chrisvoncsefalvay/vaers-outcomes huggingface dataset:
congestion; fever blisters on lip; nose is constantly running; no sleep in 4 days; sick; slight fevers every night; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL CONGESTION (congestion), LIP BLISTER (fever blisters on lip), RHINORRHOEA (nose is constantly running), INSOMNIA (no sleep in 4 days) and ILLNESS (sick) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On an unknown date, the patient experienced NASAL CONGESTION (congestion), LIP BLISTER (fever blisters on lip), RHINORRHOEA (nose is constantly running), INSOMNIA (no sleep in 4 days), ILLNESS (sick), PYREXIA (slight fevers every night) and HEADACHE (headache).   The patient was treated with LEVOFLOXACIN for Sickness, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (congestion), LIP BLISTER (fever blisters on lip), RHINORRHOEA (nose is constantly running), ILLNESS (sick), PYREXIA (slight fevers every night) and HEADACHE (headache) had not resolved and INSOMNIA (no sleep in 4 days) had resolved.      Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-048206 (Patient Link).
TD given 11/04/2005 Presents 11/07/2005 6 x 10cm area red, swollen, T 99.5, ice, Benadryl.
Horrific pain in left arm, shoulder, neck  every day since the first injection.  Pain is 24/7, ongoing, causes lack of sleep, severe discomfort, inability to function
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; LIPITOR; multivitamin (unspecified). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (26Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; COVID 19 Treatment included Paxlovid from 21Aug2022 to 26Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contribution of the suspect drug to the onset of event "COVID 19 treatment" cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Tinnitus. I had tinnitus many years ago, late 2014 and 2015. But it subsided long ago, maybe a couple of years ago. Suddenly on the evening of December 8,  2021, two days after the booster, it came back. Also, minor ear pressure, stiffness in back of head, neck and shoulders (worse at night than during the day). I haven't seen anyone about it, just waiting to see if it goes away so far.
p/vax pt devel chickenpox that consisted of 30 lesions;pt to MD office;tx w/DPH pt fine now;
flare up, and pain; felt like she had flu like symptoms / hospitalized monday / until tuesday; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included lamotrigine, vitamin d, salbutamol sulfate (Proair Hfa), tiotropium bromide (Spiriva Respimat), budesonide + formoterol fumarate (Symbicort), roflumilast (Daliresp), duloxetine hydrochloride, hydrochlorothiazide, cyclobenzaprine hydrochloride, metformin hydrochloride (Metformin Er) and tofacitinib citrate (Xeljanz).   On 5th June 2021, the patient received Shingrix. On 5th June 2021, less than a day after receiving Shingrix and an unknown time after starting lamotrigine and vitamin d, the patient experienced influenza-like symptoms (serious criteria hospitalization). On 8th June 2021, the patient experienced exacerbation of pain (serious criteria hospitalization). The patient was treated with steroids nos (Steroids), tramadol and prednisone. On an unknown date, the outcome of the influenza-like symptoms and exacerbation of pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and exacerbation of pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received Shingrix shot in the morning and in afternoon she felt like she had flu symptoms.  On 7th June 2021, the patient called the physician and was told to go the emergency room and was hospitalized. The patient was treated with intravenous steroids every 3 hours while at hospital. On 8th June 2021, 3 days after vaccination, the patient had flare up pain (5 out of 10) and was prescribed tramadol and Prednisone and was discharged. The reporter consented to follow up with her and prescriber. No additional information was reported.
diarrhea, nausea, anemia; diarrhea, nausea, anemia; diarrhea, nausea, anemia; This is a spontaneous report from a contactable consumer (patient herself). A 77-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6207; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:00 (at age of 77-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included hypertension, vascular stent stenosis, seasonal allergy from an unknown date and unknown if ongoing. Concomitant medications included losartan (LOSARTAN), metoprolol tartrate (METOPROLOL TARTRATE), fexofenadine hydrochloride (ALLEGRA), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication. The patient previously took cipro [ciprofloxacin], crestor, dulera and percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced drug hypersensitivity. Historical vaccine included first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6203; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:00 (at age of 77-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 21Mar2021 the patient experienced diarrhea, nausea, anemia. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of diarrhea, nausea, anemia as patient had received treatment with omeprazole, benefiber and iron. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was not resolved.  No follow-up attempts are possible. No further information is expected.
1/23/09 1:30 p.m. I administered MMR and Varicella IM rather than sub q.  There were no adverse reactions while client here.
Following morning had swollen lymph node in right clavicle. Sore Neck. 2nd day after the swollen lymph node on the clavicle is noticeably larger. Neck is stiff and painful. Also feel sore lymph node under right armpit.
Patient has a history of seizure disorder. Often reacts to injections with seizure. Within seconds of injection, child became unresponsive and went into a 4 minute tonic seizure. Patient has a vagal stimulator implant and mother used the stimulator X 3 every minute after the seizure started. Seizure resolved within 4 minutes.
