chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient (14 years old) fainted in the observation area receiving the first dose of the Pfizer vaccine. Patient fell from chair and had some scratches to right temporal region. Patient was accompanied by his mother. Patient was assisted to chair and appeared very pale and disoriented to time and place. EMS was called at 1138. Patient also stated his vision was blurred, reported nausea (emesis x1), and reported feeling very weak and ?really weird?. Patient also reported he was very sleepy and wanted to go to sleep. Patient was kept awake. Mother stated patient had history of ADHD and anxiety but no other past medical history. Paramedics arrived at 1145 and assessed patient. Blood glucose and VS were normal. Patient continued to report feeling unwell and wanted to go to the hospital but also wanted to ?stop for food?. Patient?s mother reported that patient was starting to sound like his normal self and that his color was returning. Patient?s mother agreed for the paramedics to transfer patient to ED for further evaluation. Patient left in ambulance at 1157.
Right arm was sore at the injection site; Lethargic; Tired; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th December 2019, less than a day after receiving Shingrix, the patient experienced lethargy, tiredness and muscle pain. On 9th December 2019, the patient experienced injection site pain. On 8th December 2019, the outcome of the lethargy, tiredness and muscle pain were resolved with sequelae. On 11th December 2019, the outcome of the injection site pain was resolved with sequelae.   It was unknown if the reporter considered the lethargy, tiredness, muscle pain and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of the Shingrix vaccine and felt lethargic, tired, and had muscle aches. The patient right arm was sore at the injection site. All symptoms have resolved. Reporter gave permission for his physician to be contacted.
This spontaneous report as received from a Licensed Practical Nurse. On 13-MAY-2013, multiple unspecified patients were vaccinated with GARDASIL (lot # H014645, exp. 27-MAR-2015). The nurse reported the dose of GARDASIL were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Red rash, generalized hives, parent noticed 800 am 8Jan91, TX by MD inject in ofc, & RX Hydroxyzine HCL 10 mg-3cc po prn.
No adverse event; First dose on 12Jan21 and Second dose on 02Feb2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 12Jan21 and Second dose on 02Feb2021) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 039K20A) for COVID-19 prophylaxis.     No known drug allergy.  Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Multiple sclerosis and GERD. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN XR), EMPAGLIFLOZIN and INSULIN GLARGINE (LANTUS) for Diabetes mellitus, ATORVASTATIN for Hyperlipidemia, AMLODIPINE for Hypertension.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 12Jan21 and Second dose on 02Feb2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 12Jan21 and Second dose on 02Feb2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 12Jan21 and Second dose on 02Feb2021).    It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19.  On 01-Nov-2021, the patient received third dose (batch number 939905) on left deltoid. On 27-Apr-2022, the patient received third dose with the (batch number 001M21A) on left deltoid of 0.25cc..  Treatment medications were not reported.   This case was linked to MOD-2023-696703 (Patient Link).
My child has a crusty marking where the injection site was  She had the hep a and varceila (chickenpox) vaccine same day. I noticed it today then researched reactions to bth vaccines and what she has resembled reaction to the varceilpa vaccine
Patient had red rash running down her arm starting after the injection. Arm was sore first day but afterwards. Vaccination was on 7/8/17, returned to store on 7/10/17. Patient was treated with lotion.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: patient recieved vaccination at 5:25 PM . at 5:30 pm she felt weak at the knees, and was feeling faint, and was sweating, therefore EMS was called and they checked her vitals in the ambulance. Patient was awake and aware and felt better by the time the ambulance arrived.
Patient presented with documentation for school advising patient of need for 5th dose of DTAP; DTAP vaccination administered, despite child being 8 years old, should have received Tdap
Patient presented with bruising on arm below where injection was administered. She stated that she experienced pain > normal post inj then the bruising became evident. (Not taking blood thinners or meds that cause bleeding).
extremely cold and she thought it's because of the PEG within it; I'm extremely cold/freeze to death; Shaky; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included high blood pressure and it hadn't been this high in a quiet a few years, colonoscopy. The patient's concomitant medications were not reported. The patient was extremely cold and she thought it's because of the PEG within it. PEG is one of excipients of BNT162B2. Last year, when the patient had her colonoscopy done, they gave her Gavilyte and she frozen to death, walked like a frozen death person (Miralax/Gavilyte) It was for about a week. She stayed so cold. It took all her vitamins, that stuff was wicked. As she ate different foods that had the component in it. She felt better. The last one she ate was potato chips (eat very few). It was the salt, so she could eat more. The salt in the chips straightened her out. Gavilyte took the salt out of her system. The patient had to drink 12 Gatorades. It was making her fall. It's not the chills, she was cold from the inside out. It was worse than being cold from cleaning a walk in freezer. She was a "walking dead person" same cold. It's that bad. She had 3 outfits on, a cold and blankets. Never been that cold in her life and it was from Gavilyte. (After receiving the first dose of the Pfizer vaccine) She felt that away for about a week and now it's gone. It brought it all back, same feeling, freeze to death, shaky. The patient stated she would see her heart doctor. The outcome of events was unknown. On 17Feb2021 she's scheduled for the 2nd dose of BNT162B2.
