chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was given early. First shot was given 1/8/21 and the second dose was given 22 days later on 1/30/21. This was due to a documentation error on the first vaccine. The first vaccine was originally charted as a Pfizer vaccine so her 2nd appointment was made 22 days later.
Pt c/o feeling dizzy, lightheaded, nauseous. Placed in supine position and evaluated by EMS. HR noted to be in 50's, pt mildly diaphoretic.  Given po fluids and monitored for additional 15 minutes. Symptoms resolved, VSS, pt sent home without incident.
This spontaneous report was received from a pharmacist and refers a 60 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 02-DEC-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1705USA006382: US-009507513-1705USA006383: US-009507513-1703USA010654: US-009507513-1705USA006385: US-009507513-1705USA006380: US-009507513-1705USA006381.
I was achy and became weak and dizzy about 1pm. By 2pm , I developed Ortho static hypotension which caused my blood pressure to drop and travel to ER via ambulance .
Vaccine was punctured 1st on 4/19/23 at 10:40AM and beyond the recommended stability duration.
gastrointestinal problems; nausea; cramps; This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal disorder in a patient who received Herpes zoster (Shingrix) for an unknown indication.   On 11th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced gastrointestinal disorder, nausea and cramp. Shingrix was discontinued. On an unknown date, the outcome of the gastrointestinal disorder, nausea and cramp were unknown.   It was unknown if the reporter considered the gastrointestinal disorder, nausea and cramp to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on 11th September 2019, ever since then patient had experienced various gastrointestinal problems, including nausea and cramps. The patient certainly not going to do a 2nd shot. The patient was enquiring if there was anything that could be done to offset these gastro issue in the way of medication or food or anything else.
Pt received her flu vaccine and Pneumovax prior to being discharged from the hospital.  She reports that the pain started immediately after receiving her Pneumovax.  She is complaining of left arm pain and swelling.  Treatment:  Prednisone for 6 days, ultram for pain and zyrtec.  CBC to assess allergic versus infectious type reaction.
Pentacel given without ActHIB component (Only the DTaP/IPV component given)
This spontaneous report was received from a nurse refers to 3 unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On unspecified dates the patients were vaccinated with an improperly stored dose of GARDASIL (incorrect product storage) (lot # K008931, expiry date 04-MAR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the GARDASIL experienced a temperature of 27 degrees Fahrenheit for a time frame of 60 days (multiple cycles). It was reported that the GARDASIL was back in range. It was reported that the GARDASIL experienced no previous temperature excursion. This case was reported due to a data logger. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
went in for a CT scan for a fracture and the doctors noticed swollen lymphodes on the left side, went in for another scan last Thursday (5/21/2021) and they were still swollen
Shot at 10 am on Saturday 2/20/21 and at 3 PM became very lethargic. At 9 PM temp was 101.1. At 10 PM was 99.1 after taking two Tylenol. Sunday to Tuesday regain strength vitals were normal. Tuesday 2/23/21 visited doctor and tested for COVID-19 and flu. Also received a chest X-ray. Tuesday to Saturday regained strength and vitals are normal.
Fever, chills, body aches, panic attacks, couldn?t stay asleep, hallucinations
Felt like scratch, swelling and hot where vaccination was administered. The next day the patient felt more swelling and heat at the location and it was vissible red.
arthralgia; muscle soreness; This case was reported by a pharmacist via call center representative and described the occurrence of arthralgia in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than 2 weeks after receiving Shingrix, the patient experienced arthralgia and muscle soreness. On an unknown date, the outcome of the arthralgia and muscle soreness were not recovered/not resolved.   It was unknown if the reporter considered the arthralgia and muscle soreness to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced arthralgia and muscle soreness. The reporter did not consent to follow up.
"I felt electrodes on both sides of my forehead, my ears, the sides of my neck, my shoulders, & down to my feet; I had no strength my body. I didn't have any energy; I couldn't get out of bed. I can barely walk, it's not a straight posture.; I can barely walk, it's not a straight posture; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL ("I felt electrodes on both sides of my forehead, my ears, the sides of my neck, my shoulders, & down to my feet), ASTHENIA (I had no strength my body. I didn't have any energy), MOBILITY DECREASED (I couldn't get out of bed. I can barely walk, it's not a straight posture) and GAIT DISTURBANCE (I can barely walk, it's not a straight posture) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced FEELING ABNORMAL ("I felt electrodes on both sides of my forehead, my ears, the sides of my neck, my shoulders, & down to my feet), ASTHENIA (I had no strength my body. I didn't have any energy), MOBILITY DECREASED (I couldn't get out of bed. I can barely walk, it's not a straight posture) and GAIT DISTURBANCE (I can barely walk, it's not a straight posture). On 20-Apr-2022, ASTHENIA (I had no strength my body. I didn't have any energy) had resolved. At the time of the report, FEELING ABNORMAL ("I felt electrodes on both sides of my forehead, my ears, the sides of my neck, my shoulders, & down to my feet), MOBILITY DECREASED (I couldn't get out of bed. I can barely walk, it's not a straight posture) and GAIT DISTURBANCE (I can barely walk, it's not a straight posture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. It was reported that patient took all the other Moderna shots without side effects, except this one.
