chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Between 1st and 2nd dose developed dizziness and headache that required emergency room visit.  Was diagnosed with vertigo and flare-up of chronic headache condition.  Six weeks after the 2nd dose (03/16/21) had a second episode of dizziness, HA, loss of balance.
This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored MMR II lot # L000458, expiration date: 06-JAN-2017, therapy type: rHA (dose, route and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
"Patient is a 67 yo M calling for fever that started yesterday. He got the pneumovax yesterday afternoon, then developed fever to 101F last evening. Has been treating with tylenol every 4 hours. Developed chills, sore muscle, especially at site of injection. Temperature this evening spiked to 104.0F, he took a motrin and protonix and temp went down to 102F. He did have his COVID vaccination series, last dose 2/9/21."
pt recvd vax & exp swelling, hot arm, fever, pain in elbow to shoulder;
Patient experienced COPD exacerbation beginning two hours post vaccine dose. Symptoms were fever, shortness of breath, wheezing, chills, lethargy. Eval. at PCP office revealed decreased O2 sat of 89%; wheezing and crackles bilat. lungs. Treated with steroids, antibiotic, inhaled resp. meds. Expected to recover fully.
Patient delivered a viable female neonate with Apgars of 8,9. EBL 25cc. Excellent uterine tone at termination of delivery. No lacerations. Patient denies additional symptoms including fevers, chills, chest pain, sob, nausea, vomiting, and pain, dysuria, hematuria, or changes in bowel habits. Date of delivery was 5/17/2022.
This spontaneous report as received from a 71 year old female patient reporting on herself. The patient's medical history included shingles three time over the years (in 1990, 2004 and 2007). The patient had no known drug reactions or allergies. On 05-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K000325, expiration date 27-FEB-2015 (route was not provided) for prevention of shingles. Concomitant therapies included ZETIA, amlodipine besylate and calcium. On 05-SEP-2014, in the evening after receiving ZOSTAVAX at her local pharmacy, the patient experienced a red, warm, painful, raised, after receiving ZOSTAVAX. No treatment was given for the adverse event. The patient did not seek medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 58 year old female patient. No information about medical history and concomitant medications were reported. The reporter stated that patient has a rash since an unspecified date prior 6to the administration of ZOSTAVAX was vaccinated with ZOSTAVAX lot #J011339 expiration date 13-DEC-2014, dose 0.65 ml, route subcutaneous, on 14-JUL-2014. On 16-JUL-2014, the patient was diagnosed with shingles. The outcome of shingles was reported as recovering/resolving. Patient sought medical attention at physician's office on an unspecified date and was prescribed FAMVIR. No product quality complaint was involved. Additional information has been requested.
Vaccinated 4/23/03.  8 days post vaccine. Temp 100.8. Chest pressure "really tight". Headache, achy all over - Day 9 Temp 101.2. SOB chest feels "heavy" to ER with diagnosis of upper lobe pneumonia. Z-pack started 5/2/03. On 5/13 re-Xrayed after 2 Z-packs. LL pneumonia. Started on Tequine. To follow up in 10 days.
Low grade fever for two days until 5/3. Went to ER with severe nausea, muscle pains. Fainted in ER waiting room. Was extremely sick for three days with nausea, pain, low energy and side effects. Am still having leg muscle pain on 5/10 as well as low energy, being unable to sleep, no appetite, depression. Went to Urgent Care on 5/10, vitals are good
Patient felt faint and then passed out. Her breathing stopped momentarily and we called 911 and put her on the floor to do CPR. She began to moan and awoke before starting CPR. She then vomited. She stayed laying on the floor for about 15 minutes until she felt well enough for her husband to put her in a wheelchair and take her home. Her husband called the doctor who told her to rest.
Violent vomiting, fever, headache, weight loss. Symptoms lasted for over two weeks. I was out of work for a week and a half.
Patient developed rashes on the right side of the face and some redness on the left. They were immediately referred to the Clinic and was seen by Dr.
vial underwent a temperature excursion; No adverse event; patient received vaccine from vial that underwent a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion).    No concomitant medications were reported.   The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the freezer, and they just found out about the excursion in an audit. No adverse event reported for the patient.   No treatment medications were reported.
arm was killing her for 2 days after the first dose; This is a spontaneous report from a contactable health care professional (patient).  A 33-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 07Jan2021 on the arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Prior to the vaccination, the patient has not been diagnosed with COVID-19. The patient stated that her arm was killing her for 2 days after the first dose on an unspecified date in Jan2021. The outcome of the event was unknown. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested
Pt given vaccines 10:30 am, began with vomiting, uncontrollable crying and apnea 45 min-1 hr later. Heard pt on phone - screaming, high pitched crying, and swelling, redness at injection site. Afebrile. Tylenol given, cool compress to legs. Appt scheduled to be seen - at office  - then mom called back to cancel. Pt settled down. Total time increased crying about 2-3 hours.
