chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling on left side of neck noted on 3/2/2021 which continued to enlarge to a hard lump with with difficulty eating and swallowing. Saw Dr on 3/5/2021. Antibiotics and prednisone prescribed for diagnosis of sialadenitis.  Took theses medications which reduced the swelling and hard lump but started to experience acute pain throat , chest and stomach when eating.  Actually was unable to eat solid food for the acute pain and could only sip small quantities of tepid fluid. On 3/8/2021 went to MD and diagnosed with esophagitis and was prescribed Pantoprazole 40mg. It took another week before I felt like eating anything. Had little energy and loss of taste for food.  I have never had any of these problems before and do not wish to take the second vaccine injection.
2:00 am chills.  3:00 am my whole body ached very badly, couldn?t get out of bed. Arm sore.  slight fever.  Only lasted 24 hours.
Patient found in respiratory arrest at 4:20am on 6/19/21. CPR initiated and continued by EMS, along with IV fluids and intubation, remained in asystole throughout course of CPR. CPR terminated by EMS.
Mother of pt reports that 15-20 minutes post vax, pts face began to swell. Ears became swollen and eyes swelled shut. Hives on trunk, back and armpits. Pt began coughing/gagging in ER. Pt had possible difficulty breathing and went to ER. Pt was given epinephrine, Benadryl and Prednisolone. Pt was prescribed Prednisolone and Benadryl.
Pt received TwinRix dose for Hep A/Hep B Dose. Pt received 1 dose of Vaqta (Hep A) in 2016 and 2 doses of Engerix B (Hep B) in 2017. Guidelines state the series does not need to be restarted but dose should be administered as soon as possible. Engerix B has same dose of Hep B as Twinrix so they can be interchanged. However, the TwinRix dose of Hep A does not equal the dose in Vaqta. Pt needs to receive a dose of Vaqta to finish her Hep A series. Contacted Merck to receive guidance on when her Hep A dose can be administered. They said she can receive the Vaqta dose as soon as possible even though she received the TwinRix dose 8/17/23.
diffuse itchy red rash covering legs, and back  I took  one dose of OTC anti-histamine (diphenhydramine) which reduced the itching for some time, but it has returned.  I have now taken cetirizine (one dose) with no effect as yet.
Arm warm/hot to touch; Redness the size of a grapefruit; 3 welts on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm warm/hot to touch), VACCINATION SITE URTICARIA (3 welts on arm of injection) and VACCINATION SITE ERYTHEMA (Redness the size of a grapefruit) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (3 welts on arm of injection). On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm warm/hot to touch) and VACCINATION SITE ERYTHEMA (Redness the size of a grapefruit). At the time of the report, VACCINATION SITE WARMTH (Arm warm/hot to touch), VACCINATION SITE URTICARIA (3 welts on arm of injection) and VACCINATION SITE ERYTHEMA (Redness the size of a grapefruit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       . No relevant concomitant medications were reported  No treatment information was provided.
had to the first dose was a very sore arm; low grade fever; chilly; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2020AMR078358.).   On 6th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, fever and chilliness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the fever and chilliness were unknown.   It was unknown if the reporter considered the pain in arm and chilliness to be related to Shingrix. The reporter considered the fever to be possibly related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and arm hurting pretty significantly chilly and also developed a low grade fever. The reporter asked could fever be a side effect of the 2nd dose of Shingrix. The reporter thinking the fever was associated with the shot but with all the Covid going around at the time of reporting.
Received the first dose of the Moderna vaccine in May but haven't received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna vaccine in May but haven't received the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna vaccine in May but haven't received the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna vaccine in May but haven't received the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Rash. It started on my right hand, then appeared on my neck. It next appeared on both arms, the left side of my chest, on my right hip, then on my forehead and eyelid. I went to Dr. and he told me that it looks like Sweet's Syndrome. He took a biopsy to confirm and put me on Prednisone
feel lousy/feeling worse/I don't feel good physically; feeling psychotic; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel lousy/feeling worse/I don't feel good physically) and PSYCHOTIC DISORDER (feeling psychotic) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (feel lousy/feeling worse/I don't feel good physically) and PSYCHOTIC DISORDER (feeling psychotic). At the time of the report, MALAISE (feel lousy/feeling worse/I don't feel good physically) outcome was unknown and PSYCHOTIC DISORDER (feeling psychotic) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. concomitant information was not provided.
