chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FALL; DIZZINESS, FEELING FAINT FELT LIKE BLACKOUT, LIKE FALLING DOWN, LIKE PASSING OUT; TINGLING; SHAKING; SKIN REACTION ON LEFT SIDE UPPER ANKLE AREA; FUNNY FEELING; NUMBNESS; HAND SWELLING; UNABLE TO FOCUS; BODY ACHES; FACE SWELLING; CONFUSION; BODY CHILLS; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included black plastics color allergy, and other pre-existing medical conditions included the patient had no known allergies and the patient was not pregnant at the time of event reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 121001A, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-MAR-2021, the subject experienced body chills. On 28-MAR-2021, the subject experienced light headache. On 29-MAR-2021, the subject experienced body aches. On 29-MAR-2021, the subject experienced face swelling. On 29-MAR-2021, the subject experienced confusion. On 29-MAR-2021, the subject experienced hand swelling. On 29-MAR-2021, the subject experienced unable to focus. On 31-MAR-2021, the subject experienced funny feeling. On 31-MAR-2021, the subject experienced numbness. On 31-MAR-2021, the subject experienced skin reaction on left side upper ankle area. On 04-APR-2021, the subject experienced fall. On 04-APR-2021, the subject experienced dizziness, feeling faint felt like blackout, like falling down, like passing out. On 04-APR-2021, the subject experienced tingling. On 04-APR-2021, the subject experienced shaking. Laboratory data included: Blood test (NR: not provided) normal, Computerized tomography (NR: not provided) normal, and Urinalysis (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body chills, body aches, numbness, face swelling, confusion, shaking, dizziness, feeling faint felt like blackout, like falling down, like passing out, light headache, funny feeling, fall, hand swelling, and unable to focus, and had not recovered from tingling, and skin reaction on left side upper ankle area. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Hives, area on posterior right arm 6 x 12cm. appt, at clinic on 05/21/12, continue with otc Benadryl.
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#J007946, exp. 24-MAR-2016) (incorrect product storage). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
chills; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (Slight headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (Slight headache). At the time of the report, CHILLS (chills) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-274270 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received on 09-AUG-2021 and included No New Information.
Shortly after vaccine, there was swelling & heat. I was nauseated. 2nd day spot was double in size & heat. 3rd day size of softball w/ heat pain in whole arm.
Hepatitis vax given and pt left clinic to 'play ball.'  Clinic received telephone call around 6:00 PM from mother who stated that child had generalized red/wheal-like rash. She was flushed, nauseated, weak. Administered Benadryl, 80 mg IM, and sent to clinic STAT with mother.
Patient  has a heavy limp leg and is having difficulty walking and going up steps. Both of his  legs also  had tremors.  He has  also been  unusually fatigued past what would seem reasonable.
Patient came in for his booster shot - he had gotten his first two shots at the county. they were not entered in our medical record. He did not have his card with him. The shot was given and then immunizations were reconciled in the computer and found that he had recieved Moderna for his first two and not Pfizer.
PT has proximal femoral focal deficiency (PFFD). One femur is shorter than the other. Her hip is deformed and has to go thru 10-12 yrs of surgery. She was born with this.
Patient was noted to be febrile and nauseated the day following injection. She was given Tylenol which decreased her temperature.
Fever of 101.7F while taking 500mg of acetaminophen every 6 hours. Chills, night sweats, headache, fatigue, backache/myalgias.
