chrisvoncsefalvay/vaers-outcomes huggingface dataset:
took the Moderna COVID-19 vaccine and was having a reaction 6 days later; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (took the Moderna COVID-19 vaccine and was having a reaction 6 days later) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (took the Moderna COVID-19 vaccine and was having a reaction 6 days later). At the time of the report, VACCINATION COMPLICATION (took the Moderna COVID-19 vaccine and was having a reaction 6 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Presented w/ dehydration, weakeness, SOB, diarrhea. Tx for gastroenteritis, COVID+/pneumonia, electrolyte imbalance, arrhythmia, anemia. Remdesevir, Dexamethasone, O2, Vit C, Zinc
Bell's Palsy--left lower facial droop and numbness started 4/23/21 Treated with Prednisone and Valacyclovir on 4/25/21
This is a spontaneous case, initially received from pharmacist on 26-Dec-2017, concerning a 59-year-old adult female patient. The patient had no relevant medical history and she did not receive any concomitant medications. On 29-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, 25-gauge 1 inch needle, batch number: 195245, expiry date: 30-Jun-2018). On the same day, 2 to 3 hrs after vaccination, the patient experienced pain in the arm at the vaccination site. It was reported that the pain was horrible. The patient consulted her physician, who said she had a hematoma". The physician advised the patient to take TYLENOL, ibuprofen, meloxicam (for pain) and apply heat to the area (warm compresses 4 times a day). The patient also reported that it hurt every day to the point and she cried from the pain. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious. Non-significant follow up received on 07-Feb-2018: The reporter confirmed that, the patient had no relevant medical history. Non-significant case correction received 26-Dec-2017: Narrative was reframed "The patient consulted her physician, who said she had a hematoma'.
I mistakenly administered a Moderna COVID booster vaccine meant for patients aged 6-11 years to this patient who is 57 years old. I spoke with nurses and doctors and no adverse outcome is expected
Started my menstrual cycle 3 weeks early. I am normally very regular in my cycle. It also lasted 4 days longer than normal.; Started my menstrual cycle 3 weeks early. I am normally very regular in my cycle. It also lasted 4 days longer than normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 11:30 (Lot number: 33025BD) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]; MELATONIN; COLLAGEN. Vaccination history included: Bnt162b2 (lot number: EP7534, time: 04:45 PM, dose number:2 vaccine location:Right arm), administration date: 30Mar2021, when the patient was 40 years old, for covid-19 immunisation; Bnt162b2 (lot number: EP7534, administration time: 04:45 PM, dose number: 1, vaccine location: Right arm), administration date: 20Apr2021, when the patient was 40 years old, for covid-19 immunisation. The following information was reported: POLYMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 20Jan2022, outcome "recovered" and all described as "Started my menstrual cycle 3 weeks early. I am normally very regular in my cycle. It also lasted 4 days longer than normal.". Therapeutic measures were not taken as a result of polymenorrhoea, heavy menstrual bleeding.  Adverse event: Facility type vaccine at facility Patient did not received other vaccine in four weeks. Started my menstrual cycle 3 weeks early. I am normally very regular in my cycle. It also lasted 4 days longer than normal. Ae resulted in: [None of the above] Patient did had covid prior to vaccination and not tested covid post vaccination. The patient had known allergies.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a certified medical assistant (C.M.A) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 24-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), hearing loss (serious criteria GSK medically significant and life threatening) and meningococcal infection (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure, hearing loss and meningococcal infection were unknown. It was unknown if the reporter considered the vaccination failure, hearing loss and meningococcal infection to be related to Meningococcal B vaccine. Additional details were provided as follows: It was reported that the patient caught a different strand and he almost died, thak god he did not but unfortunately he had lost his hearing and felt bad. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown.
A few  hours after receiving my vaccine I started with some soreness in my arm, it then moved to a fever and I started to experience some chills all over my body. I could not get warm with the chills. I stayed in bed the next day because they were flu like symptoms. I started to feel better within a day and half after receiving my vaccination.
PATIENT HAD PFIZER COVID VACCINE ON Dose 1 date: 02/17/2021, Dose 2 date: 03/10/2021, AND TESTED POSITIVE TO COVID.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 17-JUN-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K000456 and expiry date: 15-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Cold sweats all over body for week and a half; Felt as if she is going to sink; Light headed, Dizzy; Felt like lying down; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweats all over body for week and a half), FEELING ABNORMAL (Felt as if she is going to sink), DIZZINESS (Light headed, Dizzy), ASTHENIA (Felt like lying down) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L02A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLD SWEAT (Cold sweats all over body for week and a half), FEELING ABNORMAL (Felt as if she is going to sink), DIZZINESS (Light headed, Dizzy), ASTHENIA (Felt like lying down) and PYREXIA (Fever). At the time of the report, COLD SWEAT (Cold sweats all over body for week and a half), FEELING ABNORMAL (Felt as if she is going to sink), DIZZINESS (Light headed, Dizzy), ASTHENIA (Felt like lying down) and PYREXIA (Fever) outcome was unknown.            No concomitant medication provided. No treatment medication provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.
