chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt states a week after the covid vax she noticed her left arm is warm and swollen around the injection site.  Pt said she will contact PCP to let them know about her symptoms.
This spontaneous report was received from a medical assistant, referring to a 11 year old patient of unknown gender. The patient had no pertinent medical history, concurrent conditions, drug reactions/allergies, or concomitant medications. On 31-JUL-2018, the patient was vaccinated with GARDASIL 9 lot # N025429 (expiration date: 21-JUL-2020) for prophylaxis (strength, dose, frequency, route of administration were not reported). Almost immediately after being vaccinated, the patient "shook a bit", and then, about two minutes after the administration, of GARDASIL 9, the patient became "unresponsive, shortness of breath and looked pale in the color". Subsequently, the emergency medical service was called and the patient was taken to an unspecified hospital emergency room. No laboratory diagnostic studies and no intervention to prevent serious criteria were performed. By the time of the report, the outcome of unresponsive to stimuli, dyspnoea, pallor, and tremor was unknown. The causality relationship between the aforementioned events and GARDASIL 9 was not reported. Upon internal review, unresponsive event was determined to be medically significant. All telephone attempts to obtain follow up information had been unsuccessful and additional information has been requested. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA000589: US-009507513-1808USA000592.
-100º fever started 12 hours after injection. -Fever quickly progressed to 103º (within 3 hours) and  lasted for 6 hours -Body aches, chills, extreme headache, tired -Fever reduced to 100º and lasted for 1 day (24 hours after injection) -Headaches continued for 48  hours after injection
ED visit - loss of appetite for 2 weeks, treated and discharged. ED to hospital admission 5 days later - Acute on chronic diastolic heart failure. Continue on IV Lasix 20 mg twice daily, Lopressor 50 mg twice daily, echocardiogram ordered.  Biopsy of the colon confirms lymphocytic colitis.  Case discussed with Dr. recommend treatment with budesonide, 9 mg daily for 2 weeks and then 6 mg daily for 2 weeks and then 3 mg daily for 1 month. Continued treatment and discharge to skilled nursing facility. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Background on first covid-19 vaccine dose: Patient received her 1st dose of Pfizer covid-19 vaccine at vaccine clinic on 1/12/21 (this clinic is outside of the Health- system). Pfizer vaccine lot# EN3249 left deltoid. She was sent to an emergency department due to dizziness, nausea (ondansetron given in route). Given diphenhydramine in ED. Work up in the ED suggested anxiety reaction/stress response surrounding vaccine rather than an allergic reaction to the vaccine itself.   Reported incident related to 2nd dose: Patient received 2nd dose of Pfizer coivd-19 vaccine lot #EN6206 on 2/25/21 at Vaccine Clinic (seen there instead of Center) to allow for closer monitoring. She pre-medicated with 50mg of diphenhydramine on 2/25/21 at 1200 per her PCP's recommendation. She was monitored in the covid vaccine clinic waiting area where at 1310, she felt shaky, pressure headache, and body feeling tight. BP 155/110, HR 90, RR 24, SpO2 100%. had patient lie down. 1325: BP 155/103 HR 90, RR 24, O2 99%. same symptoms as listed above. 1340: BP 150/101. patient reports shorter quicker breathing. O2 WNL and RR 24. 1400: BP 143/98. Patient reports body feeling very exhausted which is what happened with the first shot. No other change in symptoms. 1430: patient up the bathroom using wheelchair, able to stand on own two feet to void, but reports feeling weak. 1445: BP 135/91. Pt not feeling better, but states she feels ok to go home. encouraged patient to continue to rest and find a ride home. Pt is in agreement. 1515: BP 135/99. Patient rested until 1615 and a friend came to pick her up. Wheeled out in wheelchair and able to get into car on own two feet.   Seen in PCP clinic on 2/26/21 for BP monitoring/follow up. Pt?s BP 130/80. Pt reports feeling fine. Denied shortness of breath/chest pain/pressure/palpitations. Pt has never had this type of reaction to other vaccines. BPs in clinic over the past year have mostly been 120-130s/70-80s.
This was my second dose, and the side effects were the same as the first time. Joint pain, extreme fatigue for about 16 hours.
c/o chills, congestion 24 hrs p/inject; did not take temp; seen by provider, had temp, put on ATB;
Sudden onset extreme dizziness/vertigo. So severe and sudden I called 911 because I felt I might lose consciousness. Followed by nausea and violent vomiting. (EMT Vitals were all normal and they didn't think it was an allergic reaction this long after vaccine so I declined hospital ER visit.)  After several hours of severe dizziness I developed violent chills with heavy breathing that lasted 20 minutes then stopped.  Much improved after 24 hours but two days later I still have considerable dizziness. Headaches occurred Earlier in the week but none with onset of dizziness. Otherwise I experienced the typical fatique and flulike vaccine side effects with no pain at injection site about 2 days after vaccination that lasted several days.
