chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Close to syncope. Very dizzy, nauseous, not able to function at all. Episode lasted for about 1-2 minutes. I was able to sit down and lay my head on the table when it started.  I was completely covered in sweat when it stopped. I was weak and tired for the rest of the day. Spent my day in bed.
Chills; fever (100.4); fatigue on the day of injection and the following day.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 44-year-old female patient who received TWINRIX adult (batch number 797K7, expiry date 29th April 2017). Co-suspect products included ADACEL (batch number U5081AA, expiry date 25th June 2017). Concurrent medical conditions included drug allergy (to codeine). Concomitant products included TYPHOID. On 16th March 2015, the patient received the 1st dose of TWINRIX adult (intramuscular) 1 ml and ADACEL (intramuscular) .5 ml. on 16th March 2015, less than a day after receiving TWINRIX adult, the patient experienced injection site pain (serious criteria disability), injection site wheal (serious criteria disability), injection site warmth (serious criteria disability), chills (serious criteria disability), numbness of upper extremities (serious criteria disability), injection site induration (serious criteria disability), injection site erythema (serious criteria disability) and stiff neck (serious criteria disability). On an unknown date, the outcome of the injection site pain, injection site wheal, injection site warmth, chills, numbness of upper extremities, injection site induration, injection site erythema and stiff neck were unknown. The reporter considered the injection site pain, injection site wheal, injection site warmth, chills, numbness of upper extremities, injection site induration, injection site erythema and stiff neck to be possibly related to TWINRIX adult. Additional information was provided as follow: The medical assistant reported that the patient had two vaccines in her left arm (TWINRIX and ADACEL) and experienced the above side effects.
I woke up the next day at 1:30am with headache, and trembling as if I was cold. Was physically shaking from cold, no matter how much cloths I put on. It lasted a few hours , it was gone , but that day I did have a fever with aches over my bodies and joints as if I had a flu. However, I did not have running noise or water eyes.  I had a blood test done about a month before from my right arm, there was no scars or burses. I took the vaccine on the left arm but that day I notice the burses on my right eye where I give blood a month before.  However, I am glad I took the vaccine, but I wanted to report the adverse reaction to it. My wife had no adverse reaction.
erythema over rt deltoid; extends 2/3 way to elbow; moderate warmth;
The day after shots, parents noticed redness, swelling and warmth around shots. Seen in office, 2 days after shots with a 4cm area of erythema surrounding injection sites, warm to touch and raised up. This resolved 3 days after shots. Also had a low-grade temperature of 99.5F and irritability, which all resolved.
Pt had chills, shakes, she felt like she had a lump in her throat, oxygen level was down, and she didn't feel good. Used an epi-pen on her and called 911
Starting at 2:00 PM Shoulder/neck pain, flushed cheeks. By 2:30 PM itching, hives, headache, nausea. Seen in ER. Atarax/Benadryl every 6 hours, prednisone- taper.
Itching and swelling on the injection site (looking like a bug bite); Itching and swelling on the injection site (looking like a bug bite); Hardness on the injection site on her right upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness on the injection site on her right upper arm), VACCINATION SITE PRURITUS (Itching and swelling on the injection site (looking like a bug bite)) and VACCINATION SITE SWELLING (Itching and swelling on the injection site (looking like a bug bite)) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hardness on the injection site on her right upper arm). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching and swelling on the injection site (looking like a bug bite)) and VACCINATION SITE SWELLING (Itching and swelling on the injection site (looking like a bug bite)). At the time of the report, VACCINATION SITE INDURATION (Hardness on the injection site on her right upper arm), VACCINATION SITE PRURITUS (Itching and swelling on the injection site (looking like a bug bite)) and VACCINATION SITE SWELLING (Itching and swelling on the injection site (looking like a bug bite)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included an unspecified asthma inhaler.  Treatment for the events included antihistamine.
product was given to patient, but it was expired with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender to whom vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] , but it was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength, expiry date and lot number not reported) via unknown route for immunization and but it was expired with no reported adverse event (expired product administered) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported same event for two patients. This is the first of two reports.  A 21-year-old female patient received dose 1 and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated with the Pfizer Covid vaccine in Jan2021 (reported as "Jan2020") and recently tested positive for Covid on 14Apr2021 and has had a severe case of Covid. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021444196 same reporter/drug/event, different patient
Myalgia Enlarged painful lymph node underneath left collar bone. Narrative:  Other Relevant History:
ADMINISTERED MODERNA VACCINE TO PATIENT UNDER 18 YEARS OLD.  PATIENT IS 16 YEARS OLD.  5'9 280 LBS. BLACK MALE.  Patient reports at 2nd dose appointment that he had numbness in his feet up to 1 week ago .  2nd dose appointment was August 6.
