chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nauseated; very weak; very dry throat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 12:00 (Lot number: Ft hood) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 07Apr2021 06:00, outcome "recovering", described as "nauseated"; ASTHENIA (non-serious) with onset 07Apr2021 06:00, outcome "recovering", described as "very weak"; DRY THROAT (non-serious) with onset 07Apr2021 06:00, outcome "recovering", described as "very dry throat". Therapeutic measures were not taken as a result of nausea, asthenia, dry throat.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
pt recvd vax AUG92 & pt noted that was pregnant; pt elected to have a therapeutic abortion & recovered from the exp;
Woke up 4/11/07 with 102 fever, body aches and redness, induration at site right deltoid and shoulder. Resolved after approx. 12 hours.
I had my first dose 03/31/2021 and the second dose on 05/05/2021. I am post-menopausal and have not menstruated since September 2018. Approximately 3 weeks after the second dose (at the end of May 2021), I had mild cramps and felt like I may have ovulated.  About 2 weeks after that on 06/10/2021 I started to have a period. It lasted about 4 days and was mostly a medium flow (and some light flow). My ob-gyn did tests (see below) but I did not discuss this as an adverse reaction with her. I read an article today that mentioned some women are having unusual menstrual symptoms after the vaccine and wanted to report it just in case.
Pt developed temp to 103 (R);  T would not come down, taken to ER, CXR was taken has pneumonia,Adenopathy local inject site area generalized.
Information has been received from the neighbor of an estimated 13 year old female patient, who was enrolled in a market research. On an unknown date the patient was vaccinated with GARDASIL (lot#, dosage and route unspecified). The reporter heard 3rd hand that the patient had seizure the day after getting GARDASIL in 2016. The patient was hospitalized the neighbor of an estimated 13 year old released on an unspecified date in 2016. The reporter believed there were no lasting effects. The reporter considered seizure to be related to GARDASIL. Upon internal review, seizure was considered to be medically significant. Additional information is not expected as the reporter did not want to be contacted.
Day after shot, large area around where shot was give became red, swollen, warm and tender.  Area continued to enlarge thru 3 days post shot (which is today).
p/vax pt noticed red spot around the inj site the size of silver dollar it was hot to touch & swollen;called ER MD;took DPH;
Patient hospitalized with Covid-19 on 2/21/22 even though she is fully vaccinated.
Patient developed insomnia, chills, hot flashes, and queasiness a bit after midnight the day after vaccination. Patient contacted their personal physician to seek medical advice on 02/10/2021 at 0745.  According to the patient, the physician indicated that the reaction was not serious but that the patient should call again or go into the hospital if symptoms worsen.
Initial report was received 24 January 2013 from a pharmacy employee. Case not medically confirmed. A 58 year old female patient (age also reported as 57 years) had received a left deltoid dose of FLUZONE ID (lot number UT4471BA) on 21 January 2013, and 3 days later on 24 January 2013 the pharmacist received a call from the MD who reported the patient had cellulitis at the insertion site (vaccination site). The event required medical evaluation. Outcome was not recovered. Documents held by sender: None.
Noted throbbing pain within 2 hours of vaccine administration. Within about 12 hours had pain in neck and LUE with swollen lymph nodes in neck and arm pit. Seen in ED 10/10/2020 AM and treated for inflammatory response vs  possible cellulitis with Keflex. Traveled and hospitalized 10/12/2020- 10/14/2020.  Received multiple different antibiotics, but Vancomycin IV for 4 days seemed to be the most effective. (Also received prednisone.) Discharged on Cipro and linezolid. Drove back home. Seen at ED 10/16/20 and again given Vancomycin IV. Then followed up in dermatology clinic 10/20/2020: Assessment: "Favor injection site reaction" as opposed to infection.
9/27/13 influenza, pneumonia vaccines given. 9/29 pt c/o pain (L) deltoid, redness, tender x 1 day. Diagnosis of cellulitis. KEFLEX started. 10/2/13 continues to improve.