Diagnosed with severe arthus allergic reaction and pulmonary distress. Treated with high and prolonged dose of prednisone - ongoing at present.5/4/09-records received-office note 4/1/09-follow up with allergist after difficult winter now doing signicantly better.  Routine allergy visits for follow-up care.
Narrative:  Fully vaccinated, admitted for persistent bleeding from foot wound, COVID positive at SNF day prior to admission
On 07/03/2021 Patient was administered a Johnson & Johnson Covid-19 sot in his right arm at 12:43p.m. Everything went well as far as the shot went,but as time went on 07/19/2021 he was waken at 5:30 a.m. a bad case of acid reflux which he had awhile ago  but not since he was taking prebiotics and probiotics which helped but not this time it came with a vengeance. He was vomiting and had a fever. He did take some Omeprazole that morning  which it stop for a while but the moment he went to eat some food it started all over again the vomiting and the fever was back higher then before. By Wednesday 07/28/2021 it was better bad so we went over to a Medical Center they then took a Coivd-19 Test which was negative. They did ran a battery of blood work on him but after waiting for five long hours to be seen by a doctor he was extremely cold in the waiting area and he was in great pain sitting on the uncomfortable chairs we went home. The following day we went over to urgent care and once again the PA give him another Covid-!9 test which was once again negative The PA suggested we go over to a Hospital. The next day we went over there was tested again and was negative again They checked him in but they never found the Covid-19  after being poked and stuck soo many times he was really not feeling good and they did know that he had a inflamed and infected gallbladder which the infection traveled through his blood stream Which was very dangerous for him however it appeared that they were taking his blood every two hours which became very unbearable for him and he wanted to go home. I went to pick him up at 3:00 a.m. One of the call me to convince to still in the hospital but he refused. So the next day we went over to another Hospital, Their was when he tested postive all because his gallbladder was very inflamed and infected due to the vaccine and he also has a blood clot thats on top of his liver.Now he has to wear a colonscopy bag until they can remove his gallbladder which is about four weeks . He has to wear the bag to drain any infection . They have him taking A blood thinner Drug  which was $645.93 which we can't afford.
Became feverish and body aches in evening of 8/18/06 T 97.7 per mother, at 4:30am 8/18/06 had abdominal pain and shaking legs, felt weak, seen at medical clinic that day.
Diarrhea; Colitis; Vomiting; Nausea; severe stomach pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021. The most recent information was received on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain), DIARRHOEA (Diarrhea), COLITIS (Colitis), VOMITING (Vomiting) and NAUSEA (Nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics, Allergic reaction to antibiotics, Allergic reaction to antibiotics, Diabetic, Asthma, Hypothyroidism and Angioma. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA), LEVOTHYROXINE SODIUM (SYNTHROID) and INSULIN GLARGINE (LANTUS) for an unknown indication.   On 31-Mar-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 01-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach pain), COLITIS (Colitis), VOMITING (Vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (severe stomach pain) and COLITIS (Colitis) had not resolved, DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown and VOMITING (Vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Colitis diagnosed.         Lab test include promethium test results negative. Treatment for the event include bacterium. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUN-2021. Allergic medications reported. Lab test reported. Concomitant medications were reported. outcome of the event and new event reported.
Stomach pain; Has not eaten anything; Could not get out of bed; Shaking; Headache; Muscle pain; Joint pain; Chills; Fatigue; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DECREASED APPETITE (Has not eaten anything), BEDRIDDEN (Could not get out of bed), TREMOR (Shaking) and HEADACHE (Headache) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DECREASED APPETITE (Has not eaten anything), BEDRIDDEN (Could not get out of bed), TREMOR (Shaking), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Slight fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DECREASED APPETITE (Has not eaten anything), BEDRIDDEN (Could not get out of bed), TREMOR (Shaking), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   This case was linked to MOD-2021-035030 (E2B Linked Report).
This is a spontaneous report received on 13-MAR-2017 from a pharmacist regarding a patient of unknown age and gender who received a dose of PNEUMOVAX 23 injection on an unknown date for prophylaxis. The pharmacist reported that an expired dose of PNEUMOVAX 23 lot #L012215, exp 13-JAN-2017 was administered to the patient on 13-MAR-2017. The patient has not experienced an adverse effect. No additional information was reported. No further information is expected.
Pt received 2 covid vaccines, 3/11/21 and 4/1/21 and was later hospitalized on  12/5-12/13 and pt died,
Migraine headache 3 hours post shot.  Headache each morning since. Resolves with 800IB
Patient mentioned ongoing soreness in right arm on 10/27/2019 (7 days after vaccination), but did not mention seeking medical treatment for soreness at that time.
Fluvirin w/ Thimerosal given to OB pt. LMP = 09/07/2009. EDC = 6/16/2010. Pt does NOT have an OBGYN. Pt NOT hospitalized after receiving H1N1 vaccine.
Right after receiving HAV, DTaP and Influenza vaccine hives on face and arm. Epinephrine 0.15mg IM given at 12:15pm. EMT called in. Mom refused to go to ER. Mom took him to PCP.
Broke out in red blistery, rash on 01/03/03; Mild fever; Came to office, 2 days later; Dx as 'varicella" by physician.