This case was reported by a consumer and described the occurrence of no appetite in a 83-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) and ADAIR multi dose powder inhaler for asthma, chronic obstructive pulmonary disease and bronchial disorder. A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma and chronic obstructive pulmonary disease. Concurrent medications included ADVAIR. In 2007 the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 1 puff(s) at night. On 14 September 2009, the subject received unspecified dose of Flu vaccine (injection, left arm). On an unspecified date, she experienced no appetite, ran a slight or low grade fever, weak, and laid around for a week and half, didn't feel well, and fungus in her throat were unknown. On 14 September 2009, the subject received a flu shot. On an unspecified date, she experienced no appetite, ran a slight or low-grade fever, weak, and lay around for a week and a half. The subject went to her physician and he prescribed Levaquin. On 18-SEP-2009, patient experienced throat burning after taking one dose from a new ADVAIR diskus 100/50. She rinsed her mouth with plain Listerine and after a few hours it was okay. On 19-SEP-2009, she didn't feel well, her voice was shot, and she could hardly talk. On 21-SEP-2009, she went to her physician. He prescribed Nystatin for fungus in her throat. She is still experiencing the voice shot and can hardly talk when she gets tired. The subject could not clarify if the symptoms she was experiencing (no appetite, ran a slight or low-grade fever, weak and layed around) were do to the flu shot or as a result of using ADVAIR. She has also been using ADVAIR diskus 250/50 in the morning since 2008, but she did not relate the above issues to use of the higher strength. Quality assurance results received on 9 November 2009 revealed the product complaint to be inconclusive as the complaint was received without sample.
little achy; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event little achy/pain  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the event little achy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable as the patient received both the scheduled doses of the vaccine.  The outcome of event little achy was unknown.
received an Act HIB vaccine, but it was later discovered that the diluent of that vaccine had already expired with no adverse event; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case received from a Health care professional.  This case was linked to case 2020SA263460.  This case involves a 12 months old male patient who received a 0.5 ml fourth dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB], (single dose vial) (lot: UJ114AAA, expiry date: 24-Aug-2020) once via Intramuscular route on right thigh, on 03-Sep-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13).  It was an actual medication error due to the expired product administered. It was reported that a patient received an Act HIB vaccine, but it was later discovered that the diluent of that vaccine had already expired. (latency on the same day)  At the time of reporting, the patient had no adverse event.  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.
An allergic reaction in the left arm.; Golf ball size knot; Warm to the touch; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Ew0217), via an unspecified route of administration, administered in Arm Left on 17Jun2021 at 16:30 (at the age of 43-years-old) as DOSE 1, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history was not reported. Concomitant medications included oxcarbazepine (Trileptal) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall): both for an unspecified indication, start and stop dates were not reported. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. The patient stated she developed an allergic reaction in the left arm. Golf ball size knot, warm to the touch, read at times itchy on 19Jun2021. 5 days later still there. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered at the time of this report.  Information on batch/lot numbers are available. Further information has been requested.
Mid-grade fever (topped out at 102 F), severe body aches, joint pain, headache and nausea.  Symptoms lasted for roughly 36 hours; they were very intense for the first 24 hours from the time of onset.
Conjunctivitis per eye. MD instructed her to report it. 5 x after flu shot given. C/O achiness, body leg aches, back aches- stated she is better from all that now.  It only lasted a couple of days. Her eyes still slightly red. To go to MD if not better by tomorrow.
got swelling and pain 4 days in his neck; got swelling and pain 4 days in his neck; soreness on the bone tissue around the neck for 3 days; This is a spontaneous report from Medical Information Team. A contactable consumer reported that a male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Caller mentioned that he already got the first dose of the covid vaccine and he was getting the second shot tomorrow. He said that he got swelling and pain 4 days in his neck and soreness on the bone tissue around the neck for 3 days. It has all gone away. Outcome of the events was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected. Information on about lot/batch number has been requested.
shortness of breath; cough; extreme fatigue; fever; chills; nausea; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath), COUGH (cough), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). On 12-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), COUGH (cough) and FATIGUE (extreme fatigue). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency and LEVOFLOXACIN at an unspecified dose and frequency. On 11-Mar-2021, PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, DYSPNOEA (shortness of breath), COUGH (cough) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: increased (High) Increased heart rate. On 12-Mar-2021, Oxygen saturation: low (Low) oxygen low.         No concomitant information was reported. Treatment medication included 2 rounds of ABTs,  OTC cough medicine, Advil nose spray.  Patient reported that she visited to health clinic on 31 Mar 2021 and emergency department on 05 Ape 2021 for her symptoms. She also reported that she had all test  were negative included flu test and 2 Covid 19 tests. She reported that all test were normal other than a virus detected, however it was not specified by her.  Upon in internal review on 21 May 2021, the age was corrected to an unknown age.   This case was linked to MOD-2021-075130.
