chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme fatigue (for 4 days after injection); face was hot and itchy; face was hot and itchy; pain at injection site; headache; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6204, Expiration date: not reported), via an unspecified route of administration in arm left on 12Mar2021 (at the age of 34-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included hypothyroid, fibromyalgia. The patient had no known allergies. The patient's concomitant medications in two weeks included fluoxetine hydrochloride (PROZAC), metformin, ethinylestradiol, etonogestrel (NUVARING), levothyroxine sodium (SYNTHROID), all were taken for an unspecified indication. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 12Mar2021, the patient experienced extreme fatigue (for 4 days after injection), face was hot and itchy (started about 3 hours after injection and lasted until the next morning), pain at injection site, headache (lasted 1 day after injection). Treatment was received for the events. The outcome of the event for headache was recovered on 13Mar2021 while for the other events was not recovered.  No follow up attempts are possible. No further information is expected.
Patient presented to emergency room on 11/2/2021 after testing positive for COVID-19 infection on 11/1/2021. She was experiencing shortness of breath, weakness, and cough. Patient was admitted for further management. Patient's respiratory status continued to decline despite steroids and oxygen supplementation. Patient expired on 11/15/2021.
This case was reported by a consumer and described the occurrence of brain swelling in a 6 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). This case was reported by the mother of the patient and also by the aunt of the patient. A physician or other health care professional has not verified this report. On 8/3/04, the patient received a dose of Pediarix (dose number not specified). On the same date, the patient received an injection of Haemophilus influenzae type B conjugate vaccine. The reporter stated that, prior to the administrations of the vaccines, on 8/3/04, the patient had a fever of 99.8 degrees F and was sick. Approximately 45 minutes following the administration of Pediarix, after leaving the physician's office, on 8/3/04, the patient experienced an increased fever of 101.7 degrees F. The mother called the physician's office back and was told to return to the office. The patient was seen at a physician's office around 6 PM on 8/3/04, and was subsequently sent to the emergency room and admitted to the hospital (on 8/3/04). According to the patient's mother, the patient was treated with IV fluids and underwent a spinal tap. According to the patient's aunt, her nephew experienced brain swelling. The events resolved on an unspecified date. Comment: brain swelling is considered medically serious (OMIC).
This is a spontaneous report from a physician referring to a female pt who is approximately 65 years of age. The pt received her 1st dose of Lymerix in June of 1999 and her 2nd dose in July of 1999. In August of 1999, she experienced myalgia. The most recent information, received on 9/13/1999, reports the condition of the pt in unknown. No further information is available.
I experienced chest pain and tachycardia immediately after receiving the vaccine. Went to the medic tent, where they saw my blood pressure was really high and my heart rate was elevated. So, they transferred me to the ER. They did a work up, monitored me for a few hours, and then I was released. I had the chest pain for about another day or so then it resolved.
abdo cramps, diarrhea, chills, sweating, weakness, neck & body aches;
Initial unsolicited report received from a consumer on 21 April 2015. A female patient (age not reported) whose medical history and concomitant medication were not reported had received a second dose of meningococcal vaccine (batch number, dose of vaccine, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, patient's arms were swollen and seem to be red around the injection site. Corrective treatments and lab investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
An initial report was received in the USA from a health care professional on 7/29/05. A 62 year old female patient experienced flu-like symptoms six days after receiving a SC injection of YF-VAX, lot number UE500AA, in the right arm, an IM injection of TYPHIM Vi, lot number X0464-2 in the right deltoid, and HEPATITIS A AND B COMBO VACCINE, lot number AHABB029AB, in the left deltoid. All of these vaccines were the first doses received by the patient. She was diagnosed with pneumonia and pleurisy the following day on 7/26/05. She was also noted to be spitting up blood. She was treated with Tequin 400mg daily for 14 days and recovered. The patient had a past medical history of having pneumonia several times. The patient was referred to a pulmonologist whose name and address was also provided. (OMIC) Follow-up information received on 06/Sep/2005 from a health care provider. It was reported that the patient returned in September 2005. She reporter that she was very sick with high altitude sickness. She had DIAMOX to take, but her physician only wanted her to take half strength. When she returned to sea level she was much better, but was scheduled to follow-up with her pulmonologist in six months.
Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
This 94 year old female received the Covid shot on  4/13/21    and went to the ED on 4/16/21     and was admitted  on 4/16/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC)
PT FILLED OUT SCREENING FORM  DENIED ANY PREGNENCY RETURN TWO WEEKS LATER HAD POSITIVE PREGNANCY TEST
(L) arm swelling and soreness, (+) redness, inflammation and warmth to (L) outer and inner bicep region. Tx = cool compresses and KEFLEX 500 mg  and PO Q 12 hrs x 7 days.
Soreness; Muscle pain; Nausea; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), MYALGIA (Muscle pain), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (Soreness), MYALGIA (Muscle pain), NAUSEA (Nausea) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (Soreness), MYALGIA (Muscle pain), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Area was red, itchy and inflammed around injection site by the next morning afer receiving the vaccine. Three days later the red area was spreading getting larger.  By the fourth day the size started to diminish.  By 7 days later the rash had diminished and was much better.
patients complain of acute hearing loss; This serious case was reported by a nurse via sales rep and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hearing loss (Verbatim: patients complain of acute hearing loss) (serious criteria GSK medically significant). The outcome of the hearing loss was not reported.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.     It was unknown if the company considered the hearing loss to be related to Shingrix.   Additional Information: GSK receipt date:22-MAR-2023 The reporter reported that the patient complained of acute hearing loss after administration of Shingrix vaccine. Some resolve but some sent to specialty. The reporter agrees to follow up from GlaxoSmithKline. This case had been linked with US2023AMR044540 reported by the same reporter; Sender's Comments:  US-GSK-US2023AMR044947:Same reporter
This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date, "less than 10" patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, orally, lot # N000193, expiration date 20-OCT-2018 and lot # N013989 (unknown expiration date) both for prophylaxis (frequency, route and anatomical location were not provided). The mentioned doses were under a temperature excursion in the range between 32°F to 35°F (35°F) during 24 hours as recorded by a digital data logger. No adverse effect reported.
Phone call from client's Mom R arm muscle sore, has nausea and vomiting X 1 some diarrhea, fever 99.9 f,  chills, some illness in family and friends. Back to school today 10/28/05.
HA and feeling hot 12 hrs after injection. No pain or irritation at vaccine site. Examined 7 hrs after onset of sx. Pt had no fever but was flushed chills. PE was wnl.
ACUTE RESPIRATORY FAILURE 10/28/2021 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION ACUTE RESPIRATORY FAILURE 10/28/2021 PNEUMONIA ACUTE RESPIRATORY FAILURE 10/28/2021 CONSTIPATION
heart palpitations for hours at a time that come in waves and generally always at night racing heart rate sometimes as high at 160 beats per minute tingling / electric sensation in the skin muscle aches in both calve muscles light sweat diarreah fatigue
Narrative: 74 year old female admitted on September 3 2022 with fever, hypoxia and cough. She had received Moderna vaccine x 3 on December 28 2020, January 26 2021, October 29 2021. She was treated with remdesivir x 4 days and dexamethasone x 4 days. She clinically improved and oxygenation improved. Was transferred back to LTC after isolation ended.
No additional AE; HCP called to report inadvertent administration of expired MMR-II to a patient. Product expired on 23SEPT2023 and was administered on 02NOV2023.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-NOV-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) injection, therapy type: rHA, valid lot #U029793, expiration date: 23-SEP-2023, administered for prophylaxis (strength and route of administration were not provided) (Expired product administered). No additional adverse event was reported (No adverse event).
