chrisvoncsefalvay/vaers-outcomes huggingface dataset:
74-year-old male presented with cough and shortness of breath.  He tested positive for COVID-19 viral infection prior to this admission.  He was noted to have significant hypoxia and lactic acidosis upon admission.  His chest x-ray showed bilateral infiltrates, primarily involving the lower lobes concerning for viral pneumonia.  He was initially placed on BiPAP because of acute respiratory distress, but his respiratory condition continued to deteriorate ultimately requiring him to be  intubated and placed on mechanical ventilation.  He was treated with IV Decadron, IV remdesivir, IV tocilizumab.  His treatment included those agents.  He developed hypotension, required vasopressor support.  His  renal function deteriorated early in the hospital stay.  His hospital stay was complicated by gastrointestinal bleeding, necessitating blood transfusion. Ultimately, he was weaned from mechanical ventilation.  He was quite  weak secondary to his prolonged respiratory failure and initially transferred to a Rehab facility was contemplated.  The patient's family, however, was opposed to Rehab placement and insisted that he be discharged home  with home care.  He was discharged home on 11/20/2021 in stable and improved condition.
Two days following pneumonia immunization patient c/o vomiting fever, and reddened area at site of injection.  Seen by MD on 11-13-08 & diagnosed with cellulitis and treated with KEFLEX.
On the 3rd day of the vacation I began to present an allergy that began in my neck and spread throughout my body, at first it only turned red but later at night it began to get much more rash and hives.
Passed out and threw up within 15 minute waiting period. Since then have had a fever, body aches, headache, nausea, chills and joint pain.
1115 resident w hx congenital weakness to R arm reporting R arm tingling sensation after Moderna COVID 19 injection at 1100. On assessment, injection site without bleeding or edema, R arm warm, dry, pink, cap refill <2 sec in R hand. R hand grip 4/5. Continue to monitor. 1130: sensation resolving, physical exam unchanged. 1140: sensation completely resolved. Resident to report any new or worsening. Report in VAERS.
Nausea, achy joints, fever, swelling under (L) arm and sore neck. Tingling & numbness left side of face.
patient received expired dose of IPOL/ NO AE; Initial information received on 29-Apr-2021 regarding an unsolicited valid  non-serious case received from a pharmacist via call center.  This case involves a 5 years old female patient who received first dose on 22-Feb-2016, second dose on 21-Apr-2016, and third dose on 21-Sep-2016 (not expired) of IPV (VERO) [IPOL]  then expired 0.5 mL booster dose of IPOL (strength: standard, frequency: once, lot number: R1B252M and expiry date: 13-Mar-2021 via subcutaneous route) (expired product administered) on 29-Apr-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  Reporter want to know do they need to re-dose. Pharmacist asking about revaccination. Pharmacist asking if they should wait a week or longer before revaccinating. Pharmacist states that he will speak with the physician. Pharmacist states that the physician may want to wait four weeks before revaccinating.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016262956) on 25 May 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of TETANUS TOXOID (Batch number, expiration date, dose, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient developed allergic to tetanus toxoid. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
I had a sore arm for 12 hours after receiving the 3rd dose. I did not take any TYLENOL or receive any treatment. On July 25, 2022, I tested positive for COVID-19. I had a sore throat. I was very tired and fatigued. The doctor prescribed PAXLOVID and I took it for five days. I started to feel better. I tested negative for 3 days. After those three days, I then tested positive for COVID-19. I was told to take PAXLOVID again but I refused it.
About a day and a half after receiving my 2nd dose of the Moderna vaccine, my old childhood vaccination site turned red. I received my vaccine as a baby. The Moderna vaccine was placed about 2 inches above my old vaccine. The Moderna site is swollen,  but not red. This side effect didn't occur with my first dose of Moderna. The redness of the childhood site is not large and not painful. I'm not concerned about this side effect, I just figured I should report it. My other symptoms included 101.4 degree fever, headache and fatigue. All are going down, so again, I'm not too concerned. I can send a photo of my childhood injection site if needed for assessment. Many thanks for ensuring vaccine safety!
Initially, moderate headache, about 8 hours later, low fever and very achy, also extreme fatigue, . also, arm at vaccination site quite tender. tender arm and achy  body and fatigue still present 28 hours after vaccination.
Tingling & numbness at injection site (right deltoid), tingling & numbness continued down right arm into hand, at 10 am symptoms starting to resolve.
Arthralgias, muscle weakness, Purpura seen @ ER 24 hours after immunization.
