chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweating; heart palpitations; could not breath; felt really sick; severe migraine; felt hot; shaking; stomach feels like she has the flu; shoulder hurt; fells like flu; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received a couple of years ago) and Shingrix with an associated reaction of nausea (1st dose received on an unknown date, refer case US2019225168).   On 9th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, less than a day after receiving Shingrix, the patient experienced sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced during the night sweating, having heart palpitations, could not breath, and felt really sick. She also had a severe migraine, felt hot and shaking.  Her stomach feels like she had the flu, and her whole left shoulder hurts after receiving 2nd dose of Shingrix. Reporter gave permission for her physician to be contacted.
Puked all over the work; Feel sick alittle; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old male consumer reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 05May2021 at 21:15 in left arm as a single dose for covid-19 immunization. Medical history and concurrent conditions were reported as none. Prior to 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 vaccine within four weeks prior to the COVID vaccine or any other medications within two weeks of vaccination. Concomitant medications and relevant past drug history were not reported. The patient received first dose of vaccine on 05May2021 at 21:15 and felt fine that night. On an unknown date in May2021, he went to work and felt sick a little, puked all over the work van and he felt fine after two days. The events were assessed as non-serious. Patient was not hospitalized for the events. The outcome of the events was resolved in May2021.  Information about batch/Lot number has been requested.
Severe arm pain. Reduced range of motion. Pain radiates down my arm. Pain in the morning is unbearable.
Right ear Hearing loss; more tinitas in ear; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 at 12:15 PM (Lot number: er8734) on the left arm as single dose for COVID-19 immunization. Medical history was not provided. There were no allergies to medications, food, or other products. Patient had unspecified concomitant medication(s). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 03:00 AM, the patient experienced right ear hearing loss, and more tinitas in ear, happened 4 days after injection; events also resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events including took Sudafed for 5 days. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Dose 1 Moderna side effects:  lymph nodes down left side of neck and into left armpit for about 3 weeks.  Sore arm lasting 1 week. Dose 2 Moderna side effects:  severe chills and sweating approx 12 hrs from injection.  18 hrs- severe joint pain especially in hips and lower back, fever of 102.3 and resting heart rate of 122 bpm.  24 hrs from vaccination-  swollen (size of egg) , hard, red and warm  2? x 1? around injection site upper left deltoid. 36 hrs from vaccination nausea and chills.  Fever and chills have continued the last 40 hrs.
Slight soreness in my left upper arm which lasted for 24 hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/ Lot number: EL1283), intramuscularly, administered in left arm, administration date 28Jan2021 at 11:00  at the age of 72 years as dose 1, single for COVID-19 immunisation. Relevant medical history included mitral valve regurgitation; ongoing mild asthma started in 1953; ongoing hypertension mild (controlled) started in 1980; ongoing asymptomatic brain cavernoma (no symptoms) started Feb2021 (as reported); penicillin allergy; chocolate allergy; COVID-19 with very mild symptoms from 28Sep2020 (tested positive) until 28Oct2020 (tested negative); ongoing "thyroid" (as reported); sulfa allergy and thyroidectomy started in Oct2004. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start date: 2004 (ongoing); verapamil taken for increased blood pressure (ongoing); carvedilol (COREG) taken for increased blood pressure (ongoing); calcium, zinc and vitamin D. The patient was previously given contrast iodine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 at 04:00am, the patient experienced slight soreness in her left upper arm which lasted for 24 hrs. The patient did not receive any treatment due to the event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on 31Jan2021 at 04:00.   No follow-up attempts are possible. No further information is expected.  Follow-up (21Apr2021): This is a spontaneous follow-up report from a contactable consumer in response to Non-HCP letter sent. Updated information: dose 1 vaccine details (lot number, route of administration, administration time, age at vaccination and dose description in the narrative), relevant medical history and concomitant details, and event end date.
