chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Non-injected arm developed itchiness; Non-injected arm developed welts; Rash on foot; Elbow of injected arm developed a rash; Injected arm developed sweatiness; Diarrhea; Both hands became numb; Both hands felt dead; Headache; Chills; Nausea; Fatigue; injected arm felt tingly; injected arm felt cold; Injected arm felt itchy; Stomach became itchy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy), ABDOMINAL DISCOMFORT (Stomach became itchy) and DIARRHOEA (Diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy) and ABDOMINAL DISCOMFORT (Stomach became itchy). On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), HYPOAESTHESIA (Both hands became numb), HYPOAESTHESIA (Both hands felt dead), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue). On 19-Mar-2021, the patient experienced HYPERHIDROSIS (Injected arm developed sweatiness) and RASH (Elbow of injected arm developed a rash). On 24-Mar-2021, the patient experienced RASH (Rash on foot). On 28-Mar-2021, the patient experienced PRURITUS (Non-injected arm developed itchiness) and URTICARIA (Non-injected arm developed welts). At the time of the report, PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy), ABDOMINAL DISCOMFORT (Stomach became itchy), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Both hands became numb), HYPOAESTHESIA (Both hands felt dead), HYPERHIDROSIS (Injected arm developed sweatiness), PRURITUS (Non-injected arm developed itchiness), URTICARIA (Non-injected arm developed welts), RASH (Rash on foot), RASH (Elbow of injected arm developed a rash), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Patient has used cold cream and Calmoseptine ointment.
Information has been received from a nurse, via a company representative, concerning a 23 year old ("about 23 years old") female patient, who on 13-JUN-2007 was vaccinated with the first dose of Gardasil with no difficulties reported, and on 14-AUG-2007, was vaccinated with the second dose, 0.5 ml, of Gardasil (lot #658282/0929U).  Concomitant therapy included ADACEL.  On 14-AUG-2007, following the second vaccination, a family member called the office to report the patient felt dizzy and was "acting loopy."  Subsequently, the patient recovered (date and duration not specified).  The patient's 14 year old sister also experienced a similar event as described above, when vaccinated with Gardasil (lot #658282/0929U) (WAES # 0709USA00082).  Additional information has been requested.
Swelling on outside of left arm (side) and back of arm, around the arm where the IM injection occurred. Swelling started on 11/3/16. Reported on 11/4/16, and patient did acknowledge improvement.
arm was quite sore; terrible pain on right side from hips down; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 28Jan2021 12:45 (Batch/Lot Number: el3302) at the age of 71 years old as dose 2, single for COVID-19 immunisation. Medical history included sleep apnoea syndrome, allergy to penicillin and sulfur drug. Patient was not pregnant. Concomitant medication(s) included citalopram, metformin, montelukast and omeprazole, all taken for unspecified indications, start and stop dates were not reported. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (Batch/Lot Number: ek9231), administered in left arm on 07Jan2021 at 13:00. On 29Jan2021 at 03:00, after receiving the 2nd Pfizer dose the patient's arm was quite sore; after waking up early the next day (as reported) she was in terrible pain on right side from hips down. Eventually went to emergency room, she had horrible pain. The doctor gave her several pain killers over several hour, Morphine, valium, and several others to calm the pain down. She was able to go home several hours later. Events resulted in Emergency room/department or urgent care with treatment received (several pain killers). The patient recovered with lasting effects. No COVID prior vaccination and was COVID tested post vaccination. COVID test post vaccination: COVID rapid test (Nasal Swab) was Negative. Outcome of events were recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
- extreme neck pain,. Comparable to pinched nerve  type of pain in neck. Originated on the left side but now primarily on the right side - blurred vision in right eye.
10/20 heat and pain at injection site. 10/23 body aches, headache, cough-no fever.
From initial information received on 9/30/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that an elderly female patient (exact age not reported) received TD ADS ADULT vaccination, lot number U1347AA, administered in the right deltoid on 9/23/04. An unspecified amount of time later, the patient experienced swelling, redness, and induration measuring 14cmx12cm at the site of injection. She also developed pain in the right axilla and neck area. She was seen by a physician and prescribed Decadron and Zyrtec. At the time of this report, the patient had not recovered from these events. The reporter of this case is the same as for case 200403263.
PT STATED SHE FELT SLUGGISH, HAD SORE MUSCLES, JOINT SORENESS,AND BODY ACHES LASTING FOR 24 HRS. SKIN ALL OVER WAS VERY SORE TO THE TOUCH. TOOK TYLENOL FOR THE DISCOMFORTS.
