chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Head aches; Nausea; Fever; Metal flavor on mouth; This is spontaneous report from a contactable consumer.   A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), unknown route (site of vaccination left arm), on 16Dec2020 05:00 PM at single dose for COVID-19 immunisation. Medical history was none. Concomitant drugs were unknown. The patient experienced headache, nausea, fever, metal flavor on mouth, all at 07:30 PM on 17Dec2020. Patient was treated with acethaminophen. The action taken in response to the events for BNT162B2 was not applicable. The outcome of the events was recovered   Information about lot/batch number has been requested.
Drop in blood pressure. Patient was monitored for 15 minutes and after, the patient was not at base. Patient was moved from chair to bed and was monitored constantly for 1 hour
This spontaneous case reported by an other healthcare professional, describes the occurrence of vaccination site warmth (redness at injection site is warm), vaccination site pruritus (redness at injection site is itchy) and vaccination site erythema (redness at injection site/red) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site warmth (redness at injection site is warm), vaccination site pruritus (redness at injection site is itchy) and vaccination site erythema (redness at injection site/red). At the time of the report, vaccination site warmth (redness at injection site is warm), vaccination site pruritus (redness at injection site is itchy) and vaccination site erythema (redness at injection site/red) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Onset fever (101F), headache, nausea, vomit, diarrhea on 36 hours after ingestion 1st vivotif tab.  Symptoms resolved over 48 hours on Phamargam, advil, Ragleam compazine, Tylenol.
Patient became dizzy and diaphractic about 10 minutes into the 15 minute waiting period. Nausea;Lightheadedness;Confusion;Other.
Severe pain at site of injection, unable to raise arm for 5 days.  Gradual decrease in pain and improved mobility since then.  Continues to have pain at injection site w/ certain movements.
Loss of equilibrium, aching muscles, soreness, shaking, symptoms of vertigo, anxiety, weakness, loss of balance, loss of dexterity, loss of muscle memory,
This spontaneous report as received from a healthcare worker via a company representative, refers to multiple (over 40) unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown dates since 06-MAY-2016, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, lot number reported as L042214 and expiration date of 14-JUN-2017 (strength and dose were not reported), which was stored on 05-MAY-2016 at -49 Fahrenheit degrees for 15.5 hours, from 06-MAY-2016 to 09-MAY-2016 at -48.7 Fahrenheit degrees for 63.5 hours and on 03-JUN-2016 at -46.9 Fahrenheit degrees for 63.5 hours. The temperature excursions were not detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
STOMACH PAINS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced stomach pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, and fatigue, and had not recovered from stomach pains. This report was non-serious.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was not reported.  Vaccine was administered after 4days from first puncture of vial.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Expired vaccine used for mRNA-1273, Lot# 037C21A with no associated AEs. Causality for this medication error is not applicable.
Hot; Rash around the injection site; Pink/rash is very pink; Swelling/raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE ERYTHEMA (Pink/rash is very pink) and VACCINATION SITE SWELLING (Swelling/raised) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE ERYTHEMA (Pink/rash is very pink) and VACCINATION SITE SWELLING (Swelling/raised). On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE ERYTHEMA (Pink/rash is very pink) and VACCINATION SITE SWELLING (Swelling/raised) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Received shots at health dept b 11am were at doctors for check-up and noticed hives all over body. No apparent itching. No difficulty breathing. By noon, hives were fading. Doctor advised Benadryl cream.
16MAY94 mom called stating pt c/o h/a & stiff neck; pt has elevated temp & enlarged nodes from below each ear & down neck; ref to MD; 17MAY94 pt was seen by MD who took a throat culture for strept;
This spontaneous report was received from a medical assistant and refers to a 42-year-old patient. No information regarding the patient's medical history, concurrent conditiond and concomitant medications was provided. On 13-DEC-2017, the patient was vaccinated with a dose of PROQUAD injection (dose, route of administralion, lot number and expiration date were not reported). The dose of the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1712USA006857:
SINCE I RECEIVED THE J&J VACCINE (SINGLE DOSE) IN APRIL 2021, THIS WAS A BOOSTER. WOKE ON MORNING OF JAN 13 TO ITCHY SKIN AND MILD INFLAMMATION OF YELLOW JACKET STING SITE (RECEIVED A WEEK EARLIER) IN RIGHT ARM. (VACCINE WAS IN LEFT ARM) 8 HOURS LATER RETURNED HOME FROM WORK WITH SEVERE INFLAMMATION AND ITCHING OF STING SITE AND ITCHY HIVES SPREAD FROM LEFT ARMPIT ACROSS CHEST AND STOMACH TO RIGHT SHOULDER. TOOK BENADRYL AND APPLIED HYDROCORTISONE EVERY 4- HOURS SINCE EARLY MORNING, BUT PROVIDED VERY LITTLE RELIEF.
