chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion for IPV (VERO) [IPOL] as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event; administration of vaccine post excursion with no reported adverse event; Initial information received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 4 years old female patient and reporter reported temperature excursion for IPV (VERO) [IPOL] as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event and administration of vaccine post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  Caller reported that opened IPV (VERO) [IPOL] Suspension for injection (lot V1A021M, expiry date- 27-FEB-2024) at a dose of 0.5mL once via intramuscular route in unknown administration site for Immunization was exposed to temperature excursion as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event (product storage error) (unknown latency) and On 26-May-2023, the patient had administration of vaccine post excursion with no reported adverse event (poor quality product administered) (latency- same day). Human error was involved.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.
On 7 March 2001 (right deltoid) and 4 April 2001 (left deltoid), the vaccinee received her first and second doses of Engerix-B, respectively. Following the second Engerix-B dose, she experienced metallic taste in her mouth, and neck and arm soreness. As of 5 April 2001, the outcome of the event is recovered.
Patient complained of N/V, stomach bloating, and cough up some blood on 10/30/2020.  She did not take any medications that evening.  When she complained on 11/3/2020, we gave her two 25mg Benadryl capsules.
Rash on chest, neck and right side; pallor; swelling of hands at 13:35; emesis at 14:00; flu-like symptoms for 24 hours, post vax.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The Patient received booster dose of Moderna COVID-19 Vaccine.  No treatment medications were reported. Rx number was 801035
This spontaneous report was received from a physician and a healthcare worker concerning an unknown number of patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On 21-MAR-2016, the patients were vaccinated with doses of improperly stored ROTATEQ (Lot # L037574; expiration date: 01-JUL-2017 and L038536; expiration date: 19-AUG-2017) oral. The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 18 degree C for 22.5 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
48 hours after injection, developed moderate to severe redness, swelling pain, increased heat at injection site, along with headache, dizziness, fatigue, loss of appetite. Sx improved in the morning but they all recurred the next day in the afternoon. Gradually subsided on the third day. Mostly all resolved for three days then developed redness, swelling, heat, and pain again at injection site along with headache and swollen axillary lymph node. This occurred today, January 30, 2021.
Patient experienced seizure-like adverse effect less than a minute after vaccine. She lost consciousness, slumped in her chair, and her arms flailed for about 15 seconds before she regained consciousness.  After waking she couldn't remember anything happening and complained of blurry vision, a sore throat, and difficulty breathing. This could have been a vagovasal reaction but I was concerned based on the way her arms flailed, so I called 911. Paramedics arrived within 5 minutes and they checked her vitals and determined she didn't need to go to the hospital
redness on arm; pain on arm/ hurt arm; itching in arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced erythema of extremities, pain in arm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities, pain in arm and itchy upper limbs were unknown.   It was unknown if the reporter considered the erythema of extremities, pain in arm and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The reporter mentioned that her friend received the first dose of Shingrix and she developed redness with pain on her arm with itching and her arm hurt. The reporter stated that her friend had pain and itching in her arm but no flu like symptoms. The reporter consented to follow up. There was discrepancy in date of birth reported, it was reported which is future date. The date of birth was captured.
patient contracted strep throat approx 2 weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGITIS STREPTOCOCCAL (patient contracted strep throat approx 2 weeks after first dose) in a  patient of an unknown age and gender who received mRNA-1273 (batch no. unknown) for COVID-19 vaccine.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGITIS STREPTOCOCCAL (patient contracted strep throat approx 2 weeks after first dose). At the time of the report, PHARYNGITIS STREPTOCOCCAL (patient contracted strep throat approx 2 weeks after first dose) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medication includes unknown antibiotic.
Was in bed for 2 days; Very horrible body aches; Had very high fever (Almost 103); This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for 2 days), MYALGIA (Very horrible body aches) and PYREXIA (Had very high fever (Almost 103)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced BEDRIDDEN (Was in bed for 2 days), MYALGIA (Very horrible body aches) and PYREXIA (Had very high fever (Almost 103)). On 18-Feb-2021, BEDRIDDEN (Was in bed for 2 days) had resolved. On 19-Feb-2021, MYALGIA (Very horrible body aches) and PYREXIA (Had very high fever (Almost 103)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: almost 103 (High) Almost 103.         No concomitant medication was reported.  The patient's antibody test done on an unknown date came back negative.  No treatment information was reported.
3 days after shot:  chills, dizziness, headache, weakness, fatigue, lower legs swelling, palpitations. Symptoms come & go- headache has subsided. Lower legs swelling have become worse. Treated at home w/ ice packs. Presently treating swollen legs & feet.
A nurse reported the occurrence of an injection site reaction in a 15 month old male who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history and received no concurrent medications. He experienced no adverse events following previous immumizations. On 8/28/02 at 10:15, the subject received his fourth injection of Infanrix (545B9). At 17:00, it was noted that the subject had developed an injection site reaction characterized by redness, warmth, an area of swelling measuring 16cm by 10cm, and a 9cm area of induration. The subject was limping on his left leg. The subject was seen in the ER. The events resolved on 9/3/02.
