chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to pharmacy on 9/2/17 to discuss injection site soreness and start of a rash. Patient had a 2X2 inch inflamed area around injection site and then explained that she had started getting a rash on the back of her leg and lower left torso about a day later. It was itchy and starting to get painful. I explained that she was presenting with shingles and recommended she get medical attention. she was going to go to a local urgent care since her MD was not available.
Fever to 101.6, chills, headache, swelling at injection site, headache, nausea, dizziness, decreased appetite.
Adverse events: vomiting, upset stomach, headache, slight fever (99.6 deg.) Treatment: Soda, Pedialyte, Children's Motrin Outcomes: TBD
her first two doses were the Moderna COVID vaccines; her first two doses were the Moderna COVID vaccines; "throbbing, constant pain" in her left arm, specifically "in the shoulder; in the shoulder, like the rotator cuff; Her arm has a throbbing, constant pain; the arm she took it in, and she can't raise it; Her arm has a throbbing, constant pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Oct2021 (Lot number: FF2593) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; ALENDRONATE SODIUM. Vaccination history included: Moderna covid vaccines (Dose no :1, Lot Number: 010M2OA), administration date: 29Jan2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "Fever", "headache", "fatigue", "pain at the injection site"; Moderna covid vaccines (Dose no: 2, Lot Number: 014M2OA), administration date: 28Feb2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "Fever", "headache"; Moderna covid vaccines (Dose no: 2, Lot Number: 014M2OA), for Covid-19 Immunization, reaction(s): "fatigue", "pain at the injection site".  The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "her first two doses were the Moderna COVID vaccines"; ARTHRALGIA (non-serious), outcome "not recovered", described as ""throbbing, constant pain" in her left arm, specifically "in the shoulder"; ROTATOR CUFF SYNDROME (non-serious), outcome "not recovered", described as "in the shoulder, like the rotator cuff"; LIMB DISCOMFORT (non-serious) with onset Oct2021, outcome "not recovered", described as "the arm she took it in, and she can't raise it"; PAIN (non-serious) with onset Oct2021, outcome "not recovered", PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "Her arm has a throbbing, constant pain". Therapeutic measures were taken as a result of arthralgia, rotator cuff syndrome, limb discomfort, pain, pain in extremity.  Additional information: it was reported that patient received Tylenol, bio freeze, artic cream and the hemp oil as a result of treatment for adverse events.  No follow-up attempts are possible. No further information is expected.
premature ventricular contractions; Within 5 minutes of receiving the vaccines I begin to have heart palpitations; This is a spontaneous report from contactable consumer (patient). A 36-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in right arm on 25Feb2021 at 10:00 AM (at the age of 36 years old) as single dose for COVID-19 immunisation. The patient medical history included hypertension, atrial fibrillation (2 events in 10 years non-sustained) and the patient has a history of known allergies of Tree-nuts. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). The patient has not received any other vaccines in four weeks. There was no Covid prior vaccination and has not been tested for Covid post vaccination. Within 5 minutes of receiving the vaccines on 25Feb2021 at 10:15 AM the patient began to have heart palpitations that were later confirmed to be premature ventricular contractions. This lasted for about 1.5 hours before going away. Paramedic were called but not transported to hospital. Adverse event was resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Left arm tingling slightly numb and left tip of my pinky is totally numb!  It dissipated a bit mid day and now it is numb again so I thought I would fill this out because it?s abnormal
pain in the arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is the first case out of 2 cases. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 13Aug2021 (Age at vaccination was 69 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included glaucoma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 23Jul2021 (Age at vaccination was 69 years) as dose 1, single for COVID-19 immunization. On 13Aug2021 the patient reported that, patient and his wife both got pains in their arms that they got them in, they went back to get the 2nd shot, now patient just got pain in the arm that he got it from. The treatment was not received. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
No additional adverse event; the patient was inadvertently administered a dose of VARIVAX, on 7/20/2020, that had been improperly stored.; Information has been received from a nurse, referring to a 12 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 20-JUL-2020, the patient was inadvertently vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail and route of administration were not provided; lot # T002844 with expiration date 23-JAN-2022) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (lot number and expiration date were not reported).  The vaccine experienced a temperature excursion of 70 degrees Fahrenheit (F) for 48 hours. There were no previous excursions reported. The digital data logger was involved. No adverse event was reported.
two patients complain of nose bleeds after receiving the Pfizer vaccine; This is a spontaneous report received from a contactable Pharmacist. This report was received via a sales representative.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that recently two patients complain of nose bleeds after receiving the Pfizer vaccine and wanted to know if that was normal. Its advised that it would be best to bring this up with the medical line. Event took place after use of product. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Epistaxis cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Child had recieved school entry immunizations total of 4.  Child was sitting on father's lap during procedure. Child was alert and oriented the entire time.  Child did not cry during process. Nurse turned back to clear area. Father related "she fainted". Child was laying on the floor. Child not alert but when touched opened eyes and responded. Child assisted to the clinic table where she started to cry.  No apparent injury to body was noted with exam. Father verbalized he did not think she hit her head. Child wanted water. Only complaint was that of "stomach ache".  Child ambulated from the clinic in hand of father. Father was informed to seek medical attention should child have issues with headache, seizures, hives or shortness of breath. He verbalized understanding.