After the girl got the vaccine, we walked with her dad to schedule her 2nd dose. While she was standing here she all of a sudden went rigor and tensed up really bad and got red in the face. Her dad lowered her to the ground and he said her eyes went in the back of her head and she was shaking some. Called 911 and paramedics came. Then 1-2 minutes later to came right out of it and was standing up and talking. Had her sit down with the paramedics and they chose not to bring her to the hospital because EMS  believed it wasn't a seizure but that she was holding her breath or was very nervous and panicked.
All the SEs in the label. What can you say to help me sleep?; All the SEs in the label / A muscle relaxant?; All the SEs in the label / And a pain med?; This case was reported by a consumer via interactive digital media and described the occurrence of sleeplessness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2021, the patient received the 1st dose of Shingrix. On 20th May 2021, less than a day after receiving Shingrix, the patient experienced sleeplessness, muscle tension and pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the sleeplessness, muscle tension and pain were unknown.   It was unknown if the reporter considered the sleeplessness, muscle tension and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. On day of reporting, the patient was vaccinated with Shingrix. The patient had all the side effects (SE) in the label. The patient was asked what could help to sleep.  The patient had a muscle relaxant and a pain medication. The patient was asked for advise.
Developed soreness, weakness starting day after vaccine. Went to ED and received myocarditis diagnosis.
PATIENT CALLED AND STATED HE DEVELOPED 12 CHICKEN POX RANDOMLY OVER BODY A FEW DAYS AFTER RECEIVING THE VACCINATION. HE STATED HE JUST WANTED TO LET US KNOW AND WILL BE CALLING HIS DOCTOR.
Nodule at  bilateral sites, mild pain on palpation Encouraged warm compresses and massage
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical conditions reported.). Concomitant products included Pre-natal vits for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Nov-2020 and the estimated date of delivery was 15-Aug-2021. On 01-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Pregnancy test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
broke out with a large reaction at the injection site; hot; itchy; swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (broke out with a large reaction at the injection site), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE REACTION (broke out with a large reaction at the injection site), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE REACTION (broke out with a large reaction at the injection site), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.; 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.
Breakthrough COVID illness. Positive test result with home test kit. Reported symptoms are similar to a common cold.; Breakthrough COVID illness. Positive test result with home test kit. Reported symptoms are similar to a common cold.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), on 28Mar2021 as dose 2, single (Lot number: EN6205), on 28Dec2021 as dose 3 (booster), single (Lot number: FE35Q4) and on 28Jun2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Sep2022, outcome "recovering" and all described as "Breakthrough COVID illness. Positive test result with home test kit. Reported symptoms are similar to a common cold.". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (04Sep2022) Positive, notes: covid test type post vaccination=Nasal Swab covid test date=04Sep2022 covid test result=Positive; SARS-CoV-2 test: (unspecified date) Positive, notes: home test kit. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: Breakthrough COVID illness. Positive test result with home test kit. Reported symptoms are similar to a common cold. Dose received More than 3.  Follow-up attempts are completed. No further information is expected.
pt recvd vax; next day, had chills,T 103;9cm red swollen area lt deltoid,central 12mm vesicle, slightly indented;prednisone,atb given;referred to MD for I&D & debridement of abcess;
After first day got shill over body, and on six day got hives all over my body and face
This medically confirmed report (initial receipt 02-May-2012) concerns a female patient. On an unspecified date 6 years ago the patient was administered a dose of influenza vaccine (manufacturer was unknown, batch number not specified). Following administration the patients arm swelled up. The patient recovered. No further information was available.
failure to thrive, AKI, NSTEMI transaminitis - concern vaccine related by some specialists Severe acute liver injury: -Etiology likely related congestive hepatopathy and ischemic hepatitis in setting of congestive HF. urine tox screen -ve, acetaminophen level -ve, blood alcohol level -ve. HBSAG/HCV ab -ve. Autoimmune work up, Hep E IgM, EBV/CMV/HSV testing are pending. Doppler US of liver sowed patent hepatic vasculature.  Right upper quadrant ultrasound reviewed with no evidence of chronic liver disease or biliary obstruction -Stopped NAC as acetamniophen is undetectable. Liver enzymes trending down -Monitor LFTs and INR daily Patient expired on day 5 of hospitalization
Local site soreness swelling, itching. Pt. felt it necessary to go to emergency room due to swelling and irritation.
After about 40 hours after the time of injection, I started having a runny nose and watery eyes. 4 hours after those onset symptoms, I became dizzy and started sweating. Headaches/back aches, severe fatigue, congestion, and sore throat presented throughout that evening, and persists with equal intensity 50 hours after symptom onset.
Patient received adult Pfizer vaccine of 0.2ml instead of pediatric Pfizer vaccine. Error was discovered after administering second dose when reviewing LOT numbers of previous dose. Patient and primary care physician were contacted about the error. No adverse effects were reported by patient or caregiver. The vaccination series is complete for this patient.
