chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red injection site; indurated at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2019) for prophylaxis.   On 2nd November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd November 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site induration. On an unknown date, the outcome of the injection site erythema and injection site induration were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site induration to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that the patient received Shingrix and developed a red, indurated area 3 inches by 2 inches at the injection site. She states that this has resolved at the time of reporting and unsure of the date of resolution. The reporter did not consent to follow up. The health care professional did not consent to follow up for this adverse event.
Multiple 50-60 chicken pox lesions on 5/31/05 examination.
Case number PHEH2015US026933, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 08 months old male patient. Past medical history and concomitant medication were not reported. The male neonate of 08 months was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in right deltoid on 13 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
sleepy; tired; cannot put weight on her right leg; She has not been out of bed for over a week; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included arm and leg nerve damage; cardiac, liver and lung disease. Concomitant medications included lorazepam taken for an unspecified indication from an unspecified start date and ongoing; melatonin taken for an unspecified indication from an unspecified start date and ongoing; cetirizine hydrochloride (ZYTREC) taken for an unspecified indication from an unspecified start date and ongoing; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication from an unspecified date; the patient also took her heart medication she did not know the name. The patient wanted to report that after taking shot she was sleepy and tired and could not put weight on her right leg. She took a Benedryl before taking the shot and was told she should not have done that after receiving the shot (pharmacy name) gave her another after taking the shot. She had not been out of bed for over a week. She was afraid to take the second shot. The patient further stated that she was experiencing serious adverse effect from COVID vaccine. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Information has been received from a health professional concerning a patient with a history of premature birth and with significant past history (unspecified), who was vaccinated with a first and second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) as directed.  It was reported that one week after both doses the patient developed two weeks of diarrhea.  It was reported that there were no other untoward effects and medical intervention was not required.  Current patient status was not reported.  The mother had declined to have the patient receive the third dose of the series.  A product quality complaint was not reported.  No further information was available.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 12/3/2007.  Information has been received from a health professional concerning a 56 day old female with pulmonary stenosis and gastrooesophageal reflux disease with a history of premature birth, fallot's tetralogy (repaired) who on 26-JUL-2007 was vaccinated with ROTATEQ.  Concomitant vaccinations included an intramuscular dose in the left upper thigh of  TRIPEDIA (lot# 2605AA), an intramuscular dose in the left lower thigh of ACTHIB (lot#UF111AA), an intramuscular dose in the right lower thigh of PREVNAR (lot#858845H), and an intramuscular dose in the right upper thigh of RECOMBIVAX HB (lot# "0551U").  There was no reported illness at the time of the vaccinations.  Approximately two weeks (approx 09-AUG-2007), the patient developed diarrhea.  It was reported that there were no other untoward effects and medical intervention was not required.  It was indicated that on an unspecified date, the patient had recovered.  On 02-OCT-2007, she received her second oral dose of ROTATEQ.  Concomitant vaccinations included an intramuscular dose in the left upper thigh of TRIPEDIA (lot# C2765AA), a subcutaneous dose in the right upper thigh of VERO (lot# A0273), an intramuscular dose in the right lower thigh of PREVNAR (lot# U58845M), and an intramuscular dose in the left lower thigh of ACTHIB (lot# UF214AB).  There was no reported illness at the time of the vaccinations.  Approximately two weeks after the vaccinations (approx 14-OCT-2007), she developed diarrhea.  Additional information indicated that after receiving the first and second doses of ROTATEQ, she encountered "3 (*) weeks of diarrhea".  Diagnostic studies approx 01-NOV-2007) included clostridium difficile (negative), ova and parasite (negative), Giardia lamblia (negative), and rotavirus (negative).  Medical attention sought and treatment was not specified.  On an unspecified date, the patient had recovered.  The mother had declined to have the patient receive the third dose of the series.  A product quality complaint was not reported.  Additional information has been requested.
