chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Viral infection; Suspected COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Viral infection) and SUSPECTED COVID-19 (Suspected COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced VIRAL INFECTION (Viral infection) and SUSPECTED COVID-19 (Suspected COVID-19). The patient was treated with OXYGEN for Adverse event, at a dose of Unknown. At the time of the report, VIRAL INFECTION (Viral infection) and SUSPECTED COVID-19 (Suspected COVID-19) outcome was unknown.            No concomitant medications were reported It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
A report was received from a healthcare professional concerning a female vaccinee of unspecified age who experienced a rash and itching on the neck the day after receiving Fluvirin on 10/28/2003. On the 10/29/2003, the vaccinee experienced a rash and itching in the neck region.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 February 2004. A follow up report was received from a healthcare professional indicating that the 44 year old vaccinee developed an itchy rash over arms and trunk, the day after receiving Fluvirin.  According to the reporter the event is most likely resolved as the vaccinee did not call back.  No follow up pending, no further information available.
Patient c/o R arm itiching at the site of injection.  Some redness noted about palm size with swelling.  Checked 1/31/13 2:30 p.m states swelling decreasing. Patient did not go to Primary MD or ER.
On Tuesday 3/14/23, patient received 1st dose of HPV vaccine to left deltoid. On Friday 3/17/2023,  patient retuned for an office visit reporting pain around her right ear and jaw, facial drooping, numbness and inability to close her right eye completely since Wednesday 3/15/2023. Provider diagnosed patient with Bell's Palsy and started treatment of  Prednisone 10mg tablet 3 tablets once a day for 5 to 10 days, Valacyclovir 1 gram tablet 1 tablet 3 times a day for 7 days and Artificial eye lubricant  83-15% to apply small amount to into right eye twice a day. Patient was also instructed to follow-up with physical therapy to help with her symptoms.  See Labs ordered in item 19. At follow up on Tuesday 3/21/2023, patient reported improvement of symptoms. Provider recommended patient to continue taking prednisone 10mg 3 tablets a day for 10 more days plus the use of artificial eye ointment and physical therapy. At follow up on Tuesday 4/03/2023,  patient was still unable to close right eye completely. Smile and frontal area were more expressive. Patient was instructed to continue with physical therapy and a follow up appointment was scheduled for 05/08/2023. On Monday 04/17/2023 patient had an appointment to recieve the 2nd HPV vaccine. Upon reviewing chart for 1st HPV dose and recent diagnosis, possible connection between 1st HPV dose and Bell's palsy was considered.  After consulting with provider, the 2nd dose of HPV vaccine was not administed.
Fussy. Mild fever - lasted only 1 day after vaccine administration. Bruising to body, head/scalp; neck, R/L forearm legs. Back & some to tummy. Some have induration. Onset 7/29/12.
warmth at the injection site; Soreness at the injection site; tiredness that lasted for 3 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (warmth at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (tiredness that lasted for 3 days) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced VACCINATION SITE WARMTH (warmth at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (tiredness that lasted for 3 days). At the time of the report, VACCINATION SITE WARMTH (warmth at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown and FATIGUE (tiredness that lasted for 3 days) had resolved.            No concomitant medications were reported.  The patient received his first Moderna Covid 19 vaccine primary series on 19JAN2021 Lot number 011L20A, second Moderna Covid 19 vaccine primary series on 16FEB2021 Lot number 007H20A, third full dose on 22OCT2021 Lot number 014F21A and first booster dose on 19MAR2022 Lot number 033ZX21-2A.   Patient reported adverse reactions of tiredness that lasted for 3 days. Event end date will be in SEP-2022.  No treatment medications were reported.   This case was linked to MOD-2022-676537, MOD-2022-676548, MOD-2022-676549 (Patient Link).
