chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible nerve pain in my feet; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced nerve pain (Verbatim: Terrible nerve pain in my feet). The outcome of the nerve pain was resolving.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.     It was unknown if the company considered the nerve pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR067876   Additional Information: GSK receipt date: 31-MAR-2023. This case was reported by a consumer via interactive digital media  The patient reported that, a few weeks after first dose  the patient came down with terrible nerve pain in his/her feet, it started to ease up. Not knowing it was from the shingrix vaccine. Follow up would not be possible. This case had been linked with US2023AMR067876 by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR067876:Same patient
On 02/10/2023, I had a bit of a soreness at the base of my tongue. I have food allergy reactions, so I thought it was that. The next morning, it was on the other side which was strange. I took an at home COVID-19 test and it was positive. I went to the doctor the next day, they gave me PAXLOVID. Aside from the sore throat, I felt a little tired, but I didn't have any extraordinary cough or anything. I had a bit of a dry cough, but it didn't last. My biggest thing was feeling a little tired. The first day or so of the medication, I just felt like I wanted to sleep. I was still able to work virtually.
I began vomiting around 5:30 a.m. on April 10. I continued vomiting over and over and over again throughout the day until I was able to take a small sip of water around 8:00 p.m. I also had fever, chills, muscle aches, headache, nausea and diarrhea. Nowhere did I see vomiting listed as a possible side effect of the vaccine. I lost seven pounds in 24 hours.
I have extreme diarrhea and vomiting. I had episodes in the double digits and the diarrhea persisted for 24 hours. I was not able to think clearly or function normally until 5 days after the shot
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of oral ROTATEQ, lot # L042215, expiration date:02-JUN-2017 , lot E M019707, expiration date:25-OCT-2017 or lot# L048854, expiration date:31-AUG-2017, (strength and dose were not reported). Patients' concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Felt weird; Sore; Runny nose; Massive headache; Body aches; A spontaneous report was received from a male patient of unknown age concerning himself received first dose of mRNA-1273 experienced feeling weird (Feeling abnormal), sore (Pain), had a runny nose (Rhinorrhea), a massive headache (Headache) and body aches (Myalgia).   The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 29-Dec-2020, approximately 3 days prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   One 01-Jan-2021, three days after receiving first dose of mRNA-1273, the patient reported that he felt weird, sore, had a runny nose, a massive headache and body aches.    Treatment for the events was not provided.    Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were not provided.; 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.
severe allergic reactions; Severe headaches; facial swelling; numbness; Palpitations; lock of jaw; fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), HYPOAESTHESIA (numbness), PALPITATIONS (Palpitations), JOINT STIFFNESS (lock of jaw) and TACHYCARDIA (fast heartbeat) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced SWELLING FACE (facial swelling), HYPOAESTHESIA (numbness), PALPITATIONS (Palpitations), JOINT STIFFNESS (lock of jaw), TACHYCARDIA (fast heartbeat) and HEADACHE (Severe headaches). On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reactions). At the time of the report, SWELLING FACE (facial swelling), HYPOAESTHESIA (numbness), PALPITATIONS (Palpitations), JOINT STIFFNESS (lock of jaw), TACHYCARDIA (fast heartbeat) and HEADACHE (Severe headaches) had not resolved and HYPERSENSITIVITY (severe allergic reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter
Was painful, swollen and red in color. The redness started to travel down the arm. Somewhat itchy and annoying.
while administration vaccine was spill over her wrist; she think that full dose of vaccine was not administered; This spontaneous case was reported by a patient and describes the occurrence of DEVICE CONNECTION ISSUE (while administration vaccine was spill over her wrist) and UNDERDOSE (she think that full dose of vaccine was not administered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (while administration vaccine was spill over her wrist) and UNDERDOSE (she think that full dose of vaccine was not administered). At the time of the report, DEVICE CONNECTION ISSUE (while administration vaccine was spill over her wrist) and UNDERDOSE (she think that full dose of vaccine was not administered) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.; Reporter's Comments: This report refers to a case of under dose and medication error for mRNA-1273, lot # 031L20A with no associated Adverse Events.