Pfizer-BioNTech COVID-19 I got the 2nd shot around 3pm and felt fine throughout the rest of the day. Around 10pm when I started feeling feverish. Around 11pm, while laying in bed, it started getting much worse - shaking uncontrollably, feeling nauseous, very dizzy, fever - flu like symptoms which seemed normal for the vaccine, but then they got much worse and very strong. I couldn't fall asleep and at 1am I got out of bed to get tylenol. I took the tylenol and was still feeling naeusous so went to the bathroom. I don't remember what happened next because I fainted and woke up on the floor. I hit my head in the fall and head to get 4 staples and  had a laceration above my eye. I think I may have fainted again shortly after that but don't remember because I was out of it. I went to the ER - all tests came back normal at that point. I had covid about 2 months before the vaccine. I had no side effects from the first shot.
Injection site pain; now have more body aches; chills; 101 degree fever; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose on unknown date, refer case US2020AMR221090).   On 4th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced general body pain, chills and fever. On an unknown date, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, chills, fever and injection site pain were unknown.   It was unknown if the reporter considered the general body pain, chills, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had few body aches and injection site pain and more body aches, chills and 101 degree F fever.  The reporter asked was this normal and should assume it.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221090:same reporetr
Breakthrough case after two vaccines Moderna 5/20/21 Lot# 050C21A;  Moderna 6/18/21 Lot# 002B21A
High fever, 104, after Hep A vaccine. *Also child had tonsillitis and O.M.
Patient received 1st primary Moderna dose on 4/16/21 and never came back for the 2nd shot; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received 1st primary Moderna dose on 4/16/21 and never came back for the 2nd shot) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received 1st primary Moderna dose on 4/16/21 and never came back for the 2nd shot) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received 1st primary Moderna dose on 4/16/21 and never came back for the 2nd shot) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient received 1st primary Moderna dose on 4/16/21 and never came back for the 2nd shot).    Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Per patient, received vaccine on 1/20/21, but states side effects did not present until 1/28/21. Reported to this office 1/29/21. States on 1/28/21 injection site red and itchy; 1/29/21-site itchy; 1/30/21-itchy, blistery; 2/1-resolved
I experience similar symptoms I had after being diagnosed with a positive test.  The symptoms included pain around waist area, pain in muscle joints, sleepiness and inability to walk steadily.  I ended up going back to bed and the symptoms subsided.  I reported this because I think others may experience the same.
This spontaneous report was received from an office manager and refers to a 16 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 26-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX) lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509:US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Symptoms: chest pain, headache , fever , pain while deep breathing , and painful when moving or lying down
Extreme atrial fibrillation requiring hospitalization.  Went to ER where they administered IV medication.  Admitted for additional tests.
pain; chileed; can´t walk; worsened condition; fever; nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in June 2019, experienced right knee and ankle sore, refer linked case US2019172858).   On 19th September 2019, the patient received the 2nd dose of Shingrix. On 19th September 2019, less than a day after receiving Shingrix, the patient experienced headache, fever and nausea. On 20th September 2019, the patient experienced knee pain, chills, walking difficulty and condition aggravated. On 21st September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the headache, knee pain, nausea, chills, walking difficulty and condition aggravated were unknown.   It was unknown if the reporter considered the headache, knee pain, fever, nausea, chills, walking difficulty and condition aggravated to be related to Shingrix.  Additional information received were as follows: On Thursday, the patient received Shingrix in her left arm. On the same night, the patient experienced headache with a fever and nausea. 1 day after receiving Shingrix, the patient was chilled and knees started to hurt. The patients left knee was sore and her left ankle. The knee pain was still unresolved after 10 days but the others side effects had resolved. The patient reported that the second injection had a lot more side effects than the first vaccination. The patient had a fever for two days. The patient reported that she was in pain and she cannot walk. The patient had previous flares of knee pain but the pain had worsened after the vaccination. The patient use to run two miler per day and at the reporting date, she cannot walk across her house. The reporter consented to follow up. The reporter reported that they follow-up directly with the patient.