chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine leaked out; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (vaccine leaked out) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-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 19-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (vaccine leaked out). At the time of the report, DEVICE CONNECTION ISSUE (vaccine leaked out) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a adult female patient who received Flu Seasonal QIV Dresden for prophylaxis. Concurrent medical conditions included drug allergy (thimerosal). On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced loss of consciousness (serious criteria GSK medically significant), respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever. On an unknown date, the outcome of the loss of consciousness, respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever were recovered/resolved. It was unknown if the reporter considered the loss of consciousness, respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: Last year in 2017, the patient had flu vaccine. She did not know the brand name. The patient said that she experienced similar symptoms to what she experienced in the reporting year (refer case US2018188513).  The patient experienced chest congestion. The patient was knocked out for about 2 to 3 weeks after receiving flu vaccine. The patient had denied permission to contact their physician.
This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age. On 18-AUG-2017, 20-AUG-2017 and 21-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis, which were reconstituted with properly stored sterile diluent(DILUENT MRK). No adverse events reported. The vaccines were exposed to a temperature excursion -14°C to -10°C, during a time frame of 4 hours and 30 minutes. There was no previous temperature excursion.; Sender's Comments: US-009507513-1708USA010724:
pt recv vax in lt deltoid & 5 mins later devel local rxn w/sl edema & redness; watches for 30mins-no further problems-redness
pt presented for chest pain for 7 days. labs and chest xray ordered.  elevated ESR. presumptively dx with acute pericarditis treated colchicine and motrin
4/19/21 PER CLINIC PHONE NOTE FROM MOM: STATES PATIENT IS HAVING A BAD ECZEMA FLAIR UP  4/23/21 ALLERGIST, DIAGNOSED PATIENT WITH INFANTILE ATOPIC DERMATITIS, FLEXURAL ATOPIC DERMATITIS, DRY SKIN, IMPETIGO, STAPHYLOCOCCAL INFECTION, PRURITIC RASH
This spontaneous report was received from a clinical supervisor who was a medical assistant, regarding to multiple (unspecified number) patients. Patient demographics were not reported. Information on concurrent conditions, medical history and drug allergies of the patients were not reported. Illness of the patients/siblings at the time of/prior to vaccination were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016) the patient was vaccinated with GARDASIL 9 (lot # L018351, expiry date 11-AUG-2017), (lot # L013429, expiry date 21-JUL-2017), (lot # K026246, expiry date 28-JAN-2017) (dose number, dosage units, route and anatomical location not specified). Concomitant medication were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016), the reporter stated that the unspecified number of patients received unspecified doses of GARDASIL 9 that were improperly stored. Temperature at which the vaccines were maintained was reported to be 54.1 (units not provided), time frame was 3.5 hours, no previous temperature excursions were performed. No adverse effects were reported. Additional information has been requested.
Erythema and painful swelling at injection site, patient self-treated with OTC diphenhydramine and ibuprofen, duration of symptoms > 1 hr (exact duration unknown).
Headache began on March 6th.  Fever of 103 degrees started at 530pm and continued through 8am on March 7th.  Fever went up and down through out the day on March 7th and dissipated completed on March 8th.
Patient tolerated vaccine during 15-min observation period on 1/6/21. Localized swelling at injection site moderate on 01/09/2021; recurring angioedema only suppressed with treatment starting on 01/10/2021 (i.e., swelling on cheek/face, and at one point felt as if throat might be swelling up). Reported significant lip swelling on 1/15/21. Stated she was prescribed Benadryl and Medrol Dose-Pack and had to stay on them to control symptoms.
This spontaneous reprot as received from a pharmacist refers to a female patient of unknown age. The patient was not a pregnant. The patient pertinent medical history and drug allergies were unspecified. On an unknown date in 2014 (reported as approximately one year ago) the patient was vaccinated with PNEUMOVAX23 (dose, frequency and route were unspecified). Concomitant medications were unspecified. On an unspecified date the patient experienced anaphylaxis with unspecified symptoms. The outcome of anaphylaxis was unknown. The causality of anaphylaxis was not reported. No product quality complaint (PQC) was reported for PNEUMOVAX23. Additional information has been requested.