Difficulty breathing; Throat pain; Fever; contracted COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19), DRUG INEFFECTIVE (Lack of drug effect), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Throat pain) and PYREXIA (Fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046321A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Iodine allergy and Contrast media allergy (Allergic to contrast.). Concomitant products included ROSUVASTATIN CALCIUM (LUSTATIN) and CARVEDILOL for an unknown indication.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced COVID-19 (contracted COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and PYREXIA (Fever). On 20-Jan-2022, the patient experienced OROPHARYNGEAL PAIN (Throat pain). On 24-Jan-2022, the patient experienced DYSPNOEA (Difficulty breathing). The patient was treated with ALBUTEROL [SALBUTAMOL] (nasal) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and OXYGEN for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID-19), DRUG INEFFECTIVE (Lack of drug effect), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Throat pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Zpack.  Company Comment: This is a spontaneous case concerning a 77-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 3 months 13 days after the second dose of mRNA-1273 vaccine administered on 1-Oct-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 14-Jan-22 was positive. At the time of report outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 77-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 3 months 13 days after the second dose of mRNA-1273 vaccine administered on 1-Oct-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 14-Jan-22 was positive. At the time of report outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Improper storage of product in use; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 24-MAY-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHa)) (PROQUAD) for prophylaxis (strength, dose, route of administration, and anatomical location were not reported; lot number T008281 had been verified to be a valid number; expiration date 05-SEP-2021 (conflicted information also reported 25-JUN-2022)). The  temperature  excursion was at -14 degree Celsius (C), for a time frame of 35 hours and 43 minutes, No had the previous temperature excursion. It was reported that the call was due to data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA001746:
Patient reported to us on 9/23 about event. On 9/18 in the evening patient started to get a redness at the injection site and it ended up extending 3-4" down to the elbow area. She reported that is was also itchy. She took benadryl nightly and it resolved by 9/22. We spoke with nurse at Dr's office on 9/24 and informed them of reaction. Patient reported that she had no issues with flu shots previously.
4 days after Tetanus Shot, pain, burning swelling around injection area. Increasing daily. Pain will radiate through arm/hand and eventually left side of neck.
Patient stated she was feeling dizzy approximately 15 minutes after immunization. Told patient to sit longer and offered water.  Patient became increasingly dizzy then started getting short of breat. Took patients blood pressure which was 209/107. Offered to call 911 and patient accepted
9 days after the vaccine, he was unusually fussy and sleepy and had a fever of 101 degrees F.  10 days after the vaccine, he woke up with a rash all over his body and a slight fever.  The rash has lasted from Monday morning and he still has it.  Today, Wednesday, his cheeks have been bright red, he has a slight fever, and the rash all over still.
Noticed redness in left eye corner and went to eye doctor. Doctor gave me an eye drop prednisolone 1% and when it did not work, She gave me Prednisone 20 MG tablet and refer to primary Physician. When Primary Physician tested blood my ANA came at positive 1:80. They advise me to go to Rheumatology for further evaluation of an autoimmune disease. Blood test in December 2020 was normal with WBC in normal range but when I did the test on May 12th, it came as High.
Two weeks later blood clots that stopped in the new.; Fatique; Infection; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 11:30 (Lot number: ER8731) at the age of 65 years as dose 2, single and administered in arm left, administration date 24Mar2021 11:45 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes 2" (unspecified if ongoing), notes: diabetes 2; "hbp" (unspecified if ongoing), notes: hbp; "anxiety" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; PLAVIX; CRESTOR; METFORMIN. Relevant past drug history: Name of Drug as Reported: no; Reaction: Allergy. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 26Mar2021 16:00, outcome "recovered" (2021), described as "Two weeks later blood clots that stopped in the new."; FATIGUE (hospitalization) with onset 26Mar2021 16:00, outcome "recovered" (2021), described as "Fatique"; INFECTION (hospitalization) with onset 26Mar2021 16:00, outcome "recovered" (2021), described as "Infection"; HEADACHE (hospitalization) with onset 26Mar2021 16:00, outcome "recovered" (2021), described as "headache". The patient was hospitalized for thrombosis, fatigue, infection, headache (hospitalization duration: 4 day(s)). The events "two weeks later blood clots that stopped in the new.", "fatique", "infection" and "headache" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Mar2021) negative, notes: Nasal Swab; (02Jan2022) negative, notes: Nasal Swab; (06Sep2021) negative, notes: Nasal Swab; (24Jan2022) negative, notes: Nasal Swab. The patient had not received any other vaccine within 4 weeks. Prior to vaccination and since the vaccination, patient was not diagnosed with COVID-19. Patient taken other medications within 2weeks was Gabapentin, plavix, clonazapril, crestor, metformin. Therapeutic measures were taken as a result of thrombosis, fatigue, infection, headache. The patient was hospitalized after first blood clots. Infection. Treatment received for the adverse event includes blood thinners, IV antibiotics  No follow-up attempts are possible. No further information is expected.
I was given the H1N1 mist, I have no reactions but per CDC I am to report to you. 11/10/09 Vaccine records received.
Patient received vaccine at approximately 10:55a.m. and started reacting at 10:57a.m.  Patient stated that he started to feel like he was blacking out, alerted staff at the vaccination site.  When staff got to patient he was incoherent and having body movements similar to a seizure, when staff spoke to patient he immediately responded as other staff went to get epi.  Pulse was racing, breathing was normal, and patient able to communicate.  Epi not administered, as soon as epi arrived to patient and 911 called at 10:58a.m. patient was talking normal, responding to questions, heart rate was returning.  Staff stayed with patient to wait for EMS to arrive, police officer arrived pulse ox reading was 99% saturation, and heart rate of 59bpm.  Applied oxygen with non-rebreather to help stabilize.  Patient continued to improve, vision blurriness was the last symptom to fully return.  Patient evaluated by EMS staff and released shortly after.