Within hours of vaccination patient developed, muscle aches, headache, nausea, fever, neck pain, muscle spasms, sinus congestion, ear pain and unable to work for over 7 days.  Patient reports that it has been 11 days day and she still does not feel well, she continues to have chronic sinus congestion and fatigue.
Rash/welt puffiness on my arm in area where shot was given, soreness is going away, but redness area and itching persist, applied cortisone cream to relief the itching and it does alleviate  Experience where I am trying to breath in deeply but  I cannot get the breath, I have to yawn and that kind of helps sometimes My fingertips on both hands feel a bit of numbness, and are very cold Other bumps on skin on legs
MRI showed acute injury to brain; Had double vision; paraesthesia on one side of the body/tingling on one side of body; A spontaneous report was received from a physician concerning a 29-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paresthesia on one side of body/tingling on one side of body /hemiparaesthesia, had double vision and MRI showed acute brain injury.  The patient's medical history, as provided by the reporter, included some neurological issues but all the tests were reported as normal prior to vaccine administration. Concomitant medications were not provided.  On 24 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown)intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced tingling and paraesthesia on one side of body. After a few days on an unknown date the patient had double vision and magnetic resonance imaging was done which showed acute brain injury. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), paresthesia on one side of body/tingling on one side of body /hemiparaesthesia, had double vision and MRI showed acute brain injurywas unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I95.9 HYPOTENSION 7/2/2023 ODYNOPHAGIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/28/2023 ODYNOPHAGIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/2/2023 ODYNOPHAGIA R09.02 HYPOXIA 7/1/2023 ODYNOPHAGIA
Dose 1- five minutes after vaccine, a tingling sensation started in my back and I  did not realize until I was home it was actually a COVID rash- confirmed by doctor. Also sought treatment from PCP for heart palpitations starting the day after vaccine  as well as the  last three fingers of my hands going numb at night, starting the night I got the shot. Dose 2- severe joint pain in left hip and back to the point it was difficult to walk, had to take pain relief every 6 hours, stay off feet and heat pack for 4 days. Have never had any pain hip or back prior to shot.
Fever up to 102.5F, extreme malaise, headache, chills lasted for about 1 day
Flu-like; Hot; Sore arm; Low level fever of 100.3 degrees; Muscle ache; Joint aches; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like), FEELING HOT (Hot), PAIN IN EXTREMITY (Sore arm), PYREXIA (Low level fever of 100.3 degrees) and MYALGIA (Muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event history).    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 INFLUENZA LIKE ILLNESS (Flu-like), FEELING HOT (Hot), PAIN IN EXTREMITY (Sore arm), PYREXIA (Low level fever of 100.3 degrees), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like), FEELING HOT (Hot), PAIN IN EXTREMITY (Sore arm), PYREXIA (Low level fever of 100.3 degrees), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            Treatment information was not provided. Concomitant medication was not provided.    Reporter did not allow further contact
Certified immunizing tech gave vaccine to patient at 3.49pm,  patient immediately fainted and starting shaking for about 10 seconds. Certified immunizing tech called out for help and by the time the pharmacist arrived, patient was waking up on her own with a confused and blank look on her face. We asked if she felt okay and she only nodded her head "yes". After about 30 seconds patients' eyes started to roll and head fell down towards her chest with some mild shaking as stated previously. Again patient experienced this for around 5-20 seconds and then woke up on her own. Patient was pale in her face, eyes were drooping and patient was stating that she was tired and hot. After we got a verbal confirmation that she was understanding us we gave patient water, ice pack and a granola bar. Upon further questioning, patient stated she did not eat anything since the morning which was a small snack which was normal for her. Patient also told pharmacist before vaccine was given that she has had episodes of fainting previously. Patients parent was called to come to the store. Parent knew of the history and refused contacting a paramedic or taking patient in to see medical professional.
Injection site pain, 3 inch diameter red and hard raised area, painful, itchy, and warm to touch.
Information has been received from a registered nurse concerning a 24 year old female with gastrooesophageal reflux disease and a history of anaphylactic reaction while on therapy with VICODIN who on 04-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of Gardasil (lot 657622/0388U). Concomitant therapy included NUVARING, PRILOSEC, cholestyramine resin, vitamins (unspecified) and probiotics "PB8". The patient left the office after receiving the dose of Gardasil. Within 15 minutes, the patient started to have shortness of breath, difficulty swallowing, and a feeling of her throat tightening. The patient was never unconscious and had no other symptoms. The patient went to the emergency room where she received possibly prednisone, BENADRYL, and TAGAMET IV. The patient was discharged to home after 4 hours. Subsequently, the patient recovered and was not receiving further treatment for the event. Shortness of breath, difficulty swallowing and throat tightness were considered to be immediately life-threatening by the reporter. Additional information has been requested.
