chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. The physician reported that she reviewed an unspecified article that described the patients, who, on unknown dates, were vaccinated with doses of GARDASIL (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided). On unknown dates, an unspecified amount of time after the doses were administered, the patients were diagnosed with Guillain-Barre Syndrome and there were 44 deaths associated with GARDASIL. The outcome of Guillain-Barre syndrome was reported as unknown. The reporter considered death to be related to GARDASIL. The relatedness between Guillain-Barre syndrome and GARDASIL was not reported. Upon internal review, the events of Guillain-Barre syndrome and death were considered to be medically significant. Additional information has been requested.
1/13/21  Evening of vaccination pt experienced body aches. States she feels like she had the flu.  Reports feeling better Friday, Sat and Sunday.  Cough productive of green phlegm. Weakness and dizziness that kept her from getting off toilet.  Fell or passed out upon return to bed.
C/O more intense burning at injection site at time of vaccine administration.  No bleeding observed, inj site re wiped with alcohol swab and Bandaide applied.  HA began 4 hrs after inj. R-sided migraine type with a little blurred vision and color aura (which is normal for this person when a migraine occurs).  Took 600 mg Ifuprofen at 4 pm.which is what she normally takes for HA.  Had slight injection site irritation and swelling that evening.  Removed bandaid and applied ice at 6 pm.  No further c/o or action taken that evening.  Tues 10/21/08 upon arising noted itching, redness, heat, swelling at the inj site.  HA continued.  Took Ifuprofen 600 mg at 6 am and 12 noon without relief for HA.  Purchased generic extra stringth "Excedrin Migraine" took two tablets at 5:30 pm.  Arm continued with burning, itching, redness and localized pain.  HA continued but was resolved by AM 10/22/08.  Arm symptoms continued 10/22 but no action taken.  10/23/08 contacted individual who administered immunization to report current symptoms of reddness, and itching. Seen by RN.  Noted 2.5" x 4.5" area of induration, warmth and firmness.  Skin color not changed.  Rec ice or heat for comfort, OTC cream/lotion for itching if needed.  See PMD if symptons worsen.  CDC/VEARS report completed.
Information has been received from a physician concerning a 24 month old female patient who on 23-JUL-2010 was vaccinated subcutaneously with the "first shot" of VARIVAX (Merck) (lot # 666821/0223Z). Concomitant therapy included MMR II (MSD), ROCEPHIN and an unspecified steroid "shot". The physician reported that the patient was using VARIVAX (Merck) and experienced a large red knot at injection site. On an unspecified date, the patient recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source with the same vaccine lot number. The physician expressed concern for this lot. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of (VARIVAX (Merck)). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the physician who reported that the 24 month old patient with sinusitis and wheezing at the time of vaccination and an allergy to AMRIX on 23-JUL-2010 at 11:30 am was vaccinated subcutaneously into the right thigh with the first dose of VARIVAX (Merck) (lot # 666821/0223Z). On the same day, the patient was vaccinated subcutaneously into the left thigh with the first dose of MMR II (Lot # 666293/1740Y). The physician reported that on 24-JUL-2010 the patient developed a local reaction, red, swollen and hot thigh. On an unspecified date, the patient had recovered. No further information is expected.
Roughly 1 hour after receiving vaccine pt had 99.2 F low grade increased temp (hers is normally 97 F). Following day pt complains of difficulty even lifting limbs (because of fatigue, but not inability to do so), difficulty keeping steady while standing, dizziness, and central moderate chest pain. Pt not on any immune system lowering conditions or meds. Pt not have sx of hemiplegic migraine such as numbness or paralysis (so migraine unlikely concern). Pt possibly experiencing acute cerebellar ataxia similar to what might occur with the virus itself. Evidence seems to show that this should resolve with time and no specific treatment is needed.
Moderna COVID-19 Vaccine EUA- Hard lump the size of a marble on the right collarbone, swelling of the face and neck above area.