Hives on face reported by Mon > post 20 min imm. Hives cleared before patient was seen by provider.
inadvertently administered Kinrix to a 3 month old patient yesterday; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2TP74, expiry date 10-JUN-2024) for prophylaxis.   On 14-JUN-2023, the patient received Kinrix (right thigh). On 14-JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered Kinrix to a 3 month old patient yesterday). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-June-2023 The pharmacist called to inquire on how to proceed and what to look for in the patient. The reporter stated that Kinrix was inadvertently administered to a 3 month old patient.  The reporter confirmed vaccine was administered at their facility. The reporter did not consent to follow-up. A 3 months old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration.
Injection site pain; Muscle pain; Joint pain; Fever up to a 100.2; Nausea; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK9231, via an unspecified route of administration on 01Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, "I had the COVID shot today (01Jan2021). This morning I had the first shot of the medicine Covid-19 Vaccine Pfizer. This is what is happening. I had the shot around may be 10-10:30. I felt great all the day and after 7 O?clock I started getting injection site pain, muscle pain, joint pain, and fever up to a 100.2, nausea on 01Jan2021. Is there anything that I can do home for the fever especially? Let me give you the number that I got on my vaccination record card. It is Pfizer EK9231 (not clarified)." The patient further stated, "I wanted someone to tell me if I can take Tylenol. Do I have a situation like to go to the hospital?." The patient was advised to visit the nearest emergency room or can contact the physician as the department is closed. The patient further stated, "I will probably go to the hospital if I threw or some temperature if it is higher. I got to do something. I got so many symptoms. I had probably 19 in Nov, in Nov I spent three days on bed in Hospital. It is fine now and I was in hospital. I do not know what is happening now. It was good all the day but then at night these things." The patient underwent lab tests and procedures which included body temperature: 100.2 on 01Jan2020. The outcome of the events was unknown.
Last night I started running a low grade fever (98.9) and experienced chills until I went to bed.  This morning I feel fatigued and have a slight headache.  The injection site is pretty sore.
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine  was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Pain and warm on the injection area; Warm on the injection area; Redness 5 inch; Dermatitis; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2020, the patient received the 2nd dose of Shingrix. On 24th August 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, erythema and dermatitis. On an unknown date, the outcome of the injection site pain, injection site warmth, erythema and dermatitis were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, erythema and dermatitis to be related to Shingrix.  Additional information was provided as follows: The patient expereinced local reaction, redness 5 inch, pain and warm on the injection area and dermatitis after second dose of shingrix. The reporter consented to follow up.
2 hours after the vaccine I experienced the sudden onset of a strong metallic taste on my tongue. This taste lessened on a daily basis and finally disappeared after 5 days.
Went into AFib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Went into AFib) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A, 006M20A and 039C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced ATRIAL FIBRILLATION (Went into AFib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Went into AFib) outcome was unknown.     Concomitant product use was not provided by the reporter.  Patient was currently on blood thinner for the AFib.  Company Comment - This case concerns a 67-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred 8 months and 7 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 67-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred 8 months and 7 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Further information was requested.
Patient came in for 2nd Pfizer vaccine, a new vial was pulled from bag of bivalent and it happened to be a misplaced monovalent vaccine. Patient was given the monovalent instead of bivalent. Monovalent was discontinued. Vaccine was not expired.
FLU LIKE SYMPTOMS; TINGLING IN LIPS; TOUNGE FELT THICK/HEAVY; ELEVATED HEART RATE; HEART BEGAN RACING (CONSISTENT95-100 BPM); This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, breast cancer, skin cancer, and clot, and concurrent conditions included seafood allergy, erythromycin allergy, sulfa allergy, high cholesterol, thyroid, glucose intolerance, non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient has no history of drug abuse. patient height was 5'7 and weight was 220. patient did not have illness at the time of vaccination, has past history of similar events, did not have any adverse event after any previous vaccination, did not have any pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days with cause, no any family disease history, patient was not pregnant at the time of vaccination, and not breastfeeding at the time of reporting. The patient was previously treated with semaglutide for clot, and levothyroxine sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for cholesterol, atorvastatin for glucose intolerance, levothyroxine for thyroid disorder, and rivaroxaban for thyroid disorder. On 13-MAR-2021, the subject experienced tingling in lips. On 13-MAR-2021, the subject experienced tounge felt thick/heavy. On 13-MAR-2021, the subject experienced elevated heart rate. On 13-MAR-2021, the subject experienced heart began racing (consistent95-100 bpm). Laboratory data included: Heart rate (NR: not provided) 95-100 BPM. On 14-MAR-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 100.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in lips, tounge felt thick/heavy, elevated heart rate, and heart began racing (consistent95-100 bpm) on 14-MAR-2021, and flu like symptoms on MAR-2021. This report was non-serious.
