chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nov 13, 2020, 2pm - Significant pain in shoulder radiating down the arm and into the left hand.  4pm fatigue and ill feeling.  By 6:30pm registered a fever of 99.6 ( my norm is below 98) with headache and body aches throughout.   Chills and greater body aches by 8:30pm.   Headache and fever all night.  Fever did not abate until 9:30am the following morning.  At 4:00am fever was 101.6.  Nov 14, 2020 - Full body aches and fatigue continue - definitely a "sick" day.  At 2:00pm headache is gone and temperature registers normal.
Developed diarrhea x 10 episodes on 12/17/2020 through 7:00PM on 12/18/2020. Treated with Zofran, Pepcid, and Lactaid.
flu-like symptoms; loss of appetite; body did not feel right; fever 101.5F; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (loss of appetite), VACCINATION COMPLICATION (body did not feel right), PYREXIA (fever 101.5F) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M2UF and DISM20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (loss of appetite), VACCINATION COMPLICATION (body did not feel right), PYREXIA (fever 101.5F) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (loss of appetite), VACCINATION COMPLICATION (body did not feel right), PYREXIA (fever 101.5F) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 101.5 (High) 101.5 degrees Fahrenheit.         Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided.
Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The pharmacist called to report that the multiple patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # I027321 with expiration date: 21-OCT-2016; dose and route not reported) on unspecified dates since 04-DEC-2015. The vaccine was stored in 42F for 5 hours. No adverse effects were reported. It was unspecified if the patients sought medical attention or not. Additional information has been requested.
It was a few days after the intial side effects an in the middle of the night my arm was hurting throbbing, and there was a lump. The next morning it was red and hot and very itchy. Used cortisone cream for the itching. I took two tylenol. It seems better today, but it is still itchy and hot to the touch.
Information has been received from a health professional concerning a 21 year old female with a history of acne who on 30-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot # not reported). Concomitant therapy included DENTOMYCIN and vitamins (unspecified). On 31-OCT-2007 the patient experienced a syncopal episode. Patient passed out and regained consciousness almost immediately. Subsequently, the patient recovered from syncopal episode on the same day. On 02-JAN-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# not reported) with no adverse reaction noted. The patient sought medical attention in the office. Additional information has been requested.
PT C/O OF DIZZINESS, PERIORAL PARESTHESIA, EYE FLOATERS WHICH STARTED A FEW MINUTES AFTER RECEIVING THE VACCINATION. PT HAS A HISTORY OF COVID 19 W/CHRONIC "BREATHING PROBLEMS."  10:02 BP 161/82 HR 77 O2 97%  10:05 AM BP 169/79 HR 75  10:09 AM 156/82 HR 75 O2 97% PT WAS MONITORED WITH REPEAT VITALS FOR 15 MIN IN ADDITION TO REQUIRED OBSERVATION TIME. THE REPORTED FLOATERS STARTED TO RESOLVE, BUT PT CONTINUED TO FEEL SHE WAS HAVING A "MIGRAINE LIKE AURA". THE PARESTHESIAS RESOLVED. NO FURTHER ACUTE CHANGES OCCURRED AND PT FELT COMFORTABLE TO LEAVE OBSERVATION SITE. PT WAS ADVISED TO F/U WITH HER PCP.
Severe diarrhea, chills, extreme pain in arm where vaccine was injected from neck to fingers. Pain raising arm over head. Tingling and numbness. Extreme pain moving arm.
AWFUL; FELT LIKE HIT BY A BUS; COULD NOT SLEEP THAT NIGHT; SORE; CHILLS; FEVER; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-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 MAR-2021, the patient experienced awful. On MAR-2021, the patient experienced felt like hit by a bus. On MAR-2021, the patient experienced could not sleep that night. On MAR-2021, the patient experienced sore. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the awful, felt like hit by a bus, fever, chills, could not sleep that night and sore was not reported. This report was non-serious.
