chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu; pneumonia; Initial information received on 20-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves an Adult and unknown gender patient who had pneumonia and flu after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 02-Dec-2022, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with unknown formulation, strength, dose, route, lot number, expiration and at unknown administration site) for prophylactic vaccination(immunization) and flu(influenza).  ON 27-Dec-2022, the patient developed pneumonia and flu (influenza) (latency:25 days) following the administration of Influenza Vaccine.  No lab data were reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both events.  At time of reporting, the outcome was Unknown for both events.  Seriousness criteria: hospitalized for both events.; Sender's Comments: Sanofi company comment dated 25-Jan-2023: This case involves an Adult and unknown gender patient who had pneumonia and flu after receiving Influenza Vaccine. The time to onset was compatible with the role of vaccine. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based on information provided, the role of an individual vaccine cannot be assessed.
Upper body shakes, then about an hour later vomited 3 times, bad headache, light headed (almost fell twice). Was at my daughter's and was unable to drive home, therefore stayed overnight. Entire body felt very heavy throughout the night, as well as headache/nausea. In morning still felt the same and my sister drove me to my doctor's. Doctor prescribed Meclizine 25 MG Tablet, as well as Tylenol and Benadryl. Stayed in bed and slept. The night of Oct. 6th woke up middle of night damp pj's, as if fever had broken.  Felt better Oct. 7th.
The day of the vaccine, I had a sore arm and kind of a sore wrist on the right side. The next morning, I felt fine and put some laundry away and I immediately had to take a nap. Tired and took a lot of naps. I didn't have a high fever, my husband said I was a bit warm but no full on fever. I slept a lot on that Tuesday. After that, in the following days, I did notice I had a hard time concentrating and that lasted in all the following weeks. I felt like my energy was back but I couldn't concentrate and I felt really foggy and mind was unfocused. That is still occurring but less so. I mentioned this to my doctor. It's similar symptoms to when I'm having an auto-immune flair. I hadn't changed my diet or stopped taking my medicine but it felt like a flair-up. My doctor said I could come in to check my thyroid if I wanted to. Haven't yet but have just been diligent at taking my vitamins and meds really well so I'm trying to see if that works. I have a family friend who is a naturopath, that recommended how to get my inflammation down. She had me increase VIT D and drink more water and not eat anything that causes inflammation, no bread, pasta, nuts and dairy and she has me taking a microbiome probiotic.
Redness and swelling and warmth around injection site 4 inches x 1 1/2 inches.
Started experience what can be described as cold like symptoms 12 hours after vaccination. Next morning had full cold-like symptoms (chills, muscle aches, stuffy head, dizziness).  The second day felt better but became nauseous after physical exercise. The third day felt better in the AM but then started experiencing nausea and cold-like symptoms prior to bed. Today, the nausea continues when I eat.
Felt fatigued with arm soreness. Two days later developed left supraclavicular lymph node swelling. Pt describes swelling as size of "ping pong ball" with tenderness.  No axillary nodal swelling or tenderness. Progressive decrease in size of lymph node. Pt evaluated by clinician on 05/20/21. Non-tender palpable node measuring 2 cm X 1 cm. No axillary or cervical nodes noted. Recheck one week later, 05/27/21 - non-tender palpable node measuring 1 cm X 1 cm. CDC consultation sought 05/20 and 05/27.
feels a bit achy in his arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PAIN (feels a bit achy in his arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced PAIN (feels a bit achy in his arm). On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PAIN (feels a bit achy in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Call received 2/16/15 reporting leg pain, temp to 101.1, erythema around site, trouble sleeping, night terrors, poor appetite. Call back 2/19/15 reports 2 days of fever and leg erythema. Symptoms had resolved. Follow up visit 3/15 reported ongoing anorexia, wt loss, labs revealed IDDM.
Stomach cramping, nausea and dizziness.   Followed by headache.   Nausea issues began about 34 hours after the vaccine was given.   Headache lasted more than 24 hours.
RECEIVED EXTRA DOSE OF PENTACEL ALONG WITH REGULAR 4YEAR SHOTS.
Symptoms began day after vaccine, but consistent with highly prevalent URI in veteran patient community. Pt also c/o cold symptoms 2 weeks prior causing zoster vaccine to be rescheduled. Headache and fatigue, cough, rhinorrhea, nasal congestion.
This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 16-AUG-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.
The vaccine experienced a temperature excursion of 48.4 degrees Fahrenheit on 5/10/21 7:05am. Due to this excursion the vaccine was expired at the time of administration . The patient has not experienced any side effects at the time this report is being submitted.
One day after receiving Pneumovax right arm, patient presented with pain, redness, warmth 8-9cm area circumferentially right upper arm. Received oral dicloxacillin 250mg 4 times a day for 5 days.