This case was reported by a consumer and described the occurrence of flu-like symptoms in a female patient who received FLULAVAL QUADRIVALENT(batch number XP4J2, expiry date 30th April 2015). Previously administered products included flu vaccination with an associated reaction of influenza like illness. Concurrent medical conditions included blood pressure high, lymphoma and drug allergy (allergy to Sulfa). Concomitant products included alprazolam and PNEUMOCOCCAL VACCINE. On 24th October 2014, the patient received FLULAVAL QUADRIVALENT. On 24th October 2014, 0 min after receiving FLULAVAL QUADRIVALENT and an unknown time after starting TYLENOL, the patient experienced flu-like symptoms, fever, dehydrated and woozy. The patient was treated with medication unknown (Fluid) and TYLENOL. On 27th October 2014, the outcome of the flu-like symptoms, fever and dehydrated were recovered/resolved. On an unknown date, the outcome of the woozy was unknown. The reporter considered the flu-like symptoms, fever, dehydrated, and woozy to be not reported if related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the flu-like symptoms, fever, dehydrated and woozy to be related to FLULAVAL. Additional information: With her recent Lymphoma diagnosis, patient's physician recommended a flu shot. The concomitant pneumococcal vaccine was given on 24 October 2014. The patient indicated that on 24 October 2014 during the night or early in the morning she got up to go to bathroom and felt extremely dizzy. She felt like she could have had fever but she did not take her temperature at that time. She also felt woozy and went back to bed. When she got up next morning, she indicated that she felt like she had the flu and slept most of the day. She indicated that she felt a little better that night. The next morning, she still didn't feel right, got panicked and took her temperature (101.2 Deg F). Since she was recently diagnosed with lymphoma she called her oncologist. The oncologist advised for her to go to the emergency room. At the emergency room she was given fluid and TYLENOL and her fever was within the 100 Deg. F-range. She indicated she was very dehydrated, blood tests were run. She followed up with her oncologist the next day. Refer to case US2014GSK023485 for tolerance to previous vaccination.
broke out in shingles 3 years after receiving 2 does of Shingrex vaccination
Large bruise around site of administration 6 days after. Minor sore. No treatment requested or needed.
Diffuse red bumps on left thigh lateral thigh , Area approximately 9cm x 8cm. Scattered red bumps on right thigh anterior and posterior thigh. No drainage , no bleeding , no red streaking from  rash area. No rash noted on stomach and back .
Covid Arm for 2 days. 2 inches in diameter of soreness and redness. This lasted for 2-3 days.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient returned to pharmacy around 30 minutes after vaccination reporting narrowing of vision angle and possible swelling around the eyes.  Administered 50mg Benaryl orally and monitored patient for around 30 minutes.  Patient reported no further progression of symptoms while waiting and patient decided to return home.  Instructed patient to continue to monitor and followed up by phone encounter around 3 hours later.  Patient stated no further progression of syptoms at that time.
Patient  experienced rash, itch, swelling on bilateral hands. Vital signs were stable feeing dizziness after 10 minutes of vaccination. Benadryl 50mg IM were given and monitoring over one hour.   Continued stable, no SOB, itchy and rash went away.
Extreme fatigue; Loss of appetite; Severe headache; Bodily aches and pains Some symptoms lasting longer then 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "migraine headaches" (unspecified if ongoing), notes: other medical history: migraine headaches; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: Tetracycline, latex. Concomitant medication(s) included: FAMOTIDINE; VIT D [VITAMIN D NOS]; B 12; CRANBERRY [ASCORBIC ACID;VACCINIUM SPP.]. Past drug history included: Known allergies: tetracycline, reaction(s): "Known allergies: Tetracycline", notes: Known allergies: Tetracycline, latex. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Location of injection: Arm Left, Vaccine administration date: 19Jan2021, Vaccine Administration Time: 03:00 PM), administration date: 19Jan2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Location of injection: Arm Left, Vaccine administration date: 01Apr2022), administration date: 01Apr2022, when the patient was 79-year-old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 10Sep2022 at 18:00, outcome "not recovered", described as "Bodily aches and pains Some symptoms lasting longer then 2 days"; FATIGUE (non-serious) with onset 10Sep2022 at 18:00, outcome "not recovered", described as "Extreme fatigue"; DECREASED APPETITE (non-serious) with onset 10Sep2022 at 18:00, outcome "not recovered", described as "Loss of appetite"; HEADACHE (non-serious) with onset 10Sep2022 at 18:00, outcome "not recovered", described as "Severe headache". Therapeutic measures were not taken as a result of fatigue, decreased appetite, headache, pain.  Additional information: Facility type vaccine was pharmacy or Drug Store No other vaccine in four weeks. Other medications in two weeks was Famotidine, Vit D, B12,Cranberry Capsules. No Covid prior vaccination and no Covid tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pneumonia; Information has been received from a lawyer referring to a 65 year-old male patient (pt) regarding a case in litigation. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about 20-OCT-2017, the pt was administered zoster vaccine live (ZOSTAVAX) vaccine at a local pharmacy by a pharmacist for the long-term prevention of shingles and zoster-related conditions.        On 23-APR-2018, 6 months 4 days after vaccination, the pt was treated and diagnosed with pneumonia. At the reporting time, the outcome of pneumonia was unknown and this event was considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, pneumonia was considered a medically significant event.
Patient had a rash break out on his chest, it is itchy, and appears to be many pimples just starting out, states that he has never had any type of acne of this magnitude.
FLUVIRIN was administered to a pregnant women. On 11/08/08 this patient should have received FLUARIX (thimerosal free) vaccine Per follow-up: Box 11 - There is no adverse event. Customer is fine.
