chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through the pharmacy LTC partnership vaccination program. Resident had no adverse effects until around 8:00 pm she began complaining of body aches, and chills, Tylenol was given at this time. Around 9:30pm resident was sleeping in bed. Around 12:00 am the CNA called nurse into room to assess resident as the resident stated she did not feel good. Temperature at that time was 102.2, and vomiting. RN came to assess @ 1220 am She was noted to be vomiting, diaphoretic, pale and having trouble breathing. Temp was 97.3 after vomting, Pulse 53, Resp 20, o2 sats were 40-45%, unable to obtain Blood pressure, Applied 5 L of oxygen at this time and had LPN call 911 immediately. Resident was repsonsive and able to follow staff members instructions but was only answering yes or no simple questions at the time time of assessment. Paramedics arrived at 0040 and resident was sent to Hospital. @ 0130 ER nurse called to nursing facility to notify resident had coded in the ER and passed away @ 0110.
Covid monitoring documentation. PT admitted 12/16/22 documented to have positive covid. PT received Pfizer 1/15/21 Lot EL0140 for dose 1. Dose 2 was Pfizer given on 2/5/21 Lot EL3302. PT received Pfizer Booster on 11/04/21 Lot FH8027.
Urinary incontinence and increased frequency starting 1 day following injection and continuing into day 2.
vision loss; shingles; other zoster related injuries; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-OCT-2015 (61 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles, vision loss and other zoster related injuries. The outcome of these events was unknown.  Upon internal review, vision loss was determined to be medically significant.
Patient reports left arm pain ongoing since April 2018, starting with the Pneumonia shot. Patient reports left arm continues to ache, worse with movement. Patient notes pain feels like a pulled muscle-not electric like a nerve pain. No better with taking meloxicam. Provider has started patient on orphenadrine for possible muscle spasm and lidocaine topical to the area.
This spontaneous report was received from a pharmacist referring to a 64 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were reported as none. On 02-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Units (PFU), subcutaneously, in the left upper arm, lot # M033335 with expiration date 11-OCT-2017, for prevention of shingles. On the same day, the patient noticed some of the "regular adverse effects": tenderness, redness, pain and "skin was hard". The patient stated she must had been scratching the injection site at her sleep as she noticed "pus coming out of her injection site" that night. The patient also reported that her injection site was "blistery" and that the redness was spreading. It was stated that the patient treated the injection site with hydrogen peroxide topically. The patient had not consulted her primary healthcare provider and would have a visit to the pharmacy on 03-MAY-2017, so the pharmacist might examine the patient's injection site adverse symptoms. It was also reported that her healthcare professional was interested in a Varicella-zoster virus (VZV) analysis by Polymerase Chain Reaction (PCR) and wanted to send viral isolates. At the time of reporting the outcome of the adverse events was reported as not recovered. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Patient presented to facility with chest pain radiating to left arm.  Patient ruled out non-infectious.
12 days p/vax pt devel generalized red, raised, blotchy rash;also hadswelling of elbows, knees, & ankles;also had wheezing;seen in MD office admitted to hosp;given DPH;hosp x 2 days;cont on steroids & DPH;rash today light, resolving;
Mother talked to PHN per phone 12/16. Stated shortly after vaccination administered to daughter (12/15), pt became hoarse and started "crying and screaming" about pain to right arm, site of flu vaccine. Denied shortness of breath. Mother referred to ER. Daughter was not crying then, stated she didn't want to cry in front of the nurses and doctors. They (ER?) will have her incident reported (I am assuming she was not seen by MD - that the mother telephoned and she was referred to ER then). Daughter was assessed, no procedures administered. Mother stated arm "looked fine" with exception of red splotchiness to entire arm "like spider veins - or the way your face does when you cry a lot".
Tired, cranky 24 hours, post vax. No fever with Tylenol as instructed. Local reaction on left leg, 48 hours, post vax, with edema, redness and hard area at site.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 11:30 (Lot number: FC3182) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D NOS. The following information was reported: TASTE DISORDER (non-serious) with onset 03Sep2021 06:00, outcome "not recovered", described as "Within 30 minutes of shot I experienced a distinct taste in my mouth/throat (minor)"; MENSTRUAL DISORDER (non-serious) with onset 03Sep2021 06:00, outcome "not recovered", described as "Then within 24 hours I started a menstrual cycle. Currently on day 7 of bleeding". Therapeutic measures were not taken as a result of taste disorder, menstrual disorder. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient currently has the Mirena IUD. The IUD prevents her from having a menstrual cycle. Within 30 minutes of shot I experienced a distinct taste in her mouth/throat (minor). Then within 24 hours I started a menstrual cycle. Currently on day 7 of bleeding. A bit alarming to why my body is reacting in this way. And enquired about Causing a hormonal spike. No follow-up attempts are possible. No further information is expected.