COVID; COVID; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "acid reflux" (unspecified if ongoing), notes: Stopped taking my acid reflux and my Omeprazole which is for my acid reflux, my acid reflux is almost resolved; "Eyesight" (unspecified if ongoing), notes: taking is Areds 2 multivitamins, which is for my eyesight. Concomitant medication(s) included: ATORVASTATIN; OMEPRAZOLE taken for gastrooesophageal reflux disease; AREDS 2 PLUS MULTI VITAMIN taken for eye disorder. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "unknown" and all described as "COVID". The event "covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was taking Triology spray as concomitant medication where his dentist has recommended stating that it kills 99.9% of COVID-19 virus. It was sprayed in mouth or on hands and has been using it for all most for a year now. No investigations were done. The patient experienced COVID-19 on 14Mar2023 (Tuesday) evening, it just had some symptoms showed up and on 15Mar2023 (Wednesday), the patient contacted his doctor's office and one of his associates gave a prescription for Paxlovid and started to take it from 15Mar2023 (Wednesday) around 13:00 (1 o'clock) and took more on 15Mar2023 (Wednesday) evening just before the patient went to bed around 22:00 (10 o'clock).     The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
child became pale after IM injection, clammy skin, vomited x 1. Pt assisted to floor. Legs elevated, cool compress to forehead. Observed 20 mins. Child placed in chair. Drinking feeling better - gait steady.
Patient developed rash on back of neck and dizziness following covid vaccine. It spread to upper extremities. Was given doxycycline and rash resolved.
Neck pain; Intermittent dull, throbbing headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Jul2021 13:00 (Lot number: EW0189) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex; "Chronic fatigue" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: NECK PAIN (non-serious) with onset 20Jul2021 14:30, outcome "not recovered", described as "Neck pain"; HEADACHE (non-serious) with onset 20Jul2021 14:30, outcome "not recovered", described as "Intermittent dull, throbbing headache". The events "neck pain" and "intermittent dull, throbbing headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of neck pain, headache.  Additional information: Concomitant medications included ritual prenatal vitamin (MANUFACTURER UNKNOWN) and immunity medicine (MANUFACTURER UNKNOWN) both for unknown indications from unknown dates and unknown if ongoing.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with ibuprofen (MOTRIN) or paracetamol (TYLENOL) and there was no relief with these medications.   No follow-up attempts are possible. No further information is expected.
Post vaccine, patient reported feeling "strange", HR 170, BP elevated. Reported feeling "anxious". Patient stated she had not taken her blood pressure medicine today. Oxygen applied at 2 lpm for report of chest "pressure". Patient refused EMS transport to hospital for evaluation. Benadryl 50 mg given PO. Prior to discharge, HR in low 100's, BP remained elevated.
Sore muscles; Slight headaches; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 13Jan2021 (13:30) at a single dose on the left arm, with route of administration unspecified for COVID-19 immunization at the workplace clinic. Medical history included high blood pressure (HBP); and high cholesterol. Concomitant medications included atorvastatin, citalopram, metoprolol and fenofibrate. The patient previously took dextromethorphan, and had drug allergy. On 13Jan2021 (15:00), the patient had sore muscles and slight headaches. The patient had not received any treatment for the reported events. The outcome of the events, sore muscles and slight headaches, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
headache; tired; general feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 13Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots", start date: 06Jan2021 (unspecified if ongoing), notes: Before any of the Pfizer shots.; "breathing issue on", start date: 06Jan2021 (unspecified if ongoing), notes: 4 days in hospital breathing issue on oxygen supply for 3month; "osteoporosis" (ongoing); "thyroid (low)" (ongoing); "cholesterol (high)" (ongoing); "Protect stomachache from prednisone" (ongoing), notes: Reason for use: Protect stomachache from prednisone. Concomitant medication(s) included: ALENDRONATE SODIUM taken for osteoporosis (ongoing); PREDNISONE taken for polymyalgia rheumatica (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); PRAVASTATIN taken for blood cholesterol increased (ongoing); OMEPRAZOLE taken for abdominal pain upper (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired", "headache", "feeling unwell"; bnt162b2 (DOSE 2, SINGLE Lot: EW0172 on left Arm, Intramuscular), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired", "headache", "feeling unwell"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE Lot: FE3590 on left arm, intramuscular), administration date: 12Nov2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired", "headache", "feeling unwell". The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell". Relevant laboratory tests and procedures are available in the appropriate section.