Extremely low blood pressure lowest was 80/42, near fainting, black and white vision - unsteady lasted about a month - Clinic appt increase fluids and salt already was doing was not helping. Unrelated health issues was put on steroids' and help to raise blood pressure. Since then have not had dangerously low blood pressure. Also, had chest pain/pressure underneath sternum and would radiate towards over left side of chest. Different than anything I have ever felt before. Same time frame as low blood pressure, I own echo machine and took pictures and everything fine.
About nine days after my first vaccination, I experienced limited mobility and some discomfort with movement with my left shoulder. Since then I have let it rest from activities but  I have done range of motion exercises as well as strengthening exercises. I have also taken 400 mg of ibuprofen twice daily for about a week. I stopped the ibuprofen approximately a week later but I?ve continue to do strengthening and stretching exercises of my left shoulder with some improvement. I reported this both to my internal medicine doctor whom I have given you her name of as well as my sports Medicine doctor. They agreed with my regime . I still don?t have full range of motion as well as some pain with certain movements with my left shoulder.
The first two days the site of injection was extremely painful. over the course of the last few months the pain is intermittent and sporadic. it is not entirely debilitating, but does sometime cause issues when lifting and typing. The pain/discomfort is always at the sight of injection. it has been 4 months and the pain discomfort is at least a few days a week. It has migrated from a pain to more of a discomfort.  Personally not enough to stop the vaccine, but it is enough to for me to think long and hard as to a booster. Also all this happened after the 2nd shot. The first there was a little discomfort same place but not much.
patient stated her tongue was tingling similar to "anaphylaxis" she had previously.  Please note description of her anaphylaxis events prior were to a topical application of peppermint oil before a nursing school test and she didnt react until hours later with a racing heart and tingling mouth.  Told ER doctor she had similar reaction to avacados.  Patient stated tongue felt zingy like touching tip to battery so we proceeded from unit to ER where she was give prednisone and bendadryl and symptoms resolved within 20 minutes.  She was monitored for an hour total and released without any more symptoms.
local reaction, irritability, swelling, heat, tenderness & induration @ inject site, vomiting, fever lasted about 24 hrs; rx ice packs & reduce amount 2nd vax;
Information has been received from a registered nurse concerning  multiple unspecified amounts of children with unknown age and gender. On an unknown dates, the children received doses of improperly stored M-M-R II injection (lot # K012472 with expire date 11-JUN-2016) (dose and route unspecified). The products were stored in temperature of refrigerator 48.7F for 18 minutes. There was no previous temperature excursion. No adverse effect was reported at this time. This was one of several reports received from same reporter. Additional information is not expected because the reporter refused additional contact.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 27-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
dizziness; itchiness (left arm); hives on left arm, size of her hand; injection site pain in left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, dizziness, itchy upper limbs and hives. On an unknown date, the outcome of the injection site pain and dizziness were recovered/resolved and the outcome of the itchy upper limbs and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, dizziness, itchy upper limbs and hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: The reporter was patient itself. After her first dose of Shingrix, she experienced dizziness which lasted for a few arms and a pain in her left arm at the site of the injection which lasted about 4 days.  24 hours after the Shingrix injection, she experienced itchiness in her left arm along with hives on her upper left arm which were the size of her hand. The itchiness and hives had not resolve. The reporter did not consent to follow-up.
Stiff neck started next day. Unable to sleep that night. Extreme head pain, took TYLENOL, CELEBREX, VICODIN. 12/29 - Shortness of breath, used inhaler and ALLEGRA - D for relief within few hours. Headache lasted about 14 hours.
brain fog; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog". Additional Information: She has experienced "brain fog" since receiving Pfizer covid-19 vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up in middle of night with chills, slight nausea, light-headedness that lasted an hour until Tylenol, warm milk, and slice of toast kicked in. After waking for the day at 8 am, chills, body aches, and light-headedness required more Tylenol. Body ache persisted for several hours, but chills subsided by afternoon.  Persistent dry cough started by late afternoon, but this is not a usual Shingrix symptom and may be due to something else going on.
Never had a heart issue before but ended up in Hospital on 4/23 for 5 nights on AFIB.
Patient developed redness, swelling, heat and rash at the injection site. this occured approximately 24 hrs after the injection.
