chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received through the Merck pregnancy registry from a registered nurse concerning a 21 year old female with a history of radiation exposure, alcohol use and IV drug use who on 27-SEP-2007 was vaccinated with her first dose of Gardasil (Lot #1063U/Batch #658563) intramuscularly in the left deltoid. Concomitant therapy included OMEGA-3). On 10 19-OCT-2007 the patient tested positive for Chlamydia. On 05-DEC-2007 the patient had a upper respiratory infection and was treated with ZITHROMAX Z-Pack). The patient was also taking prenatal vitamins (unspecified). Her estimated date of confinement is 25-JUN-2008 and LMP was 26-SEP-2007. The patient also had an ultrasound on 21-NOV-2007 which showed intrauterine pregnancy x 1 with a heart rate of 169 beats/minute. There are no other details. The nurse reported that a patient who received one dose of Gardasil was pregnant. No symptoms reported. Additional information has been requested.
For five days, starting the afternoon of immun, child was irritable, crying & w/fever greater than 101;
Vaccine given 10/29/09-Parent reports redness and rash @ site began later the same day. L arm 10 days  later child dx with Chicken Pox by MD
Burning sensation to back of thighs.  No redness or rash.  Moved to burning sensation abdomen, lower back, lower buttock, and right side of face.  Tried Lidocaine .5%, doesn't help.  1/3/08 minimal spots on abd & lower back but right side of scalp hurts when touched.  Burning sensation.
Initially client experienced soreness, fatigue, Temp of 99.4 and some body aches.  Awoke feeling same on 1/27 but then heart palpitations and elevated heart rate (120), as well as elevated blood pressure and headache occurred.  She was at work, which is an urgent care center-evaluated by their providers and had a normal EKG.  Feeling somewhat better later in the day.
Patient reports fever, pain and redness at the injection site. Patient reports symptoms have not yet resolved as of 10/25/15.
Child received 12+ vaccine for which they are not eligible.  Parents informed and no additional doses given and scheduled for 21 days for dose 2 of pediatric Pfizer.  Today mother reports child has sore arm and slight fever.
04/24/06 seen by Dr for viral URI and rash on neck. 4/25/06 Seen by another DR. Presented with itchy, burning rash on face and body, Numerous bumps on torso and extremities as vesicles. A couple were scabbed, Diagnosed with chickenpox. Treatment calamine lotion, Aveeno oatmeal baths, Zovirax.
Information has been received from a Registered Nurse, concerning a 50 year old female patient with no pertinent medical history, who on an unspecified date was vaccinated with a dose of MMR II as a child. There was no concomitant medication. The Nurse reported that on 05-MAR-2010, a titer for mumps antibodies was done and the result was negative. At the time of reporting, the patient had not recovered. The patient sought medical attention through office visit. Additional information has been requested.
Pt. received the 1st dose of TRUMENBA yesterday - last night pts. arm felt hard and began to swell and was red, this am it had grown and doesn't seem to be getting smaller and is painful. Was seen in office today by MD who instructed pt. to apply ice periodically and use TYLENOL when needed for pain. Instructed to return to clinic PRN.
PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH SYMPTOMS OF FEVER, CHILLS, AND GENERAL MALAISE TWO DAYS POST VACCINATION. PATIENT HAS HISTORY OF COVID+ IN NOVEMBER 2020. PATIENT WAS NOT GIVEN MEDICAITON AT HOME PRIOR TO ARRIVING TO EMERGENCY DEPARTMENT. PATIENT HAS PRIOR HISTORY OF SHORTNESS OF BREATH AND REQUIRES OXYGEN WHILE HOSPITALIZED BUTH HAS NOT HAD ANY ARTIFICIAL OXYGENATION SINCE. NO COUGH, NO SHORTNESS OF BREATH REPORTED AT EMERGENCY DEPARTMENT. PATIENT ADMITTED FOR FURTHER WORKUP. PATIENT STAYED 1 NIGHT - RECEIVED 2 DOSES OF CEFTRIAXONE IVPB FOR SUSPECTED PYELONEPHRITIS, WHICH WAS EVENTUALLY RULED OUT. PATIENT FOUND TO HAVE AKI. PATIENT DISCHARGED ON 1/28/2021 IN STABLE CONDITION AND RENAL FUNCTION IMPROVI
31 Patients were administered a dose after the 30 day beyond use date.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (31 Patients were administered a dose after the 30 day beyond use date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (31 Patients were administered a dose after the 30 day beyond use date.). In July 2021, EXPIRED PRODUCT ADMINISTERED (31 Patients were administered a dose after the 30 day beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications were reported.  Dose Count is 31 Refrigeration Date is 5/21/2021 Vaccination Dates 2021 , 01-July and 02-july. Refrigerated Storage Temperature  35°F to 38°F, It was reported that Moderna cannot guarantee patients received full protection against the COVID-19 Virus.      This case was linked to MOD-2021-323906 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Dose details were captured On 06-Oct-2021: Follow-up received on 06-OCT-2021 contains no newsignificant information found.
