chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VARIVAX was administered following temperature excursion; No adverse effects or symptoms following administration; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided by the reporter.  On 15-MAY-2022, the vaccine underwent a temperature excursion of 6 Fahrenheit (F) for 7 minutes. There was no previous temperature excursion. Following the temperature excursion, on 02-JUN-2022, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, lot# U020244 with expiration date 28-JUN-2023 (strength and route of administration was not reported), administered for prophylaxis. No adverse effects or symptoms following administration.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001549: US-009507513-2206USA001318: US-009507513-2206USA001331: US-009507513-2206USA001347: US-009507513-2206USA001555: US-009507513-2206USA001558:
PATIENT STATED THAT BY BEDTIME ON THE DAY OF THE VACCINATION A HUGE KNOT FORMED WITH WARMTH AND REDNESS EXTENDING DOWN INTO HER BICEP AND WRAPPING AROUND HER ARM TO HER TRICEP. SHE SAID IT WAS EXTREMELY SORE TO THE TOUCH AND KEPT HER FROM BEING ABLE TO SLEEP FOR ALMOST A WEEK FROM THE PAIN.
TC from Grandmother; client awoke at midnight 6-24-08 (24 hours later) with numbness in all 4 extremities, dizziness and dyspnea. Took her to ER, she was treated for "panic attack" with Benadryl and muscle relaxer. Continues with tingling and cant make fist with her hands. 7/4/08 Reviewed hospital medical records of 6/25/2008. FINAL DX: vaccine reaction & panic crisis. Records reveal patient experienced SOB, crying, numbness/tingling, panic feeling, anxious, hyperventilating.  No abnormal physical exam findings.  Tx w/meds, improved & d/c to home.
was given only the liquid portion; was given only the liquid portion; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was given only the liquid portion of Menveo at age 11 (age unit not provided), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up. This case has been linked to the case US2021AMR131344, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR131344:same reporter
This spontaneous report as received from a medical technologist (other health professional) refers to a 10 year old patient of unknown gender with no pertinent medical history or drug reactions/allergies. On 24-JUN-2014, the patient was vaccinated with a booster dose of VARIVAX (merck) INJ (lot # J014228; expiration date 08-NOV-2015), 0.5 ml, once, subcutaneous in the left arm. No co-suspect therapies were reported. Concomitant therapies included ADACEL, on 24-JUN-2014. On 24-JUN-2014, the patient experienced "pain at (injection) site, welts to it, erythema, swelling". The reporter stated it was considered an immediate reaction". At the time of the report, the outcome of the events was recovering/resolving (also reported as patient was "doing good"). The patient sought medical attention by office visit. No treatment was given and the patient was told to contact again if it got worse. No lab diagnostics studies were performed. Two more patients presented adverse events with the same lot of VARIVAX (Merck). This case is linked to case MARRS # 1407USA000221 (same reporter link). Additional information has been requested.
From initial information received on 06/11/04 from an registered nurse regarding an adverse event occurring in the USA, it was reported that a 72 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1270AA, administered intramuscularly in the left deltoid on 10/14/03 at 11:00 AM. One week later, on 10/21/03, the patient developed a sore left arm at the site of injection. He was unable to lift the arm over his head and internal rotation of the arm was painful. Treatment included Vioxx 25mg daily, which reportedly helped initially, but the patient is never pain free. The patient has not recovered from these events. From additional information received on 09/07/04 from the initial reporter, it was reported that the number of previous Fluzone doses the patient received is not known. It was also stated that this report was " reviewed, no additional information at this time. "
At 1350 patient complained of redness and itching at injection site.  No other complaints noted. No difficulty breathing or swelling.  Provided cool pack to injection site.  At 1400 patient stated she was having difficulty taking a deep breath and felt dizzy.  Injection arm was red, slightly swollen and warm to touch.  RN administered 50 mg Benadryl IM into right arm (adjacent to injection site).  EMS arrived.  Vital signs: 124/91, P-94.  Patient awake/alert.  Transported via ambulance to ER.  While in ambulance, patient became unconscious with difficulty breathing.  EMS administered Epi.  Hospital ER monitored and discharged patient with 5 day oral steroid pack.  Patient followed up with primary care provider.  Also to consult with allergist.
I developed classic UTI symptoms on 10OCT2022,  approximately 3.5 weeks after bivalent vaccine. Treating with TMP/SMX and symptoms are improving. Not related to vaccine but within reporting window
I got the shot at 3:45 pm. At approximately 8 pm I started feeling like I was loosing my voice and I felt like my upper chest was congested and I needed to cough and clear my throat alot.  I also felt a mild sharp pain in my throat when I swallowed that seemed to move around.  I had been to the Dentist at 2:45  that same day so I thought what I was feeling was from that. (I asked the Dentist the next day and he said it was more likely a reaction to the flu shot) These symptoms lasted till about 11 pm (4 hours) I then at 11pm started to feel achy all over  like I had a fever.  I checked my temperature and it was normal.  I went to bed and awoke at 1am feeling hot as if in a oven. I again checked my temperature at 1 am and it was normal.  These symptoms lasted till 5:30 am when both the achy ness and feeling of being hot went away.   I fell back to sleep and when I awoke at around 8 am I felt much better just tired.  Thank You.
