chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu; Initial information was received on 09-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional..  This case involves adult patient of unknown gender who had flu (influenza), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) 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 were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "the following potential adverse event has been found on a public post on a social media page. I took flu shots twice and both times ended up with the flu! When I started taking Vitamin D3, I stopped getting colds and flus!"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available  The patient was treated with VITAMIN D3 for Influenza.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's medical history, concomitant medications and drug reactions/allergies was not provided. On 07-SEP-2018, the patient was inadvertently administered improperly stored PROQUAD (lot # R002934, expired date 29-JUL-2019) for prophylaxis, which was reconstituted with properly stored sterile diluent (MERCK). The vaccine was exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 46 minutes. Data logger was involved. The vaccine was previously exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 28 hours and 24 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 35 hours and 21 minutes.  No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA004377.
My son was given the Hepatitis B vaccine at birth without my consent. I am submitting this report as documentation on behalf of hospital error. This report reflects the abuse of care by doctors whose views don?t align with yours. He was scheduled to come home and then they extended his stay 5-7 days without cause. He started having reflux issues after injection and because of the lack of quality in care I?m unsure if it?s related.
5 days post injection I started to have intense nausea and a headache with GI disturbance as well. The following day I was extremely fatigued with the same symptoms. The 7th day I experienced a migraine headache that was so intense and still fatigued. I am lactating and breastfeeding and the baby seemed more bothered as well during this time..
A lot of fatigue. When she first got the shot, she had flu like symptoms. It lasted for about 3 days. I also had trouble walking after. I ended up getting physical therapy for 2 months. After booster shot, I was hospitalized. I had a fever and just not feeling good. On Dec. 3rd, I fell and hit my head because I was out of it. I was in the hospital for about 6 hours.
Pt was given a COVID 5-11 pfizer bivalent and was supposed to be given a 5-11 COVID primary series.
DEEP , SHARP BILATERAL BACK PAIN; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous accident causing herniated discs ( unknown when ).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 06-APR-2021, the subject experienced deep, sharp bilateral back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep , sharp bilateral back pain. This report was non-serious.
Severe unprovicated crying; lack of sleep; Sensory processing issues; regression of speech (complete loss); anti-social behavior; limited to no eye-contact; aversion to certain food textures; repetitive behaviors and delayed cognitive skills.
Pt return 3 days after vaccine was administered, complaining of redness that was worse the day before but was leaving a redness 10x12cm on (R) thigh/no tender/no /warm on touch. No fever/no sign of /no sign of . Receiving Tx for cellulitis.
severe soreness, very red, lots of swelling, inj. site very swollen and red, ran fever, muscle aches and headache. Started between 4-5 pm, got worse after that. Took acetaminophen and went to bed. Worse next morning. Couldn't move arm at all. No fever, but lots of pain on Thursday. Stayed on acetaminophen and bed rest all day Thursday. Friday: still swollen and red, no fever, lots of pain still. Saturday saw my PCP Dr. Swelling down, still red and hot to the touch. More acetaminophen and ice packs. Sunday: much better!
light headedness; queasiness; I was functional but I wasn't myself; This is a spontaneous report from a contactable 81-year-old female consumer reported for herself started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via Intramuscular on 29Jan2021 at single dose in arm left for covid-19 immunization. The patient relevant medical history included I have environmental allergies pollen (took an antihistamine), mild asthma and paroxysmal atrial fibrillation. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) for environmental allergies. Past drug included Allegra (before I took the shot and I also gave an Allegra to my husband before he took his shot, and he was fine). On an unknown date, the patient experienced a mild reaction which was light headedness, queasiness and it lasted several hours. She was functional but she wasn't herself. After about several hours the patient began to feel somewhat better. The patient didn't take any treatment for the events. The outcome of the events was recovering.
12/29/2016 Received Pneumococcal (PPSV23) vaccine. Within 6 hours developed extreme soreness in left shoulder (where vaccine given) plus chills, fever, stomach distress and overall body discomfort. As of 1/9/17 still some shoulder soreness.
On 9-15-09 pt developed nausea, then hives to left back in the evening. Pt also reported itching all over on 9-15-09. On 9-16-09, all symptoms resolved.
Patient hospitalized for repeat low transverse cesarean section within 6 weeks of receiving covid vaccination. "She delivered a viable male infant weighing 3460gm, with APGARs of 8 and 8 at 1 and 5 minutes, respectively; in NICU for management of NAS. Patient is Rh (+) blood type, GBS negative."