Light-headed and slightly shaky approximately 5 minutes after receiving vaccine, so once I got my card we left to go immediately to the Emergency Room, approximately 10 minutes away. The symptoms progressed  including strong tremors, mucus production, coughing and loss of bladder.  I administered an EpiPen in the vehicle.  I was immediately triaged at hospital and admitted for observation. No additional medications were administered.  I was under observation for four (4) hours and discharged, making sure I had additional EpiPens.  Since vaccination, I have been extremely reactive in a Mast Cell Flare, and am taking 50 mg of Prednisone, Benadryl and Nebulizer as needed.
All symptoms starting about 9 hours after injection: body aches, fever, chills and headache. All symptoms gone by 7PM  ON 5/19/2021
Periodic spasms of the back muscles; mostly around the thoracic region. Persisted intensely for 36 hrs, symptoms gone by 5 days.
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.            No information regarding concomitant medication was provided.  No information regarding treatment was provided .
Pt presents at the ER complaining of left sided chest pain, which began 2 hours prior. She had eaten a normal evening meal and felt like her abdomen was full but otherwise felt okay. Physician reports second vax received Nov 1. Exam reveals hyperactive bowel tones. Left thoracic area is tender to palpitation and this is approximately a 3-4 inch band extending from midline to the back of the thoracic area. No apparent rash. Headache, backache, pain in left side around back, lower back. When pt breathes deeply, there was more pain. Analysis: Chest wall pain probably secondary to new onset of herpes zoster. Given injection of Demerol 100mg/Phenergan 50mg IM. Observed for 10 minutes. Did have episode of emesis. Received starter pack of Darvocet N 100, 1-2 Q4H PRN pain and prescription for an additional 30. Also prescribed Farnvir 500mg to take 1 TID for seven dashed. If pain becomes more intense or moves from current location, she was asked to return for further work up. She was cautioned about the contagious nature of shingles for anyone who has not had varicella.
Sore, swollen arm with bruise at injection sight , Fever, chills, nausea, headache, vertigo 3 days after injection. Lasted 36 hrs
4/7/10 Emesis x 3-4. Then wretching and became blue and limp. Pulse Ox 84%. 911 called. Baby very unresponsive and gradually became more alert. No definitive seizure activity.
On 09/23/2009 our son had a well-check with his pediatrician, was diagnosed in very good health and given an MMR vaccine.  It was recommended at that time he receive a flu shot too, but that they were currently out of stock.  On 09/25/2009 he returned and was given an Influenza PF vaccine.  For several days following the vaccinations our son had a persistent low grade fever.  The following week he appeared to be in good health.  Two weeks after vaccination he began to develop extreme thirst, frequent urination, dehydration, fatigue, weight loss and became very agitated. On 10/14/2009 we took him to his pediatrician who advised that his symptoms were most likely due to an onset of type 1 diabetes.  He sent us immediately to the local hospital lab for blood work to confirm.  Shortly after we were notified that our son was experiencing severe hyperglycemia and ketoacidosis and were advised to immediately take him to the hospital where he was admitted to the pediatric ICU.
My left arm where the shot was given. My arm swelled from the shoulder to elbow the next day, day after, from the elbow to wrist and then in 5 days all swelling was gone! No pain involved!
mom states pt was not interested in feeding noc 30APR & early 1MAY morning; pt taken to ER was admitted for testing & observation; pt later arrested & was resusitated to ICU where arrested again & could not be revived;
Started having stomach pain less than 24 hours after my Second vaccine.  It?s been 3 days and I am still having issues.
This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 14-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # H020002, expiry date: 08-AUG-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: EW0173, Expiration Date: 21Aug2021) at the age of 76 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Cancer" (ongoing); "diabetic" (ongoing); "Neuropathy" (ongoing), notes: direct result of Chemo in the beginning; "Triglycerides high" (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "immunocompromised" (ongoing); "multiple myeloma" (ongoing). Concomitant medication(s) included: Darzalex; Dexamethasone; Singulair; Benadryl; Tylenol; Insulin taken for neuropathy peripheral (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical location: Right Arm), administration date: 25Mar2021, when the patient was 75 years old, for Covid-19 immunization, reaction(s): "swollen lymph node"; Bnt162b2 (Dose: 2, Batch/Lot No. EP7534, Expiry date: Jul2021, Anatomical location: Right Arm), administration date: 12Apr2021, when the patient was 75 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 28Aug2021, outcome "recovering", described as "Fatigue"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 27Aug2021, outcome "unknown", described as "The expiration date was 21Aug2021 and they took the vaccine on 27Aug2021". Additional information: The caller was calling about the Covid- 19 vaccine. The caller and her husband had their third vaccine on Saturday. The patient was immunocompromised and has cancer, the caller is his caregiver. When the caller looked at her record cards after they got home. The caller realized the sticker gave the lot number, but the expiration date was 21Aug2021 and they took the vaccine on 27Aug2021. The patient got the two doses and had a swollen lymph node under the right arm which is the same arm he received the vaccines in. The lymph node swelling started a couple of days after the first day after the patient received the first dose. It comes and goes and the Nurse Practitioner said it was not unusual. This never went away before the second dose. They ordered an ultrasound for it but they haven't scheduled it yet. After the third dose the patient has had fatigue. The patient has ongoing fatigue with the cancer and treatment but he slept a good bit on Saturday and yesterday. No follow-up attempts are possible. No further information is expected.