Pfizer-BioNTech COVID-19 Vaccine (Purple Top) vial was not diluted prior to administration; therefore, the patient received the entire vial as dose #2 in his series (vial should have given 6 doses upon proper dilution). Patient has had no adverse effects reported at this time since dose given.
excruciating pain on the left side of her body; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (excruciating pain on the left side of her body) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061B22A, 078J21A, 032B21A and 002A21A) 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) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (excruciating pain on the left side of her body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, MYALGIA (excruciating pain on the left side of her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. The event caused the patient to seek medical care.
Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and then blacked out woke up laying on floor, couldn't move arms or legs, not sure if hit head,  laid on floor close to 1 hour, difficulty getting back into bed, extreme nausea, dry heaves, weak, headache, dizzy, chills, dizzy x 1 week, dizzy 3/3/21, got into bed 6:30 PM,  face flushed and reddened, called daughter who is nurse, daughter checked temperature and blood pressure, no fever, B/P 156/102 (normally  120/82), B/P came down to when retaken to 140/90), was "upset" at time of first B/P reading, causing elevation. Continues to have weakness and fatigue, headache comes and goes.
Headache, Arthralgia, Fever, Chills, light sensitivity, hyperesthesia
No adverse events. Patient was given a DT vaccine instead of a DTaP vaccine. Parents were notified and mother brought daughter in this office for a DTaP vaccine.
The first and second dose of Moderna is greater than 30 days/first dose on 21 Mar 2021, second dose on 2 Feb 2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first and second dose of Moderna is greater than 30 days/first dose on 21 Mar 2021, second dose on 2 Feb 2022) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FK9729) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first and second dose of Moderna is greater than 30 days/first dose on 21 Mar 2021, second dose on 2 Feb 2022). On 02-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first and second dose of Moderna is greater than 30 days/first dose on 21 Mar 2021, second dose on 2 Feb 2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. Treatment information was not provided. Patient had no medication history and no allergy.
Received call from Health center at 20:28 regarding seizure-like activity. Discussed with mother who stated that patient seemed herself until early evening when she seemed fussy and clingy, not her usual temperament. Around 7:30 PM her mother was preparing a bath for her to soothe her when she noticed patient was staring off and not responding. She then started having full body jerking and stiffening which lasted no longer than 30 seconds. When her mother picked her up she seemed like "dead weight...limp." She initially was not responding to her mother calling her nickname. She eventually came out of it and then seemed fussy and tired afterward. She now is watching tv show and seems more tired than usual (bedtime around 9-9:30 PM) and very clingy. She seems like she is blinking often almost trying to stay awake. She occasionally pokes at her eyes which is a new behavior. She has not received any medicine. She had her well visit today which prompted catch-up vaccines including MMR, varicella, Dtap/Hib/IPV and Prevnar. She has not had reaction to vaccines in the past Temperature never measured greater than 99
A blotchy red rash about 2 inches round - itches - near the injection site
04/14/2021 diagnosed as diabetic keto acidosis.  Type 1 diabetic.  Treatment life long insulin.    Blood sugar was 880.   Bbecame sick on 4/14/2021 extreme exhaustion and racing heart extremely thirsty was brought to hospital and remained in ICU for 4 days.
Itchy eyelids/ Eyelid swelling/Dry skin - eyebags - began 2nd - 3rd day eczema - hands/neck/ shaky/cold - Day 6 low energy 6 - 8 day - sleeping/napping more  Day 3 & 4 -Took Benadryl - did not help with swelling/ did help with discomfort Day 5 & 6- took Zyrtec and anti-itch eye drops - this helped  95% cleared of symptoms
I had arm tenderness at the injection site for about a day. I have a history of degenerative disease. After my vaccine, the disease did not get worse.
After receiving the shot at 8:30 am on 7/20, my son's left shoulder began to swell and was hard and red around the injection site. He complained of itching throughout the day, but seemed otherwise fine. Throughout the day on 7/20, 7/21 and 7/22, his arm became so swollen and hard and the redness and swelling moved down to his elbow and around the back of his shoulder and arm. I took him to the Urgent Care to have him evaluated. It was determined that it was a significant negative reaction but there was no infection or cellulitis. They advised me to give him some Benadryl.
GIVEN POST EXPIRATION; This spontaneous report received from a health care professional concerned an adult 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 (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced given post expiration. The action taken with covid-19 vaccine  was not applicable. The outcome of given post expiration was not reported. This report was non-serious.
