chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MISSED THE SECOND DOSE; This spontaneous case report was received from a pharmacist (PVX2019-361) on 08-Feb-2019. The report describes a female consumer who "missed the second dose". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif on 05-Feb-2019 but she missed to take the second dose which was due on 07-Feb-2019.  The action taken with Vivotif with respect to the event "missed the second dose" was not applicable.  The clinical outcome of the event "missed the second dose" was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.
her blood sugar had gone extremely low and is having low blood sugars at night; Has had muscle soreness bilaterally in both upper arms and has been fatigued; Low-grade fever; Has been fatigued; Felt crappy, describing that the dose really took her down; Had a fall; She was weak; Not feeling very well; This spontaneous case was reported by a nurse and describes the occurrence of DEPRESSED MOOD (Felt crappy, describing that the dose really took her down), FALL (Had a fall), ASTHENIA (She was weak), FEELING ABNORMAL (Not feeling very well) and BLOOD GLUCOSE DECREASED (her blood sugar had gone extremely low and is having low blood sugars at night) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood sugar increased (140's and 150's at night). Concomitant products included METOPROLOL, METFORMIN HYDROCHLORIDE (GLUCOPHAGE FORTE), SEMAGLUTIDE (RYBELSUS), CITALOPRAM, OMEPRAZOLE, LEVOTHYROXINE SODIUM (SYNTHROID), EMPAGLIFLOZIN (JARDIANCE) and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.   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) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DEPRESSED MOOD (Felt crappy, describing that the dose really took her down), FALL (Had a fall), ASTHENIA (She was weak), FEELING ABNORMAL (Not feeling very well), MYALGIA (Has had muscle soreness bilaterally in both upper arms and has been fatigued), PYREXIA (Low-grade fever) and FATIGUE (Has been fatigued). On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (her blood sugar had gone extremely low and is having low blood sugars at night). In April 2021, DEPRESSED MOOD (Felt crappy, describing that the dose really took her down) had resolved. At the time of the report, FALL (Had a fall), ASTHENIA (She was weak), FEELING ABNORMAL (Not feeling very well), BLOOD GLUCOSE DECREASED (her blood sugar had gone extremely low and is having low blood sugars at night), MYALGIA (Has had muscle soreness bilaterally in both upper arms and has been fatigued), PYREXIA (Low-grade fever) and FATIGUE (Has been fatigued) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Blood glucose decreased: 46 Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No specific follow-up information recorded.
Patient reported 10 minutes after the flu shot she had severe pain, redness-2 inches around her bandaid and warmth on her left arm where the shot was given. She reported over the next 5 days she had no range of motion of left arm, the pain was very severe she said a 10 on  a scale of 1-10 it went up around her neck and up above her scapula and just above her elbow down her arm She stated she used hot and cold packs on her arm. The pain got better on Sunday the 21st but today when she came in she said her range of motion is still 80% and it still hurts a bit to lift her arm or reach out. She did not have a fever or dizziness. I told her to reach out to her doctor if the pain got worse again or she had a fever. She has not gone to the doctor - she does have a regular appointment on November 16th.
not feeling well; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), HEADACHE (Headache) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus (Type 1 diabetes mellitus). Concomitant products included INSULIN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (not feeling well), HEADACHE (Headache) and FATIGUE (Fatigue). On 11-Mar-2021, MALAISE (not feeling well) and FATIGUE (Fatigue) had resolved. On 12-Mar-2021, HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood glucose: 99 (normal) Blood sugar 99 when vomiting..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported.
On 06/26/2013 patient came to clinic complaining of right arm being red, swollen, warm to touch and sore to touch. Patient did see a provider was given Benadryl Cream.  Patient came back to clinic today complaining of right arm not being any better.  Also left arm is red, has a knot, warm to touch. She did see a provider again today.  Also yesterday temp was 99 oral, today it was 97.4 oral.  Today was given Atarax 10mg to use also.
Admitted to acute care as inpatient with severe thrombocytopenia (1000) treated with Immunoglobulin
Redness, swelling, warm to touch. Given BENADRYL. Cool compresses.
0920 Throat tightness. Hx of allergies. BP 151/87, HR 66, Resp 17 unlabored, Sats 98%. Refused epi injection reports he has epi pin at home. Stated "it's not that bad". 0930 left ambulating for home accompanied by his son. Stating "if it was going to be bad it would have gotten worse by now". Educated on S/S to seek immediate care for. He verbalized understanding
DTaP #5 and IPV #4 given 2/5/03. Mother came to clinic 2/7/03, reporting fever onset 2/6/03 and red, swollen, hot L arm at injection site. Fever+105 deg F in clinic 2/7/03 with Motrin given 2 hr ago. No appetite, no fluid intake. Pt is weak, but alert.
Pt is immunocompromised and was given Jansen Covid for 2nd dose 10/29/2021 and Booster dose 04/13/2022. Technically patient (immunocompromised) should have been given mRNA vaccine for each of these doses (Pfizer or Moderna). However, CDC guidelines and literature suggest that if patient really wants to have J&J vaccine due to preference/insistence and no previous reaction then they cannot be forced into another vaccine.
