chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient (associate) came back to pharmacy after eating his lunch stating he felt a little dizzy and his mouth a little tingling. He wanted to know if the Pneumovax interacted with his blood pressure medicine, amlodipine. The pharmacist called his doctor and store management sent patient to the immediate care center across the street from the store. This patient denied wanting to use a scooter for transport around the store and denied taking any diphenhydramine offered by the pharmacist.
Vessicles and pink dots all over.  Various stages of healing and new vessicles forming while in the room.  Arms, legs, face, abdm, back
irritable;leg edema thigh to ankle;t 102.8;diag:rt.otitis media
pt recv vax 21APR97 & inj site reddened & swollen about 2" in diameter;smaller reddened areas below inj site (about 1/2" diameter) on 30APR97;pt saw MD took DPH orally x 4 days & used DPH;
p/vax pt devel severe red rashes around the entire upper arm of the inj site area;pt devel significant dependent edema extending from the pt elbow to the wrist;pt recovered w/in 48hr;
Approximately five minutes after receiving the shot, I began to feel a burst of pain rush through my entire left arm. A few seconds afterwards, I started to feel nauseated. Immediately, I felt weak, light-headed, and tired. I began to sweat profusely, as well. I could barely move my arm to flag down one of attendants who was monitoring us. She asked me what was wrong, and I tried to describe what was going on, but I could barely talk or keep my eyes open. She radioed for help and the paramedics came over to me. They wanted to move me to a private room and asked if I could walk. I tried to walk there, but I started to fall so one of the paramedics hoisted me up to help me. They asked me some questions will they were waiting for a stretcher, all of which I could hear and understand, but I was unable to response to. The stretcher came and I laid down, but I was already starting to feel better by then. I was very out of it, but I think this entire process took maybe 10-15 minutes. I laid there for maybe another 15 minutes, and I began to be able to talk again and open my eyes. I tried sitting up and that went alright. I answered some questions for them while they took my blood pressure, monitored my pulse, and took my temperature. After another 15 minutes or so, I felt well enough to walk back to my office in the Health Department. I didn't have any other problems for the rest of the day.
Fatigue, hot and cold flashes, headache, sore throat, mild joint pain, Nausea
Initially just a sore arm; however, on day 7 post vaccine (3/9), I developed a red patch (approx 10 cm) over the injection site accompanied by burning and itching.  On day 8 (3/10) post vaccine, I developed additional red patches on the front and back of the L upper arm and L axillary lymphadenopathy and tenderness.  These symptoms have gotten progressively worse.     After reading an article from the New England Journal of Medicine on delayed reactions, I started taking Allegra 180 mg daily (starting 3/15).  Now just watching for improvement and hopefully resolution of this "Covid arm".
(L) shoulder pain after shot (immediately) then resolved after a few days, then recovered, now persists. 1 month after vaccine.
Information has been received from a nurse concerning an adolescent female ("older teen") who on an unspecified date was vaccinated with HPV rL1 6 11 16 18  VLP vaccine (yeast) (Lot# not reported). The nurse could not remember if this was the first dose of the vaccine the patient had received. Subsequently, post vaccination the patient developed localized redness at the injection site which lasted until the next day. Unspecified medical attention was sought. By the next day the patient was considered to have recovered from localized redness at the injection site. Additional information has been requested.
Left Swollen arm at injection site which is red, raised, warm to touch and painful. He is nauseated and has been since the evening after his flu shot on 11/01/08. His mom plans on taking him to his pediatrician
Hallucinations; Chills; Fever; Body aches; This is a spontaneous report from a contactable consumer. A non-pregnant 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), intramuscular in left arm, on 22Apr2021 at 10:00 AM (at the age of 26 years), as second dose, single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 on 01Apr2021 (at the age of 26 years) for COVID-19 immunization (arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a workplace clinic facility. On 22Apr2021 at 10:00 PM, the patient experienced chills, fever, hallucinations, and body aches. No treatment was received for the events. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the events in Apr2021.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.
