chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 2:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 2:22 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 47.65 years.  No concomitant medications were reported.  Batch number 031L20A  underwent temperature excursion on 14-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM to 11:00 AM and from 2:00 PM to 3:00 PM with temperature 35 degrees Fahrenheit. The vial was initially moved to the fridge on 09-Feb-2021 and proposed beyond use date was 10-Mar-2021. Product moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. 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.
Her arm was red; Swollen at the injection site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Her arm was red), VACCINATION SITE SWELLING (Swollen at the injection site) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included Brain injury (3-years ago- Has short term memory), Shingles (Two episodes of shingles) and Oxygen therapy (On oxygen for 7yrs) since an unknown date. Previously administered products included for an unreported indication: HERPES SIMPLEX 2 VACCINE (1-year ago- still have knot on right arm from shot). Concurrent medical conditions included Immunocompromised, Asthma and Osteoporosis. Concomitant products included PREDNISONE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Her arm was red), VACCINATION SITE SWELLING (Swollen at the injection site) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE ERYTHEMA (Her arm was red) and VACCINATION SITE SWELLING (Swollen at the injection site) outcome was unknown and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient used cold packs and cold washcloth for the treatment.     This case was linked to MOD-2021-077748 (Patient Link).
No adverse event; 0.4 ml administered; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (0.4 ml administered) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050022A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Primary vaccination series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .4 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.4 ml administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (0.4 ml administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (0.4 ml administered).    No concomitant medications were reported. The nurse administered about 0.4 ml of a Moderna bivalent booster and wanted to know if that was okay. No treatment medications were reported.
Pt recvd vax & approx 1 mon p/vax began having problems w/urticaria; felt swelling sensation in throat; pruritic; dx chronic urticaria; poss urticarial vasculitis;
pt recv vax & 8mo post vax pt was tested for seroconversion;lab eval revealed varicella titer 0.22 & a low level of antibody was detected;
Muscle, joint pain, inflammation, exhaustion, lower back pain (constant), bones in back and neck crack with deep breaths.
Headache, Myalgia, sore arm, HA mild myalgias Narrative:
30min screaming/flushed, face/grand mal sz w/tonic-clonic movements x 2min, then limp & listless x 5min; pt exp sz activity w/eyes rolled back x 2min; now fine
Her husband had stronger side effects with the second dose; Little bit of body aches and muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Her husband had stronger side effects with the second dose) and MYALGIA (Little bit of body aches and muscle aches) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Her husband had stronger side effects with the second dose) and MYALGIA (Little bit of body aches and muscle aches). At the time of the report, VACCINATION COMPLICATION (Her husband had stronger side effects with the second dose) and MYALGIA (Little bit of body aches and muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.
patient had redness at the injection site and most of upper arm.  Arm felt hot to touch.  Minor spasms in the arm.  Patient had general malaise.
I had no symptoms with my other two covid-19 shots so I was expecting the same for my booster. When I got home my arm was getting more sore throughout the night but I just kept trying to stretch it before I went to bed. I woke up around 4 AM and I had a headache, muscular pain & body aches, and I felt rather warm. I took my temperature and it was 99.7 and I took some medicine and made myself some tea. Before I could drink it I threw up everything and that happened around 5:45 AM. I have had the same symptoms  all day until time of reporting this (1:50 PM) including nausea, body aches & muscular pain, headaches, fever, chills.
Pt found expired no breathing - non responsive next AM after getting shots.  12/18/07 Reviewed provider medical records including vax records which confirm vax dose & lot #s as reported. Family found patient not breathing in crib.  07/04/2008 Reviewed the pathology report received via fax from CDC: FINAL DX: mild focal tracheitis & vascular congestion of multiple organs.  No immunohistochemical or PCR based evidence of influenza A or B, mycoplasma pneumoniae or bacillus cereus.  No infectious etiology identified.  9/11/09 Autopsy report received. DOD 11/30/07 - Sudden Infant Death Syndrome.
Patient was inadvertently given a Moderna Booster when she should have had Pfizer based on age. No adverse reaction noted.
