chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POUNDING HEADACHES; FEVER; HIGH BLOOD PRESSURE; CHILLS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and high blood pressure, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:45 for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure. On 10-APR-2021, the subject experienced high blood pressure. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever.  Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 10-APR-2021 14:00, the subject experienced pounding headaches. On 12-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 159/110 mmHg. On 13-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 148/102 mmHg, 112/78 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 10-APR-2021, and had not recovered from pounding headaches, and high blood pressure. This report was non-serious.
Experiencing a fever; Headaches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Experiencing a fever), HEADACHE (Headaches) and ARTHRALGIA (Joint pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (Experiencing a fever), HEADACHE (Headaches) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 3 doses. At the time of the report, PYREXIA (Experiencing a fever), HEADACHE (Headaches) and ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported Treatment medication included 3 doses of Tylenol
12/17/2020 It got really red over the first 16 hours and hot to the touch and tender. The discomfort went about 6 inches in diameter and my skin was very swollen. Took Tylenol for the discomfort and avoided sleeping on my left side. I did reach out to one of my doctors and was told to just keep a close eye on it. It progressively worsen and stayed that way for a week and within another week it had fully resolved.
Swollen face and puffy, red eyes. Could not breath out of nose and felt a lot of sinus pressure. Took Mucinex, benedryl and used Afrin around 12p. Nasal passages opened and could breath out of nose, but facial swelling continues and nasal passages starting to get blocked again (6p).
Severe headaches, body aches and chills started 24hrs after injection that continued up until 48 hrs despite taking (2) 500 mg acetomenaphine tablets every 6 hrs. Headaches lead to nausea and vomiting on 4/20/20 from 11 pm to 5 am.
sore arm and I have never been in a vaccine with a sore arm; Dizzy; This is a spontaneous report from a contactable consumer(patient). A 66-year-old consumer (Patient)  of an unspecified gender received first dose of BNT162B2 (formulation: Solution for injection, lot number: EN6202), via an unspecified route of administration at the left arm on 23Feb2021 08:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The Patient had sore arm, the patient had never been in a vaccine with a sore arm after 4 hours of vaccination and also the patient was feeling dizzy after 18 hours of vaccine shot on 23Feb2021. The Patient thought it would had suppressed immune reactions and took one Ibuprofen, It was 30 % controlled and took second Ibuprofen and its about 85% controlled and the patient was curious to know whether ibuprofen would be recommended for Dizziness. The outcome of the events was recovering.
Information has been received from a registered nurse concerning a 26 year old female with no pertinent medical history who on 17-APR-2007 was vaccinated intramuscularly in the right arm with a pre-filled syringe of Gardasil (655503/0012U). On 18-JUN-2007  the patient was vaccinated with a second dose of Gardasil (Lot #657737/0522U). On approximately, 20-JUN-2007 the patient developed a "small lump bump" on the right arm at the injection site. The patient reported that it was "achy similar to a bruise". It was described as a small moveable bump under the skin at the injection site. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient was recovering. Additional information has been requested.
Breakthrough Covid. I started having very mild Covid symptoms on June 19th after air travel.    Because a co-worker tested positive, I knew to keep testing and to isolate.  On June 21st, I tested positive.   I called my Dr immediately and was started on a course of Paxlovid.   My symptoms never moved from the mild stage (scratchy throat, slight stuffy nose).  No fever, no fatigue.  I quarantined but worked from home.  I then tested negative on June 26th.   Because I had Paxlovid, i also tested every few days and never tested positive again.
Patient states 3 days after receiving the 1st dose of the PFIZER COVID- 19 Vaccination, he began to feel SOB. States he was at the gym doing his normal cardio routine and in doing so felt SOB which is unusual for him.   States 3 days later began having right calf pain and swelling with a blue/green discoloration.  He continued to have SOB for the following 2 weeks to the point he was winded with walking to the car or to get the mail and finally went to the ER when the SOB was getting worse, he began having some chest discomfort, pain with taking a deep breath, feeling  like he had fever, lightheadness, weakness and feeling like he was going to pass out.