Vomiting, rigors, headache, left axillary lymphadenopathy and breast tenderness
pt admitted to hospital 8/31/21 for LLE ischemia-- > Surgical intervention needed for LLE angiogram intervention. Hospital stay complicated with ARF. Pt still hospitalized as of 9/3 needed for mechanical ventilation.
Information has been received from a medical assistant referring to an unknown number of patients of unknown gender and age. The patients' concurrent condition and medical history were not reported. On unknown dates, an unknown number of patients were vaccinated with improperly stored ZOSTAVAX (dose, route unknown, lot# M034765 and expiration date 26-OCT-2017) for prophylaxis (Incorrect product storage). It was unknown if the sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. The vaccine was improperly stored at 6 to 14 degrees Fahrenheit for 51 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 3 hours. The phone call was a result of the data logger.  No adverse effects were reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1709USA009051: US-009507513-1709USA009052:
devel fever 103 that noc felt achy; devel rash & numbness; had cysts all over body (face, underarms, pubic area & a few near site of inject;
Taking a test at school, felt chills, became nauseous, stood up to go to the bathroom and fainted, then vomited in the health room, stomach pain, Temp. of 99 degrees. Took to doctor for examination.  Rested at home for the remainder of the day.
Circular rash under the injection site , also while taking a bath felt sudden pain on my shin which later on turned into a big bruise . Also bruise on the injection site. All appeared after a week of getting the vaccine.
THE DAY AFTER THE SHOT, I HAD SEVERE FATIGUE AND WEAKNESS AND BODY ACHES. THAT LASTED FOR 24 HOURS. THE DAY AFTER THE SHOT I ALSO DEVELOPED A HEADACHE. I HAD THE HEADACHE FOR 8 STRAIGHT DAYS. NOW, I GET HEADACHES 3-5 DAYS PER WEEK.  I ALSO FEEL FOGGY. LIKE I CANT THINK STRAIGHT OR CONCENTRATE.
w/in sec 2 1/2cm raised sl bluish/hived center around site;also 6" diameter erythema around site of lt arm
Muscle pain in arm (tolerable)  Headache, Muscle pain all over and shivering  while attempting to sleep 11 hours after the vaccination
sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 2nd dose of Shingrix. On 8th October 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had symptoms after she received the vaccine. The patient sore arm started the day after her injection.  She took Tylenol and the soreness resolved within a day.  Outcome date for sore arm was reported as 9th October 2019 however as per narrative description, the event resolved on same day of occurrence. No further details were provided. The reporter consented to follow up. This case has been linked with US2020220500 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220500:same reporter
Patient came to me at pharmacy and said a few days after her RSV vaccine, the spot around her vaccination site became red and itched, burned at times. She said it comes and goes. I saw the site, and it was a tint of purplish-red around the site. I advised her it was a site reaction, and with time it will go away, but could possibly take a month. I told her ibuprofen would help if it is hurting, otherwise hydrocortisone or benedryl cream would help with swelling and itch, along with ice pack.
Temperature 99.9 degrees on 4/18/2008.  Right upper arm red, warm, and swollen on 4/19/2008.  16 x 20 cm area of erythema, heat & edema of R upper arm above the elbow on 4/21/2008.
Breakthrough case admission after three vaccines Pfizer 3/31/21 Lot# En6208;  Pfizer 4/21/21 lot# Er8732;  Pfizer 11/15/21 Lot# FH8028
pt devel reddened, warm, 4" by 2" area @ inj site about 4-6hr p/vax;site became larger next day;3 days p/vax redness faded;area itching;
This spontaneous report was received from a pharmacist refers to 46-year-old patient of unknown gender. On 23-SEP-2012 the patient was vaccinated with a dose of 0.5 milliliters (ml) PNEUMOVAX23 lot # (667915/1111Z, expiration date 02-MAR-2012) intramuscularly. No concomitant medications were reported. On 23-SEP-2012 the patient was administered expired dose of PNEUMOVAX23. No adverse effects reported. No further information is available. This was 1 of 2 cases being reported by the pharmacist regarding expired dose of PNEUMOVAX23 administered to a patient. This is one of several reports from the same source. Additional information has been requested.