This spontaneous report as received from a healthcare worker refers to 2 patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # K009105, expiry date: 21-JAN-2016, dose, route of administration and anatomical location was unknown). Concomitant medications were unspecified by reporter. On an unknown date the patients "broke out" in fever and chills. The outcome of fever and chills was reported as recovered/resolved without treatment. The causality was unknown. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Dose1 14Jan2021 / Dose2 14Jan2021; Super heavy and painful menstrual cycles since taking the vaccine.; painful menstrual cycles since taking the vaccine; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non pregnant female patient received first dose of BNT162B2 (Batch/Lot number: EL8972, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN5318, Expiration Date was not reported) via an unspecified route of administration, administered in left arm on an unspecified date as dose 2, single and for COVID-19 immunization at hospital. The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT, 50mg, 1x per day), dulaglutide (TRULICITY, biweekly). List of any other medications the patient received within 2 weeks of vaccination included Zoloft 50mg, 1x per day. Trulicity biweekly. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 12:00AM the patient experienced super heavy and painful menstrual cycles since taking the vaccine. Patient was not hospitalized. No treatment was received for adverse event. Device Date: 04Jul2021. The outcome of the event Super heavy and painful menstrual cycles since taking the vaccine was not recovered and rest event was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Four hours after the shot I began to feel achy. I went to sleep. Two hours later I woke up sweating profusely. I woke up because I could hear my heart pounding in my ears very hard. I tried to fall asleep but it continued to get worse. I got up and took my blood pressure and it was very high, too high, and my heart rate was 122. I tried to relax for an hour; however, my heart rate never dropped below 102 and my blood pressure continue to be in the high range. by 11 PM I had called the emergency room and although they could not to offer me advice I? decided to go there. My heart felt like it was going to explode. Since I have Ehlers Danlos syndrome which is a connective tissue disorder and there is a concern about aortic aneurysms, and my mother had an aortic aneurysm and a stroke, I was terrified. I am only six years younger than she was at her time of death from a stroke that resulted after an aortic aneurysm.
Received a full Moderna dose which is intended for immunocompromised patients. Should have been given a half dose for the booster.
grandmother reported from hosp ER that pt had sz @ home & was taken to hosp by amb AM p/vax;2nd sz in ER waiting room;
exacerbation of dyspnea that the patient was recovering from since acute covid-19 infection, from which he recovered one week prior to vaccination
Fatigue, Malaise > 60 days - thinks this has been occurring since receipt of the anthrax vaccine; never sought medical evaluation; thought it was related to work schedule.  Extreme pain of site and affected arm during injection and for 24 hours following vaccine receipt.  Headache, general - not sure when they started; pain from forehead to teeth; not relieved with Naprosyn, triggered/aggravated by bright lights; sometimes accompanied by nausea.  Memory loss, short term started after she received anthrax vaccine, but does not recall any details.
My left arm has weakness and has pain when I fully extend my arm up. This started about 5 days after injection and is ongoing.; My left arm has weakness and has pain when I fully extend my arm up.  This started about 5 days after injection and is ongoing.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 24Feb2021 at 18:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies to medication, food or other products. 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 receive any other medications within two weeks of vaccination. On 01Mar2021, 5 days after vaccination, the patient experienced left arm weakness and pain when she fully extend her arm up. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm has weakness and has pain when fully extend arm up. This started about 5 days after injection and is ongoing was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt went to MD and was told she had an infection due to injection in the left arm, Pt received an antibiotic from the prescriber.
Patient did not have any symptoms of an adverse event, but when using the Pharmajet injector, a significant amount of the vaccine came out of the side of the injector and did not get injected into the patient even though his skin was broken.
Patient received the dose of vaccine and waited in a chair for 15 minutes. Once the patient got up to stand he said that he felt lightheaded and then he passed out. He regained consciousness within 1 minute. After the patient regained consciousness the only side effect he reported was light-headedness and nausea. 911 was called and the patient was evaluated by EMS and was cleared to return home with his girlfriend.
Husband vaccinated with SPV around 09 Apr 09, approx 24 Apr wife developed a lesion near her eye, her arm and multiple lesions on vaginal area.  Did seek medical attention;  given abx and pain meds, cultures + Vaccinia PCR.  Spoke with pt 20 May.  Lesions completely cleared.  Denies scarring.
This information has been received from an office administrator concerning unspecified patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on an unknown date, the patients were vaccinated with two pediatric doses of VAQTA in place of one adult dose of VAQTA "20/0.5" (dose number, lot number, expiration date, route of administration and anatomical location were not provided), administered for prophylaxis. No product quality complained was involved. No adverse experience was reported. Additional information has been requested.
