chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Donor received Tetanus vaccine 12/29/17 at 1600 the next morning at 12/30/17 at approx. 0830 donor noticed left arm had become swollen, tender and pain at the puncture site. Donor states later that night 12/30/17 he developed chills, low grade fever and body aches. Donor denies seeking care for symptoms just rested and symptoms resolved. Upon examination of donors arm today 1/2/18 left bicep moderately swollen BP 118/82 Pulse 78 Temp 98.2.
Minor Cellulitis, treated PO Cephalexin on 10/4/2020
Rash around the injected site 7 days after vaccine administered. Itchy and uncomfortable around upper arm and shoulder.  Progressively got larger for the subsequent 3 days until it faded on day 10 after the injection.
Tinnitus Left Ear Narrative:  Patient stated the side effect started this AM; 3 days after vaccination. will attempt to follow up with ENT
MODERNA COVID-19 VACCINE  SORE LEFT ARM, SORE NECK WHEN SITTING FOR LONG PERIODS OF TIME
After the shot I had a pasta lunch and then took a nap for about one hour.  When I woke up ( 3-4 hours after the shot) I had a fever.  I could tell because I was very hot and sweaty even though my room was air conditioned.  I drank water and immediately was nauseous and vomited.  I continued to have sweats, chills, and after about another hour body aches set in.  My whole body was cramping up and my hands were shaky.  I was very short of breath over short movements like to get to the bathroom, I would be out of breath and dizzy.   Around 1700  (6 hours post shot) I took Tylenol and continued to take it every six hours.  I was able to keep ginger ale and crackers down but didn't eat much else until the next morning.  I think the fever broke in the night.  The next morning I was just really tired and sore, but much less achy than the day prior.   I was able to eat light meals  and I stopped taking Tylenol sometime that mid-morning.  I felt fine the next day (about 48 hours after the shot).
Information has been received from a consumer concerning her 7 year old daughter who in approximately 1994 was vaccinated with Hep B vaccine. It was reported by the mother that in 1994 the child contracted an autoimmune disorder and developed alopecia areata. No further information is available.
Feels really awful; She is achy/achy all over; Her arm hurt/arm hurts; Nausea; Diarrhea; I threw up. Not only that, it was brown; feel lazy; I threw up; I threw up it was brown and my stomach hurt too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 12May2021 (Lot number: EW176) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feels really awful"; PAIN (non-serious), outcome "unknown", described as "She is achy/achy all over"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Her arm hurt/arm hurts"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; DISCOLOURED VOMIT (non-serious), outcome "unknown", described as "I threw up. Not only that, it was brown"; LAZINESS (non-serious), outcome "unknown", described as "feel lazy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "I threw up; I threw up it was brown and my stomach hurt too".  Additional information: Patient wanted to know about food she stay away from food or she can eat anything. Patient was looking for the card and didn't know where the card was. Patient had a vaccination last night and wanted to know if I had a major problem now. Patient never threw up and not from years in time. She also wanted to know If I go to emergency room.  No follow-up attempts are possible. No further information is expected.
Parent reported on 6FEB92 that pt exp a 10min sz on 11FEB92 adm to hosp 11FEB & discharged 12FEB92; exp temp of 104;
Lightheaded(mild); Fatigue(mild); muscle pain at injection site(moderate); tingling in fingertips(mild); This is a spontaneous report from a contactable consumer or other non HCP (Patient, reported for self)  A 28-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:15 as single dose for covid-19 immunization. (vaccination Facility: Other). Medical history was not reported. The patient concomitant medications were not reported. patient did not took any other vaccine in four weeks. Patient did not experience COVID prior to vaccination. No known allergies. Patient had no known allergies. Other medical history: None. On 05Feb2021 at 10:45 AM patient experienced Lightheaded(mild), Fatigue(mild) muscle pain at injection site(moderate) and tingling in fingertips(mild). Patient did not receive any treatment for the adverse events. Patient was not tested for COVID post vaccination. Outcome for the events was reported as Recovering.   Follow-up attempts are completed. No further information is expected.