The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 09-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 09-Apr-2022) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022.   The pharmacist reported that vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. The vial had not undergone any temperature excursions. The pharmacist does not have any other information on the patients at that time and would call Moderna when additional information was known. The health care professional further stated to provide missed information and mentioned that 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022.  No treatment medications were reported.
Patient's arm swelled up  and turned red sometime,  after injection at patient's  home.
19FEB96 was seen area had been cleared up (?) several days;pt reports site deltoid edema & redness & pain;pt also report alot yellow drain from nose-had injury & laceration to this area (nose);
Not feeling good; Fatigue; headache; Chills; soreness; fever; A spontaneous report was received from a consumer concerning a 76-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not feeling good, fatigue, headache, chills, soreness and fever.  The patient's medical history included having COVID-19 in December 2020. Concomitant product use was not provided.  On 04 Jan 2021, the patient received their first dose of mRNA-1273 (Lot number unknown) in his left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, The patient experienced symptoms of not feeling well with fatigue, headache, soreness, chills all day and then had a fever that evening. No treatment information were provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s) not feeling good, fatigue, headache, chills, soreness and fever were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Swelling of arm where vaccine was given. Arm swollen and tender. Red raised bump the seize of a silver dollar.
painful site of injection; rash on the site of injection; Headache; swelling site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling site of injection), VACCINATION SITE PAIN (painful site of injection), VACCINATION SITE RASH (rash on the site of injection) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, ROSUVASTATIN, CALCIUM, CHLORTHALIDON, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), UBIDECARENONE (COENZYME Q-GEL) and MAGNESIUM for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling site of injection). On an unknown date, the patient experienced VACCINATION SITE PAIN (painful site of injection), VACCINATION SITE RASH (rash on the site of injection) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swelling site of injection), VACCINATION SITE RASH (rash on the site of injection) and HEADACHE (Headache) outcome was unknown and VACCINATION SITE PAIN (painful site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Re-occurrence of Lyme symptoms that had been in remission - double vision, memory problems especially short-term memory, headache, back and neck pain, insomnia,
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021 at 2:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 2:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 71.72. Concomitant products were not provided. On 08-Feb-2021, Excursion time was 10 AM and 11 AM, temperature was 29 and 35, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 08-Feb-2021. 3 vials were sent to clinic. Vaccine BUD date was 04-Mar-2021. Vial was stored on cooler 1, on 08-Feb-2021, Excursion duration At 9 AM: 36, 10 AM: 29, 11 AM: 35, 12 AM: 38, 1PM : 43, 2 PM : 42, 3 PM: 42, 4 PM: 42. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not  reported.
seizure, no treatment, hearing loss, dizziness,  arching seizure collapse onto floor, semi conscious  15-20 seconds
sore arm; Left arm achiness; a little light headedness/slight lightheadedness; slight blurred vision/slight blurry/ fuzzy vision; slight headache; This is a spontaneous report from a contactable Consumer. A 73 year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN, expiry date: 31May2021), via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunisation. The patient medical history included ongoing Lymphocytosis and the patient is allergic to eggplant, Aspirin and penicillin.The patients concomitant medications were unknown.On 30Jan2021, the patient received the 1st dose of the vaccine and experienced nothing major but a sore arm that resolved, a little light headedness and ever so slight blurred vision that resolved on the night of the shot. she had her first Pfizer shot and she had the usual side effects that evening of a slight headache and feeling achy afterwards. She says after the shot she was fine, but a little bit of lightheadedness and a little bit of fuzzy vision but it was minimal. She says it's like if you're looking in the distance at a stop sign, it was a little fuzzy. These happened last Saturday. These two symptoms were very slight, the lightheadedness was nowhere near passing out and the little bit of blurry vision was ever so slight and gone several hours later. Outcome of event sore arm; Left arm achiness, a little light headedness/slight lightheadedness, slight blurred vision/slight blurry/ fuzzy vision and slight headache was recovered.  No follow up attempts are possible. No further information is expected.
The patient was inadvertently given a Pfizer Bivalent instead of the monovalent.  Phone call made to mom to explain.  She reports child has no adverse reactions to the vaccine.
Experienced extreme onset of symptoms 12 hours after the 2nd dose w/ intense headache, severe leg pain, painful chills, fever and extreme fatigue and arm weakness in both arms, lasting  approximately 12 hours and then subsiding for 12 hours for 4 days - extreme symptoms for 12 hours and then subsides - severity of the symptoms remains the same and doesn't lessen w/ each 12 hour episode. The leg pain is severe. Alternating Tylenol and Ibuprofen provides minimal relief and doesn't break the fever.
This infant had an injection, about 25 hours after the parent noted that the left upper arm was hot and swollen, no fever, appetite good, normal activity. They returned to the clinic the examiner noted that the left deltoid area was inflammed and indurated. At the clinic given children's Advil. On 12/31, the mother reported the arm was completely normal.