Punctured vial was stored in refrigerator and administered to other patient on 22Mar2022; administered with the vaccine from a vial punctured for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Punctured vial was stored in refrigerator and administered to other patient on 22Mar2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was stored in refrigerator and administered to other patient on 22Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Punctured vial was stored in refrigerator and administered to other patient on 22Mar2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. Vial was initially stored in the refrigerator on 16-Mar-2022 at 8:00am and at 8:02 am the vial was first punctured. Post puncture the vial was stored in refrigerator and 2nd dose from the same vial was administered to patient on 22-Mar-2022 around noon time. The vial did not undergo any temperature excursions and for 15 minutes time the vial was exposed to room temperature range (8 Degree to 25 Degree Celsius = 46 Degree to 77 Degree Fahrenheit). No information on treatment medications were reported
blood pressure 154/80; Temperature today at 12:25 pm 100.5Temperature today at 12:48pm 101.2; body aches; extremely thirsty and cant get enough to drink; a little tingling around the lips for just a short time and then it went away; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration in the right arm on 10Apr2021 at 12:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer since 1999, IVP(Intravenous pyelogram) allergy, surgery in 2020, lumpectomy on an unspecified date in Feb2017, lymph node biopsy on 31Mar2021 and COVID-19 from unknown date to an unknown date. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and amlodipine besilate (MANUFACTURER UNKNOWN) for unknown indications from unknown date. The patient previously took tetanus vaccine toxoid (MANUFACTURER UNKNOWN), pentosan polysulfate sodium (ELMIRON), atorvastatin calcium (LIPITOR), rosuvastatin calcium (CRESTOR), methotrexate(MANUFACTURER UNKNOWN), boric acid (MANUFACTURER UNKNOWN), sulfamethoxazole, trimethoprim(SEPTRA) and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 12:45, the patient experienced a little tingling around the lips for just a short time and then it went away and at night had diarrhea and also on 11Apr2021 (next day) morning. On 11Apr2021, the patient was extreme thirsty and cannot get enough to drink, body aches and at 12:25, the patient had temperature of 100.5(fever), at 12:47, the patient had a blood pressure of 154/80(high blood pressure) and at 12:48, temperature of 101.2. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. On 11Apr2021, the patient underwent body temperature, blood pressure, heart rate tests and resulted with a temperature of 100.5 and 101.2(unspecified units), blood pressure of 154/80(unspecified units) and heart rate of 68(unspecified units). The clinical outcome of the event tingling lips was recovered on 10Apr2021, while that of diarrhea, body aches, extreme thirsty, temperature of 100.5, 101.2 and blood pressure of 154/80 were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning a 12 year old male patient, who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported). Secondary suspect therapy included AFLURIA (manufacturer unknown). Concomitant therapy included meningococcal vaccine (unspecified). The nurse reported that the patient fainted after receiving all three vaccines and a blood drawn (results not provided). The patient hit his head as he was fainting and was sent to emergency room. Additional information has been requested.
One month after Hep B #1 immunization, abdomen began to itch.  1-2 days later, red patches began to appear.  In subsequent weeks they grew in number and spread to arms and neck.  Large patch at spot of immunization which expanded from an initial patch present from the time of injection.  All patches began to develop a light center with a red outer ring after 2 weeks.  Condition prevails.
Patient received vaccines at approximately 09:30, and waited in the common area under observation until roughly 10:00.  Patient then asked to go to his room, which he was granted, as his waiting period was over.  Patient was then found dead at approximately 12:00pm by Facility Staff when they went to get him for lunch.  Reason for Death is unknown at this time.
Sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2023, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick) (serious criteria hospitalization). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the parent of the patient via interactive digital media. The reporter reported that the patient just received Shingles vaccine and experienced sick which was enough to end up in the hospital. Follow-up would not possible, as no contact details were available.
VACCINE EXPOSURE DURING PREGNANCY; SOME SIDE EFFECTS FOR 48 HOURS; This spontaneous pregnancy 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. It was not reported whether the patient had been pregnant before. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 06-APR-2021, the subject experienced vaccine exposure during pregnancy. On 06-APR-2021, the subject experienced some side effects for 48 hours. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some side effects for 48 hours on 08-APR-2021, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
running a fever; tired; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (running a fever) and FATIGUE (tired) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer (Patient is currently on chemotherapy for lung cancer). Concomitant products included BENZONATATE for Cough, PANTOPRAZOLE, METOPROLOL and SIMVASTATIN for an unknown indication, APIXABAN (ELIQUIS).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced PYREXIA (running a fever) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (running a fever) and FATIGUE (tired) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Elevated resting heart rate (1 week), fatigue (2 weeks), change in taste (ongoing) and change in smell (ongoing).
This spontaneous report was received from a consumer via social media, referring to an unspecified number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with a dose of an unidentified HPV vaccine (name and lot number not provided) for prophylaxis. The reporter stated that "did research and found out a leading scientist for the drug came out and said it's killing kids". The reporter considered the event was related the unidentified Merck HPV vaccine. Upon internal review, the event "death" was considered to be medically significant. This is one of several reports received from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004856: US-009507513-1701USA005334: Interaction number.