First day sore arm and slight headache, next day approximately 22 hours later, chills and slight body aches, then highly congested and fever of 101degrees.  Fever broke about 3 am in the morning and I noticed that I could not hear out of right ear.  Left and right face was tender and made metal drum like sounds in right ear.  Went to urgent care on Friday and received a steroid shot and anti-biotics.  Relieved sensitive face symptoms, but still had hearing loss and high tinnitus.  Went to ENT was put on high dose of steroids, no difference,  Hearing test, loss of 70% hearing in right ear.  Hearing test one month prior 12% hearing loss.  Sensitivity to touch ear yet.
Mom called on 1/9/03 and stated child broke out with about 10-20 chickenpox. Did have vaccine in the past. Also had a low-grade temperature of 100F.
Local redness; warmth, swelling, hives on injection site, 5 minutes after injection. No resp distress. Pt alert and crying 2"x2" area.
I started with a sudden consistent dry cough. I took a home test the next day it was positive, and I called the doctor. I was told to take Nyquil and Dayquil.  The cough was really bad it was keeping me awake. I had fatigue and five days in I had a really bad eczema outbreak. It was on my chest back, and stomach. I ran a fever on and off the entire time. It was up to 102.  It took almost 10 days to be relieved of symptoms. I suffered from fatigued the entire month. I did develop a metallic taste in my mouth during that month.  I'm still a little bit tired, I cant work out like I used to. It is significantly better I don't have to take naps like before after working.
While pt was sitting in observation for about 15 minutes she reported feeling excessive nasal congestion. EMS was on site, Pt's BP was 224/112, came down to 203/108. Pt reported nasal congestion seemed to be getting better. Pt denied headache, dizziness, visual changes, chest pain, sob, swelling, tingling. Pt reports she usually has normal BP. Pt did not want to go to the hospital. She signed a refusal for transport to the hospital with EMS. Pt was advised to call her doctor when she got home. Pt was advised on ED precautions and when to call 911. Pt verbalized understanding.
Red streak about 6 inches long and 3 inches wide from the site of the injection down the arm.  Itching, stinging and warmth. Began 2 days after the injection and is still present on the 4th day after injection. I have applied Benadryl cream, and have taken Tylenol.  It appears a little better today.
Myalgia, Arthralgia & Fever Narrative: Severe fever, chills, arthralgia, myalgia x4 days. Sought medical care with PCP and was informed to not receive 2nd dose. PCP advised rest, antipyretics, and fluids for management.
Day after vaccine started with  headache, blurred/double vision, nausea, difficulty concentrating.
Pain, arm swelled to 3 times size, but not where injection was given, fever between 99+99.9 (normal temp is usually 97.6).
Patient complained of feeling dizzy and short of breath immediately after receiving the vaccine. She states that she feels this way every time she gets a vaccine.  Her BP was 98/60 mmHg,  pulse 62 BPM and RR 18 breaths/minute. She lied down for 15 minutes and reported that she felt normal. BP was rechecked to be 110/60 mmHg. Her mother was with her and she felt well enough to leave.
About 20-25min p/MMR adm, pt developed hives on face, had tearing & became congested (nasal); Mild wheezing in auscultation; Given 0.25ML EPI SQ; good response; Given Diphenhydramine 5mg/kg/d orally, maintenance;
administered expired daptacel to patients; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA150849, 2019SA150852, 2019SA150840, 2019SA150851 and 2019SA150853 (same reporter).  This case involves a 5 years old female patient who received fifth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (formulation: unknown, lot: C52028A, expiry date: 17-May-2019) via unknown route in unknown administration site on 24-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  It was unknown if any adverse event was occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
PATIENT PASSED OUT IN DAD'S ARMS, CAME TO WHEN WE LAID HER DOWN SWEATINESS AND DIZZINESS RESOLVED ON ITS OWN
States had a rash on feet the next morning. We saw her Employee Health 2 days following vaccines, Influenza and Tdap. She had 6cm dark spot with rash on L foot R foot was darkened with rash on shin. Has tingling and pain. States was seen by a physician.
