chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fainted during the night; I had chills with a high fever; A spontaneous report was received from a female consumer, age not reported who experienced "chills with a high fever", and "fainted during the night" after receiving the second dose of mRNA-1273.  The patient's medical history was not reported. Concomitant product use was not reported.  On 27-Jan-2021 prior to the onset of symptoms, the patient received her second dose of mRNA-1273, route,  site and Batch number not reported, for prophylaxis of Covid-19 infection.  The patient reported a bad reaction approximately after ten or eleven hours after her immunization, she had chills with a high fever and then fainted during the night. She reported that she did come to a moment later. On 29-Jan-2021 she reported that she is feeling fine that day. The patient stated that she felt it was an unusual reaction that should be reported. Treatment for the event was not reported.  Action taken with the study drug due to the events "chills with a high fever", and "fainted during the night was not reported.  The events  "chills with a high fever", and "fainted during the night",  were considered recovered/resolved on 29-Jan-2021.; Reporter's Comments: This case concerns a female patient, who experienced events of chills with a high fever, and fainted during the night. The events occurred 10-11 hours after the second and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Pt's wife reported a 4 x 4 inch hard knot where PNEUMOVAX was given. It was also red, tender, and feverish. Pt was advised to see primary care physician. No further information has been received regarding follow-up or treatment.
Fever, nausea, vomiting, diarrhea, abdominal pain began 1 day after booster given.
I?m not sure if it was related to the vaccine but on day after shot I had loss of appetite. Day 2 after shot I feel like I can?t get enough to eat.  I?m not sure if this has any relation to that though
10:25am Attendee received injection. 10:35am Had reaction dizziness, flushing, sweaty, cool clammy, and pale. Put on cot with legs bent. EMS contacted. 10:50 Given water. Stable V/S. Refused EMS transport. Mother came and stated patient had prior reaction before. 11:11 Patient and mother left.
headache; pretty full body aches, head to toe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: EW0164, Expiration Date: 31Aug2021) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EP6955, Anatomical location: Right arm), administration date: 26Mar2021, when the patient was 34 years old, for Covid-19 immunization, reaction(s): "Sore arm", "positive blood test for celiac disease", "Reporter added they basically said to redo all the shots.". The following information was reported: HEADACHE (non-serious) with onset 17Apr2021, outcome "recovered" (17Apr2021), described as "headache"; PAIN (non-serious) with onset 17Apr2021, outcome "recovered" (17Apr2021), described as "pretty full body aches, head to toe".  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect was none. No any additional vaccines administered on same date of the Pfizer suspect. Their was no AE's following prior vaccination. The patient had not received any other vaccine within 4 weeks. Adverse events did not require emergency room and physician office visit. Vaccine administered by injection. No patient's medical history (including any illness at time of vaccination).  No follow-up attempts are possible. No further information is expected.
pt recv vax & T97.1, P88, R22, Ht 44;1110AM parent reported edema to face & eyes along congestion, P146, R16;epi given;P146, R16;
This is a spontaneous report received from a non-contactable consumer. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), on unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if prior to vaccination the patient was diagnosed with COVID-19. On Jul2021 the patient experienced breakthrough symptomatic COVID-19 infection as confirmed by positive COVID-19 polymerase chain reaction (PCR) test. The patient had been tested for COVID-19 since the vaccination. The patient underwent lab test and procedure which included: COVID-19 PCR test nasal swab (positive) on Jul2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, Headache & NauseaVomiting Narrative: Other info: After covid vaccine on 12/23/20 patient had complaints of dizziness and headached and went to primary care for this on 12/25/20. Patient was diagnosed on 12/25/20 with a benign brain tumor and hypertension and started on blood pressure medicine (first amlodipine and changed to Lisinopril) Patient still has dizziness and occasional fatigue ("feels like heavy shoulders") Patient called today to report that symptoms previously reported in VAESR on 12/30/20 are still ongoing.
