chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it was four days after my second COVID-10 vaccination that this latest major depression hit; This is a spontaneous report from a contactable reporter.   A female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection; Lot Number and expiry date was unknown), via an unspecified route of administration on an unspecified date and second dose (lot number and expiry date was unknown) via an unspecified route of administration on 20Feb2021 as a single dose for COVID-19 immunization. The patients medical history included secondary progressive multiple sclerosis and Major Depressive Disorder. Concomitant medication included Lexapro (20mg) Wellbutrin (450mg). On an unknown date in February, the depression came back terribly. The patient worked with a psychologist, physician took her off Lexapro and put her on Trintellix (10 mg). After a month, with no success, she increased the Trintellix to 20mg and weaned of the Wellbutrin. The patient felt a little better for a couple of weeks, but the overwhelming black cloud had returned. Some interesting extra information she thought that much of the change may have been after changing from the Brand Name Lexapro to the generic drug. Also, it was four days after second COVID-10 vaccination that this latest major depression hit (2nd vaccine was February 20th and the horrid black cloud hit on February 24th). She did not know if there was any real drug interaction. The outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Came into pharmacy claiming knot at injection site with pain.
~3PM PATIENT RECEIVED COVID VACCINE AND WAITED AT COUNSEL WINDOW TO ASK RPH A QUESTION. WHILE WAITING PATIENT COLLAPSED TO FLOOR FACE FIRST WHICH WAS WITNESSED BY PHARMACIST. PHARMACIST IMMEDIATELY CALLED 911 AND TECHNICIAN AND TECHNICIAN WENT TO ASSIST THE PATIENT. PHARMACIST MAINTAINED LINE OF SIGHT ON PATIENT DURING 911 CALL. PATIENT REGAINED AWARENESS OF SURROUNDINGS ~1 MINUTE AFTER FALLING AND ASKED HOW HE FELL. PATIENT REMAINED SEATED ON FLOOR FOR ROUGHLY 10 MINUTES WHILE WAITING FOR PARAMEDICS TO ARRIVE AND WAS OBSERVED DURING THE ENTIRE TIME BY PHARMACIST AND TECHNICIANS.  PATIENT DRANK SOME WATER DURING THIS TIME FROM A BOTTLE PROVIDED BY TECHNICIAN. PARAMEDICS CARED FOR PATIENT AND LEFT STORE ~15 MINUTES AFTER ARRIVAL.
Around midnight had severe dizziness and nausea. The next day I had fever and chills, those lasted until Saturday. Had a swollen tongue for two days. As of friday I still could not keep any food down. Saturday, I can only keep cereal down everything else i vomit up.
Moderna COVID-19 Vaccine EUA gave me a delayed, localized immune response. I experienced symptoms 8 days after the vaccine delivery. It was at the site of injection, left arm, and was the size of 1"x3". It included redness, itchiness, and some hive-like bumps. It lasted for 24 hours.
Information has been received from a registered nurse concerning a 28 year old female patient with end stage renal failure (dialysis patient), who on 10-JUN-2010 was vaccinated with a dose of PNEUMOVAX 23 intravenously (Lot No. not reported). Following vaccination the patient experienced flushing, stomach ache and shortness of breath. Oxygen was supplied and the patient was reclined. The patient recovered shortly after these side effects but still complained of a stomach ache for about two hours. Once she left dialysis facility she noted that she was back to herself. Follow up information has been received from a registered nurse concerning a 20 year old female patient (previously reported as 28 year old), with end stage renal failure (ESRD), primary oxalosis and azithromycin allergy, who on 10-JUN-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot # 65401/1320Y) IV at 13:30. Concomitant therapy included MANTOUX SKIN TEST (Lot #C3506AB) SQ in the forearm on 08-JUN-2010 at 12:00. On 10-JUN-2010, the patient became short of breath, nauseated and complained of stomach pain (that lasted several hours). The patient became flushed and hot. The symptoms were treated with oxygen. The patient laid back and dialysis continued. After a period of 10 minutes, the patient reported feeling better and stomach pain remained for four hours. It was reported that the patient did not seek medical attention. The patient recovered on the same day. Additional information is not expected.
1/4/2021  vaccination. Arm started to hurt at 9:30 pm. Developed rigors, muscle aches; lasted till 6am.  Next 24 hours; fatigue, nausea, body aches.  *wasn't able to do much *Can't still really move arm *Had COVID in August  *3rd pregnancy. 06/03/2021
Baby became very agitated and fidgety would not sleep at night anymore, was not nursing well.  Baby was flailing arms around and hitting and moving head in head butting motion.  Baby was not cooing or smiling anymore she changed drastically.  These symptoms lasted 10-12 days gave baby a bath to soak in epsom salt for 20-30 min.