A few hours after the injection burning feeling in the upper palate of the mouth. Still have the feeling two later. eighteen hours after injection severe headache. Pain was in the back of the head. Felt as if my head wanted to separate from the body and only a couple of muscles held it in place. That headache is now gone and has been replaced with a mild migraine.
Hospitalized 07/05/2021 with Acute Respiratory failure with hypoxia. Pneumonia due to COVID-19 virus.
On the evening of March 31, 2021, itching was noticed at the injection site. Prior to this, no side effects after the March 23, 2021, injection had been observed. By the morning of April 1, 2021, a red, raised, itchy rash was noticeable at the injection site that was warm/hot to the touch. The rash continued to spread through April 6, 2021, running from about 4 cm above the elbow to the shoulder and encompassing most of the "injection side" of the arm. An ice gel bead pack was applied to the rash area multiple times per day April 1-April 6, 2021. The arm ached shoulder to hand on April 5, 2021. That evening, two ibuprofen caplets (400 mg total) were taken, followed up with the same dose both the morning and evening of April 6, 2021. The rash faded as quickly as it appeared starting the morning of April 7, 2021. As of the submission of this report, very mild itching is still present but the rash has faded almost entirely and can only be seen at the margins if you know where to look.
On 4/27/99, the pt's laboratory values indicated that the pt failed to seroconvert.
I become very weak and faint and very tired; I felt this way for a couple of days and took a home Covid test and it was positive.
Large raised red area around site of injection that has grown and has surrounding rings.  The red area is warm to the touch.  Smaller red, round areas on wrist with surrounding rings.  Tingling in fingertips and headache on left side.
menstrual flooding/one of the heaviest periods experienced; sitting uncomfortably; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (menstrual flooding/one of the heaviest periods experienced) and DISCOMFORT (sitting uncomfortably) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HEAVY MENSTRUAL BLEEDING (menstrual flooding/one of the heaviest periods experienced) and DISCOMFORT (sitting uncomfortably). At the time of the report, HEAVY MENSTRUAL BLEEDING (menstrual flooding/one of the heaviest periods experienced) and DISCOMFORT (sitting uncomfortably) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that after receiving first dose of a COVID-19 vaccine in early 2021, 10 days later found patient sitting uncomfortably in a work meeting during one of the heaviest periods patient had experienced. The patient had what was often called menstrual flooding. The patient would not have thought to connect the experience to the Moderna dose patient had received, were it not for the patients graduate student who had the worst cramps of life after COVID-19 vaccination. Patient had not experienced similarly intense symptoms after the second dose. Treatment information was not provided.
13OCT91 abdominal pain rt lower, nausea & fever remote hx ovarian cyst; t100.5, 14OCT temp returns to normal; 16OCT oncology consult: leukopenia, fall in neutrophils, "flu-like illness or rxn to flu shot";
Injection site very sore, muscle very sore for 6 hours; injection site and muscle mildly sore for 6 hours.
Pt felt hot and weak 10 mins after nasal vaccine given. At 11 AM wife chose to transport husb to PC MD for evaluation since he was still feeling hot and weak when he stood up. Patient came into clinic for H1N1 vaccine with his family, wife and son. They were eligible today because they have a child under the age of 6 months in their household. The wife and son were given the H1N1 injection, but because he was healthy, the nurse offered the mist. He took the mist, and reported that immediately he felt weak and hot. He went outside to the cool fall air and said he felt better there, but his wife felt he needed to be inside where he could be watched, so he came back in and sat down in the chair. 10:45 AM I was called and I asked him back to the clinic and had him lay down on the exam table. BP 144/82, face flushed. Pt. stated that he felt better and wanted to sit up, but as soon as he sat up he c/o feeling hot and weak. I had him lay down again and called our health officer. He came in and assessed him, suggested he remain in the clinic for another 15 minutes. Patient was given water to drink. His wife took their son to her mother's because he was hungry. 11:00 AM She came back and he attempted to sit up. His BP was then 172/98 when sitting up. He does not have a primary care physician. The wife and Dr. discussed sending him to Emergency Room as he was still was feeling ill via EMS but she preferred to transport him there or clinic. 11:20 AM Phone call from wife asking why we gave mist to her husband when they have small children in the household. She had been told at clinic that he should not have been given the live vaccine because they have small children in household. I explained that we are following the recommendations from CDC who supplies the vaccine to the country.