About a month after 2nd dose i started noticing some strange sensations through my entire body, by 4/20/2021 it was extremely bad. I have a tingling/pins and needle sensation in my hands, arms, chest, shoulders, neck, head, legs, feet and stomach.  I cannot grip things and often drop objects, I often cant open doors, my hands also jerk and twitch, I have to use both hands to do any task. I am no longer able to write neatly and have a hard time typing, using phones, etc
Within an hour of 1st vaccine dose all my pre-covid symptoms reoccurred. I had covid-19 starting March 24, 2020, tested positive 7 days later after searching for a test kit. Tested positive followed by almost a year of positive antibody testing. It took my lungs almost 4 months to return to normal after having the coronavirus. My symptoms following the vaccine imitated my experience with actually contracting the virus. They were the following, most experienced within the first hour of the vaccination on August 2, 2021. The normal expected side effects of arm pain from injection, fatigue, headache, etc. However, my COVID-19 cough from the initial real infection returned with a vengeance, fever of 103/104 degrees, inability to walk up flight of stairs, dizziness, full body swelling, itching, rashes, shortness of breath, high heart rate, trouble breathing deeply due to coughing, joint pain, muscle pain, extreme sinus like pressure exactly like when I had covid-19 (much more than a normal "headache"), trouble sleeping, blurry vision, mental confusion for days, and more. The seriousness of side effects despite Tylenol, Advil and rest over days sent me to an urgent care for testing. A PCR test indicated I was negative for COVID-19, possible respiratory virus from the vaccine was reported as well as systemic inflammatory syndrome.  I was sent home and now 5-6 days later still not improving.
Improper storage of product in use; No Adverse Event; This spontaneous report was received from a physician refers to a 6-month-old patient of unknown gender.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) pneumococcal vaccine conj 13v (PREVENAR 13), and famotidine.  On 15-JUN-2023, the patient was vaccinated with the third dose of improper storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1968385, expiration date:22-MAY-2024, oral (exact dose was not provided) for prophylaxis.   The administered dose underwent a temperature excursion during unreported amount of time on unreported temperature. It was reported the alarm was believed to be due to sensory issues and the temperatures were monitored with back up logger, which was by the time of the report was replaced with a new one and temperature was then in range. There was a previous temperature excursion (product storage error). No additional adverse event reported (no adverse event).   This is one of two reports of the same patient.
7 days after dose chest neck developed raised red bumps rash slightly painful to touch not itching so far not spreading past chest and neck.
allergic reaction; he developed a rash on the arm in which the vaccine was received; This is a spontaneous report from a contactable consumer (patient's spouse). A 90-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, for covid-19 immunisation  .  Medical history and concomitant medications were not reported.  The wife stated that her husband is 90 years old and he experienced an allergic reaction after receiving the first dose of the Pfizer COVID-19 vaccine. She stated he developed a rash on the arm in which the vaccine was received, on part of his waist and below. His doctor has told him that he would be okay to receive the second dose of the vaccine. "The doctor I took him to put him on 50 mg Benadryl 3 times a day for 7 day, then they also put him on Prednisone. We did not think he had allergy but I am thinking that about 8 months ago I used the new laundry detergent."The outcome of the event was  not reported.
Rapid heart rate, legs and feet turned blue, short of breath around 16 hours after vaccine. Lasted for several hours.
soreness at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). At the time of the report, VACCINATION SITE PAIN (soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.  Reporter stated that the patient age was above 80 years.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Updated reporter information, patient demographics, product start date, event start date and outcome.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Swollen lymph nodes on collarbone; Arm pain; Fever; Nausea; Neck pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Mar2021 at 11:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 31Mar2021 at 15:00, the patient experienced swollen lymph nodes on collarbone, arm pain, fever and nausea, still had swollen lymph nodes and arm/neck pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen lymph nodes on collarbone, arm pain, neck pain, fever and nausea were resolved with sequelae.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt vaccinated with DTP/OPV experienced excessive crying (screaming 12 hrs after first DTP).