Received the Td shot 22 Feb 2006 around 2pm. Dosage 0.5mL (VIS Version of 06/10/1994). Tech asked if I was allergic to any meds etc, and I said not that I'm aware...  Night came about 9pm and I started to feel feverish and lots of joint pains all over my body and couldn't make any movement with my arm, chills all over, upper and lower eye lids burning and some terrible headaches.  It has been well over 28 hrs and my symptoms are still strong even though I have taken an 800 mlg Motrin. This reaction has happened to me 10 years ago and, I suffered for about a week with the same symptoms.  I need to know if this is an allergic reaction or not!
Fever, chills, nausea - symptoms within 3-4 hours post vaccination.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. ON 3/19/21 Patient had a CT that showed a possible malignancy of lung cancer with possible liver metastases. He went to the ED on 3/25/21 with severe abdominal pain and later passed away that day. Care was outside of clinic, so unable to determine diagnosis or suspected cause of death. Comorbidities include CHF, afib, COPD, smoker, anemia, HTN, HLD, PTSD.
Extra whiny, walking less than usual, slight limp, crying when falling (more than usual, actual pain cry).  As of this morning, it has significantly worsened, she will not walk, stand, and is just limp.  If picked up she will slump over the shoulder and not want to move.  In obvious discomfort/pain, fever is evident.  Overall not her normal joyous self.
Information has been received from a 25 year old (reported as 22 year old in the initial report) female who on 30-MAR-2010 was vaccinated with GARDASIL, a Pregnancy Registry product. The patient stated that she saw the GARDASIL pregnancy registry and called to report she received her third dose of the GARDASIL when she was 4 weeks pregnant, (patient gave her LMP as 28-FEB-2010). She stated that she was vaccinated at the health clinic with her third dose of GARDASIL on 30-MAR-2010, but did not know she was pregnant at that time. She took a home pregnancy test and it was positive, but she did not specify the date. Caller stated she is not having any problems. Based on the LMP, the system estimated the delivery date as 05-Dec-2010. The patient reported her estimated due date as 11-DEC-2010. The patient sought unknown medical attention. Follow up information has been received from an unspecified health care professional concerning the 25 year old female who on 30-MAR-2010 was vaccinated with GARDASIL. On unknown date the patient experienced reflux and on 08-SEP-2010 was treated with ZANTAC. She had no previous pregnancies. Her estimated delivery date was 11-DEC-2010 (previously reported as 05-DEC-2010). On 16-JUN-2010 and 09-JUL-2010 she had routing and dating ultrasound scan which showed simple live intrauterine pregnancy (SLIUP) with positive heart  rate (HR). On 25-JUN-2010 Maternal Serum Alpha-Fetoprotein (MSAFP) was done for birth defects screen. The screen tests were negative. On 04-DEC-2010, 39 weeks from last menstrual period (LMP), the patient delivered a normal, healthy male baby weighing 5.2 pounds. There were no congenital anomalies. There were no other complications or abnormalities. There were no complications during pregnancy or labor/delivery. No further information is available.
Headache, Chills, Muscle Ache, Fatigue in the 48 hours after the injection.  Swelling, pain and redness at the site of the injection that is not improving four days after the injection. The area of swelling is approximately 2.5 inches in diameter.
An employee heath nurse reported the occurrence of a 35 year old female subject who did not respond to a series of hepatitis B vaccine for prophylaxis.  The subject's relevant medical history, concurrent conditions and concurrent medications were not specified.  On unspecified date, the subject completed a three injection series of hepatitis B vaccine (unknown manufacturer).  an unspecified titer was drawn with a negative result.  A fourth injection of hepatitis B vaccine (unknown manufacturer) (date not specified) was administered.  A second unspecified titer was drawn again with a negative result.
Per hospital report Patient received 3 immunizations on 2/9/22. Had vaccination reaction (lump on thigh) and was seen on 2/18/22. It was at that time that it was discovered that the vaccines were never documented in the patient chart and the visit was still open with vaccines pending. Patient was again seen on 2/23/22 and this had not been resolved.