Developed pruritis and erythema surrounding the site of injection lasting approximately 48 hours before completely resolving.
This case was reported by a physician and described the occurrence of seizure-like episode in a 6-week-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included 10 valent pneumococcal conjugate vaccine; manufacturer unspecified given on 7 December 2009; HIB; manufacturer unspecified given on 7 December 2009; live attenuated human rotavirus vaccine; manufacturer unspecified given on 7 December 2009. On 7 December 2009 the subject received 1st dose of PEDIARIX (details unknown). On 7 December 2009, at night less than one day after vaccination with PEDIARIX, the subject experienced seizure-like episode, of moving head and jerking for approximately 15 minutes. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with PEDIARIX.
Heartbeat raised up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heartbeat raised up) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heartbeat raised up). At the time of the report, HEART RATE INCREASED (Heartbeat raised up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not reported.
60 year old diabetic female patient started feeling dizzy and fainted while seated approximately 5 minutes after receiving a HEP A vaccine. Patient was seated in immunizations waiting area at the time. Patient was roused with an ammonia inhalant and asked if she was having difficulty breathing to which she shook her head no. Patient was extremely diaphoretic and had a very weak and slow pulse. Code Blue was called. Patient was asked if she knew her name but fainted again before replying. Patient was roused again by shaking/tapping her shoulder. Patient was asked if she knew where she was to which she replied "I don't remember how I got here". Approximately 1-2 minutes after code was called the response team arrived. Husband of patient checked patient's glucose with her personal glucometer and reported it to be normal. Pulse Oximeter was placed on patient and read 85% oxygen level with a heart rate of 31. Patient at this time was able to verbalize her name and where she was. Patient was placed on a gurney and transported to ER.
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 03-JUL-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB INJ 10, 0.5 ml, intramuscularly (lot number was not provided). No co-suspect or concomitant therapies were reported. The nurse reported that on 10-SEP-2013, the patient was vaccinated with the second dose of RECOMBIVAX HB INJ 10, 0.5 ml, intramuscularly (lot number not provided). No adverse effects were reported. Additional information has been requested.
low-grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low-grade fever) and CHILLS (chills) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low-grade fever) and CHILLS (chills). At the time of the report, PYREXIA (low-grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Blood pressure dropped from 107/72 to 103/67. HR dropped from 73 to 60. O2 sat from 96 to 97%
Pt vax'd w/ 1st dose of hepatitis B vac & exp. vertigo,paresthesias,myalgia,w/edema and redness at site of injection.
Patient came in for 2nd dose and mentioned a rash showed up on arm approximately 7 days after immunization and resolved on its own. Rash was about 1 inch from the injection site.
In October of 2021, 5 months after my second dose of the Pfizer covid19 shot I developed seizures and as of todays date 3\15\2022 I've had 3 seizures since  the first onset in October. I've had a seizure approximately 3 months apart.  I'm being monitored by a neurologist and am on seizure medication.   I'm unsure of any correlation however I feel I need to report this unusual behavior.     I am currently on disability from work as I'm unable to drive until my seizures are under control.
