chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on jaw line of face; dermatitis; Bumpy, red but not itchy or sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 16:00 (Lot number: FK6127) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 22Oct2021. Past drug history included: Augmentin, reaction(s): "Allergy_Augmentin".  The following information was reported: RASH (non-serious) with onset 15Nov2021 20:00, outcome "unknown", described as "Rash on jaw line of face"; DERMATITIS (non-serious) with onset 15Nov2021 20:00, outcome "unknown", described as "dermatitis"; ERYTHEMA (non-serious) with onset 15Nov2021 20:00, outcome "unknown", described as "Bumpy, red but not itchy or sore". Therapeutic measures were not taken as a result of rash, dermatitis, erythema.  Additional information: Seriousness criteria-Results in death. Seriousness criteria-Life threatening. Seriousness criteria-Caused/prolonged hospitalization. Seriousness criteria-Disabling/Incapacitating. Seriousness criteria-Congenital anomaly/birth defect were not reported. Other vaccine 4 weeks product Flu vaccine. List of any other medications the patient received within 2 weeks of vaccination No. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
1st dose February 2, 2012 Pfizer lot# EL8982, 2nd dose February 20, 2021 Pfizer lot# EN6203 Symptoms: February 21, 2021 - 24 hours of mild diarrhea, chills, muscle aches, no fever All symptoms gone by February 22, 2021
Pain to the arm which traveled to my arm pit the next day with swelling to lymph nodes on axillary region causing pain at rest and increased pain with movement. Pain is reduced today but is still present at rest
Pt recv vax on 1/21/98; on 1/22/98 pt exp pain & swelling of knee, elbow & wrist
Faint; Spinal pain; Arthritis; Freezing rash around mouth; Dizzy; Feeling of shock happening; Sweating; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), SPINAL PAIN (Spinal pain), ARTHRITIS (Arthritis), COLD URTICARIA (Freezing rash around mouth), DIZZINESS (Dizzy), FEELING ABNORMAL (Feeling of shock happening), HYPERHIDROSIS (Sweating) and PAIN IN EXTREMITY (Sore arm). In June 2021, SYNCOPE (Faint), SPINAL PAIN (Spinal pain), ARTHRITIS (Arthritis), COLD URTICARIA (Freezing rash around mouth), DIZZINESS (Dizzy), FEELING ABNORMAL (Feeling of shock happening), HYPERHIDROSIS (Sweating) and PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Body temperature: 96 (Low) low. On 27-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The concomitant medications were not reported. The treatment information was not provided.  Company Comment :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.   This case was linked to MOD-2021-294546 (Patient Link).; 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.
Fever; chills; body aches; fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), intramuscular on the right arm, on 28Jan2021 07:30, at SINGLE DOSE for covid-19 immunisation, at the workplace clinic. Medical history included asthma, allergies and COVID-19 (prior to vaccination). The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 28Jan2021 at 20:00, the patient experienced fever, chills, body aches and fatigue. The patient was not tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
chills within 30 minutes, then headache, fever (102), arms and legs muscle spasms, overall pain, nausea
INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE EXPIRED DUE TO TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the patient experienced administration of vaccine expired due to temperature excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine expired due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916910, 20210915646, 20210915719, 20210916697, 20210916959, 20210917160, 20210916965, 20210916808, 20210915661, 20210915623, 20210915748, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210915852, 20210916658, 20210917500, 20210916584, 20210915731, 20210916228, 20210916312, 20210916300, 20210916455, 20210916520, 20210916129, 20210916415, 20210916498, 20210916465, 20210913164, 20210916849, 20210916965, 20210917074, 20210916401 and 20210917603.
Sore left arm at injection site 1st two days; Swollen lymph node(s) under left armpit 2nd & 3rd days, golf-ballsized; very painful; Soaking night sweats Monday night and Tuesday nights.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 02:45 (Lot number: FG3527) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "IBS" (unspecified if ongoing); "PMR in remission" (unspecified if ongoing); "Latex" (unspecified if ongoing); "eggs" (unspecified if ongoing); "yeast" (unspecified if ongoing), notes: Known allergies: Yeast; "Sensitive to: Gluten" (unspecified if ongoing); "molds" (unspecified if ongoing); "preservative" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE ACETATE taken for polymyalgia rheumatica; SYNTHROID; NALTREXONE; BUPROPION. Past drug history included: Guaifenesin, reaction(s): "Known allergies: guaifenesin"; Erythromycin, reaction(s): "Known allergies: erythromycin"; Lactose, reaction(s): "known allergies: lactose". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, No effects at all 1st and 2nd injection), administration date: 07May2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "No reaction"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, No effects at all 1st and 2nd injection), administration date: 16Apr2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "No reaction".The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Nov2021 16:00, outcome "recovering", described as "Sore left arm at injection site 1st two days"; LYMPHADENOPATHY (non-serious) with onset 15Nov2021 16:00, outcome "recovering", described as "Swollen lymph node(s) under left armpit 2nd & 3rd days, golf-ballsized"; PAIN (non-serious) with onset 15Nov2021 16:00, outcome "recovering", described as "very painful"; NIGHT SWEATS (non-serious) with onset 15Nov2021 16:00, outcome "recovering", described as "Soaking night sweats Monday night and Tuesday nights.". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy, pain, night sweats.Follow-up attempts are completed. No further information is expected.