A non-serious, spontaneous report of "developed the flu" was received from a physician's assistant, concerning a male child (age not reported) subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on an unknown date. On 12-Oct-2009 the patient developed flu-like symptoms with a high fever and aches. The reporter stated influenza had been "going around" the child's class. The outcome for the event was not reported. The reporter stated the patient "developed the flu, but not because of FLUMIST." Required follow-up attempts have been performed, requested information unable to be obtained. 22-Feb-2010.
Feels dry throat/faint/dizzy/shaky but did not lose conscious. Paramedic consulted. BP 105/60 103/60. Pulse 72. Observed 40 mins. All sxs resolved.
pt recv vax; 4 days later,exp fainting spells in which body went limp;exp severe lethargy,face went pale & was very sleepy;turned yellow,became slightly anemic,feeding pattern changed; hosp for 8 days; sx still present but not as severe
Myalgia, Fever, Diarrhea, NauseaVomiting, fever 102.4 Narrative:
Monday morning, Dec. 30, 2019, I a headache,  felt nauseous, my fever spiked, and my blood pressure dropped dangerously low. I fainted. I was transported by ambulance with a temp of 105, BP: 70/30. I spent the day in hospital ER and was admitted to hospital that night with continued hypotension. I was released from hospital after 6PM on 12/31/19 when BP was acceptably low.
Extreme headache, pressure in head, total loss of hearing, right ear, partial hearing loss left ear, sense of taste and smell, loss of feeling on right side of head. ENT physician visit, ER visit, meds, Valtrex, Prednisone orally, steroid placed in right ear after no effect with oral meds. Left hospital AMA after told I did not have a stroke. NO! They did not like it, but I was trying to save money that I did not have! I wish that I had stayed--hind sight!
23 year old complained of being tired after received vaccine. Onsite EMS was called vital BP 126/80  100% O2 HR 92. She refused further evaluation & care
This case was reported by a physician and described the occurrence of a 38-year-old male subject not responding to therapy following vaccination with Engerix B for prophylaxis. On 21 March 2006, 12 December 2005 and 12 September 2005 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown). Approximately 14 months after completion of the three dose series of Engerix B, the subject's titer was less than 5 mIU/ml. No other titers had previously been drawn. The subject had not responded to therapy with Engerix B. At the time of reporting the outcome of the event was unspecified.
Information has been received from a health professional concerning a physician who on approximately 03-NOV-2005 'within the last two weeks" was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#649914/0578P). Within the last two weeks, the physician developed nausea, vomiting and diarrhea.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Patient got warm and lightheaded about 6 mins after being given the vaccine. Patient was helped up and said he may have blacked out either from the shot or the needle itself he is unsure. He passed out or fainted.
area is a 3 inch x 5 inch patch on muscle around the injection site; njection site became itchy; injection site became warm; fever; pink at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE ERYTHEMA (pink at injection site), VACCINATION SITE PRURITUS (njection site became itchy), VACCINATION SITE WARMTH (injection site became warm) and VACCINATION SITE RASH (area is a 3 inch x 5 inch patch on muscle around the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Leukaemia. Concomitant products included natural hormone replacement, LEVOTHYROXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PROBIOTIC 10, sambucol elderberry gummy and super beet chew for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE ERYTHEMA (pink at injection site). On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (njection site became itchy) and VACCINATION SITE WARMTH (injection site became warm). On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (area is a 3 inch x 5 inch patch on muscle around the injection site). At the time of the report, PYREXIA (fever), VACCINATION SITE ERYTHEMA (pink at injection site) and VACCINATION SITE WARMTH (injection site became warm) had resolved and VACCINATION SITE PRURITUS (njection site became itchy) and VACCINATION SITE RASH (area is a 3 inch x 5 inch patch on muscle around the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: Advil
Hives; This is a spontaneous report from a contactable consumer (patient).  A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, batch number and expiry date were no reported) via an unspecified route of administration on an unspecified date as Dose 1 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. The patient experienced hives that erupted 9 days (unspecified date) after the first shot. The patient was looking for advice on if she should get the second shot. Outcome of event was unknown at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got pneumococcal conjugate vaccine (PCV-13) on Mon., June 6th, 2016, went back to doctor Tues., June 7, 2016 w/extreme pain, no use of right arm got shot in and still to 7-20-16 and continuing cough since shot, thick, white, foamy mucus.
