chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warm, red welt at the injection site; Red welt at the injection site of the size of golf ball with indefinite margin; warm, red welt at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (warm, red welt at the injection site), VACCINATION SITE URTICARIA (Red welt at the injection site of the size of golf ball with indefinite margin) and VACCINATION SITE ERYTHEMA (warm, red welt at the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm, red welt at the injection site), VACCINATION SITE URTICARIA (Red welt at the injection site of the size of golf ball with indefinite margin) and VACCINATION SITE ERYTHEMA (warm, red welt at the injection site). At the time of the report, VACCINATION SITE WARMTH (warm, red welt at the injection site) had not resolved and VACCINATION SITE URTICARIA (Red welt at the injection site of the size of golf ball with indefinite margin) and VACCINATION SITE ERYTHEMA (warm, red welt at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment included Benadryl oral and Benadryl topical cream.
This spontaneous report was received from a physician and refers to a 4 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On 17-MAY-2017, the patient was inadvertently vaccinated with a dose of ZOSTAVAX lot # M039452 with expiration date 19-DEC-2017 (dose and route of administration were not reported) instead of VARIVAX because ZOSTAVAX was mistakenly ordered instead of VARIVAX. No treatment was given. The patient did not seek medical attention. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA001908:
Injection site very fiery / Injection site very sore; Headaches; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site burning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 2nd October 2019, less than 2 years after receiving Shingrix, the patient experienced injection site burning and headache. On an unknown date, the outcome of the injection site burning and headache were unknown.   It was unknown if the reporter considered the injection site burning and headache to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. At 12:45 hrs, the patient experienced injection site very fiery and sore, headaches.
Headache, low grade fever, chills, fatigue, muscle aches, diaphoresis
vaccine prior to administer it to a patient a portion of the dose leaked on her eye; vaccine prior to administer it to a patient a portion of the dose leaked on her eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of exposure via eye contact in a female 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 exposure via eye contact (Verbatim: vaccine prior to administer it to a patient a portion of the dose leaked on her eye) and occupational exposure while administering product (Verbatim: vaccine prior to administer it to a patient a portion of the dose leaked on her eye). The outcome of the exposure via eye contact and occupational exposure while administering product were unknown.   Additional Information: GSK Receipt Date: 24-MAY-2023 The pharmacist reported that while she was holding a Shingrix vaccine prior to administer it to a patient a portion of the dose leaked on her eye.  The healthcare professional asked for safety information and she asked how to proceed.  The healthcare professional did not provide data about Shingrix dose. The reporter consented to follow up. A portion of the Shingrix dose leaked on the pharmacist eye, which led to exposure via eye contact and occupational exposure while administering product.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 17 years old adolescent and unknown gender. On 30-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
severe lower back pain; pain from his hip down to his right leg; it is getting worse; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient woke up with severe lower back pain, and pain from his hip down to his right leg. He said that it is getting worse and wants to know if this is a common side effect that is associated with the vaccine. He said he called to ask for guidance on what to do. The Outcome of the events was unknown.  No follow-up attempts are possible. Information on batch/lot number could not be obtained. No further information is expected.
Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient had no pertinent medical history or drug reactions/allergies. On 01-JUL-2015 the patient was vaccinated with a 0.5 ml PNEUMOVAX 23 (lot # K009874, expiration date: 19-MAR-2016, subcutaneous). On the next day, 02-JUL-2015 the patient experienced an injection site reaction. The injection site reaction was described as "a swollen arm, redness, pain, and warm to the touch". The patient sought medical attention by office visiting and was prescribed an unspecified dose of Ibuprofen by an unspecified physician. There were no lab diagnostics studies performed. The patient recovered from the event in July 2015 (reported as "in a few days"). Causality between the event and PNEUMOVAX 23was not provided. Additional information has been requested.
Within 8 hours of injection, developed loud tinnitus.  Woke up the next morning with almost total hearing loss in left ear and  vertigo to the point where I was in bed except to go to the bathroom.  Called Tele Doc but was unable to assists.  Was able to g appointment with ENT for March 23.  Diagnosed with profound Asymmetrical Sensorineural Hearing Loss in left ear,  tinnitus and vertigo.  Elected treatment to include intratympanic steroid (24mg) injections and oral prednisone.  Receiving PT for vertigo.  Tinnitus is unchanged as of the date of this report.  Hearing test on 3/31 noted a slight change in ability to comprehend speech (2 words vs 0 words).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 14-OCT-2014 the patient was vaccinated with a dose of RECOMBIVAX HB (lot number, expiration date, dose, route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Three days after receiving the shot my heart rate became irregular. Heart palpitations increased even more so when I drink coffee. Laying in bed at night my heart stays racing. I had extreme weakness for 3 days in my left arm immediately after the shot. The weakness went away on about day 4 but the palpitations continue to current day. I have no health insurance and can't afford Healthcare. I have had extreme lethargy since getting the shot and my joints ache almost constantly now.
