chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored ROTATEQ (lot # M019706, expiration 24-OCT-2017, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014500: US-009507513-1610USA013229: US-009507513-1612USA014502: US-009507513-1612USA014503: US-009507513-1612USA014499: US-009507513-1612USA014501.
Sore arm; Has not received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the second dose) and PAIN IN EXTREMITY (Sore arm) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B021A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient did not received the second dose due to anxiety and a lot of emotional baggage from the pandemic. Treatment information was not provided.
This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Felt lethargic and tired) and FATIGUE (Felt lethargic and tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and unknown) for COVID-19 vaccination.     Concomitant products included CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.   On 09-Feb-2021, the patient received second 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 10-Feb-2021, the patient experienced LETHARGY (Felt lethargic and tired). On an unknown date, the patient experienced FATIGUE (Felt lethargic and tired). At the time of the report, LETHARGY (Felt lethargic and tired) and FATIGUE (Felt lethargic and tired) outcome was unknown.            No treatment information were reported. Action taken with mRNA-1273 in response to the event was not applicable.
pain in the arm; can't move arm above shoulder/Barely could move the arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jan-2021 and was forwarded to Moderna on 20-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (can't move arm above shoulder/Barely could move the arm) and VACCINATION SITE PAIN (pain in the arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided) since an unknown date.    On 19-Jan-2021 at 8:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 20-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (can't move arm above shoulder/Barely could move the arm). On 20-Jan-2021 at 2:00 AM, the patient experienced VACCINATION SITE PAIN (pain in the arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (can't move arm above shoulder/Barely could move the arm) and VACCINATION SITE PAIN (pain in the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant information was not provided.
started having lots of leg and arm pains on april 6th, burning pains etc.  very tired, felt like she would pass out and this continued till april 11th when she fainted  and she went to hospital
This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a adult subject who received dTpa vaccine. On an unknown date, 11 days after receiving dTpa vaccine, the subject developed acute disseminated encephalomyelitis. Serious criteria included GSK medically significant. The outcome of acute disseminated encephalomyelitis was unknown. The investigator considered the acute disseminated encephalomyelitis to be possibly related to dTpa vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis (ADEM) in an adult of unspecified gender who was vaccinated with unspecified Tdap vaccine (manufacturer unknown). The patient was part of the study that aimed to analyse the association of immunisation and subsequent development of transverse myelitis (TM) or ADEM. All cases of TM and ADEM in the Vaccine Safety Datalink (VSD) population were identified. The study used a case-centered, which compares vaccination patterns during an exposure interval prior to the outcome in cases vs the entire study population, matched by age, sex, and site. Study population included all children and adults of any age enrolled in the health plans at 6 VSD sites who received 1 or more vaccines during the period from 1 January 2007 through 31 December 2012. The patient was healthy. No information on patient's family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received Tdap vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The patient was routinely vaccinated. On an unspecified date between 1 January 2007 and 31 December 2012, 11 days after vaccination, the patient developed the symptoms of ADEM. (In this study, trained medical records analysts (MRAs) reviewed all identified cases to verify that a neurologist made the diagnosis within 3 months of the first electronic diagnosis, to validate the date of onset, to ensure the diagnosis did not change over time, and to abstract pertinent information. Following this, a neurologist with expertise in demyelinating illnesses reviewed each case. For ADEM, cases were confirmed using the Brighton Collaboration Criteria, and  accepted diagnostic levels of certainty 1, 2, and 3 as cases). Treatment was unknown. The outcome of the event was not reported. The authors commented "for ADEM, we found a possible association with the Tdap vaccine in the 5 to 28 day risk interval." The authors concluded "TM and ADEM are rarely, if ever, associated with vaccines. If there is an association of ADEM with Tdap, the excess risk is not likely to exceed 1.16 cases of ADEM per million doses of Tdap administered." This is 1 of the 5 valid cases reported in the same literature article.
Information has been received from a physician concerning a female who was vaccinated with a first dose of Gardasil (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment. Additional information has been requested.
Dizziness, sweating Narrative: employee came to monitor saying employee was in distress by the office, sent for help in the clinic.myself and another team member assessed employee. employee was sweating and felt dizzy but had strong pulse on plpation and was breathing wnl. rapid response was reached. wheelchair arrived before team arrived pt was sent to er with another rn to give report.
the patient experienced muscle tenderness in her upper back and left shoulder; This spontaneous report has been received from an around 49 years old female patient via Merck employee, referring to herself. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were unknown by reporter.  On 14-MAY-2020, the patient was administered a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (route, dose, strength, lot# and expiration date were unknown by reporter) in her left arm for prevention of human papillomavirus (HPV).  In May 2020 (reported as on an unspecified date after 14-MAY-2020), the patient experienced muscle tenderness in her upper back and left shoulder. It was unknown if lab diagnostics/studies were performed. The patient had not sought medical attention. The outcome of the event was recovered. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event was unknown.
