chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse concerning a 13 year old female patient with no relevant drug reactions or allergies and with no pertinent medical history reported. On 14-AUG-2014, the patient was vaccinated with a first dose of GARDASIL (lot#, route and anatomical location was not reported). Other suspect vaccines included a first dose of VAQTA (lot#, route and anatomical location was not reported), administered on the same day. There was no concomitant medication. The registered nurse reported that the patient experienced an injection site rash, following the administration of the vaccines approximately in August 2014. Additionally, it was also mentioned that the patient reported that the rash spread all over her body, on an unspecified date in 2014. The treatment was prescribed by an unspecified physician in the form of BENADRYL, 10 mg, every 6 hours for 24 hours. No laboratory tests were performed. The patient sought medical attention by calling the physician's office. Finally, the registered nurse reported that following the treatment with BENADRYL, the patient's rash and injection site rash had currently resolved (stop date unspecified). The relatedness between the events and suspect vaccines were not provided. Additional information has been requested.
Work up on March 30th, 2021 at 2 am with severe pain in my right forearm. It felt as if I had a blood pressure cuff on way too tight. I got out of bed and took two Advil. When the alarm went off at 5:50 am, I told my husband about my pain and he called my doctor's office and got me an appointment at 8:30 am with a PA. She told me to ice my arm and to take 600 mg of Advil every 6 hours. The pain seemed to have lessened, but on Friday, April 2nd, I realized I couldn't bend the top knuckle of my right thumb, and both my right and left forearms were numb. I got another appt with the PA, and she ordered an x-ray of my cervical spine/neck.
This was my second vaccine for Covid.  I experience headache, shaking chill and flu- like symptoms.  My left arm was also sore.  I had similar sx with the firat dose of the two but the second dose was definitley more symptomatic.  My chillswere so bad that I could bvarely open the Tylenol container to get the medicine out.  I should also state that I also had the Covid disease and I know that this is a risk factor for having a reaction.  I think people should be told that they could have a reaction so they do not plan anything important the following day, but they should still get the vaccine. The day following the reaction I felt perfect.
blisters in her mouth; it has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine. This spontaneous case was reported by a pharmacist and describes the occurrence of ORAL MUCOSAL BLISTERING (blisters in her mouth) and PRODUCT DOSE OMISSION ISSUE (it has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine.) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL MUCOSAL BLISTERING (blisters in her mouth) and PRODUCT DOSE OMISSION ISSUE (it has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine.). At the time of the report, ORAL MUCOSAL BLISTERING (blisters in her mouth) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (it has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.
This patient as brought in to the clinic at the time when Pfizer vaccine was just authorized for 5 years and up. The father that brought the patient in filled out the forms required at the time for the vaccine. The date on the form was put down on the form to present the patient as a 5 year old. The parent signed the form attessting that all information was correct including the date of birth. Which I got a verbal confirmation from the parent. Sometime after that it was found out that the information given to us by the parent was incorrect regarding the DOB at the time the vaccination was to be intered in system. Parents were attempted to be reached and we were not able to make contact. The patient was monitered post vaccination for the required 15 minutes and did not exibit any adverse reactions,symptoms or complaints. The patient left ambulatory with the parent.
Pt experienced personality and emotional changes, paleness, weakness, headache, joint stiffness, rash, and difficulty breathing.
A very small amount of vaccine was visible on arm after syringe was removed. Based on manufacturer recommendations, revaccination is not required.
I experienced the normal expected symptoms after the booster (sore arm, lethargy) but the Adverse Side Effect that I would like to report is mild Vertigo,  mostly upon waking up in the mornings.
pt recvd vax & devel fever of 103; blotchy rash & swelling left leg up to inguinal area; nervous acting; acted stiff;
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 17-OCT-2012 01:11, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
12 hours after receiving 1st vaccine I awoke with severe shoulder pain in both shoulders, worse in right shoulder (opposite from vaccine arm), very limited mobility in arms.  Also pain in most other joints and muscle weakness.  The situation is ongoing, some days are slightly better some are worse.  Knees, shoulders and right hand are most afflicted.  Pain is non-stop.  Muscle weakness has grown worse.  Having an extremely difficult time filling this form.
BODY MALAISE; SORENESS AT INJECTION SITE; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 23-JUL-2021, the subject experienced fever. Treatment medications included: paracetamol. On an unspecified date, the subject experienced body malaise, soreness at injection site, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 25-JUL-2021, and nausea, and headache, was recovering from body malaise, and had not recovered from soreness at injection site. This report was non-serious.