24SEP91 mom states swelling immediately post vax; 1" x 1" area moveable localized swelling starting approx 1/4" above inject site; 5mm area redness center of swelling; 24SEP91 exam by MD @ clinic dx hematoma; 26SEP91 less redness knot same;
Headache, Arthralgia, NauseaVomiting, Intermittent Narrative:
After receiving Covid-19 product Moderna NDC 80777-0275-99 RX team and RPh were under the impression that this product was to be used for booster doses. After due diligence and checking VARS it was found to be that this patient may have received 0.25ml of that product (rather than the recommended 0.5ml dose for boosters). I will then contact the patients physician to see if they would like us to repeat the dose.
goid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EN6206) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot# EN6203), for Covid-19 immunization. The following information was reported: CUSHINGOID (non-serious) with onset 21Feb2021, outcome "unknown", described as "goid".  No follow-up attempts are possible. No further information is expected.
Mom called on 10/29 concerned about her daughter  who received her moderna covid booster on 10/28. mom stated daughter is currently in chemotherapy and has developed several symptoms such as a fever of over 100* for 24 hours, cold sweats, swelling at the injection site, swollen lymph nodes, and confusion. I told mom to tell daughter to seek medical attention at either an urgent care or at the ER and to also inform her doctor of the reaction.
Flu like symptoms; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and NAUSEA (Nausea) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included taking fluids.; Sender'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.
Caller's son also tested positive; Caller's son also tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Feb2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Caller's son also tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) positive, notes: tested positive.  Clinical course: Caller's son also tested positive and caller wanted to talk to her provider about all of it. Caller's son had his Covid vaccine on 04Feb2023. That was his fourth one and he has been vaccinated all along and tested positive for Covid. He was sick last week. Figured out tomorrow is 10 days. Caller declined report for her son, isn't that par for the course at this point. Is there a product complaint to report was yes. Description of Product Complaint: Description of complaint, Caller's son had his Covid vaccine on 04Feb2023. That was his fourth one and he has been vaccinated all along and tested positive for Covid. Caller declined report for her son. Product strength and count size dispensed was not provided. Additional lot numbers was not provided.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt became cold and clammy. Non verbal for a few seconds (during the onset of vagal response. Pt immediately placed in supine postion with legs elevated. BP 113/66 HR 54. Pt kept for 30 minutes after vaccine event. Pt with irregular heart rate and low HR. Pt unsure if this was normal. Pt stated had not eaten anything today. Bp 114/70 and HR 54 on discharge.
This case was reported by a healthcare professional and described the occurrence of red area at injection site in a 18-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  Concurrent medical conditions included unknown allergies. Concurrent medications included Allergy injection.  On 16 September 2008 at 14:20 the subject received 1st dose of FLULAVAL at 0.5 ml, subcutaneously in the right arm.  This was considered to be the wrong route of administration.  FLULAVAL should be given intramuscularly.  On 17 September 2008, 1 day after vaccination with FLULAVAL, the subject experienced a red area at the injection site and swelling at the injection site.  At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 14 November 2008, via pharmacist, who reported the subject was given FLULAVAL intradermally in the right forearm. The site was swollen and red for three days. The events resolved on 19 September 2008. The pharmacist considered the events possibly related to vaccination with FLULAVAL. The events were also associated with erroneous administration.
Developed spreading erythematous nonvesicular macular rash starting on L shoulder and axilla 1 week later; spread to rest of body
About 5 hrs after had terrible stomach gas pains for several hours. Had terrible chills and became very woozy. Still chilled and woozy at 12 hrs after shot
This spontaneous report as received from a 67 years old male consumer refers to himself. The patient's medical history included carpal tunnel surgery. The patient did not have drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot number not provided) two to two and a half years ago. Concomitant medications included allopurinol and unspecified blood pressure medications. A month to 6 weeks ago, approximately in March 2013, the patient developed shingles. The shingles was diagnosed at a routine physical where because of a rash the doctor noticed. The patient said that he did feel like a bug bit him, but said there was no itching or pain, and the rash had "faded". The patient noted the healthcare professional (HCP) said that his lack of some more painful symptoms may be attributable to the ZOSTAVAX vaccination. No treatment was given for adverse event. No lab diagnostics studies were performed. The patient did not sought medical attention. Additional information has been requested.