The patient experienced swelling at the injection site accompanied by severe pain and high temperature ( 101). She had to see a doctor on 02/05/2019 as her symptoms were getting worse and her doctor gave her an antibiotic as he diagnosed it as a skin infection in the vaccination site of administration. The patient refused to release the antibiotic name.
Slight swelling at injection site. Itchy. Hard. Warm to the touch. NOT painful.
hx rash started @ the inject site & spread along legs then arms face & abdo; no discomfort; no fever; rash is lacy macular blanching on extensors; sl warm but non tender;
Approximately 3am, I woke up and had chills. Went back to bed and woke up again at 630am with chills, 100.0 temp, and nausea. I then went back to bed until 11am. Woke up again...no fever, no chills, no nausea, but had light body aches. All symptoms were gone by 2pm. Then approximately 21:00 I started to have chills again.   woke up on 1/29/21 with no symptoms
PT C/O migraine type headache approx.5min after 2nd dose of Pfizer covid vaccine,vitals stable,pt denied any SOB,palpitations,chest pain,itching or any discomfort.  Felt better after one dose of Tylenol
This spontaneous report as received from a certified medical assistant refers to a 2-month-old patient of unknown gender. Patient's medical history, current conditions and concomitant medications were not reported. On 13-NOV-2015, the patient received a dose of oral, ROTATEQ, (dose and lot number were not provided). On the same day, immediately after receiving the vaccine, the patient vomited. The outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected as there was no consent for the follow-up.
Headache, whole body ache, nausea, pain behind eyes, chills, injection site pain, whole body stiffness
Increased body temperature; Heartbeat increased; A spontaneous report was received from a consumer of an unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced increased body temperature and heartbeat.  There were no medical history and concomitant medications reported.  On 31 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Patient reported that he began to experience increased body temperature and heartbeat. No treatment information was provided.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events increased body temperature and heartbeat was unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender. The medical history is not provided. The patient experienced non-serious unexpected events of Body temperature increased and Heart rate increased at on unknown date after receiving their first of two planned doses of mRNA-1273 (Lot unknown).  Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Throat, tongue, and eye lid swelling. 12/11/09 Medical records received for DOS 11/05/09. Pt. presented with left arm itching and tingling and left facial swelling under eyelid. Treated with benadryl.  Symptoms resolved in 30 mins.
Tachycardia, and dry heaving episodes following 2nd dose of Pfizer Covid vaccine
Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 70-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 23-OCT-2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for shingles resulting from her use zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Patient developed a 6 inch area of erythema around injection site on left thigh. The area was warm and slightly tender. Symptoms lasted until 6/14/01.
THIS 15 YEAR OLD WAS GIVEN A PEDIATRIC DOSE OF VACCINE IN ERROR
Pins and needles; Prickling over entire body; All over body itching; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 06Apr2021 at 16:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included crohn's disease, inflammatory arthritis and fibromyalgia. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication, BENADRYL on an unknown date for unknown indication, vitamin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and TYLENOL on an unknown date for unknown indication. 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 06Apr2021 at 20:00, the patient experienced all over body itching, pins and needles, prickling over entire body at once for two days so far. The patient went to sleep itching and wake up itching under skin, like thousands of little bugs crawling under skin. Started about four hours after injection. Therapeutic measures were taken as a result of events and included treatment with tylenol, benadryl, and 20 mg prednisone on an unknown date. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events prickling over entire body, body itching, pins and needles was not resolved.  No follow-up attempts are needed; Information regarding lot number cannot be obtained. No further information is expected.
Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a family care center for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Information has been received from a literature article concerning a 13 year old female patient developed uveitis, glaucoma and blindness, following administration of GARDASIL. The patient had as a pre-existing conditions arthralgia. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was of 210 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.