About 8 days after I received the vaccine, my arm developed a red, lumpy rash that tingles and is warm to the touch.
Antigen was reconstituted with normal saline instead of the adjuvant; Antigen was reconstituted with normal saline instead of the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   On 21st July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 21st July 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were p[rovided as follows: The age at vaccination was not reported. Health care professional reported that a patient was administered the antigen was reconstituted with normal saline instead of the adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter mentioned that, only information about the patient that was currently available was she was female. Minimal information was available from the reporter. The reporter consented to follow up.
HEART FLUTTERING; PAIN EVERYWHERE/ACHY FROM HEAD TO TOES; DID NOT FEEL GOOD; EXTREMELY TIRED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight was 260 pounds, and height was 64 inches. The patient's past medical history included: liver transplant and blood clot. The patient experienced cellulitis when treated with levofloxacin (Lovenox), and oxycodone hydrochloride/paracetamol (Percocet). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 09-SEP-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, amlodipine besilate, bupropion hydrochloride, empagliflozin, ergocalciferol, ezetimibe, levothyroxine sodium, losartan, metoprolol, mycophenolate sodium, pioglitazone, calcium and tacrolimus. On 10-SEP-2021, the patient felt extremely tired and did not feel good. The patient went to bed around 9 pm and on 11-SEP-2021, she woke up at 4 am and felt like somebody beat her and she had pain everywhere, also her hair hurt. The patient was achy from head to toes, and her pain was over 10/10 on the pain scale. The patient took 2 Tylenols and felt no relief. On the same day, the patient felt like her heart was fluttering a couple of times. Laboratory data included: Pain scale (NR: not provided) pain over 10/10. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain everywhere/achy from head to toes, and heart fluttering, and the outcome of extremely tired and did not feel good was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210921278-COVID-19 VACCINE AD26.COV2.S- heart fluttering. 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).
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored dose of M-M-R II lot # K022284 expiration date 12-NOV-2016 (indication and dose number were not reported) was given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of the several reports of the same source. Additional information has been requested.
experienced pain in his shoulder; This is a spontaneous report from a contactable consumer (patient himself). A male patient of unspecified age (reported as 'Age:68; Unit: Unknown') received received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. Medical history included injury unrelated to the COVID-19 vaccine. The patient's concomitant medications were not reported. The patient stated he only experienced pain in his shoulder on an unspecified date. He had several injuries unrelated to the COVID-19 vaccine and wanted to know how long he had to wait to take a pain pill for his other injuries. Outcome of the event was unknown.    Follow-up attempts are completed. No further information is expected.
Mother of patient reported some swelling after first day, which progressed to the left upper arm down to mid forearm swelling with edema. Pt was seen 8/13/09. Ice applied. Course of Keflex for treatment along with benadryl and ibuprofen.
Started with flashing light in lower right eye late January ; by mid March symptoms included heart racing, internal tremors, tinnitus, swollen under arms, bloody noses, worsening visual symptoms, paresthesia, vertigo, excessive fatigue, nausea; I have had some combination of these symptoms 24/7 this whole time ; the tremors and heart racing  stopped early on. Another symptom that has reduced a lot  is the scalp crawling sensation  that would fire up up and  seem to trigger tingling in other parts of my body. The tinnitus has decreased over time,   though I still have it; the visual symptoms are the most troubling . I still have the paresthesia to some degree although some of it is likely a side effect of the Topiramate. These past two weeks I have started feeling some of my energy coming back; nausea is less frequent;
On October 21, 2019 an influenza vaccination I received at the Drugs noted above, was not appropriately administered into my left deltoid muscle as intended. As a result I have a shoulder injury related to the misplaced injection (SIRVA). I remain in active treatment as of this date. Over my lifetime, I have received many types of vaccinations at various care facilities without concern or complication - including previously a this location. However, I believe this particular injection was not appropriately administered into my left deltoid muscle. The individual who gave me the influenza vaccination stood when administering my injection while I was seated in a chair. The actual injection of the needle in my arm caused immediate and significant pain - not the slight "prick" of pain normally experienced. I said, "Ow!" but thought nothing more of it until the morning of October 24, 2019, when I began to experienced severe pain and range of motion limitations to my left shoulder and arm. Since that time, the symptoms have been chronic and have negatively impacted my quality of life. Initially, I tried relieving pain with over-the-counter medications. When those did not provide relief I pursued medical attention - multiple visits with providers and multiple MRI's.