gout flare; This is a spontaneous report from a sponsored program. A contactable male consumer of unspecified age, the patient, reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Nine days after the first dose, the patient experienced gout flare. The outcome of gout flare was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Client speaks a different language. Interpreter stated that patient started having dizziness and ringing in ears on Friday night, 3/11/22.
nerve facial issues; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient's wife) via social media.  This case involves a male patient of unknown age who was suffering from nerve facial issues (facial nerve disorder), after patient was vaccinated with INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination, family history and concomitant medication was not reported.  On an unknown date in 2019, the patient received INFLUENZA VACCINE [lot number and expiration date unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in 2019, (latency unknown) after starting the INFLUENZA VACCINE therapy, the patient was suffering from nerve facial issues (facial nerve disorder). Naturopath advised could be from the additives in the INFLUENZA VACCINE as well as metals. Healthy diet, supplements and good hygiene was the corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Systemic: Knot developed on right wrist approximately 2-3 hours after administration.-Mild
On April 16th I was weight training when my R arm became suddenly painful and heavy feeling.  A few hours later I noticed my arm had gotten very swollen and blue.  I went to urgent care and was sent for an US.  It showed a large clot in my internal jugular vein as well as clots in my R subclavian, axillary, brachial, proximal cephalic, and proximal basilic veins.  They sent me to ER and did a CT and also found a small PE in my L lower lobe pulmonary artery.  Currently I am on enoxaparin and very limited in use of my R arm.  The cause of my clots remains unknown.  I am waiting on blood tests to see if I have any genetic factors.  It seems unlikely that this is tied to the vaccination but I wanted to report in case there end up being similar cases.
patient after the injection did not feel well and stated she was likely going to have a seizure. Patient seized for 30 seconds to a minute and then came back to. Vitals were stable at that time and the patient was responsive. EMTs came to check in with her and she refused to go in for any additional evaluation.
started crying @ 1130 the day p/ & would not quit cried until 5PM; fever of 102;
UPSET BOWELS; INCREASED GASSINESS; DIARRHEA; RUNNY NOSE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with promethazine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced severe headache. On 14-MAY-2021, the subject experienced upset bowels. On 14-MAY-2021, the subject experienced increased gassiness. On 14-MAY-2021, the subject experienced diarrhea. On 14-MAY-2021, the subject experienced runny nose. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe headache, and the outcome of upset bowels, increased gassiness, diarrhea and runny nose was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Arm swollen, itching in arm, warm to touch at 2:30 PM.  Around 5:30 PM face was itching and arm was itching.  Arm swollen in 4" diameter.  Nausea & no appetite.  States reaction similar to shellfish allergic reaction.
Received Pfizer vaccines on 1/7/21, 1/28/21 Tested positive for COVID-19 by PCR on 7/22/21.
Admitted to hospital on 12/6/00 with cellulitis to left arm which was red and swollen with tenderness.
chills, headache, temperature 2.5 degrees higher than baseline, muscle aches, nausea and vomiting, injection site tenderness
High fever, wheezing, coughing, vomiting, difficulty breathing, weakness, and fast heart beat.
Tuesday the pain was intense and scheduled a appoint with my doctors office they scheduled a ultra sound and blood work no findings of a blood clot; The pain is not as intense but she is still limping around and in pain.; I had severe leg cramping and body cramping; The next day my leg hurt behind the knee in the calf and the thigh. I could hardly walk by Sunday and went to urgent care they check my leg over could not see a reason for my pain.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 51-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN620A and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 01Apr2021 (at the age of 51 years) as single for covid-19 immunization. Medical history included ITP and diabetes from an unknown date and unknown if ongoing. Patient also had Penicillin Allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm right on 11Mar2021 11.00 as single for covid-19 immunization. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and medications in two weeks. On 02Apr2021 the patient experienced leg hurt behind the knee in the calf and the thigh. she could hardly walk by Sunday and went to urgent care they check my leg over could not see a reason for my pain. They didn't visually see a blood clot and sent me home. she had severe leg cramping and body cramping. Tuesday the pain was intense and scheduled a appoint with my doctors office they scheduled a ultra sound and blood work no findings of a blood clot. she also scheduled an appointment with a chiropractor and had no indication of back or knee injuries. she had severe pain for over two month in leg knee lower leg and thighs. The pain is not as intense but she is still limping around. The patient underwent lab tests and procedures which included glycosylated haemoglobin found to be 5.8 on unspecified date. The outcome the events was recovering.
Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CALCIUM for an unknown indication.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, the patient experienced INSOMNIA (Insomnia). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency. At the time of the report, INSOMNIA (Insomnia) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications include antivirals, immune boosters. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up accepted on 27-May-2021
Developed deep vein Thrombosis at right knee ~48 hours after first Pfizer shot.  Resolved with blood thinner in 48 hours.  No negative effect from second shot.
Patient with dementia NOS received COVID-19 vaccination first dose (as reported) on 3/30/2021. Family reported she was feeling unwell with vague complaints thereafter. Found dead on 4/27/2021. Autopsy performed on 4/28/2021 revealed ischemic bowel with an acute superior mesenteric artery thrombosis. She had little other cardiovascular disease to account for the thrombosis.
Patient presented for follow-up a few weeks later and mother reports that he had vesicular rash, now crusted and papules with umbilicated center. ? varicella like rash from vaccine
Information has been received from a nurse referring to a patient of unknown age and gender. In October 2015 the patient was inadvertently received a dose of expired VARIVAX (Merck) (Lot# J012381, exp: 03-OCT-2015; 0.5ml once) that had not undergone any temperature excursion (Expired vaccine used) subcutaneously. No adverse effects were reported. Additional information has been requested.
stopped getting the flu when I stopped getting the flu shot; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from the patient.  This case involves an unknown age and unknown gender patient who stopped getting the flu when stopped getting the flu shot while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dosage regimen, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.   On an unknown date, the patient developed a non-serious event 'stopped getting the flu when i stopped getting the flu shot' (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The case received from Social media Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I stopped getting the flu when I stopped getting the flu shot."   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was drug withdrawn.  It was not reported if the patient received a corrective treatment for the event (stopped getting the flu when I stopped getting the flu shot).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event 'stopped getting the flu when i stopped getting the flu shot'.
After vaccination the patient is experiencing headache off; the site of injection is sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (After vaccination the patient is experiencing headache off) and VACCINATION SITE PAIN (the site of injection is sore) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (After vaccination the patient is experiencing headache off) and VACCINATION SITE PAIN (the site of injection is sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEADACHE (After vaccination the patient is experiencing headache off) and VACCINATION SITE PAIN (the site of injection is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
On 6/7/21 I noticed my right lower leg was swollen. On 6/9/21 I went to my PCP and she sent me to get an ultrasound. The Ultrasound showed a large DVT and I was sent to emergency room. In emergency room a Cat scan of my chest was completed and showed several pulmonary embolism. I  was admitted overnight and started on Eliquis.  I was told to follow up with my PCP.
Scratchy throat, 9/22 cutting sore throat with cough, Monday 9/23 low grade fever 100.8 sinus pain yellow mucous with cough, malaise, aches. Wednesday same symptoms slightly better. Cough continues, nose continues. Contacted MD if by Friday no improvement will need to see them.
Cramps; Started her period again after being post menopausal; Dark urine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on 22May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the 1st dose of the Pfizer COVID19 vaccine 22May2021 and since then she has had dark urine, cramps, and has started her period again after being post-menopausal on an unspecified date. Her 2nd dose was scheduled to be had 28Jun2021 and she was asking if there was any guidance for her regarding getting the 2nd dose or not. She stated she was terrified. She continued to have intermittent cramping this week with dark urine. She remembered hearing something and unsure if there was possible blood in her urine. Caller stated this was infuriating to people like her after advises no information available for consumers regarding post-menopausal bleeding and referring to HCP. She states that she has done some of her own research and felt it was 100 percent associated with the vaccine. Millions of women were experiencing this. She would like this concern to be forwarded to whomever needs to know this was happening. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Body aches, high fever, throw up. Fever for four days, and body aches four days. Administered fever reducing medicine.
pt rcvd vax; pt devel nausea w/ 1 episode of vomiting; w/ 2nd dose of vax,pt devel severe nausea & was vomiting; had diarrhea & severe chills;
painful joints-pain come & go;pain began in lt arm on 28SEP98;deep muscle pains that come & go;sx started 29SEP98 no rxn @ inj site x/for pain x36hr;