discomfort in his arm; flu-like symptoms; fever of 101.1; weakness; chills; kind of tired; sore arm; flushing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), LIMB DISCOMFORT (discomfort in his arm) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE and ROSUVASTATIN for an unknown indication.   On 14-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 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), CHILLS (chills) and FATIGUE (kind of tired). On an unknown date, the patient experienced LIMB DISCOMFORT (discomfort in his arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever of 101.1) and ASTHENIA (weakness). At the time of the report, PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), LIMB DISCOMFORT (discomfort in his arm), CHILLS (chills), FATIGUE (kind of tired), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever of 101.1) and ASTHENIA (weakness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  Treatment medications included Tylenol and low dose Allegra.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-032046 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: No specific follow-up information recorded. On 10-May-2021: updated contact information
Woke up with my whole face swollen; Right side of face is like puffy; My lips is big; My nodes is just swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: PH8028) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Albuterol for Asthma, notes: I have not taken my Albuterol since 2 months, Expiration date of Albuterol: Consumer stated, "Jan2022., LOT#: 9G4N. The following information was reported: SWELLING FACE (non-serious) with onset 01Dec2021, outcome "unknown", described as "Woke up with my whole face swollen"; SKIN SWELLING (non-serious) with onset 01Dec2021, outcome "unknown", described as "Right side of face is like puffy"; LIP SWELLING (non-serious) with onset 01Dec2021, outcome "unknown", described as "My lips is big"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021, outcome "unknown", described as "My nodes is just swollen".  Additional information: Patient took the vaccine yesterday. And had a side effect from the vaccine. Patient just woke up in the afternoon and when she woke up and went to the bathroom to look at her face and her face was swollen. So her sister said to call and report it. But she was going to her Doctor office to take a look and to make sure that she was not having an allergic reaction or something because her face was swollen. And one side of her face, the right side of her face was like puffy. Her nodes was just swollen to the point that it is was and her lips were big. No Prior vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected
Pt was at work, reported "feeling drunk".  Exhibited slight slurring of speech, jocular manner.  Was unsteady on her feet, "not lightheaded really but more like I had a few shots...  and I don't drink".   Pt was kept under observation for approx 30m from reporting onset of symptoms to supervisor.  Observed and interviewed at pharmacy.   Pt's daughter was notified to come pick her up.  Checked in with pt the following day, symptoms had resolved.
1/11/21 6:00 pm low grade fever 99.5, body aches 1/12/21 same 1/13/21 morning, no fever, felt better, went to work 1/13/21 12 noon  started feeling poorly, headache, body aches 1/13/21 5 pm severe headache, 100.5 fever, chills, severe muscle and joint pain 1/13/21 5:15 began rotation of 800 mg Ibuprofen, 500 mg Tylenol every 2 hours, bed ridden 1/14/21 1:00 am fever of 101.5 on medication, severe aches and chills 1/14/21 2 pm no fever, severe headache and body aches, bed ridden 1/15/21 6 am severe headache , no fever mild body aches, started gastrointestinal symptoms diarrhea  1/16 & 1/17/21 severe headache and diarrhea 1/18/21 felt better, returned to work
asymptomatic soft palate & anterior tonsillar pillar, vesicles/ulcerations;questionable soft palate submucosal hyperplasia;1st noted 4 days p/2nd shot;
This spontaneous report as received from a registered nurse refers to a 6 month old patient of an unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 25-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014706:
Parent mother reported to staff, patient experiencing throat tingling, itchiness and mild SOB while in the observation area around 0909. Per patient symptoms started approx 15-20 post vaccine administration. Patient was brought back to triage area. 0910: VS BP 110/80, HR 63, Temporal temp 98.3 F, 100% RA. Monitoring continued, MD and mother at bedside. Patient given benadryl 25mg per MD order and water. Patient reported symptoms improved after medication administration. 0920: Vitals BP 111/74 HR 57 Temporal temp 98F, 98% RA.  Per patient SOB resolved. Throat itchiness and tingling improving. Leader discussed with mother regarding second dose. MD continued to monitor and patient discharged from triage at 0940 with mother per MD.
Flu like symptoms aching joints, weakness, muscle aches, mild head ache. Felt like I had aged 10 years.  Went back to clinic.  No treatment. A/o 2/10/13 above systoms still persist.
This was booster dose for patient. received J &J vaccine on 3.13.21. no adverse events reported by patient. Patient was given vaccine that was BUD by 27 minutes. The BUD was 11.26.21 @ 9am, but the patient received this vaccine on 11.26 @ 9:27am. Worked directly with Pfizer and per Pfizer, the extended stability data is good thru 32 days, which means there is no excursion for patient.
Right arm redness/ tenderness around. No fever. Pruritis- hydrocortisone 2.5 apply locally.
Fever for three days, tiredness, chills, severe muscle pain, inability to carry on daily functions for 24 hrs, headache, and nausea. Tylenol did not help until day 2 where my fever fluctuated between normal and 99.5. On day three still a fever of 99.1 and headache persisted.
PATIENT RETURNED TO THE PHARMACY TODAY TO INFORM US OF AN ADVERSE REACTION TO THE MODERNA COVID SHOT. SHE SAID AFTER GETTING THE SHOT HER ARM WAS VERY SORE. ON THE 4TH DAY AFTER THE SHOT SHE DISCOVERED A RASH HAD DEVELOPED AROUND THE INJECTION SITE. IT HAS BEEN WARM AND PAINFUL AND NOW 2 WEEKS LATER IT IS GROWING. PATIENT WAS INSTRUCTED TO GO SEE THEIR PRIMARY DOCTOR TO OBTAIN TREATMENT AND MANAGEMENT OF THEIR REACTION.