This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 61-year-old male patient who received SHINGRIX (batch number XC534, expiry date May 2019). Concomitant products included Atorvastatin, diclofenac sodium, esomeprazole, Hydroxyzine, Levothyroxine, Loperamide, FOLBIC Tablet, LYRICA and metaxalone. On 4th May 2018, the patient received SHINGRIX (subcutaneous) .5 ml. On 4th May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In May 2018, the patient experienced joint pain and pain in arm. In May 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the joint pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the joint pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated that the SHINGRIX vaccine was administered to the patient at their pharmacy and he did not give the vaccine to the patient. The patient received the SHINGRIX via subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. Less than a month after vaccination, the patient complained about pain from the side administrations from the triceps all the way down to his forearm for 8 to 9 days. The patient also complained about elbow joint pain. The reporter provided batch number as 5/2019 however, said that this was probably incorrectly put in by the computer.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling and redness around the injection site on her arm) and VACCINATION SITE ERYTHEMA (Swelling and redness around the injection site on her arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol total abnormal NOS. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling and redness around the injection site on her arm) and VACCINATION SITE ERYTHEMA (Swelling and redness around the injection site on her arm). At the time of the report, VACCINATION SITE SWELLING (Swelling and redness around the injection site on her arm) and VACCINATION SITE ERYTHEMA (Swelling and redness around the injection site on her arm) outcome was unknown.            Other concomitant medication included cholesterol medication.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.
bad headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (bad headache) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose-1, Lot#028L20A) on 21-Jan-2021, Moderna COVID-19 Vaccine (Dose-2, 022M20A) on 18-Aug-2021, Moderna COVID-19 Vaccine (Dose-3, Lot#077C21B) on 29-Oct-2021, Moderna COVID-19 Vaccine (Dose-4 (Booster dose), Lot#056A22A) on 06-Apr-2022, Moderna COVID-19 Vaccine (Dose-5 and Lot#AS7145B) on 12-Sep-2022; for Drug use for unknown indication: CoQ10, Calcium with D3, Probiotic gummies, pantoprazole, famotidine, levothyroxine, B12 gummies (B12 gummies), Lisinopril and amlodipine. Past adverse reactions to the above products included No adverse event with B12 gummies, Calcium with D3, CoQ10, Lisinopril, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Probiotic gummies, amlodipine, famotidine, levothyroxine and pantoprazole. Concurrent medical conditions included Seasonal allergy and Drug allergy (Sulfa).    On 20-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 21-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HEADACHE (bad headache). At the time of the report, HEADACHE (bad headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient did not received any other vaccines in 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was also reported that patient would like to know it it was okay to take ibuprofen or tylenol. Treatment details was not reported by the reporter.
Awake from nap, crying unconsolably w/high pitched cry for about 45min; Cried so hard blood vessel burst in eye; Given APAP & placed in tepid water; MD will give DT;
Information was received 11-JUL-2017 via a phone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 (Lot number M042853, expiration 17-JUL-2019) was administered to a patient on 03-JUL-2017 (age and gender not provided; only the initials of the patient were provided). The GARDASIL 9 had been stored in at 32 to 35 degrees Fahrenheit for 2 hours and 30 minutes. There had been a previous temperature excursion of 32 to 35 degrees Fahrenheit for 15 minutes. The registered nurse had reported this due to a data logger. No adverse effects were reported. No further information was provided. Additional information was requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-AUG-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Thursday, May 13 around 6:30pm, arm started to hurt as well as my back muscles. Continued to hurt throughout my body, had low grade fever of 100, chills, restlessness in my legs, congestion and sinus issues that muffled my hearing temporarily. All these symptoms continued nonstop until Friday, May 14 around 11:00pm. I still am sore and swollen around injection site.
