chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
Mother described left arm as being hot and swollen on 9/6/06. Ice applied and Tylenol given per conversation with mom.
LOWER BACK PAIN; SPINE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced lower back pain, and spine pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lower back pain and spine pain was not reported. This report was non-serious.
3 days after injection shoulder blade pain started, intense muscle aches in back with headache. Day 4 (Saturday) throat hurting - 10pm red spot noticed on back of throat Day 5 still throat pain, fatigue as expected saw doctor said it was reaction to vaccine Day 6 still uncomfortable- start throwing up at 6 pm  Day 7 post shot extreme fatigue, arms and legs felt on fire, slept all day, chills after eating, blood pressure 174-109 and brought to the ER. Tested negative for COVID and labs came back normal  Day 8 slept the entire day  Day 9 uncomfortable but felt more alert - no appetite  Muscle aches and pain persist - stomach pain right side begins and intense cramping right side of body Frequent bowel movement and abominable discomfort Excessive thirst  Chest pain 21 days post vaccination with still muscle weakness, feeling of being lightheaded, fatigue, and stomach discomfort
developed a 105 fever and was taken to an unspecified hospital; repetitive tonsilitis; ear infections; This spontaneous report was received from a consumer referring to his son at an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2007 (reported as 12 years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type, dose, site, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date within a week of the vaccination, the patient developed a 105 (unit not provided) fever and was taken to an unspecified hospital by ambulance and admitted what was not clarified further by the reporter. Additionally, on unknown dates, the patient experienced repetitive tonsillitis and ear infections, treated with a tonsilectomy and ear tubes, respectively (dates of the procedures were not reported). The outcome of the events and the relatedness between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.; Sender's Comments:  US-009507513-1907USA013750: US-009507513-1907USA013751: US-009507513-1907USA013749:
Left upper are swollen, hot to touch. 2 days after immunizations given. Mom states school nurse said "liquid was coming from swollen area". Ice and heat were applied, told to keep arm moving and take ibuprofen.
About 3 days after the 2nd dose vaccine,  my whole right side including my back  lost muscle function and was in pain and I collapsed to the floor.  I was in a lot of pain.  I thought I was having kidney stones. I went to the doctor and did a CT scan and gave me a shot in my back for pain.  The CT scan did not show any kidney stones or liver issues.  I went back to the doctor and he diagnosed me with muscle inflammation.  I am a healthy person and the pain came out of nowhere. The pain is in the lower right hip side.   My whole right side is in pain and the left side of my body is fine and not in pain.  I had the 2nd vaccine in my right arm and whole right side of the body is affected.  On a scale, my pain is an 8/10.  I did get a prescription for the pain meds  but the it's not really helping that much.
Possible vaccine adverse reaction. Received Moderna #1 on 1/27/2021.  Initially had no real concerns however on day 5 after vaccine, 2/5/2021, patient had an itchy full sensation that he describes as a mosquito bite inside the muscle.  Over the next few days he developed small pustules in a concentric circle a few centimeters outside the initial injection site.  Did not have any real pain and starting today the rash is beginning to resolve.  At no time did he have any systemic symptoms.  Denies any shortness of breath fullness of tongue or throat, GI upset or diarrhea, or any other rashes.---------Exam: Skin:  Warm and dry. injection site is a tiny punctate point in the center of an equilateral triangle of 3 resolving pustules on L deltoid.  Patient states the triangle is what is left of the full circle of pustules that was there previously.
At her exit from the hospital, the patient received a flu shot and for -4 days, she has had intermittent low-grade fevers to about 100.4.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: patient experienced nervousness.
soreness of arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness of arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 013L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness of arm). At the time of the report, MYALGIA (soreness of arm) had resolved.            No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2021-330997, MOD-2021-331146 (E2B Linked Report).; Sender's Comments:  MOD-2021-331146:Dose 3 case MOD-2021-330997:Dose 1 case
pt recv vax & 21SEP94 exp a fever of 102 to 103 which lasted seven days;no further details were provided;
This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a female patient of an unspecified age. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper. One of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and struck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. On 02-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, deltoid, batch number: 252234, expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019, FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. The reporter assessed this case as non-serious. This case 201804826 was cross-linked with the original case 201804823 due to the same reporter. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.