Amenorrhea- no menstrual cycle since vaccine as of 10/27/2021
had the shots and still got shingles/Suspected vaccination failure; still got shingles; miserable and was bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received one shot about 10 years ago ).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling bad. On an unknown date, the outcome of the vaccination failure, shingles and feeling bad were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling bad to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had one shot about 10 years ago and the 2 new ones a year before and still got shingles.  The patient was miserable for more than 2 months. The patient had shingles on the right side of my face, in my ear and scalp 3 days before his/her 91st birthday, miserable and was bad for a couple of months. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient felt ill right after getting  vaccine. She complained of temporarily losing vision and hearing. Patient became pale in  appearance and  vomited once. An ambulance was dispatched and patient was taken to an emergency room
Pt recvd 3 doses of Engerix-B vax & antibody test was neg; pt recvd a booster dose of Engerix-B on 6AUG91 & antibody levels will be rechecked;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 33.78 for dose administered on 15-APR-2021 .  No concomitant medications were reported.  On 06-APR-2021 , the vaccine with batch number 044B21A was moved to fridge. On 15-Apr-2021, 18 vials were moved to the clinic. On 15-Apr-2021 at 9 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 09-May-2021. Total 188 doses given for the day for batch number 044B21A. Temperature excursion was reported for cooler 1 of the device. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a nurse concerning a 13 year old female who on 01-FEB-2008 was vaccinated with the first dose of Gardasil and is now pregnant.  Concomitant therapy included MIRALAX.  The patient is currently spotting and cramping which is relieved by rest.  Medical attention was sought at the school nurse.  Patient outcome is unknown.  No product quality complaint was involved.  Additional information has been requested.   This is in follow-up to report (s) previously submitted on 3/14/2008.  Additional information has been received from the physician who stated that the patient "had no complications from the vaccine" and she and the baby were fine.  The physician reported that the patient was diagnosed with pre-eclampsia and delivered at about 30-32 weeks gestation by cesarean section.  The physician also added the mother and the baby were both doing fine now.  The mother was physically fine.  The reporter also added that the baby had no anomalies "nothing untoward because of the vaccine".  Upon internal review, pre-eclampsia and delivered at about 30-32 weeks gestation by cesarean section were considered to be Other Important Medical Events.  Additional information is not expected.
5  hrs of high pitched, unconsolable crying; seen in urgent care @ 4PM by MD; fussy; MD stated pt to have no more pertussis;
My back of my leg hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My back of my leg hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN IN EXTREMITY (My back of my leg hurts). At the time of the report, PAIN IN EXTREMITY (My back of my leg hurts) outcome was unknown.            Treatment information not provided. Concomitant medications were not provided.
Information has been received from a registered nurse concerning a 14 year old female who on 11-JAN-2007 was vaccinated with Varivax (lot # not provided). On 15-JAN-2007, the patient experienced breakthrough varicella rash after receiving Varivax. The nurse reported that the patient had approximately 50 lesions or more. The patient outcome was not reported. There was no product quality complaint.
Itchy wrists and red splotches on wrist, elbows, arms and underarms (so far...this just started 60 minutes ago) Just took an Allegra as suggested by associate at the pharmacy where vaccine was administered.
A throbbing headache that worsened when standing. It has lasted for about 12 hours and is almost completely gone starting about 17 hours after receiving the 2nd dose of the Moderna vaccine.  Sleeping and fluids helped make the pain manageable, but ultimately just had to wait it out.
Post vax, the next morning, the pt has high-grade fever of 102.9F. The fever continued and on 6/18/01, her temperature was 101.4F, she had anorexia and fussiness. Parent takes baby to the doctor on 6/18/01. Baby takes ibuprofen and rash started from head down to feet and entire body which lasted until 6/22/01. All this, despite Tylenol and ibuprofen around the clock.
Swelling  and erythema hands bilaterally. Swelling of feet right upper cheek/lip.
April 10th, 2021 is when symptoms began. I had ear pressure and my right sinuses, decreased hearing ability and some pain as well. April 20th, 2021 was when I got care for what they thought was a sinus infection. Then they put me on steroids, Sudafed and Flonase which didn't really improve anything; this was on 4/28/2021 at clinic. So, then they sent me to an ENT doctor on 6/1/2021 and he told me I had 15% hearing loss. He prescribed me more steroids which did nothing for my hearing in fact I felt like it got worse. He checked my hearing again and it was still 15% loss of hearing, I had an MRI and it showed nothing abnormal. The doctors do not know why; no fluids in my ears found by the ENT and no tumors.
ALL OVER PAIN FOR A COUPLE OF WEEKS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (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 patient experienced all over pain for a couple of weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from all over pain for a couple of weeks. This report was non-serious.
