chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 25-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012257:
This is a spontaneous report from a contactable consumer, reported for a female patient. A female patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Mar 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Feb 24, 2021, single dose, for COVID-19 immunization. Reportedly, she is experiencing adverse events: aches, fever and fatigue (after receiving the second vaccine) on an unspecified date. Created manual AE form. She also wanted to know if she can take pain relievers. The outcome of the events unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
pt recv vax & stopped breathing;CPR was administered by pt father;pt taken to hosp ER & hosp;pt also exp swelling of inj site;addtl info 19AUG96 blood, urine & sputum samples were collected for cult & sensitivity & CXR results not reported
January 29, 2021- 1st Covid 19 vaccine, no problems. February 26, 2021 2nd Covid 19 vaccine. February 27, 2021, passed out in bathroom at 5am.  March 1, 2021, went to primary doctor saw PA only, with dizziness, advised to go to ER BP very elevated.  After March 1, 2021, I began experiencing shortness of breath, but thought it was my anxiety and weight.   I did not have health insurance at the time.  March 5, 2021, still dizzy I arrived at Medical Center given meclizine.  April 2, 2021, ringing in ears and passed out in bedroom for 3 minutes.  Changed primary doctors to hospital.  First appt on Aug. 24, 2021, at 1 pm.  Was in emergency surgery for Pacemaker implantation by 5pm.
Arm still hurts at injection site; lymph nodes in  neck are swollen.; Left clavicle started hurting; Swelling above left clavicle; Fatigue; Chills; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 16:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, penicillin allergy, sulfa allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took hydrocodone bitartrate/paracetamol (VICODIN) for unknown indication on an unknown date and experienced drug allergy. On 04Mar2021 at 14:00, 24 hours after vaccination, the patient experienced fatigue, chills, headache, muscle aches and nausea. On 05Mar2021, 48 hours after vaccination, the patient's left clavicle started hurting and developed swelling above it. On 06Mar2021, the next day after that, the patient's lymph nodes in the neck were swollen. On 08Mar2021, 5 days later, the patient's arm still hurt at injection site. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, chills, headache, muscle aches, nausea, left clavicle started hurting and swelling above it, lymph nodes in the neck are swollen and arm still hurt at injection site were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
I received my first booster of the COVID vaccine at 10:20 AM. At 9PM I began to feel really cold and tired, I went to bed. I felt like I couldn?t get warm, and at approx. 10:30 I had uncontrollable body shakes and felt like I was sitting in an igloo even though I had blankets layered on top of me. I got up to get water and I felt so weak from  muscles being tense I could barely walk, I could hardly speak due to the severe shakiness I was experiencing. At around 2:00AM I started running a high fever of 102 which didn?t subside for two days. I woke up at 6AM with severe nausea and the fever. I had bodily shakes all throughout the day of 8/9/22. The days of 8/9-8/11/22 I was experiencing a severe migraine that made it difficult to function normally. Friday, 8/12 all side effects subsided and the migraine had lessened to an off and on headache. By 8/13/22 all side effects were gone.
Tachycardia starting in middle of night followed by resumption of afib which had been in remission for 11 months. My wife who does not have afib had an episode of tachycardia the next morning, Still have proximal afib every other day. I don?t think vaccine caused afib but tachycardia RE triggered my disease.
Stomach cramp; Gas; Watery diarrhea; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramp), FLATULENCE (Gas), DIARRHOEA (Watery diarrhea), CHILLS (Chills) and NAUSEA (Nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramp), FLATULENCE (Gas), DIARRHOEA (Watery diarrhea), CHILLS (Chills) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramp), FLATULENCE (Gas), DIARRHOEA (Watery diarrhea), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
severe allergic reaction; A spontaneous report was received from a health care professional, concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced severe allergic reaction.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On an unknown date, approximately 15 minutes prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced a severe allergic reaction. The symptoms were discovered during the 15 minute, post-vaccination observation period. The patient had no prior history of anaphylactic reactions. The patient was not hospitalized. Treatment information was not provided.   The second dose of mRNA-1273 was discontinued in response to the event.   The event severe allergic reaction was considered Recovered/Resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. Hypersensitivity is considered listed.
Dizziness & SkinRash HTN, DIZZY, COOL SKIN. ONE HIVE L ARM NEAR  VACCINE SITE, TREATED FAMOTIDINE AND DIPHENHYDRAMINE,  OBSERVED, HIVE AND DIZZINESS RESOLVED.