08/21/04-Severe swelling of entire left leg and foot and fever of 101-called emergent doc and she advised was normal reaction-give mortin and zyrtec. 08/22/04-Hives, red rash (hot to the touch), swelling and fever 08/23/04-Symtoms worsened:purple rash (hot to the touch),continual swelling and hives.Called clinic-advised that could be infection and needed to be seen ASAP. 08/23/04-Was seen in clinic by RN and the doctor. Both indicated that reaction was not common. Judged against tissue infection after reviewing the symptons again and again.Advised to increase dose of Zyrtec to 1 1/2 teaspoons nightly.  09/02/04-Purple rash is still visible. All other symptoms subsided.
sick for 4 days; dizziness; she could not go to the bed and bathroom; achiness; nausea; fatigue; fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 4 days), DIZZINESS (dizziness), HYPOKINESIA (she could not go to the bed and bathroom), MYALGIA (achiness) and NAUSEA (nausea) in a 67-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.    Co-suspect product included non-company product DUPILUMAB injection for Eczema, Atopic dermatitis and Asthma.    The patient's past medical history included Depression from October 2020 to December 2020, COVID-19 ((latency: 1 year 3 months 6 days), the patient had fever (pyrexia), she did not have a cough and was sick for a month (illness).) on 12-Mar-2020, COVID-19 pneumonia on 13-Mar-2020, Dry eye and Cataract operation. Concurrent medical conditions included Pruritus (severe itching of the scalp and the shoulders) and Condition aggravated (history of lower back flaring in the previous years).   On 06-Dec-2020, the patient started DUPILUMAB (Subcutaneous) 600 mg. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (sick for 4 days), DIZZINESS (dizziness), HYPOKINESIA (she could not go to the bed and bathroom), MYALGIA (achiness), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (fever of 102). At the time of the report, ILLNESS (sick for 4 days), DIZZINESS (dizziness), HYPOKINESIA (she could not go to the bed and bathroom), MYALGIA (achiness), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2020, SARS-CoV-2 antibody test: positive (Positive) SARS-CoV-2 test-Positive. In March 2020, Chest X-ray: inconclusive (Inconclusive) no improvement on the Chest X-ray. In February 2021, Body temperature: 102 (High) fever of 102.         No Concomitant medications were reported No treatment information was provided The action taken for mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-004691.
puking; worst headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (puking) and HEADACHE (worst headache) 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 30-Jun-2021, the patient experienced VOMITING (puking) and HEADACHE (worst headache). At the time of the report, VOMITING (puking) and HEADACHE (worst headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Myalgia fatigue  Muscle ache and soreness all over. Fatigue experienced.
Fever between 99 and 101 for almost 4 days, dizzy, cold childs, weakness, stomach pain.
chills and rigors started at 1 am through the next  24 hours.  Fatigue for the following 24 hours.  Cancelled personal care appt.
Sore, red arm at injection site.  Continued into next day, very red arm, feeling of sickness, nausea, dizzy, entire arm is sore.  Felt feverish, but had no fever. Took tramadol.
Same day as vacc, mom noticed child appeared hot, did not take temp.  Woke early morning screaming, axillary temp 101.9. Administered tylenol, l/arm red, slight swollen. Observe for SOB, and hive like bumps. Seek ER ASAP.
Moderna COVID-19 Vaccine Patient got Moderna booster dose (0.25ml) on 12/31/2021 at 17:30. Patient had chest pain and shortness of breath at 20:00 on the same date 12/31/2021. Patient's family member called ambulance and send her to hospital. Patient lost consciousness when paramedic arrived. Patient passed away in the hospital on 01/12/2022.
This spontaneous report was received from a nurse concerning a 3 years and 6 months old patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 01-JUN-2016, the patient was vaccinated with VARIVAX for prophylaxis, non valid lot number L027432 (dose, route of administration, anatomical location and expiration date were not reported). On an unknown date, the patient was exposed to another child with chickenpox (exposure to communicable disease) at an unspecified daycare. The outcome of exposure to communicable disease and the causal relationship between the event and therapy with VARIVAX were not reported.