Fast heartbeat after second shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (vaccine: 1st dose, Date: 19Oct2021, NDC/expiration: unknown, Lot: unknown, Site: right arm), administration date: 19Oct2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Fast heartbeat after second shot.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient is on several medications but does not feel it is relevant to the report. investigation Assessment: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (15Dec2021): Follow-up activities closed. Batch/lot number not available
The patient is a 68-year-old woman with a past medical history significant for severe chronic obstructive pulmonary disease, ongoing tobacco abuse, hypertension, type 2 diabetes, hyperlipidemia, and protein calorie malnutrition presenting due to shortness of breath and hypoxia.  Patient was unaware of how ill she looked, and when her children came to see her they made her seek care at the emergency department.  There she was found to have an oxygen saturation of 79%.  Also found to be positive for COVID-19.  She was admitted to the internal medicine service for further evaluation and management.  Given concern of pulmonary hypertension, pulmonology was consulted for assistance with management.  They agreed with continuing 6 mg of Decadron daily to complete a 10 day course.  They will follow up with her in their clinic as an outpatient both to continue monitoring the pulmonary hypertension and to obtain follow-up imaging regarding COVID and the incidental 6 mm nodule seen in the right lower lobe on CT.  Her oxygen needs have now stabilized and she requires 4 L of oxygen at rest and with exertion.  Suspect she is needed oxygen even prior to being sick given the severity of her chronic obstructive pulmonary disease.  At this time she is stable, improved, and ready for discharge home.  Of note she was vaccinated and boosted against COVID- booster received in October 2021.
17 year old received his first MODERNA COVID-19 vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received his first MODERNA COVID-19 vaccination) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received his first MODERNA COVID-19 vaccination). On 17-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received his first MODERNA COVID-19 vaccination) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Diarrhea; Injection site is sore; Felt hot; Pain from my arm radiated into my armpit; The most intense, crazy, scary nightmare that I've had in my entire life; Iodine flavor in his mouth; A spontaneous report was received from a consumer concerning for himself a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events most intense, crazy, scary nightmare that i've had in my entire life/nightmare, iodine flavor in his mouth/dysgeusia, diarrhea, pain from my arm radiated into my armpit/pain in extremities, felt hot, Injection site is sore/ Vaccination site pain.  The patient's Current Condition included TMJ. Concomitant medications reported were hydrocodone, Carisoprodol both used for TMJ.  On 13Mar2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 13Mar2021, the patient experienced the event iodine flavor in his mouth. On 15Mar2021, the patient experienced the event most intense, crazy, scary nightmare that he had in his entire life and the same day he visited Emergency room. On an unknown date, the patient experienced the events diarrhea, pain from my arm radiated into my armpit, felt hot and injection site was sore. The event pain from his arm radiated to armpit was reported medically significant.  Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of events, most intense, crazy, scary nightmare that he had in his entire life, iodine flavor in his mouth, diarrhea, pain from arm radiated into his armpit, felt hot, injection site was sore was unknown, at the time of this report.; Reporter's Comments: This case concerns a 41 Y/O M with a serious unexpected event of pain in extremity and nonserious unexpected diarrhea, dysgeusia, feeling hot, nightmare, and expected vaccination site pain. Event onset the same day as first dose mRNA-1273. Treated with hydrocodone and Soma. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt recieved an appropriately spaced Pneumovax 23 sub-q and Zostavax sub-q both in the left tricep area and a IM Fluvirin. The next day the pt experienced a 2x4in oval red mark seemingly between the sites of pneumo and zoster injections with clearly defined margins and complains of itchiness and pain on palpitation. Pt used topical Benadryl on 9/25/2014 with no relief. Suggested to the patient that topical hydrocortisone would be a better option for the itching and redness. Didn't mention any pain relief options to pt because I was concerned if possible systemic effects arose and I wanted to avoid fever suppression.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.