Information has been received from a physician concerning an 18 year old female patient with reaction/allergy to dairy and no pertinent medical history, who on 15-OCT-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 663452/0671Y). The same day the patient was vaccinated with a dose of HAVRIX and MENACTRA. The patient fainted 24 hours after the injections. The patient recovered the same day. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Additional information has been requested.
Ringing in ears, blurry vision, difficulty breathing, tingling in left foot. Denies headache, chest pain/tightness. VSS. RR 16. O2sat 98%. HR 79. Symptoms improved with rest. Discharged with parent in stable condition.
Mild to moderate Chills, mild fever, body aches, moderate to severe muscle tightness and cramping in leg, mild headache. Onset at 1 am the night after injection. Continued symptoms through 4/22 (today).
Loss of hearing in left ear; resolved Tinnitus - unresolved  Platelet count fell to 3,000 (admitted to hospital; given IVIG infusions)
Hospitalized 09/24/2021; COVID-19 positive 09/24/2021; fully vaccinated  HOSPITAL COURSE:     Patient is a 43 y.o. female  Comes from an AFC home Mother is guardian History is obtained from supervisor of AFC Home who is at bedside   It appears on the 19th, patient had onset of symptoms of fever, shortness of breath, cough Also recalls some diarrhea but denies any loss of taste or smell Self-medicated with Tylenol and Robitussin At that point, she was tested, results of which came back positive 9/21   She presented on 09/24 due to shortness of breath Was 92% on room air in the emergency department Chest x-ray obtained, patient was discharged on doxycycline She was referred to the monoclonal antibody clinic A she received monoclonal antibody 9/24   Upon returning to facility, patient appeared to be more short of breath Was found to be hypoxic, 87 on room air and febrile She was brought in for repeat evaluation.  CT angiogram thorax obtained. CT angiogram thorax negative for PE but did show a pneumonia In addition, she was requiring supplemental oxygen, received dexamethasone, ceftriaxone, doxycycline Subsequently admitted to Medicine. She was treated with Remdesevir and Decadron , and empirically with IV ceftriaxone and Doxycyline, her procal was low and there was no evidence of Secondary bacterial infection, antibiotics discontinued and she was successfully weaned of O2 , she remain afebrile while she is in the hospital . She was discharged in stable condition .
extremely tired all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Patient had both the shots.), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extremely tired all the time".  Additional Information: since patient had both shots, patient was extremely tired, all the time this was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022). No concomitant product use was reported. Reportedly, Patient received full dose. Vial did not undergo any temperature excursions. No treatment information was provided.
Patient with cellulitis to left upper arm at site to PREVNAR injection. Tmax 100.0 x 2 days and firmness now resolved. Had chills x 2 days now resolved. Redness.
bad headache(9) for at least 3hrs my head still hurts (5) all day and today.... nausea joint pain  chills
pt recv vax 13SEP96 & 16SEP97 & w/in 12hr p/vax pt exp a fever of 39C;condition of pt is currently unk;
In the PM, began to have chills, muscle spasms, nausea, sent to ER.  Fever 101, dehydrated, chills, Stated reaction to Immunization shots, rapid heart beat (149).
Syncope immediately following injection of HPV vaccine. No fall or injury. Rapid recovery - regained consciousness when client placed in suppine position.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Tenderness, shoulder pain-Medium
Donor was injected with 1 cc of Rabies vaccine (RabAvert). Stated that (12) minutes after inj was given her throat became slightly constricted. Still was able to talk and have a patent airway. States that it stayed slightly constricted for 2-3 min and returned back to normal.
This spontaneous report as received from a female consumer of unknown age. Pertinent medical history, drug reactions or allergies were unspecified. On 30-SEP-2014 (also reported as 2 days prior), the patient "fell into gravel and dirt, cutting her leg". On 02-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. On an unknown date in October 2014 the patient's physician informed her that the cut was infected (also reported as "it is infected"). BACTRIM was given as treatment for the adverse event. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected because no reporter details were provided.
Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxiety). At the time of the report, ANXIETY (Anxiety) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Likely had a seizure the night of her first set of routine immunziations. It was an episode of not nuring, eyes deviating followed by sleepiness. Returned to normal and has been fine since. Temp was 100.4 axillary at the time. Dad had febrile seizures as a child. CT and EEG have been normal. Question is if the seizure was fever related or vaccine related.
Patient complained of rash and itching on left and right arm. Also a pale rash on chest area. Complaints of dry throat with difficulty swallowing. Instructed to notify personal physician. Seen in doctor's office. Patient reports that she was given Dexamethasone IM. Symptoms subsided 30 minutes to 1 hour after injection.