PATIENT REPORTED NO ADVERSE EVENT. THIS IS BEEN SUBMITTED AS REQUIREMENT FOR PATIENT RECEIVING WRONG VACCINE
ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY 3/25/2023 PREDIABETES ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY 3/25/2023 HTN (HYPERTENSION)
missed periods; Period cramps for a week now; Period still hasnt came; Nauseous A few days; Chills; Mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Aug2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. On an unknown date in 2021, the patient experienced missed period, period cramps for a week (at the time of reporting), nauseous a few days, chills and mild headache, periods still did not come. The patient also reported that she was not pregnant. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of reported events. The clinical outcome of the events missed period, period cramps, nauseous, chills and mild headache, periods did not come was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient resident of healthcare facility.  Patient with dementia was trying to use walker at home and stumbled an fell at home breaking his left femur.  He is s/p total hip arthroplasty.  Admitted to hospital on 02/08/2022.  Patient tested positive for Covid-19 on 02/15/2022.  Patient expired on 02/19/2022.
swelling went down to elbow; two big lumps; swelling of the arm on the injection site; it's a booster, afterwards confirming the HCP wrote full dose on the card due to his wife's medical condition; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling went down to elbow), VACCINATION SITE MASS (two big lumps), VACCINATION SITE SWELLING (swelling of the arm on the injection site) and ACCIDENTAL UNDERDOSE (it's a booster, afterwards confirming the HCP wrote full dose on the card due to his wife's medical condition) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 013C20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and MS. Concomitant products included LABETALOL, HYDROCHLOROTHIAZIDE, GABAPENTIN, OXCARBAZEPINE (OXTELLAR XR) and OCRELIZUMAB (OCREVUS) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced JOINT SWELLING (swelling went down to elbow), VACCINATION SITE MASS (two big lumps) and VACCINATION SITE SWELLING (swelling of the arm on the injection site). 03-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (it's a booster, afterwards confirming the HCP wrote full dose on the card due to his wife's medical condition). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 03-Dec-2021, ACCIDENTAL UNDERDOSE (it's a booster, afterwards confirming the HCP wrote full dose on the card due to his wife's medical condition) had resolved. At the time of the report, JOINT SWELLING (swelling went down to elbow), VACCINATION SITE MASS (two big lumps) and VACCINATION SITE SWELLING (swelling of the arm on the injection site) had not resolved.
A Pharmacy technician gave a Moderna as a second dose Pfizer to a 15 year old. The mother and child remained in store for 30 minutes before leaving and nothing had happened at that point. I called the "Immunization Specialist"  and he said to call mother and tell her that this type of accident has happened before and she will need to bring patient back in 28 days for a second dose Moderna shot.
Entire right side hurts. Neck, arm, head.  My arm is swollen .  My lymph nodes are extremely swollen and painful.
Acute hypoxemic respiratory failure due to COVID-19; SEPSIS due to COVID-19 Pneumonia
Patient was given a boost dose of Moderna (0.25 ml) vs. the second dosage necessary for a second dose in the primary series. Per CDC Administration Errors Revaccination Guidance, patient was notified of error and scheduled repeat dose for later today.
a little puffy in the beginning and its fading now; a little on the warm side; a big round red rash (4 inch red rash) at the injection site, the rash was very dark; itches; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (a little puffy in the beginning and its fading now), INJECTION SITE WARMTH (a little on the warm side), INJECTION SITE RASH (a big round red rash (4 inch red rash) at the injection site, the rash was very dark) and INJECTION SITE PRURITUS (itches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included CHLORTHALIDONE and ROSUVASTATIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced SKIN SWELLING (a little puffy in the beginning and its fading now), INJECTION SITE WARMTH (a little on the warm side), INJECTION SITE RASH (a big round red rash (4 inch red rash) at the injection site, the rash was very dark) and INJECTION SITE PRURITUS (itches). At the time of the report, SKIN SWELLING (a little puffy in the beginning and its fading now), INJECTION SITE WARMTH (a little on the warm side), INJECTION SITE RASH (a big round red rash (4 inch red rash) at the injection site, the rash was very dark) and INJECTION SITE PRURITUS (itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included antibiotics and steroids for drug use for unknown indication. Treatment details included Steroids, Antibiotics   Reporter did not allow further contact
Patient received PNEUMOVAX 23 vaccine on 9/24/12, but already received PNEUMOVAX 23 last year on 10/4/2011. Patient complaining high fever, sore arm, fatigue, headache. Called primary MD who said to take TYLENOL. Also called Merck manufacturer.
I had no adverse event after receiving my vaccine. I tested positive on 07/19/2022 with COVID-19 with a home test. I had a telehealth visit with my provider and they prescribed PAXLOVID. My symptoms like a cold with sinus draining, sore throat and a low grade fever. I did have rebound case after taking PAXLOVID.
Patient given vaccine that was not diluted per manufacturer direction, given undiluted vaccine, children's formulation (PEDS).
pt recvd vax & devel a fever as well as pain & tenderness in left arm & shoulder; MD thinks vax might have been admin to low in the arm;
About 10 minutes after the immunization patient started feeling light headed and his facial complexion was pasty white. Talked with the patient and he was not very responsive then went unconscious where he was kept him from hitting the ground. I grabbed the patient to prevent them from falling, his eyes appeared to roll slightly and his leg twitched. He was unconscious  and unresponsive for approximately 10 seconds or less while making some grunts/groans. He came to consciousness and sat upright and began drinking water. He says he remembers immediately before but couldn't remember the exact event. The ambulance was called at initial event and arrived and took him at that point to continue checking on him. Blood pressure was approximately 117/76 with a pulse of 55 form blood pressure cuff over his shirt.
