chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown), on 31Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: wheat" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The covid-19 treatment included pfizer paxlovid started on 23Jun2022, discontinued on 28Jun2022.  Additional information: Paxlovid rebound. Developed symptoms (mild allergy-like symptoms) on 06Jul2022; had completed course of Paxlovid on 28Jun2022. Tested positive on 07Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Following first dose, pain in arm at injection site following pain behind the knee with stiffness and hip pain radiating down left leg with slight swelling & continuing, after 2nd same issues with joint pain here & there month of May, June & July is progressed from my knee, elbows, hip ankle and toes. I'm having issues with my back, headache everyday.
pt recv vax & had a severe rxn;shoulder was red & inflamed;it extended across the chest area & was hot to touch;pt c/o pain in affected area as well;
Fever of 101, extreme fatigue, chills, muscle aches. Unexplained vaginal bleeding (just ended period 4 days prior). Have been experiencing vaginal bleeding for 2 weeks after receiving vaccine. Bleeding is brown in color. Foul odor in urine.
Headache CHILLS, FATIGUE Narrative:  Headaches, chills, fatigue, was advised  PRN otc tylenol
Patient get sick every single time she got the flu shot; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a female patient who get sick every single (illness), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who get sick every single (illness), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Three days after injection 1 I developed a server tooth ache that lasted three days.  two weeks after second shot I developed a severe toothache that has lasted five days and still persists   will be seeing a dentists on 5/02.2021. ( hopefully)  Is this a known symptom of the covid vacination.
Fever; A spontaneous report (United States) was received from a consumer concerning herself, a female patient, of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event fever.  The patient's medical history included knee surgery and was having trouble to walk. Concomitant medication use was not provided by reporter.   On an 25-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number unknown ) intramuscularly for COVID-19 infection prophylaxis.   On 25/Feb/2021, after second dose of the Moderna vaccine, the patient experienced event fever.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event fever was considered to be resolved at the time of this report.
A swollen lump appeared on patient's right arm and is still present today (a month later).
Approximately 30 hours after receiving the injection I noticed bruising on each inner thigh: two bruise streaks on my right inner thigh, and three bruise dots on my left inner thigh. I cannot think of what else might explain the bruising.  While this was my booster, it was my first time receiving Moderna. I received Pfizer for both my first and second shots back in April.
Left arm swelling; Bump at injection site; Injection site hot; Lump on back of neck; This spontaneous report was received from a pharmacist and refers to a 57-year-old female patient.  The patient's concurrent conditions included high cholesterol and breast cancer. Medical history, drug allergies or reactions were not reported. Concomitant therapies were anastrozole and rosuvastatin calcium (CRESTOR).  On 12-AUG-2023, the patient started therapy with creatine (+) galantamine hydrobromide (+) royal jelly (+) sodium phytate (ENERGIX), one time on her left arm, lot # 4JG5Y expiry date 12-AUG-2024 (dose, strength, formulation, indication, and route of administration were not provided). On 14-AUG-2023, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin (rHA)) one time, lot #W035041 (which was confirmed to be a valid lot # for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)), expiration date reported as 01-MAY-2024 but confirmed to be 24-MAY-2024, intramuscularly on her left arm (strength not provided) as prophylaxis for immigration. On 15-AUG-2023, she was vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), one time on her left arm, lot # 2CA61C1, expiry date 30-JUN-2025 (strength, formulation, indication, and route of administration were not provided).   On 19-AUG-2023, the patient experienced left arm swelling (peripheral swelling), bump at injection site and hot (vaccination site mass, vaccination site warmth), as well as a lump back of neck (neck mass), she sought medical attention and received treatment for the events. The action taken with creatine (+) galantamine hydrobromide (+) royal jelly (+) sodium phytate (ENERGIX), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not applicable. At the time of reporting, the patient was recovering from the events.  The causality between the events and creatine (+) galantamine hydrobromide (+) royal jelly (+) sodium phytate (ENERGIX), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