Pt reports that she had a globus sensation and some shortness of breath PRIOR to receiving the vaccine.  She was monitored 15 minutes post-injection without incident.  When she walked out to the hallway to go home she reported that she felt like she was going into anaphylaxis and a Rapid Response was called overhead.  She was complaining of feeling like her hands and feet were swelling and that he voice was hoarse.  Her lips were noted to be large and her husband confirmed that they looked larger than normal.  She was found to be hypertensive to 196/109 so analyphylactic shock was ruled out and she was not treated with an epi pen.  She was transferred to the ER.  Exam found scattered wheezing, mildly protuberant lower lip, no tongue swelling, no drooling.  She was treated with IV solumedrol 125mg, IV benadryl, IV famotidine, and a racemic epi nebulizer.  ENT came and visualized her airway via NPL and found no oropharyngeal or laryngeal edema. She was admitted to the MICU for 48-hour anaphylaxis observation and continued on steroids and anti-histamines.  By the following morning she was feeling well.
Injection site soreness and pain, with swelling and tenderness, worsening throughout day. Pt c/o N/V. Pt was taken to local ER, given solumedrol, ranitidine, and and benadryl IVP. Pt remained stable and VSS throughout. Discharged that night.
Reported via phone: Numbness tingling hads + feet 1 wk p Covid Vac.
per tp had dizziness within an hour and nausea and vomiting, also report muscle rigidity in vaccination site. Pt was too fatigued to work or get out of bed for 5 days .
Sedation, Myalgia, Chills and runny nose, and sore throat reported Narrative: Reported symptoms, but no apparent loss of function or decrease in ADL's
Thrombocytopenia; He had clot in the legs and in the lungs; He had clot in the legs and in the lungs; Low platelet count; This is a spontaneous report from a contactable Other-HCP. A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 67 years). Medical history included diabetes. Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]); colecalciferol (VITAMIN D [COLECALCIFEROL]); lisinopril; insulin taken for diabetes mellitus. The patient experienced thrombocytopenia, he had clot in the legs and in the lungs and have a low platelet count on an unspecified date. The patient was hospitalized for the events on an unspecified date. The patient underwent lab tests and procedures which included CBC: unknown result on 08Apr2021, Heparin associate antibody: unknown result, comprehensive metabolic panel (CMP): unknown result and platelet count: low on an unspecified date. Therapeutic measures were taken as a result of thrombosis included Heparin drip and Argatroban. Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: The reported events are considered unrelated to BNT162B2 vaccine, being rather intercurrent occurrences. Clots in the legs and in the lungs were likely favored by the mentioned diabetes and by a possible hyperlipidemia (the patient was taking  atorvastatin) in a setting of possible arterial hypertension (the patient was taking lisinopril).  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Night sweats,   some lethargy,  affected breathing during walking regine (6 to 7 miles daily). .reaction  to routine allergy injections on the the 8th of March -  fist size swelling on both arms at the injection sites.  This had never occured before, and I have been on the allergy medicines  for 4 years..
This spontaneous report was received from a Registered Nurse (R.N) concerning a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. The Registered Nurse reported that on an unspecified dates, these multiple unspecified patients were administered improperly stored doses of GARDASIL 9 (Lot # and doses were not reported) which was exposed to 8.8 degrees C but it was unsure of cumulative time out of range and it was every 15 minutes then fluctuating every two hours (Cumulative: unsure of time frame). There was no previous temperature excursion and the call was made because of a digital data logger. No adverse effects were reported. These is one of several cases from the same source (MARRS # 1607USA004237, 1607USA006261 and 1607USA006262)
Sore right posterior neck opposite side of injection site. Patient attributes this to vaccine reaction. Feels well otherwise. No redness at site of injection.
woke up 8 days later with itching, redness, soreness, and heat at the site of the injection on my left arm. Also experiencing intermittent pain in my left arm pit.
Persistent pain in spine, arms, legs, testicles. Intermittent chest pain. Level of pain gradually reducing since injection, but still noticeable as of 11/22.