soreness at injection site for 36 hours  pains to joints to fingers, toes and bones in both feet to ankle  headache, sinus pressure, severe nausea for 4 -days, fatigue for 3 days Meds : Tylenol 500 mg -1000 mg every 6 hours as needed, Sinex tabs daily for 3 days, as needed, Zofran 4 mg prescribed by radiology oncologist
Recieved vaccines on Monday Oct. 7th  afternoon at the pharmacy. On Wednesday the 9th,developed a red painful rash on her right lower rib area . Presented to the clinic to see DR on Wednesday afternoon, suspecting shingles. DR started her on Valtrex regimen. Shingles continued to spread around her right side towards her back throughout the weekend. She was unable to sleep on Friday night and Saturday night due to the pain. She did sleep Sunday night due to taking Tylenol PM and an over the counter cream called Shingles cream.  The pain started radiating to her right shoulder and right hip to her ankle. She actually thought she may be developing shingles in her right ankle, as well, as it was that painful.  She came into see Dr today 10-15-19 and was started on gabapentin three times a day.
This case was reported by a healthcare professional and described the occurrence of pneumococcal meningitis in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR 13 (unspecified manufacturer), Haemophilius influenza type b vaccine (Sanofi Pasteur MSD, Hib vaccine) and ROTATEQ (Merck). The subject's medical history included fetal distress syndrome. Birth weight was 8 pounds and 7 ounces, with a length of 52.1 cm and a head circumference of 36.1 cm. Concurrent medical conditions included hematochezia and milk allergy. On 4 August 2010 the subject received unspecified dose of PREVNAR 13 intramuscularly in the left leg. On the same day, the subject also received unspecified dose of HIB vaccine intramuscularly in the right leg. Later, on 17 August 2010 the subject received unspecified dose of ROTATEQ (oral) as well as an unspecified dose of intramuscular PEDIARIX in the right leg. On 17 September 2010, 31 days after vaccination with PEDIARIX and ROTATEQ, 44 days after vaccination with Hib vaccine and PREVNAR 13, the subject experienced upper respiratory infection with fever. The following day, on 18 September 2010, the subject's condition worsened with fussiness, pallor, bulging fontanelle and otitis media. The next day, on 19 September 2010, the subject had strep pneumo meningitis and experienced a seizure. The subject was hospitalised for 14 days. It was noted that "the medication" was ineffective. At the time of reporting the outcome of the events was unspecified. It was noted that "the vaccine" was administered by a healthcare professional. The medication was stored appropriately and not altered in any way. The subject's developmental milestones and physical growth were all normal. It as reported that the subject was recovering from the events with mild hearing loss.
Information has been received from a physician concerning a 5 year old male well child with no medical history who on 10/11/2006 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot 646814/0629R). On 10/11/2006 the pt experienced an anti epileptic reaction. The pt was given epinephrine and subsequently recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from a medical assistant who reported that the pt was being seen for a physical on 10/11/06 when he was vaccinated with a dose of Varicella vaccine. Immediately after vaccination, the site was red, he complained of pain, and there was swelling at the injection site. The reporter confirmed that Epinephrine was not given because they did not have any in the office. The pt was treated with Ibuprofen (Motrin), ice and Triaminic cold and Allergy with diphenhydramine hydrochloride. the physician considered this a vaccine reaction. Before the pt left the office he felt better and had relief after the Motrin and ice. The pt was seen two days later for a routine check up and had recovered. The pts experiences were considered to be an other important medical events by the reporter (OMIC). Additional information has been requested.
Rash developed five days after vaccination and spread across almost all of torso as itchy red bumps. Most prevalent in arm pits and elbows.
Patient reported on 12/4/15. Patient reported having felt sore in the afternoon of 11/13/15. He noticed swelling that worsened over the next day or two. He said the arm felt tight and sore. He iced the arm and elevated it per a nurses instructions. He reported the swelling started to go down on 11/15/15.
ASTHMA SYMTOMS / BECAME WORSE PERICARDITIS/CHEST PAIN
2nd dose on 02/02/2021 red, hot, swollen, hard, painful and a blister at the injection site. Mild joint aches.
celiac disease; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 10-year-old patient received BNT162b2 (BNT162B2), as dose 1 (orange cap), single (Batch/Lot number: unknown) and as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COELIAC DISEASE (medically significant), outcome "unknown", described as "celiac disease".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1 week after receiving the first dose of Shingrix (given concurrently with first Humira dose) she developed sacral shingles around the anus.