Dizziness, Headache, Arthralgia, Fever, CoughWheeze, Diarrhea, sore throat, chills, injection site pain Narrative:
the patient had a 103 degree fever.; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for immunisation; hpv vaccine vlp rl1 4v (yeast) (GARDASIL; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The doctor reported that there was an increased adverse reactions when coadministering Trumenba with Guardasil. In one case, the patient had a 103 degree fever on an unspecified date. Event took place after the use of product. The patient underwent lab tests and procedures which included fever: 103 Fahrenheit on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Seen in Primary Care Clinic 4-12-2008.  Complained of right deltoid with raised red area since recurring vaccine injections 4-10-2008.  Treatment: warm moist packs alternating with cool pack at site.  Ibuprofen as directed every 6 hours or PMD.
It was reported to this writer that the guest reported feeling some chest tightness and reveled that she was newly diagnosed with asthma. She also stated that she did not have her inhaler nor had any food or drink yet today. Guest declined any medical attention on first assessment. Guest declined to be seen by Medics. Guest stated that she just needed to go home and use her inhaler. Guest in no respiratory distress. Guest left accompanied by friend.
Presented on 10/29/09 to Medical Center with c/o difficulty walking sensory changes.   11/23/09 Discharge summary, hospital records received, service dates 10/29/09 to 11/10/09. Assessment: Miller Fischer Varient. Patient presents with blurry vision, lightheadedness, dizziness. Sore throat. Slurred speech, difficulty with gait and handwriting. Double vision. Dysarthria, (L) lateral rectus palsy, hyporeflexia lower extremities.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Rash swelling local pain
6/10/21, began experience LUE pain/weakness. Found to have left brachial artery thrombus and aortic arch atheroma. Placed on Heparin drip initially, transitioned to Bivalrudin gtt, then now on Eliquis. Hypercoagulable work-up overall unremarkable.
Had COVID ARM immediately. It lasted one week. Second, more serious reaction occurred, unexpectedly, on August 6, 2022, it resulted in pleurisy in both lungs, with possible arteroseptal infarction, or myocardial infarction.
3 or 4 Days after vaccination, Pt noticed raised itchy rash on (L) arm where injection was given. Pt states it is itchy still on 5-18. Pt picked up some Hydrocortisone 1% cream to apply QID. Also, suggested Benadryl PO if it is excessively itchy.
Anaphylaxis; Difficulty breathing; Wheezing, coughing; Vomiting; Collapsing or losing consciousness.
Arm got hot, itchy and hard lump, redness up to shoulder 3" diameter.
pt recvd vax;devl hives,swollen eyes;tx w/atarax;next day,rash,tx w/decadron;spleen enlarged,exp severe stiffnessd/joint pain;erythrocyte sedimentation rate elev;sore throat;lyme titer test result=295 ABR(wkly reactive)dx serum sickness;
mild adverse reaction / mild fever; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The case was reported by the patient. The patient had received 1st doses of the Shingrix vaccine recently. Upon receiving the 1st dose, the patient had an adverse reaction that was mild fever in that evening. After doing some reading online, before receiving 2nd dose took some Aleve and Tylenol, wondering whether sabotaged the efficacy of the 2nd dose.
reported that the eczema keeps getting worse; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Patient received the second dose of the Moderna vaccine on 30March2021/ reported that the eczema keeps getting worse) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Patient received the second dose of the Moderna vaccine on 30March2021/ reported that the eczema keeps getting worse). At the time of the report, ECZEMA (Patient received the second dose of the Moderna vaccine on 30March2021/ reported that the eczema keeps getting worse) had not resolved.            The patient stated that about  3 months ago , her dermatologist that she had been seeing her prescribing a steroid cream. Concomitant drug information does not provided.   This case was linked to MOD-2021-318836 (Patient Link).
moderate supraclavicular lymph node sweeping and lymphadenopathy behind left ear and armpit on left side; This is spontaneous report from a contactable nurse (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left arm), on 06Jan2021 at 15:45, at a single dose, for COVID-19 immunization. The patient has no relevant medical history, no known allergies, and was not taking concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ek5730) intramuscular in the right arm on 16Dec2020 at 18:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 05Jan2021, at 16:30, the patient experienced moderate supraclavicular lymph node sweeping and lymphadenopathy behind left ear and armpit on left side. It was unknown if the patient received treatment for the events. Outcome of the events was not recovered.
