chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The night after vaccine administration, the patient noted that his arm was swollen and turning red. Patient returned to the pharmacy the day after vaccine administration, and it was noted that redness was present from the right shoulder to elbow. Patient stated they will monitor symptoms.
Swollen Arm with red rash, pain and warm to touch. After few hours, fever and fatigue. Effects lasted for 6-8 hours. Day after mostly fatigue.
Loss of sense of taste; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of AGEUSIA (Loss of sense of taste) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced AGEUSIA (Loss of sense of taste) and HEADACHE (Headache). At the time of the report, AGEUSIA (Loss of sense of taste) and HEADACHE (Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.
Trouble in her ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Trouble in her ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (Trouble in her ear). The patient was treated with AMOXICILLIN for Ear injury, at an unspecified dose and frequency. At the time of the report, EAR DISCOMFORT (Trouble in her ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Vial 1# exp/lot t5242 exp 3/31/2020, vial #2 exp/lot 5223c 4/28/2020 Patient came back the next day after first shot and right arm at site of injection was red/swollen/ sore/fever, prob about 2 inches by 2 inches in size, informed patient that we needed to monitored and ice on site to help with heat/fever and TYLENOL/ibu for swelling and pain.
delrium  type symptons startng about 24 hours after vaccine, lasting for about 24 hours.  Did some research on line and my husband decided it was subsyndomal delrium .  I mostly slept .  my husband would talk with me but i have no memory  for at least 18 hours. We read a study about nursing home patients and this problem.
Pt vaccinated next day redness 2in X 1 1/2in, 1/4in raised, hard not reported until 2NOV90 still red 6NOV, swelling down. Pt was unsure if nausea was from injection or from her ulcer.
exactly 96 hrs p/vax h/a, nausea, chills; in other words flu (w/diarrhea tossed in for good measure);the event lasted 4 1/2hrs, almost to the minute, and ended, w/negligible traces of illness; tx hot tea, sweetened; 3 1/2 hrs of sleep
He tested positive for Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (He tested positive for Covid-19) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57144B) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Sep-2022, the patient experienced COVID-19 (He tested positive for Covid-19). At the time of the report, COVID-19 (He tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         On 25-Jan-2021, patient received first dose of Moderna vaccine (monovalent). Lot number was provided as 011L20. On 28-Feb-2021, patient received second dose of Moderna vaccine (monovalent). Lot number was 002A21A On 27-Oct-2021, patient received first booster dose of Moderna vaccine (monovalent). Lot number was 045C21A. On:20-Apr-2022, patient received second booster dose of Moderna vaccine (monovalent). Lot number was 045L21A. On 09-Sep-2022, patient also received flu 65 shot. No treatment medications were reported.  Company Comment:  This is a spontaneous case, reported by a patient family member, concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred 9 days after receiving a dose of mRNA-1273.222 as the fifth dose of COVID-19 vaccine. Patient also had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 34 days and 2 booster dose of Moderna COVID-19 vaccine with no reported adverse event, prior to mRNA-1273.222 vaccination. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a patient family member, concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred 9 days after receiving a dose of mRNA-1273.222 as the fifth dose of COVID-19 vaccine. Patient also had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 34 days and 2 booster dose of Moderna COVID-19 vaccine with no reported adverse event, prior to mRNA-1273.222 vaccination. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.
6-24-15 13:10 vaccine administered. 1830-fever 99.8. 6-25-15 12:30 localized redness, itching (mild) measures 1 1/2 inches x 1 1/2 inches. Left arm. 6-26-15 temp decreased 98.1-redness continues. Itching 1325. No treatment resolved-06/30/15.
T max 102 yesterday, 100-101 today. Very dizzy, not eating X1 day later.