I woke up at 4:00 am after tossing and turning during the night and not having a comfortable deep sleep. I took a few steps in my living room and felt I was about to faint any seconds. Since I live by myself I rushed to my door and laid down outside my apartment door on the floor and put my feet up on the wall to get more blood flow to my brain. The reason I went outside my apartment was because I felt like I could get unconscious and wanted people to find my dead body in case I died. I could not get to my phone in my kitchen to call 911. I laid there for 20 minutes and I was sweating profusely. Then tried to get up after that and I felt I was about to faint again. So I laid down there for another 20 minutes . Then I slowly crawled back to my apartment and slept on the floor for 3 hours. It was around 7:30 when I tried to get up and start the day, but as I got up I was feeling that could faint again. So I went back to sleep again until noon.
Nose bleeding; Feeling sick; Headaches; A spontaneous report was received from a physician assistant concerning herself, a 52-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nose bleeding (epistaxis), headaches and sickness (malaise).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 010m20a) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, after the vaccination, the patient experienced sickness and headaches. On 18 Feb 2021, the patient experienced nose bleeding. The patient visited the emergency room on 18 Feb 2021 and 19 Feb 2021. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  Laboratory information included MIT, in which no capillary injury was found.  The outcome of the event, nose bleeding, was not recovered.   The outcome of the events, headaches and sickness, was considered as resolved on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Difficulty breathing; Throat tightness; frequent throat clearing; shortness of breath; This is a spontaneous report from a non-contactable healthcare professional.  A 34-year-old male patient received the first dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6207) via an unspecified route of administration on 18Mar2021(at the age of 34-year-old) as a single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. On 18Mar2021, during the patients 15-minute waiting period after the injection, the patient began to experience difficulty breathing and throat tightness. He denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient complained of frequent throat clearing and shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The therapeutic measures included treatment with water and the follow up response to treatment was excellent. The patient was discharged and was stable to go home and was advised to follow up with PCP (primary care physician). The outcome of the events dyspnoea, throat tightness and throat clearing was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: shortness of breath added, for all events, stop date added 2021, and final sentence should be updated to No follow-up attempts are possible. No further information is expected.
feeling bad; 100 degree fever; chills; body aches; headache; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number CH9899), via an unspecified route of administration from 11Jan2021 08:30 to 11Jan2021 08:30 at a single dose for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) On 21Dec2020 at first dose. Concomitant medication included melatonin. It was reported that the patient feeling bad after injection, got 100 degree fever, chills, body aches and headache; all on 11Jan2021 16:00. Took aspirin to reduce side effects but headache remains. The outcome of the event headache was not recovered while recovering for the other events.
Report describes headache in a male vaccinee of unspecified age who received hep A vaccine. Medical history, concurrent conditions, and concurrent medications were not specified. On 10/30/1998, the vaccinee received his first injection of Havrix. An unspecified time post-immunization, he experienced a "violent" headache with nausea and felt "as if he was going out of his mind." The headache resolved after three or four days. The nausea and feeling tat he "was going out of his mind" resolved after an unspecified period of time. The vaccinee reportedly attributed these events to a "thimerosal reaction." The Havrix immunization series was discontinued.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itching). On 08-Feb-2021, PRURITUS (Itching) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were taken by the patient. Treatment medications were unknown.    This case was linked to MOD-2021-230247 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains non-significant information.
No adverse event; They gave the vaccine more than 12 hours post 1st puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave the vaccine more than 12 hours post 1st puncture) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave the vaccine more than 12 hours post 1st puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave the vaccine more than 12 hours post 1st puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They gave the vaccine more than 12 hours post 1st puncture).    No concomitant medications were reported.   It was reported that, on 21-Oct-2022 (at 9:00-9:30 AM) nurse gave a Moderna COVID-19 bivalent booster vaccine from a vial which had been first punctured on 20-Oct-2022 at 10:20 AM. They gave the vaccine more than 12 hours post 1st puncture. Vial size reported was 2.5 milliliter. The vial was initially stored in refrigerator on 20-Oct-2022 at 17:03 PM. The vial was stored at room temperature post puncture, and it did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 23 hours and some minutes.  No treatment details were reported.