Fever, vomiting, cough, nasal congestion. Motrin, Rondec and Phenergan
Arm red, warm to touch on 10/19/2010. Mother states pt had "bandaid" rash day of vaccine. Pt had nosebleed on 10/20/10.
Given DTAP on 9/5, next day redness at site of injection. Increased redness next day 3x4 cm, then larger next day 8x13 cm started on KEFLEX on 9/7, since worse next day taken to urgent care. Told to cont. KEFLEX, use ibuprofen & benadryl. Less red by 9/10. Pt never had fever, pain, still very ache.
Systemic: Nausea-Medium, Additional Details: Patient felt nauseous ~5mins after vaccine. She laid on the floor which she said helped, she did not feel lightheaded or other symptoms. Pharmacist sat with her for 15 mins and she said she felt better and went home, no ambulance required.
Patient administered vaccine expiration past due. Expiration date was 08/30/2021 and the vaccine was administered on 09/29/2021. The manufacturer was contacted and they stated they have in house date to support that no additional vaccination was required and the potency of the vaccine is supported. Patient was also notified of the incident and will be followed up with to ensure no side effects arise.
Sick; Initial information received on 02-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who had sick (illness), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Everyone I know who gets it gets Sick".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
A non-serious spontaneous report of gave H1N1 LAIV to 22-month-old child was received from a registered nurse/health professional concerning a 21-month-old female. The patient had no any medical history and she was not on any concomitant medications. On 04-Nov-2009, the patient received first dose of H1N1, Intranasal. When she was brought back for the second dose on 08-Dec-2009, it was then they realized the medication error. At that time, she was switched to receive the H1N1 injection, and received that injectable dose. She therefore received only one dose of the intranasal vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable. The outcome of the event was considered recovered. Additional information received on 23-Dec-2009 and incorporated into the narrative: medical history-none, concomitant medications-none, first dose of vaccine.
Hot to touch, swelling and rash going down for the last four days.  Using Benadryl and ice packs with no improvement.
i had side effects with my 1st; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (i had side effects with my 1st) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (i had side effects with my 1st). At the time of the report, VACCINATION COMPLICATION (i had side effects with my 1st) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
2 hours after vaccination started having numbness in R face, jaw and neck, R eye blinking slower than left
The next morning after I woke up with a high fever which elevated to about 102.4, chills and body aches which lasted about 48hrs off and on and all symptoms diminished on their own. I took OTC Tylenol to help with the symptoms.
pt recv vax 13OCT97 & pt devel cellulitis w/in the last week;
Patient presented in office in the afternoon of 10/12/12 with decreased oral intake and fussiness. Around 1300 patient had a bloody bowel movement. Mom brought the diaper into the office- gross hematochezia noted (stool in diaper dark brown with mucous and some blood clumps). Positive hemoccult. Due to presentation patient sent to emergency room for further management.
febrile, achey, "missed heart beats" on 1/22,  went to ED on 1/23 to r/o anything acute and feels better now
I had same anticipated joint and muscle pain with chills and fatigue for 24-36 hours after both first and second vaccine. I returned to normal health for almost 72 hours and then noted the new symptoms. I am experiencing skin hypersensitivity over the zoster scars (left abdomen) from my zoster outbreak  of roughly 40 years ago. I also now have a headache and some back pain in the same dermatome, but opposite side. I don't know if these are related.
I got the flut shot on 25-OCT-2006 so I wouldn't get sick because I don't have a car for over 3 years and have to catch bus/cab which is expensive and dirty. For three weeks straight I've been sick with chest pains, sore ribs, hoarseness and I have to walk to the mail box 30 minutes in the snow/cold with that sickness. It snowed the day after (26-OCT-2006) when I got my shot. Last year the shot didn't make me sick. This year was my second time getting the flu shot. Barely recovered. The two 1-800 numbers didn't work to complain about the vaccine.
STIFFNESS IN THE NECK; RINGING IN THE EAR; This spontaneous report received from a consumer concerned a male of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stiffness in the neck, and ringing in the ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiffness in the neck, and ringing in the ear. This report was non-serious.
No adverse event; Patient received bivalent booster as second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received bivalent booster as second dose) and NO ADVERSE EVENT (No adverse event) in a 20-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 18-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received bivalent booster as second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received bivalent booster as second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received bivalent booster as second dose).    No concomitant medications were reported. On 19-Oct-2022, Patient received first dose of Moderna COVID-19 vaccine monovalent of unknown Batch number. No treatment information was provided.