Pt received dose #1 of the Moderna COVID19 vaccine today. Immediately following the injection while still sitting in the vaccination station he began to feel very dizzy and started to sweat profusely. Pt did not lose consciousness. Pt was laid down on a cot and recovered within 10-15 minutes. ER care was on site and evaluated the pt. BP 88/56 HR 67. Repeat BP 143/87 HR 100. Pt signed refusal for transport to the hospital. Pt stated this has not happened to him before. Pt was advised to call his PCP and have his 2nd dose scheduled in a medical facility. Pt verbalized understanding.
Just a few minutes after the shot became very dizzy, had severe medicine head for about 25 minutes. Face was very flushed and felt extremely tired. Symtoms subsided at around 30 min. Flu-like symptoms the rest of the day
Information has been received from a physician concerning a female (age not reported) who on 14-Nov-2007 was vaccinated with the second dose of Gardasil (lot not reported).  "Within 24 hours" of vaccination, the patient experienced diarrhea.  It was reported that the patient sought unspecified medical attention on 15-Nov-2007.  Subsequently, the patient recovered from diarrhea.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Follow up information was received on 18-JAN-2008. The nurse reports that the above incident was most likely related to a question and if this was possible to occur with GARDASIL vaccine. She states that the diarrhea was most likely not related to GARDASIL vaccine. She also does not remember who the patient was and therefore she cannot complete the B form.
SLIGHT SWELLING AROUND BOTH EYES; TEMPERATURE OF 100 DEGREES; This spontaneous report received from a consumer concerned a 32 year old female. 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 not reported, batch number: UKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 08-APR-2021, the patient experienced slight swelling around both eyes. On 08-APR-2021, the patient experienced temperature of 100 degrees. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from temperature of 100 degrees, and slight swelling around both eyes. This report was non-serious.
9 doses administered out of a vial that has a particulate; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT CONTAMINATION PHYSICAL (9 doses administered out of a vial that has a particulate) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT CONTAMINATION PHYSICAL (9 doses administered out of a vial that has a particulate). At the time of the report, PRODUCT CONTAMINATION PHYSICAL (9 doses administered out of a vial that has a particulate) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported
This spontaneous report as received from a pharmacist refers to a 67 year old male patient. The patient's medical history included chicken pox. On 15-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot number [J00431] is an invalid lot number, Expire date 12-JUL-2014) Vial 19400 PFU in the left arm for routine vaccination (route and dose not reported). On an unknown date in 2013, the patient experienced some "lesions" on his arm and torso, two lesions on his right upper arm and one lesion on his right lower abdomen (stomach). The patient said that the lesions were itchy and red and looked like chicken pox. When the nurse examined him the two spots on his right upper arm were about a quarter of an inch cross, raised, pink, itchy and crusty (scaly) and the lesion on his stomach was described as one third to one half of an inch across light brown raised and itchy (the nurse felt the scabs had come off the lesions on his upper arm). The patient reported that the lesions had become progressively less itchy and were getting better. The pharmacist reported that no samples from the lesions were able to be collected. The patient sought medical attention by notified pharmacist. Additional information has been requested.
Information has been received from a pharmacist concerning a 77 year old female with allergy to VALIUM, nitroglycerine, beta-blockers and calcium channel blockers, leukaemia, atrial fibrillation, gastrooesophageal reflux, obesity and hyperlipidaemia who on 09-SEP-2009 was vaccinated intramuscularly into the right arm with a 0.5mL dose of PNEUMOVAX 23 (lot number 662842/1296X). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown) (left arm on the same date), digoxin, PROTONIX, COUMADIN and SPRYCEL. Later that evening, on 09-SEP-2009 the patient experienced pain and redness of right arm where she received PNEUMOVAX 23. The next day, on 10-SEP-2009, the patient experienced fever and worsening of pain and some swelling. She was seen by a physician and admitted to the hospital on 12-SEP-2009. Laboratory tests performed included blood tests, chest X-ray and x-ray of right arm (results not provided). The patient was treated with intravenous UNASYN and was discharged from the hospital on 16-SEP-2009. It was noted that five years ago, the patient also received PNEUMOVAX 23 (dose, route and lot number not reported) and flu vaccines previously with no adverse symptoms noted. This is one of several reports from the same source. Additional information has been requested.