Mild swelling and erythema left deltoid area 24 hours after vaccine given. Benadryl recommended.
Got very dizzy, confused, could not speak. 911 was called and was transported to hospitol for stroke sysmptons
inadvertently administered expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4F99G, expiry date 19th August 2022) for prophylaxis.   On 30th August 2022, the patient received Boostrix. On 30th August 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 14-Sept-2022 Reporter's comment: The office manager called to inquired that the patient should get revaccinated. Did not consent to follow-up. Additional supportive information: The patient inadvertently administered an expired dose of Boostrix, which led to expired vaccine used.
Apprx. 15 minutes after immunizations, small whelps appeared on LA at injection site. Further exam showed small whelps on right arm and right wrist. Mother declines tx at this site and took child to ER for eval. No SOB, US Stable, NAD noted. Follow up phone call to parents shows phone number disconnected.
THE VACCINE WAS DILUTED WITH SALINE FROM A SINGLE-DOSE VIAL THAT HAD BEEN PREVIOUSLY PUNCTURED. TYPICAL PROTOCOL IS TO USE ONE SINGLE DOSE VIAL WITH EACH VACCINE. CORRECT AMOUNT WAS GIVEN AND ASEPTIC TECHNIQUE WAS USED AS WELL AS A NEW NEEDLE WAS USED TO PUNCTURE THE VIAL.
Fatigue, Fever/chills, cough, sore throat, slight headache muscle aches, stuffy nose. Throughout the PM of 09/25/2012.
Injection given on 7-5-07, pt left office after 15 min of inj. okay. Called back states she had immediate response felt very tired feverish and dizzy.
Flu and pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC. No adverse effects.
Patient was accidentally given another dose of Pfizer Bivalent booster. She had previously already received in November 2022. The covid card was misread due to not having indicated it was a Bivalent booster.
Patient had dizziness and was lightheaded when standing, which increased with walking. She became weak, momentarily lost vision and collapsed. Symptoms appeared to be that of fainting. After sitting/laying back for 5+ minutes, symptoms faded. Haylie was given water to drink and then had a small cookie. She felt shaky afterwards, but otherwise normal.
p/vax pt fell to the floor from a standing position; p/being pick up pt stiffened; eyes were rolled to the lt side of her head; EMS called; BP 70/pal 96.8ax
Headache, nausea, fatigue, felt temperature fluctuations in body, but did not have a fever, more heart palpitations than normal
pain around lung on the left side; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (pain around lung on the left side) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (pain around lung on the left side). At the time of the report, PULMONARY PAIN (pain around lung on the left side) outcome was unknown. Not Provided          No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. The patient experienced pain around their lung on the left side after receiving the second dose of the Moderna COVID-19 vaccine. The patient especially noticed the lung pain when they try to lie or sit down with their back pressed against anything.   Very limited information regarding this events has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
autoimmune disease; low platelet count on the month on June; This serious case was reported by a pharmacist via call center representative and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-MAY-2023, the patient received the 1st dose of Shingrix. In JUN-2023, less than 2 months after receiving Shingrix, the patient experienced platelets decreased (Verbatim: low platelet count on the month on June). On an unknown date, the patient experienced autoimmune disorder (Verbatim: autoimmune disease) (serious criteria GSK medically significant). The outcome of the autoimmune disorder and platelets decreased were unknown.   It was unknown if the reporter considered the autoimmune disorder and platelets decreased to be related to Shingrix.     It was unknown if the company considered the autoimmune disorder and platelets decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-AUG-2023 A pharmacist called to inform that a patient that received the 1st dose of Shingrix back and presented a low platelet count on the month of June. At the moment the pharmacist called they said the patient had stabilized.  However, also the pharmacist said that the patient had a possible diagnosis of an autoimmune disease.  The pharmacist was not able to say if the autoimmune disease was diagnosed before or after receiving the 1st dose of Shingrix.  Upon escalation to 2nd line, health care professional (HCP) stated they are unsure if patient had a prior history of low platelets prior to receiving first dose of Shingrix or if low platelets occurred following administration of the first dose of Shingrix. The HCP will follow up with more details if this occurred following vaccination with Shingrix. The case US2023104716 was found as duplicate of this case. All the information from the case US2023104716 was merged into this case. The case US2023104716 was deleted and this case stand as case of record for this patient.
My left shoulder was moderately sore for about 3 days after the injection.  The soreness didn't interfere with activities but did interfere with  my sleep.  Other than that I had no immediate reaction.  However, early on day 7 (01/11), I developed itching at the injection site and as the day progressed I developed redness, irritation, hotness, and continued itching.  It began as a small area about the circumference of a golf ball and spread, over the course of the day, to about the size of a grapefruit.  The symptoms lasted about 2 days (01/11-12).  By the evening of day 9 (01/13), hives began to appear, mostly on my arms and legs, with minimal bumps also on my torso and neck.  I'm submitting this report on the evening of day 10 and the hives are still present.  The hives itch and are easily irritated.
