chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Vomiting; Metallic taste; Tingly mouth; Difficulty swallowing; Rapid heartbeat; Flushed red face; Flushed red face; This is a spontaneous report from a contactable consumer (patient). This 38-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0150) via an unspecified route of administration on 07Apr2021 at 14:00 (at the age of 38-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history penicillin allergy and artificial food dye allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included a multivitamin. The patient previously received vancomycin from an unknown date and experienced allergy. On 07Apr2021 at 14:15 the patient experienced dizziness, vomiting, metallic taste, tingly mouth, difficulty swallowing, rapid heartbeat, and flushed red face. The patient visited an emergency room/department or urgent care as a result of the events. The patient received treatment with diphenhydramine (BENADRYL), famotidine (PEPCID), cetirizine (ZYRTEC), dexamethasone (DECADRON), and albuterol. The outcomes of dizziness, vomiting, metallic taste, tingly mouth, difficulty swallowing, rapid heartbeat, and flushed red face were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Diagnosed with 4th nerve Palsy; Double vision; This spontaneous case was received on 02-Jan-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-00003) and concerned a 79-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 21-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On 23-Oct-2021, two days after receiving Fluad Quadrivalent, the patient experienced double vision.   On an unspecified date in 2021, the patient was evaluated and had a magnetic resonance imaging (MRI), computed tomography (CT) scan, blood tests and heart tests and nothing was found on any of these tests. He saw an ophthalmologist and was diagnosed with 4th nerve Palsy. He was not received any treatment.  At the time of initial reporting on 02-Jan-2022, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The event of '4th nerve Palsy' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company Comment: A 79-year-old, patient was vaccinated with Fluad Quadrivalent. Two days following vaccination, the patient experienced double vision. Reportedly, the patient was evaluated and had a magnetic resonance imaging (MRI), computed tomography (CT) scan, blood tests and heart tests and nothing was found on any of these tests. The patient was diagnosed with 4th nerve Palsy by ophthalmologist. Information regarding medical history, and concomitant medications was not provided. Causal role of the suspect vaccine is unassessable with the currently available information.; Sender's Comments: A 79-year-old, patient was vaccinated with Fluad Quadrivalent. Two days following vaccination, the patient experienced double vision. Reportedly, the patient was evaluated and had a magnetic resonance imaging (MRI), computed tomography (CT) scan, blood tests and heart tests and nothing was found on any of these tests. The patient was diagnosed with 4th nerve Palsy by ophthalmologist. Information regarding medical history, and concomitant medications was not provided. Causal role of the suspect vaccine is unassessable with the currently available information.
Since administration on 07/31/2003; child has had 3 chickenpox outbreaks approximately 2-3 weeks apart.  Only cutaneous symptoms-no systemic symptoms.
Redness and swelling x 2 days. Treatment cool compress and Tylenol as per doctor.
Numbness starting at the tip of my tongue then it spread entire tongue, roof of my mouth and my lips. And then it reversed, appearing to be getting better and then it came back to just the tip of my tongue.
Four days after receiving Shingrix vaccine I came down with shingles even though everyone says that can't happen!!
Soreness to his arm; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness to his arm on an unspecified date. Caller wanted to know how long the vaccine will lose its efficacy under room temperature. The outcome of the event pain in extremity was unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
being diagnosed with "HPV pre-cancerous cells for cervical cancer"; being diagnosed with "HPV pre-cancerous cells for cervical cancer"; Information has been received from a 30 years old female patient (inconsistent information: age also reported as 32) via an agent, referring to herself. Information of concomitant medication and medical history was not reported. The patient had no drug reactions or allergies.  On an unknown date when the patient at 18 or 19 years old (inconsistency information: therapy start date also reported as 30 years old), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)(dose detail, frequency, route, lot# and expiration were unknown) for prophylaxis.         On an unknown date when the patient at 30 years old, the patient was diagnosed with "human papilloma virus (HPV) pre-cancerous cells for cervical cancer" (precancerous cells present and papilloma viral infection). The patient received treatment of a "leak was placed" and a present status of "negative with two normal pap smears". The outcome of the events was reported as recovered. The causality assessment between these events and suspect product was not provided by the reporter.
Initial report received from a health care professional on 7/14/05. An 18 year old male patient received an IM left deltoid injection of Menactra, lot number U1494AB, and an ID right forearm injection of Tubersol 5 TU., lot number C2116AA, on 6/10/05. 15 days later he experienced intermittent tingling in his feet. He was seen by a physician on 6/26/05 and was admitted to the hospital to rule out Guillain-Barre Syndrome. He was released from the hospital on 6/29/05, but was re-admitted on 7/1/05 with facial weakness and slurred speech. He was diagnosed with Guillain-Barre Syndrome. The patient received treatment with plasmaphoresis and was discharged on 7/8/05. As per the reporter, the patient's recovery status is unknown.