SCAR TISSUE IN LUNGS; ADRENAL GLAND INSUFFICIENCY; SUSPECTED LUNG DISEASE; CHEST PAIN; This spontaneous report received from a patient via a company representative concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose and start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in 2021, the patient had scar tissue in lungs and suspected lung disease. The patient underwent computed tomography (CAT) scan which was found to be abnormal and showed scar tissue in the lungs with lung disease suspected.  On an unspecified date, the patient had multiple symptoms of fatigue, nausea, chest pain and difficulty breathing. She had done multiple test and it revealed adrenal gland insufficiency due to steroid usage. She had started an oral medication for treatment of condition and felt like she was noticing improvement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient was recovering from adrenal gland insufficiency, and chest pain, and the outcome of scar tissue in lungs and suspected lung disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20211108588 covid-19 vaccine ad26.cov2.s-scar tissue in lungs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211108588 covid-19 vaccine ad26.cov2.s- adrenal gland insufficiency .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: CONMEDS-OTHER SUSPECT DRUGS
pt recv vax & approx 2hr later pt had episode of shaking, sz like activity (last about 20sec then apneic, turned blue around lips & hands;otherwise white;was adm to hosp-lethargic to 5-6hr;t103 R emp throughout the noc-vomited 1x;
Large Bruise (still visible), arm and finger tingling lasted 6 days, circular rash below injection site, Headache for 5 days, Fever 101 - 103.9 for 24 hours, Chest and neck tightness, felt like sharp glass in neck Rash on stomach and waist area for 5 days
Patient states that about 5 hours after she received the Flu vaccine, she had uncontrollable shivers, the room started to spin, nausea and vomiting, weakness, unable to get up on her own. States that by next day she was better. Patient did not go to see MD for this until her follow appointment on 10/2/17 when she reported this to our office.
Developed headache Tuesday 2/14/12. Wed. 2/13/12 went to her PCP and was diagnosed with an upper URI (antibiotics begun). PCP felt headache from Gardasil. Told by our office staff to call if headache persists.
patient complains about hot, red area at injection site with significant pain upon moving the arm. Also she complained about swelling from shoulder to elbow.
Information has been received from an office manager concerning a female who was vaccinated with the first, the second and the third dose of GARDASIL on 11-MAY-2007, 19-JUL-2007 and 18-JAN-2008 respectively. The patient was requesting records due to GARDASIL and there was a lawyer involved. The patient did not mention any problems or why the medical records were needed for the lawyer. The office manager thought that this may be due to the patient not wanting to pay her bill. The office manager was also not positive if this was about GARDASIL or the patient was mixed up with another shot such as Depo-provera. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
MODERNA COVID VACCINE # 3 GIVEN 11/18/21, LOT #027H21B; pt lives at an assisted living facility, 2/14/22 pt had a positive COVID test in the facility; was followed by Home Health and Hospice care; pt is O2 dependent prior to COVID; SOB is worse with exertion, but pt is not compliant with wearing her O2 in the facility; pt was found deceased on 2/28/22 in the facility
12/16/02 - Mom called and states child had seizure. 12/5/02 - was seen at a medical facility. 3/18/03 - Phoned dad states neither he nor mom witnessed the seizure - it was a relative, have left message for this witness to call reporter back - no response.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Systemic: Weakness-Severe
Meningococcal MCV4 Lot# U3433AA - Exp. 08/02/11 vaccine administered 08/10/11, 8 days after expiration date. Meningococcal MCV4 Lot# U3778AA Exp. 10/14/12 readministered: 8/15/11.
Patient came to the ED with shortness of breath, dizziness, and chills.  Symptoms started after dose of Paxlovid and azithromycin.  Patient was admitted to the hospital with Covid and treated with remdesivir.
Information has been received from an emergency medical technician concerning a 35 year old female mother. On 1/6/03 her child was vaccinated with a dose of Haemophilus B conjugate vaccine (lot number not reported). A small drop of vaccine splashed in the mother's eye and she reported a slight sting and blurring of vision. Unspecified medical attention was sought. Additional information has been requested.
Very red at site with raised hard spot as reported by the mother on the evening that he received the vax. Redness and swelling gone the next day.
She states she received all 4 COVID-19 Vaccines in her left arm and has 4 tiny scar spots. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:  An 88-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9262) at the age of 86 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: taking Synthroid for years and thinks 10, years. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. The following information was reported: SCAR (non-serious), outcome "unknown", described as "She states she received all 4 COVID-19 Vaccines in her left arm and has 4 tiny scar spots.". Sender's Comments: Linked Report(s) : US-PFIZER INC-202200789445 same reporter, patient, drug and different event;
Information has been received from a physician concerning a 13 year old female with no pertinent medical history and no drug reactions/allergies, who on 28-SEP-2007 was vaccinated with her 0.5 ml second dose of Gardasil (lot number: 1427F/655619) and fainted.  Concomitant therapy included ADACEL.  On unspecified date the patient recovered from fainting.  Unspecified medical attention was sought.  No further information was provided.  Additional information has been requested.