The week after I received the Moderna COVID-19 shot 1st dose I had a big whelped circle at the injection site with warm to the touch feel and a lot of itching. Circle was about 4" in diameter. The date of the injection was 01/25/2021 and right at a week when this happened was 02/01/2021. To this day (02/04/2021) I still have a little itching and a circle still appears on my arm, it's not warm to the touch. Dr. at work place advised me to put CORTIZONE for the itch and keep it hydrated with eucrin cream.
Lt. arm redness/warmth approximately 3 1/2" by 3 1/2". No temp (96.9). Treatment - Prednisone 40mg 'PO' at 1700, Benadryl 50 mg 'PO'.
This spontaneous report as received from a pharmacist and 57 year old female consumer refers to herself. Pertinent medical history included scleroderma, type B pulmonary hypertension, allergy to egg products, iodine products and Penicillin. On 11-FEB-2015, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location and lot number was unspecified by reporter). Concomitant therapies included LETAIRIS, TYVASO and unspecified blood pressure medication. On an unknown date in February 2015 the patient experienced itching, soreness, and swelling after receiving the ZOSTAVAX at the injection site. The reporter also stated that there was a lump or nodule, the size of a quarter, around injection site. The patient sought medical attention by making a call to pharmacist. No treatment was given for the events. The outcome of vaccination site nodule was reported as not recovered/not resolved. The outcome of itching, soreness, and swelling after receiving the ZOSTAVAX at the injection site was reported as recovering/resolving (reported as lasted for four to five days and then subsided). The causal relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
1/30/2022- Presents to ER, c/o SOB and back from fall 2 weeks ago. Baseline o2 use, 2L via NC. Covid+ test, d-Dimer-549, Hgb-7.2 1 unit PRBC given.  Chest x ray-bibasilar infiltrates. Admit acute chronic respiratory failure with hypoxia and hypercapnia pneumonia due to Covid-19 with COPD.   Placed on bipap, 80% Fi02 96%, ABG- 7.3/52.1/77/30.3. Started on Solu-medrol, IV vancomycin x 1 dose, IV zosyn x 1 dose , bariticinib and sotrivimab.  1/31/2022- Chest CT-severe Covid pneumonia. Fio2 reduced to 70%, o2 sat 96%. Doxycycline PO and Rocephin IV. Increase Hgb- 8.2. D/c antibiotics due to procalcintonin of 0.11. Currently satting 97% on 30L HFNC. 2/8/2022- D- Dimer improved at 392. Maintaining o2 sat with NC at 2L. 2/9/2022- Tapered down to 2L o2 via NC. Continue steroids and discharged home.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; 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 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 9:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 9:18 AM, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.48.  Concomitant products were not provided.  On 12-Jan-2021, Excursion time was 08 AM, temperature was 34, Excursion time was 09 AM, temperature was 34, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021. 3 vials were sent to clinic. Vaccine BUD date was 7-Feb-2021.On 12-Jan-2021?, no hourly temperature recordings available.  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 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
The pt experienced pain and left sided spasm which resolved within 30 minutes. Questionable allergy. Elevated Blood pressure of 250/150 and a neuro exam was completed by MD. The pt was advised to take rest and warm compresses.
On the night of the injection she developed chills and severe swelling and  redness of the entire arm below the injection site down to the forearm. No dyspnea, sob, angioedema, fever.
w/in 24hr of vax pt devel gen urticaria;this is 1 of 3 reports from this facility of an adverse exp p/vax;
25jul90 pt vax hepta B. 29jul90 pt ex severe stomach cramps, feelings of nausea, and insomnia.  03sep90 pt vax 2nd hepta B w/o reaction.
She developed red dots (petechiae) and bruising on Saturday. She also developed vaginal bleeding on Saturday that was heavy and had clots. Her period was ending on Saturday and had been normal up to that point. She continues to have heavy vaginal bleeding. Went to PCP and routine labs revealed thrombocytopenia.  She has never had thrombocytopenia before. Was sent to ED for blood transfusion and was admitted to hospital. Dishcarged home 4/27 after platelet infusion.