Migraine; Extreme fatigue; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Nov2021 at 19:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks of vaccination which included tetanus vaccine (MANUFACTURER UNKNOWN) on an unknown date in 2021 for immunization. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 03Nov2021, the patient experienced migraine and extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/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 events migraine and extreme fatigue were unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Mother stated that child developed low grade fever, headache, and 4 itchy lesions (2 on chest and 2 on back) approximately 3 days after vaccine.  Mother treated child with Aveeno and Tylenol.  *Brother was ill with Varicella at this time - he had not been vaccinated.
Information was received on 15-JUL-2016 from an medical assistant regarding a patient (gender and age not reported) who received the first dose in the GARDASIL series as GARDASIL (lot # 1262AA, expiration 20-MAR-2013) on 21-APR-2012, the second dose of GARDASIL (lot #J006236, expiration 01-JUL-2014) on 01-JUL-2014. The third dose was inadvertently given as GARDASIL 9 (lot # L014415, expiration 30-NOV-2015) on 03-NOV-2015, and the patient was inadvertently given a fourth dose of GARDASIL 9 (lot # L024993, expiration 17-OCT-2017) on 12-JUL-2016. No adverse effects were reported. No concurrent conditions or medical history were reported. No concomitant medication was reported. No further information was provided. Additional information has been requested.
Per pt report, had not received any doses of COVID vaccine, 1st dose in Pfizer series administered based on this information as we were at an outreach event and unable to access database.  When looked up in database, pt had received a Moderna vaccine in 12/2021.
Chills, body aches, extreme headache and low grade temperature overnight.  Used ibuprofen and Tylenol to reduce temperature.  Headache, body aches improve a bit but persist after medication.
About a week and a half after booster vaccination, I developed a rash/hives on different parts of my body at different times. They last about 30-40 minutes and then move to a different part of my body. Areas affected include arms, armpit, face, knees, thighs, hands, back, chest, groin. Rash will only be in 1-2 places at once and then move to another area.
Pt received vaccine approved for 4-6 yrs. of age. Pt tolerated the vaccine with no adverse affects post event. Dr spoke with parents, giving then current info, they have appt on 6.5.14.
stiff right shoulder; pain upper back.; severe low back pain; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266) via an unspecified route of administration in left arm on 11Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke on an unknown date in 2010, aneurysm repair on an unknown date in 2020, asthma, bilateral hip replacements, kidney stones, osteopenia, amyloid disease from an unspecified date. The patient did not have allergies to medications, food, or other products.  Medications the patient received within 2 weeks of vaccination included Aspirin (MANUFACTURER UNKNOWN), pulmicort (MANUFACTURER UNKNOWN) 180mcg, atorvastatin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 21Jan2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12Feb2021, the patient experienced stiff right shoulder and upper back pain. Four weeks later the patient experienced severe low back pain on getting up from a seated position. The adverse events resulted in a doctor or other healthcare professional office or clinic visit. The patient received Muscle relaxant and Medrol pack as therapeutic measures for the reported events. The clinical outcome of the event upper and lower back pain, stiff right shoulder was resolving at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Spasms like seizures; Fidgeting non-stop; Barring their teeth like a grimace; Low-grade fever; A spontaneous report was received on 10 Mar 2021 from a consumer concerning a 81-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced spasms like seizures/ seizure, fidgeting non-stop/restlessness, barring their teeth like a grimace/bruxism and low-grade fever/pyrexia.   The patient's medical history included COVID-19 and severe Alzheimer's disease. Concomitant product use was not provided.   On 09 Mar 2021, approximately 1 day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.    On 10 Mar 2021, the patient experienced low-grade fever, spasms like seizures, fidgeting non-stop and barring their teeth like a grimace. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, spasms like seizures, fidgeting non-stop, barring their teeth like a grimace, and low-grade fever, were unknown.; Reporter'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.
redness at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness 3 to 4 cm at site of injection. The reporter did not agree to to follow up from GlaxoSmithKline.
Presented to ED for evaluation of foreign body in the esophagus. Patient noticed it the evening of 4/23.  Not able to eat since event.  Patient feels dehydrated.  Patient said he has had this happen before. Usually only lasts approximately 24 hours and then he gets better. Has been told in the past that he may had "strictures ". Does not generally follow-up with a GI doctor. Patient says he feels lightheaded and dizzy related to not drinking any fluids. He tried jumping up and drown, tried coke, none of these helped. Patient was hydrated with 1 L of fluid, his heart rate improved.  Patient was given glucagon IM, also given nitro to see if this can help with his food bolus.  Unfortunately patient was checked an hour after being given these medications, he had no change in his status. Patient admitted for observation and EGD performed.