chrisvoncsefalvay/vaers-outcomes huggingface dataset:
put had an irritation on the skin.  wife is a nurse and is concerned it is due to the vaccine not being in the muscle and causing the irritation.
2/10 1015 AM 10PM I was extremely fatigued. Slight HA. Dizziness/light vertigo. Sore shoulder on left. Symptoms with stomach cramping lasted into 2/11, all day. By 9PM, I had a severe HA, chills, spent most day in bed. My heart was pounding. Couldn't lay down, HA was throbbing. Temp was 101.5. I contacted my PCM. Advised to rotate between Tylenol and Motrin. The fever did break overnight.  2/12 I was still feeling fatigue, HA. No fever, no chills. Still having vertigo with chest tightness. That had set in on the 2/11. Started my albuterol on 2/11 and lasted till 2/16 with a slight cough.  2/16 Dr was able to see me. She could feel the inflammation in my chest. *Exacerbated the problem because on 2/13 I felt chest tightness and thought it was the asthma, exercises made my symptoms worsen. The acid reflux gave me the sense I was having tight chestness due to the asthma but it was actually due to me exercising on 2/13 which worsened by the 2/15-2/16. I had still had the chest pain, HA Prescribed Advil.
Patient received 1st dose of GARDASIL while pregnant. VFC questionnaire completed but as per pt's mother and older sister pt. did lie & withhold information. Pt instructed to follow up with OB clinic ASAP. This is in follow-up to report(s) previously submitted on 05/21/2010. No adverse reactions noted as of 6/9/10 clinic just wanted to notify CDC of incident.
On 5/7/21 noted slight swelling on left arm, below injection site tender to touch, redness and rashy area. Warm cloth applied. Resolved on 5/11/21.
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Twinrix, which led to expired vaccine used.  The reporter consented to follow up. This case had been linked with case US2021247319, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021247319:Same reporter
tightness in right leg; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (tightness in right leg) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced LIMB DISCOMFORT (tightness in right leg). At the time of the report, LIMB DISCOMFORT (tightness in right leg) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Headache, "sea sick" feeling when changing positions, moving head. Home measures. Call office if not feeling better in next 24 hours.
Per mom, patient experienced tight chest, rash on site of injection. Was seen at urgent care and prescribed Epipen, Prednisone, steroid medications.
Redness and swelling at injection site; hives on back and chest; itching on neck and chest; Benadryl taken.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent condition, drug allergies and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # M042169 , Expiry date : 22-JUN-2018 and Lot # M042172, Expiry date:08-JUN-2018 ) (Strength, dose and route of administration were not reported) for prophylaxis, which experienced a temperature excursion between 47° Fahrenheit to 77° Fahrenheit for 30 minutes. It was unknown if there was previous temperature excursions. Data logger was not involved. There was no product quality complaint involved. No adverse effects were reported (incorrect product storage and no adverse event). This is 1 of 4 reports from the same reporter.  Sender's Comments: US-009507513-1707USA008614:
Information has been received from a medical assistant referring to a 16 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Pfizer 2nd dose, batch EL3247. Period came again, 1 week after 2nd dose. Not as heavy, but only 2 weeks into regular cycle; This is a spontaneous reported from a contactable other health care professional reported for himself in response to health Care Professional letter sent in cross reference case which included that, A 31-years-old female patient received BNT162B2 (Covid-19 Vaccine; solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration on 13Jan2021 as single dose for covid-19 immunisation. Medical history included adrenogenital syndrome on Jun2020 vitamin d deficiency on unknown date in 2019, immune system disorder from 1994 and ongoing , gluten sensitivity from 2020 and ongoing , adrenogenital syndrome from 1994 and ongoing. Concomitant medication included colecalciferol (VITAMIN D) taken for vitamin d deficiency at a dose of 4000 IU per day via orally from on unknown date in 2019, methylprednisolone acetate (MEDROL) taken for adrenogenital syndrome at a dose of 3mg per day via orally from Jun2020. Historical vaccine included on 06Jan2021 BNT162B2 (Suspect Vaccine name and or/generic Name: Pfizer; Batch/Lot # and expiration date: EV0142; Prescribed dose, units and frequency: 1 Unit;Route of administration: Intramuscular; Start date: 06Jan2021; Time at vaccination: 17:30 hh: mm) for covid-19 immunisation and experienced early, heavy period on 14Jan2021. The patient reported that period came again, 1 week after 2nd dose. not as heavy, but only 2 weeks into regular cycle. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacy intern and refers to a patient of unknown age and gender. Medical history and concomitant medications were unknown by the reporter. On 22-SEP-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L036437; expiration 18-MAY-2018) intramuscularly. An unspecified date after the vaccination, the patient experienced redness and swelling from the shoulder to the elbow on the arm where PNEUMOVAX 23 was administered. The patient also experienced the area being hot to touch. The patient sought medical attention with a doctor. The patient was treated with hydroxyzine, an EPIPEN and "possibly a steroid". The symptoms lasted for an unspecified amount of time and the outcome of the events was unknown. The pharmacy intern requested a lot check for lot L036437 of PNEUMOVAX 23. Additional information has been requested.