Client in for well child visit and did have 2nd flu vaccine (first administered on 1/9/07 by RN using lot #U2175HA). The lot number for the 2nd flu shot was UT2176BA. The 2nd flu shot was administered in the am before 12pm. Accordind to Mother, the child awoke from sleep at about 10:30pm with altered LOC. The child was also starting to seize with jerking movements. At the time the child awoke, the Mother called 911 and temp 101. When the ambulance arrived approx. 30 min. after the call, the Mother states the temp was 103. On the day that the 2nd flu shot was administered, the child was also ill with an acute otitis media and anemia and was being treated with omnicef 125 1 1/4 tsp /day and ferisol drops BID. Child in today for well child visit and appears well. Advised Mother to discuss incident with her child's physician before getting another flu shot for her child in the future.  03/23/2007 MR received for an ED visit for parental report of first seizure at home on the day of Flu vax.  Child had been running a fever.  His eyes rolled back and then began shaking all over. This lasted appox. 1 minute after which he awoke and took a bottle.  PE: Crying and fretful.  Temp=103'F. Skin feels hot.  TMs red bilaterally.  Otherwise WNL.  TXd with Tylenol and Motrin with fever reduction.  DC home. Discharge DX:  Febrile Seizure.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EK5730), in right arm, on 10Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: EW0186), in right arm and on 10Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Undifferentiated mixed connective tissue disease" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE MOFETIL, start date: 30Nov2020, stop date: 20Jun2022. Past drug history included: Clindamycin, reaction(s): "Drug Allergy".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound CoVID on day 9 from positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19. This Report about covid treatment. The patient has received vaccine. Patient had other medication in 2 weeks. Patient received treatment for COVID-19 as Paxlovid from 20Jun2022 to 25Jun2022.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
no adverse event; Expired product administered; This spontaneous report as received from a nurse refers to a 34 year old female patient.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 01-NOV-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S025610 with expiration date of 18-AUG-2021; dosage regimen details were not provided)  for prophylaxis. No adverse events were reported.
in the night eyes started to get puffy; Right eyelid is red and swollen, on the top of the eye and underneath; left eye is also red and swollen but not as bad as right eye\Right eyelid is red and swollen, on the top of the eye and underneath; feeling feverish since last night,at the moment states having 100, 101 temperature; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (in the night eyes started to get puffy), OCULAR HYPERAEMIA (Right eyelid is red and swollen, on the top of the eye and underneath), EYE SWELLING (left eye is also red and swollen but not as bad as right eye\Right eyelid is red and swollen, on the top of the eye and underneath) and PYREXIA (feeling feverish since last night,at the moment states having 100, 101 temperature) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 016B21A and 025AZ8) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced PERIORBITAL SWELLING (in the night eyes started to get puffy), OCULAR HYPERAEMIA (Right eyelid is red and swollen, on the top of the eye and underneath), EYE SWELLING (left eye is also red and swollen but not as bad as right eye\Right eyelid is red and swollen, on the top of the eye and underneath) and PYREXIA (feeling feverish since last night,at the moment states having 100, 101 temperature). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PERIORBITAL SWELLING (in the night eyes started to get puffy), OCULAR HYPERAEMIA (Right eyelid is red and swollen, on the top of the eye and underneath) and EYE SWELLING (left eye is also red and swollen but not as bad as right eye\Right eyelid is red and swollen, on the top of the eye and underneath) outcome was unknown and PYREXIA (feeling feverish since last night,at the moment states having 100, 101 temperature) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: high (High) 100, 101 temperature.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.   This case was linked to MOD-2021-377259 (Patient Link).
C/O DIZZINESS, LIGHTHEAD, RACING HEART, 810PM 90/50,77, 99% GIVE H2), 815PM SLIGHT IMPROVEMENT, 820PM NO SYMPTOMS LEFT AT 840PM,905PM RETURN TO VACCINE SITE DIZZINESS/LIGHTHEADED 90/58,64, 99%  H2O, 929PM NO DIZZINESS/LIGHTHEAD FRIEND DROVE,01/8 VM&PCP
Information has been received from a health care professional concerning a 7 year old pt who on 15Oct1997 was vaccinated with a dose of varicella virus vaccine live. On 10Mar2004 the pt was diagnosed with chickenpox. The pt had lesions on his trunk, back, bottom, and legs. No fever was noted. The child was given diphenhydramine hydrochloride (Benadryl) to treat his chickenpox. Unspecified medical attention was sought. There was no product quality complaint. The outcome was reported as not recovered. The reporter also indicated that another pt experienced adverse reactions following vaccination with chickenpox (WAES0403USA01037). Additional information has been requested.  ** Follow up information indicated that the child was exposed to chickenpox by his cousin on 3/8/2004. On 3/9/2004, bumps on the childs back, legs, and stomach were noticed. The child was brought to the physicians office on 03/10/2004, and the physician verified that the child had the chickenpox with less than 20 lseions. There were no relevant diagnostic test or lab data. Additional follow up information indicated that the patient recovered on 3/17/2004. No further information is expected.