101.6 fever, chills, body aches, fatigue, and headache lasting one full day. Following first day, symptoms including feeling feverish, body aches, fatigue, and brain fog lasted another full day. Symptom of brain fog lingered for another 1-2 days.
Cried after immunization - 4 hrs later: listless for about 3 day, crying more freq.  pet pertussis rxn - hypo responsiveness.
The next two days following the vaccination, the patient was lethargic and not getting out of bed. His caregiver had to make him eat and bathe. On the third day his care giver had woken him up and found that he had wet himself (this has never happened before). He had altered mental status and was not able to recognize any of his family members. He was taken to the emergency room on 2/6/2021 where he had a seizure and found to have a subarachnoid hemorrhage. He is still hospitalized.
light lethargy; thrown up; chills; arm soreness; This spontaneous case was reported by a nurse and describes the occurrence of LETHARGY (light lethargy), INJECTION SITE PAIN (arm soreness), VOMITING (thrown up) and CHILLS (chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (no past medical history reported).    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Dec-2020, the patient experienced INJECTION SITE PAIN (arm soreness). On 07-Jan-2021, the patient experienced LETHARGY (light lethargy), VOMITING (thrown up) and CHILLS (chills). On 08-Jan-2021, LETHARGY (light lethargy), VOMITING (thrown up) and CHILLS (chills) had resolved. At the time of the report, INJECTION SITE PAIN (arm soreness) had resolved.        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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Information has been received from a company representative concerning her friend's approximately 16 month old grandson who was vaccinated with MMR II. The patient developed a measles like rash several days after vaccination. The friend was unable to describe the type of rash. The patient sought medical attention. At the time of this report, the patient's rash persisted. No further information is available.
40 minutes after terrible headache -took aleve and it subsided but didn?t go away 1 hour after severe fatigue and nausea @2 hours after severe pain on inhalation. I had no asthma issues that day or at least 5 days prior. No coughing just hurt badly to take a deep breath. I used my inhaler and then the pain went away and i was able to breath.   Second day  woke up with a severe headache again. Took Aleve. Breathing is fine. Fatigued.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 31-JAN-2011, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2011, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
right leg cramps; fatigue; feeling warmth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (feeling warmth), MUSCLE SPASMS (right leg cramps) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, HYDROCHLOROTHIAZIDE, VITAMIN D NOS, PRAVASTATIN and RETINOL, VITAMIN D NOS (VITAMIN A & D [RETINOL;VITAMIN D NOS]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE WARMTH (feeling warmth) and FATIGUE (fatigue). On 26-Mar-2021, the patient experienced MUSCLE SPASMS (right leg cramps). On 11-Mar-2021, INJECTION SITE WARMTH (feeling warmth) and FATIGUE (fatigue) had resolved. At the time of the report, MUSCLE SPASMS (right leg cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient's doctor instructed her to stop taking the medicine(Pravastatin) 2 weeks ago due to the pain in her leg. No treatment medications were reported.
WITHIN FIVE MINUTES OF RECEIVING VACCINE, PATIENT APPROACHED COUNTER AND ASKED FOR A PLACE TO LIE DOWN. WE IMMEDIATELY SAT HIM IN A CHAIR WHILE PROCURING A COT. WE CHECKED BLOOD PRESSURE WITH AUTOMATIC BP MACHINE TWICE BUT PATIENT WAS TOO HYPOTENSIVE FOR MACHINE TO READ. PATIENT REPORTED THAT HE WAS VERY HOT. PATIENT WAS SWEATING PROFUSELY, HIS HANDS AND FOREHEAD FELT VERY COLD, HIS CHEST AND NECK FELT WARMER THAN USUAL. PATIENT WAS COHERENT, BUT SPEECH INDICATED SIGNS OF DISORIENTATION. WE PROVIDED WATER AND ICE PACKS. A VISITING PHYSICIAN JOINED THE EFFORTS AND CONFIRMED HE WAS HYPOTENSIVE AND BRADYCARDIC. WE PROVIDED 25MG OF ORAL LIQUID DIPHENHYDRAMINE TO PATIENT. EMS WAS ON SITE BY THIS TIME (PROBABLY FIFTEEN TO TWENTY MINUTES AFTER VACCINE ADMINISTRATION) AND EVALUATED PATIENT. PATIENT FELT BETTER AFTER ADMINISTRATION OF DIPHENHYDRAMINE. EMS STAYED WITH PATIENT UNTIL HE RETURNED TO NORMAL STATUS.