Rash and hives on body trunk, joints began on Wednesday, continue through Thursday, visited doctor on Friday.
Changes in menstrual cycle. 7 days late to begin cycle. Usually lasts 3-4 days and I?ve had heavy bleeding for 9 days and continuing.
This spontaneous report was received from a pharmacist regarding an adult patient (reported as approximately 27 or 28 years old) of unknown gender. The patient's medical history, concomitant medication and concurrent conditions were not reported; the patient had previously received 2 doses of M-M-R II when the patient was a child. The reporter stated that an unspecified physician wanted the patient to be vaccinated again two doses of the above mentioned vaccine (Inappropriate schedule of drug administration) (Inappropriate schedule of drug administration). On an unknown date in 2017, the patient was vaccinated again with a dose of M-M-R II (strength, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Furthermore, no adverse events were reported.
Temperature: 98.6 Palpable lesion found on thigh. Right, red in color, and 2 cm in size. Shape is round, indurated, and warm. Treated with cephalexin 250/5 2 tsp po q12. Cool compresses.
ON SATURDAY 11/17/18. You received a FLUZONE IM injection. A rash started Sunday (next day) about 5 inches long and 4 inches wide and soreness and redness.
Tachyacarida/anxiety  Pulse Ox: 95 @ 4:23pm Pulse/Heart Rate: 95 @ 4:23, 73 @ 4:26pm   Transfered to EMS @ 4:29pm for evaluation, evaluated in back of ambulance, left in personal vehicle
Vial was initially stored in the refrigerator on 10-May-2022 and administered on 20-Jun-2022 and 05-Jul-2022.; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 20-Jun-2022 and 05-Jul-2022.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     It was unknow if the patient had ever been diagnosed or tested positive for COVID-19.  Patient did not had any acute illnesses at the time of vaccination and up to one month before.  Patient did not had any allergies.  Concurrent medical conditions included Type 2 diabetes mellitus and Obesity.    On 20-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 20-Jun-2022 and 05-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 20-Jun-2022 and 05-Jul-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that they looked it up and said 15-Oct-2022 and now they read and said it's only good for 30 days when they received it. Reporter confirmed the vials were in refrigerated storage. Reporter wanted to know if there was a hard cut off for the 30 days.  Patient had received booster dose of Moderna vaccine.  Date the vial was initially stored in the refrigerator was on 10-May-2022.  Date of administration of vaccine was on 20-Jun-2022.  Vial did not undergo any temperature excursions.  It was reported that patient did not had any adverse effects. .  Patient was informed of the expiration error and her dose had full efficacy even though it had past its use by date.  It was unknown if the event caused the patient to seek medical care.  It was unknown if patient had experienced any similar event in the past.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow up received significant information: Address of reporter has been updated, Patient demographics added. Medical history added. Suspect product details updated. Event onset date added and verbatim updated for event expired vaccine used. I-narrative updated
Pt was given DTaP and MMR on left arm on 4/12/04. Mother noticed redness, swelling and increased warmth of left arm on 4/13/04pm. Pt was brought to clinic on 4/14/2004.
On 4/23rd, I started to feel a slight sore throat it continued with fever and chills and a swollen sore throat through 4/25/2022. I did a home COVID-19 test and it came back positive. I waited it out on the 25th and 26th. On the 27th, I went first thing in the morning to the urgent care because I was not getting better, but not getting worse either. They saw me and did as Strep test it was negative. They prescribed me Augmentin for 10 days to avoid getting pneumonia. And they recommended Flonase. I took the medication as prescribed and started to get better. I had a COVID-19 test on May 12, 2022 and tested negative.
I had the reaction colloquially called ?covid arm?. About 7 days after my first dose, my injection site started to itch and swell. The next day the injection site had swollen rather large in diameter, was red, itchy, and painful to the touch. The redness has has finally started to subside and the swelling is down but not entirely gone yet.
Pt recvd 1st & 2nd Engerix-B vax given 12JUN91 & 12JUL91; Pt exp h/a, dizziness p/1st & 2nd dose;
Acute inflammation of contralateral/non0vaccinated arm - cervical, axillary, brachial, and ulnar nerve affected. Motor and sensory function disrupted in arm +moderate-to-severe pain
Bruise a lump 15 min. after injection    3/9/21   chills 101 temp most of day.  I run low grade.   Today 3/10/21  99.5 to 100.2. Bit of a headache.  otherwise feel ok
Fever; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Aspiration pneumonia from 12-Mar-2021 to 16-Mar-2021. Concurrent medical conditions included Cerebral palsy, Spastic quadriplegia, Seizures and Mental disability.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 05-Apr-2021 due to PYREXIA. On 05-Apr-2021, PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PYREXIA (Fever) to be related.    No concomitant medications were reported. Reported confirmed patient was transferred to a long term acute care hospital for antibiotics treatment.  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.   This case was linked to MOD-2021-078392 (Patient Link).; 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.
Extreme shivering that woke me up, took much longer than usual to get warm. Next morning, I had a headache and 100 degree fever