Mild to Moderate Fever during day and night for nearly 48 hours. Flu-like symptoms: severe muscle aches and fatigue, congestion, headache, general "fogginess". Tylenol helped but fever did not subside. Woke up during night with chills. According to wife,  was hallucinating for approximately 15-20 minutes. For about 24 -36 hours, individual felt completely "knocked out."
Mild fever noted at 99.2 degrees at approximately 6:30pm. The fever may have been higher earlier in the day at around 5-5:30pm. Some mild confusion and dizziness (though I have been experiencing cognitive issues for over a year now. I believe the fever is exasperating pre-existing symptoms). Some mild nausea and a mild headache. I am not completely back to normal yet (as of 7pm) but I do believe I will be fine as time goes on.
The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A and 016C21A) for COVID-19 prophylaxis.     Patient was never been diagnosed with or tested positive for COVID-19.  Concurrent medical conditions included Hypothyroidism and Cerebral palsy. Concomitant products included MELATONIN, LEVOTHYROXINE SODIUM (SYNTHROID), DOCUSATE SODIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 26-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Jun-2022 at 3:10 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 3:10 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022).    The reporter thought that Moderna had an extension like Pfizer, and they though it would expired on the 13-Jul-2022 but it was expired on the 13-May-2022, they realize that on the 08-Jun-2022.  The vial was initially stored in the refrigerator on 21-Jan-2022.  Vaccines were administered on 07-Jun-2022 after their expiration date set for 13-May-2022.  The used vials were placed in the refrigerator on the same day of administration 07-Jun-2022. The Vial did not undergo any temperature excursion  The event did not cause patient to seek medical care.  It was unknown if there were any other potential causes and if patient experienced a similar event in the past.  No treatment information was reported.
very weak; loss of taste; almost fainted if I didn't lay down; out of breath from just walking around; bowel movement  are loose; started having nausea again; Experince a fever of 103.4F; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (very weak), AGEUSIA (loss of taste), PRESYNCOPE (almost fainted if I didn't lay down), DYSPNOEA (out of breath from just walking around) and DIARRHOEA (bowel movement  are loose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE (HYDRODIURIL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (Experince a fever of 103.4F) and NAUSEA (nausea). On 16-Feb-2021, the patient experienced ASTHENIA (very weak), AGEUSIA (loss of taste), PRESYNCOPE (almost fainted if I didn't lay down), DYSPNOEA (out of breath from just walking around), DIARRHOEA (bowel movement  are loose) and NAUSEA (started having nausea again). On 08-Feb-2021, PYREXIA (Experince a fever of 103.4F) and NAUSEA (nausea) had resolved. At the time of the report, ASTHENIA (very weak), AGEUSIA (loss of taste), PRESYNCOPE (almost fainted if I didn't lay down), DYSPNOEA (out of breath from just walking around), DIARRHOEA (bowel movement  are loose) and NAUSEA (started having nausea again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Pyrexia (97-99): increased (High) 103.4F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Patient stated that about 6 hours after getting her 2nd dose of her Moderna vaccine, she started to feel a tingling, shaking feeling in the arm where she received her vaccine, then her arm goes numb for about 2-3 minutes. Patient also stated that her legs start to shake, she will get dizzy. Patient has been to doctor to for Adverse Event and wasn't prescribed any medication. Patient stated that this happens at least 6-8 times a day, she's only had 2 days since she was vaccinated that this hasn't happened.
Pain on movement for a period of five weeks after injection. One month after injection (and 4-1/2 months after implantation of two PP mesh surgical appliances) I have chronic fatigue. I'm unsure which event precipitated this, or if it was both.
Developed swollen posterior lymph nodes on left side of neck, swollen lymph nodes under chin, swollen lymph nodes  on back of head at base of skull
Pt. is still experiencing pain/soreness at the injection site 40 days after the injection. She says it is getting worse, not better.
No adverse events; Improperly stored VARIVAX was inadvertently administered; This report was received from a medical assistant concerning to a 7 year old male patient. No medical history nor concurrent conditions medications were reported. On 21-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. S015459, exp. date 20-MAY-2020) for prophylaxis. The vaccine was reconstituted with properly stored diluent. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
Low grade fever, chills, Headache, Nausea, Vomiting, general malaise, Fatigue
WRONG VACCINE ADMINISTRED; vaccine was supposed to be given to another patient; Patient (DOB: 26-JUN-2018) was given boostrix; Accidental underdose; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2g3ph, expiry date 27th October 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number amva640z, expiry date 20th November 2022) for prophylaxis.   On 15th March 2022, the patient received Boostrix, Boostrix Pre-Filled Syringe Device and Menveo. On 15th March 2022, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, the patient experienced wrong vaccine administered, drug administration error, inappropriate age at vaccine administration and accidental underdose. On an unknown date, the outcome of the wrong vaccine administered, drug administration error, inappropriate age at vaccine administration and accidental underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: The health care professional reported the vaccine boostrix and menveo was supposed to be given to another patient, which led to wrong vaccine administered, drug administration error, inappropriate age at vaccine administration and accidental underdose. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022047763:Same reporter - FU1 deleted US-GLAXOSMITHKLINE-US2022047764:Same reporter US-GLAXOSMITHKLINE-US2022047759:Same reporter US-GLAXOSMITHKLINE-US2022047756:Same reporter
2nd dose administered from vial that had been in refrigerator for 32 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (2nd dose administered from vial that had been in refrigerator for 32 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2nd dose administered from vial that had been in refrigerator for 32 days). At the time of the report, PRODUCT STORAGE ERROR (2nd dose administered from vial that had been in refrigerator for 32 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.