Warm to the touch Injection Site after 3rd shot; Itching from Head to toe after 3rd shot; Histamine reaction after 3rd shot; Swollen Injection Site for 3-4 days after 3rd shot; Itchy Injection Site after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), ALLERGY TO VACCINE (Histamine reaction after 3rd shot), VACCINATION SITE SWELLING (Swollen Injection Site for 3-4 days after 3rd shot) and VACCINATION SITE PRURITUS (Itchy Injection Site after 3rd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Caller stated allergic to sulfa.).  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), ALLERGY TO VACCINE (Histamine reaction after 3rd shot), VACCINATION SITE SWELLING (Swollen Injection Site for 3-4 days after 3rd shot) and VACCINATION SITE PRURITUS (Itchy Injection Site after 3rd shot). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), ALLERGY TO VACCINE (Histamine reaction after 3rd shot), VACCINATION SITE SWELLING (Swollen Injection Site for 3-4 days after 3rd shot) and VACCINATION SITE PRURITUS (Itchy Injection Site after 3rd shot) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
Besides my arm being sore, I had no issues. On the 23rd, I started having chest pains and worsened until I decided to go to the clinic. I was still having pain after they gave me some aspirin. I was taken to the hospital and admitted. They did a stress test and it was normal. I was sent home the next day and I was fine.
This spontaneous report was received from a 25 year old patient (gender unspecified) via patient support program GARDASIL (access program). The patient's concurrent conditions and medical history were not reported. On an unknown date when the patient was 17 years old he/she was vaccinated with first dose of GARDASIL (lot # and dose were reported). The patient received all the three doses at right interval. Till he time of vaccination the patient have not had sex. On an unknown date (at the age of 25), the patient experienced condyloma. The gynecologist told the patient that she could not explain to herself, why it could happen that the patient got HPV. She also said that the GARDASIL injection was not just to prevent the girls from cervix cancer, but also from condyloma. The outcome of condyloma and papilloma viral infection was unknown. The reporter did not provide the relatedness of the events with GARDASIL. Additional information has been requested.
PATIENT WAS GIVEN FLUAD 2021-2022; NO REACTION REPORTED
Information has been received from a medical assistant concerning a 79 year old female with allergies (allergic to BIAXIN) and anxiety disorder who "6 year ago", in 2004 was vaccinated with the first dose of PNEUMOVAX 23. On 12-OCT-2010 the patient was intramuscularly vaccinated with the second 0.5 ml dose of PNEUMOVAX 23 (lot # 667913/1021Z, expiration date 27-FEB-2012) in her left arm. Concomitant therapy during the same visit included a dose of influenza virus vaccine (unspecified) in her left arm and a dose of ADACEL in her right arm. Other concomitant therapy included loratadine, ADVAIR, albuterol, FLONASE and XANAX. On 13-OCT-2010 the patient experienced pain in her left arm and was unable to lift her arm. The patient was unable to sleep because of pain. The patient was examined with x-ray in the office on 02-OCT-2010 and the result showed normal with some arthritis. She experienced some improvement but still complained of left shoulder pain. The patient was prescribed KEFLEX. At the time of the report, the patient was recovering. Additional information has been requested. This is one of several reports received from the same source.
After approximately 5 minutes after the vaccination, the patient report swelling on the throat, heavy tongue, and some itching. At 5:30 pm 50 mg of oral diphenhydramine were given and after that the swelling of the tongue worsen an at 5:33pm an Epinephrine auto-injector of 0.3 mg was administered on the thigh. After that patient was transported to the nearest hospital and the family of the patient was contacted.
30 minutes after vaccine administration patient alerted paramedic in observation room that her arm was feeling tingly and worried that due to her history she was starting to have an allergic reaction. Patient self-administered oral benadryl, waited an additional 15 minutes. Patient declined need for epi-pen and adament that she did not need to be transported to emergency room. Patient left facility stating if condition got worse she would take herself to the closest emergency room and/or call 911. Contacted patient for follow-up within 5-10 minutes after leaving building. At which time she stated that she was feeling fine and thought her seasonal allergies were exacerbating symptoms, as she stated she is very allergic to pollen. In addition, patient stated she was feeling very anxious while in observation room, however feels better once exited building. Instructed patient on signs/symptoms of worsening reaction, what to look for, and when to administer epi-pen and seek additional help. Patient verbalized understanding and stated she feels fine at this time and thinks she will be okay.
Child in for Immunization 3/7/02. Given @ 09:30. Mom describes fussy through night, projectile emesis x 2 each time post dose of Tylenol -mom concerned re: breathing. Child seen 0930 3/87/2002. SA02 989, color good-remained fussy, Through visit-feeding well-weight up 3 oz from yesterday.