devel papuler-clean vesicler & erythema @ site of inject; pt scratched area; @ 1 month check for anemia-area of involvement still present;-no evidence of infect;
Tinnitus developed that night after the vaccine. Right ear greater than the left. Have had mild tinnitus for 10 plus years easily managed with white noise. This new onset is several times louder. No treatment yet.
Extreme pain in left arm by 10:00 same say as immunization. Woke up next day with high fever and rash all over body head to knees. Left arm extremely red and swollen- patient states that she had trouble moving her arm up.
08/30/2021 pt arrived via EMS from home with increased weakness x2-3 days. normally ambulates with walker, unable to ambulate for 2-3 days, sitting in recliner, wife was unable to get him out of chair. recent dementia diagnosis. The patient is an 84-year-old male with a history of diabetes and hypertension that presented to the emergency department due to generalized weakness.  Patient states he has been feeling weak and ill x4 days.  This morning he was sitting in his recliner and was unable to get up so he called EMS.  Patient noted to be positive for COVID-19 in the ED.  noted to have a fever of 102.  He received his vaccinations  in January of 2021, Pfizer.
cellulitis and abscess at injection site of DTaP requiring surgical I&D and outpatient antibiotics
extremely flirtatious during her periods towards woman; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 29-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), 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: ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "extremely flirtatious during her periods towards woman".  Additional information: I have a friend who was 29 years old. She was vaccinated with Pfizer and Moderna was (race) woman. She has an autistic brother and her son was; her grandma had her menopause at 32 years old. She also becomes extremely flirtatious during her periods towards woman.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The limited information was provided. The caller reported that he was at a myeloma support group meeting and another patient's husband (patient) reported that he had the SHINGRIX and experienced a sore arm.
Flu vaccine given in right am and 5 days later woke up with pain in left bicep, muscle soreness, dificulty using both hands, numbness and tingling.
Pt. stopped by the pharmacy today, 12/16/20, to report that her arm was so sore after her pneumovax shot that she thought she might have broken her arm.  She reports she's never had her arm hurt so bad after receiving a vaccine. She didn't report any swelling, just extreme pain for almost 2 weeks.  She took ibuprofen and acetaminophen for the pain.  I asked her if she had iced her arm and she stated sshe didn't think to try that.   Today, her arm is feeling much better but she can still feel a little discomfort when using her arm.
rash both arms, face devel 2 days following MMR immun; also devel a boil on each upper arm; w/in 4 days all sx were gone;
Fever NAUSEA AND BODY ACHES Narrative:  Other Relevant History:
Significant increase in cervical mucous and period like cramps for days (not during my period)
Received flu vaccine 12/8/04: noticed swelling under left arm pit on 12/11/04. Denies fever, no redness or induration. Was evaluated by PMD 12/14/04and instructed to apply ice packs and continue ibuprofen. Patient called health department 12/10/04 to report: swelling now subsided. Never had pervious reaction to flu shots before.
fatigue; headache; both sides of hips started hurting; arm started huting with internal pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started huting with internal pain), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (both sides of hips started hurting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M204) for COVID-19 vaccination.     Concomitant products included OLMESARTAN, ROSUVASTATIN, ESTRADIOL, CENTRUM SILVER [ASCORBIC ACID;BIOTIN;BORON;CALCIUM;CALCIUM PANTOTHENATE;CHLORINE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCH, CALCIUM and VITAMIN D3 for an unknown indication.    On 17-Feb-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021 at 11:00 AM, the patient experienced PAIN IN EXTREMITY (arm started huting with internal pain) and ARTHRALGIA (both sides of hips started hurting). On 25-Feb-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (arm started huting with internal pain) had not resolved, FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown and ARTHRALGIA (both sides of hips started hurting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication use was not provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up information received on 02-JULY-2021 contains No New information.