left arm very tender; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Mar2021 14:00 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Peaches" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "left arm very tender".  Additional information: First dose left arm very tender. There was no covid prior vaccination and the covid was not tested post vaccination. There was no other vaccine in four weeks and no other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hives on her collar bone/hives around her eyes, the hives occur mostly around her left eye, in the corner and little bit on the eyelid of that eye/hives only occur on the arm where her daughter received the BEXSERO; swelling in her right arm; This spontaneous report was received from a consumer referring to a 18-year-old female patient.  Concomitant medication and pertinent medical history were none. The patient was allergic to penicillin and cefdinir.  On 31-MAY-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in the left arm for cancer prevention (strength, dose, lot #, expiry date, and route of administration were not provided). On the same date, the patient also received meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) in the right arm for prophylaxis (strength, dose, formulation, lot #, expiry date, and route of administration were not provided).  Afterwards, on the same date, the patient experienced swelling in her right arm. Within 36 hours after receiving the vaccines, the patient developed hives on her collar bone and 24 hours after that, she developed hives around her eyes. Caller stated that the hives occur mostly around her left eye, in the corner and little bit on the eyelid of that eye. Caller stated that since then, her daughter has been experiencing these hives every 24 to 48 hours, and they pop up and then disappeared after some time before coming back again. It was also stated that the hives only occurred on the arm where the patient received the meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO). The hives were not huge, and they were small and dime-sized. The patient also only experienced the swelling in her right arm. The patient did not receive treatment for the events. Outcome of the events were not resolved.  The reporter wanted to know if hives were a common adverse reaction to the  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine. She also wanted to know if hives were considered an allergic reaction and inquired about whether or not the patient should continue the series.  The causality assessment was not reported.
administered Boostrix, the patient already had a dose; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 13-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22nd April 2023) for prophylaxis.   Previously administered products included Boostrix (had a dose back on 11th February 2020).   On 22nd September 2022, the patient received Boostrix. On 22nd September 2022, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments: The medical doctor called to inquire about how to proceed with Booster series. The physician reported that they inadvertently administered Boostrix to a patient the day before reporting. The patient already had a Boostrix dose back on 11th Feb 2020. The reporter did not consent to follow up. Additional Supportive Information: The patient received an dose of Boostrix who had already received it, which led extra dose administered.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month. On 03-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened. The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.   This case was linked to MOD-2021-402935 (Patient Link).
26jul90 pt vax hepta B. pt ex vertigo, and generalized numbness which resolved in 5 hrs. pt felt clammy but presented w/ warm and dry skin.  pt devel hives and tx w/ benadryl.
Soreness at the injection site; Pimple which is located two inches away from the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and acne.   On 24th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On 24th March 2020, 2 hrs after receiving Shingrix, the patient experienced injection site pain and pimples. On an unknown date, the outcome of the injection site pain and pimples were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pimples to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right deltoid. The patient experienced soreness at the injection site after his first dose of Shingrix. The patient also reported a pimple which was located two inches away from the injection site towards the back of the deltoid. The permission to follow up was denied. This case had been linked to the case US2020AMR053734, reported by same reporter. The outcome of the events were reported as not recovered/ not resolved in the Database however in source document, it was mentioned as recovering/resolving.
Extreme pain at injection site at time of injection. Within 2 hours vomiting and flu-like symptoms, swelling, redness at injection site.
Developed a  few blisters on legs; developed an itchy rash on right side of back--from waist to shoulder blade running diagonally toward spine; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Developed a  few blisters on legs) and RASH PRURITIC (developed an itchy rash on right side of back--from waist to shoulder blade running diagonally toward spine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 003F21A, 010M20A and 038K20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient did not have any drug allergy.  Concomitant products included SIMVASTATIN from January 2019 to 19-May-2022 for an unknown indication.   On 05-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022 at 12:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 20-May-2022, the patient experienced BLISTER (Developed a  few blisters on legs) and RASH PRURITIC (developed an itchy rash on right side of back--from waist to shoulder blade running diagonally toward spine). At the time of the report, BLISTER (Developed a  few blisters on legs) and RASH PRURITIC (developed an itchy rash on right side of back--from waist to shoulder blade running diagonally toward spine) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was in generally good health.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Reportedly, Events appeared on the first or second day of taking Paxlovid. They remains, though is not itchy, 12 days after starting Paxlovid and seven days after finishing it.  Treatment details was not reported by the reporter.  Pfizer have permission to contact them and also  have permission to contact the patient's healthcare provider about this report .  The device date was reported as 30-May-2022.