retrobulbar neuritis; This case was reported by a physician via call center representative and described the occurrence of retrobulbar neuritis in a 56-year-old female patient who received HBV (Engerix B) (batch number 5397F, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple sclerosis (patient has multiple sclerosis and was stable for 12 years).   On 3rd August 2020, the patient received Engerix B (intramuscular). On 4th August 2020, the patient received Shingrix (intramuscular). On 14th August 2020, 11 days after receiving Engerix B and 10 days after receiving Shingrix, the patient experienced retrobulbar neuritis (serious criteria GSK medically significant). On an unknown date, the outcome of the retrobulbar neuritis was unknown.   It was unknown if the reporter considered the retrobulbar neuritis to be related to Engerix B and Shingrix.  Additional details were reported as follows: The reporter was the patient's physician but not the physician who administered Engerix. On 3rd August 2020, patient received Engerix intramuscularly and on 4th August 2020, shingrix intramuscularly in opposite arm and on 14th August 220, experienced retrobulbar neuritis. The reporter mentioned that, patient has multiple sclerosis and was stable for 12 years. The reporter consented to follow up.
Patient was given a dose of dtap+IPV, he was only supposed to get a Dtap vaccine.  patient had no reaction to vaccine.
Chest pain, difficulty breathing (SOB), and tachycardia. Evaluated by EMS-Cleared.
Five to seven minutes after receiving three immunizations, patient stood up and exited exam room with parents. Patient had episode of syncope in hallway. Patient aroused less than a minute. Elevated legs and instructed to lie down on clinic bed. Patient reported had not eaten breakfast. Given granola bar and juice. Patient rested for 15-20 more minutes. After reporting improvement, departed clinic with parents. Denies history of syncope after injections.
COVID-19 breakthrough report. I received my 3rd dose on 11/11/2021. I contacted Covid on 04/14/2022. My adverse event 04/12/2022 I started getting achy along with fever, headache, fatigue, I had cough, little not much so I took a Covid home test and result came in as positive. Wed-Friday fever. I was very tired I was quarantine for 5 days. Then I went back to work. I will be getting my second booster soon. I had tele visit she told me not to take it. If it worsens then to take it. But luckily I did not need it.
27OCT93 lip drooping & eye tearing; water runs out of mouth; dx Bell's palsey;
This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 09:30 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Allergies to medications, food or other products was reported as not that the patient knows of. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 09:30 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 07:00, the patient experienced innumerable petechiae on torso, arms and legs. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event innumerable petichiae on torso, arms and legs was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Generalized Body Aches -Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: tachycardia, trouble breathing-Severe
flu like symptoms tired and achy lasted a few days - after 1st vaccine then second vaccine 2/10/2021 10:00am  few hours later fever chills shaking chills joint hurt - nausea  lasted intensitly for whole day - aching joint continuing for 1 week
10/20: Patient is a 82 y.o. female who presents with severe weakness occurring after receiving Covid booster.  Patient apparently received a COVID booster on Saturday, and developed severe weakness lethargy within 8 to 12 hours after having received it.  Patient became so weak that she could barely walk and had to use a walker and assistance of her husband to get into the office today.  In the office the patient was ill-appearing and had an irregularly irregular rhythm/tachycardic in the office.  Patient was subsequently sent to the emergency room in the ER the patient had CT of the brain which did not show anything acute.  Telemetry monitor confirmed atrial fibrillation with rapid rate and the patient was admitted for new onset atrial fibrillation.     10/22: Patient very weak today.  Will most likely need subacute rehabilitation.  However patient needs to be stable from a cardiac standpoint first.   10/23: Much stronger today.  Patient was walking with the assistance of a walker and therapist.  However will need SAR as she is at risk for falling and is on anticoagulation now. Continue metoprolol diltiazem.  Patient will need to come back eventually for cardioversion. 10/24: Heart rate better controlled.  Needs SAR.   10/26: discharge to SAR
Pnu-Immune given 10/02/2001. Presents to clinic 10/04/2001 with cellulitis of left upper arm. Given Cipro for treatment (Pt is allergic to PCN).