Extreme muscle pain in the deltoid area beginning withing days after the shot.  It has been 9 months and the pain is only slightly better.
sore injection site, swelling, achy, fevers, nausea, tiredness, headaches, flushed. rubbing site, moving arm. fluids, rest. not able to work at job for a week.
Patient complained of stomach ache and felt dizzy after leaving clinic - stepped out of elevator and fainted - hit back of head on floor - episode lasted < 5 min - occurred at 10:40AM. Patient taken to ER for evaluation by EMS.
8JAN97 pt recv vax & 10JAN98 AM several red dots 1/2cm in size over upper chest;3PM eyelid swelling bilaterally, red dots of different sizes from 1/2cm in size all over body;hive-like rash;eczema;
Patient received the flu vaccine without complications on 10/20/06 at an offsite clinic.  Nothing stood out in my mind.  Patient presented with bruising on Monday 10/23/06.  The pharmacist who viewed the site called me.  Said that there was significant bruising below the site of injection.  The pharmacist said she could view where I injected her, it was in the deltoid muscle, and the bruising was lower then the site and down to her elbow.  Patient also brought it to our attention then that she was on plavix.  We called her doctor, no answer.  We instructed her to go to the emergency room.  I did a follow up call with her latter on 10/23/06 and she said she did see her doctor, that there was no infection and that it would take time to clear up.  There is minimumal discomfort and she is able to move her arm freely.  I told her I would follow up with her on Tuesday 10/24/06.  When I talked with her in the morning trying to assess what was going on she seem conherent and able to answer all of my questions without problems.  When I called to check on her she seemed out of it and had no idea who I was.  I will continue to follow up.
sensorineural hearing loss 1st noted p/vax;(missing data: pt does not have some speech devel; failed BAER otoacoustic emission test as well as BAER test); will under go experimental genetic eval to see if genetic cause can be identified;keh
Patient state he felt dizzy about five minutes after the shot. He collapsed but didnt lose consciousness. When he sat up he was very pale and sweating.  We had him sit with his feet up and gave him a glass of water. After about 10 minutes his color returned and he said he felt better and left with his wife
Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Concomitant product use was not provided by the reporter  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11 MAY 2021, TCR-Added outcome as recovered.
Had a fever for 2 days (101.4)-severe body aches and pains-red line on arm (3-4 inches long-11/2-2 inches wide).
Information has been received from a physician concerning an 11 year old HIV positive male patient with acquired immunodeficiency syndrome and no known drug allergies/drug reactions, who in August 2008 ("also reported as approximately 2 months ago"), was vaccinated with a dose of VARIVAX (reported as "most likely a 2nd dose"). Concomitant therapy included vancomycin, acyclovir, ceftriaxone and voriconazole. It was reported that in October 2008, the patient developed disseminated chickenpox. The patient was hospitalized from 16-OCT-2008 to 19-OCT_2008 for the lesions. On 02-DEC-2008, the patient was hospitalized again for disseminated chickenpox. It was reported that the patient also experienced headaches, photophobia, and phonophobia. The physician took a spinal tap and was interested in sending this for analysis along with skin swab (results not reported). The patient was currently at the hospital, and sought unspecified medical attention. Disseminated chickenpox (second occurrence), headaches, photophobia and phonophobia were considered to be immediately life-threatening. Disseminated chickenpox (second occurrence), headaches, photophobia and phonophobia were considered to be other important medical events. A phone call was received on 05-DEC-2008, the physician was contacted and she stated that she was interested in sending a specimen for a patient who was experiencing disseminating varicella. The physician stated that the patient was presently experiencing his second episode of disseminated varicella and that he had no CD4 count. An additional telephone call was placed on 09-DEC-2008, the physician stated that the specimen was sent today. The physician stated that the patient was stable while being treated with acyclovir. The patient was still hospitalized. Additional information has been requested.
Fatigue, excessive thirst, muscle soreness, headache within 1 hour of receiving vaccine. Symptoms subsided within 24 hours
Was having discomfort when walking and exercising. Went to a cardiologist and was given a CT Scan. During scan they found blockage in one of my arteries. Had Cardiac Catherization. Confirmed had blockage and placed two stints in my arteries. Hospitalized 1 day. Discharged the next day and prescribed PLAVIX and LIPITOR.
After patient received Gardasil vaccine, she proceeded out to the waiting area. She then became lightheaded and LOC. Instantly she regained consciousness and was diaphoretic and pale. She was able to get up and sit in a chair. Then walked back to a exam room, where she laid down. Given water and cool rag. After physician eval., she had received her color back. Vitals WNL. Able to dangle legs w/o probs. Able to ambulate out of office.
DIARRHEA; NAUSEA/VOMITING; NOT FEEL WELL; This spontaneous report received from a consumer concerned a 48 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 19:00 for prophylactic vaccination. No concomitant medications were reported.  On 28-MAR-2021, the subject experienced diarrhea. On 28-MAR-2021, the subject experienced nausea/vomiting. On 28-MAR-2021, the subject experienced not feel well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, nausea/vomiting and not feel well was not reported. This report was non-serious.