After receiving vaccine at 4:44pm by 6:15pm my stomach was in so much pain I was doubled over and with in 10 min I was vomiting every 10-15 min could not even keep water down after the second day straight of vomiting I went to urgent care where I recived iv fluids from being dehydrated given Zofran for the nausea and was told to go straight to the emergency room where I went to hospital and was given more fluid and Zofran was told to have an egd done to make sure this was a reaction to the flu vaccine and not something else I had the procedure and nothing else was found.
103 temperature; Chills; Headache; Body aches; Initial information regarding this unsolicited valid non-serious courtesy case from Pfizer was received from a physician (AER No: AER 2020444724) and transmitted to Sanofi on 11-Nov-2020.   This case involves 18 year old female patient who experienced 103 temperature (pyrexia), chills, headache and body aches (pain), while she received vaccines MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included Menactra and had no adverse event.  The patient's medical history, medical treatments, concomitant medications and family history were not provided.   On 02-Jul-2020, the patient received a dose of suspect MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) lot number unknown) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number unknown expiration date: 10-Jan-2021) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient de experienced 103 temperature (pyrexia), chills, headache and body aches (pain) (Unknown latency) following the administration of MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient was treated with IBUPROFEN for all events.  Event outcome was reported as Unknown for all the events.  There will be no information regarding the batch number for the case.
Patient states that on 12/23, he received a tetanus shot to his right upper arm. Says that that evening, he noticed that the area was starting to get red and swell, which has been getting worse since then. Denies feeling feverish. Advised of clinic recommendation and to apply ice to arm. Says that pain increases to an 8 when he grazes it; asks what can be taken for that? States he has no liver involvement to take ibuprofen.
Patient was experiencing congestion and was taking Zyrtec prior to Vaccine. He also states his "stomach was off" then night shift before his vaccine. States that his stomach started to feel better so he went ahead with the vaccine. After the vaccine he developed diarrhea in which he had about 6 episodes of, a head ache,  nausea, and a dry cough. States he was feeling a little better this morning,  but started having diarrhea again and had to take Tylenol for his head ache. States arm is sore from the injection.
Headache, tired, dizziness, red hot rash around neck, nausea, diarrhea, side redness and swelling, site itching  Immediately after first dose I had rapid heartbeat, dizziness then fever, nausea, diarrhea, muscle aches, sore arm,
Thrombocytopenic Purpura.  Signs and symptoms revealed 15 days following injection of MMR at child's 15 month pediatrician visit.  Child noted with generalized petechiae and ecchymosis to face, limbs, trunk, and buttocks.  Platelet level on 6/13/05 was 1,000.  Platelet level on 6/15/05 was 2,000.  Platelet level on 6/20/05 was 42,000.  Visited pediatric hematologist. No treatment given, just close watch given over child to prevent any type of injury.  Platelet on 6/28/05 was 54,000.  Child was adopted and received one previous MMR vaccine prior to adoption and prior to one year of age.  Received Prevnar, MMR, and chickenpox vaccines on same day-5/26/2005.  Information received from medical records state thrombpcytopenia.
Patient reports history of Bell's Palsy that developed end of 2016 and resolved in early 2017 and a history of gastric sleeve surgery in February 2019. No known allergies.   Patient reports symptoms that started on 4/8/2021, the day after receiving her vaccine. Patient with ?groggy? feeling that has since resolved, headaches that haven?t resolved rated at a 4-5/10 that are relieved with OTC pain medication, and pain in left arm near injection site along with pain in left neck that radiates to left elbow rated at 4/10 that worsens with left arm abduction and isn?t alleviated with OTC pain medication.   On 4/24/2021, patient reported a worsening of headaches rated at 7-8/10 that were eventually relieved by OTC pain medication, chest pain rated at 9/10 described as constant tightness that lasted for about an hour, and LUQ pain rated at 9/10 described as a stabbing pain that was relieved after sitting down/relaxing for about an hour.  Patient did not seek medical attention.  On 4/26/2021 during patient interview, reviewed the importance of following up with PCP based on her symptoms and patient stated she will be reaching out to her HCP.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a 50-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included acid reflux and hypertension. Concurrent medical conditions included tuberculosis test on 17 December 2009. Concurrent medications included PREVACID and SLIMQUICK. On 17 December 2009 at 08:00 the subject received 2nd dose of ENGERIX B (1 ml, unknown route, left arm). On 25 December 2009, 8 days after vaccination with ENGERIX B, the subject experienced injection site reaction, arm pain, shoulder pain, loss of range of motion and difficulty lifting arm. The events were described as local injection site reaction. The healthcare professional considered the events were clinically significant (or requiring intervention). Relevant tests included x-ray taken on 03 June 2010; results not available at the time of reporting. At the time of reporting the events were unresolved. The healthcare professional considered the events were unrelated to vaccination with ENGERIX B.