A few hours after receiving my first shot my right arm started to hurt. It was difficult to raise my arm. I also experienced fatigue. I went to bed that night at 7:00pm due to be so tired. I took Tylenol for the arm pain. I woke up the next morning with my arm still hurting and still feeling tired. The tiredness continued throughout the day. The arm pain subsided by that evening (7/1/2021 around 7:00 pm).  The tiredness is getting better, but I?m not yet back to my energetic self as of this morning (7/3/2021)
Chills, Aches, Back pain, swollen ankles, Pain at injection site.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (159558). The reporter is the patient. A male patient received the 4th (second booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 8, 2022, single dose, for COVID-19 immunisation. The patient's medical history included allergies (unspecified if ongoing), notes: he had allergies previously. The patient's concomitant medications not reported. Vaccination history included the COVID-19 vaccine (primary series complete, manufacturer unknown), for COVID-19 immunization; and the 3rd (first booster) dose of BNT162B2. The patient had pain in extremity/arm was a bit aching after the shot, onset Apr 8, 2022, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Information has been received from a nurse concerning an unknown number of patients. The nurse reported that unknown doses of VARIVAX (lot # L001326, expiry date 13-JAN-2017; lot # L042265 expiry date 26-OCT-2016; lot # L023594, expiry date 26-JUN-2016) were administered to an unknown patients on unknown dates. No adverse effect was reported. Digital data logger indicated that temperature excursion occurred during the storage of the vaccines. Temperature was 26F and time frame was 16 hours. This is one of several reports received from the same source. Additional information has been requested.
missed appointment for second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed appointment for second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-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 PRODUCT DOSE OMISSION ISSUE (missed appointment for second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed appointment for second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant was provided no treatment medication was provided
Severe headaches, Nausea, severe muscle aches & joint aching, fever, sweating through clothes in bed, significant hives on day 2 post vaccine causing need for shots of toradol and sotradecol.
?Heavy? arm feeling as soon as injected almost like numb. Symptoms last about a day then very tired, headache, hot flashes. Didn?t feel like myself till 4 days after
Shortly after receiving the first dose of the vaccine (1-2 minutes), I started to feel pain at the site of my injection along with a feeling of light headedness, nausea, sweating, and a loss of vision and hearing. These symptoms led to me fainting and needing assistance from the pharmacist along with emergency paramedical personnel. After about 15-20 minutes after the onset of symptoms I began to feel normal again.
Temperature over 105F (even with having taken Tylenol to reduce any fever) - led to vomiting and a febrile seizure (which lasted no more than 10 minutes).  This all happened about 11 hours after the DTaP immunization.
Shivering, fever 100.8 F, muscle aching entire body, headache lasted 24 hours.
Headache Pain Scale Level 2/10; feeling achy. Self-medicated with two Extra Strength Tylenol tablets before reporting symptoms to clinic.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider (HCP) for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
heart attack; shortness of breath; had soreness in her arm; felt really tired for quite some time after that; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01L20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Costochondritis and Heart attack. Concomitant products included VITAMINS NOS for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, 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 experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (had soreness in her arm) and FATIGUE (felt really tired for quite some time after that). The patient was treated with RIVAROXABAN (XARELTO) at a dose of Once in a day and METOPROLOL TARTRATE at a dose of Twice a day. At the time of the report, MYOCARDIAL INFARCTION (heart attack), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (had soreness in her arm) and FATIGUE (felt really tired for quite some time after that) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not reported.  Patient had heart attack on 23 APR 2021.  Patient was not sure which arm was vaccinated but thinks it is probably her left arm as she was right handed.  Company Comment: This case concerns a 73 year-old, female patient, who experienced the unexpected event of myocardial infarction. The event occurred an unknown date. The rechallenge was unknown since there's no clear information about which events are related to the first and the second dose. The age of the patient and the uncertainty of the date on which the event occurred are potential confounders. The benefit-risk relationship of Spikevax is not affected by this report. Further information is required.; Sender's Comments: This case concerns a 73 year-old, female patient, who experienced the unexpected event of myocardial infarction. The event occurred an unknown date. The rechallenge was unknown since there's no clear information about which events are related to the first and the second dose. The age of the patient and the uncertainty of the date on which the event occurred are potential confounders. The benefit-risk relationship of Spikevax is not affected by this report. Further information is required.