Stated with severe pain in left shoulder, back and neck a couple days after 2nd shot. One week after 2nd shot, parasthesia & weakness in left arm. Pain resolved in about a month. Parasthesia and weakness did not resolve for about 2 1/2 months.
Patient was unsure of the exact date of her COVID vaccines. Side effects occurred after the 2nd COVID vaccine and included nausea, chills, increased Temp, and muscle aches.
Hospitalized (5.24.22);  COVID-19 (5.24.22);  Fully vaccinated  BRIEF OVERVIEW: Admission Date: 5/24/2022 Discharge Date: 5/26/2022 DETAILS OF HOSPITAL STAY: ADMISSION DIAGNOSES: 1. Intrauterine pregnancy at 35 weeks gestation 2. Normal labor 3. Non-refractory idiopathic generalized epilepsy 4. Unwanted Fertility 5. Diet Controlled Gestational Diabetes  6. COVID in Pregnancy  DISCHARGE DIAGNOSES 1. Intrauterine pregnancy at 35w3d gestation, delivered 2. Lactating mother 3. Non-refractory idiopathic generalized epilepsy 4. Gestational Hypertension  5. Unwanted Fertility  6. COVID in Pregnancy  CONDITION ON DISCHARGE: Good INTRAPARTUM COMPLICATIONS: None Pregnancy/Labor Details Patient is a 28 y.o. G4P0212 female who presented to L&D at 35 weeks gestation who presented in preterm labor and was found to be have preterm rupture of membranes. Pregnancy complicated by Idiopathic Epilepsy, gestational hypertension, gestational diabetes, and COVID in pregnancy. She was monitored overnight and made slow progress. She was started on pitocin and made good progress. She progressed to complete at 1245 and delivered at 1319. She had a uncomplicated vaginal delivery.  Delivery Details DELIVERY TYPE: Vaginal, Spontaneous   ESTIMATED DUE DATE: Estimated Date of Delivery: 6/25/22 GESTATIONAL AGE AT DELIVERY: 35w3d  G4P0313 DELIVERY PROVIDER:   ASSISTING PROVIDER(S):   FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  girl   Delivery Date/Time:  1:19 PM   WEIGHT: 2.69 kg  APGAR:  1 minutes 5 minutes 10 minutes  7  8   POSTPARTUM DETAILS: The patient met all of her postpartum milestones. Her pre-delivery Hgb was 11.6 . She is breastfeeding her infant. She received a breast pump prescription and was seen by a lactation consultant for breastfeeding support. She desired a tubal ligation for contraception but due to her COVID + status she was agreeable with Micronor as a bridge to tubal ligation. Postpartum course was uncomplicated.  She was discharged home in stable condition on postpartum day #2. She was given standard postpartum discharge instructions. Warning signs of postpartum hemorrhage, infection, pre-eclampsia, DVT/PE and depression were discussed. She is to follow up with her OB Dr. in 1 week for a BP check and in six weeks for a postpartum check-up.
I was having some palpitations and some tingling in my left arm off and on starting the end of February or beginning of March and it was noted my blood pressure was high so I started taking Valsartin.  On March 30th the tingling and weakness in my left arm became worse and went down my left leg also.  I was advised to go to the ED and my blood pressure was very high 200's/100's.  I was admitted and they did tests to rule out a stroke TIA.  There wasn't evidence of that and my symptoms did get better.  I was discharged with an increase in the BP medication and a tentative diagnosis of Complex migraine or possible TIA.  I'm now on 160 Valsartine and 5mg of Amlodipine and my blood pressure as stayed normal.
Patient passed out, fell off of exam table and hit her head. Pt came to after a 40 seconds. Neuro and vital check completed - normal. All results normal. Adv'd to return to go to ER if needed.