on the third day began to feel headache, body aches,  and extreme fatigue.  On day 9 I saw that my face was drooping and mouth was crooked, my L eye did not close, L ear pain, L buzzing in ear.  I was taken to emergency room and admitted to the hospital on 4/5/21.  Was diagnosed with Bell's Palsy.  Was discharged back home on 4/8/21
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information has been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographics details for each patient were provided. This report referred to a 17-year-old female patient, who was allergic to amoxapine and amoxicillin and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 29-JAN-2014 at 9:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient did not repeat vaccination dose at visit on 18-JUN-2014. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case was received.
3 days after my second vaccine I woke up with severe brain fog/dizziness that lasted all day. I have continued to have this intense brain fog intermittently for the last 19 months. It is usually accompanied by palpitations, shortness of breath, blurred vision, dry eyes, headaches frequently. I also have trouble with information retention and memory loss. I have tried multiple treatments but continue to worsen.
Increased heart rate; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced increased heart rate after COVID vaccine on 21Jun2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever, didn't eat, pain in legs, completely lethargic, unresponsive to me or my presence, would lay awake all through night staring, not really responding to me.  This went on for 3-4 days.  The staring and lethargy is what scared me the most!
Anaphylactic reaction, elevated blood pressure........Benedryl......taken to emergency room at Hospital......ekg, blood pressure taken, and fluids.....left hospital and went home, my choice
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 19-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Drug ineffective; Patient developed meningitis after having been vaccinated with Trumenba; Couple of strokes; This is a spontaneous report from a contactable consumer via a Pfizer sales representative.  A 19-year-old male patient received the 2nd dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on 07Oct2017, at single dose, for immunization and the 1st dose via an unspecified route of administration, on 10Mar2017, at single dose, for immunization. Medical history included meningitis (before any vaccination with Trumenba). Concomitant medications were none. The patient experienced meningitis in May2019 with outcome of unknown and couple of strokes on an unspecified date with outcome of unknown.  The information on the lot number has been requested.
Patient fainted (syncope) within 2 minutes. Fell off her chair and hit her front tooth which broke off.  911 was called, her vitals were taken.  Cleared by medical staff.  Patient and mother refused to be taken to the Hospital.  Both signed waivers of fact.  Patient walked off without assistance.
Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced COVID-19 (Contracted COVID). At the time of the report, COVID-19 (Contracted COVID) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-090432 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090432:
Became sick with fever; Became sick with fever; body cramps and aches; body cramps and aches; Menstrual cycle started with immense pain; Moderna (two doeses) Pfizer (booster); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 at 13:30 as dose 3 (bivalent; booster), single (Batch/Lot number: unknown) at the age of 26 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: moderna (brand= Moderna ,, administration time= 04:45 PM,, dose number= 2,, vaccine location= Left arm.), administration date: 06Jun2021, when the patient was 24-year-old, for COVID-19 immunization; moderna (brand= Moderna,, administration date= 30Jun2021,, administration time= 04:45 PM,, dose number= 1,, vaccine location= Right arm.), administration date: 30Jun2021, when the patient was 24-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 02Dec2022 at 13:30, outcome "unknown", described as "Moderna (two doeses) Pfizer (booster)"; ILLNESS (non-serious), PYREXIA (non-serious) all with onset 03Dec2022 at 12:00, outcome "recovering" and all described as "Became sick with fever"; DYSMENORRHOEA (non-serious) with onset 03Dec2022 at 12:00, outcome "recovering", described as "Menstrual cycle started with immense pain"; MUSCLE SPASMS (non-serious), PAIN (non-serious) all with onset 03Dec2022 at 12:00, outcome "recovering" and all described as "body cramps and aches". Therapeutic measures were not taken as a result of illness, pyrexia, muscle spasms, pain, dysmenorrhea.  Additional information: No other vaccine in four weeks. No known allergies. The patient did not had covid prior vaccination. The patient was not tested for covid post vaccination. The patient received other vaccine in two weeks: Birth control. On 03Dec2022 at 12:00 AM, the patient became sick with fever, body cramps and aches. Menstrual cycle started with immense pain which is unusual. especially because I take birth control. The patient did not receive any treatment for the events.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Humming/ringing in the right ear that started 6 days after the first dose which was followed by localized pain in the injection site the next day. Injection site was in pain for 3-4 days after the injection and pain had gone away but came back the day after the humming/ringing in the ear started. The humming/ringing is worst in the morning after I wake up and slowly subsides throughout the day.  There are moments in the morning where it gets really loud.