A report has been received from a Physician via medical representative, then follow-up received from a health professional. The report concerns concerning a 4 years old male patient. Concomitant medications, concurrent diseases and medical history were not provided. On an unknown date, the patient received nasal FLUMIST QUADRIVALENT. On 08-Jan-2014 the patient tested positive for flu A, after receiving FLUMIST QUADRIVALENT. The patient recovered from the event on an unspecified date. The report was considered to be non-serious by company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 04-Feb-2014 from health professional: patient identifier were reported, event term changed to tested positive from flu A from twelve to fifteen patients developed fairly severe flu A after receiving FLUMIST QUADRIVALENT, event start date added, lot and expiration date for the suspect product added, case became valid, narrative updated.
died; This case was reported by a consumer via interactive media and described the occurrence of unknown cause of death in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal.   The reporter considered the unknown cause of death to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by the sibling of the patient. The age at vaccination was not reported. The reporter stated that the patient died from the vaccine.; Reported Cause(s) of Death: Unknown cause of death
Tingling in cheeks and face. 25mg Bendadryl given. Stated improvement of tingling after about 15 minutes, however, swallowing juice that was provided was difficult. Patient given another 25mg Benadryl. By 3:50pm, patient stated improvement in swallowing. She left with her husband. Patient and husband instructed to go ED if any symptoms worsen. They verbalized understanding.
This is a 70 y.o. female with PMH of HTN, hypothyroidism, anxiety presents with concerns of hypertension. Pt is accompanied by her son, who provides a majority of the peripheral history. Pts family notes prolong hx of poor blood pressure control, but recent pt has been having difficulty keeping track of her medication. Family has taken extra precautions to fill and label medication, but has found pt is improperly taking/mixing them up. Pt's son states that she has been having problems with her short term memory progressing for the past 1-1.5 months. Son also reports concern for depression. States that pt has been saying she would rather take all of her pills at once than go to a nursing home. Pt lives at home, takes daily medications for HTN and hypothyroidism. Son also states that a couple of weeks ago, pt fell after drinking at least 5 vodka drinks, for which she was never medically evaluated. Pt does not typically drink. Pt denies fever, chills, nausea, vomiting, change in motor or sensory, CP, or SOB. Admits to headache  that has not changed over the course of the day.
8-10PM on 12/9/02, patient had three episodes of vomiting and was difficult to arouse, was seen in ER. Labs and CT of brain (normal) done 12/10/02. Also rechecked in office 12/10/2002.
Feels like fluids in one side of the head; Some parts of patient's body swelling up; Dizziness; Heaviness in patient's eyes; allergic reaction; throat swelling; tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction), PHARYNGEAL SWELLING (throat swelling), HEAD DISCOMFORT (Feels like fluids in one side of the head), SWELLING (Some parts of patient's body swelling up) and DIZZINESS (Dizziness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PHARYNGEAL SWELLING (throat swelling) and FATIGUE (tired). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction), HEAD DISCOMFORT (Feels like fluids in one side of the head), SWELLING (Some parts of patient's body swelling up), DIZZINESS (Dizziness) and ASTHENOPIA (Heaviness in patient's eyes). At the time of the report, HYPERSENSITIVITY (allergic reaction), PHARYNGEAL SWELLING (throat swelling), HEAD DISCOMFORT (Feels like fluids in one side of the head), SWELLING (Some parts of patient's body swelling up), DIZZINESS (Dizziness), ASTHENOPIA (Heaviness in patient's eyes) and FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication  details were provided.
red spot has become elongated and is traveling down the patient's arm; red spot on arm at injection site; 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 MACULAR (red spot has become elongated and is traveling down the patient's arm) and VACCINATION SITE ERYTHEMA (red spot on arm at injection site) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red spot has become elongated and is traveling down the patient's arm) and VACCINATION SITE ERYTHEMA (red spot on arm at injection site). At the time of the report, RASH MACULAR (red spot has become elongated and is traveling down the patient's arm) and VACCINATION SITE ERYTHEMA (red spot on arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
I'm achy all over; a lot of aches to his arms and joints and stuff; a lot of aches to his arms and joints and stuff; makes him sluggish; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTCH COVID-19 VACCINE; Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left arm on 01Mar2021 at 16:00 (at the age of 75-year-old) as dose 2, single for COVID-19 immunization. Medical history included heart bypass in Jan2003, minor stroke in Mar2014 and cholesterol. Concomitant medication included evolocumab (REPATHA). The patient previously received BNT162B2 (PFIZER-BIONTCH COVID-19 VACCINE; Batch/Lot Number: EM9810), via an unspecified route of administration, administered in left arm on 06Feb2021 at 16:00  (at the age of 75-year-old) as dose 2, single for COVID-19 immunization. On 02Mar2021, the patient mentioned he was achy all over, a lot of aches to his arms and joints and stuff which made him sluggish. It was reported that the patient would like to know if it would be alright to take Aleve, Advil, or Tylenol or something like that. The outcome was unknown for the reported events.   No follow-up attempts are possible; no further information is expected.