Inadvertent higher then recommended dose 1.0 vs 0.5ml IM
Heartbeats increased; the anxiety is still ongoing; tiredness is still ongoing; arm swollen; anxiety; heart racing; fatigue; headache; chills; nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen), ANXIETY (anxiety), PALPITATIONS (heart racing), TACHYCARDIA (Heartbeats increased) and ANXIETY (the anxiety is still ongoing) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Penicillin allergy and Allergy to animal (allergy to bees).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swollen), ANXIETY (anxiety), PALPITATIONS (heart racing), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness). On 08-Apr-2021, the patient experienced ANXIETY (the anxiety is still ongoing) and FATIGUE (tiredness is still ongoing). On an unknown date, the patient experienced TACHYCARDIA (Heartbeats increased). At the time of the report, PERIPHERAL SWELLING (arm swollen), ANXIETY (anxiety), PALPITATIONS (heart racing), TACHYCARDIA (Heartbeats increased), ANXIETY (the anxiety is still ongoing), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), FATIGUE (tiredness) and FATIGUE (tiredness is still ongoing) 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.   Concomitant medications included blood pressure medication, vanet for an unknown indication
Within 10 minutes hives on face, BENADRYL, ice and elevation recommended! Respiratory distress if occurred needs to be seen.
12/20/2020  12:00 PM DEVELOPED LAPID ATRIAL FIB.  WENT TO ER WHEN IT PERSISTED, MEDICAL CENTER. ADMITTED TO INPATIENT; 12/21/2020 - ELECTRICAL CARDIOVERSION. MONITORED OVERNIGHT.  12/22/2020 - DISCHARGED *ON CHRONIC BLOOD THINNER
Breakthrough case admission after 4 vaccines Pfizer 9/29/21 Lot# 30145BA;  Pfizer 3/29/22 Lot# FK9896;  MOderna 9/9/22 Lot# AS7145B;  MOderna Lot# AS7171B
8 hours post vaccination, developed subjective fever, chills, headache, malaise 6/2: Around 32 hours post vaccination, developed acute chest pain, shortness of breath, difficulty breathing when laying flat. Required ibuprofen. 6/3: felt better, required ibuprofen.  Presented to ED on 6/4 with continued symptoms (chest pain, shortness of breath), noted to have elevated troponins. Transferred to Hospital on 6/4 to ICU for monitoring.   To the floor on 6/5.  Clinically doing well just on NSAIDs with slowly decreasing troponins.  Dx:  probable acute myocarditis per cardiology based on clinical symptoms and troponin leak
Left bicep area tightened up within 20 minutes of shot; then the left upper arm ached. An 8 on a 1-10 pain scale. Like the bone has been bruised. The area near the bicep actually turned black and blue. By Oct. 6 the aching stopped and the bruising gradually disappeared in 10 days.
8 days after receiving the vaccine (Saturday), next to the injection site, I noticed a circular slightly elevated redness on upper left arm (deltoid) and warm approx 730pm. On Sunday, upon wakening, the area took on an irregular circular pattern, larger in size and still warm to touch. On Monday morning, the area takes on a defined rectangular shape, red, and warm. No discomfort or other symptoms associated.
Could not sleep the night of the vaccine. Woke in the morning with muscle aches, joint pain, a headache and a temperature of 99.9, sweating.  Fixed a cup of coffee and my legs gave way and I fell on the floor of the kitchen.
dorsal numbness of the tongue; mild dizziness; posterior Headache for 5 days; This case was reported by a other health professional and described the occurrence of headache in a 33-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date unknown) for prophylaxis.   On 25th September 2019, the patient received FluLaval Tetra 2019-2020 season. On 29th September 2019, 4 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced headache (serious criteria hospitalization), numbness of tongue (serious criteria hospitalization) and dizziness (serious criteria hospitalization). On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the numbness of tongue and dizziness were unknown.   It was unknown if the reporter considered the headache, numbness of tongue and dizziness to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient has no known allergies. It was reported that 4 days after flu shot the patient experienced adverse reaction like posterior headache for 5 days, numbness of dorsal tongue and mild dizziness. Emergency room visit required. The patient was discharged by neurology. This was 1 of 5 cases reported by same reporter.
Initial and follow-up information has been received from a registered nurse concerning a 6 month old patient who on 12-JUN-2007 was inadvertently vaccinated with PNEUMOVAX instead of PREVNAR.  No adverse reactions were reported at the time of the report and the patient was "safe."  The reporter stated that the medical assistant made an error and "chose the wrong vial from the refrigerator and didn't know there was a difference."  Additional information has been requested.