Pt is a 67 year old male who was in his normal state of health until approx three weeks ago. He began to experience aching on the backs of his legs and in his low back. He then developed numbness that started in his feet but extended approx 2" up his shins. He now has difficulty walking and feels as though he is slightly weak in his legs. He does have mild tingling in his fingertips bilaterally. Approx one week prior to the onset of his symptoms he did receive a Pneumococcal vaccine. On brief physical examination he has full strength of his upper extremities. In his lower extremities he has full strength in all muscle groups except for toe extension and flexion, which are 4+/5 bilaterally. He has 1+ reflex in his right biceps otherwise he has no reflexes in any of his extremities. He has decreased sensation from the toe to 2" above the ankle bilaterally. This history and physical are consistent with Guillain Barre Syndrome, CIDP, or a toxic polyneuropathy. Electrodiagnostic studies were designed to test for these possibilities. He had no significant change is symptoms. Still has persistent paresthesias and numbness in both lower extremities and both hands and forearms. Still requires the walker to walk. He has had no significant falls. He has had no progressive weakness. He does not a right foot drop. He is unaware of significant difference in size of muscles in the right leg and thigh and calf comparing to his left. His chronic mild diarrhea three or four stools a day persists. He has nocturia X1 or X2. He has chronic leg pain and his leg pain is significantly improved, but he still has posterior medial pain in the right thigh. He has had a temp to 100.7F associated with nasal congestion and a feeling of stuffiness and pressure back into his ears. He was confined to bed for 6 days straight and got very weak.  Pt's goal for therapy : walk normal again, be able to return to work at least part time if able. Follow up 02/22/05: Exact date and time of onset of adverse event not known. No success contacting patient. 60 Day Follow up: Has been placed in leg braces, still going to physical therapy. Still has "numb" areas on both legs; is not in leg braces anymore-but gait is "staggered".  Is still on a heart pill to prevent dysrrythimias - all per telephone call to wite 4/13/06 still seeing Neuro MD at hosp.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a father regarding his 8 year old son who experienced fever of 99-100, sore throat, headache, coughing and more raspy breathing.  At 8 years of age, the pt received a dose on 12/08/03.  The pt's concurrent illness includes seasonal asthma (October to April).  Indication for Flumist (2003-2004 formula) was immunization. Product was administered on 12/08/03.  Dose regimen was 0.5mL (IN).  Concomitant therapy included Albuterol.  On the evening of 12/11/03, 3 days post-immunization, the child experienced coughing, "more raspy breathing", fever of 99-100, sore throat and headache.  He was treated with albuterol nebulizer and given Children's Advil.  No additional information was available at the time of this report.
Sore arm upon exertion and laying upon the arm. Rates the pain 7/10.
Received Pfizer vaccine on 4/15/21 and 5/6/21. Found to be COVID positive on 1/19/22. She came to hospital to give brith at 40 weeks and 6 days. Baby was 7 pounds and 14 ounces. Apgars were 9 and 9 at one and five minutes. gravida 1, para 0. Her postpartum course was unremarkable and was discharged the same day in stable condition.
lightheadednes, nausea, "I think I had an anxiety attack!"  "when I have had mutli vials blood drawn I get the same feeling"    143/107- take BP meds " I have white coat syndrome"
I am experiencing skipped heartbeats which my Dr has described as Premature Ventricular Contractions (PVCs). I first experienced this sensation on April 11 and have continued to experience them after my second dose until this very day. I have not experienced anything like before receiving the vaccine. I have received multiple diagnostic tests so far and to the best of my knowledge they only show that my heart is skipping beats and no other damage or issues have been found.
Serious stomach pain, cramping along with nausea, vomiting and diarreah Approximately a week to 2 weeks later, facial numbness, right side of face, check and right arm
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-OCT-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous) that had expired in September 2014 (lot # not reported). No adverse events were reported. Additional information is not expected as there was no consent to contact physician.
Information has been received from a vaccine coordinator, referring to unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported in any patients. The vaccines had a temperature excursion of 7.52 Fahrenheit (F) for 24 hours. It was reported that the vaccines had a previous temperature excursion of 5.5 F for 1 hour and a digital data logger was involved.
Presented to emergency department on 4/22/21 after having an unwitnessed syncope episode at home. Was found to be in atrial fibrillation with RVR. He denies any COVID-19 exposure, but was found to be positive upon screening for admission. No COVID-19 symptoms were reported during admission.