Left hand/finger numbess tingling, radiating to upper arm. Jittery Feeling that will not go away
Cough that won't go away; when she coughs her nose runs; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough that won't go away) and RHINORRHOEA (when she coughs her nose runs) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced COUGH (Cough that won't go away) and RHINORRHOEA (when she coughs her nose runs). At the time of the report, COUGH (Cough that won't go away) and RHINORRHOEA (when she coughs her nose runs) outcome was unknown. Not Provided          No relevant concomitant medications were reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: The TCR follow up received in which second dose information is added.
Started to feel not like myself in May around the 10th, very tired and weak. Around June 15th I started having bad pressure in my head and ears,  a June 26th I woke up with neck/shoulder pain that went down my right arm.. I was checked out at a urgent care June 28th around 11am. I was given muscle relaxers and a steroid for the neck/shoulder pain. The head pressure and ?swishing? noise that went with my heart beat in my ears, got very intense and I had horrible painful headaches. July 3rd I was seeing double vision, I went to a Mac center that night and was checked out there. They said all my testing came back normal and sent me home, and told me to follow up with my primary if my vision didn?t get better. July 5th I went to my primary since my vision wasn?t normal. I was ordered to get an MRI and see an ophthalmologist. I saw an ophthalmologist a few days later who told me my optic nerves were very swollen and that meant I had inner cranial pressure.. I got in with a neurologist July 8th who wanted more tests done before he diagnosed me?. Later on July 8th my symptoms got worse, I Brain. I am diagnosed with CVST
I felt lousy after receiving the vaccine but it was better than with the Moderna vaccine.  I started feeling bad on 07/21 with a scratchy throat. I tested for COVID-19 with a home test on 07/23 and it was negative and tested again on 07/24 and it was positive. I contacted my doctor via the health chart and I was prescribed Paxlovid and I could not tolerant it.  After taking three doses, I was very nauseated and vomited. I alternated Tylenol and Advil to help with my symptoms. During this time I continued to take my allergy medication. As of today, I am still in quarantined.
pt experienced syncope post injection, reported that he could not hear or speak for a moment. Benadryl and Epipen were present, but pharmacist on site performed blood pressure reading, and did not believe it was anaphylaxis. Paramedics arrived and patient tried to refuse medical care, but paramedics convinced patient to go with them to the ambulance so that they can monitor blood pressure, heart, and blood glucose.
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, rhinorrhea, nasal congestion, sore throat Narrative:
On 12/31/15 pm - injection area starting itching and was red. On 1/1/16, pt came into pharmacy where, I as a pharmacist, saw area. Pt claimed was much worse on this day. Area appeared as deep red area about 5 inches in diameter and hot. Advised pt to go to immediate care or ER. Pt saw NP and MD. Was told to use ice packs at 15 minute intervals and use cetirizine 10 mg once daily. Pt was much improved on 1/3/16 per follow up phone call by me.
Information was received on 14-JUL-2017 from a nurse who reported that on an unspecified date, an unspecified patient received an improperly stored dose of VARIVAX (lot# M048200, expiration 07-DEC-2018) reconstituted with properly stored sterile water diluent (lot#/expiration not reported). Temperature was -14 degrees C to -10 degrees C for 170 hours and 26 minutes; -9 degrees C to 8 degrees C for 8 hours and 26 minutes. There was a previous temperature excursion. No adverse effects reported. No further details provided. Additional information has been requested.
HEP B was given with along with Pediarix (Dtap-IPV-Hep B) Child had 2 hep B on this date. Provider was notified. Parents was also made aware. No adverse reaction was noted.
Green mucucs discharge, cough for 1 month without resolution, sleep disturbance.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 1:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 1:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.17 for dose administered on 12-Jan-2021.  No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 12-Jan-2021. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 12-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
A non-serious spontaneous report of syringe broke and bloody nose has been received from a physician concerning a nine-year-old male, subsequent to FLUMIST. Neither medical history, nor concomitant medications were reported. On 09-Sep-2011, patient received FLUMIST. On 09-Sep-2011, while administering the vaccine syringe broke into half and patient got bloody nose. The doctor checked the child and did not see any glass in the child's nose. The outcome of event syringe broke was resolved and outcome of bloody nose was unknown.
24 hrs p/receiving MMR/Hep B, broke out in hive-like rash from head to toe; fever, chills, itching; lasting approx 1 wk; called clinc seen by pvt MD;
I had the shot/Suspected Vaccination Failure; I got a horrible case of shingles/got a terrible case case of shingles; Nerve damage; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the shot/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: I got a horrible case of shingles/got a terrible case case of shingles) and nerve damage (Verbatim: Nerve damage). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the nerve damage was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and nerve damage to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient via interactive digital media. The patient had Shingles shot but got a horrible case (terrible) of shingles in December and still not fully recovered.  The patient also had nerve damage. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Started with body aches & chills around 3pm on 12/29/2020.  Temp 99.3  By 8pm, increase in muscle & joint aches & pains...took 600mg ibuprofen & went to bed.  By 12:30am on 12/30/2020, woke up soaking wet from fever breaking.  Performed normal activities on 12/30/2020 during morning, but around 3pm, started with joint & muscle aches & pains & chills.  @ 1845, temp was 101.3 & 20 minutes later, was 103.2.  I took 600mg ibuprofen at 1925. Muscle & joint pains persisted so at 2025, temp was 104.6 & I took 1000mg Tylenol & went to bed.  By 2300, I woke drenched in sweat again.   It is now 12/31/2020 @ 1245 & so far, I feel only a slight chill & my temp is 98.6.
