sensation in left foot slowly became accompanied by a pain that grew over course of a week. throbbing sensation comes and goes still, pain (especially when walking) is still present
Patient reported that he developed multiple lesions on back of neck. The following day he was feeling achy with a low grade fever and got fatigued during his run. Denied chest pain, SOB. Reported slight itching of lesions. Pictures provided for review. Rash consists of multiple papules and few pustules on back of neck, just above collar.  Reported other than rash he is feeling well.   Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Left arm red from shoulder to just above elbow by the end of the day received the vaccine.  c/o arm hurts and itches.  Cold compress applied to arm.  Mother applied benadryl/cortisone cream to reddened area as instructed by ER.  Took child to PCP 2/21/20.  Instructed to continue with cold compress 6-10 hours qd, continue with benadryl/cortisone cream to reddened area, and also ordered claritin.
Patient complained of pain at site of injection. Could not move her (left) arm and get out of bed. Still hurting at site of injection. No swelling observed on 9/23/12. Cannot move her left arm beyond a certain height.
Body aches; cant sleep well; body is so hot; I feel chilled; Rash is itchy all over; Headache; Nausea; low-grade fever (99.5); skin started to feel flush; "a rash starting to form. The next day, I had a severe full-body rash"; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 08:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Concomitant medications included sulfamethoxazole (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. On 11Apr2021 at 15:00, 5 days after the vaccine, the patient got a headache, nausea, and a low-grade fever (99.5). The patient's skin started to feel flush, and noticed a rash starting to form. The next day on 12Apr2021, the patient had a severe full-body rash, body aches, and a continued headache. The patient couldn't sleep well because her body was so hot, yet felt chilled, and the rash was itchy all over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 12Apr2021, the patient underwent nasal swab test for COVID-19 and result was found to be negative and the patient also underwent saliva test for COVID-19 and result was pending. Therapeutic measures were taken as a result of the reported events and included treatment with unspecified antibiotic medications. The clinical outcome of the events headache, nausea, low-grade fever (99.5), skin started to feel flush, "a rash starting to form. The next day, the patient had a severe full-body rash", body aches, could not sleep, body was so hot, feel chilled, rash was itchy all over were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
tinnitus; This is a spontaneous report received from a non-contactable reporter (Consumer) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9-29-10 TC from client she reports - she had a flu shot in her left arm on 9-27-10, and when she got the vaccine she felt a sharp pain at injection site on 9-28-10 AM. She had left wrist pain. Denies swelling, redness at injection site. She told RN the pain radiates to her fingers. The pain occurs with use of left hand and still has achyness with hand at rest. She told RN she is taking TYLENOL 500mg PO PRN for discomfort declined to call her MD to report symptoms. 9-30-10 TC from client - she reports her wrist is better - she continues to take 500mg TYLENOL 500mg PRN - she said her fingers are also better but still aches - advised to call MD - but said she is having less pain and will not call MD.
have stiffness in the shoulder that goes to the hand/shoulder stiffening and difficult to bend without pain; gets worse at night; his shoulder is real stiff and it's hard to bend without pain; with pain in the joints; a nerve could have been affected by the 5 inches needle used in the administration of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 29Sep2019 at a single dose for immunization at the physician's office. There were no medical history and concomitant medications. On 29Sep2019, the patient had stiffness in the shoulder that goes to the hand on with pain in the joints. His physician suggested that a nerve could have been affected by the 5 inches needle used in the administration of the vaccine on 29Sep2019. His shoulder was real stiff and it's hard to bend without pain on 29Sep2019. It gets worse at night. The symptoms started twelve hours after he received the shot. He didn't know if there was something he could do. He asked his doctor and he said none of it; the shot can't be the problem. He does not have results to share but he did get blood work on an unspecified date after the shot. He was just wondering how long this will persist. Outcome of the stiffness shoulder and shoulder pain was not recovered while of the remaining events was unknown.  Information on the lot/batch number has been requested.
cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (cancer) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Chemotherapy NOS (The patient was currently on chemo treatments) since an unknown date.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced NEOPLASM MALIGNANT (cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (cancer) outcome was unknown.            No concomitant medication were reported.  Patient had clean mammogram prior to vaccine.  The reporters causality for the event of CANCER was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns an elderly female patient, in treatment with co  suspect product Adalimumab for Rheumatoid arthritis, who received two doses of mRNA-1273 vaccine and experienced the serious medically significant unexpected event of neoplasm malignant. Onset date of the event was not provided, hence latency and temporal association cannot be properly assessed. No further information has been provided for medical reviewing. The report mentioned the patient was currently on chemo treatments, which could be a confounding factor. The benefit  risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient, in treatment with co  suspect product Adalimumab for Rheumatoid arthritis, who received two doses of mRNA-1273 vaccine and experienced the serious medically significant unexpected event of neoplasm malignant. Onset date of the event was not provided, hence latency and temporal association cannot be properly assessed. No further information has been provided for medical reviewing. The report mentioned the patient was currently on chemo treatments, which could be a confounding factor. The benefit  risk relationship of mRNA-1273 vaccine is not affected by this report.
temperature excursion that exceeded the stability data documented in the local labelling administered to patients with no reported adverse event; vaccine administered to patients after temperature excursion with no reported adverse event; Expired vaccine administered with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 54 years old and unknown gender patient and reported temperature excursion that exceeded the stability data documented in the local labelling administered to patients with no reported adverse event, vaccine administered to patients after temperature excursion with no reported adverse event and expired vaccine administered with no reported adverse event while receiving vaccine influenza quadrival a-b multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2022, the patient received a dose of suspect influenza quadrival a-b multidose vaccine preserved Suspension for injection (lot UJ899AA, expiry date- 30-Jun-2022) with an unknown strength via unknown route in unknown administration site for prophylactic vaccination.  On 22-Sep-2022, the patient had developed a non-serious temperature excursion that exceeded the stability data documented in the local labelling administered to patients with no reported adverse event (product storage error), vaccine administered to patients after temperature excursion with no reported adverse event (poor quality product administered) and vaccine administered with no reported adverse event (expired product administered),  latency same day following the administration of influenza quadrival a-b vaccine.  Action taken - not applicable.  Outcome - Unknown for all the events  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.
dizziness, severe headache, nausea, vomiting 10/16/09 Medical records received for dates 10/12/09 to 10/15/09. Symptoms: Pt received vaccine 10/12/09 parent called MD office to state approx. ½ hour after vaccine pt. c/o dizziness, diarrhea, HA, vomiting 2-3x, syncope. F/u appt. 10/15/09 c/o stomach issues, HA, nausea. Decreased appetite continued. Assessment: Mild TTP LLQ, referred to GI specialist. Pt has HA if overeacts then vomits, stress worsens problem. DX: Possible reaction to vaccine. Chronic abdominal pain, chronic HA.
Vaccinated 1/13/11. Developed hard red area above vaccine site about 01/20/11. Broke out with vesicular, impetiginous rash 1/28/11. Started BACTROBAN 1/21/11 & BACTRIM po 1/28/11.
Pt had low grade fever for two days following the vaccine. Pt started having small bumps like pimple all over body which appeared red in color and itchy after a week of the vaccine.
Fever for 24hrs which resolved. 3 inch lump on left thigh at site of MMRV vaccination with redness, warmth, and soreness to the touch. Treatment recommended by doctor: cool packs, Benadryl if itching develops, Tylenol for pain prn, go to clinic if symptoms persist or worsen. Patient's mother was comfortable with monitoring symptoms over the weekend and treating them as recommended at home. Outcome unknown as symptoms still present at time of reporting.
Pain around the breast; Pain around her neck; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain around the breast) and NECK PAIN (Pain around her neck) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Pain around the breast) and NECK PAIN (Pain around her neck). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form and NAPROXEN ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 06-Feb-2021, BREAST PAIN (Pain around the breast) and NECK PAIN (Pain around her neck) had resolved.            Concomitant product use was not provided by the reporter.    Patient took second shot of vaccine and 15 days later she had pain around the breast and neck.
Diarrhea; Bone pain; Muscle spasms; Arm soreness; Joint pain; Headache; Fatigue; Fever; Chills; Vomiting; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness) and ARTHRALGIA (Joint pain) in a 40-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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (Nausea). On 03-Feb-2021 at 4:00 PM, the patient experienced DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        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.   No concomitant medication was reported.  No treatment medication was reported.
Tested covid-19 positive; Tested covid-19 positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested covid-19 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
large 3-4cm wheal adjacent to inject site following MMR; pt given DPH;