Pt had TDAP on 5/16/12. Pt came to show redness on 5/23/12. Pt states redness start on site & going down to elbow area. Redness & warm to touch. Notified Dr.
This was the second of two inoculations on this vaccine. The first one was on 01/09/2018 in which I only experienced soreness at site of injection and tiredness. The second one on 03/10/2018, in addition to soreness at injection site: chills, fever, exhaustion, body ache in evening; I took 2 ibuprofen and was able to sleep; when I awoke this morning, the chills were gone, but still had exhaustion, body ache, plus nausea and depression.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/10/21 pfizer,Lot#012L20A 2nd dose:02/07/21 Pfizer,Lot# 012M20A Diagnosed covid positive:08/11/21 Symptom onset:08/10/21 Exposure:Home Symptoms:Runny nose, head ache
5ml syringes that had been provided by local Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Severe headpains, affecting my face & sinuses & causing blurred vision at times.  Private consultation with a neurologist who has prescribed a class C drug
Redness at site-tenderness for 2 days, started on 8/19/06 spread from elbow to upper arm-resolved on 8/22/06
Redness, swelling at injection site. Treated with Benadryl oral and applied ice.
The lower part of my forearm has a bad burning sensation.  No redness or swelling. Injection site hurts as described it would.
Began with significant dizzy spells, shortness of breath, irregular heartbeat. Dizzy to point of unable to leave bed. Gradually symptoms reduced. Then mostly irregular heartbeat and short breath, occasional dizzy spells. Coming and going all summer. Still have irregular heartbeat and short of breath. CArdiologist tells me Premature Ventricular contractions. I have been wearing a heart monitor for 3 weeks now.
Reporting administration error.  We contacted Pfizer for expiration dates, pfizer vaccine specialist advised expiration dates and deemed vaccine viable t the time of vaccine administration.  Pfizer vaccine vials only include manufacturer dates on the box and vials. Therefore, we contacted pfizer to attain expirations dates directly from them.   No adverse reaction reported from the patient at the time of vaccination and no adverse reaction  reported since given the vaccine.
One day after injection patient noticed an erythemic induration, warm to the touch which she believes to be the size of a half-dollar coin. She believes it to be spreading. I advised her to use cold compresses, anti-inflammatory meds and to mark the border of the swelling and if it spreads to seek medical attention.
Pt  expressed apprehension about receiving  vaccine, but was doing so because required by employer. While waiting in observation pt expressed a desire to lie down. Once pt was let back into immunization room and allowed to lay down he started to suffer an anxiety attack. Pt complained of tingling in extremities and lightheaded when moving from sitting to laying down. Paramedics were called and tested pt. All was good, pt just couldn't relax and get breathing under control. Ultimately pt was taken out side on gurney and paramedics observed him until anxiety subsided. Pt's spouse ultimately picked up pt. I phoned pt later that evening and he stated that he was feeling fine.
UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Information has been received from a health professional concerning an 8 year old male with no known medical history who at 12 months of age, in approximately 1999, was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. in February 2006, the patient experienced a case of breakthrough. He developed less than 50 vesicles on his thorax and torso. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Initially it was a low grade fever, followed by a rash.  Went to pediatrician on the 11th, had red swollen glands and pus in neck, but negative for strep.  The fever lasted one week, then when he woke up on the 22nd, he couldn't stand.  Went to pediatrician and ER, and ultimately diagnosed with transient synovitis of the hip, but because biopsy showed pus, had to have a full hip irrigation.
I am a full week out from my second dose and still am experiencing daily headaches and dizziness. I am prone to migraines and tried taking my migraine medication, but this is a different pain toward the back of my head that is also making me feel dizzy. The symptoms seem to get worse throughout the day.
Bumps; Burning; Rash covered her entire body; Possible allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Bumps), SKIN BURNING SENSATION (Burning), RASH (Rash covered her entire body) and HYPERSENSITIVITY (Possible allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (Bumps), SKIN BURNING SENSATION (Burning), RASH (Rash covered her entire body) and HYPERSENSITIVITY (Possible allergic reaction). At the time of the report, RASH (Bumps), SKIN BURNING SENSATION (Burning), RASH (Rash covered her entire body) and HYPERSENSITIVITY (Possible allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided was Antihistamines and Zyrtec.