Vomiting, cramps, Fever 101.2,  Chills, headache still experiencing
this pattern keeps repeating itself daily.; swollen top lip; swollen (rash); itchy(rash); rash; swollen (rash); swollen (rash); This spontaneous case was reported by a consumer and describes the occurrence of the first episode of SWELLING (swollen (rash)), RASH (rash), the third episode of SWELLING (swollen (rash)), the second episode of RASH PRURITIC (itchy(rash)) and the third episode of RASH PRURITIC (itchy(rash)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included METFORMIN and VALSARTAN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Mar-2021, the patient experienced the first episode of SWELLING (swollen (rash)) and the first episode of RASH PRURITIC (itchy(rash)). On 18-Mar-2021, the patient experienced RASH (rash), the second episode of RASH PRURITIC (itchy(rash)) and the second episode of SWELLING (swollen (rash)). On 29-Mar-2021, the patient experienced the third episode of SWELLING (swollen (rash)), the third episode of RASH PRURITIC (itchy(rash)) and LIP SWELLING (swollen top lip). On an unknown date, the patient experienced ADVERSE DRUG REACTION (this pattern keeps repeating itself daily.). On 19-Mar-2021, RASH (rash) had resolved. At the time of the report, last episode of SWELLING (swollen (rash)), the last episode of RASH PRURITIC (itchy(rash)), LIP SWELLING (swollen top lip) and ADVERSE DRUG REACTION (this pattern keeps repeating itself daily.) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Updated reporter information, outcome of events lip swelling and adverse drug reaction from unknown to recovering/resolving.
Vaccination Monday, 22nd.  Itching and stiffness Tuesday. Down from arms big red swelling. to ER.
rash became blistery/shingles; became blistery.; head headache that felt "nervy; rash "straight ine" down her neck and appeared on right side of body; swelling of lips slightly; tingly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash "straight ine" down her neck and appeared on right side of body), LIP SWELLING (swelling of lips slightly), PARAESTHESIA (tingly), HERPES ZOSTER (rash became blistery/shingles) and BLISTER (became blistery.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), AMLODIPINE, HYDROCHLOROTHIAZIDE, ROSUVASTATIN CALCIUM (CRESTOR), CALCIUM, MAGNESIUM, TURMERIC [CURCUMA LONGA RHIZOME], ASPIRIN [ACETYLSALICYLIC ACID] and PROBIOTICS NOS for an unknown indication.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced RASH (rash "straight ine" down her neck and appeared on right side of body), LIP SWELLING (swelling of lips slightly), PARAESTHESIA (tingly) and HEADACHE (head headache that felt "nervy). On 11-Apr-2021, the patient experienced HERPES ZOSTER (rash became blistery/shingles) and BLISTER (became blistery.). The patient was treated with CORTISONE (topical) for Rash, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH (rash "straight ine" down her neck and appeared on right side of body), LIP SWELLING (swelling of lips slightly), PARAESTHESIA (tingly), HERPES ZOSTER (rash became blistery/shingles), BLISTER (became blistery.) and HEADACHE (head headache that felt "nervy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-075599, MOD-2021-075599 (Patient Link).
got the shot, and still had outbreaks, shingles/ Suspected vaccination failure; still had outbreaks, shingles; extremely painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox and shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported he/she had shingles, got the shot and still had outbreaks. The patient takes oral medication daily for it now. The patient stated it was extremely painful and you were at higher risk if you have had chicken pox. The patient said get that shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
1. Sore arm for 2 days 2. Mild fever for 1 day (99.1  F) 3. Mild chest discomfort / shortness of breath for 3 days 4. Mild headache for 2 days 5. Fatigue for 2 days 6. Mild stomach ache for 1 day
Pt flush c/o nausea, confusion, diaphoresis and sick.  BP 130/80 P74- pt on co + next to RN for observation and cont. monitoring.  Denies SOB/tighness in chest.
Client received the 1st dose of the COVID vaccine (Moderna Lot # 027C21A and expiration date 07/01/2021) at 1934. At 1948, EMT noticed that the client?s face was becoming pale and diaphoretic. EMT alerted PHN and both responded to the patient at 1948 and transitioned the client into the zero gravity chair. Client was reluctant to sit in the zero gravity chair and stated, ?I?m feeling anxious and this is not helping especially with my aunt.? Client?s aunt was very concerned and was anxious about what was happening and was standing over the client. PHN asked the aunt to sit in her seat and allow us to assess the client. PHN also explained to the client that this was a precaution and not meant to create more anxiety. PHN offered the client a juice which he accepted and drank. At 1952 client stated, ?I?m feeling fine now, I?m not sweating anymore.? Vital signs were taken at 1952 (Blood pressure 130/70, heartrate 87, Oxygen 98%). At 1952, client?s color had returned to his face and his skin was no longer diaphoretic. PHN  asked the client if he has history of fainting from needles, and the client stated, ?no, but I have anxiety.? Vital signs were taken at 2002 (blood pressure 112/70, heart rate 68, oxygen 97%). Client stated that he ate two hours before receiving the vaccine. Vital signs taken at 2010 (blood pressure 114/74, heart rate 78, oxygen 97%). Vital signs taken at 2018 (112/74, heart rate 66, oxygen 97%). Client does not have any medical conditions or allergies and is not taking any medications. PHN  provided education to the client on when to seek emergency medical services and to follow up with his primary care provider before receiving his second dose. At 2019 client stated, ?I?m feeling fine,? and left the facility unassisted with a steady gait.