No adverse event; patient received a Monovalent Booster dose instead of a bivalent booster shot; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a Monovalent Booster dose instead of a bivalent booster shot) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a Monovalent Booster dose instead of a bivalent booster shot). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a Monovalent Booster dose instead of a bivalent booster shot) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a Monovalent Booster dose instead of a bivalent booster shot).    No concomitant drug was reported. No treatment drug was reported.   Reporter did not allow further contact
blood clog on left leg; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: Ep8732, also reported as Em9809), at the age of 66 years old, in right arm on 24Mar2021 at 09:30 at single dose for COVID-19 immunisation. The patient's medical history was not reported. Known allergies was N/A. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications were received in two weeks was N/A. On 12Aug2021 at 20:15, the patient had a blood clog on left leg. Clog removed on 16Aug2021. Event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for one day. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test (nasal swab): unknown results on 06Aug2021. Therapeutic measures were taken as a result of event and included treatment with surgery. The outcome of event was unknown.
Client called clinic to report severe left arm pain on 2/1/21 that started after vaccination was given.
This spontaneous report as received from a nurse refers to a currently 38-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided. On an unknown date in July 2018, the patient was vaccinated with first dose of VAQTA (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date in September 2018, the patient was vaccinated with the second dose of VAQTA (lot number and expiration date were not provided) and on 05-FEB-2019 the patient received another dose of VAQTA, lot # R030120, expiration date 15-NOV-2019. It was reported that this schedule was not recommended. No adverse effects were reported.
after his dose he had a warm/burning sensation at the injection site; after his dose he had a warm/burning sensation at the injection site; This is a spontaneous report from a contactable consumer who reported on behalf of her husband. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration in his left arm on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. About 1 to 2 hours after his dose, he had a warm/burning sensation at the injection site, which resolved on an unspecified date. Reporter was curious as to why the nurse told patient the vaccine goes in his left arm, even though he was left handed. No follow-up attempts are possible, information about batch number cannot be obtained.
Client reported left sided facial numbness/paralysis/droop, diminished taste, drooling, left eye twitch, difficulty swallowing. Client seen in PCP office on 09/14/16 for symptoms. Advised client have CT of head, be seen in emergency department for evaluation. Client seen in health department office 09/15/16, symptoms remain as described above. Client alert, oriented x3, tongue center without deviation, gaze/vision normal, no extremity weakness/motor loss noted, skin normal without rash/hives, respirations normal, vital signs normal/afebrile. Mother states that no CT of head has been completed, advised client to be seen in ER for evaluation. Mother and client in route to emergency department.
Child refusing to walk, reported poor balance, cold legs (transient) - red throat CSG negative referral to neurology. Injection site normal.
Headache, Myalgia, Arthralgia, Fever & NauseaVomiting  Narrative:  Patient received 1st dose of vaccine on 3/10/21 at 3pm and began  experiencing symptoms 3/11/21 by 10am. Reported symptoms include injection  site pain/discomfort, redness, and itching, as well as headaches, fever (100.4 F),  chills, body aches, joint pain, nausea, and fatigue. Reports husband complained of  same symptoms after receiving his vaccine the same day. Used Tylenol 500mg x  doses on 3/11/21 and 3/12/21.  Other Relevant History:
This spontaneous report was received from a healthacre business professional and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. On 05-OCT-2021, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # U020244, expiration date 28-JUN-2023 or lot# U010395; expiration date: 01-APR-2023 (reporter was unable to clarify which lot# was administered to the patient at event time; both lot# were verified to be valid) for prophylaxis (dose, route of administration, and anatomical location were not reported). Administered dose of vaccine has been stored in the temperature of 1.45 degrees Celsius (°C) for 6 hours. There were previous temperature excursions reported. No adverse event was reported.
feel fatigue; feel  malaise; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2022, the patient received the 1st dose of Shingrix. On 11th May 2022, 1 days after receiving Shingrix, the patient experienced fatigue and malaise. On an unknown date, the outcome of the fatigue and malaise were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and malaise to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-May-2022 Reporter's comments: The patient received Shingrix and following day after vaccination he began to feel fatigue and malaise. The symptoms have yet to resolve as of today. The reporter provided information as per content on side effects. The patient referred to the healthcare professional. The reporter declined to provide full patient demographics. The reporter did not consent to follow-up.
pt feel off chair @ lunch hit the back of head on floor & lost consciousness for between 30sec to 1min;initially would not respond verbally & had lost control of bladder;pt better in 15min;pt felt eye twitching & felt very dizzy;
convulsive shaking and extremely cold. Severe muscle aches and severe headache. vomiting. Over course of 3 days took extra strength Tylenol,  aspirin, Hydrocodone nothing relieved the severe pressure headache. Used ice packs to help with the pain. Was very weak for a week and slowly could start eating something.
Narrative: Patient with a relevant PMH of COPD, tobacco use, obesity, and sleep apnea. Patient administered Moderna COVID vaccine on 02/11/21 and 03/11/21. On 08/31/2021 patient reported to PCP that he was "having lung issues" after his second vaccine and reported having several tests done at a Pulmonary clinic outside of the Facility. At that time he reported that "his Pulmonologist was concerned hat he might have an autoimmune disease". Upon review of his CPAP history on 09/21/21 patient reported to not using his CPAP due to "the COVID 19 vaccine triggering an autoimmune response and the bottom half of both lungs are black". Outside medical records report patient is a poor historian