Medical assistant, administered the wrong vaccine to the wrong client. This client was to have received Moderna for the second dose and received Pfizer. No signs & symptoms noted after waiting 15 minutes as we encouraged.
Cx developed localized reaction at injection site the day after vaccination for 2 days. Took antihistamine BENADRYL CA couple of doses it subsided. On October 27, cx developed blister on the scalp by the hair line and next day more blisters on adjacent area. On Oct 30, 08, dr prescribed VALTREX 1gm 3 times daily for 7 days.
On Saturday little blood clot, no liquid blood, and this morning this same; a little blood in the urine; This is a spontaneous report from a contactable consumer (the patient). A male patient (Age: 77, Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included little blood clot, no liquid blood, 7 years ago (unspecified date in 2014). The patient's concomitant medications included fish oil and acetylsalicylic acid (ASPIRIN). The patient stated he received the first dose of the COVID shot on Thursday (unspecified date). The next morning, there was a little blood in the urine. On Saturday, little blood clot, no liquid blood, and this morning the same. The patient had this before 7 years ago. The patient asked if anyone else reported this and for information. The clinical outcome of little blood clot and a little blood in urine was unknown.   Information on Lot/Batch number has been requested.
Approximately 5-10 minutes after injection, pt. felt weak, faint, had syncopal episode in car in parking lot. Returned to exam room and monitored for >1 hour.
High Fever >102, dizziness, fatigue, body aches, back pain, headache, numbness in fingertips and toes
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Wrong Route (SC, IM, etc.), Additional Details: Shot was administered too low in arm.
Pain like it was bruised; Pain like it was bruised; Extreme swelling under her right arm and breast area; Extreme swelling under her right arm and breast area; This case was reported by a other health professional via sales rep and described the occurrence of pain in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number ZY975, expiry date unknown) for prophylaxis.   The patient's past medical history included lymph node excision (previously had lymph nodes removed in right arm).   On 25th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 25th October 2019, 12 hrs after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced pain, contusion, local swelling and breast swelling. The patient was treated with cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the pain, contusion, local swelling and breast swelling were unknown.   It was unknown if the reporter considered the pain, contusion, local swelling and breast swelling to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Fluarix quadrivalent 2019-2020 in the right arm. About 12 hours after vaccination, the patient had pain like it was bruised. Within 24 hours after vaccination, the patient had extreme swelling under right arm and breast area. It was engorged and the patient could not get dressed because of it. The patient received 3 doses of Zyrtec over 2 days helped the swelling go down. The reporter consented to follow up.
Rash on her stomach, back and both of her arms/ not sure of contact with partner's vaccinated arm; Bad headache; Fatigue; Diarrhea; Vomiting; Information received on 13AUG2019 from a consumer.   A 23-year-old female reported developing rash on her stomach, back, and both her arms/ not sure of contact with partner's vaccinated arm (PT: Secondary transmission), diarrhea (PT: Diarrhoea), vomiting (PT: Vomiting), bad headache (PT: Headache), and fatigue (PT: Fatigue), after being in contact with her partner who was vaccinated with ACAM2000 vaccine. She stated the rash takes up 5% or less of her body surface area. She stated that the day the rash appeared (11AUG2019) she went to her general practitioner who prescribed some creams. She had vomiting on 12AUG2019 and diarrhea on 12AUG2019 and 13AUG2019. She also had bad headache and felt fatigued since an unknown date. She stated that her doctor believed that she had food poisoning but she had not eaten anything strange. On 16AUG2019 additional information was received from the reporter and she reported that her rash was resolving and fatigue and headache were still apparent.  Action taken was not applicable.  Treatments included mometasone furoate and Bactrim (trimethoprim/sulfamethoxazole).  Company comment: In this case, a female patient was exposed to vaccinia virus through contact with her partner who was vaccinated with ACAM2000 vaccine and experienced the events "secondary transmission, diarrhea, vomiting, headache and fatigue". These events are known effects of ACAM2000, and therefore are considered to be causally related to ACAM2000.; Sender's Comments: Company comment: In this case, a female patient was exposed to vaccinia virus through contact with her partner who was vaccinated with ACAM2000 vaccine and experienced the events "secondary transmission, diarrhea, vomiting, headache and fatigue". These events are known effects of ACAM2000, and therefore are considered to be causally related to ACAM2000.