Information has been received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On 15-OCT-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L019125, expiration date: 27-MAY-2017, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
sore arm, fever up to 102, chills, body aches and pains, severe nausea, vomited x1, stomach cramps, diarrhea x2 - total severe symptoms lasted about 24 hours, but total symptoms lasted 60 hours
Increased fever to 99.6 degrees F. Achy - muscle. Chills Headache. Missed work.
body and muscle aches; a low fever; that nite the aches got worse; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (that nite the aches got worse), MYALGIA (body and muscle aches) and PYREXIA (a low fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS (tested positive for the SARS but had no symptoms) in November 2020.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced CONDITION AGGRAVATED (that nite the aches got worse). On 14-Jul-2021, the patient experienced MYALGIA (body and muscle aches) and PYREXIA (a low fever). At the time of the report, CONDITION AGGRAVATED (that nite the aches got worse), MYALGIA (body and muscle aches) and PYREXIA (a low fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Left upper leg redness, hardness to palpation, mild to moderate. Brought to ER. Received Benadryl, Motrin and warm compress.
Patient said he did not have a problem until the third day after immunization. He said it was very sore, red, and was swollen at site of injection. He also said that he became very weak and tired and also felt very dizzy. The next day he said he was much better.
Difficulty breathing for 3 days, unable to take a deep breath for 7 days, whole left arm numbness/tingle, left arm pain in hand for 1.5 days, unable to sleep night after injection
Rheumatoid arthritis, like his arthritis more severe; his arm was swollen, his hands were swollen; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 14Mar2021 (lot number not reported), at the age of 57-years-old, at single dose for COVID-19 immunization. Patient medical history included ongoing rheumatoid arthritis. Concomitant medications were not reported. The patient had his first vaccine on 14Mar2021 and he started experiencing (probably 4 or 5 days later) unspecified date in Mar2021, like almost to rheumatoid arthritis, like his arthritis more severe. It was reported that he had before feels like joints were swollen and painful but it wasn't very reoccurring and then it seems like after the vaccine it was very, constantly the joints were inflamed, he couldn't close his hands because you know his arm was swollen, his hands were swollen and you know then he didn't take the second dose because he had to travel as far the country and his second dose was 2 days ago which was 40 days from the first dose. Outcome of the events was unknown.  Information about lot/batch number has been requested.
After 2 hours of administration pt needed to be taken to ER with severe N/vomiting. She was given IV anti-emetic & IV fluids for dehydration.
Pt felt lightheadedness, requested some water, gave him water, and asked him to lay down. After about 5 minutes, he felt better.
Patient was mistakenly given 0.1ml of the Moderna COVID-19 vaccine by a staff member for her 2nd dose.  The mistake was recognized on August 4, 2021 and all patients effected were informed.  Patient has since been revaccinated on 8/5/21.
Fever of 100.3 a couple of hrs after shot that lasted only a few hrs. Then 48 hrs after injection the lump in my arm became red and hot. It started out about the diameter of a golf ball then over a period of a week was about 4 x6 inches on my arm. It was raised, hard, and hot. My bicep muscle twitched during that time several times a day. On about the 8th day after icing it several times the solid lump flattened and appeared to become a ring of red instead of a patch. On day 10 it was mostly invisible and twitches stopped. The area still feels slightly bruised. I haven't noticed other symptoms.
sore arm at the injection site; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site) and INJECTION SITE RASH (rash at the injection site) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE RASH (rash at the injection site). On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm at the injection site). At the time of the report, INJECTION SITE PAIN (sore arm at the injection site) outcome was unknown and INJECTION SITE RASH (rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fainted within five minutes of receiving and sitting after the vaccine. Experienced a complex migraine with aura for the entire day after, no relief until having slept through the night.
LPNN came to get provider immediately after administering this pt's flu vaccine. Per LPN, pt reported immediate pain and numbness in the entire length of the RUE following admin of flu shot. Provider went to the bedside and found pt sitting comfortably, but holding her right arm out in front of her. Pt tells me that she felt immediate, severe pain upon insertion of the vaccine in her arm. She still had this pain, though slightly improved, upon my entrance into the room. Pt says she was still experiencing numbness in the entire RUE, including all fingers, and she had never had anything like this before. She says that she does have some numbness in the right 4th digit at baseline, but this is different. Pt will full ROM of neck and RUE upon my evaluation. Grip strength was intact and arm was TTP. I asked pt to show me the injection site and found the Band-Aid placed in the middle of her right upper arm. I spoke with the LPN who advised she used a 1 inch needle but did not insert this needle all the way given the pt's small stature (87 lbs). Pt did report immediate symptoms. Provider explained to pt, and LPN, that it was a clinical suspicion that pt suffered a radial nerve injury during this vaccine administration. Provider explained to the pt what sx she may expect in the coming days and advised she treat with tylenol and ice/heat. Follow up on the patient 2 days later showed patient was much improved. Still tender and sore, but Tylenol helping.
Bloody nose; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) on an unknown date (at the age of 35-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included methylenetetrahydrofolate reductase gene mutation(MTHFR), cervical intraepithelial  neoplasia (CIN3 in cervix) and obese. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported bloody noses for a week after first and second dose. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event bloody nose was recovered after a week of vaccination on an unknown date.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Behavior has become hostile and agressive.  Stated to me (his mother) that he feels mean in the brain.  HE WAS NOT LIKE THIS PRIOR TO HIS VACCINATIONS!!