she has stage 4 lung cancer.; This spontaneous case was reported by a patient and describes the occurrence of LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV (she has stage 4 lung cancer. ) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV (she has stage 4 lung cancer. ) (seriousness criterion medically significant). At the time of the report, LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV (she has stage 4 lung cancer. ) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported.  It was reported that patient received all Moderna Vaccines. No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Lung carcinoma cell type unspecified stage IV, which occurred related to the mRNA-1273 vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The outcome was not reported. The company considered the event as not related to the vaccine due to the nature of the event, lack of biological plausibility, short latency and known safety profile of the vaccine. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact
I suffered moderate fever chills that lasted roughly 24 hours and kept me bundled in multiple extra layers beyond what weather conditions required.
pt recvd vax & 5 hrs p/vax devel erythema, swelling, itching in lt arm-area hot to touch;sxs subsided p/3 days;day 4 arm & hand became red-streaked & itchy; day 5-feet itchy;sxs persisted 6mos;recovered;MD report dx dermatographism
Patient described original "tenderness" after shot then that went away. Approx. 2 to 3 weeks later pt felt that the arm where the shot was given became lame and had some restriction of mobility but experienced NO tenderness. Since fully resolved over the next 2 days. NO tenderness, redness, rash, or trouble breathing reported.
Pain in area of where the lower buttocks meet the upper leg. Pain radiating down and across upper leg. I wouldn't have even thought about this being related to the vaccine, but 2 other acquaintences have mentioned the same problems coming up since the last vaccine. There has been no injury or event to explain this pain.
Patient was given the 2nd dose 21 days after 1st dose. Patient described more severe side effects such as fatigue, fever, body ache, and heart palpitation
Cough; COVID-19; Temperature of 99.4F; missed second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine), COVID-19 (COVID-19), COUGH (Cough) and PYREXIA (Temperature of 99.4F) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine), COVID-19 (COVID-19), COUGH (Cough) and PYREXIA (Temperature of 99.4F). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine) had resolved and COVID-19 (COVID-19), COUGH (Cough) and PYREXIA (Temperature of 99.4F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 (normal) Normal. On an unknown date, SARS-CoV-2 test positive: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.  No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received included no new significant information. Corrections made in initial where lab data added,covid investigation removed from event tab and added event COVID-19
Client complained of pain and swelling in right calf area 2 -3 days before going to ER  , at ER.  Doppler study confirmed popliteal DVT
3 vaccines were given, the patient was conversing with giver of immunization while drawing up 4th vaccine - Pt fell out of chair, hit head and was seizing with 5-10 sec diminished consciousness. Laceration on head was treated after LOC had been restored.
Rash on face, sensitivity to  light, headaches. Sore mouth -- these disappeared after a week and treatment with Advil and cortisteroid cream.  Chilblains on fingers continue to be a problem.  Doctor has done blood test for Lupus and report is negative.
On 05/11/2021 by evening I had intense chills, fever rising. The next day I had 103.7, my vision was seriously impaired. I could not read or see anything. 05/12/2021 I went to see my pediatrician. She told me if my fever did not go down by the next day to go to hospital by 05/13/2021, my fever started to break the previous day, but it completely went down on 05/13/2021. Under a week post vaccine, I had slight pain in my wrist and elbow, nerve pain would shoot throughout my forearm. It was in both arms, not just the arm I received my vaccine in. I occasionally get nerve pinches because of my hypermobility. Within 7 days the nerve pain was intense and it stayed that way for over a month. I was unable to use my arms for a month and a half. That settled on its own a month or 2 later. The never pain itself has settled down. My doctors have told me we can't eliminate the possibility that the vaccine triggered it. My health has declined. I was diagnosed with POTS on 09/20/2021. I was having those symptoms several months before that. I do have family members with POTS, but I have never had any symptoms. The symptoms came on suddenly and the doctors are wondering if there was a trigger that set off the symptoms, were the symptoms were so bad and so sudden. I now have a long term health condition. I still don't know if this was caused by the vaccine. My doctors still think it might be a possibility that it was caused by the vaccine. I am still in my current occupation. My arm pain is gone but my arms are just weak now. I did not need accommodations at school prior to the vaccine and I do now.
MCV4 GIVEN ON 2-1-06 @1000.  SXS OF DIZZINESS, BLURRED VISION BEGAN AT APPROXIMATELY 1730.  VS T (100.9) P(120), BP(124/70), R (20).  SENT TO ER WHERE HE C/O OF GENERAL ACHINESS, CHILLS AND HA.  TX'D WITH MOTRIN 400MG AS DIRECTED.
I was just under six weeks pregnant when recieved the flu shot via needle, so it was not the live virus that was administered to me. My body continued to think that it was pregnant and I made it to just over 12 weeks thinking that my baby was still growing inside of me. I was not able to get to appointments earlier due to my having just moved and getting settled in here. When I went for my appointment at what was suppose to be just over 12 weeks we discovered that my baby had passed away at 6 weeks and roughly 4 days. I had to have a D&C in order to remove my baby and the hospital sent her to pathology where they determined that the baby was female and her chromosomes were normal.