Extreme body ache, particularly abdomen and back, to the extent I could not fully inhale without severe acute pain in lower back. Extreme restlessness and anxiety. Breathing difficulty.
after about 5 minutes she came and said she was starting to itch and roof of mouth was feeling funny , I gave her 2 Benadryl 25 mg and she stated she was feeling better after about 15 to 20 minutes
Very sore / swollen right arm; Very sore / swollen right arm; high fever; severe joint pain; serious shortness of breath; serious fatigue; This is a spontaneous report from a contactable consumer.   A 76-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration, administered in arm right on 17Jul2021 12:00 pm (age at vaccination 76 years) as dose 1, single for covid-19 immunization. The patient medical history Breast cancer, uterine cancer, COVID twice, pneumonia twice and allergies to mold and pollen. The patient known allergies included Bee / wasp stings, some shellfish and mushrooms. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant medications were not reported. The patient received other medications within 2 weeks of vaccination. On 18Jul2021, the patient had experienced Very sore / swollen right arm, high fever, severe joint pain, serious shortness of breath and serious fatigue- all were worse than when I actually had COVID the second time, when I was hospitalized and on oxygen. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were recovering.  Information about the Lot/batch number has been requested
SWELLING IN THROAT "FEELS TIGHT", PRESSURE IN CHEST, COUGH. EVALUATED BY EMS-CLEARED
Sore arm/unable to lay on it; Fever of 100.4-100.5; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date and experienced pain in arm, refer case US2022AMR112652).   On 27th July 2022, the patient received the 2nd dose of Shingrix. On 27th July 2022, less than a day after receiving Shingrix, the patient experienced pain in arm and fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR112652   Additional Information: GSK receipt date: 28-Jul-2022 Reporter comment: The case was self reported by the patient.  The patient received second dose of Shingrix yesterday (from the day of reporting) in left arm. Last night, the patient experienced a fever of 100.4 to 100.5. The patient also experienced sore arm in which patient was unable to lay on it. The patient took the Tylenol to alleviate symptoms. Patient gave consent to follow up with HCP (pharmacy).; Sender's Comments:  US-GSK-US2022AMR112652:Same reporter, same case
pt recvd vax & seen in ER 28SEP94 w/ 2 1/2" diameter circular area of erythema, indurated area size of quarter lt arm; no temp taken told to put ice/warm packs to area alternately;
At roughly 3:30 AM on May 4th, about 11 hours after receiving the 2nd Pfizer dose, I suddenly woke up with a very high heart rate and pounding heartbeat. I measured it using my pulse oximeter. It was in the 120-135 BPM range while lying down, and in the 150-170 BPM range while standing. I attempted to lower my heart rate by lying down calmly and doing slow breathing exercises, but it did not improve. I called my insurance provider's 24/7 nurse hotline and was advised to go to the emergency room.
rash and swelling around right eye; swelling around right eye; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN) via an unspecified route of administration on 23Mar2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, the patient experienced rash and swelling around right eye. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events rash and swelling around right eye was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A non-serious spontaneous report of fever and influenza B was received from a physician concerning a five-year-old male. No relevant medical or drug history information was reported for this patient. The patient received the initial dose of FLUMIST on an unknown date. On 16Oct2007, a physician reported fever (101.5 F) and a positive antigen test for influenza B strain 72 hours following FLUMIST vaccination. After checking the child's temperature, the physician performed a quick antigen test: results positive for influenza B strain but negative for the A strain. The physician conjectured that since the test was negative for any A strain, the infection may not have been caused by the A strain in the vaccine. The child also attends day care. The physician prescribed the child TAMIFLU and notified the sponsor. The outcome was not reported. The physician indicated that the causality was not clear (wild strain vs. B strain). The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Nurse gave MMR vaccine 8 days early in error. No side effects occurred. Nurse noticed error right after vaccinating the patient.
7 cm erythema/pain/edema around injection site. No pus/bullous lesions.
Patient admitted to ED with complaints of numbness in head. MRI head showed acute left lacunar infarct. Per discussion with neuro stroke service, plan for optimal blood pressure control.  Patient is being discharged with new blood pressure medication and blood pressure cuff to monitor BP.  Patient will continue PTA aspirin and statin on discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Nausea, vomiting x1 episode, heart racing. Symptoms started about 3-4 hours after vaccine. Advised to take 25mg of BENADRYL, about 4-5 hours after vaccine. 8-10 hours after vaccine, all symptoms resolved. Patient thought BENADRYL may have caused vomiting.
On 11/11/2022 my smart watch went off and said my heart rate was too high. I was having problems breathing and chest pain. I went to the ER, and they did an EKG and X-ray which showed I had a lung infection. I stayed in the hospital for 4 days and they sent me home with several medication. They said it may have been the start of pneumonia. I have to use a daily inhaler but I am getting better.
She became COVID positive on 08Aug2022; She became COVID positive on 08Aug2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EM9810), on 11Mar2021 as dose 2, single (Lot number: EN6207) and on 25Mar2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "unknown" and all described as "She became COVID positive on 08Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive.  Clinical information: Patient recently had COVID and had asthma and she was fearful to get sick. She personally got vaccinated. She was treated with Albuterol for asthma. Her concomitant medication included birth control and vitamins. No other conditions reported. Patient received bivalent vaccine on 19Sep2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201233138 same patient/drug, different event/dose;