Patient developed colitis 3 days after first injection; This is a spontaneous case received from a contactable Physician. A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unknown date to an unknown date (at the age of 59-years-old) as single dose in the unknown anatomical location for COVID-19 immunization. The patient's medical history includes HTN, high cholesterol and chronic back pain. The patient's concomitant medications include HYDRALAZINE, ATORVASTATIN, paracetamol, tramadol hydrochloride (ULTRAM) and MAGNESIUM. On an unknown date, the patient developed colitis 3 days after first injection. The patient has received treatment for the event. The outcome of the event was recovering.
lymph nodes were swollen for 4 months and had to be removed from his neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003887.  A male patient received BNT162b2 (BNT162B2), as dose 1, 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: LYMPHADENOPATHY (medically significant), outcome "not recovered", described as "lymph nodes were swollen for 4 months and had to be removed from his neck". The patient had a bad reaction after the first dose of the Pfizer shot. The patient's lymph nodes were swollen for 4 months and had to be removed from his neck because the swelling did not subside.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nightmares; Fatigue; Groggy feeling; Nightmares have continued nightly and wake me up; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 17:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included norethisterone acetate, ethinylestradiol, ferrous fumarate (LOESTRIN 24 FE) taken for an unspecified indication from an unknown date. The patient previously took cephalosporin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 31Mar2021 at 16:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 06:30, the patient experienced nightmares, fatigue and groggy feeling. Nightmares had continued nightly and woken the patient, she never remembered the dreams or woke up from them, ever. The only thing in her life that had changed is that she had received the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nightmares, fatigue and groggy feeling were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient developed fever of 106 7 days after the MMR was administered. Swollen Lymph glands on both sides of the groin, vomitting, diarhea, hair loss and thyroid problems.
INITIALLY, HAD TENDERNESS AT SITE OF INJECTION THEN AFTER 2 DAYS IT BECAME RED, SWOLLEN AND WARM TO THE TOUCH. SHE SAID SHE TOOK BENADRYL. SHE WAS ADVISED TO TAKE IBUPROFEN OR TYLENOL, IF NEEDED. IT WAS STILL SWOLLEN AND WARM TO TOUCH EVEN AFTER 1 WEEK AFTER VACCINATION.  PATIENT SAID SYMPTOMS HAVE SUBSIDED AS OF MAY 18, ABOUT 8 DAYS AFTER.  LAST CHECKED 9 DAYS AFTER VACCINATION, PATIENT SAID SHE'S GETTING BETTER.
ON THE DAY OF THE VACCINE PERIOD - she had a reaction the first dose - itchy face - after one day. she talked with her hcp and was told to take steroids afterwards. discussed risks and benefits, she would like to go ahead and get the 2nd dose. advised to let RN on appointment day know. EMTS SUGGEST TAKING BENEDRYL ABOUT 15-30 MINUTES AFTER THE DOSE. SHE IS ALLERGIC TO MANY THINGS SO UNSURE IF THE REACTION WAS TO THE VACCINE. WAITED FOR 30 MINUTES FOR THE FIRST DOSE, WILL DO THE SAM EFFORT THIS ONE AS WELL. PARAMEDICS STAYED WITH PATIENT FOR OBSERVATION PERIOD. ON 5/2/21 - RN CONTACTED PATIENT TO SEE HOW SHE WAS DOING. PATIENT STATED SHE HAD REDNESS ON THE LEFT CHEEK THAT STARTED RIGHT UNDER HER EYE AND ENDED AT HER CHIN. SHE STATED SHE WOKE UP THAT DAY WITH DRY EYE AS WELL. SHE ALSO NOTED TO THE RN SHE HAD HAD CATARACT SURGERY WITHIN THE LAST 4 WEEKS. RN STATED THAT SHE SHOLD FOLLOW UP WITH HER HCP BUT PATIENT STATED SHE DIDN;T HTINK SHE NEEDED TO SINCE "IT WASN;T THAT SERIOUS".
The first week in May, I began experiencing numbness, tingling, pins/needles in both of my arms and hands at night when laying down. The right side was worse than the left and was very painful at times. Had milder symptoms sometimes when sitting or raising my arms above my head. Thought it may part of menopause, so I did not go to the doctor right away. Called my OBGYN and she  recommended I see my PCP. At the time, I did not consider that this may a reaction to the vaccine. To date, symptoms have improved, however they are not completely gone. Wanted to report these symptoms in case it is related to the vaccine because I have never experienced anything like it before.