79 y/o female complain of headache and "empty feeling in stomach."  Vital signs checked by onsite EMS.  B/P 140/82, P 70.  Client monitored for 35 minutes.  Reported symptoms "better".  Encouraged to follow up with ER or PCP if needed.  Verbalized understanding.
Acute Ischemic  Multifocal Posterior Circulation strokes resulting in L sided weakness, L facial droop and dysphagia. Hospital course complicated by respiratory failure. Patient had placement of tracheostomy en g-tube given failure to wean off the ventilator and prolonged dysphagia with poor mental status to aid in swallowing
swelling at the injection site and edema measuring 13 cm x 10 cm;, of the right arm, after the adacel vaccine was administered subcutaneously; area is surrounded by an area of erythema; patientt received the vaccine to the back of arm subcutaneous instead of Intramuscular; Initial information received on 15-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 53 years old female patient who had swelling at the injection site and edema measuring 13 cm x 10 cm;, of the right arm, after the adacel vaccine was administered subcutaneously, area is surrounded by an area of erythema and patient received the vaccine to the back of arm subcutaneous instead of intramuscular after receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].  The patient's family history included Cellulitis staphylococcal. The patient's past medical history, medical treatment(s), vaccination(s) was not provided.   On 11-Jun-2023, the patient received a 0.5 ml once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection, lot L17837AA, 25-Jul-2025 via subcutaneous route in the back of the right arm for Prophylactic Vaccination(immunisation).  On 11-Jun-2023 the patient developed a non-serious swelling at the injection site and edema measuring 13 cm x 10 cm; of the right arm, after the adacel vaccine was administered subcutaneously (vaccination site swelling), area is surrounded by an area of erythema (vaccination site erythema) and patient received the vaccine to the back of arm subcutaneous instead of intramuscular (incorrect route of product administration) (latency: same day).  The swelling is to the right arm; that the swelling is described as having hard tissue area measuring 5 cm x 6 cm and that area is surrounded by an area of erythema and edema measuring 13 cm x 10 cm.  Lab data was not reported.  Action taken was not applicable.  The patient was treated with DOXYCYCLINE (DOXYCYCLINE) for Vaccination site swelling.  Outcome: Recovering / Resolving for the event swelling at the injection site and edema measuring 13 cm x 10 cm;, of the right arm, after the adacel vaccine was administered subcutaneously, area is surrounded by an area of erythema and was Unknown for the event patientt received the vaccine to the back of arm subcutaneous instead of intramuscular.  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 the guidelines. 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.
about 4 hrs p/vax pt found by parents to be cyanotic, apneic & stiff; father gave CPR, ambulance called & pt taken to hosp, t 105 @ hosp; septic w/u done, dx febrile seizure;
Severe chest heaviness reaching shoulders and back, dizzy, lightheaded, tingling in pinky finger, numbness in face, severe headache (worse than any type of headache I?ve ever had (pressure at back of head). Sweating at palms of hands and bottoms of feet, unable to get words out when these ?episodes ? occur. Very weak after episodes occur. They started out not as severe, gradually started happening more often and last longer. Never felt this way in my entire life!!! Ended up in ER, and was admitted.
a consumer received an MMR vaccine in hopes that if they contract COVID-19, he may possibly have an attenuated response to that disease based on a current plausible medical history.; Information has been received from a Doctor of Veterinary Medicine (V.M.D.), referring to himself, a male patient of unknown age. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)(strength, dose, frequency, route, lot# and expiration date were unknown) in hopes that if they contract coronavirus disease (COVID-19), he may possibly have an attenuated response to that disease based on a current plausible medical history (product use in unapproved indication).
Presented with weakness, diagnosed with Covid PNA. Fully vaccinated in April.  Treated with abx, O2 and steroids.  Discharge to facility for physicial therapy
Immediately upon withdrawal of the needle from her arm, the employee complained of feeling sick and nauseated. The employee became very pale/diaphoretic and cool with episodes of syncope and tachycardia. The employee also complained of severe pain in extremities, related to violent muscle cramping. 50mg of IV Benadryl was given.
Information has been received from a registered nurse, at a public health center, concerning a female who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently, the patient had a negative measles titer.  The reporter stated she had no further information, as the patient was at a local physician's office.  It was unknown if medical attention was sought.  Additional information has been requested.