Information has been received from a 78 year old female with no pertinent medical history or drug reactions/allergies, who on 06-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.65 mL. There was no concomitant medication. On approximately 27-JUN-2008 (about 3 weeks after receiving the vaccine), the patient experienced a mild case of shingles in her foot and buttock. The patient sought medical attention and saw the physician. A couple of weeks after getting shingles, the patient had recovered, no labs or diagnostics studies were performed. Additional information is not expected.
3 hours after flu shot-101 degree fever with headache chills and arm pain. Still miserable 24 hrs later.
Pt vax w/ hepta B; exp local inject site muscle soreness, fever 103F.
COUGH; SHAKES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25/MAY/2021) .5 ml, administered on 07-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cough. On 08-MAR-2021, the subject experienced shakes. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, shakes, fever, cough, and headache. This report was non-serious.
Bruising, red and purple around injection site and soreness shooting up to neck. Warm to touch, and raised. Patient went to urgent care and md confirmed no infection. Advised to take Tylenol and or ibuprofen
Individual received the vaccine and was initially stable. Approximately 10 minutes after receiving the vaccine, she reported increasing dizziness and became extremely pale with BP 73/44. She became nauseated and vomited. She also reported numbness in the right arm and hand. A doctor was onsite to evaluate. She eventually recived epinephrine 1 amp. She had improving symptoms and remained very pale and shaky. Her BP improved to 94/66, HR 88, and O2 sats 100%.
PT COMPLAINS OF REDNESS, RASH TO BILAT ARMS. C/O ITCHING AND BURNING TO SKIN ON ARMS AND CHEST. CONSULTED WITH ON-SITE MD, WHO ORDERS BENADRYL 25MG PO. PT REMAINS STABLE AND MONITORED FOR ADDITIONAL 30MIN. DISCHARGED TO HOME IN STABLE CONDITION.
Breakthrough case admission after 3 vaccines Pfizer 5/27/21 Lot# Ew0183;  Moderna 8/3/22 Lot# 006M21A;  Pfizer 11/8/22 Lot# GJ6665
Not able to make second appointment; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Detached retina repair on 19-Feb-2021. Concurrent medical conditions included Immunocompromised.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported. On 19-Feb-2021, the patient underwent detached retina surgery. It was known that the operation was not planned before the administration of the vaccine and was not assumed to be a side effect of the vaccination.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Information was received from the patient indicating they were able to get their second dose with a few days to spare and they had no adverse reactions to either shot.
During post-vaccine monitoring period, patient experienced tightness in throat and shortness of breath approximately 5 minutes after vaccine administration. Epi pen 0.3 mg SQ, Benadryl 25 mg PO administered by healthcare personnel at vaccine site. Patient's daughter administered Dexamethasone 8 mg IM (patient's own supply). Patient has a history of laryngospasm related to vaccines.
Client seen face down on floor. At first, client seemed like he could be convulsing so 911 was called immediately. 2 PHNs and one safety officer came to be with the client and assess. Client suddenly woke up after being on the ground for approximately 5-10 seconds. Client was awake and able to talk. Client?s legs were elevated on a chair. Per safety officer, client hit left forehead on ground. Dr. came over to assess the client. Vital signs taken. BP=152/71, HR=72, 99=O2. Client explained that he had yogurt and honey along with coffee that morning for breakfast. Client explained that he has feeling lightheaded at first when walking back to observation area, he sat down, and then he suddenly woke up on the ground. Client did not want offered ice pack for his forehead. Dr. gave the OK to cancel EMS after assessment of client. Client given juice, fruit strips, and water. Client moved carefully to chair with armrests and seen sitting with roommate, which he came to the clinic with. Rechecked client again around 1045. BP=127/79, HR=68, and O2=98%. Client said his head was feeling OK, but neck felt like it was tweaked but said a hot shower would likely help. Client said he did not need an ice pack. Dr. reassessed the client saying he was good to go. Before client left, he was given additional fruit strips and juice. Client walked out of clinic with roommate.
Gardasil HPV vaccine Administered on 05/08/07 cough on 05/14/07 vomiting 5/15/07 morning at school, sweating followed by syncope few minutes no Tonic-Clonic seizure. MRI done in ER showed Demyelinated Foci in Occipital, L temporal lobes and R frontal L 7/5/07-records received from facility for DOS 05/18-05/23/07-DC DX: Multiple Sclerosis. Previously healthy femal who was admitted due to a lesion seen on brain MRI. Patient reports symtoms became in December when she started having numbness in left thumb and slowly spread down her hands and arms. Also had some funny feeling in lower back. Symptoms resolved. Since then she has intermittent numbness with more than 50 episodes per day last less than 1 minutes. On 5/14 she started having nonproductive cough and sore throat, and posttussive vomiting the day after. Felt tingling over her left hand, right fingers and toes for less than 1 minute. Lightheaded, fell and hit her head. Out for almost 10 minutes. Disoriented.