Patient experienced tingling in her lips and an itchy throat.. treated with Zyrtec 10 mg orally and she responded well reporting that throat itchiness subsided and lips felt better
"deathly ill"/got very sick like if had Covid-19; "deathly ill"/got very sick like if had Covid-19; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. This consumer reported similar events for 2 patients (herself and her husband). This is first of two reports. An 84-year-old female patient (consumer) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 02Mar2021 (at the age of 84-years-old) at single dose for COVID-19 vaccination. Medical history included Covid-19 in Dec2020. Concomitant medications were not reported. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 02Mar2021, the next day (03Mar2021) she got very sick like "deathly ill" when she had Covid-19 (got the Covid-19 back in December and were told that it was safe for them to receive the vaccine). The symptoms went as fast as they came, around 6:30 for her. The outcome of the events was recovered in Mar2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s): same reporter/drug/event, different patient (husband)
Lost my vision and felt very weak. Doctor concluded I had a mild stroke(TIA), also they found a DVT in my right leg and DVT in my left leg. My vision returned in about 1 hour. Was given 2 shots a day of Lovonox for 13 days and was immediately put on  Warfarin
pneumonia; Tired; Achy; Muscle weakness in left arm; Arm  was swollen; This spontaneous report was received on 10FEB2021 from a consumer which refers to a 76-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced injection arm swelling, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and pneumonia.  The patient's medical history was not provided. Concomitant medications were not reported.   On 15JAN2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 intramuscularly (Lot number: 026L20A). On 16JAN2021, the patient noted a start date for Pneumonia.  On 10FEB2021, the patient called the medical information call center and reported, "he is on antibiotics for pneumonia. His 2nd question is can he delay the 2nd dose since he is suffering from pneumonia. Patient was administered 1st dose of vaccine on 15/Jan/2021 in his left non dominant arm. The lot# was provided, but expiration date is unknown. Patient experienced some expected side effects, which he is not concerned about".  The event(s) were arm swollen, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and tested positive for pneumonia 1 day after receiving the vaccine.  The action taken for Moderna COVID-19 (mRNA-1273) Vaccine was reported by the patient as Tylenol.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events of fatigue, arm swelling, myalgia, muscle weakness, a causal relationship cannot be excluded.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Pneumonia is assessed as unlikely related. Further information has been requested.
Patient received 3 shots (Hep A, Varicella, HPV) on 10-2-07. 24 hours after the vaccine, pt first noticed stinging at shot administration site. Then redness and swelling were noted. Increased swelling and stinging and itching noted and increasing pain. Tylenol used.
After 30 minutes soreness in injection site and most muscles in the rest of the body, after an hour headache and dizziness, after 6 hours nausea, vomiting, diarrhea, weakness, as well as an excema-like rash noticed at the injection site, after 8 hours mild fever at 99.4 degrees which gradually reached 100.7 over an hour.  Treated nausea with pepto bismol within 30 minutes of nausea which worked in preventing further vomiting and diarrhea, but did not end the general nausea. Tylenol was taken for the headache and fever when the fever was first noticed, after an hour temperature was back to normal and some of the body soreness had dissipated.
A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 19-Dec-2012. On 19-Dec-2012, the patient received FLUMIST, which expired on 03-Dec-2012. The patient experienced COUGH which started during Jan-2013. The outcome of the event of EXPIRED FLUMIST GIVEN and COUGH is unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 14-Feb-2013 from Health Professional: new event of COUGH added, narrative updated.
A mother reported that her son received doses of Prevnar, HibTiter, DTaP (manuf unk) and IPV (manuf unk) vaccines. Subsequent to administration, her son developed injection site reactions characterized by redness and swelling and also experienced inconsolable crying. No further info was available at the date of the report.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse, illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 07:00, the subject experienced chills. On 10-APR-2021 07:00, the subject experienced fever. On 10-APR-2021 07:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and headache. This report was non-serious.
I was 6 weeks pregnant. And within 24 hours of getting the second covid dose my baby stopped growing and it?s heart stopped beating.
Rash behind ears about 8pm further developing all over body, hair, face, neck, back, shoulder, arms, chest, torso, legs and feet into hives by the next morning, as well as headache and dizzy. Swelling in arm pit of vaccine. Patient began taking benadryl next day - Rash and discomfort not subsiding - went to Urgent Care 12/12/21 treated with steroid injection, benadryl and steroid pack. 12/14/21 rash/hives still  increasing called Doctor - said stop benadry - take Allegra 180mg bid -  not resolved
No additional AE/PQC.; Caller reported AE on behalf of a patient who was administered an expired dose of MMR-II (no prior TEs). Caller confirmed that STERILE DILUENT was not expired. No symptoms reported.  Obtained consent to contact HCP. No additional AE/PQC.; This spontaneous report was received from a medical assistant regarding 1-year-old patient of unspecified gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 15-AUG-2023, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5ml/dose (lot number U024229 and expiration date 04-AUG-2023 have been confirmed as valid) (no more vaccination details were reported). The reporter confirmed that the STERILE DILUENT was not expired. No symptoms reported. No additional adverse event (AE)/product quality complaint (PQC).
Constant dry cough (non stop) and minor chest pain started a few days after the second dose. Unable to breath properly with my mouth,  nasal breathing was ok.