Flu like symptoms for following two weeks. Severe (helmet-like) headaches still happening. Increase of knee joint pain. Left hip pain onset - Severe joint pain. Week 4 started creaking noise (like knees) swelling. Does not respond to OTC pain killer. Two falls due to hip pain so far.
Second day after Hepatitis A #1. Prevnar in Left thigh. Noted erythema and pruritis. Subject is fever suspect. Cellulitis vs allergic reaction. Prescription Benadryl and Cephelixin.
This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified).  It was reported that the physician had at least one patient and possibly more.  On an unspecified date the subject received 3rd dose of Hepatitis B vaccine (unknown) to complete the series.  At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced not responding to therapy.  At an unspecified time later, the subject received the entire hepatitis B vaccine (unknown) series a second time.  At an unspecified time after vaccination with the second series of Hepatitis B vaccine, the subject experienced not responding to therapy.  The reporter noted that the type of testing or quantitative values for the subject's levels were unknown.  It was reported that the subject had the entire series twice and still did not "show seroprotective levels."  At the time of reporting the outcome of the events were unspecified.
shortness of breath, chest pain, vomiting, cough on 12/5/21. Lungs clear, regular heart rate and rhythm. No accessory muscle use while breathing. No lesions, rashes on skin. Seen in walk in clinic.  On 12/6/21, presented to ED with c/o nausea, vomiting, achy muscles and fatigue.
11/9/2021-Husband tested positive for COVID-19 last night. They have had multiple close contact exposure (daughter, son-in-law, grandson), they live on their property in a camper while their home is being built so they have frequent close contact with them. She started with cough Saturday. History of COPD. URI This is a new problem. The current episode started in the past 7 days. The problem has been waxing and waning. There has been no fever. Associated symptoms include congestion and coughing. Pertinent negatives include no abdominal pain, diarrhea, headaches, nausea, rhinorrhea, vomiting or wheezing. She has tried nothing for the symptoms.
Received shot on 09/29/17, on 10/01/17 had black right eye, on 10/02/17 had left black eye around 3:00pm. Came into work and other associates noticed his left eye was black.
sensation on forehead that turned between eyes; high blood pressure; mental sensation on the throat; throat clamed down and lose air breath; throat clamed down; A spontaneous report was received from a consumer concerning his twin brother a 51-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sensation on forehead that turned between eyes, blood pressure went high, mental sensation on the throat, throat clamed down and lose air breath.  The patient's medical history was not reported. Concomitant medications included metformin.  On 13 JAN 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch No: unknown) for prophylaxis of covid 19 infection.  On 13 Jan 2021, the patient experienced, Sensation on forehead that turned between eyes, blood pressure went high, mental sensation on the throat. He at 11 minute throat clamed down, loose air breath and they were told not to receive the second shot.   Treatment received included steroid and Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s), sensation on forehead that turned between eyes, blood pressure went high, mental sensation on the throat, throat clamed down and lose air breath were considered resolved 6 hours after the vaccine on 13 Jan 2021.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Seizure: generalized tonic-clonic movements of body, unresponsiveness, oral and nasal secretions.  Lasted greater than 10 minutes.  Associated with fever of 103.  Transported by EMS to ED.
Severe diarrhea, headaches, nausea, could not even keep water down, dizziness, night sweats, muscle and body pain, fever, tiredness, weakness, back pain, rectal pain.
Injection site reaction Information has been received from a registered nurse concerning a patient who on 29-OCT-2005 was vaccinated intramuscularly with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot #651329/1047P). Concomitant therapy included influenza virus vaccine (unspecified). Eight to twelve hours later the patient developed a local injection site reaction. Unspecified medical attention was sought. It was reported that the patient was recovering. No product quality complaint was involved. Additional information has been requested.
The next day after vaccination, patient developed red, hot swollen rashes on her upper arm down to elbow. The rashes lasted for 4 days and went away. Patient did not seek medical treatment.
Patient developed redness, swelling, pain, warmth at immunization site. Does not recall if shot was given IM or SQ. Did not treat and symptoms resolved within 2 weeks.
This spontaneous report as received from a registered nurse refers to a 14 year old patient with unknown gender. On 02-MAY-2013 the patient was vaccinated with PROQUAD, 0.5 ml (anatomical location, dose number, lot number and expiration date unknown) via subcutaneous, concomitant medications were not reported. The reporter stated that on 02-MAY-2013 (yesterday), the 14 year old patient received a dose (merck) PROQUAD, and no adverse effect reported. Additional information has been requested.