Severe joint pain and fever of 101.9 for first 24 hours. Severe headache.
Stiffness to back of left increased arm, not at the injection site. Symptom started at 6:00pm lasted until 7:00 or 7:30pm on 8-15-08
This spontaneous report was received from a registered nurse concerning a female patient of unknown age. On an unknown date (reported as one  unspecified patient received the vaccine about a year ago and the other unspecified patient received the vaccine about a couple of years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date (reported as recently), the patient was diagnosed with shingles after receiving ZOSTAVAX. The patient sought an unspecified medical attention. An unspecified treatment was given to the patient. It was unspecified if any lab tests were performed. On an unknown date, the patient was recovered from shingles. The relatedness for shingles was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information is not expected.
10/14/16 2-4 pm-noticed the site of injection; red circle around 2 inch diam. Warm area, no pain. No temp. Advise=keep eye on situation, may take TYLENOL if warranted.
WOOZY STOMACH; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced woozy stomach, sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, woozy stomach and sore arm was not reported. This report was non-serious.
Left arm red, swollen and warm to touch in deltoid region. Pt afebrile.
in one week after vaccination, frequent urination were found, follows with short of breath, and constantly fatigue after two weeks. With this condition for several months, I decided to see doctor, and diagnosed with pericarditis.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 14:00 as dose 1, single (Lot number: EN6199), in left arm, on 07Apr2021 at 14:00 as dose 2, single (Lot number: EB8737), in left arm and on 05Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Meperidine, reaction(s): "Known allergies: meperidine class"; Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had not received other medication in 2 weeks. Patient received of COVID 19  treatment Paxlovid from 18Jul2022 till 23Jul2022.  Follow-up attempts are completed. No further information is expected.
Patient stated that her arm is swollen (4x4 inch area) and that she has a rash.
An eleven year old male patient with no significant past medical history except for allergy to Penicillin, had received a first, right deltoid dose of Menactra on 04/Oct/2006.  The lot number and route of administration was not reported.  Approximately eight hours post-immunization, the patient developed a rash on his trunk, buttocks, thigh, ankle and a red, warm, swollen, right middle finger joint.  The patient was evaluated by a physician and diagnosed with poison ivy.  Treatment received was not reported.  The recovery status of the patient was reported as unknown. The mother requests that the responsible facility not be contacted for follow-up information.
Case number PHEH2012US024362 is an initial spontaneous report received from a pharmacist on 06 Dec 2012. This report refers to a 38-years-old male patient. He had an allergy to thiomersal. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that he had fever for three days after receiving the flu vaccine. The outcome of the event was not reported. He was further vaccinated with FLUVIRIN (batch number: not reported) on 28 Oct 2012 (see related case: PHEH2012US024660).
pt recv vax 19OCT94 & sx began afternoon 21st; taken to ER on 22nd w/t103.9, irritable, bulging fontanel, LP done; BC & spinal fluid cultures, urine c&s all neg on 3rd day; tx w/ATB & IV therapy; DC fr hosp on 25OCT94
Signs and symptoms appeared the next evening, 24 hours after receiving the shot. The area was red, swollen, hardeneded and sore. The redness improved each day and was gone after 1 week. A bruise remains one week later. No treatment was used by patient.
Mom states child has 3 inch circle of redness at site of injections left arm. States there is a bruise in the center of redness.
Felt "loopy and drunk; Face is Numb; Face is hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING DRUNK (Felt "loopy and drunk), HYPOAESTHESIA (Face is Numb) and FEELING HOT (Face is hot) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FEELING DRUNK (Felt "loopy and drunk), HYPOAESTHESIA (Face is Numb) and FEELING HOT (Face is hot). At the time of the report, FEELING DRUNK (Felt "loopy and drunk), HYPOAESTHESIA (Face is Numb) and FEELING HOT (Face is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were prolided.