Pt presented to Emergency Department with pain, redness and swelling of her upper arm where the vaccine was administered.
Per call with hospital infection control nurse, client reported lower extremity weakness at hospital 4/16/21 and was advised to follow up with family physician. Client admitted to hospital 4/18/21 with severe lower extremity weakness. Weakness progressed to upper extremities. Diagnosis of guillain-barre was made. No mechanical ventilation required. Client to be discharged to rehabilitation center.
My arm is in so much pain! From my elbow up to my shoulder is hurting so bad. I would say on a scale from 1 to 10 being 10 there are moments when it is a 10. Definitely sending pain throughout my whole body. I can barely push through showering and dressing myself. It's not just 'sore' around the shot spot.
9/25 - h/a,  9/27 - fever to 101 degrees, 9/28 - tingling/pain of hands/torso; morbilliform rash; 10/3 - vesicles on lower lip.
Overactive thyroid; Shortness of breath; Chest tightness; Fever; Fatigue; Anxiety; Panic; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), via an unspecified route of administration in left arm, on 15Apr2021, as second dose, single, for COVID-19 immunization. The patient's medical history included asthma and allergies to tree nuts and penicillin. The patient's concomitant medications included fluticasone propionate (FLOVENT), salbutamol sulfate (ALBUTEROL), and an unspecified multivitamin. The patient previously took montelukast sodium (SINGULAIR) and bacitracin/ neomycin sulfate/ polymyxin B sulfate (TRIPLE ANTIBIOTIC Ointment) and experienced allergies to both; and the first dose of BNT162B2 (Lot Number: ER8727) on 19Mar2021 at the age of 20 years for COVID-19 immunization (right arm). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 15Apr2021, the patient experienced initial anxiety or panic after shot was given. On 16Apr2021 (next day), the patient had fever and fatigue. The second day after (17Apr2021), the patient had shortness of breath and chest tightness. After several trips to the emergency room, the primary care physician (PCP) did laboratory tests that diagnosed an overactive thyroid (17Apr2021). Symptoms still remain and are being treated by an endocrinologist. Treatments included methimazole, lorazepam (ATIVAN), and diltiazem. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient has not been tested for COVID-19 post vaccination. The patient had not recovered from the events.
minor swelling at the site of vaccine injection; rash; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site swelling and injection site rash. On an unknown date, the outcome of the injection site swelling and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient asked the duration required to completely recover from rash and swelling which occurred at injection site and if any treatment needed for that. The patient did not provided demographic details and preferred to remain anonymous.
Patient requested help after complaining of vertigo after receiving her vaccine.  Patient was assessed by EMS and nursing and she stated she felt better and was okay to go home and rest.
ADMINISTERED 0.3 ML OF UNDILUTED PEDIATRIC PFIZER COVID BIVALENT VACCINE INSTEAD OF 0.3 ML OF ADULT (GREY TOP) PFIZER COVID BIVALENT VACCINE. ULTIMATELY, EQUIVALENT DOSE OF 30 MCG GIVEN.
Urticarial rash on different parts of body, would come & go as described by mom started 24 hrs post vax;
at injection site my skin turned yellow like a big spot about 3-4" across; arm a little sore; A spontaneous report  was received from an 81 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed vaccination site discolouration and vaccination site pain.  The patient's medical history was not provided. Concomitant medications included metformin, simvastatin, prazosin, tiotropium, losartan, nifedipine, spironolactone, mirtazapine, ergocalciferol, lansoprazole, atenolol, baby aspirin, lantus, oxybutynin, albuterol, venlafaxine, pramipexole dihydrochloride, and apixaban.  On 22-JAN-2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (lot#: 013L20A) in the right arm for the prophylaxis of COVID-19 infection.  On 22-JAN-2021, the patient developed little soreness in the arm. On 26-JAN-2021, the patient noticed that at injection site the skin turned yellow like a big spot about 3-4 across. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, vaccination site discolouration and vaccination site pain, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.