arm swelling next day p/vax w/redness, followed by fevers, resolved w/2 days of pred
Patient said that he felt like he was having a nervous breakdown, he had anxiety, nervousness, shaking hands.  He said his skin felt like it was on fire (feeling like sunburn), he was sensitive to temperature, loss of appetite (lost 5-10 pounds), He said that there was no rash, swelling, or shortness of breath.  He said he is normally a good sleeper but, for about a week and a half he could only sleep for about 3 hours and then was wide awake.  He tried taking melatonin.  He said he went to the immediate care who wouldn't treat him since they thought it sounded like he was having a nervous breakdown.  He said he called his primary physician who gave him Lexapro but, when I spoke to their office, they didn't realize he had an issue with a vaccine.  The patient said the Lexapro didn't work and he wasn't taking that anymore.
Vertigo; numbness in chest; tingling in arms; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), HYPOAESTHESIA (numbness in chest), PARAESTHESIA (tingling in arms) and DIZZINESS (dizzy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (dizzy). On 14-Apr-2021, the patient experienced VERTIGO (Vertigo), HYPOAESTHESIA (numbness in chest) and PARAESTHESIA (tingling in arms). On 01-Apr-2021, DIZZINESS (dizzy) had resolved. At the time of the report, VERTIGO (Vertigo), HYPOAESTHESIA (numbness in chest) and PARAESTHESIA (tingling in arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal (abnormal) Vertigo diagnosed. On an unknown date, X-ray: abnormal (abnormal) Vertigo diagnosed.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had a lot of health issues and a breathing condition. No concomitant medication provided.  No treatment medication were reported.
Dizzy,  feeling light headed & nauseated 26 hours after shot,  then by late Sunday evening I was running a fever of 103, Tylenol was able to keep it down but not for a long period of time,  upset stomach,  cold chills,  and hot at the same time.  Feeling very sore all over,  like I had a bad flu.  I was very fatigue,  sleeping 18 hours straight.  Extremely thirty,  diarrhea and vomiting.  By Tuesday night I was fine.  I was still sore all over,  but fever had gone back to normal & I was able to eat some chicken noodle soup.  Wednesday morning I was back to me.  Feeling well now.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 28Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "vertigo" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA, start date: 01Mar2022, stop date: 30Jun2022; AMLODIPINE, start date: Jan2019, stop date: 07Jul2022; LISINOPRIL, start date: Jan2019, stop date: 07Jul2022; PRESERVISION, start date: Jan2020, stop date: 07Jul2022; VITAMIN D [VITAMIN D NOS], start date: Feb2022, stop date: 07Jul2022. Past drug history included: Maxzide, reaction(s): "Known allergies: Maxzide".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative for Covid on an antigen test after completing the treatment; positive, notes: I began treatment after a positive pcr Covid test; positive, notes: A few days later I had symptoms of nasal congestion, sneezing, headache and tested positive on a PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was reporter and reported about covid treatment. Patient received vaccine and other medication in 2weeks.Patient received Paxlovid as antiviral therapy from 16Jun2022 to 20Jun2022 as treatment of COVID-19 she received BNT162B2 vaccine first dose on date Apr2021 and time 01:00 PM on right arm. Patient received BNT162B2 vaccine second dose on date Apr2021 and time 10:00 AM on right arm. And third dose on date Nov2021 and time 02:00 PM on right arm. Patient received BNT162B2 vaccine fourth dose on date 28Apr2022 and time 02:00 PM on right arm. It was reported that patient began treatment after a positive PCR Covid test and had a sore throat her symptoms went away and tested negative for Covid on an antigen test after completing the treatment. A few days later had symptoms of nasal congestion, sneezing, headache and tested positive on a PCR test. Adverse events start date was reported as 26Jun2022 and time 03:00 PM. Patient was recovered no treatment adverse event was reported. Patient had Known allergies with Maxzide and other medical history was Asthma, hypertension, vertigo.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial unsolicited report received from a Consumer on 11 March 2015. A male patient, whose medical history and concomitant medications were not reported, had received a dose of Tdap (batch number, dose in series, route and site of administration were not reported) on an Unspecified date. It was reported that the patient had experienced sore arm 6 weeks post vaccination and patient stated he discussed this with the pharmacist and he believes the wrong length of needle was used. Laboratory investigations were not reported. It was reported that patient had used Ibuprofen, topical preparations of Icy Hot and Ben Gay as corrective treatments, but which were ineffective. It was reported that the patient required ER/doctor visits. At the time of this report the patient outcome was unknown. Documents held by sender: none.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 26-FEB-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
8 hrs after shot got sore joints, bones, and muscles, head ache, chills, fever up to 101. Fever broke 8 am the next morning. Soreness for the next 2 days. tired for 4 days.