This spontaneous report has been received from a consumer via company representative referring to a 1 year old male patient. There were no drug reactions, pertinent medical history, and concurrent conditions reported. Concomitant vaccines included PREVNAR 13 and influenza virus vaccine (manufacturer unknown). On 16-JAN-2017, the patient was vaccinated with VARIVAX, (dose, frequency, route of administration, lot#, and expiration date were not provided) for prophylaxis, and also was vaccinated with M-M-R II (dose, frequency, route of administration, lot#, and expiration date were not provided) for prophylaxis. On the same date of the vaccination, after the patient woke up from a nap, the patient had a temperature of 105 (units not provided). On 17-JAN-2017,  the patient's mother went to the pediatrician because her son still had a temperature of 103.8 (units not provided), she stated that the pediatrician did a unspecified blood test which resulted in a "white blood cell count of  30000" (units not provided), also it was performed an unspecified urinalysis test and chest x-ray which both came back negative. The patient's mother stated that her son had no signs of the flu, respiratory syncytial virus infection (RSV) or strep infection, the patient was treated with ROCEPHIN and also reported that she will visit the pediatrician on 19-JAN-2017. The outcome of the events was unknown. The relatedness between the events and VARIVAX, M-M-R II were not reported. Upon internal review, the temperature of 105/ 103.8, and white blood cell count of 30000 were determined to be medically significant. Additional information has been requested.
Hives; itching/itching on injection site; Redness,Lump, itching on injection site a few days after vaccination; Redness,Lump, itching on injection site a few days after vaccination; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported that:  A 64-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration in Arm Left on 13Apr2021 at 12:30 PM (age at the time of vaccination was 64 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient known allergies: fluconazole. The patient medical history includes high blood pressure, osteoporosis, arthritis, herniated disc. Concomitant medication was not reported. The patient receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 8727), via an unspecified route of administration in Arm Left on 23Mar2021 at 14:00 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced hives and itching half hour after vaccine. On 13Apr2021 13:00 patient experienced hives, itching/itching on injection site. On unspecified date in 2021 had redness and lump on injection site a few days after vaccination. Patient didn't received treatment for the events. The clinical outcome of the events was not recovered.   No follow-up attempts are required. No further information is expected.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from Consumer. This case involves a 72 years old male patient who received FLUBLOK QIV but told him it was FLUZONE HIGH DOSE (batch number, expiry date were not reported for both vaccine) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administration as 72 year old and when he went to the doctor's office thinking he was getting the FLUZONE HIGH DOSE they gave him the FLUBLOK QUADRIVALENT but told him it was FLUZONE HIGH DOSE. It was unknown if the patient had any 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. List of documents held by sender: none.
chest pressure; throat closing; whole face with hives; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERSENSITIVITY (allergic reaction). On 15-Jan-2021, HYPERSENSITIVITY (allergic reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. treatment medication includes antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI
This spontaneous report was received from a certified registered nurse practitioner via a company representative regarding a 26 year old female patient. No concurrent condition or medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL 1 vial, intramuscularly. On an unknown date, the patient was at unspecified OBGYN's office and after the patient received her second dose of GARDASIL, she had a seizure (for unspecified time). The patient did not get the third dose of GARDASIL. On an unknown date, the patient recovered from the event (reported as after stopping the therapy). Reporter causality was not provided. No product quality complaint was reported. No further information was given. Upon internal review the event of seizure was considered to be medically significant. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, chills, fatigue
temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 18-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Slight muscle ache in arm; Other vaccine same date vaccine; Other vaccine same date vaccine; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN9581) via unspecified route of administration in the left arm on 05Feb2021 at 15:45 (at the age of 73-years-old) as a single dose for COVID-19 immunization. Medical history included sulfa allergy from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. Concomitant medications included ascorbic acid (VITA C), ergocalciferol (VITA D), biotin, fexofenadine hydrochloride (ALLERFEX), magnesium, and glucosamine hydrochloride (GLOCOSAMIN), all from unknown dates for unknown indications. The patient did not receive any other vaccines in the four weeks prior to the COVID vaccine. On 05Feb2021 at 22:00 the patient experienced slight muscle ache in arm during the first night; and on 05Feb2021 the patient experienced other vaccine same date vaccine. No treatment was provided for the events. The clinical outcome of slight muscle ache in arm was recovered in Feb2021; the clinical outcomes of other vaccine same date vaccine were recovered on 05Feb2021. It was also reported the patient was not COVID tested post vaccination.
This spontaneous report was received from a registered nurse and refers to a 6 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.