Client given dose of Pfizer vaccine on 10/15/2021 for 3rd dose when initial vaccine series was Moderna for 1st 1/26/21 and 2nd 2/23/21. LPN and RN Lead notified medical Director and Clinic Supervisor. Client and spouse counseled on signs and symptoms of adverse reactions and when to notify MD or seek emergency medical treatment. Client was monitored by RN post vaccination for 30 minutes without any signs or symptoms of  adverse reactions.
Pt has an allergy to peanuts.  Pt reported itching in the mouth after leaving vaccination site (~1hr post vaccination).  Pt took Benadryl at home and symptoms resolved.  Pt disclosed this reaction after receiving second dose.
Flare up of symptoms of multiple Sclerosis, saw doctor on day she took last fader was given steroid pack. Took more steroids 2 weeks. 2 weeks after that given IV. Steroids. (weakness, numbness,pain).
R deltoid area swollen 4in X 3in, mild erythema, pruritis, no pain reported.
moderately high fever, headache for two days,  then  three days later (Tuesday morning) Signs of TIA - slurred speech, central vision blurry, word recall difficulty
Chronic joint pain in R wrist,  Achilles tendonitis bilat, R hip pain - pain started a few days post vaccine and has been ongoing despite treatment. Have seen my provider and have been taking anti-inflammatories, and have done recommended therapies.  Xrays do not support level of pain.
Within hours on the same day of vax, pt experienced severe pain, swelling and redness at the injection site, accompanied by a high fever. Family doctor contacted and was seen in 24 hours. Dx'd with acute cellulitis, left deltoid area, at Pnu-Imune site. Rx'd IV antibiotics in doctor's office and antibiotic therapy at home.
Within hours post vax, the pt developed fever, arthralgias, and a rash which appeared on various parts of the body. A dx of serum sickness was made and the pt was treated with prednisone. Symptoms reoccurred when the prednisone was tapered.
On December 14th, 2021, at 13:13 I, administered the Pfizer booster to a patient. The patient received Pfizer booster 2 weeks too soon, the patient received their second dose of Pfizer on 07/02/2021. The patient was observed in observation for 15 minutes post administration, and no adverse effects were noted. This error was noticed around 1900.
Pain at the injection site; Itchiness at the injection site; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) outcome was unknown.            No treatment information provided, no concomitant medications reported. Patient called to report her adverse events Pain, Itchiness and Rash at the injection site, following her second shot of MODERNA COVID 19 Vaccine intramuscularly on the left arm, last Friday, 26FEB2021. Consumer confirmed using ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021:
2nd dose was given early- 14 days after the 1st dose. Based on local and CDC guidelines we will re-dose patient 21 days after the early 2nd dose was given.
No additional AE reported; Patient was administered improperly stored ROTATEQ; This spontaneous report was received from a Healthcare Professional, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 01-FEB-2022, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742429, expiration date 11-SEP-2022, dose, and strength were not provided) or prophylaxis (product storage error).    The vaccine administered experienced temperature excursion of 34.0 Degree Fahrenheit for 3 hours and 36 minutes on 10-OCT-2021. Previous temperature excursion was not applicable. After Event Time, affected product experienced additional temperature excursions as follows: Below 36 Degree Fahrenheit with an average of 34.0 Degree Fahrenheit for 6 hours and 4 minutes on 08-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.3 Degree Fahrenheit for 23 minutes on 10-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.3 Degree Fahrenheit for 21 minutes on 11-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.3 Degree Fahrenheit for 22 minutes on 17-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.5 Degree Fahrenheit for 18 minutes on 18-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.7 Degree Fahrenheit for 19 minutes on 23-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.3 Degree Fahrenheit for 5 minutes on 24-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.3 Degree Fahrenheit for 18 minutes on 25-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.9 Degree Fahrenheit for 16 minutes on 02-MAR-2022. Below 36 Degree Fahrenheit with an average of 34.7 Degree Fahrenheit for 19 minutes on 03-MAR-2022. No additional information provided. No additional adverse event reported.  This is one of two cases from same reporter.   ; Sender's Comments:  US-009507513-2203USA005701:
Pt. reports having intermittent heart palpitations 2 weeks after she received Covid vaccine