Subsequently post vax, the pt developed arm pain which lasted 2 to 3 days. The pt recovered.
One hour post vax, the pt started feeling tingly and warm. The pt went to sleep and woke up with headache, joint pains, and bloodshot eyes. The next day, the pt had cramps and diarrhea. Went to the MD on 4/4/00. The MD felt the episode was a vaccine reaction.
with:c/o receiving the pneumovax vaccine Yesterday and now his left upper arm is red and sore and swollen. He has never had a pneumovax vaccine before that he knows about. SKIN: SMALL RED, TENDER, SWOLLEN AREA LEFT UPPER ARM POSTERIORLY WITH SOME SWELLING OF THE ARM RADIATING DOWN TO ELBOW POSTERIORLY Plan: Moist Compresses as directed x 20 mins bid Motrin 800mg tid prn
Very rapid weight gain as evident massive edema, Extreme fatigue, nausea, imbalance muscle & joint aches, kicked in the diaphragm  feeling.
Hep A given in R leg Wed morning, started getting spots on Right leg Wed evening also got a couple spots on left leg. On Friday morning mother noticed some spots on both arms, no spots on trunk or face, mother denies fever or other problems. Told mother to go to her doctor or ER. On 11/04/04 Mother called, went to Doctor, the rash was not related to Hep A, rash was gone next day.
he took blood sugar (which in normally around 130) but was  97 and 108; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient's wife). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EL9262) (at the age of 66-years-old) as 0.3 mL, single for covid-19 immunisation. Medical history included diabetes from 1998 and ongoing and ongoing blood thinner. Concomitant medication included apixaban (ELIQUIS) taken for anticoagulant therapy from Sep2019 and ongoing. The patient previously took warfarin, the patient took it only once a day. The doctor changed it to Eliquis. On 29Jan2021, the patient blood sugar has been lower in the mornings and soreness at injection site. The patient doesn't over his starches or anything. He has had no bad feelings from that. He was okay with it. Having a lower blood sugar was better than having a high one. The patient got the vaccine because he wants to live. He also got it because he was diabetic and high risk. He doesn't want to take changes. The patient underwent lab tests and procedures which included blood sugar was 130 (normal blood sugar is around 130 in the mornings) on unknown date, on 29Jan2021, it is 97 and 108 (Blood sugar decreased. Despite the number of starches, he eats) and A1C on 28Jan2021 was 5.5 (which was good for him as a diabetic). The outcome of the events was unknown.
This is a spontaneous report from a contactable other healthcare professional and from a contactable pediatrician via a Pfizer sales representative. A 16-year-old female patient of unspecified ethnicity received TRUMENBA (lot number M37314, expiry date 17Apr2016) at 0.5 ml single and MENACTRA (lot number M15066 and expiry date 30Sep2016) at an unknown dose both via an unspecified route of administration, on unknown date for meningitis-like reaction. Relevant medical history and concomitant medications were not reported. The patient previously received two doses of MENACTRA at the age of 11 and 12 year-old respectively, without problem. the patient experienced syndrome of meningeal irritation on unknown date which required hospitalization with symptoms of stiff neck and fever. The outcome of the event was unknown.
Fatigue; Fever; Arm pain; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines and prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included magnesium glycinate (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN) and colecalciferol (VITAMIN D3); all for unknown indications from unknown dates and unknown if ongoing. On 29Apr2021 at 20:30, the patient experienced fatigue, fever, arm pain, nausea and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, fever, arm pain, nausea and diarrhea were unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pharmacist accidentally injected a COVID vaccine to a 4 year old on 2/24.; pharmacist accidentally injected a COVID vaccine to a 4 year old on 2/24.; fever; This is a spontaneous report from a contactable pharmacist via medical information team. A 4-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number was not reported, Expiry date was not reported), via an unspecified route of administration on 24Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the child experienced fever within 24 hours. The reporter stated, that at one of the mass immunization site, the pharmacist accidentally injected a COVID vaccine to a 4-year-old on 24Feb. The child experienced fever within 24 hours. The child was now acting normal. They are wondering how they should proceed and what advice to be given. The outcome of the event fever was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I did not have an adverse reaction to the vaccine. I began not feeling well on 03/26/2023 with a sore throat and with cold symptoms. I went to the doctor and was bronchitis on 04/03/2023 and I got prescription for an antibiotic.  I was tested for COVID-19, and it was negative.