Information has been received from a physician concerning a 2 year old male who was vaccinated at 1 year of age, with a dose of varicella virus vaccine live. The physician reported that the patient subsequently developed a chickenpox like rash with less than 50 lesions. Unspecified medical attention was sough, but no treatment was required. At the time of this report, the outcome was unknown. Additional information has been requested.
Lost diluent, need to take 2nd dose; Lost diluent, need to take 2nd dose; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Lost diluent, need to take 2nd dose) and inappropriate dose of vaccine administered (Verbatim: Lost diluent, need to take 2nd dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAR-2023  This report was submitted via the online direct entry reporting system The patient lost diluent so need to take his second dose.  The patient received Shingrix vaccine and lost diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Hives, all over body, unbearably itchy rash from soles of feet right up to head. Dr has prescribed anti histamines
Rash on legs 10/31 generalized by time of office visit 11/01 "petechea showering".  Follow up visit 11/05/07 - resolved.
Less than 10 minutes after we left the facility my son said that his ears were itchy, about 10 minutes later he developed very red blotchy skin with small white hives, after calling his doctor I gave him 2 Benadryl and took him to the ER because he complained of chest pain.  By time we reached the hospital (about 7-8 minutes later) his body was bright red with fist size welts all over and his hands were blue, eyes glossy and he was starting to fade out.  This all happened by 5:00PM.  At the hospital they pushed epinepherin, steroids, and other medications including saline.  They also placed him on oxygen immed. It took about 20 minutes and we started to see the hives slow down and his redness go down a little.
Car accident; miss second dose; chills; "little" fever; "little" headache; This spontaneous case was reported by a consumer and describes the occurrence of ROAD TRAFFIC ACCIDENT (Car accident) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included METFORMIN, INSULIN and ENALAPRIL for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced CHILLS (chills), PYREXIA ("little" fever) and HEADACHE ("little" headache). On 15-May-2021, the patient experienced ROAD TRAFFIC ACCIDENT (Car accident) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (miss second dose). At the time of the report, ROAD TRAFFIC ACCIDENT (Car accident), CHILLS (chills), PYREXIA ("little" fever), HEADACHE ("little" headache) and PRODUCT DOSE OMISSION ISSUE (miss second dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient miss the second shot because on 15 May 2021 his had a car accident and his was hospitalized. His was crashed by another car.  Concomitant medication included blood pressure pill.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events (Chills, Pyrexia, Headache), a causal relationship cannot be excluded.; 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 (Chills, Pyrexia, Headache), a causal relationship cannot be excluded.
MODERNA COVID-19 EUA: fully vaccinated patient presented 072321 with complaints of cough, N/V/D, sinus pressure, HA, fever, sore throat, sneezing, watery eyes and loss of taste and smell.
Approximately 2-3 days after vaccination infant started crying constantly, not easily consolable.  Lasted approximately 1 week; had low grade fever 99.4.  Tylenol given.
Numbness in fingers and part of left hand, toes on left foot and right side of chin and jaw.
Patient developed a very large bruise at site of administration. She reports she bruises easily; however, the bruise was larger than the size of a quarter in diameter. Tender at site of administration.
Varicella  0.5cc SQ given at 2pm 10/17/2005, local redness to site at 2:03pm 2 x 4 inches wide on left lateral thigh, no swelling. Also local redness 1 2 inches right leg lateral thigh with MMR 0.5cc. Dr checked child ice pack placed for 5 minutes on site and off and on. Redness decreased to 1 inches right thigh where MMR given and 2 x 3 inches left leg where varicella given.
Sudden onset extreme vertigo, nausea, vomiting, balance difficulties, nystagmus.  Taken to hospital for Sroke Protocol.  Stroke ruled out by CT and MRI.  3 days in hospital diagnosed with vestibular neuritis
THE MOTHER BROUGHT TWO BROTHERS FOR SHOTS. BOTH 4 YEARS AND ABOUT THE SAME HEIGHT. I ASKED 3 TIMES WHICH WAS WHICH AND ACCORDING WHO SHE TOLD ME IT WAS I GAVE THE IMMUNIZATIONS. AFTER THE IMMUNIZATIONS WERE GIVEN SHE TOLD ME I GAVE THE ONE WHO WAS SUPPOSE TO GET 6 IMMUNIZATIONS 4 IMMUNIZATIONS AND THE OTHER WHO WAS TO GET 4 IMMUNIZATIONS 6 IMMUNIZATIONS. I TOLD HER SHE TOLD ME THE NAMES AND NOW SHE CHANGED THEM. SO I GAVE THE CHILD WHO ONLY RECEIVED THE FOUR IMMUNIZATIONS THE OTHER TWO IMMUNIZATIONS WHICH WERE THE PNEUMOCOCCAL CONJUGATE AND THE Hib. THE OTHER CHILD AS A RESULT RECEIVED 5 DOES OF THE PNUMOCCAL CONJUGATE AND 5 DOSES OF HIB. THE MOTHER NEVER SAID ANYTHING UNTIL THE IMMUNIZATIONS WERE GIVEN.