Strong reaction; Feeling lousy; Very sick; Severe intense fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Strong reaction), FEELING ABNORMAL (Feeling lousy), ILLNESS (Very sick) and FATIGUE (Severe intense fatigue) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was hospitalized due in COVID-19 infection in November of last year for 20 days.) in November 2020.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ADVERSE REACTION (Strong reaction), FEELING ABNORMAL (Feeling lousy), ILLNESS (Very sick) and FATIGUE (Severe intense fatigue). At the time of the report, ADVERSE REACTION (Strong reaction), FEELING ABNORMAL (Feeling lousy) and FATIGUE (Severe intense fatigue) outcome was unknown and ILLNESS (Very sick) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
breaking out into a hot rash all over her body including chest and face; hands are swelling and feel splotchy; hands are swelling and feel splotchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (breaking out into a hot rash all over her body including chest and face), PERIPHERAL SWELLING (hands are swelling and feel splotchy) and RASH (hands are swelling and feel splotchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH (breaking out into a hot rash all over her body including chest and face), PERIPHERAL SWELLING (hands are swelling and feel splotchy) and RASH (hands are swelling and feel splotchy). At the time of the report, RASH (breaking out into a hot rash all over her body including chest and face), PERIPHERAL SWELLING (hands are swelling and feel splotchy) and RASH (hands are swelling and feel splotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
I went to the emergency room with chest and back pain. A CT scan of my chest revealed a pulmonary embolism in my right lung.  It also showed a small amount of fluid around my heart and a mass on the right side of my lung.  an ultrasound of my heart showed minimal fluid around my heart and that my heart was pumping normally. a PET-CT ordered to better define the lung mass.  Given blood thinner by stomach injection and placed on apixaban on July 22, 2021.
6:30 p.m. chills, body aches, fever 99.9  8:30 p.m. nausea, fever 101.4  10:00 p.m. fever 101.9   1:00 a.m. headache  2:15 a.m. headache fever 99.7  - took 2 Advil
fluid retention required a visit to the emergency room; shortness of breath; fluid retention; This is a spontaneous report from contactable consumer, the patient.  A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN9581), via an unspecified route of administration on 04Feb2021 at 09:00 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family history was denied. However, the patient did say that he had fluid retention prior to the vaccination (duration not specified). The patient further reported that he had illness at vaccination; he specified that he was experiencing fluid retention when he got the first dose of the Pfizer COVID 19 vaccine  Concomitant medications were not provided. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports that he had fluid retention and shortness of breath and was admitted to the hospital "the week of 20Feb2021."  He was discharged that weekend, on Friday. He knows it was that week because on 25Feb2021 he was supposed to get the second shot and he missed it because he was in the hospital. He has fully recovered now from the fluid retention and shortness of breath. Adds he had the fluid retention prior to receiving the first dose of the Pfizer COVID 19 vaccine and was experiencing fluid retention when he got the first dose of the Pfizer COVID 19 vaccine. The received unspecified treatment for the events. The clinical outcomes of the events fluid retention and shortness of breath were reported as recovered on 27Feb2021.
The day following my injection I experienced escalated Tinnitus.  Different tones and pitches.  Occasional ear pain.  Feeling of fullness in the ears that was not present before vaccine. Neck and shoulder pains.  1 week away from second dose and I am still experiencing escalated tinnitus.   Slightly improved from initial response but escalated from level before injection.  I feel I have had some hearing loss.
his immune system was going nuts; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program . The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "his immune system was going nuts". Additional information: Patient was inquiring if that would affect the vaccine effectiveness.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
patient with history of fainting during vaccine started passing out a few minutes after the shot and had jerk like/seizure like movements. pt eventually woke up and was fine. did not need to call 911
prickly heat type rash started 19DEC-face trunk arms & legs & back fine small dot like-chicken pox & measles
Patient was given Shingrix and Boostrix in the left arm intramuscularly around 12:45 PM on 11/20/2020. Shingrix vaccine was given first.  Patient experience extreme pain upon injection. Boostrix was given after, and patient did not experience pain with that shot. Patient was able to move their arm afterward. Roughly 3 hours later patient called pharmacy from home reporting continued pain and restricted motion of arm.  Patient used hydrocodone and acetaminophen tablets prescribed for another condition and aspirin, which did not seem to help the condition. Patient was advised to seek medical treatment immediately. On 11/21/2020 patient still reported pain that affected their sleep and restricted motion of the arm. As of 11/23/2020 patient has not been seen by a doctor, but they have scheduled an appointment with urgent care today 11/23/2020. They report improved movement but still a significant amount of pain.
contracting covid for third time/I've had two Pfizer covid vaccines and one booster; contracting covid for third time/I've had two Pfizer covid vaccines and one booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "small wart" (unspecified if ongoing), notes: I had a small wart on my hand that I've had for almost 30 years. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracting covid for third time/I've had two Pfizer covid vaccines and one booster". Therapeutic measures were taken as a result of covid-19. Patient recently went through a 5 day course of Paxlovid after contracting covid for third time and I noticed an interesting side effect. I had a small wart on my hand that I've had for almost 30 years. I've had it frozen off four or five times over the years but it always came back. It disappeared after Paxlovid and I just have a small scar there now. I'm amazed and I thought you might want to know. I've had two Pfizer covid vaccines and one booster. I guess I don't develop good immunity to covid.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.