I received the vaccine on 04/18/2022. I started having symptoms on 05/26/2022. my symptoms were nasal stuffiness, really bad head ache, coughing, muscle pain, and no energy fatigue. Tested positive for Covid on 05/27/2022 with a home test and confirmed with a PCR test on 05/28/2022. Symptoms lasted about 4 days with ongoing congestion.
shingles; neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified gender and age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 02-JUL-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles and neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, neuropathy was considered to be medically significant. The reporter considered both events to be disability.
This is a spontaneous report from a contactable consumer or other non-Health Care Professional (Patient). A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number and Expiration date was not provided) via an unspecified route of administration in Arm Left on 05Mar2021 at 14:00 (at the age of vaccination 52-years-old) as 2 ND DOSE, SINGLE for COVID-19 immunization at Public Health Clinic/Veterans. The patient medical history included type 1 diabetes mellitus. The patient had known allergies to Tetracycline. The patient received medications within 2 weeks of vaccination included insulin (INSULIN). The patient previously took tetracycline and experienced drug hypersensitivity and the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, in Left arm on 12Feb2021 at 02:30 PM as single dose for COVID-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 06Mar2021 at 12:00 AM, the patient had experienced fever of 102, fatigue, muscle pain and weakness. The patient underwent lab tests and procedures which included body temperature: 102. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Feverish, achy, soreness, nausea, dizziness. All occurred within one hour of vaccine up to 48 hrs after.
Pt recvd vax & 2 hrs p/vax devel nausea, vomiting, fever, chills, fever blisters, seen by ER; treated w/Zovirax topical & oral capsules;
Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
4Apr21  patient developed a major head to toe reaction where skin is red with dry blisters, per patient's husband reaction is possibly a drug induced Lupus. Patient has been to an urgent care and her primary care provider.  She was given a steroid cream at the urgent care. On 23 Apr she also showed some aspects of kidney infection with nausea and fever so was put on an antibiotic.  Name of physician or treating hospital (if applicable) :Urgent Care  Dr  taking over care now that she is back home and is scheduled to see a rheumatologist and dermatologist.
On the afternoon of the 24th of March, after receiving the second dose of the Moderna vaccine, I experienced chills but no discernible fever.  That evening I experienced night sweats.  Early on the morning of the 25th of March I experienced aches and pains -- largely in my joints -- common in previously experienced flu symptoms.  Later on March 25th, I experienced severe skin sensitivity -- air from the air conditioner felt painful against my skin.  I also saw the beginnings of a rash on my left arm at the injection site.  By the morning of the 27th of March, though other symptoms had largely faded, I noted something like a welt/weal or extremely large hive on my left arm, the diameter of which is several inches all the way around, that is very red, very swollen, warm to the touch, and very painful.  I also cannot move my arm at all without pain.
fainted and fell to the floor; so wet from perspiration; clammy; hot and cold; This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (fainted and fell to the floor), HYPERHIDROSIS (so wet from perspiration), COLD SWEAT (clammy) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced SYNCOPE (fainted and fell to the floor). July 2021, the patient experienced HYPERHIDROSIS (so wet from perspiration), COLD SWEAT (clammy) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold). At the time of the report, SYNCOPE (fainted and fell to the floor), HYPERHIDROSIS (so wet from perspiration), COLD SWEAT (clammy) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.  It was reported that 12 hours later patient fainted and fell to the floor.  When  patient woke up had to call family to get up. Patient was so wet from perspiration and clammy then hot and cold.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected non serious events of syncope, hyperhidrosis (so wet from perspiration), cold sweat (clammy) and feeling of body temperature change (hot and cold). The event syncope occurred 12 hours after the unknown dose number of mRNA-1273 vaccine administration. The patient fainted and fell on the floor, the patient was so wet from perspiration and clammy then hot and cold. No reported treatment medication. The outcome of the events were unknown. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected non serious events of syncope, hyperhidrosis (so wet from perspiration), cold sweat (clammy) and feeling of body temperature change (hot and cold). The event syncope occurred 12 hours after the unknown dose number of mRNA-1273 vaccine administration. The patient fainted and fell on the floor, the patient was so wet from perspiration and clammy then hot and cold. No reported treatment medication. The outcome of the events were unknown. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Headache for several days, menstrual cycle came on 8 days early with terrible cramps, soreness at site of injection and upper back, inability to sleep
Patient had Quantitative HCG this morning it shows 18743 units- approx 6 weeks. By this calculation, patient was 2 weeks pregnant when she recieved the live influenza vaccine. On the day of vaccination the urine pregnancy test result was NEG.
No additional AEs; patient was administered PROQUAD and VARIVAX on 3/7/23; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-MAR-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, both administered for prophylaxis (overdose) (strengths, dosages, vaccination schemes, routes of administration, anatomical site of injections, lot numbers, and expiration dates were not reported). No additional adverse event was reported.
Redness and edema at site of injection (l deltoid)to left elbow.  Advised yesterday to apply ice and give po anti-inflammatory.  Today no pain or redness.  Some swelling noted.