This is a vaccine administration error report. The vaccine administered to the patient was drawn from a vial used the previous day instead of a fresh vial. Total time between first vial puncture and when this was administered was 27.5 hours. The patient had no other observed adverse events.
Left arm tender after shot given. That night arm was numb. Pain continued and employee reported on 12/8/17 to Employee Health. She was referred to another provider. She did not go and did not respond to email sent on 12/22/17. I spoke with her today. States she hadn't felt the pain "for awhile" until recently going ice fishing. She felt like the cold made her left arm hurt again. She felt the nurse giving the shot gave it too high.
rash on my torso that developed within 48 hours of the vaccination, rash on his chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my torso that developed within 48 hours of the vaccination, rash on his chest) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH (rash on my torso that developed within 48 hours of the vaccination, rash on his chest). On 26-Jan-2021, RASH (rash on my torso that developed within 48 hours of the vaccination, rash on his chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.  Second dose is scheduled for 20Feb2021.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: cellulitis-Severe, Additional Details: pt got cellulitis. went to urgent care and got antibiotics, is improving
Shortness of breath, low oxygen saturation. Admitted to hospital and placed on oxygen. DDimer elevated, liver enzymes elevated.
Patient was given a first dose of the Pfizer covid vaccine, however after the vaccine was given it was discovered he already had the Johnson and Johnson vaccine.
Pt complains of moderate pain. Pain is a 5 on scale 1-10. Pain described as sharp and throbbing. Pain is localized to (R) hip. Pain radiates to (R) thigh. Pain began 3 days ago pain worsens with ambulation and weight bearing. Pain improves with rest. No swelling or stiffness.
Sore throat, dry eyes, mild stomach upset, head ache, muscle and joint pain/aches
Guillain Barre syndrome; shortness of breath; tingling in her hands; legs were numb and tingling; feet were swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) 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 medical history reported). Concomitant products included AMLODIPINE and BISACODYL (LAXATIVE [BISACODYL]) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (feet were swollen). On 01-Apr-2021, the patient experienced HYPOAESTHESIA (legs were numb and tingling). On 02-Apr-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criteria hospitalization and medically significant). On 19-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) and PARAESTHESIA (tingling in her hands). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to GUILLAIN-BARRE SYNDROME. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), DYSPNOEA (shortness of breath), PERIPHERAL SWELLING (feet were swollen), HYPOAESTHESIA (legs were numb and tingling) and PARAESTHESIA (tingling in her hands) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   treatment information not provided  Additional information:by 02Apr2021 she was admitted to the hospital and was diagnosed with GBS (Guillain Barre syndrome) She stayed in the hospital for 5 days.  Company Comment  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. However, Further information has been requested.
Bruised area on left tricep (Immunization given in left deltoid). Bruise roughly 3 x 12", appears to be resolving. Was somewhat painful.
Fever, HA, neck pain, photophobia. Hospitalized 9/19/10 to 6/22/10. Diagnosed as viral meningitis.
This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (feels a bit bad), feeling hot (at night he was hot) and headache (bit of a headache/little headaches) in an adult male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 027H21B, 027C21A and 016B21A) for COVID-19 immunization. No medical history reported. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 21, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal (feels a bit bad), feeling hot (at night he was hot) and headache (bit of a headache/little headaches). At the time of the report, feeling abnormal (feels a bit bad), feeling hot (at night he was hot) and headache (bit of a headache/little headaches) outcome: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-424356 (patient link).
Swelling noted with redness and warmth in the upper right arm where the deltoid is.
Headaches, brain fog, and fatigue starting 5 hours post vaccine. Shivering (feeling cold), fever, body ache.   Took NyQuil once fever reached 102F 8 hours post vaccine which helped.   Woke up better but a bit tired and headache still persisting. Took a Tylenol.
Headache, body ache, difficulty breathing, extreme fatigue, weakness, cold chills, fever on day after vaccination  Two days after vaccination:  fatigue
headache; sick; nausea; she was feeling terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sick" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; ILLNESS (non-serious), outcome "unknown", described as "sick"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she was feeling terrible". Therapeutic measures were taken as a result of headache, illness, nausea, feeling abnormal.  Additional information: She was already sick when she took the Pfizer Covid-19 vaccine first dose on 09Apr2021. The 2nd dose was 3 weeks later and didn't provide the exact 2nd dose schedule. She took some Tylenol and had been feeling better now. He would like to consult if it was ok to take medication such as Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My husband developed a low-grade fever, chills, sore throat,  Mild cough, and extreme fatigue.  He also tested positive for COVID.  He had COVID test a day prior to vaccine and tested negative.