Patient developed a rash on his torso, but no difficulty breathing or swallowing.  Mother was told to give the patient Benadryl tablets and if the reaction intensifies or leads to difficulty breathing or swallowing to seek emergency help immediately. Spoke to mother at 6:00pm patient was at work had taken the Benadryl and reaction had not intensified
Injection was made into the correct location of the deltoid, however, the patient reported immediate numbness from shoulder to finger tips.
allergies; tested positive for COVID-19; did not feel well the next day after receiving the vaccine; fatigue; severe headache; This is a spontaneous report from contactable consumers (spouse and patient) via medical information team. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 02Mar2021 at 13:36 (at the age of 66-year-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history included cough (ongoing) on 28Feb2021. The patient concomitant medications were not reported. It was reported that the patient was not feeling well the next day after receiving the vaccine and thought it may have just been side effects from receiving the vaccine. The next day 03Mar2021, the patient had a severe headache that persisted until 16Mar2021; fatigue that was improved; and a cough which he had a couple of days before getting the vaccination. Added they thought it was allergies. The cough was getting better now. On 09Mar2021 (reported as a week later), he felt worse and tested positive for COVID-19. After spoke with doctor this past Friday and she advised him that he should wait to receive their second dose as it might be too soon. He treated with zinc, vitamin C, vitamin A, vitamin D, and melatonin. The patient symptoms were all improving. The fatigue was tremendous. He was scheduled to receive their second dose tomorrow 23Mar2021. The patient asked if fatigue and cough would be considered symptoms of COVID-19 and if he should wait to receive the second dose of the Pfizer COVID-19 vaccine if they still have those symptoms. The patient further asked if he receive second dose of the Pfizer COVID-19 vaccine past the recommended 3 weeks would his first dose be null and void. Outcome of the event severe headache was recovered on 16Mar2021; for tested positive for COVID-19, did not feel well the next day after receiving the vaccine and fatigue was recovering while unknown for allergies.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021313502 same reporter/similar events, different patients
Pt c/o tingling, itching and numbness to tongue x 10 min.
Injection was given at 3:20pm. At 3:48pm, patient was cleared to return home. At approx. 8:20pm, patient became disoriented, faint and pale. He experienced hot and cold flashes, in addition to auditory disruption and continued disorientation. Thereafter, he experienced diarrhea. This form is being completed at 9:25pm and he continues to experience body aches, cramping and coldness.  We are unable to call employee health as they are closed and there is no ability to contact anyone at the hospital he works at d/t the time of day.
Encephalitis, Failure to Thrive, Hypersomnolance, Developmental Delay
rash, redness, hot to the touch, itchiness, pain, large red spot about 5in x 4in upper left arm. vaccine on the 14th  issues started around the 17th and still continue as of 12/20/2021. after the second shot same arm as first. I did not go to a doctor and filled this out myself.
"bad taste in mouth, tongue feels funny, numb." B/P 102/60           P 68
High Ig M (over 1000) and internal lumps at bottom of my feet from toes to arch and continuing up foot. Caused meniscus to tear while running and can't do tennis, yoga, running etc.  have to be cautious about falling.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "low weight" (unspecified if ongoing), notes: Patient is low weight (88 lbs); "slow metabolizer" (unspecified if ongoing), notes: history of being a slow metabolizer (needs lower doses of medicines). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Weight: Low; 88. Therapeutic measures were taken as a result of suspected covid-19. Clinical course included: The patient received Paxlovid oral for the treatment of COVID-19 from 17May2022 to 19May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dose of expired Jynneos administered; Case reference number US-BN-2022-004183 is a spontaneous case report initially received on 12-Oct-2022 from Other Health Professional (reference number: USBAV22-1691) and concerns a patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose, at an unknown route or site of administration, for an unknown indication.  As reported, the vaccine that was administered to the patient had expired two days prior to vaccination (explicitly coded as 'expired product administered').  At the time of this report, it was unknown if the patient experienced any adverse events due to Jynneos.  Additional information received from Bavarian Nordic on 12-Oct-2022 included the local case ID.; Reporter's Comments: The patient of unknown age or gender was vaccinated with the Jynneos vaccine on an unspecified date at an unknown dose, route or site of administration. Reportedly, the vaccine that was administered to the patient had expired two days prior to vaccination which is considered expired product administered. The event is considered listed per the Company conventions. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events following vaccination. Expired product administered is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: The patient of unknown age or gender was vaccinated with the Jynneos vaccine on an unspecified date at an unknown dose, route or site of administration. Reportedly, the vaccine that was administered to the patient had expired two days prior to vaccination which is considered expired product administered. The event is considered listed per the Company conventions. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events following vaccination. Expired product administered is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Pfizer vaccines and the temparature fallsoutside of the ranges; controllant monitor that automatically stops 2 days ago; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "Pfizer vaccines and the temparature fallsoutside of the ranges"; PRODUCT STORAGE ERROR (non-serious), outcome "unknown", described as "controllant monitor that automatically stops 2 days ago".  Additional information: The vials in the freezer w/ are currently at -22 degrees Fahrenheit w/c is -9 degrees cooler than what is stated w/c is -13.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling and redness in left foot and ankle. Swelling started 1 week after vaccine and has persisted.