Donor reported to center stating adverse symptoms of fever, runny nose, nauseous, headaches, not feeling well and a rash around injection site. Symptoms duration from 01/13/2023 to 01/18/2023
INFANT RECEIVED THE 2 MONTH IMMUNIZATIONS ON 5-22-08 AT APPROX. 1OAM. MOM CALLED AT 4PM STATING INFANT HAS CRIED NON-STOP FOR THE PAST 3-4 HOURS. INFANT NOT CRYING WHILE NURSE ON THE PHONE. ADVICE GIVEN FOR IMMUNIZATION REACTION AND ADVISED TO GO TO ED IF WORSENS.
Headache, Myalgia, chills, fatigue, pain injection site Narrative:
pfizer vaccine as booster dose to J&J vaccine 8 months prior.  had flu shot in same location about 5 weeks prior.  h/o prior reactions to flu shot with "red hard lump" but this flu shot, did not have that.   about 1 day after vaccine, had typically chills, fever, fatigue lasting less than 24 hours.  Then about 2-3 days after vaccine- had redness/ purple discoloration of the left arm near the injection site.  6 days post vaccine still has light pink and light purple discoloration in a patch distribution. itchy at times.  Was raised and more painful and hot yesterday.  not hot today.
My son received the DTaP and HIB vaccines. By the time we got home from the doctor's office, which takes about 20 minutes to half an hour, my son was covered in a rash. It looked like a heat rash, but was mostly on the front of his legs. It was from head to toe though. All over his face, body, arms, legs, feet. He had fallen asleep in the car so I put him down for a nap. When he woke up at about 2:00 PM, the rash had diminished a little bit, but was still there. I put in a call to the pediatrician. During that time, he was fussy eating, and projectile vomited. The doctor who called me back told me to keep an eye on it and just give him Benadryl if it got worse. He vomited once more that night, and barely ate. The rash stayed for 3-4 days, coming and going randomly. It was not hot in our home (where we were the entire time), so it was not just a regular heat rash, even though that's what it reminded me of.
12 - 14 days after vax pt devel fever 104F & extensive rash.
Foul/putrid smelling bowels and flatulence (1st symptom that has lasted for some weeks), severe headaches/migraine type headaches, sharp stabbing abdominal pains (non-menstrual), bloody stools.
Patient was administered DTap/IPV at age 9 months. Per the CDC guidelines, DTap/IPV should not be administered under the age of 4 due to high risk complications. It was discussed with the provider and staff that the patient should have been administered a DTap/IPV/Hib (Pentacel), or a seperate DTap and IPV. Provider and Nurse educated with CDC VIS.  Provider is to call patient's family and notify them of mistake.
No adverse side effects. Vaccination was given to patient to soon at PCP office. Patient was asked if she wanted Flu vaccine and patient stated she wanted Flu vaccine and completed consent form. Also our EMR system had been alerting us that patient needed Flu shot.  After administrating flu vaccine and trying to input info to our EMR system an alert showed up stating patient had already received Flu Vaccine on  09/21/21, prior to 10/19/21.
Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28-FEB-2023) for prophylaxis.   On 07-MAR-2023, the patient received the 2nd dose of Bexsero. On 07-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered).  The outcome of the expired vaccine used 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: 07-MAR-2023 Practice Manager stated that one of the staff administered an expired dose of Bexsero to a patient.  The reporter consented to follow up via postal. Patient received a dose of Bexsero on 7th March 2023 which was expired on 28th February 2023, which led to expired vaccine used.
Severe headache/migraine in all parts of the head, not concentrated in one location. The use of pressure and an ice pack helped, but this continued from 5am to 6pm the day following the vaccine. Temperature  of 101, called doctor and was told to take ibuprofen.   Pale, weakness, dizziness, nausea, throwing up continued for two hours after waking up (5am) the day after the shot was given.
redness at injection site; Pain at injection site.; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The emergency room physician called to report that the patient received Shingrix, and had pain and reddness, demarcated area approximately 7cm, on deltoid, for 5 days. The Shingrix was given at another location listed in adverse event.