Initial report received on 04 March 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had three doses of PENTACEL: dose one, (lot number not reported) received on 14 July 2011; dose two, (lot number not reported) received on 29 September 2011; and dose three, lot number C3952AA received on 28 November 2011 (routes and sites of administration not reported). The subject developed a cough on 15 July 2012, approximately seven months after the last dose. The subject developed a paroxysmal cough on 19 July 2012 with a whoop. The subject also experienced apnea, post-tussive vomiting and sleep disturbance (unspecified dates). Laboratory testing included a positive PCR on 22 July 2012. Chest x-ray findings were negative for pneumonia/ Corrective treatments consisted of azithromycin starting on 22 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 30 July 2012, the subject's cough was still persisting. The duration of the cough was reported as 15 days at that time. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient has constant crying from the day vaccines were given until 3 days after.  No significant fever, Tylenol was given to patient.  Patient seen in office 2 days after vaccine administration with no localizing finding on exam except for crying.
The Patient is a 23 year old female.  She reported: Encounter Background Information: pt was discharged from the medical center today.  Pt was in-patient at the medical center bec of possible varicella after the chicken pox vaccination 3-4 wks ago. Pt was told that it could just be a allergic reaction to the varicella shot.  Pt. stayed in the hospital for 5 days.  The skin lesions are all gone at this time.  No other c/o.  Skin symptoms skin rashes are all healed.  7/11/08 Case will be closed w/medical records that accompanied report. Hospitalized 6/1-6/4/2008.  FINAL DX: Allergic reaction to varicella vaccination. Records reveal patient received varicella vaccine due to negative serology for VZV & experienced erythematous rash at injection site next day.  Then experienced neck stiffness & pain, LUE swelling, rash, sore throat, HA approx 4 wks s/p vaccinations.  Started on oral antibiotics for LUE infection day before.  Exam 5/30/08 revealed revealed tonsillar enlargement, LUE swollen, tender, erythema w/diffuse papular lesion over face, scalp, arms & trunk.  Admitted to hospital for observation for possible varicella post vaccine.  ID consult done & felt was allergic reaction, not chickenpox.  No complications & most lesions healed by d/c to home.
Diarrhea for approximately 4 weeks,  Heart palpitations and skipping beats starting at vaccine date and still currently happening.
About 4 weeks after the 2nd dose, I experienced sever joint pain that persisted for nearly 6 months. I also stopped all medication at the time I was having the joint pain except for the eye drops
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent. A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. Relevant medical history included: "Not sexually active" (unspecified if ongoing), notes: she is not sexual active. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown; Manufacturer: unknown), for Covid-19 immunisation. The mother's vaccination history included: Covid-19 vaccine (Dose no -2, Manufacturer- unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose no -1, Manufacturer- unknown), for COVID-19 immunisation. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "I don't have my menstrual period". Additional information: Reporter received her three doses of Covid-19. After her third dose she don't have her menstrual period and she was not pregnant. Reporter asking whether any statistics about this problem. Reporter daughter received the third dose, and she has the same problem and she is not sexual active. She was not pregnant she was virgin. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
PATIENT BROKE OUT IN HIVES 2-30 HOURS AFTER VACCINE ADMINISTRATION. WENT TO URGENT CARE AND RECEIVED AN STEROID INJECTION WHICH HELPED ALLEVIATE THE SYMPTONS.  HOWEVER, THE NEXT DAY THE HIVES CAME BACK IN DIFFERENT PARTS OF THE BODY.  DR  PRESCRIBED A STEROID DOSE PARK
Patient was supposed to receive Covid Moderna Bivalent 0.5ml and only received Covid Moderna Bivalent 0.25ml
I woke up and the hemangioma on my left cheek had a larger bump - size of pea - and was painful  (Thursday Aug 12). Next day I got up and it was normal.