Red bumps all over the body from the breast down to the pelvic bone and traviling to her back.
Vaccine administered in the late morning/early afternoon. Later in the afternoon and into the evening, patient suffered from upset stomach (gas, diarrhea). Around 2:30AM, he awoke sweating, with a fever (99.6) and chills/shivering. The fever lasted into the day. In the late morning it was 99.9. Around 6PM it was 103. He has also been experiencing a headache and soreness at the site of the injection.
I got the vaccine,  only had one mild case/suspected vaccination failure; mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles several times around right eye) and ophthalmic herpes zoster (had shingles several times on right eye).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient had shingles several times around and on his/her right eye.  The patient got the Shingles vaccine and had only one mild case since. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Patient started to show symptoms like weakness, Paramedic takes vitals Dxt 111, P63 BP 100/60, R17, ox 99, patient was in observation for 30 minutes. Vitals are taken again. BP 120/70, ox 99, P67 patient reports feeling better.
CONFUSION STATE AS CLOSED TO SUFFERING OF DEMENTIA; PAIN IN BOTH EARS; INJECTION SITE PAIN; HIGH FEVER; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight was 145 pounds, and height was 162 centimeters. The patient's past medical history included covid 19, and concurrent conditions included fibromyalgia, contrast dye allergy, kiwi allergy, raw shellfish anaphylaxis, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use.  The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 206AZIA, and  expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced confusion state as closed to suffering of dementia. On 30-APR-2021, the subject experienced injection site pain. On 30-APR-2021, the subject experienced high fever. On 30-APR-2021, the subject experienced pain in both ears. Laboratory data included: Body temperature (NR: not provided) 104 F. On 01-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 104 F, 103 F.  Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from confusion state as closed to suffering of dementia, injection site pain, high fever, and pain in both ears on 02-MAY-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
We were coming back from a trip; I got what I thought was a common cold. sinus drainage, cough. I took a home COVID-19 test that came back positive. I called my MD and had a telehealth visit, found that I was one day too late to get the Paxlovid. I was prescribed antibiotics and benzonatate to help with the cough. I cannot seem to get rid of this cough.
Patient calls to report pain in left shoulder, from shoulder to elbow since  getting the covid booster vaccine on 11/03/2021. Patient reports pain 2/10 now  but increases to 8/10 in the evenings. Pain in left shoulder with colder  temperature. Patient had a previous accident in 1995 he got L hand little finger  pinched in chain binder and Doctor had concerns he may lose his finger. Patient reports left hand little finger pain at 2/10 now. Has not taken Tylenol  regularly, he reports pain is not that severe. Advised to call back if not  improved in the next week or two.  Patient also reports on 11/05/2021 he was driving and became  disoriented to place. He states his directions were completely incorrect. This  lasted almost 30 minutes. Patient reports he had just had ears checked at Hospital. Discussed low blood sugar s/s, Patient not on any DM meds.  Patient reports 2 weeks after 2nd dose of covid vaccine. Patient developed  malaise, decreased appetite, low energy. Discussed he may have to deter from  taking any further covid vaccines/boosters. Informed him his reactions would be  documented and reported as Patient requested.
mom called to report that pt had a rxn to vax given 13MAR96;pt face & hands turned purple & has some breathing problems;temp 103-105;PMD dx rxn to DTP
No adverse event; Bivalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient).    Concomitant product use was not provided by the reporter.   No treatment information was provided.
No fever but severe chills that lasted through the night and sever aching in my joints  - it was so bad in my hips I could barely walk and in my shoulders that it hurt to hold the steering wheel
Pt recvd vax & w/in 20 minutes of inject exp numbness from fingertips up to jaw, tightness in chest, slurred speeh, chest pain, pain in lt arm & neck, difficulty in swallowing, SOB, dizziness & visual tunneling;
a19 months old female patient received a dose of Adacel insted of Daptacel vaccine, no AE; a19 months old female patient received a dose of Adacel vaccine, no AE; Initial information received on 08-Jun-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 19 months old female patient who received a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U66688A Expiry date: 30-Apr-2022) via intramuscular route in the left thigh for prophylactic vaccination on 08-Jun-2020 at 11:15am instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due wrong vaccine administered and inappropriate age at vaccine administration.  It was reported that the child had a cut on the head and has never had any vaccinations before and they wanted her to have the tetanus.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.