Patient had headache, blurred vision, sensitivity to light, loss of balance, back ache, throat ache, right side of body from hip to shoulder and right arm went numb, vomiting, nausea, and weakness of both extremities right side more severe than left. 5/19/08-records received for DOS 5/13-5/14/08-DC DX:  Vaccination reaction, probably the yellow fever, although she had a Hepatitis vaccination too. Presented with headache, neck pain, swelling, muscle aches and edema at the site. Intractable vomiting.
Patient received FLUZONE HD. About an hour later, she felt burning in her throat. Went to local ER and was treated for allergic reaction including fluids and prednisone.
Unconsolable crying-stopped crying when held. Slight swelling at injection site (RAT) approx 2-2 1/2" diameter, slight swelling at site on RAT.
Chest pain which stared a few days after receiving 2nd dose vaccine and has persisted with activity. EKG was normal without any ST segment changes. Echocardiogram is normal. Will consider exercise stress test in 3 months
Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.            Patient was not sure to get the vaccine due to the ingredient (Polyethylene). However, caller reported that he received both doses of the vaccine and did not have any issues other than a minor rash.   Treatment medication was not provided  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-072708 (Patient Link).
Information has been received from a healthcare worker refers to an the patient of unknown age. The healthcare worker reported an unspecified number of unspecified patients were administered an unspecified number of improperly stored doses of ROTATEQ (doses, route and lot# not reported). No adverse effect was reported. It was unknown if the patients sought medical attention. This is one of the several reports with the same reporter. Additional information has been requested.
Initial and follow up information has been received from a nurse concerning a 19 month old female infant with no pertinent medical history, drug reactions/allergies or concomitant medication usage who on 28-NOV-2006 was vaccinated (route and site not reported) with the third dose of RECOMBIVAX HB (lot # not reported) at her pediatrician's office. Concomitant therapy included VARIVAX (MSD) and MMR (MSD) given on 29-May-2007. On approximately 08-JUN-207, 10 days post vaccination of receiving VARIVAX (MSD) and MMR (MSDI), the patient developed a generalized rash. The rash subsided within a unspecified period of time. On approximately 08-DEC-2006, 10 days post vaccination of receiving RECOMBIVAX HB vaccine the patient developed generalized rash. The rash subsided within a unspecified period of time. The patient was referred to the physician's office on 13-Dec-2007 for evaluation of allergies, the generalized rash and nasal congestion. The patient was prescribed a normal saline nasal spray for congestion. No other symptoms or treatment was reported. No diagnostic lab tests were performed. At the time of this report the outcome of the rash and nasal congestion was unknown. No further information was available. Additional information is not expected.
The evening of receiving vax pt had a temp of 103.8 and was cranky. On 8/25/01 his temp was 103. The duration of the temp was 1.5 days.
?Covid arm? that felt like a hive. Raise and red bump that itched and felt hot to the touch.  The size of two quarters.
Onset 4-6 hours after vaccination with pain, redness, swelling to R upper arm injection site. Pt then developed fever 100 degrees on Saturday up to 101 degrees on Sunday with generalized malaise, shortness of breath, & extreme fatigue.  Pt states had pneumonia vaccine in past with no reaction.
Has not received dose 2 as of yet.; Had a shingles outbreak a few weeks  ago; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In July 2020, between 11 and 12 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had shingles outbreak. The patient had not received dose 2 yet, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Patient fainted after receiving vaccine after a minute of receiving  vaccine. He hit his head and had a lip bleeding.  Patient rejected the paramedics advise to go to hospital.
On Wednesday October 14, 2009 I went to pharmacy for the shingles vaccine. On the way home I got a headache, then my left side got very sensitive. By the next day I started breaking out and it keeps getting worse.
Patient was given the Pfizer vaccine at 15 years 8 months old.  Spoke with patient's father who stated that the patient didn't have any adverse reactions to the vaccine.  He thought it was ok for his daughter to receive the Pfizer vaccine since she is a frontline worker regardless of her age.  Her father questioned whether his daughter will be able to receive her 2nd dose in three weeks or will she have to wait until she turn 16 years old.
I95.9 HYPOTENSION 4/26/2022 CANCER METASTATIC TO BONE J96.10 CHRONIC RESPIRATORY FAILURE 4/15/2022 CANCER METASTATIC TO BONE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/26/2022 CANCER METASTATIC TO BONE R09.02 HYPOXIA 3/17/2022 CANCER METASTATIC TO BONE I95.9 HYPOTENSION 4/26/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 4/15/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/26/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 3/17/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Bells Palsy was the diagnosis, pain and numbness started a few hours after the vaccine in the arm and face
Pt diagnosed with Chicken pox disease on 12/15/2005 in office.