4 days after the vaccine was given, i started a getting a rash.  day 5 I called the COVID nurse Day 6 I called my doctor and was put on a steroid
Heat near Injection Site; Blotchy right below the injection site; Redness right below the injection site; Pain near Injection Site; Swelling near Injection Site; A spontaneous report was received from a Consumer concerning a 55 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Injection site pain, Injection site rash, Injection site erythema, Injection site swelling and Injection site warmth.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 09 Jan 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Left Upper Arm for prophylaxis of COVID-19 infection.  On 09 Jan 2021, The patient experienced Redness, Pain, Blotchy and Swollen Skin that projects Heat.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event(s) Injection site pain, Injection site rash, Injection site erythema, Injection site swelling and Injection site warmth were unknown; Sender'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.
I have had two herpes sensations. However, they never came to be.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: EW0150) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "genital herpes" (unspecified if ongoing), notes: I have had genital herpes for 50 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Batch/Lot Number: EL1283), administration date: 15Jan2021, for covid-19 immunization; Bnt162b2 (Dose: 2, Batch/Lot Number: EL9264), administration date: 05Feb2021, for Covid-19 immunization.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have had two herpes sensations. However, they never came to be.".   Additional information: It was reported that patient had herpes for 50 years. Patient can tell when it was going to activate fully. Since vaccine shots, Patient had 2 that felt coming on. However, they never fully developed post the little tingle stage. This has been only since the vaccine. Perhaps the vaccine was helping with the herpes virus.  No follow-up attempts are possible. No further information is expected.
pt brought to hosp ED via EMS with cardio-pulmonary arrest; ACLS protocol on way to ED; ROSC after code run in the ED; pt intubated; per family pt c/o chest pain prior to collapse; diagnosed 1 wk prior with COVID; PCP treated with steroids and hydroxychloroquine; CT showed cerebral edema; transferred to ICU; condition grim; family declined aggressive measures; withdrew care; pt extubated and died in the hosp
The night taking the shot, I noticed what look like chicken pox marks on the inside of my left and right arm.  The next day those hives and more spreaded down both inside my forearms. From there everyday more would appear. My torso, under my breast, through out my back, neck and bum. Itch profusely and burning sensation.  I called my doctor, she prescribed  Hydroxyzine. It help at night but caused drowsiness. Stop taking 3 times a day prescribe, I slept through them. She suggest taking Zyrtec to help during the day. To date the itching is not as severe, I'm bearing it. Yesterday was the first day back to work. I did flare up
Body joint aches over a week. Took the shingles vaccine have felt deathly ill since. Body aches feels like a fever without a temp. Vomiting.
Information has been received from a certified medical assistant (CMA) referring to multiple unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date these patients were vaccinated with improperly stored (Merck) VARIVAX (lot#, expiration date, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
sore/scratchy throat, sinus congestion and body aches. She subsequently developed a mild cough. starting 1/1/22
Fever; crying; large, red welt at sight of injection.  Mom stated that the child cried all night and had a fever.  She stated that she had had a reaction to Tetanus when she was young.
I was supposed to get my second one on April the 18th but I was in the hospital so I couldn't get it; I was supposed to get my second one on April the 18th but I was in the hospital so I couldn't get it; I am on oxygen.; I have a bad rotator cuff in my right shoulder and it is been, it felt swollen; shoulder lets me know what's there, it feels like a 'bone' strap across my shoulder; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196, Expiration date was not reported), dose 2 via an unspecified route of administration on 07Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT: ER2613) on 26Mar2021 for covid-19 immunization. On an unspecified date the patient experienced she was supposed to get her second one on 18Apr2021 but she was in the hospital so she couldnt get it, she is on oxygen (po2), she has a bad rotator cuff in her right shoulder, and it is been, it felt swollen, shoulder lets her know what's there, it feels like a 'bone' strap across her shoulder (musculoskeletal discomfort). Patient stated, if she had to explain it and she didnt know if that would be a Covid side effect or just her rotator cuff acting that. The outcome of events was unknown.