She vomited; She was dizzy; Nausea; Tired all day; headache; vomited again; she fell getting up; Ended up getting heart rate went up; This is a spontaneous report from a contactable Consumer (daughter) reported for mother. A 58-year-old female patient (mother) received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for Injection, Lot number: EL9269, Expiration date: May2021), via an unspecified route on 07Feb2021, Sunday at 13:30 (Age at vaccination: 58-year-old) as Dose 1, single for covid-19 immunization. Medical history included asthma and blood pressure. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Pfizer-BioNtech Covid-19 Vaccine, Solution for Injection, Lot number: EL3247) as a single dose for covid-19 immunization. On 09Feb2021, patient experienced vomiting since 3am, no fever, no change in heart rate, only dizziness and nausea, she was just very tired all day yesterday, last night she ended up getting her heart rate went up a little bit and she got slightly dizzy, and it was all about 11 0'clock in night she went to bed and woke up at 3 am today extremely dizzy that she couldn't even stand up on her feet she fell getting up and vomited. About 11PM last night had a headache. She woke up at 4am to use the bathroom, was very dizzy, vomited, drank water and vomited again. She was vomiting non-stop. This morning she was feeling better, but she hasn't vomited till 5 :30 in the morning but she is still extremely dizzy, dizziness will like a severe reaction, but it's been almost 36 hours caller don't think she would have a severe reaction 36 hours later. Caller would like to know if this is a normal reaction to be this dizzy. Therapeutic measures taken as a result of headache included Tylenol, after that she went to bed and was fine. The patient underwent lab test and procedure which included no change in heart rate and heat rate went up in Feb2021. The clinical outcome of headache was resolved on Feb2021,vomiting, dizziness was not recovered and nausea, all day tired, vomiting again, fell getting up ,ended up getting her heart rate went up was unknown.  Follow-up attempts completed. No further information expected.
fever, cough , poor appetite, nausea, diarrhea, headache, muscle aches, fatigue and chills.
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 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 11:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 12:09 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced 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). 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 24.88 for dose administered on 14-Feb-2021 and 24.97 for dose administered on 21-Mar-2021.  No concomitant medications were reported.  Batch number 031L20A  underwent temperature excursion on 14-Feb-2021 with temperature 32, 32 ,32,35and 35 degrees Fahrenheit from  09:00AM to 03:00 PM. This vial was moved to fridge 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature 34-, 32- and 34-degrees Fahrenheit from 09:00AM to 11:00 AM. This vial was moved to fridge 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
I experienced red rash around where I got the Injection; got the Injection and it was about 2 inches long and 1 inch wide and I still have the itchiness; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 20Feb2021 (Batch/Lot Number: EN9810; 79-year at the time vaccination) as single dose for covid-19 immunisation. Medical history included cholesterol; blood pressure. Concomitant medications included losartan 50 mg; rosuvastatin 5 mg; ezetimibe 10 mg. The patient previously received first single dose of bnt162b2 for Covid-19 immunization. It was reported " I got the Pfizer second vaccine on the 20Feb2021 and I experienced red rash around where I got the Injection and it was about 2 inches long and 1 inch wide and I still have the itchiness." Consumer stated, "No I went on (Search engine) and wash it with soap and water, I have been taking it what you call it Advil or Tylenol. Today the itching is not as bad and pain is gone." The outcome of the events recovering.
After waiting 15 mins I went to leave clinic I was fine. About 20 mins after injection I noticed my face beet red, top lip swollen slightly. No other symptoms at that time. The next morning I contacted my doctor about the reaction. When I took my pulse it was slightly high 95. I went to see my doctor at 2:30 p.m. she advised me not to get the second dosage and or see an allergist. If I were to get the second dosage she advised it be in a medical facility In case Worst reaction. The following 2 days very tired and had a headache.