Symptoms started 13:30 PM, unable to raise right arm. Swollen right arm. Aching on back on right arm. When arrived home after work applied ice. Then went to heat during night. Unable to sleep, taking Advil, rated pain as 9 on scale 1 to 10. Advil doesn't relieve pain. Advised to check with her doctor. 10/17/01, spoke with pt, she did not go to doctor. Pain decreased with ice, heat, Aleve, back at work. A follow up report received 10/25/2001 adds: Pt was very clear she had much improved overnight when reporter had called day after injection given.
Patient states when she received the vaccination it was administered too high in the arm and she immediately felt nerve pain. The pain did not resolve  quickly so she visited her primary care physician who did a physical examination. The PCP stated that there was no visible injury and that the pain will take time to heal on its own. The patient states there is currently no visible evidence of injury (redness, swelling, etc) however the nerve pain remains, often keeping her up at night.
This spontaneous report as received from a nurse via a company representative refers to a female patient who was "either in seventh or eleventh grade". On 14-AUG-2014 the patient received her first dose of GARDASIL (lot# not reported, dose 0.5 ml, intramuscularly) in the morning. Concomitant therapies included TDAP and meningococcal vaccine (unspecified). The nurse reported that on 14-AUG-2014 the patient had a "full blown seizure" after administration. The nurse stated that the patient did not have a history of seizures but once "fell down so hard that she blacked out from crying". The nurse reported that the patient walked out of the facility unaided and went home with her mother, but that they later decided to go to unspecified hospital. It was not clear whether or not the patient had been admitted to the hospital. No treatment was given for the adverse event. The outcome of the event was not reported. Upon internal review, "full blown seizure" was determined to be medically significant. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 72.07 years.  No concomitant product use was reported.  It was reported that patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored on cooler 1, on 07-Jan-2021, Excursion duration at 9 am: 34, at 10 am 34, at 11 am 36, at 12 pm 37, at 1 pm 38, at 2 pm 38, at 3 pm 40, at 4 pm 40.  On 07-Jan-2021, excursion time and temperature at 09 am and 10 am was 34 and 34 respectively, total doses given for the day was 96, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 6 vial was moved to clinic. Vaccine BUD date was 27-Jan-2021.  Vials only punctured right before administration.  Temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Generalized weakness, headache and numbness and tingling in hands. 01/23/07-records received and reviewed from Dr. for DOS 12/11/06 and 1/8/07. One week after receiving Menactra vaccine began to experience weakness, chills and tingling in his fingers. Persisted for one week and essentially resolved but recurred a few days later, again lasting 2-3 days. Over past 5 days before 12/11/06 visit he has felt normal but does indicate he still has some tingling in the fingertips of both hands. Denies any weakness at this time. Recalls feeling weak all over for that week of symptomatology as well as experiencing frequent chills at night. Denies any neck pain or lethargy or headache. PE: WNL His plantar responses are bilaterally downgoing. Impression: idiosyncratic reaction to Menactra. Neuro exam unremarkable. Subjective sensation of occasional paresthesia. His neurological exam and clinical picture certainly do not support a post vaccination Guillain Barre syndrome evolution.  Exam on 1/8/07, no further complaints except over past 5-7 days noticed increased frequency of paresthesia over his left forearm extending in an ulnar distribution over his left hand. Similar but less severe symptoms in right upper extremity.  Neuro exam unremarkable. He is a weight lifter and has been bench pressing fairly extensively at a frequency of 3 times a week over the past few months. MRI of CS spine scheduled to look for evidence of spinal cord pathology. Limit weight lifting routine as may predispose him to an ulnar neuropathy.
I received my 5th vaccine on 09/19/2022. My COVID-19 infection symptoms in the evening around 06:00PM. I had a sore throat.  The next day I had a headache,  body aches , fever, tiredness,  and runny nose.  I had cold symptoms. On 12/14/2022 I tested positive for COVID-19. After I tested positive I called my doctor's office and did a telehealth with my doctor. She prescribed me  with Paxlovid  for 5 days 2 times a day.  She  also advised me to take over counter medications as per needed but, I didn't need any.