Fever 101.1, unresponsive episode.  Transferred to Hospital on 1/28. Diagnosis there was anemia and CHF, aware that he had vaccine day prior. Transfused with 2 units pRBC's. Transferred back to Nursing Home on 1/30 and passed away 0140 1/31/2021
12mins post vaccination pt states she feels dizzy and lightheaded and "spaced out".  Vitals WNL.  No remarkable findings on assessment. Vitals: 130/82, 80, 19, 99% Pt stable and released from the vaccination site.
Wife called and reported patient sick in bed, weak, low grade fever,  acting confused and delirious.
Onset of erythema multiforme dx 6/6/07 No other source for infection found; only med-Tylenol x 1 dose on evening of vaccination.
Spoke w/ pt Pain 8/10. Received vaccine around 11:30am. Pt went home, took a nap for about 30 minutes, and when pt woke up, pt saw swelling in shoulder. Size of about finger length. Pain is now radiating towards the neck. Denies redness or streaking. Denies fever although pt does not know her temp (states "I don't think so" when asked). Denies chest pain, SOB. Advised ok to go to the ER tonight if pt unable to tolerate pain. Scheduled appt tomorrow.  On 6/27/17 Left Deltoid with large area of erythema,warm to touch,no swelling,but tender to light touch. States pain radiates down arm. Start Cyclobenzaprine HCl Tablet, 5 MG, 1 tablet as needed, Orally, Three times a day, 5 days, 15 Tablet, Refills 0. Start Ibuprofen Tablet, 800 MG, as directed, Orally, twice a day, 5 days, 10, Refills 0. Clinical Notes: Localized vaccine reaction clear, but pain d/t reaction seems to be a rare reaction. Suspect it's related to either muscle spasms or nerve impingement d/t inflammatory response.
arm itchy and sore; arm itchy and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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: PRURITUS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "arm itchy and sore".  Additional information: Received call from consumer who provided her middle initial as (Withheld). While reporting for herself, she mentioned that everyone has itchiness and soreness. She did not have anyone specific to report on except two ladies that live in the same senior community.  They had an itchy arm and soreness.  Other than that, they were fine and did not have any lethargy, sore throat and did not have the feeling that they were not going to be able to make it that she had.  She did not wish to complete a report for them. This report was not related to a study or programme. Reporter seriousness for arm itchy and sore was unspecified. This report was to capture information for the first lady.  No further details provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (26Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Severe local rxn. Erythemic/indurated area ivo. vaccine site, 15cm x 15cm. Pt on shot #6 of anthrax.
Seizure activity-Was found in bathroom with vomitus and seizure-like activity noted. Was cyanotic and noted with tonic/clonic activity, grinding of the teeth. After cessation of seizure activity, was agitated, disoriented and confused.
TD after immunization, swelling, redness, warmth at site that progressed to include entire ant thigh over 24 hours. TX on day 2 started with po Cephalexin.
I am still experiencing pain at the injection site from when I received the vaccine. I have been experiencing heart palpitations that have been waking me up in the morning as well. I'm not sure if it's from the vaccine, or the nasal spray that I have had an allergic reaction to. My stomach still seems off. I'm not feeling right. I saw Dr. about my allergies and allergic reaction.
3 welts on left upper arm below the injection site. welt #1 3.5cmx 4cm, welt #2 2cm x2cm, welt 3 3cm x 4 cm. Small amount of soreness.