received injection at 1015am; approx 1 1/2 hrs after receiving experienced extreme tiredness, dizziness, nausea, headache and muscle aches. towards the evening, started having joint pains and stomach pains. at approx midnight i had a migraine and at 3 am work up with joint and muscle pain and stomach pain along with nausea. on day 2 i had all the above symptoms. on day 3 i had some muscle ache.  i mainly took acetaminophen extend release tablets
Pt received her second moderna inj and, after completing the inj, she stood up and walked over to sit in a chair outside of the inj booth to wait for 15 minutes. She sat down, but after about 5 minutes, a customer yelled at us that someone had fainted. Upon walking out to the pt, she was laying face down on the floor, passed out. She had fainted. We helped her to sit upright, on the floor. She had fallen on floor and landed on her face. Her forehead was read, but her nose seemed ok. She was a little shaky. We gave her a bottle of water to drink and helped her into a wheel chair. Her husband came to pick her up. The tech explained to the husband that she hit her forehead on the floor and needed a ct scan to make sure she did not have a concussion. The husband only replied "ok", asked his wife if she was ready to go and wheeled her out in the wheelchair to his car.
Has a "deviated septum"; This is a spontaneous report from a contactable consumer (reporter's son).   A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient historical vaccine included first dose of BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. He got the first dose of Trumenba last 25Jul2019. Her son never went to get the second dose. Her son had both doses of his Pfizer-BioNTech COVID-19 Vaccine. He was a college student. He was advised not to get the second dose of Trumenba. On an unspecified date, patient has a "deviated septum". The outcome of the event was unknown.  Information about lot/batch number has been requested.
new daily persistent headache started 3 days after vaccine & has not subsided after 7+ months
two days after getting my second Covid shot I noticed a persistent sound in my ears.  It sounds sort of like crickets on a summer night blended with a humming sound.  It doesn't lessen or go away during the day and I am still experiencing it 6 days after my shot.
Fever, redness, & swelling at site extending down arm to elbow, pain, joint pain, chills, diarrhea.
Red arm red, swollen and warm to touch after DTaP booster. Dx with local reaction - treated with warm soaks.
Narrative:  76yo male patient died on 12/18/2021 from Cardiac pulmonary arrest at outside hospital Pt had received one J&J covid vaccine on 8/3/2021. This death is not related to the covid vaccine.
Flush all over body after about 20 minutes. Head started feeling peculiar. Heart started palpitating and beating in an odd rhythm. I had to pull over on the way home from the vaccination clinic. Within a few hours (3-4 hours), my arm was hurting from the shoulder all the way down to my fingers, aching and stiff. By the next morning, I could not lift my arm higher than parallel to the ground and it caused excruciating pain to attempt to lift it above that / sleep on that side. I could not lift anything of any weight - a couple of pounds at most. Frequently, shooting pains would run the length of my arm from shoulder down to arm, causing crippling pain. These symptoms lasted for 13 months, when they lessened considerably but have never fully gone away. I can still pinpoint the exact spot of the injection site. I would consider there to be permanent damage as I am still bothered by these symptoms.
This is a spontaneous report from a contactable physician received from Merck Research Laboratories (Case Number: 00834228). A pediatric patient of unspecified age and gender received PREVNAR 13, (batch/lot and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pediatric patient experienced fever and chills on an unspecified date. The outcome of the events was unknown. The information on the batch/lot number and expiration date has been requested.
Three days after injection, patient developed red, warm, raised area 14 cm x 14 cm on/below L deltoid - reports stinging; used ice at home.