Thigh swelling, redness, itching. Thigh swelled to almost twice its normal size.
immediate nausea, dizziness, headache.  By that evening, I had chills, was febrile, body aches, GI issues that lasted until Thursday 12/31 and abruptly stopped at around 18:00 hours.  The second injection was the same but, more intense. Almost immediate nausea, headache and dizziness.  After approx. 40 min I was taken down to the ER.  A line was established. I was given IV Zofran and Tramadol. I became diaphoretic with pallor. blood tubes were drawn, I am unaware if any tests were ran.  I was released with a script for Tramadol and was told to take it with Benadryl. I again became febrile with chills, I had body aches, and pain in my spine and headache.  I did not have GI problems this time. At night I experienced full body itching (only at night) that would keep me up at night.  The head ache remained for two weeks (dull).  The spine pain is still present.  It has become less painful but is present everyday.  It does progress in pain as the day goes on.  The injection site became red an inflamed (more so than the first injection), there was a large lump that lasted for 12 days and is still tender to touch at this time.
Had severe chills at around 11pm on 11/07/2021, had to put on long pjs and 3 blankets.  Woke up at 0530 with a severe headache & a temperature of 101.6.  I had body aches and was extremely tired.  I slept all day.  I had a little cough with phlegm.  I still had the chills & had to stay cornered up.  I took some Tylenol through out the day and slept most of the day.  My fever broke early at about 8am.  The body aches and headache were all day.  At about 1200a on 01/09/2021 my headache & body aches were feeling better, chills were gone.  I woke up at 0630 on 01/09/221 with a temp of 99.5, still have a light headache, little body aches.  I?m feeling much better on 01/09/2021 at 0726.
She got the first dose on 01APR2021.She tested positive to COVID-19 on 06APR2021.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose on 01Apr2021. She tested positive to COVID-19 on 06Apr2021. The next dose is scheduled on 25Apr2021. She wanted to know if she should still get the dose on the scheduled date or she should wait for a specific time. The outcome of the event was unknown. The event was assessed as non-serious.   Information about lot/batch number has been requested.
Burning; Itching; Rash on her back, legs, and arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning), PRURITUS (Itching) and RASH (Rash on her back, legs, and arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning), PRURITUS (Itching) and RASH (Rash on her back, legs, and arm). At the time of the report, BURNING SENSATION (Burning), PRURITUS (Itching) and RASH (Rash on her back, legs, and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient stated the reaction was getting better on her legs but was still there and she was experiencing the most discomfort in her back.   Treatment for the event included an antibiotic cream and a product that helps prevent drying of the skin.
Large round, red, hot rash 15 x 13 cm. Spread quickly by 6 cm. Today still large, hot but more hive-like. Hard lump BENADRYL 1 1/2 tsp Q 6 hours no fever, positive itching.
I was vaccinated on 4/30/2021 at about 4PM and began having symptoms at about 3AM on 5/1/2021. At that time, I began shaking uncontrollably. I didn't have chills. It was as if I was sort of convulsing and my muscles were spasming. This lasted for about an hour. This has happened to me daily ever since I received the vaccine. The times vary now. Sometimes it's as brief as 30 minutes, other times it can last all day long. Sometimes my whole body spasms, other times, isolated areas (such as my leg or my back) will spasm. I have been to various care providers, and I am currently seeing a neurologist. On 5/6/2021, not only was I spasming, but the right side of my body went numb and I had chest pains. I went to the ER as a result.
Got vaccine when getting off 3rd shift - no previous history of reaction to flu vaccine - went home/bed - woke up in afternoon with shortness of breath, hoarseness, coughing, sx. progressed - used EPIPEN and immediately felt better - then seen ED - c/o report attached.
A 75 year old female reported that, post vax, 2 days later, she developed a 2" red area at the injection site. On 1/16/00, the site became very red, warm, itchy and inflammed; the inflammation extended from the upper arm to below the elbow. The pt was seen by the physician on 1/17/00 and treated with Benadryl, prednisone and applications of ice to the affected area. The pt's previous dose of TD was given in 1967.
Narrative: COVID infection following COVID vaccine series 01/1, Pfizer, dose #1 02/02, Pfizer, dose #2 09/27 , Pfizer, dose #3 08/22 COVID swab, result: detected 08/22 pt cc: cough, diarrhea, fatigue, myalgias, rhinorrhea exposure: unknown 09/09 clinically resolved 09/24 CXR impression: No acute abnormality. Resolved opacities in the LEFT lung base last month.
face burning sensation; left hand partially numb; burning feeling in stomach; headache 24/7; muscle soreness on the back of legs especially; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (face burning sensation), HYPOAESTHESIA (left hand partially numb), DYSPEPSIA (burning feeling in stomach), HEADACHE (headache 24/7) and MYALGIA (muscle soreness on the back of legs especially) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (face burning sensation), HYPOAESTHESIA (left hand partially numb), DYSPEPSIA (burning feeling in stomach), HEADACHE (headache 24/7) and MYALGIA (muscle soreness on the back of legs especially). At the time of the report, BURNING SENSATION (face burning sensation), HYPOAESTHESIA (left hand partially numb), DYSPEPSIA (burning feeling in stomach), HEADACHE (headache 24/7) and MYALGIA (muscle soreness on the back of legs especially) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
t105 ax @ 3AM following immun; next day t102; seen by MD was dx w/OM given Amoxil;