No Adverse Event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 prophylaxis.     Medical History or Condition were not reported.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding.  Concomitant product use was not provided by the reporter.  Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 1st out of 8 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735647, US-MODERNATX, INC.-MOD-2023-735653, US-MODERNATX, INC.-MOD-2023-735657, US-MODERNATX, INC.-MOD-2023-735666, US-MODERNATX, INC.-MOD-2023-735674, US-MODERNATX, INC.-MOD-2023-735682, US-MODERNATX, INC.-MOD-2023-735693 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735666:5 out of 8 patients US-MODERNATX, INC.-MOD-2023-735657:4 out of 8 patients US-MODERNATX, INC.-MOD-2023-735647:2 out of 8 patients US-MODERNATX, INC.-MOD-2023-735653:3 out of 8 patients US-MODERNATX, INC.-MOD-2023-735674:6 out of 8 patients US-MODERNATX, INC.-MOD-2023-735682:7 out of 8 patients US-MODERNATX, INC.-MOD-2023-735693:8 out of 8 patients
Following immunization, patient had itchy, warm rash that appeared on deltoid and bicep.
starting to get a fever; very tired/couldn't even get up; Right above my top lip, it tingles; it's like numb; tenderness at the site/sore arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Right above my top lip, it tingles), HYPOAESTHESIA ORAL (it's like numb), VACCINATION SITE PAIN (tenderness at the site/sore arm), CHILLS (chills) and PYREXIA (starting to get a fever) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced PYREXIA (starting to get a fever). 09-Oct-2021, the patient experienced FATIGUE (very tired/couldn't even get up). In October 2021, the patient experienced PARAESTHESIA ORAL (Right above my top lip, it tingles), HYPOAESTHESIA ORAL (it's like numb), VACCINATION SITE PAIN (tenderness at the site/sore arm) and CHILLS (chills). The patient was treated with NAPROXEN on 08-Oct-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Right above my top lip, it tingles), HYPOAESTHESIA ORAL (it's like numb), VACCINATION SITE PAIN (tenderness at the site/sore arm), CHILLS (chills), PYREXIA (starting to get a fever) and FATIGUE (very tired/couldn't even get up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided,   This case was linked to MOD-2021-347091 (Patient Link).; Sender's Comments: This case concerns a 31-year-old female patient with no previous relevant medical history, who experienced the expected non serious events of Fatigue, Pyrexia, Chills, Vaccination site pain and the unexpected non serious events of Hypoasthesia oral and Paraesthesia oral after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The events occurred approximately 1 day after the second dose of Spikevax. The patient characterize her symptoms as "fells like COVID", but as there is no evidence to suggest Suspected COVID at this moment it is not captured as an event.  The rechallenge is not applicable, since the schedule of vaccination has been completed and a further dose is not expected. The benefit-risk relationship of Spikevax vaccine is not affected by this report.
She got her 4th vaccine, she had shooting pain suddenly if she was putting her arm backwards or trying to straighten her pillow out.  She had severe pain, her arm does not go back to fasten her bra.  Very painful, not able to lift her arm to her other arm.  The pain comes down  from the shoulder to her arm.  This all happened after this vaccination.  She thought it would go away, and kept waiting.  Last night again it was troublesome and she got up and said that she may have to see her doctor and came to the pharmacist to see what went wrong, and wanting her to file a report.  Wondering if she put the vaccine in wrong, hit a nerve or something.  The pain does not happen all the time but then it suddenly pops up.    With the other vaccines she had the normal pain, tiredness, took Tylenol and then in 2-3 days it went away, but this has not gone away.    She is concerned that something has happened to her shoulder from the vaccine, and wants to know what she can do.
red circle at injection side; had diarrhea; feeling a little funny; arm ached; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (had diarrhea), FEELING ABNORMAL (feeling a little funny), PAIN IN EXTREMITY (arm ached) and VACCINATION SITE ERYTHEMA (red circle at injection side) in a 79-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 16-Apr-2021, the patient experienced DIARRHOEA (had diarrhea), FEELING ABNORMAL (feeling a little funny) and PAIN IN EXTREMITY (arm ached). On 28-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle at injection side). At the time of the report, DIARRHOEA (had diarrhea), FEELING ABNORMAL (feeling a little funny), PAIN IN EXTREMITY (arm ached) and VACCINATION SITE ERYTHEMA (red circle at injection side) outcome was unknown. Unknown          No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow-up received on 29-May-21 and contains no new information.