Less than a week after my COVID booster I had blood work done.  I had never had any problems with A1C or blood glucose before, but was called in the middle of the night after the blood work on the afternoon of 9/28/21 to say I needed to get to the urgent care.  I went in first thing in the morning.  My blood glucose was 540 and needed to be given insulin.  I left the critical care with a diagnosis of diabetes type 2.  By the end of the week I had more blood work and my gaba results indicated that I was Diabetic Type 1.5 (LADA).  I had had no indicators of this at my last blood draw less than a year before. I am now fully dependent on insulin and wear a CGM.
Vaccine was administered unusually high into the shoulder. Intense left shoulder pain started within hours of vaccine administration and continues as of 12/10/18. Pain has been improving with heat, ice, light stretching, and ibuprofen.
Reported flu-like symptoms 24 hrs after the vaccine and reported soreness and slight inability to move arm.
Several episodes of mild transient and migratory urticaric skin hives; This is a spontaneous report from a contactable consumer (patient). This 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN9581) via an unspecified route of administration in the left arm on 03Feb2021 at 14:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, no concomitant medications and was not diagnosed with COVID-19 prior to vaccination. The patient previously took ibuprofen from an unknown date for an unknown indication and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported he had several episodes of mild transient and migratory urticaric skin hives starting on 04Feb2021 at 07:00, which he was not certain were related to the vaccine. He reported the first episode occurred 17 hours after vaccination, located over right knee and lower leg and lasted 2 hours. The second episode occurred 36 hours after vaccination located on left forearm and lasted one hour. The third episode occurred 48 hours after vaccination located over right knee and lasted 2 hours. The patient experienced no other symptoms and reported that all resolved spontaneously. The event was reported as non-serious and did not require hospitalization. No treatment was provided for the event. The clinical outcome of several episodes of mild transient and migratory urticaric skin hives was recovered in Feb2021. It was also reported that since vaccination the patient had not been tested for COVID-19.
Myalgia, Fever, NauseaVomiting, chills, sweats, loss of appetite, injection site pain Narrative:
My wife started feeling "Bad" in the evening and got very ill feeling-nausea, head ache at 6:00AM. She got up to go to the bathroom and fainted dead away. She recovered in about 5 minutes but was sick all day Friday and slept most of the day. She started feeling better about 11:00PM on Friday night. Sat she is fine. Great appetite.
Redness in arm; Swelling in arm; Hot arm; Hard lump; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), HOT FLUSH (Hot arm) and MASS (Hard lump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), HOT FLUSH (Hot arm) and MASS (Hard lump). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), HOT FLUSH (Hot arm) and MASS (Hard lump) outcome was unknown.        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 product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-128305, US-MODERNATX, INC.-MOD-2021-128576, US-MODERNATX, INC.-MOD-2021-128649, US-MODERNATX, INC.-MOD-2021-128643, US-MODERNATX, INC.-MOD-2021-128612, US-MODERNATX, INC.-MOD-2021-128689 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128305: US-MODERNATX, INC.-MOD-2021-128576: US-MODERNATX, INC.-MOD-2021-128649: US-MODERNATX, INC.-MOD-2021-128689: US-MODERNATX, INC.-MOD-2021-128612: US-MODERNATX, INC.-MOD-2021-128643:
The pt complained of joint pain at the shoulder, elbow, wrist. No redness or swelling. The pt hasn't taken anything. Took ibuprofen over the weekend and was better on Monday.
Cold symptoms (runny nose, congestion), chills, low grade fever, persistent cough (mainly dry cough although some yellow phlegm produced).
Swelling at injection site, site is warm to the touch and began swelling/soreness at Day 6 post vaccine administration
Pt developed a temperature to 104 F the evening of 10/4/01 and then had a febrile seizure. She was taken to the ER where she was evaluated and monitored. She was discharged home later that evening.
Initial misuse report received on 14 November 2013 from a pharmacist. A 62 year old patient whose gender, medical history and concomitant medications were not reported, accidentally received a dose of FLUZONE HD (lot number, route and site of vaccination was not reported) on an unspecified date. As of 14 November 2013, patient did not have any adverse events. List of documents held by sender: none.
Myalgia, Fever, Site discomfort, Chills, Fatigue Narrative:
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: itchy, diffuse rash mostly at joints