tingling/ felt in one arm/ then moved to the other; burning sensation/ felt in one arm/ then moved to the other; This case was reported by a consumer via other manufacturer and described the occurrence of tingling in a patient who received HBV (Engerix B) for prophylaxis.   On 1st February 2013, the patient received Engerix B. On an unknown date, several days after receiving Engerix B, the patient experienced tingling and burning sensation. On an unknown date, the outcome of the tingling and burning sensation were unknown.   It was unknown if the reporter considered the tingling and burning sensation to be related to Engerix B.  Additional details were provided as follows: Age at vaccination was not reported. The patient received Engerix B and several days after the injection experienced a tingling and burning sensation that was felt in one arm then moved to the other. No additional information and adverse event were provided. No product quality complaint was reported.
Patient came in nervous, before needle was removed from arm patient stated didn't feel good. Told to sit 15 min. After 1 minute patient claimed loss of vision,  dizzy, "not feel good" full body sweat. Asked to call EMT. Called EMT. Patient stated feeling better. Once EMT arrived, patient "not feel good"
Fever 99.9,  right arm very sore,  body aches,  tiredness, headache lasting about 24 hours.
This spontaneous report as received from a registered nurse refers to a 9 months and 30 days old male patient. The registered nurse reported that on 16-MAY-2013 another nurse from the practice inadvertently administered the patient a dose of PNEUMOVAX23 (lot # H012650, expiration date reported as 27-FEB-201) (dose, route, anatomical location unspecified). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
At time if waking up around 7:30 to 8 am on 3/9, started sneezing, running nose, foggy brain, red face, some minor headache but no fever. It lasted that day (3/9) but brain doggies lasted till 3/10 early afternoon
Left arm very swollen, hot to the touch, pain in whole arm, injection site hard as a rock, injection site very red, red circle around injection site. Went to ER, blood work and ultrasound done. Prescribed steroids and Claritin
Arm is tingling; My middle finger of the left hand between the middle joint looks a little blue, like a bruise; Arm is tingling; My middle finger of the left hand between the middle joint looks a little blue, like a bruise; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Mar2021 16:00 (at the age of 58-year-old) (Lot Number: ER8730; Expiration Date: 31Jul2021) as dose 2, single for COVID-19 immunization. The patient medical history was none and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Mar2021 (at the age of 58-year-old) (Lot Number: EN6203; Expiration Date: 30Jun2021) as dose 1, single for COVID-19 immunization and experienced little swelling on the arm. The patient reported that her arm was tingling; her middle finger of the left hand between the middle joint looked a little blue, like a bruise on 28Mar2021 16:00. The patient did not receive treatment for the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is excepted.
prolonged crying for approx 6 hrs inconsolable occurred from 20-26 hrs p/vax;
Case number PHHY2011US36763 is an initial report from a nurse received on 29 Apr 2011: This report refers to an 18-year old male patient. His medical history included vaccination with DTaP, OPV, MMR and HepB, peda/adol. He was given only the CYW-135 liquid component MENVEO (batch number 100005) intramuscularly on 28 Apr 2011 and was concomitantly also given DTaP on the same day. No other adverse reaction was reported. Follow up received from a physician on 09 May 2011: Updated information about patient's demographics, vaccination history, concomitant medication and date of vaccination.
mild throat swelling Narrative:  Did not seek medical attention. Mild throat swelling occurred 30mins - 4 hours after the first COVID-19 vaccine dose.
The patient came to the pharmacy for her second Covid 19 vaccination.  I administered Moderna.  It was only after the vaccination that Pfizer was administered for dose 1
Child began vomiting at 6 PM. Diarrhea began around 2:30 am, along with vomiting. Child vomited repeatedly and voided bowels at the same time. Took Child to ER around 10:30 am 12/05/2013. Was given anti nausea medication and sent home. 2 hours later Child then began to have severe leg pain and swelling. Returning to the ER at 2:30pm 12/05/2013.