No appetite; Felt rotten; Got very warm; Very dizzy/ lightheaded; Very weak / still feel a little weak today; Feeling feverish (but never had a temperature); I was shaking to the point where I thought I was having a seizure; Horrible case of chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak / still feel a little weak today), TREMOR (I was shaking to the point where I thought I was having a seizure), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rotten) and FEELING HOT (Got very warm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 031L20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced TREMOR (I was shaking to the point where I thought I was having a seizure) and CHILLS (Horrible case of chills). On 24-Nov-2021, the patient experienced ASTHENIA (Very weak / still feel a little weak today), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rotten), FEELING HOT (Got very warm), DIZZINESS (Very dizzy/ lightheaded) and PYREXIA (Feeling feverish (but never had a temperature)). On 25-Nov-2021, DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rotten), FEELING HOT (Got very warm), DIZZINESS (Very dizzy/ lightheaded) and PYREXIA (Feeling feverish (but never had a temperature)) had resolved. At the time of the report, ASTHENIA (Very weak / still feel a little weak today) had not resolved and TREMOR (I was shaking to the point where I thought I was having a seizure) and CHILLS (Horrible case of chills) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient reported that 24 hours later post getting the booster dose, on 23-Nov-2021, the patient had a horrible case of chills. The patient was shaking to the point where they thought they were having a seizure. On 24-Nov-2021-25-Nov-2021, the patient got very warm and was feeling feverish but never had a temperature, the patient was very weak, very dizzy, no appetite, lightheaded and felt rotten. Reportedly, the patient was still feeling a little weak on 29-Nov-2021, at the time of call but was glad that they got the vaccine.   This case was linked to MOD-2021-400085, MOD-2021-400094 (Patient Link).
Flu-like symptoms (sneezing, coughing, aches) the evening of vaccine then gone next morning. Injection site warm and swollen x 3 days.
Patient was seen for Well Visit 07/02/14; He received HPV GARADASIL (L) Deltoid and MENVEO (R) Deltoid. Patient return on 7/16/14 with swollen lip and face was drawing to right side; patient stated began 1-2 days after check up and vaccines. Patient evaluated in office determined 1-2 weeks prior to 7/16/14 visit developed Bell's Palsy - left CN7.
PATIENT RECEIVED VACCINES.  SAT IN LOBBY AFTERWARD.  STARTED FEELING DIZZY, SICK AND WAS LOSING VISION. PATIENT TALKED WITH PHARMACIST AND LAID DOWN.  BY THE TIME RESPONDERS ARRIVED (EMTS) PATIENT WAS FEELING BETTER.  EMT CHECKED PATIENT AND CLEARED HIM.  NOT SURE OF TIME COURSE SINCE I WASN'T RPH INVOLVED AND THAT RPH WORKS AT ANOTHER STORE.  I'D ESTIMATE 30 TO 40 MINUTES FROM START TO FINISH.
patient states that shoulder soreness started after vaccine and has not gone away in 4 months. She states she has limited range of motion and has a hard time pushing herself up from laying down. She did speak to her provider once and was unable to replicate the pain and she will be following up with the doctor again in March
Chills, aches and coughing.  Also sweating and queasy stomach. Recorded a temperature of 99.2 on Sunday, 10/04/2015.  Generally flu-like symptoms for 2.5 days.
previous elbow tendon inflammation/flare 2011, 2013 in arm vaccine given, exempt until facility mandated Flu vaccine as employment . denied exempt. received vaccine 1/28/2022 left deltoid .  headache x 3 days , fatigue x 3days . 1-31-2021 am left elbow tendon flare, inflammation- pain with certain movement . (like before with injections ) continues with increase pain with movement today (4 days)
Patient's mom called at pharmacy on 5/17/21 to report patient experienced side effects like muscle aches, headache, 101.8 fever at night on 5/15/21, spine and teeth ache and injection site was elevated and hot to touch. Mom said patient felt better after taking Tylenol and most side effects have subsided, but she just wanted to report about side effects. Patient feels much better today (5/17/21) so mom said they are not planning to make doctor visit.
flare up of chronic pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient 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. The following information was reported: PAIN (non-serious), outcome "unknown", described as "flare up of chronic pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.